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PubMed · 10152873

Adapting a commercially available software program to improve ADR reporting.

A J Ries·M A Kraynak
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Abstract

To facilitate the long-term storage, retrieval, and analysis of adverse drug reaction (ADR) data, the drug information service at the University of Texas Health Science Center at San Antonio selected a computer software program with the capability to compile sets of relational databases. Five subsets were created to form the ADR database--patient demographics, medications, American Hospital Formulary Service classifications, adverse reactions, and case reports. This computerized system allows for quick information retrieval as well as the generation of monthly ADR reports. With such information, trends in ADRs can be identified and targeted for intervention programs to improve patient care and to comply with JCAHO requirements.

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Adverse Drug Reaction Reporting SystemsClinical Pharmacy Information SystemsHospital Bed Capacity, 500 and overHospital RecordsHospitals, TeachingJoint Commission on Accreditation of Healthcare OrganizationsQuality of Health CareSoftwareTexasJournal Article

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BibTeXRIS

A J Ries, M A Kraynak. 1995. Adapting a commercially available software program to improve ADR reporting.. https://pubmed.ncbi.nlm.nih.gov/10152873/

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PubMed2002

Timing of new black box warnings and withdrawals for prescription medications.

CONTEXT: Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE: To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market. DESIGN AND SETTING: Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning). MAIN OUTCOME MEASURES: Frequency of and time to a new black box warning or drug withdrawal. RESULTS: A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years. CONCLUSIONS: Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

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