Affiliations: Department of Infectious Diseases, Department of Interdisciplinary Research, Maharashtra University of Health Sciences, Nashik, India | Department of Clinical Pharmacology, Seth GS Medical College, King Edward Memorial Hospital Mumbai, India | WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden | West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham, UK | Department of Clinical Pharmacology, University of Birmingham, Birmingham, UK
Note: [] Address for correspondence: Dr N.A. Kshirsagar, Department of Clinical Pharmacology, Seth GS Medical College and King Edward Memorial Hospital, Acharya Donde Marg, Parel, Mumbai 400 012, India. Tel.: +919821036616; Fax: +91224112871; E-mail: [email protected]
Abstract: Background: The ultimate goal of pharmacovigilance is to protect patients from drug-induced harm and allow them to derive maximum benefits from medicines. All pharmacovigilance centres have an interest in showing the extent to which they achieve this aim. A core activity is spontaneous reporting. We have considered here whether it is possible to construct appropriate performance indicators for this method. Methods: We set out the stages in the process of pharmacovigilance and sought to decide what specific objectives of the centres could be helpful as practical indicators related to desired outcomes of pharmacovigilance and considered criteria to assess the practicality of an indicator. Results: We constructed a model of the pharmacovigilance process, listed the core functions and deduced a series of potential performance indicators that would be used in practice. Examples included number of reports per million population; proportion of valid reports; number of signals identified; regulatory or clinical action taken. For example data from USA compared to African country show how huge resources in USA give myriad reports, signals and regulatory decisions compared to Africa. Discussion: Pharmacovigilance centres have limited influence over the many complex interactions between patient, prescriber, manufacturer, government and media. However the proposed indicators can be measured in different countries, regions and at different times and allow comparisons. Conclusion: The pharmacovigilance system is a subsystem of a larger healthcare system and is affected by many factors. It is not easy to demonstrate the benefits of pharmacovigilance towards patient safety. However pharmacovigilance centres need to show the extent to which they achieve their objective such as number of reports, number of signals identified, regulatory or clinical action taken. These allow comparison between countries and overtime.
