R Fernandopulle

What can consumer adverse drug reaction reporting add to existing health professional-based systems? Focus on the developing world.

The current system of pharmacovigilance encourages reporting of adverse drug reactions (ADRs) mainly from healthcare professionals. Underreporting is a major problem, more so in the developing world than in the developed world. Less than 3% of reports added to the WHO database in the year 2000 originated from developed countries, although around 80% of the global population lives in the developing world. Also a considerable time lag still exists in recognition of serious ADRs. Hence, there is a need for a different approach to pharmacovigilance.We present an overview of possible reasons for underreporting by healthcare professionals with particular emphasis on the developing world, and the potential benefits of encouraging consumer reporting. Only a few countries accept consumer reports. We suggest an independent consumer reporting system for hypothesis generation to complement the present health professional-based system. We also highlight the low priority given by multinational pharmaceutical companies to the developing countries regarding new safety information.The important questions are whether the resources available would be sufficiently robust to sustain such a system in the developing world, and whether it will be sufficiently robust and sensitive for the early detection of signals.

Diarrhea: Case definition and guidelines for collection, analysis, and presentation of immunization safety data ,

. Gidudua,∗, D.A. Sackb, M. Pinac, M.J. Hudsond, K.S. Kohla, P. Bishope, A. Chatterjee f, E. Chiappinig, . Compingbutraa, C. da Costah, R. Fernandopulle i, T.K. Fischer j, P. Habera, W. Masanak, artins R. de Menezes l, G. Kangm, N. Khuri-Bulosn, L.A. Killiono, C. Nairp, G. Poerschkeq, B. Rathr, . Salazar-Lindos, R. Setseb, P. Wenger t, V.C.N. Wongu, K. Zamanv, he Brighton Collaboration Diarrhea Working Group

Template protocol for clinical trials investigating vaccines—Focus on safety elements

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.

Pharmacovigilance through consumer feedback (reporting) in the mass treatment of lymphatic filariasis using diethylcarbamazine and albendazole in two districts of Sri Lanka

Objective  To document the types and severity of adverse drug reactions to diethylcarbamazine and albendazole in randomly selected urban populations from Colombo and rural populations from Gampaha, Sri Lanka.