Magazine article Drug Topics

Final Act

Magazine article Drug Topics

Final Act

Article excerpt

104th Congress

mulls pharmacy

issues as it starts


It's show time for Congress. From now until August, when the political conventions take the stage, most of the star-quality legislative performances will have to go on--or be put off for the new cast, whose tryouts end Nov. 5. After the party nominations of Bob Dole in San Diego and Bill Clinton in Chicago, Congress will have a curtain call in September. But that's likely to be a mad dash of a few remaining must-do bills, so lawmakers of both parties can take their acts on the road in early fall.

For pharmacy, two major wishes on its list are riding on legislation reforming the Food & Drug Administration: killing MedGuide and protecting compounding. But a sweeping overhaul of the FDA is looking less and less likely to make its way through the House and Senate, and anything too radical will face a Presidential veto. So, alternate routes are being sought.

Retention of state any-willingprovider laws looks safer for community pharmacists at this time, and so do federal regulations of nursing homes, which consultant pharmacists favor. Of interest to home care and health-system pharmacists is the overuse of vancomycin, the only antibiotic Medicare covers for home infusion therapy. A legislative prescription could help reduce development of vancomycin-resistant organisms.

Other pharmacy concerns that Congress may address in- clude a patent row between generic and brand-name drugmakers, use of mail order in a federal employee retirement plan, medical record confidentiality, and physician selfreferral. Here's a look at where these issues stand:

MedGuide: Persuading elected officials that their sick constituents will not be better off with a free instruction leaflet to help them make the best use of their medicines does not sound like an election-year winner. But that is pharmacy's task, and it seems to be succeeding. It helps, of course, that one of the capital's least popular agencies among the new Republican majoritythe FDA-is behind the MedGuide initiative. It also helps that pharmacy groups and manufacturers are united in their opposition and, not least of all, that they can make a good case.

With MedGuide, the FDA is proposing that 75% of patients receive useful written information with each new prescription by the year 2000. By 2006, the figure should hit 95%. Under one option, the FDA is considering making the leaflets mandatory.

John A. Gans, executive v.p. of the American Pharmaceutical Association, called MedGuide "a significant step in the wrong direction ... an idea whose time has come and gone." At an FDA workshop, he said "counting the number of patients who receive pieces of paper is a poor way to measure the effectiveness of professional/patient education."

NARD and the National Association of Chain Drug Stores, in testimony submitted to a Senate committee, argued that great strides have been made in having pharmacists voluntarily provide useful written information to patients and described the FDA effort as an attempt to regulate the practice of pharmacy.

All three associations pointed out that standardized leaflets would only confuse patients prescribed drugs for offlabel uses or drugs that can be used to treat many different conditions. "Every individual's prescription information needs are different," said NARD/ NACDS, "and should be treated differently within the judgment of the health-care professional."

In late March, the Senate Labor & Human Resources Committee voted to kill MedGuide by a 13-3 vote. The committee added an amendment to its FDA reform package that would put in place a private sector plan to attempt to achieve the same MedGuide goals without federal regulation. Rep. Michael Crapo (R, Idaho) has introduced a bill that would kill MedGuide outright, which can either stand alone or be added to FDA reform.

*Compounding: This is another area where pharmacy is united in its belief that the FDA is trying to regulate the practice of pharmacy, traditionally the purview of state pharmacy boards. …

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