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Sample records for adverse drug reaction

  1. Pharmacogenomics and adverse drug reactions in children

    OpenAIRE

    Rieder, Michael J; Carleton, Bruce

    2014-01-01

    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...

  2. Monitoring Adverse Drug Reactions: A Preliminary Study

    OpenAIRE

    Reynolds, J. L.

    1981-01-01

    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 ...

  3. Pharmacogenetics of idiosyncratic adverse drug reactions.

    Science.gov (United States)

    Pirmohamed, Munir

    2010-01-01

    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

  4. Adverse drug reactions in the elderly

    Directory of Open Access Journals (Sweden)

    Dhriti K Brahma

    2013-01-01

    Full Text Available Medications probably are the single most important health care technology in preventing illness, disability, and death in the geriatric population. Age-related changes in drug disposition and pharmacodynamic responses have significant clinical implications; increased use of a number of medications raises the risk that medicine-related problems may occur. The relationship between increased use of drugs including the prescription medication and elderly is well established. Majority of ADRs (80% causing admission or occurring in hospital are type A reactions. Although less common occurring in elderly, type B ADRs may sometimes cause serious toxicity. Studies have correlated the integral association between old age and increased rate of adverse drug reactions arising out of confounding association between age and polypharmacy contributed by age-related changes in pharmacodynamics and pharmacokinetics at least for some medical conditions. A drug combination may sometimes cause synergistic toxicity which is greater than the sum of the risks of toxicity of either agent used alone. But, strategies to increase opportunities for identifying ADRs and related problems have not been emphasised in current international policy responses especially in India to the increase in elderly population and chronic conditions. Careful epidemiological studies that encompass large numbers of elderly drug users are required to obtain this information as increased knowledge of the frequency and cost of adverse drug reactions is important in enabling both more rational therapeutic decisions by individual clinicians and more optimal social policy.

  5. Serum tryptase levels in adverse drug reactions.

    Science.gov (United States)

    Ordoqui, E; Zubeldia, J M; Aranzábal, A; Rubio, M; Herrero, T; Tornero, P; Rodríguez, V M; Prieto, A; Baeza, M L

    1997-11-01

    We evaluated the usefulness of individual tryptase levels and variations after adverse drug reactions in 64 patients. Our aim was to find a tool for the diagnosis of drug allergy. Thirty-seven subjects were confirmed to have drug allergy, 12 had nonsteroidal anti-inflammatory drug (NSAID) reactions, five had negative controlled drug challenges (NAAR), and 10 had symptoms after placebo intake (PLA). Serum tryptase levels greatly increased after anaphylactic shocks (2242%) and anaphylaxis (710.5%). Patients with allergic urticaria and those with idiosyncratic responses to acetylsalicylic acid (ASA) exhibited a small increase in serum tryptase (49.5% and 38.2%, respectively). In the other two groups (NAAR and PLA), no variation in this serum protease was observed. The time of appearance of the serum tryptase peak differed considerably among patients with similar clinical reactions (from 30 min to 6 h) and was independent of the latent period, severity of symptoms, or the amount of tryptase released. We conclude that serum tryptase determinations are helpful in the diagnosis of anaphylactic shock and anaphylaxis, but serial measurements may be needed to confirm mast-cell participation in milder reactions.

  6. Ranking Adverse Drug Reactions With Crowdsourcing

    KAUST Repository

    Gottlieb, Assaf

    2015-03-23

    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.

  7. Detect adverse drug reactions for drug Pioglitazone

    OpenAIRE

    Liu, Yihui; Aickelin, Uwe

    2013-01-01

    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...

  8. Epidemiology of adverse drug reactions in Europe

    DEFF Research Database (Denmark)

    Bouvy, Jacoline C; De Bruin, Marie L; Koopmanschap, Marc A

    2015-01-01

    Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3....... These results indicate that the occurrence of ADRs in the European hospital setting-both ADRs that result in hospitalization and ADRs that occur during the hospital stay-is significant. Furthermore, the limited number of studies that were performed in the outpatient setting identify a lack of information...

  9. Consumer reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Aagaard, Lise; Nielsen, Lars Hougaard; Hansen, Ebba Holme

    2009-01-01

    BACKGROUND: Reporting adverse drug reactions (ADRs) has traditionally been the sole province of healthcare professionals. Since 2003 in Denmark, consumers have been able to report ADRs directly to the authorities. The objective of this study was to compare ADRs reported by consumers with ADRs...... medicines on level 1 of the anatomical therapeutic chemical (ATC) classification system. ADR reports from consumers were compared with reports from other sources (physicians, pharmacists, lawyers, pharmaceutical companies and other healthcare professionals). Chi-square and odds ratios (ORs) were calculated...... to investigate the dependence between type of reporter and reported ADRs (classified by ATC or SOC). FINDINGS: We analysed 6319 ADR reports corresponding to 15 531 ADRs. Consumers reported 11% of the ADRs. Consumers' share of 'serious' ADRs was comparable to that of physicians (approximately 45%) but lower than...

  10. Cutaneous adverse drug reactions caused by antituberculosis drugs.

    Science.gov (United States)

    Rezakovic, Saida; Pastar, Zrinjka; Kostovic, Kresimir

    2014-01-01

    Multidrug antituberculosis regimen is associated with diverse clinical patterns of cutaneous adverse drug reactions (CADR), ranging from mild and moderate such as pruritus, maculopapular exanthems, lichenoid eruptions, fixed drug eruptions and urticaria to severe and even life threatening ones like acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These adverse reactions to antituberculosis drugs are commonly observed adverse events. This is of particular importance for high HIV prevalence settings and developing countries where tuberculosis is common infection resulting in higher occurrence rate of these reactions. There is still significant heterogenity in definition and classification of CADR, as well as diversity in treatment modalities following adverse reactions and rechallenge management. The aim of this review is to discuss clinical presentation, occurrence of CADR caused by antituberculosis drugs, to identify risk factors for intolerance of the standard therapy as well as to draw attention to importance of multi-disciplinary approach, early detection, prompt diagnosis and in time management of antituberculosis drugs associated CADR. CADR can cause significant treatment interruption and alteration, resulting in increased risk of treatment failure, drug resistance, relapses and increased risk of complications including even lethal outcome. Finally, it can be concluded that it is of great importance to identify the best possible treatment and preventive regimens in order to enable continuity of the antituberculosis therapy to the full extent. PMID:25039910

  11. Adverse reactions to new anticonvulsant drugs.

    Science.gov (United States)

    Wong, I C; Lhatoo, S D

    2000-07-01

    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

  12. Children and ADRs (Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Napoleone Ettore

    2010-01-01

    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.

  13. Adverse Cutaneous Reactions to Psychotropic Drugs: A Review

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    Filipa Novais

    2015-11-01

    Full Text Available Introduction: Psychotropic drugs are often implicated in cutaneous adverse drug reactions. While most of these reactions have a benign character, it is still important, however, to consider its role in the increasing stigma and treatment adherence. A small number of the cutaneous adverse drug reactions can develop into serious and potentially fatal conditions. Objectives: This article aims to review the most common cutaneous adverse drug reactions in patients taking psychotropic drugs. Methods: In this study, a search was carried out in the MEDLINE database for English language articles published , from 1999 to 2014, using as keywords: psychiatric, psychotropic, cutaneous, adverse reaction, antidepressive agents, antipsychotics, benzodiazepines, mood stabilizers, anticonvulsant, dementia. Information available from the Portuguese regulatory and supervising agency (Infarmed was also included.Results: 121 articles were found with reference to cutaneous adverse drug reactions associated with psychotropic drugs. The drugs most frequently reported as associated with such adverse effects were anticonvulsants used as mood stabilizers, followed by the antipsychotics . The antidementia drugs were rarely associated with serious cutaneous adverse reactions. Discussion and Conclusion: Cutaneous drug adverse reactions are common in psychiatric clinical practice and typically are minor in severity. The most severe reactions are most often associated with the use of mood stabilizing medications. Some of these side effects can be solved with reduction or drug discontinuation. More severe cases should be referred to a specialist in dermatology.

  14. Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

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    JiHyeon Ryu

    Full Text Available We analyzed differences between spontaneously reported drug-induced (not including contrast media and contrast media-induced adverse reactions.Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed.Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021% and 3.9/100,000 (outpatients, 0.004%. The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001, and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001. Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001 but not among contrast media-induced adverse reactions (56.6%, p = 0.066. Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001.We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health

  15. Promoting adverse drug reaction reporting: comparison of different approaches

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    Inês Ribeiro-Vaz

    2016-01-01

    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.

  16. Cutaneous adverse drug reactions in dogs treated with antiepileptic drugs

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    Tina eKoch

    2016-04-01

    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.

  17. A Survey of Adverse Drug Reactions in Family Practice

    OpenAIRE

    Reynolds, J. L.

    1984-01-01

    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...

  18. Epidemiology and prevention of adverse drug reactions in the elderly

    Institute of Scientific and Technical Information of China (English)

    Lexin WANG

    2005-01-01

    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.

  19. Adverse drug reactions in self-medication

    OpenAIRE

    Smuseva O.N.; Solovkina Yu.V.

    2012-01-01

    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...

  20. Adverse drug reactions to ibuprofen: a case report

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    Khobragade Yadneshwar

    2016-02-01

    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

  1. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

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    Ghosh S

    2006-01-01

    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.

  2. Adverse drug reactions in the paediatric population in Denmark

    DEFF Research Database (Denmark)

    Aagaard, Lise; Weber, Camilla Blicher; Hansen, Ebba Holme

    2010-01-01

    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 n...

  3. Predicting risk of adverse drug reactions in older adults

    OpenAIRE

    Lavan, Amanda Hanora; Gallagher, Paul

    2016-01-01

    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...

  4. ARWAR: A network approach for predicting Adverse Drug Reactions.

    Science.gov (United States)

    Rahmani, Hossein; Weiss, Gerhard; Méndez-Lucio, Oscar; Bender, Andreas

    2016-01-01

    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.

  5. Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance

    OpenAIRE

    S. Malhotra; Karan, R; P. Pandhi; S. Jain

    2001-01-01

    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...

  6. Parkinsonism caused by adverse drug reactions: a case series

    Directory of Open Access Journals (Sweden)

    Agaba Emmanuel I

    2011-03-01

    Full Text Available Abstract Introduction Parkinsonism puts a high direct cost burden on both patient and caregiver. Several reports of drug-induced parkinsonism have been published, but to the best of our knowledge, there has not been any report of quinine or halothane inducing parkinsonism. Case presentation We describe two cases of parkinsonism possibly caused by adverse drug reaction to quinine in a 29-year-old black Nigerian woman and to halothane in a 36-year-old black Hausa (Nigerian man who received it as general anaesthesia for appendicectomy in our teaching hospital. Conclusion These are two unusual cases of parkinsonism caused by adverse drug reactions to high-dose quinine and to halothane as general anaesthesia. We consider that these two cases are important in bringing this potential side-effect to the attention of both pharmacologists and primary care physicians as these are two of the most commonly used medications in our clinics. We conclude that parkinsonism should be included among the adverse drug reactions to high-dose quinine and halothane general anaesthetic.

  7. Patients’ attention to and understanding of adverse drug reaction warnings

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    Tresa Muir McNeal

    2010-12-01

    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

  8. Retrospective evaluation of adverse drug reactions induced by antihypertensive treatment

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    Pierandrea Rende

    2013-01-01

    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.

  9. Identification of possible adverse drug reactions in clinical notes

    DEFF Research Database (Denmark)

    Warrer, Pernille; Jensen, Peter Bjødstrup; Aagaard, Lise;

    2015-01-01

    information is generally available for causality assessment. However, manual review of clinical notes is too time-consuming for routine use and hence there is a need for developing information technology (IT) tools for automatic screening of patient records with the purpose to detect information about......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...

  10. EDITORIAL ADVERSE DRUG REACTIONS: A MULTIFORM PATHOLOGY RESPONSABILITY OF MANY

    Directory of Open Access Journals (Sweden)

    Joan-Ramon Laporte

    2009-09-01

    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

  11. Information about adverse drug reactions reported in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

    2010-01-01

    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...... 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......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...

  12. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal

    OpenAIRE

    Ghosh S; Acharya Leelavathi; Rao Padma

    2006-01-01

    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...

  13. Physician access to drug profiles to reduce adverse reactions

    Science.gov (United States)

    Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.

    1995-10-01

    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.

  14. Adverse Reactions to Antituberculosis Drugs in Iranian Tuberculosis Patients

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    Aliasghar Farazi

    2014-01-01

    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.

  15. Predicting risk of adverse drug reactions in older adults.

    Science.gov (United States)

    Lavan, Amanda Hanora; Gallagher, Paul

    2016-02-01

    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

  16. Adverse drug reactions associated with asthma medications in children

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    from 1 to 22 months. The most frequently reported ADRs were exacerbation of asthma, respiratory tract infection, cough, fever and headache. Only few ADRs were rated as being serious, however a number of children dropped out of the clinical trials due to serious ADRs, and, therefore, the real number......Background Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. Objective To review published clinical trials...... on the 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...

  17. Ethnic differences in adverse drug reactions to asthma medications

    DEFF Research Database (Denmark)

    Hu, Yusun; Cantarero-Arévalo, Lourdes

    2016-01-01

    BACKGROUND: Information on ethnic diversity of adverse drug reactions (ADRs) to asthma medications is rare despite evidence suggesting higher risk for African Americans when using β2-adrenergic receptor agonists. The objectives are to investigate how ethnic background was involved in ADR assessment...... and to examine the relationship between ethnic background and ADRs to asthma medications. METHODS: MEDLINE was searched until March 2014. All types of studies reporting ADRs to asthma medications involving more than one ethnic group were included. Extracted information includes study designs, ethnic backgrounds...... studies disaggregated information by ethnic background, and reports of ADRs to asthma medications in different ethnic groups were rare. We suggest that the inclusion of ADR analysis by different ethnic backgrounds is desirable....

  18. Toxic epidermal necrolysis: a severe cutaneous adverse drug reaction

    Directory of Open Access Journals (Sweden)

    K. N. Chidananda

    2015-02-01

    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

  19. An overview on adverse drug reactions to traditional Chinese medicines.

    Science.gov (United States)

    Chan, Kelvin; Zhang, Hongwei; Lin, Zhi-Xiu

    2015-10-01

    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

  20. Adverse drug reactions to herbal and synthetic expectorants.

    Science.gov (United States)

    Ernst, E; Sieder, C; März, R

    1995-01-01

    Our knowledge relating to adverse drug reactions (ADRs) of phytomedicines is highly fragmentary. The aim of this study was to define the prevalence of ADRs following medication with herbal or synthetic expectorants. In a multicentre, comparative post-marketing surveillance study of more than 3000 patients with acute bronchitis, about half were treated with a herbal remedy (SinupretR) and the other half with various other expectorants. In ascending order of incidence, ADRs were noted during mono-medication of SinupretR (0.8%), Ambroxol (1.0%) and acetylcysteine (4.3%). When concomitant drugs were used, this rank order was unchanged but incidence rates were markedly increased (3.4, 6.5 and 8.2%, respectively). The most frequent ADRs were gastrointestinal symptoms. It is concluded that expectorants are associated with ADRs in roughly 1-5% of cases undergoing single drug treatment and in 3-10% when more than one medication is being used. Amongst the expectorants used in this study, the herbal preparation SinupretR is associated with the lowest incidence of ADRs.

  1. Bias in spontaneous reporting of adverse drug reactions in Japan.

    Directory of Open Access Journals (Sweden)

    Shinichi Matsuda

    Full Text Available Attitudes of healthcare professionals regarding spontaneous reporting of adverse drug reactions (ADRs in Japan are not well known, and Japan's unique system of surveillance, called early post-marketing phase vigilance (EPPV, may affect these reporting attitudes. Our objectives were to describe potential effects of EPPV and to test whether ADR seriousness, prominence, and frequency are related to changes in reporting over time.A manufacturer's database of spontaneous ADR reports was used to extract data from individual case safety reports for 5 drugs subject to EPPV. The trend of reporting and the time lag between ADR onset and reporting to the manufacturer were examined. The following indices for ADRs occurring with each drug were calculated and analyzed to assess reporting trends: Serious:Non-serious ratio, High prominence:Low prominence ratio, and High frequency:Low frequency ratio.For all 5 drugs, the time lag between ADR onset and reporting to the manufacturer was shorter in the EPPV period than in the post-EPPV period. All drugs showed higher Serious:Non-serious ratios in the post-EPPV period. No specific patterns were observed for the High prominence:Low prominence ratio. The High frequency:Low frequency ratio for peginterferon alpha-2a and sevelamer hydrochloride decreased steadily throughout the study period.Healthcare professionals may be more likely to report serious ADRs than to report non-serious ADRs, but the effect of event prominence on reporting trends is still unclear. Factors associated with ADR reporting attitude in Japan might be different from those in other countries because of EPPV and the involvement of medical representatives in the spontaneous reporting process. Pharmacovigilance specialists should therefore be cautious when comparing data between different time periods or different countries. Further studies are needed to elucidate the underlying mechanism of spontaneous ADR reporting in Japan.

  2. Adverse Drug Reactions: Knowledge, Attitude and Practice of Pharmacy

    Directory of Open Access Journals (Sweden)

    Maryam Etminani-Isfahani

    2015-10-01

    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.

  3. Perception of Nigerian medical students on adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Abdullahi Rabiu Abubakar

    2015-01-01

    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.

  4. Pharmaco-epidemiology of Sumatriptan : cardiovascular adverse reactions to a new antimigrainous drug

    NARCIS (Netherlands)

    J.P. Ottervanger (Jan Paul)

    1996-01-01

    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

  5. Prospective Observational Study of Adverse Drug Reactions of Anticancer Drugs Used in Cancer Treatment in a Tertiary Care Hospital

    OpenAIRE

    V. K. Saini; Sewal, R. K.; Ahmad, Yusra; B Medhi

    2015-01-01

    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 ...

  6. Usefulness of drug provocation tests in children with a history of adverse drug reaction

    OpenAIRE

    Hye Ran Na; Jeong Min Lee; Jo Won Jung; Soo-Young Lee

    2011-01-01

    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 ...

  7. Quality check of spontaneous adverse drug reaction reporting forms of different countries.

    Science.gov (United States)

    Bandekar, M S; Anwikar, S R; Kshirsagar, N A

    2010-11-01

    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.

  8. Sex-related differences in hospital admissions attributed to adverse drug reactions in the Netherlands

    NARCIS (Netherlands)

    E.M. Rodenburg (Eline); B.H.Ch. Stricker (Bruno); L.E. Visser (Loes)

    2011-01-01

    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

  9. Antiepileptic Drug-Related Adverse Reactions and Factors Influencing These Reactions

    Directory of Open Access Journals (Sweden)

    Parvaneh KARIMZADEH

    2013-08-01

    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

  10. Usefulness of drug provocation tests in children with a history of adverse drug reaction

    Directory of Open Access Journals (Sweden)

    Hye Ran Na

    2011-07-01

    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.

  11. Pharmacoepidemiological characterization of drug-induced adverse reaction clusters towards understanding of their mechanisms.

    Science.gov (United States)

    Mizutani, Sayaka; Noro, Yousuke; Kotera, Masaaki; Goto, Susumu

    2014-06-01

    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

  12. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo

    2016-09-01

    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

  13. Vitamin D deficiency as adverse drug reaction? A cross-sectional study in Dutch geriatric outpatients

    NARCIS (Netherlands)

    Orten-Luiten, van A.C.B.; Janse, A.; Dhonukshe-Rutten, R.A.M.; Witkamp, R.F.

    2016-01-01

    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

  14. Genetic polymorphisms affect efficacy and adverse drug reactions of DMARDs in rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun

    2014-11-01

    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.

  15. Genetic polymorphisms affect efficacy and adverse drug reactions of DMARDs in rheumatoid arthritis.

    Science.gov (United States)

    Zhang, Ling Ling; Yang, Sen; Wei, Wei; Zhang, Xue Jun

    2014-11-01

    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

  16. Cutaneous adverse drug reactions seen at a university hospital department of dermatology

    DEFF Research Database (Denmark)

    Borch, Jakob E; Andersen, Klaus E; Bindslev-Jensen, Carsten

    2006-01-01

    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...

  17. Adverse drug reactions: 'six rights' to ensure best practice for children.

    Science.gov (United States)

    Kanneh, Agnes

    2011-06-01

    In the second of a two-part article on adverse drug reactions Agnes Kanneh describes the six 'rights' of the recipient of a drug. These are: that the right person should receive the right drug, in the right dose, at the right time within the right intervals, via the right route, followed by the right (correct) documentation. The author argues that the observance of these 'rights' by children's nurses ensures the best pharmacotherapeutic practice, thus a robust practical safeguard in adverse drug reactions and threats to the good reputation of the nursing profession.

  18. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    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

  19. Adverse drug reactions to ibuprofen: a case report

    OpenAIRE

    Khobragade Yadneshwar; Khobragade Sujata

    2016-01-01

    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...

  20. Adverse drug reactions and organ damage: The liver.

    Science.gov (United States)

    Licata, Anna

    2016-03-01

    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

  1. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    OpenAIRE

    Deepti Chopra; Rehan, Harmeet S.; Vibha Sharma; Ritu Mishra

    2016-01-01

    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...

  2. Analysis of adverse drug reactions of atypical antipsychotic drugs in psychiatry OPD

    Directory of Open Access Journals (Sweden)

    Kiran G Piparva

    2011-01-01

    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.

  3. Vitamin D deficiency as adverse drug reaction? A cross-sectional study in Dutch geriatric outpatients

    OpenAIRE

    Orten-Luiten, van, A.C.B.; A. Janse; R. A. M. Dhonukshe-Rutten; Witkamp, R F

    2016-01-01

    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...

  4. Adverse Drug Reaction Reports of Patients and Healthcare Professionals : How Different Are They?

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; van Puijenbroek, Eugène; van Grootheest, Adrianus

    2013-01-01

    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

  5. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions : an example with diuretics and non-steroidal anti-inflammatory drugs

    NARCIS (Netherlands)

    van Puijenbroek, E P; Egberts, A C; Heerdink, E R; Leufkens, H G

    2000-01-01

    OBJECTIVE: Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable si

  6. Erythema multiforme-like eruption from a slimming drug preparation cutaneous adverse drug reaction

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    Linda Tognetti

    2011-01-01

    Full Text Available We report a case of a 34-year-old woman presenting with an erythema multiforme (EM-like eruption. Lesions developed after a 12-day treatment with a slimming drug preparation (food integrator with thermogenic activity and a herbal remedy (pilosella tincture. Serological investigations excluded viral or bacterial infections. Patch testing with galenic preparations of both drugs demonstrated sensitization to the slimming drug preparation. According to literature reports and immune-chemical properties, those components that are likely to have triggered the skin eruption are clorazepate dipotassium and theobromine. Their interaction with other two constituents such as pseudoephedrine hydrochloride and dehydrocholic acid may have caused the adverse reaction by means of a summation effect. There are no reports specifically about EM caused by a slimming drug preparation and no studies have identified thermogenic pills as cause of EM/EM-like eruption. Weight-loss compounds in slimming preparations should be kept in mind as a possible cause of drug-induced EM-like eruption.

  7. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs

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    Moore N

    2015-07-01

    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

  8. Drug reaction with eosinophilia and systemic symptoms (DRESS) : an original multisystem adverse drug reaction. Results from the prospective RegiSCAR study

    NARCIS (Netherlands)

    Kardaun, S. H.; Sekula, P.; Valeyrie-Allanore, L.; Liss, Y.; Chu, C. Y.; Creamer, D.; Sidoroff, A.; Naldi, L.; Mockenhaupt, M.; Roujeau, J. C.

    2013-01-01

    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

  9. ADVERSE DRUG REACTIONS: FACTORS AND ROLE OF PHARMACIST IN THEIR PREVENTION.

    Science.gov (United States)

    Bushra, Rabia; Baloch, Saba Ajaz; Jabeen, Aisha; Bano, Nusrat; Aslam, Nousheen

    2015-01-01

    Adverse drug reactions (ADRs) are the undesirable effects of drugs even when administered in daily normal doses. It has been seen that ADRs may arise even after single administration of drug(s), however, long term therapies are more prone to ADRs. Currently it has become a burning issue all around the world and connected with financial expansion owing to hospitalization. Pharmacists are the custodians of drugs especially clinical pharmacists play a vital role in preventing the risks of ADRs. This review deals with the factors leading to possible ADRs, its prevention and the role of pharmacist in management of ADRs.

  10. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information

    NARCIS (Netherlands)

    Rolfes, Leàn; van Hunsel, Florence; Wilkes, Sarah; Grootheest, Kees van; Puijenbroek, Eugène van

    2015-01-01

    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

  11. Reporting of adverse drug reactions by general practitioners : a questionnaire-based study in the Netherlands

    NARCIS (Netherlands)

    Passier, Anneke; ten Napel, Marije; van Grootheest, Kees; van Puijenbroek, Eugène

    2009-01-01

    BACKGROUND: There has been a gradual decline over the years in the number of spontaneous reports of potential adverse drug reactions (ADRs) from general practitioners (GPs) in the Netherlands. OBJECTIVE: To reveal aspects of knowledge, attitudes and behaviour that can stimulate GPs to submit (more)

  12. Adverse drug reactions in older patients during hospitalisation: are they predictable?

    LENUS (Irish Health Repository)

    O'Connor, Marie N

    2012-11-01

    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.

  13. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, Eugène; Diemont, Willem; van Grootheest, Kees

    2003-01-01

    The primary aim of spontaneous reporting systems (SRSs) is the timely detection of unknown adverse drug reactions (ADRs), or signal detection. Generally this is carried out by a systematic manual review of every report sent to an SRS. Statistical analysis of the data sets of an SRS, or quantitative

  14. Analysis of spontaneous reports of thromboembolic adverse drug reactions associated with cyproterone/ethinylestradiol

    NARCIS (Netherlands)

    Van Hunsel, F.; Van Puijenbroek, E.

    2013-01-01

    Introduction: After media attention on thromboembolic adverse drug reactions (ADRs) and the use of cyproterone/ethinylestradiol [1], the Netherlands Pharmacovigilance Centre Lareb received a high number of reports about this association, which called for a more detailed analyses. Aim: To provide an

  15. Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    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 con...... consumer for nervous system medications....

  16. Adverse drug reaction-related hospitalisations: A nationwide study in The Netherlands

    NARCIS (Netherlands)

    C.S. van der Hooft (Cornelis); M.C.J.M. Sturkenboom (Miriam); K. van Grootheest (Kees); H.J. Kingma (Herre); B.H.Ch. Stricker (Bruno)

    2006-01-01

    textabstractBackground: The incidence of adverse drug reaction (ADR)-related hospitalisations has usually been assessed within hospitals. Because of the variability in results and methodology, it is difficult to extrapolate these results to a national level. Objectives: To evaluate the incidence and

  17. Musculoskeletal adverse drug reactions: a review of literature and data from ADR spontaneous reporting databases.

    Science.gov (United States)

    Conforti, Anita; Chiamulera, Christian; Moretti, Ugo; Colcera, Sonia; Fumagalli, Guido; Leone, Roberto

    2007-01-01

    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

  18. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    Science.gov (United States)

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    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.

  19. Monitoring of Adverse Drug Reactions Associated with Antihypertensive Medicines at a University Teaching Hospital in New Delhi

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    Fowad Khurshid

    2012-09-01

    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.

  20. Are Migraineurs at Increased Risk of Adverse Drug Responses? : A Meta-Analytic Comparison of Topiramate-Related Adverse Drug Reactions in Epilepsy and Migraine

    NARCIS (Netherlands)

    Luykx, J.; Mason, M.; Ferrari, M. D.; Carpay, J.

    2009-01-01

    To compare adverse drug reactions (ADRs) to topiramate in patients with migraine and patients with epilepsy, we systematically reviewed all published randomized controlled trials (RCTs) that compare topiramate monotherapy in epilepsy and migraine. We included four epilepsy RCTs (N = 1,179 patients;

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

    Directory of Open Access Journals (Sweden)

    Johnson Segun Showande

    2013-01-01

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

  2. Enhancing communication about paediatric medicines: lessons from a qualitative study of parents' experiences of their child's suspected adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    Janine Arnott

    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

  3. Feature Selection in Detection of Adverse Drug Reactions from the Health Improvement Network (THIN Database

    Directory of Open Access Journals (Sweden)

    Yihui Liu

    2015-02-01

    Full Text Available Adverse drug reaction (ADR is widely concerned for public health issue. ADRs are one of most common causes to withdraw some drugs from market. Prescription event monitoring (PEM is an important approach to detect the adverse drug reactions. The main problem to deal with this method is how to automatically extract the medical events or side effects from high-throughput medical events, which are collected from day to day clinical practice. In this study we propose a novel concept of feature matrix to detect the ADRs. Feature matrix, which is extracted from big medical data from The Health Improvement Network (THIN database, is created to characterize the medical events for the patients who take drugs. Feature matrix builds the foundation for the irregular and big medical data. Then feature selection methods are performed on feature matrix to detect the significant features. Finally the ADRs can be located based on the significant features. The experiments are carried out on three drugs: Atorvastatin, Alendronate, and Metoclopramide. Major side effects for each drug are detected and better performance is achieved compared to other computerized methods. The detected ADRs are based on computerized methods, further investigation is needed.

  4. To Discuss the Adverse reaction of Chinese Patent Drug%浅谈中成药的不良反应

    Institute of Scientific and Technical Information of China (English)

    刘伦栋

    2014-01-01

    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。

  5. Digging Up the Human Genome: Current Progress in Deciphering Adverse Drug Reactions

    Directory of Open Access Journals (Sweden)

    Shih-Chi Su

    2014-01-01

    Full Text Available Adverse drug reactions (ADRs are a major clinical problem. In addition to their clinical impact on human health, there is an enormous cost associated with ADRs in health care and pharmaceutical industry. Increasing studies revealed that genetic variants can determine the susceptibility of individuals to ADRs. The development of modern genomic technologies has led to a tremendous advancement of improving the drug safety and efficacy and minimizing the ADRs. This review will discuss the pharmacogenomic techniques used to unveil the determinants of ADRs and summarize the current progresses concerning the identification of biomarkers for ADRs, with a focus on genetic variants for genes encoding drug-metabolizing enzymes, drug-transporter proteins, and human leukocyte antigen (HLA. The knowledge gained from these cutting-edge findings will form the basis for better prediction and management for ADRs, ultimately making the medicine personalized.

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

    Directory of Open Access Journals (Sweden)

    Caterina Palleria

    2013-01-01

    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.

  7. Predicting and detecting adverse drug reactions in old age: challenges and opportunities.

    Science.gov (United States)

    Mangoni, Arduino A

    2012-05-01

    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

  8. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    Science.gov (United States)

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  9. Adverse drug reactions in children reported by European consumers from 2007 to 2011

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2014-01-01

    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...... of the general type (20 %) and nervous system disorders (15 %). The largest share of serious ADRs was of the type nervous system disorders (17 % of all serious). Three cases of death were reported. Vaccines and anti-infectives for systemic use contributed to 30 % of ADRs, antineoplastic and immunomodulating...

  10. Pattern of angiotensin-converting enzyme inhibitors induced adverse drug reactions in South Indian teaching hospital

    Directory of Open Access Journals (Sweden)

    Uday Venkat Mateti

    2012-01-01

    Full Text Available Background: Adverse drug reactions (ADRs occur frequently with cardiovascular drugs leading to change in therapy, increasing morbidity, and mortality. Aim: The study was conducted to evaluate the incidence of ADRs due to angiotensin-converting enzyme Inhibitors in cardiology department. Materials and Methods: A cross-sectional observational study was carried out for a period of 6 months. The data were assessed for the pattern of the ADRs with respect to patient demographics, nature of the reaction, outcome of the reactions, causality, severity, and preventability. Results: Among 692 patients, 51 (7.36% had developed 60 ADRs, and majority of cases (56.66% were in the age group of >61 years and most of them were developed in female (80%. The common ADRs observed were cough, hypotension, hyperkalemia, and acute renal failure. In 21.66% cases the dose of the suspected drug was altered and in 78.33% cases the drug was withdrawn. Considering the outcome, 93.33% of cases recovered from ADRs, whereas in 6.66% cases were continuing. Causality assessment showed that majority of ADRs was probable and were found to be moderately severe. Conclusion: Our study concludes geriatrics and female patients have higher incidence of ADRs. So early identification and management of ADRs are essential for this population.

  11. Cutaneous adverse drug reaction type erythema multiforme major induced by eslicarbazepine.

    Science.gov (United States)

    Massot, Andreu; Gimenez-Arnau, Ana

    2014-10-01

    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

  12. Medicinal plant reported with adverse reactions in Cuba: potential interactions with conventional drugs

    Directory of Open Access Journals (Sweden)

    Ioanna Martínez

    2015-04-01

    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.

  13. Severe cutaneous adverse drug reactions:a review on epidemiology,etiology,clinical manifestation and pathogenesis

    Institute of Scientific and Technical Information of China (English)

    Tomy Martin; LI Hui

    2008-01-01

    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.

  14. Relationship between serum acetaminophen concentration and N-acetylcysteine-induced adverse drug reactions.

    Science.gov (United States)

    Zyoud, Sa'ed H; Awang, Rahmat; Sulaiman, Syed Azhar Syed; Khan, Halilol Rahman Mohamed; Sawalha, Ansam F; Sweileh, Waleed M; Al-Jabi, Samah W

    2010-09-01

    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

  15. Prescribing pattern and adverse drug reactions monitoring in patients with rheumatoid arthritis in a tertiary care hospital

    OpenAIRE

    Lakshmi Prabha M; Geetha Rani A; Meenakshi Balasubramanian; Ezhil Ramya J

    2016-01-01

    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 ...

  16. Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

    Science.gov (United States)

    Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

    2016-01-01

    Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

  17. Chemotherapy-induced adverse drug reactions in oncology patients: A prospective observational survey

    Directory of Open Access Journals (Sweden)

    Deepti Chopra

    2016-01-01

    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.

  18. A PROSPECTIVE, OBSERVATIONAL STUDY OF ADVERSE REACTIONS TO DRUG REGIME FOR MULTI-DRUG RESISTANT PULMONARY TUBERCULOSIS IN CENTRAL INDIA.

    Directory of Open Access Journals (Sweden)

    Dr. Rohan C. Hire

    2014-09-01

    Full Text Available Abstract Objective: 1 To assess the adverse drug reactions of second line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR TB in central India on the basis of causality, severity and avoidability scales. 2 To study the relationship of type of MDR TB (primary or secondary and presence of diabetes mellitus (DM with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug resistant tuberculosis patients enrolled for DOTS‑Plus regimen at TB and Chest Disease Department from January to December 2012. They were followed for 9 months thereafter and encountered adverse drug reactions (ADRs were noted along with the time of sputum conversion. The data were analysed by Chi-square or Fisher’s exact test and unpaired student’s‘t’ test. Results: Total 64 ADRs were reported in 55 patients out of total 110 patients (n = 110. As per the Naranjo causality assessment of ADRs, 7 patients had “definite” causal relation, 45 had “probable” causal relation and 3 had “possible” causal relation with drugs of DOTS Plus regime. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being “Definitely avoidable”, 26 “Possibly avoidable”, 23 “Not avoidable” and 3 “unevaluable”. . Mean sputum smear conversion time is significantly higher in patients with secondary type than that of primary type of MDR TB (p = 0.0001 and in patients with DM than those without DM (p <0.0001. Conclusion: ADRs were common in patients of MDR TB on DOTs-Plus drug regime. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regime compared to DOTS regime in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and

  19. An intensive monitoring of adverse drug reaction in indoor patients of medicine department at tertiary care teaching hospital

    OpenAIRE

    Nishita H. Darji; Shilpa Jadav; Chintan Doshi; Rutvij Hedamba; Rusva Mistry; Hiren Trivedi

    2016-01-01

    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...

  20. Ci4SeR--curation interface for semantic resources--evaluation with adverse drug reactions.

    Science.gov (United States)

    Souvignet, Julien; Asfari, Hadyl; Declerck, Gunnar; Lardon, Jérémy; Trombert-Paviot, Béatrice; Jaulent, Marie-Christine; Bousquet, Cédric

    2014-01-01

    Evaluation and validation have become a crucial problem for the development of semantic resources. We developed Ci4SeR, a Graphical User Interface to optimize the curation work (not taking into account structural aspects), suitable for any type of resource with lightweight description logic. We tested it on OntoADR, an ontology of adverse drug reactions. A single curator has reviewed 326 terms (1020 axioms) in an estimated time of 120 hours (2.71 concepts and 8.5 axioms reviewed per hour) and added 1874 new axioms (15.6 axioms per hour). Compared with previous manual endeavours, the interface allows increasing the speed-rate of reviewed concepts by 68% and axiom addition by 486%. A wider use of Ci4SeR would help semantic resources curation and improve completeness of knowledge modelling.

  1. Knowledge of adverse drug reaction reporting in first year postgraduate doctors in a medical college

    Directory of Open Access Journals (Sweden)

    Upadhyaya P

    2012-06-01

    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

  2. Dose-Specific Adverse Drug Reaction Identification in Electronic Patient Records: Temporal Data Mining in an Inpatient Psychiatric Population

    DEFF Research Database (Denmark)

    Eriksson, Robert; Werge, Thomas; Jensen, Lars Juhl;

    2014-01-01

    Data collected for medical, filing and administrative purposes in electronic patient records (EPRs) represent a rich source of individualised clinical data, which has great potential for improved detection of patients experiencing adverse drug reactions (ADRs), across all approved drugs and across...

  3. Harvesting candidate genes responsible for serious adverse drug reactions from a chemical-protein interactome.

    Directory of Open Access Journals (Sweden)

    Lun Yang

    2009-07-01

    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.

  4. A Review of Adverse Cutaneous Drug Reactions Resulting from the Use of Interferon and Ribavirin

    Directory of Open Access Journals (Sweden)

    Nisha Mistry

    2009-01-01

    Full Text Available Drug-induced cutaneous eruptions are named among the most common side effects of many medications. Thus, cutaneous drug eruptions are a common cause of morbidity and mortality, especially in hospital settings. The present article reviews different presentations of drug-induced cutaneous eruptions, with a focus on eruptions reported secondary to the use of interferon and ribavirin. Presentations include injection site reactions, psoriasis, eczematous drug reactions, alopecia, sarcoidosis, lupus, fixed drug eruptions, pigmentary changes and lichenoid eruptions. Also reviewed are findings regarding life-threatening systemic drug reactions.

  5. A systematic review of observational studies evaluating costs of adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Batel Marques F

    2016-08-01

    ,192.36.Discussion: Methodological heterogeneities were identified among the included studies, such as design, type of ADEs, suspected drugs, and type and structure of costs. Despite such discrepancies, the financial burden associated with ADE costs was found to be high. In the light of the present findings, validated methods to measure ADE-associated costs need future research efforts. Keywords: drug costs, health care costs, drug-related side effects and adverse reactions, review

  6. Do no harm - But first we need to know more: The case of adverse drug reactions with antiepileptic drugs

    Directory of Open Access Journals (Sweden)

    Gagandeep Singh

    2011-01-01

    Full Text Available An adverse drug reaction (ADR is defined by the World Health Organization as a noxious, unintended, and undesired drug effect, when used for therapeutic purposes in humans. ADRs to anti-epileptic drugs (AEDs significantly impact the quality of life of people with epilepsy and account for a little less than half of all recorded treatment failures with AEDs. Hence prevention and early recognition of ADRs constitute an important aspect of management of epilepsy. Recent developments have improved our ability to predict and hence potentially prevent the occurrence of some of the serious ADRs to AEDs. One example is the potential prediction of the risk of severe cutaneous hypersensitivity reactions including Stevens Johnson syndrome and toxic epidermal necrolysis by testing for expression of HLA BFNx011502 allele in people of Asian origin who are prescribed carbamazepine. The association between HLA BFNx011502 expression and carbamazepine skin reactions has been documented in India but the role of HLA testing in Indian populations needs to be clarified in larger studies across different ethnic groups within the country.

  7. Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

    Directory of Open Access Journals (Sweden)

    Sato I

    2013-06-01

    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

  8. Adverse reactions to cosmetics

    OpenAIRE

    Dogra A; Minocha Y; Kaur S

    2003-01-01

    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 ...

  9. Trends of adverse drug reactions related-hospitalizations in Spain (2001-2006

    Directory of Open Access Journals (Sweden)

    de Miguel Gil

    2010-10-01

    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.

  10. Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

    Directory of Open Access Journals (Sweden)

    M. Süsskind

    2012-01-01

    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.

  11. Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

    Science.gov (United States)

    Sato, Izumi; Akazawa, Manabu

    2013-01-01

    Background 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 Japanese patients (men, 41.8%; 75 years or older, 35.1%) registered in the database, 2491 patients (4.0%) experienced a total of 3144 ADR events during the study period. The rate of ADR per 10,000 person-days was 2.0 for the monotherapy group, 5.1 for

  12. Extent of poly-pharmacy, occurrence and associated factors of drug-drug interaction and potential adverse drug reactions in Gondar Teaching Referral Hospital, North West Ethiopia

    OpenAIRE

    Endalkachew Admassie; Tesfahun Melese; Woldeselassie Mequanent; Wubshet Hailu; B Akshaya Srikanth

    2013-01-01

    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...

  13. A Retrospective Analysis of Spontaneous Adverse Drug Reactions Reports Relating to Paediatric Patients.

    Directory of Open Access Journals (Sweden)

    Rosliana Rosli

    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

  14. Adverse drug reactions associated with the use of disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis.

    Science.gov (United States)

    Machado-Alba, Jorge Enrique; Ruiz, Andrés Felipe; Machado-Duque, Manuel Enrique

    2014-12-01

    This study describes the adverse drug reactions (ADRs) and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART). A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years); these patients were from a cohort of 1,364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9). The cohort was mostly female (366, 87.4%) and had a mean age of 52.7 years (± 13.1). The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively). The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.

  15. Predicting adverse drug reactions in older adults; a systematic review of the risk prediction models.

    Science.gov (United States)

    Stevenson, Jennifer M; Williams, Josceline L; Burnham, Thomas G; Prevost, A Toby; Schiff, Rebekah; Erskine, S David; Davies, J Graham

    2014-01-01

    Adverse drug reaction (ADR) risk-prediction models for use in older adults have been developed, but it is not clear if they are suitable for use in clinical practice. This systematic review aimed to identify and investigate the quality of validated ADR risk-prediction models for use in older adults. Standard computerized databases, the gray literature, bibliographies, and citations were searched (2012) to identify relevant peer-reviewed studies. Studies that developed and validated an ADR prediction model for use in patients over 65 years old, using a multivariable approach in the design and analysis, were included. Data were extracted and their quality assessed by independent reviewers using a standard approach. Of the 13,423 titles identified, only 549 were associated with adverse outcomes of medicines use. Four met the inclusion criteria. All were conducted in inpatient cohorts in Western Europe. None of the models satisfied the four key stages in the creation of a quality risk prediction model; development and validation were completed, but impact and implementation were not assessed. Model performance was modest; area under the receiver operator curve ranged from 0.623 to 0.73. Study quality was difficult to assess due to poor reporting, but inappropriate methods were apparent. Further work needs to be conducted concerning the existing models to enable the development of a robust ADR risk-prediction model that is externally validated, with practical design and good performance. Only then can implementation and impact be assessed with the aim of generating a model of high enough quality to be considered for use in clinical care to prioritize older people at high risk of suffering an ADR.

  16. Adverse Drug Reactions in HIV/AIDS Patients at a Tertiary Care Hospital in Penang, Malaysia.

    Science.gov (United States)

    Khan, Kashifullah; Khan, Amer Hayat; Sulaiman, Syed Azhar; Soo, Chow Ting; Akhtar, Ali

    2016-01-01

    In the current study we explored the occurrence of adverse drug reactions (ADRs) to antiretroviral therapy among human immune-deficiency virus (HIV)/AIDS patients. We concluded an observational retrospective study in all patients who were diagnosed with HIV infection and were receiving highly active antiviral therapy from Jan. 2007 to Dec. 2012 at Hospital Pulau Pinang, Malaysia. Patient socio-demographic details along with clinical features and susceptible ADRs were observed during the study period. Out of 743 patients, 571 (76.9%) were men, and 172 (23.1%) were women. Overall 314 (42.2%) patients experienced ADRs. A total of 425 ADRs were reported, with 311 (73.1%) occurring in men and 114 (26.8%) in women, with a significant statistical relationship (P value (P) = 0.02, OR = 1.21). Overall 239 (56.2%) ADRs were recorded among Chinese, 94 (22.1%) in Malay, and 71 (16.7%) in Indian patients, which had a statistically significant association with ADRs (P = 0.05, OR = 1.50). Out of a total 425 among ADRs, lipodystrophy was recorded in 151 (35.5%) followed by skin rashes in 80 (18.8%), anemia in 74 (17.4%), and peripheral neuropathy in 27 (6.3%) patients. These findings suggest a need of intensive monitoring of ADRs in HIV treatment centres across Malaysia.

  17. Designing a national combined reporting form for adverse drug reactions and medication errors.

    Science.gov (United States)

    Tanti, A; Serracino-Inglott, A; Borg, J J

    2015-06-09

    The Maltese Medicines Authority was tasked with developing a reporting form that captures high-quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/medication error reporting and to improve the quality of data capture within their systems.

  18. Hospitalization in older patients due to adverse drug reactions -the need for a prediction tool.

    Science.gov (United States)

    Parameswaran Nair, Nibu; Chalmers, Leanne; Peterson, Gregory M; Bereznicki, Bonnie J; Castelino, Ronald L; Bereznicki, Luke R

    2016-01-01

    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

  19. Profile of rheumatology patients willing to report adverse drug reactions: bias from selective reporting

    Directory of Open Access Journals (Sweden)

    Protić D

    2016-02-01

    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

  20. Adverse Drug Reaction Mining in Pharmacovigilance data using Formal Concept Analysis

    OpenAIRE

    Villerd, Jean; Toussaint, Yannick; Lillo Le-Louët, Agnès

    2010-01-01

    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...

  1. The Clinical Manifestations, Treatment Efficacy and Adverse Drug Reactions in 62 Iranian Child with Wilson Disease

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    Mehri Najafi

    2014-09-01

    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.

  2. Development of an adverse drug reaction risk assessment score among hospitalized patients with chronic kidney disease.

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    Fatemeh Saheb Sharif-Askari

    Full Text Available 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 [16] 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.

  3. Treatments that generate higher number of adverse drug reactions and their symptoms

    Directory of Open Access Journals (Sweden)

    Lucía Fernández-López

    2015-12-01

    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.

  4. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

    NARCIS (Netherlands)

    van Puijenbroek, Eugène P; Bate, Andrew; Leufkens, Hubert G M; Lindquist, Marie; Orre, Roland; Egberts, Antoine C G

    2002-01-01

    PURPOSE: A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways

  5. Spontaneous monitoring of adverse reactions to drugs by Italian dermatologists: a pilot study. Gruppo Italiano Studi Epidemiologici in Dermatologia.

