Risk management plans as a tool for proactive pharmacovigilance

DEFF Research Database (Denmark)

Vermeer, N S; Duijnhoven, R G; Straus, S M J M

2014-01-01

Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which...... of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning....

Advances in pharmacovigilance initiatives surrounding antimicrobial resistance-Indian perspective.

Science.gov (United States)

Bairy, Laxminarayana Kurady; Nayak, Veena; A, Avinash; Kunder, Sushil Kiran

2016-08-01

In recent years the development of antimicrobial resistance has been accelerating, the discovery of new antimicrobial agents has slowed substantially in past decades. This review mainly focuses on the problem of antimicrobial resistance(AMR); the various contributor mechanisms, consequences and future of AMR. The review also highlights the irrational use of antimicrobials, improving their usage and problems associated with pharmacovigilance of antimicrobial resistance. Pharmacovigilance in the form of surveillance of antibiotic use is being done in 90% of the countries worldwide through the WHONET program developed by WHO. However, the data comes from a limited area of the globe. Data from every part of the world is required, so that there is geographical representation of every region. A major hurdle in quantifying the extent of antimicrobial resistance is the fact that there are several known microbes, that may turn out to be resistant to one or more of the several known antimicrobial agents. The global action plan initiated by WHO, if implemented successfully will definitely reduce AMR and will help in evaluating treatment interventions.

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Science.gov (United States)

Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-10-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

Science.gov (United States)

Kunac, Desireé L; Tatley, Michael V

2011-01-01

Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and

Patient-Reported Safety Information : A Renaissance of Pharmacovigilance?

NARCIS (Netherlands)

Härmark, Linda; Raine, June; Leufkens, Bert|info:eu-repo/dai/nl/075255049; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-01-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years

Pharmacovigilance in China: current situation, successes and challenges.

Science.gov (United States)

Zhang, Li; Wong, Lisa Y L; He, Ying; Wong, Ian C K

2014-10-01

With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.

Pharmacovigilance in developing countries (part I): importance and challenges.

Science.gov (United States)

Elshafie, Shaimaa; Zaghloul, Iman; Roberti, Anne Marie

2017-12-16

The thalidomide disaster was the significant historical event that acted as a catalyst for pharmacovigilance activity. Following this event developed countries initiated drug monitoring systems that evolved and now extend their scope to broader drug-related safety issues; however, this was not the case in developing countries. Pharmacovigilance is still a relatively new concept with low priority in developing countries although various issues are raising concerns that magnify the need for systems to monitor post marketing drug safety in these countries. This article analyzes the barriers to introducing robust pharmacovigilance systems in developing countries.

Social media and pharmacovigilance: A review of the opportunities and challenges.

Science.gov (United States)

Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

2015-10-01

Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. © 2015 The British Pharmacological Society.

[Pharmacovigilance of major parmaceutical innovation].

Science.gov (United States)

Xiang, Yongyang; Xie, Yanming; Yi, Danhui

2011-10-01

With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.

A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

Science.gov (United States)

Aljadhey, Hisham; Mahmoud, Mansour A; Alshammari, Thamir M; Al-Dhaeefi, Mohammed; Le Louet, Herve; Perez-Gutthann, Susana; Pitts, Peter J

2015-09-01

To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

[Pharmacovigilance center --internal medicine interactions: A useful diagnostic tool].

Science.gov (United States)

Rochoy, M; Gautier, S; Bordet, R; Caron, J; Launay, D; Hachulla, E; Hatron, P-Y; Lambert, M

2015-08-01

Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect. This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression. We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]). In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value. Copyright © 2015 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.

Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.

Science.gov (United States)

Santoro, Aniello; Genov, Georgy; Spooner, Almath; Raine, June; Arlett, Peter

2017-10-01

This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation.

Science.gov (United States)

Agoro, Oscar O; Kibira, Sarah W; Freeman, Jenny V; Fraser, Hamish S F

2018-06-01

Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya. The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system. Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives. While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.

A global view of undergraduate education in pharmacovigilance.

Science.gov (United States)

Hartman, Jenny; Härmark, Linda; van Puijenbroek, Eugène

2017-07-01

The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants. The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula. This study gave a good general impression in current educational activities and the respondents' needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.

Utilizing social media data for pharmacovigilance: A review.

Science.gov (United States)

Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O'Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

2015-04-01

Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. We identified studies describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to extract ADR information posted by users on any publicly available social media platform. We categorized the studies according to different characteristics such as primary ADR detection approach, size of corpus, data source(s), availability, and evaluation criteria. Twenty-two studies met our inclusion criteria, with fifteen (68%) published within the last two years. However, publicly available annotated data is still scarce, and we found only six studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been the most popular. Our review suggests that interest in the utilization of the vast amounts of available social media data for ADR monitoring is increasing. In terms of sources, both health

Utilizing Social Media Data for Pharmacovigilance: A Review

Science.gov (United States)

Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O’Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

2015-01-01

Objective Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. Methods We identified studies, describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to utilize ADR information posted by users on any publicly available social media platform. We categorized the studies into various dimensions such as primary ADR detection approach, size of data, source(s), availability, evaluation criteria, and so on. Results Twenty-two studies met our inclusion criteria, with fifteen (68.2%) published within the last two years. The survey revealed a clear trend towards the usage of annotated data with eleven of the fifteen (73.3%) studies published in the last two years relying on expert annotations. However, publicly available annotated data is still scarce, and we found only six (27.3%) studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been

Pharmacovigilance: the devastating consequences of not thinking ...

African Journals Online (AJOL)

Pharmacovigilance: the devastating consequences of not thinking about adverse drug reactions: The burden of adverse drug reactions (ADRs) on patient care has been found to be high globally and is particularly high in South Africa.

75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

Science.gov (United States)

2010-10-22

...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

Science.gov (United States)

Endrikat, J; Schwenke, C; Prince, M R

2015-07-01

To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals.

Science.gov (United States)

Stergachis, Andy; Bartlein, Rebecca J K; Dodoo, Alexander; Nwokike, Jude; Kachur, S Patrick

2010-05-30

Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests. The Global Fund-Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund-Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan. Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities. There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active

Modern Approaches to Continuous Audit in the Pharmacovigilance System Vinnytsia region: the Results of 2016

Directory of Open Access Journals (Sweden)

Fedir Hladkykh

2017-12-01

Full Text Available The results of the pharmacovigilance system operation in Vinnytsia region during 2016 are presented based on the data of the electronic online system "Pharmacovigilance-2016", which was first introduced by us on the basis of the table editor Microsoft Excel of the file-hosting system Google Drive. The formula for calculating the efficiency of the pharmacovigilance implementation as an integral assessment of the safety oversight of medical devices in their use in Vinnytsia region during 2016 is proposed, taking into account the capacity of health facilities at the local level.

Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood ...

African Journals Online (AJOL)

... possible link between the constituents of the slimming tea and increased blood pressure and also provide evidence of other possible harmful effects that may occur with the use of the slimming tea. Keywords: Pharmacovigilance, hypertension, slimming tea. West African Journal of Pharmacology and Drug Research Vol.

Are we pharmacovigilant enough in ophthalmic practice?

Directory of Open Access Journals (Sweden)

Ashok Dubey

2013-01-01

Full Text Available No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

Vaccine Pharmacovigilance: Adverse Effects Reported and the ...

African Journals Online (AJOL)

Routine utilization of vaccines during immunization in children is a tool in the reduction of childhood morbidity and mortality of infectious disease globally. This requires pharmacovigilance to ensure safety among the category of patients. Due to the exposure of new born to vaccine at birth, it became necessary to assess the ...

Sequence symmetry analysis in pharmacovigilance and pharmacoepidemiologic studies

DEFF Research Database (Denmark)

Lai, Edward Chia Cheng; Pratt, Nicole; Hsieh, Cheng Yang

2017-01-01

Sequence symmetry analysis (SSA) is a method for detecting adverse drug events by utilizing computerized claims data. The method has been increasingly used to investigate safety concerns of medications and as a pharmacovigilance tool to identify unsuspected side effects. Validation studies have i...

The importance of intra-hospital pharmacovigilance in the detection of medication errors

Science.gov (United States)

Villegas, Francisco; Figueroa-Montero, David; Barbero-Becerra, Varenka; Juárez-Hernández, Eva; Uribe, Misael; Chávez-Tapia, Norberto; González-Chon, Octavio

2018-01-01

Hospitalized patients are susceptible to medication errors, which represent between the fourth and the sixth cause of death. The department of intra-hospital pharmacovigilance intervenes in the entire process of medication with the purpose to prevent, repair and assess damages. To analyze medication errors reported by Mexican Fundación Clínica Médica Sur pharmacovigilance system and their impact on patients. Prospective study carried out from 2012 to 2015, where medication prescriptions given to patients were recorded. Owing to heterogeneity, data were described as absolute numbers in a logarithmic scale. 292 932 prescriptions of 56 368 patients were analyzed, and 8.9% of medication errors were identified. The treating physician was responsible of 83.32% of medication errors, residents of 6.71% and interns of 0.09%. No error caused permanent damage or death. This is the pharmacovigilance study with the largest sample size reported. Copyright: © 2018 SecretarÍa de Salud.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

International Nuclear Information System (INIS)

Endrikat, J.; Schwenke, C.; Prince, M.R.

2015-01-01

Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

Pharmacovigilance in Crisis: Drug Safety at a Crossroads.

Science.gov (United States)

Price, John

2018-05-01

Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers. The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine-learning to automate pharmacovigilance operations. These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs. Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.

Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

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Sorbello, Alfred; Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

2017-03-22

We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. All usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

From Pharmacovigilance to Clinical Care Optimization.

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Celi, Leo Anthony; Moseley, Edward; Moses, Christopher; Ryan, Padhraig; Somai, Melek; Stone, David; Tang, Kai-Ou

2014-09-01

In order to ensure the continued, safe administration of pharmaceuticals, particularly those agents that have been recently introduced into the market, there is a need for improved surveillance after product release. This is particularly so because drugs are used by a variety of patients whose particular characteristics may not have been fully captured in the original market approval studies. Even well-conducted, randomized controlled trials are likely to have excluded a large proportion of individuals because of any number of issues. The digitization of medical care, which yields rich and accessible drug data amenable to analytic techniques, provides an opportunity to capture the required information via observational studies. We propose the development of an open, accessible database containing properly de-identified data, to provide the substrate for the required improvement in pharmacovigilance. A range of stakeholders could use this to identify delayed and low-frequency adverse events. Moreover, its power as a research tool could extend to the detection of complex interactions, potential novel uses, and subtle subpopulation effects. This far-reaching potential is demonstrated by our experience with the open Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) intensive care unit database. The new database could also inform the development of objective, robust clinical practice guidelines. Careful systematization and deliberate standardization of a fully digitized pharmacovigilance process is likely to save both time and resources for healthcare in general.

Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review.

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Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Jeblee, Serena; Warren, Rachel; Khan, Paul A; Robson, Reid; Pham, Ba'; Hirst, Graeme; Straus, Sharon E

2018-06-14

A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products. Our specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016. Any type of document (e.g., manuscripts, reports) that described the use of social media data for detecting health product AEs was included. Two reviewers independently screened citations and full-texts, and one reviewer and one verifier performed data abstraction. Descriptive synthesis was conducted. After screening 3631 citations and 321 full-texts, 70 unique documents with 7 companion reports available from 2001 to 2016 were included. Forty-six documents (66%) described an automated or semi-automated information extraction system to detect health product AEs from social media conversations (in the developmental phase). Seven pre-existing information extraction systems to mine social media data were identified in eight documents. Nineteen documents compared AEs reported in social media data with validated data and found consistent AE discovery in all except two documents. None of the documents reported the validity and reliability of the overall system, but some reported on the performance of individual steps in processing the data. The validity and reliability results were found for the following steps in the data processing pipeline: data de-identification (n = 1), concept identification (n = 3), concept normalization (n = 2), and relation extraction (n = 8). The methods varied widely, and some approaches yielded better results than others. Our results suggest that the use of

Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia.

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Alshammari, Thamir M; Alamri, Khaled K; Ghawa, Yazeed A; Alohali, Noura F; Abualkol, Shaza A; Aljadhey, Hisham S

2015-12-01

Drug safety has major implications for patients' lives. However, this concept is still considered new to some healthcare professionals. This study aims to investigate the knowledge and awareness of Saudi healthcare professionals to pharmacovigilance (PV). Setting Governmental and private hospitals at three main cities in Saudi Arabia (Riyadh, Jeddah, and Dammam). A cross-sectional survey among healthcare professionals (pharmacists, physicians, and nurses) within 12 Saudi hospitals was conducted between November and December 2012. The questionnaire consisted of 18 questions assessing the knowledge, awareness, and attitude of healthcare professionals (HCPs) towards science and the concept of PV. Descriptive statistics were used to analyze the data. The data were analyzed using Statistical Analysis Software (SAS 9.3). Main outcome measure Knowledge, attitude and practice of HCPs toward pharmacovigilance. Three-hundred and thirty-two healthcare professionals completed the survey (response rate 72 %), 110 (34 %) physicians, 106 (33 %) pharmacists, and 104 (32 %) nurses. More than half of the participants (55 %) did not know the correct definition of PV. Two-thirds of the respondents, 207 (65.5 %), had knowledge of the aim of post-marketing surveillance, yet only 113 (36.9 %) were aware that the National Pharmacovigilance and Drug Safety Center is the official body for monitoring adverse drug reaction in Saudi Arabia. In addition, 34.7 % agreed that lack of time could be a major barrier for reporting. The majority of the respondents (78.4 %) believed that reporting was a professional obligation and hospitals should have a drug safety department. There was a limited knowledge of pharmacovigilance that could have affected reporting incidence. Educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacovigilance and drug safety culture in Saudi Arabia.

Pharmacovigilance Mobile Tool Design in the Field of Arhroplasty.

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Åserød, Hanne; Babic, Ankica

2017-01-01

Pharmacovigilance is an important part of the patient safety and it has a great appeal to physicians. It is concerned with the safety of medical devices and treatments in the light of understanding the risks and dangers based on the already reported safety issues. Internet resources such as the Manufacturer And User Facility Device Experience (MAUDE) web-site are often retrieved due to the lack of internal, local safety databases. The research looked at how Human Computer Interaction could improve user experience. We have designed data entry for safety reporting and pharmacovigilance based on the web-bases system called WebBISS (Web-based implant search system). The expectation is not only to improve usability, but also to stimulate physicians to enter their safety data and become also contributors, and not only users of information. The expert evaluation has been generally positive and encouraged stronger help and error reporting functions. The high fidelity design has given a good impression of the future mobile solution.

Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

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Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

2015-04-01

Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.

The EU-ADR Web Platform: delivering advanced pharmacovigilance tools.

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Oliveira, José Luis; Lopes, Pedro; Nunes, Tiago; Campos, David; Boyer, Scott; Ahlberg, Ernst; van Mulligen, Erik M; Kors, Jan A; Singh, Bharat; Furlong, Laura I; Sanz, Ferran; Bauer-Mehren, Anna; Carrascosa, Maria C; Mestres, Jordi; Avillach, Paul; Diallo, Gayo; Díaz Acedo, Carlos; van der Lei, Johan

2013-05-01

Pharmacovigilance methods have advanced greatly during the last decades, making post-market drug assessment an essential drug evaluation component. These methods mainly rely on the use of spontaneous reporting systems and health information databases to collect expertise from huge amounts of real-world reports. The EU-ADR Web Platform was built to further facilitate accessing, monitoring and exploring these data, enabling an in-depth analysis of adverse drug reactions risks. The EU-ADR Web Platform exploits the wealth of data collected within a large-scale European initiative, the EU-ADR project. Millions of electronic health records, provided by national health agencies, are mined for specific drug events, which are correlated with literature, protein and pathway data, resulting in a rich drug-event dataset. Next, advanced distributed computing methods are tailored to coordinate the execution of data-mining and statistical analysis tasks. This permits obtaining a ranked drug-event list, removing spurious entries and highlighting relationships with high risk potential. The EU-ADR Web Platform is an open workspace for the integrated analysis of pharmacovigilance datasets. Using this software, researchers can access a variety of tools provided by distinct partners in a single centralized environment. Besides performing standalone drug-event assessments, they can also control the pipeline for an improved batch analysis of custom datasets. Drug-event pairs can be substantiated and statistically analysed within the platform's innovative working environment. A pioneering workspace that helps in explaining the biological path of adverse drug reactions was developed within the EU-ADR project consortium. This tool, targeted at the pharmacovigilance community, is available online at https://bioinformatics.ua.pt/euadr/. Copyright © 2012 John Wiley & Sons, Ltd.

Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

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Edwards, Brian

2004-01-01

The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

Pharmacovigilance training for specialist oncology nurses-a two way evaluation

NARCIS (Netherlands)

Schutte, T.; Van Eekeren, R.; Richir, M.; Van Staveren, J.; Van Puijenbroek, E.P.; Tichelaar, J.; Van Agtmael, M.A.

2017-01-01

Background: In a new prescribing qualifcation course for specialist oncology nurses, we thought it important to emphasize pharma-covigilance and adverse drug reaction (ADR)-reporting. To this end, our aim was to develop and evaluate an ADR reporting assignment for specialist oncology nurses.

Pharmacoenvironmentology – a component of pharmacovigilance

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Gupta Varun

2007-07-01

Full Text Available Abstract According to WHO, Pharmacovigilance activities are done to monitor detection, assessment, understanding and prevention of any obnoxious adverse reactions to drugs at therapeutic concentration on animal and human beings. However, there is also a growing focus among scientists and environmentalists about the impact of drugs on environment and surroundings. The existing term 'Ecopharmacology' is too broad and not even defined in a clear manner. The term 'Pharmacoenvironmentology' seeks to deal with the environmental impact of drugs given to humans and animals at therapeutic doses.

Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

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van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

2003-01-01

The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

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Marília Berlofa Visacri

2014-04-01

Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

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Francesca Scicchitano

2012-01-01

Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.

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Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2012-09-01

Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested). Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

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Elham Azhdari

2013-02-01

Full Text Available Background: Following establishment of Iranian Adverse Drug Reaction (ADR Monitoring Center in 1997, ADR committees were established in all hospitals of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists. Methods: This study included Yellow Cards filled out by healthcare providers in Mazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs, route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs (4.8% were related to 2004-2007. Most of the reports generated by Nurses (49.3% followed by Pharmacists and Physicians (P Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under-reporting is still a major drawback of spontaneous reporting. Keywords: Pharmacovigilance, Adverse Drug Reaction, Mazandaran, Adverse Drug Reaction Reporting Systems

Early detection of pharmacovigilance signals with automated methods based on false discovery rates: a comparative study.

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Ahmed, Ismaïl; Thiessard, Frantz; Miremont-Salamé, Ghada; Haramburu, Françoise; Kreft-Jais, Carmen; Bégaud, Bernard; Tubert-Bitter, Pascale

2012-06-01

Improving the detection of drug safety signals has led several pharmacovigilance regulatory agencies to incorporate automated quantitative methods into their spontaneous reporting management systems. The three largest worldwide pharmacovigilance databases are routinely screened by the lower bound of the 95% confidence interval of proportional reporting ratio (PRR₀₂.₅), the 2.5% quantile of the Information Component (IC₀₂.₅) or the 5% quantile of the Gamma Poisson Shrinker (GPS₀₅). More recently, Bayesian and non-Bayesian False Discovery Rate (FDR)-based methods were proposed that address the arbitrariness of thresholds and allow for a built-in estimate of the FDR. These methods were also shown through simulation studies to be interesting alternatives to the currently used methods. The objective of this work was twofold. Based on an extensive retrospective study, we compared PRR₀₂.₅, GPS₀₅ and IC₀₂.₅ with two FDR-based methods derived from the Fisher's exact test and the GPS model (GPS(pH0) [posterior probability of the null hypothesis H₀ calculated from the Gamma Poisson Shrinker model]). Secondly, restricting the analysis to GPS(pH0), we aimed to evaluate the added value of using automated signal detection tools compared with 'traditional' methods, i.e. non-automated surveillance operated by pharmacovigilance experts. The analysis was performed sequentially, i.e. every month, and retrospectively on the whole French pharmacovigilance database over the period 1 January 1996-1 July 2002. Evaluation was based on a list of 243 reference signals (RSs) corresponding to investigations launched by the French Pharmacovigilance Technical Committee (PhVTC) during the same period. The comparison of detection methods was made on the basis of the number of RSs detected as well as the time to detection. Results comparing the five automated quantitative methods were in favour of GPS(pH0) in terms of both number of detections of true signals and

Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER) supplement. Magnet system special investigations

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1981-01-01

The results of magnet system special investigations listed below are summarized: 4 Tesla Magnet Alternate Design Study; 6 Tesla Magnet Manufacturability Study. The conceptual design for a 4 Tesla superconducting magnet system for use with an alternate (supersonic) ETF power train is described, and estimated schedule and cost are identified. The magnet design is scaled from the ETF 6 T Tesla design. Results of a manufacturability study and a revised schedule and cost estimate for the ETF 6 T magnet are reported. Both investigations are extensions of the conceptual design of a 6 T magnet system performed earlier as a part of the overall MED-ETF conceptual design described in Conceptual Design Engineering Report (CDER) Vol. V, System Design Description (SDD) 503 dated September, 1981, DOE/NASA/0224-1; NASA CR-165/52.

Pharmacovigilance in resource-limited countries.

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Olsson, Sten; Pal, Shanthi N; Dodoo, Alex

2015-01-01

In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the WHO's global PV network. However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework as well as financial support to build sustainable PV systems are needed. Public health programs need to integrate PV to monitor new vaccines and medicines introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy. WHO has a major role in supporting and coordinating these developments.

The Internet and drug safety: what are the implications for pharmacovigilance?

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Cobert, B; Silvey, J

1999-02-01

Use of the Internet is becoming widespread throughout the world. Its use in the domain of drug safety and pharmacovigilance is spreading rapidly. Governments and industry have taken the lead in developing extensive web sites. The US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other agencies have developed sites containing enormous amounts of information both on pharmacovigilance in general and on specific drugs in particular. Under the US 'Freedom of Information Act' the FDA has put major parts of its adverse event database on line. Regulatory documents are also available from the FDA site or from hyperlinks described in the site. The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announcement service of these updates. Similarly, the EMEA updates its site frequently and publishes extensive material including regulatory documents, guidelines, European Public Assessment Reports on newly approved medications and other useful information. A free update service by e-mail is also available. Although English is the primary language used on the EMEA site, some of the information is available in other languages. Pharmaceutical companies are not using the Internet for pharmacovigilance yet. Rather, the Internet is being used for promotion of their products and for informing consumers on general information on diseases, for financial and investor data and for employment opportunities, etc. Other organisations such as lobbies, consumer groups and medical journals are also beginning to use the Internet. The electronic transmission of safety information, using the standards developed by the International Conference on Harmonization, is currently being tested for the transmission of individual patient adverse event information between companies and governments. In addition, the FDA has begun to accept adverse events from healthcare providers and consumers

Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda project.

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Bousquet, P-J; Demoly, P; Romano, A; Aberer, W; Bircher, A; Blanca, M; Brockow, K; Pichler, W; Torres, M J; Terreehorst, I; Arnoux, B; Atanaskovic-Markovic, M; Barbaud, A; Bijl, A; Bonadonna, P; Burney, P G; Caimmi, S; Canonica, G W; Cernadas, J; Dahlen, B; Daures, J-P; Fernandez, J; Gomes, E; Gueant, J-L; Kowalski, M L; Kvedariene, V; Mertes, P-M; Martins, P; Nizankowska-Mogilnicka, E; Papadopoulos, N; Ponvert, C; Pirmohamed, M; Ring, J; Salapatas, M; Sanz, M L; Szczeklik, A; Van Ganse, E; De Weck, A L; Zuberbier, T; Merk, H F; Sachs, B; Sidoroff, A

2009-02-01

Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.

Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation.

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Ozcan, Gulnihal; Aykac, Emel; Kasap, Yelda; Nemutlu, Nergiz T; Sen, Ebru; Aydinkarahaliloglu, N Demet

2016-03-01

In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities.

The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France.

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Olivier, Pascale; Montastruc, Jean-Louis

2006-11-01

Because of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France. Data coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case-control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR. A total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type-B ('unexpected') reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case-control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision. This study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco-epidemiological population-based database could represent a helpful tool to both generate and test safety hypotheses.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives

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Zhengwu Lu

2009-10-01

Full Text Available Zhengwu LuClinical Research Department, Abbott Vascular, Santa Clara, CA, USAAbstract: Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.Keywords: information technology, pharmacovigilance, safety, standard, risk management, adverse event

Assessment of pharmacovigilance approaches for monitoring the safety of antimalarial drugs in pregnancy

NARCIS (Netherlands)

Dellicour, S.O.M.C.

2014-01-01

Post-marketing surveillance of drugs used in pregnancy is challenging, especially in developing countries where resources for pharmacovigilance are rare. There is a need to establish simple but effective systems to monitor safety of drugs given during pregnancy in resource constrained countries.

Quality management system as a tool for improvement of the dutch pharmacovigilance system

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Zweers, P.G.M.A.; Van Puijenbroek, E.P.; Van Grootheest, A.C.

2009-01-01

Introduction: The Netherlands Pharmacovigilance centre Lareb started as a regional organization in 1985. In 1995 it was appointed by the Health Authorities as the national centre for collection and analysis for reports of adverse drug reactions. Since then, Lareb has become a solid, professional

Sources of information on lymphoma associated with anti-tumour necrosis factor agents: comparison of published case reports and cases reported to the French pharmacovigilance system.

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Théophile, Hélène; Schaeverbeke, Thierry; Miremont-Salamé, Ghada; Abouelfath, Abdelilah; Kahn, Valentine; Haramburu, Françoise; Bégaud, Bernard

2011-07-01

Anti-tumour necrosis factor (TNF) agents, through their intense immunoregulatory effect, have been suspected to increase the risk of malignant lymphoma. However, the classical epidemiological approaches conducted over about the last 10 years have not totally succeeded in addressing the question of a causal or artifactual association. Therefore, the analysis of a substantial set of case reports, although usually considered as poorly generalizable to the general population, could be particularly informative. Two main sources of case reports in postmarketing settings are available; publications in medical journals and reports to pharmacovigilance systems. The aim of the study was to compare the characteristics of case reports from both these sources in order to understand whether they provided the same information for the investigation of the causal link between lymphoma and anti-TNF agents. All case reports of malignant lymphoma in patients treated with an anti-TNF agent published in MEDLINE and all reports to the French pharmacovigilance system up to 1 February 2010 were identified. Cases of malignant lymphoma identified in postmarketing surveillance from both sources were compared regarding the following variables: age, sex, anti-TNF agent involved, indication for use, type of lymphoma, prior or concomitant immunosuppressive drugs and time to onset of lymphoma. A total of 81 published case reports and 61 cases reported to the French pharmacovigilance system were compared. In published reports, patients were younger (p = 0.03) and more frequently receiving a first anti-TNF treatment (p = 0.03), particularly infliximab (p = 0.03). Conversely, in the pharmacovigilance system reports, a succession of different anti-TNFs (p = 0.03) and adalimumab (p French pharmacovigilance system differed markedly for all characteristics tested, except sex and the use of prior or concomitant immunosuppressive drugs. Published case reports favoured convincing arguments

An analysis of Vigimed, a global e-mail system for the exchange of pharmacovigilance information.

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Johansson, Kristina; Olsson, Sten; Hellman, Björn; Meyboom, Ronald H B

2007-01-01

The Internet provides novel ways for communication and data exchange between national regulators. One innovation was the introduction of Vigimed, an e-mail discussion forum for national pharmacovigilance centres (NPCs). We reviewed a sample of Vigimed messages to learn more about this new tool and about the problems encountered in everyday pharmacovigilance and how these are handled. We analysed the contents of 100 subsequent questions and the corresponding responses as stored in the Vigimed datafile. To the 100 questions circulated through Vigimed, 575 answers were received; mean number of answers per question 6, range 0-20. Fifty-five (77%) of the 71 collaborating countries and 88 (43%) of the 204 individuals who had access in the study period had submitted at least one question or answer. These countries were in all parts of the world and in various phases of development. A total of 38% of the questions concerned the regulatory status of a drug; 30% safety issues; 13% regulatory actions under consideration; and 10% drug use-related problems (more than one category possible). Of the questions, 89% concerned established drugs; 11% were classified as new. A total of 90% of the questions concerned specific active substances or drug groups. Of the drugs, 73% were classified as 'orthodox' and 9% as herbal; 4% were vaccines and 4% excipients. Emerging drug groups (anatomical therapeutic chemical codes) were NSAIDs and analgesics (M01, N02), antibacterials (J01), antiobesity drugs (A08), psychotropic drugs (N05) and antihistamines (R06). NPCs operate in a restricted environment and there is little published information about the daily practices and experiences at NPCs. Our study concerned a sample in a limited period in time. In the meantime, the use of Vigimed has greatly expanded. The data in the Vigimed records are subjected to confidentiality in regard to the identities of countries, staff members, drug products and pharmaceutical companies, which limits the

A day in the life of a pharmacovigilance case processor.

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Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Veterinary pharmacovigilance in India: A need of hour.

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Kumar, Rishi; Kalaiselvan, Vivekanandan; Verma, Ravendra; Kaur, Ismeet; Kumar, Pranay; Singh, G N

2017-01-01

Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.

Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

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Maša Amrain

2014-09-01

Full Text Available Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87% completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH. Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4% of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

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Solomon, Cristina; Korte, Wolfgang; Fries, Dietmar; Pendrak, Inna; Joch, Christine; Gröner, Albrecht; Birschmann, Ingvild

2016-01-01

Background Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile. PMID:27781024

Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

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O'Callaghan, J; Griffin, B T; Morris, J M; Bermingham, Margaret

2018-06-01

In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.

Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.

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Hopf, Y M; Francis, J; Helms, P J; Haughney, J; Bond, C

2016-01-01

Adverse drug events are a major cause of patient safety incidents. Current systems of pharmacovigilance under-report adverse drug reactions (ADRs), especially in children, leading to delays in their identification. This is of particular concern, as children especially have an increased vulnerability to ADRs. The objective was to seek consensus among healthcare professionals (HCPs) about barriers and facilitators to the linkage of routinely collected health data for pediatric pharmacovigilance in Scotland. A Delphi survey was conducted with a random sample of HCPs including nurses, pharmacists and doctors, working in primary or secondary care, in Scotland. Participants were identified from sampling frames of the target professionals such as an NHS workforce list for general practitioners and recruited by postal invitation. A total of 819 HCPs were invited to take part. Those agreeing to participate were given the option of completing the questionnaires online or as hard copy. Reminders were sent twice at a fortnightly interval. Questions content included description of professional role as well as testing for the willingness to support the proposed project and was informed by the Theoretical Domains Framework of Behavior Change (TDF) and earlier qualitative work. Three Delphi rounds were administered, including a first round for item generation. 121 of those invited agreed to take part (15%). The first round of the Delphi study included 21 open questions and generated over a 1000 individual statements from 61 participants that returned the questionnaires (50.4%). These were rationalized to 149 items for the second round in which participants rated their views on the importance (or not) of each item on a 9-point Likert scale (strongly disagree - strongly agree). After the third round, there was consensus on items that focused on professional standards, and practical requirements, overall there was support for data linkage and a multi-professional approach. It would

Heparin pharmacovigilance in Brazil.

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Junqueira, Daniela Rezende Garcia; Viana, Thércia Guedes; Peixoto, Eliane R de M; Barros, Fabiana C R de; Carvalho, Maria das Graças; Perini, Edson

2011-01-01

To investigate the biological origin of injectable unfractioned heparin available in Brazilian market by discussing the impact of the profile of commercial products and the changes in heparin monograph on the drug safety. The Anvisa data base for the Registered Products of Pharmaceutical Companies and the Dictionary of Pharmaceutical Specialties (DEF 2008/2009) were searched. A survey with industries having an active permission for marketing the drug in Brazil was conducted. Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

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Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

2016-01-01

With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process.

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Bousquet, Cedric; Dahamna, Badisse; Guillemin-Lanne, Sylvie; Darmoni, Stefan J; Faviez, Carole; Huot, Charles; Katsahian, Sandrine; Leroux, Vincent; Pereira, Suzanne; Richard, Christophe; Schück, Stéphane; Souvignet, Julien; Lillo-Le Louët, Agnès; Texier, Nathalie

2017-09-21

Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules

The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist.

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Moore, Nicholas

2013-05-01

Over the years since 1961 and the identification of thalidomide as the common link in thousands of birth defects, daily pharmacovigilance activities and signal generation have evolved from the analysis of individual case reports and imputology, to case series and underreporting, to spontaneous report databases and disproportionality analyses, to data mining in population databases. Regulatory requirements have also changed from purely passive monitoring and reacting to alerts to a proactive approach that includes risk management plans and risk minimization, and from reporting only by healthcare professionals to patient reporting and exploration of social media. The emphasis only on risk assessment is changing towards assessment of the risk/benefit ratio and the exploration of real-life efficacy studies to complement the measure of real-life risk. The interactions between industry and regulators have been amplified and strengthened. However, most adverse reactions, including severe ones, are related to well-known and often pharmacological effects of the older drugs, possibly with genetic predispositions. Prevention is the next frontier for pharmacovigilance, beyond simply generating alerts, and it involves not only the removal of drugs from the market, but also promotion of proper drug prescribing by better trained physicians and the proper use of drugs by better informed patients.

Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?

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Pramod Kumar Sharma

2016-01-01

Full Text Available Background and Objectives: Reporting adverse drug reactions (ADRs associated with drug use is an important factor in patient safety. Majority of ADRs are preventable through improved prescribing and monitoring. Endocrinologists prescribe drugs with actions on almost all organs and for relatively longer durations. ADR are expected following the use of these drugs. Pharmacovigilance is the study of drug-related adverse effects aimed at protecting patients and public from drug-related harms. The concept of pharmacovigilance is relatively new in India, and this survey is an attempt to explore awareness among doctors of an establishing institution of national importance. Materials and Methods: The survey was conducted on faculty and resident doctors by administering a written structured questionnaire in a voluntary manner. The questionnaire contained questions meant to evaluate their awareness, understanding, and misconception about ADR reporting. Identity of the responder was kept confidential. Results: A total of 106 (faculty = 56; residents = 50 participated in survey. The most common cause cited for not reporting an ADR was “do not know how to report” by 64.15%. Majority of them (64% had no information about the Pharmacovigilance Programme of India (PvPI, and only few (8.5% had actually reported or published an ADR. Interpretation and Conclusions: ADRs are major public health problem that needs to be addressed at all levels of health care. High index of clinical suspicion are crucial for their timely detection and management. Various educational interventions have shown to improve medical professionals' awareness, understanding about ADRs and in their reporting behavior. PvPI is an important initiative toward ensuring patient safety.

Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

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Johnson, F Reed; Zhou, Mo

Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Effectiveness of Pharmacovigilance Training of General Practitioners A Retrospective Cohort Study in the Netherlands Comparing Two Methods

NARCIS (Netherlands)

Gerritsen, Roald; Faddegon, Hans; Dijkers, Fred; van Grootheest, Kees; van Puijenbroek, Eugene

2011-01-01

Background: Spontaneous reporting is a cornerstone of pharmacovigilance. Unfamiliarity with the reporting of suspected adverse drug reactions (ADRs) is a major factor leading to not reporting these events. Medical education may promote more effective reporting. Numerous changes have been implemented

The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

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Smith, Meredith Y; Benattia, Isma

2016-09-01

Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation.

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Leporini, Christian; Marrazzo, Giuseppina; Mumoli, Laura; Esposito, Stefania; Gallelli, Luca; Mangano, Giovanna; Brancati, Giacomino; De Francesco, Emanuela Adele; Russo, Emilio; De Sarro, Giovambattista

2017-05-01

The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.

Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.

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Lardon, Jérémy; Abdellaoui, Redhouane; Bellet, Florelle; Asfari, Hadyl; Souvignet, Julien; Texier, Nathalie; Jaulent, Marie-Christine; Beyens, Marie-Noëlle; Burgun, Anita; Bousquet, Cédric

2015-07-10

The underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients' experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance. A scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance. Daubt et al's recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2. Of the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified. This scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily

Should methods of correction for multiple comparisons be applied in pharmacovigilance?

Directory of Open Access Journals (Sweden)

Lorenza Scotti

2015-12-01

Full Text Available Purpose. In pharmacovigilance, spontaneous reporting databases are devoted to the early detection of adverse event ‘signals’ of marketed drugs. A common limitation of these systems is the wide number of concurrently investigated associations, implying a high probability of generating positive signals simply by chance. However it is not clear if the application of methods aimed to adjust for the multiple testing problems are needed when at least some of the drug-outcome relationship under study are known. To this aim we applied a robust estimation method for the FDR (rFDR particularly suitable in the pharmacovigilance context. Methods. We exploited the data available for the SAFEGUARD project to apply the rFDR estimation methods to detect potential false positive signals of adverse reactions attributable to the use of non-insulin blood glucose lowering drugs. Specifically, the number of signals generated from the conventional disproportionality measures and after the application of the rFDR adjustment method was compared. Results. Among the 311 evaluable pairs (i.e., drug-event pairs with at least one adverse event report, 106 (34% signals were considered as significant from the conventional analysis. Among them 1 resulted in false positive signals according to rFDR method. Conclusions. The results of this study seem to suggest that when a restricted number of drug-outcome pairs is considered and warnings about some of them are known, multiple comparisons methods for recognizing false positive signals are not so useful as suggested by theoretical considerations.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

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Lu, Zhengwu

2009-01-01

Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

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Fabiana Rossi Varallo

Full Text Available OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1 an interactive lecture, 2 a practical class, 3 a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4 educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations and the relevance (seriousness and expectancy of the events. RESULTS: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001 and their knowledge of pharmacovigilance (p<0.0001. The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. CONCLUSIONS: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in

Patient-centered pharmacovigilance: A review | Saleh | Tropical ...

African Journals Online (AJOL)

The studies were extracted from seven databases, viz, Google Scholars, Medline, Academic Search Complete “EBSCO”, Health and Medical Complete ProQuest, Science Direct- Elsevier, SCOPUS and Wiley Online Library. Results: The review revealed that although the reports by patients were of good quality, the patients' ...

Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.

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Montastruc, Guillaume; Favreliere, Sylvie; Sommet, Agnès; Pathak, Atul; Lapeyre-Mestre, Maryse; Perault-Pochat, Marie-Christine; Montastruc, Jean-Louis

2010-03-01

To evaluate putative associations between drugs and dilated cardiomyopathy. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were 'suspect'. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors . . .), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals.

Epistaxis and other haemorrhagic events associated with the smoking cessation medicine varenicline : a case series from two national pharmacovigilance centres

NARCIS (Netherlands)

Harrison-Woolrych, Mira; Harmark, Linda; Tan, Ming; Maggo, Simran; van Grootheest, Kees

Purpose To present a case series of haemorrhagic events associated with varenicline identified from the New Zealand (NZ) and Netherlands national pharmacovigilance centres and propose a possible mechanism for these adverse events. Methods Reports of epistaxis and other haemorrhagic events (in all

Semantic distance-based creation of clusters of pharmacovigilance terms and their evaluation.

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Dupuch, Marie; Grabar, Natalia

2015-04-01

Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs or biologics. The detection of adverse drug reactions is performed using statistical algorithms and groupings of ADR terms from the MedDRA (Medical Dictionary for Drug Regulatory Activities) terminology. Standardized MedDRA Queries (SMQs) are the groupings which become a standard for assisting the retrieval and evaluation of MedDRA-coded ADR reports worldwide. Currently 84 SMQs have been created, while several important safety topics are not yet covered. Creation of SMQs is a long and tedious process performed by the experts. It relies on manual analysis of MedDRA in order to find out all the relevant terms to be included in a SMQ. Our objective is to propose an automatic method for assisting the creation of SMQs using the clustering of terms which are semantically similar. The experimental method relies on a specific semantic resource, and also on the semantic distance algorithms and clustering approaches. We perform several experiments in order to define the optimal parameters. Our results show that the proposed method can assist the creation of SMQs and make this process faster and systematic. The average performance of the method is precision 59% and recall 26%. The correlation of the results obtained is 0.72 against the medical doctors judgments and 0.78 against the medical coders judgments. These results and additional evaluation indicate that the generated clusters can be efficiently used for the detection of pharmacovigilance signals, as they provide better signal detection than the existing SMQs. Copyright © 2014. Published by Elsevier Inc.

Pharmacovigilance in oncology: evaluation of current practice and future perspectives.

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Baldo, Paolo; De Paoli, Paolo

2014-10-01

Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.

From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources.

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Trifirò, Gianluca; Sultana, Janet; Bate, Andrew

2018-02-01

In the last decade 'big data' has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processes and clinical practice by different healthcare professionals: from doctors recording their patients' medical history, drug prescriptions or medical claims to pharmacists registering dispensed prescriptions. For a long time, this data accumulated without its value being fully recognized and leveraged. Today big data has an important place in healthcare, including in pharmacovigilance. The expanding role of big data in pharmacovigilance includes signal detection, substantiation and validation of drug or vaccine safety signals, and increasingly new sources of information such as social media are also being considered. The aim of the present paper is to discuss the uses of big data for drug safety post-marketing assessment.

Role of Pharmacovigilance in India: An overview.

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Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

2015-01-01

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

[Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

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Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

2008-03-01

Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

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Subhrojyoti Bhowmick

2014-01-01

Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding

Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety.

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Choonara, Imti

2013-05-01

Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.

Pharmacovigilance activities in ASEAN countries.

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Suwankesawong, Wimon; Dhippayom, Teerapon; Tan-Koi, Wei-Chuen; Kongkaew, Chuenjid

2016-09-01

This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries. This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database. Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015). Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd. Copyright �

False-positive results in pharmacoepidemiology and pharmacovigilance.

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Bezin, Julien; Bosco-Levy, Pauline; Pariente, Antoine

2017-09-01

False-positive constitute an important issue in scientific research. In the domain of drug evaluation, it affects all phases of drug development and assessment, from the very early preclinical studies to the late post-marketing evaluations. The core concern associated with this false-positive is the lack of replicability of the results. Aside from fraud or misconducts, false-positive is often envisioned from the statistical angle, which considers them as a price to pay for type I error in statistical testing, and its inflation in the context of multiple testing. If envisioning this problematic in the context of pharmacoepidemiology and pharmacovigilance however, that both evaluate drugs in an observational settings, information brought by statistical testing and the significance of such should only be considered as additional to the estimates provided and their confidence interval, in a context where differences have to be a clinically meaningful upon everything, and the results appear robust to the biases likely to have affected the studies. In the following article, we consequently illustrate these biases and their consequences in generating false-positive results, through studies and associations between drug use and health outcomes that have been widely disputed. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Hearing impairment associated with oral terbinafine use : a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™

NARCIS (Netherlands)

Scholl, Joep H G; van Puijenbroek, Eugene P

2012-01-01

BACKGROUND: The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR)

Sistema de Farmacovigilância do Ceará: um ano de experiência Ceará State Pharmacovigilance System: a year of experience

Directory of Open Access Journals (Sweden)

Helena Lutéscia Coêlho

1999-09-01

Full Text Available No presente trabalho, o relato do primeiro ano de atividade do Sistema de Farmacovigilância do Ceará (SIFACE é apresentado como estratégia para a discussão de questões práticas e metodológicas envolvendo as dificuldades na implantação de atividade dessa natureza no Brasil. O SIFACE está sendo estruturado pelo GPUIM (Grupo de Prevenção ao Uso Indevido de Medicamentos, tendo como ponto de apoio as unidades de farmácias hospitalares. Foram processadas 63 notificações (119 suspeitas de reação adversa, em sua maioria correspondentes a mulheres (55,7% e a pacientes de 0-14 anos (34,4%, sendo os antibióticos e as reações dermatológicas os medicamentos e os tipos de reações mais freqüentes, respectivamente. Em 20% dos casos houve reexposição dos pacientes a fármacos aos quais aqueles eram intolerantes, o que ressalta a importância preventiva da farmacovigilância.This paper summarizes the first year of activity of the Ceará State Pharmacovigilance System (SIFACE as a strategy to discuss practical and methodological problems related to developing pharmacovigilance in Brazil. SIFACE is being structured by the Group for the Prevention of Improper Use of Pharmaceuticals (GPUIM, based on hospital pharmacies. A total of 63 reports (119 suspected adverse drug reactions, or ADRs were processed, the majority among women (55.7% and children (34.4%. Antibiotics were the drug group most frequently involved, and the most common reactions were dermatological. In 20% of the cases, patients had been re-exposed to drugs previously reported as producing adverse reactions, thus highlighting the importance of pharmacovigilance to prevent ADRs.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

NARCIS (Netherlands)

Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; Jong-van den Berg, de Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

2016-01-01

BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized

Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

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Kalaivani, M; Singh, Abhishank; Kalaiselvan, V

2015-01-01

A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies.

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Hauben, Manfred; Hung, Eric; Wood, Jennifer; Soitkar, Amit; Reshef, Daniel

2017-05-01

The aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance. We used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes. These medical concepts (MCs) were mapped to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) used in FAERS to code AEs. Negative controls (NC) were MCs with circumscribed PTs not included in the corresponding US package insert (USPI). We calculated shrinkage-adjusted observed-to-expected (O/E) reporting frequencies for the aforementioned drug-PT pairs. We also formulated an adjudication framework to calculate performance at the MC level. Performance metrics [sensitivity, specificity, positive and negative predictive value (PPV, NPV), signal/noise (S/N), F and Matthews correlation coefficient (MCC)] were calculated for each analysis and compared. The PC reference set consisted of 11 drugs, 487 PTs, 27 MCs, 37 drug-MC combinations and 638 drug-event combinations (DECs). The NC reference set consisted of 11 drugs, 9 PTs, 5 MCs, 40 drug-MC combinations and 67 DECs. Most drug-event pairs were not highlighted by either analysis. A small percentage of signals of disproportionate reporting were lost, more noise than signal, with no gains. Specificity and PPV improved whereas sensitivity, NPV, F and MCC decreased, but all changes were small relative to the decrease in sensitivity. The overall S/N improved. This oncology drug restricted analysis improved the S/N ratio, removing proportionately more noise than signal, but with significant credible signal loss. Without broader experience and a calculus of costs and utilities of correct versus incorrect classifications in

78 FR 72091 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Science.gov (United States)

2013-12-02

..., CDER should be contacted immediately at [email protected] in adherence to existing recall... responses per Total annual Average burden Total hours respondents respondent responses per response Notify...\\ Number of Average burden Absenteeism guidance Number of records per Total annual per Total hours...

