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Impact of a clinical pharmacy consult service on guideline adherence and management of gabapentin for neuropathic pain.

OBJECTIVE: Our objectives were to (1) determine whether a computerized clinical pharmacy approval and follow-up consult process for ordering new prescriptions for gabapentin for the treatment of neuropathic pain decreased the number of patients without documented treatment benefit while increasing follow-up and documentation of effectiveness, and (2) describe gabapentin use patterns at a Veterans Affairs (VA) Medical Center, including the use of first-line therapies prior to gabapentin therapy for neuropathic pain. METHODS: The clinical pharmacy intervention included review of (1) the indication for gabapentin; (2) the required use and failure or contraindication of 3 first-line therapies: nonsteroidal anti-inflammatory drugs (NSAIDs), tricyclic antidepressants (TCAs), and capsaicin cream; (3) the initial pain assessment; and (4) patient follow-up in 4 to 6 weeks, with repeat pain assessment. A retrospective chart review was performed for all patients who received a new prescription for gabapentin from October 2002 to April 2003 at the Portland VA Medical Center (PVAMC). The outcomes of interest for the provider group versus the clinical pharmacy managed group included follow-up at 6 weeks or less versus follow-up at more than 6 weeks, documentation of treatment benefit, how many of the 3 first-line therapies were tried before gabapentin, and whether the gabapentin therapy was discontinued. RESULTS: There were 237 patients who received a new prescription for gabapentin between October 2002 and April 2003. Of these gabapentin prescriptions, 61% (n=144) were prescribed for neuropathic pain. Of the new gabapentin prescriptions for neuropathic pain, 61% (n=88) were made from approved clinical pharmacy consults, 38% (n=54) were ordered without a clinical pharmacy consult, and 1% (n=2) were not included because the patient received the drug despite denial by the clinical pharmacy consult. The rate of follow-up to assess documentation of benefit of therapy with gabapentin was 87% (n=62) in the clinical pharmacy consult group compared with 51% (n=27) in the provider-managed group (chi2=18.07, P<0.001). Of the patients who were assessed by follow-up, 89% (n=55) of the clinical pharmacy consult group received follow-up within 6 weeks versus 52% (n=14) of the provider-managed group (chi2=12.63, P <0.001). Compared with the patients managed by clinical pharmacists, 43% (n=23) of the gabapentin patients in the provider-managed group had no evidence of prior use of any of the 3 agents required by the gabapentin neuropathic pain guideline, 55% (n=29) had evidence of prior use of 1 or 2 first-line agents, and only 2% (n=1) had evidence of prior use of all 3 required first-line agents, versus 100% (n=71) of the patients managed by clinical pharmacy consult. There was no difference in the rate of continuation of gabapentin therapy in the group of patients who received clinical pharmacy consults (65%) compared with the provider-managed group (68%, chi2=0.11, P=0.718). Of the 148 pharmacy consults for new gabapentin prescriptions that were completed during the 7-month period from October 2002 through April 2003, 60 (40%) were denied, which resulted in the lack of gabapentin use in these 60 patients. CONCLUSIONS: A clinical pharmacy intervention as part of the management of a treatment guideline for appropriate gabapentin use promotes documentation of drug therapy effectiveness in neuropathic pain and prevention of gabapentin use prior to a trial with alternative first-line therapies.

Amines↗

Drug and medical cost effects of a drug formulary change with therapeutic interchange for statin drugs in a multistate managed Medicaid organization.