    Science.gov (United States)

    1991-01-01

    During 1988, the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED) coordinated a pilot study aimed at evaluating the feasibility of a system for spontaneous monitoring of adverse drug reactions in dermatological practice in Italy. Approximately 400 dermatologists were asked to collaborate, and 141 agreed to the study. Procedures similar to those well established in other surveillance programs (including the use of standard forms and standardized assessment procedure) were adopted. In a 2-month period 775 reports were collected, of which 711 were maintained after careful evaluation. The general profile of the adverse reactions reported was in accordance with the experience derived by other spontaneous surveillance programs. The main purpose of spontaneous reporting systems is the identification of new reactions, and a model analysis was proposed, in our study, with reference to skin reactions to bamifylline. The demonstration of the feasibility of a drug-monitoring program in Italy, where little tradition exists in the area, is the most important result of our study.

  6. Propranolol-induced gingival hyperplasia with Nager syndrome: A rare adverse drug reaction.

    Science.gov (United States)

    Raheel, Syed Ahamed; Kujan, Omar Bashar; Tarakji, Bassel; Umar, Dilshad; Ibrahim, Salah

    2016-01-01

    Drug reactions are a group of reactionary lesions generally show their manifestations in the oral cavity. The drug reactions may vary from local rashes to well-developed swellings in the oral cavity especially involving the gingiva. Most of the drug reactions are asymptomatic and commonly triggered from the active metabolite of a drug used for a long time. Nager syndrome is a group of acrofacial dysostosis that usually results in craniofacial and limb malformations. The craniofacial defects are very similar to the mandibulofacial dysostosis. A very early intervention is needed for the habilitation of the patient especially when it is concerned with speech and language development. This paper reports a case of a 32-year-old female with craniofacial, limb, and skeletal abnormalities along with a drug-induced gingival hyperplasia.

  7. Propranolol-induced gingival hyperplasia with Nager syndrome: A rare adverse drug reaction

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    Syed Ahamed Raheel

    2016-01-01

    Full Text Available Drug reactions are a group of reactionary lesions generally show their manifestations in the oral cavity. The drug reactions may vary from local rashes to well-developed swellings in the oral cavity especially involving the gingiva. Most of the drug reactions are asymptomatic and commonly triggered from the active metabolite of a drug used for a long time. Nager syndrome is a group of acrofacial dysostosis that usually results in craniofacial and limb malformations. The craniofacial defects are very similar to the mandibulofacial dysostosis. A very early intervention is needed for the habilitation of the patient especially when it is concerned with speech and language development. This paper reports a case of a 32-year-old female with craniofacial, limb, and skeletal abnormalities along with a drug-induced gingival hyperplasia.

  8. Development, implementation, and analysis of adverse drug reaction monitoring system in a rural tertiary care teaching hospital in Narketpally, Telangana

    OpenAIRE

    S.M. Shareef; C. D. M. Naidu; Shrinivas R. Raikar; Y. Venkata Rao; U. Devika

    2015-01-01

    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...

  9. Refill adherence and self-reported adverse drug reactions and sub-therapeutic effects : a population-based study

    OpenAIRE

    Hedna, Khedidja; Hägg, Staffan; Andersson Sundell, Karolina; Petzold, Max; Hakkarainen, Katja M

    2013-01-01

    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...

  10. Sex-dimorphic adverse drug reactions to immune suppressive agents in inflammatory bowel disease

    Institute of Scientific and Technical Information of China (English)

    Zuzana Zelinkova; Evelien Bultman; Lauran Vogelaar; Cheima Bouziane; Ernst J Kuipers; C Janneke van der Woude

    2012-01-01

    AIM:To analyze sex differences in adverse drug reactions (ADR) to the immune suppressive medication in inflammatory bowel disease (IBD) patients.METHODS:All IBD patients attending the IBD outpatient dinic of a referral hospital were identified through the electronic diagnosis registration system.The electronic medical records of IBD patients were reviewed and the files of those patients who have used immune suppressive therapy for IBD,i.e.,thiopurines,methotrexate,cyclosporine,tacrolimus and anti-tumor necrosis factor agents (anti-TNF); infliximab (IFX),adalimumab (ADA) and/or certolizumab,were further analyzed.The reported ADR to immune suppressive drugs were noted.The general definition of ADR used in clinical practice comprised the occurrence of the ADR in the temporal relationship with its disappearance upon discontinuation of the medication.Patients for whom the required information on drug use and ADR was not available in the electronic medical record and patients with only one registered contact and no further followup at the outpatient clinic were excluded.The difference in the incidence and type of ADR between male and female IBD patients were analyzed statistically by x2 test.RESULTS:In total,1009 IBD patients were identified in the electronic diagnosis registration system.Out of these 1009 patients,843 patients were eligible for further analysis.There were 386 males (46%),mean age 42 years (range:16-87 years) with a mean duration of the disease of 14 years (range:0-54 years); 578 patients with Crohn's disease,244 with ulcerative colitis and 21 with unclassified colitis.Seventy percent (586 pts) of patients used any kind of immune suppressive agents at a certain point of the disease course,the majority of the patients (546 pts,65%) used thiopurines,176 pts (21%) methotrexate,46 pts (5%) cyclosporine and one patient tacrolimus.One third (240pts,28%) of patients were treated with anti-TNF,the majority of patients (227 pts,27%) used IFX,99 (12

  11. Predicting adverse drug reactions in older adults; a systematic review of the risk prediction models

    Directory of Open Access Journals (Sweden)

    Stevenson JM

    2014-09-01

    Full Text Available Jennifer M Stevenson,1,2 Josceline L Williams,1,2 Thomas G Burnham,2 A Toby Prevost,3 Rebekah Schiff,4 S David Erskine,2 J Graham Davies1 1Institute of Pharmaceutical Sciences, King’s College London, London, UK; 2Pharmacy Department, St Thomas’ Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, UK; 3Department of Primary Care and Public Health Sciences, King’s College London, London, UK; 4Department of Ageing and Health, Guy’s and St Thomas’ NHS Foundation Trust, London, UK Abstract: Adverse drug reaction (ADR risk-prediction models for use in older adults have been developed, but it is not clear if they are suitable for use in clinical practice. This systematic review aimed to identify and investigate the quality of validated ADR risk-prediction models for use in older adults. Standard computerized databases, the gray literature, bibliographies, and citations were searched (2012 to identify relevant peer-reviewed studies. Studies that developed and validated an ADR prediction model for use in patients over 65 years old, using a multivariable approach in the design and analysis, were included. Data were extracted and their quality assessed by independent reviewers using a standard approach. Of the 13,423 titles identified, only 549 were associated with adverse outcomes of medicines use. Four met the inclusion criteria. All were conducted in inpatient cohorts in Western Europe. None of the models satisfied the four key stages in the creation of a quality risk prediction model; development and validation were completed, but impact and implementation were not assessed. Model performance was modest; area under the receiver operator curve ranged from 0.623 to 0.73. Study quality was difficult to assess due to poor reporting, but inappropriate methods were apparent. Further work needs to be conducted concerning the existing models to enable the development of a robust ADR risk-prediction model that is externally validated, with

  12. [Analysis on 315 cases of clinical adverse drug reaction/event induced by gastrodin].

    Science.gov (United States)

    Zheng, Yang-yang; Dong, Zhi; Lu, Xiao-qin; Xia, Yong-peng; Zhu, Shu-bing

    2015-05-01

    With patients' general situation, medication use, occurrence time of adverse drug reaction/event (ADR/ADE), clinical manifestations and prognosis as reference items, a retrospective study was made for 315 cases with ADR/ADE induced by Gastrodin in Chongqing from January 2008 to June 2014, in order to analyze the characteristics of ADR/ADE and provide reference for rational clinical medication. The results showed that among the 315 cases with ADR/ADE, 143 cases (45.4%) were males and 172 cases (54.6%) were females, most of them (74.9%) were aged above 45; 60 cases (19.0%) with ADE were caused by off-label indications and 66 cases (21.0%) with ADE were caused by over dosage; ADR/ADE cases induced by intravenous drip mainly happened within 30 min (85.5%), ADR/ADE cases induced by oral administration mainly happened within 2 h (74.4%), and all of ADR/ ADE cases induced by intramuscular injection happened within 10 min. Totally 593 ADR/ADE cases were reported, which were mainly damages in gastrointestinal system, skin and its adnexa; And 61.9% of ADR/ADE cases were newly reported. It is suggested that medical workers shall learn about the regularity and characteristics of ADR/ADE induced by gastrodin, apply it in clinic with standards, pay close attention to changes of patients' situations and attach importance to the monitoring of ADR/ADE, so as to enhance the safety of medication.

  13. The attitudes of pharmacists and physicians in Bosnia and Herzegovina towards adverse drug reaction reporting

    Directory of Open Access Journals (Sweden)

    Tarik Catic

    2016-04-01

    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.

  14. Adverse reactions to cosmetics

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    Dogra A

    2003-03-01

    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.

  15. Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria

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    Kenneth A Agu

    2013-01-01

    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

  16. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: myocardial and infectious adverse reactions as application cases.

    Science.gov (United States)

    Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

    2015-02-13

    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

  17. Adverse cutaneous drug reactions: Clinical pattern and causative agents in a tertiary care center in South India

    Directory of Open Access Journals (Sweden)

    Pudukadan David

    2004-01-01

    Full Text Available Background: Adverse cutaneous drug reactions (ACDRs are caused by a wide variety of agents. Aims: Our objective was to ascertain the clinical spectrum of ACDRs and the causative drugs in this part of India and to find any risk factors. Methods: Ninety patients with adverse cutaneous drug reactions were recruited for this study during 2001-2003. Hematological and biochemical investigations were done in all of them. The VDRL and HIV (ELISA tests were performed where the underlying risk factors were present. Patch testing, intradermal testing and oral provocation tests were done wherever feasible. Results: The mean age of the patients with cutaneous drug eruptions was 37.06 years. Most of them (52.2% were in the age group of 20-39 years. The male to female ratio was 0.87: 1. The most common eruptions observed were fixed drug eruption (31.1% and maculopapular rash (12.2%, and the most common causes were co-trimoxazole (22.2% and dapsone (17.7%. Conclusion: The pattern of ACDRs and the drugs causing them is remarkably different in our population. Knowledge of these drug eruptions, the causative drugs and the prognostic indicators is essential for the clinician.

  18. Risk factors of adverse drug reaction from non-steroidal anti-inflammatory drugs in Shanghai patients with arthropathy

    Institute of Scientific and Technical Information of China (English)

    Wen SHI; Yong-ming WANG; Shao-li LI; Min YAN; Duan Li; Bin-yah CHEN; Neng-neng CHENG

    2004-01-01

    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.

  19. Heparin-induced thrombocytopenia: a review of concepts regarding a dangerous adverse drug reaction.

    Science.gov (United States)

    Junqueira, Daniela Rezende Garcia; Carvalho, Maria das Graças; Perini, Edson

    2013-01-01

    Heparin is a natural agent with antithrombotic action, commercially available for therapeutic use as unfractionated heparin and low molecular weight heparin. Heparin-induced thrombocytopenia (HIT) is a serious adverse reaction to heparin that promotes antibody-mediated platelet activation. HIT is defined as a relative reduction in platelet count of 50% (even when the platelet count at its lowest level is above>150 x 10(9)/L) occurring within five to 14 days after initiation of the therapy. Thrombocytopenia is the main feature that directs the clinical suspicion of the reaction and the increased risk of thromboembolic complications is the most important and paradoxical consequence. The diagnosis is a delicate issue, and requires a combination of clinical probability and laboratory tests for the detection of platelet activation induced by HIT antibodies. The absolute risk of HIT has been estimated between 1% and 5% under treatment with unfractionated heparin, and less than 1% with low molecular weight heparin. However, high-quality evidence about the risk of HIT from randomized clinical trials is scarce. In addition, information on the frequency of HIT in developing countries is not widely available. This review aims to provide a better understanding of the key features of this reaction and updated information on its frequency to health professionals and other interested parties. Knowledge, familiarity, and access to therapeutic options for the treatment of this adverse reaction are mandatory to minimize the associated risks, improving patient safety.

  20. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    International Nuclear Information System (INIS)

    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

  1. Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Kejian, E-mail: kejian.wang.bio@gmail.com [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)

    2015-02-13

    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.

  2. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    李青; 张素敏; 陈华庭; 方世平; 于星; 刘东; 施侣元; 曾繁典

    2004-01-01

    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

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

    OpenAIRE

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

    2016-01-01

    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...

  4. Hospitalization in older patients due to adverse drug reactions –the need for a prediction tool

    OpenAIRE

    Parameswaran Nair, Nibu

    2016-01-01

    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...

  5. Hospitalization in older patients due to adverse drug reactions – the need for a prediction tool

    OpenAIRE

    Parameswaran Nair N; Chalmers L; Peterson GM; Bereznicki BJ; Castelino RL; Bereznicki LR

    2016-01-01

    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...

  6. Identification of possible adverse drug reactions in clinical notes:the case of glucose-lowering medicines

    OpenAIRE

    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

    2015-01-01

    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 ...

  7. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    OpenAIRE

    Het B Upadhyaya; Vora, Mukeshkumar B.; Jatin G Nagar; Patel, Pruthvish B.

    2015-01-01

    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...

  8. Adverse Drug Reaction Reporting” Knowledge, Attitude and Practices of Community Pharmacy Dispensers in Dar es salaam, Tanzania

    OpenAIRE

    Shimwela, Grace Mng’ong’o

    2011-01-01

    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...

  9. CORRELATION OF THE SERUM LEVEL OF CARBAMAZEPINE WITH SEIZURE CONTROL AND ADVERSE DRUG REACTIONS AMONG EPILEPTICS IN IBADAN, NIGERIA

    Directory of Open Access Journals (Sweden)

    Joseph O. Fadare

    2010-12-01

    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.

  10. [Research on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system (SRS) data].

    Science.gov (United States)

    Wang, Zhi-Fei; Xiang, Yong-Yang; Xie, Yan-Ming

    2013-09-01

    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

  11. In vitro testing for diagnosis of idiosyncratic adverse drug reactions: Implications for pathophysiology.

    Science.gov (United States)

    Elzagallaai, Abdelbaset A; Rieder, Michael J

    2015-10-01

    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

  12. Adverse reactions following mass drug administration with diethylcarbamazine in lymphatic filariasis endemic areas in the Northeast of Brazil

    Directory of Open Access Journals (Sweden)

    Ana Wládia Lima

    2012-12-01

    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.

  13. Practice Gaps: Drug Reactions.

    Science.gov (United States)

    Wolverton, Stephen E

    2016-07-01

    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

  14. Adverse reactions of HMG—CoA reductase inhibitors as a consequence of drug—drug interaction

    Institute of Scientific and Technical Information of China (English)

    IkedaT

    2002-01-01

    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.

  15. 阿片类镇痛药物的不良反应%Adverse Drug Reactions of Opioid Analgesics

    Institute of Scientific and Technical Information of China (English)

    赵文亭

    2015-01-01

    Objective To investigate the side effects of opioid analgesics.Methods The clinical data of 38 patients with opioid analgesic drugs used in District,Linzi District,January 2015 to January 2014, were colected and analyzed.Results The adverse reactions of opioid analgesics were the most common in patients aged 70 to 70 years,and the incidence of adverse reactions was 60 to years old.The highest adverse reaction rate of opioid analgesics was fentanyl,folowed by the treatment of the pain,and the main adverse reactions were constipation.Conclusion The main adverse reactions of opioid analgesics are constipation, so that the elderly patients can be seen,the clinical application should take ful account of the patient's constitution and tolerance,reduce the incidence of adverse reactions,improve the clinical rational drug use.%目的:探讨阿片类镇痛药物的不良反应。方法收集2014年1月至2015年1月临淄区妇幼保健院使用阿片类镇痛药物出现不良反应的38例患者的临床资料,统计患者的性别、年龄、用药类型、不良反应的类型等,分析导致不良反应发生的原因。结果阿片类镇痛药物的不良反应以>70岁患者最常见,其次为60~70岁;发生率最高的为芬太尼,其次为哌替啶;主要不良反应为便秘。结论阿片类镇痛药物主要不良反应为便秘,以老年患者多见,临床应用要充分考虑患者体质和耐受性,以降低不良反应的发生率,提高临床合理用药。

  16. 我院251例药品不良反应报告分析%Analysis of 251 cases of adverse drug reactions in our hospital report

    Institute of Scientific and Technical Information of China (English)

    唐锦辉

    2013-01-01

      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.

  17. Cutaneous adverse drug reactions: clinical pattern and causative agents--a 6 year series from Chandigarh, India.

    Directory of Open Access Journals (Sweden)

    Sharma V

    2001-04-01

    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.

  18. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    Energy Technology Data Exchange (ETDEWEB)

    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: appo@xmu.edu.cn [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)

    2014-01-01

    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.

  19. High-throughput identification of off-targets for the mechanistic study of severe adverse drug reactions induced by analgesics

    International Nuclear Information System (INIS)

    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

  20. Extent of poly-pharmacy, occurrence and associated factors of drug-drug interaction and potential adverse drug reactions in Gondar Teaching Referral Hospital, North West Ethiopia

    Directory of Open Access Journals (Sweden)

    Endalkachew Admassie

    2013-01-01

    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.

  1. Respiratory paradoxical adverse drug reactions associated with acetylcysteine and carbocysteine systemic use in paediatric patients: a national survey.

    Directory of Open Access Journals (Sweden)

    Pauline Mallet

    Full Text Available OBJECTIVE: To report pediatric cases of paradoxical respiratory adverse drug reactions (ADRs after exposure to oral mucolytic drugs (carbocysteine, acetylcysteine that led to the withdrawal of licenses for these drugs for infants in France and then Italy. DESIGN: The study followed the recommendations of the European guidelines of pharmacovigilance for medicines used in the paediatric population. SETTING: Cases voluntarily reported by physicians from 1989 to 2008 were identified in the national French pharmacovigilance public database and in drug company databases. PATIENTS: The definition of paradoxical respiratory ADRs was based on the literature. Exposure to mucolytic drugs was arbitrarily defined as having received mucolytic drugs for at least 2 days (>200 mg and at least until the day before the first signs of the suspected ADR. RESULTS: The non-exclusive paradoxical respiratory ADRs reported in 59 paediatric patients (median age 5 months, range 3 weeks to 34 months, 98% younger than 2 years old were increased bronchorrhea or mucus vomiting (n = 27, worsening of respiratory distress during respiratory tract infection (n = 35, dyspnoea (n = 18, cough aggravation or prolongation (n = 11, and bronchospasm (n = 1. Fifty-one (86% children required hospitalization or extended hospitalization because of the ADR; one patient died of pulmonary oedema after mucus vomiting. CONCLUSION: Parents, physicians, pharmacists, and drug regulatory agencies should know that the benefit risk ratio of mucolytic drugs is at least null and most probably negative in infants according to available evidence.

  2. Adverse respiratory reactions to aspirin and nonsteroidal anti-inflammatory drugs.

    Science.gov (United States)

    Simon, Ronald A

    2004-01-01

    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

  3. Analysis of Adverse Reaction of Analgesics, Antipyretics and Non-Steroidal Anti-Inflammatory Drugs Prescribed by Physicians of Health Care Facilities in Podilskyi Region during 2015

    OpenAIRE

    Stepaniuk, N. H.; Hladkykh, F. V.; Basarab, O. V.

    2016-01-01

    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...

  4. Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India

    Directory of Open Access Journals (Sweden)

    Ajitha Sharma

    2015-01-01

    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.

  5. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

    Science.gov (United States)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

    2014-06-01

    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

  6. Factors affecting the development of adverse drug reactions to β-blockers in hospitalized cardiac patient population

    Directory of Open Access Journals (Sweden)

    Mugoša S

    2016-08-01

    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

  7. A rare adverse reaction to ethambutol: drug-induced haemolytic anaemia.

    Science.gov (United States)

    Nicolini, A; Perazzo, A; Gatto, P; Piroddi, I M G; Barlascini, C; Karamichali, S; Strada, P

    2016-05-01

    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

  8. Pharmacy student driven detection of adverse drug reactions in the community pharmacy setting

    DEFF Research Database (Denmark)

    Christensen, Søren Troels; Søndergaard, Birthe; Honoré, Per Hartvig;

    2011-01-01

    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...

  9. Monitoring of incidence, severity, and causality of adverse drug reactions in hospitalized patients with cardiovascular disease

    Directory of Open Access Journals (Sweden)

    Sharminder Kaur

    2011-01-01

    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.

  10. Hospitalization in older patients due to adverse drug reactions – the need for a prediction tool

    Directory of Open Access Journals (Sweden)

    Parameswaran Nair N

    2016-05-01

    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

  11. 21 CFR 606.170 - Adverse reaction file.

    Science.gov (United States)

    2010-04-01

    ... 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...

  12. Adverse drug reactions to tocolytic treatment for preterm labour : prospective cohort study

    NARCIS (Netherlands)

    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.

    2009-01-01

    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

  13. Adverse drug reactions to tocolytic treatment for preterm labour: prospective cohort study

    NARCIS (Netherlands)

    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

    2009-01-01

    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

  14. Adverse drug reactions to tocolytic treatment for preterm labour: prospective cohort study

    NARCIS (Netherlands)

    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.

    2009-01-01

    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

  15. Knowledge, Attitude and Practices towards Pharmacovigilance and Adverse Drug Reactions in health care professional of Tertiary Care Hospital, Bhavnagar

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    Dr.Mukeshkumar B Vora

    2014-11-01

    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

  16. Development of a combined system for identification and classification of adverse drug reactions: Alerts Based on ADR Causality and Severity (ABACUS).

    Science.gov (United States)

    Koh, Yvonne; Yap, Chun Wei; Li, Shu-Chuen

    2010-01-01

    Currently, adverse drug reaction (ADR) causality and severity are assessed using different systems but there is no standard method to combine the results. In this work, a combined ADR causality and severity assessment system, including an online version, was developed. Logical rules were defined to translate the score obtained from the system into three alert zones: green, amber, and red. The alert zones are useful for triaging ADR cases as they help define the seriousness of the ADR and the urgency of the responses required. This new scoring system may be useful for clinicians, investigators, and regulators seeking information on the likelihood of a drug causing an adverse reaction, and whether an adverse reaction is sufficiently dangerous for the drug to be withheld or undergo further investigation.

  17. 药品不良反应行为主体利益博弈分析%Analysis of Benefit Game on Adverse Drug Reaction Subjects

    Institute of Scientific and Technical Information of China (English)

    刘花; 冯变玲; 杨世民

    2013-01-01

    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.

  18. Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan

    Directory of Open Access Journals (Sweden)

    Yamamoto M

    2015-01-01

    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

  19. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    Directory of Open Access Journals (Sweden)

    Perrone V

    2014-12-01

    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

  20. Factors affecting the development of adverse drug reactions to β-blockers in hospitalized cardiac patient population

    Science.gov (United States)

    Mugoša, Snežana; Djordjević, Nataša; Djukanović, Nina; Protić, Dragana; Bukumirić, Zoran; Radosavljević, Ivan; Bošković, Aneta; Todorović, Zoran

    2016-01-01

    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.

  1. Mortality due to acute adverse drug reactions in Galicia: 1997-2011.

    Science.gov (United States)

    Miguel-Arias, Domingo; Pereiro Gómez, César; Bermejo Barrera, Ana M; López de Abajo Rodríguez, Benito; Sobrido Prieto, María

    2016-01-01

    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

  2. Abuse liability of flupirtine revisited: implications of spontaneous reports of adverse drug reactions.

    Science.gov (United States)

    Gahr, Maximilian; Freudenmann, Roland W; Connemann, Bernhard J; Hiemke, Christoph; Schönfeldt-Lecuona, Carlos

    2013-12-01

    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

  3. A study on adverse drug reactions to non-ionic contrast medium in an Indian population: a 1-year experience

    Directory of Open Access Journals (Sweden)

    Subhrojyoti Bhowmick

    2014-12-01

    Conclusions: This pilot study reveals that adverse reactions to NICM are rare and severe reactions are less common among the patients of Indian origin. However, a larger multicentric study across the country should be carried out to understand the safety profile of these CM better among the Indian population. [Int J Basic Clin Pharmacol 2014; 3(6.000: 1066-1071

  4. Cross-sectional study exploring barriers to adverse drug reactions reporting in community pharmacy settings in Dhaka, Bangladesh

    Science.gov (United States)

    Amin, Mohammad Nurul; Khan, Tahir Mehmood; Dewan, Syed Masudur Rahman; Islam, Mohammad Safiqul; Moghal, Mizanur Rahman

    2016-01-01

    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

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

    NARCIS (Netherlands)

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

    2014-01-01

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

  6. Adverse drug reactions in hospitalised children in Germany are decreasing: results of a nine year cohort-based comparison.

    Directory of Open Access Journals (Sweden)

    Ann-Kathrin Oehme

    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

  7. Adverse Drug Reactions Causing Admission to Medical Wards: A Cross-Sectional Survey at 4 Hospitals in South Africa.

    Science.gov (United States)

    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

    2016-05-01

    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

  8. Attitude of nurses and pharmacists on adverse drug reactions reporting in selected hospitals in Sokoto, Northwest Nigeria

    Science.gov (United States)

    Umar, Muhammad Tukur; Bello, Shaibu Oricha; Chika, Aminu; Oche, Oche Mansur

    2016-01-01

    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.

  9. Knowledge, attitude and practices toward pharmacovigilance and adverse drug reactions in postgraduate students of Tertiary Care Hospital in Gujarat

    Directory of Open Access Journals (Sweden)

    Het B Upadhyaya

    2015-01-01

    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.

  10. Automatic Identification of Messages Related to Adverse Drug Reactions from Online User Reviews using Feature-based Classification.

    Directory of Open Access Journals (Sweden)

    Jingfang Liu

    2014-11-01

    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.

  11. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy

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    B Akshaya Srikanth

    2012-01-01

    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.

  12. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy.

    Science.gov (United States)

    Srikanth, B Akshaya; Babu, S Chandra; Yadav, Harlokesh Narayan; Jain, Sunil Kumar

    2012-01-01

    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

  13. Adaptation and validation of an adverse drug reaction preventability score for bleeding due to vitamin K antagonists.

    Science.gov (United States)

    Liabeuf, Sophie; Masmoudi, Kamel; Scailteux, Lucie-Marie; Moragny, Julien; Masson, Henri; Brnet-Dufour, Valérie; Andrejak, Michel; Gras-Champel, Valérie

    2016-09-01

    Although drug therapy is inherently associated with the risk of adverse drug reactions (ADRs), some of these events are preventable. The estimated proportion of preventable ADRs varies from one study or clinical context to another. Bleeding caused by antithrombotic agents (and particularly vitamin K antagonists, VKAs) constitutes one of the most frequent causes of ADR-related hospitalization.Hence, the objective of the present study was to adapt and validate an ADR preventability score for bleeding due to VKAs and evaluate the preventability of bleeding in 906 consecutive hospitalized, VKA-treated adult patients with a risk of major bleeding (defined as an international normalized ratio ≥5) over a 2-year period. A specific preventability scale for VKA-associated bleeding was developed by adapting a published tool.Overall, 241 of the 906 patients in the study experienced at least 1 VKA-associated bleeding event. The scale's reliability was tested by 2 different evaluators. The inter-rater reliability (evaluated by calculation of Cohen's kappa) ranged from "good" to "excellent." Lastly, the validated scale was used to assess the preventability of the VKA-associated bleeding. We estimated that bleeding was preventable or potentially preventable in 109 of the 241 affected patients (45.2%).We have developed a useful, reliable tool for evaluating the preventability of VKA-associated bleeding. Application of the scale in a prospective study revealed that a high proportion of VKA-associated bleeding events in hospitalized, at-risk adult patients were preventable or potentially preventable. PMID:27684801

  14. Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

    Science.gov (United States)

    Perrone, Valentina; Conti, Valentino; Venegoni, Mauro; Scotto, Stefania; Degli Esposti, Luca; Sangiorgi, Diego; Prestini, Lucia; Radice, Sonia; Clementi, Emilio; Vighi, Giuseppe

    2014-01-01

    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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2016-01-01

    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

  17. Analysis of adverse reaction reports of penicillin drugs%青霉素类药物不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张兵; 冯变玲; 赵晓红; 吉天天

    2013-01-01

    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 .

  18. Adverse Drug Reaction reports for cardiometabolic drugs from sub-Saharan Africa : a study in VigiBase

    NARCIS (Netherlands)

    Berhe, Derbew Fikadu; Juhlin, Kristina; Star, Kristina; Beyene, Kidanemariam G. M.; Dheda, Mukesh; Haaijer-Ruskamp, Flora M.; Taxis, Katja; Mol, Peter G. M.

    2015-01-01

    OBJECTIVE: Identifying key features of cardiometabolic ADR reports in sub Saharan Africa (SSA) compared with reports from the rest of the world (RoW). METHODS: Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from

  19. Adverse drug reaction prediction using scores produced by large-scale drug-protein target docking on high-performance computing machines.

    Directory of Open Access Journals (Sweden)

    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

  20. [Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

    Science.gov (United States)

    Wang, S F; Zhan, S Y

    2016-07-01

    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.

  1. [Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

    Science.gov (United States)

    Wang, S F; Zhan, S Y

    2016-07-01

    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

  2. 羟苯酯类防腐剂的不良反应%Adverse Drug Reactions Induced by Parabens Used as Preservatives

    Institute of Scientific and Technical Information of China (English)

    李中东; 张云轩; 郭燕萍; 施孝金; 钟明康

    2012-01-01

    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.

  3. Adverse effects of antihypertensive drugs.

    Science.gov (United States)

    Husserl, F E; Messerli, F H

    1981-09-01

    Early essential hypertension is asymptomatic and should remain so throughout treatment. In view of the increasing number of available antihypertensive agents, clinicians need to become familiar with the potential side effects of these drugs. By placing more emphasis on non-pharmacological treatment (sodium restriction, weight loss, exercise) and thoroughly evaluating each case in particular, the pharmacological regimen can be optimally tailored to the patient's needs. Potential side effects should be predicted and can often be avoided; if they become clinically significant they should be rapidly recognised and corrected. These side effects can be easily remembered in most instances, as they fall into 3 broad categories: (a) those caused by an exaggerated therapeutic effect; (b) those due to a non-therapeutic pharmacological effect; and (c) those caused by a non-therapeutic, non-pharmacological effect probably representing idiosyncratic reactions. This review focuses mainly on adverse effects of the second and third kind. Each group of drugs in general shares the common side effects of the first two categories, while each individual drug has its own idiosyncratic side effects.

  4. Identifying Adverse Drug Events by Relational Learning.

    Science.gov (United States)

    Page, David; Costa, Vítor Santos; Natarajan, Sriraam; Barnard, Aubrey; Peissig, Peggy; Caldwell, Michael

    2012-07-01

    The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task, related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events. PMID:24955289

  5. Analysis of Withdrawn Drugs Because of Cardiovascular Adverse Reactions%因心血管不良反应撤市的药物情况分析

    Institute of Scientific and Technical Information of China (English)

    毛璐; 高杰

    2013-01-01

    OBJECTIVE: To investigate the drugs withdrawn from the market because of cardiovascular adverse reactions in recent years, and to sum up the characteristics leading to cardiovascular adverse reactions and provide reference for rational use of drugs in the clinic. METHODS: Retrieved from domestic and foreign literature databases and the Internet, the data of drugs withdrawn from the market because of cardiovascular adverse reactions and related information were collected and summarized in recent years. RESULTS: In recent years because of cardiovascular events, more than ten drugs were withdrawn, involving non-steroidal anti-inflammatory drugs, diet pills, anti-histamine, etc. CONCLUSION: The cardiovascular adverse drug reactions should be noticed. The dosage and combined use of drugs should be standardized, in order to improve the safety and effectiveness of clinical medication.%目的:调查近年来因心血管不良反应撤市的药品情况,总结其引发心血管不良反应的特点,为临床合理使用药物提供借鉴.方法:检索国内外文献数据库及互联网,收集近年来因引起心血管不良反应而撤市的药物及其相关信息,并进行总结.结果:近年来在国内外因心血管事件撤市的药品涉及非甾体抗炎药、减肥药、抗组胺药等十余品种.结论:临床应警惕药物的心血管不良反应,规范用药剂量及合并药物,提高临床用药的有效性和安全性.

  6. Analysis of Adverse Drug Reaction with Allopurinol Colchicine%别嘌呤醇与秋水仙碱的不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    苏明

    2015-01-01

    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。

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

    Directory of Open Access Journals (Sweden)

    Akram Ahmad

    2013-01-01

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

  8. Systematic review of antiretroviral-associated lipodystrophy: lipoatrophy, but not central fat gain, is an antiretroviral adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    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.

  9. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim

    Directory of Open Access Journals (Sweden)

    Supratim Datta

    2015-01-01

    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.

  10. 168例药品不良反应事件分析%Analysis of Adverse Drug Reactions in 168 Cases

    Institute of Scientific and Technical Information of China (English)

    马勇

    2016-01-01

    Objective To analyze and evaluate the adverse drug reaction events, and promote the rational use of drugs. Methods reported adverse drug reactions to events, the use of mathematical principles respectively on source, taxonomy, the crowd, the drug distribution, frequency of varieties, results and correlations for statistical processing, according to and rational use of the relevant provisions on the administration of drugs, evaluation and analysis. Results adverse events in hospital more than out-patient;report to general based (75.60%);classifi-cation to skin reaction (30.95%); elderly (45.24%) than the other age group; antibacterial drugs account for the first (27.98%); of amoxicillin and clavulanate potassium frequency was the highest (12 times); adverse events results all of the cases were cured. Conclusion the adverse drug reaction is positively correlated with the number of drug use, rational use of drugs can effectively reduce and control the risk of drug use.%目的:分析评价药品不良反应事件,促进人们合理用药。方法将上报的药品不良反应事件,运用数学原理分别对来源、类型、分类、人群、药物分布、品种频次、处理结果以及相关性等进行统计处理,按照《药品不良反应报告和监测管理办法》及合理用药管理相关规定,进行评价分析。结果不良事件住院多于门诊;报告类型以一般为主(75.60%);分类以皮肤反应为主(30.95%);老年(45.24%)较其他年龄段多;抗菌药物占首位(27.98%);阿莫西林克拉维酸钾频次最高(12次);不良事件结果均为痊愈。结论药品不良反应与药品使用的多少成正相关,合理用药能够有效减少与控制用药风险。

  11. 老年患者药物不良反应分析%Analysis of adverse drug reaction in elderly

    Institute of Scientific and Technical Information of China (English)

    潘祺琦; 罗璨

    2015-01-01

    目的:分析老年患者药物不良反应(ADR)发生的特点,以利于临床上提高监测和应对。方法回顾性地分析国家药品不良反应监测中心数据库收集的南京医科大学第一附属医院2012年1月至2014年11月>65岁的老年患者的ADR报告。结果共收集212例次老年患者ADR报告(占总体ADR的21.3%),其中男性91例次,女性121例次,平均年龄(75.25±6.43)岁;91例次发生于门急诊(42.9%),114例次发生于住院非ICU(53.78%);涉及药品98种,主要为抗感染药物(30.66%),其次为中枢神经系统药物(26.42%);用药途径主要是静脉滴注(86.32%);ADR所累及的器官或系统损害主要是全身性损害(23.10%),其次是皮肤及其附件损害(19.49%),主要表现为过敏样反应、皮疹。结论本研究反映了我院老年患者发生ADR的主要风险药物、给药途径、临床表现等,应重点关注应用高风险药物的人群,用药过程中密切监测。对门急诊、院外老年患者的用药安全及口服药物的安全性也应加以重视。由于存在漏报现象,本研究的报告率仅能从一定程度上反映老年患者ADR的发生情况,应进一步重视和加强老年患者ADR的监测上报工作。%Objective To analyze the features of adverse drug reaction (ADR) in the elderly (>65 years old) in order to improve its surveillance and coping strategies. Methods All ADR reports in the elderly patients from the First Affiliated Hospital, Nanjing Medical University during the years of 2012 to 2014 in the National Center for ADR Monitoring Database were collected and retrospectively analyzed. Results There were 212 ADR reports in the elderly patients (accounting for 21.3% of the total ADR reports). They were 91 males and 121 females, at an average age of (75.25±6.43)years. Ninety-one ADRs (42.9%) occurred in the outpatient or emergency department, and 114 reports occurred in the non

  12. Analysis of drug adverse reactions induced by Aidi injection%艾迪注射液的不良反应分析

    Institute of Scientific and Technical Information of China (English)

    张彦凤

    2013-01-01

      目的分析艾迪注射液引起的不良反应。方法按照患者年龄、性别、不良反应类型及临床表现等进行统计、分析。结果7例不良反应中,男性4例(57.1%),女性3例(42.9%);不良反应主要的临床表现:过敏4例(57.1%),恶心呕吐1例(14.3%),静脉炎1例(14.3%),一过性转氨酶增高1例(14.3%)。结论艾迪注射液的不良反应大多为一般过敏反应,但应加强其监测工作。提醒临床医务工作者加强用药监护,提高合理用药水平,从而保证公众用药安全。%Objective To investigate drug adverse reactions induced by Aidi Injection.Methods Statistical analysis was carried out according to the ages, gender, the types of drug adverse reactions and manifestation of symptoms. Results Of the 7 cases, 4 cases (57.1%) were female, 3case (42.9%) was male;Of the main manifestation of drug adverse reactions, 4 cases(57.1%) were allergic reactions,1case (14.3%) was nausea and vomiting, 1case (14.3%) was phlebitis, 1case (14.3%) was a short time raise up of transaminase. Conclusion Most of the drug adverse reactions induced by Aidi Injection were common drug anaphylaxis. But monitoring of drug adverse reactions induced by Aidi Injection should be strengthened in order to remind the medical woker to pay attention to clinical pharmaceutical care . improve rational medication and guarante safety use of drug.

  13. [Future direction of pharmacogenomics: identification of genes associated with risk of adverse drug reactions using genome-wide association study].

    Science.gov (United States)

    Mushiroda, Taisei

    2014-01-01

    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

  14. 帕罗西汀的不良反应/事件分析%Analysis on the Adverse Drug Reactions / Events of Paroxetine

    Institute of Scientific and Technical Information of China (English)

    程丽玲; 徐作国

    2012-01-01

    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.

  15. The antinociceptive effect and adverse drug reactions of oxycodone in human experimental pain in relation to genetic variations in the OPRM1 and ABCB1 genes

    DEFF Research Database (Denmark)

    Zwisler, Stine T; Enggaard, Thomas P; Noehr-Jensen, Lene;

    2010-01-01

    -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 oxycodone......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......% for the wild-type carriers, P = 0.007). C3435T: The carriers of the variant T allele generally had less adverse drug reactions on oxycodone than the carriers of the wild-type genotype. G2677T/A: The carriers of the variant T allele had a better antinociceptive effect of oxycodone than the carriers of the wild...

  16. Revisiting cutaneous adverse reactions to pemetrexed

    OpenAIRE

    Piérard-Franchimont, Claudine; Quatresooz, Pascale; Reginster, Marie‑Annick; Piérard, Gérald E.

    2011-01-01

    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...

  17. Analysis on 11 Cases of Adverse Drug Reaction by Xiyanping Injection%11例喜炎平注射液致不良反应分析

    Institute of Scientific and Technical Information of China (English)

    邝颖颐; 陈文静

    2013-01-01

    Objective:To explore the rules and causes of adverse reactions by using Xiyanping Injection. Methods:Analysing 11 patients' basic,primary disease,the incidence of adverse reactions who causing adverse drug reactions by Xiyanping Injection. Results:11 cases of Xiyanping injection adverse reactions in patients with women slightly more than men,but there is no statistical significant(P>0.05);Patients under 15 years of age accounted for 8 cases of adverse reactions in patients,the age of 15 to 60 accounted for 3 cases,with statistically significant (P<0.05);11 patients' primary disease are infectious diseases;adverse reactions occur in 15min-45min accounted for 8 cases,compared to<15min group,the difference was statistical significant(P<0.05);clinical manifestations of adverse reactions included the systemic reactions (6 cases),skin and appendages (3 cases),cardiovascular system damage (2 cases). Conclusions:Xiyanping injection adverse reactions caused no significant relationship with patients' gender,adverse reactions mostly occurred in patients under the age of 15,the adverse reaction time more appear in 30min after administration,adverse reactions more performance for the damage to the systemic reactions,skin and its appendages and cardiovascular system damage.%  目的:探讨使用喜炎平注射液后发生不良反应的特点及规律。方法:对11例使用喜炎平注射液后出现不良反应的患者的基本情况、原发疾病、不良反应发生情况进行分析。结果:喜炎平注射液所致11例不良反应患者女性较男性稍多,但没有统计学差异(P>0.05);不良反应患者中15岁以下的占8例,与其余年龄段相比,具有统计学差异(P<0.05);11例患者原发病均属于感染性疾病;不良反应出现在15~45min者占8例,与<15min组相比差异具有统计学意义(P<0.05);不良反应临床表现为全身反应(6例),皮肤及附件损害(3例

  18. The Analysis of 358 Adverse Drug Reaction Reports in Children%358例儿童药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    陆晓彤; 刘海涛; 张健; 张春

    2011-01-01

    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.

  19. 21例克林霉素注射液致不良反应分析%Analysis on 21 Cases of Adverse Drug Reaction by Clindamycin Injection

    Institute of Scientific and Technical Information of China (English)

    邓益暖; 李旭星

    2013-01-01

      Objective To explore the rules and causes of adverse reactions by using Clindamycin Injection. Methods Analysing 21 patients' basic, primary disease, the incidence of adverse reactions who causing adverse drug reactions by Clindamycin Injection. Result 21 cases of Clindamycin injection adverse reactions in patients with women slightly more than men, but there is no statistical significant(P >0.05); 60 years old or more accounted for 17 cases of adverse reactions in patients, under the age of 60 accounted for 4 cases, with statistically significant(P 45min group, the difference was statistical significant(P 0.05);不良反应患者中60岁以上占17例,60岁以下占4例,具有统计学差异(P 45min组相比差异有统计学意义(P <0.05);不良反应临床表现为皮肤及附件损害(9例),全身反应(6例),心血管系统损害(3例),呼吸系统损害(3例)。结论克林霉素注射液致不良反应与患者性别无明显关系,不良反应多发生在60岁以上患者中,时间多出现在用药后30min左右,多表现为皮肤及附件损害,严重者会出现过敏性休克、胸闷、呼吸困难等症状。

  20. 14例红花注射液致不良反应分析%Analysis on 14 Cases of Adverse Drug Reaction by Carthamus Injection

    Institute of Scientific and Technical Information of China (English)

    吴康郁; 朱群娣; 黄志辉; 张建环

    2013-01-01

    Objective To explore the rules and causes of adverse reactions by using Carthamus Injection. Methods Analysing 14 patients' basic, primary disease, the incidence of adverse reactions who causing adverse drug reactions by Carthamus Injection. Result 14 cases of Carthamus injection adverse reactions in patients with women slightly more than men, but there is no statistical significant(p>0.05); 60 years old or more accounted for 12 cases of adverse reactions in patients, under the age of 60 accounted for 2 cases, with statisticaly significant(p45min group, the difference was statistical significant(p<0.05); clinical manifestations of adverse reactions included the skin and appendages (7 cases), systemic reactions (5 cases), cardiovascular system damage (two cases). Conclusion Carthamus injection adverse reactions caused no significant relationship with patients' gender, adverse reactions mostly occurred in patients over the age of 60, the adverse reaction time more appear in 30min after administration, adverse reactions more performance for the damage to the skin and its appendages, systemic reactions and cardiovascular system damage.%  目的探讨使用红花注射液后发生不良反应的特点及规律。方法对本院14例使用红花注射液后出现不良反应的患者的基本情况、原发疾病、不良反应发生情况进行分析。结果红花注射液所致14例不良反应患者女性较男性稍多,但没有统计学差异(p>0.05);不良反应患者中60以上的占12例,60岁以下的占2例,具有统计学差异(p<0.05);14例患者原发病均属于心脑血管疾病;不良反应出现在15min-45min者占13例,与<15min组及>45min组相比差异具有统计学意义(p<0.05);不良反应临床表现为皮肤及附件损害(7例),全身反应(5例),心血管系统损害(2例)。结论红花注射液致不良反应与患者性别无明显关系,不良反应多发生在60岁以上患者

  1. Exploring off-targets and off-systems for adverse drug reactions via chemical-protein interactome--clozapine-induced agranulocytosis as a case study.

    Directory of Open Access Journals (Sweden)

    Lun Yang

    2011-03-01

    Full Text Available In the era of personalized medical practice, understanding the genetic basis of patient-specific adverse drug reaction (ADR is a major challenge. Clozapine provides effective treatments for schizophrenia but its usage is limited because of life-threatening agranulocytosis. A recent high impact study showed the necessity of moving clozapine to a first line drug, thus identifying the biomarkers for drug-induced agranulocytosis has become important. Here we report a methodology termed as antithesis chemical-protein interactome (CPI, which utilizes the docking method to mimic the differences in the drug-protein interactions across a panel of human proteins. Using this method, we identified HSPA1A, a known susceptibility gene for CIA, to be the off-target of clozapine. Furthermore, the mRNA expression of HSPA1A-related genes (off-target associated systems was also found to be differentially expressed in clozapine treated leukemia cell line. Apart from identifying the CIA causal genes we identified several novel candidate genes which could be responsible for agranulocytosis. Proteins related to reactive oxygen clearance system, such as oxidoreductases and glutathione metabolite enzymes, were significantly enriched in the antithesis CPI. This methodology conducted a multi-dimensional analysis of drugs' perturbation to the biological system, investigating both the off-targets and the associated off-systems to explore the molecular basis of an adverse event or the new uses for old drugs.

  2. Drug Reactions

    Science.gov (United States)

    ... 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 ginkgo and blood thinners ...

  3. Analysis of analgesic drug for its clinical adverse reactions%镇痛药物临床不良反应分析

    Institute of Scientific and Technical Information of China (English)

    桂承江

    2012-01-01

      解热镇痛药的不良反应属于药学栏目范畴,属于非处方用药,好多感冒患者缺乏相应的医药知识,患了感冒以后急于治好,经常两种或两种以上感冒药同时服用,但常用的药也会引起严重的不良反应。尤其是两种以上的感冒药同时服用等于是加大解热镇痛药的剂量,更容易引起严重的不良反应。%  adverse reaction are pharmacy section of antipyretic analgesics category belonging to over-the-counter medications many flu patients with lack of medical knowledge eager to heal after caught a bad cold often two or more colds at the same time taking.commonly used drugs can also cause severe adverse reactions.especially more cold medicine while taking the amount to increase the dosage of antipyretic analgesics more likely to cause serious adverse reactions.