78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

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2013-08-07

... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying for... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998...

A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project.

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Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M; Corripio, Iluminada; Aguilar, Eduardo J; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J; Bernardo, Miguel

2016-04-01

The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, Psecurity issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. © The Author 2015. Published by Oxford University Press on behalf of CINP.

75 FR 32786 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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2010-06-09

... follow specific procedures to submit information to FDA of any changes, in the product, production... feasible (or based on evidence of effectiveness from studies in animals). Section 601.93 provides that... an Antibiotic Drug for Human Use'' to harmonize application procedures between CBER and CDER. The...

Hospital medication errors in a pharmacovigilance system in Colombia

Directory of Open Access Journals (Sweden)

Jorge Enrique Machado-Alba

2015-11-01

Full Text Available Objective: this study analyzes the medication errors reported to a pharmacovigilance system by 26 hospitals for patients in the healthcare system of Colombia. Methods: this retrospective study analyzed the medication errors reported to a systematized database between 1 January 2008 and 12 September 2013. The medication is dispensed by the company Audifarma S.A. to hospitals and clinics around Colombia. Data were classified according to the taxonomy of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP. The data analysis was performed using SPSS 22.0 for Windows, considering p-values < 0.05 significant. Results: there were 9 062 medication errors in 45 hospital pharmacies. Real errors accounted for 51.9% (n = 4 707, of which 12.0% (n = 567 reached the patient (Categories C to I and caused harm (Categories E to I to 17 subjects (0.36%. The main process involved in errors that occurred (categories B to I was prescription (n = 1 758, 37.3%, followed by dispensation (n = 1 737, 36.9%, transcription (n = 970, 20.6% and administration (n = 242, 5.1%. The errors in the administration process were 45.2 times more likely to reach the patient (CI 95%: 20.2–100.9. Conclusions: medication error reporting systems and prevention strategies should be widespread in hospital settings, prioritizing efforts to address the administration process.

Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.

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Haas, Jennifer S; Amato, Mary; Marinacci, Lucas; Orav, E John; Schiff, Gordon D; Bates, David W

2012-08-01

While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. Compared with the package insert, patients taking zolpidem were significantly (p zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.

Analysis of Patient Narratives in Disease Blogs on the Internet: An Exploratory Study of Social Pharmacovigilance.

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Matsuda, Shinichi; Aoki, Kotonari; Tomizawa, Shiho; Sone, Masayoshi; Tanaka, Riwa; Kuriki, Hiroshi; Takahashi, Yoichiro

2017-02-24

Although several reports have suggested that patient-generated data from Internet sources could be used to improve drug safety and pharmacovigilance, few studies have identified such data sources in Japan. We introduce a unique Japanese data source: tōbyōki, which translates literally as "an account of a struggle with disease." The objective of this study was to evaluate the basic characteristics of the TOBYO database, a collection of tōbyōki blogs on the Internet, and discuss potential applications for pharmacovigilance. We analyzed the overall gender and age distribution of the patient-generated TOBYO database and compared this with other external databases generated by health care professionals. For detailed analysis, we prepared separate datasets for blogs written by patients with depression and blogs written by patients with rheumatoid arthritis (RA), because these conditions were expected to entail subjective patient symptoms such as discomfort, insomnia, and pain. Frequently appearing medical terms were counted, and their variations were compared with those in an external adverse drug reaction (ADR) reporting database. Frequently appearing words regarding patients with depression and patients with RA were visualized using word clouds and word cooccurrence networks. As of June 4, 2016, the TOBYO database comprised 54,010 blogs representing 1405 disorders. Overall, more entries were written by female bloggers (68.8%) than by male bloggers (30.8%). The most frequently observed disorders were breast cancer (4983 blogs), depression (3556), infertility (2430), RA (1118), and panic disorder (1090). Comparison of medical terms observed in tōbyōki blogs with those in an external ADR reporting database showed that subjective and symptomatic events and general terms tended to be frequently observed in tōbyōki blogs (eg, anxiety, headache, and pain), whereas events using more technical medical terms (eg, syndrome and abnormal laboratory test result) tended to be

[Hydroxychloroquine-induced hearing loss: First case of positive rechallenge and analysis of the French pharmacovigilance database].

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Chatelet, J-N; Auffret, M; Combret, S; Bondon-Guitton, E; Lambert, M; Gautier, S

2017-05-01

Several cases of hearing loss induced by hydroxychloroquine have been reported in the literature but the role of hydroxychloroquine still remains debated. We report the first case, to our knowledge, of hearing loss induced by hydroxychloroquine with a positive re challenge in a woman treated for systemic lupus. An analysis of the French pharmacovigilance database allowed to identify 23 additional cases of hearing loss in patients treated with hydroxychloroquine and, among them, 8 had systemic lupus. Despite an excellent tolerance and high efficacy-side effect ratio, this case report adds some evidence for an otoxicity of hydroxychloroquine. Copyright © 2016 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier SAS. All rights reserved.

Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries.

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Kovacs, Stephanie D; Mills, Brianna M; Stergachis, Andy

2017-07-11

Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President's Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank's grants for malaria prevention and control. All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0. The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance-related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug

76 FR 44593 - Identifying the Center for Drug Evaluation and Research's Science and Research Needs...

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2011-07-26

... research needs outlined in the report, CDER hopes to stimulate research and foster collaborations with... research needs, CDER hopes to stimulate research and foster collaborations with external partners and... issues across teams, divisions, or offices; and (3) emerging scientific challenges. A comprehensive set...

Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

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Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

2018-05-01

Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2018. Published by Elsevier Inc.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

OpenAIRE

Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; de Jong-van den Berg, Lolkje; Zetstra - van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella CF

2016-01-01

BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. OBJECTIVE: To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a stu...

A day in the life of a pharmacovigilance case processor

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Ritesh Bhangale

2017-01-01

Full Text Available Pharmacovigilance (PV has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon” (Greek for drug and “Vigilare” (Latin for to keep watch. It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study.

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Hanke, A A; Joch, C; Görlinger, K

2013-05-01

The rapid reversal of the effects of vitamin K antagonists is often required in cases of emergency surgery and life-threatening bleeding, or during bleeding associated with high morbidity and mortality such as intracranial haemorrhage. Increasingly, four-factor prothrombin complex concentrates (PCCs) containing high and well-balanced concentrations of vitamin K-dependent coagulation factors are recommended for emergency oral anticoagulation reversal. Both the safety and efficacy of such products are currently in focus, and their administration is now expanding into the critical care setting for the treatment of life-threatening bleeding and coagulopathy resulting either perioperatively or in cases of acute trauma. After 15 yr of clinical use, findings of a pharmacovigilance report (February 1996-March 2012) relating to the four-factor PCC Beriplex P/N (CSL Behring, Marburg, Germany) were analysed and are presented here. Furthermore, a review of the literature with regard to the efficacy and safety of four-factor PCCs was performed. Since receiving marketing authorization (February 21, 1996), ~647 250 standard applications of Beriplex P/N have taken place. During this time, 21 thromboembolic events judged to be possibly related to Beriplex P/N administration have been reported, while no incidences of viral transmission or heparin-induced thrombocytopenia were documented. The low risk of thromboembolic events reported during the observation period (one in ~31 000) is in line with the incidence observed with other four-factor PCCs. In general, four-factor PCCs have proven to be well tolerated and highly effective in the rapid reversal of vitamin K antagonists.

Saudi Vigilance Program: Challenges and lessons learned.

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Alharf, Adel; Alqahtani, Nasser; Saeed, Ghazi; Alshahrani, Ali; Alshahrani, Mubarak; Aljasser, Nasser; Alquwaizani, Mohammed; Bawazir, Saleh

2018-03-01

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program's performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.

Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements

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Karen Maigetter

2015-05-01

Full Text Available Background Pharmacovigilance (PV data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI interviews and compares them with the World Health Organization’s (WHO’s minimum PV requirements for a Functional National PV System. Methods A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs, members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory

Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.

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Cocos, Anne; Fiks, Alexander G; Masino, Aaron J

2017-07-01

Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media. We developed a recurrent neural network (RNN) model that labels words in an input sequence with ADR membership tags. The only input features are word-embedding vectors, which can be formed through task-independent pretraining or during ADR detection training. Our best-performing RNN model used pretrained word embeddings created from a large, non-domain-specific Twitter dataset. It achieved an approximate match F-measure of 0.755 for ADR identification on the dataset, compared to 0.631 for a baseline lexicon system and 0.65 for the state-of-the-art conditional random field model. Feature analysis indicated that semantic information in pretrained word embeddings boosted sensitivity and, combined with contextual awareness captured in the RNN, precision. Our model required no task-specific feature engineering, suggesting generalizability to additional sequence-labeling tasks. Learning curve analysis showed that our model reached optimal performance with fewer training examples than the other models. ADR detection performance in social media is significantly improved by using a contextually aware model and word embeddings formed from large, unlabeled datasets. The approach reduces manual data-labeling requirements and is scalable to large social media datasets. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

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Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

Effects of order and sequence of resistance and endurance training on body fat in elementary school-aged girls

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Ana R. Alves

2017-12-01

Full Text Available The purpose of this study was to analyse the effects of order and sequence of concurrent resistance and endurance training on body fat percentage (BFP in a large sample of elementary school-aged girls. One hundred and twenty-six healthy girls, aged 10-11 years (10.95 ± 0.48 years, were randomly assigned to six groups to perform different training protocols per week for 8 weeks: Resistance-only (R, Endurance-only (E, Concurrent Distinct Endurance-Resistance (CDER, Concurrent Parallel Endurance-Resistance (CPER, Concurrent Parallel Resistance-Endurance (CPRE, and a Control group (C. In R and E, the subjects performed single sessions of resistance or endurance exercises, respectively (two days per week. In CDER, resistance-endurance training was performed on different days each week (four days per week. CPER and CPRE performed single-session combined endurance-resistance training or combined resistance-endurance training, respectively, each week (two days per week. After an 8-week training period, BFP decreased in all experimental groups (CPER: 13.3%, p0.05; and CDER: 5.6%, p>0.05. However, a significant difference was found in CPER and CPRE when compared to CDER, E, and R, indicating that training sequence may influence BFP. All programmes were effective, but CPER and CPRE obtained better results for BFP than CDER, E, or R. The effects of concurrent resistance and endurance training on body fat percentage can be mediated by order and sequence of exercise. These results provide insight into optimization of school-based fat loss exercise programmes in childhood.

Investigating patient narratives posted on Internet and their informativeness level for pharmacovigilance purpose: The example of comments about statins.

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Kheloufi, Farid; Default, Anne; Blin, Olivier; Micallef, Joelle

2017-09-01

Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines. One day of December 2012, postings about simvastatin, rosuvastatin and atorvastatin publicly available on the website were collected. Their informativeness according to 16 key elements of information (including drug start and stop date, duration of treatment, time to onset and duration of the ADR, outcome, medical history, concomitant medication) was assessed. General information about reported ADRs was also investigated. Among the 96 postings related to statins, 72 (40 women, 32 men; mean age: 59 [40-78]) mentioned at least one ADR accounting for a total of 176 ADRs. Musculoskeletal and connective tissue disorders (42.6%) and nervous system disorders (15.3%) were the main represented ADRs. Only 2 patients mentioned ADRs that could be considered as serious but 24 patients mentioned they stopped or switched their treatment toward another lipid modifying agent because of the ADR. Mean number of available key elements of information per narrative was 6/16. Time to onset and duration of the ADR were respectively available in only 31% and 3% of the narratives. Medical history and concomitant medication were respectively lacking in 87% and 86% of the narratives. Outcome was found only in 39% of the narratives. Patient narratives posted on Internet include mainly non-serious expected ADR. However, their informativeness level is very incomplete and makes difficult their assessment and use for

Defending submission-year analyses of new drug approvals.

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Carpenter, Daniel P

2003-01-01

In response to the critique of Mary Olsen, Daniel Carpenter, on behalf of his co-authors, addresses the issue of analysis based on the year a new drug is submitted for Food and Drug Administration (FDA) approval, not the year it is approved. Both substantive knowledge of the FDA drug review process and sound social science theory favor submission-year averaging. The history and bureaucratic mechanics of the Center for Drug Evaluation and Review (CDER) conform to the author's assumption. The statistical theory of optimal experimentation also points to the beginning of review as a locus for effects upon decisions.

Statistical Signal Process in R Language in the Pharmacovigilance Programme of India.

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Kumar, Aman; Ahuja, Jitin; Shrivastava, Tarani Prakash; Kumar, Vipin; Kalaiselvan, Vivekanandan

2018-05-01

The Ministry of Health & Family Welfare, Government of India, initiated the Pharmacovigilance Programme of India (PvPI) in July 2010. The purpose of the PvPI is to collect data on adverse reactions due to medications, analyze it, and use the reference to recommend informed regulatory intervention, besides communicating the risk to health care professionals and the public. The goal of the present study was to apply statistical tools to find the relationship between drugs and ADRs for signal detection by R programming. Four statistical parameters were proposed for quantitative signal detection. These 4 parameters are IC 025 , PRR and PRR lb , chi-square, and N 11 ; we calculated these 4 values using R programming. We analyzed 78,983 drug-ADR combinations, and the total count of drug-ADR combination was 4,20,060. During the calculation of the statistical parameter, we use 3 variables: (1) N 11 (number of counts), (2) N 1. (Drug margin), and (3) N .1 (ADR margin). The structure and calculation of these 4 statistical parameters in R language are easily understandable. On the basis of the IC value (IC value >0), out of the 78,983 drug-ADR combination (drug-ADR combination), we found the 8,667 combinations to be significantly associated. The calculation of statistical parameters in R language is time saving and allows to easily identify new signals in the Indian ICSR (Individual Case Safety Reports) database.

Gentamicin nephrotoxicity: Animal experimental correlate with human pharmacovigilance outcome

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Olufunsho Awodele

2015-04-01

Full Text Available Background: National Agency for Food and Drugs Administration and Control (NAFDAC, which is responsible for pharmacovigilance activity in Nigeria, recently withdrew injection gentamicin 280 mg, used in the management of life-threatening and multidrug-resistant infections from circulation, due to reported toxicity. Thus, this study aimed to investigate the toxicity profile of the commonly used strengths (80 mg and 280 mg of gentamicin on kidney using animal models. Methods: Animals were divided into five groups of 16 rats each. For rats of groups 1 and 2, gentamicin (1.14 mg/kg each group was administered intramuscularly twice daily for 7 and 14 days, respectively, after which eight of them were sacrificed by cervical dislocation. Blood was collected via cardiac puncture and the kidneys were carefully removed and weighed immediately. The remaining eight animals were kept for reversibility study for another 7 and 14 days, respectively. For groups 3 and 4, gentamicin (4 mg/kg each group was administered as a single daily dose for 7 and 14 days, respectively, and eight animals from the groups were subjected to reversibility study for 7 and 14 days, respectively. Group 5, the control group animals, were given 10 ml/kg distilled water for 14 days. Histopathology of the kidneys, serum creatinine levels, and antioxidant enzyme activities were investigated. Results: Significant increase (p ≤ 0.001 in the level of creatinine of rats administered 4.0 mg/kg for 14 days was observed compared with all other groups. Significant (p ≤ 0.001 elevations in the lipid peroxidation in all gentamicin-administered animals and acute tubular necrosis in most of the gentamicin-administered animals were observed. Conclusion: Toxicity profile of gentamicin on the kidneys is dependent on both dose and duration of administration. The findings justify the decision made by NAFDAC to ban the use of high-dose inj. gentamicin 280 mg in Nigeria.

Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

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Kabanywanyi Abdunoor M

2010-07-01

Full Text Available Abstract Objectives To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL administered as first-line treatment for uncomplicated malaria in rural Tanzania. Methods Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS. Three distinct channels for identification of adverse events (AEs and serious adverse events (SAEs were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact study (conducted only in March-April 2008. Results Training was provided for 40 healthcare providers (with refresher training 18 months later and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Discussion Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Conclusion Experience gained in this setting could help to improve

Value Assessment in the Regulatory Context.

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Miller, Kathleen L; Woodcock, Janet

2017-02-01

Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Ontology-based Vaccine and Drug Adverse Event Representation and Theory-guided Systematic Causal Network Analysis toward Integrative Pharmacovigilance Research.

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He, Yongqun

2016-06-01

Compared with controlled terminologies ( e.g. , MedDRA, CTCAE, and WHO-ART), the community-based Ontology of AEs (OAE) has many advantages in adverse event (AE) classifications. The OAE-derived Ontology of Vaccine AEs (OVAE) and Ontology of Drug Neuropathy AEs (ODNAE) serve as AE knowledge bases and support data integration and analysis. The Immune Response Gene Network Theory explains molecular mechanisms of vaccine-related AEs. The OneNet Theory of Life treats the whole process of a life of an organism as a single complex and dynamic network ( i.e. , OneNet). A new "OneNet effectiveness" tenet is proposed here to expand the OneNet theory. Derived from the OneNet theory, the author hypothesizes that one human uses one single genotype-rooted mechanism to respond to different vaccinations and drug treatments, and experimentally identified mechanisms are manifestations of the OneNet blueprint mechanism under specific conditions. The theories and ontologies interact together as semantic frameworks to support integrative pharmacovigilance research.

Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: application to rhabdomyolysis

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Vilar, Santiago; Harpaz, Rave; Chase, Herbert S; Costanzi, Stefano; Rabadan, Raul

2011-01-01

Background Adverse drug events (ADE) cause considerable harm to patients, and consequently their detection is critical for patient safety. The US Food and Drug Administration maintains an adverse event reporting system (AERS) to facilitate the detection of ADE in drugs. Various data mining approaches have been developed that use AERS to detect signals identifying associations between drugs and ADE. The signals must then be monitored further by domain experts, which is a time-consuming task. Objective To develop a new methodology that combines existing data mining algorithms with chemical information by analysis of molecular fingerprints to enhance initial ADE signals generated from AERS, and to provide a decision support mechanism to facilitate the identification of novel adverse events. Results The method achieved a significant improvement in precision in identifying known ADE, and a more than twofold signal enhancement when applied to the ADE rhabdomyolysis. The simplicity of the method assists in highlighting the etiology of the ADE by identifying structurally similar drugs. A set of drugs with strong evidence from both AERS and molecular fingerprint-based modeling is constructed for further analysis. Conclusion The results demonstrate that the proposed methodology could be used as a pharmacovigilance decision support tool to facilitate ADE detection. PMID:21946238

A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

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Liu, Xiao; Chen, Hsinchun

2015-12-01

Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada.

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Thibault B Ali

Full Text Available This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS and the Canada Vigilance Adverse Reaction Database (CVARD concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR. A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94-3.98; P<0.0001 and CVARD (ROR = 3.67; CI95% = 1.92-7.00; P = 0.001 databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer's disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration.

Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study.

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Ajanal, Manjunath N; Nayak, Shradda U; Kadam, Avinash P; Prasad, B S

2015-01-01

Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines. To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup. In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed. In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence. The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines.

A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.

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Chan, Cheng Leng; Ang, Pei San; Li, Shu Chuen

2017-06-01

Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA). Comparisons were conducted with centres outside ASEAN. A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA. Data were collected from nine ASEAN countries and seven other countries. PV activities were conducted in all these countries, which were at different stages of development. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN countries. Eighty percent agreed that the development of a QSDA would help in drug signal detection. The main limitation identified was the lack of knowledge and/or lack of resources. Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals.

Adverse drug reaction monitoring of newer oral anti diabetic drugs – a pharmacovigilance perspective

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Ankita Bhattacharjee

2016-04-01

Full Text Available Objective: To monitor and evaluate adverse drug reactions (ADRs of newer oral anti-diabetic drugs in type II diabetics by spontaneous/solicited ADR monitoring.Material and methods: Two hundred and thirty two diabetic patients on newer oral antidiabetic drugs were evaluated prospectively in a cross-sectional study over a period of eighteen months. All patients were followed up for ADRs which were evaluated for incidence, frequency, severity and causality. ADR severity was graded according to University of Virginia Health System Adverse Drug Reaction Reporting program criteria and causality assessment was done using WHO-UMC scale.Results: 190 out of 232 patients (42 patients lost to follow up were evaluated. ADRs were observed in 34 cases (17.9%. Most common ADRs were gastrointestinal (44.2% followed by musculoskeletal (17.6%, metabolic (14.7%, infections (5.9% and others (17.6%. The maximal frequency of ADRs was seen with sitagliptin (6.4% followed by vildagliptin(3.8%, saxagliptin(2.7%, saroglitazar(2.1%, linagliptin(1.6%, canagliflozin(1.6%. 25(73.5%, 8(23.5% and 1(3% ADRs were mild, moderate and severe respectively. 24(70% ADRs were classified as possible, 9(27% probable and 1(3% unlikely on causality assessment. Conclusion: Newer oral antidiabetic drugs like gliptins and SGLT-2 inhibitors have potential to cause ADRs. Gastro-intestinal, musculoskeletal, metabolic were most common ADRs. Active pharmacovigilance should be carried out for risk identification and management. 

Patterns of adverse drug reaction signals in NAFDAC Pharmacovigilance activities from September to November, 2014.

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Awodele, Olufunsho; Ibrahim, Ali; Orhii, Paul

2016-03-16

Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank. Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals. A total of about 100 reported cases with arrays of adverse drug reactions were reported between September and November, 2014 and the data were analyzed using SPSS version 17. Efavirenz/Tenofovir/Lamivudine combination was the highest reported drugs (24.2%) while efavirenz alone was reported in 8 times (8.8%) and HIV (63.3%) was the highest reported indication of drug use. Efavirenz caused central nervous system adverse reactions as revealed in the ADRs analyses. Zidovudine/Lamivudine/Nevirapine combination in concomitant use with Cotrimoxazole were reported 8 times with generalized maculopapular rashes on the trunk with some area of hyper pigmentation with intense itching documented twice and big/swollen rashes all over the faces. Zidovudine was also reported four times to cause severe anaemia. More surveillance is advocated so as to ascertain the consistency of the observed ADRs and thereafter establish appropriate signals.

Ademe et Vous. International Newsletter No. 26, Sept.-Oct.-Nov. 2013. Energy efficiency: MEDENER's progress

International Nuclear Information System (INIS)

Martin, Valerie; Seguin-Jacques, Catherine; Tappero, Denis

2013-09-01

Starting on 13 February 2012 and for a period of two years, ADEME is holding the presidency of the MEDENER association. Here is a review of its main energy management actions. By helping take innovation to the market, ADEME goes beyond research and acts as a catalyzer for innovation in its various fields of expertise. For twenty years now, ADEME and its Moroccan counterparts ADEREE, which replaced CDER in 2010, have maintained constructive and privileged relations. A European institutional twinning has further enhanced this cooperation

Lessons learned on the design and the conduct of Post-Authorization Safety Studies

DEFF Research Database (Denmark)

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise

2017-01-01

Aims: To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. Methods: A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted...... the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. Conclusions: To the best of our...... knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review...

Patient-centered pharmacovigilance: A review | Saleh | Tropical ...

African Journals Online (AJOL)

Tropical Journal of Pharmaceutical Research. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 17, No 1 (2018) >. Log in or Register to get access to full text downloads.

Gingival bleeding, a possible "serious" adverse drug reaction: An observational study in the French PharmacoVigilance Database.

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Bondon-Guitton, Emmanuelle; Mourgues, Thibaut; Rousseau, Vanessa; Cousty, Sarah; Cottin, Judith; Drablier, Guillaume; Micallef, Joëlle; Montastruc, Jean-Louis

2017-09-01

Antithrombotic drugs are known to increase the risk of gingival bleeding because they affect coagulation. However, other drugs could also be involved in gingival bleeding. We performed a pharmacoepidemiological study to identify the drugs most frequently "suspected" in the occurrence of gingival bleeding. We selected reports of "gingival bleeding" from 1 January 1985 to 30 September 2014 in the French PharmacoVigilance Database. Among 523,808 reports of adverse drug reactions, we identified 454 reports of gingival bleeding (0.09%). Most of them were "serious" (58.4%) and occurred in females (54.6%). The frequency of gingival bleeding increased with age. The most frequently "suspected" drugs were antithrombotics (67.8%), particularly fluindione. Other drugs frequently involved were furosemide followed by paracetamol, amiodarone, amoxicillin, paroxetine, ketoprofen, zolpidem, enalapril and ramipril. Thirty-nine reports involved a drug-drug interaction with antithrombotics, mainly with anti-infectives. Gingival bleeding can be an adverse drug reaction, often "serious" and rarely fatal. Patients older than 50 years and women are particularly at risk. Among drugs known to increase the risk of gingival bleeding, the most frequently involved were fluindione, furosemide, paracetamol, amiodarone, amoxicillin, paroxetine or ketoprofen. We also identified signal for drugs not usually known to be involved in bleeding, like zolpidem, enalapril or ramipril. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events

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Acquavella J

2016-07-01

. Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Follow-up will extend from the first administration of antiresorptive treatment to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naïve patients, zoledronic acid-naïve patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly established national ONJ databases and adjudicated by the committee that functioned during the XGEVA® clinical trials program. Conclusion: This study will provide a real world counterpart to the clinical trial-estimated risks for ONJ and serious infections for cancer patients initiating denosumab or zoledronic acid. The establishment of ONJ databases in the three Scandinavian countries will have potential benefits outside this study for the elucidation of ONJ risk factors and the evaluation of ONJ treatment strategies. Keywords: cohort study, osteonecrosis of the jaw, pharmacovigilance, postmarketing drug surveillance, denosumab, zoledronic acid

Pharmacovigilance of artemether-lumefantrine in pregnant women followed until delivery in Rwanda

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Rulisa Stephen

2012-07-01

Full Text Available Abstract Background The World Health Organization presently recommends Artemisinin-based combination therapy (ACT as first-line therapy for uncomplicated P. falciparum malaria. Many malaria-endemic countries, including Rwanda, have adopted these treatment guidelines. The Artemisinin derivative Artemether, in combination with lumefantrine, is currently used in Rwanda for malaria during the second and third trimesters of pregnancy. Safety data on the use of ACT in pregnancy are still limited though and more data are needed. Methods In this pharmacovigilance study, the exposed group (pregnant women with malaria given artemether-lumefantrine, and a matched non-exposed group (pregnant women without malaria and no exposure to artemether-lumefantrine were followed until delivery. Data were collected at public health centres all over Rwanda during acute malaria, routine antenatal visits, after hospital delivery or within 48 hours after home delivery. Information gathered from patients included routine antenatal and peri-partum data, pregnancy outcomes (abortions, stillbirths, at term delivery, congenital malformations and other adverse events through history taking and physical examination of both mothers and newborns. Results The outcomes for the total sample of 2,050 women were for the treatment (n = 1,072 and control groups (n = 978 respectively: abortions: 1.3% and 0.4%; peri-natal mortality 3.7% and 2.8%; stillbirth 2.9% and 2.4%; neonatal death [less than or equal to]7 days after birth 0.5% and 0.4%; premature delivery 0.7% and 0.3%; congenital malformations 0.3% and 0.3%. A total of 129 obstetric adverse events in 127 subjects were reported (7.3% in the treatment group, 5.0% in the control group. In a multivariate regression model, obstetric complications were more frequent in the treatment group (OR (95% CI: 1.38 (0.95, 2.01, and in primigravidae (OR (95% CI 2.65 (1.71, 4.12 and at higher age (OR per year: 1.05 (1.01-1.09. Conclusions

Center for Drug Evaluation and Research

Data.gov (United States)

Federal Laboratory Consortium — The Center for Drug Evaluation and Research(CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the...

Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features.

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Nikfarjam, Azadeh; Sarker, Abeed; O'Connor, Karen; Ginn, Rachel; Gonzalez, Graciela

2015-05-01

Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs). ADRMine utilizes a variety of features, including a novel feature for modeling words' semantic similarities. The similarities are modeled by clustering words based on unsupervised, pretrained word representation vectors (embeddings) generated from unlabeled user posts in social media using a deep learning technique. ADRMine outperforms several strong baseline systems in the ADR extraction task by achieving an F-measure of 0.82. Feature analysis demonstrates that the proposed word cluster features significantly improve extraction performance. It is possible to extract complex medical concepts, with relatively high performance, from informal, user-generated content. Our approach is particularly scalable, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians.

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Hopf, Yvonne Marina; Bond, Christine B; Francis, Jill J; Haughney, John; Helms, Peter J

2014-02-12

The inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Qualitative study using semistructured face-to-face interviews addressing the study aims. Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important factors to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source datasets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership and responsibilities of data owners.

Data mining for signals in spontaneous reporting databases: proceed with caution.

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Stephenson, Wendy P; Hauben, Manfred

2007-04-01

To provide commentary and points of caution to consider before incorporating data mining as a routine component of any Pharmacovigilance program, and to stimulate further research aimed at better defining the predictive value of these new tools as well as their incremental value as an adjunct to traditional methods of post-marketing surveillance. Commentary includes review of current data mining methodologies employed and their limitations, caveats to consider in the use of spontaneous reporting databases and caution against over-confidence in the results of data mining. Future research should focus on more clearly delineating the limitations of the various quantitative approaches as well as the incremental value that they bring to traditional methods of pharmacovigilance.

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

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... FDA-approved prescription drug that treats ED. Mark Hirsch, a medical team Leader in CDER's Division of ... with drugs that a consumer is already taking," Hirsch says. For example, taking sildenafil in addition to ...

Farmacovigilância em tuberculose: relato de uma experiência no Brasil | Pharmacovigilance in tuberculosis: report of an experience in Brazil

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Jorge Luiz da Rocha

2015-05-01

Program and the National Health Surveillance Agency (ANVISA developed a partnership to implement a pilot pharmacovigilance project to encourage the reporting of adverse reactions to antitubercular agents. Training followed by monitoring visits was conducted by three reference health services for TB treatment. Among the bottlenecks identified, we found limitations in access to the information system (NOTIVISA, slow Internet connection, poor adverse event reporting in medical records, lack of multidisciplinary integration and involvement of managers, and fragility of information flows. As a consequence, technical instructional materials were developed, the NOTIVISA form was improved and shortened, indicators for monitoring notifications were proposed, and information flows were reset. We conclude that the partnership was successful and suggest a similar strategy for other programs. Integration of health teams as well as development of simplified notification tools are challenges to be overcome if pharmacovigilance actions are to be sustainable in the country.

Active and passive surveillance of yellow fever vaccine 17D or 17DD-associated serious adverse events: systematic review.

Science.gov (United States)

Thomas, Roger E; Lorenzetti, Diane L; Spragins, Wendy; Jackson, Dave; Williamson, Tyler

2011-06-20

To identify the rate of serious adverse events attributable to yellow fever vaccination with 17D and 17DD strains reported in active and passive surveillance data. We conducted a systematic review of published literature on adverse events associated with yellow fever. We searched 9 electronic databases for peer reviewed and grey literature in all languages. There were no restrictions on date of publication. Reference lists of key studies were also reviewed to identify additional studies. We identified 66 relevant studies: 24 used active, 17 a combination of passive and active (15 of which were pharmacovigilance databases), and 25 passive surveillance. ACTIVE SURVEILLANCE: A total of 2,660,929 patients in general populations were followed for adverse events after vaccination, heavily weighted (97.7%) by one large Brazilian study. There were no observed cases of viscerotropic or neurotropic disease, one of anaphylaxis and 26 cases of urticaria (hypersensitivity). We also identified four studies of infants and children (n=2199), four studies of women (n=1334), and one study of 174 HIV+, and no serious adverse events were observed. PHARMACOVIGILANCE DATABASES: 10 of the 15 databases contributed data to this review, with 107,621,154 patients, heavily weighted (94%) by the Brazilian database. The estimates for Australia were low at 0/210,656 for "severe neurological disease" and 1/210,656 for YEL-AVD, and also low for Brazil with 9 hypersensitivity events, 0.23 anaphylactic shock events, 0.84 neurologic syndrome events and 0.19 viscerotropic events cases/million doses. The five analyses of partly overlapping periods for the US VAERS database provided an estimate of 6.6 YEL-AVD and YEL-AND cases per million, and estimates between 11.1 and 15.6 of overall "serious adverse events" per million. The estimates for the UK were higher at 34 "serious adverse events" and also for Switzerland with 14.6 "neurologic events" and 40 "serious events not neurological"/million doses

Causes for the underreporting of adverse drug events by health professionals: a systematic review

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Fabiana Rossi Varallo

2014-08-01

Full Text Available Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29 for physicians (22/29, and pharmacists (10/29. The main causes related to underreporting were ignorance (24/29, insecurity (24/29 and indifference (23/29. Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

Condições de implantação e operação da farmacovigilância na indústria farmacêutica no Estado de São Paulo, Brasil Pharmacovigilance implementation and operational conditions in the pharmaceutical industry in São Paulo State, Brazil

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Márcia Sayuri Takamatsu Freitas

2007-01-01

Full Text Available O desenvolvimento de novos produtos farmacêuticos e as limitações dos ensaios clínicos controlados têm sido responsáveis pelo aumento das possibilidades de eventos adversos a medicamentos. A farmacovigilância é essencial para detectar e avaliar eventos adversos a medicamentos reduzindo riscos e evitando gastos excessivos em saúde pública. Este trabalho objetivou conhecer programas de farmacovigilância de indústrias farmacêuticas sediadas no Estado de São Paulo, Brasil. Os dados foram coletados utilizando-se questionário enviado eletronicamente a 105 empresas, das quais 41,9% retornaram. O motivo principal para implantação de programas foi atender exigências regulatórias e a principal justificativa para sua ausência foi produção limitada aos produtos fitoterápicos, ofici-nais e suplementos. Discutem-se as dificuldades para implantação dos programas, os recursos utilizados e características de alguns deles. Conclusões: (a a normatização é fonte de motivação para o aumento dos programas e do número de relatos mas é insuficiente sem esclarecimentos mais específicos; (b os resultados dependem de envolvimento multisetorial; (c o Serviço de Atendimento ao Consumidor é importante fonte de relatos; (d a estrutura da operação do serviço pode ser pouco dispendiosa em termos de recursos humanos e materiais.The development of new drugs and limitations of clinical trials have increased the likelihood of adverse drug events. Pharmacovigilance is essential to detect and evaluate adverse drug events, thereby reducing risks and avoiding excessive public health costs. This study focused on the pharmacovigilance programs in the pharmaceutical industry in São Paulo State, Brazil. Data were collected through questionnaires sent electronically to 105 companies, 41.9% of which responded. The main reason for implementing pharmacovigilance programs was to comply with legal requirements, while the main justification for its absence

Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union.

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Inácio, P; Cavaco, A; Allan, E; Airaksinen, M

2018-02-01

In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, patient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. Qualitative study design. Twelve representatives from national pharmacovigilance centres and/or authorities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face-semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. Four themes (attitudes and beliefs, system maturation factors, regulatory improvements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Adverse drug reaction and concepts of drug safety in Ayurveda: An overview

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Ajanal, Manjunath; Nayak, Shradda; Prasad, Buduru Sreenivasa; Kadam, Avinash

2013-01-01

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb–herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance. PMID:24563588

Evaluation of Palm Oil-Based Paracetamol Suppositories by ...

African Journals Online (AJOL)

Methods: The suppository base was prepared by mixing hydrogenated palm oil and palm kernel ... DSC can be used to predict drug release in paracetamol suppository formulations. Keywords: Palm oil, Liquefaction time, Paracetamol, Suppositories, Thermal analysis. ..... Drug Evaluation & Research (CDER), Food and.

76 FR 26305 - Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To...

Science.gov (United States)

2011-05-06

... to satisfy the previously mentioned statutory requirement. The importance of obtaining these data.... Marketing Applications/Submissions In 2010, CDER and CBER received 165 new drug applications (NDA... ANDA marketing applications and submissions. It is assumed that the sponsor/applicant/submitter has...

76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Science.gov (United States)

2011-12-02

... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

76 FR 37131 - Statement of Organizations, Functions, and Delegations of Authority

Science.gov (United States)

2011-06-24

... delegations and redelegations of authority made to officials and employees of affected organizational...] Statement of Organizations, Functions, and Delegations of Authority AGENCY: Food and Drug Administration... of Organization, Functions, and Delegations of Authority for CDER (35 FR 3685, February 25, 1970, 60...

75 FR 4081 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing...

Science.gov (United States)

2010-01-26

... any changes, in the product, production process, quality controls, equipment, facilities, or... from studies in animals). Section 601.93 provides that biological products approved under subpart H are... an Antibiotic Drug for Human Use'' to harmonize application procedures between CBER and CDER. The...

77 FR 71804 - Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments...

Science.gov (United States)

2012-12-04

...] Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments; Correction... ``Antiseptic Patient Preoperative Skin Preparation Products.'' The document was published with an incorrect... New Hampshire Ave. Silver Spring, MD 20903, 301-796-3441, Fax: 301-847-8753, email: CDER- Antiseptic...

Farmacovigilância da heparina no Brasil Heparin pharmacovigilance in Brazil

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Daniela Rezende Garcia Junqueira

2011-06-01

in Brazil was conducted. RESULTS: Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. CONCLUSIONS: Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

Piloting social engagement on a federal agency-administered Facebook page.

Science.gov (United States)

Chiu, Kimberly; Wagner, Lindsay; Choe, Lena; Chew, Catherine; Kremzner, Mary

2016-01-01

To evaluate the impact of a Federal drug information center initiating engagement with stakeholders on a Facebook Page administered by a Federal Agency. The U.S. Food and Drug Administration (FDA) Facebook page from July 21, 2014, to October 18, 2014. FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) Office of Communications serves as a federal drug information center providing timely, accurate, and useful information on CDER initiatives and CDER-regulated products. We report a 90-day (July 21 to October 18, 2014) pilot during which DDI pharmacists monitored and moderated comments received on FDA's Facebook page to identify those warranting a reply. Once identified, DDI pharmacists replied within 2 business days. Impact was measured by comparing the average number of Likes, Shares, and Reach for Facebook posts before and after the pilot. Additional metrics collected include the number of DDI replies provided to stakeholders' comments and the number of DDI replies provided on time (within 2 business days). During the pilot, DDI contributed 14 posts. On average, each post reached 23,582 more individuals (an increase of 187% compared with pre-pilot posts). On average, each post also received 463 more Likes (450% increase) and 130 more Shares (271% increase). DDI pharmacists replied to 3% (121/3994) and hid 0.58% (23/3994) of Facebook comments received during the 90-day period. All actions were taken within 2 business days. Initiating social engagement had a positive impact on FDA's Facebook page. Published by Elsevier Inc.

CONOCIMIENTOS Y PRÁCTICAS SOBRE FARMACOVIGILANCIA EN PERSONAL DE ESTOMATOLOGÍA

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Ruiz Hernández A

2014-03-01

Full Text Available Cuban system of pharmacovigilance had insufficient reports of adverse drug reactions from personal of dentistry, which constitutes a problem. Our aim was identify knowledge and practical of pharmacovigilance from dentists at Guanabacoa municipality. Method. Observational, descriptive and traverse study. We inquired 104 people (45 dentists and 59 technicians about knowledge and practical in pharmacovigilance. We also asked about years of professional experience, specialty or scientific category. The study was conducted from December 2011 to January 2012. Results. We observed dentists didn't know adverse drug reaction concept (99% although they recognized drug can cause adverse reaction (76%; they didn't know the Cuban official model to report adverse drug reactions (94,2% but the majority recognized pharmacovigilance usefulness (92,3%; they said inform an adverse drug reaction if it appear (85,6%; dentists didn't consult correct sources of information about pharmacovigilance (63,5%; not all of them asked to patient about medications (75%; greater part of them never reported an adverse drug reaction (90,4%. Much of these persons had more than 5 years of professional experience (65,4%; more than middle of dentists was specialist (55,6% but a few of them showed educational or scientific category (9,8%. Conclusions. The knowledge and practical in pharmacovigilance from dentists were deficient; educational and administration strategies about pharmacovigilance can revert these results and improve sanitary attention.

75 FR 34452 - Center for Drug Evaluation and Research Data Standards Plan; Availability for Comment

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2010-06-17

... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane... sources. This wealth of data holds great potential to advance CDER's regulatory and scientific work, but... improvements requires careful analysis, advanced planning, project management, expert input, and effective...

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

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2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

21 CFR 600.2 - Mailing addresses.

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2010-04-01

... Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. (3) Advertising and Promotional Labeling (CDER). All advertising and promotional labeling supplements required under § 601.12(f) of this chapter must be sent to: Division of Drug Marketing, Advertising and Communication, Center for Drug...

Atropinic burden of prescriptions forms in patients with Alzheimer disease: a cross-sectional study in a French PharmacoVigilance Database.

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Montastruc, François; Rouanet, Sarah; Gardette, Virginie; Rousseau, Vanessa; Bagheri, Haleh; Montastruc, Jean-Louis

2015-07-01

Atropinic drugs in patients with Alzheimer disease (AD) can decrease the effects of anticholinesterase drugs and/or induce adverse drug reactions (ADRs). Several atropinic risk scales defining an atropinic burden of drugs were proposed but were little used in AD patients. All ADRs' notifications of AD patients registered in the Midi-Pyrénées PharmacoVigilance Database between 1999 and 2013 were analyzed using Anticholinergic Drug Scale (ADS) and Anticholinergic Duran's list. The primary objective was to quantify atropinic burden in AD patients and the secondary one to investigate associated factors. Among the 475 notifications, at least one atropinic drug was found in 282 notifications (59.4%) according to ADS and 214 (45.1%) according to Duran. Mean number of atropinics per notifications was 0.9 ± 0.9 (ADS) and 0.7 ± 0.9 (Duran). Mean atropinic burden per notifications was 1.2 ± 1.5 (ADS) and 0.9 ± 1.3 (Duran). Atropinic burden ≥ 3 was found in 87 notifications (18.2%) according to ADS and 50 (10.5%) according to Duran. There was no association between atropinic burden and age of patients. The number of drugs is associated to a high atropinic burden. The present work found an association between an atropinic drug and an anticholinesterase agent in around 1 out of 2 AD patients and a clinically significant atropinic burden (≥ 3) in around 1 to 2 AD patients out of 10. The benefit harm balance of atropinic drugs must be discussed before each prescription in AD patients.

Seizures during antidepressant treatment in psychiatric inpatients--results from the transnational pharmacovigilance project "Arzneimittelsicherheit in der Psychiatrie" (AMSP) 1993-2008.

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Köster, M; Grohmann, R; Engel, R R; Nitsche, M A; Rüther, E; Degner, D

2013-11-01

There is little clinical data available about seizure rates in psychiatric inpatients, and there are no studies with reference data to the frequencies of antidepressant (AD) use for this important clinical population. This study investigates seizure rates during AD treatment in psychiatric inpatient settings, drawn from the transnational pharmacovigilance programme Arzneimittelsicherheit in der Psychiatrie (AMSP) in relation to the known frequencies of ADs used in the participating clinics. Comparisons are made to former publications and their limitations. Seventy-seven cases were identified with grand mal seizures (GMS) during AD treatment between 1993 and 2008, with a total number of 142,090 inpatients under surveillance treated with ADs in the participating hospitals. The calculated overall rate of reported seizures of patients during AD treatment in this collective is 0.05 % for ADs imputed alone or in combination with other psychotropic drug groups and 0.02 % when only ADs were given and held responsible for GMS. The patients receiving tri- or tetracyclic ADs (TCAs) had a 2-fold risk to develop a seizure as compared to the overall average rate in this sample. In 11 cases, there was only one AD imputed--the majority of these cases (9/11) were TCA. Monotherapy with selective serotonin reuptake inhibitors (SSRI) or dual serotonin and noradrenaline reuptake inhibitors (SNRI) were never imputed alone in this sample. The results of the study favour the assumption that SSRIs, noradrenergic and specific serotonergic antidepressants (NaSSA) and dual SNRI might be more appropriate than TCAs for the treatment of psychiatric patients with an enhanced seizure risk.

76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

Science.gov (United States)

2011-01-19

...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

Aplicación de la minería de datos al Sistema Cubano de Farmacovigilancia Application of data mining to the Cuban Pharmacovigilance System

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Omar Calzadilla Fernández de Castro

2007-12-01

Full Text Available En el año 1999, se crea la Unidad Nacional Coordinadora de Farmacovigilancia, la cual funciona como el órgano técnico-científico que desarrolla la política de vigilancia de seguridad de medicamentos del Ministerio de Salud Pública e integra las actividades de los centros provinciales y de otros programas concertados de farmacovigilancia en un sistema único. Entre sus funciones más relevantes se encuentran la de definir, diseñar y desarrollar los sistemas de información; administrar la base de datos nacional; depurar y validar la información contenida en ella; y realizar y coordinar estudios científicos sobre la seguridad de los medicamentos; así como elaborar informes para las autoridades sanitarias y el Sistema Nacional de Salud. En este sistema existe la necesidad de utilizar herramientas de análisis, por lo que se trazó el objetivo de definir, diseñar y desarrollar los sistemas de tratamiento de la información y administrar la base de datos nacional "VigiBaseCuba". Aplicando una serie de transformaciones, validaciones y la adecuación de la metodología CRISP-DM para la elaboración de proyectos de minería de datos, se conformó la base de datos nacional, en un sistema de gestión de bases de datos relacional con los registros de las notificaciones de sospechas de reacciones adversas a los medicamentos y un proceso de descubrimiento de conocimiento que permite gestionar eficazmente la seguridad de los medicamentos, así como desarrollar aplicaciones para la visualización de las señales de reacciones adversas y su evoluciónIn 1999, The National Coordinating Unit of Pharmacovigilance was created. It works as a scientific and technical agency that develops the drug safety surveillance policy of the Ministry of Public Health, and integrates the activities of the provincial centres and other pharmacovigilance programs in a unique system. Some of its most important functions are to define, design and develop the information

[Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

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Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

2018-01-01

The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

75 FR 15639 - Revision of the Requirements for Constituent Materials

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2010-03-30

... preservative, except that a preservative need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live... and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as... and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...

