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At least 19 recordsLinked to original sources
PubMed2005

Veterinary pharmacovigilance. Part 2. Veterinary pharmacovigilance in practice -- the operation of a spontaneous reporting scheme in a European Union country -- the UK, and schemes in other countries.

Veterinary pharmacovigilance, as it operates in the European Union (EU), covers a very broad remit, including adverse effects in treated animals, exposed humans and the environment, and in addition, it extends to cover the violation of maximum residue limits. The mainstay of veterinary pharmacovigilance is the spontaneous reporting scheme working along side other systems such as those reporting on residues surveillance. One of the most well established schemes in the EU is that operating in the UK and this paper examines the evolution of that scheme and some of its findings, data from other countries, and information available from the literature. It also tentatively examines the ways that pharmacovigilance can be used for regulatory purposes, and the contribution from pharmacoepidemiology.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Good practices of publication of clinical cases of pharmacovigilance: comments, Groupe de Travail sur les Bonnes Pratiques de Publication de Cliniques en Pharmacovigilance: commentary].

This paper introduces some comments on the complete text of Good Pharmacovigilance Publishing Practices, which forms appendix number 2 of the Good Pharmacovigilance Practices now published by the French Drug Agency, as was Good Clinical Practices. Each good practice is printed in italic and presented in a frame; the following comments are designed to facilitate its application. The technical terms that are used in this text are presented according to the glossary in Good Pharmacovigilance Practices.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Pharmacovigilance of antibiotics. Evaluation by the Midi-Pyrénées Pharmacovigilance Center between 1989 and 1992].

The present retrospective study investigates the antibiotic-induced side effects in a regional French Pharmacovigilance Center between 1989 and 1992. Five-hundred and seventy six side effects were reported, involving 611 drugs and accounting for 18% of the total activity of the pharmacovigilance center. Most of the side effects involved penicillins and systemic quinolones followed by sulfonamides, cephalosporines and glycopeptides. When expressed in number of adverse effects in Defined Daily Dose, the maximal frequency of side effects was observed with sulfonamides. In contrast, the frequency of penicillin-induced adverse events was low. The most frequently reported side effects were cutaneous and/or immunologic (54%) and digestive (24%) disturbances. Among serious side effects, 3 toxic epidermal necrolysis (2 with cotrimoxazole), 16 pseudomembranous colitis (11 with beta-lactam antibiotics, 4 with macrolides and lincomycines and 1 with vancomycin), 14 neuropsychiatric reactions (seizures, confusions and hallucinations with beta-lactam antibiotics and fluoroquinolones) were notified. Five antibiotic-induced side effects led to the death.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

[Adverse effects of Disulone; results of the France pharmacovigilance inquiry. Regional Centers of Pharmacovigilance].

Disulone (dapsone + ferrous oxalate) is a sulphone marketed in France since 1958 and authorized in P. Carinii prophylaxis in HIV+ cotrimoxazole intolerant patients, bullous dermatosis, leprosy and polychondritis. Between 1983 and 1998, 249 adverse reactions were reported to French pharmacovigilance centres and Aventis, the manufacturer. Every side-effect was reviewed and the causal relationship was assessed on the basis of the French method for causality assessment. Main side-effects were divided as follows: 117 blood dyscrasias (generally neutropenia and agranulocytosis, rarely methaemoglobinaemia, haemolysis, macrocytosis, anaemia, aplastic anaemia, haemochromatosis and sulphaemoglobinaemia); 29 hypersensitivity syndrome; 39 cutaneous reactions, generally rash; 27 liver injuries (cholestatic, cytolytic and mixed hepatitis); 27 neurological and psychiatric side-effects including 7 axonal neuropathy; 10 gastrointestinal effects, generally nausea and vomiting. Five deaths were reported (4 septicaemia including one case not due to dapsone and 1 digestive bleeding due to underlying disease). In the other cases the outcome was favourable. The results were compared with the published references. It would seem to be important to reinforce information to prescribers about the possible serious adverse reactions with dapsone, particularly hypersensitivity syndrome and agranulocytosis, that can cause death if the drug is not stopped in time.

AIDS-Related Opportunistic Infections↗
PubMedDate not supplied

[Pharmacovigilance of hypolipidemic drugs (fibrates and probucol), from databanks of the French System of Pharmacovigilance].

