THE APPLICATION OF ADVERSE DRUG REACTION DATA TO DRUG CHOICE DECISIONS MADE BY PHARMACY AND THERAPEUTICS COMMITTEES - AN AUSTRALIAN PERSPECTIVE

Pharmacy and Therapeutics (P&T) committees undertake policy, regulator y and educational activities to promote rational use of medicines in t heir institutions with the aim of improving the quality of health and economic outcomes at these institutions. Formulary management is an im portant part of the P&T committees' activities and making drug choices is one of the committees' most difficult tasks. The 3 types of inform ation most commonly identified by P&T committees as necessary for maki ng drug choices are effectiveness, safety and cost data; usually in th is order of importance. There is some evidence, however, that safety d ata are not considered by all committees when they make decisions abou t adding a new drug to a formulary. The role of adverse drug reaction (ADR) data in formulary decision-making (for registered drugs) occurs at several levels. First, ADR data obtained from pre-marketing studies of the drug are important and enable the committee to make an assessm ent of the risk of toxicity that should be anticipated for the drug. H owever, the limited nature of this information makes an absolute asses sment impossible. Secondly, comparative safety information is necessar y when deciding the place in therapy of a particular drug. Weighing up the comparative risks and benefits is a complex task which is a routi ne activity for most P&T committees whatever level of sophistication i s applied. Thirdly, ADR data are an important ingredient of any econom ic assessment considered by a P&T committee. Calculation of the costs and consequences associated with the adverse effects of treatment dema nd careful assessment. Finally, aggregated adverse drug event reports which collate not only the consequences of adverse drug reactions but also medication incidents (medication errors) and which have been repo rted locally can be a useful quality assurance process for a P&T commi ttee. This information will contribute to the identification of drugs for deletion from the formulary and less commonly in making decisions about additions to the formulary. As formulary management forms only p art of a P&T committee's work, so the committee's interest in ADR is b roader than the use of these data in making drug choices. The P&T comm ittee may also be involved in promoting ADR reporting to either a cent ral database or primary carers. Although often of limited availability , ADR information has an important role in the formulary management pr ocess of P&T committees.