ANALYSIS AND CONTRIBUTION OF PHARMACEUTICAL DRUG PACKAGES AND PACKAGE INSERTS TOWARDS THE DEVELOPMENT OF PHARMACOVIGILANCE SYSTEM IN PAKISTAN.

Abstract

Introduction: Safe use of a drug is promoted via accurate information. The most accessible form of information for patients regarding drugs is the drug package and package insert, especially, in case of adverse event. Reporting of adverse drug reaction is an important element of pharmacovigilance. Objective: The aim of the study was to analyze the pharmaceutical drug packages and their package inserts available in Pakistan, and identify their contribution towards the development of pharmacovigilance system in Pakistan. Settings and Design: Collection of drug packages and package inserts from various pharmacies of Karachi. Methods: Two hundred and fifty two drug packages and package insert of local (n=178) and multinational (n = 74) origin were randomly selected, based on their availability in Pakistan. Each of the drug package and package insert was evaluated as per the criteria laid down by the Drug Regulatory Authority of Pakistan (DRAP). Additionally, they were also analyzed for the presence of the information regarding adverse drug reaction (ADR) reporting.Statistical analysis used: SPSS Version 20.0. Results: Information regarding dosing in special population, clinical pharmacology, patient counseling information etc. was not found in majority of the package inserts. ADR reporting information lacked in both the drug packages and inserts. Only 3% (n = 9) of the drug packages and 0.8% (n = 2) of the inserts had included the reporting information. The reporting information was shared by multinational pharmaceutical companies. None of the local pharmaceutical companies had shared the ADR reporting information. Conclusion: Majorly, the drugs packages and to some extent the package inserts comply with the rules. However, no information regarding ADR reporting was found. Hence, it is recommended that measures such as provision of a toll-free number would encourage ADR reporting among the drug consumers.
Key-words: ADR reporting, Drug package, Package inserts, Pharmacovigilance, Pakistan