Rieder, Michael J; Carleton, Bruce
Adverse drug reactions are a common and important complication of drug therapy in children. Over the past decade it has become increasingly apparent that genetically controlled variations in drug disposition and response are important determinants of adverse events for many important adverse events associated with drug therapy in children. While this research has been difficult to conduct over the past decade technical and ethical evolution has greatly facilitated the ability of investigators...
Reynolds, J. L.
The feasibility of family physicians functioning as monitors of adverse drug reactions (ADR) was examined over one month in ten practices. This was done as a preliminary trial, before attempting to use the 200 family physicians of the National Reporting System of the College of Family Physicians of Canada to monitor ADRs on a national basis. Both of these trials were designed to examine the feasibility of family physicians acting as prospective monitors of ADRs in newly marketed drugs and to ...
Idiosyncratic adverse drug reactions are unpredictable and thought to have an underlying genetic etiology. With the completion of the human genome and HapMap projects, together with the rapid advances in genotyping technologies, we have unprecedented capabilities in identifying genetic predisposing factors for these relatively rare, but serious, reactions. The main roadblock to this is the lack of sufficient numbers of well-characterized samples from patients with such reactions. This is now beginning to be solved through the formation of international consortia, including developing novel ways of identifying and recruiting patients affected by these reactions, both prospectively and retrospectively. This has been led by the research on abacavir hypersensitivity - its association with HLA-B*5701 forms the gold standard of how we need to identify associations and implement them in clinical practice. Strong genetic predisposing factors have also been identified for hypersensitivity reactions such as are associated with carbamazepine, allopurinol, flucloxacillin, and statin-induced myopathy. However, for most other idiosyncratic adverse drug reactions, the genetic effect sizes have been low to moderate, although this may partly be due to the fact that only small numbers have been investigated and limited genotyping strategies have been utilized. It may also indicate that genetic predisposition will be dependent on multiple genes, with complex interactions with environmental factors. Irrespective of the strength of the genetic associations identified with individual idiosyncratic adverse drug reactions, it is important to undertake functional investigations to provide insights into the mechanism(s) of how the drug interacts with the gene variant to lead to a phenotype, which can take a multitude of clinical forms with variable severity. Such investigations will be essential in preventing the burden caused by idiosyncratic reactions, both in healthcare and in industry
Background: There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events. Objective: The intent of the study was to rank ADRs according to severity. Methods: We used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs. Results: There is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy. Conclusions: ADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making.
Liu, Yihui; Aickelin, Uwe
In this study we propose a novel method to successfully detect the ADRs using feature matrix and feature selection. A feature matrix, which characterizes the medical events before patients take drugs or after patients take drugs, is created from THIN database. The feature selection method of Student's t-test is used to detect the significant features from thousands of medical events. The significant ADRs, which are corresponding to significant features, are detected. Experiments are performed...
Wong, I C; Lhatoo, S D
A lack of systematic pharmacoepidemiological studies investigating adverse drug reactions (ADRs) to anticonvulsants makes it difficult to assess accurately the incidence of anticonvulsant-related ADRs. Most of the available information in this regard stems from clinical trial experience, case reports and postmarketing surveillance, sources that are not, by any means, structured to provide precise data on adverse event epidemiology. For various ethical, statistical and logistical reasons, the organisation of structured clinical trials that are likely to provide substantial data on ADRs is extremely difficult. This review concentrates on current literature concerning serious and life-threatening ADRs. As with the older anticonvulsants, the majority of ADRs to newer anticonvulsants are CNS-related, although there are several that are apparently unique to some of these new drugs. Gabapentin has been reported to cause aggravation of seizures, movement disorders and psychiatric disturbances. Felbamate should only be prescribed under close medical supervision because of aplastic anaemia and hepatotoxicity. Lamotrigine causes hypersensitivity reactions that range from simple morbilliform rashes to multi-organ failure. Psychiatric ADRs and deterioration of seizure control have also been reported with lamotrigine treatment. Oxcarbazepine has a safety profile similar to that of carbamazepine. Hyponatraemia associated with oxcarbazepine is also a problem; however, it is less likely to cause rash than carbamazepine. Nonconvulsive status epilepticus has been reported frequently with tiagabine, although there are insufficient data at present to identify risk factors for this ADR. Topiramate frequently causes cognitive ADRs and, in addition, also appears to cause word-finding difficulties, renal calculi and bodyweight loss. Vigabatrin has been reported to cause seizure aggravation, especially in myoclonic seizures. There have been rare reports of other neurological ADRs to
Full Text Available Abstract Many medicines are prescribed to the paediatric population on an unlicensed or 'off-label' basis because they have not been adequately tested and/or formulated and authorized for use in appropriate paediatric age groups. Regulatory authorities also need to remind health professionals about the importance of their contribution towards the process of paediatric pharmacovigilance thanks to their reporting of adverse drug reactions. The lack of reliable data in the paediatric population is associated with specific problems including: limited availability of safety data due to the lack of clinical trials in the paediatric population; under- or over-dosing in some age groups due to the lack of pharmacokinetics data or dose-finding studies; maturation, growth and development of the paediatric population susceptible to drug-induced growth and development disorders as well as to delayed ADRs not findable in adults. Pre-marketing trials are able to provide information about the benefits of drugs but do not manage to establish a safety profile. Spontaneous reporting of suspected ADRs become an important means to promote reasonable warning signs. Therefore some ADRs may be known in their qualitative aspect and quantitative aspect only after successful marketing and use in the population during a "normal" use. When the drug is used in clinical practice in large unselected populations, epidemiological post-marketing studies are useful as they find their major confirmation in recalling all the events that occur during monitoring, with estimates of incidence of ADRs that can not be obtained by spontaneous reports. In these studies a significant role can be played by the Family Pediatricians with the participation to active pharmacovigilance projects.
Possibly still are health professionals that when hearing about adverse drug reactions only think in cutaneous rash, blood dyscrasias, anaphylactic shock and congenital malformations. The mentioned adverse effects are real, but relatively infrequent. Furthermore, are unexpected, not related with the pharmacological mechanism of action, unpredictable and dose independent. These adverse drug reactions are like a therapeutic lottery, depending on «luck».However, when the pharmacological patholog...
Full Text Available ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each, followed by first educational approach (265 reports, 20.31 €/report and by the hyperlink approach (136 reports, 15.59 €/report. Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs. Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report, followed by first educational approach (38.79 €/report. CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.
Full Text Available Epilepsy is one of the most common neurologic disorders in dogs and life-long treatment with antiepileptic drugs (AED is frequently required. Adverse events of antiepileptic drugs targeting the skin are only rarely reported in veterinary medicine and the true incidence and spectrum of cutaneous reactions in epileptic dogs remains unknown. In this study we hypothesized that cutaneous reactions commonly occur in epileptic dogs and are related to AED treatment. A retrospective case review of 185 dogs treated for epilepsy identified 20.0% with simultaneous appearance of dermatologic signs. In a subsequent prospective case investigation (n=137 we identified newly appearing or distinct worsening of skin lesions following initiation of antiepileptic drug therapy in 10.9% of dogs treated for epilepsy (95% CI 6.8- 17.7%. Cutaneous lesions were classified as probably drug-induced in 40.0% of these cases. Patch-testing and intradermal testing was further investigated as potential diagnostic methods to confirm antiepileptic drug hypersensitivity. They were of high specificity but sensitivity and positive predictive value appeared inappropriate to recommend their routine use in clinical practice.
Reynolds, J. L.
In this study, 232 Canadian family physicians recorded suspected adverse drug reactions (SADRs) in their practices for five months. Patients' age and sex, the drug(s) implicated, type of reaction and any disability were recorded on a card and sent to a central coordinating office each week. The number of SADRs in clinical practice seems to be small. An estimated 300,000 patients were involved in the study, and a total of 314 suspected adverse drug reactions in 314 patients were reported. A pr...
Aagaard, Lise; Hansen, Ebba Holme
Medical product information contains information about efficacy and safety for marketed pharmaceuticals. Three studies have compared safety labelling for different therapeutic categories in different countries and detected large variations in a number of reported adverse drug reactions (ADRs). The...
Many studies have demonstrated a correlation between increasing age and adverse drug reactions. This increased risk is related to aged-related changes in pharmacokinetics and pharmacodynamics. In addition, chronic illnesses such as congestive heart failure, coronary artery disease and hypertension are more prevalent in the elderly who also have an increased risk of diabetes, arthritis and cancer. Consequently elderly patients are often treated with multiple medications, which may cause drug interactions and adverse drug reactions. Adequate undergraduate training in clinical pharmacology and continued professional development in evidence-based therapeutics will undoubtedly reduce inappropriate prescribing and improve the quality of medications. Good communications between physicians and patients are also critically important in avoidance or prevention of adverse drug reactions in the elderly.
Smuseva O.N.; Solovkina Yu.V.
The research goal is to study the actual problem of self-medication. The Association of the European Self-Medication Industry (AESGP) considers the term «responsible self-medication». The key characteristic is that the patients are responsible for their health. The article presents cases of self-medication thoroughly analyzed in Volgograd Regional Centre of Drug Safety Monitoring. Some of them may be considered as unfavourable and even lethal. Therefore it should be mentioned that there is on...
Full Text Available Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here severe distress hypersensitive reaction with ibuprofen induced hypersensitivity syndrome. Within two hours of consumption of ibuprofen patient developed severe bronchospasm, throat and laryngeal oedema leading to respiratory distress. He was treated with salbutamol, hydrocortisone, deriphylline and supportive oxygen, but did not respond and went into coma. Unlike acetaminophen, ibuprofen does not have any antidote hence managing adverse drug reactions (ADR due to ibuprofen is big challenge. Therefore understanding pathophysiology of ADR to Ibuprofen is necessary to manage the patient. Literature in the field of allergic drug reaction shows that epinephrine, a physiological antagonist of histamine is the first drug of choice for the treatment of allergic or drug induced angioedema, laryngeal oedema and bronchospasm due to its direct action on target organs. Such reactions should therefore be managed by epinephrine without loss of time. ADR due to ibuprofen could be prevented by (a avoiding unnecessary intake of drug, (b educating patients / families and public about adverse drug reactions (c surveillance and monitoring of drug reactions (d record keeping (e drug audit and (f reporting of ADR to state/central pharmacovigilance agency. We do observe doctors having misconception about adrenaline, its actions, usage and side effects especially cardio-vascular, hence are reluctant to use. But in severe violent adverse drug reaction we have to use our wisdom and judgement
Full Text Available The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the adverse drug reactions were also studied. Adverse drug reactions were also assessed for causality, using Naranjo′s scale, severity, and preventability, using Hartwig et al. scale. Adverse drug reaction attributes to 77% of the hospital visit. Incidence of reported cutaneous adverse drug reactions, were 2.85%. Majority of the adverse drug reactions (96% were of type B. Antibiotics (30%, were the common class of drugs, causing a cutaneous adverse drug reactions. Maximum number of adverse drug reactions were due to Acetaminophen, Amoxicillin, antitubercular drugs, and Phenytoin. Most of the adverse drug reactions were managed by withdrawal of drug (81%, and 58% patients were recovered from the reaction. Naranjos scale classifies, 29 as probable, 21 as possible, and 3 as definite adverse drug reactions. Most of the adverse drug reactions were of moderate severity, however 13 adverse drug reactions were severe. All the adverse drug reactions were probably preventable on extreme caution.
In a multicenter trial over a 4-year period, three different contrast medium strategies were used in consecutive patients undergoing intravenous urography or CT. The first included ionic agents only; subsequently, iohexol (Omnipaque) or ionic agents plus two doses of oral steroid premedication were studied to compare the incidence and severity of adverse drug reactions. The results are presented in the paper
Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise;
Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose low...
Aagaard, Lise; Weber, Camilla Blicher; Hansen, Ebba Holme
BACKGROUND: The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important new...
Aagaard, Lise; Hansen, Ebba Holme
occurrence and characteristics of adverse drug reactions (ADRs) in children, reported for asthma medications licensed for paediatric use. Methods We systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed, Embase...
Combi, Carlo; Lora, Riccardo; Moretti, Ugo; Pagliarini, Marco; Zorzi, Margherita
Pharmacovigilance is the field of science devoted to the collection, analysis and prevention of Adverse Drug Reactions (ADRs). Efficient strategies for the extraction of information about ADRs from free text resources are essential to support the work of experts, employed in the crucial task of detecting and classifying unexpected pathologies possibly related to drug assumptions. Narrative ADR descriptions may be collected in several way, e.g. by monitoring social networks or through the so c...
Lavan, Amanda Hanora; Gallagher, Paul
Adverse drug reactions (ADRs) are common in older adults, with falls, orthostatic hypotension, delirium, renal failure, gastrointestinal and intracranial bleeding being amongst the most common clinical manifestations. ADR risk increases with age-related changes in pharmacokinetics and pharmacodynamics, increasing burden of comorbidity, polypharmacy, inappropriate prescribing and suboptimal monitoring of drugs. ADRs are a preventable cause of harm to patients and an unnecessary waste of health...
Kuo, M H; Kushniruk, A W; Borycki, E M; Greig, D
The objective of this research is to assess the suitability of the Apriori association analysis algorithm for the detection of adverse drug reactions (ADR) in health care data. The Apriori algorithm is used to perform association analysis on the characteristics of patients, the drugs they are taking, their primary diagnosis, co-morbid conditions, and the ADRs or adverse events (AE) they experience. This analysis produces association rules that indicate what combinations of medications and patient characteristics lead to ADRs. A simple data set is used to demonstrate the feasibility and effectiveness of the algorithm. PMID:19745239
Rahmani, Hossein; Weiss, Gerhard; Méndez-Lucio, Oscar; Bender, Andreas
Predicting novel drug side-effects, or Adverse Drug Reactions (ADRs), plays an important role in the drug discovery process. Existing methods consider mainly the chemical and biological characteristics of each drug individually, thereby neglecting information hidden in the relationships among drugs. Complementary to the existing individual methods, in this paper, we propose a novel network approach for ADR prediction that is called Augmented Random-WAlk with Restarts (ARWAR). ARWAR, first, applies an existing method to build a network of highly related drugs. Then, it augments the original drug network by adding new nodes and new edges to the network and finally, it applies Random Walks with Restarts to predict novel ADRs. Empirical results show that the ARWAR method presented here outperforms the existing network approach by 20% with respect to average Fmeasure. Furthermore, ARWAR is capable of generating novel hypotheses about drugs with respect to novel and biologically meaningful ADR. PMID:26638149
S. Malhotra; Karan, R; P. Pandhi; S. Jain
BACKGROUND—Adverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed. METHODS—A total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance with medication regimens, their causes, conse...
Mulugeta Tarekegn Angamo; Nasir Tajure Wabe
AIM: Adverse drug reaction is noxious and unwanted reaction to drugs at dose used in humans for diagnosis, treatment or prophylaxis. Adverse drug reaction monitoring is an area of drug information that has been given little attention yet. Spontaneous reporting is currently the major back bone for the detection of adverse drug reactions. The objective of this study was to assess the knowledge, attitude and practices of adverse drug reaction reporting among health professionals in selected heal...
Full Text Available Background: Adverse cutaneous drug reactions (ACDRs are the most commonly reported adverse drug events. The causative drugs and clinical patterns of ACDRs are different in various populations. This study was conducted to identify the clinical patterns, causative drugs and reasons for drug administration in patients hospitalized due to ACDR. Materials and Methods: This retrospective study was carried out in a referral university hospital, Isfahan, Iran. The medical records of all patients who were hospitalized in the Dermatology Department due to ACDRs were reviewed covering an 8-year period between December 2006 and August 2013. Results: A total number of 282 patients with the mean age of 29.48 ± 21.18 years were hospitalized in this time period, of which 61% were females. The most common clinical patterns regarding the final diagnosis were Stevens-Johnson syndrome (SJS (32%, exanthematous drug eruptions (24.5% and toxic epidermal necrolysis (TEN (11%. Anticonvulsants were the most frequently implicated drug group (51.8% followed by antibiotics (33.7% and analgesics and non-steroidal anti-inflammatory drugs (5.7%. The most common cause of drug administration was seizure (30% and then upper respiratory tract infections (12%. The frequency distribution of clinical types of reactions was different between age groups (P < 0.001. The severe types (SJS, TEN, drug rash with eosinophilia and systemic symptoms and overlap syndrome were more frequent in the patients aged ≤50 years old (55.2% compare to those aged ≤50 years (28% (P = 0.001. Conclusion: The main causative drugs of ACDRs were anticonvulsants and antibiotics. However, the sever types of reactions were more prevalent.
Full Text Available Aim: To study the adverse drug reaction (ADR pattern in a pediatric population in a tertiary care hospital. Materials and Methods: An observational study was done in the department of pediatrics in a tertiary care hospital. The ADRs occurring in the inpatient wards and outpatient department of pediatrics were actively monitored. The collected reports were analyzed for ADR pattern, drug groups, demographic profile, causality, severity, and preventability of the ADR. Results: A total of 30 ADRs were documented during the mid period of 2009 among pediatric patients. Most of the ADRs (60% occurred below the age of 1 year. Antibiotics comprised the major group of drugs causing ADRs (67%. Rashes and urticaria were the most common type of ADR (37% followed by fever, anaphylactic shock, vomiting, chills, and rigors. A single case of death had been reported in the study period. There were more occurrences of ADRs with multiple drugs compared to single drug therapy. About 80% of the ADRs were of probable causality and 87% were of probable preventability. There were no mild reactions, with 77% of reactions being moderate and 23% of reactions being severe in the severity scale. Conclusions: ADRs occur more among infants and antibiotics were more commonly implicated. Most of the reactions were of moderate severity. This indicates the need for a rigid ADR monitoring among pediatric patients to ensure safety of drug therapy.
Full Text Available Background: Adverse drug reaction (ADR monitoring is slowly developing as an important aspect of healthcare. The aim of the study was to study the pattern of adverse drug reactions in the Oncology department of a tertiary care hospital. Materials And Methods: This was a prospective study conducted in the Oncology department of a tertiary care hospital in which ADRs were reported spontaneously. The ADRs were noted from 1st January, 2007 to 30th June, 2011. Following were noted: demographics, premedication (if any, diagnosis, chemotherapy (regimen, cycles, medication history, and alteration in the treatment or co morbidities, ADRs (severity and management. Adverse drug reactions were noted by patient interview, collaborating with information on file, recording changes in the prescribing chart and investigations, consulting the doctor on duty. Results: During this study period, there were total of 14,475 visits of patients from which 2500 ADRs were recorded. Maximum number of ADRs were noted with platinum compounds (25.52% followed by pyrimidine antagonists (19.88%. The most common malignancy reported in our hospital was Carcinoma breast (20% followed by leukemia (12% and Ca ovary (12%. Alopecia (27.76% was the most common ADR followed by anemia (7.48%, thrombocytopenia (6.96% and constipation (6.16%. Conclusion: Alopecia is the most common ADR and platinum compounds were responsible for the maximum number of ADRs. The most common carcinoma reported during this period was carcinoma breast.
Full Text Available Background and Aim: Patent blue vital (PBV dye is used for varied perioperative indications, and has a potential for causing life-threatening allergic reactions. In this retrospective case series study, at a tertiary level neurosciences centre, we analysed the nature, management and outcome of adverse drug reaction to the preoperative use of PBV for marking vertebral level prior to back surgeries. Methods: Patients were identified from the theatre and radiology database. Data were collected from the patients′ notes retrieved from the medical records division. Results: Eleven of 1247 (0.88% patients experienced adverse reactions: 6 (0.48% patients had minor grade I reactions (urticaria, blue hives, pruritis or generalised rash, 4 (0.32% had grade II reactions (transient hypotension/bronchospasm/laryngospasm and grade III reaction (hypotension requiring prolonged vasopressor support was noted in 1 (0.08% patient. No mortality was seen. The time of onset (range 10-45 min frequently coincided with induction of anaesthesia or prone positioning of patient. Seven (63.6% cases were cancelled or postponed (range 2-63 days. Treatment varied independent of the grade of reaction. Allergy workup (often incomplete was done for 6 (54% patients. Conclusion: An awareness of the time of onset and infrequency of life-threatening reactions to patent blue dye may result in better management, less postponement, more complete workup and referral of these events.
Tresa Muir McNeal
Full Text Available Tresa Muir McNeal1, Colleen Y Colbert1, Christian Cable1, Curtis R Mirkes1, June G Lubowinski2, John D Myers11Department of Medicine, Texas A&M University System HSC College of Medicine, Scott & White Healthcare, Temple, TX, USA; 2RD Haynes Medical Library, Scott & White Healthcare, Temple, TX, USAIntroduction: Medications are critical to the management of patient conditions, and they can have significant effects on the success or failure of medical interventions. Patient perceptions of drug warnings play an important role in medication compliance and ultimately disease management. Several factors may affect patients’ understanding of drug warnings and drug labeling, including health literacy and interactions with physicians and pharmacists.Purpose: The purpose of this article is to provide a review of the literature related to patient perceptions of drug warnings and drug labeling. Descriptive articles and studies regarding patient perceptions and knowledge of adverse drug reaction warnings were reviewed.Methods: The following databases were utilized to search the literature related to patient perceptions of drug warnings: PubMed, Academic Search Premiere, CINAHL, Medline, Psych Info, Business Source Complete, Alternative Healthwatch, Health Source (both Nursing/Academic and Consumer additions, JSTOR, and Master File Premiere. For the purpose of this review, any peer-reviewed article was eligible. Exclusionary criteria included: articles published in languages other than English, articles/studies on patient perceptions of vaccines and chemotherapy, and articles related to perceptions of medications administered in the inpatient setting. Forty-six articles were included in the review.Results: Health literacy has been shown to have a major impact on patients’ ability to understand potential adverse reactions and instructions on correct dosing of medications. Direct communication with physicians and pharmacists is one of the most important and
Palmero, Domingo; Cruz, Víctor; Museli, Tomás; Pavlovsky, Hernán; Fernández, Juan; Waisman, Jaime
Multidrug-resistant tuberculosis (MDRTB) poses difficulties in diagnosis and treatment, including increased frequency of adverse reactions to antituberculosis drugs (ADRAs), which compromise the effectiveness of treatment. This is specially complicated in the treatment of patients co-infected with HIV which includes the antiretroviral therapy plus the treatment of eventual comorbidities. A total of 121 MDRTB patients, 87 HIV-negative and 34 HIV positive, assisted in the Hospital F. J. Muñiz, Buenos Aires, during the period 2003-2007 were retrospectively studied. The incidence of ADRAs among the two groups of patients was compared. All the patients with adherence to treatment (no more than one abandon, recovered) were included in the study. Antituberculosis drugs used were: ethambutol, pyrazinamide, ofloxacin, moxifloxacin, cycloserine, ethionamide, PAS, streptomycin, kanamycin, amikacin and linezolid. The emergence of ADRAs and the proportion of severe reactions attributed to antituberculosis drugs were similar in both groups: 44.8% in HIV negative and 44.1% in HIV positive, but it was observed an additional 23.5% of adverse reactions to antiretroviral therapy in the second group. There were differences in the type of reactions and time of occurrence between the two groups. One HIV positive patient died of epidermolysis. The proportion of adverse reactions in HIV/AIDS patients increased 50% when those attributed to antiretroviral treatment were included. We conclude that the studied population showed a frequency of ADRAs higher than it would be expected in the treatment of susceptible TB, but there was no difference in its frequency among HIV-negative and positive patients. PMID:20920959
Full Text Available The use of cardiovascular drugs is related to the development of adverse drug reactions (ADRs in about 24% of the patients in the Cardiovascular Care Unit. Here, we evaluated the ADRs in patients treated with antihypertensive drugs. The study was conducted in two phases: In the first phase, we performed a retrospective study on clinical records of Clinical Divisions (i.e., Internal Medicine Operative Unit and Geriatric Operative Unit from January 1, 2012 to December 31, 2012. Moreover from January 1, 2013 to March 30, 2013 we performed a prospective study on the outpatients attending the Emergency Department (ED of the Pugliese-Ciaccio Hospital of Catanzaro, by conducting patient interviews after their informed consent was obtained. The association between a drug and ADR was evaluated using the Naranjo scale. We recorded 72 ADRs in the Clinical Divisions and six in the ED, and these were more frequent in women. Using the Naranjo score, we showed a probable association in 92% of these reactions and a possible association in 8%. The most vulnerable age group involved in ADRs was that of the elderly patients. In conclusion, our results indicate that antihypertensive drugs may be able to induce the development of ADRs, particularly in elderly women receiving multiple drug treatment. Therefore, it is important to motivate the healthcare providers to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs, as also all the essential activities for optimizing patient safety.
Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme
included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category......AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...... inpatients and outpatients. However, prevalence and incidence were much lower in the national databases. Types of reported ADRs, seriousness of ADRs and types of medicines differed substantially between studies due to differences in time periods and patient populations. Information about ADRs was mainly...
