Description and Analysis of the VA National Formulary (2000) / Chapter Skim
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What are the Effects of the National Formulary and Related Policies on Quality of Care?
What are the Effects of the National Formulary and Related Policies on Quality of Care?
Pages 120-148
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From page 120... ...
Convincing reassurance regarding quality effects of the VA National Formulary would require data relating formulary and formulary system elements to veterans' health outcomes. Since such data were typically not available, the committee relied on other kinds of information, surrogate or secondary measures, and a few outcome results determined by analyzing hospital discharge data or monitoring the effects of formulary therapeutic or disease management guidelines.
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From page 121... ...
VA sources included short IOM e-mail or telephone interview surveys of pharmacy and clinical personnel in all 22 VISNs and in many hospitals; collection of data from the VA PBM, FLAP, and National Acquisition Center; personal corurnunications from VA staff; official VA, VISN, and hospital policy and procedure documents; VA responses to questions from Congress and written questions from the IOM; VA manuals or handbooks; and the VA PBM Drug and Pharmaceutical Program Management website (www.dppm.med.va.gov)
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From page 122... ...
. The committee also examined drug class reviews, therapeutic guidelines, the nonformulary process, therapeutic interchange policy, and drug utilization review (DUR)
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From page 123... ...
Some special programs were initiated in which pharmacists monitored adherence to specific clinical guidelines in situations where national (Joint National Committee, 1993) and VA (http://www.
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From page 124... ...
Performance of VA clinical pharmacists was reported by Gray (1992) early in the l990s to positively affect proper dosing, indications for drug treatment, laboratory monitoring, and nonformulary requesting.
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From page 125... ...
Traditionally, a pharmacy service representative serves as the VA facility's P&T committee secretary and is responsible for the minutes of the committee meetings. Some VA P&T committees are said to consider staff requests for nonformulary drugs, ensure that mandatory contract sources are honored, develop and revise the facility formulary, monitor adverse drug events, ensure mandatory generic prescribing or substitution, and design and implement local therapeutic interchanges and approve pharmacist substitutions, among others (VA Manual, M-2, Part 1, Chapter 3, Clinical Programs, Pharmacy and Therapeutic Committee, Dec.
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From page 126... ...
There are no formal studies of VISN formulary committees' effects on veterans' care. The necessary, but not sufficient, conditions for producing higher-quality effects would be to maintain a quality listing of drugs, ensure access to drugs through a smoothly functioning nonformulary process, and provide competent management of the National Formulary at the regional level.
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From page 127... ...
The VHA reorganization authorized and funded the creation of VISNs and VISN formularies, planning for the National Formulary, a VA Pharmacy Benefits Management Strategic Healthcare Group, a Medical Advisory Panel, and a VISN Formulary Leaders Committee. These are described briefly in Chapter 1 of this report.
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From page 128... ...
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From page 129... ...
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From page 130... ...
Physician satisfaction and acceptance may influence how the National Formulary affects quality of care. The IOM committee assessed VA PBM performance by examining the quality of the formulary, additions of drugs, drug class reviews and therapeutic guidelines, the nonformulary process, therapeutic interchange policy, and other elements of the system that affect quality.
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From page 131... ...
The drug class review was originally a tool for the pharmacy administration to standardize therapies and reduce inventory. As formularies began to be used to manage drug benefits, drug class reviews came to provide comparative analyses of knowledge about a drug and drug class and the applicability of this knowledge to accepted medical practice.
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From page 132... ...
Since decisions on the recommendations of drug class reviews are made jointly by the VA PBM, the MAP, and VISN Formulary leaders, these recommendations are likely to be implemented in the National Formulary. IOM committee members with experience and expertise as physician leaders of P&T committees and as responsible officials of MCOs and PBMs examined the conclusions and recommendations of nine VA drug class reviews (ACEIs, alpha blockers, prokinetics, LHRHs, CCBs, H2R blockers, HMG CoA RIs, PPIs, and SSRIs)
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From page 133... ...
The IOM committee reviewed all of the clinical guidelines found at the VA PBM drug and pharmaceutical product management website (www.dppm.
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From page 134... ...
Although proper indications for prescribing this drug were followed, monitoring of liver toxicity was spotty. A requirement for documentation of liver function test results on prescriptions improved compliance with monitoring for this adverse drug reaction.
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From page 135... ...
A template for the report will be provided to VISN formulary leaders by the PBM. As noted elsewhere, information from ted and tf]
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From page 136... ...
Historically, one large VA medical center reported that 7.7% (about 25 per month) of interactions between clinical pharmacists and physicians in clinical settings involved nonformulary requests (Gray, 1992~.
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From page 137... ...
TABLE 4.2 Results from IOM Exploratory Inquir,v into the Nonformulary Approval Process Nonformulary Process Not Recordeda (in = 22) Prescription is sent to the pharmacy without a form and is changed to a formulary item Prescription is sent to the pharmacy without a form and is denied Prescription is sent to the pharmacy without a form, and is denied, form is sent in but is denied.
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From page 138... ...
Therapeutic Interchange, Policy, and Results Therapeutic interchange policy and practice are reviewed in Chapter 2 of this report. In this chapter, the committee briefly discusses issues relevant to quality of care including policy direction, evidence for problems in VA interchanges, the relationship to a flexible nonformulary process, and prescriber control.
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From page 139... ...
Inclusion in a closed class on the National Formulary, however, is not the only significant driving force for drug utilization. In drug classes where more than one agent is on the National Formulary, national contracts or drug usage criteria are also associated with prescribing changes.
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From page 140... ...
~ ~ c~ cr) ~ ~ c~ FIGURE 4.3 National formulary policies affect market share of the proton pump inhibitor drugs.
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From page 142... ...
antagonist drug utilization for VISN 20. If veterans travel to a different VISN where local or regional programs to encourage prescribing of particular members of a drug class are in force, they may experience quality problems unless interchange and nonformulary programs are responsive.
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From page 143... ...
Few VISN formulary committees collect and discuss ADEs. VISN 2 and VISN 4 are part of the breakthrough series on ADEs.
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From page 144... ...
Although the VA National Formulary has introduced structural changes related to ADEs, other concurrent changes not resulting directly from the formulary (bar code recording, electronic prescribing, breakthrough series) confound a determination of Formulary effects on ADEs.
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From page 145... ...
The IOM contacted VA patient advocates at each facility for formulary-related complaints. Patient advocates did not code for formulary complaints prior to establishment of the VA National Formulary.
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From page 146... ...
A large VA multicenter study of a therapeutic interchange program between HMG CoA RIs (switching fluvastatin to simvastatin) was carried out in 1999.
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From page 147... ...
General surveys in the medical literature suggest that physicians do not automatically approve of formulary systems, especially those that practice therapeutic interchange. Navarro and Cahill (1999)
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From page 148... ...
In this latter regard, concerns are expressed in this chapter about the nonformulary process, the composition of committees, physician and patient satisfaction, therapeutic interchange policies, notice of interchanges, and education, follow-up and monitoring of clinical guidelines, and addition of newly FDA-approved drugs among others. The committee also strongly urges the VA to focus its considerable health services research capacity on National Formulary and drug treatment issues, in a way that hitherto has not been the case, as the responsibility of a national program to illuminate these issues.
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