OBJECTIVE: Therapeutic interchange (TI) interventions are commonly used to manage pharmacy benefit costs. While several studies have considered the effect that TI interventions have on drug costs, most have not considered the effect they have on medical management costs. The purpose of the present study was to assess drug cost and drug therapy management costs of a TI intervention following a change in the drug formulary for 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) drugs, including the conversion of atorvastatin from formulary to nonformulary status. METHODS: A retrospective, quasi-experimental within-subjects design was used in this study. Administrative claims data were obtained from a select northeastern segment of a multistate Medicaid managed care organization (MCO). To be included in the study, patients had to meet the following criteria: (1) they must have had a minimum of 3 atorvastatin prescriptions during a 6-month enrollment phase, (2) they must have been continuously enrolled throughout the 900-day study period, and (3) they must have switched from atorvastatin to another statin between April 1, 2003, and July 31, 2003. The day of the switch from atorvastatin marked for each patient the end of the 12-month pre-TI period and the beginning of the 12-month post-TI period. Two separate dependent variables were developed: (1) statin drug costs (statin cost + dispensing fee) and (2) the costs paid by the MCO for the medical management of statin therapy, including office visit costs and the medical laboratory costs of measuring lipids and creatine kinase, and of checking liver functions. To estimate expenditures over 24 months, a panel analytic technique was used that allows each patient to serve as his or her own control. Multivariate models were used to assess the effects of the TI policy while controlling for age, gender, adjunctive dyslipidemia therapy, comorbidity, presence of a prior coronary artery event, statin compliance, cardiologist management, and disease severity. RESULTS: Of the 3,636 patients who met the study inclusion criteria and were converted from atorvastatin to an alternate statin drug, 129 patients (3.5%) switched back to atorvastatin following the TI. The average statin cost per claim in the 12-month post-TI period was Dollars 70.93, 9.5% less than the average cost in the 12-month pre-TI period (Dollars 78.40). The average cost per patient per year (PPPY) for statin laboratory tests (lipid panels, creatine kinase tests, and liver function tests) increased by 31.5% to Dollars 16.15 in the post-TI period compared with Dollars 12.28 PPPY in the pre-TI period, and medical office visit costs increased by 44.9% to Dollars 20.70 PPPY in the post-TI period compared with Dollars 14.29 PPPY in the preperiod. These increased costs related to the medical management of statin therapy were overwhelmed by an 11.7% reduction in statin drug costs, from Dollars 793.69 PPPY in the pre-TI period to Dollars 701.01 PPPY in the post-TI period, resulting in a net 10.0% reduction for combined statin costs and related medical costs, from Dollars 820.27 PPPY in the pre-TI period to Dollars 737.87 in the post-TI period. After limiting the analysis to patients who did not convert from atorvastatin to pravastatin (which cost more than atorvastatin before the rebate) and controlling for the influence of potential confounders, statin expenditure decreased by 33% (P < 0.001). Multivariate models indicated no statistically significant differences in the costs related to the medical management of statin therapy after the TI compared with before the TI.

Acyl Coenzyme A↗

Duloxetine: a balanced and selective norepinephrine- and serotonin-reuptake inhibitor.

PURPOSE: The pharmacology, pharmacokinetics, efficacy, safety, drug interactions, dosage and administration, cost, and place in therapy of duloxetine for major depression, pain from diabetic peripheral neuropathy, and stress urinary incontinence are reviewed. SUMMARY: Duloxetine is a balanced selective serotonin and norepinephrine-reuptake inhibitor available in the United States for the treatment of major depressive disorder (MDD) and diabetic peripheral neuropathic pain (DPNP). Duloxetine has also been used for the treatment of stress urinary incontinence (SUI). Absorption of duloxetine begins two hours after oral administration, reaching a maximum plasma concentration in six hours. Half-life and volume of distribution are 12 hours and 1640 L, respectively. The recommended dosage of duloxetine is 40-80 mg daily, depending on the indication, preferably split into two doses per day. For the treatment of major depression, duloxetine has achieved remission rates similar to that of existing selective serotonin-reuptake inhibitors (SSRIs). For SUI and pain associated with diabetic peripheral neuropathy, duloxetine has not demonstrated equivalence or superiority to existing therapies. The adverse effects of duloxetine are similar to those of traditional SSRIs. Nausea is common and has been cited as the primary reason for discontinuation of duloxetine in trials. Increases in blood pressure have been mild, but caution should be used in patients with hypertension. Patients with a creatinine clearance of <30 mL/min and patients with hepatic impairment should avoid duloxetine. Duloxetine should not be recommended as first-line therapy for SUI or DPNP. For MDD, duloxetine may be a useful alternative for patients who do not benefit from or are unable to tolerate other antidepressant therapy. CONCLUSION: Duloxetine has been approved for the treatment of MDD and pain associated with diabetic peripheral neuropathy in adults.

