Adverse Drug Reactions from Database to Prescriber: The United Kingdom Experience

Abstract

This paper provides an insight into the methods used by the international headquarters of Zeneca Pharmaceuticals for the production of a core prescribing text. Information is provided on the sources of information used for screening for adverse drug events, including the worldwide computer adverse drug experience (ADE) database safety experience collated using reported events (SECURE).

The method of database interrogation by means of a formalized process—the safety and efficacy review meeting (SERM) — will be presented, together with how proposed changes are justified and conveyed to the business. The remit of SERM is to “provide coordinated and professional product reviews, provide confidence to the business, and control the frequency of prescribing information change.”