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Clinical considerations and costs associated with formulary conversion from tobramycin to gentamicin.

The clinical and financial effects of replacing tobramycin with gentamicin on the formulary of a 550-bed teaching hospital were studied. On the recommendation of the pharmacy and therapeutics committee, the formulary aminoglycoside was changed from tobramycin to gentamicin in June 1985; the nonformulary status of amikacin was unchanged. Five weeks later, physician compliance was assessed and the reasons for prescribing nonformulary aminoglycosides were determined. Two four-month-long evaluations were done at 6 and 18 months after implementation to assess patterns of use of nonformulary aminoglycosides. The impact on costs was determined after one and two years by considering use patterns of formulary and nonformulary aminoglycosides, as well as those of third-generation cephalosporins and mezlocillin. Resistance patterns of two gram-negative organisms, Pseudomonas aeruginosa and Serratia marcescens, were assessed for 1982-1987. Finally, the rate of nephrotoxicity in gentamicin-treated patients was determined. During the first five weeks after the formulary conversion, 80.3% (106 of 132) of the aminoglycoside orders received were for gentamicin. After telephone follow-up by the pharmacy department, that figure rose to 93.9%. During the four-month reviews beginning at 6 and 18 months, nonformulary orders accounted for 10.9% and 7.4%, respectively, of the total number of courses of aminoglycosides prescribed. In the majority of these cases, tobramycin and amikacin were used to treat infections caused by organisms with documented resistance to gentamicin or to gentamicin and tobramycin, respectively. No clear-cut changes in resistance patterns for Ps. aeruginosa or S. marcescens could be associated with the formulary conversion.(ABSTRACT TRUNCATED AT 250 WORDS)

Bacteria↗

Computer-based system for maintaining and printing a hospital formulary.

Use of a pharmacy department personal computer (PC) with database management and word processing (WP) systems to maintain a hospital formulary is described. Data input and formatting were accomplished with IBM-PC/XT-compatible equipment, the Nutshell (Leading Edge) database management system, and the Wordperfect (WordPerfect Corporation) WP system. Computer-generated pages were photocopied and placed in loose-leaf binders; reduced copies were made for pocket-size binders. The cost of an outside printing service was eliminated, and the loose-leaf format made it possible to replace only the pages with revisions. The large binders were prominently placed and clearly marked to encourage use by physicians; the number of copies needed was reduced because individual copies were no longer provided to each physician. Excluding first-year one-time costs, the annual formulary maintenance cost (for 250 copies) was projected to be approximately one sixth the cost incurred previously, when 1300 bound formularies were printed annually. Maintaining and printing the hospital formulary on a PC facilitated the updating of the formulary and reduced printing costs.

Computer Systems↗

Poor utilisation and limited impact of formularies on quality of prescribing by hospital doctors.

We determined the utilisation and perceived value of formularies amongst 104 Non Consultant Hospital Doctors (NCHDs). Only 58% routinely carry a formulary, largely the British, National Formulary (BNF) which is considered by 93% to be the best. The overall quality of prescribing in surgical wards was poorer compared to medical wards. However, after distribution of "free BNF's" significant improvements (p < 0.05) occurred, but only in surgical wards and only in aspects of prescribing specifically highlighted (generic prescribing and limiting the duration of intravenous medications). These improvements lasted four weeks before returning to previous levels. Our results suggest that despite recognising their value a significant proportion of Irish hospital doctors do not routinely carry a formulary. The beneficial effects of distributing free formularies was shortlived.

Chi-Square Distribution↗

[Comparison of regional formularies for general practitioners].