  4. Clinical Analysis of Adverse Drug Reaction of 289 Cases Caused by Insulin%289例胰岛素不良反应病例分析

    Institute of Scientific and Technical Information of China (English)

    赵珩; 李怡; 徐厚明; 余江毅

    2013-01-01

    Objective:To analyze the clinical characteristics of adverse drug reaction cases caused by insulin to provide reasonable advice for clinical use.Methods:The adverse drug reactions cases caused by insulin were retrieved in the database of Center for ADR Monitoring of Jiangsu to analyze the clinical nanifestations,systems involved,types of drugs,etc.Results:143 cases of 289 cases involved were male,and 146 were female.The types of the suspected drugs were mostly regular insulin,ultra short-acting insulin and insulin analogue.The systems with adverse drug reactions included the skin and its appendages,metabolism and nutrition disorder and systemic damages.283 cases were healed or improved after therapy,2 cases had sequela of partial lipodystrophy,and 4 cases were not healed.Condusion:Adverse drug reactions caused by insulin occurred in more than one system at the same time; and therefore,clinical medicine use should be closely monitored,and attention should be paid to some rare adverse drug reactions to ensure the safe drug use.%目的:分析胰岛素不良反应病例发生的特点,为临床合理用药提供参考.方法:从2004年1月~2012年11月江苏省药品不良反应数据库中检索出胰岛素的不良反应病例,采用描述性分析的方法,对药品不良反应累及的系统、怀疑药品的种类等进行统计分析.结果:共检索出符合条件的病例报告表289例,其中男143,女146例.短效、超短效胰岛素,胰岛素类似物不良反应所占比例较大.药品不良反应累及的系统/器官主要有皮肤及其附件损害、代谢和营养障碍、全身性损害.其中283例通过治疗均好转或痊愈,2例病例留有皮下脂肪萎缩后遗症,4例未好转.结论:胰岛素引起的不良反应累及的系统/器官较多,常多个不良反应同时发生,临床上要进行密切的用药监护,关注少见的不良反应,确保用药安全.

  5. Analysis of the adverse drug reaction of the Chinese herbal%活血化瘀中药的不良反应分析

    Institute of Scientific and Technical Information of China (English)

    白宇明; 魏国义

    2013-01-01

    目的 分析活血化瘀中药的不良反应发生情况,促进临床合理用药.方法 通过以中药“不良反应”为关键词,检索CHKD期刊全文数据中1998-2011年国内所有文献,查阅中药致不良反应文献的原文,并进行分析.结果 15种常用活血化瘀基本中药引起的12类不良反应及药源性疾病共计203例,其中累及系统主要为泌尿系统62例,呼吸系统47例,皮肤症状27例,急性中毒13例和循环系统12例.引起不良反应较多的药物为斑蝥(6种)、水蛭、丹参、马钱子(各5种),当归、川芎、乳香、三七(各3种).年龄越大,活血化瘀中草药不良反应构成比越高.女性活血化瘀中草药不良反应构成比较男性高.结论 活血化瘀中药不良反应分类繁多,临床表现多种多样,应引起医务人员和广大患者的重视.%Objective To analyze the adverse drug reaction of blood-activating and stasis-resoloing Chinese herbal medicine.And in order to promote the clinical reasonable using medicine.Methods "Adverse drug reaction" was as the key words,all literature of full text data the CHKD journal from 1998 to 2011 were retrieved,literature of adverse reactions caused by the original inspection Chinese medicine were checked.Results A total of 15 kinds of commonly used blood circulation Chinese medicine caused 12 adverse reactions and drug-induced disease was 203 cases,involving 62 cases of the urinary system,47 cases of the respiratory system,27 cases of skin symptoms,13 cases of acute poisoning and cyclesystem in 12 cases.Drugs to cause adverse reactions were cantharidin (6 species),leeches,Salvia,horse vomica (5),Angelica,Chuanxiong,frankincense,Panax (3).The older,the higher the ratio of adverse reactions of Chinese herbal medicine.The female had higher incidence than men.Conclusion Traditional Chinese medicine has adverse classification and diverse clinical manifestations.The medical staff and the majority of patients should pay more attention on

  6. 浅谈我院药品不良反应的监测及管理现状%Status monitoring and management of adverse drug reaction

    Institute of Scientific and Technical Information of China (English)

    高寿宝; 邢娟

    2014-01-01

    目的:探讨我院药品不良反应的监测及管理现状。方法对患者实行药品的不良反应监测,包括分类方法、现状分析等措施,同时对处方药与非处方药的管理现状、抗生素的应用现状及执业药师的执业现状进行分别进行现状探讨、对药品分类管理实施中存在着的问题及时加以解决。结果经过实行药品的不良反应监测及药品的分类管理,有效地加强对处方药的监督管理,防止消费者因自我行为不当导致滥用、误用药物,危及生命健康,消除安全用药的隐患。最重要的是有利于克服药品的使用不当或药品滥用而造成的用药危害及资源浪费,保证人民的用药安全。结论通过药品的不良反应监测与分类管理对安全用药可得到明显的治疗效果,不良反应的发生率低,且用药安全有效。%Objective to investigate the status of monitoring and management of adverse drug reaction in our hospital. Monitoring of adverse reaction method to implement thedrugs to patients, including classification, analysis of the current situation of such measures, the prescription and non prescription drugs management status, antibioticapplication status and licensed pharmacist practicingstatus respectively, on the status of drug classificationmanagement implementation exists the question to be addressed in a timely manner. Results after classificationmanagement monitoring and adverse drug reactions todrugs, effectively strengthen the supervision and management of prescription drugs, to prevent consumers from the self misconduct lead to abuse, misuse of drugs,endangering the life and health, eliminate the drug safetyhidden danger. the most important is to overcome drugor drug abuse caused by improper use of the drug harm and the waste of resources, ensure the people's drug safety. Conclusion the adverse reaction monitoring anddrug classification management of safe medication can obtain

  7. Adverse drug reactions associated with the use of liraglutide in patients with type 2 diabetes - focus on pancreatitis and pancreas cancer

    DEFF Research Database (Denmark)

    Chalmer, Thor; Almdal, Thomas P; Vilsbøll, Tina;

    2014-01-01

    Introduction: The glucagon-like peptide-1 (GLP-1) receptor agonist, liraglutide , is a widely used drug for the treatment of type 2 diabetes. Liraglutide is one of several incretin-based agents that have been suggested to be associated with pancreatitis and pancreas cancer. The suspicion...... 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...

  8. Pattern of Adverse Drug Reactions in Children Attending the Department of Pediatrics in a Tertiary Care Center: A Prospective Observational Study

    Science.gov (United States)

    Digra, Kishour Kumar; Pandita, Aakash; Saini, GS; Bharti, Rajni

    2015-01-01

    AIM To study the pattern of various adverse drug reactions (ADRs) occurring in children attending the Department of Pediatrics, SMGS Hospital, Jammu over 1 year. SUBJECTS AND METHODS This was a prospective study, with study population of patients attending Department of Pediatrics over a period of 1 year. A structured format was used to enroll the participants. A pilot study was conducted to test the suitability of the format and feasibility of the study. The study was carried out to review various pattern of ADRs by using the Naranjo probability scale, and severity was assessed by using the Hartwig severity scale. ADRs were classified according to the classification used by the Adverse Drug Reaction Monitoring Center, Central Drugs Standard Control Organization, New Delhi, India. RESULTS In the present study, 104 patients were found to have developed acute drug reactions. Among these, 83.6% were type B, 14.42% type A, and 1.92% were type U. Furthermore, 25.96% ADRs were due to anticonvulsants, followed by antibiotics (22.11%), antipyretics (11.53%), vaccination (8.65%), steroids (6.73%), decongestants (5.67%), snake antivenom and antiemetics (3.84%), and fluids, insulin, and antacids (1.92%). The patients’ dermatological system was involved in 67.30%, followed by the central nervous system (CNS) in 11.53% patients. Renal system was involved in 6.73% patients. Cardiac, musculoskeletal, metabolic, and other systems were involved in 4.80%, 3.84%, 2.88%, and 0.96%, respectively. According to the Hartwig severity scale of ADRs, 64.4% patients had moderate ADRs, 29.8% patients had severe ADRs, and 5.76% had mild ADRs. In the present study, 64.4% patients expressed moderate severity, whereas 29.8% expressed high severity and 5.76% expressed mild ADRs. CONCLUSION ADRs were seen in 71% of the patients between 1 and 5 years of age, 26% in the age group of 5–10 years, and 3% were more than 10 years old. Anticonvulsants (25.96%) and antibiotics (22.11%) were responsible

  9. 药物不良反应的遗传药理学研究进展%Research advances in pharmacogenetics and adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    陈旺青; 张伟

    2011-01-01

    药物不良反应(adverse drug reactions,ADRs)目前已成为危害人类健康的重要公共卫生问题,不仅损害国民健康而且对社会经济造成难以估量的损失,因而如何合理用药避免药物不良反应具有重要意义.导致药物不良反应的原因众多,如药物、环境、机体、用药和其他因素等.随着人类基因组计划的完成和药物遗传靶标的不断发现,药物不良反应的遗传因素已成为研究药物不良反应的一个全新领域.本文主要阐述遗传因素与药物不良反应的关系.%Adverse drug reactions (ADRs) have become an important public health issue that hazards to human health, which has caused immeasurable losses to national health and economics, so it is of great significance to explore how to use drugs rationally. Many factors lead to ADRs, such as those from drugs, environments, organisms, drug administration and others. With the development of human genome project and the continuing discoveries of genetic targets, the studying of genetic factors in ADRs has become a new field. This paper described the various genetic factors impacting ADRs.

  10. Adverse reactions to food: allergies and intolerances.

    Science.gov (United States)

    Montalto, Massimo; Santoro, Luca; D'Onofrio, Ferruccio; Curigliano, Valentina; Gallo, Antonella; Visca, Dina; Cammarota, Giovanni; Gasbarrini, Antonio; Gasbarrini, Giovanni

    2008-01-01

    All the anomalous reactions secondary to food ingestion are defined as 'adverse reactions to food'. In 1995 the European Academy of Allergology and Clinical Immunology suggested a classification on the basis of the responsible pathogenetic mechanism; according to this classification, non-toxic reactions can be divided into 'food allergies' when they recognize immunological mechanisms, and 'food intolerances' when there are no immunological implications. The diagnostic approach to adverse reactions to food is based on accurate clinical history and objective examination, and further execution of specific tests when allergy or intolerance is suspected. The therapy for food allergies is the elimination of the food to which hypersensibility has been found; this strategy can lead, especially in pediatric age, to tolerance. If elimination diets cannot be completely performed, or if it is not possible to identify the food to eliminate, some drugs (e.g. antihistaminics, steroids, etc.) can be administered. Specific allergen immunotherapy has been recently introduced. Fundamental is food allergy prevention, especially in high-risk subjects. The therapeutic approach to secondary food intolerances is based principally on primitive disease resolution; on the other hand, some specific treatments (e.g. beta-galactosidases in lactose malabsorption) are available in case of primary intolerance. PMID:18431058

  11. SePreSA: a server for the prediction of populations susceptible to serious adverse drug reactions implementing the methodology of a chemical-protein interactome.

    Science.gov (United States)

    Yang, Lun; Luo, Heng; Chen, Jian; Xing, Qinghe; He, Lin

    2009-07-01

    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

  12. Caffeic Acid Phenethyl Ester: A Review of Its Antioxidant Activity, Protective Effects against Ischemia-reperfusion Injury and Drug Adverse Reactions.

    Science.gov (United States)

    Tolba, Mai F; Omar, Hany A; Azab, Samar S; Khalifa, Amani E; Abdel-Naim, Ashraf B; Abdel-Rahman, Sherif Z

    2016-10-01

    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

  13. Srudy on Definition and Scope of Adverse Drug Reaction Surveillance%药品不良反应监测的定义和范畴研究

    Institute of Scientific and Technical Information of China (English)

    王大猷

    2014-01-01

    Objective To clarify the definition and scope of "adverse drug reaction surveillance". Methods The etymology, usages, and previous definitions of 'surveillance' were examined. The history and practice of adverse drug reaction surveillance was reviewed and a distinction among the concept framework of "adverse drug reaction surveillance","pharmacovigilance" and"pharmacoepidemiology" was made. Results The targets of surveillance are harmful potentially; "ongoing","systematic", "collection", "analysis", "interpretation", and "dissemination" have been seen in any surveillance program. Surveillance starts as soon as the drug is first approved or at any time thereafter. The collected data involves not only the safety problems caused by the nature of the drug, but also related to drug standards, pharmaceutical production, drug storage and drug usages. Information technology has greatly promoted the surveillance. Conclusion Definition of adverse drug reaction surveillance is proposed: A public health program aimed to adverse drug reactions, consisting of a set of processes for the ongoing systematic collection, compilation, analysis, interpretation of drug safety data(including relevant spontaneous reports, electronic health records, and experimental data), closely integrated with the timely and coherent dissemination of the results and assessment to those (including regulators, healthcare professionals and public) who have the right to know so that action can be taken. The purpose is to learn the distribution and trend of drug safety, to identify, evaluate, understand, and communicate the unexpected adverse drug effects, to perfect the drug benefit -risk profile, in order to prevent or mitigate the harmful effects of drugs.%目的:明确“药品不良反应监测”的定义及范畴,厘清药品不良反应监测的概念。方法回顾“监测”的语源学,以及作为术语在疾病监测或公共卫生监测中的定义和范畴;回顾药品不良反应

  14. Analysis on 70 Cases of Serious Adverse Drug Reactions%70例严重药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张利国; 周颖; 张琼丹; 曾永兰

    2013-01-01

    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.

  15. Literature Analysis of 82 Cases of Adverse Drug Reactions Induced by Geiftinib%82例吉非替尼不良反应的文献分析

    Institute of Scientific and Technical Information of China (English)

    夏惠红

    2016-01-01

    Objective To investigate the characteristics and mechanism of adverse reactions induced by geiftinib, and to ifnd its risk factors and provide technical support for safe and rational use of the drugs in clinic.Methods “Geiftinib”, “adverse reaction”and “caused by” were used as key words to retrieve articles in CNKI and VIP database. 57 literatures which met the inclusion and exclusion criteria were extracted and analyzed.ResultsThere were 82 cases of ADR in literatures, which mainly involved the gastrointestinal system, skin and appendages, respiratory system. Diarrhea, acne-like rash, cough, interstitial pneumonia were most common and some cases were serious even to death. The majority cases were senile male patients.ConclusionIt is important to pay attention to the adverse reactions caused by geiftinib, especially to strengthen post-marketing surveillance for elderly lung cancer patients, so as to prevent severe and rare adverse drug reactions.%目的:分析吉非替尼致药品不良反应(ADR)相关规律和特点,发现吉非替尼使用风险点,为临床合理用药提供参照。方法以“吉非替尼”、“不良反应”、“致”、“gefitinib”等为检索词,检索中国期刊网全文数据库、维普中文期刊全文数据库,按纳入、排除标准共纳入57篇文献,并进行整理和分析。结果共提取82例病例,累及系统-器官主要为胃肠系统损害、皮肤及其附件损害、呼吸系统损害等,不良反应以腹泻、痤疮样皮疹、咳嗽、间质性肺炎等最为常见,严重可致死亡;病例多为男性中老年患者。结论重视吉非替尼在抗癌治疗中的不良反应,加强老年肺癌患者的用药监测,防范严重和罕见的不良反应发生。

  16. PROSPECTIVE OBSERVATIONAL, NON-RANDOMIZED, PARALLEL SEQUENCE STUDY FOR ASSESSMENT OF ADVERSE DRUG REACTIONS DUE TO CHEMOTHERAPEUTIC TREATMENT IN DIFFERENT TYPES OF CANCER PATIENTS

    Directory of Open Access Journals (Sweden)

    Mrugank B.P. * and Hareesha R.P.

    2013-01-01

    Full Text Available Objective: To assess incidence, causality, severity, predictability and preventability of adverse drug reactions (ADRs in hospitalised oncology patients.Materials and Methods: A prospective observational, non-randomized, parallel sequence study was conducted at Dr B. Borooah Cancer Institute (BBCI after getting an approval from human ethical committee. Patients hospitalised at BBCI from Aug 2010 to June 2011 were interviewed about symptoms related to their drug therapy. Patient medical records were also reviewed for data collection.Results: Total 663 patients associated with hospitalizations were interviewed. 899 ADRs were identified in total 410 (61.84% patients detected with ADRs. Most of all ADRs were moderate, predictable and not preventable. The most common ADRs were leucopenia, weakness, anorexia, alopecia, vomiting, diarrhoea, nausea, abdominal pain, fatigue, and anaemia in this study.Conclusions: For definite conclusion study should be repeated. Strict drug analyzing and in vivo study is also required if feasible.Key message: The process of defining and concluding about ADRs should be continuous and ongoing to keep a record of newly marketed drugs and medicinal products.

  17. Using Rich Data on Comorbidities in Case-Control Study Design with Electronic Health Record Data Improves Control of Confounding in the Detection of Adverse Drug Reactions

    Science.gov (United States)

    Chase, Herbert

    2016-01-01

    Recent research has suggested that the case-control study design, unlike the self-controlled study design, performs poorly in controlling confounding in the detection of adverse drug reactions (ADRs) from administrative claims and electronic health record (EHR) data, resulting in biased estimates of the causal effects of drugs on health outcomes of interest (HOI) and inaccurate confidence intervals. Here we show that using rich data on comorbidities and automatic variable selection strategies for selecting confounders can better control confounding within a case-control study design and provide a more solid basis for inference regarding the causal effects of drugs on HOIs. Four HOIs are examined: acute kidney injury, acute liver injury, acute myocardial infarction and gastrointestinal ulcer hospitalization. For each of these HOIs we use a previously published reference set of positive and negative control drugs to evaluate the performance of our methods. Our methods have AUCs that are often substantially higher than the AUCs of a baseline method that only uses demographic characteristics for confounding control. Our methods also give confidence intervals for causal effect parameters that cover the expected no effect value substantially more often than this baseline method. The case-control study design, unlike the self-controlled study design, can be used in the fairly typical setting of EHR databases without longitudinal information on patients. With our variable selection method, these databases can be more effectively used for the detection of ADRs. PMID:27716785

  18. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

    DEFF Research Database (Denmark)

    Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl;

    2014-01-01

    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...

  19. Adverse Drug Reactions of Targeted Anti-tumor Drugs in Clinical Trials%临床试验中靶向抗肿瘤药物不良反应分析

    Institute of Scientific and Technical Information of China (English)

    朱迎迎; 吴剑秋; 汤唯艳; 寇莹莹; 李辰晨; 冯继锋; 汤依群

    2014-01-01

    目的:比较分析4种靶向抗肿瘤药物的不良反应。方法:收集使用4种靶向抗肿瘤药物患者的临床资料,统计分析各种不良反应的类型和发生率,记录结果。结果:阿西替尼较常见的不良反应为高血压和腹泻;埃克替尼主要是皮疹和腹泻;利妥昔单抗使用时应注意其相关输液反应和感染;西妥昔单抗主要是痤疮样皮疹。结论:不同靶向药物其不良反应特点各不相同,临床医生应重点关注不同靶向药物常见或主要不良反应及其特点,及时处理重度甚至致死性不良反应,提高治疗的安全性和依从性。%To compare and analysis adverse reactions of four targeted anti-tumor drugs. Methods: Clinical data were collected from patients received four targeted anti-tumor drugs for adverse reaction types and incidence rates. Result: The common adverse reactions of Axitinib were hypertension and diarrhea; the skin reaction and diarrhea were mainly for Icotinib; infusion related reaction and infection occurred more when Rituxan was used; acne skin rash was mainly for Cetuximab. Conclusion:Every targeted anti-tumor drug has its own adverse reactions, clinicians should pay attention to the common or major adverse reactions and their charactertics, timely deal with those severe or even fatal adverse reactions and enhance the safety and compliance of treatment.

  20. Methodological framework to identify possible adverse drug reactions using population-based administrative data [v1; ref status: indexed, http://f1000r.es/3ys

    Directory of Open Access Journals (Sweden)

    Brian Sauer

    2014-10-01

    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

  1. Awareness of adverse drug reactions in third M.B.B.S students practicing self-medication

    Directory of Open Access Journals (Sweden)

    Shreyas R. Burute

    2016-02-01

    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

  2. Study of prescription pattern and adverse drug reactions in patients with cervical cancer in tertiary care teaching institute

    Directory of Open Access Journals (Sweden)

    Ankita Sunilrao Jire

    2016-08-01

    Conclusions: Among patients with CA cervix, cisplatin was most commonly prescribed drug. Nausea was most common ADR which is of and lsquo;mild level 1' severity. [Int J Basic Clin Pharmacol 2016; 5(4.000: 1594-1597

  3. Adverse Reactions to Radiographic Contrast Material

    OpenAIRE

    Bush, William H.; Mullarkey, Michael F.; Webb, D. Robert

    1980-01-01

    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...

  4. 碘对比剂的不良反应分析%Analysis the adverse drug reaction of iodine contrast agent

    Institute of Scientific and Technical Information of China (English)

    谢升阳

    2013-01-01

    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%).

  5. 114例儿童药品不良反应报告分析%Analysis of 114 Pediatric Adverse Drug Reaction Reports in Our Hospital

    Institute of Scientific and Technical Information of China (English)

    李榕; 陈崇泽

    2011-01-01

    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.

  6. Post-marketing assessment of the safety of strontium ranelate; a novel case-only approach to the early detection of adverse drug reactions

    OpenAIRE

    Grosso, A.; Douglas, I.; Hingorani, A.; MacAllister, R.; Smeeth, L

    2008-01-01

    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...

  7. Pharmacogenomics and Global Precision Medicine in the Context of Adverse Drug Reactions: Top 10 Opportunities and Challenges for the Next Decade

    Science.gov (United States)

    Alessandrini, Marco; Chaudhry, Mamoonah; Dodgen, Tyren M.

    2016-01-01

    Abstract In a move indicative of the enthusiastic support of precision medicine, the U.S. President Barack Obama announced the Precision Medicine Initiative in January 2015. The global precision medicine ecosystem is, thus, receiving generous support from the United States ($215 million), and numerous other governments have followed suit. In the context of precision medicine, drug treatment and prediction of its outcomes have been important for nearly six decades in the field of pharmacogenomics. The field offers an elegant solution for minimizing the effects and occurrence of adverse drug reactions (ADRs). The Clinical Pharmacogenetics Implementation Consortium (CPIC) plays an important role in this context, and it aims at specifically guiding the translation of clinically relevant and evidence-based pharmacogenomics research. In this forward-looking analysis, we make particular reference to several of the CPIC guidelines and their role in guiding the treatment of highly relevant diseases, namely cardiovascular disease, major depressive disorder, cancer, and human immunodeficiency virus, with a view to predicting and managing ADRs. In addition, we provide a list of the top 10 crosscutting opportunities and challenges facing the fields of precision medicine and pharmacogenomics, which have broad applicability independent of the drug class involved. Many of these opportunities and challenges pertain to infrastructure, study design, policy, and science culture in the early 21st century. Ultimately, rational pharmacogenomics study design and the acquisition of comprehensive phenotypic data that proportionately match the genomics data should be an imperative as we move forward toward global precision medicine. PMID:27643672

  8. 喹诺酮类药物的耐药、联合用药及不良反应分析%Analysis of drug resistance,drug combination and adverse reactions of quinolones

    Institute of Scientific and Technical Information of China (English)

    孙志勇

    2013-01-01

    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.

  9. Snake antivenoms: adverse reactions and production technology

    OpenAIRE

    VM Morais; H Massaldi

    2009-01-01

    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 ...

  10. A prospective study on the use of magnesium sulfate in prevention and management of eclampsia with emphasis on adverse drug reactions

    Directory of Open Access Journals (Sweden)

    Heena Shah

    2013-04-01

    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

  11. Adverse Drug Reactions Reported in Our Hospital: Analysis of 560 Cases%我院560例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    张夏华; 吴广通; 石玉岚; 米丽

    2009-01-01

    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.

  12. 171例严重药品不良反应报告分析%ADR Report Analysis of 171 Cases of Serious Adverse Drug Reactions

    Institute of Scientific and Technical Information of China (English)

    文加勇; 张万智; 唐晓霞

    2015-01-01

    目的:了解严重药品不良反应(ADR)的发生特点,为ADR监测工作提供参考。方法:提取国家ADR监测系统中2011-2013年孝感市上报的ADR严重病例报告171份,对报告来源、患者性别、药品种类、给药途径、ADR累及器官/系统等进行分析。结果:严重ADR报告率与年龄因素和性别因素有关,且儿童和老年人高于中青年人(P <0.05),女性高于男性(男女之比为1∶1.44, P <0.05);171份严重 ADR 报告中,抗感染药(78,45.62%)、维生素、营养药、调节水电解质和酸碱平衡药(37,21.64%)和中药注射剂(15,8.77%)位居前三;静脉滴注给药125例(73.09%),口服给药26例(15.20%);过敏性反应82例(47.95%),皮肤及附件损害36例(21.05%)。结论:2011-2013年孝感市严重ADR高发于女性、儿童和老年人用药、抗感染药物和静脉滴注给药,在ADR监测中应引起注意。%ABSTRACTObjective:To investigate the characteristics of serious adverse drug reactions(ADRs)so as to pro-vide a reference for ADR monitoring.Methods:The reports of 171 cases of severe ADRs submitted by Xiaogan city from 2011 to 2013 were extracted from the National Adverse Drug Reaction Monitoring System. The data was analyzed such as the source of report, patient sex, drug species, route of administration and ADR involving or-gans/systems.Results:The serious ADR reporting rate was associated with age and gender factors, serious ADRs in children and the elderly were higher than young and middle-aged people(P<0.05)and higher in women than in men(the ratio of male to female was 1∶1.44,P<0.05). In 171 cases of severe ADRs, 78 cases(45.62%) ever used anti-infective drugs, 37 cases(21.64%)used Vitamins, nutritional supplements and the drugs of regulat-ing water-electrolyte and acid-base balance, and 15 cases(8.77%)were given traditional Chinese medicine injec-tions. About 125 cases(73.09%)received intravenous

  13. 135例氟喹诺酮类抗菌药物致不良反应%135 Cases of Adverse Drug Reactions Induced by Fluoroquinolones Antibiotics

    Institute of Scientific and Technical Information of China (English)

    张益钦; 谢根英; 辜雅莉; 吴小红

    2016-01-01

    OBJECTIVE: To investigate the occurrence of adverse drug reactions ( ADR ) induced by fluoroquinolones antibiotics in clinic , so as to provide some tips for the clinic to attach more importance to the adverse drug reactions and promote the rational drug use .METHODS: ADR cases induced by fluoroquinolones antibiotics received by ADR monitoring center of Xiamen Haicang Hospital during 2012-2015 were statistically analyzed . RESULTS:Of the 135 cases, 36 cases were ≥60 years old, accounting for 26.67%; including three kinds of fluoroquinolones antibiotics , and moxifloxacin dominated the first place , followed by levofloxacin and ciprofloxacin . 73 cases were induced by oral administration , and 62 cases were induced by intravenous administration .The main manifestations of ADR induced by fluoroquinolones antibiotics were central nervous system symptoms , followed by gastrointestinal symptoms and anaphylactic reactions , etc..CONCLUSIONS: The incidence of ADR induced by fluoroquinolones antibiotics is relatively high , the clinic should strictly apply fluoroquinolones antibiotics according to the information of usage and dosage , contraindications, matters need attention, ADR, drug combination and medication of special crowd .Meanwhile , the clinic should closely observe the changes of patients'conditions , timely withdrawal drugs and give symptomatic treatment to the patients , so as to improve the rationality of drug use .%目的:了解氟喹诺酮类抗菌药物在临床应用中的不良反应发生情况,提醒临床警惕该类药物的不良反应,促进合理用药。方法:对厦门市海沧医院2012—2015年药品不良反应监测中心收到的氟喹诺酮类抗菌药物所致的不良反应进行整理和分析。结果:135例发生药品不良反应的患者中,≥60岁36例,占26.67%;涉及3种氟喹诺酮类抗菌药物,主要为莫西沙星,其次为左氧氟沙星,再次为环丙沙星;口服给药73例,静脉给药62

  14. 邢台市人民医院2009年药物不良反应报告分析%Analysis of adverse drug reaction report of Xingtai People' hospital in 2009

    Institute of Scientific and Technical Information of China (English)

    李福秀

    2012-01-01

    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.

  15. Management of acute adverse reactions to contrast media

    Energy Technology Data Exchange (ETDEWEB)

    Thomsen, Henrik S. [Department of Diagnostic Radiology 54E2, Copenhagen University Hospital at Herlev, Herlev Ringvej 75, 2730, Herlev (Denmark); Morcos, Sameh K. [Department of Diagnostic Imaging, Northern General Hospital, Sheffield Teaching Hospitals NHS Trust, S5 7AU, Sheffield (United Kingdom)

    2004-03-01

    When anaphylactoid and other severe adverse reactions to contrast media occur, prompt recognition and immediate treatment are essential. Simple guidelines for treatment have been requested by many radiologists, and therefore the Contrast Media Safety Committee has produced guidelines for treatment of acute adverse reactions to contrast media. The committee made an extensive review of the literature on treatment of adverse reactions to contrast media. Based on this, a report and guidelines were prepared. The resulting report was discussed at the 10th European Symposium on Urogenital Radiology in Uppsala. Sweden, September 2003. Guidelines for treatment of acute adverse reactions and a list of first-line drugs and equipment that should be available in the room where contrast medium is given are provided. (orig.)

  16. Management of acute adverse reactions to contrast media.

    Science.gov (United States)

    Thomsen, Henrik S; Morcos, Sameh K

    2004-03-01

    When anaphylactoid and other severe adverse reactions to contrast media occur, prompt recognition and immediate treatment are essential. Simple guidelines for treatment have been requested by many radiologists, and therefore the Contrast Media Safety Committee has produced guidelines for treatment of acute adverse reactions to contrast media. The committee made an extensive review of the literature on treatment of adverse reactions to contrast media. Based on this, a report and guidelines were prepared. The resulting report was discussed at the 10th European Symposium on Urogenital Radiology in Uppsala. Sweden, September 2003. Guidelines for treatment of acute adverse reactions and a list of first-line drugs and equipment that should be available in the room where contrast medium is given are provided. PMID:14740165

  17. Pilot study on developing a decision support tool for guiding re-administration of chemotherapeutic agent after a serious adverse drug reaction

    Directory of Open Access Journals (Sweden)

    Chew Lita

    2011-07-01

    Full Text Available Abstract Background Currently, there are no standard guidelines for recommending re-administration of a chemotherapeutic drug to a patient after a serious adverse drug reaction (ADR incident. The decision on whether to rechallenge the patient is based on the experience of the clinician and is highly subjective. Thus the aim of this study is to develop a decision support tool to assist clinicians in this decision making process. Methods The inclusion criteria for patients in this study are: (1 had chemotherapy at National Cancer Centre Singapore between 2004 to 2009, (2 suffered from serious ADRs, and (3 were rechallenged. A total of 46 patients fulfilled the inclusion criteria. A genetic algorithm attribute selection method was used to identify clinical predictors for patients' rechallenge status. A Naïve Bayes model was then developed using 35 patients and externally validated using 11 patients. Results Eight patient attributes (age, chemotherapeutic drug, albumin level, red blood cell level, platelet level, abnormal white blood cell level, abnormal alkaline phosphatase level and abnormal alanine aminotransferase level were identified as clinical predictors for rechallenge status of patients. The Naïve Bayes model had an AUC of 0.767 and was found to be useful for assisting clinical decision making after clinicians had identified a group of patients for rechallenge. A platform independent version and an online version of the model is available to facilitate independent validation of the model. Conclusion Due to the limited size of the validation set, a more extensive validation of the model is necessary before it can be adopted for routine clinical use. Once validated, the model can be used to assist clinicians in deciding whether to rechallenge patients by determining if their initial assessment of rechallenge status of patients is accurate.

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

    Directory of Open Access Journals (Sweden)

    Aagaard L

    2011-12-01

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

  19. Analysis of spontaneous inquiries about suspected adverse drug reactions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”

    Directory of Open Access Journals (Sweden)

    Dobashi A

    2016-04-01

    Full Text Available Akira Dobashi,1 Kaori Kurata,1 Mitsuhiro Okazaki,2,3 Mari Nishizawa4 1Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Hachioji, Tokyo, 2Faculty of Health Sciences, Health Innovation and Technology Center, Hokkaido University, Hokkaido, 3Cross Care Field Co., Ltd., 4Yakuju Corporation, Tokyo, Japan Purpose: Spontaneous inquiries about the development of adverse drug reactions (ADRs to medicines can be extracted based on the questions posted by the general public on the electronic Japanese bulletin board “Yahoo! Japan Chiebukuro”. Our aim was to clarify the characteristics related to people’s descriptions of suspected ADRs and determine the reasons for submitting a spontaneous inquiry. Methods: Fifty brand names of medicines used for inquiry extraction were chosen by selecting 35 pharmaceutical products, based on the generic names that had the highest sales in Japan. Questions containing both the brand name of one of these medicines and the term “Fukusayō” (ADR in Japanese that were posted from July 2004 to June 2009 were extracted from the site. Results: Among 1,419 questions extracted, 614 questions had at least one identifiable brand name of a suspected medicine, an ADR description, and the extent to which the ADR appeared to be caused by the suspected medicine(s. Among these 614 questions, 589 described in detail the symptoms/signs that the inquirers themselves or their families had experienced as ADRs. The highest number of questions was found for Paxil (525. Posts asking whether the symptoms being experienced were due to an ADR accounted for the highest number of questions. In most cases, the inquirer suspected that a single medicine led to an ADR and was seeking advice from others taking the same medicine. Conclusion: Our examination of spontaneous inquiries showed that people have sufficient knowledge to adequately report potential ADRs in terms of their symptoms

  20. A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India

    Directory of Open Access Journals (Sweden)

    Farhan Ahmad Khan

    2013-10-01

    Full Text Available Background: Polypharmacy, advancing age and longer duration of hospital stay are the factors responsible for adverse drug reactions (ADRs. This study has attempted to analyze the pattern of antimicrobial prescription in OPD & IPD of the Otolaryngology department and to detect, document, assess and report the suspected ADRs due to antibiotic use and preparation of guidelines to minimize the incidence of ADRs. Methods: A prospective study conducted at the TMMC&RC on patients aged >40 years, who visited the Otolaryngology department over a period of 5 months. Suspected ADRs were assessed for causality and severity using Naranjo’s probability scale and modified Hartwig’s criteria, respectively. Results: Out of 1200, 925 prescriptions were analyzed. Most patients were from 41-60 age (59.45% followed by 61-80 age (37.29% and least from >80 yr (3.24%. But the incidence of ADRs were found to be higher in patients of >80 yr age group n=8 (26.66%. The most commonly prescribed antibacterials were β-Lactams (64.61%. Out of 925 prescriptions studied, only 94 were found to have 154 ADRs. The most commonly identified ADRs were Gastrointestinal 47.40%, followed by Neurotoxicity 24.67%, cutaneous reactions 20.12%, Hepatic 4.54% and Kidney 3.24%. 74.67% of the ADRs were probable and 20.77% were possible type and only 4.54% were definite. 74.67% ADRs were found to be type A, and 25.32% type B. Conclusions: Our study showed that prevalence of ADRs was highest in elder age group and diarrhea was the most common ADR found. Therefore elderly patients should be given special attention when prescribing medications to avoid clinically significant harmful consequences. Minimizing unnecessary antibiotic use by even a small percentage could significantly reduce the immediate and direct risks of drug-related adverse events in individual patients. [Int J Basic Clin Pharmacol 2013; 2(5.000: 548-553

  1. Standardizing adverse drug event reporting data

    OpenAIRE

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2014-01-01

    Background The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a sta...

  2. Variation of adverse drug reaction profile of platinum-based chemotherapy with body mass index in patients with solid tumors: An observational study

    Directory of Open Access Journals (Sweden)

    Dattatreyo Chatterjee

    2014-01-01

    Full Text Available Objectives: Toxicity of cancer chemotherapy may be affected by nutritional status of patients which is reflected in the body mass index (BMI. We sought to assess whether the adverse drug reaction (ADR profile of platinum-based chemotherapy varies with BMI status. Materials and Methods: Adult patients of either sex, suffering from a solid tumor (lung, head and neck, ovary, gall bladder, stomach, colon and started on platinum-based chemotherapy as initial treatment were included. BMI at chemotherapy commencement was obtained from medical records. Events were recorded and graded as per Eastern Co-operative Oncology Group Common Toxicity Criteria-patients′ complaints; clinically evident signs and laboratory reports were considered. Frequencies of individual adverse events were compared between low BMI (<18.5 kg/m 2 and satisfactory BMI groups. Similar comparisons were done for events with grades 2 or 3 severities. Results: A total of 50 patients were observed over a 3-month period of whom 17 (34% belonged to the low BMI group. Nausea, vomiting, diarrhea, stomatitis, anemia, alopecia, tinnitus and paresthesia were the commonly observed ADRs. The frequencies of anemia (P = 0.152 and vomiting (P = 0.140 and severity of grades of nausea (P = 0.066, anemia (P = 0.120 and paresthesia (P = 0.128 showed a higher trend in the low BMI group though differences were not statistically significant. The frequencies of tinnitus (P = 0.021 and paresthesia overall (P = 0.036 were significantly higher in the low BMI group. Conclusion: ADR profile of primary platinum-based chemotherapy appears to be partly influenced by BMI. This suggests the importance of maintaining adequate nutrition in patients and the need for greater vigilance in those with low BMI.

  3. Analysis of adverse drug reactions:on 93 cases report%药品不良反应93例分析

    Institute of Scientific and Technical Information of China (English)

    罗卿春

    2016-01-01

    目的:了解我院药品不良反应发生的特点及其引发的相关因素,为临床安全、合理用药提供依据。方法对该院2014年度收集上报的93例 ADR 报告进行回顾性分析。结果 ADR 93例,男性高于女性,50岁以上人群所占比例高于其他年龄段;引起 ADR 的因素以抗菌药物使用最高,占56.99%,其中又以β-内酰胺类居首,24例,占45.28%;损害器官、系统以皮肤及附件为主,引发 ADR 类型以一般药品不良反应为主,占94.62%。结论药品不良反应的发生与年龄、联合用药等因素有关,应加强 ADR 监测和报告工作,指导临床合理用药,减少药品不良反应的发生。%Objective To investigate the characteristics and the predisposing factors of adverse drug reactions(ADR) occurred in our hospital,the safety and rational use of drugs may be provided. Methods Analyzed 93 cases of ADRs,collected from a retrospective survey,in our hospital in 2014. Results Among 93 cases of ADRs,the male was more than the female in the ratio,proportion of people over the age of 50 was higher than other age groups;The incidence of ADR cases was mainly in-duced by the antimicrobial drugs,accounted for 56. 99% ,among which the cases that caused by β-lactamase antibiotics were acounted for the most(24cases,45. 28% );system-organ damages were common in skin and appendixes,the conventional ADR was most in the predisposing types of ADRs,accounting for 94. 62% . Conclusion Occurrence rate of ADR relates to the dis-tribution of patient age and approach of using drug. We should strengthen the monitoring and reporting work,in order to promote the rational drug use,and reduce ADRs.

  4. The impact of glutathione S-transferase genotype and phenotype on the adverse drug reactions to azathioprine in patients with inflammatory bowel diseases.

    Science.gov (United States)

    Liu, Hui; Ding, Liang; Zhang, Fangbin; Zhang, Yu; Gao, Xiang; Hu, Pinjin; Bi, Huichang; Huang, Min

    2015-10-01

    Azathioprine (AZA) is a thiopurine prodrug which is widely used in patients with inflammatory bowel disease (IBD). However, the use is limited in one-third of patients because of adverse drug reactions (ADRs) or a lack of clinical response. It has been considered that the polymorphic enzyme thiopurine S-methyltransferase (TPMT) plays an important role in the in vivo process of AZA and the occurrence of its myelotoxicity. Glutathione S-transferase (GST) mutation is another pharmacogenetic polymorphism which is probably involved in AZA metabolism and tolerance. The aim of this study was to investigate the association among GST polymorphism, enzyme activity and AZA-related ADRs in Chinese Han patients with IBD. We found that the patients who became neutropenic had a significantly higher GSTs activity when compared with of the patients who did not develop ADRs (analysis of variance, P GST activity constituted a pharmacogenetic high risk group for leucopenia during AZA treatment. GST-P1 Ile105/Ile105 genotype appeared to be a promising marker indicating predisposition to AZA-related ADRs. PMID:26432087

  5. 莫西沙星的严重不良反应及其防范%Severe Adverse Drug Reactions Induced by Moxifloxacin and Their Prevention

    Institute of Scientific and Technical Information of China (English)

    陈晨钟; 史道华

    2011-01-01

    目的:提示临床高度关注莫西沙星的不良反应.方法:检索我院不良反应监测系统,对其中莫西沙星产生的3例严重不良反应报告进行分析.结果:3例莫西沙星严重不良反应中,暴发性肝衰竭1例,经抢救无效死亡;过敏性休克2例,经抢救未产生严重后果.结论:临床应重视莫西沙星严重不良反应的危害性.%OBJECTIVE: To prompt the adverse drug reactions (ADR) of moxifloxacin should be paid high attention to clinic.METHODS: Retrieved from ADR reporting and monitoring system of our hospital, 3 serious ADR cases induced by moxifloxacin were analyzed. RESULTS: Among 3 serious ADR cases induced by moxifloxacin, one case developed fulminant hepatic failure leading to death after rescue, and other 2 patients with anaphylactic shock was recovered without severe consequence after rescue.CONCLUSION:Great importance should be attached to ADR induced by moxifloxacin in the clinic.

  6. The Review of the Adverse Drug Reaction Using Ibuprofen Suspension%布洛芬混悬液不良反应回顾

    Institute of Scientific and Technical Information of China (English)

    万雪琴; 张华锋

    2011-01-01

    总结布洛芬混悬液出现的不良反应,以"布洛芬"为关键词,检索2000~2010年CNKI中国期刊全文数据库、维普中文数据库中4篇布洛芬混悬液不良反应捆首S例,及我院1例不良反应报道进行总结分析.布洛芬混悬液不良反应主要涉及消化系统、血液系统、神经系统、皮肤及其附件等.提示临床中儿童应注意安全使用布洛芬混悬液,以避免不良反应的发生.%This article introduces the occurrenc and distribution of adverse drug reactions(ADR) induced by Ibuprofen Suspension, With "Ibuprofen" as key word, literatures were retrieved from CNKI and CQVIP from Jan. 2000 to Jun. 2010. 4 literatures including 5 cases were analyzed statistically, and another case happened in our hospital Main clinical manifestation of ADR cases were digestive system, Blood system, Nervous system, lesion of skin and its appendants.We should strengthen to monitor the ADR of Ibuprofen Suspension and ensure rational and standardized use of children, avoid or reduce the occurrence of severe ADR.

  7. Snake antivenoms: adverse reactions and production technology

    Directory of Open Access Journals (Sweden)

    VM Morais

    2009-01-01

    Full Text Available 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 as: anaphylactic reactions mediated by IgE, anaphylactoid reactions caused by complement system activation, and pyrogenic reactions produced mainly by the presence of endotoxins in the final product. In the future, antivenoms may be replaced by humanized antibodies, specific neutralizing compounds or vaccination. Meanwhile, improvements in antivenom quality will be focused on the obtainment of a more purified and specific product in compliance with good manufacturing practices and at an affordable cost.

  8. Analysis of 266 Cases of Adverse Drug Reactions in the Hospital in 2014%医院2014年266例药品不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    蔡乐; 王颖; 史红; 苏晔

    2016-01-01

    目的:了解医院药品不良反应发生的规律及相关因素,为临床合理用药提供参考。方法对北京朝阳医院2014年266例药品不良反应报告进行归类统计、评价。结果266例药品不良反应报告中,患者男性多于女性,比例为1∶0.8,60岁以上老年患者发生不良反应为115例(43.23%)。抗菌药物不良反应发生率最高,其次为抗肿瘤药物。给药途径以静脉滴注为主,不良反应的临床表现以皮肤及其附件损害为主,其次为消化系统、血液系统及全身性损害,分别为31.20%,30.83%,9.77%,9.77%,严重不良反应15例(5.64%)。结论应进一步加强药品不良反应监测情况,加大药品不良反应宣传力度,重视抗菌药物及抗肿瘤药物的不良反应监测,以免发生严重不良反应。%Objective To understand the law of hospital adverse drug reactions and related factors, to provide reference for clinical ratio-nal drug use. Methods 266 cases of adverse drug reaction reports in The Beijing Chaoyang Hospital in 2014 were statistically classi-fied and evaluated. Results In the 266 cases of adverse drug reactions, there were more men than women, the ratio was 1∶0. 8;115 cases of adverse reactions were patients over the age of 60 ( 43. 23%) . The antimicrobial's incidence of adverse drug reactions was the highest, followed by anticancer drugs. The main route of administration was by intravenous infusion, the clinical manifestations of adverse reactions was skin and its appendages, followed by the digestive system, blood system and body damage, accounted for 31. 20% , 30. 83%, 9. 77%, 9. 77% respectively; serious adverse reactions 15 cases ( 5. 64% ) . Conclusion It is necessary to further strengthen the monitoring of adverse drug reactions, increase publicity efforts on adverse drug reactions, pay more attention to the monitoring of ad-verse reactions of antibiotics and anticancer drugs, in order to avoid the

  9. Association between thiopurine S-methyltransferase polymorphisms and thiopurine-induced adverse drug reactions in patients with inflammatory bowel disease: a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yue-Ping Liu

    Full Text Available Thiopurine drugs are well established treatments in the management of inflammatory bowel disease (IBD, but their use is limited by significant adverse drug reactions (ADRs. Thiopurine S-methyltransferase (TPMT is an important enzyme involved in thiopurine metabolism. Several clinical guidelines recommend determining TPMT genotype or phenotype before initiating thiopurine therapy. Although several studies have investigated the association between TPMT polymorphisms and thiopurine-induced ADRs, the results are inconsistent. The purpose of this study is to evaluate whether there is an association between TPMT polymorphisms and thiopurine-induced ADRs using meta-analysis.We explored PubMed, Web of Science and Embase for articles on TPMT polymorphisms and thiopurine-induced ADRs. Studies that compared TPMT polymorphisms with-ADRs and without-ADRs in IBD patients were included. Relevant outcome data from all the included articles were extracted and the pooled odds ratio (OR with corresponding 95% confidence intervals were calculated using Revman 5.3 software.Fourteen published studies, with a total of 2,206 IBD patients, which investigated associations between TPMT polymorphisms and thiopurine-induced ADRs were included this meta-analysis. Our meta-analysis demonstrated that TPMT polymorphisms were significantly associated with thiopurine-induced overall ADRs and bone marrow toxicity; pooled ORs were 3.36 (95%CI: 1.82-6.19 and 6.67 (95%CI: 3.88-11.47, respectively. TPMT polymorphisms were not associated with the development of other ADRs including hepatotoxicity, pancreatitis, gastric intolerance, flu-like symptoms and skin reactions; the corresponding pooled ORs were 1.27 (95%CI: 0.60-2.71, 0.97 (95%CI: 0.38-2.48, 1.82 (95%CI: 0.93-3.53, 1.28 (95%CI: 0.47-3.46 and 2.32 (95%CI: 0.86-6.25, respectively.Our meta-analysis demonstrated an association of TPMT polymorphisms with overall thiopurine-induced ADRs and bone marrow toxicity, but not with

  10. Prevalence of Adverse Drug Reactions in CAD STEMI Patients Treated in the Cardiac Intensive Care Unit at the Public Hospital in Bandung, Indonesia.

