Medication compliance is a hot topic these days, both in Washington and beyond the Beltway. For example, one of the concerns PBMs have had about a medical data privacy law is that they might not be able to get the kind of patient information they need—from pharmacies or physicians—to run the kind of compliance programs they think are necessary.

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Most of our readers are working hard in hospitals, managed care organizations, and other settings to reduce the epidemic of medical errors, especially those relating to the delivery of prescription medication. Indeed, volumes have now been written about medical error reduc-tion, and major national organizations are spreading the error-reduction gospel everyday. Progress appears to be painstakingly slow; however, even federal agencies such as the FDA and CMS [Centers for Medicare and Medicaid services (formerly HCFA)] are beginning to quietly seek a legislative role in error reduction.

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After a few years of revving up its regulatory engine, the Food and Drug Administra- tion (FDA) is ready to move forward with a proposal for bar coding pharmaceuticals. The idea is to use bar coding to cut down on the kinds of medication errors that were first highlighted in the National Academy of Science’s November 1999 report, ‘To Err is Human.”

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Depending on the drug-shortage profile, task forces might be created to determine what, if any, restrictions or interchanges are appropriate. Subsequently, the information is presented at the drug use committee and drug use and formulary review subcommittee of the P&T committee. Ultimately, the P&T committee reviews and accepts formulary recommendations and distributes communications about the shortage and alternatives, along with any approved restrictions. Involving key physicians who frequently prescribe the drug is helpful in developing and implementing recommendations. If time does not allow for all of these steps, an expedited review and approval process is conducted.

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During the assessment phase, the coordinator of purchasing and inventory control determines the duration and reason for the shortage. If it is determined that a short-term shortage will occur, drug quantities are ordered based on allocation by the wholesaler. If long-term shortages or unexpected emergent shortages are confirmed, the director of pharmacy delegates clinical assessments of the drug shortage to a clinical pharmacy specialist. For both long- and short-term shortages, an assessment is made of utilization specific to our organization. This includes the number of doses used per week, the supply on hand, the frequent prescribers, and the usual indications.

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The incidence of significant drug shortages has been gradually increasing since the early 1990s. Reasons for the drug shortages have included, but are not limited to, a lack of raw materials, manufacturing difficulties, voluntary recalls, and shutdowns of manufacturing plants by the Food and Drug Administration (FDA). Also, there have been more occurrences as pharmaceutical manufacturers discontinued drug product lines. Because of the shortages, pharmacies have faced an ongoing challenge to provide equivalent medications to patients without negatively affecting the quality of patient care. Despite these efforts, therapeutic options have not always existed. Therefore, hospital pharmacies have been forced to search for other buying options, therapeutic alternatives, or allocation strategies when limited supplies were available. The purpose of this article is to describe the survival strategies used by our hospital pharmacy in overcoming drug shortages. Strategy phases include shortage anticipation, assessment of shortage (management, clinical, and financial perspective), committee approvals, and education. Examples of therapeutic options will also be provided.

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Speaker: Terry S. Latanich, JD, Senior Vice President for Government Affairs, Merck-Medco, Franklin Lakes, New Jersey.

Mr. Latanich’s presentation covered the Medicare drug benefit, Medicare-endorsed prescription cards, re-importation of prescription drugs, the Patient’s Bill of Rights (PBOR), generics legislation, and issues affecting the composition of P&T committees.

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