OBJECTIVE: To inventory the similarities and differences of the contents of regional general practice formularies. DESIGN: Descriptive. SETTING: Department of General Practice Medicine, University of Groningen, the Netherlands. METHOD: Through personal contacts and an appeal in the journal Medisch Contact, 14 formularies were acquired. Of these, seven recent, still valid Dutch general practice formularies were compared as to pharmacotherapy and health problems listed. RESULTS: Volume and contents of these seven formularies showed major, inexplicable differences with regard to pharmacotherapy, while the choice of the health problems listed was not argued anywhere, and not based on prevalence figures. CONCLUSION: The regional general practice formularies examined showed little similarity in the drugs and health problems listed.

Family Practice↗

"Reverse engineering" a formulary selection algorithm to determine the economic value of pentavalent and hexavalent combination vaccines.

INTRODUCTION: Combination vaccines with overlapping, noncomplementary components are being introduced to reduce the number of separate injections required to immunize children. A vaccine selection algorithm using operations research techniques was developed as a tool for vaccine purchasers to assemble formularies of monovalent and combination vaccines that would satisfy the recommended immunization schedule. The algorithm weighs distinguishing features of economic consequence among competing vaccines to achieve the lowest overall cost to payers and/or to society for immunization. This method was adapted here to solve for the purchase price of several hypothetical future pentavalent and hexavalent combination vaccines that would permit each to "win" a place in such a lowest cost formulary. METHODS: Integer programming and an iterative bisection search method determined the maximum "inclusion price" of 4 vaccines not licensed in the United States as of September, 2001 [diphtheria-tetanus-acellular pertussis (DTPa)-Haemophilus influenzae type b (HIB)-hepatitis B (HBV), DTPa-HIB-inactivated polio vaccine (IPV), DTPa-HBV-IPV and DTPa-HIB-HBV-IPV], in competition with 15 existing formulations of licensed vaccines for these diseases at their March, 2000, federal contract discount prices. Both 5-visit and 6-visit scenarios were studied. Different preparation costs were assigned to lyophilized powder ($1.50), liquid ($0.75) and prefilled-syringe ($0.25) formulations/packaging. Injection costs were varied stepwise from $5 through $45 for each dose administered, shifting from a payer's to a societal perspective. RESULTS: Overall inclusion prices (maximum price for each candidate vaccine to be included in a lowest cost formulary) ranged from $9 to $129 per dose depending on cost assumptions and usage frequency (values would be higher if competing against private-sector vaccine prices). The range was $27 to $68 per dose for DTPa-HIB-HBV, at optimal utilization to avoid extra vaccination. Similarly, as injection costs varied from $5 to $45, DTPa-HIB-IPV ranged from $28 to $75. With the same assumptions, DTPa-HBV-IPV would earn a place in a best value formulary at prices from $35 to $76. As expected the inclusion prices for hexavalent DTPa-HIB-HBV-IPV, $40 to $123, were higher (reflecting more economic value) than for pentavalents. When the assumed injection costs rose to > or = $8, the more expensive HIB-HBV and DTPa-HIB tended to appear in lowest cost formularies, because their cost premium over separate monovalent and trivalent products was outweighed by the savings from one fewer injection. CONCLUSION: Reverse engineering the vaccine selection algorithm provides a tool to demonstrate the economic value of new combination vaccines and to make pricing decisions.

Algorithms↗

Are incentive-based formularies inversely associated with drug utilization in managed care?

