Recognizing, Reporting, and Reducing Adverse Drug Reactions

South Med J. 2001;94(4) 

In This Article

Preventing and Reporting Adverse Drug Reactions

Although completely avoiding ADRs may be impossible, some simple approaches to prevent their occurrence can be applied by individual physicians. Bardana[17] recommended making changes in systems design to avoid both ADRs and medication errors. These include (1) charting all medications when ordered and refilled and, in particular, carefully charting all drug allergies and the types of allergy; (2) paying close attention to the written prescription, eg, correct dosing, proper dosage form (controlled release versus noncontrolled release), avoiding abbreviations, and being wary of medications with similar names (eg, Celebrex versus Celexia); (3) being familiar with all potential side effects; and (4) choosing the oral route when possible, since it is the safest mode of administering a drug. In addition, informing the patient about the medication should include a discussion on risks and benefits of the proposed treatment, including alternatives, as well as risks and benefits of inaction or nonprescribing.

If a provider suspects that an ADR has occurred, proper reporting should be done, since such data are critical for postmarketing surveillance. Hospitals, health care systems, and pharmaceutical companies have systems in place to facilitate the reporting of ADRs. If a serious adverse event occurs, it can be directly reported to MedWatch, a program begun in 1993 by the FDA to monitor ADRs (telephone number, 1-800-332-1088; fax number, 1-800-332-0178; Web site, As discussed earlier, the rate at which ADRs are reported is poor, but until a different system is available, individual anecdotal reporting is the only means by which postmarketing surveillance is accomplished.

Other areas of improvement in detecting and preventing ADRs involve fundamental changes within the FDA. Moore et al[14] suggested the following: (1) expand the Office of Post-Marketing Drug Risk Assessment and give it greater independence, as is the case in the United Kingdom; (2) initiate active surveillance of common drug-induced medical problems (rather than relying on spontaneous reporting) and assess for drug involvement in cases of serious disorders, such as birth defects; and (3) develop a manner in which to assess whether physicians are following FDA warnings.


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