Posted by James
You can expect the Justice Department to pay more attention to dealings between P&T committees and drug manufacturers, now that the Inspector General at the Department of Health and Human Services has just issued guidance for the pharmaceutical industry. The Inspector General laid out some general ground rules for how both parties can avoid running afoul of federal anti-kickback rules.
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Posted by James
In an academic medical center in a galaxy far, far away, the chairman of the P&T committee’s subcommittee on medication quality received a disturbing phone call from the institution’s Chief Medical Officer, who hurriedly related a most extraordinary story. The account went something like the following:
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Posted by James
Problem: Many hospitals have replaced medication carts and open-floor stock systems with automated dispensing cabinets. These devices can streamline the distribution process, improve first dose turn-around time, and aid in securing drugs. More and more, however, we are finding that access to a wide assortment of medications has the potential to increase the risk of errors because the usual system of double checks is being bypassed. Orders might not be screened appropriately for allergies, duplicated therapies, drug interactions, or maximum doses before drugs are administered. If cabinets contain large quantities of specific medications, it is possible that staff members, unaware of the maximum doses, might administer overdoses.
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Posted by James
The lipodystrophy and metabolic complications that can arise during HAART have not been conclusively associated with one particular drug class or therapeutic agent, although some agents have been implicated more frequently. In fact, in July 2001, the FDA’s Division of Antiviral Drug Products wrote to all manufacturers of antiretroviral drugs and required that they include information on fat redistribution in their package inserts, a warning that had previously been reserved only for the PI class.
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Posted by James
Resistance to HAART therapy has been a major obstacle in the long-term management of HIV infection. Increasingly, to guide drug selection, clinicians are testing for HIV resistance to antiretroviral agents as well as assessing patients’ detailed drug histories. This testing can use either genotypic or phe-notypic methods to determine whether patients have HIV mutations that confer resistance to currently available medications.
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Posted by James
Many studies have cited an association between poor adherence and incomplete viral suppression. In one study, 84 patients were assessed after six months of antiretroviral therapy. A significant association was observed between adherence and virological suppression (P < .001). The authors concluded that a high level of adherence to therapy was important for virological success; below 95% compliance, failure rates increased rapidly. This trial suggested that a few missed doses can have a detrimental effect on clinical outcomes.
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Posted by James
On February 4, 2002, guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents, developed by the Panel on Clinical Practices for Treatment of HIV Infection of the Department of Health and Human Services (DHHS), were revised. A panel subcommittee reviews and updates these guidelines each month (see the AIDS Web site).
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