OBJECTIVE: To review recent studies comprehensively assessing the impact of incentive-based multitier formularies on pharmaceutical costs and utilization. DATA SOURCES: PubMed (2001-December 2003) was searched using the key terms formularies, cost-sharing, and drug costs. STUDY SELECTION AND DATA EXTRACTION: Studies addressing the impact of implementing multitiered incentive-based formularies as a central component of an outpatient drug benefit were selected. DATA SYNTHESIS: One study using pharmacy claims from 25 employers with data from 402 786 members modeled the range of anticipated plan/employer savings associated with single- to 3-tier shifts and found that, going from a single- to 3-tier benefit results in decreased plan/employer pharmaceutical costs from $650 to $494 (24% decrease) per member per year and decreased pharmaceutical utilization from 12.3 to 9.4 (23.6% decrease) prescriptions per member per year. Another study demonstrated that adding an additional tier decreased pharmaceutical utilization, with a dramatic increase in member contribution offsetting the plan's expected increase in expenditures. This shift in pharmaceutical expenditures appeared to have no effect on overall medical utilization over a 3-year follow-up. Finally, a study converting members from a single- to 3-tier incentive-based formulary, associated with two- to fourfold copayment increases, resulted in a 10% discontinuation rate for angiotensin-converting enzyme inhibitors, statins, and proton-pump inhibitors among members who were primarily hourly employees. For salaried workers, the addition of a tier to their benefit appeared to have minimal impact on pharmaceutical utilization. CONCLUSIONS: Emerging data suggest a potential inverse relationship between pharmaceutical utilization and incentive-based formularies that increase member contribution to drug costs. Future research should focus on identifying price points and percentage increases at which members are likely to begin discontinuing necessary medications.

Fees, Pharmaceutical↗

Enteral formulary management: a cost-effective approach.

Although enteral formularies emerged over 30 years ago, their effectiveness remains to be clearly demonstrated. Enteral formulary (EF) development has occurred over 17 years at the Toronto Rehabilitation Institute (Toronto Rehab), and a historical account is available in the literature. At Toronto Rehab, the creative process begins with a review of specific nutrition support requirements for each patient population, which is coupled with a clinical decision-making algorithm to promote standardized clinical nutrition practices and selection of products. The requirements are translated into detailed product specifications for a streamlined array of oral and tube-feeding formulae. Despite outsourced food service systems, the feasibility of simple in-house production should be considered to help curtail overall costs. The promotion of consistent practices requires nutrition support guidelines, including indications and contraindications for each EF product. Competitive bidding practices and policies that scrutinize non-formulary requests and encourage automatic substitution for non-formulary products promote formulary adherence and contain costs. Ongoing evaluation is intended to capture changes in patient populations and product availability to target opportunities for future EF revisions.

Canada↗

Drug formularies--good or evil? A view from the EEC.

The use of standard treatment schemes is believed to provide easier, safer, and more rational prescribing of drugs. Provision of neutral information on relative costs and merits of individual therapies may induce physicians to prescribe more rationally and cost effectively. A drug formulary must be developed by using clinical evidence of efficacy, taking into account all available preparations, choosing the most cost effective formulation of the drug, and as far as possible complying with formularies implemented by other health institutions. Planning process and preparation time are fundamental to formulary development work. A restrictive drug policy in the hospital environment will save time in the pharmacy, as fewer drugs are handled, and will improve prescribing as the staff have fewer drugs to familiarize themselves with. The potential benefits from increased generic prescribing, lower stock levels, and closer working relationships between members of the formulary team should all be considered. The benefit of this interdisciplinary approach to drug therapy will be rapidly recognized.

Belgium↗

The Drug Formulary Committee in a developing country.

Most developing countries suffer badly from misguided drug selection and purchases, erratic supplies and distribution, and wasteful or inappropriate drug use. Barbados is one of the few developing countries with an active Drug Formulary Committee. This committee develops a formulary that is revised and updated annually, providing guidance on rational prescribing. The Barbados Drug Formulary Committee has operated for 5 years on principles similar to those of a P & T Committee, but with a more restricted list and a flexible approach geared to specific local problems. The Drug Formulary and ongoing educational activities, which have been effective agents in promoting rational prescribing, are described.

Barbados↗

Assessing the impact of wastage on pediatric vaccine immunization formulary costs using a vaccine selection algorithm.

