FDA Can Further Improve Its Adverse Drug Reaction Reporting System

HRD-82-37: Published: Mar 8, 1982. Publicly Released: Mar 8, 1982.

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GAO reviewed the Food and Drug Administration's (FDA) adverse drug reaction reporting system, because a comprehensive survey of FDA monitoring of prescription drugs showed that many of the problems identified in a previous report still exist. In that report, GAO noted that the reporting system was underused as a tool to regulate marketed drugs.

GAO found that medical officers are making more use of the reporting system than they previously did. Many said that the system is useful and is improving. The Division of Drug Experience has offered seminars and workshops on the capabilities and limitations of the reporting system. Despite this training, some medical officers indicated that they were unaware of what the system could do. GAO reviewed individual drug reaction reports submitted by the manufacturers and found that less than half had been entered into the system and only 60 percent had reached the Division. As a result, the system failed to identify some potentially serious adverse reactions. FDA needs all the information available if it is to make timely determinations on the need for regulatory action. The procedures for routing adverse reaction reports submitted by manufacturers were revised to allow reports to reach the Division sooner. This change, however, may not result in more reports getting into the system. Because of the current budget situation, additional staff and resources may not become available, and FDA should explore alternative methods of evaluating and entering reports into the system. The Division entered over 115,000 reports into the adverse reporting system. The largest number of reports were received from manufacturers. Little has been done to encourage reporting from sources other than manufacturers, but the Division plans to increase nonmanufacturer reporting. GAO explored alternatives of increasing adverse reaction reporting.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: Discussions within FDA and with the Assistant Secretary for Health resulted in a decision that no action should be taken at this time. FDA is continuing communication activities involving other federal health professionals.

    Recommendation: The Secretary of Health and Human Services should direct administrators of hospitals within HHS to cooperate with the Division of Drug Experience by establishing and using reporting systems in their hospitals.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: Discussions within FDA and with the Assistant Secretary for Health resulted in a decision that no action should be taken at this time. FDA is continuing communication activities involving other federal health professionals.

    Recommendation: The Secretary of Health and Human Services should encourage other federal agencies operating hospitals to develop an adverse drug reaction reporting system.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to explore alternative methods for evaluating and processing nonserious, known reactions to drugs. Consideration should be given to not entering into the system some of the common, known reactions which add little or nothing to the knowledge of marketed drugs.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health and Human Services should require the Commissioner, FDA, to instruct the Division of Drug Experience to solicit feedback from medical officers in the Office of New Drug Evaluation as to how the system could be improved to better meet their needs and implement those proposals which are cost effective and could increase medical officers' use of the system.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health and Human Services (HHS) should require the Commissioner, FDA, to require medical officers to attend seminars and workshops sponsored by the Division of Drug Experience intended to train them on the capabilities of the adverse drug reaction system.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Not Implemented

    Comments: The agency determined that toll-free or collect call telephone service would be feasible but cannot implement the recommendation due to lack of funding.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to explore alternative methods, such as toll-free or collect-call service, to increase the quantity and quality of reports from nonmanufacturer sources.

    Agency Affected: Department of Health and Human Services

 

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