Weekes L M, Day R O
New South Wales Therapeutic Assessment Group Inc., Darlinghurst, Australia.
Drug Saf. 1998 Mar;18(3):153-9. doi: 10.2165/00002018-199818030-00001.
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.
药学与治疗学（P&T）委员会开展政策制定、监管及教育活动，以促进其所在机构合理用药，目的是提高这些机构的医疗质量和经济效益。药品目录管理是P&T委员会活动的重要组成部分，而选择药物是委员会最艰巨的任务之一。P&T委员会在选择药物时最常确定的三类必要信息是有效性、安全性和成本数据；通常按此重要性顺序排列。然而，有证据表明，并非所有委员会在决定将一种新药添加到药品目录时都会考虑安全性数据。药品不良反应（ADR）数据在药品目录决策（针对已注册药品）中的作用体现在多个层面。首先，从药物上市前研究中获得的ADR数据很重要，能使委员会对该药物可能预期的毒性风险进行评估。然而，这些信息的局限性使得无法进行绝对评估。其次，在确定特定药物在治疗中的地位时，比较安全性信息是必要的。权衡比较风险和益处是一项复杂的任务，对于大多数P&T委员会而言，无论采用何种复杂程度的方法，这都是一项常规活动。第三，ADR数据是P&T委员会进行的任何经济评估的重要组成部分。计算与治疗不良反应相关的成本和后果需要仔细评估。最后，汇总的药品不良事件报告不仅整理了药品不良反应的后果，还包括用药事件（用药错误），并且是本地报告的，这对P&T委员会来说可能是一个有用的质量保证过程。这些信息将有助于确定从药品目录中删除的药物，在决定添加药物到药品目录时作用相对较小。由于药品目录管理只是P&T委员会工作的一部分，所以委员会对ADR的关注范围比在药物选择中使用这些数据更为广泛。P&T委员会还可能参与促进向中央数据库或初级护理人员报告ADR。尽管ADR信息通常可用性有限，但在P&T委员会的药品目录管理过程中具有重要作用。