    Science.gov (United States)

    Amalia, Lia; Anggadireja, Kusnandar; Aprami, Toni M; Septiani, Vina

    2016-01-01

    Adverse drug reactions (ADRs) are associated with morbidity, mortality, and can contribute to increased healthcare costs. This study was conducted to identify the occurence, types, and management of ADRs, as well as analyze the causal relationship, severity, and preventability of ADRs. The study was observational analysis with concurrent data collection from patients with Coronary Artery Disease-ST segment Elevation Myocardial Infarction (CAD-STEMI) treated in the Cardiac Intensive Care Unit (CICU) at a hospital in Bandung Indonesia, during the period of December 2013 to March 2014. The occurence of identified ADRs was assessed using the probability scale of Naranjo, while the severity by the scale of Hartwig and their preventability was evaluated using the scale of Schumock-Thornton. 49 ADRs were identified in 29 patients. Organ systems most affected by the ADRs were the cardiovascular and body electrolyte, each accounting for 20.41%. The hematology and gastrointestinal systems each contributed 18.37% to ADR occurrences. The causal relationship was mostly classified as "probable," accounting for 69.39%. With regard to severity, most ADRs were classified as "moderate" at level 3, contributing to 53.06% of the occurence. In terms of preventability, most of the ADRs fell into the "non-preventable" category (79.59%). The most widely applied ADRs management was administration of an antidote or other treatments (40.82%). Further analysis revealed that the average number of drug types and duration of hospitalization significantly affected the presence of ADRs. Taken together, most patients with CAD STEMI treated in the CICU of the studied hospital experienced non-preventable ADRs and were treated with antidote or other treatments. PMID:27110507

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

    Directory of Open Access Journals (Sweden)

    Elham Azhdari

    2013-02-01

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

  12. 鲑鱼降钙素致不良反应的文献分析%A Literature Analysis of Adverse Drug Reactions Induced by Salmon Calcitonin

    Institute of Scientific and Technical Information of China (English)

    苏娜; 吴逢波; 徐珽

    2013-01-01

    Objective To study the characteristics and the general pattern of the adverse drug reaction (ADR) induced by salmon calcitonin. Methods ADR induced by salmon calcitonin reported in domestic medical journals during January 1994 to March 2012 were retrieved from CNKI and WanFang databases. Classification and statistical analysis were carried out according to patients' age, gender, route of administration, dosage, time of the occurrence of ADR, clinical symptoms, allergic history, treatment and recovery. Results Fifteen ADR cases involved the integumentary system , cardiovascular system, digestive system, nervous system and allergic reaction, with advanced age group and women showing the highest incidence. Conclusion Salmon calcitonin should be used with caution in the clinic for it may induce ADR.%目的 总结鲑鱼降钙素致不良反应的一般规律和特点.方法 检索中国期刊全文数据库(CNKI)、万方数据库(WanFang)1994年1月-2012年3月鲑鱼降钙素所致不良反应的个案报道,按患者年龄、性别、给药途径、用药剂量、不良反应发生时间、临床表现症状、有无过敏史、治疗与转归等进行分类统计分析.结果 15例不良反应包括皮肤系统、心血管系统、消化系统、神经系统和超敏反应,高年龄段和女性发生率较高.结论 临床上应重视鲑鱼降钙素可致不良反应,坚持合理用药.

  13. Analysis of the adverse reaction of fluoroquinolones and rational drug use%氟喹诺酮类药物的不良反应及合理用药分析

    Institute of Scientific and Technical Information of China (English)

    孙艳丽

    2014-01-01

    目的:分析和研究氟喹诺酮类药物的不良反应及应用规律,指导临床合理用药。方法归纳总结124例氟喹诺酮类药物不良反应情况。结果氟喹诺酮类药物用药后,不良反应多发生于胃肠道以及中枢神经系统,涉及不良反应较多的四类药物分别为左氧氟沙星(46.8%)、环丙沙星(28.2%)、加替沙星(18.5%),其中不良反应发生的主要给药途径为静脉注射。结论为了有效减少和防止氟喹诺酮类药物不良反应发生,临床用药中要根据规范要求用药,可有效减少不良反应,提高临床效果。%Objective This paper aims to analyze and study adverse reactions and application laws of fluoroquinolones drugs, and to guide rational drug use clinically.Methods 124 adverse reactions of fluoroquinolone drugs are summarized.Results After taking fluoroquinolone drugs, adverse reactions mainly occur in the gastrointestinal tract and the central nervous system, there are four drugs involving major adverse reactions, including levofloxacin(46.8%), ciprofloxacin(28.2%), and gatifloxacin(18.5%), in which the main route of medication causing adverse reactions is intravenous injection.Conclusion In order to effectively reduce and prevent the adverse reactions of fluoroquinolone drugs, clinical drugs should be used according to the regulations, so as to effectively reduce the adverse reaction and improve the clinical effect.

  14. 729例临床药品不良反应报告分析%Analysis on 729 Cases of Clinical Adverse Drug Reactions

    Institute of Scientific and Technical Information of China (English)

    于海燕; 何粤红; 胥小叶

    2016-01-01

    Objective: To analyze the clinical adverse drug reactions ( ADR ) , and provide guidances for clinical rational drug use.Methods:729 cases of ADR collected which were monitored by the national ADR system in our hospital during the year between 2010 and 2015.And then the effective statistics,analysis and evaluation works were done with data.Results:In the 729 patients, there was 45 cases whose age were less than 18 years old, 207 cases were the age of 19 to 30 years old, 237 cases were the age of 31 to 45, 168 cases were the age of 46 to 60, 65 cases were the age of 61 to 80, and 7 cases were the age more than 80 years old;Meditation meth-ods for 701 cases were oral medicine, 19 cases were intramuscular injection, 6 cases were intravenous injection, 2 cases were venous in-jection, 1 case subcutaneous injection.29 kinds of medicines were involved, among which there were 41 gauges.And there were 7 organs or systems involved, among which the nervous system damage was 520 cases, digestive system damage was 103 cases, cardiovascular sys-tem damage was 61 cases, endocrine system damage was 18 cases, immune system damage was 12 cases, blood system damage was 11 cases, urinary system damage was 4 cases.The improved outcome of adverse reactions was 571 cases (78.33%), the recovery outcome was 158 cases(21.67%).Conclusion:The incidence of ADR in our hospital was the highest during the age of 31 to 45(32.51%) , the method of adverse reaction was mainly the oral medicine, the adverse reactions were given priority with the nervous system damage.And the risperdal was reported the most ADR.ADR monitoring and reporting should be strengthened to promote the rational use of drugs of the clinical.%目的:分析临床药品不良反应( ADR)的情况,为临床合理用药提供指导。方法:对我院2010~2015年收集上报至国家药品不良反应监测系统的729例有效报告进行统计、分析、评价。结果:729例ADR报告中,患者年龄≤18岁45

  15. Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye’s Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR)

    OpenAIRE

    Bennett, Charles L.; Starko, Karen M.; Thomsen, Henrik S; Cowper, Shawn; Sartor, Oliver; Macdougall, Iain C.; Qureshi, Zaina P; Bookstaver, P. Brandon; Miller, April D; Norris, LeAnn B.; Xirasagar, Sudha; Trenery, Alyssa; Lopez, Isaac; Kahn, Adam; Murday, Alanna

    2012-01-01

    Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye’s syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998, respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who...

  16. Analysis of 748 cases of quinolone adverse drug reaction in Suzhou city of 2013%2013年宿州市748例喹喏酮类药物不良反应分析

    Institute of Scientific and Technical Information of China (English)

    郭秀秀

    2014-01-01

    目的:研究影响喹诺酮类药物不良反应的因素,以期减少药物不良反应。方法:收集宿州市2013年喹诺酮类合成抗菌药物不良反应报表进行汇总分析。结果:748例喹诺酮类药物不良反应报表以左氧氟沙星引起的不良反应最多(68.14%)。不良反应涉及器官或系统最主要表现在胃肠系统(42.80%)、皮肤(30.64%)、中枢及外周神经系统(5.73%)。结论:应加强喹诺酮类药物的临床监测,提高合理用药的安全性。%Objective Study on the influence factors of adverse drug reactions of quinolones, in order to reduce the occurrence of adverse drug reaction.Methods Collected and analyzed the reports of Quinolones synthetic antibacterial drug adverse reactions in Suzhou city of 2013.Results Levofloxacin induced adverse reaction is most(68.14%)in 748 cases of ADR reports .The adverse drug reactions involving organs or systems mainly reflected in the gastrointestinal system (42.80%), skin (30.64%), the central and peripheral nervous system (5.73%).Conclusion We should strengthen the clinical monitoring of quinolones, to improve security of rational use of drug.

  17. Adverse reactions to injectable soft tissue fillers

    DEFF Research Database (Denmark)

    Requena, Luis; Requena, Celia; Christensen, Lise;

    2011-01-01

    In recent years, injections with filler agents are often used for wrinkle-treatment and soft tissue augmentation by dermatologists and plastic surgeons. Unfortunately, the ideal filler has not yet been discovered and all of them may induce adverse reactions. Quickly biodegradable or resorbable...

  18. Retrospective Analysis of Adverse Drug Reaction of Ibuprofen%布洛芬不良反应回顾性分析

    Institute of Scientific and Technical Information of China (English)

    吴朝霞

    2014-01-01

    目的:通过分析布洛芬所致药物不良反应(ADR)的一般规律和药物流行病学特点,为临床合理安全使用提供参考。方法:以“布洛芬”、“不良反应”关键词检索中国期刊全文数据库(CNKI)和中文科技期刊数据库(VIP)1996-2012年中文期刊,收集布洛芬所致ADR案例,对其ADR信息进行回顾性分析。结果:布洛芬所致ADR在各年龄组段均有分布且临床表现复杂多样涉及多器官、多系统,应警惕其引发严重ADR。结论:应注重患者个体差异,规范用药,提高患者用药依从性,强化药物治疗监测,以确保用药安全。%Objective:To analyze the general rules of the adverse drug reactions induced by ibuprofen and the pharmacoepidemiology features so as to provide a reference for rational and safe application of ibuprofen in clinical practice. Methods: ADR cases induced by ibuprofen were retrieved through key words searching and database review of CNKI and VIP from 1996 to 2012. The ADR information was retrospectively analyzed using statistical method. Results:The ADRs induced by ibuprofen presented in all age groups and the clinical manifestations were many and complex involving multiple organs and systems, therefore precautions should be made for the occurrence of serious ADRs. Conclusion: In order to ensure safe medication attention should be paid to the individual difference of patients and the standardization of drug application, in addition, medication compliance of patients should be improved and the therapeutic drug monitoring be strengthened.

  19. Educational intervention to improve physician reporting of adverse drug reactions (ADRs in a primary care setting in complementary and alternative medicine

    Directory of Open Access Journals (Sweden)

    Ostermann Thomas

    2009-07-01

    Full Text Available Abstract Background Recent studies have shown that adverse drug reactions (ADRs are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM. Data on CAM-related ADRs, however, are sparse. Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting. Methods A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results. To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI. We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P Results A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001 in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P P Conclusion The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their

  20. Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil: comparison of product information for oral formulations in Australia, Denmark and the United States.

    Science.gov (United States)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-07-01

    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 rapid increase in use of medications for treatment of ADHD symptoms has created concern due to lack of information about effects from long-term use. The aim of this study was to compare ADR information in product information (PI)/summary of product characteristics (SPC) for oral formulations of atomoxetine, methylphenidate and modafinil marketed by the same pharmaceutical companies in Australia, Denmark and the United States. Discrepancies in listed ADRs were defined as types of ADRs (system organ class) not listed in all countries. For ADRs where discrepancies were detected, we extracted information about study design (clinical trials, spontaneous report). Discrepancies in ADR labelling for the medications were found across the three countries. A total of 75 ADR categories were listed for atomoxetine and 80% of these were listed in all three countries. For methylphenidate, totally 101 ADR categories and for modafinil 115 ADR categories were listed. For both substances approximately 60% of listed ADRs were found in all three countries. Discrepancies were primarily detected for ADRs information based on clinical trials. For methylphenidate, many ADRs labelled in Australia and Denmark were not mentioned in PIs issued in the United States. In conclusion, information about possible ADRs associated with the use of a specific product should be made available worldwide, as the prescriber information about medicines' safety profile should not depend on the country in which the medication is licensed. PMID:23914751

  1. Late adverse reactions to intravascular iodinated contrast media

    Energy Technology Data Exchange (ETDEWEB)

    Webb, Judith A.W. [Department of Diagnostic Imaging, St. Bartholomew' s Hospital, London EC1A 7BE (United Kingdom); Stacul, Fulvio [Institute of Radiology, Ospedale di Cattinara, 34149 Trieste (Italy); Thomsen, Henrik S. [Department of Diagnostic Radiology 54E2, Copenhagen University Hospital at Herlev, Herlev Ringvej 75, 2730 Herlev (Denmark); Morcos, Sameh K. [Department of Diagnostic Imaging, Northern General Hospital, Sheffield Teaching Hospitals NHS Trust, Sheffield S5 7AU (United Kingdom)

    2003-01-01

    Late adverse reactions to intravascular iodinated contrast media are defined as reactions occurring 1 h to 1 week after contrast medium injection. They have received increasing interest over the past decade, but their prevalence remains uncertain and their pathophysiology is not fully understood. The Contrast Media Safety Committee of the European Society of Urogenital Radiology decided to review the literature and to issue guidelines. An extensive literature search was carried out and summarized in a report. Based on the available information, simple guidelines have been drawn up. The report and guidelines were discussed at the 8th European Symposium on Urogenital Radiology in Genoa. Late adverse reactions after intravascular iodinated contrast medium include symptoms such as nausea, vomiting, headache, itching, skin rash, musculoskeletal pain, and fever. A significant proportion of these reactions is unrelated to the contrast medium; however, allergy-like skin reactions are well-documented side effects of contrast media with an incidence of approximately 2%. Late reactions appear to be commoner after non-ionic dimers. The majority of late skin reactions after contrast medium exposure are probably T-cell-mediated allergic reactions. Patients at increased risk of late skin reactions are those with a history of previous contrast medium reaction and those on interleukin-2 treatment. Most skin reactions are self-limiting and resolve within a week. Management is symptomatic and similar to the management of other drug-induced skin reactions. (orig.)

  2. Late adverse reactions to intravascular iodinated contrast media

    International Nuclear Information System (INIS)

    Late adverse reactions to intravascular iodinated contrast media are defined as reactions occurring 1 h to 1 week after contrast medium injection. They have received increasing interest over the past decade, but their prevalence remains uncertain and their pathophysiology is not fully understood. The Contrast Media Safety Committee of the European Society of Urogenital Radiology decided to review the literature and to issue guidelines. An extensive literature search was carried out and summarized in a report. Based on the available information, simple guidelines have been drawn up. The report and guidelines were discussed at the 8th European Symposium on Urogenital Radiology in Genoa. Late adverse reactions after intravascular iodinated contrast medium include symptoms such as nausea, vomiting, headache, itching, skin rash, musculoskeletal pain, and fever. A significant proportion of these reactions is unrelated to the contrast medium; however, allergy-like skin reactions are well-documented side effects of contrast media with an incidence of approximately 2%. Late reactions appear to be commoner after non-ionic dimers. The majority of late skin reactions after contrast medium exposure are probably T-cell-mediated allergic reactions. Patients at increased risk of late skin reactions are those with a history of previous contrast medium reaction and those on interleukin-2 treatment. Most skin reactions are self-limiting and resolve within a week. Management is symptomatic and similar to the management of other drug-induced skin reactions. (orig.)

  3. Analysis of adverse drug reactions over 60 years older female patients%60岁以上老年女性患者药物不良反应分析

    Institute of Scientific and Technical Information of China (English)

    魏晓英

    2012-01-01

    目的:分析60岁以上老年女性患者药物不良反应的原因,并给予相应的护理.方法:收集我院2011年2月~2012年1月67例出现药物不良反应老年女性患者的临床资料并进行分析.针对患者出现的不良反应给予抗过敏、激素、纠正水电解质及酸碱失衡、调节菌群等对症处理.结果:临床表现以皮肤及附件出现不良反应居多;生殖系统不良反应最少;抗菌药物引起的不良反应最高,出现20例;其他类不良反应最低.其中1例抗过敏治疗死亡,共6例无效.结论:必要的护理干预可提高老年女性患者用药的安全性,降低不良反应.%Objective: To investigate the adverse drug reaction and nursing care in more than 60 years old female patients. Methods: From February 2011 to January 2012, in our hospital, 67 cases of old female patients with adverse drug reactions were collected and analyzed. Results:The incidence of adverse drug reaction on the skin and appendages adverse reactions was highest.. The least incidence is in the reproductive system. 20 cases administered antibiotics cause highest - happened adverse reaction. The least - happened was the other type. Antiallergy, hormone, correction electrolyte, imbalance acid - base and regulation of bacteria or withdrawal of medicine were given to 67 cases of adverse reaction patients, 1 case died of allergic reaction ,6 cases were ineffective. Conclusion: The necessary nursing intervention can improve medication safety in elderly female patient and reduce the risks of adverse reaction.

  4. [Adverse or toxic effects of drugs in medical practice: a one-year follow-up].

    Science.gov (United States)

    Grange, J C

    1990-01-01

    In order to analyse the response of pharmaceutical companies to adverse drug reaction reports, 37 suspected side effects were sent by mail to the 30 companies concerned. The time period involved was 1 year and corresponded to a total of 3341 consultations in general practice. Companies answered in 29 cases (78.3%), sent 21 reply forms and returned 3 evaluations of adverse drugs reactions to the reporting doctor. The high percentage of adverse drug reactions (1.07 per one hundred consultations), the doctor's work-load and poor feed-back lead one to reflect on the usefulness of systematic adverse drug reaction reporting by general practitioners. PMID:2399517

  5. 肺结核患者抗结核药物治疗不良反应%The monitoring of adverse reaction in patients with pulmonary tuberculosis treated by anti-tuberculosis drugs (a report of 247cases)

    Institute of Scientific and Technical Information of China (English)

    曾安津; 董霞

    2012-01-01

    目的 探讨肺结核在抗结核药物治疗过程中发生的不良反应.方法 对247例行抗结核药物治疗的肺结核患者出现不良反应进行分类分析.结果 不良反应主要表现为肝肾功能损害,消化道症状和中枢神经症状等;年龄超过50岁者不良反应发生率明显高于年龄低于50岁者(P<0.05).结论 肺结核患者使用抗结核药治疗应加强督导和随访,定期复查肝肾功能,及时有效处理药物不良反应.%Objective To investigate the adverse reaction of patients with pulmonary tuberculosis during the processes of anti-tu berculosis drug treatment, and provide the evidence for the development of effective prevention and treatment measures. Method The ad verse reactions of 247 patients with pulmonary tuberculosis treated with anti-tuberculosis drug therapy were classified and statistical ana lyzed. Results The main adverse reactions were liver and kidney dysfunction, gastrointestinal symptoms and nervous symptoms. The in cidence of adverse reactions in patients over the age of 50 years was significantly higher than that of patients under the age of 50 years ( P < 0. 05 ). Conclusion The treatment of anti-tuberculosis drug in patients with pulmonary tuberculosis should be strengthened supervision and follow-up, reviewing the function of liver and kidney regularly, adverse and drug reactions should be treated timely and effective, par ticularly patients over the age of 50 years.

  6. Discussion on adverse reactions monitoring modes of drug manufacturers under new measures for administration of adverse drug reaction report and monitoring%《药品不良反应报告和监测管理办法》下药品生产企业不良反应监测工作模式探讨

    Institute of Scientific and Technical Information of China (English)

    杨延音; 董志; 夏永鹏

    2012-01-01

    Objective: To discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring. Method: Work modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains. Result and Conclusion: As there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.%目的:探讨药品生产企业在《药品不良反应报告和监测管理办法》(新《办法》)下顺利开展ADR监测工作的模式.方法:通过对新《办法》解读、现状及制约因素分析,探索生产企业ADR监测工作开展模式.结果与结论:生产企业在短期内一步到位完全按照新《办法》要求开展ADR监测工作与现状跨度较大,可以通过一“平台”四“拓展”的模式,分块逐步突破,开展ADR监测工作,最终完全达到新《办法》的要求,履行主体地位的责任和使命.

  7. Efficacy of intravenous hydrocortisone administered 2-4 h prior to antivenom as prophylaxis against adverse drug reactions to snake antivenom in Sri Lanka: An open labelled randomized controlled trial.

    Science.gov (United States)

    Kularatne, Senanayake A M; Weerakoon, Kosala; Silva, Anjana; Maduwage, Kalana; Walathara, Chamara; Rathnayake, Ishani; Medagedara, Senal; Paranagama, Ranjith; Mendis, Suresh; Kumarasiri, P V R

    2016-09-15

    The prevention of adverse drug reactions to antivenom serum poses a formidable challenge in the management of snakebite. Hydrocortisone is being used concurrently with antivenom in order to prevent these adverse drug reactions without a proven benefit. However, all previous studies seemed to ignore the testing of effectiveness of hydrocortisone therapy during its pharmacological effects, which come hours later. On this principle, we aimed to test the effectiveness of intravenous hydrocortisone given 2 h or more prior to the commencement of antivenom therapy to reduce adverse drug reactions to antivenom. In an open-labelled randomized controlled trial, patients with a history of snakebite were randomly assigned to receive either 500 mg intravenous hydrocortisone bolus given 2 h or more prior to antivenom therapy (Group A) or at the time of antivenom therapy (Group B). The primary endpoint was the reduction of adverse drug reactions to antivenom of any grade of severity within the first 48 h. This trial has been registered with the "Sri Lanka Clinical Trials Registry", number SLCTR/2010/005. A total of 236 patients were randomized to group A or Group B. In the group A, 38 participants received hydrocortisone 2 h before administration of antivenom whilst 33 received hydrocortisone less than 2 h before administration of antivenom. In the Group B, 84 participants received hydrocortisone at the time of antivenom therapy. In Group A (n, 38), and Group B (n, 84), 15 patients (39%) and 29 patients (35%) developed reactions respectively and the difference is not significant (p = 0.598). Moreover, hydrocortisone therapy did not significantly reduce the occurrence of antievnom reactions of any grade of severity. Further, it didn't delay the occurrence of antivenom reactions in patients who received hydrocortisone either more than 2 h or less than 2 h before the antivenom as opposed to the control group (group B). Intravenous hydrocortisone shows no difference in the

  8. 420例别嘌醇不良反应的文献分析%Literature Analysis of 420 Cases of Adverse Drug Reactions Induced by Allopurinol

    Institute of Scientific and Technical Information of China (English)

    郑明节; 汤韧; 王春婷

    2014-01-01

    Objective To probe into the status,characterstics and influencing factors of ADR cases induced by allopurinol, for providing a reference for clinical treatment. Methods Data were collected from domestic published literatures from"China Journal Full-text Database"before 2013, and 420 case reports of adverse drug reactions induced by allopurinol were analyzed retrospectively. Results Older male patients appear to be with a high rate. Organs involved mainly are skin and its appendages(42.33%), systemic damage(22.77%), hepatobiliary system damage(9.90%). Severe damages to the skin are erythema multiforme system eruption , exfoliative dermatitis and hypersensitivity syndrome. Conclusion Allopurinol should be used reasonably, and the monitoring of clinical use should be strengthened to ensure the safety of medication.%目的:探讨别嘌醇致不良反应的一般规律特点,为临床合理用药提供参考。方法检索中国期刊全文数据库,对2013年之前国内公开发表有关别嘌醇致不良反应420例病例文献报道进行回顾性分析。结果老年男性患者发生率高,累及系统-器官主要为皮肤及其附件损害(42.33%)、全身性损害(22.77%)、肝胆系统损害(9.90%),严重皮肤系统的损害以多形红斑型药疹、剥脱性皮炎超敏综合征为主。结论别嘌醇片安全使用丞待加强,临床应重视别嘌醇的不良反应,加强用药监测,确保安全使用。

  9. 208例骨瓜提取物注射剂严重不良反应报告分析%Analysis of 208 Cases of Serious Adverse Drug Reactions Induced by Gugua Extracts Injection

    Institute of Scientific and Technical Information of China (English)

    沈晓华; 罗凌凤; 黄亦彬

    2015-01-01

    目的:探讨骨瓜提取物注射剂致严重药品不良反应的规律及特点。方法采用回顾性研究方法,对208份骨瓜提取物注射剂的严重不良反应报告进行统计分析。结果骨瓜提取物注射剂严重不良反应主要表现为过敏性休克、过敏样反应、寒战、呼吸困难和发热等;严重不良反应多在30 min 内发生,其中过敏性休克主要集中在15 min 内发生。结论有必要对骨瓜提取物注射剂说明书进行修改和完善。%Objective To explore the characters of the serious adverse reactions caused by Gugua extracts injection. Methods 208 reports of the serious adverse reactions caused by Gugua extracts injection were analyzed via retrospective study. Results Gugua extracts injection may lead to serious adverse reactions such as anaphylactic shock, anaphylactoid reaction,rigors,dyspnea,fever, etc. The serious adverse reactions occurred within 30 min, and anaphylactic shock occurred within 15 min. Conclusion It is necessary to re-evaluate the risk of serious adverse reactions caused by Gugua extracts injection and modify the drug instructions on this basis.

  10. Psychiatric Adverse Effects of Dermatological Drugs

    Directory of Open Access Journals (Sweden)

    Mine Özmen

    2010-07-01

    Full Text Available Dermatological drugs, mostly corticosteroids and isotretinoin, cause different psychiatric adverse effects. During steroid therapy, a wide range of psychiatric conditions, from minor clinical symptoms like insomnia and anxiety to serious psychiatric syndromes like psychosis and delirium might be seen. In medical literature, a causal connection is usually suggested between “isotretinoin”, which is used for treatment of acne vulgaris and depression and suicide attempts. However, there are no statistically significant double-blind randomized studies that support this connection. Clinicians must know patient’s psychiatric history before using any dermatological treatment known as causing psychiatric adverse effects, and psychiatric consultation should be established whenever necessary.

  11. Advances in search for genetic polymorphism of pharmacogenetic biomarkers about severe adverse drug reactions%严重药物不良反应相关药物标记基因多态性研究状况

    Institute of Scientific and Technical Information of China (English)

    古先祥; 王启华

    2012-01-01

    用药过程中发生的严重药物不良反应事件,有明显的个体差异和不可预测性,个体的基因及其多态性决定着其易感性差异.如果发现更多的药物不良反应危险基因,将有助于预测个体药物不良反应的发生.本文将部分与严重药物不良反应中的皮肤及肝脏损害有关的基因及多态性研究进展进行简要综述.%Severe adverse drug reactions , which appear to be idiosyncrat-ic and unpredictable, are a major issue for drug therapy . Genetic factors or genome polymorphisms contribute to the susceptibility or heterogenei-ty. More discovery of risk alleles for these severe drug reactions may ben-efit the prediction of individuals. In this review, we clarify the current status of the genetic polymorphism of pharmacogenetic biomarkers about severe adverse drug reactions in skin and liver from open data sources.

  12. Adverse drug reactions of Qingkailing injection and Shuanghuanglian injection: Analysis of 90 cases%清开灵及双黄连注射液不良反应90例分析

    Institute of Scientific and Technical Information of China (English)

    杨帆; 高天; 何燕; 杨阳; 郭雪梅; 谢聪

    2011-01-01

    Objective To observe and compare the adverse drug reactions and safety of Qingkailing injection and Shuanghuanglian injection for children. Methods The adverse drug reaction data of children under 14 years using Qingkailing injection and Shuanghuanglian injection obtained from Sichuan Database of National Center for Adverse Drug Reactions Monitoring from 2006 to 2008 were grouped into Qingkailing group and Shuanghuanglian group and statistically analyzed. Results A total of 90 cases were selected.Adverse reactions occurred in more than 60% of the patients in the course of treatment In 80% of the cases, Qingkailing injection was used for upper respiratory tract infection. Shuanghuanglian injection was used for upper respiratory tract infection in half of the cases and for bronchial in 25% of the cases. The adverse drug reactions in two groups were significantly different ( P < 0.05 ). The main adverse drug reactions in Qingkailing group were rash ( 59% ), fever and chills ( 34% ), while in Shuanghuanglian group were rash ( 70% ). Conclusion The adverse drug reactions in both Qingkailing group and Shuanghuanglian group were mainly rash. Qingkaihng group has a higher proportion of fever and chills than Shuanghuanglian group. The clinicians should pay more attention to distinguish the fever caused by drugs and by the disease itself, so as to take proper measures to treat with them.%目的 观察比较清开灵注射液、双黄连注射液临床用于儿童患者的不良反应及安全性,为临床合理用药提供参考.方法 提取全国药品不良反应监测网四川省数据库中2006年1月1日至2008年1月4日14岁以下患者使用清开灵注射液(清开灵组)及双黄连注射液(双黄连组)不良反应病例,进行统计分析.结果 符合纳入条件者90例,用药剂量均符合药品说明书的相关规定;两组60%以上的不良反应都发生在用药过程中;清开灵注射液80%用于上呼吸道感染,而双黄连50%

  13. The associations between idiosyncratic adverse drug reactions and HLA alleles and their underlying mechanism%遗传异质性药物毒副作用与HLA基因关联及分子机制研究进展

    Institute of Scientific and Technical Information of China (English)

    王青; 梅虎; 张亚兰; 潘显超; 谭文; 晁丽

    2013-01-01

    随着高通量基因测序技术的发展,全基因组关联分析(genome-wide association study,GWAS)被越来越多地应用到遗传异质性药物毒副作用(adverse drug reactions,ADRs)研究中.越来越多的研究发现:遗传异质性ADRs与人类白细胞抗原(human leukocyte antigen,HLA)密切相关,如阿巴卡韦(abacavir)与HLA-B*5701、别嘌醇(allopurinol)与HLA-B*5801、卡马西平(carbamazepine)与HLA-B*1502等基因关联.针对上述基因关联现象,相继提出半抗原理论、危险因子理论、“P-I”理论以及最新提出的自身免疫机制.本文就遗传异质性ADRs与HLA基因关联及其机制研究的最新进展进行了详细综述.%With the advent of Twenty-First century,more and more genome-wide association studies (GWAS)showed that idiosyncratic adverse drug reactions (ADRs) were closely related with human leukocyte antigen (HLA) alleles,such as the associations of abacavir-HLA-B*5701,allopurinol-HLA-B*5801,and carbamazepineHLA-B*1502,etc.To explore the mechanisms of these idiosyncratic drug reactions,hapten hypothesis,danger signal hypothesis,pharmacological interaction (P-I) concept and autoimmune mechanism are proposed.In this paper,recent GWAS studies on the HLA-mediated adverse drug reactions and underlying mechanism are reviewed in detail.

  14. An adverse drug interaction of haloperidol with levodopa

    Directory of Open Access Journals (Sweden)

    Jisha M Lucca

    2015-01-01

    Full Text Available Drug interactions are known to play a significant role in the incidence of adverse drug reactions (ADRs both in the community and in hospitals. Both the newer atypical antipsychotics and their more traditional counterparts are subject to drug - drug interactions amongst themselves, with other psychotropics, and with the agents used in the treatment of various physical ailments. The most common interactions encountered in clinical practice are pharmacodynamic in nature. It is well established that antipsychotic drugs reduce the efficacy of levodopa in parkinson′s disease by blockade of dopamine receptors in the corpus striatum. The case reported here illustrates a common pharmacodynamic drug interaction of haloperidol with levodopa in a 60-year-old female patient.

  15. Prevention and nursing for adverse reactions of commonly used chemotherapy drugs%常用化疗药物不良反应的预防及护理探讨

    Institute of Scientific and Technical Information of China (English)

    孙萌

    2014-01-01

    Objective To investigate the adverse reactions and preventive care measures of commonly used chemotherapy drugs.Methods The adverse reactions occurrence in 321 cases of cancer patients during chemotherapy were closely observed,and the appropriate preventive care measures were implemented.Results 321 cases of adverse reactions in this group of patients was mainly hair loss,bone marrow suppression,phlebitis,mouth ulcers and other gastrointestinal reactions, after the appropriate care measures, significantly reduced the extent of adverse reactions, chemotherapy were carried out smoothly.Conclusion Close observation and timely implementation of reasonable and effective preventive care intervention can ensure the smooth progress of chemotherapy treatment,and improve the quality of life of patients.%目的:探讨常用化疗药物的不良反应及其预防护理措施。方法密切观察321例肿瘤患者在应用化疗药物期间的不良反应发生情况,并实施相应的预防护理措施。结果本组321例患者的不良反应主要为脱发、骨髓抑制、静脉炎、消化道反应以及口腔溃疡等,经相应护理措施后,不良反应程度显著减轻,化疗均顺利进行。结论密切观察并及时实施合理有效的预防护理干预可确保化疗疗程顺利进行,并改善患者的生活质量。

  16. 护理干预对降低克林霉素药物不良反应的效果%The effect of nursing intervention to reduce the adverse drug reactions of clindamycin

    Institute of Scientific and Technical Information of China (English)

    李兴革; 张建芳; 陈丽泓; 李丽仙

    2013-01-01

    目的:探讨克林霉素药物不良反应的护理干预措施及临床效果.方法:将2012年1~3月静点克林霉素人群及出现药物不良反应患者作为对照组;2012年4~6月实施护理干预后,使用该药物的人群作为观察组,对两组患者进行分析比较.结果:观察组中药物不良反应发生率是2.24%,对照组中药物不良反应发生率是8.70%.结论:针对使用克林霉素药物的患者进行有效护理干预,尤其是用药前的询问过敏史、用药方法及药物剂量的准确把握、健康宣教,使用过程中的严密观察巡视等措施,对降低克林霉素药物不良反应的发生率及减轻临床症状有极其重要的作用.%Objective:To investigate nursing interventions and clinical effects to reduce adverse drug reactions of clindamycin. Methods:General information of patients with treatment of clindamycin and adverse drug reactions from January to March in 2012 was retrospectively analyzed as control group. Patients by nursing intervention from April to June in 2012 were analyzed as observation group and compared with control group. Results :The constituent ratio of adverse drug reactions in the observation group was 2.24% ,and was 8.70% in the control group. Conclusion:The effective nursing intervention for patients using clindamycin drugs,such as the allergy medication history of inquiry before treatment,an accurate grasp for method of administration and dose,health education, closely observation,has its important role to reduce incidence of adverse drug reactions for clindamycin and reduce the clinical symptoms.

  17. The adverse reactions and causes of drug switch in 214 HIV/AIDS patients with HAART%214例HIV/AIDS病人的HAART不良反应及换药原因分析

    Institute of Scientific and Technical Information of China (English)

    覃川; 蒋忠胜; 温小凤

    2014-01-01

    目的 探讨艾滋病病毒(HIV)感染者/艾滋病(AIDS)病人(简称HIV/AIDS病人)高效抗反转录病毒治疗(HAART)的不良反应及换药原因.为保证HAART合理用药及用药安全提供依据.方法 全部病人均使用国家免费艾滋病HAART药物,按照国家免费艾滋病抗病毒药物治疗手册要求,全部病例均在HAART后1、2、3、6、9、12个月随访1次,统计病人不良反应及换药原因,数据分析用SPSS 19.0软件处理,以P<0.05为差异有统计学意义.结果 95例病人中90例出现抗病毒药物不良反应、3例一线治疗失败、2例因药物配伍禁忌更换抗病毒药物.其中90例病人因AZT、NVP、D4T不良反应更换抗病毒药物.另有3例初始HAART方案包含EFV的病人,出现神经系统症状,均自行缓解,未更换药物.将初始HAART方案包含AZT、NVP、D4T的病例分为未换药组和换药组,将两组病人的基线CD4+ T淋巴细胞(简称CD4细胞)计数值进行统计学比较,差异无统计学意义.结论 HAART的主要换药原因为抗病毒药物不良反应.在包含AZT、D4T、NVP的HAART方案中,治疗前3个月着重监测AZT、NVP的不良反应,治疗6个月后着重监测D4T的不良反应,且不良反应的出现与基线CD4细胞计数无关.同时须及早发现耐药,并须掌握药物配伍禁忌.%Objective To investigate the adverse reaction and causes of drug switch in HIV/AIDS patients with highly active antiretroviral therapy (HAART),in order to provide the basis for the rational use of drugs and drug safety.Methods All the patients took free national antiretroviral drugs.According to the requirements of free national antiretroviral treatment manual,all patients were followed up at 1,2,3,6,9 and 12 months after HAART,collecting data of adverse reaction and causes of drug switch.The data was analyzed using SPSS 19.0 software.P< 0.05 was considered statistically significant.Results There were 95 patients switching antiretroviral drugs due to

  18. Analysis of Association between Adverse Drug Reactions Induced by Cardiovascular and Cerebrovascular Drugs and Patients%心脑血管用药不良反应与用药人群间的关联关系分析

    Institute of Scientific and Technical Information of China (English)

    冯变玲; 魏芬; 杨世民; 赵君; 雷祎; 覃蓝

    2011-01-01

    目的 分析药品不良反应与用药人群的性别、年龄间潜在的关联关系,为心脑血管类疾病用药的安全、合理、有效提供参考.方法 根据江苏省药品不良反应监测中心2004-2009年收集的9 640份心脑血管疾病用药不良反应报告数据,运用数据挖掘技术中广义规则归纳法(GRI)的关联规则算法对数据进行分析.从年龄、性别支持度,不同不良反应现象与不同年龄段间关联关系的置信度以及不同不良反应现象与不同性别间关联关系的置信度进行分析,得出相关结果.结果与结论 药品不良反应主要发生在2个年龄段,一是50~59岁年龄段,不良反应主要为咳嗽和头晕;二是60~69岁年龄段,不良反应主要为头晕和恶心.药品不良反应在男性身上发生的频次较女性多;个别不良反应有较明显的性别偏向.%OBJECTIVE: To explore potential correlation of adverse drug reaction (ADR) with patient's gender and age, and to provide the best evidence for medical staff to making decision to ensure that security of drug use for cardiovascular and cerebro-vascular diseases and improve therapeutic efficacy. METHODS: 9 640 ADR reports on drug use for cardiovascular and cerebrovas-cular diseases were collected from Jiangsu Province Adverse Drug Reaction Monitoring Centre during 2004 - 2009. GRI association rules algorithm of data mining technology was used for data analysis. RESULTS: During 2004-2009, data was analyzed from support of age and gender, confidence level of association of different ADR phenomena with different age groups and confidence level of association of different ADR phenomenon with gender. Related results were obtained. CONCLUSION: The ADR mainly occurred in two age groups, 50~59 age group and ADR included coughing and dizziness; 60~69 age group and ADR included dizziness and nausea. ADR occurred in more male than female; individual ADR were more obvious gender bias, such as cough mainly in

  19. Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs in selected hospitals in Nigeria

    Directory of Open Access Journals (Sweden)

    Kenneth Anene Agu

    2012-01-01

    Full Text Available Purpose: The study evaluated the knowledge and attitudes of HIV-infected patients on ART regarding ADRs following routine patient counseling and education in selected hospitals in Nigeria. Materials and Methods: From 36,459 HIV-infected patients on ART in the 36 selected hospitals, a study-specific instrument was administered to 3,650 patients in a cross-sectional study. Patients were provided counseling and education on ADRs before and after commencing ART. Factor analysis was performed using principal components extraction. Item score means above midpoint (3.7 on a 5-point scale were regarded as positive attitudes and below as negative attitudes. A chi-square test was used for inferential statistics; P3.7 which denotes positive attitudes to ADRs. Three extracted factors accounted for 73.1% of cumulative variability. All attitude items had very significant loadings of ≥0.5. Conclusion: Overall, participants reported good knowledge and positive attitudes to adverse effects of their medicines compared to what was reported previously. The patient counseling and education on drug therapy provided to patients may have contributed to these findings and are highly recommended.

  20. Analysis of 73 Cases of Severe Adverse Drug Reactions Caused by Cephalosporin%73例头孢菌素类药物严重不良反应分析

    Institute of Scientific and Technical Information of China (English)

    吕冬莲; 龙萍; 吴方建

    2012-01-01

    目的:了解头孢菌素类药物引起的严重不良反应(SADR)的发生规律,发掘药物警戒信号,为临床安全合理用药提供参考.方法:收集武汉市不良反应监测系统数据库中2009~2011年头孢菌素类严重的(包括新的严重的)不良反应报告,从中筛选出符合标准的73例进行分析.结果:73例SADR涉及头孢菌素19个品种,其中以头孢曲松的比例最高;临床表现以过敏性休克和过敏样反应为主的全身性损害最为突出;41例SADR发生时间在30 min内;50岁以上的老年人及10岁以下儿童ADR构成比较高.从ADR病例报告中反映存在相当数量的不合理用药现象.结论:临床应高度重视头孢菌素类药物引起的过敏性休克等SADR,增强合理用药意识,以减少和避免SADR的发生.%Ohjective:To realize the regularity of severe adverse drug reaction(SADR) of cephalosporin, exploring the signal of drug alert, and providing the reference of rational use of drugs for clinical safety. Methods; Analyzed 73 oases which were up to standard from severe( including new severe) adverse reaction reports of cephalosporin from 2009 to 2011 in Wuhan adverse reaction monitoring system database. Results:'The SADR involved 19 kinds of cephalosporin, and the highest rercenlage was ceftriaxone Clinical perfor mance based on the principle of anaphylactoid reaction and anaphylac-tic shock. 41 cases SADRs appeared wilhin 30 minutes after administration, the constituent ratios of elder above 50 years old and the children under the age of 10 were a relatively high. And the reports of the SADR cases reflected a number of irrational drug use phenomenon. Conclusion: Clinical should pay high attention to anaphylactic shock and other SADRs caused by cephalosporin. To enhance the consciousness of rational drug use, in order lo reduce and avoid the happening of SADRs.

  1. 抗结核药物所致不良反应发生情况及相关危险因素分析%Risk factors of adverse reactions caused by anti-TB drugs

    Institute of Scientific and Technical Information of China (English)

    缪志伟

    2013-01-01

    Objective To study the characteristics of the adverse reactions caused by anti-TB drugs and to analyze its risk factors. Methods 1 368 cases of patients diagnosed as tuberculosis who received standard treatment options were selected from 2005 to ,2010 in Yangzhong city. The adverse reactions and its risk factors were analyzed statistcally. Results 12. 97% of these patients had adverse reaction. The main adverse reactions were liver dysfunction and gastrointestinal reactions. Univariate analysis showed that age, BMI, monthly income, diagnostic classification and history of hepatitis were the suspected risk factors. Multivariate analysis results showed that age≥60 ( OR = 3.27,95%CI=2.073 ~5.439,P = 0.002 ),BMI < 18.5( OR = 1.377,95%CI = 1.021 ~3. 548,P =0. 037 ) and with history of hepatitis( OR = 1. 82,95% CI = 1.003 ~ 6. 248, P = 0. 046 ) ) were the risk factors of adverse reactions. Conclusions The adverse reactions caused by anti-TB drugs are relatively high and if the patient was in advanced age or with poor nutritional status or with history of hepatitis the probability of adverse reactions will increase.%目的 观察抗结核药物所致的不良反应发生情况并分析与其发生相关的危险因素.方法 以2005-2010年该市使用标准化疗方案的确诊肺结核患者1 368例为研究对象,对治疗相关不良反应及其危险因素进行统计分析.结果 抗结核药所致的不良反应发生率为12.97%,主要的不良反应事件为肝功能损害及胃肠道反应;单因素统计结果发现年龄、BMI、月收入、诊断分型及肝炎病史为抗结核治疗相关可疑危险因素,多因素统计分析发现年龄≥60岁(OR=3.27,95%CI=2.073~5.439,P=0.002)、BMI<18.5(OR=1.377,95%CI=1.021~3.548,P=0.037)及肝病史(OR=1.82,95%CI=1.003~6.248,P=0.046)为治疗相关危险因素.结论 抗结核药所致不良反应发生率较高,当患者存在高龄、营养状态差及肝炎病史可一定程度增加不良反应发生率.

  2. Prevention and nursing measures of adverse drug reaction in patients with rheumatoid arthritis treated with Tolicizumab%托珠单抗治疗类风湿关节炎不良反应的预防护理

    Institute of Scientific and Technical Information of China (English)

    吴丹纯; 方蘅英; 谢园园; 姚咏梅; 周小香

    2014-01-01

    Objective To analyze the prevention and nursing measures of adverse drug reaction in patients with rheumatoid arthritis treated with Tolicizumab.Method The clinical data and nursing measures in 30 patients with rheumatoid arthritis treated with Tolicizumab were reviewed and analyzed.Result All the patients completed the treatment and no infusion reaction was observed in the first 24 hours.Conclusions Comprehensive and intensive assessment is necessary before application of Tocilizumab. Executing standard drug dispensing and injection process,mastering the infusion reaction emergency processing measures and establishing injection related systems are of great significance to observe and treat various adverse reactions in time,ensuring drug effects and safety of the patients.%目的:探讨预防托珠单抗治疗类风湿关节炎(rheumatoid arthritis,RA)不良反应的护理经验。方法回顾性分析和总结30例RA患者接受托珠单抗治疗及护理经过。结果30例RA患者全部完成治疗,24 h内无出现不良反应。结论在使用托珠单抗前进行全面、深入、细致的评估;使用过程中执行规范的配置流程和注射流程,掌握发生不良反应的应急处理措施,建立输液相关制度,及时发现和有效处理各种不良反应,对保证药物疗效和患者安全具有重要意义。

  3. 748例β-内酰胺类抗菌药物不良反应分析%Analysis on 748 Cases of β-lactam Antibiotics Drug Adverse Reaction

    Institute of Scientific and Technical Information of China (English)

    张树强; 邢蓉; 王群; 师佩兰; 谢冬梅; 许健

    2011-01-01

    目的 了解蚌埠地区β-内酰胺类抗菌药物致药品不良反应(ADR)的发生情况.方法 对2010年1~12月蚌埠地区上报的748例β-内酰胺类抗菌药物ADR病例报告,按性别、年龄、给药途径、药品类别、ADR累及系统-器官及临床表现等进行统计、分析.结果 ADR涉及的β-内酰胺类抗菌药物共26种,ADR发生频次以阿莫西林居首位,其次为头孢氨苄和头孢拉啶;主要的ADR类型为皮肤及其附件损害,占47.48%;1例严重ADR.结论 应规范β-内酰胺类抗菌药物的临床应用,以减少ADR的发生率.%Objective To investigate the situation of β- lactam antibiotics drug adverse reactions in Bengbu region. Method According to gender, age, administration route, drug category, organs or systems, clinical manifestations Involved with ADR, and so on, 748 cases of β-lactam antibiotics drag adverse reactions in Bengbu region reported from Jan 2010 to Dec 2010 were analyzed. Results 26 β-lactam antibiotics drugs were involved with ADR. As to the ADR frequence, the highest was related to amoxicillin, and then were related to cephalexin and cephradine. The major organ-system damage involved in ADR was skin and appendages disorders, which accounted for 47.48% of the total, and a serious ADR occurred. Conclusion Clinical appliance of β-lactam antibiotics drug should be standardized to reduce the ADR incidence.