Adrenergic Uptake Inhibitors↗

Evaluation of conflicting literature and application to formulary decisions.

PURPOSE: Guidelines were developed for grading the quality, quantity, and consistency of drug literature in support of formulary recommendations. METHODS: Four developmental steps were taken to create a comprehensive literature evaluation system. The first step identified the attributes of a body of literature that were most reflective of its applicability to patient care. The next step defined each domain (quality, quantity, consistency), as determined by the Agency of Healthcare Research and Quality (AHRQ), in terms of the specific qualities to be assessed; a value was assigned to those qualities. Also, a literature search was conducted to identify strategies for evaluating bodies of literature employed in published assessment tools. Following the analysis of previously published systems, which were evaluated with respect to their inclusion of the AHRQ-identified domains, the next step was the development of specific domains and definitions to get a composite grade (with "better" evidence earning more points) for formulary recommendations. The final step was the creation of a system that aggregated the final score for the recommendation. The recommendation was categorized according to quality, quantity, and consistency of supporting evidence, and the total number of points was calculated and the recommendation given letter and numerical grades. RESULTS: The guidelines that were developed allow the user to accurately, consistently, and easily determine the strength of recommendations for a body of literature that may be conflicting. The addition of criteria for quantity and consistency to previously-published grading systems has made the guidelines more objective. CONCLUSION: A system that accounts for the quality, quantity, and consistency of drug literature was developed to assist in making formulary decisions.

Contrast Media↗

Overview of Medicare Part D prescription drug benefit: potential implications for patients with psychotic disorders.

PURPOSE: Medicare Part D prescription drug benefits are reviewed. Potential implications for patients with psychotic disorders in relation to Medicare Part D are discussed. SUMMARY: The newly created Medicare Part D provides prescription drug benefits to many individuals formerly without prescription benefits and, possibly, lower-cost benefits to those who previously relied on other benefits. Participating prescription plans use a variety of pharmacy management tools to minimize costs while providing benefit plans that meet Part D requirements for composition and coverage. Patients then have the challenge of choosing a prescription drug plan that will best satisfy their prescriptions needs. CONCLUSION: The rollout of Part D has not been without problems, and although more Medicare participants are receiving prescription drug benefits at a greater savings, there are concerns that Part D may not provide adequate coverage for all patients or for patients requiring certain types of medications, especially some psychotropic medications. Pharmacists have voiced concerns about the Medicare Part D drug plan in regard to both the degree of coverage it provides to enrollees and the difficulty in administering the benefit.

Aged↗

The reimbursement factor in pharmaceutical regulation: rebates, cost-effectiveness, and practice guidelines.

The delivery of health care services in the United States is increasingly influenced by the coverage determinations of third-party payers. This paper reviews 3 specific initiatives recently undertaken by the federal government that relate directly or indirectly to reimbursement for pharmaceuticals. The 3 initiatives, involving new conditions of coverage and incorporating language and policies that signal broader changes for the future, are the Medicaid Prudent Pharmaceutical Purchasing Program enacted as part of the Omnibus Budget Reconciliation Act of 1990, the national coverage criteria proposed by the Health Care Financing Administration, and the Agency For Health Care Policy and Research with its mandate to oversee the development of clinical practice guidelines.

Centers for Medicare and Medicaid Services, U.S.↗

US Medicaid drug formularies: do they work?

Does the use of a restricted drug formulary achieve cost savings within state Medicaid programmes? Restricted formularies are often justified by putting forth the attributes of a perfectly operating and implicitly costless policy. Analysis suggests, however, that the operation of 'actual' restricted formularies produce realised effects that are substantially at odds with the desired effects. Although the implementation of a restricted formulary can reduce a state's drug expenditures, service substitution causes expenditures to increase elsewhere in the system. Furthermore, direct savings in the drug budget are completely offset by these spillover effects.

Cost Savings↗

The effect of Medicaid formularies on the availability of new drugs.

