Adverse Drug Reactions: A Review
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0092-8615/98 Copyrighf 0 1998 Drug Information Association Inc.
ADVERSE DRUG REACTIONS: A REVIEW MUNIRN. GHARAIBEH,* MD, PHD, MHPE, FCP, MD, MS, AND HOWARDE. GREENBERG, Sco-rr A. WALDMAN, MD, PHD, FCP Division of Clinical Pharmacology, Departments of Medicine and Biochemistry and Molecular Pharmacology, Thomas Jefferson University, Philadelphia, Pennsylvania
The focus of this review is to increase the knowledge and raise the awareness of health care professionals with respect to adverse drug reactions (ADRs) and to integrate the various elements of this subject in a comprehensive fashion. The review addresses the definitions of ADRs, and their epidemiology, demographics, and economics. Risk factors for the development of ADRs are defined, their general pathophysiological mechanisms are presented (type 1 or “predictable” and type 2 or “unpredictable”),and their causes and subclassifications are described. A paradigm for diagnosing ADRs is suggested and criteria are presented that assess rhe causal relationship between drug administration and clinical observations, Laboratory and clinical diagnostic and investigative methods that aid in ADR reporting mechanisms are reviewed. Methods to prevent ADRs and increase compliance in reporting are also discussed. Key Words: Adverse drug reaction; Drug effects; Epidemiology; Food and Drug Administration
INTRODUCTION ADVERSE DRUG REACTIONS remain an important issue in drug development and clinical use. The increase in the number of pharmacotherapeutics and other chemical entities to which the general population is exposed and has access necessitates critical consideration of this important problem by health care professionals and the drug development community. Drugs can produce predictable but tolerable toxic side effects at therapeutic doses,
*Award= of an Educational Commission for Foreign Medical Graduates Fellowship at Thomas Jefferson University under the International Medical Scholar Program.
Reprint address: Munir N. Gharaibeh, MD. PhD, MHPH, Department of Pharmacology, Faculty of Medicine, University of Jordan, Amman, Jordan. E-mail: MG@UJCED. Edu.
which are related to their pharmacology. In addition, unpredictable toxicity can occur which is unrelated to the pharmacological actions of these compounds. Therefore, AD& are a rather complex issue, which requires special attention: they involve patients, medical professionals, the pharmaceutical industry, drug regulatory agencies, and academic scientists. Although there are many problems which can be associated with the introduction of drugs into the human body, ADRs represent only one of eight identified categories of drug-related problems. These drug-related problems are summarized in Table 1 (1). Identification of an ADR is a task which involves important decision making at all levels of the health care system. In modem drug development, the risks of toxicity of available drugs are always weighed against the needs and efficacy of the drug under investigation. Due to the limited number of available drugs in the pas
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