Ghosh S; Acharya Leelavathi; Rao Padma
The present study emphasizes on implementation of the adverse drug reaction reporting and monitoring system, in the Dermatology department of Kasturba Hospital, Manipal, by a clinical pharmacist, using different promotional activities. Documented adverse drug reactions were assessed and analyzed for incidence, purpose of visit, types, drug classes, individual drug causing adverse drug reactions, type of cutaneous reaction, and various predisposing factors. Management and outcome of the advers...
Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.
Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.
Full Text Available Background. Antituberculosis multidrug regimens have been associated with increased incidence of adverse drug reactions (ADRs. This study aimed to determine the incidence and associated factors of ADRs due to antituberculosis therapy. Methods. This is a retrospective cross-sectional study on tuberculosis patients who were treated in tuberculosis clinics in Markazi province in Iran. The information contained in the medical files was extracted and entered into the questionnaire. Data was descriptively analyzed by using statistical package for social sciences (SPSS 18. Results. A total of 940 TB patients of 1240 patients’ medical records available in 10 medical offices were included in this study. Of the 563 ADRs found in this study, 82.4% were considered minor reactions and 17.6% were major reactions. No death from antituberculosis ADR was observed. We found that the risk of major ADRs was higher in females (P value=0.0241, age >50 y (P value=0.0223, coinfection with HIV (P value=0.0323, smoking (P value=0.002, retreatment TB (P value=0.0203, and comorbidities (P value=0.0005. Conclusions. This study showed that severe side effects of anti-TB drugs are common in patients who have risk factors of ADRs and they should be followed up by close monitoring.
Lavan, Amanda Hanora; Gallagher, Paul
Adverse drug reactions (ADRs) are common in older adults, with falls, orthostatic hypotension, delirium, renal failure, gastrointestinal and intracranial bleeding being amongst the most common clinical manifestations. ADR risk increases with age-related changes in pharmacokinetics and pharmacodynamics, increasing burden of comorbidity, polypharmacy, inappropriate prescribing and suboptimal monitoring of drugs. ADRs are a preventable cause of harm to patients and an unnecessary waste of healthcare resources. Several ADR risk tools exist but none has sufficient predictive value for clinical practice. Good clinical practice for detecting and predicting ADRs in vulnerable patients includes detailed documentation and regular review of prescribed and over-the-counter medications through standardized medication reconciliation. New medications should be prescribed cautiously with clear therapeutic goals and recognition of the impact a drug can have on multiple organ systems. Prescribers should regularly review medication efficacy and be vigilant for ADRs and their contributory risk factors. Deprescribing should occur at an individual level when drugs are no longer efficacious or beneficial or when safer alternatives exist. Inappropriate prescribing and unnecessary polypharmacy should be minimized. Comprehensive geriatric assessment and the use of explicit prescribing criteria can be useful in this regard. PMID:26834959
Full Text Available Possibly still are health professionals that when hearing about adverse drug reactions only think in cutaneous rash, blood dyscrasias, anaphylactic shock and congenital malformations. The mentioned adverse effects are real, but relatively infrequent. Furthermore, are unexpected, not related with the pharmacological mechanism of action, unpredictable and dose independent. These adverse drug reactions are like a therapeutic lottery, depending on «luck».However, when the pharmacological pathology resulting in medical care is analyzed, the perspective is very different. For instance, the predominant adverse drug reactions in emergency wards are those related with the pharmacological mechanism of action: severe hemorrhage due to anticoagulant and antiplatelet drugs; renal insufficiency and hyperkalemia by inhibitors of the renin-angiotensin axis; hyponatremia, fells and fractures by SSRI antidepressants, digitalis intoxication… These are relatively common pathologies, expectable, dose-related, and favored by patient comorbidity, preventable in many cases if the dose would have carefully individualized, if the patient complied better with the instructions (in case the patient understood the information or if a more carefully clinical surveillance were performed.A review of the literature reminds us other pathologies attended in other assistance levels, for example:- Breast cancer attributable to the hormone replacement therapy (HRT: three to four additional cases per 1.000 women treated during 5 years, this is translated in thousands of additional cases of breast cancer according to the sales data of these products between the years 1993 to 2003. Moreover, it was irresponsibly promoted for the prevention of cardiovascular events, dementia, and as the source of eternal youth without proven efficacy at that time (no evidence of efficacy exist today.- Non-steroidal anti-inflammatory drugs (NSAIDs - especially celecoxib and diclofenac -increase the
Aagaard, Lise; Strandell, Johanna; Melskens, Lars;
Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. Objective: The aim of the study was to characterize ADRs reported to....... Low-income countries reported relatively more ADRs for antiinfectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups. Conclusion: This study showed that high-income countries had the...... use' and 'antineoplastic and immunomodulation agents'. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organizational structures and economic resources of national pharmacovigilance centres and ADR reporting practices on the large...
K. N. Chidananda
Full Text Available Toxic epidermal necrolysis (TEN is a rare but serious is a rare but potentially life-threatening condition. It is primarily a cutaneous reaction to various precipitating agents, characterized by wide spread erythema and detachment of the epidermis from the dermis. Among the various cutaneous adverse drug reactions, TEN occupy a primary place in terms of mortality. In TEN large sheets of skin are lost from the body surface, thereby decreasing the protecting function of the skin, which results in complications. Usually, TEN is self-limited in absence of complications. If complicated by sepsis, there will be increased chances of mortality. The main treatment would be cessation of the causative drug and early admission of the patient for supportive care and minimizing the occurrence of complications. The present articles reviews the etiology, pathophysiology, differential diagnosis and treatment protocol, with a case of TEN occurrence in a child of 4 years age after consuming phenytoin syrup for febrile convulsions. [Int J Basic Clin Pharmacol 2015; 4(1.000: 1-5
Chan, Kelvin; Zhang, Hongwei; Lin, Zhi-Xiu
The safe use of Chinese materia medica (CMM) and products in traditional Chinese medicine (TCM) practice conventionally relies on correct pharmacognostic identification, good agricultural and manufacturing practices based on pharmacopoeia standards and rational/correct CMM combinations with TCM-guided clinical prescribing. These experience-based principles may not absolutely ensure safety without careful toxicological investigations when compared with development of new pharmaceutical drugs. Clinically observed toxicity reports remain as guidance for gathering toxicological evidence, though essential as pharmacovigilance, but are considered as late events for ensuring safety. The overview focuses on the following factors: global development of TCM that has affected conventional healthcare; examples of key toxic substances in CMM; reported adverse drug reactions (ADRs) consequential to taking CMM and TCM products; and proposals on rational approaches to integrate the knowledge of biomedical science and the principles of TCM practice for detecting early ADRs if both TCM products and orthodox drugs are involved. It is envisaged that good control of the quality and standards of CMM and proprietary Chinese medicines can certainly reduce the incidence of ADRs in TCM practice when these medications are used. PMID:25619530
Full Text Available Social media platforms are emerging digital communication channels that provide an easy way for common people to share their health and medication experiences online. With more people discussing their health information online publicly, social media platforms present a rich source of information for exploring adverse drug reactions (ADRs. ADRs are major public health problems that result in deaths and hospitalizations of millions of people. Unfortunately, not all ADRs are identified before a drug is made available in the market. In this study, an ADR event monitoring system is developed which can recognize ADR mentions from a tweet and classify its assertion. We explored several entity recognition features, feature conjunctions, and feature selection and analyzed their characteristics and impacts on the recognition of ADRs, which have never been studied previously. The results demonstrate that the entity recognition performance for ADR can achieve an F-score of 0.562 on the PSB Social Media Mining shared task dataset, which outperforms the partial-matching-based method by 0.122. After feature selection, the F-score can be further improved by 0.026. This novel technique of text mining utilizing shared online social media data will open an array of opportunities for researchers to explore various health related issues.
J.P. Ottervanger (Jan Paul)
textabstractThe rationale to study a potential adverse reaction of a specific drug mainly depends on three questions: 1) how serious is the adverse reaction? 2) what is the incidence of the adverse reaction among users of the dlUg?, and 3) what is the frequency of consumption of the specific dlUg in
V. K. Saini; Sewal, R. K.; Ahmad, Yusra; B Medhi
Adverse drug reactions associated with the use of anticancer drugs are a worldwide problem and cannot be ignored. Adverse drug reactions can range from nausea, vomiting or any other mild reaction to severe myelosuppression. The study was planned to observe the suspected adverse drug reactions of cancer chemotherapy in patients aged >18 years having cancer attending Postgraduate Institute of Medical Education and Research, Chandigarh. During the study period, 101 patients of breast cancer and ...
Egron, Adeline; Olivier-Abbal, Pascale; Gouraud, Aurore; Babai, Samy; Combret, Sandrine; Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle
Antineoplastic drugs are one of the pharmacological classes more frequently involved in occurrence of "serious" adverse drug reactions. However, few epidemiological data are available regarding the preventability of adverse drug reactions with ambulatory cancer chemotherapy. We assessed the rate and characteristics of "preventable" or "potentially preventable" "serious" adverse drug reactions induced by oral protein kinase inhibitors (PKIs). We performed a retrospective study with all "serious" adverse drug reactions (ADRs) recorded from 1 January 2008 to 31 December 2009 in the French Pharmacovigilance Database with the eight oral protein kinase inhibitors marketed in France: sorafenib, imatinib, erlotinib, sunitinib, dasatinib, lapatinib, nilotinib and everolimus (Afinitor®) using the French adverse drug reactions preventability scale. This study was carried out on 265 spontaneous notifications. Most of adverse drug reactions were "unpreventable" (63.8 %). Around one third were "unevaluable" due to notifications poorly documented (medical history, dosage, use of drugs as first or second intention, concomitant drugs). One (0.4 %) adverse drug reaction was "preventable" with dasatinib (subdural hematoma) and three (1.1 %) were "potentially preventable" (hepatic adverse drug reactions): two with imatinib and one with sorafenib. For these four cases, we identified some characteristics: incorrect dosages, drug interactions and off-label uses. An appropriate prescription could avoid the occurrence of 1.5 % "serious" adverse drug reactions with oral PKIs. This rate is low and further studies are needed to compare our results by using other preventability instruments and to improve the French ADRs Preventability Scale. PMID:25056801
Abubakar, Abdullahi Rabiu; Chedi, Bashir A Z; Mohammed, Khalid Garba; Haque, Mainul
Spontaneous reporting (SPR) and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs). Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV). In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring. PMID:26605155
Full Text Available Background: Adverse Drug Reactions (ADRs are one of the leading causes of morbidity and mortality and contribute to excessive health care costs. Detection and reporting of ADRs could decrease these consequences. The present study was designed to assess the Knowledge, Attitude and Practice (KAP of pharmacy students towards ADRs monitoring and reporting.Methods: A questionnaire was prepared to investigate the Knowledge, Attitude and Practice (KAP of pharmacy students regarding ADR reporting. The questionnaire consisting of 17 questions (7 questions on knowledge, 5 on attitudes and 5 on practice were given to pharmacy students randomly.Results: A total of 71 respondents participated in the study. 70% of participants had favorable general knowledge about ADRs but more than 60% of their professional knowledge was not satisfying. 60% of respondent believed that educational intervention will improve participating of health care professional in ADRs reporting. 63% of respondent observed ADRs cases but about 95% of them had never reported an ADR.Conclusion: In overall, pharmacy students have poor knowledge, attitude and practice towards ADRs reporting and pharmacovigilance. This suggests the need of suitable changes in the undergraduate teaching curriculum and additional training among the students regarding ADRs.
Abdullahi Rabiu Abubakar
Full Text Available Spontaneous reporting (SPR and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs. Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV. In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring.
Hye Ran Na; Jeong Min Lee; Jo Won Jung; Soo-Young Lee
Purpose : There are very few reports of adverse drug reactions (ADR) and almost no study of drug provocation test (DPT) in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods : We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009). With various ...
Bandekar, M S; Anwikar, S R; Kshirsagar, N A
Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment. PMID:20845409
E.M. Rodenburg (Eline); B.H.Ch. Stricker (Bruno); L.E. Visser (Loes)
textabstractAIM Adverse drug reactions (ADRs) are a major burden in health care, regularly leading to hospital admission, morbidity or death. Women tend to have a higher risk of adverse drug reactions with a 1.5 to 1.7-fold greater risk than men. Our primary aim was to study differences in ADR-relat
Conclusions: Cutaneous adverse drug reaction profile in this study is similar in many ways to studies conducted earlier in India. Incidence of life-threatening reactions like SJS-TEN was higher compared with studies conducted abroad. Reaction time and lesion patterns are helpful in identifying an offending drug in the setting of multiple drug therapy.
Sampathkumar, Hariprasad; Chen, Xue-Wen; Luo, Bo
Background Adverse Drug Reactions are one of the leading causes of injury or death among patients undergoing medical treatments. Not all Adverse Drug Reactions are identified before a drug is made available in the market. Current post-marketing drug surveillance methods, which are based purely on voluntary spontaneous reports, are unable to provide the early indications necessary to prevent the occurrence of such injuries or fatalities. The objective of this research is to extract reports of ...
Full Text Available How to Cite This Article: Karimzadeh P, Bakrani V. Antiepileptic Drug-Related Adverse Reactions And Factors Influencing These Reactions. Iran J Child Neurol. 2013 Summer; 7(3:23-27. ObjectiveAccording to the basic role of drug side effects in selection ofan appropriate drug, patient compliance and the quality of life inepileptic patients, and forasmuch as new dugs with unknown side effect have been produced and introduced, necessity of this research and similar studies is explained. This study was conducted to evaluate the incidence and clinical characteristics of anti epileptic drug (AED related adverse reactions in children treated with AEDs.Material & MethodsIn this descriptive study, children less than 14 years old with AEDside effects referred to the Children’s Medical Center and MofidChilderen’s Hospital (Tehran, Iran were evaluated during 2010-2012.The informations were: sex, age, incriminating drug, type of drug side effect, incubation period, history of drug usage, and patient and family allergy history. Exclusive criterions were age more than 14 years old and reactions due to reasons other than AEDs (Food, bite, non-AEDs, etc..ResultsA total of 70 patients with AED reaction were enrolled in thisstudy. They included 26 (37% females and 44 (63 % males. The maximum rate of incidence was seen at age less than 5 years old. All the patients had cutaneous eruptions that the most common cutaneous drug eruption was maculopapular rash. The incidence of systemic and laboratory adverse events was less than similar studies. The most common culprit was phenobarbital (70% and the least common was lamotrigine (1.4%.ConclusionIn this study, we found higher rates of drug rash in patients treated with aromatic AEDs and lower rates with non-aromatic AEDs. Various endogenous and environmental factors may influence the propensity to develop these reactions. Refrences1. Blume WT, Lu¨ders HO, Mizrahi E, et al. Glossary of descriptive terminology for
Glauciene Santana Damasceno
Full Text Available OBJECTIVES: This study aimed to characterize and estimate the frequency of adverse reactions to antituberculosis drugs in the population treated at the Centro de Saúde Escola Germano Sinval Faria, a primary health care clinic in Manguinhos, Rio de Janeiro City, and to explore the relationship between adverse drug reactions and some of the patients' demographic and health characteristics. METHODS: This descriptive study was conducted via patient record review of incident cases between 2004 and 2008. RESULTS: Of the 176 patients studied, 41.5% developed one or more adverse reactions to antituberculosis drugs, totaling 126 occurrences. The rate of adverse reactions to antituberculosis drugs was higher among women, patients aged 50 years or older, those with four or more comorbidities, and those who used five or more drugs. Of the total reactions, 71.4% were mild. The organ systems most affected were as follows: the gastrointestinal tract (29.4%, the skin and appendages (21.4%, and the central and peripheral nervous systems (14.3%. Of the patients who experienced adverse reactions to antituberculosis drugs, 65.8% received no drug treatment for their adverse reactions, and 4.1% had one of the antituberculosis drugs suspended because of adverse reactions. "Probable reactions" (75% predominated over "possible reactions" (24%. In the study sample, 64.3% of the reactions occurred during the first two months of treatment, and most (92.6% of the reactions were ascribed to the combination of rifampicin + isoniazid + pyrazinamide (Regimen I. A high dropout rate from tuberculosis treatment (24.4% was also observed. CONCLUSION: This study suggests a high rate of adverse reactions to antituberculosis drugs.
Full Text Available Adverse drug reactions are considered to be among the leading causes of morbidity and mortality. Approximately 5-25% of hospital admissions are due to adverse drug reactions and 6-15% of hospitalized patients experience serious adverse drug reactions, causing significant prolongation of hospital stay. Thus this study was aimed at determining adverse drug reactions by conducting spontaneous reporting in secondary care Govt. District Head Quarters Hospital at Ooty. A prospective Spontaneous Adverse Drug Reaction reporting study was conducted over a period of 12 months from July 2012 to June 2013. The assessment, categorization, causality, severity and preventability were assessed using standard criteria. A total of 47 suspected adverse drug reactions were reported during the study period. Over all incidences was 1.29% among the study population. Antibiotics (31.91% were the class of drug most commonly involved, while ciprofloxacin (14.89% was the most frequently reported. Type H (Hypersensitivity reactions (51.06% accounted for majority of the reports and a greater share of the adverse drug reactions are probable (89.36% based on causality assessment. Mild reactions accounted 82.97% based on modified Hartwig and Siegel severity scale. In 76.59% of the reports, the reaction was considered to be preventable based on Schumock and Thornton preventability scale. The implementation of monitoring based on spontaneous reporting will be useful for the detection and evaluation is associated with increase in morbidity and duration of hospitalization. This study also has established the vital role of clinical pharmacist in the adverse drug reaction monitoring program.
Mizutani, Sayaka; Noro, Yousuke; Kotera, Masaaki; Goto, Susumu
A big challenge in pharmacology is the understanding of the underlying mechanisms that cause drug-induced adverse reactions (ADRs), which are in some cases similar to each other regardless of different drug indications, and are in other cases different regardless of same drug indications. The FDA Adverse Event Reporting System (FAERS) provides a valuable resource for pharmacoepidemiology, the study of the uses and the effects of drugs in large human population. However, FAERS is a spontaneous reporting system that inevitably contains noise that deviates the application of conventional clustering approaches. By performing a biclustering analysis on the FAERS data we identified 163 biclusters of drug-induced adverse reactions, counting for 691 ADRs and 240 drugs in total, where the number of ADR occurrences are consistently high across the associated drugs. Medically similar ADRs are derived from several distinct indications for use in the majority (145/163=88%) of the biclusters, which enabled us to interpret the underlying mechanisms that lead to similar ADRs. Furthermore, we compared the biclusters that contain same drugs but different ADRs, finding the cases where the populations of the patients were different in terms of age, sex, and body weight. We applied a biclustering approach to catalogue the relationship between drugs and adverse reactions from a large FAERS data set, and demonstrated a systematic way to uncover the cases different drug administrations resulted in similar adverse reactions, and the same drug can cause different reactions dependent on the patients' conditions. PMID:24534381
Hye Ran Na
Full Text Available Purpose : There are very few reports of adverse drug reactions (ADR and almost no study of drug provocation test (DPT in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods : We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009. With various suspected drugs, 71 DPTs were done in 16 patients using our own protocol, and skin tests to antibiotics were combined in ADRs to antibiotics in medical history. Results : There were 17 (23.9% positive DPTs results out of 71 individual DPTs, and 11 patients (68.8% from 16 patients were positive to at least one drug. Drugs causing positive reactions were acetaminophen in 5 (31%, Non-steroidal anti-inflammatory drugs in 4 (25%, penicillin in 3 (19%, cephalosporin in 2 (13%, and cotrimoxazole, macrolide and lactose in 1 each. Conclusion : DPT seems a safe and useful procedure to confirm causative drug and identify safely administering alternative drugs in children with ADR.
Conclusions: Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended to be undertaken, to ensure, and improve patient′s safety. In this way, hospital/clinical pharmacists play the cornerstone role.
Aagaard, Lise; Hansen, Ebba Holme
Background Information about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children. Objective To characterize paediatric ADRs reported for asthma medications...
Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo
We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377
The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin
Orten-Luiten, van A.C.B.; Janse, A.; Dhonukshe-Rutten, R.A.M.; Witkamp, R.F.
Purpose: Adverse drug reactions as well as vitamin D deficiency are issues of public health concern in older people. However, relatively little is known about the impact of drug use on vitamin D status. Our primary aim is to explore associations between drug use and vitamin D status in older peop
Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun
Disease-modifying antirheumatic drugs (DMARDs) and biological agents are critical in preventing the severe complications of rheumatoid arthritis (RA). However, the outcome of treatment with these drugs in RA patients is quite variable and unpredictable. Drug-metabolizing enzymes (dihydrofolate reductase, cytochrome P450 enzymes, N-acetyltransferases, etc.), drug transporters (ATP-binding cassette transporters), and drug targets (tumor necrosis factor-α receptors) are coded for by variant alleles. These gene polymorphisms may influence the pharmacokinetics, pharmacodynamics, and side effects of medicines. The cause for differences in efficacy and adverse drug reactions may be genetic variation in drug metabolism among individuals. Polymorphisms in drug transporter genes may change the distribution and excretion of medicines, and the sensitivity of the targets to drugs is strongly influenced by genetic variations. In this article, we review the genetic polymorphisms that affect the efficacy of DMARDs or the occurrence of adverse drug reactions associated with DMARDs in RA. PMID:25144752
Borch, Jakob E; Andersen, Klaus E; Bindslev-Jensen, Carsten
Patients with suspected cutaneous adverse drug reactions are often referred to allergy clinics or departments of dermatology for evaluation. These patients are selected compared with patients identified in prospective and cross-sectional studies of hospital populations. This explains the observed...... variation in prevalence of specific reactions and of eliciting drugs. This study investigated the prevalence of cutaneous adverse drug reactions in a university hospital department of dermatology that is specially focused on allergy. An 8-month survey was carried out during the period April-December 2003...
de Vries, Tjalling W; van Roon, Eric N
OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs
Mulugeta Tarekegn Angamo
Full Text Available AIM: Adverse drug reaction is noxious and unwanted reaction to drugs at dose used in humans for diagnosis, treatment or prophylaxis. Adverse drug reaction monitoring is an area of drug information that has been given little attention yet. Spontaneous reporting is currently the major back bone for the detection of adverse drug reactions. The objective of this study was to assess the knowledge, attitude and practices of adverse drug reaction reporting among health professionals in selected health facilities in southwest Ethiopia. METHOD: A cross-sectional study design was used among health professionals in selected health facilities in January 2010. Prescribers other than physicians, junior pharmacy technicians and also health assistants were excluded. Data was collected using self administered questionnaires from volunteered physicians (Medical interns and above, nurses (Diploma and above and Pharmacy professionals (Diploma and above and analyzed using SPSS version 16.0. RESULTS: A total of 82 health professionals were participated in the study. From those 82 participants, only 19 (23.17% and 21 (25.61% knew the existence of national reporting system and a yellow card of adverse drug reaction reporting form. Thirteen (15.85% participants encountered adverse drug reaction in the past 12 months in their clinical activities, but none of them reported to responsible body. Even though the participants’ knowledge and practice were inadequate, most of the respondents 47 (57.31% agreed that adverse drug reaction reporting is part of duty of them and important to the public in general and to the patient in particular. CONCLUSION: There was no documentation and reporting of adverse drug reaction, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting. Our study strongly suggests that there is a great need to create awareness and to promote the reporting of adverse drug reaction amongst health professionals
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.
Khobragade Yadneshwar; Khobragade Sujata
Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here sever...
Deepti Chopra; Rehan, Harmeet S.; Vibha Sharma; Ritu Mishra
Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs). The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013) were studied. These reports were analyzed for various carcinoma...
Prashant S Dalvi
Full Text Available Aim: To monitor and evaluate the pattern of ADRs to oseltamivir in pediatric population suffering from H1N1 influenza at a tertiary care hospital. Materials and Methods: Children offered oseltamivir for treatment and chemoprophylaxis were monitored for adverse events by direct questioning for symptoms and clinical examination on day 5 and day 10. Assessment of neurological events was done by asking the parents or guardians regarding development of specific symptoms. Adverse events obtained were analyzed for severity, causality and age-group wise. Results: Out of 191 children (median age, 3 years, 69 (36.1% developed ADRs. Most common symptoms were vomiting (16.2% followed by diarrhea (12.0%, ear disorders (8.9%, and insomnia (6.8%. The incidence of neuropsychiatric symptoms was 12.6% which were mild-to-moderate on severity scale. There was no significant difference in the incidence of adverse events between children less than 1 year and other age groups. Conclusion: Oseltamivir is well tolerated in Indian children with suspected or confirmed H1N1 influenza. Our study also indicates safety of oseltamivir in infants.