Pediatric immunization is an important factor in providing protection against numerous common preventable diseases. The success of the pharmaceutical industry in developing new pediatric vaccines has resulted in a crowded recommended immunization schedule requiring several clinic visits over the first 12 years of life. Operations research models have been developed and used to make economically sound procurement choices from among a growing number of competing vaccine products. One factor that has not been incorporated into such models is the economic impact of wastage on such decisions. This paper reports results obtained from a vaccine selection algorithm that incorporates vaccine wastage data. The lowest overall cost formularies comparing no wastage costs with wastage costs are presented. A sensitivity analysis of the vaccine formulary with respect to the wastage rates associated with each available vaccine is provided. The maximum permissible wastage rate for each vaccine is determined for which the vaccine earns a place in the lowest overall cost formulary. This research provides health maintenance organizations and healthcare providers information that can be used to gain a better understanding of wastage and its impact on pediatric formulary costs.

Algorithms↗

Prediction of Medicare drug formulary drugs for treatment of overactive bladder.

PURPOSE: With the establishment and signing into law the Medicare and Prescription Drug Improvement and Modernization Act of 2003, also known as Medicare Part D, medical costs are expected to soar. In fact, the program is expected to cost more than a trillion dollars through 2015. Establishment of the Medicare Part D drug formulary will allow cost containment but still absorb patient and physician preferences as well as a consideration of efficacy and safety data. MATERIALS AND METHODS: Potential Medicare formulary choices were examined in the anticholinergic class, as commonly used by urologists, and small in number of available drugs. Formulary selection parties and issues were individually analyzed, including the government in respect to cost containment, patients in relation to efficacy and cost, physicians in relation to preferences and influence and drug companies in relation to lobbying power, country of base of operations and market shares. Costs to Medicare and patients were calculated using discount Internet sites for pricing and simulated using Medicare Part D benefits. RESULTS: Generic oxybutynin is likely to be included because it is the least expensive to patients and Medicare, but it has the lowest efficacy. Detrol LA is likely to be the long acting choice due to efficacy, cost and manufacture by a United States based company. CONCLUSIONS: A simulation of cost analysis of anticholinergics for treatment of overactive bladder would help urologists better understand the Medicare formulary selection process.

Cholinergic Antagonists↗

Access to drug therapy and substitution between alternative antidepressants following an expansion of the California Medicaid formulary.

In May 1996, the California Medicaid Program (Medi-Cal) added two SSRI antidepressants to its formulary to facilitate the substitution of the SSRIs for older medications as clinically warranted, especially in minority patients thought to be particularly at risk for poor outcomes using older medications. Moreover, it was expected that the overall use of antidepressants would increase as patients who experienced sub-optimal outcomes prior to the formulary expansion would again seek treatment once new options were available. The formulary expansion did significantly alter the clinical treatment decision process, resulting in an immediate and sustained increase in the number of depressed patients initiating antidepressant therapy, primarily with the added SSRIs. This increase in SSRI use after the formulary expansion cannot be fully attributed to desired substitution effects, such as the narrowing of racial differences in SSRI use. However, while some expansion in overall antidepressant use may have been desired, the clinical validity of this expansion cannot be determined based on the results presented here.

Adult↗

Priority setting in a hospital drug formulary: a qualitative case study and evaluation.

Dramatically rising costs for new drugs are posing major challenges for hospital budgets. In response to these pressures, hospitals must set priorities for which drugs they will list on their formularies. While there have been studies relevant to decision making in hospitals regarding drugs, none have described how priority setting for drugs in hospitals is done and evaluated it against a framework of how it should be done. In this paper we describe the process of priority setting for new drugs in a hospital formulary and evaluate it using a leading conceptual framework for healthcare priority setting--Daniels and Sabin's 'accountability for reasonableness'. The findings from this study provide an evidence base for developing strategies to improve this hospital's priority setting regarding its drug formulary. The process we utilized here, describing using case study methods and evaluating using 'accountability for reasonableness', is a generalizable process for improving the fairness of priority setting in hospital drug formularies.

Data Collection↗

Pharmacy benefit management, cost-effectiveness analysis and drug formulary decisions.