The methodology of a retrospective study of the side-effects of the most prescribed lipid lowering drugs, essentially fibrates, is described. This study concerns the last 5-years reports to the French System of Pharmacovigilance, centralized in the common data-base located in Lyon. During this period 36,875 reports were recorded, only 409 in which an hypolipidemic drug is stated as "suspect" (according to WHO's definitions) were selected and analyzed. All fibrates were involved, those most frequently implicated being the most widely prescribed (e.g. fenofibrate represents half of the reports).

Databases, Factual↗
PubMedDate not supplied

[Pharmacovigilance off the beaten track: herbal surveillance or pharmacovigilance of medicinal plants].

For several years, herbal medicines have been increasingly consumed by patients without prescription. They are traditionally innocuous but as medicinal products they require drug surveillance in order to identify their risks. However, the first concern is to give them a legal status, to evaluate their efficacy and to control their safety. Published data show that the risk is due either to a contaminant or to an added drug or falsification. Since 1985, the Regional Pharmacovigilance Centres have received about 341 reports of undesirable effects due to herbal medicines: among them 30 cases of hepatitis were reported associated with germander which has been now withdrawn from the French market. This example well illustrates the role of the national system and its responsibility for collecting and evaluating ADRs due to herbal medicines.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

In this article we review the current initiatives by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) on pharmacovigilance planning that are due for general release during 2004. These initiatives could form the basis for applying concepts of risk management to medicines throughout their life cycle, from preclinical and clinical development to marketed use. The CIOMS VI Working Group (with 28 senior scientists worldwide from drug regulatory authorities and pharmaceutical companies) is currently developing scientific guidance that relates to clinical trials for medicines during development. It recommends a developmental pharmacovigilance concept - a 'living' concept that would start early in drug development supporting the science and ethics of research leading up to licensing (marketing authorisation) and continuing to post-authorisation (postmarketing) pharmacovigilance. This approach is seen as complementary to current ICH initiatives called 'Pharmacovigilance Planning'. ICH will introduce two concepts in pharmacovigilance management of medicinal products: the 'Pharmacovigilance Specification' and the 'Pharmacovigilance Plan'. The 'Pharmacovigilance Specification' will summarise important knowns and unknowns about the medicine. It will include safety risks identified at the licensing stage, potential risks and any key missing information. These elements will be essential to the formulation of pharmacovigilance plans. Dialogue and common understanding between regulators and the pharmaceutical industry will be a key factor for developing pharmacovigilance plans during the life cycle of medicines. Appropriate interaction with health professionals and patients should also be planned for the future as regulatory systems become more transparent. Where no significant issues are apparent at the licensing (marketing authorisation) stage, routine pharmacovigilance practices will be followed during the marketing phase. Where issues do exist or the data are limited, further study, including epidemiological approaches can be planned. All types of medicines (new drugs, biological agents, orphan drugs) may be involved in these concepts, as would major extensions to existing medicines. Currently ongoing CIOMS and ICH initiatives are in line with emerging risk-management strategies in the US, the European Union and Japan aimed at early and proactive pharmacovigilance.

Drug Industry↗
PubMed2006

Issues with regulatory pharmacovigilance in East European countries: the industry perspective.

The new European Union pharmaceutical legislation emphasizes the importance of ensuring the continued safety of medicinal products in use with the main purpose to protect the public health. To fulfil this task the Member States are obliged to establish pharmacovigilance systems, which could be continually adapted to take account of scientific and technical progress. The non-EU East European countries are oriented towards the same goal on their way to the community. They are changing their legal frameworks for pharmacovigilance to harmonize it with the European requirements. As the EU accession country, Croatia is also in a phase of harmonization of the national legislation on medicines with the latest European requirements. It has established the pharmacovigilance system in which the Croatian Agency for Medicines and Medical Devices has very important role, and it involves all stakeholders-pharmaceutical industry, Healthcare Professionals and patient organizations. Belupo Inc. is faced with changes in the field of pharmacovigilance on all its markets: in Croatia, in EU as well as in the East European countries outside the EU, which are traditionally Belupo's target markets. The structure and functioning of the pharmacovigilance system in Croatia and other non-EU East European countries based on Belupo's experience gathered through the activities of its Pharmacovigilance Department and activities of its Qualified Persons for Pharmacovigilance (QP) are presented.