Drug-induced liver injury (DILI) is among the most challenging acute or chronic liver conditions to be handled by physicians. Despite its low incidence in the general population, DILI is a frequent cause of acute liver failure. As such, the possibility of DILI should be considered in all patients who present with acute liver damage, independent of any known pre-existing liver disease. DILI can be classified as intrinsic/dose-dependent (e.g., acetaminophen toxicity) or idiosyncratic/dose-independent, with the latter form being relatively uncommon. Amoxicillin-clavulanate is the antimicrobial that is most frequently associated with idiosyncratic DILI. Large, ongoing, prospective studies in western countries have reported other drugs associated with DILI, including nonsteroidal anti-inflammatory drugs, statins, and herbal and dietary supplements. An important safety issue, DILI is one of the most frequently cited reasons for cessation of drug development during or after preclinical studies and for withdrawal of a drug from the market. This review summarizes the epidemiology, risk factors, commonly implicated drugs, clinical features, and diagnosis of DILI, with the aim of aiding physicians in the management of this debated problem. Old and new biomarkers for DILI and pharmacogenetic studies are also described. PMID:26827101
Orten-Luiten, van, A.C.B.; A. Janse; R. A. M. Dhonukshe-Rutten; Witkamp, R F
Purpose Adverse drug reactions as well as vitamin D deficiency are issues of public health concern in older people. However, relatively little is known about the impact of drug use on vitamin D status. Our primary aim is to explore associations between drug use and vitamin D status in older people. Furthermore, prevalences of drug use and vitamin D deficiency are estimated. Methods In a population of 873 community-dwelling Dutch geriatric outpatients, we explored the cross-sectional relations...
Kiran G Piparva
Full Text Available Background: Novel atypical antipsychotics are superior to conventional antipsychotics as they significantly reduce both positive and negative symptoms of schizophrenia and have lower risk of extrapyramidal symptoms (EPS. However, these drugs have separate set of adverse drug reactions (ADRs. Therefore, this study was carried out to assess these ADRs, which can have impact on long-term compliance and achieving successful treatment. Materials and Methods: A prospective study of analysis of ADR of atypical antipsychotic drugs was carried out in the psychiatry outpatient department. Patients of psychotic disorder (any age, either sex, who were prescribed atypical antipsychotic drugs, were included. Those who were prescribed conventional antipsychotics or combinations of antipsychotics were excluded from the study. Apart from spontaneously reported ADRs, a questionnaire related to the likely ADR was used and patients′ responses were recorded in the case record form. Results: Totally 93 ADRs were recorded from 84 prescriptions. Majority of the ADRs (82 out of 93 were seen with risperidone and olanzepine, as they were the commonly prescribed drugs. Weight gain, dizziness, sleep disturbance and appetite disturbance accounted for nearly 78% of the total events. With risperidone (at 4-6 mg/day and olanzepine (at 10-15 mg/day, gastrointestinal and sleep disturbance were observed in the initial (within 7 days to 2-3 months after treatment course of treatment, while EPS, fatigue, seizure, increased frequency of micturition and dizziness were observed after long-term (3-9 months use. Conclusion: The present study adds to the existing information on the prevalence of adverse effects of atypical antipsychotic drugs. Role of active surveillance in post-marketing phase is also emphasized.
Rolfes, Leàn; van Hunsel, Florence; van Puijenbroek, Eugène; van Grootheest, Adrianus
Background: Changes in the European pharmacovigilance legislation make it possible for patients of all European member states to report concerns regarding drugs directly to the national reporting centre for adverse drug reactions (ADRs). Despite a number of studies that have been conducted on patien
Full Text Available Nicholas Moore,1 Charles Pollack,2 Paul Butkerait2 1Department of Pharmacology, Université de Bordeaux, Bordeaux, France; 2Pfizer Consumer Healthcare, Madison, NJ, USA Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen have a long history of safe and effective use as both prescription and over-the-counter (OTC analgesics/antipyretics. The mechanism of action of all NSAIDs is through reversible inhibition of cyclooxygenase enzymes. Adverse drug reactions (ADRs including gastrointestinal bleeding as well as cardiovascular and renal effects have been reported with NSAID use. In many cases, ADRs may occur because of drug–drug interactions (DDIs between the NSAID and a concomitant medication. For example, DDIs have been reported when NSAIDs are coadministered with aspirin, alcohol, some antihypertensives, antidepressants, and other commonly used medications. Because of the pharmacologic nature of these interactions, there is a continuum of risk in that the potential for an ADR is dependent on total drug exposure. Therefore, consideration of dose and duration of NSAID use, as well as the type or class of comedication administered, is important when assessing potential risk for ADRs. Safety findings from clinical studies evaluating prescription-strength NSAIDs may not be directly applicable to OTC dosing. Health care providers can be instrumental in educating patients that using OTC NSAIDs at the lowest effective dose for the shortest required duration is vital to balancing efficacy and safety. This review discusses some of the most clinically relevant DDIs reported with NSAIDs based on major sites of ADRs and classes of medication, with a focus on OTC ibuprofen, for which the most data are available. Keywords: adverse effects, nonsteroidal anti-inflammatory drugs, gastrointestinal, cardiovascular, renal
Alpa Pragnesh Gor
Full Text Available Objectives: To identify the ADRs due to NSAIDs and to know how to monitor the drug′s effect. Materials and Methods: A descriptive study was undertaken in the Orthopedic Outpatients Department of a tertiary care teaching hospital. Hundred patients were enrolled in this study to observe the risk of adverse drug reactions (ADRs due to NSAIDs. All the ADRs were further analyzed in relation to age and sex, type of drug and its pattern. Probability scale was used for the causality assessment of the ADRs. Results: 26% of the 100 patients developed ADR due to NSAIDs. There was not much of a difference in the number of the ADRs in relation to the gender. Diclofenac was the highest prescribed drug (65 patients, followed by paracetamol (12, nimesulide (10, ibuprofen (6, piroxicam (5 and Etoricoxib (2. Diclofenac accounted for the maximum number (73% of ADRs, followed by nimesulide (16%, paracetamol (7%, and Etoricoxib (4%. Conclusion: Pharmacovigilance improves recognition of ADRs by the medical students. It allows the treating physician to identify the ADR associated with drugs, in particular, with the ones considered relatively safe and with those commonly prescribed by the medical and non-health professionals.
Yang, Lihua; Yu, Lihua; Chen, Xinxin; Hu, Yanqun; Wang, Bin(Department of Physics and Astronomy, Shanghai Jiao Tong University, Shanghai, 200240, China)
Background Vincristine (VCR) is a major chemotherapy drug for treatment of childhood acute lymphoblastic leukemia (ALL). Triazole antifungal drugs (AFD) are the main agents for the prevention/treatment of invasive fungal infection (IFI), a common complication during the treatment of ALL. This study investigated the adverse drug reactions (ADRs) between VCR and AFD. Material/Methods A retrospective study was performed on 68 children with ALL (39 boys and 29 girls, median age: 5 years) who were...
Full Text Available Atypical antipsychotics are an important advance in the treatment of schizophrenia and other psychiatric illness, and have become widely used as first - line pharmacotherapy for psychosis. This study is a longitudinal prospective observational study of ADRs of Atypical Antipsychotic drugs in patients of psychiatric illness. Information of ADRs was data based and collected from OPD. The noted ADRs were assessed by using Naranjo’s probability assessment scale, and WHO (UMC causality assessment scale. Majority of patients in this study belonged to 21 - 30 years age group which was 24% of the total. According to the severity of ADRs, majority of cases were reported of having weight gain 38. 46% followed by sedation 19. 23%, dry mouth 13. 46% and orthostatic hypote nsion 5. 76%. 88. 47% were reported as type A and 11. 53% were reported as type B. Definite (certain relationship was established in 30. 40% patients while probable in 57. 62% and 11. 53% ADRs were categorized as possible. The ADRs can be prevented by col lecting reliable information about their frequencies and possible risk factors.
Kardaun, S. H.; Sekula, P.; Valeyrie-Allanore, L.; Liss, Y.; Chu, C. Y.; Creamer, D.; Sidoroff, A.; Naldi, L.; Mockenhaupt, M.; Roujeau, J. C.
BackgroundCases of severe drug hypersensitivity, demonstrating a variable spectrum of cutaneous and systemic involvement, are reported under various names, especially drug reaction with eosinophilia and systemic symptoms (DRESS). Case definition and overlap with other severe cutaneous adverse reacti
Rolfes, Leàn; van Hunsel, Florence; Wilkes, Sarah; Grootheest, Kees van; Puijenbroek, Eugène van
PURPOSE: This study aims to explore the differences in reported information between adverse drug reaction (ADR) reports of patient and healthcare professionals (HCPs), and, in addition, to explore possible correlation between the reported elements of information. METHODS: This retrospective study co
O'Connor, Marie N
adverse drug reactions (ADRs) are a major cause of morbidity and healthcare utilisation in older people. The GerontoNet ADR risk score aims to identify older people at risk of ADRs during hospitalisation. We aimed to assess the clinical applicability of this score and identify other variables that predict ADRs in hospitalised older people.
Aagaard, Lise; Hansen, Ebba Holme
Background Information about medicines safety in children is very limited. Consumer adverse drug reaction (ADR) reports can provide information about serious and unknown ADRs from medicine use in children. Objective To characterize ADRs in children reported by consumers in Europe from 2007 to 2011...
Aagaard, Lise; Hansen, Ebba Holme
Reporting of adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. In the European Union, more countries have allowed consumers to report ADRs directly to the regulatory agencies. The aim of this study was to characterize ADRs reported by European...
Dr. Umeshchandra C Honnaddi
Full Text Available Introduction: Tuberculosis is one of the major health problems in India and developing countries. It is the second leading infectious cause of morbidity and mortality in the world.Objective: The present study was undertaken to study the Adverse Drug Reactions (ADRs to first line Anti-tubercular drugs (ATTs prescribed to tuberculosis patients admitted to Medicine Department, BTGH, attached to M.R. Medical College, Gulbarga.Materials and Methods: A Prospective Observational study was carried among tuberculosis patients on Directly Observed Short Course Chemotherapy (DOTS, admitted to Medicine Department, BTGH, attached to M.R. Medical College; Gulbarga.120 Patients were included during the study period of 9 months from 1st October 2014 to 30th June 2015. The data was collected in a Proforma which included questionnaire.Results: A total of 120 tuberculosis patients on DOTS were enrolled for the study. Out of 107 patients, 63 patients (58.87% developed ADRs. Out of 63 patients, 32 patients (51% developed Gastro-intestinal problems, 14 patients developed CNS problems (22%, 11 patients (18% developed Hepatitis, 4 patients (6% developed Fever and 2 patients (3% developed Pancreatitis. The most serious ADR was Hepatitis.Conclusion: Results of the study reveals that about 58.87% of patients developed ADRs during the study period. These ADRs will lead to stoppage of drugs, development of Drug resistance and Therapeutic Failure. If a proper Pharmacovigilance system is implemented in the hospital, most of the patients may report their ADRs and thereby we can improve the patient adherence and treatment outcome.
Conforti, Anita; Chiamulera, Christian; Moretti, Ugo; Colcera, Sonia; Fumagalli, Guido; Leone, Roberto
The musculoskeletal system can be a target organ for adverse drug reactions (ADRs). Drug-induced muscle, bone or connective tissue injuries may be due to, i), primary direct drug action, or, ii), undirected consequence of generalized drug-induced disease. Musculoskeletal ADRs may be only temporarily disabling, such as muscle cramps, as well as in other cases may be serious and life-threatening, such as rhabdomyolysis. In the last few years there has been an increasing awareness of musculoskeletal ADRs. Some recent drug safety issues dealt with serious or uncommon musculoskeletal reactions like rhabdomyolysis associated to statins and tendon rupture associated to fluoroquinolones. In this review, we firstly selected those drug classes having a significantly high percentage of musculoskeletal disorder reports in the WHO adverse drug reaction database, maintained by the Uppsala Monitoring Centre. Secondly, the different musculoskeletal ADRs were closely analyzed through the data obtained from an Italian interregional ADRs spontaneous reporting database. The findings on drugs associated to different musculoskeletal disorders, have been integrated with a review of the epidemiological data available in the literature. For the most involved drugs (HMG-CoA reductase inhibitors, fluoroquinolones, corticosteroids, bisphosphonates, retinoids) the underlying musculoskeletal ADR mechanisms were also reviewed and discussed. PMID:18690950
Lee, Jae-Hyun; Park, Kyung Hee; Moon, Hyun Joo; Lee, Yong Won; Park, Jung-Won; Hong, Chein-Soo
Purpose Pharmacovigilance Research Network built a spontaneous reporting system and collected adverse drug reactions (ADRs) by electronic submission (e-sub) in Korea. We analyzed ADRs spontaneously reported through e-sub from regional health professionals. Materials and Methods Nine hundred and thirty three ADR cases were collected and analyzed from January to December in 2008. "A matter" was defined as one symptom matched to one culprit drug included in an ADR case. We collected and analyzed...
Gene D. Morse; Qing Ma; Star Khoza; Tinashe Mudzviti; Maponga, Charles C.
Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2%) of participants were using at least one herbal drug together wi...
Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis
Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs. PMID:26215671
Full Text Available Aim To monitor the adverse drug reactions (ADRs caused by antihypertensive medicines prescribed in a university teaching hospital.Methods:he present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO, Government of India.Results:A total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29 % than males, 7 (3.64 %. Combination therapy was associated with more number of adverse drug reactions (66.7 % as against monotherapy (33.3 %. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7, followed by diuretics (n = 5, and beta- blockers (n = 4. Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7, followed by torasemide (n = 3. Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8 % followed by musculo-skeletal complaints (23.8 % and gastro-intestinal disorders (14.3 %. Conclusions:The present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.
Johnson Segun Showande
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
Bousquet, Cédric; Gasperina, Philippe; Trombert, Béatrice; Clavel, Lucienne; Kumar, Anand; Rodrigues, Jean Marie
In a previous work we proposed a categorial structure for the representation of adverse drug reactions consisting of 16 semantic categories and 20 relations. We present an implementation of this categorial structure in Protégé based on four WHO-ART system organ classes: Gastro-intestinal system disorders, Liver and biliary system disorders, Central & peripheric nervous system disorders, and Psychiatric disorders. We compared classification according to anatomy using SNOMED CT within the PharmARTS tool and the FMA with the Pellet reasoner. This ontology contains 210 concepts for Gastroenterology, 66 concepts for Psychiatry and 85 concepts for Neurology. Classification of disorders located in the upper gastro intestinal tract was similar using both SNOMED CT and the FMA. This work is a first step towards the comparison of two models of anatomy within a common ontology of adverse drug reactions. PMID:19745363
Full Text Available BACKGROUND: There is little research on parents' experiences of suspected adverse drug reactions in their children and hence little evidence to guide clinicians when communicating with families about problems associated with medicines. OBJECTIVE: To identify any unmet information and communication needs described by parents whose child had a suspected adverse drug reaction. METHODS: Semi-structured qualitative interviews with parents of 44 children who had a suspected adverse drug reaction identified on hospital admission, during in-patient treatment or reported by parents using the Yellow Card Scheme (the UK system for collecting spontaneous reports of adverse drug reactions. Interviews were conducted face-to-face or by telephone; most interviews were audiorecorded and transcribed. Analysis was informed by the principles of the constant comparative method. RESULTS: Many parents described being dissatisfied with how clinicians communicated about adverse drug reactions and unclear about the implications for their child's future use of medicines. A few parents felt that clinicians had abandoned their child and reported refusing the use of further medicines because they feared a repeated adverse drug reaction. The accounts of parents of children with cancer were different. They emphasised their confidence in clinicians' management of adverse drug reactions and described how clinicians prospectively explained the risks associated with medicines. Parents linked symptoms to medicines in ways that resembled the established reasoning that clinicians use to evaluate the possibility that a medicine has caused an adverse drug reaction. CONCLUSION: Clinicians' communication about adverse drug reactions was poor from the perspective of parents, indicating that improvements are needed. The accounts of parents of children with cancer indicate that prospective explanation about adverse drug reactions at the time of prescription can be effective. Convergence
Lucía Fernández-López; Javier Navarro-Zaragoza; María Falcón; Aurelio Luna
Objectives: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide and generate high health costs. Therefore, the aims of this study were to determine the treatments which produce more ADRs in general population and the main symptoms they generate. Methods: An observational, cross-sectional study consisting in performing a self-rated questionnaire was carried out. 510 patients were asked about the treatments, illnesses and ADRs, they had suffered from. Resul...
Hadeer Akram AbdulRazzaq; Noorizan Abd Aziz; Syed Azhar Syed Sulaiman; Yahaya Hassan; Omar Ismail
Introduction: Statins cause adverse drug reactions (ADRs) in patients on chronic use of medications. No specific tool available for patients to report these ADRs. Most of previous studies based on the doctors’ reports.Aim: development specific tool for reporting of satins-ADRs for cardiac outpatients, and to determine the incidences and correlations among these ADRs. Method: the questionnaire based on the commonly reported ADRs of statins, researchers' agreements and the consistent understan...
Metke-Jimenez, Alejandro; Karimi, Sarvnaz
Social media is becoming an increasingly important source of information to complement traditional pharmacovigilance methods. In order to identify signals of potential adverse drug reactions, it is necessary to first identify medical concepts in the social media text. Most of the existing studies use dictionary-based methods which are not evaluated independently from the overall signal detection task. We compare different approaches to automatically identify and normalise medical concepts in ...
Bartal, Alexandra; Mátrai, Zoltán; Szucs, Attila; Belinszkaja, Galina; Langmár, Zoltán; Rosta, András
Each aspect of oncological care is widely affected by the spread of oral anticancer agents, which raises several questions in terms of safe medication use and patient adherence. Over the past decade targeted therapies have appeared in clinical practice and revolutionized the pharmacological treatment of malignancies. Regular patient - doctor visits and proper patient education is crucial in order to comply with the therapy previously agreed upon with the oncologist, to increase patient adherence, to detect and to treat adverse effects in early stages. Since the information on the new medicines in Hungarian language is sparse it is the intention of the authors to give an overview of the basic knowledge, patient safety issues, adverse effects and interactions. Official drug information summaries and data on pharmacokinetics, interactions and adverse effects from the literature are reviewed as the basis for this overview. PMID:22217686
Full Text Available An adverse drug reaction (ADR is a serious concern for practicing veterinarians and other health professionals, and refers to an unintended, undesired and unexpected response to a drug that negatively affects the patient's health. It may be iatrogenic or genetically induced, and may result in death of the affected animal. The ADRs are often complicated and unexpected due to myriad clinical symptoms and multiple mechanisms of drug-host interaction. Toxicity due to commonly used drugs is not uncommon when they are used injudiciously or for a prolonged period. Licosamides, exclusively prescribed against anaerobic pyoderma, often ends with diarrhoea and vomiting in canines. Treatment with Penicillin and β-lactam antibiotics induces onset of pemphigious vulgare, drug allergy or hypersensitivity. Chloroamphenicol and aminoglycosides causes Gray's baby syndrome and ototoxicity in puppies, respectively. Aminoglycosides are very often associated with nephrotoxicity, ototoxicity and neuromuscular blockage. Injudicious use of fluroquinones induces the onset of arthropathy in pups at the weight bearing joints. The most effective therapeutic measure in managing ADR is to treat the causative mediators, followed by supportive and symptomatic treatment. So, in this prospective review, we attempt to bring forth the commonly occurring adverse drug reactions, their classification, underlying mechanism, epidemiology, treatment and management as gleaned from the literature available till date and the different clinical cases observed by the authors.
To discuss the adverse reaction of Chinese patent drug, to study and analysis the adverse reaction of Chinese patent drug in clinic, Chinese patent drug, adverse reaction should be valued and prevent drug abusing.%探讨中成药的不良反应，分析研究中成药在临床应用中的不良反应，且对中成药的不良反应应重视并防止滥用。
Uppal, R; Jhaj, R; Malhotra, S
Use of fluoroquinolones has increased considerably in the last 5-6 years in our hospitals. With a view to ascertain their safety and the type of adverse drug reactions (ADRs) in our population, spontaneous reports were collected and analysed to ciprofloxacin (the most prescribed fluoroquinolone in our hospital) over a period of three and a half years. The pattern of reactions were rash in 18, severe reactions like Steven Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in 4, gastritis and diarrhoea in 3, shivering and rigors in 2, hemorrhagic purpuric spots in 2 and oedema of eye and lids with topical application in 1 patient. Most cases recovered on stoppage of the drug and symptomatic treatment. However, one case of SJS and one of TEN proved fatal. Care needs to be exercised in their use and they do not appear to be innocuous to severe and disturbing ADRs. PMID:11229222
Shang, Ning; Xu, Hua; Rindflesch, Thomas C; Cohen, Trevor
Pharmacovigilance involves continually monitoring drug safety after drugs are put to market. To aid this process; algorithms for the identification of strongly correlated drug/adverse drug reaction (ADR) pairs from data sources such as adverse event reporting systems or Electronic Health Records have been developed. These methods are generally statistical in nature, and do not draw upon the large volumes of knowledge embedded in the biomedical literature. In this paper, we investigate the ability of scalable Literature Based Discovery (LBD) methods to identify side effects of pharmaceutical agents. The advantage of LBD methods is that they can provide evidence from the literature to support the plausibility of a drug/ADR association, thereby assisting human review to validate the signal, which is an essential component of pharmacovigilance. To do so, we draw upon vast repositories of knowledge that has been extracted from the biomedical literature by two Natural Language Processing tools, MetaMap and SemRep. We evaluate two LBD methods that scale comfortably to the volume of knowledge available in these repositories. Specifically, we evaluate Reflective Random Indexing (RRI), a model based on concept-level co-occurrence, and Predication-based Semantic Indexing (PSI), a model that encodes the nature of the relationship between concepts to support reasoning analogically about drug-effect relationships. An evaluation set was constructed from the Side Effect Resource 2 (SIDER2), which contains known drug/ADR relations, and models were evaluated for their ability to "rediscover" these relations. In this paper, we demonstrate that both RRI and PSI can recover known drug-adverse event associations. However, PSI performed better overall, and has the additional advantage of being able to recover the literature underlying the reasoning pathways it used to make its predictions. PMID:25046831
Jaramillo, Nancy Monroy; Galindo, Ingrid Fricke; Vázquez, Alberto Ortega; Cook, Helgi Jung; LLerena, Adrián; López, Marisol López
Carbamazepine (CBZ) is a first-line widely used anticonvulsant. It has a narrow therapeutic index and exhibits considerable interindividual and interethnic variability in clinical efficacy and adverse drug reactions including potentially life-threatening hypersensitivity reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The most important pharmacogenetic finding is related to the association of CBZ-induced hypersensitivity with human leukocyte antigens (HLA class I and II alleles). Moreover, genotyping for HLA-B*15:02 allele is required prior to initiating CBZ in Asians and Asian ancestry patients, demonstrating the usefulness of biomarkers to avoid adverse drug reactions. On the other hand, in order to explain the differences in the clinical response to CBZ, genetic polymorphisms in phase I (CYP3A4, CYP3A5 and EPHX1) and phase II (UGT2B7) metabolising enzymes have been assessed; additionally, the influence of transporters (ABCB1 and ABCC2), receptors (PXR) and other drug targets (voltage- gated Na+ channels) in CBZ clinical response has been evaluated. To date, these studies are controversial and require further investigations to clarify the functional role of these polymorphisms as potential biomarkers in regard to CBZ therapy. PMID:24406279
Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki
Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women. PMID:26935093
Full Text Available 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.
Luis Carlos López
Full Text Available Introduction: Adverse drug reactions (ADRs are an important cause of morbidity and mortality among hospitalized patients. Objectives: This study was designed to describe the frequency, severity, and causality of ADRs in internal medicine units at a third-level university hospital. Materials and methods: A descriptive study was performed at internal medicine units, by means of a structured format, review of clinical records, and interview of hospitalized patients. The Naranjo algorithm was applied to patient adverse events to define causality. Additionally, ADRs were classified according to the Rawlins and Thompson criteria. Results: One hundred patients (50 men and 50 women were included in the study. Ninety nine (99 adverse events were found among the patients. The Naranjo algorithm was applied to adverse events, resulting in twenty nine (29 probable ADRs, twenty (20 possible ADRs and fifty (50 doubtful ADRs. Cardiovascular drugs and antibiotics were the most frequent therapeutic groups associated with ADRs. In addition, two preventable medication errors were identified. Conclusions: Frequency of ADRs was similar to the number reported in other studies in internal medicine units. It is necessary to systematize efforts of pharmacological surveillance in hospital wards, toward an opportune detection and prevention of ADRs.
Luis Carlos López
Full Text Available Introduction: Adverse drug reactions (ADRs are an important cause of morbidity and mortality among hospitalized patients.Objectives: This study was designed to describe the frequency, severity, and causality of ADRs in internal medicine units at a third-level university hospital.Materials and methods: A descriptive study was performed at internal medicine units, by means of a structured format, review of clinical records, and interview of hospitalized patients. The Naranjo algorithm was applied to patient adverse events to define causality. Additionally, ADRs were classified according to the Rawlins and Thompson criteria.Results: One hundred patients (50 men and 50 women were included in the study. Ninety nine (99 adverse events were found among the patients. The Naranjo algorithm was applied to adverse events, resulting in twenty nine (29 probable ADRs, twenty (20 possible ADRs and fifty (50 doubtful ADRs. Cardiovascular drugs and antibiotics were the most frequent therapeutic groups associated with ADRs. In addition, two preventable medication errors were identified.Conclusions: Frequency of ADRs was similar to the number reported in other studies in internal medicine units. It is necessary to systematize efforts of pharmacological surveillance in hospital wards, toward an opportune detection and prevention of ADRs.