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

    Directory of Open Access Journals (Sweden)

    Ogunwande Isiaka A

    2011-08-01

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

  5. Acute adverse reactions to magnetic resonance contrast media--gadolinium chelates.

    Science.gov (United States)

    Li, A; Wong, C S; Wong, M K; Lee, C M; Au Yeung, M C

    2006-05-01

    The objective of this study was to evaluate the clinical safety of intravenous gadolinium-based contrast media used in patients who underwent MRI at a single institution. Acute adverse reactions to intravenous gadolinium-based contrast media used for MRI at the Princess Margaret Hospital, Hong Kong, SAR, from January 1999 to November 2004 were recorded in an incidence log book. The medical records of patients' demographics were retrospectively reviewed and the nature, frequency and severity of the adverse reactions were investigated and documented. The incidence of acute adverse reactions to intravenous gadolinium-based contrast media was 0.48% (45 patients with 46 adverse reactions). The severity of these adverse reactions were 96% mild, 2% moderate (one patient developed shortness of breath that required oxygen supplementation and intravenous steroidal management) and 2% severe (one patient developed an anaphylactoid reaction, but successfully recovered through timely resuscitation). No patients were recorded as having contrast extravasation and none died as a result of any adverse reaction. Among the 45 patients who developed adverse reactions, three patients (6.7%) had prior adverse reactions to iodinated contrast media, three (6.7%) had prior reactions to a different gadolinium-based contrast agent, one (2%) had asthma and nine (20%) had a history of drug/food allergy. Overall, 41% of the adverse reactions were not documented in the final MRI report or the clinical medical records. Gadolinium-based contrast media are safe and well tolerated by the vast majority of patients. In our study, the adverse reaction rate (0.48%) and the incidence of severe anaphylactoid reaction (0.01%) concur with those reported in the literature. Although most of the symptoms are mild and transient, these adverse reactions must be accurately documented and managed. PMID:16632615

  6. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR)

    OpenAIRE

    Moore, Thomas J.; Bennett, Charles L.

    2012-01-01

    The U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS), familiarly known as “MedWatch,” is the nation's primary tool for postmarket pharmaceutical safety surveillance. This system relies on adverse events voluntarily reported by health care providers and consumers either directly to the FDA or to drug manufacturers, which are required to prepare and forward the information to the agency. Little is known about how frequently adverse events are reported. Previous es...

  7. Precautions and Adverse Reactions during Blood Transfusion

    Science.gov (United States)

    ... fever and need another transfusion may be given acetaminophen before the next transfusion. Allergic reactions Symptoms of an allergic reaction include itching, a widespread rash, swelling, dizziness, and headache. Less common symptoms are breathing difficulties, ...

  8. 我院129例喹诺酮类抗菌药物致不良反应报告分析%Analysis of 129 Cases of Adverse Drug Reactions Induced by Quinolones

    Institute of Scientific and Technical Information of China (English)

    金伟华; 王晓蕙; 陈华; 谭永红

    2011-01-01

    目的:探讨喹诺酮类药物致不良反应(ADR)的特点,为其临床合理应用提供参考.方法:收集2004年1月-2011年1月我院应用喹诺酮类抗菌药物致ADR的临床资料,进行总结、分析.结果:我院共报告129例喹诺酮类致ADR,涉及8个药品种类,左氧氟沙星最多,发生86例,占66.67%;从受损系统或器官看,皮肤及附件最多,发生49例,占37.98%.结论:临床应重视合理使用喹诺酮类抗菌药物,杜绝或减少ADR的重复发生.%OBJECTIVE: To explore the characteristics of adverse drug reactions (ADR) induced by quinolones and to provide reference for rational drug use in the clinic. METHODS: Clinical information of ADR induced by quinolones collected from our hospital during Jan. 2004-Jan. 2011 were analyzed and summarized. RESULTS: 129 ADR cases induced by quinolones in our hospital involved 8 drug categories. Main type of ADR-inducing drugs was levofloxacin (86 cases, accounting for 66.67% ). In respective of injured system and site, lesion of skin and its appendants occupied great proportion and appeared in 49 cases, accounting for 37.98%. CONCLUSION: To use quinolones rationally and great importance should be attached to the adverse consequences of its ADR.

  9. Optimal management of acute nonrenal adverse reactions to iodine-based contrast media

    Directory of Open Access Journals (Sweden)

    Nielsen YW

    2013-06-01

    Full Text Available Yousef W Nielsen, Henrik S Thomsen Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark Abstract: Acute adverse reactions to iodine-based contrast media occur within 60 minutes of administration. The reactions range from mild (flushing, arm pain, nausea/vomiting, headache to moderate (bronchospasm, hypotension, and severe (cardiovascular collapse, laryngeal edema, convulsions, arrhythmias. Most acute adverse reactions occur in an unpredictable manner. Use of the older group of ionic iodine-based contrast agents increases the risk of acute adverse reactions. Other risk factors include previous reactions to contrast media, asthma, and allergic conditions. The exact pathophysiology of the acute adverse reactions is unknown, but some of the reactions are pseudoallergic mimicking type 1 allergic reactions. As antibodies against contrast media have not been consistently demonstrated, the reactions are, in most cases, not truly allergic in nature. Most of the severe and fatal adverse reactions occur within the first 20 minutes after injection. Thus, it is important that patients are observed in the radiology department during this period. The radiologist should be near the room where contrast media is administered, and be ready to treat any acute nonrenal adverse reaction. Appropriate drugs and resuscitation equipment should be in/near the room where the contrast media is administered. The important first-line management of acute adverse reactions includes the establishment of an adequate airway, oxygen supplementation by mask, intravenous fluid administration, and measurement of blood pressure and heart rate. When severe anaphylactoid reactions occur, adrenaline should be given intramuscularly. Only one concentration of adrenaline (1:1000–1 mg/mL should be available in the radiology department to avoid dosing errors in stressful acute settings. Resuscitation team specialists should be the only ones giving intravenous

  10. Managing nonteratogenic adverse reactions to isotretinoin treatment for acne vulgaris.

    Science.gov (United States)

    Reilly, Bridget K; Ritsema, Tamara S

    2015-07-01

    Isotretinoin is the strongest, most effective oral treatment for patients with severe acne vulgaris, with remission rates of 89% and higher. Because of its potency, isotretinoin causes many adverse reactions. This article reviews common and severe adverse reactions to isotretinoin and how providers can best manage these reactions. Because of inconclusive research on the correlation between isotretinoin and depression and irritable bowel syndrome, providers should ask patients about symptoms monthly. Prescribing micronized isotretinoin and starting at the lowest dose with gradual upward titration also can help reduce the incidence of adverse reactions.

  11. FDI report on adverse reactions to resin-based materials.

    Science.gov (United States)

    Fan, P L; Meyer, D M

    2007-02-01

    Resin-based restorative materials are considered safe for the vast majority of dental patients. Although constituent chemicals such as monomers, accelerators and initiators can potentially leach out of cured resin-based materials after placement, adverse reactions to these chemicals are rare and reaction symptoms commonly subside after removal of the materials. Dentists should be aware of the rare possibility that patients could have adverse reactions to constituents of resin-based materials and be vigilant in observing any adverse reactions after restoration placement. Dentists should also be cognisant of patient complaints about adverse reactions that may result from components of resin-based materials. To minimise monomer leaching and any potential risk of dermatological reactions, resin-based materials should be adequately cured. Dental health care workers should avoid direct skin contact with uncured resin-based materials. Latex and vinyl gloves do not provide adequate barrier protection to the monomers in resin-based materials.

  12. Low body weight and type of protease inhibitor predict discontinuation and treatment-limiting adverse drug reactions among HIV-infected patients starting a protease inhibitor regimen: consistent results from a randomized trial and an observational cohort

    DEFF Research Database (Denmark)

    Kirk, O; Gerstoft, J; Pedersen, C;

    2001-01-01

    therapy within less than 2 years. In both populations TLADR were the most common reason for discontinuation. The incidence of TLADR in RAS was: 8.5 (indinavir), 66.0 (ritonavir), 15.6 (saquinavir hard gel) per 100 person-years of follow-up (P ... risk factors for treatment discontinuation and TLADR in both groups. In OBC, the risk of developing TLADR increased by 12% per 5 kg lower body weight when starting the PI regimen [the relative hazard (RH) was 1.12 (95% confidence interval: 1.05-1.19) per 5 kg lighter], and starting ritonavir...... was associated with a three- to sixfold higher risk of TLADR relative to other PI regimens. Very similar results were documented in RAS [RH for body weight was 1.18 (1.07-1.29)]. CONCLUSIONS: Nearly half of the patients stopped treatment with the initial PI, most commonly as a result of adverse drug reactions...

  13. Analysis of 109 Reports of Adverse Drug Reaction of Cefoperazone Sodium and Sulbactam Sodium for Injection%109例头孢哌酮钠舒巴坦钠不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    刘宪军; 付娜

    2014-01-01

    Objective To investigate relevant factors of the adverse drug reaction induced by cefoperazone sodium and sulbactam sodium for injection to provide scientific reference for the safe and rational drug use in clinic. Methods 109 ADR reports of cefoperazone sodium and sulbactam sodium for injection collected by Beijing Center for ADR Monitoring from January 2010 to October 2010 were statistically analyzed retrospectively. Results The clinical manifestations of ADR involved skins and appendages damage, blood system damage, digestive system damage, hepatobiliary system damage and generalized lesion. Most ADR cases occurred in 30 minutes after medication, and drug combination maybe cause serious adverse reactions. Conclusion The ADR induced by cefoperazone sodium and sulbactam sodium for injection is associated with its chemical structure, individual diathesis, different diet, drug combination and so on. In order to avoid the occurrence of ADR induced by cefoporazone sodium and sulbactam sodium for injection, the drug must be used rationally and the patient should be intensively warded.%目的:探讨头孢哌酮钠舒巴坦钠致不良反应发生的相关因素,为临床安全合理用药提供参考。方法采用回顾性研究方法,对2012年1月~2012年10月北京市药品不良反应监测中心收集的109例注射用头孢哌酮钠舒巴坦钠不良反应报告进行统计分析。结果头孢哌酮钠舒巴坦钠致不良反应累及系统-器官主要为皮肤及其附件、血液系统、胃肠系统、肝胆系统及全身性损害。多数不良反应出现在用药后30 min 内,且以联合用药出现不良反应的症状较重。结论头孢哌酮钠舒巴坦钠致不良反应与其化学结构、患者个体体质、饮食、联合用药等有关。加强注射用头孢哌酮钠舒巴坦钠的合理使用及用药监护,可以避免或减少不良反应的发生。

  14. The Survey of Healthcare Professionals on Cognition Degree for Adverse Drug Reaction in Jiayuguan%对嘉峪关市医务人员药品不良反应认知度的调查与研究

    Institute of Scientific and Technical Information of China (English)

    郝军祥; 严疏; 刘光斌; 刘效栓; 杨东瑞; 张莉; 李润军; 刘虎

    2011-01-01

    目的 了解嘉峪关市各级医院医务人员对药品不良反应(ADR)认知度,为开展ADR监测工作提供参考依据.方法 采用调查问卷的形式,对嘉峪关市不同级别医院的医务人员进行抽样调查.结果 医务人员对ADR概念、严重ADR的范畴、引发ADR药品类别等相关知识认知度具有显著性差异(P <0.05);不同职业者对药品不良反应知识的认知度差异具有显著性(P <0.05),其中药学人员的认知度最高,管理人员认知度最低.结论 应加强有关ADR知识的宣传与培训,提高医务人员对ADR的认知度,提升其在ADR监测工作中的自觉性.%Objective To investigate the cognition degree on adverse drug reactions(ADR) among healthcare professionals as to improve and promote the ADR reporting and monitoring.Methods A questionnaire survey was conducted among the healthcare professionals of different level hospitals and cliniques in Jiayuguan.Results The healthcare professionals' knowledge was difference on ADR concept, ADR happening scope,(P <0.05); cognition degree on adverse drug reaction was significant difference between different profession(P<0.05), where in the recognition degree of pharmacy staff was the highest, managers had the lowest awareness.Conclusion Both propaganda and education should be strengthened to improve the cognition degree about ADR during the healthcare professionals and to elevate their consciousness in the ADR monitoring.

  15. 44例聚明胶肽注射液不良反应的文献分析%Literature Analysis of 44 Cases of Adverse Drug Reactions Induced by Polygeline Injection

    Institute of Scientific and Technical Information of China (English)

    陈海涛; 张临宏; 昝旺

    2015-01-01

    Objective Through analyzing adverse drug reaction cases of polygeline injection to explore the regularity and cause of adverse drug reactions, provide reference for clinical rational drug use. Methods By retrieving CNKI database and Wanfang database, 44 cases of polygeline injection ADRs reported from 26 literatures were analyzed. Results Most of the ADRs are immediate response type, 91% cases happened within 30 mins, which involv multiple systems and organs including systemic lesions(62.50%) and cardiovascular lesions(10.94%). Allergic shock and severe anaphylactoid reactions are more obvious. At the same time, new ADRs are found in 44 cases. Conclusion More at tention should be paid to the ADRs of polygeline injection and the monitoring of medication should also be strengthened to ensure the safe medication.%目的:通过对聚明胶肽注射液致不良反应文献的病例进行分析,探讨其引起不良反应的规律和原因,为临床合理用药提供参考。方法检索中国期刊全文数据库和万方数据库所载的聚明胶肽不良反应文献,对26篇目标文献所报道的44例病例报告进行统计分析。结果聚明胶肽注射液所致不良反应多数为速发型,91%的个案发生在30 min内;聚明胶肽致不良反应累及多个系统-器官,其中以全身性损害(62.50%)和心血管系统损害(10.94%)为主,过敏性休克和严重过敏样反应突出,同时也有新的不良反应出现。结论临床应重视聚明胶肽注射液的不良反应,加强用药监测,确保用药安全。

  16. Results of serum drug concentration of Digoxin and adverse reactions analysis%219例地高辛血药浓度监测结果及不良反应分析

    Institute of Scientific and Technical Information of China (English)

    傅海媛

    2016-01-01

    Objective To summarize the results of serum drug concentration of digoxin in the hospital for clinical rational use . Methods Serum concentration of digoxin(219 cases)was determined by access immunoassay system and the results were statisti‐cally analyzed .Results there were 7 cases drug adverse reactions(ADR)with the serum drug concentration in the therapeutic win‐dow (0 .5‐2ng/mL) ,meanwhile ,9 cases ADR with the serum drug concentration higher than the maximun effective concentration (>2 .0ng/mL) .Conclusion Timely and effective monitoring of digoxin serum concentration should be established ,to individualize the treatment programs ,ensure the efficacy and reduce the occurrence of adverse reactions .%目的:对本院2015年1~9月地高辛血药浓度监测结果进行回顾性分析,为临床合理用药提供参考。方法采用全自动免疫分析仪对219例口服地高辛患者进行血药浓度的检测,并对监测结果及药品不良反应(ADR )进行统计、分析。结果地高辛血药浓度在0.5‐2.0ng/mL有153例(1.03±0.31ng/mL),发生7例不良反应;<0.5ng/mL有30例(0.3±0.13ng/mL);>2.0 ng/mL有36例(3.06±0.78 ng/mL),共9例不良反应。结论及时有效的监测地高辛血药浓度,实行个体化治疗,降低不良反应发生率。

  17. 碘造影剂不良反应文献的系统评价%Systematic evaluation of literatures regarding the adverse drug reactions to iodine contrast media

    Institute of Scientific and Technical Information of China (English)

    马祖文; 许良; 朱瑾

    2014-01-01

    目的:了解碘造影剂不良反应的发生率及其相关因素,探索药品上市后不良反应再评价的方法。方法收集、整理、分析有关碘造影剂的不良反应的临床研究、不良反应监测及案例报道,包括个案和经典案例分析。结果本研究纳入9012例碘造影剂不良反应(ADR);原发疾病为循环系统的患者、老年患者及有其他药物过敏史的患者更容易发生ADR ;ADR多发生在30 min内;根据发表资料尚无法鉴别ADR。结论当前的证据表明,碘造影剂的ADR高,临床使用应密切关注,防止给患者带来不必要的伤害。%Objective To find out the occurrence rate of adverse drug reaction (ADR) following iodine-contrast media and to under-stand the relative factors causing ADR ,to preliminarily explore the methods for re-evaluation of the drug after marketing .Method The literature was classified into 3 categorise ,i .e .synchronous clinical study ,ADR monitoring and medical records analysis ,as well as individual or typical case reports .Results Totally 9 012 cases were included in this review .Although we are unable to an-swer the question weather the incidence of adverse drug reaction (ADR) induced by iodine-contrast media due to the absence of to-tal amount of production and market information ,it was estimated based on the limited data that the possibility of ADR should be high .The review showed that the ADR was easier to occur in 30 min after injecting into the older and the one who had circulation system disease or drug allergy .Conclusion Current evidence shows that iodine-contrast media has a high risk of ADR .We should pay close attention to the application of iodine-contrast media to prevent unnecessary harmness .

  18. Inflammation and neurological adverse drugs reactions: a case of long lasting impaired consciousness after oxatomide administration in a patient with gastroenteritis

    Directory of Open Access Journals (Sweden)

    Antoniazzi Stefania

    2012-03-01

    Full Text Available Abstract Oxatomide at therapeutic doses generates occasionally drowsiness in children. When administered at toxic doses, however oxatomide may induce long lasting impaired consciousness. We now report a case of severe long lasting impaired consciousness induced by therapeutic doses of oxatomide occurring in a child affected by acute gastroenteritis. The clinical symptoms, the pharmacogenetic tests of polymorphisms in cytochrome P450 metabolizing enzymes (CYPs and the clinical and laboratory analyses indicate that the enhanced drug sedative effect is likely due to an acute, yet mild, inflammatory state of the patient. These findings highlight the importance of assessing common, not serious inflammatory states when oxatomide is prescribed in paediatric patients.

  19. Reason analysis of 98 cases of adverse drug reactions in our hospital in 2010%我院2010年度98例药物不良反应原因分析

    Institute of Scientific and Technical Information of China (English)

    陈俊涛; 邢亚丽; 刘文化

    2011-01-01

    目的:对我院98例药物不良反应(ADR)情况及特点进行分析,促进临床合理用药.方法:采用回顾性分类统计,对98例报告中涉及的年龄、性别、临床表现、给药途径、给药剂量、使用方法、配液环境、输液器材等进行整理分析.结果:药物使用不规范引起74例,配液环境引起反应6例,输液器(留置针)引起反应4例,患者体质引起反应14例.结论:提高医护人员综合素质、临床药师加强监管,对减少ADR的发生、促进合理用药具有重要性.%Objective: To analyze the conditions and characteristics of 98 cases of adverse drug reactions (ADR) in our hospital and promote clinical rational drug use. Methods: The retrospective classified statistics was used to settle and analyze age, sex, clinical manifestation, route of administration, dosage, usage, preparation environment, transfusion equipments in 98 cases. Results: Irregular drug use caused 74 cases of ADR, preparation environment caused 6 cases, transfusion e -quipments (remaining needle) caused 4 cases and physique of patients caused 14 cases. Conclusion: To improve the overall quality of health care workers and strengthen supervision over clinical pharmacists are important to reduce the inci -dence of ADR and promote rational drug use.

  20. Interactions and adverse reactions of metformin and other drugs%二甲双胍与其他药物的相互作用及不良反应的研究进展

    Institute of Scientific and Technical Information of China (English)

    孙建然; 夏同佳; 许敏; 邓大同

    2016-01-01

    Biguanides are known to inhibit glycogen output,increase the use of glucose,and enhance insulin sensitivity.In practice,the biguanides also work along with insulin and other oral medications.However,when it combined with other drugs,the enzymology phar-macokinetics actions may occur.Biguanides can cause lactic acidosis,hepatotoxicity,and hypomagnesemia.This paper will give an over-view of the interactions and adverse reactions of metformin with other drugs.%双胍类药物抑制肝糖输出,增加葡萄糖的利用和胰岛素敏感性,可与其他口服降糖药及胰岛素联合降糖。但与其他药物联用时,可能发生与酶药动学相关的反应,双胍类药物可致乳酸性酸中毒、肝毒性、低镁血症。该文就二甲双胍与其他药物的相互作用及不良反应作一概述。

  1. Report on Adverse Drug Reactions Induced by Pediatric Intravenous Transfusion and Nursing Countermeasures%小儿静脉用药引发的药品不良反应报告及护理对策

    Institute of Scientific and Technical Information of China (English)

    党玉梅; 汪友兰; 张会娥

    2016-01-01

    OBJECTIVE:To investigate the adverse drug reactions ( ADR ) induced by pediatric intravenous transfusion and nursing countermeasures .METHODS:The clinical manifestation form of 125 cases of ADR induced by pediatric intravenous transfusion admitted into Xiaogan Municipal Central Hospital ( hereinafter referred to as “our hospital”) from Mar.2013 to Mar.2015 were analyzed, and the related nursing countermeasures were discussed . RESULTS:Of the 125 ADR cases, the primary disease was respiratory disease .The highest incidence of ADR was anti-infection drugs, and digestive system was the main involved organs and (or) systems.The clinical manifestations of ADR cases induced by pediatric intravenous transfusion were closely associated with the categories of drugs and pediatric individual differences , the medical and nursing staff were suppose to strengthen the observation and nursing measures.CONCLUSIONS: The incidence of ADR cases induced by pediatric intravenous transfusion is relatively high.It is necessary for the clinic to attach more importance to this aspect and take the nursing measures during the whole process of administration , so as to reduce the incidence of ADR .%目的:了解小儿静脉用药引发的常见不良反应(adverse drug reaction,ADR)及护理措施。方法:分析孝感市中心医院(以下简称“我院”)2013年3月—2015年3月125例小儿静脉用药引发的ADR临床表现形式,探讨护理对策。结果:在发生ADR的125例患儿中,主要原发性疾病为呼吸系统疾病,ADR发生率最高的药品为抗感染药,主要累及器官和(或)系统为消化系统。小儿静脉用药ADR的发生及其临床表现形式与药物的种类、儿童个体差异密切相关,要求医、护人员加强观察,并做好护理措施。结论:儿童在进行药物静脉用药时容易发生 ADR,需引起临床重视,采取给药前、给药中以及给药后全程护理措施,以降低ADR的发生率。

  2. Literature Analysis of 61 Cases of Adverse Drug Reaction Induced by Troxerutin%61例曲克芦丁制剂不良反应的文献分析

    Institute of Scientific and Technical Information of China (English)

    冯亚楠; 刘欣欣; 李永辉; 郭瑞锋; 吕骏轻

    2015-01-01

    Objective To explore the causes and regularity of the adverse reactions (ADRs) of troxerutin , in order to provide the scientific references for safe drug use in clinic. Methods 61 cases of the ADRs of troxerutin reported in domestic literature were analyzed. Results Among 61 cases of the ADRs of troxerutin, more than 80% occurred in the age group above 45 years and 55.7% happened after the drug was taken beyond indications showed in the instructions. Futhermore, among 57 cases accepting intravenous drop infusion, 68% used glucose injection as solvent, and the ADRs of the solvent were more risky than that of other solvents. In addition, 22% occurred when troxerutin was used combining with other drugs in the same infusion bottle. 77% happened within 30 minutes after the drug was taken. Finally, the main ADRs were anaphylactic and anaphylactoid reactions. Conclusion Medical staff should well know instructions of the drugs, use it in accordance with the indications and doses labeled in the instructions strictly, and be cautious of drug combination. Furthermore, it is prohibited to use the drug combining with other drugs in the same infusion bottle. Meanwhile, the drug should be used under strict monitoring to reduce the damage caused by ADRs to a minimum.Pharmaceutical manufacturers should strengthen researches on preparation quality control and safety of troxerutin, so as to revise and improve the instructions on safety of the drugs.%目的:探讨曲克芦丁制剂不良反应的发生原因与规律,为临床安全用药提供参考。方法对国内文献报道的61例曲克芦丁制剂不良反应病例进行统计和分析。结果61例不良反应病例中,80%以上为45岁以上中老年人,55.7%存在超说明书适应证用药;57例静脉途径给药的病例报告中,68%以葡萄糖注射液为溶媒,不良反应发生风险高于其他溶媒;22%存在同瓶配伍输注现象,易发生不良反应;77%不良反应出现在用药30 min 内

  3. Drug hypersensitivity reactions involving skin.

    Science.gov (United States)

    Hausmann, Oliver; Schnyder, Benno; Pichler, Werner J

    2010-01-01

    Immune reactions to drugs can cause a variety of diseases involving the skin, liver, kidney, lungs, and other organs. Beside immediate, IgE-mediated reactions of varying degrees (urticaria to anaphylactic shock), many drug hypersensitivity reactions appear delayed, namely hours to days after starting drug treatment, showing a variety of clinical manifestations from solely skin involvement to fulminant systemic diseases which may be fatal. Immunohistochemical and functional studies of drug-specific T cells in patients with delayed reactions confirmed a predominant role for T cells in the onset and maintenance of immune-mediated delayed drug hypersensitivity reactions (type IV reactions). In these reactions, drug-specific CD4+ and CD8+ T cells are stimulated by drugs through their T cell receptors (TCR). Drugs can stimulate T cells in two ways: they can act as haptens and bind covalently to larger protein structures (hapten-carrier model), inducing a specific immune response. In addition, they may accidentally bind in a labile, noncovalent way to a particular TCR of the whole TCR repertoire and possibly also major histocompatibility complex (MHC)-molecules - similar to their pharmacologic action. This seems to be sufficient to reactivate certain, probably in vivo preactivated T cells, if an additional interaction of the drug-stimulated TCR with MHC molecules occurs. The mechanism was named pharmacological interaction of a drug with (immune) receptor and thus termed the p-i concept. This new concept may explain the frequent skin symptoms in drug hypersensitivity to oral or parenteral drugs. Furthermore, the various clinical manifestations of T cell-mediated drug hypersensitivity may be explained by distinct T cell functions leading to different clinical phenotypes. These data allowed a subclassification of the delayed hypersensitivity reactions (type IV) into T cell reactions which, by releasing certain cytokines and chemokines, preferentially activate and recruit

  4. Late adverse reactions to intravascular iodine based contrast media

    DEFF Research Database (Denmark)

    Bellin, Marie-France; Stacul, Fulvio; Webb, Judith A W;

    2011-01-01

    DEFINITION: Late adverse reactions (LAR) to contrast media (CM) are defined as reactions occurring 1 h to 1 week after exposure. NEED FOR REVIEW: In view of more prospective studies of LAR and new data about their pathophysiology, the Contrast Medium Safety Committee (CMSC) of the European Society...

  5. Analysis of the Reports of Adverse Drug Reactions Induced by PEG-interferon Alfa-2a Injection%聚乙二醇干扰素α-2a注射液不良反应报告分析

    Institute of Scientific and Technical Information of China (English)

    韩丹; 代菲; 储文功

    2013-01-01

    目的:探讨聚乙二醇干扰素α-2a注射液不良反应发生的特点及相关因素,为临床安全用药提供参考.方法:收集某省药品不良反应监测中心2004~2011年自发呈报系统上报的1 606例聚乙二醇干扰素α-2a注射液的不良反应(ADR)报告,对ADR所涉及的患者年龄、性别,以及ADR年份、类型、结果、临床表现等进行统计分析.结果:1606例报告中,男883例,女723例,30 ~60岁患者最多(72.6%);发生严重不良反应243例,新的严重ADR 86例;临床表现以血液系统损害为主占59.95%,其次为肝胆系统损害占10.76%.结论:临床在运用聚乙二醇干扰素α-2a治疗丙肝的过程中,应密切观察其ADR,制定周密的护理计划,积极干预和防治,以有效减少和防止ADR发生.%To probe into the characteristics of adverse drug reactions (ADR) caused by PEG-interferon alfa-2a injection to provide some rational clinical guidance. Methods: 1606 reports of adverse reactions caused by PEG-interferon alfa-2a injection were collected from January 2004 to December 2011 and statistically analyzed in respect of patients'sex and age, involved type, years, result, clinical manifestations, etc. Results:883 of the 1606 cases were male cases,723 were female cases, and 72. 6% were the adults at the age of 30 to 60.The incidence rate of severe ADR were 243 cases, and new and severe ADR were 86 cases. The blood system was the main lesion in ADR cases (59.95%) , and the second was liver and gall system(10.76%). Conclusion: The corresponding adverse reactions should be closely observed during the clinical use of PEG-interferon alfa-2a in the treatment of hepatitis C. The occurrence of adverse reactions could be effectively reduced and prevented by making a careful nursing plan and conducting an active intervention and control.

  6. Literature Analysis of Extract of Adverse Drug Reaction Induced by Ginkgo Biloba Leaves Injection%银杏叶提取物注射液不良反应的文献分析

    Institute of Scientific and Technical Information of China (English)

    杨乐; 杜晓曦; 郭晓昕; 任经天; 沈璐; 宋海波

    2014-01-01

    Extract of Ginkgo biloba leaves injection is ginkgo preparation and is widely used in clinic. Retrospective research method is used in the article for key analysis on post-marketing safety information of domestic literature reports. It is found that the main adverse reaction is allergy which is in a rapid reactive type. Using the drug alone or in combi-nation may either cause risks. Serious adverse reactions mainly include digestive system damage, central and peripheral nerve systems damage, skin and its accessories damages, cardiovascular system damage, etc. Main symptoms include gas-trointestinal discomfort, nausea, liquid stools, diarrhea, stress ulcer, headache, dizziness, erubescence, sweating, lower blood pressure, palpitation, conjunctival congestion, cerebral hemorrhage, insomnia, etc. Accordingly we propose recom-mendations on suitable risk control measure for a safer and more rational use of the drug.%银杏叶提取物注射液为银杏叶制剂,临床使用广泛。通过采用回顾性研究方法对银杏叶提取物注射液国内文献报道中上市后安全性信息进行重点分析,梳理出其主要不良反应为过敏反应,特点为速发型,单独用药或联合用药均可引起用药风险;主要涉及消化系统损害、中枢及外周神经系统损害、皮肤及其附件损害、心血管系统损害等,包括胃肠道不适、恶心、稀便、腹泻、应激性溃疡、头痛、头晕、皮肤潮红、多汗、血压降低、心悸、眼结膜充血、脑出血、失眠等表现。进而提出符合药品本身特点的风险控制措施,为安全、合理使用该药提供建议。

  7. Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands

    NARCIS (Netherlands)

    Oosterhuis, Ingrid; van Hunsel, Florence P. A. M.; van Puijenbroek, Eugene P.

    2012-01-01

    Background: In 2010, the Netherlands Pharmacovigilance Centre Lareb received more than 4000 reports from healthcare professionals (HCPs). All HCPs received individual personal feedback containing information about the reported drug-adverse drug reaction (ADR) association. It is unclear what type of

  8. A curated and standardized adverse drug event resource to accelerate drug safety research.

    Science.gov (United States)

    Banda, Juan M; Evans, Lee; Vanguri, Rami S; Tatonetti, Nicholas P; Ryan, Patrick B; Shah, Nigam H

    2016-01-01

    Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies. PMID:27193236

  9. Mechanisms in adverse reactions to food. The nose

    DEFF Research Database (Denmark)

    Høst, A

    1995-01-01

    Rhinitis is a common symptom in food allergic patients, but rhinitis is rarely the only symptom. Rhinitis due to adverse reactions to preservatives and colorants is very rare. In anaphylactic systemic reactions to foods the rhinitis symptoms are caused by inflammatory mediators transported...... by the circulation. In non-anaphylactic reactions, the nasal inflammation and symptoms are probably induced by interaction with food allergens transported to the nasal mucosa via the blood circulation....

  10. Pattern of adverse reactions of antipsychotics in a tertiary care hospital

    OpenAIRE

    Meenakshy T. Viswanathan; Asha Sisupalan; Vidhukumar Karunakaran

    2016-01-01

    Background: This study was undertaken to analyse the pattern of adverse drug reactions (ADR) of antipsychotics among patients attending the psychiatry outpatient department of a tertiary care centre. Methods: Patients attending the psychiatry outpatient department who have been on treatment with one or more antipsychotics for more than 6 weeks were included in the study. Details about the prescription given in the previous appointment were collected. Various adverse effects associated with...

  11. Application and effects of the monitoring and evaluation system of adverse drug reaction in outpatient transfusion rooms%药品不良反应监测评估体系在门诊输液室的应用与效果

    Institute of Scientific and Technical Information of China (English)

    容桂荣; 王芳芳; 温宇凤; 秦月明

    2011-01-01

    目的 探讨在门诊输液室建立药品不良反应监测评估体系的作用.方法 建立药品不良反应监测评估体系,明确输液室护士在药品不良反应监测中的职责,落实评估后采取的干预措施,观察干预前后药品不良反应发生率、药品应用分类和症状.结果 干预后药品不良反应总体发生率、中成药联合用药不良反应发生率、低血糖和呕吐发生率均降低(P<0.01或P<0.05).结论 药品不良反应监测评估体系在门诊输液室的应用,可有效降低药品不良反应发生率.%Objective To discuss the effects of the monitoring and evaluation system of adverse drug reaction applied in outpatient transfusion rooms. Methods The measures included establishing adverse dury reaction monitoring and evaluation system, identifying the responsibilities of adverse drug reaction monitoring of nurses in outpatient transfusion rooms, executing the interventions after evaluation. The incidence and the symptoms of adverse drag reaction in the outpatient transfusion room were collected before and after implementing the system. Results The total incidence of adverse drug reaction, the incidence of adverse drug reaction caused by Chinese herbal medicines combination therapy, and the occurrence rates of low blood sugar and vomiting were reduced significantly ( P < 0.01 orP< 0. 05). Conclusion Application of the monitoring and evaluation system of adverse drug reaction in outpatient transfusion rooms could effectively reduce the incidence of adverse drug reaction.

  12. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR)

    Science.gov (United States)

    Moore, Thomas J.; Bennett, Charles L.

    2014-01-01

    The U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS), familiarly known as “MedWatch,” is the nation's primary tool for postmarket pharmaceutical safety surveillance. This system relies on adverse events voluntarily reported by health care providers and consumers either directly to the FDA or to drug manufacturers, which are required to prepare and forward the information to the agency. Little is known about how frequently adverse events are reported. Previous estimates range from 1 to 31% depending on the event, drug, and time period. We used published incidence studies to calculate reporting rates for hemorrhage, emergency hospitalization, and venous thromboembolism (VTE) associated with four drugs. We estimated annual reporting rates of 1.07% for 33,171 emergency hospitalizations of patients older than 65 years associated with warfarin, 0.9% for 13,363 hospitalizations of clopidogrel and ticlopidine, and 1.02% for an estimated 67,200 hemorrhage cases associated with warfarin. We also estimated a 9-year reporting rate of 2.3% for VTE associated with thalidomide. The incidence of these hematologic adverse drug events is high and reporting rates are low, and near the lower boundary of the 1 to 15% range seen for other events. PMID:23086541

  13. 提高护士监测药品不良反应能力的方法与效果%The practice and effect in improving nurse's behavior of monitoring adverse drug reaction

    Institute of Scientific and Technical Information of China (English)

    花蕾

    2007-01-01

    目的 为了充分发挥护士在药品不良反应(adverse drug reaction,ADR)监测中的作用.方法 采取加大宣传力度,建立和完善ADR监测流程,加强护士药品相关知识的培训及考核,与药师合作指导患者用药,建立激励机制,强化护士ADR监测意识等.结果 2005年较2004年住院患者对用药指导满意度、护士ADR监测报表数均有明显提高,差异具有统计学意义(P<0.01或P<0 05).结论 护士在ADR监测中可以发挥应有的重要作用.

  14. Adverse Reaction of Omeprazole and Its Interaction with Other Drugs%奥美拉唑的不良反应及与其他药物的相互作用

    Institute of Scientific and Technical Information of China (English)

    张志英

    2015-01-01

    奥美拉唑为一含苯咪唑和吡啶环的弱碱性化合物,易进入酸性细胞壁,为目前最强的抑制胃酸分泌的药物。对胃泌素,组胺,乙酰胆碱,食物等激发的胃酸分泌均能抑制,对胃液总量和胃蛋白酶的分泌也有抑制作用。本文就其对消化、血液、神经、内分泌、泌尿系统、皮肤及其他方面的不良反应和与其他药物的相互作用做一研究。%Omeprazole as a weak alkaline containing benzene imidazole and pyridine ring compounds, easy to enter the cel wal s of acid, is cur ently the strongest inhibition of gastric acid secretion. The stomach secrete hormone, histamine and acetylcholine, food such as stimulating the secretion of gastric acid can inhibit, on the secretion of gastric juice and pepsin total also has inhibitory ef ect. In this paper, the digestion, blood, nerve, endocrine, urinary tract, skin and other adverse reactions and interactions with other drugs.

  15. 甘露聚糖肽皮试液浓度与皮试结果的临床观察与研究%Study of Skin Allergy Test and Adverse Drug Reaction Induced by Mannan Glycopeptides Injection

    Institute of Scientific and Technical Information of China (English)

    杨忠明; 鞠兰兰; 刘敏; 颜学分

    2012-01-01

    Objective:To investigate the characteristics of 420 cases cancer patients skin allergy test and results induced by mannan glycopeptides injection, in order to determine the safe and reliable skin test concentration and to use mannatide correctly and scientificly. Methods:After mannan glycopeptides injection were diluted to 100 times as skin test liquid with normal saline, absorbed 0.1ml skin test liquid to inject inside skin. During observation patient's skin test,paid attention to whether drug allergy and adverse reaction occuring;those who skin test negatie patients were arranged 10mg mannan glycopeptides injection joinning into 0.9% sodium chloride liquid 250ml,and slow intravenous drip, infusion rate 40/min, and observated whether with allergies, harmful response time and abnormal symptoms during infusion solution and within 24 hours after the general situation.Results: skin allergy test positive 3 cases (0.71%), suspicious positive 2 cases (0.48%), negative 415 cases (98.81%); None of the 415 cases those skin test negative occurred Immediate allergic reaction in the process of infusion, 8 casesoccurs minor adverse reactions, after oxygen, antiemetics, and other measures, the symptoms disappeared Conclusion:Adverse reactions will reduce if mannan glycopeptides injection skin test was carry out before the infusion.As skin test, mannan glycopeptides injection diluted to 100 times was safe, reliable which can maximumscreen allergic patients.In view of the different manufacturers of different production processes,the corresponding skin test methods are different.%目的:通过对420例肿瘤患者甘露聚糖肽注射液皮试方法及结果的研究,以确定安全可靠的皮试液浓度,从而指导临床正确、科学的使用甘露聚糖肽.方法:予甘露聚糖肽注射液(多抗)以生理盐水稀释至100倍配制成皮试液,吸取皮试液0.1ml进行皮内注射.皮试期间注意观察病人有无药物过敏等不良反应发生,皮试阴性患

  16. Analysis of suspected adverse reactions following immunization against pandemic influenza

    Directory of Open Access Journals (Sweden)

    Petrović Vladimir

    2011-01-01

    Full Text Available Introduction. The surveillance on adverse reaction following immunization was aimed at recording all adverse events possibly related with vaccines. During the implementation of immunization strategy against pandemic influenza A(H1N1 in 2009, the post-marketing comprehensive surveillance was suggested to be conducted due to limited clinical experience in applying this particular vaccine and because of the fact that some vaccines had been licensed only on the basis of the data regarding their quality. Material and Methods. The passive surveillance on adverse events following immunization was conducted simultaneously with immunization campaign against pandemic influenza in the Autonomous Province of Vojvodina. Reporting of adverse events was conducted by health care service through a specially designed questionnaire Results. In the period from December 17th 2009 to February 7th 2010, of the total number of 55720 people who were vaccinated, 50433 received one dose and 5287 received two doses of vaccine. The total number of doses administered was 61007. During the observed period, some adverse reactions were recorded in 37 people, the rate of occurrence of adverse reactions being 6.6 per 10.000 vaccinated. Since the majority of patients had several symptoms and signs, the number of recorded clinical manifestations was much higher (140 than the number of patients with reactions. The dominant symptoms and signs were fever (51.4%, weakness/fatigue (48.6%, headache (40.5% and myalgia (31.5%. The reactions in the majority of patients were mild and transient. Only two patients sought medical care and one was hospitalized. Since the immunization coverage was very small, it was not possible to record rare adverse events, whose expected incidence is, anyway, very low. Conclusion. Surveillance on adverse reaction following immunization represents an important component of immunization program, especially when new vaccines are introduced. Therefore, this form

  17. Adverse reactions to cosmetics and methods of testing

    OpenAIRE

    Nigam P

    2009-01-01

    Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitization and photosensitization, subchronic toxicity, mutagenicity/genotoxicity, and photot...

  18. Adverse blood transfusion reactions at tertiary care hospital

    OpenAIRE

    Surekha K. Chavan; Gorakhnath Patil; Pallavi Rajopadhye

    2016-01-01

    Background: The goal of hemovigilance is to increase the safety and quality of blood transfusion. It is necessary to recognize and prompt response to adverse transfusion reactions, which will help in taking appropriate steps to reduce their incidence and make blood transfusion process as safe as possible. The aim of the study was to determine the frequency and type of transfusion reactions (TRs) occurring in patients, reported to the blood bank at our institute. Methods: A retrospective r...

  19. Adverse reactions to acetylcysteine and effects of overdose.

    OpenAIRE

    Mant, T. G.; Tempowski, J H; Volans, G N; Talbot, J. C.

    1984-01-01

    Since the introduction in 1979 of intravenous acetylcysteine (Parvolex) as an antidote for overdosage of paracetamol the National Poisons Information Service and the manufacturer have been notified of 38 adverse reactions that were anaphylactoid in nature and 19 accidental overdoses. The most common feature of the anaphylactoid reaction to normal dosage was rash; other features reported included angioedema, hypotension, and bronchospasm; all the patients recovered. The features associated wit...

  20. Diversity and severity of adverse reactions to quinine: A systematic review.

    Science.gov (United States)

    Liles, Nathan W; Page, Evaren E; Liles, Amber L; Vesely, Sara K; Raskob, Gary E; George, James N

    2016-05-01

    Quinine is a common cause of drug-induced thrombocytopenia and the most common cause of drug-induced thrombotic microangiopathy. Other quinine-induced systemic disorders have been described. To understand the complete clinical spectrum of adverse reactions to quinine we searched 11 databases for articles that provided sufficient data to allow evaluation of levels of evidence supporting a causal association with quinine. Three reviewers independently determined the levels of evidence, including both immune-mediated and toxic adverse reactions. The principal focus of this review was on acute, immune-mediated reactions. The source of quinine exposure, the involved organ systems, the severity of the adverse reactions, and patient outcomes were documented. One hundred-fourteen articles described 142 patients with definite or probable evidence for a causal association of quinine with acute, immune-mediated reactions. These reactions included chills, fever, hypotension, painful acral cyanosis, disseminated intravascular coagulation, hemolytic anemia, thrombocytopenia, neutropenia, acute kidney injury, rhabdomyolysis, liver toxicity, cardiac ischemia, respiratory failure, hypoglycemia, blindness, and toxic epidermal necrolysis. One hundred-two (72%) reactions were caused by quinine pills; 28 (20%) by quinine-containing beverages; 12 (8%) by five other types of exposures. Excluding 41 patients who had only dermatologic reactions, 92 (91%) of 101 patients had required hospitalization for severe illness; 30 required renal replacement therapy; three died. Quinine, even with only minute exposure from common beverages, can cause severe adverse reactions involving multiple organ systems. In patients with acute, multi-system disorders of unknown origin, an adverse reaction to quinine should be considered.

  1. Diversity and severity of adverse reactions to quinine: A systematic review.

    Science.gov (United States)

    Liles, Nathan W; Page, Evaren E; Liles, Amber L; Vesely, Sara K; Raskob, Gary E; George, James N

    2016-05-01

    Quinine is a common cause of drug-induced thrombocytopenia and the most common cause of drug-induced thrombotic microangiopathy. Other quinine-induced systemic disorders have been described. To understand the complete clinical spectrum of adverse reactions to quinine we searched 11 databases for articles that provided sufficient data to allow evaluation of levels of evidence supporting a causal association with quinine. Three reviewers independently determined the levels of evidence, including both immune-mediated and toxic adverse reactions. The principal focus of this review was on acute, immune-mediated reactions. The source of quinine exposure, the involved organ systems, the severity of the adverse reactions, and patient outcomes were documented. One hundred-fourteen articles described 142 patients with definite or probable evidence for a causal association of quinine with acute, immune-mediated reactions. These reactions included chills, fever, hypotension, painful acral cyanosis, disseminated intravascular coagulation, hemolytic anemia, thrombocytopenia, neutropenia, acute kidney injury, rhabdomyolysis, liver toxicity, cardiac ischemia, respiratory failure, hypoglycemia, blindness, and toxic epidermal necrolysis. One hundred-two (72%) reactions were caused by quinine pills; 28 (20%) by quinine-containing beverages; 12 (8%) by five other types of exposures. Excluding 41 patients who had only dermatologic reactions, 92 (91%) of 101 patients had required hospitalization for severe illness; 30 required renal replacement therapy; three died. Quinine, even with only minute exposure from common beverages, can cause severe adverse reactions involving multiple organ systems. In patients with acute, multi-system disorders of unknown origin, an adverse reaction to quinine should be considered. PMID:26822544

  2. Different reactions to adverse neighborhoods in games of cooperation

    CERN Document Server

    Zhang, Chunyan; Weissing, Franz J; Perc, Matjaz; Xie, Guangming; Wang, Long; 10.1371/journal.pone.0035183

    2012-01-01

    In social dilemmas, cooperation among randomly interacting individuals is often difficult to achieve. The situation changes if interactions take place in a network where the network structure jointly evolves with the behavioral strategies of the interacting individuals. In particular, cooperation can be stabilized if individuals tend to cut interaction links when facing adverse neighborhoods. Here we consider two different types of reaction to adverse neighborhoods, and all possible mixtures between these reactions. When faced with a gloomy outlook, players can either choose to cut and rewire some of their links to other individuals, or they can migrate to another location and establish new links in the new local neighborhood. We find that in general local rewiring is more favorable for the evolution of cooperation than emigration from adverse neighborhoods. Rewiring helps to maintain the diversity in the degree distribution of players and favors the spontaneous emergence of cooperative clusters. Both propert...

  3. Adverse reactions in treatment with lithium carbonate and haloperidol.

    Science.gov (United States)

    Baastrup, P C; Hollnagel, P; Sorensen, R; Schou, M

    1976-12-01

    Hospital records of 425 patients who had been treated simultaneously with lithium carbonate and haloperidol were examined. Adverse reactions in these patients were the same as in patients given lithium alone or haloperidol alone. None of the patients developed a syndrome resembling that described by others in patients treated with a lithium and haloperidol combination. PMID:1036539

  4. Drug Reactions in Oral Mucosa

    Directory of Open Access Journals (Sweden)

    Emine Derviş

    2012-12-01

    Full Text Available Both immunologic and nonimmunologic drug reactions can be seen in oral mucosa. Since considerable number of these reactions heals spontaneously without being noticed by the patients, exact frequency of the lesions is unknown. Most common lesions are xerostomia, taste disorders, mucosal ulcerations and edema. In this article, oral lesions resulting from drug intake similar to those from oral lesions of local and systemic diseases, and diagnostic problems caused by these similarities, have been reviewed.

  5. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2002 – February 2003

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2003-07-01

    Full Text Available The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2002 to February 2003 is given. In total, 40 reports were received. This had declined from the previous year. Most reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. The animal owner predominantly administered these products. Only 1 report was received from a veterinary pharmaceutical company. Increasing numbers of reports are being received from veterinarians.