This study expands our previous work on the availability of new drug introductions to poor patients in states in the USA with restrictive Medicaid formularies. In particular, it focuses on the experience of 9 states over the period 1979 to 1985. In these states, a typical new drug took 20 months after FDA approval to gain acceptance onto the Medicaid formulary. New drug introductions were available to Medicaid patients less than 40% of the time during their first 4 years of market life. Restrictions on availability also extended to drugs ranked high in terms of both therapeutic and commercial importance. There was substantial variation observed across states and therapeutic categories. While formularies are prohibited under legislation recently enacted by the US Congress, state governments may attempt to continue to restrict access to expensive new medicines through prior approval systems. This is an issue that warrants future attention and study.

Drug Utilization↗

Simvastatin: a pharmacoeconomic evaluation of its cost-effectiveness in hypercholesterolaemia and prevention of coronary heart disease.

Epidemiological and intervention study results support reduction of coronary heart disease (CHD) risk, and hence direct and indirect costs, by lowering plasma lipids. Cost-effectiveness of a lipid-lowering strategy thus depends significantly on the extent of plasma lipid decrease achieved. The 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor simvastatin is a well tolerated and highly effective antihyperlipidaemic agent. Despite a current lack of direct evidence that simvastatin reduces CHD incidence, the cost-effectiveness of the drug {in terms of years of life saved (YOLS)} has been studied, based on findings of epidemiological trials. Simvastatin 20 mg/day is more cost-effective than cholestyramine 4g 3 times daily, particularly in men and in those with a higher pretreatment cholesterol level ( greater than 8 mmol/L) and other risk factors. Cost-effectiveness is also enhanced if treatment is started at a younger age (35 to 45 years) and maintained for a defined period rather than lifelong. Thus, while additional direct comparative studies are needed to confirm this finding, present evidence suggests simvastatin is a cost-effective intervention in appropriately selected patients.

Adult↗

A review of limited lists and formularies: are they cost-effective?

The 'limited list' or 'formulary' concept has been used to promote rational use of drugs and to set standards for drug use. Recently the concept has been aimed more toward containment of drug costs. Effective hospital formulary systems assist in purchasing and inventory management. Application of the formulary concept has resulted in savings within specific classes of drugs and in total hospital drug costs. Key features which promote effectiveness are development of policies by prescriber consensus and continued education along with feedback on drug usage. The formulary concept also provides a foundation for appropriate use of drugs in hospitals. In the community setting, limited lists can achieve cost savings and can assist in the rational use of drugs. National limited lists have been less successful in controlling overall drug costs, probably because they have focused on economic effects, rather than education, feedback or user participation. Properly organised drug rationalisation policies embracing the limited list concept can improve health outcomes by promoting rational drug use. They can also contain or reduce drug costs.

Australia↗

Imipenem/cilastatin: a pharmacoeconomic appraisal of its use in intra-abdominal infections.

Imipenem/cilastatin possesses a very broad spectrum of antibacterial activity that encompasses the range of Gram-negative and Gram-positive aerobes and anaerobes usually associated with intra-abdominal and other polymicrobial infections. Its therapeutic efficacy is comparable to that of aminoglycoside/antianaerobe combination regimens, and the most commonly reported adverse effects are similar to those of other beta-lactam antibacterials and are generally of a non-serious nature. The acquisition cost of imipenem/cilastatin is generally greater than that of aminoglycoside/antianaerobe combination regimens, but treatment with the latter incurs the additional costs of multiple intravenous administration, aminoglycoside pharmacokinetic and other monitoring, and possible nephrotoxicity and ototoxicity. The available pharmacoeconomic studies show a trend towards lower total treatment costs with imipenem/cilastatin compared with gentamicin plus clindamycin. Results from other sources suggest that imipenem/cilastatin may achieve further cost savings through reduced duration of hospitalisation. Although further study is required to confirm these trends, it appears that the total treatment cost of imipenem/cilastatin does not exceed that of usual combination therapy and the risk of aminoglycoside-induced toxicity is avoided.

Abdomen↗