Definition Of Adverse Drug Reactions Research Articles

Clarifying Terminology for Adverse Drug Events

Letters4 January 2005Clarifying Terminology for Adverse Drug EventsJonathan R. Nebeker, MS, MD, Matthew H. Samore, MD, and Paul Barach, MD, MPHJonathan R. Nebeker, MS, MDFrom Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, UT 84148, and University of Miami Medical School, Miami, FL 33136.Search for more papers by this author, Matthew H. Samore, MDFrom Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, UT 84148, and University of Miami Medical School, Miami, FL 33136.Search for more papers by this author, and Paul Barach, MD, MPHFrom Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, UT 84148, and University of Miami Medical School, Miami, FL 33136.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-142-1-200501040-00017 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We oppose the recommendation of Otero and Schmitt and others to exclude events related to error from the definition of adverse drug reactions. Doing so would significantly alter the meaning of a term used for decades by the pharmacovigilance community, including regulatory agencies worldwide. Adoption of these new definitions would force agencies to revise regulations and would diminish capacity to analyze trends in rates of adverse drug reactions. The additional complexity of classification also risks exacerbating underreporting of adverse drug reactions by clinicians.The distinction proposed by Otero and Schmitt and others has logical flaws. Regardless of whether ... Author, Article, and Disclosure InformationAffiliations: From Veterans Affairs Salt Lake City Health Care System and University of Utah School of Medicine, Salt Lake City, UT 84148, and University of Miami Medical School, Miami, FL 33136. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoClarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting Jonathan R. Nebeker , Paul Barach , and Matthew H. Samore Clarifying Terminology for Adverse Drug Events María-José Otero and Etienne Schmitt Metrics Cited BySafety 3.0 and the End of the Superstar ClinicianDesigning a Safe and Reliable Sedation Service: Adopting a Safety CultureTerminologia de incidentes com medicamentos no contexto hospitalar 4 January 2005Volume 142, Issue 1Page: 77-78KeywordsAdverse reactionsBehaviorDrug safetyDrugsPharmacists ePublished: 4 January 2005 Issue Published: 4 January 2005 CopyrightCopyright © 2005 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...

The AMSP drug safety program: methods and global results.

The AMSP (Arzneimittelsicherheit in der Psychiatry) study is a drug safety program that ensures the continuous assessment of severe adverse drug reactions (ADR) in psychiatric inpatients under the natural conditions of routine clinical treatment. It developed out of the preceding drug surveillance study AMUP (Arzneimittelüberwachung in der Psychiatrie). Currently 35 hospitals participate in the study. This paper describes the methods of the AMSP, gives detailed definitions of ADRs assessed to be "severe," and discusses the implications of these definitions and the methodological approach for evaluating the AMSP data. In addition, some overall data compiled on ADR rates from 1993 to 2000 are given.

Adverse Drug Reactions: A Review

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 the 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.

Definitions of adverse drug reactions and minimum requirements for their use — cardiovascular disease terms

AbstractThis paper is a report of a pilot project co‐ordinated by the Council for International Organizations of Medical Sciences (CIOMS). It contains definitions of cardiovascular disease terms used in reporting of adverse drug reactions and specifies basic requirements for their use in reporting.

Feasibility study of surveying the adverse drug reaction surveillance systems in a large community of hospitals.

To determine the feasibility of accurately assessing the types of hospital adverse drug reaction (ADR) surveillance systems. Cross-sectional survey by mailed, self-administered questionnaire followed by selected verification interviews. Harris County, Texas. All hospitals in the county with different pharmacy directors. Self description of surveillance system and number of ADRs reported. Forty-nine of 61 hospitals (80 percent) responded to a questionnaire. Forty-seven (96 percent) of the responding hospitals collected information on ADRs with 11 (22 percent) describing their surveillance system as active. Those individuals most often cited as responsible for ADR surveillance included pharmacists, quality assurance personnel, and nurses. Data were verified by personal interviews for 10 hospitals. The number of ADRs reported during the interviews was significantly lower than that reported in the questionnaires. Overall, the reporting of fatal and severe ADRs were more reliable than the reporting of moderate ADRs. These differences were the result of inadequate documentation and the lack of a uniform definition of ADRs. These data suggest that a large-scale ongoing survey of surveillance systems and reported adverse event rates has limitations and the reliability of data derived from a questionnaire should be verified. To improve the accuracy of surveys used to monitor hospital ADR surveillance systems, it is essential to develop reliable definitions for classifying ADRs and surveillance methods, as well as accurate measures of ADR documentation procedures.

Definition of Adverse Drug Reactions

Definition of Adverse Drug Reactions