Healthy Skepticism Library item: 3134

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Publication type: Journal Article

Alloza JL, Lasagna L.
A comparison of drug product information in four national compendia
Clinical Pharmacology and Therapeutics 1983; 33:269-277

Abstract:

Four widely used compendia of prescribing information have been received to examine the way in which some drug companies recommend uses for several anti-inflammatory products and describe the major dangers in their use. The Physician’s Desk Reference (PDR) cites the greatest absolute number of indications for steroids with systemic action, as well as the greatest number of contraindications, warnings and precautions, and adverse effects. The total number of precautions appearing in the PDR is three times the mean for the other compendia, and the number of adverse effects is four times the mean of the others. Together, these other compendia contain 70.5% of the number of words in the PDR. The PDR contains statements that are strongly directive for the physician and that do not appear in the other compendia. Regulatory and social differences may at least partially explain these discrepancies.

Keywords:
*analytic survey/Spain/Mexico/Brazil/United States/commercial compendia/quality of information/developing countries/developed countries/regulation of promotion/Food and Drug Administration/FDA/EVALUATION OF PROMOTION: COMMERCIAL DRUG COMPENDIA/EVALUATION OF PROMOTION: COMPARISON BETWEEN DEVELOPING AND DEVELOPED COUNTRIES/PROMOTION AND HEALTH NEEDS: PROMOTION IN DEVELOPED COUNTRIES/PROMOTION AND HEALTH NEEDS: PROMOTION IN DEVELOPING COUNTRIES/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION