From Signals to Policies: Academic and Regulatory Perspectives in the Philippines
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FROM SIGNALS TO POLICIES: ACADEMIC AND REGULATORY PERSPECTIVES IN THE PHILIPPINES KENNETHHARTIGAN-GO, MD, FPCP, FPSECP Project Leader, Adverse Drug Reaction Monitoring Programme, and Associate Professor, Department of Pharmacology, College of Medicine, University of the Philippines, Manila, Philippines
A signal is a suspicion of a relationship between a reaction and a drug, and an indication that no regulatory action has yet been taken. It is an initial lead that, when reported, triggers a warning. A practitioner suspects and reports an adverse drug reaction (ADR), and health authorities determine whether a warning and health policy statement should be issued. The process by which the Philippine government with the help of the Adverse Drug Reactions Monitoring Programme (ADRMP) evaluates problem drugs or problem drug use is discussed. Steps in pharmacovigilance for translating ADR signals into health policies will be proposed. Examples of cases reported to the ADRMP-defective devices, unregistered herbal medicines and antimicrobial drugs, slimming formulations, body building pills, mood altering health foods, dosage labeling confusion, suspected therapeutic inefficacy,dangerous drug product advertisements, and deregulation of prescription drugs into over-the-counter products-and the lessons learned are highlighted. Key Words: ADR; Drug safety; Pharmacovigilance; Philippines; Policies
INTRODUCTION
timely advice from a regulatory agency, a body which must have an evolving drug A SIGNAL IS A SUSPICION of a relation- monitoring system. Patients were noted to be ship between a reaction and a drug, and an able to discern between drug classes in terms indication that no regulatory action has yet of perceived risks (1) and if better informed, been taken. It is an initial lead that, when will discern more meaning to the general isreported, triggers a warning. Although the sues pertaining to risks and benefits of using end-user of a drug has the right to be in- drugs (2). Information about adverse drug formed of the known adverse effects of the effects must be shared with them as accudrug, how can clinicians and prescribers of rately as possible without causing undue drugs, who manage patients every day, deal alarm. with these issues? They need to rely on inforThere is a growing list of new adverse mation provided by standard literature and drug reactions and adverse drug events not just with new drugs but also with old ones. Therefore, many people recognize the value Presented at the DIA 34th Annual Meeting ‘Thinking of sharing this information with agencies Globally: Product Development, Registration, and Mar- in various countries which can implement keting in the New Millennium,” June 7-11, 1998, Bossafety wamings in other countries (3). In reton, Massachusetts. ality, this task is never easy. Monitoring adReprint address: Dr. Kenneth Hartigan-Go, Departverse events would be useless if this informament of Pharmacology, University of the Philippines Col
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