𝔖 Bobbio Scriptorium
✦   LIBER   ✦

Spontaneous reporting of adverse drug reactions: who reports and what?

✍ Scribed by Pascale Tubert-Bitter; Françoise Haramburu; Bernard Begaud; Anicet Chaslerie; Erick Abraham; Catherine Hagry

Publisher
John Wiley and Sons
Year
1998
Tongue
English
Weight
123 KB
Volume
7
Category
Article
ISSN
1053-8569

No coin nor oath required. For personal study only.

✦ Synopsis

A survey among Bordeaux pharmacovigilance centre users' and non-users' was conducted in Aquitaine, France. Two hundred physicians having reported to the centre at least one adverse drug reaction (ADR) during the past 3 years were matched to a randomly selected sample of 400 physicians who did not report. They were asked to anonymously ®ll out a postal questionnaire collecting data on their individual characteristics, including their practice mode, and on ADRs that they observed and reported during the past 12 months. The number of questionnaires returned was 151 (25%), of which 76 were from users (38%) and 75 from non-users (19%). The two groups had very close individual characteristics. All but three responders had observed at least one ADR during the past 12 months. For the dierent types of ADRs de®ned in terms of seriousness and labelling, more users had seen ADRs than non-users but among those who observed them, the numbers of ADRs seen were similar in both groups. In any case, the more recent the drug, the more prone to report were the physicians.

📜 SIMILAR VOLUMES

Regional reporting of adverse drug react
Regional reporting of adverse drug reactions: a new computer-based network
✍ Walter J. Swoboda; Martin Göttler; Joerg Hasford 📂 Article 📅 1999 🏛 John Wiley and Sons 🌐 English ⚖ 112 KB

The use of drugs is always accompanied by the risk of adverse drug reactions (ADRs) and adverse events (AE). Generally physicians, pharmaceutical manufacturers, and pharmacists use a paper-based form for sending spontaneous ADR and AE reports to the national drug regulatory authority. Besides underr

Quality of adverse drug experience repor
Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA
✍ Syed Rizwanuddin Ahmad; Joel P. Freiman; David J. Graham; Robert C. Nelson 📂 Article 📅 1996 🏛 John Wiley and Sons 🌐 English ⚖ 541 KB

The US Food and Drug Administration (FDA)'s Spontaneous Adverse Experience Reporting System is a computerized database with over one million adverse drug experience (ADE) reports. In 1992, the FDA received over 100,000 ADE reports and pharmacists were major contributors to these reports. In 1993, th

Basic Requirements for the Use of Terms
Basic Requirements for the Use of Terms for Reporting Adverse Drug Reactions (VIII): Renal and Urinary System Disorders
📂 Article 📅 1997 🏛 John Wiley and Sons 🌐 English ⚖ 142 KB 👁 2 views

This paper is the report of a meeting held in Geneva under the auspices of the Council for International Organizations of Medical Sciences (CIOMS) on 4±5 June 1996. It contains de®nitions of terms used in reporting adverse drug reactions of the system/organ class renal and urinary system disorders a

Definitions and basic requirements for t
Definitions and basic requirements for the use of terms for reporting adverse drug reactions (X): gastrointestinal system disorders
📂 Article 📅 1998 🏛 John Wiley and Sons 🌐 English ⚖ 92 KB 👁 2 views

This paper is the report of a meeting held in London under the auspices of the Council for International Organizations of Medical Sciences (CIOMS) on 17±18 April 1997. It contains de®nitions of terms used in reporting adverse drug reactions of the system/organ class gastrointestinal system disorders

Definitions and basic requirements for t
Definitions and basic requirements for the use of terms for reporting adverse drug reactions (XI): cardiovascular system disorders
✍ Zbigniew Bankowski 📂 Article 📅 1998 🏛 John Wiley and Sons 🌐 English ⚖ 112 KB 👁 2 views

This paper is the report of a meeting held in Geneva under the auspices of the Council for International Organizations of Medical Sciences (CIOMS) on 5±6 November 1997. It contains de®nitions of terms, and basic requirements for their use, for purposes of reporting adverse drug reactions of the syst