Drug Industry↗
PubMedDate not supplied

Contribution of Latin America to pharmacovigilance.

BACKGROUND: Pharmacovigilance activities have been ongoing for 4 decades. However, little is known (especially outside of the area) about the contribution of Latin America to this field. OBJECTIVE: To review and quantify the published literature on pharmacovigilance in Latin American countries. DATA SOURCES: We searched electronic databases including MEDLINE (1966-2004), EMBASE (1980-2004), International Pharmaceutical Abstracts (1970-2004), Toxline (1992-2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-2004), Sistema de Información Esencial en Terapéutica y Salud (1980-2004), and the Pan American Health Organization Web site (1970-2004) for articles on pharmacovigilance or adverse drug reactions in any of the 19 major Latin American countries. Papers were retrieved and categorized according to content and country of origin by 2 independent reviewers. STUDY SELECTION AND DATA EXTRACTION: There were 195 usable articles from 13 countries. DATA SYNTHESIS: Fifty-one of the papers retrieved dealt with pharmacovigilance centers (15 national centers, 10 hospitals, 26 other), 55 covered pharmacovigilance itself (21 theoretical papers, 9 with description of models, 25 educational papers), and 89 were pharmacoepidemiologic studies of adverse drug reactions (69 case reports, 13 observational cohorts, 2 cohort studies, 1 randomized clinical trial, 4 clinical papers on adverse reaction management). Studies have increased exponentially since 1980. Five countries (Argentina, Brazil, Chile, Costa Rica, Venezuela) published reports from national centers. No studies were found from 6 countries: Dominican Republic, El Salvador, Honduras, Nicaragua, Paraguay, or Uruguay. Most studied categories were antiinfectives and drugs affecting the central nervous system, cardiovascular system, and musculoskeletal system. CONCLUSIONS: Contributions of Latin American countries to the field of pharmacovigilence have been remarkable, considering the constraints on these countries. A need exists for an increased number of formal pharmacovigilance studies and research using methodologically stronger pharmacoepidemiologic models.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1999

Pharmacovigilance in perspective.

Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information needed for the evaluation of the benefits and risks of drugs is in the first place a scientific challenge. In addition, there are important ethical, logistical, legal, financial and commercial constraints. Good pharmacovigilance practice needs to be developed to ensure that data are collected and used in the right way and for the right purpose. Pharmacovigilance, and more generally the study of the benefits and risks of drugs, plays a major role in pharmacotherapeutic decision-making, be it individual, regional, national or international. In addition, pharmacovigilance is becoming a scientific discipline in its own right. A variety of changes are taking place in the complex system of drug development, regulation and distribution. Pharmacovigilance should be proactive in monitoring their possible consequences.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Adverse drug reactions in patients older than 70 years during the heat wave occurred in France in summer 2003: A study from the French PharmacoVigilance Database.

OBJECTIVE: To evaluate adverse drug reactions (ADRs) in patients older than 70 years reported during the 2003 summer heat wave in France to the French Network of Pharmacovigilance Centres and to discuss the interest of such a pharmacovigilance database in the surveillance of such sanitary alerts. METHODS: All 'serious' ADRs occurred in patients older than 70 years between 1st July and 31st August 2003, reported to the French network of Pharmacovigilance Centres and recorded in the French PharmacoVigilance Database, were analysed with respect to age, gender, type of ADR, drug(s) involved as well as imputability of heat wave. RESULTS: The total number of 'serious' ADRs registered in the French PharmacoVigilance Database in patients older than 70 years was similar in 2003 (a year with heat wave) and in 2002 (a year without heat wave). Sixty-eight ADRs [27 'possible' (I1), 27 'plausible' (I2) and 14 'likely' (I3)] related to heat occurred in 2003, with a maximal peak between the 28th July and the 17th August. The most frequently ADRs were metabolic (dehydratation, hydroelectrolytic disturbances) and neuropsychiatric (confusion, falls, coma). Drugs more frequently involved were diuretics, angiotensin converting enzyme inhibitors, antidepressants (mainly serotonin reuptake inhibitors), proton pump inhibitors, digoxin, benzodiazepines, oral hypoglycemics and sartans. CONCLUSION: This study underlines the role of heat wave in the occurrence of 'serious' ADRs in elderly. However, the French PharmacoVigilance Database was not enough sensitive to be used as an efficient surveillance system during such an acute episode, like a heat wave (at least while underreporting remains so important).