  6. ADVERSE REACTION TO LATEX CONTAINING MATERIALS IN HEALTH CARE WORKERS

    Directory of Open Access Journals (Sweden)

    Gh. Pouryaghoub

    2008-04-01

    Full Text Available Latex allergy has become an occupational hazard among healthcare workers. Atopy, intensity and duration of exposure have been recognized as predisposing factors for latex sensitization. Frequency of sensitization varies among countries. So we decided to investigate the prevalence of latex sensitization and potential risk factors among healthcare workers in a general hospital. In a cross sectional study by distributing a questionnaire among 876 employees of a general hospital, we investigated the prevalence of latex allergy and the potential risk factors for latex sensitization. We collected information about occupational history, including specific tasks performed, time of first exposure to latex, number of pairs of gloves used, and duration of weekly exposure. We also investigated the interval between first exposure and onset of symptoms. We asked about pre-existing rhinoconjuctivitis, asthma, atopic and contact dermatitis, hay fever, autoimmune diseases, and food allergies. This survey documented a high prevalence of adverse reaction to all latex containing materials (52.5%. 37.7% of responder had adverse reaction to latex gloves. The highest prevalence of adverse reaction to all latex containing materials was found in the surgical operating room, followed by emergency unit and internal medicine wards. According to this study, frequency of adverse reaction to latex was high among health care workers. This may be due to relatively low response rate, low quality of latex products in Iran, and the method of measurement. Whenever, the need for implementing prevention program, using latex-free methods and training of employees to reduce adverse reaction to latex is apparent.

  7. 湖北民族学院附属民大医院药品不良反应相关因素分析%Related Factors of Adverse Drug Reactions in Hubei University for Nationalities Affiliated Minda Hospital

    Institute of Scientific and Technical Information of China (English)

    李红玲; 庄红玲; 谭娜; 郭淑敏; 覃正碧

    2015-01-01

    OBJECTIVE:To analyze the related factors of the adverse drug reactions ( ADRs) in Hubei University for Nationalities Affiliated Minda Hospital so as to probe into the characteristics of the ADRs for clinical reference of safe medication.METHODS:A total of 75 ADR cases reported from January 2012 to October 2014 in this hospital were analyzed with regard to patients'age, drug type, routes of administration, ADR-involved organs or systems, and medication information and outcomes of the new and severe ADR cases.RESULTS: The ADRs occurred in different age group, and induced mostly by intravenously administered drugs, by anti-infective drugs and traditional Chinese medicine injections, and manifested mostly by the damage of skin and its appendages.The new and serious ADR occurred more often in patients with a history of allergy and in thosev treated with combination of multiple drugs. CONCLUSION:To avoid the risk of medication and reduce the occurrence of ADR in this hospital, it is important to attach great importance to the special population including the infants and elderly and those with hypersensitivity, reduce the ratio of intravenous administration, avoid excessive use of antimicrobial drugs and regulate the use of traditional Chinese medicine injections.%目的:通过对湖北民族学院附属民大医院上报的药品不良反应( ADR)及相关因素进行分析,了解药品不良反应发生特点,为临床安全用药提供依据。方法:收集该院2012年1月至2014年10月上报的200例ADR报告,对发生ADR的患者年龄、药品类别、用药途径、发生部位以及新发严重ADR的用药信息及转归等情况进行汇总统计分析。结果:ADR可涉及任意年龄阶段,静脉给药方式是引起ADR的主要途径,涉及药物以抗感染药物、中药注射剂为主,临床表现以皮肤及其附件损害的表现多见。新发严重ADR多发生在有过敏史的患者,且联合用药品种较多。结论:关

  8. 注射血栓通与抗生素联合用药致不良反应病例分析%Analysis of Adverse Drug Reactions Caused by Combined Injection of Thrombus and Antibiotics

    Institute of Scientific and Technical Information of China (English)

    亓凤春

    2015-01-01

    目的:探究注射用血栓通与抗生素联合用药致不良反应的病例分析。方法整理分析我院15例使用血栓通和抗生素联合用药产生不良反应患者的临床资料,并对其中2例进行详细说明。结果患者身体素质不同导致了不良反应时间的差异性;不良反应不但对皮肤有损害,并且对人体各器官也有较大损害。结论根据患者身体素质的不同有针对性的用药,最大程度上避免时间差异的不良反应;同时对联合用药进行控制,降低对人体各器官造成损害。%Objective To explore the injectable antibiotic combination therapy Xueshuantong and cause adverse reactions case analysis.Methods Arrange analysis 15 cases of hospital antibiotic use and combination therapy Xueshuantong produce adverse reactions in patients with clinical data, and where the two cases described in detail.Results Patients with diff erent physical cause adverse reaction time differences; adverse reactions not only damage the skin, and also has a larger damage on the human organs. ConclusionDepending on the patient's physical targeted medication, avoid adverse re action time difference between the maximum extent; while the combination therapy to control and reduce damage to human organs.

  9. Literature Analysis of Adverse Drug Reactions Induced by Fluoroquinolone in 181 cases%181例氟喹诺酮类药物药品不良反应文献分析

    Institute of Scientific and Technical Information of China (English)

    李容

    2016-01-01

    Objective To understand the adverse reaction of fluoroquinolones, and to explore its occurrence for rational drug use in clinic service. Methods The ADR literature causes related fluoroquinolones in CNKI ( 1994-2014 ) were searched, the case reports of ADR induced by fluoroquinolones were screened and collected and were summarized and analyzed according to age, sex, primary disease, oc-currence time, organs or systems as well as the treatment measures involved. Results There were a total of 12 species of fluoro-quinolones causing ADR, which were mainly the third and the fourth generation of fluoroquinolone drugs;the top three were levofloxacin ( 27. 07% ) , ciprofloxacin ( 14. 36% ) , and moxifloxacin ( 12. 71% ) . Age mainly focused on 60 years old ( 34. 81% ); occurred in less than 0. 5 h ( 32. 04% );the involved organs system relates to each big systems of the body, with the most common ADR in the central ner-vous system ( 27. 07% ) , systemic damage ( 21. 55% ) , skin and its accessories baseddamage ( 15. 47% ) . Conclusion The adverse reactions induced by fluoroquinolones are broad, and some are even very serious, such as anaphylactic shock. Clinical attention should be on this situation, and the majority of clinicians and pharmacists should be closely monitoredand actively promote the rational use of fluoro-quinolones clinical.%目的:了解氟喹诺酮类药物的药品不良反应(ADR)发生规律,为临床合理用药服务。方法检索中国期刊全文数据库(CNKI)中有关氟喹诺酮类药物引起ADR的文献(检索时间1994年至2014年),筛选收集其致ADR的案例报告,按年龄、性别、原患疾病、发生时间、累及器官或系统、治疗措施等进行汇总、分析。结果引发ADR的氟喹诺酮类药物共有12种,以第3代、4代氟喹诺酮类药物为主;居前3位的是左氧氟沙星(27.07%)、环丙沙星(14.36%)、莫西沙星(12.71%)。其中60岁以上老人发生占34.81%;0

  10. 7690例药品不良反应报告中ADR性别差异的回顾性分析%Retrospective analysis of gender differences in ADR of 7 690 cases of reported adverse drug reactions

    Institute of Scientific and Technical Information of China (English)

    孙言才; 刘琳琳; 史天陆; 王崇薇; 张蕾; 苏丹; 姜玲

    2015-01-01

    Objective To understand certain basic characteristics of the presented gender factors during the occurrence of adverse drug reactions (ADR)in patients for the implementation of drug safety monitoring,and to provide a reference for clinical therapy. Methods National Adverse Drug Reaction Monitoring Center database of a hospital from January 2005 to December 2010 which reported 7 690 cases of ADR was collected. A retrospective analysis was performed on the 7 690 cases of ADR reports,and gender factors were analyzed and eval-uated in correlation with other indicators such as patient age,drug class,anterior drugs,drug dosage form,route of administration,involving system/ organ. Results In 7 690 cases of ADR reports,4,052 cases were male,accounting for 52. 69%,3,638 cases were female,ac-counting for 47. 31%,and the male to female ratio was 1. 11 ∶ 1. 4 years from 2007 to 2010 the proportion of males was higher than that of fe-males,and 2 years from 2005 to 2006,male lower than female. In people aged 0 to 20,over the age of 50 years,the number of ADR cases was more in male than in female,and in people aged 21 to 50,the number of ADR cases was more in female than in male. The number of ADR cases caused by drugs affecting the blood and blood-forming system,traditional Chinese medicine,vitamins,etc. ,was more in male than in female,and the number of ADR cases caused by drugs affecting allergy and immune function,cardiovascular system drugs,respirato-ry system drugs,etc. was more in female than in male. ADR cases caused by seven kinds of drugs such as oxaliplatin for injection,fluoroura-cil injection,dexamethasone sodium phosphate injection were more male than female. ADR cases caused by levofloxacin hydrochloride injec-tion,levofloxacin lactate and sodium chloride injection,injection of ceftriaxone sodium were more female than male. ADR cases caused by six kinds of formulations like application suspensions,oral solutions,powder,etc. appeared more in male than in female

  11. Characterization of Schizophrenia Adverse Drug Interactions through a Network Approach and Drug Classification

    Directory of Open Access Journals (Sweden)

    Jingchun Sun

    2013-01-01

    Full Text Available Antipsychotic drugs are medications commonly for schizophrenia (SCZ treatment, which include two groups: typical and atypical. SCZ patients have multiple comorbidities, and the coadministration of drugs is quite common. This may result in adverse drug-drug interactions, which are events that occur when the effect of a drug is altered by the coadministration of another drug. Therefore, it is important to provide a comprehensive view of these interactions for further coadministration improvement. Here, we extracted SCZ drugs and their adverse drug interactions from the DrugBank and compiled a SCZ-specific adverse drug interaction network. This network included 28 SCZ drugs, 241 non-SCZs, and 991 interactions. By integrating the Anatomical Therapeutic Chemical (ATC classification with the network analysis, we characterized those interactions. Our results indicated that SCZ drugs tended to have more adverse drug interactions than other drugs. Furthermore, SCZ typical drugs had significant interactions with drugs of the “alimentary tract and metabolism” category while SCZ atypical drugs had significant interactions with drugs of the categories “nervous system” and “antiinfectives for systemic uses.” This study is the first to characterize the adverse drug interactions in the course of SCZ treatment and might provide useful information for the future SCZ treatment.

  12. Association between SLCO1B1 -521T>C and -388A>G polymorphisms and risk of statin-induced adverse drug reactions: A meta-analysis.

    Science.gov (United States)

    Jiang, Jiajia; Tang, Qing; Feng, Jing; Dai, Rong; Wang, Yang; Yang, Yuan; Tang, Xiaojun; Deng, Changkai; Zeng, Huan; Zhao, Yong; Zhang, Fan

    2016-01-01

    An increasing number of studies have investigated the association between SLCO1B1 -521T>C and -388A>G polymorphisms and the risk of statin-induced adverse drug reactions (ADRs), but the results have been inconsistent. This meta-analysis was performed to gain more insight into the relationship. PubMed, Embase, Cochrane Library and Web of Science were searched for relevant articles published before March 5th, 2015. The quality of included studies was evaluated by the Newcastle-Ottawa Quality scale. Pooled effect estimates (odds ratios [ORs] or hazard ratios [HRs) and corresponding 95 % confidence intervals (CIs) were calculated to assess the association in overall and subgroup analyses for various genetic models. Begg's rank correlation test and Egger's linear regression test were used to examine the publication bias. A total of nine cohort and four case-control studies involving 11, 246 statin users, of whom 2, 355 developing ADRs were included in the analysis. Combined analysis revealed a significant association between the SLCO1B1-521T>C polymorphism and increased risk for ADRs caused by various statins, but the synthesis heterogeneity was generally large (dominant model: pooled effect estimate = 1.85, 95 % CI 1.20-2.85, P = 0.005; I (2) = 80.70 %, Pheterogeneity G polymorphism and ADRs caused by various statins (dominant model: pooled effect estimate = 0.94, 95 % CI 0.79-1.13, P = 0.526; I (2) = 40.10 %, Pheterogeneity = 0.196). The meta-analysis suggests that SLCO1B1 -521T>C polymorphism may be a risk factor for statin-induced ADRs, especially in simvastatin therapy. Conversely, there may be no significant association for -388A>G polymorphism. PMID:27606156

  13. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2004 - February 2006 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2006-06-01

    Full Text Available The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again the majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were stock remedies. Veterinarians predominantly administered these products.

  14. 环丙沙星致不良反应46例文献分析%Literature Analysis of 46 Cases of Adverse Drug Reaction Induced by Ciprofloxacin

    Institute of Scientific and Technical Information of China (English)

    杨月琴; 韩志云

    2012-01-01

    OBJECTIVE: To discuss the characteristics and rules of ciprofloxacin-induced adverse drug reactions (ADR), and to provide reference for rational drug use in the clinic. METHODS: Retrieved from CNKI database, literatures about ciprofloxacin-induced ADR were collected and analyzed statistically. RESULTS: Ciprofloxacin can cause many types of ADR, the main ADR was systemic damage (27 cases, accounting for 58.70%), it can also cause rare symptom, including cardiac arrest. The male was higher than the female; ADR can be caused by intravenous infusion and oral administration, ADR induced by intravenous administration mostly occurred 1~20 min and oral administration in 1~6 h; ADR prognosis was satisfactory. CONCLUSION: Ciprofloxacin can cause a variety of ADR, so we should pay attention to its clinical applications and safety.%目的:探讨环丙沙星致不良反应(ADR)发生的规律及特点,为临床合理用药提供参考.[方法]:通过中国知网数据库(CNKI)检索有关环丙沙星ADR的文献,并进行统计、分析及评价.[结果]:环丙沙星可引起多种类型ADR,以全身性损害为主(27例,占58.70%),亦可引起心脏骤停等罕见ADR;其ADR发生率男性较女性稍高;静脉滴注和口服给药均可能发生ADR,静脉滴注给药多在用药1~20 min内发生,而口服给药多在用药1~6h内发生;ADR预后均较好.[结论]:环丙沙星可引起多种ADR,临床应用须高度重视其安全性.

  15. 264例阿洛西林钠不良反应的文献分析%Literature Analysis of 264 Cases of Adverse Drug Reactions Induced by Azlocillin Sodium

    Institute of Scientific and Technical Information of China (English)

    刘欣欣; 冯亚楠; 李永辉; 郭瑞锋

    2015-01-01

    目的:探讨阿洛西林钠不良反应的一般规律特点,为临床合理用药提供参考。方法检索中国期刊全文数据库,对2014年之前国内公开发表有关注射用阿洛西林钠264例病例文献报道进行回顾性分析。结果儿童患者发生率高,累及系统-器官主要为皮肤及其附件损害(48.43%)、全身性损害(20.24%)、胃肠系统损害(13.01%),严重全身性系统损害以过敏性休克、过敏样反应为主。结论阿洛西林钠安全使用亟待加强,临床应重视阿洛西林钠的不良反应,加强用药监测,确保安全使用。%Objective To probe into thes tatus,characterstics and influencing factors of ADR cases induced by azlocillin sodium, so as to provide a reference for clinical treatment. Methods Datas were collected from domestic published literatures from China Journal Full-text Database before 2014, and 264 case reports of adverse drug reactions induced by azlocillin sodium were analyzed retrospectively. Results Younger patients appeared to be with a high rate of ADR, which mainly involved skin and its appendages (48.43%), systemic damage (20.24), gastrointestinal system (13.01%), and the serious ones showed anaphylactic shock and anaphylactoid reaction.Conclusion Azlocillin sodium should be used reasonably, and the monitoring of clinical use should be strengthened to ensure the safety of medication.

  16. 玻璃酸钠注射液致严重药物不良反应1例%One Case of Serious Adverse Drug Reaction Caused by Sodium Hyaluronate Injection

    Institute of Scientific and Technical Information of China (English)

    刘岚

    2013-01-01

    根据患者病情以及医生给出的治疗方案描述患者对玻璃酸钠注射液的不良反应,通过讨论给出合理的建议。%According to the patient's condition the doctor gives treatment options for patients describe sodium hyaluronate injection adverse reactions, through discussion given a reasonable proposal.

  17. 560例黄芪注射液不良反应/事件文献分析%Literature Analysis on 560 Cases of Adverse Drug Reactions/Events of Astragalus Injection

    Institute of Scientific and Technical Information of China (English)

    王月; 郭利平; 商洪才; 胡晶; 付姝菲

    2011-01-01

    目的 探讨黄芪注射液所致不良反应(ADR)或不良事件(AE)发生情况及其相关因素.方法 检索中国期刊全文数据库、中文科技期刊全文数据库及中国生物医学文献数据库1995年1月~2010年5月关于黄芪注射液的临床研究及ADR报告.纳入文献共2690篇,提取分析纳入文献中ADR/AE病例原患疾病、黄芪注射液用药剂量、溶媒及配伍用药情况.ADR/AE病例的性别、年龄及有无过敏史情况,ADR/AE出现时间、类型、处理及转归等.结果 2604篇临床研究中有132篇共报道448例ADR/AE病例;86篇ADR报告共包括112例ADR/AE病例.ADR/AE病例总体多发生于40~69岁年龄段;ADR报告的ADR/AE主要集中于全身反应(发热、过敏性休克),临床研究的ADR/AE最多见于消化系统(恶心);84.46%的ADR/AE病例严重程度为Ⅲ~Ⅳ级,无死亡病例;ADR/AE病例原患疾病最主要为心肌炎和心功能衰竭;13例(11.61%)ADR/AE病例有过敏史;黄芪注射液ADR/AE病例所用溶媒主要为5%葡萄糖液、10%葡萄糖液和生理盐水,共107例(19.10%)ADR/AE病例为黄芪注射液和其他药物配伍使用;首次用药者ADR/AE病例占总ADR/AE的66.96%.结论 黄芪注射液ADR/AE的发生是由多因素导致,临床使用须以说明书为参照,辨证使用,严格掌握用药禁忌,使用前询问过敏史,慎重选用溶媒,做好全程监控及随访.%Objective To analyze the adverse drug reactions (ADR) or adverse events (AE) of Astragalus Injection and their related factors.Methods All the clinical studies and adverse reaction reports on the Astragalus Injection from January 1995 to May 2010 in the CNKI, VIP, and CBM database were retrieved and totally 2 690 papers were enrolled for analysis.The information of the ADR/AE cases such as the original diseases, dosage, and compatibility of the Astragalus Injection; the age, gender and allergic history of patients; the happening time, type, treatment, and prognosis of the ADR/AE was

  18. Pharmacogenetic research in the association between human leukocyte antigen and adverse drug reactions%HLA与药物不良反应相关性遗传药理学方法研究进展

    Institute of Scientific and Technical Information of China (English)

    熊艳; 张伟; 陈小平

    2014-01-01

    With the rapid development of pharmacogenetics, more and more studies have shown evidence in the association between polymorphisms at the human leukocyte antigen (HLA) loci and severe adverse drug reactions (SADRs). Several HLA-B alleles proved to be associated with SADRs for drugs such as carbamazepine, allopurinol, lamotrigine, and lfucloxacillin. hTe USA Food and Drug Administration (FDA) has even recommended routine screening for HLA-B allele before the use of abacavir and carbamazepine. With the completion of human genome project and the Hapmapproject, several new pharmacogenetics approaches such as genome-wide association study (GWAS) have emerged. hTese newly developed methods will undoubtedly accelerate the identiifcation and clinical utilization of the pharmacogenetic biomakers. In addition, the immunogenetic mechanisms by which the HLA alleles cause SADRs are explored at the cellular and molecular level. hTis review focuses on the recent progresses in HLA alleles and ADRs regarding both the clinical translation and modern pharmacogenetic methods.%随着遗传药理学的迅速发展,越来越多的研究发现人类白细胞抗原(human leukocyte antigen,HLA)基因型与严重药物不良反应之间的关系,如已证实的HLA-B等位基因与阿巴卡韦、卡马西平、别嘌呤醇、拉莫三秦、氟氯西林等药物所致严重皮肤不良反应发生的风险相关。美国食品药物管理局(Food and Drug Administration,FDA)甚至已批准在阿巴卡韦和卡马西平药品标签中增加建议在用药前对HLA-B等位基因进行分型的信息。人类基因组计划(human genome project,HGP)和人类单倍型作图计划(Hapmap计划)的完成为遗传药理学研究带来了新的思路和研究方法,如全基因组关联研究等,这些无疑加快了药物基因组分子遗传标志物的发现及临床转化应用的步伐。同时, HLA等位基因导致药物不良反应发生机制的细胞分子水平研究方面也取得了较大的进展。

  19. Safely Using TCM Herbs: Adverse Reaction and Precautions

    Institute of Scientific and Technical Information of China (English)

    陈楷; AngelaBerscheid

    2004-01-01

    Adverse reactions and toxicity: Amygdalin is the main toxic constituent, which can be decomposed to hydrocyanic acid. Toxicity is dose related; 55--60 pieces of Xing ren, containing approximately 1.8 g of amygdalin, is often the fatal dose in adults. Two hours after administration, the first symptoms often appear, such as a bitter taste in mouth accompanied with oversalivation, nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, palpitations, dyspnea, cyanosis, which may lead to coma and death due to respiratory arrest .

  20. Adverse cutaneous reactions induced by exposure to woods

    Directory of Open Access Journals (Sweden)

    Dorota Chomiczewska-Skóra

    2013-02-01

    Full Text Available Various adverse cutaneous reactions may occur as a result of exposure to wood dust or solid woods. These include allergic contact dermatitis, irritant contact dermatitis and, more rarely, contact urticaria, photoallergic and phototoxic reactions. Also cases of erythema multiforme-like reactions have been reported. Contact dermatitis, both allergic and irritant, is most frequently provoked by exotic woods, e.g. wood of the Dalbergia spp., Machaerium scleroxylon or Tectona grandis. Cutaneous reactions are usually associated with manual or machine woodworking, in occupational setting or as a hobby. As a result of exposure to wood dust, airborne contact dermatitis is often diagnosed. Cases of allergic contact dermatitis due to solid woods of finished articles as jewelry or musical instruments have also been reported. The aim of the paper is to present various adverse skin reactions related to exposure to woods, their causal factors and sources of exposure, based on the review of literature. Med Pr 2013;64(1:103–118

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

    DEFF Research Database (Denmark)

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

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

  2. 中药注射剂不良反应103例回顾性分析%An retrospective analysis of adverse drug reaction in 103 cases of traditional Chinese medicine injection

    Institute of Scientific and Technical Information of China (English)

    易智勇

    2014-01-01

    目的:探讨中药注射剂不良反应( ADR)发生的规律及特点,为安全合理使用中药注射剂提供参考。方法对安徽省淮南新华医疗集团新华医院2010年1月至2013年12月663例ADR报告进行归纳整理,其中103例中药注射剂ADR报告,按患者年龄、性别、给药途径、报告来源、评价、临床表现、ADR涉及系统/器官等方面进行统计、分析。结果103例ADR报告中,共涉及26种药品,均为静脉给药方式,有90例(87.37%)发生在用药30 min 以内,男女性别比例为60:43,60岁以上老年患者 ADR 发生率最高(54.37%),以皮肤及附件损害为主(35例,33.98%),灯盏花素ADR例数最多(15例,14.56%)。结论应坚持开展中药注射剂ADR监测与上市后再评价,规范、合理使用中药注射剂,保障用药安全。%Objective To understand the rules and characteristics of adverse drug reaction ( ADR) in Xinhua Hospital of Xinhua Medical Group ( Huainan City Anhui Province )′s traditional Chinese medicine ( TCM) injection ca-ses,and to provide reference for rational and safety usage of TCM injection .Methods Reorganization was preformed on 663 cases of ADR report from January 2010 to November 2013 in this hospital .We selected 103 cases of TCM in-jection′s ADR reports,and made statistics and analysis according to patients′age,sex,drug source,report source,eval-uation,clinical features,system and organ ADR involved,etc.Results 103 cases of ADR reports involved in 26 kinds of drugs.All of them were vein medication .87.37%of the above cases were happened in 30 minutes with gender ratio of 60:43.54.36%were old patients over 60 with the highest incidence rate .33.98%were skin and appendages dis-orders.14.56%were Breviscapine ADR reports which was the most one .Conclusion It must insist on monitoring ADR of TCM injection and re-evaluation of market products ,to use TCM injection normative and rational ,and

  3. Clinical analysis of adverse drug reaction of Insulin in treatment of patients with diabetes%胰岛素治疗糖尿病不良反应的临床分析

    Institute of Scientific and Technical Information of China (English)

    周国坚; 谌剑飞

    2011-01-01

    Objective: To analyze clinical manifestation of adverse drug reaction (ADR) of Insulin in treatment of patients with diabetes mellitus, and to discuss relationship of hypoglycemia's probability and degree enhanced with different variety of Insulin, to raise the awareness of prevention. Methods: The clinical date of ADR in 516 diabetes mellitus patients treated with Insulin were analyzed, and compared with hypoglycemia rate. Results: The most ADR were hypoglycemia (20.6%), next for weight gain (7.1%), systemic or local allergic reactions (1.9%), edema of face and lower limb (1.7%); Other ADR were the fatty tissue proliferation, Somongyi phenomenon, adipose atrophy and Insulin antibody production. The inci -dence and the degree of hypoglycemia was the highest in patients who were given ordinary Insulin strengthening therapy, the next were 30/70 Mixture recombinant human Insulin, Novolin 30R, Novomix 30R, hypoglycemia rate of Humalog 25R was less, and hypoglycemia degree of Glargine was lowest, the differences were highly significant (P<0.01). When the Insulin combined with oral administrational Sulfonylureas, the incidence of hypoglycemia had close relationship with variety of In -sulin,the differences were highly significant (P<0.01). Conclusion: The hypoglycemia is common in ADR of Insulin, weight gain and allergic reactions for the next, we should pay more attention to it; the incidence and degree of hypoglycemia has close relationship with variety of Insulin and treatment method, selecting the varieties and taking positive measure for pre -vention are the key.%目的:分析胰岛素治疗糖尿病不良反应的临床表现,探讨不同品种的胰岛素与低血糖发生率的关系,以提高对其的防范意识.方法:回顾性分析516例使用胰岛素治疗糖尿病患者不良反应的临床资料,并与低血糖发生率进行比较.结果:不良反应最多为低血糖(20.6%),其次为体重增加(7.1%)、全身或局部过敏反应(1.9%)

  4. Potential Role of Pharmacogenomics in Reducing Adverse Drug Reactions A Systematic Review%药物基因组学降低不良药物反应的潜在作用系统综述

    Institute of Scientific and Technical Information of China (English)

    Kathryn A. Phillips; David L. Veenstra; Eyal Oren; Jane K. Lee; Wolfgang Sadee

    2002-01-01

    @@ 背景:不良药物反应(adverse drug reaction,ADRs)是致死和致病的重要原因.尽管许多不良药物反应都被认为是不可避免的,但是最近的进展表明,以遗传信息为基础的个体化治疗,可以避免这些反应,这也是药物基因组学(pharmacogenomics)的一种应用. 目的:评价药物基因组学降低不良药物反应发生率的潜在作用. 数据来源:于MEDLINE检索1995年1月~2000年6月发表的有关不良药物反应的英文文献,以及1997年1月~2000年8月发表的有关药物代谢酶等位基因变异的综述. 研究选择:使用详尽的纳入标准选择有关研究.从333篇不良药物反应研究中挑选了18篇,从61篇等位基因变异综述中挑选了22篇. 数据提取:所有研究者均用标准的摘要格式对有关文章进行审查及编码. 数据综合:我们选择了27种经常被不良药物反应研究提及的药物.其中59%至少由1种有变异等位基因的酶代谢,已知这种基因变异能引起代谢障碍.相反,在随机选择的药物当中,只有7%~22%由有遗传变异性酶代谢. 结论:根据个体遗传构造选择药物治疗能明显降低临床不良药物反应.我们的研究可作为将来进一步研究药物基因组学如何减少不良反应发生率的基础,也是了解其对临床、社会、经济影响的基础.

  5. 我国药品不良反应报告质量评估现状的分析与思考%Study on the Evaluation for Quality of Adverse Drug Reaction Reports in China

    Institute of Scientific and Technical Information of China (English)

    刘巍; 李馨龄; 程刚; 沈璐; 董铎; 刘翠丽; 王亚丽

    2014-01-01

    s:Objective To review the progress of the evaluation for the quality of the adverse drug reactions (ADR) in China. Methods Progress of the evaluation for the quality of the ICSRS and the ADR database in China were reviewed and summarized. Results By the evaluation for the quality of the ICSRS, the detail problems such as spelling could be found. By the evaluation for the quality of the ADR database, the macroscopic problems such as the method and the trend could be found. They complement each other and play a positive role for the healthy development of ADR monitor-ing. Conclusion The quality of ADR report is an important content of the ADR monitoring, so it is very necessary to establish scientific and operable evaluation system and methods.%目的:分析药品不良反应报告质量评估工作的现状。方法对目前国内药品不良反应个案报告表质量和药品不良反应数据库整体质量评估工作的历史和现状进行回顾和总结。结果对每份个案报告表质量的评估能发现报告表填写、评价审核中存在的细节问题,而药品不良反应数据库整体质量评估则能发现监测工作在方法、导向以及趋势等方面相对宏观的问题。二者互为补充,对推动监测工作健康发展具有积极作用。结论药品不良反应报告质量提高工作是药品不良反应监测工作的重要内容,亟待建立针对药品不良反应个案报告表和药品不良反应数据库建立科学、可操作的评估体系和方法。

  6. Mining for adverse drug events with formal concept analysis

    CERN Document Server

    Estacio-Moreno, Alexander; Bousquet, Cédric

    2009-01-01

    The pharmacovigilance databases consist of several case reports involving drugs and adverse events (AEs). Some methods are applied consistently to highlight all signals, i.e. all statistically significant associations between a drug and an AE. These methods are appropriate for verification of more complex relationships involving one or several drug(s) and AE(s) (e.g; syndromes or interactions) but do not address the identification of them. We propose a method for the extraction of these relationships based on Formal Concept Analysis (FCA) associated with disproportionality measures. This method identifies all sets of drugs and AEs which are potential signals, syndromes or interactions. Compared to a previous experience of disproportionality analysis without FCA, the addition of FCA was more efficient for identifying false positives related to concomitant drugs.

  7. [Adverse reactions to iodinated contrast media: how to prevent them?].

    Science.gov (United States)

    Berner, Jeanne; Poletti, Pierre-Alexandre; Becker, Christoph D; Nendaz, Mathieu

    2009-10-14

    The incidence of acute iodine contrast media reactions, appearing within the first hour after the procedure, is low but clinically important due to their daily use. Previous adverse reactions to iodinated contrast media, asthma and a history of allergic reaction are the most recognized risk factors, but the identification of patients at risk remains difficult. The efficacy of preventive measures such as corticosteroid and/or antihistaminic administration rests on low-level evidence. Practical recommendations are presented in this article. Rather than relying on the sole administration of a premedication, the importance of other measures must be stressed: assessing the relevance of the indication to the radiologic exam, use of low osmolarity contrast media, and ensuring a proper monitoring of the patient during and after the procedure. PMID:19911686

  8. Adverse Drug Event Prevention: 2014 Action Plan Conference.

    Science.gov (United States)

    Ducoffe, Aaron R; Baehr, Avi; Peña, Juliet C; Rider, Briana B; Yang, Sandra; Hu, Dale J

    2016-09-01

    Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use.

  9. 改良药品不良反应监测评估体系在门、急诊输液中的应用%Application of the improved monitoring and evaluation system of adverse drug reaction during infusion in clinic and emergency department

    Institute of Scientific and Technical Information of China (English)

    容桂荣; 张莉莉; 韦艳春; 王芳芳; 温宇凤

    2014-01-01

    Objective To develop the improved monitoring and evaluation system of adverse drug reaction during infusion in clinic and emergency department,and investigate the effect of this system.Methods To develop monitoring and evaluation system of adverse drug reaction,which was consistent with the medical safety (adverse) event reporting,and running it.The system consisted of organizational structure,knowledge training,event reporting and processing,data analysis,quality control and continuous improvement.We collected the observed indicators of the cases of adverse drug reaction,quality and network reporting time pass rate,which were compared with those of the conventional system.Results One year during the improved system running,the cases of adverse drug reaction in clinic and emergency department infusion was reduced,the quality of reporting and handling significantly improved,network report pass rate increased.Conclusions Improved monitoring and evaluation system of adverse drug reactions has some significance in safety management of clinic and emergency department infusion,which is worthy of promotion in clinical work applications.%目的 探讨在门、急诊输液室建立改良药品不良反应监测评估体系管理模式的效果.方法 制订并运行与医疗安全(不良)事件报告一致的药品不良反应监测评估体系,内容包括组织结构、知识培训、事件报告和处理、数据分析研究、质量控制与持续改进等,与常规药品不良反应监测评估体系运行对比,统计门、急诊输液药品不良反应数量、质量、网络上报时间合格率等.结果 改良的药品不良反应监测评估体系实施1年内,门、急诊输液药品不良反应报告数量减少,报告和处理质量明显提高,网络上报合格率提高.结论 改良的药品不良反应监测评估体系在门、急诊输液安全管理中有一定指导意义,值得在临床工作中推广应用.

  10. Reactions and interactions in handling anticancer drugs.

    Science.gov (United States)

    D'Arcy, P F

    1983-01-01

    The clinical toxicity of anticancer drugs has been well documented with regard to the adverse effects of treatment in patients. However, many of these drugs have a direct irritant effect on the skin, eyes, mucous membranes, and other tissues. Handled without due care, especially when being prepared for injection, most cytotoxic drugs can cause local toxic or allergic reactions; they also present hazards of carcinogenicity and mutagenicity. This spectrum of potential risk should be kept in mind by personnel administering or handling these drugs, especially in oncology units where just a few individuals may routinely and frequently reconstitute many doses of cytotoxic agents. This is work in which the hospital pharmacist should and must be involved; indeed, many of the techniques and skills required are identical with those used in standard aseptic procedures for preparing pharmaceutical products. Pharmacy departments should take the initiative in making hospital staff aware of the potential risks of handling neoplastic agents, and they should spearhead a multidisciplinary assessment for producing local guidelines for working with these drugs. This article warns practitioners about the inherent dangers of these practitioner-drug interactions and suggests ways in which they may be reduced. Information is given in tabular form regarding recommended procedures for reconstituting 24 anticancer drugs and precautions to protect the personnel handling them, especially when there is spillage of powdered or liquid drugs. Also, guidelines are given about incompatibilities with admixtures of such drugs, and the literature is reviewed relative to recent developments in hospital pharmacy departments where reconstitution of anticancer drugs has been incorporated into existing intravenous fluid preparation/admixture units. Not only has this been shown to be safer and more effective in terms of time and labor, but also it has cut the cost of injectable cytotoxic drugs by an

  11. Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

    Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

  12. CYP2C9 polymorphism in patients with epilepsy: genotypic frequency analyzes andphenytoin adverse reactions correlation

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    Carlos Alexandre Twardowschy

    2011-04-01

    Full Text Available OBJECTIVE: CYP2C9 is a major enzyme in human drug metabolism and the polymorphism observed in the corresponding gene may affect therapeutic outcome during treatment. The distribution of variant CYP2C9 alleles and prevalence of phenytoin adverse reactions were hereby investigated in a population of patients diagnosed with epilepsy. METHOD: Allele-specific PCR analysis was carried out in order to determine frequencies of the two most common variant alleles, CYP2C9*2 and CYP2C9*3 in genomic DNA isolated from 100 epileptic patients. We also analyzed the frequency of phenytoin adverse reactions among those different genotypes groups. The data was presented as mean±standard deviation. RESULTS: The mean age at enrollment was 39.6±10.3 years (range, 17-72 years and duration of epilepsy was 26.5±11.9 years (range 3-48 years. The mean age at epilepsy onset was 13.1±12.4 years (range, 1 month-62 years. Frequencies of CYP2C9*1 (84%, CYP2C9*2 (9% and CYP2C9*3 (7% were similar to other published reports. Phenytoin adverse reactions were usually mild and occurred in 15% patients, without correlation with the CYP2C9 polymorphism (p=0.34. CONCLUSION: Our findings indicate an overall similar distribution of the CYP2C9 alleles in a population of patients diagnosed with epilepsy in the South of Brazil, compared to other samples. This sample of phenytoin users showed no drug related adverse reactions and CYP2C9 allele type correlation. The role of CYP2C9 polymorphism influence on phenytoin adverse reaction remains to be determined since some literature evidence and our data found negative results.

  13. Adverse Reactions of Trivalent Influenza Vaccine in HIV-Infected Individuals

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    Mahboube Hajiabdolbaghi

    2010-03-01

    Full Text Available In this study, we assessed the adverse reactions to influenza vaccination in HIV- infected individuals. From November 2006 to January 2007, a total of 203 HIV-infected persons were recruited. Demographic data were collected. Subjects were evaluated 48 h and 15 days after vaccination for symptoms and significant health events as possible side effects. Participants were instructed to measure their temperature in the morning and evening for 2 days post-immunization and to assess injection site and systemic adverse reactions. 80.3% of the subjects were male. The mean age of the subjects was 36.9±7.9 years. Local and systemic reactions were reported by 61 (30% and 62 (30.5% persons, respectively. The most common adverse reactions to the influenza vaccine included skin redness (37 cases, induration (32 cases, and pain (55 cases as local reac-tions, and fever (22 cases, myalgia (46 cases, headache (12 cases and weakness (35 cases as general reactions. 1.4 % of the subjects had fever over 38.5 ºC. There were significant associations between myalgia and flushing with CD4 counts (P<0.05. We found no relationship between ad-verse reactions and sex, history of smoking, allergy, alcohol, and drug usage, stage of HIV infec-tion, anti-retroviral therapies, anti-TB medication and previous vaccination. We concluded that inactivated influenza vaccine administered in HIV-infected adults did not result in potential ad-verse events in this study population.

  14. Analysis on the adverse drug reaction signal and its impact factors induced by oral hypoglycemic agents%口服抗糖尿病药物不良反应信号及其相关因素分析

    Institute of Scientific and Technical Information of China (English)

    柯俊; 汤文璐; 薛浩; 庞露微

    2012-01-01

    目的 研究口服抗糖尿病药物不良反应特征,并提供相应临床合理用药的依据.方法 通过上海市不良反应监测中心收集2006至2010年有关口服抗糖尿病药物不良反应的数据,使用描述性统计,logistic回归模型及不相称性,对不良反应发生的特征、风险因子和相关因素进行分析.结果 共获得812例口服抗糖尿病药物的不良反应报告.结果显示老年人和女性占不良反应发生的多数;不良反应级别以一般为主;2009至2010年间作为药品说明书中未记载的新的不良反应有上升的趋势;双胍类及磺酰脲类(SU)不良反应最为突出;logistic回归模型显示女性、日服用药频次多、单一用药是胃肠道不良反应的危险因素.体质量是皮肤损害的危险因素,联合用药、患者年龄大是SU致低血糖的危险因素.不相称性研究同时也得到一些口服抗糖尿病药物致不良反应的信号.结论 口服抗糖尿病药物不良反应累及系统器官广泛,像性别、年龄、体质量、用药频次、是否联合用药都会在一定程度上影响不良反应的发生.故口服抗糖尿病药物在临床使用时应加强不良反应监测,重视和控制其风险因子,以期更合理安全地用药.%AIM To study the feature and regularity of adverse drug reaction (ADR) induced by oral hypoglycemic agents (OHAs) and provide reasonable advice for clinical use.METHODS By collecting ADR reports of OHAs from database of Shanghai ADR spontaneous reporting system from 2006 to 2010,we made through analysis on the character and risk factors of ADR induced by OHAs using descriptive statistics and logistic regression model,and also applied disproportional measures on data mining of ADR signal and its relevant factors.RESULTS A total of 812 ADR reports induced by OHAs were included in this study.The results indicated that the senior and female patients were mostly concerned,and mainly marked as moderately injured

  15. Application of quality control circle in reducing the adverse reaction of non-steroidal anti-inflammatory drugs in rheumatology department%品管圈在降低风湿科非甾体类抗炎药不良反应中的应用

    Institute of Scientific and Technical Information of China (English)

    蒋楠; 李晓兰; 刘秋玉; 冯子芸; 黄霞霞; 邓小虎

    2014-01-01

    Objective:To evaluate the effect of quality control circle activities in reducing the adverse reaction of non-steroidal anti-inflammatory drugs in rheumatology department. Methods: Quality control circle was set up and PDCA method was applied to analyze the cause of adverse reactions induced by non-steroidal anti-inflammatory drugs, and the corresponding improvement measures were formulated. Reducing adverse reactions associated with non-steroidal anti-inflammatory drugs in rheumatology department was set as the primary goal. Results:By improving the form and content of health education, admission assessment, offering physical and mental support, the occurrence rate of adverse reactions induced by non-steroidal anti-inlfammatory drug decreased from prior 17.1%to now 6.9%. Conclusion:Quality control circle activities reduced the occurrence rate of non-steroidal anti-inlfammatory drugs adverse reactions in rheumatology department and improved the medical security. Meanwhile, teamwork among colleagues was established in the process of data collecting and explaining, overall nursing care was applied well in clinic.%目的:探讨品管圈活动对降低风湿科非甾体类抗炎药不良反应的效果。方法:成立品管圈,运用PDCA法,以降低“风湿科非甾体类抗炎药不良反应”为主题,对发生不良反应的原因进行统计、分析,制定相应的改进措施。结果:通过观察并总结风湿科非甾体类抗炎药不良反应发生的原因,从健康教育的形式、内容、入院评估、身心并护等方面入手,使风湿科非甾体类抗炎药不良反应的发生率从活动前的17.1%降低至活动后的6.9%。结论:品管圈活动降低了风湿科非甾体类抗炎药不良反应的发生率,提高了用药安全性,培养了同事间的团队精神,使责任制整体护理更好的运用于临床工作中。

  16. Revisión sistemática de los estudios de evaluación del coste de las reacciones adversas a medicamentos Systematic review of studies assessing the cost of adverse drug reactions

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    Antonio Vallano Ferraz

    2012-06-01

    Full Text Available Objetivos: Las reacciones adversas a medicamentos (RAM son un problema sanitario relevante. El objetivo fue revisar los estudios publicados que han analizado los costes de las RAM en cualquier ámbito asistencial. Métodos: Se realizó una búsqueda de artículos publicados en bases bibliográficas (1970-2010. Se identificaron 28 estudios y se seleccionaron 16 que incluyeron casos de RAM según la definición de la Organización Mundial de la Salud. Se revisó la información relacionada con las características del diseño de los estudios, los tipos de costes analizados y los resultados descritos. Resultados: Las características del diseño y de las poblaciones incluidas en los estudios fueron heterogéneas. Sólo en dos se definió explícitamente la perspectiva del estudio. Sólo cinco estudios compararon los casos de los pacientes con RAM con controles apareados sin RAM. Todos los estudios analizaron los costes directos sanitarios, pero ninguno los costes indirectos o intangibles. En 14 estudios se analizaron los costes de los días de hospitalización. El porcentaje medio (DE de RAM fue de 3,04% (2,3 [mediana 2,4%, mínimo 0,70% y máximo 26,1%]. La mediana de días de hospitalización de los pacientes con RAM fue de 8,8 días (intervalo de 0,15 a 19,2 días. Los sistemas de contabilidad y los costes monetarios fueron muy variables. Conclusión: Los estudios sobre los costes de las RAM tienen diseños heterogéneos, han evaluado los costes directos sanitarios hospitalarios y sus resultados indican que las RAM generan costes significativos. Son necesarios estudios sobre los costes de las RAM realizados con una metodología adecuada.Objective: Adverse drug reactions (ADRs are an important healthcare problem. The objective of this study was to review published articles analyzing the cost of ADRs in any healthcare setting. Method: We conducted a search of articles published on the cost of ADRs in the bibliographic databases from 1970 to 2010

  17. Adverse drug events with hyperkalaemia during inpatient stays: evaluation of an automated method for retrospective detection in hospital databases

    OpenAIRE

    Ficheur, Grégoire; Chazard, Emmanuel; Beuscart, Jean-Baptiste; Merlin, Béatrice; Luyckx, Michel; Beuscart, Régis

    2014-01-01

    Background Adverse drug reactions and adverse drug events (ADEs) are major public health issues. Many different prospective tools for the automated detection of ADEs in hospital databases have been developed and evaluated. The objective of the present study was to evaluate an automated method for the retrospective detection of ADEs with hyperkalaemia during inpatient stays. Methods We used a set of complex detection rules to take account of the patient’s clinical and biological context and th...

  18. Analysis on highly cited papers published in Adverse Drug Reactions Journal during 2009 to 2013%《药物不良反应杂志》高被引频次论文分析

    Institute of Scientific and Technical Information of China (English)

    孟艳

    2015-01-01

    Objective To analyze the characteristics of highly cited papers published in Adverse Drug Reactions Journal( our journal)during 2009 to 2013,understand the hot spots of subject development and demands of readers,and improve impact and quality of our journal. Methods The citation frequency of papers published in our journal from 2009 to 2013 was searched in China Academic Journal Network Publishing Database(as of April 30,2015). Price law was used to determine the highly cited papers. The main statistical parameters included total citation frequency of papers published in our journal,average citation frequency of papers,citation frequency of highly cited papers,and average citation frequency of highly cited papers. The distribution of subjects of highly cited papers,regional distribution of authors, distribution of article types,and funding sources were analyzed descriptively. Results A total of 1 052 articles were searched and 736 articles were entered into the study,including 147 original articles,85 reviews,and 504 case reports. Of the 736 articles,517 were cited( 70. 2%) and the total citation frequency was 2 170 times and average citation frequency of papers was 4 times. According to the Price law, the papers which were cited≥5 times were considered as highly cited papers in our journal during the study period. The citation frequency of 138 highly cited papers was 1 388 times which accounted for 64. 0% of total frequency(2 170 times)during the study period and average citation frequency of highly cited papers was 10 times. The subjects of highly cited 138 papers are relatively centered and the top 5 subjects were antimicrobial agents(44 papers,31. 9%),Chinese Medicine(22,15. 9%),cardiovascular system drugs (19,13. 8%),antineoplastic drugs(11,8. 0%),and endocrine system drugs(5,3. 6%);there were 87 papers(63. 0%)distributed in Beijing and 51 papers(37. 0%)distributed in other 17 provinces or municipality directly under the central government;33 of the highly

  19. A study:adverse drug reactions to infliximab treatment in patients with inflammatory arthritis%英夫利西单抗治疗炎性关节炎不良事件分析

    Institute of Scientific and Technical Information of China (English)

    夏晓茹; 王坚; 王博; 陈培荣; 秦韦; 朱小春

    2012-01-01

    AIM To evaluate the tolerance and risk of infliximab in the treatment of patients with inflammatory arthritis including rheumatoid arthritis ( RA) , ankylosing spondylitis ( AS) , psoriatic arthritis (PsA). METHODS According to the World Health Organization Adverse Reaction Terminology (WHOART) classification, a retrospective analysis from January 2007 to December 2010 about incident rate of adverse events ( AEs) , serious adverse events ( SAE) and abnormal laboratory test results was conducted in 137 patients with RA, AS and PsA treated with infliximab, to estimate the safety. RESULTS Among the 137 patients treated with infliximab, 14 patients were screened AEs associated to the medication, including allergic reactions (4.4%), upper respiratory infection (2.9%), tuberculosis (1.5%) and so on. Except 3 patients of SAE occurred ( 2.2% , 1 patient of severe infusion reactions and 2 patients of tuberculosis) and had to withdraw from infliximab, the others completed the treatment after the symptomatic treatment. CONCLUSION The tumor necrosis factor antagonists infliximab is safe and well tolerated in patients with inflammatory arthritis. The serious infusion reaction and tuberculosis are the main reasons of withdrawal, thereby, the indication should be strictly abide by avoiding SAE such as tuberculosis.%目的 探讨英夫利西单抗治疗炎性关节炎前后不良事件,评价其临床使用的安全性.方法 随访2007年1月至2010年12月期间进行英夫利西单抗治疗的137例(共537次注射)类风湿关节炎、强直性脊柱炎和银屑病关节炎患者,对其治疗期间及随访过程中所发生的全部不良事件、严重不良事件、实验室检查进行总结分析,根据世界卫生组织不良反应术语命名系统进行分类、观察不良事件的发生情况.结果 有14例18例次发生治疗药物相关的不良事件,主要表现为轻度过敏反应、上呼吸道感染症状、结核感染等,发生率分别为4.4%、2.9

  20. Comparison of serious adverse reactions between thalidomide and lenalidomide: analysis in the French Pharmacovigilance database.

