This Module consists of two volumes which focus on safety in the use of medicines in the postmarketing period. Volume 1 looks at Pharmacovigilance which has been described as 'All methods of assessment and prevention of adverse drug reactions' (Begaud 1993), and will incorporate systems set up to collect, assess and monitor adverse reactions to medicinal products. The course will discuss the history of major adverse events that has lead to the current monitoring programmes as well recent approaches to improving methods for detecting potential adverse drug reactions. The responsibilities of the pharmaceutical companies is covered; the aims of the collection of ADR/ADE information and the data bases used in this process are addressed. Information from the impact of international harmonization of procedures to the local operating company procedures is covered. Also covered are causality assessment, categories of causal relationship, the incidence of adverse reactions and their assessment, and risk/benefit issues. A major chapter on the classification and mechanisms of adverse drug reactions provides pharmacological understanding of the types of ADRs, long-term effects and effects on the embryo, foetus and neonate. The classification and mechanisms of drug interactions often associated with ADRs are covered. Volume 2 of this Module will address Pharmaceutical Information. The course will discuss the information resources and information services required to bring together and utilize all the information about a drug product which has been generated during its development and marketing. It provides an introduction to and an understanding of the restrictions under which pharmaceutical companies operate in terms of the provision of information, promotion and advertising. Core to this will be an understanding of the requirements and the writing of the Product Information and Consumer Medicine Information documents. The advertising and promotion of therapeutic goods as controlled by government and industry regulations are discussed.

Note: This course is a compulsory programmes 5504, 9060.