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November 29, 1965

Medicolegal Aspects of Reports on Adverse Drug Reaction

Author Affiliations

From the Law Department, American Medical Association, Chicago.

JAMA. 1965;194(9):1003. doi:10.1001/jama.1965.03090220059016

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With the rapid development of new drugs to treat human illness, the problem of adverse reactions to drugs has increased. In order to assure adequate care, the physician must have available to him the most complete and current information obtainable. To assist in providing this information, the Council on Drugs of the American Medical Association has established the Registry on Adverse Reactions.

Physicians and hospitals throughout the country are being urged to report detailed information on instances of adverse effects from drugs to the Registry. Because follow-up of these cases may be required to obtain more information from the physician, it is necessary to identify the cases. A code number is used for this purpose in order to keep the identity of the patient strictly confidential.

Obviously certain medicolegal questions arise when any program of this kind is established. Do physicians or hospitals encounter new legal risks or increase their

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