The application of adverse drug reaction data to drug choice decisions made by pharmacy and therapeutics committees. An Australian perspective.

Abstract

Pharmacy and Therapeutics (P&T) committees undertake policy, regulatory and educational activities to promote rational use of medicines in their institutions with the aim of improving the quality of health and economic outcomes at these institutions. Formulary management is an important part of the P&T committees' activities and making drug choices is one of the committees' most difficult tasks. The 3 types of information most commonly identified by P&T committees as necessary for making drug choices are effectiveness, safety and cost data; usually in this order of importance. There is some evidence, however, that safety data are not considered by all committees when they make decisions about 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 assessment of the risk of toxicity that should be anticipated for the drug. However, the limited nature of this information makes an absolute assessment impossible. Secondly, comparative safety information is necessary when deciding the place in therapy of a particular drug. Weighing up the comparative risks and benefits is a complex task which is a routine activity for most P&T committees whatever level of sophistication is applied. Thirdly, ADR data are an important ingredient of any economic assessment considered by a P&T committee. Calculation of the costs and consequences associated with the adverse effects of treatment demand 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 reported locally can be a useful quality assurance process for a P&T committee. 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 part of a P&T committee's work, so the committee's interest in ADR is broader than the use of these data in making drug choices. The P&T committee may also be involved in promoting ADR reporting to either a central database or primary carers. Although often of limited availability, ADR information has an important role in the formulary management process of P&T committees.