US HHS OKs MedGuides, Despite Objections

27 January 1997

Over objections from several medical groups and pharmaceuticalmanufacturers, a voluntary public/private MedGuide plan to give patients better information about their prescription medicines has been approved by US Health and Human Services Secretary Donna Shalala.

The plan was created by a 34-member commission of doctors, drugmakers and patient advocates at Congress' request after it had rejected a mandatory drug information plan proposed by the Food and Drug Administration. Its goal is to end reported widespread errors in the use of medication, which, a 1995 study found, cause $77 billion in medical expenses annually.

The plan encourages pharmacists to distribute to everyone getting new prescriptions a standardized, easy-to-read pamphlet describing the drug's uses and possible side effects and interactions. This will include all FDA-approved uses; doctors and pharmacists can provide further data about possible uses case-by-case. If the voluntary program does not ensure that 75% of patients get adequate drug information by 2000, and 95% by 2006, the FDA's mandatory plan will be imposed. The plan also calls for government officials to conduct periodic surveys to monitor progress towards the goal of 95%.

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