77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

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2012-02-29

...] Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Size of Beads in Drug Products Labeled for... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

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Kalaiselvan, Vivekanandan; Sharma, Surbhi; Singh, Gyanendra Nath

2014-09-01

Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI). Individual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome. Of the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%). Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.

Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database.

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Chavant, Francois; Favrelière, Sylvie; Lafay-Chebassier, Claire; Plazanet, Caroline; Pérault-Pochat, Marie-Christine

2011-12-01

To investigate putative associations of reports of memory disorders and suspected drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval. Among the 188,284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4-93). The maximal number of cases occurred between 40-49 and 50-59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin. Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature. Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011

77 FR 16237 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for...

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2012-03-20

... perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3... dispute resolution so that the Center may quickly and efficiently respond to the request: (1) A brief but... single respondent submits more than one time. FDA estimates that CDER receives approximately 18 requests...

76 FR 27332 - Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing

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2011-05-11

... the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast... Genentech and CDER reported that they were unable to reach agreement on how to frame the issues to be resolved. The issues for decision will thus be stated in accordance with the statute and regulations. The...

78 FR 42084 - Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug...

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2013-07-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0812... so that safe and effective products can get to market sooner. It is aligned with the objectives of... as captured in the FDA Safety and Innovation Act. The CDER Data Standards Strategy supersedes version...

Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs

Science.gov (United States)

Aagaard, Lise; Hansen, Ebba Holme

2009-01-01

Background Despite surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after marketing. The aim of this article is to analyse ADRs reported by available ADR signal detection approaches and to explore which information about new and unexpected ADRs these approaches have detected. Methods We selected three therapeutic cases for the review: antibiotics for systemic use, non-steroidal anti-inflammatory medicines (NSAID) and selective serotonin re-uptake inhibitors (SSRI). These groups are widely used and represent different therapeutic classes of medicines. The ADR studies were identified through literature search in Medline and Embase. The search was conducted in July 2007. For each therapeutic case, we analysed the time of publication, the strengths of the evidence of safety in the different approaches, reported ADRs and whether the studies have produced new information about ADRs compared to the information available at the time of marketing. Results 79 studies were eligible for inclusion in the analysis: 23 antibiotics studies, 35 NSAID studies, 20 SSRI studies. Studies were mainly published from the end of the 1990s and onwards. Although the drugs were launched in different decades, both analytical and observational approaches to ADR studies were similar for all three therapeutic cases: antibiotics, NSAIDs and SSRIs. The studies primarily dealt with analyses of ADRs of the type A and B and to a lesser extent C and D, cf. Rawlins' classification system. The therapeutic cases provided similar results with regard to detecting information about new ADRs despite different time periods and organs attacked. Approaches ranging higher in the evidence hierarchy provided information about risks of already known or expected ADRs, while information about new and previously unknown ADRs was only detected by case reports, the lowest ranking approach in the evidence hierarchy. Conclusion Although the medicines were launched in different

Сучасні підходи до безперервного аудиту в системі фармаконагляду Вінницької області: підсумки 2016 року

OpenAIRE

Hladkykh, Fedir; Stepaniuk, Heorhii

2017-01-01

The results of the pharmacovigilance system operation in Vinnytsia region during 2016 are presented based on the data of the electronic online system "Pharmacovigilance-2016", which was first introduced by us on the basis of the table editor Microsoft Excel of the file-hosting system Google Drive. The formula for calculating the efficiency of the pharmacovigilance implementation as an integral assessment of the safety oversight of medical devices in their use in Vinnytsia region during 2016 i...

Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

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Thomas RE

2015-04-01

Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD medications in the pediatric population: a qualitative review of empirical studies

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Aagaard L

2011-12-01

Full Text Available Lise Aagaard1-3, Ebba Holme Hansen1-31Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark; 2FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark; 3Danish Pharmacovigilance Research Project (DANPREP, Copenhagen, DenmarkBackground: To review empirical studies of adverse drug reactions (ADRs reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD symptoms in the pediatric population.Methods: PubMed, Embase, and PsycINFO® databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, atomoxetine, methylphenidate, and modafinil in children from birth to age 17 were included. Information about ADR reporting rates, age and gender of the child, type, and seriousness of ADRs, setting, study design, ADR assessors, authors, and funding sources were extracted.Results: The review identified 43 studies reporting ADRs associated with medicines for treatment of ADHD in clinical studies covering approximately 7000 children, the majority of 6- to 12-year-old boys, and particularly in the United States of America (USA. The most frequently reported ADRs were decrease in appetite, gastrointestinal pain, and headache. There were wide variations in reported ADR occurrence between studies of similar design, setting, included population, and type of medication. Reported ADRs were primarily assessed by the children/their parents, and very few ADRs were rated as being serious. A large number of children dropped out of studies due to serious ADRs, and therefore, the actual number of serious ADRs from use of psychostimulants is probably higher. A large number of studies were conducted by the same groups of authors and sponsored by the pharmaceutical companies manufacturing the respective medications.Conclusion: Reported ADRs from use of

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

Science.gov (United States)

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

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Bahk, Chi Y; Goshgarian, Melanie; Donahue, Krystal; Freifeld, Clark C; Menone, Christopher M; Pierce, Carrie E; Rodriguez, Harold; Brownstein, John S; Furberg, Robert; Dasgupta, Nabarun

salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido ( n  = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered "well documented" 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals. Outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

Science.gov (United States)

Bigi, Caterina; Tuccori, Marco; Bocci, Guido

2017-02-17

To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media.

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Comfort, Shaun; Perera, Sujan; Hudson, Zoe; Dorrell, Darren; Meireis, Shawman; Nagarajan, Meenakshi; Ramakrishnan, Cartic; Fine, Jennifer

2018-06-01

There is increasing interest in social digital media (SDM) as a data source for pharmacovigilance activities; however, SDM is considered a low information content data source for safety data. Given that pharmacovigilance itself operates in a high-noise, lower-validity environment without objective 'gold standards' beyond process definitions, the introduction of large volumes of SDM into the pharmacovigilance workflow has the potential to exacerbate issues with limited manual resources to perform adverse event identification and processing. Recent advances in medical informatics have resulted in methods for developing programs which can assist human experts in the detection of valid individual case safety reports (ICSRs) within SDM. In this study, we developed rule-based and machine learning (ML) models for classifying ICSRs from SDM and compared their performance with that of human pharmacovigilance experts. We used a random sampling from a collection of 311,189 SDM posts that mentioned Roche products and brands in combination with common medical and scientific terms sourced from Twitter, Tumblr, Facebook, and a spectrum of news media blogs to develop and evaluate three iterations of an automated ICSR classifier. The ICSR classifier models consisted of sub-components to annotate the relevant ICSR elements and a component to make the final decision on the validity of the ICSR. Agreement with human pharmacovigilance experts was chosen as the preferred performance metric and was evaluated by calculating the Gwet AC1 statistic (gKappa). The best performing model was tested against the Roche global pharmacovigilance expert using a blind dataset and put through a time test of the full 311,189-post dataset. During this effort, the initial strict rule-based approach to ICSR classification resulted in a model with an accuracy of 65% and a gKappa of 46%. Adding an ML-based adverse event annotator improved the accuracy to 74% and gKappa to 60%. This was further improved by

A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

Directory of Open Access Journals (Sweden)

Masakazu Fujiwara

Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study.

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Ali, Ayad K; Heran, Balraj S; Etminan, Mahyar

2015-07-01

Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary to low-dose finasteride use in young men. Retrospective pharmacovigilance disproportionality analysis. United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Low-dose finasteride-related adverse event reports for men aged 18-45 years that were submitted to the FAERS between 1998 and 2013 were retrieved. Multi-item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (EBGM) and corresponding 95% confidence interval (CI) as an association metric between low-dose finasteride and the events of interest. Signals were defined as associations with thresholds of a CI lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to SD and SI were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent SD and 39 SI adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low-dose finasteride; 34 (87.2%) of the 39 men with SI also experienced SD. The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low-dose finasteride was associated with more than expected reporting of SD in young men compared with reporting of these events with all other drugs within the database (EBGM 28.0, 95% CI 26.1-30.0). Disproportional reporting in SI events was noted, although it did not reach signal threshold (EBGM 1.72; 95% CI 1.31-2.23). Among serious SD events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life-threatening. Six fatal SD

Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

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Wang, Hui-Po; Wang, Chun-Li

2018-04-01

The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication. Copyright © 2018. Published by Elsevier B.V.

Text mining for adverse drug events: the promise, challenges, and state of the art.

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Harpaz, Rave; Callahan, Alison; Tamang, Suzanne; Low, Yen; Odgers, David; Finlayson, Sam; Jung, Kenneth; LePendu, Paea; Shah, Nigam H

2014-10-01

Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. It is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event (ADE) detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources-such as biomedical literature, clinical narratives, product labeling, social media, and Web search logs-that are amenable to text mining for pharmacovigilance. Given the state of the art, it appears text mining can be applied to extract useful ADE-related information from multiple textual sources. Nonetheless, further research is required to address remaining technical challenges associated with the text mining methodologies, and to conclusively determine the relative contribution of each textual source to improving pharmacovigilance.

The Impact of Experiencing Adverse Drug Reactions on the Patient's Quality of Life : A Retrospective Cross-Sectional Study in the Netherlands

NARCIS (Netherlands)

Rolfes, Leàn; van Hunsel, Florence; Taxis, Katja; van Puijenbroek, Eugène

INTRODUCTION: There is little information as to what extent adverse drug reactions (ADRs) influence patients' health-related quality of life (HR-QOL). From a pharmacovigilance perspective, capturing and making the best use of this information remains a challenge. The Netherlands Pharmacovigilance

The use of cyproterone acetate/ethinyl estradiol in hyperandrogenic skin symptoms - a review.

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Bitzer, J; Römer, T; Lopes da Silva Filho, A

2017-06-01

Hyperandrogenism affects approximately 10-20% of women of reproductive age. Hyperandrogenic skin symptoms such as hirsutism, acne, seborrhea and alopecia are associated with significant quality of life and psychological impairment. Women with abnormalities in androgen metabolism may have accompanying anovulation and/or polycystic ovary syndrome (PCOS), both of which have reproductive and metabolic implications if left untreated. Cyproterone acetate (CPA), combined with ethinylestradiol (EE), is indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age. To review the data on the efficacy and safety of CPA 2 mg/EE 35 μg for the treatment of hyperandrogenic skin symptoms in women. A non-systematic narrative review based on a literature search of the PubMed database. Seventy-eight studies were identified. The majority of sufficiently powered studies show a high efficacy of CPA 2 mg/EE 35 μg in the treatment of severe acne and hirsutism. Studies show that therapeutic response in women with hirsutism requires a long-term approach and that hyperandrogenic skin symptoms in patients with PCOS are efficiently treated. Additional benefits include cycle control and, in some women, improvement in mood and perception of body image. Safety and tolerability data are summarized by the pharmacovigilance risk assessment committee (PRAC) of the European Medicine's Agency's (EMA). This review provides a comprehensive overview about the efficacy of CPA 2 mg/EE 35 μg in the treatment of hyperandrogenic skin symptoms, thus allowing both health care professionals and women to balance the risks and benefits of treatment based on evidence.

Protecting the people?: risk communication and the chequered history and performance of bureaucracy.

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Hugman, Bruce

2012-11-01

The history and characteristics of bureaucracy1 are examined with a view to understanding the impact of the bureaucratic mindset on medicines' regulation, the pharmaceutical industry and healthcare delivery with a focus on risk communication, pharmacovigilance and patient safety. Controversies and allegations relating to common, negative effects of bureaucratic regulatory and management systems are reviewed and examples of creative and effective practice provided. Strategic directions and specific actions for reform are proposed.2.

Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia.

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Sales, Ibrahim; Aljadhey, Hisham; Albogami, Yasser; Mahmoud, Mansour A

2017-09-01

Purpose: To assess the general public awareness and perception about Adverse Drug Reactions (ADRs) reporting and pharmacovigilance. Method: A cross-sectional study conducted on June 2012 during awareness campaign held in two malls in Riyadh city for two days. A self-administered questionnaire consisting of three parts was distributed to the attendees who accepted to participate in the study. Results: A total of 204 questionnaires were collected with a response rate of 68%. Twenty-three percent could correctly define ADRs. Only 13(15.7%) of responders were familiar with the term "Pharmacovigilance" and only 78.6% were aware about the Saudi Pharmacovigilance Center. Sixty-seventy percent indicated that their physicians or pharmacists don't actively encourage them to report ADRs that may occur when they take their medications. The majority of responders (73.2%) believed that the medical team, rather than consumers, should report ADRs. When asked why patients do not report ADRs, 19.1(48.5%) believed that patients do not know whether the ADR is from the medication or not, 18.1(46.1%) stated that the reason was because patients don't know about the Pharmacovigilance Center, 16(40.7%) think that patients don't know about the importance of ADRs reporting, and 14(36.3%) responded that patients probably don't know how to report ADRs. Conclusion: The general public in Saudi Arabia are not aware about ADRs reporting and the pharmacovigilance system. The Saudi Food and Drug Authorities (FDA) need to put more efforts to increasing public awareness about the importance of ADRs reporting process and the importance of pharmacovigilance system in promoting patient safety.

The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university

Directory of Open Access Journals (Sweden)

Johnson Segun Showande

2013-01-01

Full Text Available Adverse drug reaction (ADR is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students’ knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of pharmacy students on the concept of pharmacovigilance and adverse drug reaction reporting and also to evaluate their opinions on the National Pharmacovigilance Centre guidelines on adverse drug reaction reporting. A pretested 34-item semi-structured questionnaire was administered among 69 pharmacy undergraduate students in their penultimate and final years that consented to take part in the study, in one of the universities in Nigeria. The study was carried out strictly adhering to the principles outlined in the Helsinki declaration of 1964, which was revised in 1975. The questionnaire used had four sections which included a section on biographical data, a section which evaluated the students knowledge on the concept of pharmacovigilance and adverse drug reaction reporting, a section on students personal experiences of adverse drug reactions and modes of reporting them and the final section of the questionnaire evaluated the students’ opinions on the National Pharmacovigilance Centre guidelines for reporting adverse drug reactions. Descriptive statistics, Mann-Whitney U and Kruskal Wallis statistical tests were used to analyze the data obtained. None of the participants knew the sequence of reporting ADR. More than half, 40(58.0% had heard about pharmacovigilance at symposiums, 7(10.1% during clinical clerkship program and 18(26.1% from media jingles. Twenty nine (42.0% agreed that pharmacovigilance was in their curriculum, however only 16(23.2% could define the term correctly. None of the participants had seen or used an ADR form prior to the study, but the students could easily identify and describe the type of ADR they had

Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature

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M. Varenna

2013-10-01

Full Text Available The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.

Pharmacovigilance Evaluation of the Association Between DPP-4 Inhibitors and Heart Failure: Stimulated Reporting and Moderation by Drug Interactions.

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Fadini, Gian Paolo; Sarangdhar, Mayur; Avogaro, Angelo

2018-04-01

In the SAVOR-TIMI trial, the risk of heart failure (HF) was increased by 27% in T2D patients randomized to the dipeptidyl peptidase-4 inhibitor (DPP4i) saxagliptin. Other studies have provided inconsistent results regarding this association. Herein, we performed a pharmacovigilance analysis of the rate of HF associated with DPP4is, focusing on stimulated reporting and moderation by drug-drug interactions. We mined the FDA adverse event (AE) reporting system (FAERS) from 2004q1 to 2017q3, including a total of 9906,642 AE reports. Rates (/1000 reports) of HF within the reports for DPP4is and reports for other antidiabetic drugs were calculated for the period up to 2013q3 (date of publication of the SAVOR-TIMI trial results) and from 2013q4 to 2017q3. Analyses were refined by filtering according to therapeutic area, concomitant diseases and drugs, and competing AEs. The rate of HF among the AE reports filed for DPP4is significantly increased after 2013q3, especially for saxagliptin. When compared to non-insulin non-glitazone antidiabetic drugs, the proportional reporting ratio (PRR) of HF for DPP4is was 0.62 (95% CI 0.56-0.68) up to 2013q3 and 2.12 (95% CI 1.96-2.28) from 2013q4 to 2017q3. This stimulated reporting was consistent in subanalyses based on the presence/absence of cardiac disorders and after controlling for competing AEs. The rate of HF among AE reports for DPP4is was modestly moderated by the concomitant use of metformin (- 15%) and strongly moderated by the concomitant use of SGLT2 inhibitors (- 63%), even after excluding competing AEs. Within the FAERS, the association between HF and DPP4is was biased by stimulated reporting, implying that the publication of the SAVOR-TIMI trial and the subsequent regulatory warnings primed clinicians to report HF events in DPP4i users as drug-related AEs. The rate of HF associated with DPP4is was moderated when they were used in combination with SGLT2 inhibitors.

Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report

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Sarayu A Pai

2016-01-01

Interpretation & conclusions: In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study

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Akram Ahmad

2013-01-01

Full Text Available Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists′ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.. The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion : The Indian pharmacists have poor knowledge, attitude, and practice (KAP towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists

Medication safety knowledge, attitudes and practices among community pharmacists in Lebanon.

Science.gov (United States)

Hajj, Aline; Hallit, Souheil; Ramia, Elsy; Salameh, Pascale

2018-01-01

The effectiveness of a national post-marketing surveillance program depends directly on the active participation of all health professionals. There is no current comprehensive and active pharmacovigilance program available in Lebanon. To assess the knowledge, attitudes, and practices (KAP) among community pharmacists in Lebanon with respect to potential pharmacovigilance and adverse-drug-reaction reporting in Lebanon. A cross-sectional descriptive study, using a self-administered KAP questionnaire and conducted between March and July 2016, included 1857 pharmacists practicing in community settings. Statistical analysis included χ 2 test for dichotomous or multinomial qualitative variables, and Wilcoxon test for quantitative variables with non-homogeneous variances or non-normal distribution. The majority of responders had good knowledge concerning the concept and purpose of pharmacovigilance as well as adverse drug reactions (how to report these/the importance of reporting adverse events/the definition of an adverse event and pharmacovigilance). Concerning community pharmacists' attitudes and practice towards pharmacovigilance, the majority described having a positive attitude towards their role in adverse drug reaction reporting and this activity was even seen as one of their core duties. The questionnaire revealed a lack of practice and training regarding pharmacovigilance. Nonetheless, the pharmacists agreed on the Order of Pharmacists in Lebanon and the Ministry of Health's role in promoting this practice and helping them be more involved in reporting adverse drug reactions (ADRs). The pharmacists thought that they are well positioned regarding patient-safety practice in their pharmacies and the results were not statistically different between pharmacy employers and employees. Lebanese pharmacists have the required knowledge and positive attitude to start reporting ADRs, were aware of ADRs occurring with various medicines post-marketing, yet were currently not

European Medicines Agency initiatives and perspectives on pharmacogenomics

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Ehmann, Falk; Caneva, Laura; Papaluca, Marisa

2014-01-01

Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to support further the implementation of pharmacogenomics in drug development and surveillance so that patients and the public can benefit from advances in genomic science and technology. PMID:24433361

Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 1: Executive summary

Science.gov (United States)

1981-01-01

Main elements of the design are identified and explained, and the rationale behind them was reviewed. Major systems and plant facilities are listed and discussed. Construction cost and schedule estimates are presented, and the engineering issues that should be reexamined are identified. The latest (1980-1981) information from the MHD technology program is integrated with the elements of a conventional steam power electric generating plant.

Global shortage of neonatal and paediatric antibiotic trials: rapid review.

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Thompson, Georgina; Barker, Charlotte I; Folgori, Laura; Bielicki, Julia A; Bradley, John S; Lutsar, Irja; Sharland, Mike

2017-10-13

There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. Studies were identified using key word searches of the ClinicalTrials.gov registry and were manually filtered using prespecified inclusion/exclusion criteria. 76 registered open CTs of antibiotics in children were identified globally; 23 (30%) were recruiting newborns (only 8 (11%) included preterm neonates), 52 (68%) infants and toddlers, 58 (76%) children and 54 (71%) adolescents. The majority of registered trials were late phase (10 (15%) phase 3 and 23 (35%) phase 4/pharmacovigilance). Two-thirds were sponsored by non-profit organisations, compared with pharmaceutical companies (50 (66%) vs 26 (34%), respectively). A greater proportion of non-profit funded trials were efficacy-based strategic trials (n=34, 68%), in comparison with industry-led trials, which were most often focused on safety or pharmacokinetic data (n=17, 65%). Only 2 of the 37 antibiotics listed on the May 2016 Pew Charitable Trusts antibiotic development pipeline, currently being studied in adults, appear to be currently recruiting in open paediatric CTs. This review highlights that very few paediatric antibiotic CTs are being conducted globally, especially in neonates. There is a striking disparity noted between antibiotic drug development programmes in adults and children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Efficacy and Safety Data of Subsequent Entry Biologics Pertinent to Nephrology Practice: A Systematic Review

Directory of Open Access Journals (Sweden)

Judith Genevieve Marin

2014-12-01

Full Text Available Background: Subsequent entry biologics (SEBs may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. Objectives: To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Design: Systematic review. Sources of information: Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Patients: Adult patients with chronic kidney disease (CKD. Methods: Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs, quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Results: Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic. Limitations: Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled

Pacific Island Pharmacovigilance

DEFF Research Database (Denmark)

McEwen, John; Vestergaard, Lasse S.; Sanburg, Amanda L C

2016-01-01

Many Pacific Island countries (PICs) are recipients of funding support from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). However, most of these countries cannot be expected to meet Global Fund and World Health Organization (WHO) minimum requirements for a functioning...

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance

OpenAIRE

Berrewaerts, Jo?lle; Delbecque, Laure; Orban, Pierre; Desseilles, Martin

2016-01-01

In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might bec...

Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness.

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Fadlallah, Racha; El-Jardali, Fadi; Annan, Farah; Azzam, Hayat; Akl, Elie A

2016-01-01

A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. We conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention. Of 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success. Several factors are critical to the successful design

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

Science.gov (United States)

Amarasinghe, Ananda; Black, Steve; Bonhoeffer, Jan; Carvalho, Sandra M Deotti; Dodoo, Alexander; Eskola, Juhani; Larson, Heidi; Shin, Sunheang; Olsson, Sten; Balakrishnan, Madhava Ram; Bellah, Ahmed; Lambach, Philipp; Maure, Christine; Wood, David; Zuber, Patrick; Akanmori, Bartholomew; Bravo, Pamela; Pombo, María; Langar, Houda; Pfeifer, Dina; Guichard, Stéphane; Diorditsa, Sergey; Hossain, Md Shafiqul; Sato, Yoshikuni

2013-04-18

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable

Knowledge, Attitude, and Practices regarding Pharmacovigilance and Adverse Drug Reaction reporting among Dental Students in a Teaching Hospital, Jodhpur, India: A Cross-sectional Study.

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Chhabra, Kumar G; Sharma, Ashish; Chhabra, Chaya; Reddy, J Jyothirmai; Deolia, Shravani G; Mittal, Yogesh

2017-10-01

This is a cross-sectional knowledge, attitude, and practices (KAPs) study on pharmacovigilance (PV) and adverse drug reaction (ADR) reporting among dental students in a teaching hospital in India. The aim of this study was to assess the KAP of dental students regarding PV, ADR reporting, and barriers toward the same. A cross-sectional survey using a self-administered, investigator-developed, close-ended questionnaire was conducted in an academic dental hospital in India. All prescribers including third year students, final year students, and house surgeons of the same institute were included for assessment of KAP regarding PV using 16, 8, and 8 items respectively. Data regarding barriers toward ADR reporting and demographics were also collected. Mann-Whitney U-test and Kruskal-Wallis test were applied followed by post hoc test. A total of 241 of 275 respondents participated in the study with a response rate of 87.5%. Overall, 64% reported that they had no idea about the term PV. Age was significantly associated with knowledge (p = 0.045) and attitude (p = 0.016). Barriers contributing to underreporting were difficulty in deciding whether or not an ADR has occurred (52.0%), concerns that the report may be wrong (37%), lack of confidence to discuss ADR with colleagues (29%), and almost no financial benefits (24%). Participants had a comparatively favorable attitude toward PV, but their knowledge and practice need considerable improvements. This study highlights the need for appropriate dental curriculum changes and further multicentric studies to shed more light on important issues of PV among dentists in India. This study explores dentists' knowledge, attitude, and behavior regarding PV, which could help to improve patient's safety and care. The favorable attitude of dentists is an indication that PV could be added in depth in the curriculum and in general practice. Information on barriers for reporting the ADRs could help to find possible solutions for removing the

TwiMed: Twitter and PubMed Comparable Corpus of Drugs, Diseases, Symptoms, and Their Relations.

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Alvaro, Nestor; Miyao, Yusuke; Collier, Nigel

2017-05-03

Work on pharmacovigilance systems using texts from PubMed and Twitter typically target at different elements and use different annotation guidelines resulting in a scenario where there is no comparable set of documents from both Twitter and PubMed annotated in the same manner. This study aimed to provide a comparable corpus of texts from PubMed and Twitter that can be used to study drug reports from these two sources of information, allowing researchers in the area of pharmacovigilance using natural language processing (NLP) to perform experiments to better understand the similarities and differences between drug reports in Twitter and PubMed. We produced a corpus comprising 1000 tweets and 1000 PubMed sentences selected using the same strategy and annotated at entity level by the same experts (pharmacists) using the same set of guidelines. The resulting corpus, annotated by two pharmacists, comprises semantically correct annotations for a set of drugs, diseases, and symptoms. This corpus contains the annotations for 3144 entities, 2749 relations, and 5003 attributes. We present a corpus that is unique in its characteristics as this is the first corpus for pharmacovigilance curated from Twitter messages and PubMed sentences using the same data selection and annotation strategies. We believe this corpus will be of particular interest for researchers willing to compare results from pharmacovigilance systems (eg, classifiers and named entity recognition systems) when using data from Twitter and from PubMed. We hope that given the comprehensive set of drug names and the annotated entities and relations, this corpus becomes a standard resource to compare results from different pharmacovigilance studies in the area of NLP. ©Nestor Alvaro, Yusuke Miyao, Nigel Collier. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 03.05.2017.

Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

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Pai, Sarayu A; Kshirsagar, Nilima A

2016-11-01

With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

The Potential Return on Public Investment in Detecting Adverse Drug Effects.

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Huybrechts, Krista F; Desai, Rishi J; Park, Moa; Gagne, Joshua J; Najafzadeh, Mehdi; Avorn, Jerry

2017-06-01

Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available. The drug examples studied were rofecoxib, cerivastatin, and troglitazone. Using an individual patient simulation model and the health care system perspective, we estimated the potential costs that could have been averted by early systematic detection of safety hazards through the implementation of active surveillance programs. We found that earlier drug withdrawal made possible by active safety surveillance would most likely have resulted in savings in direct medical costs of $773-$884 million for rofecoxib, $3-$10 million for cerivastatin, and $38-$63 million for troglitazone in the United States through the prevention of adverse events. By contrast, the yearly public investment in Food and Drug Administration initiated population-based pharmacovigilance activities in the United States is about $42.5 million at present. These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public.

High-Performance Signal Detection for Adverse Drug Events using MapReduce Paradigm.

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Fan, Kai; Sun, Xingzhi; Tao, Ying; Xu, Linhao; Wang, Chen; Mao, Xianling; Peng, Bo; Pan, Yue

2010-11-13

Post-marketing pharmacovigilance is important for public health, as many Adverse Drug Events (ADEs) are unknown when those drugs were approved for marketing. However, due to the large number of reported drugs and drug combinations, detecting ADE signals by mining these reports is becoming a challenging task in terms of computational complexity. Recently, a parallel programming model, MapReduce has been introduced by Google to support large-scale data intensive applications. In this study, we proposed a MapReduce-based algorithm, for common ADE detection approach, Proportional Reporting Ratio (PRR), and tested it in mining spontaneous ADE reports from FDA. The purpose is to investigate the possibility of using MapReduce principle to speed up biomedical data mining tasks using this pharmacovigilance case as one specific example. The results demonstrated that MapReduce programming model could improve the performance of common signal detection algorithm for pharmacovigilance in a distributed computation environment at approximately liner speedup rates.

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance

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Berrewaerts, Joëlle; Delbecque, Laure; Orban, Pierre; Desseilles, Martin

2016-01-01

In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e., Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects). This article describes these advances and highlights their respective contributions. PMID:27148052

[Summarizing of medicinal alerts in Ivory Coast from 2001 till 2010].

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N'Guessan-Irié, Amenan Geneviève; Yavo, Jean-Claude; Guillaume Amari, Antoine Serge; Yapi, Ange Désiré

2012-01-01

STUDY'S AIM: This study aims a more efficient follow-up of the safety of medicines with human usage on the Ivory Coast territory. The structure responsible for pharmacovigilance in Ivory Coast i.e. DPM listed the medicinal alerts from 2001 till 2010. It emerges 237 medicinal alerts among which 145 stops of marketing, 55 withdrawals of lots, 33 information notes and 4 levying of suspension of medicines. These alerts result mainly from pharmaceutical companies (49%) and the French Drug Agency or ANSM (ex-Afssaps) (43%). They mainly concern drugs of infectious target (22%) and pneumology (18%) and their motivations are so much industrial with mainly commercial reasons (27%) as of pharmacovigilance dominated by unfavorable profit/risk connections. These results constitute an important database for the survey of the medicines market in Ivory Coast and an additional motivation to accelerate the implementation of a real national center of pharmacovigilance. © 2012 Société Française de Pharmacologie et de Thérapeutique.

How to improve communication for the safe use of medicines?: Discussions on social marketing and patient-tailored approaches at the annual meetings of the WHO Programme for International Drug Monitoring.

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Bahri, Priya; Harrison-Woolrych, Mira

2012-12-01

Over the past decade, the annual meetings of national centres participating in the WHO Programme for International Drug Monitoring have increasingly included discussions on how to improve communication between national pharmacovigilance centres, patients, healthcare professionals, policy makers and the general public, with the aim of promoting the safe use of medicines. At the most recent meetings, working groups were dedicated to discuss possible applications and implementation of social marketing and patient-tailored approaches. This article provides the history and a summary of the recent discussions and recommendations to support progress in this respect at national and global level. Recommendations are made to investigate and pilot these approaches in small-scale projects at national pharmacovigilance centres. Applying elements from the social marketing and patient-tailored approaches to support behaviours of safe medicines use in patients and healthcare professionals should give the pharmacovigilance community new tools to achieve their goal to minimize risks with medicines and improve patient safety.

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance.

Science.gov (United States)

Berrewaerts, Joëlle; Delbecque, Laure; Orban, Pierre; Desseilles, Martin

2016-01-01

In recent years, pharmacovigilance has undergone some major changes. First, the patient's active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e., Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects). This article describes these advances and highlights their respective contributions.

Patient participation and the use of ehealth tools for pharmacoviligance

Directory of Open Access Journals (Sweden)

Joelle eBerrewaerts

2016-04-01

Full Text Available In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT. Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e. Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects. This article describes these advances and highlights their respective contributions.

Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two “challenging” case reports

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Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M.; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

2013-01-01

Introduction: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. Materials and Methods: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. Results: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Discussion and Conclusion: Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health. PMID:24347986

Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports.

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Palleria, Caterina; Leporini, Christian; Chimirri, Serafina; Marrazzo, Giuseppina; Sacchetta, Sabrina; Bruno, Lucrezia; Lista, Rosaria M; Staltari, Orietta; Scuteri, Antonio; Scicchitano, Francesca; Russo, Emilio

2013-12-01

Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.

Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant. Conceptual Design Engineering Report (CDER). Volume 4: Supplementary engineering data

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1981-01-01

The reference conceptual design of the Magnetohydrodynamic Engineering Test Facility (ETF), a prototype 200 MWe coal-fired electric generating plant designed to demonstrate the commercial feasibility of open cycle MHD is summarized. Main elements of the design are identified and explained, and the rationale behind them is reviewed. Major systems and plant facilities are listed and discussed. Construction cost and schedule estimates, and identification of engineering issues that should be reexamined are also given. The latest (1980-1981) information from the MHD technology program are integrated with the elements of a conventional steam power electric generating plant. Supplementary Engineering Data (Issues, Background, Performance Assurance Plan, Design Details, System Design Descriptions and Related Drawings) is presented.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.

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Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; de Jong-van den Berg, Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

2016-01-01

Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes. The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms. Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (Padvertisement methods used and in their ability to recruit participants in early pregnancy. Recruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs incurred are not insubstantial. Future research is

Do final‐year medical students have sufficient prescribing competencies? A systematic literature review

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Tichelaar, Jelle; Graaf, Sanne; Otten, René H. J.; Richir, Milan C.; van Agtmael, Michiel A.

2018-01-01

Aims Prescribing errors are an important cause of patient safety incidents and are frequently caused by junior doctors. This might be because the prescribing competence of final‐year medical students is poor as a result of inadequate clinical pharmacology and therapeutic (CPT) education. We reviewed the literature to investigate which prescribing competencies medical students should have acquired in order to prescribe safely and effectively, and whether these have been attained by the time they graduate. Methods PubMed, EMBASE and ERIC databases were searched from the earliest dates up to and including January 2017, using the terms ‘prescribing’, ‘competence’ and ‘medical students’ in combination. Articles describing or evaluating essential prescribing competencies of final‐year medical students were included. Results Twenty‐five articles describing, and 47 articles evaluating, the prescribing competencies of final‐year students were included. Although there seems to be some agreement, we found no clear consensus among CPT teachers on which prescribing competencies medical students should have when they graduate. Studies showed that students had a general lack of preparedness, self‐confidence, knowledge and skills, specifically regarding general and antimicrobial prescribing and pharmacovigilance. However, the results should be interpreted with caution, given the heterogeneity and methodological weaknesses of the included studies. Conclusions There is considerable evidence that final‐year students have insufficient competencies to prescribe safely and effectively, although there is a need for a greater consensus among CPT teachers on the required competencies. Changes in undergraduate CPT education are urgently required in order to improve the prescribing of future doctors. PMID:29315721

Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

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Lopez-Gonzalez, Elena; Herdeiro, Maria T; Piñeiro-Lamas, María; Figueiras, Adolfo

2015-02-01

The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs). To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system. A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months. Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55). Pharmacovigilance educational interventions that have proved effective can be

Application of an empiric Bayesian data mining algorithm to reports of pancreatitis associated with atypical antipsychotics.

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Hauben, Manfred

2004-09-01

To compare the results from one frequently cited data mining algorithm with those from a study, which was published in a peer-reviewed journal, that examined the association of pancreatitis with selected atypical antipsychotics observed by traditional rule-based methods of signal detection. Retrospective pharmacovigilance study. The widely studied data mining algorithm known as the Multi-item Gamma Poisson Shrinker (MGPS) was applied to adverse-event reports from the United States Food and Drug Administration's Adverse Event Reporting System database through the first quarter of 2003 for clozapine, olanzapine, and risperidone to determine if a significant signal of pancreatitis would have been generated by this method in advance of their review or the addition of these events to the respective product labels. Data mining was performed by using nine preferred terms relevant to drug-induced pancreatitis from the Medical Dictionary for Regulatory Activities (MedDRA). Results from a previous study on the antipsychotics were reviewed and analyzed. Physicians' Desk References (PDRs) starting from 1994 were manually reviewed to determine the first year that pancreatitis was listed as an adverse event in the product label for each antipsychotic. This information was used as a surrogate marker of the timing of initial signal detection by traditional criteria. Pancreatitis was listed as an adverse event in a PDR for all three atypical antipsychotics. Despite the presence of up to 88 reports/drug-event combination in the Food and Drug Administration's Adverse Event Reporting System database, the MGPS failed to generate a signal of disproportional reporting of pancreatitis associated with the three antipsychotics despite the signaling of these drug-event combinations by traditional rule-based methods, as reflected in product labeling and/or the literature. These discordant findings illustrate key principles in the application of data mining algorithms to drug safety

Exposure to anti-malarial drugs and monitoring of adverse drug reactions using toll-free mobile phone calls in private retail sector in Sagamu, Nigeria: implications for pharmacovigilance

Directory of Open Access Journals (Sweden)

Ogunwande Isiaka A

2011-08-01

Full Text Available Abstract Background Adverse drug reactions (ADRs contribute to ill-health or life-threatening outcomes of therapy during management of infectious diseases. The exposure to anti-malarial and use of mobile phone technology to report ADRs following drug exposures were investigated in Sagamu - a peri-urban community in Southwest Nigeria. Methods Purchase of medicines was actively monitored for 28 days in three Community Pharmacies (CP and four Patent and Proprietary Medicine Stores (PPMS in the community. Information on experience of ADRs was obtained by telephone from 100 volunteers who purchased anti-malarials during the 28-day period. Results and Discussion A total of 12,093 purchases were recorded during the period. Antibiotics, analgesics, vitamins and anti-malarials were the most frequently purchased medicines. A total of 1,500 complete courses of anti-malarials were purchased (12.4% of total purchases; of this number, purchases of sulphadoxine-pyrimethamine (SP and chloroquine (CQ were highest (39.3 and 25.2% respectiuvely. Other anti-malarials purchased were artesunate monotherapy (AS - 16.1%, artemether-lumefantrine (AL 10.0%, amodiaquine (AQ - 6.6%, quinine (QNN - 1.9%, halofantrine (HF - 0.2% and proguanil (PR - 0.2%. CQ was the cheapest (USD 0.3 and halofantrine the most expensive (USD 7.7. AL was 15.6 times ($4.68 more expensive than CQ. The response to mobile phone monitoring of ADRs was 57% in the first 24 hours (day 1 after purchase and decreased to 33% by day 4. Participants in this monitoring exercise were mostly with low level of education (54%. Conclusion The findings from this study indicate that ineffective anti-malaria medicines including monotherapies remain widely available and are frequently purchased in the study area. Cost may be a factor in the continued use of ineffective monotherapies. Availability of a toll-free telephone line may facilitate pharmacovigilance and follow up of response to medicines in a resource

Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

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Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

2018-02-01

Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

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Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

2015-11-15

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

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Balassy, Csilla; Roberts, Donna; Miller, Stephen F

2015-11-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

International Nuclear Information System (INIS)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

2015-01-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

Nicorandil, Gastrointestinal Adverse Drug Reactions and Ulcerations: A Systematic Review.

Science.gov (United States)

Pisano, Umberto; Deosaran, Jordanna; Leslie, Stephen J; Rushworth, Gordon F; Stewart, Derek; Ford, Ian; Watson, Angus J M

2016-03-01

Nicorandil is a popular anti-anginal drug in Europe and Japan. Apart from some common adverse drug reactions (ADR), its safety is satisfactory. Several reports have suggested a link between nicorandil, gastrointestinal (GI) ulceration and fistulas. The review aims to critically appraise, synthesize and present the available evidence of all known GI ADR per anatomical location. The study complied with the PRISMA statement. Literature and pharmacovigilance databases were used to provide rate and/or calculate parameters (median age, median dose, history of symptoms, length of therapy and healing time after withdrawal of the drug). Differences in distribution of quantitative variables were analyzed via Mann-Whitney test. Correlation between quantitative variables was assessed with a Spearman's correlation coefficient. A p value <0.05 was significant. Oral ulcerations occur in 0.2% of the subjects, anal ulcerations are present between 0.07% and 0.37% of patients. Oral and distal GI involvements are the most common ADR (28-29% and 27-31% of all GI ADR, respectively). The hepatobiliary system, the pancreas and salivary glands are not affected by nicorandil exposure. The time to develop oral ulcerations is 74 weeks among people on <30 mg/day compared to only 7.5 weeks in individuals on higher regimens (p = 0.47). There is a significant correlation between dose and ulcer healing time (Spearman's 0.525, p < 0.001). Ulcerative disease is a very commonly reported GI ADR. A delayed ulcerative tendency supports the hypothesis of an ulcerogenic metabolite. Nicorandil seems to act as a cause of the ulcerations, but appears to also work in synergy with other promoting factors. Whether the action of the metabolites relies on a specific mechanism or a simple chemical ulceration is still to be established.

Critical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommendation for Suspension of the Marketing Authorizations for 4 Linear Agents.

Science.gov (United States)

Runge, Val M

2017-06-01

For magnetic resonance, the established class of intravenous contrast media is the gadolinium-based contrast agents. In the 3 decades since initial approval, these have proven in general to be very safe for human administration. However, in 2006, a devastating late adverse reaction to administration of the less stable gadolinium-based contrast agents was identified, nephrogenic systemic fibrosis. The result of actions taken by the European Medicines Agency and the US Food and Drug Administration, stratifying the agents by risk and contraindicating specific agents in severe renal dysfunction, has led to no new cases being identified in North America or Europe. Subsequently, in 2014, long-term deposition in the brain of gadolinium was first shown, after administration of 2 nonionic linear chelates, gadodiamide, and gadopentetate dimeglumine. This has led to an intense focus on the question of in vivo distribution, possible dechelation, and subsequent deposition of gadolinium, together with substantial clarification of the phenomenon as well as stratification of the agents on this basis. This review focuses on 8 critical questions regarding gadolinium deposition in the brain and body, with the answers and discussion therein important for future regulatory decisions and clinical practice. It is now clear that dechelation of gadolinium occurs in vivo with the linear agents and is responsible for this phenomenon, with key experts in the field recommending, except where there is no suitable alternative, a shift in clinical practice from the linear to macrocyclic agents. In addition, on March 10, 2017, the Pharmacovigilance and Risk Assessment Committee of the European Medicines Agency recommended suspension of the marketing authorization for 4 linear gadolinium contrast agents-specifically Omniscan, Optimark, Magnevist, and MultiHance (gadodiamide, gadoversetamide, gadopentetate dimeglumine, and gadobenate dimeglumine)-for intravenous injection. Cited in the report was

Do final-year medical students have sufficient prescribing competencies? A systematic literature review.

Science.gov (United States)

Brinkman, David J; Tichelaar, Jelle; Graaf, Sanne; Otten, René H J; Richir, Milan C; van Agtmael, Michiel A

2018-04-01

Prescribing errors are an important cause of patient safety incidents and are frequently caused by junior doctors. This might be because the prescribing competence of final-year medical students is poor as a result of inadequate clinical pharmacology and therapeutic (CPT) education. We reviewed the literature to investigate which prescribing competencies medical students should have acquired in order to prescribe safely and effectively, and whether these have been attained by the time they graduate. PubMed, EMBASE and ERIC databases were searched from the earliest dates up to and including January 2017, using the terms 'prescribing', 'competence' and 'medical students' in combination. Articles describing or evaluating essential prescribing competencies of final-year medical students were included. Twenty-five articles describing, and 47 articles evaluating, the prescribing competencies of final-year students were included. Although there seems to be some agreement, we found no clear consensus among CPT teachers on which prescribing competencies medical students should have when they graduate. Studies showed that students had a general lack of preparedness, self-confidence, knowledge and skills, specifically regarding general and antimicrobial prescribing and pharmacovigilance. However, the results should be interpreted with caution, given the heterogeneity and methodological weaknesses of the included studies. There is considerable evidence that final-year students have insufficient competencies to prescribe safely and effectively, although there is a need for a greater consensus among CPT teachers on the required competencies. Changes in undergraduate CPT education are urgently required in order to improve the prescribing of future doctors. © 2018 VU University Medical Centre. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Blueprint for prescriber continuing education program.

Science.gov (United States)

2012-06-01

On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.

Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

Science.gov (United States)

Sessa, Maurizio; Rossi, Claudia; Rafaniello, Concetta; Mascolo, Annamaria; Cimmaruta, Daniela; Scavone, Cristina; Fiorentino, Sonia; Grassi, Enrico; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

2016-12-01

The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations.

Science.gov (United States)

Martín Arias, L H; Sanz Fadrique, R; Sáinz Gil, M; Salgueiro-Vazquez, M E

2017-09-05

While vaccination injection site adverse reactions are usually mild and transient in nature, several cases of bursitis and other shoulder injuries have been reported in the medical literature. However, these lesions are not included in vaccine label inserts. To identify the characteristics of post-vaccination shoulder injuries and those of patients and involved vaccines, as well as their potential causes, a systematic review of the cases of vaccination-related bursitis and other shoulder injuries reported in the literature and notified to the Spanish Pharmacovigilance System database (FEDRA) have been conducted. We found 45 cases of bursitis and other shoulder injuries that appeared following the vaccine intramuscular injection given into the deltoid muscle (37 from the systematic review of the literature, and 8 from the scrutiny in the Spanish Pharmacovigilance System database, FEDRA). All the patients were adult, 71.1% females, with a mean and median age of 53.6years (range: 22-89). The most frequently involved vaccines were influenza and pneumococcal vaccines, respectively; followed by diphtheria-tetanus-pertussis, diphtheria-tetanus toxoid, human papillomavirus, and hepatitis A vaccines. The most frequent shoulder lesion was bursitis. Most of patients required medical care due to severe local pain and arm mobility restriction. In a majority of cases, symptoms started 48h post vaccination. Subdeltoid or subacromial bursitis and other shoulder lesions may be more common than suspected. Such lesions predominantly affect women. The cause may be related to antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response. However, they are more likely to be the consequence of a poor injection technique (site, angle, needle size, and failure to take into account patient's characteristics, i. e., sex, body weight, and physical constitution). Therefore, vaccination-related shoulder injuries would be amenable to prevention. Copyright

Hearing impairment associated with oral terbinafine use: a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™.