Pharmacy benefit management companies (PBMs) have evolved over the past decade in response to the increased demand for health care cost containment. Their activities include the implementation of drug formularies and the negotiation of rebates from manufacturers. Our analysis of this industry is based on interviews and materials provided by the top five ranked PBM companies which account for over 80% of beneficiaries covered within formulary plans. The formularies of these companies are relatively inclusive, but they are becoming more restrictive over time. At present the use of cost-effectiveness (C-E) studies in the formulary decisions of PBMs has been limited. In this regard, the surveyed PBMs emphasized that most C-E studies have not compared therapeutic substitutes in populations with characteristics that are similar to those of their clients. Pharmacy benefit management companies also have had strong incentives to focus narrowly on drug costs because they typically manage drug benefits on a "carved-out" basis. However, PBMs anticipate a growing future role in the integrated management of patient care (disease management) for certain high cost chronic diseases and conditions. All of the leading firms we surveyed have disease management programs in development. The importance of C-E studies to PBM decisions is expected to increase significantly as disease management programs are implemented. The data infrastructure inherent to the PBM industry and the increasing number of employees with advanced training in pharmacoeconomics will permit firms to perform their own internal C-E studies. They are also establishing various alliances and joint ventures with drug manufacturers, health maintenance organizations, and academic institutions to perform these analyses. The leading PBMs tend to favor active participation in the development of methodological approaches to C-E studies over government regulations such as those proposed by the FDA in 1995.

Cost Control↗

Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK.

BACKGROUND: Use of unlicensed and off-label medications is common in hospital based paediatric practice. Whilst inpatient prescription can be closely monitored within the hospital setting, it is subspecialties like paediatric gastroenterology, caring for chronically ill children on an outpatient basis that require administration of regular medications in the community. Local practitioners rely on available paediatric formularies or information provided by the tertiary unit for monitoring and dispensing further prescriptions. AIM: To assess the proportion of unlicensed and off-label medications prescribed in a paediatric gastroenterology unit to children discharged to the community and assess adequacy of information about these medications in commonly used British formularies. METHODS: All prescriptions prescribed over a six-month period (Jan-Jul 2002) either in the paediatric gastroenterology outpatient department or for children discharged home after an inpatient stay, were retrieved from the pharmacy database. The main outcome measures were to assess the proportion of medications prescribed for unlicensed or off-label use. RESULTS: 308 patients received 777 prescriptions of which 384 (49%) were for unlicensed or off-label use. Of these 291 (76%) were off-label; 208 in relation to indication and 83 to child's age. 93 of the prescribed medications were unlicensed; 37 were due to manipulation of formulation. Of the commonly used formularies in the UK, only 'Medication for Children(R)' contained dosage information on more than half (9/13) of the most often prescribed off-label/unlicensed medications in paediatric gastroenterology. CONCLUSIONS: Use of unlicensed and off-label medications remains a problem in paediatric practice. Until licensing laws change and more drugs are licensed in children, paediatric gastroenterologists remain responsible for provision of information to families, local practitioners, nurses and pharmacists. Of the commonly used formularies, 'Medicines for Children' is the most detailed and comprehensive, and should be available to all general practitioners and pharmacists in the UK. Clear communication between specialist units and local practitioners is imperative to ensure safe and effective prescribing to children.

Ambulatory Care↗

The Academy of Managed Care Pharmacy Format for Formulary Submissions: an evolving standard--a Foundation for Managed Care Pharmacy Task Force report.