Adverse Drug Reaction Reporting Systems↗
PubMed1992

Veterinary pharmacovigilance in the European context.

Pharmacovigilance (or pharmaco-surveillance) is the surveillance of adverse drug reactions (ADRs) which are noxious and of unintended reactions which occur at doses normally used in animals in accordance with the terms of the marketing authorization. From this definition, the scope of veterinary pharmacovigilance should be clearly defined, especially with regard to associated problems of lack of efficacy, resistance, effects in man, residues, etc. Priorities should be established concerning adverse effects in animals in order to set up an operational system. Methodological tools are being developed such as causality assessment, thesaurus, data banks, alert systems. The situation of veterinary pharmacovigilance in countries is very different. The existing systems are based on two different conceptions: a pharmacovigilance of the administrative type, made by authorities; a pharmacovigilace of the interactive type, made in veterinary universities, linked with the authorities. In industry, the importance of pharmacovigilance is increasing; collaborations have been set up but should certainly be developed. Finally, the sensitization of the veterinary practitioners, which play a key-role in the system of spontaneous reporting of ADRs, is to be developed in many ways: interaction during or after the report, publication of data, concrete actions, improvement of side-effect warnings and prevention, etc. Veterinary pharmacovigilance should be a very interesting area of cooperation between the field, universities, industry and regulation authorities.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

[New methods for studying drug associated risk: experience of the Toulouse Regional Pharmacovigilance Center].

This review examines the methods used to study adverse drug reactions (ADRs) and to quantify drug risk in pharmacovigilance. Beside analysis of spontaneous reports (the basic and universal alert method in pharmacovigilance), epidemiological methods can also be used. Classical methods are based on intensive recording, case-control or cohort studies, and clinical trials. Other more recent methods have been applied to pharmacovigilance. Using recent personal data, the authors present and discuss these new methods. Case/non-case studies quantify drug risk based on a pharmacovigilance database, and are used as signals in pharmacovigilance. Analysis of laboratory data can also be used to evaluate biological ADRs such as elevated liver enzyme and creatine phosphokinase levels. Cross-linkage studies can be used to minimize the consequences of under-notification in pharmacovigilance. Finally, ADR perception analysis is a useful method to evaluate the perceived social and medical importance of drug risks in different populations (public, pharmacists, general practitioners, medical specialists).

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Defining the competencies of those conducting pharmacovigilance.

PURPOSE: The absence of agreed competencies in pharmacovigilance and patient risk management is a key factor hindering the development of training and a curriculum in these interrelated disciplines. If competencies were to be developed, they could be tailored to the different roles and responsibilities of the various staff involved. PROPOSAL: We describe a simple theoretical model of functional and behavioural competencies that is based on an organisation with three levels of staff: evidence collectors and gatherers, evidence processors and distillers, and decision makers. CONCLUSIONS: To stimulate discussion about how to enhance the progress already being made in pharmacovigilance and patient risk management, we have proposed functional and behavioural competencies for pharmacovigilance as a way of identifying and measuring scientific and personal skills pertinent to pharmacovigilance. Competencies should, we believe, be agreed and adopted by all those seeking to improve pharmacovigilance. We invite discussion of these proposals.

Communication↗
PubMed2005

Veterinary pharmacovigilance. Part 1. The legal basis in the European Union.

Pharmacovigilance is a growing discipline and nowhere is this more true than in the context of the legislative requirements for veterinary pharmacovigilance within the European Union (EU), or more specifically, within the European Economic Area. Since 1995, the legislation governing the authorization of veterinary medicinal products in the EU has resulted in the older national procedures being replaced by the mutual recognition procedure and the centralized procedure. Also since 1995, the regulatory requirements for pharmacovigilance have developed and grown, as have the associated guidelines. The recent review of European veterinary medicines legislation, which concluded with the publication of an amending directive and a new regulation in March 2004, has introduced refinements to the pharmacovigilance system. This paper examines the EU legislation governing the authorization of veterinary medicinal products, including the elaboration of maximum residue limits, and the way in which this relates to the requirements of pharmacovigilance.

Animals↗