Managed Care Systems and Emerging Infections Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention: Workshop Summary (2000) / Chapter Skim
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6 Drug Formularies
6 Drug Formularies
Pages 62-75
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From page 62... ...
In practice, however, costs have not been reduced and antibiotic resistance has risen. The following presentation summaries examine how managed care systems govern fonnulary management decisions, how pharmaceutical companies interact with the managed care system, and how formulary decisions could effectively address, in part, the problem of antibiotic resistance in emerging infections with respect to discovery and development of new agents.
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From page 63... ...
The agency acted because of evidence that suggested that medical product manufacturers could avoid regulatory oversight of promotional activities by allowing pharmacy benefit management companies and other health care organizations to disseminate volatile information on their behalf. Although not a legally binding document, the guidance represents FDA's expectations with respect to existing laws.
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From page 64... ...
The 12-month study also examined practical cost-containment practices believed to have no negative repercussions on the quality of health care. These included greater control of second-opinion requirements, increased rigidity of gatekeepers and case managers, implementation of drug and physician office visit copayment levels, greater use of generic drugs, and greater limitation on formularies (defined as the percentage of FDA-approved drugs for a specific condition included in a provider's formulary and not requiring physician approval before generic prescription drugs are dispensed)
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From page 65... ...
Professor of Pharmacy, State University of New York at Buffalo and Director, Clinical Pharmacokinetics Laboratory, Millard Fillmore Health System It has become difficult to target the causes of antibiotic resistance in the current health care environment. There is reason for concern because the cycle of antibiotic resistance is not only complex but it also seems to be intensifying (Figure 6-1~.
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From page 66... ...
Research demonstrated that the minimum effective antimicrobial dose consisted of an area under the inhibitory concentration titer (AUIC; an average level in serum over 24 hours in relation to the MIC)
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From page 67... ...
Because infection control measures are not designed to address either the endogenous production of a pool of resistant organisms or the increase in the inoculum arising from the use of broad-spectrum suppressive antibiotic therapy, it is critical that antibiotic selective pressure be managed if there is to be any hope of successfully suppressing the endemic resistance patterns. Several management strategies have already been implemented to counter some of the less desirable effects of formularies as well as microbial resistance patterns.
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From page 68... ...
, other institutions were able to quickly access information that could assist them with the development of management strategies that combat antibiotic resistance. Sharing of other types of information is also critical to becoming better prepared to address antimicrobial resistance.
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From page 69... ...
Dispensation of new antibiotics alone will not counter antimicrobial resistance; thus, pharmaceutical companies cannot solely be responsible for effectively resolving this problem. A crucial step will involve changing the ways in which hospitals conduct business, such as by using the combined strategies of Infection control and antibiotic management.
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From page 70... ...
These 30 studies not only varied considerably in quality but also involved many different health care settings and a wide range of providers and payers, including hospitals, managed care organizations, Medicaid, and nursing homes. Although the findings suggest that formularies can control drug costs in some cases, these results farther indicated that use of formularies was associated with increases in the costs of other health care services as well as overall costs.
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From page 71... ...
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From page 72... ...
In addition, FDA is uniquely positioned to implement health care policies in an effort to efficiently and swiftly disseminate information on new uses of drugs and medical devices, as well as provide guidance on medical product promotion in the managed care environment and guidance on broadcast advertising policies. A continued revision of guidance and policy is likely to sustain the positive effect that FDA has on health care activities in the changing health care environment.
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From page 73... ...
, it will become critically important to develop and implement strategies so that antibiotic selective pressure is effectively managed to suppress the endemic resistance patterns. Management strategies can be implemented or continued to be enforced to counter some of the less desirable effects of formularies as well as microbial resistance patterns.
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From page 74... ...
New strategies are required to realize cost savings from lower levels of antibiotic use as a result of formulary management decisions, such as conducting benchmarking studies and developing an iterative computerized system to help track antimicrobial resistance. Health care policies that provide efficient and swift dissemination of information on new uses of drugs, and that provide guidance on the promotion of medical products in the managed care environment should be implemented.
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From page 75... ...
FDA is developing guidelines for off-label use, product marketing information, direct advertising to the consumer, and on the role of pharmaceutical benefits management companies; the effects of these regulations on drug development and drug formularies remain to be determined.
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