Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
The New Zealand Intensive Medicines Monitoring Programme in pro-active safety surveillance
Autore:
Coulter, DM;
Indirizzi:
Univ Otago, Dunedin Sch Med, Dept Prevent & Social Med, Ctr Adverse React Monitoring, Dunedin, New Zealand Univ Otago Dunedin New Zealand e React Monitoring, Dunedin, New Zealand
Titolo Testata:
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
fascicolo: 4, volume: 9, anno: 2000,
pagine: 273 - 280
SICI:
1053-8569(200007/08)9:4<273:TNZIMM>2.0.ZU;2-M
Fonte:
ISI
Lingua:
ENG
Keywords:
adverse drug reaction reporting systems; adverse drug reactions; adverse events; observational cohort studies; pharmacoepidemiology; postmarketing surveillance; signal detection; spontaneous adverse drug reaction reporting;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
15
Recensione:
Indirizzi per estratti:
Indirizzo: Coulter, DM Univ Otago, Dunedin Sch Med, Dept Prevent & Social Med, Ctr Adverse React Monitoring, POB 913, Dunedin, New Zealand Univ Otago POB 913 Dunedin New Zealand Dunedin, New Zealand
Citazione:
D.M. Coulter, "The New Zealand Intensive Medicines Monitoring Programme in pro-active safety surveillance", PHARMA D S, 9(4), 2000, pp. 273-280

Abstract

Purpose - The purpose of this paper is to demonstrate the pro-active nature of the New Zealand Intensive Medicines Monitoring Programme (IMMP) and make an assessment of its effectiveness in postmarketing drug safety evaluation. Methods - The IMMP undertakes prospective observational cohort studies of selected new drugs. Patient cohorts are established from prescription data received from dispensing pharmacists nationwide. Adverse events are reported by doctors on prescription follow-up questionnaires or as spontaneous reports. The method of signal generation is reviewed with particular emphasis on the review of individual event reports and their relationship to the medicine. Signals reported over the last 10 years are assessed for timeliness in advising the regulatory authority. Results - Mean cohort size is 10,964 patients and the mean study period for each drug was 58 months. A total of 153 signals were recorded from II drugs with 132 (86%) being notified to the regulatory authority prior to any publication in the literature. The use of 'incidents' in controlling for reporting bias is illustrated and examples are given of data on safety in pregnancy and lactation, the assessment of deaths, reassurance with drug scares, risk comparison and signal validation studies. Conclusion - PEM type methodology is effective and cost-efficient in pro-active safety surveillance even with limited resources. Copyright (C) 2000 John Wiley & Sons, Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/01/20 alle ore 23:04:41