Adverse drug reactions information sources

Adverse drug reaction (ADR) data can be found in a number of sources. Useful resources to start your search include the BNF, SPC, Martindale and AHFS Drug Information [1,3,4]. 

This is a completely new edition of what has become the standard reference text in the field of adverse drug reactions and interactions since Leopold Meyler published his first review of the subject 55 years ago. Although we have retained the old title, Meyler s Side Effects of Drugs, the subtitle of this edition, The Encyclopedia of Adverse Drug Reactions and Interactions, reflects both modern terminology and the scope of the review. The structure of the book may have changed, but the Encyclopedia remains the most comprehensive reference source on adverse drug reactions and interactions and a major source of informed discussion about them. 

Since the last edition of this book the internet has become a valuable source of information on adverse drug reactions and pharmacovigilance. The various directives, regulations and guidelines referred to in this chapter are now readily available from this source, and the reader will be able to obtain the full versions of all such documents. A paper by Cobert and Silvey 55 contains much useful information and many internet addresses. 

There are several important questions in drug safety evaluation How to detect unexpected adverse drug reactions while handling the multiplicity issue properly How to s)mthesize data from different trials, or even different sources How to deal with rare events How to evaluate multidimensional, complex safety information as a whole Can we monitor a potential safety issue in a continuous manner during a trial so that patients can be better protected These questions lead to some unique statistical challenges in quantitative safety analysis including low power due to rare events, multiplicity. 

The patient safety program must include the development of a continuous assessment process to prevent error occurrence. Event information from data and incident occurrence reports should be reviewed by the multidisciplinary team to prioritize organizational efforts. Sources of data could include incident reports, medication errors, adverse drug reactions, transfusion reactions, sentinel events, and other adverse events. The patient safety program encompasses the patient population, visitors, volunteers, physicians, and staff and addresses improvement issues in every department. Senior leadership must be responsible for ensuring full implementation of the program, with an emphasis on the following functions ... 

The Pharmacokinetics section of each chapter covers absorption, tissue distribution, elimination, and body fluid concentrations. Such pharmacokinetic information is usually not included in other sources and may be useful in forensic investigations or in the clinical setting regarding use of the product in patients with renal or hepatic insufficiency. A section on Adverse Effects and Toxicity follows and includes detailed information on case reports of adverse reactions to the herb. The Interactions section includes discussions of interactions between the supplement and drugs or foods. The Reproduction section follows and is generally limited because of lack of information. Each chapter ends with a discussion of Regulatory Status of the product. The amount of information included in each of these sections varies according to availability. 

Each chapter is followed by one or more case studies to illustrate the clinical use of drugs and problems that may arise from drug-drug interactions and adverse reactions. The situations are not based on any particular individuals rather information has been gathered from many sources including my colleagues in physiotherapy and podiatry and used to construct the cases. 

Westcrholm, B. (1976) Sources of information on adverse reactions and drug consumption. In Proceedings, International Symposium on Clinical Pharmacy and Clinical Pharmacology. Editors V. A. Gouveia, G. Tognoni and F. van der Kleijn. Klsevier/North-Holland, Amsterdam, in press. 

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