Mangoni, Arduino A
Increased, often inappropriate, drug exposure, pharmacokinetic and pharmacodynamic changes, reduced homeostatic reserve and frailty increase the risk of adverse drug reactions (ADRs) in the older population, thereby imposing a significant public health burden. Predicting and diagnosing ADRs in old age presents significant challenges for the clinician, even when specific risk scoring systems are available. The picture is further compounded by the potential adverse impact of several drugs on more 'global' health indicators, for example, physical function and independence, and the fragmentation of care (e.g., increased number of treating doctors and care transitions) experienced by older patients during their clinical journey. The current knowledge of drug safety in old age is also curtailed by the lack of efficacy and safety data from pre-marketing studies. Moreover, little consideration is given to individual patients' experiences and reporting of specific ADRs, particularly in the presence of cognitive impairment. Pending additional data on these issues, the close review and monitoring of individual patients' drug prescribing, clinical status and biochemical parameters remain essential to predict and detect ADRs in old age. Recently developed strategies, for example, medication reconciliation and trigger tool methodology, have the potential for ADRs risk mitigation in this population. However, more information is required on their efficacy and applicability in different healthcare settings. PMID:22512705
Rodgers, Bradley K; Kumar, Avinash B
Toxic epidermal necrolysis syndrome (TEN) is a rare severe cutaneous adverse drug reaction that involves skin and mucous membranes. We describe a case of TEN presenting with stage III acute kidney injury, rhabdomyolysis, and acute respiratory failure likely triggered by allopurinol for recently diagnosed gout. Prompt diagnosis, multidisciplinary management, including aggressive resuscitation, cardiorespiratory support, intravenous immunoglobulin therapy, and daily wound care resulted in a positive outcome despite a predicted mortality greater than 60%. Although allopurinol is a known triggering agent, TEN presenting with rhabdomyolysis and acute kidney injury is rare. PMID:24832386
Massot, Andreu; Gimenez-Arnau, Ana
Severe skin reactions occur less frequently with eslicarbazepine (ESL) than with the other aromatic anticonvulsants. We report the first case of cutaneous adverse drug reaction (CADR) to ESL and co-sensitization between ESL and betalactams. A 41-year-old white woman developed focal epilepsy due to a meningioma that was removed. As post-operatory complication, she suffered meningitis as well as a maculo-papular erythema caused by the treatment with meropenem. Subsequently, ESL was started and gradually increased until 800 mg/day. Twenty-five days later, the patient developed an Erythema Multiforme Major (EMM). Strong positive immediate reaction was induced by prick test with carbamazepine (CBZ) and ESL at 0.01 and 0.1% within 15 and 30 minutes; however the delayed reading at 48 hours was negative. The patient was not carrier of the HLA alleles A3101 and B1502 associated with CBZ induced EMM. The hypersensitivity pathogenic mechanism of EMM is unclear and a delayed hypersensitivity process is speculated. However, the patch and intradermal tests in our patient did not show a delayed reaction but an immediate cutaneous one. A first allergic episode may elicit a massive nonspecific activation of the immune system, providing an enhanced expression of co-stimulatory molecules that decreases the level of tolerance to other drugs. When prescribing ESL, we suggest ruling out previous CADR, especially to CBZ and oxcarbazepine but also other chemically unrelated drugs such as beta-lactams. PMID:25422574
Full Text Available Context: Herbal drugs are a mixture of active compounds and the chemical complexity of each formulation increase with the possibility of interactions between them and conventional drugs. Many mechanisms are implicated in the interactions; scientific community has dedicated the attentions to enzymes as P-gp and CYP450. Aims: To investigate in the literature the principal plants with suspicions of adverse reactions in Cuba and their potential interactions with conventional drugs. Methods: PubMed was the database used as source of information until February 2014. Key words: Herb-Drug, Drug-Plant, Herbal–Drug, Interactions with scientific names of plants was used. Information was structured and analysed with EndNote X4. Analysis and integration of the information: Allium sativum L. (garlic was the plant with the high number of studies related with CYP450 and P-gp. Plants with great demand as Morinda citrifolia L. (noni, Psidium guajava L. (guayaba, Zingiber officinale Roscoe (ginger and Eucalyptus spp. (eucalyptus have a very small number of studies. The professionals of the health should keep in mind the possibility of interactions between herbal products and conventional drugs to increase the effectiveness of phytotherapy. Conclusions: It is necessary enhance reports and investigations and to put to disposition of the system of health information on the interactions of plants and to stimulate the investigation that offers information for the rational use of our medicinal plants.
Tomy Martin; LI Hui
Purpose To review the current progress in epidemiology, etiology, clinical manifestation, and pathophysiology of severe cutaneous adverse drug reactions(SCADRs). Data sources Data were acquired by using Blackwell-Synergy, PubMed, original articles published in the main Chinese journals and related medical textbooks materials. Study-selection and date extraction Throughout the literature review 49 articles were selected. Results SCADRs cases are rare, however, the implication is life threatening with significant mortatity rates. Epidemiology studies have shown various incidences from different regions, gender, age, race and concurrent illness. There are typical signs and symptoms for each type of SCADRs, but this is not always so. Drugs associated with inducing SCADRs are anticonvulsants, antibiotics, NSAIDs and antirheumatic drugs. In some countries, especially in Asia, traditional drugs are offen the cause of SCADRs. Genetic polymorphisms and viral infections are predisposition factors of SCADRs. Patients with certain genetic alleles and underlying diseases are vulnerable to SCADRs. The exact pathogenesis of SCADRs is not well defined. Nonetheless, recent study showed that reactive metabolites and immunological processes have a significant role in SCADRs. Conclusions The different SCADRs reactions are attributed by different intrinsic factors, such as genetic polymorphisms, gender, age and race as well as extrinsic factors, such as underlying diseases. Different regions and culprit drugs also play a role in the various types of SCADRs.
Lakshmi Prabha M; Geetha Rani A; Meenakshi Balasubramanian; Ezhil Ramya J
Background: Rheumatoid arthritis is a chronic inflammatory arthritis which requires lifelong treatment to prevent the damage to joints and to maintain day to day functioning of patients. All the drugs used in the treatment of rheumatoid arthritis show significant toxicity and hence it is very important that their use require regular monitoring for adverse reactions. The present study is designed to estimate the prescribing pattern and the occurrence of adverse drug reactions in patients with ...
Zyoud, Sa'ed H; Awang, Rahmat; Sulaiman, Syed Azhar Syed; Khan, Halilol Rahman Mohamed; Sawalha, Ansam F; Sweileh, Waleed M; Al-Jabi, Samah W
Intravenous N-acetylcysteine is usually regarded as a safe antidote. However, during the infusion of the loading dose, different types of adverse drug reactions (ADR) may occur. The objective of this study was to investigate the relation between the incidence of different types of ADR and serum acetaminophen concentration in patients presenting to the hospital with acetaminophen overdose. This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 5 years (1 January 2004 to 31 December 2008). Parametric and non-parametric tests were used to test differences between groups depending on the normality of the data. SPSS 15 was used for data analysis. Of 305 patients with acetaminophen overdose, 146 (47.9%) were treated with intravenous N-acetylcysteine and 139 (45.6%) were included in this study. Different types of ADR were observed in 94 (67.6%) patients. Low serum acetaminophen concentrations were significantly associated with cutaneous anaphylactoid reactions but not other types of ADR. Low serum acetaminophen concentration was significantly associated with flushing (p acetaminophen concentrations between patients with and without the following ADR: gastrointestinal reactions (p = 0.77), respiratory reactions (p = 0.96), central nervous reactions (p = 0.82) and cardiovascular reactions (p = 0.37). In conclusion, low serum acetaminophen concentrations were associated with higher cutaneous anaphylactoid reactions. Such high serum acetaminophen concentrations may be protective against N-acetylcysteine-induced cutaneous ADR. PMID:20374238
Full Text Available Background: Chemotherapy, a multimodal approach to oncological treatment, involves highly complex regimens and hence accounts to high susceptibility toward adverse drug reactions (ADRs. The present study aims to determine the prevalence of adverse events in patients treated with chemotherapy. Materials and Methods: Spontaneous ADR report of patients on antineoplastic drugs received in the past 2 years (January 2011-January 2013 were studied. These reports were analyzed for various carcinomas under treatment, medications used, types of ADRs, organ system involvement, severity, causality assessment, and preventability. Results: Over a period of 2 years, a total 591 cases were received with an incidence of 58.6%. The prevalence of ADRs was more in female patients (73.6% as compared to men. ADRs mostly occurred in the age group of 41-50 years (27.4%. Patients treated for breast carcinoma (39.1% reported the highest incidence of ADRs. Cisplatin (19.6% was found to be the most common offending drug. The most common ADR reported was nausea and vomiting (23%. Gastroenterology (40.1% was the most affected system. About 50.2% of the ADRs required treatment and 12.9% ADRs were considered serious. Causality assessment revealed that 80% of the ADRs were possible. About 86.97% cases were found to be mild, and 51% were not preventable. Conclusion: The success of chemotherapy comes with the word of caution regarding toxicities of antineoplastic drugs. Pharmacovigilance of these drugs needs to be explored, and use of preventative measures needs to be enhanced in order to reduce the incidence and severity of ADRs.
Mudzviti, Tinashe; Maponga, Charles C; Khoza, Star; Ma, Qing; Morse, Gene D
Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART). Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2%) of participants were using at least one herbal drug together with ART. The most common herbal remedies used were Allium Sativum (72.7%), Bidens pilosa (66.0%), Eucalyptus globulus (52.3%), Moringa oleifera (44.1%), Lippia javanica (36.3%), and Peltoforum africanum (34.3%). Two indigenous herbs, Musakavakadzi (OR = 0.25; 95% CI 0.076-0.828) and Peltoforum africanum (OR = 0.495; 95% CI 0.292-0.839) reduced the occurrence of adverse drug events. Conclusions. The use of herbal drugs is high in the HIV-infected population and there is need for pharmacovigilance programs to recognize the role they play in altering ADR profiles. PMID:22506106
Nishita H. Darji; Shilpa Jadav; Chintan Doshi; Rutvij Hedamba; Rusva Mistry; Hiren Trivedi
Background: Use of drugs itself may result into illness and death due to their adverse effects. In India 10-20% of inpatients developed adverse drug reactions. Most of these problems can be overcome by undertaking hospital based intensive monitoring. Objective of this study was to estimate the incidence and document the spectrum of ADRs in studied patients in terms of causality, severity, frequency, type and preventability. A prospective, observational, single centre study conducted among the...
Full Text Available Prerna Upadhyaya,1 Vikas Seth,2 Vijay V Moghe,1 Monika Sharma,1 Mushtaq Ahmed11Department of Pharmacology, Mahatma Gandhi Medical College, Sitapura, Jaipur, Rajasthan, 2Department of Pharmacology, Hind Institute of Medical Sciences, Safedabad, Barabanki, Lucknow, Uttar Pradesh, IndiaIntroduction: Poor reporting of adverse drug reactions (ADRs by doctors is a major hindrance to successful pharmacovigilance. The present study was designed to assess first-year residents’ knowledge of ADR reporting.Methods: First-year postgraduate doctors at a private medical college completed a structured questionnaire. The responses were analyzed by nonparametric methods.Results: All doctors were aware of the term “adverse drug reactions.” Fifty percent of the doctors reported being taught about ADR reporting during their undergraduate teaching, and 50% had witnessed ADRs in their internship training. Ten percent of patients suffering an ADR observed and reported by doctors required prolonged hospitalization for treatment as a result. Only 40% of interns reported the ADRs that they observed, while 60% did not report them. Twenty-eight percent reported ADRs to the head of the department, 8% to an ADR monitoring committee, and 4% to the pharmacovigilance center. Eighty-six percent of the doctors surveyed felt that a good knowledge of undergraduate clinical pharmacology therapeutics would have improved the level of ADR reporting.Conclusion: The knowledge of first-year doctors regarding ADR reporting is quite poor. There is a dire need to incorporate ADR reporting into undergraduate teaching, and to reinforce this during internships and periodically thereafter.Keywords: ADR reporting, pharmacovigilance, first-year postgraduate doctors
Full Text Available Identifying genetic factors responsible for serious adverse drug reaction (SADR is of critical importance to personalized medicine. However, genome-wide association studies are hampered due to the lack of case-control samples, and the selection of candidate genes is limited by the lack of understanding of the underlying mechanisms of SADRs. We hypothesize that drugs causing the same type of SADR might share a common mechanism by targeting unexpectedly the same SADR-mediating protein. Hence we propose an approach of identifying the common SADR-targets through constructing and mining an in silico chemical-protein interactome (CPI, a matrix of binding strengths among 162 drug molecules known to cause at least one type of SADR and 845 proteins. Drugs sharing the same SADR outcome were also found to possess similarities in their CPI profiles towards this 845 protein set. This methodology identified the candidate gene of sulfonamide-induced toxic epidermal necrolysis (TEN: all nine sulfonamides that cause TEN were found to bind strongly to MHC I (Cw*4, whereas none of the 17 control drugs that do not cause TEN were found to bind to it. Through an insight into the CPI, we found the Y116S substitution of MHC I (B*5703 enhances the unexpected binding of abacavir to its antigen presentation groove, which explains why B*5701, not B*5703, is the risk allele of abacavir-induced hypersensitivity. In conclusion, SADR targets and the patient-specific off-targets could be identified through a systematic investigation of the CPI, generating important hypotheses for prospective experimental validation of the candidate genes.
Full Text Available Izumi Sato,1 Manabu Akazawa21Department of Epidemiology and Statistics, Graduate School of Medicine, The University of Tokyo Tokyo, Japan; 2Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, JapanBackground: The concomitant use of multiple medications by elderly patients with hypertension is a relatively common and growing phenomenon in Japan. This has been attributed to several factors, including treatment guidelines recommending prescription of multiple medications and a continuing increase in the elderly population with multiple comorbidities.Objective: This study was aimed at investigating the association between polypharmacy, defined as the concomitant use of five or more medications, and risk of adverse drug reaction (ADR in elderly Japanese hypertensive patients to examine the hypothesis that risk of ADR increases with the administration of an increasing number of co-medications.Methods: Using a retrospective cohort design, the data regarding all hypertensive patients aged 65 years or older were extracted from the Risk/Benefit Assessment of Drugs – Analysis and Response Council antihypertensive medication database. The data were reviewed for classification of patients into one of three groups according to drug use at the initiation of therapy – a monotherapy group composed of patients who had taken the investigated drug only, a co-medication group composed of patients who had taken the investigated drug and a maximum of three other medications, and a polypharmacy group composed of patients who had taken the investigated drug and four or more other medications – and determination of the number of ADR events experienced. Estimated rate ratios (RRs and 95% confidence intervals (CIs were calculated using a Poisson regression model adjusted for drug category and patient age and sex. Various sensitivity analyses were performed to confirm the robustness of the study findings.Results: Of 61,661 elderly
de Miguel Gil
Full Text Available Abstract Background Adverse drug reactions (ADR are a substantial cause of hospital admissions. We conducted a nationwide study to estimate the burden of hospital admissions for ADRs in Spain during a six-year period (2001-2006 along with the associated total health cost. Methods Data were obtained from the national surveillance system for hospital data (Minimum Basic Data Set maintained by the Ministry of Health and Consumer Affairs, and covering more than 95% of Spanish hospitals. From these admissions we selected all hospitalization that were code as drug-related (ICD-9-CM codes E, but intended forms of overdoses, errors in administration and therapeutics failure were excluded. The average number of hospitalizations per year, annual incidence of hospital admissions, average length of stay in the hospital, and case-fatality rate, were calculated. Results During the 2001-2006 periods, the total number of hospitalized patients with ADR diagnosis was 350,835 subjects, 1.69% of all acute hospital admissions in Spain. The estimated incidence of admissions due to ADR decreased during the period 2001-2006 (p Conclusions Approximately 1.69% of all acute hospital admissions were associated with ADRs. The rates were much higher for elderly patients. The total cost of ADR-related hospitalization to the Spanish health system is high and has increased between 2001 and 2006. ADRs are an important cause of admission, resulting in considerable use of national health system beds and a significant number of deaths.
Ghattaoraya, Gurpreet S; Dundar, Yenal; González-Galarza, Faviel F; Maia, Maria Helena Thomaz; Santos, Eduardo José Melo; da Silva, Andréa Luciana Soares; McCabe, Antony; Middleton, Derek; Alfirevic, Ana; Dickson, Rumona; Jones, Andrew R
Human leukocyte antigens (HLA) are an important family of genes involved in the immune system. Their primary function is to allow the host immune system to be able to distinguish between self and non-self peptides-e.g. derived from invading pathogens. However, these genes have also been implicated in immune-mediated adverse drug reactions (ADRs), presenting a problem to patients, clinicians and pharmaceutical companies. We have previously developed the Allele Frequency Net Database (AFND) that captures the allelic and haplotype frequencies for these HLA genes across many healthy populations from around the world. Here, we report the development and release of the HLA-ADR database that captures data from publications where HLA alleles and haplotypes have been associated with ADRs (e.g. Stevens-Johnson Syndrome/toxic epidermal necrolysis and drug-induced liver injury). HLA-ADR was created by using data obtained through systematic review of the literature and semi-automated literature mining. The database also draws on data already present in AFND allowing users to compare and analyze allele frequencies in both ADR patients and healthy populations. The HLA-ADR database provides clinicians and researchers with a centralized resource from which to investigate immune-mediated ADRs.Database URL: http://www.allelefrequencies.net/hla-adr/. PMID:27189608
Dogra A; Minocha Y; Kaur S
Adverse reaction to cosmetics constitute a small but significant number of cases of contact dermatitis with varied appearances. These can present as contact allergic dermatitis, photodermatitis, contact irritant dermatitis, contact urticaria, hypopigmentation, hyperpigmentotion or depigmentation, hair and nail breakage. Fifty patients were included for the study to assess the role of commonly used cosmetics in causing adverse reactions. It was found that hair dyes, lipsticks and surprisingly ...
Full Text Available Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs caused by anthroposophical medicines (AMEDs in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code, causality (according to the Uppsala Monitoring Centre WHO criteria, and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6% experienced 211 ADRs (CTCAE grade 2/3 n=191, 90.5%, CTCAE grade 4/5 n=20, 9.5% of which 57 ADRs (27.0% were serious. The median age of patients with ADRs (62.1% females was 72.0 (IQR: 61.0; 80.0. Six patients (0.2% experienced six ADRs (2.8% of ADRs caused by eight suspected AMEDs, all of which were mild reactions (grade 2. Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.
Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme
Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency ...
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
Full Text Available Adequate controlled clinical trials in pediatric population, especially in oncology and vaccinations are still insufficient due to ethical considerations. Certain conditions in children in general and in Indian children in particular, suggested the need for Adverse Drug Reaction (ADR monitoring. Thus this study was aimed to investigate the incidence of ADRs in pediatric populations. A prospective spontaneous reporting study was conducted over a period of six months from October 2012 to March 2013 in pediatric inpatients ward of Bharati Hospital in Pune. Reported ADRs were assessed for its causality by using WHO causality assessment scale, and its severity by using Hart wig Severity Scale. A total of 107 suspected ADRs were reported and evaluated from 54 patients, showing an overall incidence of 4.75%. Incidence rate of ADRs during hospitalization was 4.13%, while ADRs induced hospitalization was 0.62%. The gastrointestinal system (48.59% was the most affected, and antibiotics was the most common the drug class associated to ADRs. In term of causality, 55.14% of the reactions were classified as possible, while in term of severity, 64.49% were classified as moderate. Most patients (60.75% recovered from the incidence. Although the prevalence and severity of ADRs in pediatrics populations is reported to be higher than those of in adults, the incidence of ADRs in our study was only 4.75% which is lower than those of reported in adults, this may due to the spontaneous reporting system that used in this study.
Endalkachew Admassie; Tesfahun Melese; Woldeselassie Mequanent; Wubshet Hailu; B Akshaya Srikanth
The aim of this study was to assess the extent of poly-pharmacy, occurrence, and associated factors for the occurrence of drug–drug interaction (DDI) and potential adverse drug reaction (ADR) in Gondar University Teaching Referral Hospital. Institutional-based retrospective cross-sectional study. This study was conducted on prescriptions of both in and out-patients for a period of 3 months at Gondar University Hospital. Both bivariate analysis and multivariate logistic regression were used to...
Heus, R.; Mol, B. W.; Erwich, J.J.H.M.; van Geijn, H.P.; Gyselaers, W.J.; Hanssens, M.; Harmark, L.; van Holsbeke, C.D.; Duvekot, J.J.; Schobben, F.F.A.M.; Wolf, Hans; Visser, G. H. A.
textabstractObjective To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. Design Prospective cohort study. Setting 28 hospitals in the Netherlands and Belgium. Participants 1920 consecutive women treated with tocolytics for threatened preterm labour. Main outcome measures Maternal adverse events (those suspected of being causally related to treatment were considered adverse dru...
Kanagaratnam, Lukshe; Dramé, Moustapha; Trenque, Thierry; Oubaya, Nadia; Nazeyrollas, Pierre; Novella, Jean-Luc; Jolly, Damien; Mahmoudi, Rachid
Elderly subjects with cognitive disorders are at particularly high risk of adverse drug reactions (ADRs). The objectives of our systematic review were to describe the prevalence of ADRs in elderly patients with cognitive disorders, the different types of ADRs and the medications suspected of involvement; to describe whether the ADRs were preventable or not, and to identify risk factors for occurrence of ADRs in this population. A bibliographic search was performed in the following databases: PubMed, Embase, Google Scholar, Opengrey and Scopus. The search included all publications up to and including 4th February 2015, with no specific start date specified. Studies concerning ADRs in elderly patients with cognitive disorders or dementia were included. Two senior authors identified eligible studies and extracted data independently. In total, 113 studies were identified by the bibliographic search, of which six full-text articles were retained and analyzed. Prevalence of ADRs ranged from 4.8 to 37%. The main ADRs reported were neurological and psychological disorders, gastro-intestinal disorders, dermatological and allergic disorders, falls, renal and urinary disorders, cardiovascular disorders, metabolic disorders and electrolyte imbalance, and hemorrhagic events. The medications most commonly suspected of involvement in the ADRs were drugs affecting the nervous system, cardiovascular drugs, anticoagulants, and painkillers. Medical prescriptions should take into account the presence of Alzheimer's disease and related syndromes. Compliance should systematically be evaluated, and cognitive disorders need to be better recognized. Therapeutic education of patients and/or their caregiver is key to management of elderly patients with cognitive disorders. PMID:26857880
Full Text Available Spontaneous reporting on adverse drug reactions (ADR has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups.Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification, category of ADR (according to system organ class as well as the severity of the ADR.In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%. The most common ADRs reported were from the following system organ classes: application site disorders (32.2%, skin and appendages disorders (20.6%, body as a whole general disorders (12.8% and central and peripheral nervous system disorders (11.2%. Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0% were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%. Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities.ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of
Parameswaran Nair, Nibu; Chalmers, Leanne; Peterson, Gregory M; Bereznicki, Bonnie J; Castelino, Ronald L; Bereznicki, Luke R
Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related hospitalization. This review summarizes the available evidence on ADR-related hospital admission in older patients living in the community, with a particular focus on risk factors for ADRs leading to hospital admission and the need for a prediction tool for risk of ADR-related hospitalization in these individuals. The reported proportion of hospital admissions due to ADRs has ranged from 6% to 12% of all admissions in older patients. The main risk factors or predictors for ADR-related admissions were advanced age, polypharmacy, comorbidity, and potentially inappropriate medications. There is a clear need to design intervention strategies to prevent ADR-related hospitalization in older patients. To ensure the cost-effectiveness of such strategies, it would be necessary to target them to those older individuals who are at highest risk of ADR-related hospitalization. Currently, there are no validated tools to assess the risk of ADRs in primary care. There is a clear need to investigate the utility of tools to identify high-risk patients to target appropriate interventions toward prevention of ADR-related hospital admissions. PMID:27194906
Full Text Available Dragana Protić,1 Nada Vujasinović-Stupar,2 Zoran Bukumirić,3 Slavica Pavlov-Dolijanović,4 Snežana Baltić,5 Slavica Mutavdžin,6 Ljiljana Markovic-Denić,7 Marija Zdravković,8 Zoran Todorović1 1Department of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 2Department 2, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 3Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 4Department 5, Institute of Rheumatology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 5Department 5, Institute of Rheumatology, Belgrade, Serbia; 6Institute of Physiology “Rihard Burjan”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 7Institute of Epidemiology, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 8Department of Cardiology, Medical Center “Bežanijska kosa”, Faculty of Medicine, University of Belgrade, Belgrade, Serbia Background: Adverse drug reactions (ADRs have a significant impact on human health and health care costs. The aims of our study were to determine the profile of rheumatology patients willing to report ADRs and to identify bias in such a reporting system. Methods: Semi-intensive ADRs reporting system was used in our study. Patients willing to participate (N=261 completed the questionnaire designed for the purpose of the study at the hospital admission. They were subsequently classified into two groups according to their ability to identify whether they had experienced ADRs during the previous month. Group 1 included 214 out of 261 patients who were able to identify ADRs, and group 2 consisted of 43 out of 261 patients who were not able to identify ADRs in their recent medical history. Results: Group 1 patients were more significantly aware of their diagnosis than the patients from group 2. Marginal significance was found
Villerd, Jean; Toussaint, Yannick; Lillo Le-Louët, Agnès
International audience In this paper we discuss the problem of extracting and evaluating associations between drugs and adverse effects in pharmacovigilance data. Approaches proposed by the medical informatics community for mining one drug - one effect pairs perform an exhaustive search strategy that precludes from mining high-order associations. Some specificities of pharmacovigilance data prevent from applying pattern mining approaches proposed by the data mining community for similar pr...