    Science.gov (United States)

    Olivier-Abbal, Pascale; Teisseyre, Anne-Charlotte; Montastruc, Jean-Louis

    2013-12-01

    Thalidomide and lenalidomide are structural analogs and immunomodulatory drugs. Lenalidomide appears to have a different safety profile than thalidomide and could be less toxic, and as far as we know, we did not found any study comparing their safety profile. The objective of our study was to review and compare serious adverse drug reactions (SADRs) of thalidomide and lenalidomide spontaneously reported to the French Pharmacovigilance database. We extracted all medically confirmed spontaneous reports of SADR for lenalidomide-based regimens and thalidomide-based regimens from the French Pharmacovigilance database. A "serious" adverse drug reaction (ADR) was defined as an ADR that is fatal or life threatening, which causes hospitalization or prolongation of hospitalization, or permanent or significant disability. The study period was between marketing of 2 drugs and January 15, 2012. A total of 392 SADRs related to thalidomide-based regimens were identified in 244 patients and 377 SADRs related to lenalidomide-based regimens in 220 patients. In spite of their structural analogy, this study highlights interesting differences between lenalidomide and thalidomide's safety profile: nervous system and vascular disorders are more frequent with thalidomide-based regimens while hematologic, skin, infectious disorders and secondary primary cancers are more frequent with lenalidomide-based regimens.

  1. Adverse effects of the antimalaria drug, mefloquine: due to primary liver damage with secondary thyroid involvement?

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    Herxheimer Andrew

    2002-03-01

    Full Text Available Abstract Background Mefloquine is a clinically important antimalaria drug, which is often not well tolerated. We critically reviewed 516 published case reports of mefloquine adverse effects, to clarify the phenomenology of the harms associated with mefloquine, and to make recommendations for safer prescribing. Presentation We postulate that many of the adverse effects of mefloquine are a post-hepatic syndrome caused by primary liver damage. In some users we believe that symptomatic thyroid disturbance occurs, either independently or as a secondary consequence of the hepatocellular injury. The mefloquine syndrome presents in a variety of ways including headache, gastrointestinal disturbances, nervousness, fatigue, disorders of sleep, mood, memory and concentration, and occasionally frank psychosis. Previous liver or thyroid disease, and concurrent insults to the liver (such as from alcohol, dehydration, an oral contraceptive pill, recreational drugs, and other liver-damaging drugs may be related to the development of severe or prolonged adverse reactions to mefloquine. Implications We believe that people with active liver or thyroid disease should not take mefloquine, whereas those with fully resolved neuropsychiatric illness may do so safely. Mefloquine users should avoid alcohol, recreational drugs, hormonal contraception and co-medications known to cause liver damage or thyroid damage. With these caveats, we believe that mefloquine may be safely prescribed in pregnancy, and also to occupational groups who carry out safety-critical tasks. Testing Mefloquine's adverse effects need to be investigated through a multicentre cohort study, with small controlled studies testing specific elements of the hypothesis.

  2. Adverse Reaction to Cetuximab, an Epidermal Growth Factor Receptor Inhibitor.

    Science.gov (United States)

    Štulhofer Buzina, Daška; Martinac, Ivana; Ledić Drvar, Daniela; Čeović, Romana; Bilić, Ivan; Marinović, Branka

    2016-04-01

    Dear Editor, Inhibition of the epidermal growth factor receptor (EGFR) is a new strategy in treatment of a variety of solid tumors, such as colorectal carcinoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and pancreatic cancer (1). Cetuximab is a chimeric human-murine monoclonal antibody against EGFR. Cutaneous side effects are the most common adverse reactions occurring during epidermal growth factor receptor inhibitors (EGFRI) therapy. Papulopustular rash (acne like rash) develop with 80-86% patients receiving cetuximab, while xerosis, eczema, fissures, teleangiectasiae, hyperpigmentations, and nail and hair changes occur less frequently (2). The mechanism underlying these skin changes has not been established and understood. It seems EGFRI alter cell growth and differentiation, leading to impaired stratum corneum and cell apoptosis (3-5). An abdominoperineal resection of the rectal adenocarcinoma (Dukes C) was performed on a 43-year-old female patient. Following surgery, adjuvant chemo-radiotherapy was applied. After two years, the patient suffered a metastatic relapse. Abdominal lymphadenopathy was detected on multi-slice computer tomography (MSCT) images, with an increased value of the carcinoembryonic antigen (CEA) tumor marker (maximal value 57 ng/mL). Hematological and biochemical tests were within normal limits, so first-line chemotherapy with oxaliplatin and a 5-fluorouracil (FOLFOX4) protocol was introduced. A wild type of the KRAS gene was confirmed in tumor tissue (diagnostic prerequisite for the introduction of EGFRI) and cetuximab (250 mg per m2 of body surface) was added to the treatment protocol. The patient responded well to the treatment with confirmed partial regression of the tumor formations. Three months after the patient started using cetuximab, an anti-EGFR monoclonal antibody, the patient presented with a papulopustular eruption in the seborrhoeic areas (Figure 1) and eczematoid reactions on the extremities

  3. Adverse reactions to cosmetics and methods of testing

    Directory of Open Access Journals (Sweden)

    Nigam P

    2009-01-01

    Full Text Available Untoward reactions to cosmetics, toiletries, and topical applications are the commonest single reason for hospital referrals with allergic contact dermatitis. In most cases, these are only mild or transient and most reactions being irritant rather than allergic in nature. Various adverse effects may occur in the form of acute toxicity, percutaneous absorption, skin irritation, eye irritation, skin sensitization and photosensitization, subchronic toxicity, mutagenicity/genotoxicity, and phototoxicity/photoirritation. The safety assessment of a cosmetic product clearly depends upon how it is used, since it determines the amount of substance which may be ingested, inhaled, or absorbed through the skin or mucous membranes. Concentration of ingredients used in the different products is also important. Various test procedures include in vivo animal models and in vitro models, such as open or closed patch test, in vivo skin irritation test, skin corrosivity potential tests (rat skin transcutaneous electrical resistance test, Episkin test, eye irritation tests (in vivo eye irritancy test and Draize eye irritancy test, mutagenicity/genotoxicity tests (in vitro bacterial reverse mutation test and in vitro mammalian cell chromosome aberration test, and phototoxicity/photoirritation test (3T3 neutral red uptake phototoxicity test. Finished cosmetic products are usually tested in small populations to confirm the skin and mucous membrane compatibility, and to assess their cosmetic acceptability.

  4. [Histamine intolerance - are the criteria of an adverse reaction met?].

    Science.gov (United States)

    Reese, Imke

    2016-06-01

    Searching the internet for an explaination of recurring symptoms, many people come across the so-called histamine intolerance disorder. Also many practitioners like to diagnose this disorder without making sure that reproducibility, a prerequisite for an adverse reaction, is present. Consequently, presumably affected persons are often advised to follow a low-histamine diet. Depending on the source of information, these diets often avoid a huge variety of foods containing more or less histamine, which has a considerable impact on patient quality of life. While most persons benefit from such a diet in the beginning - this might be due to the change in dietary habits or the expectation of symptom improvement by dieting - in the long run the expected loss of symptoms will not happen. Underlying a diminished capacity for histamine degradation, the lack of partial or complete symptom improvement might be due to the fact that endogenous histamine release is responsible for reactions. The role of ingested histamine is discussed controversially. However, it is more than obvious that the histamine content of a certain food alone is not enough to predict its tolerance.If histamine intolerance is suspected, an individual diagnostic and therapeutic procedure is mandatory in order to minimize avoidance and to preserve a high quality of life. Ideally this is done in a close cooperation between allergologists and nutritionists/dieticians. PMID:27177895

  5. 磷霉素治疗小儿急性细菌性痢疾的疗效及不良反应文献分析%Document analysis of curative effect and adverse drug reaction of acute bacillary dysentery treated by Fosfomycin

    Institute of Scientific and Technical Information of China (English)

    范燕

    2012-01-01

    目的 通过对磷霉素治疗小儿急性细菌性痢疾(简称菌痢)的文献报道进行分析,评价磷霉素对小儿急性菌痢的疗效及安全性,为小儿急性菌痢的诊治提供更加安全的治疗方案.方法 以"磷霉素"并含"小儿急性菌痢"为主要检索词,检索CNKI数据库1980~2011年间涉及磷霉素治疗小儿急性菌痢的文献报道,分别从治愈、有效、无效3个疗效标准及不良反应的发生情况等方面进行统计分析.结果 共检索出12篇810例病例,治愈756例(93.3%),好转43例(5.3%);无效11例(1.4%);发生不良反应26例(3.2%).结论 采用磷霉素治疗小儿急性菌例疗效明显,不良反应发生率低,在临床治疗小儿急性菌痢方面值得选用.%Objective To analyze the curative effect and adverse drug reaction of acute bacillary dysentery treated by Fosfomycin. Methods Actual data related to the acute bacillary dysentery treated by fosfomycin spanning years 1980-2011 were collected from the China National Knovledge Infrastructure(CNKI). Data should be analyzed through cure, effective, invalid and adverse drug reaction. Results Actual data originated from 12 publications encompassing 810 cases including 756 cases of cure (93.3%), 43 cases of effective (5.3%), 11 cases of invalid (1.4%) and 26 cases of adverse drug reaction (3.2%). Conclusion There are obvious curative effect and low incidence rate of adverse drug reaction in the acute bacillar}' dysentery treated by Fosfomycin.

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

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

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

  7. Consideration of Adverse Reaction to MDCT Contrast Media

    International Nuclear Information System (INIS)

    In this experiment, we investigated 82 patients who suffered adverse reactions due to contrast medium. We selected the subjects out of 21,178 people who had an intravenous injection of contrast medium to undergo MDCT examination at one university hospital in Busan in 2007. As a result, the largest groups of the patients were as follows. 52.4% of the patients were male when classify by gender; 28.0% of the patients were 50's by age; 45% of the patients got when it was spring(April and March); 75.6% of the patients had a side effects when the speed of injection is 2.5 mL/sec; 58.5% of the patients were suffered when the volume of injected contrast medium is over 130 mL. Urticaria was the main symptom of side effect as 26.8%. And the main treatment for the effect was alleviating the symptoms before making patients to return home. Thus, practical preventive measures are needed as follows: use the OCS system to observe warning signs at risky patients, secure warming spaces for patients to cope with season changing, prepare enough emergency kits for the patients in danger, and establish CPR call systems, explain the risk of contrast medium and get agree about using contrast medium.

  8. Safely Using TCM Herbs:Adverse Reaction and Precautions (Continued)

    Institute of Scientific and Technical Information of China (English)

    CHEN Kai(陈楷); Angela Berscheid

    2004-01-01

    @@ Chan su (Venenum Bufonis,蟾酥) Its main active and toxic constituent is bufotoxin, which has a function similar to digitalis glycosides. Adverse reactions and toxicity: Chan su, although it is used in patentpreparations, is traditionally known for its toxicity and is seldom used in decoctions. Toxicity is often due to over dosage of the patents, such as Liushenwan (六神丸) and Houzhengwan (喉症丸,). After administration one and a half to two hours, symptoms similar to digitalis toxicity appear, such as nausea, which is often the first indicator of toxicity, anorexia, vomiting, visual disturbances relating to colour vision, headache, weakness, psychosis, arrythmias, slowing of heart rate, AV block, and asystole.Severe cardiac damage is the major cause of death. It has al so been known to promote contraction of the uterus; therefore it should not be used in pregnant women(40,41). One paper has reported 27 cases intoxicated by Liushenwan, inclu ding one fatal(13).

  9. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    OpenAIRE

    Fabiana Rossi Varallo; Helaine Carneiro Capucho; Cleópatra da Silva Planeta; Patrícia de Carvalho Mastroianni

    2014-01-01

    OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to Decemb...

  10. The severe adverse reaction to vitamin k1 injection is anaphylactoid reaction but not anaphylaxis.

    Science.gov (United States)

    Mi, Yan-Ni; Ping, Na-Na; Xiao, Xue; Zhu, Yan-Bing; Liu, Jing; Cao, Yong-Xiao

    2014-01-01

    The severe adverse reaction to vitamin K1 injection is always remarkable and is thought to result from anaphylaxis. Paradoxically, however, some patients administered vitamin K1 injection for the first time have adverse reactions. Using beagle dogs, the present study tested the hypothesis that the response to vitamin K1 is an anaphylactoid reaction. The results showed that serious anaphylaxis-like symptoms appeared in beagle dogs after the administration of vitamin K1 injection for the first time. The plasma histamine concentration increased, and blood pressure decreased sharply. After sensitization, dogs were challenged with vitamin K1 injection and displayed the same degree of symptoms as prior to sensitization. However, when the vitamin K1 injection-sensitized dogs were challenged with a vitamin K1-fat emulsion without solubilizers such asTween-80, the abnormal reactions did not occur. Furthermore, there was no significant change in the plasma immunoglobulin E concentration after vitamin K1 challenge. Following treatment with vitamin K1 injection, the release of histamine and β-hexosaminidase by rat basophilic leukemia-2H3 cells as well as the rate of apoptosis increased. The Tween-80 group displayed results similar to those observed following vitamin K1 injection in vivo. However, the dogs in the vitamin K1-fat emulsion group did not display any abnormal behavior or significant change in plasma histamine. Additionally, degranulation and apoptosis did not occur in rat basophilic leukemia-2H3 cells. Our results indicate that the adverse reaction induced by vitamin K1 injection is an anaphylactoid reaction, not anaphylaxis. Vitamin K1 injection induces the release of inflammatory factors via a non-IgE-mediated immune pathway, for which the trigger may be the solubilizer. PMID:24594861

  11. The severe adverse reaction to vitamin k1 injection is anaphylactoid reaction but not anaphylaxis.

    Directory of Open Access Journals (Sweden)

    Yan-Ni Mi

    Full Text Available The severe adverse reaction to vitamin K1 injection is always remarkable and is thought to result from anaphylaxis. Paradoxically, however, some patients administered vitamin K1 injection for the first time have adverse reactions. Using beagle dogs, the present study tested the hypothesis that the response to vitamin K1 is an anaphylactoid reaction. The results showed that serious anaphylaxis-like symptoms appeared in beagle dogs after the administration of vitamin K1 injection for the first time. The plasma histamine concentration increased, and blood pressure decreased sharply. After sensitization, dogs were challenged with vitamin K1 injection and displayed the same degree of symptoms as prior to sensitization. However, when the vitamin K1 injection-sensitized dogs were challenged with a vitamin K1-fat emulsion without solubilizers such asTween-80, the abnormal reactions did not occur. Furthermore, there was no significant change in the plasma immunoglobulin E concentration after vitamin K1 challenge. Following treatment with vitamin K1 injection, the release of histamine and β-hexosaminidase by rat basophilic leukemia-2H3 cells as well as the rate of apoptosis increased. The Tween-80 group displayed results similar to those observed following vitamin K1 injection in vivo. However, the dogs in the vitamin K1-fat emulsion group did not display any abnormal behavior or significant change in plasma histamine. Additionally, degranulation and apoptosis did not occur in rat basophilic leukemia-2H3 cells. Our results indicate that the adverse reaction induced by vitamin K1 injection is an anaphylactoid reaction, not anaphylaxis. Vitamin K1 injection induces the release of inflammatory factors via a non-IgE-mediated immune pathway, for which the trigger may be the solubilizer.

  12. Does an allergy to fish pre-empt an adverse protamine reaction? A case report and a literature review.

    LENUS (Irish Health Repository)

    Collins, C

    2008-11-01

    The operating theatre exposes patients to myriad potential agents which could result in a life-threatening anaphylactic reaction. Anaesthetic drugs, blood products, and latex are only some of the possible allergens. Reactions are deemed to be anaphylactic when immediate sensitivity is combined with cardiovascular collapse. A patient who had a known allergy to shellfish presented for first time cardiopulmonary bypass. The perfusion team were concerned that there was a realistic possibility that an adverse reaction to protamine could occur. Anaphylactic reactions to protamine in patients allergic to fish have been reported. The anaesthetic team were informed and the necessary precautions taken. We report on the outcome for our patient and also discuss other risk factors and the types of reactions that can result when an adverse reaction to protamine occurs.

  13. 膝髋关节置换术后抗凝药物不良反应的观察及护理对策%Nursing interventions and Observation on Anticoagulant Drug Adverse Reactions After Joint Replacement of Hip and Knee

    Institute of Scientific and Technical Information of China (English)

    郭冬梅

    2015-01-01

    目的:探索膝髋关节置换术后使用抗凝药物不良反应的观察及护理对策。方法选取我院的120例患者,分为观察组和对照组,每组各有60例患者,对照组采用常规护理,观察组采用优质护理。结果观察组的患者总不良反应发生率以及住院时间与住院费用优于对照组(P<0.05)。结论优质护理在膝髋关节置换术后使用抗凝药物不良反应中的护理效果确切。%Objective To explore nursing strategy and the anticoagulant drug adverse reactions after joint replacement of hip and knee.Methods 120 cases were divided into observation group and control group, each group with 60 cases, control group received conventional nursing, observation group received high quality nursing.Results The observation group of patients with total incidence of adverse reactions and the length of hospital stay and hospital costs significantly better than that of control group (P<0.05).Conclusion The effect of high quality nursing in drug adverse reactions after joint replacement of hip and knee is exact.

  14. Drug adverse events and drop-out risk: a clinical case.

    Science.gov (United States)

    Scoyni, R M; Aiello, L; Trani, I; Felli, B; Masin, A M R; Camponi, V; Dignazio, L; Cortese, M; Pacitti, M T; Carratelli, D; Morocutti, C

    2007-01-01

    We report a brief discussion on a clinical case of a female patient, 85 years old, affected by severe cognitive impairment and chronic obstructive pulmonary disease (COPD). The patient was not taking drugs at home (apart from promazine: 10 drops when necessary to control her behavioral diseases). A previous neuropsychological evaluation had shown a severe cognitive impairment MMSE=16/30; ADL=3/6; IADL=0/8) due to multiple brain ischemic areas (confirmed in 2003 by MRI neuroimaging). When the patient was admitted to our center she was able to perform some basic activities of daily living such as eating and walking and was not too confused. She was included in cognitive rehabilitation groups. Since she showed signs of Parkinsonism, a therapy based on omeprazol 20mg, acetylsalicylic acid, donepezil 10mg, pramipexol 0.18 mg, nimodipine 10 drops, levodopa+carbidopa 100/25mg was started. A few days later she became sleepy during daytime and, once, she lost her balance and fell. She was not self-sufficient any more. At first this was attributed to a lung infection that the patient had, but her state continue after the infection was completely cured with appropriate antibiotics therapy. At that point an adverse drug reaction was suspected and therapy with pramipexol 0.18 mg was interrupted. In a few days the patient regained her previous level of consciousness and self-sufficiency. We consider this a typical case of complex management in a patient with dementia and comorbidity in which adverse drug reactions can play an important role in lowering the level of cognitive functions. In this case the relationship with the family of the patient was made difficult by the attitude of the patient's daughter who decided, after the onset of the adverse drug reaction, to interrupt her mother's stay in our center even at risk of the worst consequences. PMID:17317475

  15. Inappropriate prescribing and adverse drug events in older people

    Directory of Open Access Journals (Sweden)

    Gallagher Paul F

    2009-01-01

    Full Text Available Abstract Inappropriate prescribing (IP in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs, morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  16. Inappropriate prescribing and adverse drug events in older people.

    LENUS (Irish Health Repository)

    Hamilton, Hilary J

    2009-01-01

    Inappropriate prescribing (IP) in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs), morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  17. Heparin-induced thrombocytopenia: a review of concepts regarding a dangerous adverse drug reaction Trombocitopenia induzida por heparina: revisão de conceitos de uma importante reação adversa a medicamentos

    Directory of Open Access Journals (Sweden)

    Daniela Rezende Garcia Junqueira

    2013-04-01

    Full Text Available Heparin is a natural agent with antithrombotic action, commercially available for therapeutic use as unfractionated heparin and low molecular weight heparin. Heparin-induced thrombocytopenia (HIT is a serious adverse reaction to heparin that promotes antibodymediated platelet activation. HIT is defined as a relative reduction in platelet count of 50% (even when the platelet count at its lowest level is above > 150 x 10(9/L occurring within five to 14 days after initiation of the therapy. Thrombocytopenia is the main feature that directs the clinical suspicion of the reaction and the increased risk of thromboembolic complications is the most important and paradoxical consequence. The diagnosis is a delicate issue, and requires a combination of clinical probability and laboratory tests for the detection of platelet activation induced by HIT antibodies. The absolute risk of HIT has been estimated between 1% and 5% under treatment with unfractionated heparin, and less than 1% with low molecular weight heparin. However, high-quality evidence about the risk of HIT from randomized clinical trials is scarce. In addition, information on the frequency of HIT in developing countries is not widely available. This review aims to provide a better understanding of the key features of this reaction and updated information on its frequency to health professionals and other interested parties. Knowledge, familiarity, and access to therapeutic options for the treatment of this adverse reaction are mandatory to minimize the associated risks, improving patient safety.A heparina é um agente natural com ação antitrombótica, sendo disponibilizadas para uso terapêutico a heparina não fracionadaeaheparina de baixo peso molecular. A trombocitopenia induzida por heparina (TIH é uma reação adversa grave às heparinas mediada por anticorpos que promovem ativação de plaquetas. A TIH é definida como uma redução rela- tiva na contagem de plaquetas de 50% (mesmo se

  18. [Adverse reaction induced by licorice preparations: clinical analysis of 93 cases].

    Science.gov (United States)

    Mao, Min; Li, Wei; Wang, Wei; Wang, Shu-Xia; Lu, Jin; Chang, Zhang-Fu

    2013-11-01

    Licorice is a traditional Chinese medicine commonly used in clinic. The products,what contain licorice or licorice extract, has early been involved in the field of cosmetics except for the field of pharmaceuticals and food. Consequently, the reporting on adverse reactions induced by licorice preparations are more frequent. Based on the clinical data of licorice preparations adverse reactions, we described the characteristics of the licorice-related adverse reactions, and proposed specific measures to reduce the incidence of adverse reactions, provided a reference for the rational use of licorice preparations. PMID:24494570

  19. Adverse Reaction Following Intravenous Immunoglobulin in Primary Immunodeficiency Patients

    Directory of Open Access Journals (Sweden)

    J. Ghaffari, M.D.+

    2007-01-01

    Full Text Available AbstractBackground and Purpose: Intravenous immunoglobulin is used for primary immunodeficiency disorders. There have been some reports that intravenous immunoglobulin causes side effects. The aim of this study was to investigate intravenous immunoglobulin side effects in immunodeficiency patients.Materials and Methods: The study utilized the data of 29 primary immunodeficiency patients that were referred to allergy and immunology department in Medical Children Center in Tehran. 29 patients having completed record data files in the hospital, were the subjects of this study.Results: Of 29 immune deficiency patients (aged 15 months to 55 years, they were 19 Males (65/51% and 10(34/48% Females. Prevalence of disorders include common variable immunodeficiency 16(55/17%, Bruton disease 8(27/58%, hyper IgM 4 (13/79% and severe combind immunodeficiency 1 (3/44%. Based on the recorded data, the duration of infusion has been 5 months to 15 years. 15 patients had reported side effects (51/72%. 34 infusions from the total of 1,626 infusions accompanied with side effects (2/09%. Most side effects were occurred during 30 minutes onset of infusion and most were caused by rapid infusion. Most side effects were mild reactions (fever, chills and ….Conclusion: Intravenous immunoglobulin is a rather safe drug with mild side effects. With an appropriate technique and proper infusion, these side effects can be reduced.

  20. Reações adversas causadas por fármacos que atuam no sistema nervoso: análise de registros de um centro de farmacovigilância do Brasil Adverse reaction caused by drugs acting in nervous system: records analysis of a farmacovigilance center in Brazil

    Directory of Open Access Journals (Sweden)

    Marta Maria de França Fonteles

    2009-01-01

    Full Text Available CONTEXTO: A morbimortalidade por uso de medicamentos é um grande problema de saúde. As reações adversas a medicamentos podem resultar em óbito, aumento de internações hospitalares e dos custos com a saúde. OBJETIVOS: Descrever e analisar as notificações de suspeitas de reações adversas causadas por medicamentos que atuam no sistema nervoso (RAM-SN, registradas no Centro de Farmacovigilância do Ceará, de janeiro de 1997 a março de 2008. MÉTODOS: As RAM-SN foram classificadas segundo os critérios da Organização Mundial da Saúde. Uma relação de causalidade entre o fármaco administrado e a reação adversa identificada foi realizada, bem como a análise da reação quanto à gravidade. RESULTADOS: Foram registradas 176 notificações de RAM-SN. A maioria (n = 145; 82,4% ocorreu no ambiente hospitalar. O principal notificador foi o farmacêutico. As RAM-SN foram classificadas como: possíveis (n = 110, prováveis (n = 37 e definidas (n = 17. Quanto à gravidade, foram consideradas: leves (n = 21, moderadas (n = 127, graves (n = 15 e fatais (n = 1. O caso fatal foi notificado por médico e envolveu medicamentos anestésicos. Geralmente, as reações adversas observadas foram causadas predominantemente por analgésicos, anestésicos e antiepilépticos. DISCUSSÃO: Os dados demonstram o valor potencial de se ter acesso a sistemas de farmacovigilância local para registrar possíveis riscos com o uso de fármacos.BACKGROUND: The morbi-mortality by the use of medicines is a major health problem. The drug adverse reactions may result in death, increased hospitalizations and healthcare costs. OBJECTIVES: Describe and analyze reports of suspected adverse reactions caused by drugs that act on the nervous system (SN-ADR, registered in the database of the Pharmacovigilance Centre of Ceará, from January 1997 to March 2008. METHODS: All the NS-ADRs were classified according to criteria of the World Health Organization. The causality

  1. Characteristics of ambulatory anticoagulant adverse drug events: a descriptive study

    Directory of Open Access Journals (Sweden)

    Eckstrand Julie

    2010-02-01

    Full Text Available Abstract Background Despite the high frequency with which adverse drug events (ADEs occur in outpatient settings, detailed information regarding these events remains limited. Anticoagulant drugs are associated with increased safety concerns and are commonly involved in outpatient ADEs. We therefore sought to evaluate ambulatory anticoagulation ADEs and the patient population in which they occurred within the Duke University Health System (Durham, NC, USA. Methods A retrospective chart review of ambulatory warfarin-related ADEs was conducted. An automated trigger surveillance system identified eligible events in ambulatory patients admitted with an International Normalized Ratio (INR >3 and administration of vitamin K. Event and patient characteristics were evaluated, and quality/process improvement strategies for ambulatory anticoagulation management are described. Results A total of 169 events in 167 patients were identified from December 1, 2006-June 30, 2008 and included in the study. A median supratherapeutic INR of 6.1 was noted, and roughly half of all events (52.1% were associated with a bleed. Nearly 74% of events resulted in a need for fresh frozen plasma; 64.8% of bleeds were classified as major. A total of 59.2% of events were at least partially responsible for hospital admission. Median patient age was 68 y (range 36-95 y with 24.9% initiating therapy within 3 months prior to the event. Of events with a prior documented patient visit (n = 157, 73.2% were seen at a Duke clinic or hospital within the previous month. Almost 80% of these patients had anticoagulation therapy addressed, but only 60.0% had a follow-up plan documented in the electronic note. Conclusions Ambulatory warfarin-related ADEs have significant patient and healthcare utilization consequences in the form of bleeding events and associated hospital admissions. Recommendations for improvement in anticoagulation management include use of information technology to assist

  2. Analysis of Related Factors of Adverse Drug Reaction Occurred in the Methadone Maintenance Treatment%美沙酮药物维持治疗中药品不良反应事件发生的相关因素分析

    Institute of Scientific and Technical Information of China (English)

    李群

    2014-01-01

    目的:分析美沙酮药物维持治疗中药品不良反应事件发生的相关因素。方法:回顾性分析我院2011年8月~2013年6月收治的100例接受美沙酮药物维持治疗的海洛因成瘾者的临床资料。结果:美沙酮维持治疗引入期和维持期出现的不良反应发生率最高的是便秘,分别占总数的60%和71%;不同既往海洛因用量的患者的便秘发生率相比具有显著的统计学差异(P0.05)。结论:美沙酮药物维持治疗中药品不良反应事件发生的相关因素有既往海洛因滥用量、美沙酮用药时间及维持剂量等,临床应给予这些因素以充分重视。%To analyze the related factors of adverse drug reaction occurred in the methadone maintenance treatment. Methods:A retrospective analysis of the clinical data of methadone maintenance treatment of drug addicts in our hospital in 2011 August to 2013 June were treated 100 cases.Results:The adverse reaction of methadone maintenance treatment is introduced and maintenance period is the highest rate of constipation,accounted for 60%and 71%respectively;the different amount of heroin patients the incidence of constipation compared with significant statistical difference (P0.05).Conclusion:Methadone maintenance treatment of drug related factors of adverse drug reaction occurred with the heroin abuse dosage,time of methadone administration and maintenance dose,clinical should give full attention to these factors.

  3. Late adverse reactions to intravascular iodine based contrast media

    DEFF Research Database (Denmark)

    Bellin, Marie-France; Stacul, Fulvio; Webb, Judith A W;

    2011-01-01

    of approximately 2%-4% after nonionic monomers. LAR are commoner by a factor of three to four after nonionic dimers. The commonest skin reactions are maculopapular rashes, erythema and skin swelling. These reactions are T cell-mediated immune reactions, and the diagnosis may be confirmed using skin tests (patch......-induced skin reactions. To reduce the risk of repeat reactions avoidance of the relevant CM and any cross-reacting agents identified by skin testing is recommended....

  4. Analysis of Adverse Reaction of Shuanghuanglian Injection%双黄连注射液的不良反应

    Institute of Scientific and Technical Information of China (English)

    李凤玲; 雍雯

    2014-01-01

    387 patients in our hospital in 2012 June ~2014 year in June use of Shuanghuanglian injection, of which 58 cases of adverse reactions occur, analysis of the characteristics of the adverse reaction of Shuanghuanglian injection, to provide the reference for the clinical use of Shuanghuanglian injection. To prevent and reduce the adverse reaction of Chinese medicine. Factors af ecting the occur ence of adverse reactions, including gender, medication time, and the age of patients has no significant ef ect on the incidence of. Factors af ecting the relevant staf should pay more at ention to the adverse reaction of Shuanghuanglian injection, try to avoid the occur ence of adverse reactions, appropriate drugs, to ensure drug safety.%选取我院2012年6月~2014年6月使用双黄连注射液的患者387例,其中58例发生不良反应,分析双黄连注射液的不良反应特点,为临床使用双黄连注射液提供参考。预防和减少中成药不良反应的发生。不良反应发生的影响因素,包括性别、用药时间等,而患者年龄对发生率无明显影响。相关工作人员要多关注双黄连注射液不良反应的影响因素,尽量避免发生不良反应,适量用药,保证用药安全。

  5. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-03-01

    Full Text Available OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%, fatigue (12.3%, and chest pain (9.0%. Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

  6. Core Concepts Involving Adverse Psychotropic Drug Effects: Assessment, Implications, and Management.

    Science.gov (United States)

    Goldberg, Joseph F; Ernst, Carrie L

    2016-09-01

    Adverse effects from psychiatric drugs can profoundly influence treatment adherence and outcomes. Good care involves addressing adverse effects no differently than any other component of treatment. Knowledge about adverse effect assessment and management fosters a proper context that helps clinicians not sacrifice a drug's potential therapeutic benefits because of greater concerns about its tolerability. This article provides an overview of basic concepts related to the assessment and management of suspected adverse effects from psychotropic drugs. Key points are discussed regarding clinical, pharmacogenetic, pharmacokinetic, and pharmacodynamic risk factors for treatment-emergent adverse effects, alongside recommendations for their systematic assessment. PMID:27514295

  7. Analysis and Prospect of the Present Situation of Grassroots Level Adverse Drug Reaction Monitoring System Construction in Our Country%我国基层药品不良反应监测体系建设现状分析及展望

    Institute of Scientific and Technical Information of China (English)

    金锋; 曲毅; 樊若曦; 李馨龄

    2015-01-01

    Objective Through analyzing researches on the current status of the grassroots adverse drug reaction (ADR) monitoring organization in the country, to provide reference for the food and medicine monitoring organizations at different levels to develop ADR monitoring system, so as to better serve the overall safety monitoring of the medicine, medical device and cosmetic product. Methods Questionnaire survey was used to conduct research on the current status of the local adverse drug reaction monitoring system in our country. Results and Conclusion Through analyzing current status, common issues of the grassroots ADR monitoring organizations are discussed. These issues include incomplete reform progress, insufficient organization functions, most of the organizations not being independent, personnel team needing improvement, etc. The author makes proposals to the future local adverse drug reaction monitoring system development in the country and gives constructive advices to all levels of the monitoring departments to improve the monitoring system development.%目的:对当前全国基层药品不良反应监测机构现状进行分析,旨在为各级食品药品监督管理部门促进药品不良反应监测体系建设提供参考,更好地服务药品、医疗器械、化妆品上市后安全性监管工作大局。方法通过问卷调研的方式对我国目前基层药品不良反应监测体系建设现状进行了调研。结果与结论通过现状分析,讨论了基层药品不良反应监测技术机构存在的普遍问题,如改革进程尚未完成、机构职责还不健全、机构设置多未独立、人员队伍建设尚需加强等,并对未来全国基层药品不良反应监测体系建设提出了愿景,对各级监管部门完善监测体系建设工作提出了建设性的意见。

  8. Adverse reactions of hyperbaric oxygen therapy - case description of a generalised seizure

    Directory of Open Access Journals (Sweden)

    Grobelska Kinga

    2016-03-01

    Full Text Available Hyperbaric oxygen therapy (HBOT is a safe treatment, provided fulfilling certain rules of patient qualifications to treatment, as well as supervision over the course of therapy by qualified medical staff. Side effects reported in the literature are rare, and are usually mild and transient. Professional medical staff allows minimising the adverse events occurrence. The scale of complications is unknown, especially in Polish hyperbaric center. Careful analysis could be used to develop prevention procedures for patients of hyperbaric oxygen therapy. Hyperbaric Oxygen Centre and Wound Treatment in Bydgoszcz during 28 months performed hyperbaric oxygen therapy (HBOT in case of 423 patients. During this period, adverse events occurred occasionally. 17 cases have been reported. Authors described study case 77 year-old patient who was admitted due to non-healing wound-left lower abdomen (state after radiotherapy. During the fourth session, on decompression phase patient have had a generalized seizure (tonic-clonic. The decompression was stopped, the oxygen supply was disconnected but only after the drug administration seizures terminated. The most likely causative agent of the adverse reactions of the patient treated with HBOT was the oxygen toxic effect on the brain tissue. However, analyzing the circumstances of the seizure termination: phase of decompression at the pressure 2ATA and lack of oxygen disconnection response, it cannot be excluded other causes of this complication.

  9. A case of levocetirizine-induced fixed drug eruption and cross-reaction with piperazine derivatives

    OpenAIRE

    Kim, Mi-Yeong; Jo, Eun-Jung; Chang, Yoon-Seok; Cho, Sang-Heon; Min, Kyung-Up; Kim, Sae-Hoon

    2013-01-01

    Fixed drug eruption is an uncommon adverse drug reaction caused by delayed cell-mediated hypersensitivity. Levocetirizine is an active (R)-enatiomer of cetirizine and there have been a few reports of fixed drug eruption related to these antihistamines. We experienced a case of levocetirizine-induced fixed drug eruption and cross-reaction with other piperazine derivatives confirmed by patch test. A 73-year-old female patient presented with recurrent generalized itching, cutaneous bullae format...

  10. An analysis of potential costs of adverse events based on Drug Programs in Poland. Pulmonology focus

    Directory of Open Access Journals (Sweden)

    Szkultecka-Debek Monika

    2014-06-01

    Full Text Available The project was performed within the Polish Society for Pharmacoeconomics (PTFE. The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.

  11. Adverse blood transfusion reactions at tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Surekha K. Chavan

    2016-06-01

    Conclusions: Not a single case of anaphylactic reactions, TRALI, acute immune hemolytic transfusion reaction, and Sepsis was observed. This can be an underestimation of the true incidence because of under reporting which can be improved by proper hemovigilence system to provide better patient care. [Int J Res Med Sci 2016; 4(6.000: 2402-2407

  12. Prevention and Management of Adverse Reactions Induced by Iodinated Contrast Media.

    Science.gov (United States)

    Wu, Yi Wei; Leow, Kheng Song; Zhu, Yujin; Tan, Cher Heng

    2016-04-01

    Iodinated radiocontrast media (IRCM) is widely used in current clinical practice. Although IRCM is generally safe, serious adverse drug reactions (ADRs) may still occur. IRCM-induced ADRs may be subdivided into chemotoxic and hypersensitivity reactions. Several factors have been shown to be associated with an increased risk of ADRs, including previous contrast media reactions, history of asthma and allergic disease, etc. Contrast media with lower osmolality is generally recommended for at-risk patients to prevent ADRs. Current premedication prophylaxis in at-risk patients may reduce the risk of ADRs. However, there is still a lack of consensus on the prophylactic role of premedication. Contrast-induced nephropathy (CIN) is another component of IRCM-related ADRs. Hydration remains the mainstay of CIN prophylaxis in at-risk patients. Despite several preventive measures, ADRs may still occur. Treatment strategies for potential contrast reactions are also summarised in this article. This article summarises the pathophysiology, epidemiology and risk factors of ADRs with emphasis on prevention and treatment strategies. This will allow readers to understand the rationale behind appropriate patient preparation for diagnostic imaging involving IRCM. PMID:27292007

  13. Optimal management of acute nonrenal adverse reactions to iodine-based contrast media

    OpenAIRE

    Nielsen YW; Thomsen HS

    2013-01-01

    Yousef W Nielsen, Henrik S Thomsen Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark Abstract: Acute adverse reactions to iodine-based contrast media occur within 60 minutes of administration. The reactions range from mild (flushing, arm pain, nausea/vomiting, headache) to moderate (bronchospasm, hypotension), and severe (cardiovascular collapse, laryngeal edema, convulsions, arrhythmias). Most acute adverse reactions occur in an unpredictable manner. Use of ...

  14. Optimal management of acute nonrenal adverse reactions to iodine-based contrast media

    OpenAIRE

    Thomsen, Henrik

    2013-01-01

    Yousef W Nielsen, Henrik S Thomsen Department of Radiology, Copenhagen University Hospital Herlev, Copenhagen, Denmark Abstract: Acute adverse reactions to iodine-based contrast media occur within 60 minutes of administration. The reactions range from mild (flushing, arm pain, nausea/vomiting, headache) to moderate (bronchospasm, hypotension), and severe (cardiovascular collapse, laryngeal edema, convulsions, arrhythmias). Most acute adverse reactions occur in an unpredictable manner. Use of...

  15. Ziconotide: new drug. Limited analgesic efficacy, too many adverse effects.

    Science.gov (United States)

    2008-10-01

    (1) When oral morphine does not relieve severe pain and when there is no specific treatment for the underlying cause, the first option is to try subcutaneous or intravenous administration. If this standard treatment fails or is poorly tolerated, intrathecal injection is usually preferred as the direct route to the central nervous system. However, one-quarter to one-half of patients still do not achieve adequate pain relief, and adverse effects are relatively frequent; (2) Ziconotide is not an opiate and is not related to the usual classes of drugs that interfere with nervous transmission in the posterior horn of the spinal cord. Marketing authorization has been granted for "severe, chronic pain in patients who require intrathecal analgesia". The Summary of Product Characteristics (SPC) recommends continuous infusion via an intrathecal catheter connected to a pump; (3) Clinical evaluation of ziconotide does not include any trials versus morphine in patients with nociceptive pain, or any trials versus tricyclic or antiepileptic drugs in patients with neurogenic pain; (4) In a trial in 220 patients in whom systemic morphine had failed, the mean pain score on a 100-mm visual analogue scale was 69.8 mm after three weeks on ziconotide, compared to 75.8 mm with placebo. This difference, although statistically significant, is clinically irrelevant. The proportion of "responders" (reduction of at least 30% in the initial pain score) was respectively 16.1% and 12.0% (no statistically significant difference); (5) The two other placebo-controlled trials included 112 patients with pain linked to cancer or HIV infection, and 257 patients with non-cancer pain. After a titration phase lasting 5 to 6 days, a combined analysis of the two trials showed that the mean pain score was 48.8 mm with ziconotide and 68.4 mm with placebo (statistically significant difference). However, many patients did not complete the titration phase. Efficacy also appeared to differ according to the type

  16. To discuss the adverse reaction of Fluoroquinolones%对氟喹诺酮类药物的不良反应的探讨

    Institute of Scientific and Technical Information of China (English)

    刘伦栋; 徐婷

    2013-01-01

    目的:探讨氟喹诺酮类药物在临床应用中的不良反应。方法:分析研究氟喹诺酮类在临床中的应用及其不良反应。结果与结论:对氟喹诺酮类的不良反应应重视并防止滥用。%objecttive: To discuss the adverse reaction of fluoroquinolones in clinic. Methods:To study and analysis the adverse reaction of fluoroquinolones in clinic. Results & Conclusion: Fluoroquinolones, adverse reaction should be valued and prevent drug abusing.

  17. 药品不良反应循证医学证据关联性评价方法学的教学体会%Didactical Experience and Research of Causality Assessment of Evidence-based Medicine for Adverse Drug Reaction

    Institute of Scientific and Technical Information of China (English)

    杜广清; 张祥华; 门阳; 吴华; 魏永祥

    2011-01-01

    OBJECTIVE: To provide reference for the improvement of teaching level of causality assessment of evidence-based medicine for adverse drug reaction. METHODS: The experiences of causality assessment of evidence-based medicine for adverse drug reaction were summarized. The interests of students were activated by using heuristic teaching method and multimedia, combining with heuristic questions using problems as orientation, introducing classical case. RESULTS & CONCLUSION: The experience of authors indicates that the application of a variety of teaching methods is helpful to improve the interest of students and the teaching quality, culturing diagnosis and resolution ability of students in field of ADR etiology and ADR judgement in evidence-base medicine.%目的:为提高药品不良反应循证医学证据关联性评价方法学的教学水平提供参考.方法:总结药品不良反应循证医学证据关联性评价的教学体会,采用启发式教学方法并配合多媒体授课,同时结合以问题为导向、启发式提问及经典案例介绍的教学方法,激发学生学习兴趣.结果与结论:笔者的教学实践证明,多种教学方法联合运用,有助于提高学生学习兴趣,提高教学质量,培养学生药品不良反应病因学循证诊断、处理以及循证医学实践中的药品不良反应临床判断能力.

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

    Science.gov (United States)

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

    2014-01-01

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

  19. [Adverse drug events of older patients presenting in the emergency department].

    Science.gov (United States)

    Malinovska, Alexandra; Bingisser, Roland; Nickel, Christian H

    2015-12-01

    The effect of medication is always a balance between their beneficial effects and any adverse reactions they might elicit. The main risk for adverse drug events {ADEs) is polypharmacy, which is the simultaneous use of multiple drugs.This often applies to older patients, who suffer from multiple diseases and therefore take multiple medications. Thus, itis not surprising, that ADEs are frequention older patients and account up to 16% of emergency visits. It is still under discussion, whether age is an independent risk factor for ADEs. However, there are some age-related changes in the pharmacokinetic and pharmacodynamics properties of many drugs, which may influence the highly fragile balance between benefit and harm in older patients. Though there are multiple risk factors for and causes of ADEs, it could be shown that a lot of ADEs are preventable and even predictable: Budnitz eta/. showed that almost two thirds of emergency hospitalisations occur due to four medication classes: warfarin, oral antiplatelet agents, insulin and oral hypoglycaemic agents. Nevertheless, only 40-60% ofA DEs are recognized in the emergency department. This might be explained by the broad clinical symptoms, ranging from bleeding due to anticoagulants to the more nonspecific symptom of weakness due to hyponatraemia secondary to thiazide diuretics. Detecting and avoiding ADEs could be aided by using lists such as Beers criteria or STOPP/FART which list medications which are potentially inappropriate for older patients. PMID:26654810

  20. Long-term endocrine therapy-related adverse drug reactions in patients after breast cancer surgery and treatment strategies%乳腺癌患者术后长期内分泌治疗的不良反应及治疗策略

    Institute of Scientific and Technical Information of China (English)

    王涛; 叶棋浓; 江泽飞

    2014-01-01

    内分泌治疗是乳腺癌患者术后治疗的重要手段,目前临床应用的主要药物有选择性雌激素受体调节剂他莫昔芬和芳香化酶抑制剂阿那曲唑、来曲唑及依西美坦。乳腺癌术后辅助内分泌治疗通常需要5年,部分患者可长达10年。他莫昔芬治疗引起的不良反应主要包括妇科和心血管系统不良反应。处理措施为定期检测子宫内膜及血压、血脂等指标,对症处理。芳香化酶抑制剂治疗引起的不良反应主要包括:(1)骨不良反应。处理措施为根据情况予以维生素D和钙剂治疗,必要时给予双膦酸盐类药物。(2)关节肌肉症状。病情较轻者可补充维生素D和钙剂,并进行适当体育锻炼;疼痛明显者可服用非甾体类抗炎药,也可以考虑停药3~4周。(3)心血管系统不良反应。处理措施为对症处理。%Endocrine therapy is an important treatment method for patients after breast cancer surgery. At the present,selective estrogen receptor modulator( such as tamoxifen)and aromatase inhibitors ( such as anastrozole,letrozole,and exemestane)are main treatment drugs for patients after breast cancer surgery. The patients receiving adjuvant endocrine therapy need usually about 5 years and some patients need 10 years. The adverse reactions induced by tamoxifen were symptoms related to gynecology and cardiovascular system. The treatment measures include regular detection of the patients' endometrium, pressure,and blood lipid,etc. and symptomatic treatments. The adverse reactions induced by aromatase inhibitors are as follows.(1)Adverse reactions related to bone. The treatment measures are supplement of vitamin D and calcium,and bisphosphonates maybe given. ( 2 )Joint and muscle symptoms. The patients with mild symptoms are given vitamin D,calcium,and appropriate physical exercise. The patients in marked symptoms are given non steroidal anti-inflammatory drugs or the treatment drugs are

  1. Adverse events of modern antifungal drugs during treatment of invasive fungal infections

    Directory of Open Access Journals (Sweden)

    N. V. Dmitrieva

    2013-01-01

    Full Text Available Characteristics of adverse events of modern antimycotics by organ systems and comparative frequency between different medicines and their groups are presented. The examples of incompatibility of antifungal drugs with other pharmacological groups are discussed. Records of adverse events and drug compatibility will allow the practitioner to prevent and timely cure possible complications, should they arise.