Science.gov (United States)

Scholl, Joep H G; van Puijenbroek, Eugene P

2012-08-01

The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR) reporting and from Vigibase™, the ADR database of the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre. The objective of the current study was to identify whether the observed association between oral terbinafine use and hearing impairment, based on cases received by Lareb, constitutes a safety signal. Cases of hearing impairment in oral terbinafine users are described. In a case/non-case analysis, the strength of the association in Vigibase™ and the Lareb database was determined (date of analysis August 2011) by calculating the reporting odds ratios (RORs), adjusted for possible confounding by age, sex and ototoxic concomitant medication. For the purpose of this study, RORs were calculated for deafness, hypoacusis and the combination of both, defined as hearing impairment. In the Lareb database, six reports concerning individuals aged 31-82 years, who developed hearing impairment after starting oral terbinafine, were present. The use of oral terbinafine was disproportionally associated with hypoacusis in both the Lareb database (adjusted ROR 3.9; 95% CI 1.7, 9.0) and in Vigibase™ (adjusted ROR 1.7; 95% CI 1.0, 2.8). Deafness was not disproportionally present in either of the databases. Based on the described cases and the statistical analyses from both databases, a causal relationship between the use of oral terbinafine and hearing impairment is possible. The mechanism by which terbinafine could cause hearing impairment has not been elucidated yet. The pharmacological action of terbinafine is based on the inhibition of squalene epoxidase, an enzyme present in both fungal and human cells. This inhibition might result in a decrease in

Safety and pharmacokinetics of dolutegravir in HIV-positive pregnant women: a systematic review.

Science.gov (United States)

Hill, Andrew; Clayden, Polly; Thorne, Claire; Christie, Rachel; Zash, Rebecca

2018-04-01

The integrase strand transfer inhibitor dolutegravir (DTG) is being introduced into low- and middle-income countries (LMICs) as an alternative to first-line treatment with non-nucleoside reverse transcriptase inhibitors. However, DTG is not yet widely recommended for use in pregnant women. The aim of this systematic review was to analyse all available data on birth outcomes and congenital anomalies in the infants of pregnant women treated with DTG. A PubMed and Embase search was conducted using the terms "dolutegravir" or "DTG" and "pregnancy" or "pregnant" from the earliest available date on the database to 26 July 2017. Any reports involving women who were pregnant, HIV positive and taking DTG were included. The percentage of pregnant women with adverse birth outcomes or congenital anomalies in their infants after taking dolutegravir was compared with five historical control databases. There were six databases included in the main analysis of birth outcomes and congenital anomalies, with a total of 1200 pregnant women. The percentage of pregnant women taking DTG with adverse birth outcomes and congenital abnormalities was similar to results from historical control studies of HIV-positive women. However, there was significant heterogeneity among the six databases - the percentage of infants with congenital anomalies ranged from 0.0% in Botswana (0/116 infants) to 13.3% in IMPAACT P1026S (2/15 infants). Up to 15 million people could be on treatment with DTG in LMICs within the next 5 years, of whom a substantial percentage is likely to be women of child-bearing potential. In many countries with large HIV epidemics, unplanned pregnancies are common and access to antenatal clinic facilities may be limited. Continued pharmacovigilance is essential, but it is reassuring that no clear safety signals have been detected, to date, for pregnant women treated with DTG in terms of birth outcomes or congenital anomalies.

EFECTOS ADVERSOS DERMATOLÓGICOS POR ANTIBACTERIANOS.SISTEMA CUBANO DE FARMACOVIGILANCIA. 2007-2009

Directory of Open Access Journals (Sweden)

Alfonso Orta Ismary

2012-01-01

Full Text Available Introduction: Adverse reactions to antimicrobials in Cuba have taken place since 2003 to date, the first in the report of adverse reactions in general, as well as serious and fatal reactions, on the skin and schedules are the systems more affected. This research aimed to characterize the antibacterial dermatologic toxicities reported by the national coordinating pharmacovigilance unit from 2007 to 2009. Method: An observational study of Pharmacovigilance, descriptive and transversal using Spontaneous Reporting of Suspected Adverse Reaction database and the Cuban system of pharmacovigilance. Reports were analyzed for antibacterial dermatologic toxicities reported from 2007 through 2009, the primary endpoint was the dermatologic adverse effect reported. Results: A total of 3006 suspected adverse reactions to skin. Predominated in females (60.2% and in adults, 53.7%. The antibacterial associated with increased number of notifications were 18.5% RL penicillin, amoxicillin, cephalexin, 17.3% and 9.7%. Dermatological adverse events predominated were rash and urticaria. Moderate adverse effects predominated (64.4%, 87.5% were probable and 81.8% common. Conclusions: Adverse dermatologic antibacterial dominated by females and in adults. RL Penicillin was the drug most associated with adverse reactions. Moderate adverse reactions, probable and common were the more frequent in the study.

Project Maghreb - Europe: Solar Production of Hydrogen. Phase I: Feasibility and opportunity study of the project; Projet Maghreb - Europe: Production d'hydrogene solaire. Phase I: Etude d'opportunite et de faisabilite du projet

Energy Technology Data Exchange (ETDEWEB)

Mahmah, Bouziane; Belhamel, Maiouf; Chader, Samira; M' Raoui, Abdelhamid; Harouadi, Farid; Etievant, Claude; Lechevalier, Steve; Cherigui, Abdel-Nasser

2007-07-01

During the 16th World Hydrogen Energy Conference which held on June 13-16, 2006, in Lyon (France), an important project appeared, the Maghreb-Europe Project for production and export of solar hydrogen, proposed in the Algiers Declaration of the hydrogen of origin renewable and directed by the researchers efforts of the Renewable Energies Development Center of Algiers (CDER) and members of the European company of Hydrogen Technologies (CETH). The present introductory communication exposes a scientific study on the appropriateness and the feasibility of the Project, as well as the objectives, missions and the fundamental elements for a scientific and technique accompaniment of this important project. (auth)

Textbook of pharmacoepidemiology

National Research Council Canada - National Science Library

Strom, Brian L; Kimmel, Stephen E

2006-01-01

... Pharmacovigilance Reporting Systems, 101 Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin 8 Overview of Automated Databases in Pharmacoepidemiology, 118 Brian L. Strom 9 Examples of Existing Automated ...

Potential genotoxicity of traditional chinese medicinal plants and phytochemicals: an overview.

Science.gov (United States)

Zhou, Jue; Ouedraogo, Moustapha; Qu, Fan; Duez, Pierre

2013-12-01

In the last decades, cases of poisoning due to herbal medicines have occurred in many countries; Chinese herbal medicines (CHMs) are occasionally involved. The experience gained from traditional use is efficient to detect immediate or near-immediate relationship between administration and toxic effects but is quite unlikely to detect medium- to long-term toxicities; thorough investigations of herbal medicines (toxicity assessments, active pharmacovigilance) appear then essential for their safe use. Genotoxicity is an especially insidious toxicity that may result in carcinoma development years after exposure; it can arise from multiple compounds, with or without metabolic activation. The present work reviews traditional CHMs and phytochemicals that have been shown to present a genotoxic hazard. Copyright © 2013 John Wiley & Sons, Ltd.

Assessment of the knowledge, attitude and practice of ...

African Journals Online (AJOL)

for access and distributed under the terms of the Creative Commons Attribution License ... Its success depends on the awareness ..... result in failure of pharmacists to report ADRs ... PROJECT: Pharmacovigilance for Antiretroviral Drugs.

Mechanism-based drug exposure classification in pharmacoepidemiological studies

NARCIS (Netherlands)

Verdel, B.M.

2010-01-01

Mechanism-based classification of drug exposure in pharmacoepidemiological studies In pharmacoepidemiology and pharmacovigilance, the relation between drug exposure and clinical outcomes is crucial. Exposure classification in pharmacoepidemiological studies is traditionally based on

Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

Science.gov (United States)

Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

2014-01-01

Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

Social Media Listening for Routine Post-Marketing Safety Surveillance.

Science.gov (United States)

Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

2016-05-01

Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

[Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception].

Science.gov (United States)

Pérez-Vilar, S; Díez-Domingo, J; Gomar-Fayos, J; Pastor-Villalba, E; Sastre-Cantón, M; Puig-Barberà, J

2014-08-01

The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

Using Long-Term Satellite Observations to Identify Sensitive Regimes and Active Regions of Aerosol Indirect Effects for Liquid Clouds Over Global Oceans

Science.gov (United States)

Zhao, Xuepeng; Liu, Yangang; Yu, Fangquan; Heidinger, Andrew K.

2018-01-01

Long-term (1981-2011) satellite climate data records of clouds and aerosols are used to investigate the aerosol-cloud interaction of marine water cloud from a climatology perspective. Our focus is on identifying the regimes and regions where the aerosol indirect effects (AIEs) are evident in long-term averages over the global oceans through analyzing the correlation features between aerosol loading and the key cloud variables including cloud droplet effective radius (CDER), cloud optical depth (COD), cloud water path (CWP), cloud top height (CTH), and cloud top temperature (CTT). An aerosol optical thickness (AOT) range of 0.13 change of long-term averaged CDER appears only in limited oceanic regions. The signature of aerosol invigoration of water clouds as revealed by the increase of cloud cover fraction (CCF) and CTH with increasing AOT at the middle/high latitudes of both hemispheres is identified for a pristine atmosphere (AOT polluted marine atmosphere (AOT > 0.3) in the tropical convergence zones. The regions where the second AIE is likely to manifest in the CCF change are limited to several oceanic areas with high CCF of the warm water clouds near the western coasts of continents. The second AIE signature as represented by the reduction of the precipitation efficiency with increasing AOT is more likely to be observed in the AOT regime of 0.08 < AOT < 0.4. The corresponding AIE active regions manifested themselves as the decline of the precipitation efficiency are mainly limited to the oceanic areas downwind of continental aerosols. The sensitive regime of the conventional AIE identified in this observational study is likely associated with the transitional regime from the aerosol-limited regime to the updraft-limited regime identified for aerosol-cloud interaction in cloud model simulations.

FDA toxicity databases and real-time data entry

International Nuclear Information System (INIS)

Arvidson, Kirk B.

2008-01-01

Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared

OntoADR a semantic resource describing adverse drug reactions to support searching, coding, and information retrieval.

Science.gov (United States)

Souvignet, Julien; Declerck, Gunnar; Asfari, Hadyl; Jaulent, Marie-Christine; Bousquet, Cédric

2016-10-01

Efficient searching and coding in databases that use terminological resources requires that they support efficient data retrieval. The Medical Dictionary for Regulatory Activities (MedDRA) is a reference terminology for several countries and organizations to code adverse drug reactions (ADRs) for pharmacovigilance. Ontologies that are available in the medical domain provide several advantages such as reasoning to improve data retrieval. The field of pharmacovigilance does not yet benefit from a fully operational ontology to formally represent the MedDRA terms. Our objective was to build a semantic resource based on formal description logic to improve MedDRA term retrieval and aid the generation of on-demand custom groupings by appropriately and efficiently selecting terms: OntoADR. The method consists of the following steps: (1) mapping between MedDRA terms and SNOMED-CT, (2) generation of semantic definitions using semi-automatic methods, (3) storage of the resource and (4) manual curation by pharmacovigilance experts. We built a semantic resource for ADRs enabling a new type of semantics-based term search. OntoADR adds new search capabilities relative to previous approaches, overcoming the usual limitations of computation using lightweight description logic, such as the intractability of unions or negation queries, bringing it closer to user needs. Our automated approach for defining MedDRA terms enabled the association of at least one defining relationship with 67% of preferred terms. The curation work performed on our sample showed an error level of 14% for this automated approach. We tested OntoADR in practice, which allowed us to build custom groupings for several medical topics of interest. The methods we describe in this article could be adapted and extended to other terminologies which do not benefit from a formal semantic representation, thus enabling better data retrieval performance. Our custom groupings of MedDRA terms were used while performing signal

Contrast media-induced nephropathy: how has Italy contributed in the past 30 years? A systematic review

Directory of Open Access Journals (Sweden)

Sessa M

2017-10-01

contrast-induced nephropathy in Italy during the last three decades. These studies covered procedures to prevent contrast-induced nephropathy or aimed to identify risk factors, biomarkers, and scores, and their related prognosis. Keywords: nephropathy, contrast media, Italy, systematic review, drug safety, adverse drug reaction, pharmacovigilance, post-marketing surveillance

Pan African Medical Journal - Vol 11, No 1 (2012)

African Journals Online (AJOL)

Physical activity and cardiovascular disease risk factors among young and .... A pharmacovigilance study of adults on highly active antiretroviral therapy, South .... with cutaneous psoriasis as the presenting feature of coeliac disease: A case ...

Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis

Science.gov (United States)

2013-01-01

Background Tofacitinib is a disease-modifying antirheumatic drug (DMARD) which was recently approved by US Food and Drug Administration (FDA). There are several randomised clinical trials (RCTs) that have investigated the efficacy and safety of tofacitinib in adult patients with rheumatoid arthritis (RA). A systematic review with a meta-analysis of RCTs was undertaken to determine the efficacy and safety of tofacitinib in treating patients with RA. Methods Electronic and clinical trials register databases were searched for published RCTs of tofacitinib between 2009 and 2013. Outcomes of interest include 20% and 50% improvement in the American College of Rheumatology Scale (ACR20 and ACR50) response rates, rates of infection, the number of immunological/haematological adverse events (AEs), deranged laboratory results (hepatic, renal, haematological tests and lipoprotein level) and the incidence of drug withdrawal. Results Eight RCTs (n = 3,791) were reviewed. Significantly greater ACR20 response rates were observed in patients receiving tofacitinib 5 and 10 mg bid (twice daily) versus placebo at week 12, with risk ratios (RR) of 2.20 (95% CI 1.58, 3.07) and 2.38 (95% CI 1.81, 3.14) respectively. The effect was maintained at week 24 for 5 mg bid (RR 1.94; 95% CI 1.55, 2.44) and 10 mg bid (RR 2.20; 95% CI 1.76, 2.75). The ACR50 response rate was also significantly higher for patients receiving tofacitinib 5 mg bid (RR 2.91; 95% CI 2.03, 4.16) and 10 mg bid (RR 3.32; 95% CI 2.33, 4.72) compared to placebo at week 12. Patients in the tofacitinib group had significantly lower mean neutrophil counts, higher serum creatinine, higher percentage change of LDL/HDL and a higher risk of ALT/AST > 1 ULN (upper limit of normal) versus placebo. There were no significant differences in AEs and withdrawal due to AEs compared to placebo. Conclusion Tofacitinib is efficacious and well tolerated in patients with MTX-resistant RA up to a period of 24 weeks. However

Renal function, nephrogenic systemic fibrosis and other adverse reactions associated with gadolinium-based contrast media.

Science.gov (United States)

Canga, Ana; Kislikova, Maria; Martínez-Gálvez, María; Arias, Mercedes; Fraga-Rivas, Patricia; Poyatos, Cecilio; de Francisco, Angel L M

2014-01-01

Nephrogenic systemic fibrosis is a fibrosing disorder that affects patients with impaired renal function and is associated with the administration of gadolinium-based contrast media used in MRI. Despite being in a group of drugs that were considered safe, report about this potentially serious adverse reaction was a turning point in the administration guidelines of these contrast media. There has been an attempt to establish safety parameters to identify patients with risk factors of renal failure. The close pharmacovigilance and strict observation of current regulations, with special attention being paid to the value of glomerular filtration, have reduced the published cases involving the use of gadolinium-based contrast media. In a meeting between radiologists and nephrologists we reviewed the most relevant aspects currently and recommendations for its prevention.

Knowledge, perceptions and practices of pharmacovigilance ...

African Journals Online (AJOL)

M.C. Joubert

b University of KwaZulu Natal, School of Health Science, Discipline of ... component of the process ensuring that the risk of drug use does not outweigh the benefit. Pharmacists are valuable in collecting PV information, but not many studies ...

The contribution of pharmacogenetics to pharmacovigilance.

Science.gov (United States)

Bondon-Guitton, Emmanuelle; Despas, Fabien; Becquemont, Laurent

2016-04-01

Since the beginning of this century, information on pharmacogenetics appears in the summary of product characteristics (SPC) of drugs. Pharmacogenetic tests particularly concern the enzymes involved in the metabolism of drugs, among which P450 cytochromes. Some patients known as poor metabolisers eliminate some drugs more slowly, causing overdoses and adverse drug reactions (ADRs). The best-known examples are AVK and VKORC1-CYP2C9 or clopidogrel and CYP2C19. In the USA, the tests are recommended before the introduction of these drugs to prevent the occurrence of ADRs. Other tests are also commonly performed to address the toxicity of certain anticancer drugs (DPYD-capecitabine, UGT1A1-irinotecan, TPMT 6-mercaptopurine). Pharmacogenetic testing is also available to identify HLA loci that are very strongly associated with the occurrence of immuno-allergic reactions to a specific drug. The best-known example is HLA-B*5701, strongly associated with hypersensitivity to abacavir, and this test is now always prescribed before the instatement of this drug. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Clinical Pharmacology of Paracetamol in Neonates: A Review

Directory of Open Access Journals (Sweden)

Gian Maria Pacifici, MD, PhD

2015-12-01

Paracetamol clearance is lower in neonates than in children and adults. After metabolic conversion, paracetamol is subsequently eliminated by the renal route. The main metabolic conversions are conjugation with glucuronic acid and with sulphate. In the urine of neonates sulphated paracetamol concentration is higher than the glucuronidated paracetamol level, suggesting that sulfation prevails over glucuronidation in neonates. A loading dose of 20 mg/kg followed by 10 mg/kg every 6 hours of intravenous paracetamol is suggested to achieve a compartment concentration of 11 mg/L in late preterm and term neonates. Aiming for the same target concentration, oral doses are similar with rectal administration of 25 to 30 mg/kg/d in preterm neonates of 30 weeks’ gestation, 45 mg/kg/d in preterm infants of 34 weeks’ gestation, and 60 mg/kg/d in term neonates are suggested. The above-mentioned paracetamol doses for these indications (pain, fever are well tolerated in neonates, but do not result in a significant increase in liver enzymes, and do not affect blood pressure and have limited effects on heart rate. In contrast, the higher doses suggested in extreme preterm neonates to induce closure of the patent ductus arteriosus have not yet been sufficiently evaluated regarding efficacy or safety. Moreover, focussed pharmacovigilance to explore the potential causal association between paracetamol exposure during perinatal life and infancy and subsequent atopy is warranted.

Spontaneous reports of thromboembolic events associated with cyproterone/ethinylestradiol after media attention

NARCIS (Netherlands)

Van Hunsel, Florence; Van Puijenbroek, Eugene; Kant, Agnes

2014-01-01

Background: After extensive media attention on thromboembolic adverse drug reactions (TE-ADRs) and the use of cyproterone/ethinylestradiol (CE), the Netherlands Pharmacovigilance Centre Lareb received a high number of reports about this association, which prompted for detailed analyses. Objectives:

Hearing impairment associated with oral terbinafine use

NARCIS (Netherlands)

Scholl, Joep; Van Grootheest, Kees; Van Puijenbroek, Eugene

Background: The Netherlands Pharmacovigilance Centre Lareb received six reports of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database of spontaneous ADR reporting and from Vigibase, the

Probabilistic record linkage for monitoring the safety of artemisinin-based combination therapy in the first trimester of pregnancy in Senegal

NARCIS (Netherlands)

Dellicour, Stephanie; Brasseur, Philippe; Thorn, Per; Gaye, Oumar; Olliaro, Piero; Badiane, Malik; Stergachis, Andy; ter Kuile, Feiko O.

2013-01-01

There are insufficient data on the safety in early pregnancy of the artemisinins, a new class of antimalarials. Assessment of drug teratogenicity requires large sample sizes for an adequate risk-benefit assessment. There is currently limited pharmacovigilance infrastructure in malaria-endemic

Verstoring van de pilcyclus tijdens het gelijktijdig gebruik van itraconazol en orale anticonceptiva

NARCIS (Netherlands)

van Puijenbroek, E P; Feenstra, J; Meyboom, R H

1998-01-01

Since the introduction of itraconazole in the Netherlands, the Netherlands Pharmacovigilance Foundation LAREB and the Inspectorate for Health Care received 15 reports of pill cycle disturbances and one of pregnancy occurring during simultaneous use of itraconazole and oral contraceptives. Twelve

Syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatraemia associated with valproic Acid : four case reports from the Netherlands and a case/non-case analysis of vigibase

NARCIS (Netherlands)

Beers, Erna; van Puijenbroek, Eugène P; Bartelink, Imke H; van der Linden, Carolien M J; Jansen, Paul A F

The Netherlands Pharmacovigilance Centre Lareb received four cases of severe symptomatic hyponatraemia or syndrome of inappropriate antidiuretic hormone secretion (SIADH) in association with valproic acid use, in which a causal relationship was suspected. This study describes these cases and gives

Adverse Drug Reactions Reported With Cholinesterase Inhibitors : An Analysis of 16 Years of Individual Case Safety Reports From VigiBase

NARCIS (Netherlands)

Kroeger, Edeltraut; Mouls, Marie; Wilchesky, Machelle; Berkers, Mieke; Carmichael, Pierre-Hugues; van Marum, Rob; Souverein, Patrick; Egberts, Toine; Laroche, Marie-Laure

2015-01-01

Background: No worldwide pharmacovigilance study evaluating the spectrum of adverse drug reactions (ADRs) induced by cholinesterase inhibitors (ChEI) in Alzheimer's disease has been conducted since their emergence on the market. Objective: To describe ChEI related ADRs in Alzheimer's disease

The IMI PROTECT project : purpose, organizational structure, and procedures

NARCIS (Netherlands)

Reynolds, Robert F; Kurz, Xavier; de Groot, Mark C H|info:eu-repo/dai/nl/313936455; Schlienger, Raymond G; Grimaldi-Bensouda, Lamiae; Tcherny-Lessenot, Stephanie; Klungel, Olaf H|info:eu-repo/dai/nl/181447649

2016-01-01

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015,

Alopecia in association with lamotrigine use : an analysis of individual case safety reports in a global database

NARCIS (Netherlands)

Tengstrand, Maria; Star, Kristina; van Puijenbroek, Eugène P; Hill, Richard

BACKGROUND: The WHO Programme for International Drug Monitoring, maintained by the Uppsala Monitoring Centre (UMC), has more than 90 member countries contributing individual case safety reports (ICSRs) from their existing national pharmacovigilance systems; these reports are stored in the WHO global

Leg amputation following intramuscular injection of iron dextran in a 32 year old woman

Directory of Open Access Journals (Sweden)

Gloria Shalviri

2015-10-01

Full Text Available To inform healthcare professionals of a rare serious reaction leading to leg amputation following intramuscular injection of iron dextran and report comments for preventing such reactions.A case of leg amputation following intramuscular injection of iron dextran reported to Iranian Pharmacovigilance Center was reviewed. Patient and reaction data was collected by assessing the reported yellow card, patient chart review and interviewing with patient and physicians. World Health Organization definition for serious reactions was used to determine the seriousness of the reaction. Naranjo algorithm was used to determine probability scale. The probability of the reaction was determined based on questionnaire of Schumock et al. The studied case is classified as a rare and serious but preventable reaction induced by intramuscular injection of iron dextran in a 32 year old woman. The probability of the reaction is appeared to be “probable” based on Naranjo algorithm. It seems that Iron dextran could cause serious and life threatening adverse effects. It is necessary for healthcare professionals to be informed of such rare but serious reaction in order to apply preventive actions.

Knowledge, Attitude and Practice of Adverse Drug Reaction ...

African Journals Online (AJOL)

Erah

Purpose: To determine the knowledge, attitude and practice of ADR monitoring and ... of nurses in pharmacovigilance will go a long way in improving reporting of ADRs. .... Know. None. Suspected ADR. Medical practitioner. Pharmacy. Nursing. 31. 01 .... patients, especially patients on hospital .... international experience.

Bijwerkingen van anti-epileptica en convulsies als bijwerkingen : Medicamenten en epilepsie

NARCIS (Netherlands)

Diemont, W.L.; Van Puijenbroek, E.P.; Hekster, Y.A.

2002-01-01

The Netherlands Pharmacovigilance Foundation(Lareb) evaluates the reports as generated by the spontaneous adverse event reporting system. This article describes the adverse event profile of antiepileptic drugs, as well as other drugs that may cause seizures that have been reported to Lareb.

Adverse Drug Reactions Reported With Cholinesterase Inhibitors: An Analysis of 16 Years of Individual Case Safety Reports From VigiBase

NARCIS (Netherlands)

Kroger, E.; Mouls, M.; Wilchesky, M.; Berkers, M.; Carmichael, P.H.; van Marum, R.J.; Souverein, P.; Egberts, T.; Laroche, M.L.

2015-01-01

Background: No worldwide pharmacovigilance study evaluating the spectrum of adverse drug reactions (ADRs) induced by cholinesterase inhibitors (ChEI) in Alzheimer’s disease has been conducted since their emergence on the market. Objective: To describe ChEI related ADRs in Alzheimer’s disease

The concept of adverse drug reaction reporting: awareness among ...

African Journals Online (AJOL)

Arun Kumar Agnihotri

concept of pharmacovigilance and adverse drug reaction reporting, a section on ... ADR go undocumented worldwide8,9. ... international drug monitoring collaborating centre, ... practitioners to report all suspected ADR, the few .... more with some of the guidelines such as nurses, .... patients: a meta-analysis of prospective.

Adverse drug reaction reports for cardiometabolic drugs from sub Sahara Africa: A study in VigiBase

NARCIS (Netherlands)

Berhe, Derbew F.; Juhlin, Kristina; Star, Kristina; Haaijer-Ruskamp, Flora M.; Michael, Kidane; Taxis, Katja; Mol, Peter G. M.

2014-01-01

Background: Many pharmacovigilance centers have been established in Sub Sahara Africa (SSA) in recent years. Their focus has been on ADRs to drugs for communicable diseases. Little is known about ADRs caused by drugs for cardiometabolic diseases, although its burden is increasing rapidly in SSA.

The impact of withdrawal rofecoxib on NSAIDs utilization

NARCIS (Netherlands)

Atthobari, J.; Boersma, C.; Visser, S.T.; Postma, M.J.; De Jong-Van Den Berg, L.T.W.

2010-01-01

Background: Pharmacovigilance is an important tool to gather real-life information on effectiveness and adverse effects of drugs. Therefore, post-marketing study can lead to new therapeutic insights or even market withdrawal. In September 2004, rofecoxib was withdrawn from the market for reasons of

Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events

DEFF Research Database (Denmark)

Roitmann, Eva; Eriksson, Robert; Brunak, Søren

2014-01-01

New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse...

A Cross-Sectional Study on Knowledge and Perceptions of ...

African Journals Online (AJOL)

Purpose: To assess the perceptions and knowledge of pharmacovigilance and adverse drug reactions (ADRs) reporting among Bachelor of Pharmacy (BPharm) and Doctor of Pharmacy (PharmD) students of selected tertiary institutions in Jordan. Methods: A cross-sectional study involving 434 pharmacy students from three ...

Influence of aerosol-cloud interaction on austral summer precipitation over Southern Africa during ENSO events

Science.gov (United States)

Ruchith, R. D.; Sivakumar, V.

2018-04-01

In the present study, we are investigating the role of aerosols-and clouds in modulating the austral summer precipitation (December-February) during ENSO events over southern Africa region for the period from 2002 to2012 by using satellite and complimentary data sets. Aerosol radiative forcing (ARF) and Cloud radiative forcing (CRF) shows distinct patterns for El-Nina and La-Nina years. Further analysis were carried out by selecting the four Southern Africa regions where the precipitation shows remarkable difference during El-Nino and La-Nina years. These regions are R1 (33°S-24°S, 18°E-30°E), R2 (17°S-10°S, 24°E-32°E), R3 (19°S-9°S, 33°E-41°E) and R4 (7°S-0°S, 27°E-36°E). Aerosol Optical depth (AOD) shows considerable differences during these events. In region R1, R2 and R3 AOD shows more abundance in El-Nino years as compared to La-Nina years where as in R4 the AOD shows more abundance in La-Nina years. Cloud Droplet Effective radius (CDER) shows higher values during La-Nina years over R1, R2 and R3 regions but in R4 region CDER shows higher values in El-Nino years. Aerosol indirect effect (AIE) is estimated both for fixed cloud liquid water path (CLWP) and for fixed cloud ice path (CIP) bins, ranging from 1 to 300 gm -2 at 25 gm -2 interval over all the selected regions for El-Nino and La-Nina years. The results indicate more influence of positive indirect effect (Twomey effect) over R1 and R3 region during El-Nino years as compared to La-Nina years. This analysis reveals the important role of aerosol on cloud-precipitation interaction mechanism illustrating the interlinkage between dynamics and microphysics during austral summer season over southern Africa.

Gaps in monitoring systems for Implanon NXT services in South Africa

African Journals Online (AJOL)

Staff often took the initiative to fill gaps in reporting systems. Current systems are unable to accurately monitor uptake or discontinuation, or identify aspects of services requiring strengthening. Lack of pharmacovigilance data is especially concerning. Deficiencies noted in these monitoring systems may be common to family ...

Bijwerkingen van tramadol : 12 jaar ervaring in Nederland

NARCIS (Netherlands)

Kabel, J S; van Puijenbroek, E P

2005-01-01

Tramadol is a synthetic opioid that has been available in the Netherlands since 1992 and is usually used as a centrally-acting analgesic when paracetamol or an NSAID provides insufficient relief. In the period 1 January 1992--30 November 2003, the Netherlands Pharmacovigilance Centre Lareb received

[Drug surveillance and adverse reactions to drugs. The literature and importance of historical data].

Science.gov (United States)

Mariani, L; Minora, T; Ventresca, G P

1996-12-01

The authors highlight the essential role of pharmacovigilance and the need for a simple, efficient and low-cost system of adverse reaction (AR) reporting which could cover the whole population and all marketed drugs, and suggest that the only one presently viable is based on spontaneous reporting. To support their proposal the authors provide a definition of AR and of the different monitoring system, and list as many drugs as possible to find in the literature that have been associated with a specific AR, together with the active molecule, the therapeutic indication, the features of the AR and the regulatory actions (withdrawal from the market, restriction of use). Moreover, by describing the "history" behind some of these drugs the authors highlight the contribution that pharmacovigilance and spontaneous reporting have had to the development of regulations for approval and marketing of new drugs. It is also highlighted how some of these unexpected events (thalidomide, DES) have had a significant and important contribution to pharmacological and toxicological knowledge.

An EAACI “European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)”: the methodology

DEFF Research Database (Denmark)

Calderón, Moises A; Rodríguez Del Río, Pablo; Vidal, Carmen

2014-01-01

and a "harmonised terminology" according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective...

The value of time-to-onset in statistical signal detection of adverse drug reactions : a comparison with disproportionality analysis in spontaneous reports from the Netherlands

NARCIS (Netherlands)

Scholl, Joep H G; van Puijenbroek, Eugène P

2016-01-01

PURPOSE: In pharmacovigilance, the commonly used disproportionality analysis (DPA) in statistical signal detection is known to have its limitations. The aim of this study was to investigate the value of the time to onset (TTO) of ADRs in addition to DPA. METHODS: We performed a pilot study using

Magnetohydrodynamics (MHD) Engineering Test Facility (ETF) 200 MWe power plant Conceptual Design Engineering Report (CDER)

Science.gov (United States)

1981-01-01

The reference conceptual design of the magnetohydrodynamic (MHD) Engineering Test Facility (ETF), a prototype 200 MWe coal-fired electric generating plant designed to demonstrate the commercial feasibility of open cycle MHD, is summarized. Main elements of the design, systems, and plant facilities are illustrated. System design descriptions are included for closed cycle cooling water, industrial gas systems, fuel oil, boiler flue gas, coal management, seed management, slag management, plant industrial waste, fire service water, oxidant supply, MHD power ventilating

Pharmacovigilance: the devastating consequences of not thinking ...

African Journals Online (AJOL)

safety profile of the complex drug regimens that patients with HIV/. AIDS are often ... found that the cost of managing ADRs places a significant burden on health care ... major global public health problem that needs to be addressed at all levels of health care. .... elderly, pregnant women) is often not available or incomplete ...

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

Science.gov (United States)

Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène

2017-07-01

Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

Practice implications and recommendations for managing codeine misuse and dependence

Directory of Open Access Journals (Sweden)

Bergin Michael

2015-12-01

Full Text Available Codeine, a weak opiate, requires increased pharmacovigilance relating to availability, heterogeneous nature of misuse, dependence and associated harm. A scoping review of literature on codeine was conducted using Arksey & O’Malley’s framework (1. Databases searched included PubMed, EBSCO Host, Science Direct, EMBASE, PsycINFO, Cochrane library and Medline from 1994 to 2014. Follow-up search strategies involved hand searching and searching of pharmaceutical, health, medical and drug related websites. Initial zscreening identified 3,105 articles with 475 meeting the inclusion criteria. Eight broad categories organised the literature, data charting and qualitative synthesis. This paper presents implications for practice and makes recommendations to address these issues. Themes identified relate to raising public and practitioner awareness, risk management, dispensing practices and monitoring and surveillance of codeine. Evidence to inform law enforcement, drug surveillance, public health initiatives, harm reduction approaches, pharmacy, clinical and treatment practices is warranted.

Het melden van bijwerkingen in Nederland : Een substantiële bijdrage van de apothekers

NARCIS (Netherlands)

Van Grootheest, A.C.; Van Puijenbroek, E.P.; De Jong-van den Berg, L.T.W.

2003-01-01

Purpose. Aim of the study is to get a better view of the contribution of pharmacists to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. Methods. 15,293 reports, sent to the Netherlands Pharmacovigilance Foundation

Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.

Science.gov (United States)

Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

2018-01-01

Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index. We included licensed analgesics that were withdrawn after marketing because of adverse reactions between 1950 and March 2017. We excluded herbal products, non-human medicines, and non-prescription medicines. We used the Oxford Centre for Evidence Based Medicine criteria to document the levels of evidence, and chi-squared tests to compare withdrawal patterns across geographical regions. Expert opinion: Pharmacovigilance systems in low-resource settings should be strengthened. Greater co-ordination across regulatory authorities in assessing and interpreting the benefit-harm balance of new analgesics should be encouraged. Future reporting of harms in clinical trials of analgesics should follow standardized guidelines.

Author Details

African Journals Online (AJOL)

Oriaifo, SEO. Vol 22 (2007) - Articles Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood Pressure Abstract. ISSN: 0303-691X. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners · Terms and Conditions of Use · Contact ...

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Science.gov (United States)

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

Big data - smart health strategies. Findings from the yearbook 2014 special theme.

Science.gov (United States)

Koutkias, V; Thiessard, F

2014-08-15

To select best papers published in 2013 in the field of big data and smart health strategies, and summarize outstanding research efforts. A systematic search was performed using two major bibliographic databases for relevant journal papers. The references obtained were reviewed in a two-stage process, starting with a blinded review performed by the two section editors, and followed by a peer review process operated by external reviewers recognized as experts in the field. The complete review process selected four best papers, illustrating various aspects of the special theme, among them: (a) using large volumes of unstructured data and, specifically, clinical notes from Electronic Health Records (EHRs) for pharmacovigilance; (b) knowledge discovery via querying large volumes of complex (both structured and unstructured) biological data using big data technologies and relevant tools; (c) methodologies for applying cloud computing and big data technologies in the field of genomics, and (d) system architectures enabling high-performance access to and processing of large datasets extracted from EHRs. The potential of big data in biomedicine has been pinpointed in various viewpoint papers and editorials. The review of current scientific literature illustrated a variety of interesting methods and applications in the field, but still the promises exceed the current outcomes. As we are getting closer towards a solid foundation with respect to common understanding of relevant concepts and technical aspects, and the use of standardized technologies and tools, we can anticipate to reach the potential that big data offer for personalized medicine and smart health strategies in the near future.

Big Data - Smart Health Strategies

Science.gov (United States)

2014-01-01

Summary Objectives To select best papers published in 2013 in the field of big data and smart health strategies, and summarize outstanding research efforts. Methods A systematic search was performed using two major bibliographic databases for relevant journal papers. The references obtained were reviewed in a two-stage process, starting with a blinded review performed by the two section editors, and followed by a peer review process operated by external reviewers recognized as experts in the field. Results The complete review process selected four best papers, illustrating various aspects of the special theme, among them: (a) using large volumes of unstructured data and, specifically, clinical notes from Electronic Health Records (EHRs) for pharmacovigilance; (b) knowledge discovery via querying large volumes of complex (both structured and unstructured) biological data using big data technologies and relevant tools; (c) methodologies for applying cloud computing and big data technologies in the field of genomics, and (d) system architectures enabling high-performance access to and processing of large datasets extracted from EHRs. Conclusions The potential of big data in biomedicine has been pinpointed in various viewpoint papers and editorials. The review of current scientific literature illustrated a variety of interesting methods and applications in the field, but still the promises exceed the current outcomes. As we are getting closer towards a solid foundation with respect to common understanding of relevant concepts and technical aspects, and the use of standardized technologies and tools, we can anticipate to reach the potential that big data offer for personalized medicine and smart health strategies in the near future. PMID:25123721

Antimalarial activity of medicinal plants from the Democratic Republic of Congo: A review.

Science.gov (United States)

Memvanga, Patrick B; Tona, Gaston L; Mesia, Gauthier K; Lusakibanza, Mariano M; Cimanga, Richard K

2015-07-01

Malaria is the most prevalent parasitic disease and the foremost cause of morbidity and mortality in the Democratic Republic of Congo. For the management of this disease, a large Congolese population recourses to traditional medicinal plants. To date the efficacy and safety of many of these plants have been validated scientifically in rodent malaria models. In order to generate scientific evidence of traditional remedies used in the Democratic Republic of Congo for the management of malaria, and show the potential of Congolese plants as a major source of antimalarial drugs, this review highlights the antiplasmodial and toxicological properties of the Congolese antimalarial plants investigated during the period of 1999-2014. In doing so, a useful resource for further complementary investigations is presented. Furthermore, this review may pave the way for the research and development of several available and affordable antimalarial phytomedicines. In order to get information on the different studies, a Google Scholar and PubMed literature search was performed using keywords (malaria, Congolese, medicinal plants, antiplasmodial/antimalarial activity, and toxicity). Data from non-indexed journals, Master and Doctoral dissertations were also collected. Approximately 120 extracts and fractions obtained from Congolese medicinal plants showed pronounced or good antiplasmodial activity. A number of compounds with interesting antiplasmodial properties were also isolated and identified. Some of these compounds constituted new scaffolds for the synthesis of promising antimalarial drugs. Interestingly, most of these extracts and compounds possessed high selective activity against Plasmodium parasites compared to mammalian cells. The efficacy and safety of several plant-derived products was confirmed in mice, and a good correlation was observed between in vitro and in vivo antimalarial activity. The formulation of several plant-derived products also led to some clinical trials

Language does not come "in boxes": Assessing discrepancies between adverse drug reactions spontaneous reporting and MedDRA® codes in European Portuguese.

Science.gov (United States)

Inácio, Pedro; Airaksinen, Marja; Cavaco, Afonso

2015-01-01

The description of adverse drug reactions (ADRs) by health care professionals (HCPs) can be highly variable. This variation can affect the coding of a reaction with the Medical Dictionary for Regulatory Activities (MedDRA(®)), the gold standard for pharmacovigilance database entries. Ultimately, the strength of a safety signal can be compromised. The objective of this study was to assess: 1) participation of different HCPs in ADR reporting, and 2) variation of language used by HCPs when describing ADRs, and to compare it with the corresponding MedDRA(®) codes. A retrospective content analysis was performed, using the database of spontaneous reports submitted by HCPs in the region of the Southern Pharmacovigilance Unit, Portugal. Data retrieved consisted of the idiomatic description of all ADRs occurring in 2004 (first year of the Unit activity, n = 53) and in 2012 (n = 350). The agreement between the language used by HCPs and the MedDRA(®) dictionary codes was quantitatively assessed. From a total of 403 spontaneous reports received in the two years, 896 words describing ADRs were collected. HCPs presented different levels of pharmacovigilance participation and ADR idiomatic descriptions, with pharmacists providing the greatest overall contribution. The agreement between the language used in spontaneous reports and the corresponding MedDRA(®) terms varied by HCP background, with nurses presenting the poorer results than medical doctors and pharmacists when considering the dictionary as the gold standard in ADRs' language. Lexical accuracy and semantic variations exist between different HCP groups. These differences may interfere with the strength of a generated safety signal. Clinical and MedDRA(®) terminology training should be targeted to increase not only the frequency, but also the quality of spontaneous reports, in accordance with HCPs' experience and background. Copyright © 2015 Elsevier Inc. All rights reserved.

Safety of Seasonal Malaria Chemoprevention (SMC with Sulfadoxine-Pyrimethamine plus Amodiaquine when Delivered to Children under 10 Years of Age by District Health Services in Senegal: Results from a Stepped-Wedge Cluster Randomized Trial.

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J L NDiaye

Full Text Available It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age.A surveillance system was established to record all deaths and all malaria cases diagnosed at health facilities and a pharmacovigilance system was established to detect adverse drug reactions. Health posts were randomized to introduce SMC in a stepped wedge design. SMC with SPAQ was administered once per month from September to November, by nine health-posts in 2008, by 27 in 2009 and by 45 in 2010.After three years, 780,000 documented courses of SMC had been administered. High coverage was achieved. No serious adverse events attributable to the intervention were detected, despite a high level of surveillance.SMC is being implemented in countries of the sub-Sahel for children under 5 years of age, but in some areas the age distribution of cases of malaria may justify extending this age limit, as has been done in Senegal. Our results show that SMC is well tolerated in children under five and in older children. However, pharmacovigilance should be maintained where SMC is implemented and provision for strengthening national pharmacovigilance systems should be included in plans for SMC implementation.ClinicalTrials.gov NCT 00712374.

[Post-marketing drug safety-risk management plan(RMP)].

Science.gov (United States)

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

[Peranesthesic Anaphylactic Shocks: Contribution of a Clinical Data Warehouse].

Science.gov (United States)

Osmont, Marie-Noëlle; Campillo-Gimenez, Boris; Metayer, Lucie; Jantzem, Hélène; Rochefort-Morel, Cécile; Cuggia, Marc; Polard, Elisabeth

2015-10-16

To evaluate the performance of the collection of cases of anaphylactic shock during anesthesia in the Regional Pharmacovigilance Center of Rennes and the contribution of a query in the biomedical data warehouse of the French University Hospital of Rennes in 2009. Different sources were evaluated: the French pharmacovigilance database (including spontaneous reports and reports from a query in the database of the programme de médicalisation des systèmes d'information [PMSI]), records of patients seen in allergo-anesthesia (source considered as comprehensive as possible) and a query in the data warehouse. Analysis of allergo-anesthesia records detected all cases identified by other methods, as well as two other cases (nine cases in total). The query in the data warehouse enabled detection of seven cases out of the nine. Querying full-text reports and structured data extracted from the hospital information system improves the detection of anaphylaxis during anesthesia and facilitates access to data. © 2015 Société Française de Pharmacologie et de Thérapeutique.

Biosimilars: A new scenario in biologic therapies.

Science.gov (United States)

Serra López-Matencio, José M; Morell Baladrón, Alberto; Castañeda, Santos

There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Re-Viewing Peer Review

Science.gov (United States)

Flynn, Elizabeth A.

2011-01-01

In this article, the author revisits her essay, "Students as Readers of Their Classmates' Writing," by providing a review of the literature on peer review over the past three decades and comments on patterns she sees in waves of peer review research and theorizing. She describes her subsequent experience with peer review in her own classes, and…

The need for greater opioid pharmacovigilance in COPD

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Vozoris NT

2017-01-01

Full Text Available Nicholas T Vozoris1–3 1Division of Respirology, Department of Medicine, St Michael’s Hospital, Toronto, ON, Canada; 2Keenan Research Centre in the Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, ON, Canada; 3Department of Medicine, University of Toronto, Toronto, ON, Canada I read with interest the article by Ahmadi et al1 that described the use of prescription opioid drugs among Swedes with advanced COPD. The authors are to be commended for their research work on this important clinical topic. I would like to bring to the attention of your readers several points though. Read the original article by Ahmadi et al

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

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Amur, S; LaVange, L; Zineh, I; Buckman-Garner, S; Woodcock, J

2015-07-01

The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration. © 2015 American Society for Clinical Pharmacology and Therapeutics.

1827-IJBCS-Article- Barry Mamoudou

African Journals Online (AJOL)

hp

La spiruline est une algue utilisée pour ses effets nutritionnels et thérapeutiques. Cependant son innocuité et ses éventuelles interactions avec les médicaments semblent peu étudier. Le présent travail se propose de résumer les quelques étude et les rapports de pharmacovigilance de la spiruline chez l'homme. La.

E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions.

Science.gov (United States)

Neubert, Antje; Dormann, Harald; Prokosch, Hans-Ulrich; Bürkle, Thomas; Rascher, Wolfgang; Sojer, Reinhold; Brune, Kay; Criegee-Rieck, Manfred

2013-09-01

Computer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity. A computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients. A total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively. This study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data.

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Nyeland, Martin Erik; Laursen, Mona Vestergaard; Callréus, Torbjörn

2017-06-01

For both marketing authorization holders and regulatory authorities, evaluating the effectiveness of risk minimization measures is now an integral part of pharmacovigilance in the European Union. The overall aim of activities in this area is to assess the performance of risk minimization measures implemented in order to ensure a positive benefit-risk balance in patients treated with a medicinal product. Following a review of the relevant literature, we developed a conceptual framework consisting of four domains (data, knowledge, behaviour and outcomes) intended for the evaluation of risk minimization measures put into practice in the Danish health-care system. For the implementation of the framework, four classes of monitoring variables can be named and defined: patient descriptors, performance-related indicators of knowledge, behaviour and outcomes. We reviewed the features of the framework when applied to historical, real-world data following the introduction of dabigatran in Denmark for the prophylactic treatment of patients with non-valvular atrial fibrillation. The application of the framework provided useful graphical displays and an opportunity for a statistical evaluation (interrupted time series analysis) of a regulatory intervention. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd.

Combining Review Text Content and Reviewer-Item Rating Matrix to Predict Review Rating

Science.gov (United States)

Wang, Bingkun; Huang, Yongfeng; Li, Xing

2016-01-01

E-commerce develops rapidly. Learning and taking good advantage of the myriad reviews from online customers has become crucial to the success in this game, which calls for increasingly more accuracy in sentiment classification of these reviews. Therefore the finer-grained review rating prediction is preferred over the rough binary sentiment classification. There are mainly two types of method in current review rating prediction. One includes methods based on review text content which focus almost exclusively on textual content and seldom relate to those reviewers and items remarked in other relevant reviews. The other one contains methods based on collaborative filtering which extract information from previous records in the reviewer-item rating matrix, however, ignoring review textual content. Here we proposed a framework for review rating prediction which shows the effective combination of the two. Then we further proposed three specific methods under this framework. Experiments on two movie review datasets demonstrate that our review rating prediction framework has better performance than those previous methods. PMID:26880879

Combining Review Text Content and Reviewer-Item Rating Matrix to Predict Review Rating.