Full Text Available Ranitidine hydrochloride is a widely used drug that is generally well-tolerated. Anaphylaxis is rarely observed with ranitidine. We report a case who developed severe anaphylaxis following single dose of intravenous ranitidine. The article highlights the importance of recognition of this serious adverse event and re-emphasizes the need for cautious use of drugs, especially in those with known history of allergy.
Full Text Available Introduction: The Wilson disease is an autosomal recessive disease in which the liver, central nervous system, eyes, blood and other parts of the body involved. Timely diagnosis and appropriate treatment of the disease requires awareness of the clinical presentations of this disease in children.Methods: This case series study included 62 patients with Wilson disease who admitted to children's Medical Center in the years 2012-2003.Results: 56% of patients were male. The average age of diagnosis was 9.73 years old (5-17 years and this was higher in patients with early neurologic symptoms (P = 0.85.( 64.5% of the patients had the hepatic symptoms at the time of diagnosis and the most common type of hepatic involvement was cirrhosis (39.3% and hepatitis (17.5% respectively. 17.7% of the patients also had early neurological symptoms. A positive family history for the Wilson Disease were found in 27.4% of patients. 74.2% of patients had KF ring and the frequency of these symptom was higher in patients with early neurological involvement. 83.9% of patients were treated successfully with D-penicillamine and In 30% of patients, adverse drug reactions were seen.Conclusion: Children with unknown liver disease should be evaluated for Wilson disease and the first-degree relatives of patients should be screened. . D-penicillamine have important side effects, but due to the low cost and the availability is an appropriate drug to treat the Wilson disease..Key words: Wilson Disease, Hepatic Involvement, Neurologic Involvement , KF ring ,D-Penicillamine.
Saheb Sharif-Askari, Fatemeh; Syed Sulaiman, Syed Azhar; Saheb Sharif-Askari, Narjes; Al Sayed Hussain, Ali
Background Adverse drug reactions (ADRs) represent a major burden on the healthcare system. Chronic kidney disease (CKD) patients are particularly vulnerable to ADRs because they are usually on multiple drug regimens, have multiple comorbidities, and because of alteration in their pharmacokinetics and pharmacodynamic parameters. Therefore, one step towards reducing this burden is to identify patients who are at increased risk of an ADR. Objective To develop a method of identifying CKD patients who are at increased risk for experiencing ADRs during hospitalisation. Materials and Methods Factors associated with ADRs were identified by using demographic, clinical and laboratory variables of patients with CKD stages 3 to 5 (estimated glomerular filtration rate, 10–59 ml/min/1.73 m2) who were admitted between January 1, 2012, and December 31, 2012, to the renal unit of Dubai Hospital. An ADR risk score was developed by constructing a series of logistic regression models. The overall model performance for sequential models was evaluated using Akaike Information Criterion for goodness of fit. Odd ratios of the variables retained in the best model were used to compute the risk scores. Results Of 512 patients (mean [SD] age, 60  years), 62 (12.1%) experienced an ADR during their hospitalisation. An ADR risk score included age 65 years or more, female sex, conservatively managed end-stage renal disease, vascular disease, serum level of C-reactive protein more than 10 mg/L, serum level of albumin less than 3.5 g/dL, and the use of 8 medications or more during hospitalization. The C statistic, which assesses the ability of the risk score to predict ADRs, was 0.838; 95% CI, 0.784–0.892). Conclusion A score using routinely available patient data can be used to identify CKD patients who are at increased risk of ADRs. PMID:24755778
Full Text Available Objectives: Adverse drug reactions (ADRs are an important cause of morbidity and mortality worldwide and generate high health costs. Therefore, the aims of this study were to determine the treatments which produce more ADRs in general population and the main symptoms they generate. Methods: An observational, cross-sectional study consisting in performing a self-rated questionnaire was carried out. 510 patients were asked about the treatments, illnesses and ADRs, they had suffered from. Results: 26.7% of patients had suffered from some ADR. Classifying patients according to the type of prescribed treatment and studying the number of ADR that they had, we obtained significant differences (p ≤ 0.05 for treatments against arthrosis, anemia and nervous disorders (anxiety, depression, insomnia. Moreover, determining absolute frequencies of these ADRs appearance in each treatment, higher frequencies were again for drugs against arthrosis (22.6% of patients treated for arthrosis suffered some ADR, anemia (14.28%, nerve disorders (13.44% and also asthma (16%. Regarding the symptoms produced by ADRs, the most frequent were gastrointestinal (60% of patients who suffered an ADR, had gastrointestinal symptoms and nervous alterations (dizziness, headache, sleep disturbances etc (24.6%. Conclusion: Therapeutic groups which produce more commonly ADRs are those for arthrosis, anemia, nervous disorders and asthma. In addition, symptoms which are generated more frequently are gastrointestinal and nervous problems. This is in accordance with the usual side effects of mentioned treatments. Health professionals should be informed about it, so that they would be more alert about a possible emergence of an ADR in these treatments. They also could provide enough information to empower patients and thus, they probably could detect ADR events. This would facilitate ADR detection and would avoid serious consequences generated to both patients' health and health economics.
Hedna, Khedidja; Hägg, Staffan; Andersson Sundell, Karolina; Petzold, Max; Hakkarainen, Katja M
PURPOSE: To assess refill adherence to dispensed oral long-term medications among the adult population and to investigate whether the percentages of self-reported adverse drug reactions (ADRs) and sub-therapeutic effects (STEs) differed for medications with adequate refill adherence, oversupply, and undersupply. METHOD: Survey responses on self-reported ADRs and STEs were linked to the Swedish Prescribed Drug Register in a cross-sectional population-based study. Refill adherence to antihypert...
S.M. Shareef; C. D. M. Naidu; Shrinivas R. Raikar; Y. Venkata Rao; U. Devika
Background: Adverse drug reactions (ADR) are the fourth leading cause of mortality and a great concern in therapeutics. Pharmacovigilance is more important in India as the health care system is inadequate with poor doctor-patient ratio, high incidence of self-medication, and presence of counterfeit drugs. The present study was conducted with the aim of analyzing the pattern of ADR occurring in a rural tertiary care hospital with a newly established pharmacovigilance center and to identify the...
Richa; V R Tandon; S Sharma; V Khajuria; Mahajan, V.; Z Gillani
Aim of Study: To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3-year period. Material and Methods: A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI). Results: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intraveno...
Waring, R H; Harris, R M; Hunter, J O; Mitchell, S C
The interactions between disease processes and the metabolism of therapeutic drugs have not been systematically investigated. Inflammation, with the presence of pro-inflammatory cytokines, affects Phase 1 metabolism, particularly the activity of the CYP isoforms. Inflammatory factors also alter the activity of some Phase 2 enzymes, particularly the sulphotransferases (SULT isoforms) responsible for drug sulphonation and the enzyme pathway involved in the supply of sulphate for this reaction. Being ill may, therefore, in itself make drug metabolism unpredictable. PMID:23176089
Meenakshi B.; Ezhil Ramya J.; Ananthy Shri T. R. R.
Background: Epilepsy is a clinical diagnosis made after a child has had two (or) more unprovoked seizures. Ideal goal in the management of childhood epilepsy is complete control with minimal side effects. The incidence of adverse effects is an important issue with antiepileptic drugs (AEDs). We took up this study to analyse the pattern of AEDs prescribed and adverse drug reaction (ADR) profile in children with epilepsy being treated at a tertiary care Teaching hospital of South Tamil Nadu. ...
Full Text Available Introduction: Adverse drug reactions (ADRs are threat to the patient’s safety and the quality of life, and they increase the cost of health care. Spontaneous ADR reporting system mainly relies on physicians, but also pharmacists, nurses, and even patients. The aim of this study was to explore attitudes, barriers, and possible improvements to ADR reporting practices in Bosnia and Herzegovina.Methods: A self-reported questionnaire was developed to collect data on the perception of pharmacovigilance practice and ADR reporting. The survey was conducted in the period between September, 2014 and October, 2014.Results: The response rate was 73% (44 of 60 and 93% (148 of 160 among the pharmacist and family medicine physician groups, respectively. Regarding the attitudes to pharmacovigilance practice and reporting, both the pharmacists and physicians found the practices important. The majority of pharmacists and physicians in year 2014 did not report any ADR, while 18% of the pharmacists and 12% of the physicians, who participated in this study, reported one ADR. Reporting procedure, uncertainty, and their exposure were the main barriers to reporting ADRs for the pharmacists. The physicians claimed lack of knowledge to whom to report an ADR as the main barrier. A significant number of the respondents thought that additional education in ADR reporting would have a positive impact, and would increase the ADR reporting rate.Conclusions: Despite the overall positive attitude towards ADR reporting, the reporting rate in Bosnia and Herzegovina is still low. Different barriers to the ADR reporting have been identified, and there is also the need for improvements in the traditional education in this field.
Full Text Available Adverse reaction to cosmetics constitute a small but significant number of cases of contact dermatitis with varied appearances. These can present as contact allergic dermatitis, photodermatitis, contact irritant dermatitis, contact urticaria, hypopigmentation, hyperpigmentotion or depigmentation, hair and nail breakage. Fifty patients were included for the study to assess the role of commonly used cosmetics in causing adverse reactions. It was found that hair dyes, lipsticks and surprisingly shaving creams caused more reaction as compared to other cosmetics. Overall incidence of contact allergic dermatitis seen was 3.3% with patients own cosmetics. Patch testing was also done with the basic ingredients and showed positive results in few cases where casual link could be established. It is recommended that labeling of the cosmetics should be done to help the dermatologists and the patients to identify the causative allergen in cosmetic preparation.
Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin
Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure-activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. PMID:25576362
Kenneth A Agu
Full Text Available Aim: This study evaluated the suspected adverse drug reactions (ADR reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV positive patients receiving antiretroviral therapy (ART in Nigeria Materials and Methods: This descriptive study analyzed individual case safety reports (ICSRs in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. All ICSRs during this period were included. Chi-square was used to test the association between variables at 95% confidence interval. Results: From 1237 ICSRs collated, only 1119 (90.5% were valid for analysis. Mean age of patients was 35.3 (95%CI, 35.1-35.5 years; and 67.1% were females. A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD of 1.5 (± 0.8 ADR cases per patient. Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. The commonest ADRs included (12.0% peripheral neuropathy, (11.4% skin rash, (10.1% pruritus and (6.5% dizziness. ADR occurrence was associated with ART regimens, concomitant medicines and age (P < 0.05 unlike gender. Anaemia was associated with Zidovudine (AZT/ Lamivudine (3TC /Nevirapine (NEV regimen [Odds ratio, OR = 6.4 (3.0-13.8; P < 0.0001], and peripheral neuropathy with Stavudine (d4T/3TC/NEV regimen [OR = 8.7 (5.8-30.0, P < 0.0001] and Tenofovir (TDF/Emtricitabine (FTC/Efavirenz (EFV regimen [OR = 2.1 (1.0-4.1, P = 0.0446]. Skin rash and peripheral neuropathy were associated with patients aged < 15years [OR = 3.0 (1.3-6.6, P = 0.0056] and 45-59years [OR = 1.9 (1.3-2.7, P = 0.0006] respectively. Palpitation and polyuria were associated with Salbutamol [OR = 55.7 (4.9-349.6, P = 0.0000] and Nonsteroidal anti-inflammatory drugs (NSAIDS [OR = 50.2 (0.9-562.1, P = 0.0040] respectively. Conclusion: ADRs were less likely to occur in patients on stavudine-based and tenofovir-based regimens compared to
Anshu Kumar Jha
Full Text Available Context: The advancement and development of new drugs and treatment strategies increase the risk of unusual Adverse Events (AEs in HIV patients. Aims: The objective of our study was to assess the incidence, types and nature of AEs in HIV positive subjects. Settings and Design: Patients with WHO stage IV disease irrespective of the CD4 cell count, or WHO stage III disease with a CD4 cell count <350 cell/cu. Mm, or, WHO stage I or II disease with a CD4 cell count of <200 cells/cu. mm, and on prior anti-retroviral therapy for not more than six months preceding the observation date, were included in the study. After initiation of therapy, the patients were examined for the occurrence any adverse events including the type and severity, or any other abnormal laboratory findings. Causality assessment of the adverse events was done using the Naranjo′s scale. Results: Out of 327 patients studied prospectively, 43 patients developed AEs. Out of these, 23 (53.5% were males and 20 (46.5% were females. A total of 53 (16.21% AEs were reported. Antitubercular drugs caused the maximum AEs (28.3% followed by zidovudine (20.7%, nevirapine (15.0% and efavirenz (5.6%. Stavudine, ethambutol, sulfamethoxazole and trimethoprim, and atazanavir were also responsible for 3.7% of AEs individually. Causality assessment done according to the Naranjo′s scale revealed that 66.04% AEs were ′probable′ and 33.96% were ′possible′. Conclusions: Anemia, hepatitis and dermatological adverse effects are the most common AEs. Antitubercular drugs contributed significantly for the incidence of AEs in these patients. Frequency of AEs was slightly more in males compared to females.
Wen SHI; Yong-ming WANG; Shao-li LI; Min YAN; Duan Li; Bin-yah CHEN; Neng-neng CHENG
AIM: The study was to screen the possible risk factors of adverse drug reaction (ADR) induced by non-steroidal anti-inflammatory drugs (NSAIDs) in Shanghai patients with arthropathy. METHODS: The subjects were randomly selected from a database of outpatients with arthropathy from 9 main hospitals in Shanghai. A door to door retrospective epidemiological survey was used to collect demographic information about the patients, both individual and familial. This included data on their medical histories, lifestyle and dietary habits, history of smoking and alcohol consumption, history of drug therapy, quality of life (QOL) prior to NSAIDs intake, history of NSAIDs therapy and its ADR events, etc. Descriptive statistical methods and univariate analysis were also used to identify possible risk factors for ADRs induced by NSAIDs. RESULTS: Of the 1002 patients surveyed, the average length of NSAIDs intake was 2 years. ADR incidence from different NSAIDs was high, in a range from 46.7 %-66.2 %.In general, the candidate risk factors for ADRs were different for each NSAID. Each of the candidate risk factors were defined and studied in order to evaluate its role in the determination of ADRs from NSAIDs. "Family history of ADRs caused by NSAIDs" was found to be a significant risk factor for the four commonly used NSAIDs:meloxicam, diclofenac, nimesulide, and nabumetone. CONCLUSION: A retrospective epidemiological survey was useful in detecting the risk factors for ADRs caused by NSAIDs. The study found that different NSAIDs might have different risk factors and that there is no single risk factor universally applicable to all NSAIDs.
Mohammad Reza Rafati
Full Text Available , (Received 16 May, 2009 ; Accepted 8 July, 2009AbstractBackground and purpose: Adverse drug reactions (ADRs are one of the leading causes of morbidity and mortality, worldwide. Mortality rate due to ADRs are ahead of pulmonary disease, AIDS, pneumonia and automobile accidents. This study evaluated the admission rates in a University teaching hospital related to ADRs.Materials and methods: During this retrospective study between 2001 and 2007, all patients admitted due to adverse drug reaction in Sari Bo-Ali Sina Hospital were evaluated.Results: In these years, 31 patients out of 71,680 were admitted, due to ADRs. Most common ADRs were skin reaction (74% and fever (22%. Phenobarbital and penicillin were the most common drugs causing ADRs.Conclusion: Only 0.04% of hospital admissions were drug related, while reported admission due to ADRs in other countries were 2.4 to 6.2%. It appears that less drug-depended hospital admissions in Iran rational drug administration, but are due to lack of enough detection, records and reporting procedures.J Mazand Univ Med Sci 2009; 19(71: 67-70 (Persian.
Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development
Wang, Kejian, E-mail: firstname.lastname@example.org [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Weng, Zuquan [Japan National Institute of Occupational Safety and Health, Kawasaki (Japan); Sun, Liya [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Sun, Jiazhi; Zhou, Shu-Feng [Department of Pharmaceutical Sciences, College of Pharmacy, University of South Florida, Tampa, FL (United States); He, Lin, E-mail: helin@Bio-X.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China)
Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.
Full text. An adverse reaction can occur following administration of a radio pharmaceutical, but fortunately reactions are uncommon. They are usually mild and do not require intensive treatment. This is probably related to the fact that only small chemical quantities of material are administered to patients and that only one or a small number of doses are administered. Since symptoms are unrelated to any known pharmacology of the agents, they can be described as Type B reactions according to the classification of Rawlings and Thompson. Types of reaction that occur and possible mechanisms will be described. The reactions most commonly observed are skin rashes and vasomotor symptoms. It is important that, as far as possible, a cause - effect relationship can be established between the administration of the radio pharmaceutical and the symptoms caused. Some classification schemes therefore exclude vasomotor reactions such as hypotension and slow pulse, since such events can arise in a variety of clinical situations unrelated to radio pharmaceutical administration. It is important for nuclear medicine departments to be aware of the nature of reactions such that they can be recognized and appropriate re-assurance and/or prompt treatment can be given to their patients. Radio pharmaceuticals most frequently mentioned in reporting schemes are di phosphonates used for bone imaging. This probably reflect the fact that these agents are the most frequently used in current practice rather than that they cause more reactions. Problems in establishing the overall frequency of adverse reactions to radio pharmaceuticals include the fact that events may not be recognized if they occur after the patient has left the Nuclear Medicine Department and that reactions are never reported. Two recent studies have attempted to obtain more definitive information by performing prospective studies in a large number of departments. A study in the USA found that there was a rate of 2.3 events per
李青; 张素敏; 陈华庭; 方世平; 于星; 刘东; 施侣元; 曾繁典
Background A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.Methods Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.Results The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22.8% of nurses, and 29.7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs, yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67.9%), unavailability of the ADR
Ozcan, Gulnihal; Aykac, Emel; KASAP, Yelda; Nemutlu, Nergiz T.; Sen, Ebru; Aydinkarahaliloglu, N. Demet
Introduction 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. Objective In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. Methods We analysed ADR reports submitted to the Turkish Pharmac...
Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise; Jensen, Lars Juhl; Brunak, Søren; Krag, Malene Hammer; Rossing, Peter; Almdal, Thomas; Andersen, Henrik Ullits; Hansen, Ebba Holme
Objective: Through manual review of clinical notes for patients with type 2 diabetes mellitus attending a Danish diabetes center, the aim of the study was to identify adverse drug reactions (ADRs) associated with three classes of glucose-lowering medicines: "Combinations of oral blood-glucose lowering medicines" (A10BD), "dipeptidyl peptidase-4 (DDP-4) inhibitors" (A10BH), and "other blood glucose lowering medicines" (A10BX). Specifically, we aimed to describe the potential of clinical notes ...
Het B Upadhyaya; Vora, Mukeshkumar B.; Jatin G Nagar; Patel, Pruthvish B.
Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR). Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP) toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Guj...
He Ping; Yang Li; Chen Da; Wang Hong; Gao Wei; Zhu Li; Zhou Lin; Chen Yi; Tu,, Y.; Yuan Yan; Wang Xiao; Liu Fei; Hu Dai; Xia Yin; Li Xiao
Abstract Background More than 1 million tuberculosis (TB) patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS) in China every year. Adverse reactions (ADRs) induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Metho...
Shimwela, Grace Mng’ong’o
Under reporting of adverse drug reactions (ADRs) by healthcare personnel is a common problem of many Pharmacovigilence programs. Lack of involvement of healthcare professionals such as pharmacists and other pharmaceutical dispensers has been cited as one of the reasons for under reporting. Pharmaceutical dispensers in the community pharmacies are in unique position by virtue of their training and profession to observe ADRs in patients, as many patients often try to avoid doctor consultation f...
Parameswaran Nair, Nibu
Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related...
Parameswaran Nair N; Chalmers L; Peterson GM; Bereznicki BJ; Castelino RL; Bereznicki LR
Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related...
Joseph O. Fadare
Full Text Available Background: Epilepsy is a chronic neurological disorder requiring long-term treatment. Seizure control requires adequate blood levels of anti-seizure drugs. Carbarmazepine is one of the most prescribed antiepileptic drugs in Nigeria. This study was carried out to investigate the correlation between serum levels of carbamazepine and seizure control and adverse drug reactions among epileptics in Ibadan, Nigeria. Methods: In a cross-sectional study, sixty-nine patients with confirmed diagnosis of epilepsy who had been on treatment with carbamazepine alone or in combination with phenytoin for at least one month were enrolled into the study and divided into two groups based on seizure control. Drug level in pre-dose (steady state venous blood was analyzed using high performance liquid chromatography. Result: The mean serum concentration of carbamazepine (CBZ and carbamazepine-epoxide (CBZ-EP was 13.5±9.3ìg/mL and 6.34±12.61ìg/mL respectively. Patients with good seizure control had mean serum CBZ concentration of 12.7 ± 9.2ìg/mL versus 15.02 ± 9.7ìg/mL among patients with poor seizure control (P=0.33. The serum concentration of CBZ-EP in patients with good seizure control was 8.05 ± 15.2ìg/mL while it was 3.11 ± 3.5ìg/mL in the second group (P=0.122. Drowsiness was the commonest adverse drug reaction (26.1% and it did not necessitate withdrawal of the drug. Conclusion The study showed that serum level of carbamazepine does not correlate with seizure control and adverse drug reactions.
Wang, Zhi-Fei; Xiang, Yong-Yang; Xie, Yan-Ming
This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. The article found that Xiyanping's incidence rate of erythra was higher than for background-drugs in every year and in every season. Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety. PMID:24471321
Full Text Available Background: The prevalence, clinical patterns, and causative drugs of cutaneous adverse drug reactions (cADR vary among the different populations previously studied. Aim: To determine the prevalence, the clinical patterns of drug eruptions, and the common drugs implicated, particularly in severe cADR such as Stevens-Johnson Syndrome/Toxic epidermal necrolysis (SJS/TEN and drug rash with eosinophilia and systemic symptoms (DRESS in our population. Methods: We analyzed the database established for all cADR seen by the department of Dermatology from January 2001 till December 2010. Results: A total of 362 cADR were seen among 42 170 new clinic attendees, yielding an incidence rate of 0.86%. The most common reaction pattern seen was maculopapular eruption (153 cases followed by SJS/TEN (110 cases and DRESS (34 cases. Antibiotics was the most commonly implicated drug group (146 cases followed by anticonvulsants (81 cases and antigout drugs (50 cases. The most frequently implicated drug was allopurinol (50 cases. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN accounting for 21.8%, 20.9%, and 12.7%, respectively, of the 110 cases seen, whereas DRESS was mainly caused by allopurinol (15 cases. Mortality rates for TEN, SJS, and DRESS were 28.6%, 2.2%, and 5.9%, respectively Conclusions: The low rate of cADR with a high proportion of severe reactions observed in this study was probably due to referral bias. Otherwise, the reaction patterns and drugs causing cADR in our population were similar to those seen in other countries. Carbamazepine, allopurinol, and cotrimoxazole were the three main causative drugs of SJS/TEN in our population.
Elzagallaai, Abdelbaset A; Rieder, Michael J
Idiosyncratic drug reactions (IDRs) represent a major health problem, as they are unpredictable, often severe and can be life threatening. The low incidence of IDRs makes their detection during drug development stages very difficult causing many post-marketing drug withdrawals and black box warnings. The fact that IDRs are always not predictable based on the drug's known pharmacology and have no clear dose-effect relationship with the culprit drug renders diagnosis of IDRs very challenging, if not impossible, without the aid of a reliable diagnostic test. The drug provocation test (DPT) is considered the gold standard for diagnosis of IDRs but it is not always safe to perform on patients. In vitro tests have the advantage of bearing no potential harm to patients. However, available in vitro tests are not commonly used clinically because of lack of validation and their complex and expensive procedures. This review discusses the current role of in vitro diagnostic testing for diagnosis of IDRs and gives a brief account of their technical and mechanistic aspects. Advantages, disadvantages and major challenges that prevent these tests from becoming mainstream diagnostic tools are also discussed here. PMID:25199801
Ana Wládia Lima
Full Text Available INTRODUCTION: The Global Programme to Eliminate Lymphatic Filariasis was launched with the goal of eliminating this disease via the annual mass drug administration (MDA of a single dose of antifilarial drugs. Adverse drug reactions following MDA are a major factor of poor treatment adherence in several countries. This study assessed the occurrence of adverse drug reactions (ADRs following the first round of mass treatment in two communities treated with different dosages of diethylcarbamazine (DEC in the City of Recife, Brazil. METHODS: Population-based cross-sectional surveys were conducted in a random sample of the population living in both communities (Areas I and II. The dose of DEC recommended by the WHO (6mg/kg was calculated based on the individual's weight-for-age. In Area II, weight differences between the genders were also considered when determining dosage. Data were obtained through interviews conducted in the first 12 to 48h and on the 5th day after MDA during household visits. RESULTS: A total of 487 and 365 individuals were interviewed in Areas I and II, respectively. The prevalence of ADRs in Area I (23.6; 95%CI: 19.1-29.5 was higher than in Area II (16.2; 95%CI:11.9-21.5(p=0.0078. The prevalence of ADRs among females was higher than in males in Area I (p=0.0021. In Area II, no significant difference between the genders was observed (p=0.1840. Age was not associated with ADRs in either area. CONCLUSIONS: Adjusting MDA dosage schedules according to weight-for-age and sex may be may contribute to reduce the occurrence of adverse drug reactions in the population.