  2. Study on the Application of Common Signal Detection Methods for Adverse Drug Reaction Reports%药品不良反应报告常用信号检测方法应用研究

    Institute of Scientific and Technical Information of China (English)

    汤榕; 李林贵; 孙维红; 顾希; 杜慧; 王晓霞

    2012-01-01

    OBJECTIVE: To provide reference for safe and rational use of drugs in the clinic and further drug safety risk evaluation. METHODS: 8 795 cases were collected from ADR monitoring network in our region from 2007 to 2010, and determined quantitatively by using proportional reporting ratio (PPR), Reporting odds ratio(ROR)and Bayesian confidence propagation neural network (BCPNN). The suspicious signal were compared and analyzed, and the quantitative signal detection method based on autonomous reporting system database and the scientific ADR signal detection way were explored. RESULTS & CONCLUSION: 3 common methods were all adopted to detect 869 types of Drug-ADR and 66 types of Drugs-ADR quantitatively. Part of signal could be detected. The results of PRR and ROR method were similar, and BCPNN method was different from them significantly. The signal strengths of 3 methods were not identical.%目的:为指导临床安全、合理用药和进一步评价药品安全风险提供参考.方法:通过收集我区2007-2010年药品不良反应(ADR)监测网络ADR报告8 795份,运用频数法中的比例报告(PRR)法、报告比值比(ROR)法和贝叶斯判别可信区间递进神经网络模型(BCPNN)法进行定量检测,对生成的可疑信号进行比较分析,探索以自发呈报系统数据库为基础的定量信号检测方法的运用和科学的ADR信号检测途径.结果与结论:通过对869种Drug-ADR组合和66种Drugs-ADR组合进行3种常用方法信号定量检测,发现对部分已知信号能够检出,PRR法、ROR法结果相近,BCPNN法差别较大,3种方法信号强度各不相同.

  3. Adverse reactions, psychological factors, and their effect on donor retention in men and women

    NARCIS (Netherlands)

    Veldhuizen, I.; Atsma, F.; Dongen, A. van; Kort, W. de

    2012-01-01

    BACKGROUND: This study investigates the effect of a vasovagal reaction (VVR) or needle reaction (NR) on the risk of stopping as a blood donor, taking into account variables from the Theory of Planned Behavior (TPB). Is stopping risk solely related to the adverse reaction itself, or do the TPB variab

  4. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors

    Directory of Open Access Journals (Sweden)

    Bero Lisa

    2010-11-01

    Full Text Available Abstract Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Methods Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Results Over half of responding chiropractors (62% reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Conclusions Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.

  5. Mechanisms in adverse reactions to food. The ear

    DEFF Research Database (Denmark)

    Høst, A

    1995-01-01

    Otitis media with effusion is rarely caused by allergy to food. Allergic inflammation in the nasal mucosa, mainly due to IgE-mediated reactions to foods, may cause eustachian tube dysfunction and subsequent otitis media with effusion. Inflammatory mediators from the nasal mucosa transported via t...

  6. 血塞通注射液不良反应分析%Analysis of Xuesaitong injection adverse reactions

    Institute of Scientific and Technical Information of China (English)

    石二霞

    2015-01-01

    目的:探讨血塞通注射剂不良反应发生的原因及相关因素,促进临床合理应用。方法:通过对2例应用血塞通注射剂后发生不良反应案例进行分析,总结出现不良反应的原因及避免不良反应发生措施。结果:临床使用血塞通注射液应严格按照说明书的适应症,选择适当的溶媒,密切观察用药过程,将药物不良反应发生率降至最低,促进临床合理用药。%Objective To investigate the occurrence of adverse reaction of Xuesaitong injection and its related factors,in order to promote the rational use of traditional Chinese medicine injection. Methods Through the correlation analysis on 2 cases of adverse reactions induced by Xuesaitong injection after application case,summarized the reasons of adverse reactions and corresponding measures. Results The clinical use of Xuesaitong injection should be strictly in accordance with the instructions,reduce the incidence of adverse drug reactions to a minimum and improve public safety.

  7. 93例莫西沙星致严重不良反应报告分析%Analysis of 93 Cases of Severe Adverse Drug Reactions Caused by Moxifloxacin

    Institute of Scientific and Technical Information of China (English)

    周冰; 张俊; 张黎明

    2011-01-01

    目的 分析93例莫西沙星致严重不良反应报告,探讨莫西沙星致严重不良反应的特点和规律,为临床安全合理用药提供参考.方法 对2004年1月1日至2009年12月31日,北京市药品不良反应监测中心收到的93例莫西沙星致严重不良反应报告按人群、药品、不良反应情况等方面进行统计、分析.结果 临床使用莫西沙星多数能够按照药品使用说明书使用,少数存在不合理用药现象.结论 使用莫西沙星应严格按药品使用说明书用药,加强用药过程监护,减少药品带来的伤害.%Objective To probe into the general pattern and characteristics of severs ADRs indused by moxifloxacin so as to procide references for clinic retional use of moxifloxacin. Methods A total of 93 cases indused by moxifloxacin received from 2004 to 2009 in Beijing were analyzed statistically. Results The clinical use of moxifloxacin most can defer to the drugs instruction, the minority exists the irreasonabl phenomenon. Conclusion The use of moxifloxacin should strictly accord to the drugs instruction, enhance medication monitoring process, reduce the injury which the drugs bring.

  8. Adverse reactions to tattoos: a study from the hilly region in northern India

    OpenAIRE

    Subhash Kashyap; Ajay Kumar

    2016-01-01

    Background: Body art in the form of ornamental tattoos has been prevalent since ages and is followed with increased popularity in modern times. Tattoo prevalence ranges from 8.5% to 24%, higher among younger ages. Two third of such people who ever had a tattoo reported of being regretted of having a tattoo itself while 2% have adverse reactions. The aim was to study the adverse reaction to tattoos and histological variants in the chronic tattoos. Methods: An observational prospective stud...

  9. Transfusion-related adverse reactions: From institutional hemovigilance effort to National Hemovigilance program

    OpenAIRE

    Rahul Vasudev; Vijay Sawhney; Mitu Dogra; Tilak Raj Raina

    2016-01-01

    Aims: In this study we have evaluated the various adverse reactions related to transfusion occurring in our institution as a pilot institutional effort toward a hemovigilance program. This study will also help in understanding the problems faced by blood banks/Transfusion Medicine departments in implementing an effective hemovigilance program. Materials and Methods: All the adverse reactions related to transfusion of whole blood and its components in various clinical specialties were studied ...

  10. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country

    OpenAIRE

    Sadia Sultan; Mohammad Amjad Baig; Syed Mohammed Irfan; Syed Ijlal Ahmed; Syeda Faiza Hasan

    2016-01-01

    Objectives: Fragmented blood transfusion services along with an unmotivated blood donation culture often leads to blood shortage. Donor retention is crucial to meet the increasing blood demand, and adverse donor reactions have a negative impact on donor return. The aim of this study was to estimate adverse donor reactions and identify any demographic association.   Methods: We conducted a prospective study between January 2011 and December 2013. A total of 41,759 healthy donors were enrol...

  11. [Suggestions for prevention of adverse reactions after intravasal administration of iodinated contrast media].

    Science.gov (United States)

    Kuefner, Michael A; Heinrich, Marc; Bautz, Werner; Uder, Michael

    2008-01-01

    Iodinated contrast media are widely used in computed tomography and angiography. Adverse reactions such as contrast-medium induced nephropathy (CIN), anaphylactoid reactions and iodine-induced thyrotoxicosis are associated with intravasal administration of contrast agents. Iodinated contrast agents are generally considered to be safe, but in rare cases they can cause severe life threatening situations. In this review we present an overview about the incidence, pathways, and risk factors of adverse reactions. Simple schemes including hydration protocols for prevention of CIN, medication for prophylaxis of iodine-induced thyrotoxicosis with thyreostatics and anaphylactoid reactions with histamine antagonists and corticosteroids are suggested. PMID:19294866

  12. 某基层医院中老年人药品不良反应特点及合理用药建议%Characteristics of Adverse Drug Reactions in Middle Aged and Elderly People and Suggestions for Rational Drug Use

    Institute of Scientific and Technical Information of China (English)

    陈宗清

    2015-01-01

    Objective To understand the clinical characteristics of adverse drug reactions ( ADR ) to offer reference for clinical rational drug use in future. Methods The clinical data of 1260 inpatients in the internal medicine department of our hospital from March. 2012 to May. 2013 were collected, in which 726 cases aged more than 49 years were selected as the research subjects. The general informa-tion, disease course, length of hospital stay, liver or renal function, ADR history, clinical manifestations, etc. were statistically ana-lyzed. Results There were 138 cases of ADR with the ADR occurrence rate of 19. 01% and the case-times rate of 21. 90%; the mild and moderate ADR was predominant, which accounted for 80. 43%. ADR occurred in 10 categories of drugs, which were mainly antimicrobial agents, accounted for 30. 19%, followed by the circulatory system drugs, accounted for 19. 50%, digestive system drugs was the third, accounted for 11. 32% ; the intravenous drip or intravenous injection were the main administration mode causing ADR ( 69. 18% );skin, digestive and nervous systems were the main ADR involving parts;91. 30% of cases were cured after actively symp-tomatic treatment. The single factor chi-square analysis found that females, the patients aged over 60 years old, with abnormal liver or renal function, past history of ADR, and the diseases more than 3 kinds were more likely to happen ADR, there were statistically signif-icant differences ( P< 0. 05 or P< 0. 01 ) . Conclusion The middle aged and elderly people have the higher occurrence rate of ADR. Recognizing the patients with susceptibility to ADR on admission and by combining the clinical characteristics of ADR can increase the rate of rational drug use, thus reduce the occurrence rate of ADR.%目的:了解中老年人发生药品不良反应(ADR)的临床特点,为临床合理用药提供借鉴。方法收集2012年3月至2013年5月期间医院内科病房1260例患者

  13. Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension

    Directory of Open Access Journals (Sweden)

    Inoue K

    2012-01-01

    Full Text Available Kenji Inoue1, Minako Shiokawa1, Michitaka Sugahara1, Risako Higa1, Masato Wakakura1, Goji Tomita21Inouye Eye Hospital, Tokyo, Japan; 2Second Department of Ophthalmology, Toho University School of Medicine, Tokyo, JapanPurpose: To prospectively investigate adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. We also examined patient attitudes to adverse reactions via a questionnaire.Methods: Fifty-two Japanese patients with glaucoma or ocular hypertension were enrolled. Iridial, eyelid, and eyelash photographs were taken before and at 6 months after bimatoprost treatment. Increase in eyelid pigmentation, iridial pigmentation, eyelash growth and bristle, and vellus hair of the lid was assessed from the photographs. Questionnaires completed by patients provided insight into their subjective judgment of adverse reactions.Results: Increase in eyelash bristle (53.8%, iris pigmentation (50.0%, eyelash growth (46.2%, vellus hair of the lid (40.4%, and eyelid pigmentation (7.7% was evident after bimatoprost treatment. The objective and subjective assessments were in agreement in terms of increase in eyelash bristle, eyelash growth, and increase in vellus hair of the lid.Conclusion: Most patients were conscious of these adverse reactions. Before administering bimatoprost, sufficient explanation of potential adverse reactions should be provided; after initiating treatment, careful observation is required.Keywords: bimatoprost, adverse reaction, eyelid pigmentation, changes in eyelashes, iris pigmentation 

  14. 40例盐酸氨溴索注射剂致严重不良反应/事件分析%Analysis of 40 Cases of Adverse Drug Reactions/Event Induced by Ambroxol Hydrochloride Injection

    Institute of Scientific and Technical Information of China (English)

    黄元; 李泮海; 田月洁

    2013-01-01

    目的 探讨盐酸氨溴索注射剂致严重不良反应/事件(ADR/ADE)的一般规律、特点及影响因素,为临床用药提供参考.方法 对我中心2011年收集到的40例由盐酸氨溴索注射剂引起的严重不良反应/事件报告进行统计、分析.结果 患者集中分布在14岁以下和45岁以上,二者合计95%;严重不良反应表现主要为急性过敏样反应的症状;在30min内发生ADR的占总例数的92.5%.结论 盐酸氨溴索注射剂致严重不良反应的发生与多种因素有关,对其引起的急性过敏样反应应高度重视,用药过程中必须严密监测.%Objective To probe into the status.characterstics and influencing factors of ADR/ADE cases induced by Ambroxol Hydrochloride injection. Methods We analyzed 40 ADR/ADE cases induced by ambroxol hydrochloride injection which were collected by Shandong ADR monitoring network from Jan. to Dec. of 2011. Results 95% of the patients were under 14 or more than 45 years old. The symptoms of serious ADR were mainly anaphylactoid reactions. 92.5% of ADR/ADE appeared within 30 min. Conclusion Serious ADR/ADE can be caused by a variety of factors. High attention should be paid to acute anaphylactoid reactions. Ambroxol hydrochloride injection should be used with more caution and exact monitoring.

  15. ADVERSE REACTIONS TO VACCINES AND WAYS OF ITS PREVENTION

    Directory of Open Access Journals (Sweden)

    Yelyseyeva I. V

    2011-04-01

    Full Text Available The overview concerns allergic reaction on vaccines and possible ways of increasing safety of immunization on basis of use of local specific immunotherapies (SIT experience, particularly the sublingual route. The use of chemically altered allergens, allergoids; alternative routes of administration, particularly the sublingual route; use of novel adjuvants, such as CpG oligonucleotides and mycobacterial vaccines; other approaches, such as allergenic peptides, relevant T-cell epitope peptide immunotherapy; DNA vaccination, recombinant and engineered allergens, chimeric molecules and combined therapy are all approaches that have yielded positive results to increase safety of SIT and improve its efficacy.

  16. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country

    Directory of Open Access Journals (Sweden)

    Sadia Sultan

    2016-03-01

    Full Text Available Objectives: Fragmented blood transfusion services along with an unmotivated blood donation culture often leads to blood shortage. Donor retention is crucial to meet the increasing blood demand, and adverse donor reactions have a negative impact on donor return. The aim of this study was to estimate adverse donor reactions and identify any demographic association.   Methods: We conducted a prospective study between January 2011 and December 2013. A total of 41,759 healthy donors were enrolled. Professionally trained donor attendants drew blood and all donors were observed during and following donation for possible adverse events for 20 minutes. Blood donors were asked to report if they suffered from any delayed adverse consequences.   Results: Out of 41,759 blood donors, 537 (1.3% experienced adverse reactions. The incidence was one in every 78 donations. The mean age of donors who experienced adverse events was 26.0±6.8 years, and all were male. Out of 537 donors, 429 (80% developed vasovagal reaction (VVR, 133 (25% had nausea, 63 (12% fainted, 35 (6% developed hyperventilation, 9 (2% had delayed syncope, and 9 (2% developed hematoma. Arterial prick, nerve injury, cardiac arrest, and seizures were not observed. Donors aged less than < 30 years and weighing < 70 kg were significantly associated with VVR, hyperventilation, and nausea (p < 0.005. Undergraduates and Urdu speaking donors also had a significant association with fainting and nausea, respectively (p < 0.05.   Conclusion: The prevalence of adverse events was low at our tertiary center. A VVR was the predominant adverse reaction and was associated with age and weight. Our study highlights the importance of these parameters in the donation process. A well-trained and experienced phlebotomist and pre-evaluation counseling of blood donors could further minimize the adverse reactions.

  17. Hospitalizations Due to Adverse Drug Events in the Elderly—A Retrospective Register Study

    Science.gov (United States)

    Laatikainen, Outi; Sneck, Sami; Bloigu, Risto; Lahtinen, Minna; Lauri, Timo; Turpeinen, Miia

    2016-01-01

    Adverse drug events (ADEs) are more likely to affect geriatric patients due to physiological changes occurring with aging. Even though this is an internationally recognized problem, similar research data in Finland is still lacking. The aim of this study was to determine the number of geriatric medication-related hospitalizations in the Finnish patient population and to discover the potential means of recognizing patients particularly at risk of ADEs. The study was conducted retrospectively from the 2014 emergency department patient records in Oulu University Hospital. A total number of 290 admissions were screened for ADEs, adverse drug reactions (ADRs) and drug-drug interactions (DDIs) by a multi-disciplinary research team. Customized Naranjo scale was used as a control method. All admissions were categorized into “probable,” “possible,” or “doubtful” by both assessment methods. In total, 23.1% of admissions were categorized as “probably” or “possibly” medication-related. Vertigo, falling, and fractures formed the largest group of ADEs. The most common ADEs were related to medicines from N class of the ATC-code system. Age, sex, residence, or specialty did not increase the risk for medication-related admission significantly (min p = 0.077). Polypharmacy was, however, found to increase the risk (OR 3.3; 95% CI, 1.5–6.9; p = 0.01). In conclusion, screening patients for specific demographics or symptoms would not significantly improve the recognition of ADEs. In addition, as ADE detection today is largely based on voluntary reporting systems and retrospective manual tracking of errors, it is evident that more effective methods for ADE detection are needed in the future. PMID:27761112

  18. Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database

    OpenAIRE

    Abe, Junko; Umetsu, Ryogo; Mataki, Kanako; Kato, Yamato; Ueda, Natsumi; NAKAYAMA, Yoko; Hane, Yuuki; Matsui, Toshinobu; Hatahira, Haruna; Sasaoka, Sayaka; Motooka, Yumi; Hara, Hideaki; Kato, Zenichiro; Kinosada, Yasutomi; Inagaki, Naoki

    2016-01-01

    Background Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions associated with fatal disorders. Although many causes of SJS/TEN have been proposed, the time-to-onset for SJS/TEN and the relationship between aging and SJS/TEN are still not clear. Therefore, the aim of this study was to determine the relationship between aging and SJS/TEN using the Japanese Adverse Drug Event Report (JADER) database and analyze the time-to-onset profile of ...

  19. Is it Safe? Adverse drug effects and cardiac arrhythmias

    OpenAIRE

    Varkevisser, R.

    2014-01-01

    The potentially life-threatening polymorphic ventricular arrhythmia Torsade de Pointes (TdP) generally occurs in the setting of delayed ventricular repolarization, as reflected on the ECG by a prolonged QT interval. A growing number of drugs are associated with QT prolongation and/or TdP, as a result, development of promising new drugs has been aborted, and already marketed drugs have received severe restrictions or have been withdrawn. To address this cardiac safety issue, international guid...

  20. 基于 HIS 的药品不良反应快速上报与智能搜索系统研究与应用%Research and Application of Adverse Drug Reaction Rapid Reporting and Intelligent Searching System Based on HIS

    Institute of Scientific and Technical Information of China (English)

    邓剑雄; 王玲; 陈文戈; 舒婷; 张业象

    2015-01-01

    solved under reporting, misinformation, delay reporting and other issues of adverse drug reactions, achieved rapid reporting and intelligent searching functions, improved the hospital's ADR reporting rate and the reporter's initiative, and let the adverse drug reaction monitoring mode turn from the traditional"passive" to the "active". Conclusion The ADR rapid reporting and intelligent searching system effectively enhances the capacity of drug post-marketing surveillance, and greatly improves the rational drug use in medical institutions, and it is of significant importance to strengthen drug safety monitoring and evaluation in our country.

  1. Prevalência de admissão hospitalar por reação adversa a medicamentos em Salvador, BA Prevalence of hospital admission due to adverse drug reaction in Salvador, Bahia

    Directory of Open Access Journals (Sweden)

    Antonio Carlos Beisl Noblat

    2011-02-01

    Full Text Available OBJETIVO: Determinar a prevalência de admissão por RAM em hospitais de Salvador-BA e seus desfechos. MÉTODOS: Todos os pacientes admitidos nos quatro hospitais sentinela da Anvisa em Salvador-BA foram avaliados e seguidos para determinar a prevalência de admissão por RAM e seus desfechos de abril a dezembro de 2007. Os casos foram validados por três algorítmos. Os medicamentos foram classificados pelo Anatomical-Therapeutic-Chemical Classification, órgãos e sistemas afetados pelos critérios da OMS e a gravidade segundo Pearson et al. O tipo seguiu critérios de Rawlins e Thompson. RESULTADOS: A prevalência de admissão por RAM foi 0,56% e corrigida (expostos de 2,1%, com 316 casos. Tempo médio de hospitalização por RAM foi de 12,3 dias. Jovens e idosos representaram 28,8% e 31,1% dos pacientes. Gênero feminino e raça negra corresponderam a 60% dos casos. Os principais grupos farmacológicos envolvidos foram antineoplásicos, antibióticos e diuréticos, afetando pele, sistema gastrointestinal e hematológico. Reações certas ou provadas corresponderam 70%, 80% dos casos foram do tipo A, com 90% recuperáveis e um óbito. CONCLUSÃO: A prevalência de admissão por RAM foi semelhante às descritas na literatura e somente um paciente foi a óbito. Por tratar-se do primeiro estudo nacional, servirá de base para futuras investigações.OBJECTIVE: To determine the prevalence of hospital admissions due to ADR in Salvador, Bahia and their outcomes. METHODS: All patients admitted in four Sentinel Hospital (ANVISA in Salvador-Ba were evaluated and followed to determine the prevalence of admissions due to ADR and their outcomes from April to December 2007. Cases were validated by 03 algorithms. The drugs were classified by Anatomical-Therapeutic-Chemical Classification, organs and systems affected by the WHO criteria and severity seconds Pearson et al. Type of ADR was analyzed by Rawlins and Thompson. RESULTS: The prevalence of ADR

  2. The mechanisms of delayed onset type adverse reactions to oseltamivir.

    Science.gov (United States)

    Hama, Rokuro

    2016-09-01

    Oseltamivir is recommended for the treatment and prophylaxis of influenza in persons at higher risk for influenza complications such as individuals with diabetes, neuropsychiatric illnesses, and respiratory, cardiac, renal, hepatic or haematological diseases. However, a recent Cochrane review reported that reduction of antibody production, renal disorders, hyperglycaemia, psychiatric disorders, and QT prolongation may be related to oseltamivir use. The underlying mechanisms are reviewed. There is decisive evidence that administration of a clinically compatible dose of oseltamivir in mice challenged by a respiratory syncytial virus (RSV) that lacks a neuraminidase gene showed symptom-relieving effects and inhibition of viral clearance. These effects were accompanied by decreased level of T cell surface sialoglycosphingolipid (ganglioside) GM1 that is regulated by the endogenous neuraminidase in response to viral challenge. Clinical and non-clinical evidence supports the view that the usual dose of oseltamivir suppresses pro-inflammatory cytokines such as interferon-gamma, interleukin-6, and tumour necrosis factor-alpha almost completely with partial suppression of viral shedding in human influenza virus infection experiment. Animal toxicity tests support the clinical evidence with regard to renal and cardiac disorders (bradycardia and QT prolongation) and do not disprove the metabolic effect. Reduction of antibody production and cytokine induction and renal, metabolic, cardiac, and prolonged psychiatric disorders after oseltamivir use may be related to inhibition of the host's endogenous neuraminidase. While the usual clinical dose of zanamivir may not have this effect, a higher dose or prolonged administration of zanamivir and other neuraminidase inhibitors may induce similar delayed reactions, including reduction of the antibody and/or cytokine production. PMID:27251370

  3. Optimising the retrieval of information on adverse drug effects.

    Science.gov (United States)

    Golder, Su

    2013-12-01

    Pharmaceutical interventions have brought about many benefits to health, improving the population's well-being and life expectancy. However, these interventions are not without potential harmful side-effects and yet searching for the evidence on adverse effects is challenging. This article summarises a PhD whose main aim was to develop a better understanding of the implications of using different sources and approaches to identifying relevant data on adverse effects. The author is Su Golder, who has recently completed her PhD at the University of York and who has already published several articles on specific aspects of her research, including this journal. This article is the first in the Dissertations into Practice series to report on a PhD study, and it summarises her research in a way which emphasises the implications for practice.

  4. Nonsteroidal Anti-Inflammatory Drugs: Adverse Effects and Their Prevention

    NARCIS (Netherlands)

    Vonkeman, Harald E.; Laar, van de Mart A.F.J.

    2010-01-01

    Objectives: To discuss nonsteroidal anti-inflammatory drugs (NSAIDs), their history, development, mode of action, toxicities, strategies for the prevention of toxicity, and future developments. - Methods: Medline search for articles published up to 2007, using the keywords acetylsalicylic acid, asp

  5. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    OpenAIRE

    Brown, S.L.; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to ...

  6. Safety profile and protocol prevention of adverse reactions to uroangiographic contrast media in diagnostic imaging.

    Science.gov (United States)

    Rossi, C; Reginelli, A; D'Amora, M; Di Grezia, G; Mandato, Y; D'Andrea, A; Brunese, L; Grassi, R; Rotondi, A

    2014-01-01

    The purpose of the study is to examine the incidence of adverse reactions caused by non-ionic contrast media in selected patients after desensitization treatment and to evaluate the safety profile of organ iodine contrast media (i.c.m.) in a multistep prevention protocol. In a population of 2000 patients that had received a CT scan, 100 patients with moderate/high risk for adverse reactions against iodinated contrast agents followed a premedication protocol and all adverse reactions are reported and classified as mild, moderate or severe. 1.7 percent of the pre-treated patients reported a mild, immediate type reaction to iodine contrast; of these five patients with allergy 0.71 percent had received iomeprol, 0.35 percent received ioversol and 0.71 percent received iopromide. The incidence of adverse reactions was reported to be higher (4 out of 5 patients) among those that referred a history of hypersensitivity against iodinated i.c.m. Although intravenous contrast materials have greatly improved, especially in terms of their safety profile, they should not be administered if there isn't a clear or justified indication. In conclusion, even if we know that the majority of these reactions are idiosyncratic and unpredictable we propose, with the aim of improving our knowledge on this subject, a multicenter study, based on skin allergy tests (prick test, patch test, intradermal reaction) in selected patients that have had previous experiences of hypersensitivity against parenteral organ iodine contrast media. PMID:24750802

  7. Adverse reactions to iodinated contrast media administered at the time of endoscopic retrograde cholangiopancreatography (ERCP).

    Science.gov (United States)

    Pan, Jen-Jung; Draganov, Peter V

    2009-03-01

    Adverse reactions after intravascular administration of iodine contrast media are common and prophylactic regiments consisting of the use of steroids and low osmolality contrast media are highly effective in significantly decreasing the adverse reactions rate. The same type of contrast media are also used for opacification of the biliary tree and the pancreatic duct at the time of endoscopic retrograde cholangiopancreatography (ERCP). Systemic absorption of contrast media after ERCP routinely occurs. Although the adverse reaction rate appears to be very low the exact incidence remains unknown due to the retrospective nature of all reports. Despite the lack of formal recommendations, numerous prophylactic regiments are routinely used prior to ERCP in patients with history of prior reaction to intravascular contrast media. Moreover, the use of prophylaxis has even expanded to patients with no prior reaction to intravascular contrast media who are somehow perceived to be at increase risk (e.g. shellfish allergy). Recently, the first large scale prospective study reported exceedingly low incidence of adverse reaction to high oslmolality iodine-containing contrast media administered at the time of ERCP done without prophylactic premedication even in patients considered to be at the highest risk (prior severe reaction to intravascular contrast media administration). These data suggest that the use of prophylactic regiments prior to ERCP appears to be unnecessary. PMID:19275689

  8. Adverse Selection and the Challenges to Stand-Alone Prescription Drug Insurance

    OpenAIRE

    Mark V. Pauly; Yuhui Zeng

    2003-01-01

    This paper investigates a possible predictor of adverse selection problems in unsubsidized stand-alone' prescription drug insurance: the persistence of an individual's high spending over multiple years. Using MEDSTAT claims data and data from the Medicare Survey of Current Beneficiaries, we find that persistence is much higher for outpatient drug expenses than for other categories of medical expenses. We then use these estimates to develop a simple and intuitive model of adverse selection in ...

  9. The Effects of Pharmaceutical Marketing and Promotion on Adverse Drug Events and Regulation

    OpenAIRE

    Guy David; Sara Markowitz; Seth Richards

    2009-01-01

    This paper analyzes the relationship between postmarketing promotional activity and reporting of adverse drug events by modeling the interaction between a welfare maximizing regulator (the FDA) and a profit maximizing firm. In our analysis demand is sensitive to both promotion and regulatory interventions. Promotion-driven market expansions enhance profitability yet may involve the risk that the drug would be prescribed inappropriately, leading to adverse regulatory actions against the firm. ...

  10. Analysis of 1416 Cases of Moxifloxacin-inducing Adverse Drug Reaction/event in Beijing Area from 2007 to 2011%北京地区2007~2011年1416例莫西沙星不良反应/事件分析

    Institute of Scientific and Technical Information of China (English)

    曾艳; 闫素英

    2013-01-01

    Objective:To analyze the reports of moxifloxacin-inducing adverse drug reaction/event(ADR/ADE)in Beijing area to provide reference for rational use of moxifloxacin.Methods:Collect reports of ADR/ADE induced by moxifloxacin received by the national drug adverse reaction monitoring center from January 1 th in 2007 to December 31 th in 2011,classify the adverse reactions according to MedDRA and make analysis of the patients'clinical characteristics and type and outcome of the ADR/ADE.Results:Off-label use of moxifloxacin was prominent.The clinical manifestations of ADR/ ADE were mostly skin and subcutaneous tissue damages,nervous system disorders and gastrointestinal disorders.And the serious ADR/ADE were mostly immune system disorders,nervous system disorders and hepatobiliary disorders.Conclusion:Safe to use with moxifloxacin is worth paying attention by clinicians,who should detect and deal with ADR/ADE of moxifloxacin in time on baisis of rational use.%目的:统计分析北京地区近5年来莫西沙星不良反应/事件报告,为莫西沙星的安全合理应用提供依据.方法:收集整理2007年1月1日~2011年12月3日全国药品不良反应监测网络接收到的北京地区怀疑药品为莫西沙星的不良反应/事件报告,提取患者一般情况、用药情况、不良反应/事件发生情况及转归等信息,按照MedDRA系统将不良反应或不良事件进行系统分类,进行统计分析.结果:莫西沙星的不良反应/事件报告中,患者超说明书用药、超适应证用药较为突出,不良反应主要表现在皮下及皮下组织症状、神经系统症状、胃肠系统症状等.而严重不良反应以免疫系统症状、神经系统症状、肝胆系统症状为主.结论:莫西沙星的安全性是临床应关注的问题,应该在合理使用的基础上,监测并及时处理其不良反应/事件.

  11. Adverse drug reaction suggests by a clinical vignette

    Directory of Open Access Journals (Sweden)

    Finestone AJ

    2011-07-01

    Full Text Available Albert J FinestoneTemple University School of Medicine, Philadelphia, PA, USAI had a three-lobe pneumonia and toxic encephalopathy in 2004. A lumbar puncture did not show meningitis. Magnetic resonance imaging showed a macroadenoma of the pituitary gland. Prolactin level was significantly elevated, making the diagnosis a functioning prolactinoma requiring treatment. Initially, I was treated with the dopamineagonist cabergoline, which is also used in much larger doses to treat Parkinsonism. Recent reports have indicated heart valve damage in Parkinsonism patients treated with ergot-derived dopamine-receptor agonists.

  12. Global patterns of adverse drug reactions over a decade

    DEFF Research Database (Denmark)

    Aagaard, Lise; Strandell, Johanna; Melskens, Lars;

    2012-01-01

    , classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high. Results: We analysed 1¿359¿067 ADR reports including 3¿013¿074 ADRs. Overall, 16% of reports were serious and 60% were reported for females. High-income countries had the highest ADR reporting rates (range 3...

  13. Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba Holme

    2013-01-01

    of atomoxetine, methylphenidate and modafinil marketed by the same pharmaceutical companies in Australia, Denmark and the United States. Discrepancies in listed ADRs were defined as types of ADRs (system organ class) not listed in all countries. For ADRs where discrepancies were detected, we extracted...... not mentioned in PIs issued in the United States. In conclusion, information about possible ADRs associated with the use of a specific product should be made available worldwide, as the prescriber information about medicines' safety profile should not depend on the country in which the medication is licensed....... categories and for modafinil 115 ADR categories were listed. For both substances approximately 60% of listed ADRs were found in all three countries. Discrepancies were primarily detected for ADRs information based on clinical trials. For methylphenidate, many ADRs labelled in Australia and Denmark were...

  14. Adverse drug reactions from psychotropic medicines in the paediatric population

    DEFF Research Database (Denmark)

    Aagaard, Lise; Hansen, Ebba H

    2010-01-01

    ADRs reported for psychotropic medicines in the Danish paediatric population over a decade. FINDINGS: All spontaneous ADR reports from 1998 to 2007 for children from birth to 17 years of age were included. The unit of analysis was one ADR. We analysed the distribution of ADRs per year, seriousness, age...

  15. Is it Safe? Adverse drug effects and cardiac arrhythmias

    NARCIS (Netherlands)

    Varkevisser, R.

    2014-01-01

    The potentially life-threatening polymorphic ventricular arrhythmia Torsade de Pointes (TdP) generally occurs in the setting of delayed ventricular repolarization, as reflected on the ECG by a prolonged QT interval. A growing number of drugs are associated with QT prolongation and/or TdP, as a resul

  16. Double-blind evaluation of two commercial hypoallergenic diets in cats with adverse food reactions.

    Science.gov (United States)

    Leistra, M; Willemse, T

    2002-12-01

    The aim of this study was to evaluate two commercially available selected-protein-source diets as maintenance diets in cats with dermatological manifestations of adverse food reactions. Twenty cats with a confirmed adverse food reaction were tested in a double-blind manner. An adverse food reaction was diagnosed when, after recovery with a home-cooked elimination diet, the signs relapsed after a challenge with their previous dietary components, and re-disappeared on a second elimination diet period. Hereafter the cats were blind and randomly challenged with two commercial hypoallergenic diets. Relapse of the clinical signs was seen in eight cats (40%) on a lamb and rice diet and in 13 cats (65%) on a chicken and rice diet (P>0.05). Neither one of the commercial diets was as effective in controlling the skin problems as the home-cooked elimination diet. The study confirms that commercial hypoallergenic diets are adequate for maintenance.

  17. Data mining in pharmacovigilance – to reduce Adverse Drug Effects(ADRs

    Directory of Open Access Journals (Sweden)

    Miral Kothari

    2013-01-01

    Full Text Available Pharmaceutical industry provides the medicines in different formats. It can be tablets, capsules, liquid or injectables. Every drug in any form may cause adverse effect varies from person to person. Before putting any drug in the market, the drugs are being tested for adverse effects on large scale. Pharacovigilance is a science which is purely related with discovery, understanding and anticipation of the Adverse Drug Effect (ADEs. Pharmaceutical experts and industries much rely on data mining algorithms or techniques to understand the huge data collected from healthcare professionals and patients and make the use of that data for further research and development of new drug. In this paper, author has tried to implement Bayesian Classification method of data mining to assist the research person in decision making

  18. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    Science.gov (United States)

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  19. Adverse reaction to metal debris in a painful hemiarthroplasty of the hip

    Science.gov (United States)

    Palmer, Jonathan Simon; Dean, Michael William; Briant-Evans, Toby; Stranks, Geoff

    2016-01-01

    Adverse reaction to metal debris (ARMD) in total hip arthroplasty surgery is a well-known problem. We present the case of a unipolar hemiarthroplasty requiring revision within 18 months of insertion secondary to an adverse reaction to metal debris. This case demonstrates a rare cause for failure of a hemiarthroplasty following a fragility fracture. We feel that ARMD should be considered in all cases where pain and dysfunction in the presence of any hip prosthesis cannot be explained by routine investigations. PMID:27656196

  20. Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) in an Adolescent Treated With Lamotrigine

    OpenAIRE

    Ginory, Almari; Chaney-Catchpole, Michelle; Demetree, Julie M.; Mayol Sabatier, Laura M.; Nguyen, Mathew

    2013-01-01

    Drug reaction with eosinophilia and systemic symptoms (DRESS) is a hypersensitivity syndrome most commonly associated with antiepileptic agents, allopurinol, and sulfonamides. It is a severe adverse reaction associated with fever, rash, eosinophilia, lymphadenopathy, and internal organ involvement. We present the case of a 17-year-old Caucasian female with bipolar disorder type II and posttraumatic stress disorder treated with lamotrigine for a non-Food and Drug Administration-approved indica...

  1. Adverse Food Reaction and Functional Gastrointestinal Disorders: Role of the Dietetic Approach.

    Science.gov (United States)

    Pasqui, Francesca; Poli, Carolina; Colecchia, Antonio; Marasco, Giovanni; Festi, Davide

    2015-09-01

    Bloating, abdominal discomfort or pain, disturbed bowel habits are very common symptoms, frequently reported by the patients soon after food ingestion. These symptoms may occur in different clinical conditions, such as functional bowel disorders, food adverse reactions, gluten-related syndromes, which frequently are interrelated. Consequently, in clinical practice, it is necessary to perform a correct diagnosis in order to identify, for the single patient, the most appropriate therapeutic strategy, which may include not only specific drugs, but also, and mainly, life style changes (healthy nutritional behavior and constant physical activity). The aim of this review is to provide to the general physician, according to the available evidence, the most appropriate diagnostic work-ups for recognizing the different clinical scenarios (i.e. food allergy and intolerance, functional bowel diseases, gluten-related syndromes), to identify their clinical interrelationships and to suggest the most appropriate management. In fact, as far as food intolerances are concerned, it is well known that the number of patients who believe that their symptoms are related to food intolerance is increasing and consequently they restrict their diet, possibly causing nutritional deficiencies. Furthermore, there is an increasing use of unconventional diagnostic tests for food intolerance which lack accurate scientific evidence; the application of their results may induce misdiagnosis and unhealthy therapeutic choices. Consequently the recognition of food intolerance has to be performed on the basis of reliable tests within an agreed diagnostic workup.

  2. Reaction between drug substances and pharmaceutical excipients

    DEFF Research Database (Denmark)

    Larsen, Jesper; Cornett, Claus; Jaroszewski, Jerzy Witold;

    2009-01-01

    The reactivity of citric acid towards drug substances in the solid state was examined using the beta-blocker carvedilol as a model compound. The reaction mixtures were analysed by LC-MS, the reaction products were isolated by preparative HPLC, and the structures were elucidated by microprobe NMR...... spectroscopy. Heating a mixture of solid carvedilol and solid citric acid monohydrate for 96h at 50 degrees C resulted in the formation of about 3% of a symmetrical ester as well as of a number of other reaction products in smaller amounts. Formation of the symmetrical ester was also observed at room...... temperature. At 70 degrees C, the amounts of three isomeric esters formed reached 6-8%. The minor reaction products were citric acid amides, O-acetylcarvedilol, and esters of itaconic acid....

  3. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011

    Directory of Open Access Journals (Sweden)

    Dag Ø. Nordanger

    2014-05-01

    Full Text Available Background: Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. Objective: To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. Method: We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. Results: All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents’ proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Conclusions: Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care.

  4. Adverse reactions and tolerability of high-dose sublingual allergen immunotherapy

    Science.gov (United States)

    Moral, Angel; Moreno, Victoria; Girón, Francisco; El-Qutob, David; Moure, José D; Alcántara, Manuel; Padial, Antonia; Oehling, Alberto G; Millán, Carmen; de la Torre, Fernando

    2016-01-01

    Background Sublingual allergen immunotherapy is an effective treatment against allergic respiratory disease. Many studies have shown the safety of this type of therapy, although the factors that might affect the tolerability of high-dose sublingual immunotherapy have not been well established. The aim of this study was to determine the factors that affect the tolerability of sublingual allergen immunotherapy. Patients and methods A total of 183 subjects aged ≥5 years, diagnosed with allergic rhinitis with/without mild to moderate asthma due to sensitization to grass, olive pollen, or mites, were included in this open, retrospective, multicentric, noninterventional study. Sublingual immunotherapy was administered for at least 3 months. Results The most frequent adverse reaction was oral pruritus (13.7% of the patients). Most of the reactions were local (84.7%) and immediate (93.5%) and occurred during the initiation phase (60.6%). All reactions were mild to moderate in severity. No serious adverse reactions were registered. When comparing factors with potential influence on the occurrence of adverse reactions, the results between the groups of subjects with and without adverse reactions showed no statistically significant differences in sex (P=0.6417), age (P=0.1801), years since the disease was first diagnosed (P=0.3800), treatment composition (P=0.6946), polysensitization (P=0.1730), or clinical diagnosis (P=0.3354). However, it was found that treatment duration had a statistically significant influence (3 months, >3 months: P=0.0442) and the presence of asthma was close to statistical significance (P=0.0847). Conclusion In our study, treatment duration is significantly associated with the occurrence of adverse reactions after the administration of high doses of sublingual allergen immunotherapy. PMID:27418842

  5. [Analysis on the common causes for traditional Chinese medicinal injection induced adverse reactions and the preventive countermeasures].

    Science.gov (United States)

    Wu, Guo-lin; Zhang, Li; Yu, Guo-you

    2008-12-01

    As a new dosage form, TCM injection is commonly used in clinical practice. But the increasing events of adverse drug reactions (ADRs) could even seriously endanger patients' lives. The causes of TCM injection inducing ADRs might be the unstable quality of preparation; the irrational clinical use and operation; the sensitive physique of patient and the change of patients' primary illness, etc. For preventing the occurrence of ADRs, based on guaranteeing the stable quality of product, putting stress on accurate usages and normalized operations in clinical practice, enhancing the monitor on ADRs and the precautionary awareness in medical units are very important. PMID:19317176

  6. Association between HLA alleles and lamotrigine-induced cutaneous adverse drug reactions in the Uyghur population with epilepsy of Xinjiang region%HLA 基因与新疆维吾尔族癫痫患者中拉莫三嗪所致药疹的关联性

    Institute of Scientific and Technical Information of China (English)

    高阳; 于爱平; 蒋玉凤; 于鲁海; 赵宗峰; 张艳君

    2016-01-01

    Objective To investigate the relationship between HLA -A*3001 , HLA-A*3101 , HLA-B*1502 , HLA-B*38 , HLA-B*5801 alleles and lamotrigine -induced cutaneous adverse drug reactions in Xinjiang Uyghur epilepsy patients.Methods HLA-A*3001, HLA-A*3101, HLA-B*1502, HLA-B*38, HLA-B*5801 alleles genoty-ping was performed by a polymerase chain reaction -sequence specific primers ( PCR -SSP ) method in 28 subjects who had lamotrigine .10 Uyghur subjects had lamotrigine -induced maculopapular exanthema ( MPE) , 18 lamotrigine tolerant controls ) , and 30 healthy individuals , and the correlation between HLA genes and LTG -MPE was analyzed.Results There seemed to be no statistical differences in the positive frequency of subjects with the HLA -A*3001, HLA -A*3101, HLA-B*1502, HLA -B*38, HLA -B*5801 alleles between the LTG-MPE group and LTG-tolerant group, and normal group (P>0.05). Conclusion There seems to be no significant correlation between HLA -A*3001, HLA-A*3101, HLA-B*1502, HLA-B*38, HLA-B*5801 alleles and lamotrigine induced cutaneous adverse drug reactions .%目的:探讨HLA-A倡3001,HLA-A倡3101,HLA-B倡1502,HLA-B倡38,HLA-B倡5801等位基因与新疆地区维吾尔族癫痫患者中拉莫三嗪( LTG)诱发的药疹的相关性。方法用序列特异性引物-聚合酶链式反应技术对新疆地区28例服用拉莫三嗪的维吾尔族癫痫患者[其中10例出现斑丘疹( LTG-MPE组),18例未出现皮肤不良反应( LTG-tolerant组)],以及30例维吾尔族健康受试者(对照组)进行HLA-A倡3001, HLA-A倡3101, HLA-B倡1502,HLA-B倡38,HLA-B倡5801等位基因的检测。分析HLA基因与拉莫三嗪所致皮肤不良反应的相关性。结果 HLA-B倡1502,HLA-B倡38,HLA-B倡5801,HLA-A倡3001,HLA-A倡3101的等位基因阳性率在3组间比较差异无统计学意义(P>0.05)。结论拉莫三嗪诱发的药疹与HLA-A倡3001,HLA-A倡3101,HLA-B倡1502

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    UNLABELLED: At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a "harmoni......UNLABELLED: At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a...... "harmonised terminology" according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective...... Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey. The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database. THREE QUESTIONNAIRES WERE GENERATED: i) the Doctor Questionnaire, ii) the...

  8. Transfusion-related adverse reactions: From institutional hemovigilance effort to National Hemovigilance program

    Directory of Open Access Journals (Sweden)

    Rahul Vasudev

    2016-01-01

    Full Text Available Aims: In this study we have evaluated the various adverse reactions related to transfusion occurring in our institution as a pilot institutional effort toward a hemovigilance program. This study will also help in understanding the problems faced by blood banks/Transfusion Medicine departments in implementing an effective hemovigilance program. Materials and Methods: All the adverse reactions related to transfusion of whole blood and its components in various clinical specialties were studied for a period of 1 year. Any transfusion-related adverse event was worked up in accordance with guidelines laid down by the Directorate General of Health Services (DGHS and departmental standard operating procedures. Results: During the study period from November 1, 2011 to October 31, 2012, 45812 components were issued [30939 WB/PRBC; 12704 fresh frozen plasma (FFP; 2169 platelets]. Risk estimation per 1000 units of red cells (WB/PRBC transfused was estimated to be: 0.8 for febrile nonhemolytic transfusion reaction (FNHTR, 0.7 for allergic reaction, 0.19 for acute hemolytic transfusion reaction (AcHTR, 0.002 for anaphylactoid reactions, 0.1 for bacterial sepsis, and 0.06 for hypervolemia and hypocalcemia. 0.09 is the risk for delayed transfusion reaction and 0.03 is the risk for transfusion-related acute lung injury (TRALI. Risk estimate per 1,000 units of platelets transfused was estimated to be 1.38 for FNHTR, 1.18 for allergic reaction, and 1 in case of bacterial sepsis. Risk estimation per 1,000 units of FFP was estimated to be 0.15 for FNHTR and 0.2 for allergic reactions. Conclusions: Factors such as clerical checks at various levels, improvement in blood storage conditions outside blood banks, leukodepletion, better inventory management, careful donor screening, bedside monitoring of transfusion, and documentation of adverse events may decrease transfusion-related adverse events. Better coordination between transfusion specialists and various clinical

  9. 不同温度对比剂与 CT 血管造影不良反应间的关系研究%Study of the adverse drug reactions of iodinated contrast agent in different temperatures after CT angiography

    Institute of