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ORAL SOLID DOSAGE FORM STABILITY DATA IN PATIENT USE CONTAINERS IS NEEDED

Executive Summary

ORAL SOLID DOSAGE FORM STABILITY DATA IN PATIENT USE CONTAINERS IS NEEDED from drug firms so that pharmacists can choose appropriate packaging, the American Pharmaceutical Association's Policy Committee on Scientific Affairs suggests in a list of recommendations that the House of Delegates will consider at APhA's annual meeting March 14-18. The recommendation followed committee discussion of "the many factors which could adversely affect the potency of medications after they are dispensed by the pharmacist." Some potential problems include adsorption of drugs like nitroglycerin on or into a plastic polymeric container, degradation of drugs when light passes through a clear container, and the effect of high temperatures. Stability data theoretically would help pharmacists choose appropriate drug packaging. "The least costly way to perform these studies would be to ask the manufacturers to do so," the committe decided, "since they already have the necessary expertise, the analytical methodology, and the drug products." The committee recommended that "the pharmaceutical industry begin to develop stability and compatibility data on all oral solid dosage forms which are routinely dispensed by pharmacists to patients in packaging other than the original manufacturer's package." The studies should be done in "USP-approved containers and the data made available to the profession," the committee said. The committee also recommended that APhA support "the role of the pharmacist to select appropriate drug product packaging." The panel agreed that "most packages of drug products shipped from the manufacturer to the pharmacist today are not appropriate for delivery directly to the patient." The exclusive adoption of unit-of-use packaging was opposed by the committee. Mandatory use of unit-of-use packaging could add significantly to the cost of some drugs, the report notes. Also, mandatory use of unit-of-use packages "would prevent the pharmacist from making appropriate packaging selections for elderly patients who choose not to have child-resistant packaging for the medications." However, the committee recognized that for some drugs and some patients, unit-of-use packaging has "the advantages of increased assurance of stability of the product, decreased chance for dispensing errors, increased efficiency of potential recalls, increased patient compliance, and a positive economic impact on the cost to dispense the medication." APhA's Policy Committee on Public Affairs endorsed voluntary HIV testing of pharmacists who are involved in invasive procedures or other activities that could put patients at risk. "Invasive" procedures would include: "preparation of IV admixtures and other parenteral products; drawing blood for pharmacokinetics services; preparation and administration of parenteral products in home health care practice; and drawing blood for use in screening services, e.g., glucose screening, cholesterol screening." The committee also recommended that "all pharmacy personnel should maintain knowledge of infection control through regular review of current scientific information and guidelines." In addition, the committee suggested that "confidential consultation and reasonable accommodation should be provided to infected pharmacy personnel concerning their professional activities."
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