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 inefpcacy, dangerous drug product advertisements, and deregulation of prescription drugs into over-the-counter products—and the lessons learned are highlighted.
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Hartigan-Go, K. From Signals to Policies: Academic and Regulatory Perspectives in the Philippines. Ther Innov Regul Sci 33, 949–954 (1999) doi:10.1177/009286159903300336
- Drug safety