Wolverton, Stephen E
The term "drug reactions" is relevant to dermatology in three categories of reactions: cutaneous drug reactions without systemic features, cutaneous drug reactions with systemic features, and systemic drugs prescribed by the dermatologist with systematic adverse effects. This article uses examples from each of these categories to illustrate several important principles central to drug reaction diagnosis and management. The information presented will help clinicians attain the highest possible level of certainty before making clinical decisions. PMID:27363888
purpose: to understand adverse drug reactions in our hospital (Adverse Drug Reaction) the incidence and relevant factors, provide reference for rational drug use, avoid the occurrence of adverse drug reactions. Methods: 251 cases on our 2011 colection statistics, analysis of ADR reports. Results 251 cases ADR report total involved 16 class drugs, vein drops note is caused ADR of main to drug way (201 cases); antibiotics occurred rate Supreme (142 cases), second is proprietary Chinese medicines (28 cases), and antipyretic analgesia drug (20 cases), and anti-tumor drug (16 cases), and effect blood and hematopoietic system of drug (12 cases); clinical performance main for skin and damage (99 cases), accounted for 39.44%, digestive system of of damage (75 cases) accounted for 29.88%. Conclusion: ADR is related to many factors relevant to clinical ADR monitoring work should be strengthened to reduce or avoid the occurrence of ADR.
Use of HMG-CoA reductase inhibitors in treating hypercholesterolemia is a well-established therapy.Presently,atorvastatin,fluvastatin,lovastatin,simvastatin and pravastatin are used clinically.Cerivastatin was pulled from the market in 2001 due to its higher risk of inducing rhabdomyolysis than all other drugs.Hepatotoxicity and rhabdomyolysis are the known adverse reactions by these drugs.However,the hepatotoxicity has been regarded to be mild,and is now referred to as transaminitis.Rhadomyolysis occurs in rare instances but is sometimes life threatening as a result of renal failure caused by myoglobinemia.The mechanism leading to rhabdomyolysis is unknown but in many of the reported cases,increased plasma concentratinos of thes drugs have been observed,most likely as a consequence of drug interaction.Inhibition of CYP 3A4 and UGT is believed to be the reason for this interaction.
Full Text Available AIM: To study the different clinical spectrum of cutaneous adverse drug reactions (ADR and to determine the causative drugs. MATERIALS & METHODS: A prospective, hospital based study was carried out over a period of 6 years recording various cutaneous ADR. RESULTS: A total of 500 patients with cutaneous ADR were enrolled in the study. The most common types of cutaneous ADR patterns were maculopapular rash (34.6%, fixed drug eruption (FDE (30% and urticaria (14%. The drugs most often incriminated for the various cutaneous ADR were antimicrobials (42.6%, anticonvulsants (22.2% and NSAIDs (18%. Anticonvulsants were implicated in 41.6% of maculopapular rashes. Sulfonamides accounted for 43.3% and NSAIDs for 30.7% of FDE. Urticaria was caused mainly by NSAIDs(24.3% and penicillins(20%. Anticonvulsants were responsible for 43.8% of life-threatening toxic epidermal necrolysis and Stevens Johnson syndrome. CONCLUSIONS: The clinical pattern and drugs causing cutaneous ADR are similar to those observed in other countries except for minor variations. Cutaneous ADR patterns and the drugs causing various reactions are changing every year, which may be due to the emergence of newer molecules and changing trends in the use of drugs.
Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified
Pan, Jian-Bo [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Nan; Pan, Wen; Hong, Ru [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Wang, Hao [Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China); Ji, Zhi-Liang, E-mail: email@example.com [State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian 361102 (China); Department of Chemical Biology, College of Chemistry and Chemical Engineering, The Key Laboratory for Chemical Biology of Fujian Province, Xiamen University, Xiamen, Fujian 361005 (China)
Drugs may induce adverse drug reactions (ADRs) when they unexpectedly bind to proteins other than their therapeutic targets. Identification of these undesired protein binding partners, called off-targets, can facilitate toxicity assessment in the early stages of drug development. In this study, a computational framework was introduced for the exploration of idiosyncratic mechanisms underlying analgesic-induced severe adverse drug reactions (SADRs). The putative analgesic-target interactions were predicted by performing reverse docking of analgesics or their active metabolites against human/mammal protein structures in a high-throughput manner. Subsequently, bioinformatics analyses were undertaken to identify ADR-associated proteins (ADRAPs) and pathways. Using the pathways and ADRAPs that this analysis identified, the mechanisms of SADRs such as cardiac disorders were explored. For instance, 53 putative ADRAPs and 24 pathways were linked with cardiac disorders, of which 10 ADRAPs were confirmed by previous experiments. Moreover, it was inferred that pathways such as base excision repair, glycolysis/glyconeogenesis, ErbB signaling, calcium signaling, and phosphatidyl inositol signaling likely play pivotal roles in drug-induced cardiac disorders. In conclusion, our framework offers an opportunity to globally understand SADRs at the molecular level, which has been difficult to realize through experiments. It also provides some valuable clues for drug repurposing. - Highlights: • A novel computational framework was developed for mechanistic study of SADRs. • Off-targets of drugs were identified in large scale and in a high-throughput manner. • SADRs like cardiac disorders were systematically explored in molecular networks. • A number of ADR-associated proteins were identified.
Full Text Available The aim of this study was to assess the extent of poly-pharmacy, occurrence, and associated factors for the occurrence of drug-drug interaction (DDI and potential adverse drug reaction (ADR in Gondar University Teaching Referral Hospital. Institutional-based retrospective cross-sectional study. This study was conducted on prescriptions of both in and out-patients for a period of 3 months at Gondar University Hospital. Both bivariate analysis and multivariate logistic regression were used to identify risk factors for the occurrence of DDI and possible ADRs. All the statistical calculations were performed using SPSS; software. A total of 12,334 prescriptions were dispensed during the study period of which, 2,180 prescriptions were containing two or more drugs per prescription. A total of 21,210 drugs were prescribed and the average number of drugs per prescription was 1.72. Occurrences of DDI of all categories (Major, Moderate, and Minor were analyzed and DDI were detected in 711 (32.6% prescriptions. Sex was not found to be a risk factor for the occurrence of DDI and ADR, while age and number of medications per prescription were found to be significant risk factors for the occurrence of DDI and ADR. The mean number of drugs per prescription was 1.72 and hence with regard to the WHO limit of drugs per prescription, Gondar hospital was able to maintain the limit and prescriptions containing multiple drugs supposed to be taken systemically. Numbers of drugs per prescription as well as older age were found to be predisposing factors for the occurrence of DDI and potential ADRs while sex was not a risk factor.
Simon, Ronald A
Aspirin-exacerbated respiratory disease (AERD) is an adult-onset condition that manifests as asthma, rhinosinusitis/nasal polyps, and sensitivity to aspirin and other cyclooxygenase-1 (COX-1)-inhibitor nonsteroidal anti-inflammatory drugs (NSAIDs). There is no cross-sensitivity to highly selective COX-2 inhibitors. AERD is chronic and does not improve with avoidance of COX-1 inhibitors. The diagnosis of AERD is made through provocative challenge testing. Following a positive aspirin challenge, patients can be desensitized to aspirin and NSAIDs. The desensitized state can be maintained indefinitely with continued daily administration. After desensitization, there is an approximately 48-hour refractory period to adverse effects from aspirin. The pathogenesis of AERD remains unknown, but these patients have been shown to have multiple abnormalities in arachidonic acid metabolism and in cysteinyl leukotriene 1 receptors. AERD patients can take up to 650 mg of acetaminophen for analgesic or antipyretic relief. Patients can also use weak COX-1 inhibitors, such as sodium salicylate or choline magnesium trisalicylate. Treatment of AERD patients with antileukotriene medications has been helpful but not preferential when compared with non-AERD patients. An alternative treatment for many AERD patients is aspirin desensitization. This is particularly effective in reducing upper-airway mucosal congestion, nasal polyp formation, and systemic steroids. PMID:14680616
Stepaniuk, N. H.; Hladkykh, F. V.; Basarab, O. V.
The problem of medicines rational use exists all over the world. It concerns particularly analgesics, antipyretics and non-steroidal anti-inflammatory drugs (NSAIDs). In Ukraine the side effects caused by non-steroidal antiphlogistics rank the second place according to the prevalence among all registered cases.The objective of the research was to analyze adverse drug reaction report forms concerning adverse reactions caused by the use of NSAIDs, analgesics, antipyretics, and were submitted du...
Full Text Available Purpose: Studies regarding pattern of adverse drug reactions (ADRs in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions. Materials and Methods: This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO causality assessment scale and Naranjo′s algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively. Results: Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%, nausea/vomiting (21.6% and febrile neutropenia (13%. Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be "probable" and 35% to be "possible," while Naranjo′s algorithm indicated that 65.6% of ADRs were "probable" and 34.4% were "possible". Modified Hartwig and Siegel scale showed most reactions (41.4% to be of "moderate level 4(a" severity, while 30.6% of reactions were of "mild level 1" severity. About 30.8% of the ADRs were "definitely preventable" according to the modified Schumock and Thornton scale. Conclusion: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased.
Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme
Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information. PMID:25505588
Full Text Available Snežana Mugoša,1,2 Nataša Djordjević,3 Nina Djukanović,4 Dragana Protić,5 Zoran Bukumirić,6 Ivan Radosavljević,7 Aneta Bošković,8 Zoran Todorović5,9 1Department of Pharmacotherapy, Faculty of Pharmacy, University of Montenegro, 2Clinical Trial Department, Agency for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro; 3Department of Pharmacology and Toxicology, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, 4High Medical School “Milutin Milanković”, Belgrade, 5Department of Pharmacology, Clinical Pharmacology and Toxicology, 6Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, 7Department of Surgery, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia; 8Clinic for Heart Diseases, Clinical Centre of Montenegro, Podgorica, Montenegro; 9Department of Clinical Immunology and Allergy, Medical Center “Bežanijska kosa”, Belgrade, Serbia Abstract: The aim of the present study was to undertake a study on the prevalence of cytochrome P450 2D6 (CYP2D6 poor metabolizer alleles (*3, *4, *5, and *6 on a Montenegrin population and its impact on developing adverse drug reactions (ADRs of β-blockers in a hospitalized cardiac patient population. A prospective study was conducted in the Cardiology Center of the Clinical Center of Montenegro and included 138 patients who had received any β-blocker in their therapy. ADRs were collected using a specially designed questionnaire, based on the symptom list and any signs that could point to eventual ADRs. Data from patients’ medical charts, laboratory tests, and other available parameters were observed and combined with the data from the questionnaire. ADRs to β-blockers were observed in 15 (10.9% patients. There was a statistically significant difference in the frequency of ADRs in relation to genetically determined enzymatic activity (P<0.001, with ADRs’ occurrence significantly
Nicolini, A; Perazzo, A; Gatto, P; Piroddi, I M G; Barlascini, C; Karamichali, S; Strada, P
Anti-tuberculosis drugs seldom cause serious haematological side effects. However, among these drugs, isoniazid and rifampicin, especially when administered intermittently, may very rarely be linked to acute autoimmune haemolytic anaemia. Ethambutol (EMB) can cause dose-related retrobulbar neuritis. In this paper, we present the first reported case of acute fatal autoimmune haemolytic anaemia due to EMB. PMID:27084828
Christensen, Søren Troels; Søndergaard, Birthe; Honoré, Per Hartvig;
of pharmacists in ADR reporting, although varies significantly among countries. Pharmacists in community pharmacies are in a unique position for detection of experienced ADRs by the drug users. The study reports from a study on community pharmacy internship students' proactive role in ADR detection through...... direct encountering and questioning with drug users. METHOD: Pharmacy students undertaking internship in a community pharmacy were approached. Thirteen students from nine community pharmacies participated in the project as data collectors. Prior to the study students attended an educational seminar...... focusing on ADR detection and reporting in general. Ibuprofen was chosen as the drug of study. Pharmacy students approached recurrent drug users purchasing the drug. Participating users were asked about experienced ADRs linked to ibuprofen use. Reported ADRs were collected and analysed. RESULTS: Hundred...
Conclusion : Development of ADR in one of every five cardiac patient points toward a grave situation, but a higher incidence of Type A reactions in cardiology department means that these can be avoided.
Parameswaran Nair N
Full Text Available Nibu Parameswaran Nair, Leanne Chalmers, Gregory M Peterson, Bonnie J Bereznicki, Ronald L Castelino, Luke R Bereznicki Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Hobart, TAS, Australia Abstract: Adverse drug reactions (ADRs represent a major burden on society, resulting in significant morbidity, mortality, and health care costs. Older patients living in the community are particularly susceptible to ADRs, and are at an increased risk of ADR-related hospitalization. This review summarizes the available evidence on ADR-related hospital admission in older patients living in the community, with a particular focus on risk factors for ADRs leading to hospital admission and the need for a prediction tool for risk of ADR-related hospitalization in these individuals. The reported proportion of hospital admissions due to ADRs has ranged from 6% to 12% of all admissions in older patients. The main risk factors or predictors for ADR-related admissions were advanced age, polypharmacy, comorbidity, and potentially inappropriate medications. There is a clear need to design intervention strategies to prevent ADR-related hospitalization in older patients. To ensure the cost-effectiveness of such strategies, it would be necessary to target them to those older individuals who are at highest risk of ADR-related hospitalization. Currently, there are no validated tools to assess the risk of ADRs in primary care. There is a clear need to investigate the utility of tools to identify high-risk patients to target appropriate interventions toward prevention of ADR-related hospital admissions. Keywords: adverse drug reactions, hospital admission, prediction, older patients, primary care, risk factors
... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Adverse reaction file. 606.170 Section 606.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse...
de Heus, R.; Mol, B.W.; Erwich, J.J.H.M.; van Geijn, H.P.; Gyselaers, W.J.; Hanssens, M.; Harmark, L.; van Holsbeke, C.D.; Duvekot, J.J.; Schobben, F.F.A.M.; Wolf, Hans; Visser, G.H.A.
Objective To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. Design Prospective cohort study. Setting 28 hospitals in the Netherlands and Belgium. Participants 1920 consecutive women
R. de Heus; B.W. Mol; J.J.H.M. Erwich; H.P. van Geijn; W.J. Gyselaers; M. Hanssens; L. Härmark; C.D. van Holsbeke; J.J. Duvekot; F.F.A.M. Schobben; H. Wolf; G.H.A. Visser
Objective To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. Design Prospective cohort study. Setting 28 hospitals in the Netherlands and Belgium. Participants 1920 consecutive women
Heus, R.; Mol, B.W.; Erwich, J.J.; Geijn, van H.; Gyselaers, W.J.; Hanssens, M.; Harmark, L.; Holsbeke, van C.D.; Duvekot, J.J.; Schobben, F.F.; Wolf, de H.; Visser, G.H.A.
OBJECTIVE: To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. DESIGN: Prospective cohort study. SETTING: 28 hospitals in the Netherlands and Belgium. PARTICIPANTS: 1920 consecutive w
Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to the increased hospital stay. The reporting of ADRs to regional pharmacovigilance centres should be encouraged to ensure drug safety. [Int J Basic Clin Pharmacol 2016; 5(1.000: 209-212
Dr.Mukeshkumar B Vora
Full Text Available Purpose: Adverse drug reactions (ADRs are adverse consequences of drug therapy. ADRs are representing a major concern of health systems in terms of early recognition, proper management and prevention. Under reporting of Adverse Drug Reactions (ADRs is a common problem in Pharmacovigilance programs. Poor perceptions of doctors about ADRs and risk management have contributed to high rate of ADR under-reporting in India. Underreporting has also been attributed to lack of time to doctor, misconceptions about spontaneous reporting and lack of information on how to report, where to report and a lack of availability of report forms, and also physicians' attitudes to ADRs. The objective of our study was to evaluate the knowledge, attitude and practices (KAP of health care professional towards Pharmacovigilance and adverse drug reactions in a tertiary care hospital, Bhavnagar, Gujarat, India. Methods: A cross-sectional questionnaires based study was carried out in Post graduate students and faculties of tertiary care hospital attached with Govt. Medical College, Bhavnagar, Gujarat. Post graduate students and faculties of different clinical subjects working in the tertiary care teaching hospital, Bhavnagar, Gujarat (India were enrolled and present throughout in study. 22 questionnaires about knowledge, attitude and practices towards ADRs and Pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from Pharmacology department. We were contacted directly to post graduate students and faculties of respective clinical department, questionnaires were distributed, 30 minutes time given to filled form. Any clarification and extra time was needed, provided to them. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft excel spread sheet and online statistical software. Results: In study, postgraduate residents (n=81 and faculties (n=63 from different clinical
López Lois, G; Gómez Carrasco, J A; García de Frías, E
We present a case of a 7 years old girl who developed an episode of myoclonic movements and tremors after being medicated with a not well quantified amount of a pseudoephedrine/antihistamine combination. We want to highlight the potential toxicity of pseudoephedrine, usually administered as part of cold-syrup preparations which are used for symptomatic treatment of upper respiratory tract cough and congestion associated with the common cold and allergic rhinitis. Although these products are generally considered to be safe either by physicians and parents, we can't underestimate the potential adverse events and toxic effects that can occur when administering these medications. PMID:15826569
Full Text Available La tuberculosis multidrogorresistente (TBMDR plantea dificultades diagnósticas y terapéuticas; entre ellas, la mayor frecuencia de reacciones adversas a fármacos antituberculosos (RAFAs, que comprometen la eficacia del tratamiento. Más complicado es el panorama del tratamiento en pacientes con la coinfección HIV a los que a la terapia antirretroviral se suma el de las eventuales comorbilidades. Se estudiaron retrospectivamente 121 pacientes: 87 HIV negativos y 34 HIV positivos con TBMDR asistidos en el Hospital F. J. Muñiz en el período 2003-2007, comparándose la incidencia de reacciones adversas entre ambas poblaciones. Fueron incluidos todos los pacientes con adherencia al tratamiento (no más de un abandono recuperado. Los fármacos antituberculosos empleados fueron: etambutol, pirazinamida, ofloxacina, moxifloxacina, cicloserina, etionamida, PAS, estreptomicina, kanamicina, amikacina y linezolid. La aparición de RAFAs así como la proporción de reacciones graves atribuidas a drogas antituberculosas fue similar en los dos grupos (44.8% en HIV negativos y 44.1% en HIV positivos, a quienes se agregó un 23.5% adicional de RAFAs por el tratamiento antirretroviral. Se observaron algunas diferencias en el tipo de reacciones y en el momento de aparición. Un paciente HIV positivo falleció debido a epidermolisis. La proporción de reacciones adversas en HIV/sida aumentó un 50% al considerar también las atribuidas al tratamiento antirretroviral. Se concluye que la población estudiada presentó RAFAs por encima de lo esperable en tuberculosis sensible, pero no se observaron diferencias en la frecuencia de aparición entre pacientes HIV negativos y positivos.Multidrug-resistant tuberculosis (MDRTB poses difficulties in diagnosis and treatment, including increased frequency of adverse reactions to antituberculosis drugs (ADRAs, which compromise the effectiveness of treatment. This is specially complicated in the treatment of patients co
刘花; 冯变玲; 杨世民
目的:研究药品不良反应监测工作中监管部门和报告者的博弈关系.方法:采用博弈模型进行分析.结果:我国应对现行的处罚政策做适当调整,引入奖励制度.结论:我国应建立奖罚分明的药品不良反应报告制度.%Objective: To analyze the game relationship between the regulatory authorities and the reporters in the monitoring of adverse drug reaction. Method: A game model was used in the game analysis. Result: The punishment policy in the current regulation for adverse drug reaction monitoring needed some appropriate adjustments, and the reward system should be introduced. Conclusion: Strict rules for reward and punishment in adverse drug reaction reporting system should be established in our country.
Full Text Available Michiko Yamamoto,1 Kiyoshi Kubota,2 Mitsuhiro Okazaki,3 Akira Dobashi,3 Masayuki Hashiguchi,4 Hirohisa Doi,1 Machi Suka,5 Mayumi Mochizuki4 1Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan; 2Department of Pharmacoepidemiology, Graduate School of Medicine, University of Tokyo, Japan; 3Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan; 4Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan; 5Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan Background: Patients have been allowed to report adverse drug reactions (ADRs directly to the government in some countries, which would contribute to pharmacovigilance.Objective: We started a pilot study to determine whether web-based patient ADR reporting would work in Japan. This article aims to describe the characteristics of the patient reporters, and to clarify patient views and experiences of reporting.Methods: Patients who submitted online ADR reports were contacted to respond to an ADR reporting questionnaire; only consenting reporters were included. Subjects with multiple responses were excluded from analysis. The questionnaire consisted of both closed and open questions. Questionnaire responses were examined using Pearson’s chi-squared test.Results: A total of 220 web-based ADR reports were collected from January to December 2011; questionnaires were sent to 190 reporters, excluding those who gave multiple reports and those that refused to be contacted. Responses were obtained from 94 individuals (effective response rate: 49.5%. The median respondent age was 46.0 years. Sixty-three respondents found out about this pilot study on the Internet (67.0%. The numbers of respondents claiming that they had difficulty recalling the time/date of ADR occurrence were 16 patient
Full Text Available Valentina Perrone,1,* Valentino Conti,2,* Mauro Venegoni,2 Stefania Scotto,2 Luca Degli Esposti,3 Diego Sangiorgi,3 Lucia Prestini,4 Sonia Radice,1 Emilio Clementi,5,6 Giuseppe Vighi,2,4 1Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 2Regional Centre for Pharmacovigilance, Lombardy, Milan, Italy; 3CliCon Srl, Health, Economics and Outcomes Research, Ravenna, Italy; 4Unit of Clinical Pharmacology and Pharmacovigilance, Niguarda Ca’Granda Hospital, Milan, Italy; 5Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy; 6Scientific Institute, IRCCS Eugenio Medea, Lecco, Italy *These authors contributed equally to the work Objective: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs reported in emergency departments (EDs and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal
Full Text Available Aim of Study: To evaluate adverse drug reaction (ADR profile of antimicrobials over 3-year period. Material and Methods: A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI. Results: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15% were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%. The intravenous (IV route of drug administration accounted maximum ADRs (53.32%, followed by oral route (45.41%. Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%, followed by tab. azithromycin (7.39%, tab. ofloxacin + ornidazol (5.35%, ofloxacin (3.57%, ciprofloxacin (2.29%, amoxicillin (2.55%, tab. cefixime (2.29%, inj. linezolid (2.04%. Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%, followed by gastrointestinal (GI (39.28%, central nervous system (CNS (5.35%, cardiovascular system (CVS (3.57% and renal and genitourinary (1.78%. While 47.96% ADR′s were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention. Conclusion: The current study suggest that ADRs due to antimicrobials is a significant health problem.
Full Text Available Abstract Background More than 1 million tuberculosis (TB patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS in China every year. Adverse reactions (ADRs induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Methods/Design Multiple study designs were adopted. Firstly, a prospective cohort with 4488 sputum smears positive pulmonary tuberculosis patients was established. Patients were followed up for 6-9 months in 52 counties of four regions. Those suspected ADRs should be checked and confirmed by Chinese State Food and Drug Administration (SFDA. Secondly, if the suspected ADR was anti-TB drug induced liver injury (ATLI, a nested case-control study would be performed which comprised choosing a matched control and doing a plus questionnaire inquiry. Thirdly, health economical data of ADRs would be collected to analyze financial burdens brought by ADRs and cost-effectiveness of ADRs' treatments. Fourthly, a drop of intravenous blood for each patient was taken and saved in FTA card for DNA banking and genotyping. Finally, the demographic, clinical, environmental, administrative and genetic data would be merged for the comprehensive analysis. Discussion ADACS will give an overview of anti-TB drugs induced ADRs' incidences, risk factors, treatments, prognoses, and clinical, economical and public health impacts for TB patients applying CNTS regimen in China, and provide suggestions for individualized health care and TB control policy.