OBJECTIVE: The objective of this report is to provide, in detail, the evidentiary requirements contained in Version 2.0 of the Academy of Managed Care Pharmacy's (AMCP's) Format for Formulary Submissions and to elaborate on several key issues regarding the use of the Format that users, potential users, and pharmaceutical manufacturers have raised since AMCP published the first version of the guidelines in October 2000. BACKGROUND: The AMCP published its Format for Formulary Submissions in October 2000. The AMCP leadership and its members were motivated to develop these guidelines by a growing need to ensure that any increased utilization of medications, biopharmaceuticals, and vaccine products was appropriate and that newer products would bring added clinical and economic value to covered populations. Since publication of the Format, it has garnered nationwide publicity and attracted considerable positive and negative attention. As adoption of the AMCP Format has spread, manufacturers have begun to standardize the framework within which they present population-specific data. Since publication of the AMCP Format, the AMCP and the Foundation for Managed Care Pharmacy (FMCP) have continuously sought input from pharmaceutical manufacturers and health-system pharmacists through various venues to improve and clarify the process. Version 2.0 is the first attempt to address user's comments and concerns. METHODS: The majority of the article text is taken directly from Version 2.0 of the AMCP Format for Formulary Submissions published by the AMCP in October 2002. CONCLUSION: The AMCP and the FMCP believe that the AMCP Format is a tool that will help health systems establish a record of commitment to rational decision making, thus gaining the confidence of patients, clinicians, and members. While providing manufacturers a vehicle for communicating the scientifically based value of their product to a health system, the required evidence to substantiate that value argument allows a pharmacy and therapeutics committee to determine the clinical benefits of a drug, verify any cost savings the drug may generate, and determine the overall cost consequences to their health system. The AMCP Format for Formulary Submissions is an essential tool to evaluate medications, but requires thoughtful consideration as it is used.

Academies and Institutes↗

Reduction in the incidence of methicillin-resistant Staphylococcus aureus and ceftazidime-resistant Klebsiella pneumoniae following changes in a hospital antibiotic formulary.

In 1995, changes in our hospital formulary were made to limit an outbreak of vancomycin-resistant enterococci and resulted in decreased usage of cephalosporins, imipenem, clindamycin, and vancomycin and increased usage of beta-lactam/beta-lactamase-inhibitor antibiotics. In this report, the effect of this formulary change on other resistant pathogens is described. Following the formulary change, there was a reduction in the monthly number (mean +/- SD) of patients with methicillin-resistant Staphylococcus aureus (from 21.9 +/- 8.1 to 17.2 +/- 7.2 patients/1,000 discharges; P = .03) and ceftazidime-resistant Klebsiella pneumoniae (from 8.6 +/- 4.3 to 5.7 +/- 4.0 patients/1,000 discharges; P = .02). However, there was an increase in the number of patients with cultures positive for cefotaxime-resistant Acinetobacter species (from 2.4 +/- 2.2 to 5.4 +/- 4.0 patients/1,000 discharges; P = .02). Altering an antibiotic formulary may be a possible mechanism to contain the spread of selected resistant pathogens. However, close surveillance is needed to detect the emergence of other resistant pathogens.

Acinetobacter↗

Decision analysis in the formulary process.

The use of decision analysis as a tool in making formulary decisions is discussed. Decision analysis is best applied in formulary decisions when factors other than acquisition costs are important in determining overall treatment costs for two products. The decision-analysis process assigns probabilities and costs to various treatments and outcomes. In the case of acute myocardial infarction, the decision analyst would gather data on angioplasty and thrombolysis and assign probabilities and costs for each treatment and subsequent endpoints on the basis of clinical trial data. When such data do not exist, estimates may be generated by expert panels. Applying clinical trial data to an individual hospital is not straightforward because of differences between clinical trials and clinical practice. Analysts and clinicians should evaluate any proposed model for its robustness and adaptability to local conditions and practitioner variation. Access to internal hospital data is essential in developing the model. An ideal decision-analysis model includes all important available interventions and defines and discloses the analyst's time frame and financial perspective. After implementation of the formulary decision, the results can be monitored and, if necessary, adjustments can be made in the allocation of resources. Barriers to effective decision analysis include lack of data and differences in sources of cost and outcome data. Despite the current limitations of decision analysis, clinicians and policymakers may find this technique increasingly useful in the complex formulary process.

Angioplasty↗