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Adverse drug reaction reporting. Philippine experience.

For almost 20 years, the Philippine Medical Association, and specifically its Committee on Foods, Drugs and Cosmetics, has not been able to successfully gather information on adverse drug reactions (ADRs). The reporting of ADRs began in 1967, using a very comprehensive reporting form, at a time when news items of anaphylactic shock and deaths allegedly from intramuscular injections of penicillin, and subsequent litigation, were appearing. Up until 1973, when there were new initiatives, a few ADR reports were obtained mainly from hospitals who employed Philippine Medical Association committee members. Despite the issuing of directives for co-operation from hospitals, reports were not forthcoming. Involvement of hospital pharmacists and officers of specialist societies subsequent to the arrival of a World Health Organization (WHO) consultant in 1981 resulted in a simplified reporting form. Initial enthusiasm generated some ADR reports, but information was often inadequate and requests for further details were ignored. A new form entitled 'Drug Experience Reporting'--based on the USA FDA example--was introduced in 1984, when the Philippine Pediatric Society on ADR reporting also designed a project for use in hospitals. A change in doctor and patient attitudes is necessary before progress can be made, and a new strategy based on the education of doctors and medical students has been implemented. An important requirement is a mechanism to review and assess ADRs that will satisfy health authorities and maintain confidentiality.