Mugoša, Snežana; Djordjević, Nataša; Djukanović, Nina; Protić, Dragana; Bukumirić, Zoran; Radosavljević, Ivan; Bošković, Aneta; Todorović, Zoran
The aim of the present study was to undertake a study on the prevalence of cytochrome P450 2D6 (CYP2D6) poor metabolizer alleles (*3, *4, *5, and *6) on a Montenegrin population and its impact on developing adverse drug reactions (ADRs) of β-blockers in a hospitalized cardiac patient population. A prospective study was conducted in the Cardiology Center of the Clinical Center of Montenegro and included 138 patients who had received any β-blocker in their therapy. ADRs were collected using a specially designed questionnaire, based on the symptom list and any signs that could point to eventual ADRs. Data from patients’ medical charts, laboratory tests, and other available parameters were observed and combined with the data from the questionnaire. ADRs to β-blockers were observed in 15 (10.9%) patients. There was a statistically significant difference in the frequency of ADRs in relation to genetically determined enzymatic activity (Phospitalization, CYP2D6 poor metabolizer phenotype, and the concomitant use of other CYP2D6-metabolizing drugs. Therefore, in hospitalized patients with polypharmacy CYP2D6 genotyping might be useful in detecting those at risk of ADRs.
Gahr, Maximilian; Freudenmann, Roland W; Connemann, Bernhard J; Hiemke, Christoph; Schönfeldt-Lecuona, Carlos
Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence. PMID:24037995
Miguel-Arias, Domingo; Pereiro Gómez, César; Bermejo Barrera, Ana M; López de Abajo Rodríguez, Benito; Sobrido Prieto, María
The aim of this research is to study all people who died in the Autonomous Community of Galicia from acute death after drugconsumption (ADR) in which there was judicial intervention during the period from 1997 to 2011, according to inclusion and exclusión criteria established by the National Drug Plan for the entire national territory. Sociodemographic and clinical characteristics of deceased subjects were studied, in order to identify key risk factors and/or vulnerable populations.A total of 805 deaths were recorded. The distribution by provinces and municipalities corresponds to the areas of greatest population, incidence of consumption and proximity to the coast. The average age of these patients was 34.34 years, with a gradual increase over years. Most of them were male (91.2%) and single (47.7). 43.5% of the deceased habitually used the parenteral route of administration and 36.4% had positive HIV serology. The most frequently-detected substances corresponded to opiates (heroin: 61.3%, methadone: 35.6%), followed by cocaine (53.7%), although the most common pattern was that of poly-consumption. ADR mortality figures remain relatively stable throughout the study period. The predominant pattern is that of males, opiates and a long history of consumption. PMID:26990265
Amin, Mohammad Nurul; Khan, Tahir Mehmood; Dewan, Syed Masudur Rahman; Islam, Mohammad Safiqul; Moghal, Mizanur Rahman
Objectives To assess community pharmacists'/pharmacy technicians' knowledge and perceptions about adverse drug reactions (ADRs) and barriers towards the reporting of such reactions in Dhaka, Bangladesh. Method A cross-sectional study was planned to approach potential respondents for the study. A self-administered questionnaire was delivered to community pharmacists/pharmacy technicians (N=292) practising in Dhaka, Bangladesh. Results The overall response to the survey was 69.5% (n=203). The majority of the sample was comprised of pharmacy technicians (152, 74.9%) who possessed a diploma in pharmacy, followed by pharmacists (37, 18.2%) and others (12, 5.9%). Overall, 72 (35.5%) of the respondents disclosed that they had experienced an ADR at their pharmacy, yet more than half (105, 51.7%) were not familiar with the existence of an ADR reporting body in Bangladesh. Exploring the barriers to the reporting of ADRs, it was revealed that the top four barriers to ADR reporting were ‘I do not know how to report (Relative Importance Index (RII)=0.998)’, ‘reporting forms are not available (0.996)’, ‘I am not motivated to report (0.997)’ and ‘Unavailability of professional environment to discuss about ADR (RII=0.939)’. In addition to these, a majority (141, 69.46%) were not confident about the classification of ADRs (RII=0.889) and were afraid of legal liabilities associated with reporting ADRs (RII=0.806). Moreover, a lack of knowledge about pharmacotherapy and the detection of ADRs was another major factor hindering their reporting (RII=0.731). Conclusions The Directorate of Drug Administration in Bangladesh needs to consider the results of this study to help it improve and simplify ADR reporting in Bangladeshi community pharmacy settings. PMID:27489151
Berhe, Derbew F.; Juhlin, Kristina; Star, Kristina; Haaijer-Ruskamp, Flora M.; Michael, Kidane; Taxis, Katja; Mol, Peter G.M.
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. Obj
Full Text Available BACKGROUND: In recent years, efforts have been made to improve paediatric drug therapy. The aim of this research was to investigate any changes regarding the frequency and nature of adverse drug reactions (ADRs in hospitalized children in one paediatric general medical ward over a 9-year period. METHODOLOGY: Two prospective observational cohort studies were conducted at a large University hospital in Germany in 1999 and 2008, respectively. Children aged 0-18 years admitted to the study ward during the study periods were included. ADRs were identified using intensive chart review. Uni- and multivariable regression has been used for data analysis. RESULTS: A total of 520 patients (574 admissions were included [1999: n = 144 (167; 2008: n = 376 (407]. Patients received a total of 2053 drugs [median 3, interquartile range (IQR 2-5]. 19% of patients did not receive any medication. Median length of stay was 4 days (IQR 3-7; range 1-190 days with a significantly longer length of stay in 1999. The overall ADR incidence was 13.1% (95% CI, 9.8-16.3 varying significantly between the two study cohorts [1999: 21.9%, 95% CI, 14.7-29.0; 2008: 9.2%, 95% CI, 5.9-12.5 (p<0.001]. Antibacterials and corticosteroids for systemic use caused most of the ADRs in both cohorts (1999; 2008. Exposure to systemic antibacterials decreased from 62.9% to 43.5% whereas exposure to analgesics and anti-inflammatory drugs increased from 17.4% to 45.2%, respectively. The use of high risk drugs decreased from 75% to 62.2%. In 1999, 45.7% and in 2008 96.2% of ADRs were identified by treating clinicians (p<0.001. CONCLUSIONS: Between 1999 and 2008, the incidence of ADRs decreased significantly. Improved treatment strategies and an increased awareness of ADRs by physicians are most likely to be the cause for this positive development. Nevertheless further research on ADRs particularly in primary care and the establishment of prospective pharmacovigilance systems are still
Mouton, Johannes P; Njuguna, Christine; Kramer, Nicole; Stewart, Annemie; Mehta, Ushma; Blockman, Marc; Fortuin-De Smidt, Melony; De Waal, Reneé; Parrish, Andy G; Wilson, Douglas P K; Igumbor, Ehimario U; Aynalem, Getahun; Dheda, Mukesh; Maartens, Gary; Cohen, Karen
Limited data exist on the burden of serious adverse drug reactions (ADRs) in sub-Saharan Africa, which has high HIV and tuberculosis prevalence. We determined the proportion of adult admissions attributable to ADRs at 4 hospitals in South Africa. We characterized drugs implicated in, risk factors for, and the preventability of ADR-related admissions.We prospectively followed patients admitted to 4 hospitals' medical wards over sequential 30-day periods in 2013 and identified suspected ADRs with the aid of a trigger tool. A multidisciplinary team performed causality, preventability, and severity assessment using published criteria. We categorized an admission as ADR-related if the ADR was the primary reason for admission.There were 1951 admissions involving 1904 patients: median age was 50 years (interquartile range 34-65), 1057 of 1904 (56%) were female, 559 of 1904 (29%) were HIV-infected, and 183 of 1904 (10%) were on antituberculosis therapy (ATT). There were 164 of 1951 (8.4%) ADR-related admissions. After adjustment for age and ATT, ADR-related admission was independently associated (P ≤ 0.02) with female sex (adjusted odds ratio [aOR] 1.51, 95% confidence interval [95% CI] 1.06-2.14), increasing drug count (aOR 1.14 per additional drug, 95% CI 1.09-1.20), increasing comorbidity score (aOR 1.23 per additional point, 95% CI 1.07-1.41), and use of antiretroviral therapy (ART) if HIV-infected (aOR 1.92 compared with HIV-negative/unknown, 95% CI 1.17-3.14). The most common ADRs were renal impairment, hypoglycemia, liver injury, and hemorrhage. Tenofovir disoproxil fumarate, insulin, rifampicin, and warfarin were most commonly implicated, respectively, in these 4 ADRs. ART, ATT, and/or co-trimoxazole were implicated in 56 of 164 (34%) ADR-related admissions. Seventy-three of 164 (45%) ADRs were assessed as preventable.In our survey, approximately 1 in 12 admissions was because of an ADR. The range of ADRs and implicated drugs reflect South Africa's high HIV
Umar, Muhammad Tukur; Bello, Shaibu Oricha; Chika, Aminu; Oche, Oche Mansur
Objective: Objective of this study was to assess the attitude of nurses and pharmacists towards adverse drug reactions (ADRs) reporting. Methods: The questionnaire was designed based on extended “Inman seven deadly sins.” Two hundred and seventy-two respondents were selected by stratified sampling technique. The questionnaires were delivered to the respondents at their places of practice. The data generated were analyzed by Sigma XL Software Inc. Findings: There was no statistically significant relationship between demographic profiles and reporting attitude except for qualification. On extended “Inman seven deadly sins” awareness of reporting protocol and nearby center for ADRs reporting were low 27.3 and 7.5%, respectively. However, respondents’ score on components of attitude of ADRs reporting is generally encouraging. On comparative basis, no statistical significance exists between pharmacists and nurses. Conclusion: The study showed that attitude of respondents towards ADRs reporting is good. However, there is a need for targeted health education intervention among these cadres of health-care professionals, especially on aspects of awareness of reporting protocol and reporting center.
Het B Upadhyaya
Full Text Available Being key health care professional, physicians, pharmacist and nurses have immense responsibility in reporting adverse drug reaction (ADR. Therefore, the study objective was to evaluate the knowledge, attitude and practices (KAP toward pharmacovigilance and ADRs of postgraduate students of our institute. A cross-sectional questionnaires based study was carried out in postgraduate students of the clinical department at tertiary care hospital attached with Govt. Medical College, Vadodara, Gujarat (India. A total of 22 questionnaires about KAP toward ADRs and pharmacovigilance were developed and peer viewed of all questionnaires by expert faculties from our institute. We were contacted directly to postgraduate students of respective clinical department; questionnaires were distributed and taken back after 30 min. The filled KAP questionnaires were analyzed in question wise and their percentage value was calculated by using Microsoft Excel spreadsheet. Postgraduate residents (n = 101 from different clinical departments were enrolled in the study. Average 34.83% correct and 64.08% incorrect knowledge about ADRs and pharmacovigilance and an average 90.76% students were agreed to reporting ADRs is necessary, mandatory and increased patient′s safety. Only 7.92% of postgraduate doctors were reported ADR at institute or ADR reporting center. We concluded that postgraduate students have a better attitude toward reporting ADRs, but have lack of knowledge and poor practices of ADRs. The majority of postgraduate students were felt ADR reporting and monitoring is very important, but few had ever reported ADRs because of lack of sensitization and knowledge of pharmacovigilance and ADR.
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 Ce
Kroeger, Edeltraut; Mouls, Marie; Wilchesky, Machelle; Berkers, Mieke; Carmichael, Pierre-Hugues; van Marum, Rob; Souverein, Patrick; Egberts, Toine; Laroche, Marie-Laure
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 (donepe
张兵; 冯变玲; 赵晓红; 吉天天
目的比较注射与口服青霉素类药物不良反应的差别。方法采用回顾性分析方法对2007～2012年江苏省不良反应中心收集到的青霉素类药品的不良反应报告进行分析。结果江苏省注射用青霉素的不良反应数为6082例，占92．98％；口服青霉素的不良反应数为454例，占6．94％。注射用青霉素有新的严重的不良反应2例。注射用青霉素不良反应病例经治疗后有9例死亡病例，3例病人留下后遗症；口服青霉素的不良反应经治疗后均痊愈或好转。结论口服青霉素类药物不良反应数量少，且严重程度低，经治疗后无死亡或留下后遗症的病例。%Objective Compare with injection penicillin drugs and oral penicillin drugs for ADR .Method The adverse reaction re-ports of penicillin drugs collected by Jiangsu adverse reaction center from 2007 to 2012 were analyzed retrospectively .Result The case number of adverse reactions of injection penicillin was 6 082 ,accounting for 92 .98% ;Oral penicillin adverse reactions num-ber was 454 cases ,accounting for 6 .94% ;The injection penicillin drugs had new serious adverse reactions in 2 cases ;After the treatment of injection penicillin adverse reaction ,9 cases were die and 3 cases left sequela ;On the other hand ,the cases of oral penicillin adverse reactions were recoveried or better after treatment .Conclusion For the adverse drug reactions of oral penicillin , the quantity was less and the serious degree was low and no death or sequela was reported after treatment .
B Akshaya Srikanth
Full Text Available To estimate the incidence of adverse drug reactions (ADRs in Human immune deficiency virus (HIV patients on highly active antiretroviral therapy (HAART. To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%. The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52% was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm 3 with comorbid conditions.
Srikanth, B Akshaya; Babu, S Chandra; Yadav, Harlokesh Narayan; Jain, Sunil Kumar
To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm(3) with comorbid conditions. PMID:22470896
Full Text Available User-generated medical messages on Internet contain extensive information related to adverse drug reactions (ADRs and are known as valuable resources for post-marketing drug surveillance. The aim of this study was to find an effective method to identify messages related to ADRs automatically from online user reviews.We conducted experiments on online user reviews using different feature set and different classification technique. Firstly, the messages from three communities, allergy community, schizophrenia community and pain management community, were collected, the 3000 messages were annotated. Secondly, the N-gram-based features set and medical domain-specific features set were generated. Thirdly, three classification techniques, SVM, C4.5 and Naïve Bayes, were used to perform classification tasks separately. Finally, we evaluated the performance of different method using different feature set and different classification technique by comparing the metrics including accuracy and F-measure.In terms of accuracy, the accuracy of SVM classifier was higher than 0.8, the accuracy of C4.5 classifier or Naïve Bayes classifier was lower than 0.8; meanwhile, the combination feature sets including n-gram-based feature set and domain-specific feature set consistently outperformed single feature set. In terms of F-measure, the highest F-measure is 0.895 which was achieved by using combination feature sets and a SVM classifier. In all, we can get the best classification performance by using combination feature sets and SVM classifier.By using combination feature sets and SVM classifier, we can get an effective method to identify messages related to ADRs automatically from online user reviews.
Perrone, Valentina; Conti, Valentino; Venegoni, Mauro; Scotto, Stefania; Degli Esposti, Luca; Sangiorgi, Diego; Prestini, Lucia; Radice, Sonia; Clementi, Emilio; Vighi, Giuseppe
Objective The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. Methods This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. Results 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. Conclusion ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region. PMID
Montiago X LaBute
Full Text Available Late-stage or post-market identification of adverse drug reactions (ADRs is a significant public health issue and a source of major economic liability for drug development. Thus, reliable in silico screening of drug candidates for possible ADRs would be advantageous. In this work, we introduce a computational approach that predicts ADRs by combining the results of molecular docking and leverages known ADR information from DrugBank and SIDER. We employed a recently parallelized version of AutoDock Vina (VinaLC to dock 906 small molecule drugs to a virtual panel of 409 DrugBank protein targets. L1-regularized logistic regression models were trained on the resulting docking scores of a 560 compound subset from the initial 906 compounds to predict 85 side effects, grouped into 10 ADR phenotype groups. Only 21% (87 out of 409 of the drug-protein binding features involve known targets of the drug subset, providing a significant probe of off-target effects. As a control, associations of this drug subset with the 555 annotated targets of these compounds, as reported in DrugBank, were used as features to train a separate group of models. The Vina off-target models and the DrugBank on-target models yielded comparable median area-under-the-receiver-operating-characteristic-curves (AUCs during 10-fold cross-validation (0.60-0.69 and 0.61-0.74, respectively. Evidence was found in the PubMed literature to support several putative ADR-protein associations identified by our analysis. Among them, several associations between neoplasm-related ADRs and known tumor suppressor and tumor invasiveness marker proteins were found. A dual role for interstitial collagenase in both neoplasms and aneurysm formation was also identified. These associations all involve off-target proteins and could not have been found using available drug/on-target interaction data. This study illustrates a path forward to comprehensive ADR virtual screening that can potentially scale with
Conclusion: Proper education about the importance of compliance and damaging consequences of self-modification of drug dosage in patients who are on treatment for chronic disorders like diabetes and hypertension will be an effective strategy to prevent many of these ADRs. [Int J Basic Clin Pharmacol 2015; 4(5.000: 931-935
李中东; 张云轩; 郭燕萍; 施孝金; 钟明康
Objective To review the adverse drug reactions induced by parabens when used as preservatives. Methods A simple conclusion on adverse drug reactions induced by parabens was carried out by reviewing the related references. Results Parabens are the most commonly used preservatives. Parabens are likely to cause adverse reactions as allergic reactions, cross reactions and estrogenic activity, paraben paradox can also be observed. Conclusion Professional clinicians must pay high attention to the adverse reactions of parabens contained in the pharmaceutical products and use them rationally as possible as they can.%目的 综述羟苯酯类防腐剂不良反应.方法 参阅国外相关文献,总结羟苯酯类的不良反应.结果 羟苯酯类是最常用的防腐剂,不良反应表现为过敏、交叉反应和激素效应,会发生“羟苯酯类悖论”现象.结论 医务人员使用含羟苯酯类的制剂处方时,要重视它的不良反应,做到合理运用.
Wang, S F; Zhan, S Y
Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data. The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets, and the selection of the comparative control is essential to each design. This article aims to explain the principle and application of each type of control selection, introduce the methods and parameters for method comparison, and describe the latest achievements in the batch processing of control selection, which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China. PMID:27453095
Eriksson, Robert; Werge, Thomas; Jensen, Lars Juhl;
patient-specific adverse events (AEs) and links these to specific drugs and dosages in a temporal manner, based on integration of text mining results and structured data. The structured data contained precise information on drug identity, dosage and strength.When applying the method to the 3,394 patients...... all indication areas.The aim of this study was to take advantage of techniques for temporal data mining of EPRs in order to detect ADRs in a patient- and dose-specific manner.We used a psychiatric hospital’s EPR system to investigate undesired drug effects. Within one workflow the method identified...
Objective To study the clinical adverse reaction analysis of alopurinol and colchicine, and provide reliable reference information for clinical prevention and treatment.Methods According to the adverse reaction of 5 cases in our hospital from 2005 to 2013 of colchicine and 95 patients receiving allopurinol patients with adverse reactions to carry on the research analysis, to explore the adverse reactions of their.Results Among 1 cases of colchicine have serious adverse reaction, which accounted for 20%(1/5), allopurinol has 20 cases of severe adverse reaction, which accounted for 21.05%(20/95); the main adverse reactions to skin and mucous membrane injury, and then is the digestive system adverse drug reaction performance, again is the nervous system and blood system, urinary system injury.Conclusion The clinical use of allopurinol and colchicine should pay attention to drug concentration, control the incidence of clinical adverse reactions of patients, make patients get safe and reliable treatment effect.%目的：研究分析别嘌呤醇和秋水仙碱的临床不良反应情况，为临床预防和治疗提供可靠的参考信息。方法根据我院2005至2013年接收的5例秋水仙碱不良反应和95例别嘌呤不良反应患者来进行研究分析，探讨他们的不良反应情况。结果其中秋水仙碱有1例严重不良反应，占20%（1/5），别嘌呤醇有20例严重不良反应，占21.05%（20/95）；不良反应主要以皮肤黏膜损伤为主，然后就是消化系统不良反应表现，再来就是神经系统和血液系统、泌尿系统等的损伤。结论对嘌呤醇和秋水仙碱的临床使用应该要注意药物的浓度，控制患者的临床不良反应发生率，让患者获得安全可靠的治疗效果。
Reneé de Waal
Full Text Available BACKGROUND: Lipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART. Both are assumed to be antiretroviral adverse drug reactions. METHODS: We conducted a systematic review to determine whether fat loss or gain was more common in HIV-infected patients on ART than in uninfected controls; was associated with specific antiretrovirals; and would reverse after switching antiretrovirals. RESULTS: Twenty-seven studies met our inclusion criteria. One cohort study reported more lipoatrophy, less subcutaneous fat gain, but no difference in central fat gain in HIV-infected patients on ART than in controls. Randomised controlled trials (RCTs showed more limb fat loss (or less fat gain with the following regimens: stavudine (versus other nucleoside reverse transcriptase inhibitors (NRTIs; efavirenz (versus protease inhibitors (PIs; and NRTI-containing (versus NRTI-sparing. RCTs showed increased subcutaneous fat after switching to NRTI-sparing regimens or from stavudine/zidovudine to abacavir/tenofovir. There were no significant between-group differences in trunk and/or visceral fat gain in RCTs of various regimens, but results from efavirenz versus PI regimens were inconsistent. There was no significant between-group differences in central fat gain in RCTs switched to NRTI-sparing regimens, or from PI-containing regimens. CONCLUSIONS: There is clear evidence of a causal relationship between NRTIs (especially thymidine analogues and lipoatrophy, with concomitant PIs possibly having an ameliorating effect or efavirenz causing additive toxicity. By contrast, central fat gain appears to be a consequence of treating HIV infection, because it is not different from controls, is not linked to any antiretroviral class, and doesn't improve on switching.
Full Text Available Aim: Spontaneous voluntary adverse drug reaction (ADR reporting is paramount to the success of the Pharmacovigilance Programme of India. There has however been minimal and sporadic voluntary reporting of ADR's at the ADR Monitoring Centre (AMC Gangtok, Sikkim. Knowledge, perception, attitude, and awareness of health professionals are determinants of reporting practices. This questionnaire study aims at evaluating these indicators in the teaching hospital attached to the Medical Institute and find out methods to improve existing reporting practices. Materials and Methods: This is a cross-sectional questionnaire-based observational study carried out in the Medical, Surgical and Pathology Departments of the Teaching Hospital, Gangtok, Sikkim over a period of 2 months. The questionnaires were filled by the respondents and returned back to us within the next 24 h. Data obtained from filled questionnaires were thereby analyzed. Results: The overall correct response rate to the knowledge-based questions was 56.3%. While 97% of respondents were of the view that ADR reporting was necessary, 35% of the respondents felt that the difficulty in deciding the causality of an ADR discouraged them from reporting. 79% of the respondents were not aware of the presence of an AMC affiliated to the hospital, and 87% of the respondents admitted that they were not sending filled ADR forms to the AMC. Conclusions: The study indicates that the respondents have an average knowledge and positive attitude toward ADR reporting and pharmacovigilance. There is however a lack of awareness and poor ADR reporting practices. Efforts are required to enhance awareness and attitude toward pharmacovigilance and ADR reporting.
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
Chetna K Desai
Full Text Available Objectives: Spontaneous reporting is an important tool in pharmacovigilance. However, its success depends on cooperative and motivated prescribers. Under-reporting of adverse drug reactions (ADRs by prescribers is a common problem. The present study was undertaken to evaluate the knowledge, attitude, and practices (KAP regarding ADR reporting among prescribers at the Civil Hospital, Ahmedabad, to get an insight into the causes of under-reporting of ADRs. Materials and Methods: A pretested KAP questionnaire comprising of 15 questions (knowledge 6, attitude 5, and practice 4 was administered to 436 prescribers. The questionnaires were assessed for their completeness (maximum score 20 and the type of responses regarding ADR reporting. Microsoft Excel worksheet (Microsoft Office 2007 and Chi-Square test were used for statistical analysis. Results: A total of 260 (61% prescribers completed the questionnaire (mean score of completion 18.04. The response rate of resident doctors (70.7% was better than consultants (34.5% (P < 0.001. ADR reporting was considered important by 97.3% of the respondents; primarily for improving patient safety (28.8% and identifying new ADRs (24.6%. A majority of the respondents opined that they would like to report serious ADRs (56%. However, only 15% of the prescribers had reported ADRs previously. The reasons cited for this were lack of information on where (70% and how (68% to report and the lack of access to reporting forms (49.2%. Preferred methods for reporting were e-mail (56% and personal communication (42%. Conclusion: The prescribers are aware of the ADRs and the importance of their reporting. However, under reporting and lack of knowledge about the reporting system are clearly evident. Creating awareness about ADR reporting and devising means to make it easy and convenient may aid in improving spontaneous reporting.
Objective To investigate the adverse drug reactions of Paroxetine, provide a reference for clinical safe use of drugs. Methods Statistically analyzed the articles about adverse reactions of Paroxetine published by mental illness journals for the past 10 years and medical records collected by the author. Results The adverse reactions of Paroxetine involve 9 major categories, with 22 kinds of clinical manifestations, mainly including extrapyramidal reactions(27.91%), blood system injury (11.63%) and allergic reactions(13.95%). Conclusion The adverse drug reactions of Paroxetine are relatively more but gentle, focusing on extrapyramidal injury, hepatic dysfunction, leucopenia and skin allergy.%目的 探讨帕罗西汀的不良反应,为临床安全用药提供参考.方法 对几家精神疾病类杂志近10年有关帕罗西汀不良反应的病例报告和作者临床收集的病例资料进行统计分析.结果 帕罗西汀的不良反应分9大类,22种表现.以锥体外系反应(27.91％)、血液系统损害(11.63％)、过敏反应(13.95％)为多.结论 帕罗西汀的不良反应虽然较多但较和缓,以锥体外系、肝功损害、白细胞减少和皮肤过敏为多.
