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Spontaneous Reporting (spontaneous + reporting)
Selected AbstractsThe application of knowledge discovery in databases to post-marketing drug safety: example of the WHO databaseFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2008A. Bate Abstract After market launch, new information on adverse effects of medicinal products is almost exclusively first highlighted by spontaneous reporting. As data sets of spontaneous reports have become larger, and computational capability has increased, quantitative methods have been increasingly applied to such data sets. The screening of such data sets is an application of knowledge discovery in databases (KDD). Effective KDD is an iterative and interactive process made up of the following steps: developing an understanding of an application domain, creating a target data set, data cleaning and pre-processing, data reduction and projection, choosing the data mining task, choosing the data mining algorithm, data mining, interpretation of results and consolidating and using acquired knowledge. The process of KDD as it applies to the analysis of spontaneous reports can be exemplified by its routine use on the 3.5 million suspected adverse drug reaction (ADR) reports in the WHO ADR database. Examples of new adverse effects first highlighted by the KDD process on WHO data include topiramate glaucoma, infliximab vasculitis and the association of selective serotonin reuptake inhibitors (SSRIs) and neonatal convulsions. The KDD process has already improved our ability to highlight previously unsuspected ADRs for clinical review in spontaneous reporting, and we anticipate that such techniques will be increasingly used in the successful screening of other healthcare data sets such as patient records in the future. [source] Activation of Pain by SumatriptanHEADACHE, Issue 9 2003DTM&H, David M. Coulter MB Objective.,To demonstrate that sumatriptan may induce activation or aggravation of pain at sites of inflammation caused by trauma or disease. Methods.,Case reports from the national pharmacovigilance centers of 2 countries, The Netherlands and New Zealand, are presented. These reports come from programs that use 2 methodologies to monitor drugs for adverse reactions: spontaneous reporting and a prospective observational cohort study. The potential mechanisms for pain production by sumatriptan are discussed in detail. Results.,Thirteen case reports of activation of pain by sumatriptan following injury and 8 associated with inflammatory diseases are presented. Most patients had one or more positive rechallenges. This type of reaction occurred at a higher rate with the subcutaneous formulation than with the oral preparation. Pain mostly was severe but short-lasting; pain was prolonged in some patients with inflammatory disease. Conclusions.,A strong association has been demonstrated between the use of sumatriptan and the production of pain at sites of inflammation, and there is a plausible pharmacological mechanism for this reaction. Pain activation may be a class effect of the selective serotonergic agonists used in the treatment of migraine. [source] Mirtazapine naturalistic depression study (in Sweden),MINDS(S): clinical efficacy and safetyHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 3 2006Jan Wålinder Abstract Objective To study how implementation of a naturalistic trial design for mirtazapine treatment in major depressive disorder for six (up to 12) months could be used and evaluated by means of clinical efficacy and safety. Method An open-labelled, prospective, multicenter, non-comparative trial was conducted during a 2-year period in patients with major depression according to DSM-IV treated in psychiatric departments and primary care in Sweden. Minimal inclusion and exclusion criteria were used in order to diminish the potential patient selection bias. Maximum flexibility of the dosage of mirtazapine was allowed, and clinical assessments included MADRS, CGI, vital signs and spontaneous reporting of adverse events. Results 192 patients were found eligible and enrolled in the study. A significant improvement in depressive symptoms according to MADRS and CGI was observed including particularly marked sleep improvement early in the treatment. Slight increases in body weight and BMI were observed. The investigational drug was well tolerated overall. Conclusion The clinical efficacy and safety of mirtazapine found in this naturalistic setting is in line with previously reported data on mirtazapine in traditional controlled clinical trials. The results confirm that the naturalistic study design facilitated conduct of the trial. The authors suggest that this type of study design should also be applied to other antidepressant drugs that are frequently prescribed in the general population. Copyright © 2006 John Wiley & Sons, Ltd. [source] Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professionalJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2004Marķa T. Herdeiro BS Abstract Rationale, aims and objectives, The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out. Methods, The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization. Results and conclusions, The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors. [source] New guideline for tramadol usage following adverse drug reactions reported to the Iranian pharmacovigilance center,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007K. Gholami Pharm D Abstract Background Tramadol was introduced as injection and oral form to Iranian Pharmaceutical Market in 2002. Shortly after, the injection form of the drug was observed at the top of suspected drug list of Adverse Drug Reactions (ADRs) received monthly by Iranian Pharmacovigilance Center (IPC). Objectives To detect, assess and report total number of Tramadol-induced ADRs received by IPC. To assess the frequency of reported Tramadol-induced ADRs before and after interventions. To design a guideline for prevention of probable ADRs due to Tramadol injection. Methods A descriptive study was conducted on spontaneous reporting received by IPC from April 2002 to February 2005. All ADRs suspected to be induced by Tramadol registered in the database during mentioned period were analysed. To assess the effect of different interventions based on Spontaneous Reporting System, the trend of reporting frequency of Tramadol-induced ADRs was evaluated before and after interventions. Results There were 337 cases of Tramadol-induced ADRs describing 939 reactions, reported to IPC during the study period. Although causal relationship had not been established, three cases of deaths appeared among the reports. The severity of reactions led to implementation of limitations on injectable Tramadol distribution to community pharmacies and the restriction of its use to hospitals only. Since most adverse reactions were dose-dependent, the drug potency of injectable Tramadol available in the country changed from 100,mg to 50,mg. The assessment of ADR reports received by IPC showed that the frequency of adverse reactions registered in the centre was reduced considerably following these interventions. Conclusion Designing a detailed programme by Pharmacovigilance Centres and closely monitoring of newly marketed pharmaceutical products is highly recommended. Copyright © 2006 John Wiley & Sons, Ltd. [source] Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring ProgrammePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2001DTM&H, David M. Coulter MB Abstract Purpose The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. Methods The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. Results Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. Conclusion Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information. Copyright © 2001 John Wiley & Sons, Ltd. [source] | ||||||||||