Science.gov (United States)

Wang, Bingkun; Huang, Yongfeng; Li, Xing

2016-01-01

E-commerce develops rapidly. Learning and taking good advantage of the myriad reviews from online customers has become crucial to the success in this game, which calls for increasingly more accuracy in sentiment classification of these reviews. Therefore the finer-grained review rating prediction is preferred over the rough binary sentiment classification. There are mainly two types of method in current review rating prediction. One includes methods based on review text content which focus almost exclusively on textual content and seldom relate to those reviewers and items remarked in other relevant reviews. The other one contains methods based on collaborative filtering which extract information from previous records in the reviewer-item rating matrix, however, ignoring review textual content. Here we proposed a framework for review rating prediction which shows the effective combination of the two. Then we further proposed three specific methods under this framework. Experiments on two movie review datasets demonstrate that our review rating prediction framework has better performance than those previous methods.

A scoping review of rapid review methods.

Science.gov (United States)

Tricco, Andrea C; Antony, Jesmin; Zarin, Wasifa; Strifler, Lisa; Ghassemi, Marco; Ivory, John; Perrier, Laure; Hutton, Brian; Moher, David; Straus, Sharon E

2015-09-16

Rapid reviews are a form of knowledge synthesis in which components of the systematic review process are simplified or omitted to produce information in a timely manner. Although numerous centers are conducting rapid reviews internationally, few studies have examined the methodological characteristics of rapid reviews. We aimed to examine articles, books, and reports that evaluated, compared, used or described rapid reviews or methods through a scoping review. MEDLINE, EMBASE, the Cochrane Library, internet websites of rapid review producers, and reference lists were searched to identify articles for inclusion. Two reviewers independently screened literature search results and abstracted data from included studies. Descriptive analysis was conducted. We included 100 articles plus one companion report that were published between 1997 and 2013. The studies were categorized as 84 application papers, seven development papers, six impact papers, and four comparison papers (one was included in two categories). The rapid reviews were conducted between 1 and 12 months, predominantly in Europe (58 %) and North America (20 %). The included studies failed to report 6 % to 73 % of the specific systematic review steps examined. Fifty unique rapid review methods were identified; 16 methods occurred more than once. Streamlined methods that were used in the 82 rapid reviews included limiting the literature search to published literature (24 %) or one database (2 %), limiting inclusion criteria by date (68 %) or language (49 %), having one person screen and another verify or screen excluded studies (6 %), having one person abstract data and another verify (23 %), not conducting risk of bias/quality appraisal (7 %) or having only one reviewer conduct the quality appraisal (7 %), and presenting results as a narrative summary (78 %). Four case studies were identified that compared the results of rapid reviews to systematic reviews. Three studies found that the conclusions between

Combining Review Text Content and Reviewer-Item Rating Matrix to Predict Review Rating

Directory of Open Access Journals (Sweden)

Bingkun Wang

2016-01-01

Full Text Available E-commerce develops rapidly. Learning and taking good advantage of the myriad reviews from online customers has become crucial to the success in this game, which calls for increasingly more accuracy in sentiment classification of these reviews. Therefore the finer-grained review rating prediction is preferred over the rough binary sentiment classification. There are mainly two types of method in current review rating prediction. One includes methods based on review text content which focus almost exclusively on textual content and seldom relate to those reviewers and items remarked in other relevant reviews. The other one contains methods based on collaborative filtering which extract information from previous records in the reviewer-item rating matrix, however, ignoring review textual content. Here we proposed a framework for review rating prediction which shows the effective combination of the two. Then we further proposed three specific methods under this framework. Experiments on two movie review datasets demonstrate that our review rating prediction framework has better performance than those previous methods.

Suivi thérapeutique pharmacologique de trois médicaments ...

African Journals Online (AJOL)

Introduction: le suivi thérapeutique pharmacologique (STP) des médicaments antiépileptiques (MAE) est un outil très utilisé dans la gestion de l'épilepsie. Au Maroc, ce dosage est réalisé au Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM) depuis Avril 1995. Méthodes: il s'agit d'une étude rétrospective ...

189 Traduction Pharmaceutique: Aperçu Critique D'un Cas ...

African Journals Online (AJOL)

NGOZI

la traduction des documents suivants. • rapports médicaux. • réglementaires, études de toxicité, documents de pharmacovigilance. • notices médicales ... sens émanant du texte qui lui sert d'outil de travail. Pour un traducteur littéraire la tâche est ..... Entreprendre l'inspection des aliments importés, des médicaments, des ...

Pattern of adverse drug reactions reported by the community pharmacists in Nepal

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Palaian S

2010-09-01

Full Text Available The pharmacovigilance program in Nepal is less than a decade old, and is hospital centered. This study highlights the findings of a community based pharmacovigilance program involving the community pharmacists. Objectives: To collect the demographic details of the patients experiencing adverse drug reactions (ADR reported by the community pharmacists; to identify the common drugs causing the ADRs, the common types of ADRs; and to carry out the causality, severity and preventability assessments of the reported ADRs. Methods: The baseline Knowledge-Attitude-Practices (KAP of 116 community pharmacists from Pokhara valley towards drug safety was evaluated using a validated (Cronbach alpha=0.61 KAP questionnaire having 20 questions [(knowledge 11, attitude 5 and practice 4 maximum possible score 40]. Thirty community pharmacists with high scores were selected for three training sessions, each session lasting for one to two hours, covering the basic knowledge required for the community pharmacists for ADR reporting. Pharmacist from the regional pharmacovigilance center visited the trained community pharmacists every alternate day and collected the filled ADR reporting forms. Results: Altogether 71 ADRs, from 71 patients (37 males were reported. Antibiotics/ antibacterials caused 42% (n=37 of the total ADRs followed by non steroidal anti-inflammatory drugs [25% (n=22]. Ibuprofen/paracetamol combination accounted for ten ADRs. The most common type of ADR was itching [17.2 % (n=20, followed by generalized edema [8.6 % (n=10]. In order to manage the ADRs, the patients needed medical treatment in 69% (n=49 of the cases. Over two third (69% of the ADRs had a ‘possible’ association with the suspected drugs and a high percentage (70.4% were of ‘mild (level 2’ type. Nearly two third [64.7 % (n=46] of the ADRs were ‘definitely preventable’. Conclusion: The common class of drugs known to cause ADRs was antibacterial/ antibiotics. Ibuprofen

AN APPROACH FOR REVIEWING AND RANKING THE CUSTOMERS’ REVIEWS THROUGH QUALITY OF REVIEW (QoR

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Sumit Kawate

2017-01-01

Full Text Available Quality is referred as the degree of excellence that means the expected product or service being considered to achieve desired requirements. Whereas, Quality of Reviews (QoR relates to the task of determining the quality, efficiency, suitability, or utility of each review by addressing Quality of Product (QoP and Quality of Service (QoS. It is an essential task of ranking, the reviews based on the quality and efficiency of the reviews given by the users. Whatever the reviews are provided to the particular product or services are from user experiences. The Quality of Reviews (QoR is one of a kind method that defines how the customer’s standpoint for the service or product that he/she experienced. The main issue while reviewing any product, the reviewer provides his/her opinion in the form of reviews and might be a few of those reviews are malicious spam entries to skew the rating of the product. Also in another case, many times customers provide the reviews which are quite common and that won’t helpful for the buyer to interpret the helpful feedback on their products because of too many formal reviews from distinct customers. Hence, we proposed novel approaches: i to statistical analyzes the customer reviews on products by Amazon to identify top most useful or helpful reviewers; ii to analyze the products and its reviews associated for malicious reviews ratings that skewed the overall product ranking. As this is one of the efficient approaches to avoid spam reviewers somehow from reviewing the products. With this, we can use this method for distinguishing between nominal users and spammers. This method helps to quest for helpful reviewers not only to make the product better from best quality reviewers, but also these quality reviewers themselves can able to review future products.

The Applications of Genetic Algorithms in Medicine

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Ali Ghaheri

2015-11-01

Full Text Available A great wealth of information is hidden amid medical research data that in some cases cannot be easily analyzed, if at all, using classical statistical methods. Inspired by nature, metaheuristic algorithms have been developed to offer optimal or near-optimal solutions to complex data analysis and decision-making tasks in a reasonable time. Due to their powerful features, metaheuristic algorithms have frequently been used in other fields of sciences. In medicine, however, the use of these algorithms are not known by physicians who may well benefit by applying them to solve complex medical problems. Therefore, in this paper, we introduce the genetic algorithm and its applications in medicine. The use of the genetic algorithm has promising implications in various medical specialties including radiology, radiotherapy, oncology, pediatrics, cardiology, endocrinology, surgery, obstetrics and gynecology, pulmonology, infectious diseases, orthopedics, rehabilitation medicine, neurology, pharmacotherapy, and health care management. This review introduces the applications of the genetic algorithm in disease screening, diagnosis, treatment planning, pharmacovigilance, prognosis, and health care management, and enables physicians to envision possible applications of this metaheuristic method in their medical career.

The Applications of Genetic Algorithms in Medicine.

Science.gov (United States)

Ghaheri, Ali; Shoar, Saeed; Naderan, Mohammad; Hoseini, Sayed Shahabuddin

2015-11-01

A great wealth of information is hidden amid medical research data that in some cases cannot be easily analyzed, if at all, using classical statistical methods. Inspired by nature, metaheuristic algorithms have been developed to offer optimal or near-optimal solutions to complex data analysis and decision-making tasks in a reasonable time. Due to their powerful features, metaheuristic algorithms have frequently been used in other fields of sciences. In medicine, however, the use of these algorithms are not known by physicians who may well benefit by applying them to solve complex medical problems. Therefore, in this paper, we introduce the genetic algorithm and its applications in medicine. The use of the genetic algorithm has promising implications in various medical specialties including radiology, radiotherapy, oncology, pediatrics, cardiology, endocrinology, surgery, obstetrics and gynecology, pulmonology, infectious diseases, orthopedics, rehabilitation medicine, neurology, pharmacotherapy, and health care management. This review introduces the applications of the genetic algorithm in disease screening, diagnosis, treatment planning, pharmacovigilance, prognosis, and health care management, and enables physicians to envision possible applications of this metaheuristic method in their medical career.].

Potential immediate hypersensitivity reactions following immunization in preschool aged children in Victoria, Australia.

Science.gov (United States)

Baxter, C-M; Clothier, H J; Perrett, K P

2018-04-06

Immediate hypersensitivity reactions (IHR) are rare but potentially serious adverse events following immunization (AEFI). Surveillance of Adverse Events following Vaccination in the Community (SAEFVIC) is an enhanced passive surveillance system that collects, analyses and reports information about AEFI in Victoria, Australia. We describe the incidence, timing and type of potential IHR following vaccination in preschool children reported over an 8-year period. A total of 2110 AEFI were reported in 1620 children, of which 23.5% (496) were classified as potential IHR. Of these, 37.1% (184) were suspected to be IgE-mediated, (including anaphylaxis, angioedema and/or urticaria) and 83.5% (414) occurred within 15 minutes of vaccination. The incidence of potential IHR was 5.4 per 100,000 doses, with that of suspected IgE-mediated IHR being 2.0 per 100,000 doses. The incidence of anaphylaxis was extremely low (0.13 per 100,000 doses) and is consistent with other published studies. Potential IHR following immunization should be reported to appropriate local pharmacovigilance systems and patients reviewed by specialists able to evaluate, investigate and manage future vaccinations.

Systematic reviews identify important methodological flaws in stroke rehabilitation therapy primary studies: review of reviews.

Science.gov (United States)

Santaguida, Pasqualina; Oremus, Mark; Walker, Kathryn; Wishart, Laurie R; Siegel, Karen Lohmann; Raina, Parminder

2012-04-01

A "review of reviews" was undertaken to assess methodological issues in studies evaluating nondrug rehabilitation interventions in stroke patients. MEDLINE, CINAHL, PsycINFO, and the Cochrane Database of Systematic Reviews were searched from January 2000 to January 2008 within the stroke rehabilitation setting. Electronic searches were supplemented by reviews of reference lists and citations identified by experts. Eligible studies were systematic reviews; excluded citations were narrative reviews or reviews of reviews. Review characteristics and criteria for assessing methodological quality of primary studies within them were extracted. The search yielded 949 English-language citations. We included a final set of 38 systematic reviews. Cochrane reviews, which have a standardized methodology, were generally of higher methodological quality than non-Cochrane reviews. Most systematic reviews used standardized quality assessment criteria for primary studies, but not all were comprehensive. Reviews showed that primary studies had problems with randomization, allocation concealment, and blinding. Baseline comparability, adverse events, and co-intervention or contamination were not consistently assessed. Blinding of patients and providers was often not feasible and was not evaluated as a source of bias. The eligible systematic reviews identified important methodological flaws in the evaluated primary studies, suggesting the need for improvement of research methods and reporting. Copyright © 2012 Elsevier Inc. All rights reserved.

Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria

OpenAIRE

Muganurmath, Chandrashekhar S.; Curry, Amy L.; Schindzielorz, Andrew H.

2018-01-01

Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. W...

E-commerce Review System to Detect False Reviews.

Science.gov (United States)

Kolhar, Manjur

2017-08-15

E-commerce sites have been doing profitable business since their induction in high-speed and secured networks. Moreover, they continue to influence consumers through various methods. One of the most effective methods is the e-commerce review rating system, in which consumers provide review ratings for the products used. However, almost all e-commerce review rating systems are unable to provide cumulative review ratings. Furthermore, review ratings are influenced by positive and negative malicious feedback ratings, collectively called false reviews. In this paper, we proposed an e-commerce review system framework developed using the cumulative sum method to detect and remove malicious review ratings.

Meta-Review: Systematic Assessment of Program Review

Science.gov (United States)

Harlan, Brian

2012-01-01

Over 20 years ago, Robert J. Barak and Barbara E. Breier suggested incorporating a regular assessment of the entire program review system into the review schedule in order to ensure that the system itself is as efficient and effective as the programs under review. Barak and Breier's seminal book on the goals and processes of program review has…

Pharmacovigilance of biologicals : dynamics in post-approval safety learning

NARCIS (Netherlands)

Vermeer, N.S.

2015-01-01

Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict

The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy.

Science.gov (United States)

Carnovale, Carla; Brusadelli, Tatiana; Zuccotti, GianVincenzo; Beretta, Silvia; Sullo, Maria Giuseppa; Capuano, Annalisa; Rossi, Francesco; Moschini, Martina; Mugelli, Alessandro; Vannacci, Alfredo; Laterza, Marcella; Clementi, Emilio; Radice, Sonia

2014-09-01

To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP). Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use. We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization. The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.

An Interoperability Platform Enabling Reuse of Electronic Health Records for Signal Verification Studies

Directory of Open Access Journals (Sweden)

Mustafa Yuksel

2016-01-01

Full Text Available Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information.

Book reviews

Directory of Open Access Journals (Sweden)

Redactie KITLV

2012-06-01

Full Text Available The African Diaspora: A History Through Culture, by Patrick Manning (reviewed by Joseph C. Miller Atlas of the Transatlantic Slave Trade, by David Eltis & David Richardson (reviewed by Ted Maris-Wolf Abolition: A History of Slavery and Antislavery, by Seymour Drescher (reviewed by Gregory E. O’Malley Paths to Freedom: Manumission in the Atlantic World, edited by Rosemary Brana-Shute & Randy J. Sparks (reviewed by Matthew Mason You Are All Free: The Haitian Revolution and the Abolition of Slavery, by Jeremy D. Popkin (reviewed by Philippe R. Girard Fighting for Honor: The History of African Martial Arts in the Atlantic World, by T .J. Desch Obi (reviewed by Flávio Gomes & Antonio Liberac Cardoso Simões Pires Working the Diaspora: The Impact of African Labor on the Anglo-American World, 1650-1850, by Frederick C. Knight (reviewed by Walter Hawthorne The Akan Diaspora in the Americas, by Kwasi Konadu (reviewed by Ray Kea Tradition and the Black Atlantic: Critical Theory in the African Diaspora, by Henry Louis Gates Jr. (reviewed by Deborah A. Thomas From Africa to Jamaica: The Making of an Atlantic Slave Society, 1775-1807, by Audra A. Diptee (reviewed by D.A. Dunkley Elections, Violence and the Democratic Process in Jamaica 1944-2007, by Amanda Sives (reviewed by Douglas Midgett Caciques and Cemi Idols: The Web Spun by Taino Rulers between Hispaniola and Puerto Rico, by José R. Oliver (reviewed by Brian D. Bates The Latin American Identity and the African Diaspora: Ethnogenesis in Context, by Antonio Olliz Boyd (reviewed by Dawn F. Stinchcomb Reconstructing Racial Identity and the African Past in the Dominican Republic, by Kimberly Eison Simmons (reviewed by Ginetta E.B. Candelario Haiti and the Haitian Diaspora in the Wider Caribbean, edited by Philippe Zacaïr (reviewed by Catherine Benoît Duvalier’s Ghosts: Race, Diaspora, and U.S. Imperialism in Haitian Literatures, by Jana

Cadaveric simulation: a review of reviews.

Science.gov (United States)

Yiasemidou, M; Gkaragkani, E; Glassman, D; Biyani, C S

2017-11-14

Traditional surgical training, largely based on the Halstedian model "see one, do one, teach one" is not as effective in the era of working time restrictions and elaborate shift-patterns. As a result, contemporary surgeons turned to educational methods outside the operating theatre such as simulation. Cadavers are high fidelity models but their use has ethical and cost implications and their availability may be limited. In this review, we explore the role of cadaveric simulation in modern surgical education. All the Evidence-Based Medicine databases were searched for relevant reviews. The resulting studies were assessed for inclusion to this review, according to pre-determined criteria. Data extraction was performed using a custom-made spreadsheet, and the quality of included reviews was assessed using a validated scoring system (AMSTAR). The literature review yielded 33 systematic reviews; five of which matched the inclusion criteria and were included in this review of reviews. Cadaveric simulation was found to have good face (subjective assessment of usefulness) and content validity (whether a specific element adds or retracts to the educational value) while trainees improved their surgical skills after practicing on cadavers. However, concerns have been raised about ethical issues, high cost and availability. Cadavers are an effective medium for surgical teaching, and it may be appropriate for them to be used whenever surrounding conditions such cost and availability allow. Further research is required to provide evidence on whether there is equivalence between cadavers and other educational media which may not bear the same shortcomings.

ReviewChain: Untampered Product Reviews on the Blockchain

OpenAIRE

Martens, Daniel; Maalej, Walid

2018-01-01

Online portals include an increasing amount of user feedback in form of ratings and reviews. Recent research highlighted the importance of this feedback and confirmed that positive feedback improves product sales figures and thus its success. However, online portals' operators act as central authorities throughout the overall review process. In the worst case, operators can exclude users from submitting reviews, modify existing reviews, and introduce fake reviews by fictional consumers. This ...

Book reviews

Directory of Open Access Journals (Sweden)

Redactie KITLV

2011-12-01

Full Text Available Create Dangerously: The Immigrant Artist at Work, by Edwidge Danticat (reviewed by Colin Dayan Gordon K. Lewis on Race, Class and Ideology in the Caribbean, edited by Anthony P. Maingot (reviewed by Bridget Brereton Freedom and Constraint in Caribbean Migration and Diaspora, edited by Elizabeth Thomas-Hope (reviewed by Mary Chamberlain Black Europe and the African Diaspora, edited by Darlene Clark Hine, Trica Danielle Keaton & Stephen Small (reviewed by Gert Oostindie Caribbean Middlebrow: Leisure Culture and the Middle Class, by Belinda E dmondson (reviewed by Karla Slocum Global Change and Caribbean Vulnerability: Environment, Economy and Society at Risk, edited by Duncan McGregor, David Dodman & David Barker (reviewed by Bonham C. Richardson Encountering Revolution: Haiti and the Making of the Early Republic, by Ashli White (reviewed by Matt Clavin Red and Black in Haiti: Radicalism, Conflict, and Political Change, 1934-1957, by Matthew J. Smith (reviewed by Robert Fatton Jr. Cuba in the American Imagination: Metaphor and the Imperial Ethos, by Louis A. Pérez Jr. (reviewed by Camillia Cowling Seeds of Insurrection: Domination and Resistance on Western Cuban Plantations, 1808-1848, by Manuel Barcia (reviewed by Matt D. Childs Epidemic Invasions: Yellow Fever and the Limits of Cuban Independence, 1878-1930, by Mariola Espinosa (reviewed by Cruz Maria Nazario The Cuban Connection: Drug Trafficking, Smuggling, and Gambling in Cuba from the 1920s to the Revolution, by Eduardo Sáenz Rovner (reviewed by Ivelaw Lloyd Griffith Before Fidel: The Cuba I Remember, by Francisco José Moreno, and The Boys from Dolores: Fidel Castro’s Schoolmates from Revolution to Exile, by Patrick Symmes (reviewed by Pedro Pérez Sarduy Lam, by Jacques Leenhardt & Jean-Louis Paudrat (reviewed by Sally Price Healing Dramas: Divination and Magic in Modern Puerto Rico, by Raquel Romberg (reviewed by Grant Jewell

Severe Secondary Polycythemia in a Female-to-Male Transgender Patient While Using Lifelong Hormonal Therapy: A Patient’s Perspective

OpenAIRE

Ederveen, Ellen G. T.; van Hunsel, Florence P. A. M.; Wondergem, Marielle J.; van Puijenbroek, Eugène P.

2018-01-01

After a registered drug is available on the market and used in everyday circumstances, hitherto unknown adverse drug reactions (ADRs) may occur. Furthermore, the patient can experience a previously unknown course of a known ADR. Voluntary reports by patients play an important role in gaining knowledge about ADRs in daily practice. The Netherlands Pharmacovigilance Centre Lareb received a report from a 55-year-old female-to-male transgender patient who experiences secondary polycythemia while ...

Book reviews

Directory of Open Access Journals (Sweden)

T. Abdel-Motey., C. Urfels., K. Rodriguez., J. Mardikian., J.A. Drobnicki., V. Diodato.

2000-10-01

Full Text Available Title:(1 The Library and Information Professional’s Guide to the Internet. (2 Reinvention of the Public Library for the 21st Century. (3 Public Library Collection Development in the Information Age. (4 Making Sense of Journals in the Life Science: From Specialty Origins to Contemporary Assortment. (5 The Holocaust: Memories, Research, Reference. (6 How to Index Your Local Newspaper Using WordPerfect or Microsoft Word for Windows. (7 Effective Utilization and Management of Emerging Information Technologies. (8 Information Technology and Organizations: Challenges of New Technologies. (9 Facilities Planning for School Media and Technology Centers. (10 Libraries Without Walls 2: The Delivery of Library Services to Distance Users. (11 New International Directions in HIV Prevention for Gay and Bisexual Men. (12 Soaring to Excellence Videos: Tools of Our Trade III: Books, the Internet, and Beyond.Author:(1Reviewed by Teresa Abdel-Motey. (2Review by Claire Urfels. (3Reviewed by Dr. Ketty Rodriguez. (4Reviewed by Jackie Mardikian. (5Reviewed by John A. Drobnicki.(6Reviewed by Dr. Virgil Diodato. (7Reviewed by Dr. Lisa M. Covi. (8Reviewed by Tom Zillner. (9Reviewed by Dr. W. Bernard Lukenbill. (10Reviewed by Dr. Elizabeth Buchanan. (11Reviewed by Aisha White. (12Reviewed by Phyllis Tragash

Book reviews

Directory of Open Access Journals (Sweden)

Redactie KITLV

2010-12-01

Full Text Available The Atlantic World, 1450-2000, edited by Toyin Falola & Kevin D. Roberts (reviewed by Aaron Spencer Fogleman The Slave Ship: A Human History, by Marcus Rediker (reviewed by Justin Roberts Extending the Frontiers: Essays on the New Transatlantic Slave Trade Database, edited by David Eltis & David Richardson (reviewed by Joseph C. Miller "New Negroes from Africa": Slave Trade Abolition and Free African Settlement in the Nineteenth-Century Caribbean, by Rosanne Marion Adderley (reviewed by Nicolette Bethel Atlantic Diasporas: Jews, Conversos, and Crypto-Jews in the Age of Mercantilism, 1500-1800, edited by Richard L. Kagan & Philip D. Morgan (reviewed by Jonathan Schorsch Brother’s Keeper: The United States, Race, and Empire in the British Caribbean, 1937-1962, by Jason C. Parker (reviewed by Charlie Whitham Labour and the Multiracial Project in the Caribbean: Its History and Promise, by Sara Abraham (reviewed by Douglas Midgett Envisioning Caribbean Futures: Jamaican Perspectives, by Brian Meeks (reviewed by Gina Athena Ulysse Archibald Monteath: Igbo, Jamaican, Moravian, by Maureen Warner-Lewis (reviewed by Jon Sensbach Left of Karl Marx: The Political Life of Black Communist Claudia Jones, by Carole Boyce Davies (reviewed by Linden Lewis Displacements and Transformations in Caribbean Cultures, edited by Lizabeth Paravisini-Gebert & Ivette Romero-Cesareo (reviewed by Bill Maurer Caribbean Migration to Western Europe and the United States: Essays on Incorporation, Identity, and Citizenship, edited by Margarita Cervantes-Rodríguez, Ramón Grosfoguel & Eric Mielants (reviewed by Gert Oostindie Home Cooking in the Global Village: Caribbean Food from Buccaneers to Ecotourists, by Richard Wilk (reviewed by William H. Fisher Dead Man in Paradise: Unraveling a Murder from a Time of Revolution, by J.B. MacKinnon (reviewed by Edward Paulino Tropical Zion: General Trujillo, FDR, and the Jews of Sos

Book reviews

Directory of Open Access Journals (Sweden)

Redactie KITLV

2011-06-01

Full Text Available Globalization and the Po st-Creole Imagination: Notes on Fleeing the Plantation,by Michaeline A. Crichlow with Patricia Northover (reviewed by Raquel Romberg Afro-Caribbean Religions: An Introduction to their Historical, Cultural, and Sacred Traditions, by Nathaniel Samuel Murrell (reviewed by James Houk Africas of the Americas: Beyond the Search for Origins in the Study of Afro-Atlantic Religions, edited by Stephan Palmié (reviewed by Aisha Khan Òrì?à Devotion as World Religion: The Globalization of Yorùbá Religious Culture, edited by Jacob K. Olupona & Terry Rey (reviewed by Brian Brazeal Sacred Spaces and Religious Traditions in Oriente Cuba, by Jualynne E. Dodson (reviewed by Kristina Wirtz The Coolie Speaks: Chinese Indentured Laborers and African Slaves of Cuba, by Lisa Yun (reviewed by W. Look Lai Cuba and Western Intellectuals since 1959, by Kepa Artaraz (reviewed by Anthony P. Maingot Inside El Barrio: A Bottom-Up View of Neighborhood Life in Castro’s Cuba, by Henry Louis Taylor, Jr. (reviewed by Mona Rosendahl On Location in Cuba: Street Filmmaking During Times of Transition, by Ann Marie Stock (reviewed by Cristina Venegas Cuba in The Special Period: Culture and Ideology in the 1990s, edited by Ariana Hernandez-Reguant (reviewed by Myrna García-Calderón The Cubans of Union City: Immigrants and Exiles in a New Jersey Community. Yolanda Prieto (reviewed by Jorge Duany Target Culebra: How 743 Islanders Took On the Entire U.S. Navy and Won, by Richard D. Copaken (reviewed by Jorge Rodríguez Beruff The World of the Haitian Revolution, edited by David Patrick Geggus & Norman Fiering (reviewed by Yvonne Fabella Bon Papa: Haiti’s Golden Years, by Bernard Diederich (reviewed by Robert Fatton, Jr. 1959: The Year that Inflamed the Caribbean, by Bernard Diederich (reviewed by Landon Yarrington Dominican Cultures: The Making of a Caribbean Society, edited by Bernardo Vega

Quality of systematic reviews in pediatric oncology--a systematic review.

Science.gov (United States)

Lundh, Andreas; Knijnenburg, Sebastiaan L; Jørgensen, Anders W; van Dalen, Elvira C; Kremer, Leontien C M

2009-12-01

To ensure evidence-based decision making in pediatric oncology systematic reviews are necessary. The objective of our study was to evaluate the methodological quality of all currently existing systematic reviews in pediatric oncology. We identified eligible systematic reviews through a systematic search of the literature. Data on clinical and methodological characteristics of the included systematic reviews were extracted. The methodological quality of the included systematic reviews was assessed using the overview quality assessment questionnaire, a validated 10-item quality assessment tool. We compared the methodological quality of systematic reviews published in regular journals with that of Cochrane systematic reviews. We included 117 systematic reviews, 99 systematic reviews published in regular journals and 18 Cochrane systematic reviews. The average methodological quality of systematic reviews was low for all ten items, but the quality of Cochrane systematic reviews was significantly higher than systematic reviews published in regular journals. On a 1-7 scale, the median overall quality score for all systematic reviews was 2 (range 1-7), with a score of 1 (range 1-7) for systematic reviews in regular journals compared to 6 (range 3-7) in Cochrane systematic reviews (pmethodological flaws leading to a high risk of bias. While Cochrane systematic reviews were of higher methodological quality than systematic reviews in regular journals, some of them also had methodological problems. Therefore, the methodology of each individual systematic review should be scrutinized before accepting its results.

Human-system interface design review guideline -- Reviewer`s checklist: Final report. Revision 1, Volume 2

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-06-01

NUREG-0700, Revision 1, provides human factors engineering (HFE) guidance to the US Nuclear Regulatory Commission staff for its: (1) review of the human system interface (HSI) design submittals prepared by licensees or applications for a license or design certification of commercial nuclear power plants, and (2) performance of HSI reviews that could be undertaken as part of an inspection or other type of regulatory review involving HSI design or incidents involving human performance. The guidance consists of a review process and HFE guidelines. The document describes those aspects of the HSI design review process that are important to the identification and resolution of human engineering discrepancies that could adversely affect plant safety. Guidance is provided that could be used by the staff to review an applicant`s HSI design review process or to guide the development of an HSI design review plan, e.g., as part of an inspection activity. The document also provides detailed HFE guidelines for the assessment of HSI design implementations. NUREG-0700, Revision 1, consists of three stand-alone volumes. Volume 2 is a complete set of the guidelines contained in Volume 1, Part 2, but in a checklist format that can be used by reviewers to assemble sets of individual guidelines for use in specific design reviews. The checklist provides space for reviewers to enter guidelines evaluations and comments.

Regulatory review of NPP Krsko Periodic Safety Review

International Nuclear Information System (INIS)

Lovincic, D.; Muehleisen, A.; Persic, A.

2004-01-01

At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

The clinical case report: a review of its merits and limitations.

Science.gov (United States)

Nissen, Trygve; Wynn, Rolf

2014-04-23

The clinical case report has a long-standing tradition in the medical literature. While its scientific significance has become smaller as more advanced research methods have gained ground, case reports are still presented in many medical journals. Some scholars point to its limited value for medical progress, while others assert that the genre is undervalued. We aimed to present the various points of view regarding the merits and limitations of the case report genre. We searched Google Scholar, PubMed and select textbooks on epidemiology and medical research for articles and book-chapters discussing the merits and limitations of clinical case reports and case series. The major merits of case reporting were these: Detecting novelties, generating hypotheses, pharmacovigilance, high applicability when other research designs are not possible to carry out, allowing emphasis on the narrative aspect (in-depth understanding), and educational value. The major limitations were: Lack of ability to generalize, no possibility to establish cause-effect relationship, danger of over-interpretation, publication bias, retrospective design, and distraction of reader when focusing on the unusual. Despite having lost its central role in medical literature in the 20th century, the genre still appears popular. It is a valuable part of the various research methods, especially since it complements other approaches. Furthermore, it also contributes in areas of medicine that are not specifically research-related, e.g. as an educational tool. Revision of the case report genre has been attempted in order to integrate the biomedical model with the narrative approach, but without significant success. The future prospects of the case report could possibly be in new applications of the genre, i.e. exclusive case report databases available online, and open access for clinicians and researchers.

Systematising "System": One Reviewer's Analysis of the Review Process

Science.gov (United States)

Coniam, David

2011-01-01

This paper describes one reviewer's experience of reviewing for the journal "System" over an eight-year period, 2003-2011. The paper reports on the reviews produced by the single reviewer, which have been compiled into a specific purpose--an "occluded"--corpus (Swales, 1996) of 122 reviews, comprising 93,000 words. The paper first describes the…

Quality of systematic reviews in pediatric oncology--a systematic review

DEFF Research Database (Denmark)

Lundh, Andreas; Knijnenburg, Sebastiaan L; Jørgensen, Anders W

2009-01-01

BACKGROUND: To ensure evidence-based decision making in pediatric oncology systematic reviews are necessary. The objective of our study was to evaluate the methodological quality of all currently existing systematic reviews in pediatric oncology. METHODS: We identified eligible systematic reviews...... through a systematic search of the literature. Data on clinical and methodological characteristics of the included systematic reviews were extracted. The methodological quality of the included systematic reviews was assessed using the overview quality assessment questionnaire, a validated 10-item quality...... assessment tool. We compared the methodological quality of systematic reviews published in regular journals with that of Cochrane systematic reviews. RESULTS: We included 117 systematic reviews, 99 systematic reviews published in regular journals and 18 Cochrane systematic reviews. The average methodological...

Filtering big data from social media--Building an early warning system for adverse drug reactions.

Science.gov (United States)

Yang, Ming; Kiang, Melody; Shang, Wei

2015-04-01

Adverse drug reactions (ADRs) are believed to be a leading cause of death in the world. Pharmacovigilance systems are aimed at early detection of ADRs. With the popularity of social media, Web forums and discussion boards become important sources of data for consumers to share their drug use experience, as a result may provide useful information on drugs and their adverse reactions. In this study, we propose an automated ADR related posts filtering mechanism using text classification methods. In real-life settings, ADR related messages are highly distributed in social media, while non-ADR related messages are unspecific and topically diverse. It is expensive to manually label a large amount of ADR related messages (positive examples) and non-ADR related messages (negative examples) to train classification systems. To mitigate this challenge, we examine the use of a partially supervised learning classification method to automate the process. We propose a novel pharmacovigilance system leveraging a Latent Dirichlet Allocation modeling module and a partially supervised classification approach. We select drugs with more than 500 threads of discussion, and collect all the original posts and comments of these drugs using an automatic Web spidering program as the text corpus. Various classifiers were trained by varying the number of positive examples and the number of topics. The trained classifiers were applied to 3000 posts published over 60 days. Top-ranked posts from each classifier were pooled and the resulting set of 300 posts was reviewed by a domain expert to evaluate the classifiers. Compare to the alternative approaches using supervised learning methods and three general purpose partially supervised learning methods, our approach performs significantly better in terms of precision, recall, and the F measure (the harmonic mean of precision and recall), based on a computational experiment using online discussion threads from Medhelp. Our design provides

Pattern of chemotherapy-related adverse effects among adult cancer patients treated at Gondar University Referral Hospital, Ethiopia: a cross-sectional study

Directory of Open Access Journals (Sweden)

Belachew SA

2016-12-01

Full Text Available Sewunet Admasu Belachew,1 Daniel Asfaw Erku,2 Abebe Basazn Mekuria,3 Begashaw Melaku Gebresillassie1 1Department of Clinical Pharmacy, 2Department of Pharmaceutical Sciences, 3Department of Pharmacology, School of Pharmacy, University of Gondar, Gondar, Ethiopia Background: Adverse drug reactions (ADRs are a global problem and constitute a major clinical problem in terms of human suffering. The high toxicity and narrow therapeutic index of chemotherapeutic agents makes oncology pharmacovigilance essential. The objective of the present study was to assess the pattern of ADRs occurring in cancer patients treated with chemotherapy in a tertiary care teaching hospital in Ethiopia.Methods: A cross-sectional study over a 2-year period from September 2013 to August 2015 was conducted on cancer patients undergoing chemotherapy at Gondar University Referral Hospital Oncology Center. Data were collected directly from patients and their medical case files. The reported ADRs were assessed for causality using the World Health Organization’s causality assessment scale and Naranjo’s algorithm. The severities of the reported reactions were also assessed using National Cancer Institute Common Terminology CTCAE version 4.0. The Pearson’s chi-square test was employed to examine the association between two categorical variables.Results: A total of 815 ADRs were identified per 203 patients included in the study. The most commonly occurring ADRs were nausea and vomiting (18.9%, infections (16.7%, neutropenia (14.7%, fever and/or chills (11.3%, and anemia (9.3%. Platinum compounds (31.4% were the most common group of drugs causing ADRs. Of the reported ADRs, 65.8% were grades 3–4 (severe level, 29.9% were grades 1–2 (mild level, and 4.3% were grade 5 (toxic level. Significant association was found between age, number of chemotherapeutic agents, as well as dose of chemotherapy with the occurrence of grades 3–5 toxicity.Conclusion: The high incidence of

Experiences from consumer reports on psychiatric adverse drug reactions with antidepressant medication: a qualitative study of reports to a consumer association.

Science.gov (United States)

Vilhelmsson, Andreas; Svensson, Tommy; Meeuwisse, Anna; Carlsten, Anders

2012-12-23

The new European pharmacovigilance legislation has been suggested as marking the beginning of a new chapter in drug safety, making patients an important part of pharmacovigilance. In Sweden since 2008 it has been possible for consumers to report adverse drug reactions (ADRs) to the Medical Products Agency (MPA), and these reports are now understood as an increasingly valuable contribution in the monitoring of safety aspects in medicines. Already in 2002 it was possible to report experiences with medicines to the non-profit and independent organization Consumer Association for Medicines and Health (KILEN) through a web-based report form with an opportunity to describe ADR experiences in free text comments. The aim of this study was to qualitatively analyze the free text comments appended to consumer reports on antidepressant medication. All reports of suspected adverse reactions regarding antidepressant medications submitted from January 2002 to April 2009 to KILEN's Internet-based reporting system in Sweden were analyzed according to reported narrative experience(s). Content analysis was used to interpret the content of 181 reports with free text comments. Three main categories emerged from the analyzed data material: (1) Experiences of drug treatment with subcategories (a) Severe psychiatric adverse reactions, and (b) Discontinuation symptoms; (2) Lack of communication and (3) Trust and distrust. A majority of the reports to KILEN were from patients experiencing symptoms of mental disturbances (sometimes severe) affecting them in many different ways, especially during discontinuation. Several report included narratives of patients not receiving information of potential ADRs from their doctor, but also that there were no follow-ups of the treatment. Trust was highlighted as especially important and some patients reported losing confidence in their doctor when they were not believed about the suspected ADRs they experienced, making them attempt to discontinue their

Epidemiology of symptomatic drug-induced long QT syndrome and Torsade de Pointes in Germany.

Science.gov (United States)

Sarganas, Giselle; Garbe, Edeltraut; Klimpel, Andreas; Hering, Rolf C; Bronder, Elisabeth; Haverkamp, Wilhelm

2014-01-01

Drug-induced long QT syndrome (diLQTS) leading to Torsade de Pointes (TdP) is a potentially lethal condition, which has led to several post-marketing drug withdrawals in the past decade. The true incidence of diLQTS/TdP is largely unknown. One explanation is under-reporting of this potentially life-threatening adverse event by physicians and other medical staff to pharmacovigilance agencies. To gain more insight into the incidence of diLQTS and TdP, the Berlin Pharmacovigilance Center (PVZ-FAKOS) has actively and prospectively identified patients who developed this particular type of drug-induced adverse event. Here, the basic characteristics of the affected patients are summarized and suspected drugs are discussed. Furthermore, an extrapolation of the Berlin incidence rates to the German Standard Population is presented. Using a Berlin-wide network of 51 collaborating hospitals (>180 clinical departments), adult patients presenting with long QT syndrome (LQTS/TdP) between 2008 and 2011 were identified by active surveillance of these hospitals. Drug exposures as well as other possible risk factors were obtained from the patient's files and in a face-to-face interview with the patient. One-hundred and seventy patients of possible LQTS/TdP were reported to the Pharmacovigilance Center of whom 58 cases were confirmed in a thorough validation process. The majority (66%) of these cases were female and 60% had developed LQTS/TdP in the outpatient setting. Thirty-five (60%) of 58 confirmed cases were assessed as drug-related based on a standardized causality assessment applying the criteria of the World Health Organization. Drugs assessed as related in more than two cases were metoclopramide, amiodarone, melperone, citalopram, and levomethadone. The age-standardized incidence of diLQTS/TdP in Berlin was estimated to be 2.5 per million per year for males and 4.0 per million per year for females. While European annual reporting rates based on spontaneous reports suggest an

Book Reviews

OpenAIRE

Elena Mancusi-Materi

2002-01-01

Book reviews: Helmore, K. and N. Singh, Sustainable Livelihoods – Building on the Wealth of the poor (reviewed by Elena Mancusi-Materi); Scoones, I (ed.), Dinamics and Diversity: Soil fertility and farming livelihoods in africa (reviewed by Elena Mancusi-Materi); Uphoff, N. (ed.), Agroecological Innovations – Increasing Food Production with Pariciatory Development (reviewed by Elena Mancusi-Materi); Marten, G.G., Human Ecology, Basic Concepts for Sustianable Development (reviewed by Siobhán K...

Methological quality of systematic reviews and meta-analyses on acupuncture for stroke: A review of review.

Science.gov (United States)

Chen, Xin-Lin; Mo, Chuan-Wei; Lu, Li-Ya; Gao, Ri-Yang; Xu, Qian; Wu, Min-Feng; Zhou, Qian-Yi; Hu, Yue; Zhou, Xuan; Li, Xian-Tao

2017-11-01

To assess the methodological quality of systematic reviews and meta-analyses regarding acupuncture intervention for stroke and the primary studies within them. Two researchers searched PubMed, Cumulative index to Nursing and Allied Health Literature, Embase, ISI Web of Knowledge, Cochrane, Allied and Complementary Medicine, Ovid Medline, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang and Traditional Chinese Medical Database to identify systematic reviews and meta-analyses about acupuncture for stroke published from the inception to December 2016. Review characteristics and the criteria for assessing the primary studies within reviews were extracted. The methodological quality of the reviews was assessed using adapted Oxman and Guyatt Scale. The methodological quality of primary studies was also assessed. Thirty-two eligible reviews were identified, 15 in English and 17 in Chinese. The English reviews were scored higher than the Chinese reviews (P=0.025), especially in criteria for avoiding bias and the scope of search. All reviews used the quality criteria to evaluate the methodological quality of primary studies, but some criteria were not comprehensive. The primary studies, in particular the Chinese reviews, had problems with randomization, allocation concealment, blinding, dropouts and withdrawals, intent-to-treat analysis and adverse events. Important methodological flaws were found in Chinese systematic reviews and primary studies. It was necessary to improve the methodological quality and reporting quality of both the systematic reviews published in China and primary studies on acupuncture for stroke.

Does mentoring new peer reviewers improve review quality? A randomized trial

Directory of Open Access Journals (Sweden)

Houry Debra

2012-08-01

Full Text Available Abstract Background Prior efforts to train medical journal peer reviewers have not improved subsequent review quality, although such interventions were general and brief. We hypothesized that a manuscript-specific and more extended intervention pairing new reviewers with high-quality senior reviewers as mentors would improve subsequent review quality. Methods Over a four-year period we randomly assigned all new reviewers for Annals of Emergency Medicine to receive our standard written informational materials alone, or these materials plus a new mentoring intervention. For this program we paired new reviewers with a high-quality senior reviewer for each of their first three manuscript reviews, and asked mentees to discuss their review with their mentor by email or phone. We then compared the quality of subsequent reviews between the control and intervention groups, using linear mixed effects models of the slopes of review quality scores over time. Results We studied 490 manuscript reviews, with similar baseline characteristics between the 24 mentees who completed the trial and the 22 control reviewers. Mean quality scores for the first 3 reviews on our 1 to 5 point scale were similar between control and mentee groups (3.4 versus 3.5, as were slopes of change of review scores (-0.229 versus -0.549 and all other secondary measures of reviewer performance. Conclusions A structured training intervention of pairing newly recruited medical journal peer reviewers with senior reviewer mentors did not improve the quality of their subsequent reviews.

Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study

Directory of Open Access Journals (Sweden)

Aman Goyal

2017-01-01

Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

DEFF Research Database (Denmark)

Segec, A; Keller-Stanislawski, B; Vermeer, N S

2015-01-01

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe...... use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization....