Drug-induced skin rash characterized by an acute inflammatory reaction of skin and mucous membranes is dose-independent, unpredictable, and sometimes life-threatening. In recent years, the U.S. Food and Drug Administration (FDA) has recommended genotyping of polymorphisms in the human leukocyte antigen (HLA) prior to drug administration for the avoidance of severe skin rash induced by drugs, such as abacavir and carbamazepine. A genome-wide association study (GWAS) is useful for the identification of genomic biomarkers that can predict the efficacy or risk of toxicity of various drugs. We identified novel susceptibility loci associated with the risk of a skin rash induced by nevirapine and carbamazepine in Thai and Japanese populations, respectively, through case-control GWAS with high-throughput single-nucleotide polymorphism (SNP) genotyping technology. In order to apply the genomic biomarkers to clinical therapeutics, prospective clinical trials will be necessary for the evaluation of an intervention based on genetic tests. PMID:24724431
Zwisler, Stine T; Enggaard, Thomas P; Noehr-Jensen, Lene;
the wild-type genotype in the cold pressor test (25% reduction vs. 15%, P = 0.015 in the discomfort rating and 25% reduction vs. 12%, P = 0.007 in the pain time AUC) and less adverse drug reactions. The combined wild-type genotype 3435CC-2677GG was associated with less antinociceptive effect of......The aim of this study was to search for a possible association between the variant allele of the single nucleotide polymorphisms A118G in the OPRM1 gene and C3435T and G2677T/A in the ABCB1 gene and altered antinociceptive effect and adverse drug reactions of oxycodone. Thirty-three healthy...... subjects exposed to experimental pain including electrical stimulation and the cold pressor test were included. A118G: We found that the variant G allele was associated with reduced antinociceptive effect as measured by pain tolerance thresholds to single electrical nerve stimulation (8% increase vs. 25...
Thanusubramanian, Harish; Patil, Navin; Shenoy, Smita; Bairy, K. L.; Sarma, Yashdeep
The author reports a 55-year-old female diagnosed of chronic kidney disease grade-5 with associated co-morbidities like type 2 diabetes mellitus, diabetic retinopathy and hypothyroidism was admitted for arteriovenous fistula construction. She was started on ferric carboxymaltose for the treatment of anaemia. She was given a test dose before administering the drug intravenously and she did not develop any reaction. The drug ferric carboxymaltose was then administered over a period of one hour....
Avery, A J; Anderson, Claire; Bond, C M; Fortnum, H.; Gifford, A.; Hannaford, P. C.; Hazell, L; Krska, J; Lee, A. J.; McLernon, D. J.; Murphy, Elizabeth; Shakir, S; Watson, M. C.
Background: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety ...
Full Text Available Kai Yang,1,2 Ningbo Zhao,1 Dan Zhao,1,2 Dan Chen,1 Yadong Li1 1Department of Oral and Maxillofacial Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 2Chongqing Key Laboratory for Oral Diseases and Biomedical Sciences, Chongqing Medical University, Chongqing, People’s Republic of China Background: Recent studies have shown that the growth and proliferation of cancer cells in vivo exhibit circadian rhythm, and the efficacy and adverse reactions of platinum-based anticancer drugs administered at different times of the day vary significantly on colon cancer. However, since the circadian rhythms of growth and proliferation of various cancer cells often differ, the question of whether the administration of platinum anticancer drugs at different times of the day exerts significantly different efficacy and adverse effects on oral cancers remains to be elucidated. This study has compared the efficacy and adverse effects of oxaliplatin (L-OHP administration at different times during a day on oral squamous cell carcinoma in mice and has analyzed cellular circadian rhythms. Methods: The mouse model for oral squamous cell carcinoma was established in 75 nude mice, housed in a 12 hour light/12 hour dark cycle environment. The mice were randomly divided into five groups; four experimental groups were intravenously injected with L-OHP at four time points within a 24-hour period (4, 10, 16, and 22 hours after lights on [HALO]. The control group was intravenously injected with the same volume of saline. Treatment efficacy and adverse reactions were compared on the seventh day after the injection, at 22 HALO. The existence of circadian rhythms was determined by cosine analysis. Results: Only injections of L-OHP at 16 and 22 HALO significantly prolonged animal survival time. The adverse reactions in mice injected with L-OHP at 16 and 22 HALO were significantly less than those observed in mice administered L-OHP at 4 and 10 HALO
Piérard-Franchimont, Claudine; Quatresooz, Pascale; Reginster, Marie‑Annick; Piérard, Gérald E.
Pemetrexed (Alimta®) is a multitargeted antifolate drug approved as a single agent or in combination with cisplatin for the treatment of a small number of malignancies including advanced and metastatic non-squamous non-small cell lung cancer (NSCLC), and malignant pleural mesothelioma. This review reports the recent peer-reviewed publications and original findings regarding cutaneous adverse reactions (CARs) to pemetrexed. Pemetrexed-related CARs are frequently reported under the unspecific t...
Thanusubramanian, Harish; Patil, Navin; Shenoy, Smita; Bairy, K L; Sarma, Yashdeep
The author reports a 55-year-old female diagnosed of chronic kidney disease grade-5 with associated co-morbidities like type 2 diabetes mellitus, diabetic retinopathy and hypothyroidism was admitted for arteriovenous fistula construction. She was started on ferric carboxymaltose for the treatment of anaemia. She was given a test dose before administering the drug intravenously and she did not develop any reaction. The drug ferric carboxymaltose was then administered over a period of one hour. About half an hour after drug administration, the patient developed breathlessness and myalgia. After half hour of the above episode of breathlessness and myalgia she also developed vomiting (one episode). Patient was managed with oxygen therapy, IV fluids and other drugs like corticosteroids, phenaramine maleate and nalbuphine which controlled the above symptoms. PMID:25478369
陆晓彤; 刘海涛; 张健; 张春
Objective: To summarize the results of adverse drug reaction supervision in our hospital from January in 2007 to June in 2010 in order to improve rational and safe clinical drug treatment for children. Methods: Methods of descriptive study, statistics and analysis were used to estimate some characteristics of medicine usage. This included patients' basic conditions, route of administtration, ding combination and clinic manifestations. Results: Alnong 358 reports about adverse dlug reactions, there were 169 cases aged between 0 and 3 years, which accounted for 47.2％. There were 327 cases relating to the use of antibiotics, taking up 91.34％ , in which there were 296 cases relating to β-lactaln antibiotics. The lnost usual adverse ding reaction caused by β-lactaln antibiotics were skin rashes, urticaria and anaphylactoid reactions. Alnong those 358 cases, adverse drug reaction occurred more easily when administrated via intravenous dropping method, which accounted for 83.24％ (298 cases). Conclusions: There are more adverse drug reactions taking place in neonates and children when antibiotics are administrated by intravenous dropping method. This method of treatment needs to be further studied.%目的:总结我院2007年~2010年6月药品不良反应监测情况,促进临床安全、合理用药.方法:采用描述性研究的方法,对我院上报的药品不良反应分别从患者的基本情况、给药途径、联合用药、临床表现等方面进行统计、分析与评价.结果:358例不良反应监测报告中,患儿年龄0~3岁169例,占47.20%;与抗菌药物有关的327例,占91.34%,其中β内酰胺类296例,β内酰胺类引起的ADR多为皮疹、荨麻疹、过敏样反应;以静脉滴注途径给药的发生频率最高,共298例占83.24%.结论:我院婴幼儿抗菌药物静脉注射时发生的不良反应较多,应予以重点关注.
Almost all clases of psychiatric drugs (typical and atypical antipsychotics, antidepressants, mood stabilizers, benzodiazepines) have been reported as possible causes of haematological toxicity. This is a review of the literature in which different clinical situations involving red blood cells, white blood cells, platelets and impaired coagulation are detailed and the drugs more frequently involved are listed. The haematological adverse reactions detailed here include: aplastic anemia, haemolitic anemia, leukopenia, agranulocytosis, leukocytosis, eosinophilia, thrombocytosis, thrombocytopenia, disordered platelet function and impaired coagulation. The haematologic toxicity profile of the drugs more frequently involved: lithium, clozapine, carbamazepine, valproic acid and SSRI antidepressants is mentioned. PMID:19424521
... problem is interactions, which may occur between Two drugs, such as aspirin and blood thinners Drugs and food, such as statins and grapefruit Drugs and supplements, such as gingko and blood thinners ...
Dhruv J. Modi
Full Text Available Background: Adverse reactions to intravenous iodinated contrast media may be classified as general and organ-specific, such as contrast-induced nephrotoxicity. General adverse reactions may be sub classified into acute and delayed types. Acute general adverse reactions can range from transient minor reactions to life-threatening severe reactions. This study was done to determine clinical adverse effects of the iodinated contrast media. Methods: Data of 899 consecutive patients at C.U. Shah Medical College and Hospital, Surendranagar, who received sodium meglumine diatrizoate intravenous iodinated contrast media during the period of May 2011 to April 2012, were collected for any adverse drug reactions. Results: Out of 899, 189 patients developed adverse contrast reactions. The incidences of mild, moderate and severe adverse reactions were 19.47%, 1.33% and 0.28%, respectively. There were no differences in the incidence of adverse reactions according to gender (males 21.1%; females 20.7%; p= >0.05 or age (p= >0.05. The incidence of adverse reactions was significantly higher in patients with a history of previous reactions (50% than in those with no history (21.25%; p= <0.05. Conclusions: The skin was the most commonly affected site of reactions. In reactions, mild forms were more common compared to moderate and severe. [Int J Basic Clin Pharmacol 2012; 1(3.000: 211-215
Chalmer, Thor; Almdal, Thomas P; Vilsbøll, Tina;
accelerated after publication of an autopsy study claiming increased incidences of several pathological changes in pancreata from patients with diabetes treated with incretin-based drugs. Areas covered: The aim of the present review is to give an overview of the pharmacology of liraglutide and provide a...... review of adverse reactions associated with liraglutide with a focus on the risk of pancreatitis and pancreas cancer. Expert opinion: When comprehensively reviewing the available literature, no clear and significant associations between liraglutide and pancreatitis and/or pancreas cancer seem evident...
Yang, Lun; Luo, Heng; Chen, Jian; Xing, Qinghe; He, Lin
Serious adverse drug reactions (SADRs) are caused by unexpected drug-human protein interactions, and some polymorphisms within binding pockets make the population carrying these polymorphisms susceptible to SADR. Predicting which populations are likely to be susceptible to SADR will not only strengthen drug safety, but will also assist enterprises to adjust R&D and marketing strategies. Making such predictions has recently been facilitated by the introduction of a web server named SePreSA. The server has a comprehensive collection of the structural models of nearly all the well known SADR targets. Once a drug molecule is submitted, the scale of its potential interaction with multi-SADR targets is calculated using the DOCK program. The server utilizes a 2-directional Z-transformation scoring algorithm, which computes the relative drug-protein interaction strength based on the docking-score matrix of a chemical-protein interactome, thus achieve greater accuracy in prioritizing SADR targets than simply using dock scoring functions. The server also suggests the binding pattern of the lowest docking score through 3D visualization, by highlighting and visualizing amino acid residues involved in the binding on the customer's browser. Polymorphism information for different populations for each of the interactive residues will be displayed, helping users to deduce the population-specific susceptibility of their drug molecule. The server is freely available at http://SePreSA.Bio-X.cn/. PMID:19417066
Tolba, Mai F; Omar, Hany A; Azab, Samar S; Khalifa, Amani E; Abdel-Naim, Ashraf B; Abdel-Rahman, Sherif Z
Propolis, a honey bee product, has been used in folk medicine for centuries for the treatment of abscesses, canker sores and for wound healing. Caffeic acid phenethyl ester (CAPE) is one of the most extensively investigated active components of propolis which possess many biological activities, including antibacterial, antiviral, antioxidant, anti-inflammatory, and anti-cancer effects. CAPE is a polyphenolic compound characterized by potent antioxidant and cytoprotective activities and protective effects against ischemia-reperfusion (I/R)-induced injury in multiple tissues such as brain, retina, heart, skeletal muscles, testis, ovaries, intestine, colon, and liver. Furthermore, several studies indicated the protective effects of CAPE against chemotherapy-induced adverse drug reactions (ADRs) including several antibiotics (streptomycin, vancomycin, isoniazid, ethambutol) and chemotherapeutic agents (mitomycin, doxorubicin, cisplatin, methotrexate). Due to the broad spectrum of pharmacological activities of CAPE, this review makes a special focus on the recently published data about CAPE antioxidant activity as well as its protective effects against I/R-induced injury and many adverse drug reactions. PMID:25365228
张利国; 周颖; 张琼丹; 曾永兰
Objective To understand the situation of serious adverse drug reactions ( ADR ) occurred in hospital for promoting the clinical medication safety. Methods The case reports of serious ADR during 2009-2011 were performed the retrospective analysis. Results ADR involving drugs were 6 categories 38 varieties,dominated by anticancer drugs,followed by antimicrobial drugs. The administration route was mainly intravenous infusion, accounting for 80% . The manifestations of ADR were dominated by leukopenia. Conclusion The awareness of rational drug use should be enhanced to avoid severe ADR and reduce the medical disputes.%目的 了解医院严重药品不良反应(ADR)发生情况,促进临床用药安全.方法 对2009年至2011年70例严重药品不良反应报告进行回顾性分析.结果 不良反应涉及药品6大类38种,以抗肿瘤药物为主,其次是抗微生物药物;给药途径以静脉滴注为主,占80%;不良反应表现主要以白细胞减少为主.结论 增强合理用药意识,避免严重ADR发生,减少医疗纠纷.
Full Text Available Purpose: We present a framework for detecting possible adverse drug reactions (ADRs using the Utah Medicaid administrative data. We examined four classes of ADRs associated with treatment of dementia by acetylcholinesterase inhibitors (AChEIs: known reactions (gastrointestinal, psychological disturbances, potential reactions (respiratory disturbance, novel reactions (hepatic, hematological disturbances, and death. Methods: Our cohort design linked drug utilization data to medical claims from Utah Medicaid recipients. We restricted the analysis to 50 years-old and older beneficiaries diagnosed with dementia-related diseases. We compared patients treated with AChEI to patients untreated with anti-dementia medication therapy. We attempted to remove confounding by establishing propensity-score-matched cohorts for each outcome investigated; we then evaluated the effects of drug treatment by conditional multivariable Cox-proportional-hazard regression. Acute and transient effects were evaluated by a crossover design using conditional logistic regression. Results: Propensity-matched analysis of expected reactions revealed that AChEI treatment was associated with gastrointestinal episodes (Hazard Ratio [HR]: 2.02; 95%CI: 1.28-3.2, but not psychological episodes, respiratory disturbance, or death. Among the unexpected reactions, the risk of hematological episodes was higher (HR: 2.32; 95%CI: 1.47-3.6 in patients exposed to AChEI. AChEI exposure was not associated with an increase in hepatic episodes. We also noted a trend, identified in the case-crossover design, toward increase odds of experiencing acute hematological events during AChEI exposure (Odds Ratio: 3.0; 95% CI: 0.97 - 9.3. Conclusions: We observed an expected association between AChEIs treatment and gastrointestinal disturbances and detected a signal of possible hematological ADR after treatment with AChEIs in this pilot study. Using this analytic framework may raise awareness of potential
Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl;
Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect...... defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed...
Shreyas R. Burute
Conclusions: Considering the wide range of drugs consumed, the numbers of ADRs mentioned were few and their spectrum limited indicating scope for improvement. [Int J Basic Clin Pharmacol 2016; 5(1.000: 196-201
Adopt a retrospective study method,66 cases adverse drugs reaction (ADR) of iodine contrast agent in Zhejiang Traditional Chinese Medical Hospital from 2009 to 2012 were analyzed.ADR of iodine contrast agent have variety of clinical manifestations.The most common is skin allergy,skin allergy have 46 cases(69.70％),11 cases (16.67％)occur in digestive system.%用回顾性研究方法,对本院2009～2012年收集的66例碘对比剂的药物不良反应(ADR)进行归纳分析.碘对比剂ADR的临床表现多种多样,以皮肤过敏最常见,皮肤过敏共46例(占69.70％),消化系统11例(占16.67％).
Bush, William H.; Mullarkey, Michael F.; Webb, D. Robert
Major adverse reactions to radiographic contrast media will occur more often as contrast material is now also administered during computerized tomographic (CT) scanning. Differentiation of the two major contrast reactions, the vagus reaction and the anaphylactoid reaction, is essential. Bradycardia is the key finding for identifying the vagus reaction. The vagus reaction involving hypotension and bradycardia requires treatment with large doses of atropine given intravenously. The immediate ge...
Objective:To investigate the adverse drug reactions that occurred in children. Methods: The ages, sex, drug usage, main manifestation, time of occurrence and level of severity of ADR were analyzed in 114 cases of children aged from 2 month to 15 years old. Results: Among 114 cases, 78 patients were male, 36 patients were female. There were fifty three drugs involved. Antibiotics held the first position (42. 11％) and the next was Chinese Anti-inffectives (25. 44％). The main manifestation of ADR was rash, anaphylactoid reaction and somnolence. The main route of administration was intravenous drip. Conclusions: Monitoring of ADR in children should be strengthened in order to ensure the safety of drug usage.%目的:了解儿童发生药品不良反应(ADR)的情况.方法:按患者的年龄、性别、用药情况及ADR的主要表现、发生时间、严重程度等进行统计分析.结果:114例ADR报告中,男78例,女36例,涉及药品53种,主要为抗感染药物(42.11%),其次为中药抗感染药物(25.44%).ADR主要表现是皮疹,其次是过敏样反应、嗜睡.主要给药途径是静脉滴注.结论:应加强对儿童ADR的监测工作,以保证用药安全.
Grosso, A.; Douglas, I.; Hingorani, A.; MacAllister, R.; Smeeth, L
AIMSPost licensing, the evaluation of drug safety relies heavily on the collation of sporadic, spontaneous reports on adverse effects. The aim was to assess the potential utility of a more systematic approach to the detection of adverse events that utilizes routinely collected clinical data from a large primary care population.METHODSWe used the UK General Practice Research Database to assess the risk of several recently reported adverse events linked to the use of strontium ranelate for oste...
目的研究喹诺酮类药物的耐药、联合用药和不良反应。方法对本院应用喹诺酮类药物治疗后出现不良反应的60例患者的临床资料进行回顾性分析。结果常见的不良反应主要为全身性损伤（14例，23.4%）、皮肤方面的损伤（12例，20.0%）和神经系统损伤（18例，30.0%）。喹诺酮类药物目前的耐药情况比较严重。结论喹诺酮类药物应合理使用，并掌握其临床适应证以及剂量，尽可能避免联合用药的不合理性和不良反应的发生。%Objective To investigate the resistance,drug combination and adverse reactions of quinolones. Methods Clinical data of 60 patients who had adverse reactions after using quinolones in our hospital were collected and analyzed retrospectively. Results The main common adverse reactions were systemic injury(14 patients,23.4%),skin injury (12 patients,20.0%) and nervous system injury(18 patients,30.0%). The current drug resistance situation of quinolones was severe. Conclusion Quinolones should be used rationally and their clinical indications and doses should be mastered in order to avoid the irrationality of drug combination and the occurrence of adverse reactions.
Full Text Available Tariq M Alhawassi,1,2 Ines Krass,1 Beata Bajorek,3,4 Lisa G Pont5 1Faculty of Pharmacy, University of Sydney, Sydney, NSW, Australia; 2College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 3Graduate School of Health – Pharmacy, University of Technology Sydney, 4Pharmacy Department, Royal North Shore Hospital, 5Sydney Nursing School, University of Sydney, Sydney, NSW, Australia Abstract: Adverse drug reactions (ADRs are an important health issue. While prevalence and risk factors associated with ADRs in the general adult population have been well documented, much less is known about ADRs in the elderly population. The aim of this study was to review the published literature to estimate the prevalence of ADRs in the elderly in the acute care setting and identify factors associated with an increased risk of an ADR in the elderly. A systematic review of studies published between 2003 and 2013 was conducted in the Cochrane Database of Systematic Reviews, EMBASE, Google Scholar and MEDLINE. Key search terms included: “adverse drug reactions”, “adverse effects”, “elderly patients and hospital admission”, “drug therapy”, “drug adverse effects”, “drug related”, “aged”, “older patients”, “geriatric”, “hospitalization”, and “emergency admissions”. For inclusion in the review, studies had to focus on ADRs in the elderly and had to include an explicit definition of what was considered an ADR and/or an explicit assessment of causality, and a clear description of the method used for ADR identification, and had to describe factors associated with an increased risk of an ADR. Fourteen hospital-based observational studies exploring ADRs in the elderly in the acute care setting were eligible for inclusion in this review. The mean prevalence of ADRs in the elderly in the studies included in this review was 11.0% (95% confidence interval [CI]: 5.1%–16.8%. The median prevalence of ADRs leading to
Full Text Available Introduction: The hypertensive disorders in pregnancy are the leading causes of maternal and perinatal mortality. Management of preeclampsia and eclampsia remains controversial even today. Several drugs with different regimens are available at present. As a consequence; women are treated in various ways by different regimens. Aim: Our work aimed to study the use of various magnesium sulfate regimens used in management of eclampsia in a tertiary care teaching rural hospital. Methods: A prospective, observational, non-interventional study was carried out among the eclamptic patients admitted to obstetrics ward. After explaining the purpose and method of study, through the patient information sheet, patients willing to sign the informed consent form were enrolled for the study. Relevant data was gathered from their case files and by direct interview with the patients that were recorded in the case record form. Results: Of the 35 cases of eclampsia recorded during the study period, we observed that all the patients were treated with Pritchard’s regimen of Magnesium Sulfate. It was noticed that there was improvement in all the patients with no adverse drug reactions recorded during the time of management. Conclusion: Maternal and perinatal mortality can be reduced to major extent by prevention of eclampsia. Prompt diagnosis and institution of therapy by selecting an ideal anticonvulsant is essential as the maternal and perinatal mortality progressively rises with increase no of convulsions. Magnesium Sulfate is a potent anticonvulsant with mild antihypertensive activity with less adverse effects. [Int J Res Med Sci 2013; 1(2.000: 97-100
目的 通过对某院药物不良反应报告的分析和讨论,为临床安全用药提供参考.方法 对该院2009年度上报的120例不良反应报告进行收集、汇总、统计分析.结果 药物不良反应报告主要来源于医疗机构,涉及药物不良反应的药品中抗感染药居首位,给药途径以静脉滴注为主.不良反应主要累及消化系统,皮肤及其附件.结论 应加强和重视药品不良反应的检测,保障公众安全合理用药.%OBJECTIVE To analyze and discuss the adverse drug reactions of Xingtai people' hospital and refer to the clinical medication safety. METHODS We collected summarized and analyzed the adverse drug reactions with 120 patients in 2009. RESULTS The adverse drug reaction report mainly derives from medical institution. The adverse drug reactions in our hospital were chiefly caused by antiinfectives, which the primary route of administration was intravenous drip. The major adverse reaction involved the digestive system, skin and its appendage. CONCLUSION We should strengthen and attach importance to the adverse drug reaction in order to guarantee the public to use drug safely and reasonably.
张夏华; 吴广通; 石玉岚; 米丽
To probe into the status quo and characteristics of the adverse drug reactions (ADR) occurred in our hospital. METHODS: A total of 560 ADR cases collected in our hospital from 2004 to 2008 were analyzed statistically in respect of patients' age and sex, drug varieties, route of administration and clinical manifestation, etc. RESULTS: Of all the ADR cases reported in our hospital, 51.8% were induced by anti-infective drugs vs. 10.7% by traditional Chinese medicines; 51.8% manifested as lesions of skin and its appendants, but none of them died. CONCLUSION: Clinical importance should be attached to the monitoring of ADR, the indications of the anti-infective drugs and traditional Chinese medicines should be strictly followed in order to decrease the incidence of ADR.%目的:了解我院药品不良反应(ADR)的发生情况及特点.方法:将我院2004～2008年收集的ADR报告560例,按患者性别、年龄、涉及药品种类、给药途径、临床表现等进行统计、分析.结果:在我院上报的ADR中,抗感染药引发的ADR占51.8%,中药制剂占10.7%;ADR类型以皮肤及其附件损伤最常见,占51.8%,无死亡病例报道.结论:临床应加强ADR监测工作,尤其要严格把握抗感染药及中成药的使用指征,减少ADR的发生.
VM Morais; H Massaldi
Antivenoms have been widely used for more than a century for treating snakebites and other accidents with poisonous animals. Despite their efficacy, the use of heterologous antivenoms involves the possibility of adverse reactions due to activation of the immune system. In this paper, alternatives for antivenom production already in use were evaluated in light of their ability to minimize the occurrence of adverse reactions. These effects were classified according to their molecular mechanism ...