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APhA REJECTS POLICY TO URGE HOME-USE DIAGNOSTICS DISTRIBUTION BY PHARMACISTS ONLY; ASSN. ADOPTS RESOLUTION ENDORSING THERAPEUTIC DRUG TESTING IN CHILDREN

Executive Summary

Home-use diagnostics and monitoring products should not be restricted to pharmacist-only sales, the American Pharmaceutical Association's (APhA) House of Delegates agreed at the assn.'s annual meeting on March 16-20 in San Francisco. The delegates voted down a resolution, submitted by APhA's Reference Committee on Professional Affairs, which stated: "Recognizing the need to protect the health of the American people through proper instruction in the safe and effective use of home-use in vitro diagnostic and monitoring products, the American Pharmaceutical Association urges appropriate actions to assure distribution of such products solely through pharmacists." The Reference Committee made a slight change in the Professional Affairs Policy Committee's proposal, substituting the word appropriate "actions" for appropriate "restrictions." In background information describing its recommendation, the Policy Committee said that "the committee is concerned with a number of factors that would speak against unrestricted and wide-spread distribution of IVDs, including: instructions more complex than is common for most over-the-counter products; the possibility of false-positive and false-negative results; the inability of color blind persons to properly interpret tests relying on color comparisons; and the need for professional assistance in interpreting results and recommending appropriate action, e.g., referral back to the physician." Recognizing the role of the pharmacist in providing advice and assistance to patients in the growing self-care market, APhA's Policy Committee's statement referred to the 1985 Schering Report VII, "What's Right with Pharmacy," which stated that 50% of the consumers surveyed indicated that the single most important factor in choosing a pharmacy was whether the pharmacist was available to provide counseling. The delegates rejected the resolution because of objections that in its proposed form it might appear to be "self-serving," as a North Carolina delegate commented. However, the delegates agreed that the resolution contained merit in principle and referred the measure back to cmte. for further consideration. In supporting the decision to send the resolution back to cmte., APhA Academy of Pharmacy Management member Richard Penna commented that "the policy does not address the issue of diabetic screening clinics or hypertension screening programs in which pharmacists participate but in which many other health professionals and non-health professionals participate." Penna also said the motion was "ambiguous and nonspecific." For instance, he said, in vitro diagnostic devices could be inferred to mean fever thermometers or urine testing tapes for diabetics. He concluded: "Mr. Chairman, I'm in accord with the general tenor of the recommendation, but I believe it needs additional work and consideration. I urge defeat of this recommendation so that we can get about the business of referring the recommendation back to committee for further work." Another APhA Committee on Professional Affairs recommendation, that "a policy on pharmacy buying groups is unnecessary at this time," was passed by the House of Delegates. The cmte.'s report included comment that "the Reference Committee does not intend in any way to suggest a negative attitude toward pharmacy buying groups." Voting, however, was close because of support for the view expressed by Florida delegate Allen Nichol that "no action [of getting to a one-price system] is a negative response." Explaining the cmte.'s position, chairman Philip Burgess maintained that "the establishment of buying groups [is] a response to a basic problem, discriminatory pricing by manufacturers," and the assn. should direct its resources toward eradicating the disease, rather than "developing measures for its symptomatic treatment." The Reference Committee on Scientific Affairs presented four policies, all of which were adopted by the House of Delegates. New recommendations supported the "use of alternative study designs (such as positive controls)" in testing new drugs and therapeutic drug testing in children "where appropriate safeguards are instituted . . . where the use of the drug has significant indications in children and where there is prior experience with the drug in the adult population." Two Scientific Affairs Committee measures reaffirmed past policies. The House endorsed APhA's stand supporting use of animals in drug research, "humane and adequate regulation" of animal testing and development of alternative research methods. Also reaffirmed was APhA's present policy regarding postmarketing surveillance. The policy relies on pharmacist recognition and reporting of adverse drug reactions. Current postmarketing surveillance practice was challenged in FDA's July 26, 1985 "Plan for Action" as suffering from "underreporting." Other motions carried by the APhA's House of Delegates included proposals that "APhA . . . actively seek enactment of legislation to modify the Non-profit Institutions Act to eliminate exemption for all health care institutions that dispense, issue, or supply prescription drugs and devices"; that APhA encourage "efforts that would require the listing of all active ingredients of a food promoted as a drug or drug product in written promotional and advertising material"; and that APhA support "programs that will actively market the cost-effective benefits of comprehensive pharmacy services to patients and payors."
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