Book Reviews

Directory of Open Access Journals (Sweden)

Christien Klaufus, Book Review Editor

2016-10-01

Full Text Available American Crossings: Border Politics in the Western Hemisphere, edited by Maiah Jaskoski, Arturo C. Sotomayor & Harold A. Trinkunas, 2015; reviewed by Olivier Thomas Kramsch The Remittance Landscape: Spaces of Migration in Rural Mexico and Urban USA, by Sarah Lynn Lopez, 2015; reviewed by Christien Klaufus Latin America’s Emerging Middle Classes; Economic Perspectives, editado por Jeff Dayton-Johnson, 2015; reseñado por Ludolfo Paramio Cities, Business and the Politics of Urban Violence in Latin America, by Eduardo Moncada,2016; reviewed by Gerard Martin Who Counts? The Mathematics of Death and Life after Genocide, by Diane Nelson, 2015; reviewed by Finn Stepputat Owners of the Sidewalk: Security and Survival in the Informal City, by Daniel Goldstein, 2015; reviewed by Griet Steel Beyond Tradition, Beyond Invention: Cosmic Technologies and Creativity in Contemporary Afro-Cuban Religions, edited by Diana Espírito Santo and Anastasios Panagiotopoulos, 2015; reviewed by Ken Chitwood Cuba and the U.S. Empire. A Chronological History, by Jane Franklin, 2016; reviewed by Edgar Göll Haydée Santamaría, Cuban Revolutionary: She Led by Transgression, by Margaret Randall, 2015; Vilma Espín Guillois: el fuego de la libertad, by Yolanda Ferrer Gómez and Carolina Aguilar Ayerra, 2015; reviewed by Dirk Kruijt Revolutionary Ideology and Political Destiny in Mexico, 1928-1934: Lázaro Cárdenas and Adalberto Tejeda, by Eitan Ginzberg, 2015; reviewed by Heather Fowler-Salamini Political Landscapes: Forest, Conservation and Community in Mexico, by Christopher R. Boyer, 2015; reviewed by Mariel Aguilar-Støen A Sentimental Education for the Working Man. The Mexico City Penny Press, 1900-1910, por Robert M. Buffington, 2015; reseñado por Lucas Poy Pesos and Politics: Business, Elites, Foreigners and Government in Mexico, 1854-1940, by Mark Wasserman, 2015; reviewed by Benedicte Bull State Theory and Andean Politics: New Approaches to the Study

Critical Review

DEFF Research Database (Denmark)

Rosenbaum, Ralph K.; Olsen, Stig Irving

2018-01-01

Manipulation and mistakes in LCA studies are as old as the tool itself, and so is its critical review. Besides preventing misuse and unsupported claims, critical review may also help identifying mistakes and more justifiable assumptions as well as generally improve the quality of a study. It thus...... supports the robustness of an LCA and increases trust in its results and conclusions. The focus of this chapter is on understanding what a critical review is, how the international standards define it, what its main elements are, and what reviewer qualifications are required. It is not the objective...... of this chapter to learn how to conduct a critical review, neither from a reviewer nor from a practitioner perspective. The foundation of this chapter and the basis for any critical review of LCA studies are the International Standards ISO 14040:2006, ISO 14044:2006 and ISO TS 14071:2014....

6 CFR 13.5 - Review by the Reviewing Official.

Science.gov (United States)

2010-01-01

... 6 Domestic Security 1 2010-01-01 2010-01-01 false Review by the Reviewing Official. 13.5 Section 13.5 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY PROGRAM FRAUD CIVIL REMEDIES § 13.5 Review by the Reviewing Official. (a) If, based on the report of the Investigating Official...

Essays on Online Reviews: Reviewers' Strategic Behaviors and Contributions over Time

Science.gov (United States)

Shen, Wenqi

2010-01-01

Online reviews play an important role in consumers' purchasing decisions. Researchers are increasingly interested in studying the dynamic impact of online reviews on product sales. However, the antecedent of online reviews, online reviewers' behaviors, has not been fully explored. Understanding how online reviewers make review decisions can assist…

Evaluation of the PV energy production after 12-years of operating

Science.gov (United States)

Bouchakour, Salim; Arab, Amar Hadj; Abdeladim, Kamel; Boulahchiche, Saliha; Amrouche, Said Ould; Razagui, Abdelhak

2018-05-01

This paper presents a simple way to approximately evaluate the photovoltaic (PV) array performance degradation, the studied PV arrays are connected to the local electric grid at the Centre de Developpement des Energies Renouvelables (CDER) in Algiers, Algeria, since June 2004. The used PV module model takes in consideration the module temperature and the effective solar radiance, the electrical characteristics provided by the manufacturer data sheet and the evaluation of the performance coefficient. For the dynamic behavior we use the Linear Reoriented Coordinates Method (LRCM) to estimate the maximum power point (MPP). The performance coefficient is evaluated on the one hand under STC conditions to estimate the dc energy according to the manufacturer data. On the other hand, under real conditions using both the monitored data and the LM optimization algorithm, allowing a good degree of accuracy of estimated dc energy. The application of the developed modeling procedure to the analysis of the monitored data is expected to improve understanding and assessment of the PV performance degradation of the PV arrays after 12 years of operation.

Book Reviews

Directory of Open Access Journals (Sweden)

Book Review Editor, Christien Klaufus

2015-10-01

Full Text Available Rebel Mexico: Student Unrest and Authoritarian Political Culture During the Long Sixties, by Jaime M. Pensado, 2013, and Specters of Revolution: Peasant Guerrillas in the Cold War Mexican Countryside, by Alexander Aviña, 2014; reviewed by Wil G. PanstersWe are the face of Oaxaca: Testimony and Social Movements, by Lynn Stephen, 2013; reviewed by Jaime HoogestegerMaya Exodus: Indigenous struggle for citizenship in Chiapas, by Heidi Moksnes, 2012; reviewed by Gemma van der HaarLand and Freedom: The MST, the Zapatistas and Peasant Alternatives to Neoliberalism, by Leandro Vergara-Camus, 2014; reviewed by Jonathan DeVoreIndigenous Movements and Building the Plurinational State in Bolivia: Organisation and Identity in the Trajectory of the CSUTCB and CONAMAQ, by Radosław Powęska, 2013; reviewed by Ton SalmanMovimientos estudiantiles en la historia de América Latina IV, coordinado por Renate Marsiske, 2015; reseñado por Andrés Donoso RomoEl corazón de los libros, Alzate y Bartolache: Lectores y escritores novohispanos (S. XVIII, by Mauricio Sánchez Menchero, 2012; reviewed by Helge WendtAurality: Listening and Knowledge in Nineteenth-Century Colombia, por Ana María Ochoa Gautier, 2014; reseñado por Mercedes López RodríguezThe Vanguard of the Atlantic World: Creating Modernity, Nation, and Democracy in Nineteenth-Century Latin America, by James E. Sanders, 2014; reviewed by Michiel BaudMexico’s Once and Future Revolution: Social Upheaval and the Challenge of Rule since the Late Nineteenth Century, by Gilbert M. Joseph and Jürgen Buchenau, 2013; reviewed by Dirk KruijtThe Great Depression in Latin America, coordinado por Paulo Drinot and Alan Knight, 2014; reseñado por Juan Carlos KorolEnhancing Democracy. Public Policies and Citizen Participation in Chile, by Gonzalo Delamaza, 2014; reviewed by Camila Jara IbarraCritical Interventions in Caribbean Politics and Theory, by Brian Meeks, 2014; reviewed by Hebe VerrestBlack Power in the

The quality of systematic reviews about interventions for refractive error can be improved: a review of systematic reviews.

Science.gov (United States)

Mayo-Wilson, Evan; Ng, Sueko Matsumura; Chuck, Roy S; Li, Tianjing

2017-09-05

Systematic reviews should inform American Academy of Ophthalmology (AAO) Preferred Practice Pattern® (PPP) guidelines. The quality of systematic reviews related to the forthcoming Preferred Practice Pattern® guideline (PPP) Refractive Errors & Refractive Surgery is unknown. We sought to identify reliable systematic reviews to assist the AAO Refractive Errors & Refractive Surgery PPP. Systematic reviews were eligible if they evaluated the effectiveness or safety of interventions included in the 2012 PPP Refractive Errors & Refractive Surgery. To identify potentially eligible systematic reviews, we searched the Cochrane Eyes and Vision United States Satellite database of systematic reviews. Two authors identified eligible reviews and abstracted information about the characteristics and quality of the reviews independently using the Systematic Review Data Repository. We classified systematic reviews as "reliable" when they (1) defined criteria for the selection of studies, (2) conducted comprehensive literature searches for eligible studies, (3) assessed the methodological quality (risk of bias) of the included studies, (4) used appropriate methods for meta-analyses (which we assessed only when meta-analyses were reported), (5) presented conclusions that were supported by the evidence provided in the review. We identified 124 systematic reviews related to refractive error; 39 met our eligibility criteria, of which we classified 11 to be reliable. Systematic reviews classified as unreliable did not define the criteria for selecting studies (5; 13%), did not assess methodological rigor (10; 26%), did not conduct comprehensive searches (17; 44%), or used inappropriate quantitative methods (3; 8%). The 11 reliable reviews were published between 2002 and 2016. They included 0 to 23 studies (median = 9) and analyzed 0 to 4696 participants (median = 666). Seven reliable reviews (64%) assessed surgical interventions. Most systematic reviews of interventions for

Technology-Enhanced Peer Review: Benefits and Implications of Providing Multiple Reviews

DEFF Research Database (Denmark)

Papadopoulos, Pantelis M.; Lagkas, Thomas D.; Demetriadis, Stavros N.

2017-01-01

This study analyses the impact of self and peer feedback in technology-enhanced peer review settings. The impact of receiving peer comments (“receiver” perspective) is compared to that of reaching own insights by reviewing others’ work (“giver” perspective). In this study, 38 sophomore students...... were randomly assigned in two conditions and engaged in peer review activity facilitated by a web-based learning environment asking them to provide multiple reviews. In the Peer Reviewed (PR) condition students both reviewed peer work and received peer comments for their own work. By contrast......, in the Self Reviewed (SR) condition students provided peer reviews, but did not receive any. Instead, they were asked to perform self reviewing, before proceeding to any revisions of their work. Result showed that the two groups were comparable in all aspects, suggesting that the lack of getting peer reviews...

Systematic review

DEFF Research Database (Denmark)

Bager, Palle; Chauhan, Usha; Greveson, Kay

2017-01-01

of evidence is needed and the aim of this article was to systematically review the evidence of IBD advice lines. MATERIALS AND METHODS: A broad systematic literature search was performed to identify relevant studies addressing the effect of advice lines. The process of selection of the retrieved studies...... was undertaken in two phases. In phase one, all abstracts were review by two independent reviewers. In phase two, the full text of all included studies were independently reviewed by two reviewers. The included studies underwent quality assessment and data synthesis. RESULTS: Ten published studies and 10...... congress abstracts were included in the review. The studies were heterogeneous both in scientific quality and in the focus of the study. No rigorous evidence was found to support that advice lines improve disease activity in IBD and correspondingly no studies reported worsening in disease activity. Advice...

Nuclear Posture Review

Science.gov (United States)

2018-02-01

REVIEW margin for further delay in recapitalizing the physical infrastructure needed to produce strategic materials and components for U.S. nuclear... REVIEW 2018 This page left intentionally blank REVIEW NUCLEAR POSTURE REVIEW FEBRUARY 2018...OFFICE OF THE SECRETARY OF DEFENSE This page left intentionally blank REVIEW CONTENTS SECRETARY’S PREFACE

[Prevalence of Avoidable Potential Interactions Between Antidepressants and Other Drugs in Colombian Patients].

Science.gov (United States)

Machado-Alba, Jorge E; Morales-Plaza, Cristhian David

2013-06-01

To determine the possible drugs interactions with antidepressive agents in data bases of patients in the Health Insurance System of Colombia. From data bases of about 4 million users in Colombia, a systematic review of drugs dispensation statistics was made to identify drug interactions between antidepressive agents, cholinergic antagonists and tramadol in 2010. We identified 114,465 monthly users of antidepressive agents. Of these, 5776 (5.0%) received two, and 178 (0.2%) received three antidepressive agents simultaneously. The most frequent combination was fluoxetine+trazodone (n=3235; 56.9% of cases). About 1127 (1.0%) patients were prescribed a cholinergic antagonist simultaneously; 2523 (2.1%) users were dispensed tramadol at the same time, while raising the risk of serotonin syndrome. Drug interactions represent a potential risk that is often underestimated by physicians. Pharmacovigilance is a useful tool to optimize resources and prevent negative outcomes associated with medication. It is recommended that systematic search is made to enhance surveillance programs for the rational use of medicines in this country. Copyright © 2013 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Calculus super review

CERN Document Server

2012-01-01

Get all you need to know with Super Reviews! Each Super Review is packed with in-depth, student-friendly topic reviews that fully explain everything about the subject. The Calculus I Super Review includes a review of functions, limits, basic derivatives, the definite integral, combinations, and permutations. Take the Super Review quizzes to see how much you've learned - and where you need more study. Makes an excellent study aid and textbook companion. Great for self-study!DETAILS- From cover to cover, each in-depth topic review is easy-to-follow and easy-to-grasp - Perfect when preparing for

Child maltreatment prevention: a systematic review of reviews.

Science.gov (United States)

Mikton, Christopher; Butchart, Alexander

2009-05-01

To synthesize recent evidence from systematic and comprehensive reviews on the effectiveness of universal and selective child maltreatment prevention interventions, evaluate the methodological quality of the reviews and outcome evaluation studies they are based on, and map the geographical distribution of the evidence. A systematic review of reviews was conducted. The quality of the systematic reviews was evaluated with a tool for the assessment of multiple systematic reviews (AMSTAR), and the quality of the outcome evaluations was assessed using indicators of internal validity and of the construct validity of outcome measures. The review focused on seven main types of interventions: home visiting, parent education, child sex abuse prevention, abusive head trauma prevention, multi-component interventions, media-based interventions, and support and mutual aid groups. Four of the seven - home-visiting, parent education, abusive head trauma prevention and multi-component interventions - show promise in preventing actual child maltreatment. Three of them - home visiting, parent education and child sexual abuse prevention - appear effective in reducing risk factors for child maltreatment, although these conclusions are tentative due to the methodological shortcomings of the reviews and outcome evaluation studies they draw on. An analysis of the geographical distribution of the evidence shows that outcome evaluations of child maltreatment prevention interventions are exceedingly rare in low- and middle-income countries and make up only 0.6% of the total evidence base. Evidence for the effectiveness of four of the seven main types of interventions for preventing child maltreatment is promising, although it is weakened by methodological problems and paucity of outcome evaluations from low- and middle-income countries.

Systematic review

DEFF Research Database (Denmark)

Momsen, Anne-Mette Hedeager; Hald, Kathrine; Nielsen, Claus Vinther

2017-01-01

REVIEW OBJECTIVE/QUESTION: The objective of this review is to identify the effectiveness of expanded cardiac rehabilitation (CR) in patients diagnosed with coronary heart disease (CHD). Specifically, the review question is: What is the effectiveness of expanded CR compared to standard CR in adult...

Making literature reviews more reliable through application of lessons from systematic reviews.

Science.gov (United States)

Haddaway, N R; Woodcock, P; Macura, B; Collins, A

2015-12-01

Review articles can provide valuable summaries of the ever-increasing volume of primary research in conservation biology. Where findings may influence important resource-allocation decisions in policy or practice, there is a need for a high degree of reliability when reviewing evidence. However, traditional literature reviews are susceptible to a number of biases during the identification, selection, and synthesis of included studies (e.g., publication bias, selection bias, and vote counting). Systematic reviews, pioneered in medicine and translated into conservation in 2006, address these issues through a strict methodology that aims to maximize transparency, objectivity, and repeatability. Systematic reviews will always be the gold standard for reliable synthesis of evidence. However, traditional literature reviews remain popular and will continue to be valuable where systematic reviews are not feasible. Where traditional reviews are used, lessons can be taken from systematic reviews and applied to traditional reviews in order to increase their reliability. Certain key aspects of systematic review methods that can be used in a context-specific manner in traditional reviews include focusing on mitigating bias; increasing transparency, consistency, and objectivity, and critically appraising the evidence and avoiding vote counting. In situations where conducting a full systematic review is not feasible, the proposed approach to reviewing evidence in a more systematic way can substantially improve the reliability of review findings, providing a time- and resource-efficient means of maximizing the value of traditional reviews. These methods are aimed particularly at those conducting literature reviews where systematic review is not feasible, for example, for graduate students, single reviewers, or small organizations. © 2015 Society for Conservation Biology.

78 FR 47016 - Submission for Review: Request for External Review

Science.gov (United States)

2013-08-02

... OFFICE OF PERSONNEL MANAGEMENT Submission for Review: Request for External Review AGENCY: U.S... External Review. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35... the Multi-State Plan Program (MSPP) on March 11, 2013, 78 FR 15560, which outlined an external review...

Dissemination bias in systematic reviews of animal research: a systematic review.

Directory of Open Access Journals (Sweden)

Katharina F Mueller

Full Text Available Systematic reviews of preclinical studies, in vivo animal experiments in particular, can influence clinical research and thus even clinical care. Dissemination bias, selective dissemination of positive or significant results, is one of the major threats to validity in systematic reviews also in the realm of animal studies. We conducted a systematic review to determine the number of published systematic reviews of animal studies until present, to investigate their methodological features especially with respect to assessment of dissemination bias, and to investigate the citation of preclinical systematic reviews on clinical research.Eligible studies for this systematic review constitute systematic reviews that summarize in vivo animal experiments whose results could be interpreted as applicable to clinical care. We systematically searched Ovid Medline, Embase, ToxNet, and ScienceDirect from 1st January 2009 to 9th January 2013 for eligible systematic reviews without language restrictions. Furthermore we included articles from two previous systematic reviews by Peters et al. and Korevaar et al.The literature search and screening process resulted in 512 included full text articles. We found an increasing number of published preclinical systematic reviews over time. The methodological quality of preclinical systematic reviews was low. The majority of preclinical systematic reviews did not assess methodological quality of the included studies (71%, nor did they assess heterogeneity (81% or dissemination bias (87%. Statistics quantifying the importance of clinical research citing systematic reviews of animal studies showed that clinical studies referred to the preclinical research mainly to justify their study or a future study (76%.Preclinical systematic reviews may have an influence on clinical research but their methodological quality frequently remains low. Therefore, systematic reviews of animal research should be critically appraised before

Using Semantic Web Technologies to Reproduce a Pharmacovigilance Case Study

NARCIS (Netherlands)

M. Hildebrand (Michiel); R Hoekstra; J.R. van Ossenbruggen (Jacco)

2013-01-01

htmlabstractWe provide a detailed report of a reproduction study of a paper published in the International Journal of Medical Sciences (IJMS). We first use the PROV-O ontology to model our reconstruction of the computational workflow of the original experiment and to systematically explicate all

Integration of existing systematic reviews into new reviews: identification of guidance needs

Science.gov (United States)

2014-01-01

Background An exponential increase in the number of systematic reviews published, and constrained resources for new reviews, means that there is an urgent need for guidance on explicitly and transparently integrating existing reviews into new systematic reviews. The objectives of this paper are: 1) to identify areas where existing guidance may be adopted or adapted, and 2) to suggest areas for future guidance development. Methods We searched documents and websites from healthcare focused systematic review organizations to identify and, where available, to summarize relevant guidance on the use of existing systematic reviews. We conducted informational interviews with members of Evidence-based Practice Centers (EPCs) to gather experiences in integrating existing systematic reviews, including common issues and challenges, as well as potential solutions. Results There was consensus among systematic review organizations and the EPCs about some aspects of incorporating existing systematic reviews into new reviews. Current guidance may be used in assessing the relevance of prior reviews and in scanning references of prior reviews to identify studies for a new review. However, areas of challenge remain. Areas in need of guidance include how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. For instance, empiric evidence is needed regarding how to quality check data abstraction and when and how to use study-level risk of bias assessments from prior reviews. Conclusions There remain areas of uncertainty for how to integrate existing systematic reviews into new reviews. Methods research and consensus processes among systematic review organizations are needed to develop guidance to address these challenges. PMID:24956937

Book Reviews

Directory of Open Access Journals (Sweden)

Book Review Editor, Barbara Hogenboom

2014-10-01

Full Text Available The Economic History of the Caribbean since the Napoleonic Wars, by Victor Bulmer-Thomas (2012; reviewed by Gert OostindieSubjects or Citizens: British Caribbean Workers in Cuba, 1900-1960, by Robert Whitney and Graciela Chailloux Laffita (2013; reviewed by Rose Mary AllenDebating Civil-Military Relations in Latin America, editado por David Mares y Rafael Martínez (2014; reseñado por Raul Benitez-ManautComparative Public Policy in Latin America, editado por Jordi Díez y Susan Franceschet (2012; reseñado por Gonzalo DelamazaEntre el desarrollo y el buen vivir. Recursos naturales y conflictos en los territorios indígenas, editado por José Aylwin, Salvador Martí i Puig, Claire Wright y Nancy Yañez (2013; reviewed by Almut Schilling-VacaflorDignity for the Voiceless. Willem Assies’s Anthropological Work in Context, editado por Ton Salman, Salvador Martí i Puig, y Gemma van der Haar (2014; reseñado por Ricardo Calla OrtegaDemocracy in ‘Two Mexicos’; Political Institutions in Oaxaca and Nuevo León, by Guadelupe Correa-Cabrera (2013; reviewed by Jos BartmanWhere the River Ends, by Shaylih Muehlmann (2013; reviewed by Maria L. Cruz-TorresKnowing History in Mexico. An ethnography of Citizenship, by Trevor Stack (2012; reviewed by Raymond BuveFor God and Revolution. Priest, Peasant, and Agrarian Socialism in the Mexican Huasteca, por Mark Saad Saka( 2013; reseñado por Antonio Escobar OhmstedeWorking Women, Entrepreneurs, and the Mexican Revolution: the Coffee Culture of Córdoba, Veracruz, by Heather Fowler-Salamini (2013; reviewed by Robert F. AlegreWar by Other Means. Aftermath in Post-Genocide Guatemala, edited by Carlota McAlister and Diana Nelson (2013; reviewed by Dirk KruijtLucha revolucionaria. Perú, 1958-1967, por Jan Lust (2013; reseñado por Dirk KruijtWomen in War. The Micro-Processes of Mobilization in El Salvador, by Jocelyn Viterna (2013; reviewed by Ralph SprenkelsZero Hunger: Political Culture and Antipoverty Policy in

Comments on ``Anonymous Reviews'' An Editor's View of Anonymous Reviews

Science.gov (United States)

Goff, John A.

I have read with great interest the recent Forum commentaries in Eos by Myrl Beck, Charles Robinove, Robert Criss, and Anne Hofmeister regarding anonymous reviews. I heartily support their position that anonymous reviews should be avoided. I have not written an anonymous review in ages (and regret the few that I did), and have always appreciated and respected greatly anyone who signs a critical review of one of my own papers. However, I would like to add some perspective from the editorial standpoint. I have served as JGR associate editor for 3 years (never anonymously!), and as Eos editor for seismology and tectonophysics for 4. Over the years, I have rejected a fair number of papers, most of those based on anonymous reviews (fortunately, none of the above commentators was one of them). The vast majority of anonymous reviews I received were well considered. While I would wish that all reviews were signed, I don't think we can summarily dismiss the fear that many would have of enmity and reprisal over a critical review. Some of these fears are likely justified. On more than one occasion, have I witnessed overly aggressive responses on the part of authors to anonymous reviews that I considered to be entirely fair and constructive in their criticisms. I do think we need to do all we can to discourage anonymous reviews, but it will be difficult to completely remove that choice from the process.

Proactive Reviews

DEFF Research Database (Denmark)

Kolbæk, Ditte

2014-01-01

with solving a task. They found improved ways of doing the job and identified management challenges. They shared their experience with colleagues who did not attend the Proactive Review and addressed the management challenges to the senior management. Proactive Reviews were reported 50-100 times a year....... Valid feedback from various stakeholders improved the original design of After Action Reviews into Proactive Reviews, which is helpful for local as well as global companies to learn from experience. The educational design started with personal experience that was shared with colleagues who cooperated...

Methodology in conducting a systematic review of systematic reviews of healthcare interventions

LENUS (Irish Health Repository)

Smith, Valerie

2011-02-03

Abstract Background Hundreds of studies of maternity care interventions have been published, too many for most people involved in providing maternity care to identify and consider when making decisions. It became apparent that systematic reviews of individual studies were required to appraise, summarise and bring together existing studies in a single place. However, decision makers are increasingly faced by a plethora of such reviews and these are likely to be of variable quality and scope, with more than one review of important topics. Systematic reviews (or overviews) of reviews are a logical and appropriate next step, allowing the findings of separate reviews to be compared and contrasted, providing clinical decision makers with the evidence they need. Methods The methods used to identify and appraise published and unpublished reviews systematically, drawing on our experiences and good practice in the conduct and reporting of systematic reviews are described. The process of identifying and appraising all published reviews allows researchers to describe the quality of this evidence base, summarise and compare the review\\'s conclusions and discuss the strength of these conclusions. Results Methodological challenges and possible solutions are described within the context of (i) sources, (ii) study selection, (iii) quality assessment (i.e. the extent of searching undertaken for the reviews, description of study selection and inclusion criteria, comparability of included studies, assessment of publication bias and assessment of heterogeneity), (iv) presentation of results, and (v) implications for practice and research. Conclusion Conducting a systematic review of reviews highlights the usefulness of bringing together a summary of reviews in one place, where there is more than one review on an important topic. The methods described here should help clinicians to review and appraise published reviews systematically, and aid evidence-based clinical decision-making.

Book Reviews

Directory of Open Access Journals (Sweden)

Christien Klaufus, Book Review Editor

2016-04-01

Full Text Available The Improbable Conquest: Sixteenth Century Letters from the Rio de la Plata, por Pablo García Loaeza y Victoria L. Garrett, 2015; reseñado por Judith Farberman Urban Space as Heritage in Late Colonial Cuba: Classicism and Dissonance on the Plaza de Armas of Havana: 1754-1828, by Paul Niell, 2015; reviewed by Joseph L. Scarpaci El Jefe Político. Un dominio negociando en el mundo rural del Estado de México. 1856-1911, por Romana Falcón, 2015; reseñado por Raymond Buve Miedo negro, poder blanco en la Cuba colonial, por Jorge Camacho, 2015; reseñado por Oleski Miranda Navarro Revolutionary Parks: Conservation, Social Justice, and Mexico’s National Parks, 1910-1940, by Emily Wakild, 2011; reviewed by Grant Burrier Sandino’s Nation: Ernesto Cardenal and Sergio Ramírez Writing Nicaragua, 1940-2012, by Stephen Henighan, 2014; reviewed by Grace A. Gomashie La cancha peronista. Fútbol y política (1946-1955, edited by Raanan Rein, 2015; reviewed by Alexis Sossa Rojas Chile y la Guerra Fría global, edited by Tanya Harmer and Alfredo Riquelme Segovia, 2014; reviewed by Ángela Vergara Challenging Social Inequality: The Landless Rural Workers Movement and Agrarian Reform in Brazil, edited by M. Carter, 2015; reviewed by Rebecca Tarlau Brazil: Reversal of Fortune, by Alfred P. Montero, 2014; reviewed by Edgar J. Marcolin Latin American Documentary Filmmaking – Major works, by David William Foster, 2013; reviewed by Leontien Cremers Telling and Being told: Storytelling and Cultural Control in Contemporary Yucatec Maya Literatures, por Paul Worley, 2013; reseñado por Ana Ugarte Bachata and Dominican Identity/La bachata y la identidad dominicana, by Julie Sellers, 2014; reviewed by Grant D. Moss Entrepreneurial Selves: Neoliberal Respectability and the Making of a Caribbean Middle Class, by Carla Freeman, 2014; reviewed by Emiel Martens

Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

International Nuclear Information System (INIS)

Jordan, Scott A.; Cunningham, David G.; Marles, Robin J.

2010-01-01

Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantity and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.

When reviews attack: ethics, free speech, and the peer review process.

Science.gov (United States)

Hadjistavropoulos, T; Bieling, P J

2000-08-01

The peer review process, whether formally applied in publication and grant review, or informally, such as exchange of ideas in scientific and professional newsgroups, has sparked controversy. Writers in this area agree that scholarly reviews that are inappropriate in tone are not uncommon. Indeed, commentators have suggested rules and guidelines that can be used to improve the review process and to make reviewers more accountable. In this paper, we examine the relevance and impact of ethical codes on the conduct of peer review. It is our contention that the peer review process can be improved, not by a new set of rules but through closer attention to the ethical principles to which we, as psychologists, already subscribe.

2008 annual merit review

Energy Technology Data Exchange (ETDEWEB)

None, None

2009-01-18

The 2008 DOE Vehicle Technologies Program Annual Merit Review was held February 25-28, 2008 in Bethesda, Maryland. The review encompassed all of the work done by the Vehicle Technologies Program: a total of 280 individual activities were reviewed, by a total of just over 100 reviewers. A total of 1,908 individual review responses were received for the technical reviews, and an additional 29 individual review responses were received for the plenary session review.

Simulation Modelling in Healthcare: An Umbrella Review of Systematic Literature Reviews.

Science.gov (United States)

Salleh, Syed; Thokala, Praveen; Brennan, Alan; Hughes, Ruby; Booth, Andrew

2017-09-01

Numerous studies examine simulation modelling in healthcare. These studies present a bewildering array of simulation techniques and applications, making it challenging to characterise the literature. The aim of this paper is to provide an overview of the level of activity of simulation modelling in healthcare and the key themes. We performed an umbrella review of systematic literature reviews of simulation modelling in healthcare. Searches were conducted of academic databases (JSTOR, Scopus, PubMed, IEEE, SAGE, ACM, Wiley Online Library, ScienceDirect) and grey literature sources, enhanced by citation searches. The articles were included if they performed a systematic review of simulation modelling techniques in healthcare. After quality assessment of all included articles, data were extracted on numbers of studies included in each review, types of applications, techniques used for simulation modelling, data sources and simulation software. The search strategy yielded a total of 117 potential articles. Following sifting, 37 heterogeneous reviews were included. Most reviews achieved moderate quality rating on a modified AMSTAR (A Measurement Tool used to Assess systematic Reviews) checklist. All the review articles described the types of applications used for simulation modelling; 15 reviews described techniques used for simulation modelling; three reviews described data sources used for simulation modelling; and six reviews described software used for simulation modelling. The remaining reviews either did not report or did not provide enough detail for the data to be extracted. Simulation modelling techniques have been used for a wide range of applications in healthcare, with a variety of software tools and data sources. The number of reviews published in recent years suggest an increased interest in simulation modelling in healthcare.

Roles for librarians in systematic reviews: a scoping review

Science.gov (United States)

Spencer, Angela J.; Eldredge, Jonathan D.

2018-01-01

Objective What roles do librarians and information professionals play in conducting systematic reviews? Librarians are increasingly called upon to be involved in systematic reviews, but no study has considered all the roles librarians can perform. This inventory of existing and emerging roles aids in defining librarians’ systematic reviews services. Methods For this scoping review, the authors conducted controlled vocabulary and text-word searches in the PubMed; Library, Information Science & Technology Abstracts; and CINAHL databases. We separately searched for articles published in the Journal of the European Association for Health Information and Libraries, Evidence Based Library and Information Practice, the Journal of the Canadian Heath Libraries Association, and Hypothesis. We also text-word searched Medical Library Association annual meeting poster and paper abstracts. Results We identified 18 different roles filled by librarians and other information professionals in conducting systematic reviews from 310 different articles, book chapters, and presented papers and posters. Some roles were well known such as searching, source selection, and teaching. Other less documented roles included planning, question formulation, and peer review. We summarize these different roles and provide an accompanying bibliography of references for in-depth descriptions of these roles. Conclusion Librarians play central roles in systematic review teams, including roles that go beyond searching. This scoping review should encourage librarians who are fulfilling roles that are not captured here to document their roles in journal articles and poster and paper presentations. PMID:29339933

Systematic review of reviews of risk factors for intracranial aneurysms

International Nuclear Information System (INIS)

Clarke, Mike

2008-01-01

Systematic reviews of systematic reviews identify good quality reviews of earlier studies of medical conditions. This article describes a systematic review of systematic reviews performed to investigate factors that might influence the risk of rupture of an intracranial aneurysm. It exemplifies the technique of this type of research and reports the finding of a specific study. The annual incidence of subarachnoid haemorrhage resulting from the rupture of intracranial aneurysms is estimated to be nine per 100,000. A large proportion of people who have this bleed, will die or remain dependent on the care of others for some time. Reliable knowledge about the risks of subarachnoid haemorrhage in different populations will help in planning, screening and prevention strategies and in predicting the prognosis of individual patients. If the necessary data were available in the identified reviews, an estimate for the numerical relationship between a particular characteristic and the risk of subarachnoid haemorrhage was included in this report. The identification of eligible systematic reviews relied mainly on the two major bibliographic databases of the biomedical literature: PubMed and EMBASE. These were searched in 2006, using specially designed search strategies. Approximately 2,000 records were retrieved and each of these was checked carefully against the eligibility criteria for this systematic review. These criteria required that the report be a systematic review of studies assessing the risk of subarachnoid haemorrhage in patients known to have an unruptured intracranial aneurysm or of studies that had investigated the characteristics of people who experienced a subarachnoid haemorrhage without previously being known to have an unruptured aneurysm. Reports which included more than one systematic review were eligible and each of these reviews was potentially eligible. The quality of each systematic review was assessed. In this review, 16 separate reports were

Classification of Recombinant Biologics in the EU

DEFF Research Database (Denmark)

Klein, Kevin; De Bruin, Marie L; Broekmans, Andre W

2015-01-01

BACKGROUND AND OBJECTIVE: Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level...... of biologics by national authorities responsible for ADR reporting. METHODS: A sample list of recombinant biologics from the European Medicines Agency database of European Public Assessment Reports was created to analyze five Member States (Belgium, the Netherlands, Spain, Sweden, and the UK) according...

Medication errors detected in non-traditional databases

DEFF Research Database (Denmark)

Perregaard, Helene; Aronson, Jeffrey K; Dalhoff, Kim

2015-01-01

AIMS: We have looked for medication errors involving the use of low-dose methotrexate, by extracting information from Danish sources other than traditional pharmacovigilance databases. We used the data to establish the relative frequencies of different types of errors. METHODS: We searched four...... errors, whereas knowledge-based errors more often resulted in near misses. CONCLUSIONS: The medication errors in this survey were most often action-based (50%) and knowledge-based (34%), suggesting that greater attention should be paid to education and surveillance of medical personnel who prescribe...

Bidirectional RNN for Medical Event Detection in Electronic Health Records.

Science.gov (United States)

Jagannatha, Abhyuday N; Yu, Hong

2016-06-01

Sequence labeling for extraction of medical events and their attributes from unstructured text in Electronic Health Record (EHR) notes is a key step towards semantic understanding of EHRs. It has important applications in health informatics including pharmacovigilance and drug surveillance. The state of the art supervised machine learning models in this domain are based on Conditional Random Fields (CRFs) with features calculated from fixed context windows. In this application, we explored recurrent neural network frameworks and show that they significantly out-performed the CRF models.

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.

Science.gov (United States)

Segec, A; Keller-Stanislawski, B; Vermeer, N S; Macchiarulo, C; Straus, S M; Hidalgo-Simon, A; De Bruin, M L

2015-11-01

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization. © 2015 American Society for Clinical Pharmacology and Therapeutics.

Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance.

Science.gov (United States)

Robinson, Karen A; Chou, Roger; Berkman, Nancy D; Newberry, Sydne J; Fu, Rongwei; Hartling, Lisa; Dryden, Donna; Butler, Mary; Foisy, Michelle; Anderson, Johanna; Motu'apuaka, Makalapua; Relevo, Rose; Guise, Jeanne-Marie; Chang, Stephanie

2016-02-01

As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review. Copyright © 2016 Elsevier Inc. All rights reserved.

33 CFR 385.22 - Independent scientific review and external peer review.

Science.gov (United States)

2010-07-01

... external peer review. 385.22 Section 385.22 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT... RESTORATION PLAN CERP Implementation Processes § 385.22 Independent scientific review and external peer review... members, shall not attempt to influence the panel's review or assign this panel any other tasks, nor...

State technical review of the HLNW program and the peer review process

International Nuclear Information System (INIS)

Jacob, G.R.

1986-01-01

Millions of dollars are being spent on state governments' review of the Department of Energy (DOE) high level waste (HLW) repository program. A significant portion of the review efforts focus on technical issues surrounding the development and installment of HLW disposal technologies. Some view the states' technical review efforts as part of a peer review process. However, this interpretation reveals a misunderstanding of the concept of peer review and the purposes of state technical review

Quality of systematic reviews in pediatric oncology - A systematic review

NARCIS (Netherlands)

Lundh, Andreas; Knijnenburg, Sebastiaan L.; Jørgensen, Anders W.; van Dalen, Elvira C.; Kremer, Leontien C. M.

2009-01-01

Background: To ensure evidence-based decision making in pediatric oncology systematic reviews are necessary. The objective of our study was to evaluate the methodological quality of all currently existing systematic reviews in pediatric oncology. Methods: We identified eligible systematic reviews

Environmental Review Records

Data.gov (United States)

Department of Housing and Urban Development — HUD’s Environmental Review Records page houses environmental reviews made publicly available through the HUD Environmental Review Online System (HEROS). This...

City-based action to reduce harmful alcohol use: review of reviews.

Science.gov (United States)

Anderson, Peter; Jané-Llopis, Eva; Hasan, Omer Syed Muhammad; Rehm, Jürgen

2018-01-01

Background: The World Health Organization global strategy on alcohol called for municipal policies to reduce the harmful use of alcohol. Yet, there is limited evidence that documents the impact of city-level alcohol policies. Methods: Review of reviews for all years to July 2017. Searches on OVID Medline, Healthstar, Embase, PsycINFO, AMED, Social Work Abstracts, CAB Abstracts, Mental Measurements Yearbook, Health and Psychosocial Instruments, International Pharmaceutical Abstracts, International Political Science Abstracts, NASW Clinical Register, and Epub Ahead of Print databases. All reviews that address adults, without language or date restrictions resulting from combining the terms ("review" or "literature review" or "review literature" or "data pooling" or "comparative study" or "systematic review" or "meta-analysis" or "pooled analysis"), and "alcohol", and "intervention" and ("municipal" or "city" or "community"). Results: Five relevant reviews were identified. Studies in the reviews were all from high income countries and focussed on the acute consequences of drinking, usually with one target intervention, commonly bars, media, or drink-driving. No studies in the reviews reported the impact of comprehensive city-based action. One community cluster randomized controlled trial in Australia, published after the reviews, failed to find convincing evidence of an impact of community-based interventions in reducing adult harmful use of alcohol.     Conclusions: To date, with one exception, the impact of adult-oriented comprehensive community and municipal action to reduce the harmful use of alcohol has not been studied. The one exception failed to find a convincing effect. We conclude with recommendations for closing this evidence gap.

Reporting and methodologic quality of Cochrane Neonatal review group systematic reviews

Directory of Open Access Journals (Sweden)

Al Faleh Khalid

2009-06-01

Full Text Available Abstract Background The Cochrane Neonatal Review Group (CNRG has achieved a lot with limited resources in producing high quality systematic reviews to assist clinicians in evidence-based decision-making. A formal assessment of published CNRG systematic reviews has not been undertaken; we sought to provide a comprehensive assessment of the quality of systematic reviews (both methodologic and reporting quality published in CNRG. Methods We selected a random sample of published CNRG systematic reviews. Items of the QUOROM statement were utilized to assess quality of reporting, while items and total scores of the Oxman-Guyatt Overview Quality Assessment Questionnaire (OQAQ were used to assess methodologic quality. Two reviewers independently extracted data and assessed quality. A Student t-test was used to compare quality scores pre- and post-publication of the QUOROM statement. Results Sixty-one systematic reviews were assessed. Overall, the included reviews had good quality with minor flaws based on OQAQ total scores (mean, 4.5 [0.9]; 95% CI, 4.27–4.77. However, room for improvement was noted in some areas, such as the title, abstract reporting, a priori plan for heterogeneity assessment and how to handle heterogeneity in case it exists, and assessment of publication bias. In addition, reporting of agreement among reviewers, documentation of trials flow, and discussion of possible biases were addressed in the review process. Reviews published post the QUOROM statement had a significantly higher quality scores. Conclusion The systematic reviews published in the CNRG are generally of good quality with minor flaws. However, efforts should be made to improve the quality of reports. Readers must continue to assess the quality of published reports on an individual basis prior to implementing the recommendations.

SWIFT-Review: a text-mining workbench for systematic review.

Science.gov (United States)

Howard, Brian E; Phillips, Jason; Miller, Kyle; Tandon, Arpit; Mav, Deepak; Shah, Mihir R; Holmgren, Stephanie; Pelch, Katherine E; Walker, Vickie; Rooney, Andrew A; Macleod, Malcolm; Shah, Ruchir R; Thayer, Kristina

2016-05-23

There is growing interest in using machine learning approaches to priority rank studies and reduce human burden in screening literature when conducting systematic reviews. In addition, identifying addressable questions during the problem formulation phase of systematic review can be challenging, especially for topics having a large literature base. Here, we assess the performance of the SWIFT-Review priority ranking algorithm for identifying studies relevant to a given research question. We also explore the use of SWIFT-Review during problem formulation to identify, categorize, and visualize research areas that are data rich/data poor within a large literature corpus. Twenty case studies, including 15 public data sets, representing a range of complexity and size, were used to assess the priority ranking performance of SWIFT-Review. For each study, seed sets of manually annotated included and excluded titles and abstracts were used for machine training. The remaining references were then ranked for relevance using an algorithm that considers term frequency and latent Dirichlet allocation (LDA) topic modeling. This ranking was evaluated with respect to (1) the number of studies screened in order to identify 95 % of known relevant studies and (2) the "Work Saved over Sampling" (WSS) performance metric. To assess SWIFT-Review for use in problem formulation, PubMed literature search results for 171 chemicals implicated as EDCs were uploaded into SWIFT-Review (264,588 studies) and categorized based on evidence stream and health outcome. Patterns of search results were surveyed and visualized using a variety of interactive graphics. Compared with the reported performance of other tools using the same datasets, the SWIFT-Review ranking procedure obtained the highest scores on 11 out of 15 of the public datasets. Overall, these results suggest that using machine learning to triage documents for screening has the potential to save, on average, more than 50 % of the screening

Does Indigenous health research have impact? A systematic review of reviews.

Science.gov (United States)

Kinchin, Irina; Mccalman, Janya; Bainbridge, Roxanne; Tsey, Komla; Lui, Felecia Watkin

2017-03-21

Aboriginal and Torres Strait Islander Australians (hereafter respectfully Indigenous Australians) claim that they have been over-researched without corresponding research benefit. This claim raises two questions. The first, which has been covered to some extent in the literature, is about what type(s) of research are likely to achieve benefits for Indigenous people. The second is how researchers report the impact of their research for Indigenous people. This systematic review of Indigenous health reviews addresses the second enquiry. Fourteen electronic databases were systematically searched for Indigenous health reviews which met eligibility criteria. Two reviewers assessed their characteristics and methodological rigour using an a priori protocol. Three research hypotheses were stated and tested: (1) reviews address Indigenous health priority needs; (2) reviews adopt best practice guidelines on research conduct and reporting in respect to methodological transparency and rigour, as well as acceptability and appropriateness of research implementation to Indigenous people; and (3) reviews explicitly report the incremental impacts of the included studies and translation of research. We argue that if review authors explicitly address each of these three hypotheses, then the impact of research for Indigenous peoples' health would be explicated. Seventy-six reviews were included; comprising 55 journal articles and 21 Australian Government commissioned evidence review reports. While reviews are gaining prominence and recognition in Indigenous health research and increasing in number, breadth and complexity, there is little reporting of the impact of health research for Indigenous people. This finding raises questions about the relevance of these reviews for Indigenous people, their impact on policy and practice and how reviews have been commissioned, reported and evaluated. The findings of our study serve two main purposes. First, we have identified knowledge and

Design review report, 241-S-102 cover plate review; TOPICAL

International Nuclear Information System (INIS)

ADAMS, M.R.

1998-01-01

The design for the cover plate and lead plate for shielding on 241-S-102 was reviewed on 10/21/98. All Review Comment Record comments were resolved to the satisfaction of the reviewers. Additional comments were taken during the meeting and were also resolved. A design calculation for the Radiological Design Review Screening was presented as criteria for the use of 1 inch lead plate. The review concluded that the use of 2 inch steel plate and 1 inch lead plate provided the required safety function required by HNF-SD-WM-810-001, 5.3.2.20, Basis for Interim Operation. The design was approved with the incorporated comments as recorded on RCR's and meeting minutes

Summarizing systematic reviews: methodological development, conduct and reporting of an umbrella review approach.

Science.gov (United States)

Aromataris, Edoardo; Fernandez, Ritin; Godfrey, Christina M; Holly, Cheryl; Khalil, Hanan; Tungpunkom, Patraporn

2015-09-01

With the increase in the number of systematic reviews available, a logical next step to provide decision makers in healthcare with the evidence they require has been the conduct of reviews of existing systematic reviews. Syntheses of existing systematic reviews are referred to by many different names, one of which is an umbrella review. An umbrella review allows the findings of reviews relevant to a review question to be compared and contrasted. An umbrella review's most characteristic feature is that this type of evidence synthesis only considers for inclusion the highest level of evidence, namely other systematic reviews and meta-analyses. A methodology working group was formed by the Joanna Briggs Institute to develop methodological guidance for the conduct of an umbrella review, including diverse types of evidence, both quantitative and qualitative. The aim of this study is to describe the development and guidance for the conduct of an umbrella review. Discussion and testing of the elements of methods for the conduct of an umbrella review were held over a 6-month period by members of a methodology working group. The working group comprised six participants who corresponded via teleconference, e-mail and face-to-face meeting during this development period. In October 2013, the methodology was presented in a workshop at the Joanna Briggs Institute Convention. Workshop participants, review authors and methodologists provided further testing, critique and feedback on the proposed methodology. This study describes the methodology and methods developed for the conduct of an umbrella review that includes published systematic reviews and meta-analyses as the analytical unit of the review. Details are provided regarding the essential elements of an umbrella review, including presentation of the review question in a Population, Intervention, Comparator, Outcome format, nuances of the inclusion criteria and search strategy. A critical appraisal tool with 10 questions to

20 CFR 405.410 - Selecting claims for Decision Review Board review.

Science.gov (United States)

2010-04-01

... will not review claims based on the identity of the administrative law judge who decided the claim. (b... Decision Review Board review. (a)(1) The Board may review your claim if the administrative law judge made a decision under §§ 405.340 or 405.370 of this part, regardless of whether the administrative law judge's...

