EVALUATION AND COMPARISON OF PHARMACOVIGILANCE SYSTEMS IN 70 DIFFERENT COUNTRIES FOR CONSUMER REPORTING OF ADVERSE DRUG REACTIONS

Author(s)

Abdul Razack HI1, Sree V21Accenture Services Ltd., Bangalore, Bangalore, India, 2Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Traditionally, the reporting of adverse drug reactions (ADRs) by healthcare professionals is recognized well. In the recent decades, the significance of consumer reporting of ADRs have been give due attention in the developed nations. There are documented reasons on the failure of healthcare professionals in reporting ADRs communicated by the patients. OBJECTIVES: The present study aimed to evaluate and compare the Pharmacovigilance systems in 70 different countries with regards to consumer reporting of ADRs. METHODS: The official websites of regulatory/medicines agencies or National Pharmacovigilance Centres of selected 70 countries, which joined the World Health Organization's (WHO) International Drug Monitoring Program between 1968 and 2010, were evaluated. RESULTS: In most of the countries, healthcare professionals are legally obliged to report ADRs to the respective medicines authorities. Only 17 countries (24.3%) accept ADR reports directly from consumers. Of them, only 4 countries (5.7%) accept consumer reports by phone and 11 countries (15.7%) have a web-based electronic system for consumer reporting. CONCLUSIONS: The consumers report relatively untapped suspected reactions for many prescription and non-prescription drugs. Recent literature from these countries strongly stressed the WHO's view in successful use of consumers as one of the valuable source of drug safety data. It is high time that the consumer reporting should be encouraged in all the countries, especially the developing nations, for better drug surveillance. Proper educational interventions are required to the general public towards active involvement in the respective National Pharmacovigilance Programs, which in turn improves the quality use of medicines.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP2

Topic

Patient-Centered Research

Topic Subcategory

Patient Behavior and Incentives

Disease

Multiple Diseases

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