Reviews

Science.gov (United States)

2002-11-01

CD-ROM REVIEW (551) Essential Physics BOOK REVIEWS (551) Collins Advanced Science: Physics, 2nd edition Quarks, Leptons and the Big Bang, 2nd edition Do Brilliantly: A2 Physics IGCSE Physics Geophysics in the UK Synoptic Skills in Advanced Physics Flash! The hunt for the biggest explosions in the universe Materials Maths for Advanced Physics

The Effectiveness of Parenting Programs: A Review of Campbell Reviews

Science.gov (United States)

Barlow, Jane; Coren, Esther

2018-01-01

Parenting practices predict important outcomes for children, and parenting programs are potentially effective means of supporting parents to promote optimal outcomes for children. This review summarizes findings of systematic reviews of parenting programs published in the Campbell Library. Six reviews evaluated the effectiveness of a range of…

Reviewing Reviews of Research in Educational Leadership: An Empirical Assessment

Science.gov (United States)

Hallinger, Philip

2014-01-01

Purpose: Reviews of research play a critical but underappreciated role in knowledge production and accumulation. Yet, until relatively recently, limited attention has been given to the "methodology" of conducting reviews of research. This observation also applies in educational leadership and management where reviews of research have…

Comparison of search strategies in systematic reviews of adverse effects to other systematic reviews.

Science.gov (United States)

Golder, Su; Loke, Yoon K; Zorzela, Liliane

2014-06-01

Research indicates that the methods used to identify data for systematic reviews of adverse effects may need to differ from other systematic reviews. To compare search methods in systematic reviews of adverse effects with other reviews. The search methodologies in 849 systematic reviews of adverse effects were compared with other reviews. Poor reporting of search strategies is apparent in both systematic reviews of adverse effects and other types of systematic reviews. Systematic reviews of adverse effects are less likely to restrict their searches to MEDLINE or include only randomised controlled trials (RCTs). The use of other databases is largely dependent on the topic area and the year the review was conducted, with more databases searched in more recent reviews. Adverse effects search terms are used by 72% of reviews and despite recommendations only two reviews report using floating subheadings. The poor reporting of search strategies in systematic reviews is universal, as is the dominance of searching MEDLINE. However, reviews of adverse effects are more likely to include a range of study designs (not just RCTs) and search beyond MEDLINE. © 2014 Crown Copyright.

Providing Quality Therapeutics in Switzerland: Role of the Stakeholders and Recent Incentives for Further Improvements.

Science.gov (United States)

Besson, Marie; Samer, Caroline; Rollason, Victoria; Dayer, Pierre; Desmeules, Jules

2015-07-01

Quality therapeutics play an important role in Switzerland's health care and economy. Switzerland holds a key position in the world of research and development, as well as in drug production. Recently, new emphasis has been placed on promoting clinical research and maintaining Switzerland's position as a center of excellence in the field. Recent revisions to the law regarding medical trials in human research allow for better allocation of regulatory resources and simplified procedures for drugs already authorized in Switzerland. The country has its own regulatory agency, the Swiss Agency for Therapeutic Products (Swissmedic), which is a public institution of the Swiss government. Swissmedic is responsible for ensuring safety in medicines, particularly regarding authorizations and market surveillance in the sector of medicinal products and medical devices. Although the centralized authorization procedure of the European Union for medicines does not apply to Switzerland, there are mutual recognition mechanisms between the Swiss medicine regulatory authority and the European Medicines Agency. Swissmedic is also in charge of postmarketing safety and oversees the national pharmacovigilance center, which collaborates closely with the World Health Organization center in Uppsala. In addition, university hospital-based clinical pharmacologists, who are involved in basic science and clinical research, regulatory affairs, ethics committees, and pharmacovigilance, promote quality therapeutics. This article discusses the role of the various stakeholders and the recent efforts made to provide a better allocation of resources aimed at further improving quality therapeutics in Switzerland. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

Science.gov (United States)

Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

2015-09-01

Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

Scientific computer simulation review

International Nuclear Information System (INIS)

Kaizer, Joshua S.; Heller, A. Kevin; Oberkampf, William L.

2015-01-01

Before the results of a scientific computer simulation are used for any purpose, it should be determined if those results can be trusted. Answering that question of trust is the domain of scientific computer simulation review. There is limited literature that focuses on simulation review, and most is specific to the review of a particular type of simulation. This work is intended to provide a foundation for a common understanding of simulation review. This is accomplished through three contributions. First, scientific computer simulation review is formally defined. This definition identifies the scope of simulation review and provides the boundaries of the review process. Second, maturity assessment theory is developed. This development clarifies the concepts of maturity criteria, maturity assessment sets, and maturity assessment frameworks, which are essential for performing simulation review. Finally, simulation review is described as the application of a maturity assessment framework. This is illustrated through evaluating a simulation review performed by the U.S. Nuclear Regulatory Commission. In making these contributions, this work provides a means for a more objective assessment of a simulation’s trustworthiness and takes the next step in establishing scientific computer simulation review as its own field. - Highlights: • We define scientific computer simulation review. • We develop maturity assessment theory. • We formally define a maturity assessment framework. • We describe simulation review as the application of a maturity framework. • We provide an example of a simulation review using a maturity framework

Tools for PSA reviews

International Nuclear Information System (INIS)

Linden, J. von

1998-01-01

It is desirable to have a uniform and competent procedure for the review of PSAs which are performed within the framework of the Periodic Safety Review of German Nuclear Power Plants. Guidelines for the review process should therefore be evaluated within task A. 1 of project SR 2096. The basis for this work is the experience and knowledge within GRS derived from PSA-related work and from several review projects as well as the German PSA Guide with its appendices. Furthermore, the review processes in the USA, Switzerland and Sweden and the Guidelines for the International Peer Review Service (IPERS Guidelines) were utilized. As a result, recommendations are given for the review process, with individual recommendations concerning the organization of the review, task allocation between the reviewers, interface problems, assessment criteria, the scope and depth of the review as well as the supporting documents. An additional result are checklists for the technical elements of the PSA, which are listed to facilicate the review work. It is not the intention of this report to work out complete review guidelines. Its aims is rather more to give recommondations and support for the review in addition to what can be derived from the existing documents that should be used for the review. The recommendations reflect the view of GRS and go beyond the statements given in the German PSA Guide (Leitfaden Probabilistische Sicherheitsanalyse /PSUe97/) in some points. (orig.) [de

Engineering Review Information System

Science.gov (United States)

Grems, III, Edward G. (Inventor); Henze, James E. (Inventor); Bixby, Jonathan A. (Inventor); Roberts, Mark (Inventor); Mann, Thomas (Inventor)

2015-01-01

A disciplinal engineering review computer information system and method by defining a database of disciplinal engineering review process entities for an enterprise engineering program, opening a computer supported engineering item based upon the defined disciplinal engineering review process entities, managing a review of the opened engineering item according to the defined disciplinal engineering review process entities, and closing the opened engineering item according to the opened engineering item review.

Diversifying customer review rankings.

Science.gov (United States)

Krestel, Ralf; Dokoohaki, Nima

2015-06-01

E-commerce Web sites owe much of their popularity to consumer reviews accompanying product descriptions. On-line customers spend hours and hours going through heaps of textual reviews to decide which products to buy. At the same time, each popular product has thousands of user-generated reviews, making it impossible for a buyer to read everything. Current approaches to display reviews to users or recommend an individual review for a product are based on the recency or helpfulness of each review. In this paper, we present a framework to rank product reviews by optimizing the coverage of the ranking with respect to sentiment or aspects, or by summarizing all reviews with the top-K reviews in the ranking. To accomplish this, we make use of the assigned star rating for a product as an indicator for a review's sentiment polarity and compare bag-of-words (language model) with topic models (latent Dirichlet allocation) as a mean to represent aspects. Our evaluation on manually annotated review data from a commercial review Web site demonstrates the effectiveness of our approach, outperforming plain recency ranking by 30% and obtaining best results by combining language and topic model representations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings

Energy Technology Data Exchange (ETDEWEB)

DiSabatino, A; Biswas, D; DeMicco, M; Fisher, L E; Hafner, R; Haslam, J; Mok, G; Patel, C; Russell, E

2007-04-12

This Packaging Review Guide (PRG) provides guidance for Department of Energy (DOE) review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE Order 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his or her review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. This PRG is generally organized at the section level in a format similar to that recommended in Regulatory Guide 7.9 (RG 7.9). One notable exception is the addition of Section 9 (Quality Assurance), which is not included as a separate chapter in RG 7.9. Within each section, this PRG addresses the technical and regulatory bases for the review, the manner in which the review is accomplished, and findings that are generally applicable for a package that meets the approval standards. This Packaging Review Guide (PRG) provides guidance for DOE review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE O 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. The primary objectives of this PRG are to: (1) Summarize the regulatory requirements for package approval; (2) Describe the technical review procedures by which DOE determines that these requirements have been satisfied; (3) Establish and maintain the quality and uniformity of reviews; (4) Define the base from which to evaluate proposed changes in scope

A scoping review protocol on the roles and tasks of peer reviewers in the manuscript review process in biomedical journals.

Science.gov (United States)

Glonti, Ketevan; Cauchi, Daniel; Cobo, Erik; Boutron, Isabelle; Moher, David; Hren, Darko

2017-10-22

The primary functions of peer reviewers are poorly defined. Thus far no body of literature has systematically identified the roles and tasks of peer reviewers of biomedical journals. A clear establishment of these can lead to improvements in the peer review process. The purpose of this scoping review is to determine what is known on the roles and tasks of peer reviewers. We will use the methodological framework first proposed by Arksey and O'Malley and subsequently adapted by Levac et al and the Joanna Briggs Institute. The scoping review will include all study designs, as well as editorials, commentaries and grey literature. The following eight electronic databases will be searched (from inception to May 2017): Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, EMBASE, MEDLINE, PsycINFO, Scopus and Web of Science. Two reviewers will use inclusion and exclusion criteria based on the 'Population-Concept-Context' framework to independently screen titles and abstracts of articles considered for inclusion. Full-text screening of relevant eligible articles will also be carried out by two reviewers. The search strategy for grey literature will include searching in websites of existing networks, biomedical journal publishers and organisations that offer resources for peer reviewers. In addition we will review journal guidelines to peer reviewers on how to perform the manuscript review. Journals will be selected using the 2016 journal impact factor. We will identify and assess the top five, middle five and lowest-ranking five journals across all medical specialties. This scoping review will undertake a secondary analysis of data already collected and does not require ethical approval. The results will be disseminated through journals and conferences targeting stakeholders involved in peer review in biomedical research. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

Research Review

OpenAIRE

Anonymous

1983-01-01

Research Reviewed: "The Adjustment of Nominal Interest Rates to Inflation: A Review of Recent Literature"; "Role of Government in a Market Economy"; "Economic Analysis and Agricultural Policy"; "Agricultural Research Policy"

Conflicts of interest and spin in reviews of psychological therapies: a systematic review

Science.gov (United States)

Lieb, Klaus; von der Osten-Sacken, Jan; Stoffers-Winterling, Jutta; Reiss, Neele; Barth, Jürgen

2016-01-01

Objective To explore conflicts of interest (COI) and their reporting in systematic reviews of psychological therapies, and to evaluate spin in the conclusions of the reviews. Methods MEDLINE and PsycINFO databases were searched for systematic reviews published between 2010 and 2013 that assessed effects of psychological therapies for anxiety, depressive or personality disorders, and included at least one randomised controlled trial. Required COI disclosure by journal, disclosed COI by review authors, and the inclusion of own primary studies by review authors were extracted. Researcher allegiance, that is, that researchers concluded favourably about the interventions they have studied, as well as spin, that is, differences between results and conclusions of the reviews, were rated by 2 independent raters. Results 936 references were retrieved, 95 reviews fulfilled eligibility criteria. 59 compared psychological therapies with other forms of psychological therapies, and 36 psychological therapies with pharmacological interventions. Financial, non-financial, and personal COI were disclosed in 22, 4 and 1 review, respectively. 2 of 86 own primary studies of review authors included in 34 reviews were disclosed by review authors. In 15 of the reviews, authors showed an allegiance effect to the evaluated psychological therapy that was never disclosed. Spin in review conclusions was found in 27 of 95 reviews. Reviews with a conclusion in favour of psychological therapies (vs pharmacological interventions) were at high risk for a spin in conclusions (OR=8.31 (1.41 to 49.05)). Spin was related in trend to the inclusion of own primary studies in the systematic review (OR=2.08 (CI 0.83 to 5.18) p=0.11) and researcher allegiance (OR=2.63 (0.84 to 8.16) p=0.16). Conclusions Non-financial COI, especially the inclusion of own primary studies into reviews and researcher allegiance, are frequently seen in systematic reviews of psychological therapies and need more transparency and

QA REVIEWS: HOW THEY DIFFER FROM PEER REVIEWS

Science.gov (United States)

Research papers and reports written by scientists and engineers in the United States Environmental Protection Agency are reviewed by the agency's quality assurance staff. EPA papers and reports are subjected to peer reviews that check for the validity of conclusions and the gener...

Reviewer acknowledgement 2013

OpenAIRE

Stengel, Dirk; Luckmann, Annette

2014-01-01

Contributing reviewers The editors of the Journal of Trauma Management and Outcomes and BioMed Central would like to show our appreciation for the following reviewers for their time, hard work and support by reviewing manuscripts for the journal in 2013.

Reviews of recent publications

Directory of Open Access Journals (Sweden)

2001-06-01

Full Text Available Alonso, Carlos J. The Burden of Modernity: The Rhetoric of Cultural Discourse in Spanish America Reviewed by Melvin S. Arrington, Jr. Kolocotroni, Vassiliki, Jane Goldman, and Olga Taxidou, eds, Modernism: An Anthology of Sources and Documents Reviewed by Gerd Bayer Motte, Warren. Small Worlds: Minimalism in Contemporary French Literature Reviewed by William Cloonan Melton, Judith M. The Face of Exile: Autobiographical Journeys Reviewed by Claude P. Desmarais Redding, Arthur. Raids on Human Consciousness: Writing, Anarchism, and Violence Reviewed by Gail Finney Chambers, Ross. Facing It: AIDS Diaries and the Death of the Author Reviewed by Melissa A. Fitch Marx-Scouras, Danielle. The Cultural Politics of Tel Quel: Literature and the Left in the Wake of Engagement Reviewed by Diane Fourny Foster, David William. Buenos Aires: Perspectives on the City and Cultural Production Reviewed by Gustavo Geirola Nelson, Ardis L., ed. Guillermo Cabrera Infante: Assays, essays, and other arts Reviewed by José Luis Martinez-Dueñas Fox, Claire F. The Fence and the River: Culture and Politics at the U.S.-Mexico Border Reviewed by Robert Neustadt

Interventions to Reduce Adult Nursing Turnover: A Systematic Review of Systematic Reviews.

Science.gov (United States)

Halter, Mary; Pelone, Ferruccio; Boiko, Olga; Beighton, Carole; Harris, Ruth; Gale, Julia; Gourlay, Stephen; Drennan, Vari

2017-01-01

Nurse turnover is an issue of concern in health care systems internationally. Understanding which interventions are effective to reduce turnover rates is important to managers and health care organisations. Despite a plethora of reviews of such interventions, strength of evidence is hard to determine. We aimed to review literature on interventions to reduce turnover in nurses working in the adult health care services in developed economies. We conducted an overview (systematic review of systematic reviews) using the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, Applied Social Sciences Index and Abstracts, CINAHL plus and SCOPUS and forward searching. We included reviews published between 1990 and January 2015 in English. We carried out parallel blinded selection, extraction of data and assessment of bias, using the Assessment of Multiple Systematic Reviews. We carried out a narrative synthesis. Despite the large body of published reviews, only seven reviews met the inclusion criteria. These provide moderate quality review evidence, albeit from poorly controlled primary studies. They provide evidence of effect of a small number of interventions which decrease turnover or increase retention of nurses, these being preceptorship of new graduates and leadership for group cohesion. We highlight that a large body of reviews does not equate with a large body of high quality evidence. Agreement as to the measures and terminology to be used together with well-designed, funded primary research to provide robust evidence for nurse and human resource managers to base their nurse retention strategies on is urgently required.

Elements of integrated care approaches for older people: a review of reviews.

Science.gov (United States)

Briggs, Andrew M; Valentijn, Pim P; Thiyagarajan, Jotheeswaran A; Araujo de Carvalho, Islene

2018-04-07

The World Health Organization (WHO) recently proposed an Integrated Care for Older People approach to guide health systems and services in better supporting functional ability of older people. A knowledge gap remains in the key elements of integrated care approaches used in health and social care delivery systems for older populations. The objective of this review was to identify and describe the key elements of integrated care models for elderly people reported in the literature. Review of reviews using a systematic search method. A systematic search was performed in MEDLINE and the Cochrane database in June 2017. Reviews of interventions aimed at care integration at the clinical (micro), organisational/service (meso) or health system (macro) levels for people aged ≥60 years were included. Non-Cochrane reviews published before 2015 were excluded. Reviews were assessed for quality using the Assessment of Multiple Systematic Reviews (AMSTAR) 1 tool. Fifteen reviews (11 systematic reviews, of which six were Cochrane reviews) were included, representing 219 primary studies. Three reviews (20%) included only randomised controlled trials (RCT), while 10 reviews (65%) included both RCTs and non-RCTs. The region where the largest number of primary studies originated was North America (n=89, 47.6%), followed by Europe (n=60, 32.1%) and Oceania (n=31, 16.6%). Eleven (73%) reviews focused on clinical 'micro' and organisational 'meso' care integration strategies. The most commonly reported elements of integrated care models were multidisciplinary teams, comprehensive assessment and case management. Nurses, physiotherapists, general practitioners and social workers were the most commonly reported service providers. Methodological quality was variable (AMSTAR scores: 1-11). Seven (47%) reviews were scored as high quality (AMSTAR score ≥8). Evidence of elements of integrated care for older people focuses particularly on micro clinical care integration processes, while there

Non-sedating antihistamine drugs and cardiac arrhythmias -- biased risk estimates from spontaneous reporting systems?

DEFF Research Database (Denmark)

De Bruin, M L; van Puijenbroek, E P; Egberts, A C G

2002-01-01

of these drugs. METHODS: All suspected adverse drug reactions (ADRs) reported until July 1999 to the Netherlands Pharmacovigilance Foundation Lareb were used to calculate the ADR reporting odds ratio, defined as the ratio of exposure odds among reported arrhythmia cases, to the exposure odds of other ADRs (non......-sedating antihistamines. In general non-sedating antihistamines are associated with cardiac arrhythmia to a higher extent in comparison with other drugs (ADR reporting odds ratio 2.05 [95% CI: 1.45, 2.89]). The association between arrhythmias and non-sedating antihistamine drugs calculated before 1998...

Roles for librarians in systematic reviews: a scoping review

Directory of Open Access Journals (Sweden)

Angela J. Spencer

2018-01-01

Results: We identified 18 different roles filled by librarians and other information professionals in conducting systematic reviews from 310 different articles, book chapters, and presented papers and posters. Some roles were well known such as searching, source selection, and teaching. Other less documented roles included planning, question formulation, and peer review. We summarize these different roles and provide an accompanying bibliography of references for in-depth descriptions of these roles. Conclusion: Librarians play central roles in systematic review teams, including roles that go beyond searching. This scoping review should encourage librarians who are fulfilling roles that are not captured here to document their roles in journal articles and poster and paper presentations.  This article has been approved for the Medical Library Association’s Independent Reading Program.

Book Reviews

Directory of Open Access Journals (Sweden)

Aliraza Javaid

2014-11-01

Full Text Available Criminal Justice: An Introduction to Philosophies, Theories and Practice Reviewed by Aliraza Javaid Canadian Policing in the 21st Century: A Frontline Officer on Challenges and Changes Reviewed by Katie Cook

Comparison of self-citation by peer reviewers in a journal with single-blind peer review versus a journal with open peer review.

Science.gov (United States)

Levis, Alexander W; Leentjens, Albert F G; Levenson, James L; Lumley, Mark A; Thombs, Brett D

2015-12-01

Some peer reviewers may inappropriately, or coercively request that authors include references to the reviewers' own work. The objective of this study was to evaluate whether, compared to reviews for a journal with single-blind peer review, reviews for a journal with open peer review included (1) fewer self-citations; (2) a lower proportion of self-citations without a rationale; and (3) a lower ratio of proportions of citations without a rationale in self-citations versus citations to others' work. Peer reviews for published manuscripts submitted in 2012 to a single-blind peer review journal, the Journal of Psychosomatic Research, were previously evaluated (Thombs et al., 2015). These were compared to publically available peer reviews of manuscripts published in 2012 in an open review journal, BMC Psychiatry. Two investigators independently extracted data for both journals. There were no significant differences between journals in the proportion of all reviewer citations that were self-citations (Journal of Psychosomatic Research: 71/225, 32%; BMC Psychiatry: 90/315, 29%; p=.50), or in the proportion of self-citations without a rationale (Journal of Psychosomatic Research: 15/71, 21%; BMC Psychiatry: 12/90, 13%; p=.21). There was no significant difference between journals in the proportion of self-citations versus citations to others' work without a rationale (p=.31). Blind and open peer review methodologies have distinct advantages and disadvantages. The present study found that, in reasonably similar journals that use single-blind and open review, there were no substantive differences in the pattern of peer reviewer self-citations. Copyright © 2015 Elsevier Inc. All rights reserved.

Quality of reviews on sugar-sweetened beverages and health outcomes: a systematic review123

Science.gov (United States)

Weed, Douglas L; Mink, Pamela J

2011-01-01

Background: Medical and public health decisions are informed by reviews, which makes the quality of reviews an important scientific concern. Objective: We systematically assessed the quality of published reviews on sugar-sweetened beverages (SSBs) and health, which is a controversial topic that is important to public health. Design: We performed a search of PubMed and Cochrane databases and a hand search of reference lists. Studies that were selected were published reviews and meta-analyses (June 2001 to June 2011) of epidemiologic studies of the relation between SSBs and obesity, type 2 diabetes, metabolic syndrome, and coronary heart disease. A standardized data-abstraction form was used. Review quality was assessed by using the validated instrument AMSTAR (assessment of multiple systematic reviews), which is a one-page tool with 11 questions. Results: Seventeen reviews met our inclusion and exclusion criteria: obesity or weight (16 reviews), diabetes (3 reviews), metabolic syndrome (3 reviews), and coronary heart disease (2 reviews). Authors frequently used a strictly narrative review (7 of 17 reviews). Only 6 of 17 reviews reported quantitative data in a table format. Overall, reviews of SSBs and health outcomes received moderately low–quality scores by the AMSTAR [mean: 4.4 points; median: 4 points; range: 1–8.5 points (out of a possible score of 11 points)]. AMSTAR scores were not related to the conclusions of authors (8 reviews reported an association with a mean AMSTAR score of 4.1 points; 9 reviews with equivocal conclusions scored 4.7 points; P value = 0.84). Less than one-third of published reviews reported a comprehensive literature search, listed included and excluded studies, or used duplicate study selection and data abstraction. Conclusion: The comprehensive reporting of epidemiologic evidence and use of systematic methodologies to interpret evidence were underused in published reviews on SSBs and health. PMID:21918218

Systematic review

DEFF Research Database (Denmark)

Enggaard, Helle

Title: Systematic review a method to promote nursing students skills in Evidence Based Practice Background: Department of nursing educate students to practice Evidence Based Practice (EBP), where clinical decisions is based on the best available evidence, patient preference, clinical experience...... and resources available. In order to incorporate evidence in clinical decisions, nursing students need to learn how to transfer knowledge in order to utilize evidence in clinical decisions. The method of systematic review can be one approach to achieve this in nursing education. Method: As an associate lecturer...... I have taken a Comprehensive Systematic Review Training course provide by Center of Clinical Guidelines in Denmark and Jonna Briggs Institute (JBI) and practice in developing a systematic review on how patients with ischemic heart disease experiences peer support. This insight and experience...

Random Versus Nonrandom Peer Review: A Case for More Meaningful Peer Review.

Science.gov (United States)

Itri, Jason N; Donithan, Adam; Patel, Sohil H

2018-05-10

Random peer review programs are not optimized to discover cases with diagnostic error and thus have inherent limitations with respect to educational and quality improvement value. Nonrandom peer review offers an alternative approach in which diagnostic error cases are targeted for collection during routine clinical practice. The objective of this study was to compare error cases identified through random and nonrandom peer review approaches at an academic center. During the 1-year study period, the number of discrepancy cases and score of discrepancy were determined from each approach. The nonrandom peer review process collected 190 cases, of which 60 were scored as 2 (minor discrepancy), 94 as 3 (significant discrepancy), and 36 as 4 (major discrepancy). In the random peer review process, 1,690 cases were reviewed, of which 1,646 were scored as 1 (no discrepancy), 44 were scored as 2 (minor discrepancy), and none were scored as 3 or 4. Several teaching lessons and quality improvement measures were developed as a result of analysis of error cases collected through the nonrandom peer review process. Our experience supports the implementation of nonrandom peer review as a replacement to random peer review, with nonrandom peer review serving as a more effective method for collecting diagnostic error cases with educational and quality improvement value. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Sscience & technology review; Science Technology Review

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-07-01

This review is published ten times a year to communicate, to a broad audience, Lawrence Livermore National Laboratory`s scientific and technological accomplishments, particularly in the Laboratory`s core mission areas - global security, energy and the environment, and bioscience and biotechnology. This review for the month of July 1996 discusses: Frontiers of research in advanced computations, The multibeam Fabry-Perot velocimeter: Efficient measurement of high velocities, High-tech tools for the American textile industry, and Rock mechanics: can the Tuff take the stress.

Surgical interventions for gastric cancer: a review of systematic reviews.

Science.gov (United States)

He, Weiling; Tu, Jian; Huo, Zijun; Li, Yuhuang; Peng, Jintao; Qiu, Zhenwen; Luo, Dandong; Ke, Zunfu; Chen, Xinlin

2015-01-01

To evaluate methodological quality and the extent of concordance among meta-analysis and/or systematic reviews on surgical interventions for gastric cancer (GC). A comprehensive search of PubMed, Medline, EMBASE, the Cochrane library and the DARE database was conducted to identify the reviews comparing different surgical interventions for GC prior to April 2014. After applying included criteria, available data were summarized and appraised by the Oxman and Guyatt scale. Fifty six reviews were included. Forty five reviews (80.4%) were well conducted, with scores of adapted Oxman and Guyatt scale ≥ 14. The reviews differed in criteria for avoiding bias and assessing the validity of the primary studies. Many primary studies displayed major methodological flaws, such as randomization, allocation concealment, and dropouts and withdrawals. According to the concordance assessment, laparoscopy-assisted gastrectomy (LAG) was superior to open gastrectomy, and laparoscopy-assisted distal gastrectomy was superior to open distal gastrectomy in short-term outcomes. However, the concordance regarding other surgical interventions, such as D1 vs. D2 lymphadenectomy, and robotic gastrectomy vs. LAG were absent. Systematic reviews on surgical interventions for GC displayed relatively high methodological quality. The improvement of methodological quality and reporting was necessary for primary studies. The superiority of laparoscopic over open surgery was demonstrated. But concordance on other surgical interventions was rare, which needed more well-designed RCTs and systematic reviews.

Reviewing Literature in Bioethics Research: Increasing Rigour in Non-Systematic Reviews.

Science.gov (United States)

McDougall, Rosalind

2015-09-01

The recent interest in systematic review methods in bioethics has highlighted the need for greater transparency in all literature review processes undertaken in bioethics projects. In this article, I articulate features of a good bioethics literature review that does not aim to be systematic, but rather to capture and analyse the key ideas relevant to a research question. I call this a critical interpretive literature review. I begin by sketching and comparing three different types of literature review conducted in bioethics scholarship. Then, drawing on Dixon-Wood's concept of critical interpretive synthesis, I put forward six features of a good critical interpretive literature review in bioethics: answering a research question, capturing the key ideas relevant to the research question, analysing the literature as a whole, generating theory, not excluding papers based on rigid quality assessment criteria, and reporting the search strategy. © 2015 John Wiley & Sons Ltd.

Methodology in conducting a systematic review of systematic reviews of healthcare interventions.

LENUS (Irish Health Repository)

Smith, Valerie

2011-02-01

Hundreds of studies of maternity care interventions have been published, too many for most people involved in providing maternity care to identify and consider when making decisions. It became apparent that systematic reviews of individual studies were required to appraise, summarise and bring together existing studies in a single place. However, decision makers are increasingly faced by a plethora of such reviews and these are likely to be of variable quality and scope, with more than one review of important topics. Systematic reviews (or overviews) of reviews are a logical and appropriate next step, allowing the findings of separate reviews to be compared and contrasted, providing clinical decision makers with the evidence they need.

Consideration of health inequalities in systematic reviews: a mapping review of guidance.

Science.gov (United States)

Maden, Michelle

2016-11-28

Given that we know that interventions shown to be effective in improving the health of a population may actually widen the health inequalities gap while others reduce it, it is imperative that all systematic reviewers consider how the findings of their reviews may impact (reduce or increase) on the health inequality gap. This study reviewed existing guidance on incorporating considerations of health inequalities in systematic reviews in order to examine the extent to which they can help reviewers to incorporate such issues. A mapping review was undertaken to identify guidance documents that purported to inform reviewers on whether and how to incorporate considerations of health inequalities. Searches were undertaken in Medline, CINAHL and The Cochrane Library Methodology Register. Review guidance manuals prepared by international organisations engaged in undertaking systematic reviews, and their associated websites were scanned. Studies were included if they provided an overview or discussed the development and testing of guidance for dealing with the incorporation of considerations of health inequalities in evidence synthesis. Results are summarised in narrative and tabular forms. Twenty guidance documents published between 2009 and 2016 were included. Guidance has been produced to inform considerations of health inequalities at different stages of the systematic review process. The Campbell and Cochrane Equity Group have been instrumental in developing and promoting such guidance. Definitions of health inequalities and guidance differed across the included studies. All but one guidance document were transparent in their method of production. Formal methods of evaluation were reported for six guidance documents. Most of the guidance was operationalised in the form of examples taken from published systematic reviews. The number of guidance items to operationalise ranges from 3 up to 26 with a considerable overlap noted. Adhering to the guidance will require more

Book Reviews

Directory of Open Access Journals (Sweden)

Lise Kanckos

2012-06-01

Full Text Available Believing in Belonging: Belief & Social Identity in the Modern World by Abby Day is reviewed by Lise Kanckos.Religion and the New Atheism: A Critical Appraisal, edited by Amarnath Amarasingam, is reviewed by Mikko Sillfors.

Proactive Review

DEFF Research Database (Denmark)

Kolbæk, Ditte

2015-01-01

This chapter will explore how to learn from working experience through the use of an educational approach called Proactive Review. From 2005 to 2012, Proactive Review was developed and implemented in a world-class IT company based in more than 40 countries across Europe, the Middle East, and Africa....... This chapter will include some of the theoretical considerations as well as the final educational design for a Proactive Review, as exemplified in a case study from the IT company. The aim of this chapter is to provide a theoretically based and proven educational design for Lessons Learned, including...... recommendations for successful Proactive Reviews. The theory section will explore theories regarding the following two topics: first, how an organization may understand the term “learning”; and second, the starting point of learning and how an organization may maintain a learning environment. The research...

Peer Review of Grant Applications: Criteria Used and Qualitative Study of Reviewer Practices

Science.gov (United States)

Abdoul, Hendy; Perrey, Christophe; Amiel, Philippe; Tubach, Florence; Gottot, Serge; Durand-Zaleski, Isabelle; Alberti, Corinne

2012-01-01

Background Peer review of grant applications has been criticized as lacking reliability. Studies showing poor agreement among reviewers supported this possibility but usually focused on reviewers’ scores and failed to investigate reasons for disagreement. Here, our goal was to determine how reviewers rate applications, by investigating reviewer practices and grant assessment criteria. Methods and Findings We first collected and analyzed a convenience sample of French and international calls for proposals and assessment guidelines, from which we created an overall typology of assessment criteria comprising nine domains relevance to the call for proposals, usefulness, originality, innovativeness, methodology, feasibility, funding, ethical aspects, and writing of the grant application. We then performed a qualitative study of reviewer practices, particularly regarding the use of assessment criteria, among reviewers of the French Academic Hospital Research Grant Agencies (Programmes Hospitaliers de Recherche Clinique, PHRCs). Semi-structured interviews and observation sessions were conducted. Both the time spent assessing each grant application and the assessment methods varied across reviewers. The assessment criteria recommended by the PHRCs were listed by all reviewers as frequently evaluated and useful. However, use of the PHRC criteria was subjective and varied across reviewers. Some reviewers gave the same weight to each assessment criterion, whereas others considered originality to be the most important criterion (12/34), followed by methodology (10/34) and feasibility (4/34). Conceivably, this variability might adversely affect the reliability of the review process, and studies evaluating this hypothesis would be of interest. Conclusions Variability across reviewers may result in mistrust among grant applicants about the review process. Consequently, ensuring transparency is of the utmost importance. Consistency in the review process could also be improved by

Eligibility criteria in systematic reviews published in prominent medical journals: a methodological review.

Science.gov (United States)

McCrae, Niall; Purssell, Edward

2015-12-01

Clear and logical eligibility criteria are fundamental to the design and conduct of a systematic review. This methodological review examined the quality of reporting and application of eligibility criteria in systematic reviews published in three leading medical journals. All systematic reviews in the BMJ, JAMA and The Lancet in the years 2013 and 2014 were extracted. These were assessed using a refined version of a checklist previously designed by the authors. A total of 113 papers were eligible, of which 65 were in BMJ, 17 in The Lancet and 31 in JAMA. Although a generally high level of reporting was found, eligibility criteria were often problematic. In 67% of papers, eligibility was specified after the search sources or terms. Unjustified time restrictions were used in 21% of reviews, and unpublished or unspecified data in 27%. Inconsistency between journals was apparent in the requirements for systematic reviews. The quality of reviews in these leading medical journals was high; however, there were issues that reduce the clarity and replicability of the review process. As well as providing a useful checklist, this methodological review informs the continued development of standards for systematic reviews. © 2015 John Wiley & Sons, Ltd.

Time required for institutional review board review at one Veterans Affairs medical center.

Science.gov (United States)

Hall, Daniel E; Hanusa, Barbara H; Stone, Roslyn A; Ling, Bruce S; Arnold, Robert M

2015-02-01

Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. To measure the overall and incremental process times for IRB review as a process of quality improvement. After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. Calendar days from initial submission to final approval of research protocols. Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels

Same review quality in open versus blinded peer review in "Ugeskrift for Læger"

DEFF Research Database (Denmark)

Vinther, Siri; Nielsen, Ole Haagen; Rosenberg, Jacob

2012-01-01

Research into the peer review process has previously been conducted in English-language journals. This study deals with a Danish general medical journal with a relatively small pool of both reviewers and readers. The aim of the study was to compare the quality of reviews produced by identifiable...... and anonymous reviewers, and further to characterize authors' and reviewers' attitudes towards different peer review systems....

Systematic review automation technologies

Science.gov (United States)

2014-01-01

Systematic reviews, a cornerstone of evidence-based medicine, are not produced quickly enough to support clinical practice. The cost of production, availability of the requisite expertise and timeliness are often quoted as major contributors for the delay. This detailed survey of the state of the art of information systems designed to support or automate individual tasks in the systematic review, and in particular systematic reviews of randomized controlled clinical trials, reveals trends that see the convergence of several parallel research projects. We surveyed literature describing informatics systems that support or automate the processes of systematic review or each of the tasks of the systematic review. Several projects focus on automating, simplifying and/or streamlining specific tasks of the systematic review. Some tasks are already fully automated while others are still largely manual. In this review, we describe each task and the effect that its automation would have on the entire systematic review process, summarize the existing information system support for each task, and highlight where further research is needed for realizing automation for the task. Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow. We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials, appraises them, extracts and synthesizes data, evaluates the risk of bias, performs meta-analysis calculations, and produces a report in real time. PMID:25005128

Scientific composition and review of manuscripts for publication in peer-reviewed dental journals.

Science.gov (United States)

Bayne, Stephen C; McGivney, Glen P; Mazer, Sarah C

2003-02-01

This article provides an extensive tutorial for writers and reviewers involved with the preparation and evaluation of manuscripts submitted for publication in dental journals. The contents were compiled from the Instructions for Authors printed in various peer-reviewed dental journals and from feedback from 10 workshops conducted for the Editorial Review Board of the Journal of Prosthetic Dentistry. The 10 major sections of a scientific manuscript are reviewed in detail in terms of content, format, and common errors; examples of good content are provided. The review process is described, and instructions on conducting fair and expeditious manuscript evaluations are provided for reviewers. In addition, a number of special topics are addressed, including potential conflicts of interest for an author, institutional review of experiments that involve human subjects or animals, and the reproduction of photographs and other images in color versus black and white. In summary, this article presents key guidelines to ensure compliance with the principles of sound scientific writing and the expeditious review of manuscripts prepared for publication in peer-reviewed dental journals.

After the demise of luz: a first technology assessment and pre-feasibility study for segs technology in Spain

International Nuclear Information System (INIS)

Aringhoff, R.

1993-01-01

This paper gives an overview of activities planned for the next years since LUZ, the company which designed, built and operated the world's largest solar power plants, filed for bankruptcy towards the end of 1991. With some degree of certainty, there will be no new solar thermal trough collector power plant projects in nearest future in the California energy market. In order to avoid rupture of the technology development as well as not to loose track of the learning curve achieved with the nine projects in California, FLAGSOL is committed to concentrate on further project developments in Southern Europe and the Maghreb region. For the first time, a major European utility company, ENDESA, is interested in analysing the potential of trough collector technology for regional capacity increments in their supply area. In order to support further technology dissemination in high insolation areas, the leading Moroccan solar development agency CDER is willing to join this cooperation in order to evaluate SEGS technology potential for their own fast growing electricity demand as well as to analyse future prospects for an interconnected grid with Spain. (Author) 5 refs

Magnetohydrodynamics MHD Engineering Test Facility ETF 200 MWe power plant. Conceptual Design Engineering Report CDER. Volume 3: Costs and schedules

Science.gov (United States)

1981-01-01

The estimated plant capital cost for a coal fired 200 MWE electric generating plant with open cycle magnetohydrodynamics is divided into principal accounts based on Federal Energy Regulatory Commision account structure. Each principal account is defined and its estimated cost subdivided into identifiable and major equipment systems. The cost data sources for compiling the estimates, cost parameters, allotments, assumptions, and contingencies, are discussed. Uncertainties associated with developing the costs are quantified to show the confidence level acquired. Guidelines established in preparing the estimated costs are included. Based on an overall milestone schedule related to conventional power plant scheduling experience and starting procurement of MHD components during the preliminary design phase there is a 6 1/2-year construction period. The duration of the project from start to commercial operation is 79 months. The engineering phase of the project is 4 1/2 years; the construction duration following the start of the man power block is 37 months.

NASA Product Peer Review Process

Science.gov (United States)

Jenks, Ken

2009-01-01

This viewgraph presentation describes NASA's product peer review process. The contents include: 1) Inspection/Peer Review at NASA; 2) Reasons for product peer reviews; 3) Different types of peer reviews; and 4) NASA requirements for peer reviews. This presentation also includes a demonstration of an actual product peer review.

Software Reviews.

Science.gov (United States)

Kinnaman, Daniel E.; And Others

1988-01-01

Reviews four educational software packages for Apple, IBM, and Tandy computers. Includes "How the West was One + Three x Four,""Mavis Beacon Teaches Typing,""Math and Me," and "Write On." Reviews list hardware requirements, emphasis, levels, publisher, purchase agreements, and price. Discusses the strengths…

Sulfur Dioxide (SO2) Primary NAAQS Review: Integrated Review Plan - Advisory with CASAC

Science.gov (United States)

The SO2 Integrated Review Plan is the first document generated as part of the National Ambient Air Quality Standards (NAAQS) review process. The Plan presents background information, the schedule for the review, the process to be used in conducting the review, and the key policy-...

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

Science.gov (United States)

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

Peer review: a view based on recent experience as an author and reviewer.

Science.gov (United States)

Clark, R K F

2012-08-01

Peer review is an important stage in academic publishing, as a form of quality control to maintain the integrity of both the articles and the journals they appear in. However, the confidential nature of the relationship between reviewer and author does not necessarily benefit the system; with some reviewers using their anonymity to give unnecessary, injudicious comment. This paper explores the motives behind the reviewer's comments and how peer review could be improved by openness and honesty.

Book Reviews.

Science.gov (United States)

Powicke, J. C.; And Others

1986-01-01

Reviews of 10 recent books and one new journal ("Catalyst: A Journal of Policy Debate") are provided. Topics of the books reviewed include: economics in modern Britain, world economics, the mixed economy, Milton Friedman's thought, British industry, economic issues, and London as a financial center. (JDH)

Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

Science.gov (United States)

Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

2017-02-01

Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

Herbal medicines: challenges in the modern world. Part 2. European Union and Russia.

Science.gov (United States)

Sammons, Helen M; Gubarev, Michael I; Krepkova, Lubov V; Bortnikova, Valentina V; Corrick, Fenella; Job, Kathleen M; Sherwin, Catherine Mt; Enioutina, Elena Y

2016-08-01

Herbal medicines (HMs) have been well known to people of the European Union (EU) and Russia for centuries. Currently, Western HMs can be classified into two categories, plant-derived conventional medicines and dietary supplements. Interest to HMs has grown rapidly in all countries during the past two decades. The main goal of this review article is to present the history of HMs in the EU and Russia, forms of modern HMs, including Oriental Medicines that are popular among consumers of both countries. Additional discussion points comprise safety and adulteration issues associated with HMs, including regulatory changes and new legislative measures undertaken by the authorities. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: Due to cultural diversities in the EU and Russia, traditional HMs of other regions, particularly Chinese Traditional and Ayurvedic medicines, are also popular. Recently, dietary supplements containing multiple herbal and other natural products have flooded the EU and Russian markets. Pharmacovigilance in these markets is challenging in terms of establishing quality and safety of ingredients, determining efficacy, and defining risks of herb-herb and herb-drug interactions. Both the EU and Russia have introduced new legislation aimed to overcome these deficiencies.

[Are newspapers a reliable source of information about doping in sports?].

Science.gov (United States)

Durrieu, Geneviève; Gorsse, Elisabeth; Montastruc, Jean-Louis

2004-01-01

To study the coverage by French newspapers of doping in sports, we performed a systematic review of articles appearing between January and March 2003 on the following French websites: L'Equipe, Le Monde, Le Figaro, Libération, La Dépêche du Midi and Agence France-Presse (AFP). We recorded a total of 58 articles about doping. Among them, 48 (83%) were collected from the AFP news. L'Equipe, a French sports newspaper, published seven articles (12%). Most of the recorded data reported results of worldwide antidoping control (71%). No information about new drugs was found. The analysis of the selected articles pointed out the following: (i) the seriousness of observations related to doping since, during this 3-month period, we noted two deaths of athletes; (ii) the risks associated with the use of dietary supplements, particularly products including amphetamine derivatives; (iii) the interest in judicial investigation as an information source about doping in sports (investigation of suspicious deaths of Italian football players); and (iv) identification of the sports involved in doping (cycling, but also athletics, football, rugby). Systematic analysis of newspaper reports can be considered as a relevant method for monitoring the pharmacovigilance and pharmacoepidemiology of doping in sports.

Patient Access, Unmet Medical Need, Expected Benefits, and Concerns Related to the Utilisation of Biosimilars in Eastern European Countries: A Survey of Experts

Directory of Open Access Journals (Sweden)

Andras Inotai

2018-01-01

Full Text Available This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE and Commonwealth of Independent States (CIS countries. Two experts (one public and one private sector representative from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.

Algebra & trigonometry super review

CERN Document Server

2012-01-01

Get all you need to know with Super Reviews! Each Super Review is packed with in-depth, student-friendly topic reviews that fully explain everything about the subject. The Algebra and Trigonometry Super Review includes sets and set operations, number systems and fundamental algebraic laws and operations, exponents and radicals, polynomials and rational expressions, equations, linear equations and systems of linear equations, inequalities, relations and functions, quadratic equations, equations of higher order, ratios, proportions, and variations. Take the Super Review quizzes to see how much y

Randomized controlled trial about pain medication flupirtine ignores recent pharmacovigilance warnings

Directory of Open Access Journals (Sweden)

Puljak L

2018-01-01

Full Text Available Livia Puljak1,2 1Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 2Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaOn October 16, 2017 in the Journal of Pain Research, a randomized controlled trial (RCT comparing efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery was published.1 However, this paper fails to report important information. Author’s reply Sowmya Chinnaiyan,1 Narayana Sarala,1 Heddur Shanthappa Arun21Department of Pharmacology, 2Department of Orthopedics, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India We thank Livia Puljak for the valuable insights on the article titled “A comparative study of efficacy and safety of flupirtine  versus piroxicam in postoperative pain in patients undergoing lower limb surgery” published in the Journal of Pain Research. The concerns highlighted in the Letter to the Editor have been answered.View the original paper by Chinnaiyan and colleagues. 

Leveraging graph topology and semantic context for pharmacovigilance through twitter-streams.

Science.gov (United States)

Eshleman, Ryan; Singh, Rahul

2016-10-06

Adverse drug events (ADEs) constitute one of the leading causes of post-therapeutic death and their identification constitutes an important challenge of modern precision medicine. Unfortunately, the onset and effects of ADEs are often underreported complicating timely intervention. At over 500 million posts per day, Twitter is a commonly used social media platform. The ubiquity of day-to-day personal information exchange on Twitter makes it a promising target for data mining for ADE identification and intervention. Three technical challenges are central to this problem: (1) identification of salient medical keywords in (noisy) tweets, (2) mapping drug-effect relationships, and (3) classification of such relationships as adverse or non-adverse. We use a bipartite graph-theoretic representation called a drug-effect graph (DEG) for modeling drug and side effect relationships by representing the drugs and side effects as vertices. We construct individual DEGs on two data sources. The first DEG is constructed from the drug-effect relationships found in FDA package inserts as recorded in the SIDER database. The second DEG is constructed by mining the history of Twitter users. We use dictionary-based information extraction to identify medically-relevant concepts in tweets. Drugs, along with co-occurring symptoms are connected with edges weighted by temporal distance and frequency. Finally, information from the SIDER DEG is integrate with the Twitter DEG and edges are classified as either adverse or non-adverse using supervised machine learning. We examine both graph-theoretic and semantic features for the classification task. The proposed approach can identify adverse drug effects with high accuracy with precision exceeding 85 % and F1 exceeding 81 %. When compared with leading methods at the state-of-the-art, which employ un-enriched graph-theoretic analysis alone, our method leads to improvements ranging between 5 and 8 % in terms of the aforementioned measures. Additionally, we employ our method to discover several ADEs which, though present in medical literature and Twitter-streams, are not represented in the SIDER databases. We present a DEG integration model as a powerful formalism for the analysis of drug-effect relationships that is general enough to accommodate diverse data sources, yet rigorous enough to provide a strong mechanism for ADE identification.

Why Participate in Peer Review as a Journal Manuscript Reviewer: What's in It for You?

Science.gov (United States)

Pytynia, Kristen B

2017-06-01

The peer review process for scientific journals relies on the efforts of volunteer reviewers. Reviewers are selected due to their expertise in their fields. With so many demands on professional time, the benefits of participating in peer review may not be obvious. However, reviewers benefit by exposure to the latest developments in their fields, facilitating their keeping up-to-date with the latest publications. Tenure committees look favorably on participation in peer review, and invitations to review underscore that the reviewer is a respected subject matter expert. Contacts made during the peer review process can lead to long-lasting collaboration. Continuing medical education credit can be obtained through various mechanisms. Overall, participating in peer review is an important part of career development and should be viewed as a critical component of advancement.

Root causes, clinical effects, and outcomes of unintentional exposures to buprenorphine by young children.

Science.gov (United States)

Lavonas, Eric J; Banner, William; Bradt, Pamela; Bucher-Bartelson, Becki; Brown, Kimberly R; Rajan, Pradeep; Murrelle, Lenn; Dart, Richard C; Green, Jody L

2013-11-01

To characterize the rates, root causes, and clinical effects of unintentional exposures to buprenorphine sublingual formulations among young children and to determine whether exposure characteristics differ between formulations. Unintentional exposures to buprenorphine-containing products among children 28 days to less than 6 years old were collected from the Researched Abuse, Diversion, and Addiction-Related Surveillance System Poison Center Program and Reckitt Benckiser Pharmaceuticals' pharmacovigilance system from October 2009-March 2012. After adjustment for drug availability, negative binomial regression was used to estimate average exposure rates. Root cause assessment was conducted, and an expert clinician panel adjudicated causality and severity of moderate to severe adverse events (AEs). A total of 2380 cases were reviewed, including 4 deaths. Exposures to buprenorphine-naloxone combination film were significantly less frequent than exposures to buprenorphine tablets (rate ratio 3.5 [95% CI, 2.7-4.5]) and buprenorphine-naloxone combination tablets (rate ratio 8.8 [7.2-10.6]). The most commonly identified root causes were medication stored in sight, accessed from a bag or purse, and not stored in the original packaging. Among 536 panel review cases, the most common AEs reported for all formulations were lethargy, respiratory depression, miosis, and vomiting. The highest level AE severity did not differ significantly by formulation. Unintentional exposure to buprenorphine can cause central nervous system depression, respiratory depression, and death in young children. Exposure rates to film formulations are significantly less than to tablet formulations. Package and storage deficiencies contribute to unintentional exposures in young children. Copyright © 2013 Mosby, Inc. All rights reserved.

Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America.

Science.gov (United States)

de la Cruz, Claudia; de Carvalho, André V E; Dorantes, Gladys L; Londoño Garcia, Angela M; Gonzalez, Cesar; Maskin, Matías; Podoswa, Nancy; Redfern, Jan S; Valenzuela, Fernando; van der Walt, Joelle; Romiti, Ricardo

2017-01-01

Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes. © 2016 Japanese Dermatological Association.

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register [version 2; referees: 2 approved

Directory of Open Access Journals (Sweden)

Robert Carroll

2017-11-01

Full Text Available Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS requested by the European Medicines Agency which were recorded on the European Union (EU PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP. Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26% finalised, 160 (51% ongoing and 73 (23% planned. Of those studies identified, 205 (65% included risk assessment in their scope, 133 (42% included drug utilisation and 94 (30% included effectiveness evaluation. Just over half of the studies (175; 56% used primary data capture, 135 (43% used secondary data and 4 (1% used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary. The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs. Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area.

Book Reviews.

Science.gov (United States)

Journal of Chemical Education, 1983

1983-01-01

Reviews two textbooks: "Principles of Biochemistry" by Albert L. Lehninger and "Inorganic Chemistry, A Modern Introduction" by Therald Moeller. Also reviews text, study guide, and laboratory manual for Morris Hein's "Foundations of College Chemistry, Fifth Edition" and text/study guide for David A. Ucko's "Basics for Chemistry." (JN)

IRIS Toxicological Review of Tert-Butyl Alcohol (Tert-Butanol) (External Review Draft)

Science.gov (United States)

The IRIS Toxicological Review of tert-Butyl Alcohol (tert-Butanol) was released for external peer review in June 2017. EPA’s Science Advisory Board’s (SAB) Chemical Assessment Advisory Committee (CAAC) will conduct a peer review of the scientific basis supporting ...

Book reviews online

Directory of Open Access Journals (Sweden)

Philip Barker

1997-12-01

Full Text Available Many thousands of books are published each year, and even specialists find it difficult to keep abreast of new books in their disciplines, learning technology being no exception - indeed, in our subject-area the situation is beginning to reach saturation point. The bookreview procedure facilitates selection: a good review will capture the essential content of a book, and will comment on its quality, style, level of presentation, appropriateness, and perhaps value for money. Figure 1 shows the review process, its relationship to the production of books and learned journals, and the functional similarity between book reviews and abstracts of papers published in learned journals. Abstracts are often archived in online databases or on CD-ROM, in this way acting as an alerting and brief reference service. Book reviews can be treated in the same way. This paper discusses the use of servers (Internet or intranet as a means of making them available to a global population. It also describes how such a facility could fit into a more general infrastructure for soliciting potential reviewers and drawing their attention to publications available for review.

IRIS Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE) (External Review Draft)

Science.gov (United States)

The IRIS Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE) was released for external peer review in June 2017. EPA’s Science Advisory Board’s (SAB) Chemical Assessment Advisory Committee (CAAC) will conduct a peer review of the scientific basis supporting the ETB...

[Are Interventions Promoting Physical Activity Cost-Effective? A Systematic Review of Reviews].

Science.gov (United States)

Rütten, Alfred; Abu-Omar, Karim; Burlacu, Ionut; Schätzlein, Valentin; Suhrcke, Marc

2017-03-01

On the basis of international published reviews, this systematic review aims to determine the health economic benefits of interventions promoting physical activity.This review of reviews is based on a systematic literature research in 10 databases (e. g. PubMed, Scopus, SPORTDiscus) supplemented by hand searches from January 2000 to October 2015. Publications were considered in the English or German language only. Results of identified reviews were derived.In total, 18 reviews were identified that could be attributed to interventions promoting physical activity (2 reviews focusing on population-based physical activity interventions, 10 reviews on individual-based and 6 reviews on both population-based and individual-based physical activity interventions). Results showed that population-based physical activity interventions are of great health economic potential if reaching a wider population at comparably low costs. Outstanding are political and environmental strategies, as well as interventions supporting behavioural change through information. The most comprehensive documentation for interventions promoting physical activity could be found for individual-based strategies (i. e. exercise advice or exercise programs). However, such programs are comparatively less cost-effective due to limited reach and higher utilization of resources.The present study provides an extensive review and analysis of the current international state of research regarding the health economic evaluation of interventions promoting physical activity. Results show favourable cost-effectiveness for interventions promoting physical activity, though significant differences in the effectiveness between various interventions were noticed. The greatest potential for cost-effectiveness can be seen in population-based interventions. At the same time, there is a need to acknowledge the limitations of the economic evidence in this field which are attributable to methodological challenges and

A Review of Cochrane Systematic Reviews of Interventions Relevant to Orthoptic Practice.

Science.gov (United States)

Rowe, Fiona J; Elliott, Sue; Gordon, Iris; Shah, Anupa

2017-09-01

To present an overview of the range of systematic reviews on intervention trials pertinent to orthoptic practice, produced by the Cochrane Eyes and Vision group (CEV). We searched the 2016 Cochrane Library database (31.03.2016) to identify completed reviews and protocols of direct relevance to orthoptic practice. These reviews are currently completed and published, available on www.thecochranelibrary.com (free to UK health employees) or via the CEV website (http://eyes.cochrane.org/) . We found 27 completed CEV reviews across the topics of strabismus, amblyopia, refractive errors, and low vision. Seven completed CEV protocols addressed topics of strabismus, amblyopia, refractive errors, low vision, and screening. We found 3 completed Cochrane Stroke reviews addressing visual field loss, eye movement impairment, and age-related vision loss. The systematic review process presents an important opportunity for any clinician to contribute to the establishment of reliable, evidence-based orthoptic practice. Each review has an abstract and plain language summary that many non-clinicians find useful, followed by a full copy of the review (background, objectives, methods, results, discussion) with a conclusion section that is divided into implications for practice and implications for research. The current reviews provide patients/parents/carers with information about various different conditions and treatment options, but also provide clinicians with a summary of the available evidence on interventions, to use as a guide for both clinical practice and future research planning. The reviews identified in this overview highlight the evidence available for effective interventions for strabismus, amblyopia, refractive errors, and low vision or stroke rehabilitation as well as the gaps in the evidence base. Thus, a demand exists for future robust, randomized, controlled trials of such interventions of importance in orthoptic practice.

PSA Review Handbook

International Nuclear Information System (INIS)

Hallman, Anders; Nyman, Ralph; Knochenhauer, Michael

2004-05-01

The Swedish Nuclear Power Inspectorate (SKI) expresses requirements on the performance of PSAs as well as on PSA activities in general in the the regulatory document 'Regulations Concerning Safety in Certain Nuclear Facilities', SKlFS 1998:1. The follow-up of these activities is part of the inspection tasks of the SKI. In view or this, there is a need for documented guidelines on now to perform these inspections and reviews. The SKI PSA Review Handbook is intended to be a support in the SKI inspection and control of the PSA activities or the licensees. These PSA activities include both the organisation and working procedures of the licensee, the layout and contents of the PSA, and its areas of application. Using the regulation SKIFS 1998:1 as a starting point, the review handbook presents important aspects to be considered when judging whether a licensee fulfils the requirements on PSA activities, including the performance of PSA:s or PSA applications. The handbook shall also be a guidance for the review of PSA:s. However, the intention of the PSA Review Handbook is not to be a handbook for how a PSA is performed. The PSA Review Handbook is applicable to all types or initiating events and all operating conditions, and has been structured in a way, which stresses the integrated characteristics of PSA in the creation of the risk picture of a plant. The PSA Review Handbook has been based on the requirements for PSA of nuclear power plants, as this is the most extensive application. However, the relevant parts of it are also applicable when analysing other nuclear installations. The PSA Review Handbook is published as a research report as its contents are judged to be of general interest, and the SKI welcomes comments to the handbook. An update or the PSA Review Handbook may be required as experience with the use of the handbook is acquired and if general PSA requirements change

Book reviews

Directory of Open Access Journals (Sweden)

Tore Ahlbäck

2011-05-01

Full Text Available Four book reviews are included in this issue of Approaching Religion:The Process of Buddhist-Christian Dialogue (2009 by Paul O. Ingram is reviewed by Dr Teuvo Laitila. The book deals with contemporary dialogues between Buddhists and Christians, mainly in the West, by applying a three-part perspective denoted conceptual, engaged and internal.Producing Islamic Knowledge. Transmission and Dissemination in Western Europe (2010 by Martin van Bruinessen and Stefano Allievi is reviewed by Dr Jeanette Jouili. The book investigates into Islamic knowledge production taking place in the contemporary European context, from a theoretical as well as from a richly varied empirical perspective.Grounding Religion. A Field Guide to the Study of Religion and Ecology (2011 by Whitney A. Bauman, Richard R. Bohannon II and Kevin J. O’Brien is reviewed by MA Laura Wickström. The book provides an introduction to the field of religion and ecology with special emphasis on interreligious co-operation.Mirakel, mysterier och moraliteter. Från puritanism till New Age – en religionshistorisk studie av Helen Shucman och A Course in Miracles (2010 is reviewed by Dr Tore Ahlbäck. The book is a doctoral thesis analysing the history of creation behind the highly influential spiritual guide A Course in Miracles (1965–72 and its originator Helen Shucman.

MELCOR Peer Review

International Nuclear Information System (INIS)

Boyack, B.E.; Dhir, V.K.; Gieseke, J.A.; Haste, T.J.; Kenton, M.A.; Khatib-Rahbar, M.; Leonard, M.T.; Viskanta, R.

1992-03-01

MELCOR is a fully integrated, engineering-level computer code that models the progression of severe accidents in light water reactor nuclear power plants. The newest version of MELCOR is Version 1.8.1, July 1991. MELCOR development has reached the point that the United States Nuclear Regulatory Commission sponsored a broad technical review by recognized experts to determine or confirm the technical adequacy of the code for the serious and complex analyses it is expected to perform. For this purpose, an eight-member MELCOR Peer Review Committee was organized. The Committee has completed its review of the MELCOR code: the review process and findings of the MELCOR Peer Review Committee are documented in this report. The Committee has determined that recommendations in five areas are appropriate: (1) MELCOR numerics, (2) models missing from MELCOR Version 1.8.1, (3) existing MELCOR models needing revision, (4) the need for expanded MELCOR assessment, and (5) documentation

Balanced Ethics Review: A Guide for Institutional Review Board Members

Directory of Open Access Journals (Sweden)

Ames Dhai

2016-12-01

Full Text Available The aim of this pocket-book size manual is to assist Institutional Review Board (IRB members and chairs conduct ethics review by balancing the two major morally relevant considerations in health research

40 CFR 791.60 - Review.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Review. 791.60 Section 791.60...) DATA REIMBURSEMENT Review § 791.60 Review. (a) The hearing officer's proposed order shall become the... Agency review or the Administrator of his own initiative decides to review the proposed order. (b) The...

Reviewing Manuscripts for Biomedical Journals

Science.gov (United States)

Garmel, Gus M

2010-01-01

Writing for publication is a complex task. For many professionals, producing a well-executed manuscript conveying one's research, ideas, or educational wisdom is challenging. Authors have varying emotions related to the process of writing for scientific publication. Although not studied, a relationship between an author's enjoyment of the writing process and the product's outcome is highly likely. As with any skill, practice generally results in improvements. Literature focused on preparing manuscripts for publication and the art of reviewing submissions exists. Most journals guard their reviewers' anonymity with respect to the manuscript review process. This is meant to protect them from direct or indirect author demands, which may occur during the review process or in the future. It is generally accepted that author identities are masked in the peer-review process. However, the concept of anonymity for reviewers has been debated recently; many editors consider it problematic that reviewers are not held accountable to the public for their decisions. The review process is often arduous and underappreciated, one reason why biomedical journals acknowledge editors and frequently recognize reviewers who donate their time and expertise in the name of science. This article describes essential elements of a submitted manuscript, with the hopes of improving scientific writing. It also discusses the review process within the biomedical literature, the importance of reviewers to the scientific process, responsibilities of reviewers, and qualities of a good review and reviewer. In addition, it includes useful insights to individuals who read and interpret the medical literature. PMID:20740129

The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study.

Science.gov (United States)

Schutte, Tim; van Eekeren, Rike; Richir, Milan; van Staveren, Jojanneke; van Puijenbroek, Eugène; Tichelaar, Jelle; van Agtmael, Michiel

2018-01-01

In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. The quality of report documentation was assessed with the "Clinical Documentation tool to assess Individual Case Safety Reports" (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR. Nurses' opinions of the assignment were evaluated using an E-survey. Thirty-three ADRs were reported, 32 (97%) of which were well documented according to ClinDoc. Thirteen ADRs (39%) were "serious" according to CIOMS criteria. In five cases (15%), the suspect drugs were listed for additional monitoring by EMA and in seven cases (21%), the ADR was not mentioned in the Summary of Product Characteristics. Twenty-five (78.1%) of the 32 enrolled nurses completed the E-survey. Most were > 45 years of age (68%), female (92%) and had extensive clinical experience (6-33 years). All agreed or completely agreed that the reporting assignment was useful, that it fitted in daily practice and that it increased their attention for medication/patient safety. A large majority (84.0%) agreed the assignment changed how they dealt with ADRs. Specialist oncology nurses are capable of reporting ADRs, and they considered the assignment useful. The assignment yielded valuable, relevant, and well-documented ADR reports for pharmacovigilance practice.

Mining approximate temporal functional dependencies with pure temporal grouping in clinical databases.

Science.gov (United States)

Combi, Carlo; Mantovani, Matteo; Sabaini, Alberto; Sala, Pietro; Amaddeo, Francesco; Moretti, Ugo; Pozzi, Giuseppe

2015-07-01

Functional dependencies (FDs) typically represent associations over facts stored by a database, such as "patients with the same symptom get the same therapy." In more recent years, some extensions have been introduced to represent both temporal constraints (temporal functional dependencies - TFDs), as "for any given month, patients with the same symptom must have the same therapy, but their therapy may change from one month to the next one," and approximate properties (approximate functional dependencies - AFDs), as "patients with the same symptomgenerallyhave the same therapy." An AFD holds most of the facts stored by the database, enabling some data to deviate from the defined property: the percentage of data which violate the given property is user-defined. According to this scenario, in this paper we introduce approximate temporal functional dependencies (ATFDs) and use them to mine clinical data. Specifically, we considered the need for deriving new knowledge from psychiatric and pharmacovigilance data. ATFDs may be defined and measured either on temporal granules (e.g.grouping data by day, week, month, year) or on sliding windows (e.g.a fixed-length time interval which moves over the time axis): in this regard, we propose and discuss some specific and efficient data mining techniques for ATFDs. We also developed two running prototypes and showed the feasibility of our proposal by mining two real-world clinical data sets. The clinical interest of the dependencies derived considering the psychiatry and pharmacovigilance domains confirms the soundness and the usefulness of the proposed techniques. Copyright © 2014 Elsevier Ltd. All rights reserved.

Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population.

Directory of Open Access Journals (Sweden)

Nigam H Shah

Full Text Available Proton pump inhibitors (PPIs have been associated with adverse clinical outcomes amongst clopidogrel users after an acute coronary syndrome. Recent pre-clinical results suggest that this risk might extend to subjects without any prior history of cardiovascular disease. We explore this potential risk in the general population via data-mining approaches.Using a novel approach for mining clinical data for pharmacovigilance, we queried over 16 million clinical documents on 2.9 million individuals to examine whether PPI usage was associated with cardiovascular risk in the general population.In multiple data sources, we found gastroesophageal reflux disease (GERD patients exposed to PPIs to have a 1.16 fold increased association (95% CI 1.09-1.24 with myocardial infarction (MI. Survival analysis in a prospective cohort found a two-fold (HR = 2.00; 95% CI 1.07-3.78; P = 0.031 increase in association with cardiovascular mortality. We found that this association exists regardless of clopidogrel use. We also found that H2 blockers, an alternate treatment for GERD, were not associated with increased cardiovascular risk; had they been in place, such pharmacovigilance algorithms could have flagged this risk as early as the year 2000.Consistent with our pre-clinical findings that PPIs may adversely impact vascular function, our data-mining study supports the association of PPI exposure with risk for MI in the general population. These data provide an example of how a combination of experimental studies and data-mining approaches can be applied to prioritize drug safety signals for further investigation.

Monitoring medicines use: the role of the clinical pharmacologist.

LENUS (Irish Health Repository)

Williams, David

2012-10-01

Appreciation of the potential of newly marketed medicines to produce both benefit and harm has increased the role of the clinical pharmacologist. Pharmacoepidemiology applies epidemiological reasoning, methods and knowledge to the study of the uses and effects of drugs in human populations. Pharmacovigilence identifies and then responds to safety issues about marketed drugs. Whilst adverse drug reaction (ADR) reporting systems can identify potential problems with drugs, determination of causation requires population-based studies of adverse events (including information from large clinical trials), which attempt to link unequivocally the adverse outcome to the drug in question. Pharmacovigilance is closely linked to postmarketing surveillance and is important for determining issues such as the long-term effects of drugs, identification of low-frequency ADRs, the effectiveness of drugs for their licensed indications or in new indications and other factors which may modify the efficacy and effectiveness of the drug in question. The related field of drug utilization developed in parallel with the study of adverse drug reactions, in recognition of the dramatic increase in the marketing of new drugs, the wide variations in the patterns and extent of drug prescribing, the growing concern about ADRs and the increasing costs of drugs. With the ever increasing number of recognized adverse effects of drugs, prescribing errors, patients\\' expectations concerning drug safety and the need for appropriate new drug appraisal, the clinical pharmacologist will play an important role both in the introduction of new drugs and in improving the safe and effective use of established drugs.

Medication-use evaluation with a Web application.

Science.gov (United States)

Burk, Muriel; Moore, Von; Glassman, Peter; Good, Chester B; Emmendorfer, Thomas; Leadholm, Thomas C; Cunningham, Francesca

2013-12-15

A Web-based application for coordinating medication-use evaluation (MUE) initiatives within the Veterans Affairs (VA) health care system is described. The MUE Tracker (MUET) software program was created to improve VA's ability to conduct national medication-related interventions throughout its network of 147 medical centers. MUET initiatives are centrally coordinated by the VA Center for Medication Safety (VAMedSAFE), which monitors the agency's integrated databases for indications of suboptimal prescribing or drug therapy monitoring and adverse treatment outcomes. When a pharmacovigilance signal is detected, VAMedSAFE identifies "trigger groups" of at-risk veterans and uploads patient lists to the secure MUET application, where locally designated personnel (typically pharmacists) can access and use the data to target risk-reduction efforts. Local data on patient-specific interventions are stored in a centralized database and regularly updated to enable tracking and reporting for surveillance and quality-improvement purposes; aggregated data can be further analyzed for provider education and benchmarking. In a three-year pilot project, the MUET program was found effective in promoting improved prescribing of erythropoiesis-stimulating agents (ESAs) and enhanced laboratory monitoring of ESA-treated patients in all specified trigger groups. The MUET initiative has since been expanded to target other high-risk drugs, and efforts are underway to refine the tool for broader utility. The MUET application has enabled the increased standardization of medication safety initiatives across the VA system and may serve as a useful model for the development of pharmacovigilance tools by other large integrated health care systems.

Monitoring and evaluation of malaria in pregnancy – developing a rational basis for control

Directory of Open Access Journals (Sweden)

Dellicour Stephanie

2008-12-01

Full Text Available Abstract Monitoring and evaluation of malaria control in pregnancy is essential for assessing the efficacy and effectiveness of health interventions aimed at reducing the major burden of this disease on women living in endemic areas. Yet there is no currently integrated strategic approach on how this should be achieved. Malaria control in pregnancy is formulated in relation to epidemiological patterns of exposure. Current emphasis is on intermittent preventive treatment (IPTp during pregnancy with sulphadoxine-pyrimethamine in higher transmission areas, combined with insecticide treated bed nets (ITNs and case management. Emphasis in lower transmission areas is primarily on case management. This paper discusses a rational basis for monitoring and evaluation based on: assessments of therapeutic and prophylactic drug efficacy; proportional reductions in parasite prevalence; seasonal effects; rapid assessment methodologies; birthweight and/or anaemia nomograms; case-coverage methods; maternal mortality indices; operational and programmatic indicators; and safety and pharmacovigilance of antimalarials in pregnancy. These approaches should be incorporated more effectively within National Programmes in order to facilitate surveillance and improve identification of high-risk women. Systems for utilizing routinely collected data should be strengthened, with greater attention to safety and pharmacovigilance with the advent of artemisinin combination therapies, and prospects of inadvertent exposures to artemisinins in the first trimester. Integrating monitoring activities within malaria control, reproductive health and adolescent-friendly services will be critical for implementation. Large-scale operational research is required to further evaluate the validity of currently proposed indicators, and in order to clarify the breadth and scale of implementation to be deployed.

Engineering Technical Review Planning Briefing

Science.gov (United States)

Gardner, Terrie

2012-01-01

The general topics covered in the engineering technical planning briefing are 1) overviews of NASA, Marshall Space Flight Center (MSFC), and Engineering, 2) the NASA Systems Engineering(SE) Engine and its implementation , 3) the NASA Project Life Cycle, 4) MSFC Technical Management Branch Services in relation to the SE Engine and the Project Life Cycle , 5) Technical Reviews, 6) NASA Human Factor Design Guidance , and 7) the MSFC Human Factors Team. The engineering technical review portion of the presentation is the primary focus of the overall presentation and will address the definition of a design review, execution guidance, the essential stages of a technical review, and the overall review planning life cycle. Examples of a technical review plan content, review approaches, review schedules, and the review process will be provided and discussed. The human factors portion of the presentation will focus on the NASA guidance for human factors. Human factors definition, categories, design guidance, and human factor specialist roles will be addressed. In addition, the NASA Systems Engineering Engine description, definition, and application will be reviewed as background leading into the NASA Project Life Cycle Overview and technical review planning discussion.

International Peer Reviews of Design Basis

International Nuclear Information System (INIS)

Hughes, Peter

2013-01-01

International peer reviews: Design and safety assessment review service: - Review of design requirements; - Review in support of licensing; - Review in support of severe accident management; - Review in support of modifications; - Review in relation to periodic safety, or life extension; - Reviews take place at any time in NPP lifecycle from concept, through design and operations

Acupuncture for neurological disorders in the Cochrane reviews:Characteristics of included reviews and studies

Institute of Scientific and Technical Information of China (English)

Deren Wang; Weimin Yang; Ming Liu

2011-01-01

OBJECTIVE: To summarize Cochrane reviews of acupuncture for neurological disorders, and characteristics of included reviews and studies.DATA SOURCES: A computer-based online search of the Cochrane Library (Issue 7 of 12, July 2010) was performed with the key word "acupuncture" and systematic evaluations for acupuncture for neurological disorders were screened.STUDY SELECTION: Systematic reviews on acupuncture in the treatment of neurological disorders were included, and the characteristics of these reviews were analyzed based on methods recommended by the Cochrane collaboration.MAIN OUTCOME MEASURES: Basic characteristics, methodological quality, main reasons for excluding trials, results and conclusions of Cochrane reviews were assessed.RESULTS: A total of 18 Cochrane systematic reviews were included, including 13 completed reviews and five research protocols. The 13 completed reviews involved 111 randomized controlled trials, including 43 trials (38.7%) conducted in China, 47 trials (42.3%) using sham-acupuncture or placebo as control, 15 trials (13.5%) with relatively high quality, 91 trials (81.9%) reporting data on follow-up. Primary outcomes used in the Cochrane reviews were reported by 65 trials (58.6%), and adverse events were reported in 11 trials (9.9%). Two hundred and eighty three trials were excluded. Two reviews on headache suggested that acupuncture is a valuable non-drug treatment for patients with chronic or recurrent headache, and has better curative effects on migraine compared with preventative drug treatment. CONCLUSION: Of the Cochrane reviews on acupuncture in the treatment of neurological disorders, two reviews evaluating the efficacy of acupuncture in treating headaches drew positive conculsions, while other reviews did not obtain positive conclusions due to a small sample size or low methodological quality. The methodological quality of acupuncture trials needs further improvement.

Empirical Analysis of Exploiting Review Helpfulness for Extractive Summarization of Online Reviews

Science.gov (United States)

Xiong, Wenting; Litman, Diane

2014-01-01

We propose a novel unsupervised extractive approach for summarizing online reviews by exploiting review helpfulness ratings. In addition to using the helpfulness ratings for review-level filtering, we suggest using them as the supervision of a topic model for sentence-level content scoring. The proposed method is metadata-driven, requiring no…

Clinical review

DEFF Research Database (Denmark)

Groth, Kristian; Skakkebæk, Anne; Høst, Christian

2013-01-01

Recently, new clinically important information regarding Klinefelter syndrome (KS) has been published. We review aspects of epidemiology, endocrinology, metabolism, body composition, and neuropsychology with reference to recent genetic discoveries.......Recently, new clinically important information regarding Klinefelter syndrome (KS) has been published. We review aspects of epidemiology, endocrinology, metabolism, body composition, and neuropsychology with reference to recent genetic discoveries....

Human Factors Review Plan

International Nuclear Information System (INIS)

Paramore, B.; Peterson, L.R.

1985-12-01

''Human Factors'' is concerned with the incorporation of human user considerations into a system in order to maximize human reliability and reduce errors. This Review Plan is intended to assist in the assessment of human factors conditions in existing DOE facilities. In addition to specifying assessment methodologies, the plan describes techniques for improving conditions which are found to not adequately support reliable human performance. The following topics are addressed: (1) selection of areas for review describes techniques for needs assessment to assist in selecting and prioritizing areas for review; (2) human factors engineering review is concerned with optimizing the interfaces between people and equipment and people and their work environment; (3) procedures review evaluates completeness and accuracy of procedures, as well as their usability and management; (4) organizational interface review is concerned with communication and coordination between all levels of an organization; and (5) training review evaluates training program criteria such as those involving: trainee selection, qualification of training staff, content and conduct of training, requalification training, and program management

Human Factors Review Plan

Energy Technology Data Exchange (ETDEWEB)

Paramore, B.; Peterson, L.R. (eds.)

1985-12-01

''Human Factors'' is concerned with the incorporation of human user considerations into a system in order to maximize human reliability and reduce errors. This Review Plan is intended to assist in the assessment of human factors conditions in existing DOE facilities. In addition to specifying assessment methodologies, the plan describes techniques for improving conditions which are found to not adequately support reliable human performance. The following topics are addressed: (1) selection of areas for review describes techniques for needs assessment to assist in selecting and prioritizing areas for review; (2) human factors engineering review is concerned with optimizing the interfaces between people and equipment and people and their work environment; (3) procedures review evaluates completeness and accuracy of procedures, as well as their usability and management; (4) organizational interface review is concerned with communication and coordination between all levels of an organization; and (5) training review evaluates training program criteria such as those involving: trainee selection, qualification of training staff, content and conduct of training, requalification training, and program management.

Swedish encapsulation station review

International Nuclear Information System (INIS)

Andersson, Sven Olof; Brunzell, P.; Heibel, R.; McCarthy, J.; Pennington, C.; Rusch, C.; Varley, G.

1998-06-01

In the Encapsulation Station (ES) Review performed by NAC International, a number of different areas have been studied. The main objectives with the review have been to: Perform an independent review of the cost estimates for the ES presented in SKB's document 'Plan 1996'. This has been made through comparisons between the ES and BNFL's Waste Encapsulation Plant (WEP) at Sellafield as well as with the CLAB facility. Review the location of the ES (at the CLAB site or at the final repository) and its interaction with other parts of the Swedish system for spent fuel management. Review the logistics and plant capacity of the ES. Identify important safety aspects of the ES as a basis for future licensing activities. Based on NAC International's experience of casks for transport and storage of spent fuel, review the basic design of the copper/steel canister and the transport cask. This review insides design, manufacturing, handling and licensing aspects. Perform an overall comparison between the ES project and the CLAB project with the objective to identify major project risks and discuss their mitigation

The relationship of previous training and experience of journal peer reviewers to subsequent review quality.

Directory of Open Access Journals (Sweden)

Michael L Callaham

2007-01-01

Full Text Available BACKGROUND: Peer review is considered crucial to the selection and publication of quality science, but very little is known about the previous experiences and training that might identify high-quality peer reviewers. The reviewer selection processes of most journals, and thus the qualifications of their reviewers, are ill defined. More objective selection of peer reviewers might improve the journal peer review process and thus the quality of published science. METHODS AND FINDINGS: 306 experienced reviewers (71% of all those associated with a specialty journal completed a survey of past training and experiences postulated to improve peer review skills. Reviewers performed 2,856 reviews of 1,484 separate manuscripts during a four-year study period, all prospectively rated on a standardized quality scale by editors. Multivariable analysis revealed that most variables, including academic rank, formal training in critical appraisal or statistics, or status as principal investigator of a grant, failed to predict performance of higher-quality reviews. The only significant predictors of quality were working in a university-operated hospital versus other teaching environment and relative youth (under ten years of experience after finishing training. Being on an editorial board and doing formal grant (study section review were each predictors for only one of our two comparisons. However, the predictive power of all variables was weak. CONCLUSIONS: Our study confirms that there are no easily identifiable types of formal training or experience that predict reviewer performance. Skill in scientific peer review may be as ill defined and hard to impart as is "common sense." Without a better understanding of those skills, it seems unlikely journals and editors will be successful in systematically improving their selection of reviewers. This inability to predict performance makes it imperative that all but the smallest journals implement routine review ratings

Teleconference versus face-to-face scientific peer review of grant application: effects on review outcomes.

Directory of Open Access Journals (Sweden)

Stephen A Gallo

Full Text Available Teleconferencing as a setting for scientific peer review is an attractive option for funding agencies, given the substantial environmental and cost savings. Despite this, there is a paucity of published data validating teleconference-based peer review compared to the face-to-face process. Our aim was to conduct a retrospective analysis of scientific peer review data to investigate whether review setting has an effect on review process and outcome measures. We analyzed reviewer scoring data from a research program that had recently modified the review setting from face-to-face to a teleconference format with minimal changes to the overall review procedures. This analysis included approximately 1600 applications over a 4-year period: two years of face-to-face panel meetings compared to two years of teleconference meetings. The average overall scientific merit scores, score distribution, standard deviations and reviewer inter-rater reliability statistics were measured, as well as reviewer demographics and length of time discussing applications. The data indicate that few differences are evident between face-to-face and teleconference settings with regard to average overall scientific merit score, scoring distribution, standard deviation, reviewer demographics or inter-rater reliability. However, some difference was found in the discussion time. These findings suggest that most review outcome measures are unaffected by review setting, which would support the trend of using teleconference reviews rather than face-to-face meetings. However, further studies are needed to assess any correlations among discussion time, application funding and the productivity of funded research projects.

Teleconference versus Face-to-Face Scientific Peer Review of Grant Application: Effects on Review Outcomes

Science.gov (United States)

Gallo, Stephen A.; Carpenter, Afton S.; Glisson, Scott R.

2013-01-01

Teleconferencing as a setting for scientific peer review is an attractive option for funding agencies, given the substantial environmental and cost savings. Despite this, there is a paucity of published data validating teleconference-based peer review compared to the face-to-face process. Our aim was to conduct a retrospective analysis of scientific peer review data to investigate whether review setting has an effect on review process and outcome measures. We analyzed reviewer scoring data from a research program that had recently modified the review setting from face-to-face to a teleconference format with minimal changes to the overall review procedures. This analysis included approximately 1600 applications over a 4-year period: two years of face-to-face panel meetings compared to two years of teleconference meetings. The average overall scientific merit scores, score distribution, standard deviations and reviewer inter-rater reliability statistics were measured, as well as reviewer demographics and length of time discussing applications. The data indicate that few differences are evident between face-to-face and teleconference settings with regard to average overall scientific merit score, scoring distribution, standard deviation, reviewer demographics or inter-rater reliability. However, some difference was found in the discussion time. These findings suggest that most review outcome measures are unaffected by review setting, which would support the trend of using teleconference reviews rather than face-to-face meetings. However, further studies are needed to assess any correlations among discussion time, application funding and the productivity of funded research projects. PMID:23951223

Topical report review status

International Nuclear Information System (INIS)

1997-08-01

This report provides industry with procedures for submitting topical reports, guidance on how the U.S. Nuclear Regulatory Commission (NRC) processes and responds to topical report submittals, and an accounting, with review schedules, of all topical reports currently accepted for review schedules, of all topical reports currently accepted for review by the NRC. This report will be published annually. Each sponsoring organization with one or more topical reports accepted for review copies

Systematic Reviews in Sports Medicine.

Science.gov (United States)

DiSilvestro, Kevin J; Tjoumakaris, Fotios P; Maltenfort, Mitchell G; Spindler, Kurt P; Freedman, Kevin B

2016-02-01

The number of systematic reviews published in the orthopaedic literature has increased, and these reviews can help guide clinical decision making. However, the quality of these reviews can affect the reader's ability to use the data to arrive at accurate conclusions and make clinical decisions. To evaluate the methodological and reporting quality of systematic reviews and meta-analyses in the sports medicine literature to determine whether such reviews should be used to guide treatment decisions. The hypothesis was that many systematic reviews in the orthopaedic sports medicine literature may not follow the appropriate reporting guidelines or methodological criteria recommended for systematic reviews. Systematic review. All clinical sports medicine systematic reviews and meta-analyses from 2009 to 2013 published in The American Journal of Sports Medicine (AJSM), The Journal of Bone and Joint Surgery (JBJS), Arthroscopy, Sports Health, and Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA) were reviewed and evaluated for level of evidence according to the guidelines from the Oxford Centre for Evidence-Based Medicine, for reporting quality according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, and for methodological quality according to the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Analysis was performed by year and journal of publication, and the levels of evidence included in the systematic reviews were also analyzed. A total of 200 systematic reviews and meta-analyses were identified over the study period. Of these, 53% included evidence levels 4 and 5 in their analyses, with just 32% including evidence levels 1 and 2 only. There were significant differences in the proportion of articles with high levels of evidence (P Systematic reviews and meta-analyses in orthopaedics sports medicine literature relied on evidence levels 4 and 5 in 53% of studies over the 5-year study period. Overall, PRISMA and

Inuit Elderly: A Systematic Review of Peer Reviewed Journal Articles.

Science.gov (United States)

Somogyi, Balvinder K; Barker, Melanie; MacLean, Calvin; Grischkan, Pamela

2015-01-01

Over the last century, Inuit have experienced rapid social changes that have greatly impacted their way of life, health, and intergenerational traditions. Although there is a growing body of research concerning Inuit youth, relatively little is known about elderly Inuit. In an effort to bridge this knowledge gap, a systematic review of peer-reviewed journal articles was conducted. This review identified a dearth of research on older Inuit, and highlighted limitations in service provision to this primarily rural and isolated population. Implications for policy and practice and recommendations for future research are also discussed.

Book Reviews: Volume 8

OpenAIRE

2016-01-01

Chris Frost Media Ethics and Self Regulation, reviewed by Michael Foley Damien Kiberd (ed.) Media in Ireland: The Search for Ethical Journalism, reviewed by David Quin Peter Mason and Derrick Smith Magazine Law: A Practical Guide, reviewed by Eavan Murphy

15 CFR 25.5 - Review by the reviewing official.

Science.gov (United States)

2010-01-01

... 15 Commerce and Foreign Trade 1 2010-01-01 2010-01-01 false Review by the reviewing official. 25.5 Section 25.5 Commerce and Foreign Trade Office of the Secretary of Commerce PROGRAM Fraud Civil Remedies... value of property, services, or other benefits, requested or demanded in violation of § 25.3 of this...

Down With Reviews

Energy Technology Data Exchange (ETDEWEB)

Wiley, H. S.

2010-04-01

There has been a proliferation of review articles and review journals over the last decade, and it is easy to see why. Biologists find them useful to keep up with increasingly complex science and publishers find them an easy way to increase the impact factor of journals. Unfortunately, the reasons why review articles are highly cited are mostly unrelated to their educational value. Instead, it seems mostly due to their increasing use as a surrogate for the primary literature.

Open Peer Review in Scientific Publishing: A Web Mining Study of PeerJ Authors and Reviewers

Directory of Open Access Journals (Sweden)

Peiling Wang

2016-11-01

Full Text Available Purpose: To understand how authors and reviewers are accepting and embracing Open Peer Review (OPR, one of the newest innovations in the Open Science movement. Design/methodology/approach: This research collected and analyzed data from the Open Access journal PeerJ over its first three years (2013-2016. Web data were scraped, cleaned, and structured using several Web tools and programs. The structured data were imported into a relational database. Data analyses were conducted using analytical tools as well as programs developed by the researchers. Findings: PeerJ, which supports optional OPR, has a broad international representation of authors and referees. Approximately 73.89% of articles provide full review histories. Of the articles with published review histories, 17.61% had identities of all reviewers and 52.57% had at least one signed reviewer. In total, 43.23% of all reviews were signed. The observed proportions of signed reviews have been relatively stable over the period since the Journal's inception. Research limitations: This research is constrained by the availability of the peer review history data. Some peer reviews were not available when the authors opted out of publishing their review histories. The anonymity of reviewers made it impossible to give an accurate count of reviewers who contributed to the review process. Practical implications: These findings shed light on the current characteristics of OPR. Given the policy that authors are encouraged to make their articles' review history public and referees are encouraged to sign their review reports, the three years of PeerJ review data demonstrate that there is still some reluctance by authors to make their reviews public and by reviewers to identify themselves. Originality/value: This is the first study to closely examine PeerJ as an example of an OPR model journal. As Open Science moves further towards open research, OPR is a final and critical component. Research in this

Mizan Law Review

African Journals Online (AJOL)

Mizan Law Review publishes peer reviewed scholarly articles that identify, ... legal and related principles, stipulations and concepts based on research findings. Mizan's ... Comment: Major Differences between the Revised 'Federal' and SNNP ...

Monthly Weather Review

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — Supplements to the Monthly Weather Review publication. The Weather Bureau published the Monthly weather review Supplement irregularly from 1914 to 1949. The...

Editorial Note: The Internet as "Scholarly Review Resource". Further Considerations about E-Reviewing on the Occasion of the "Special Issue: FQS Reviews IV"

Directory of Open Access Journals (Sweden)

Günter Mey

2006-03-01

Full Text Available With the growth in use of the Internet and the convenience of electronic publishing in terms of speed and publication space, book reviews have come to receive additional recognition (compared to traditional print media. This contribution points out the lack of a system for online reviewing despite multiple online review-services that already exist. Moreover, the full potential of electronic documents, such as the use of hypertext, hybrids and links to additional information, are not maximized. In order to strengthen the scientific impact of book reviews the inherent characteristics of book reviews must be more precisely defined and quality control, for example through peer review, is put in place. URN: urn:nbn:de:0114-fqs0602429

Review article The Frontier of Interculturality. A review of Wim van ...

African Journals Online (AJOL)

Review article. The Frontier of Interculturality. A review of Wim van Binsbergen\\'s Intercultural Encounters: African and Anthropological Lessons towards a Philosophy of Interculturality (2003). Sanya Osha ...

Standard review plan on antitrust reviews. Final report

International Nuclear Information System (INIS)

Lambe, W.M.; Davis, M.J.

1997-12-01

This standard review plan describes the procedures used by NRC staff to implement the antitrust review and enforcement provisions in Sections 105 and 186 of the Atomic Energy Act of 1954, as amended (the Act), and replaces NUREG-0970. These procedures are principally derived from the Commission's Rules and Regulations in 10 CFR Sections 2.101, 2.102, Part 2-Appendix A, Section X, 50.33a, 50.80, 50.90, and 52.77. These procedures set forth the steps and criteria the staff uses in antitrust reviews of construction permit applications, operating license applications, combined construction permit/operating license applications, combined construction permit/operating license applications, and applications for approval of the transfer of construction permits, operating licenses, and combined licenses. In addition, the procedures describe how the staff enforces compliance with antitrust conditions appended to licenses

[Identification of health outcome indicators in Primary Care. A review of systematic reviews].

Science.gov (United States)

Olry de Labry Lima, A; García Mochón, L; Bermúdez Tamayo, C

Outcome measures are being widely used by health services to assess the quality of health care. It is important to have a battery of useful performance indicators with high validity and feasibility. Thus, the objective of this study is to perform a review of reviews in order to identify outcome indicators for use in Primary Care. A review of systematic reviews (umbrella review) was carried out. The following databases were consulted: MedLine, EMBASE, and CINAHL, using descriptors and free terms, limiting searches to documents published in English or Spanish. In addition, a search was made for free terms in different web pages. Those reviews that offered indicators that could be used in the Primary Care environment were included. This review included a total of 5 reviews on performance indicators in Primary Care, which consisted of indicators in the following areas or clinical care processes: in osteoarthritis, chronicity, childhood asthma, clinical effectiveness, and prescription safety indicators. A total of 69 performance indicators were identified, with the percentage of performance indicators ranging from 0% to 92.8%. None of the reviews identified performed an analysis of the measurement control (feasibility or sensitivity to change of indicators). This paper offers a set of 69 performance indicators that have been identified and subsequently validated and prioritised by a panel of experts. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2001 - February 2002 : report

Directory of Open Access Journals (Sweden)

V. Naidoo

2002-07-01

Full Text Available An overview of reports of suspected adverse drug reactions received by the Veterinary Pharmacovigilance and Medicines Information Centre during the period March 2001 to February 2002 is given. A total of 77 reports were received. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most products implicated in the reports were Stock Remedies. The products were predominantly administered either by veterinarians or trained paraveterinary professionals. Although the majority of reports were received from veterinary pharmaceutical companies, the proportion of reports received directly from veterinarians increased compared with previous years.

Suspected adverse reactions to veterinary drugs reported in South Africa (January 1998 - February 2001 : special report

Directory of Open Access Journals (Sweden)

R. Gehring

2001-07-01

Full Text Available The Veterinary Pharmacovigilance Centre received 59 reports of suspected adverse drug reactions during the period January 1998 - February 2001. The number of reports received increased after the establishment of a formal procedure for recording and responding to reports. The number of reports received per species was: dogs 19, cats 15, cattle 7, sheep/ goats 6, chickens 4, pigs 3, horses 2 and giraffe 1. Many different types of adverse reactions were reported, including lack of efficacy, hypersensitivity, inappropriate use of products by non-veterinarians, known adverse effects and adverse effects encountered with extra-label use of products.

ETF interim design review

International Nuclear Information System (INIS)

Steiner, D.; Rutherford, P.H.

1980-01-01

A three-day ETF Interim Design Review was conducted on July 23-25, 1980, at the Sheraton Potomac Inn in Rockville, Maryland. The intent of the review was to provide a forum for an in-depth assessment and critique of all facets of the ETF design by members of the fusion community. The review began with an opening plenary session at which an overview of the ETF design was presented by D. Steiner, manager of the ETF Design Center, complemented by a physics overview by P.H. Rutherford, chairman of the ETF/INTOR Physics Committee. This was followed by six concurrent review sessions over the next day and a half. The review closed with a plenary session at which the Design Review Board presented its findings. This document consists of the viewgraphs for the opening plenary session and an edited version of the presentations made by Steiner and Rutherford

ATLAS Review Office

CERN Multimedia

Szeless, B