Evaluating a restrictive formulary system by assessing nonformulary-drug requests

Nonformulary-drug requests were used to evaluate a restrictive formulary system in a large university hospital, and a telephone survey of eight similar hospitals was conducted to assess the restrictiveness of their formulary systems. Nonformulary-drug requests were evaluated by two drug information pharmacists over a 12-month period (January-December 1984) to assess the frequency with which nonformulary items were ordered, the costs associated with the procurement of nonformulary drug products, and the rationales given by physicians when ordering nonformulary products. Of all nonformulary requests, 65% were for drugs previously evaluated by the pharmacy and therapeutics committee and denied admission to the formulary. A cost savings of $1887 would have resulted if formulary alternates had been used instead of nonformulary products. Excluding 22% of nonformulary items that were requested for the continuation of preadmission drug therapy, only 13% of the rationales for the remaining requests were appropriate. Although the eight other hospitals surveyed said they had restrictive formularies, all had frequent requests and procedures for procuring nonformulary items and some formularies included most available drugs. The formulary system at the study hospital was considered restrictive, but procedures for nonformulary-drug requests limited the effectiveness of the system. If any benefit is to result from formulary systems, hospitals must strengthen their enforcement of formulary restrictions.     

Pharmacoeconomics and formulary decision making

Pharmacoeconomic assessment of formulary actions has become increasingly common in local, national, and international formulary decision making. Tactics for managing medication use include formulary management and drug policies. Pharmacoeconomic data can provide support for these formulary decisions. For example, pharmacoeconomic data can support the inclusion or exclusion of a drug on or from the formulary and support practice guidelines that promote the most cost-effective or appropriate utilisation of pharmaceutical products. Various strategies can be used to incorporate pharmacoeconomics into formulary decision making. These include using published pharmacoeconomic studies and economic modelling techniques, and conducting local pharmacoeconomic research. Criteria for evaluating the pharmacoeconomic literature, suggestions for employing economic models, and suggested guidelines for conducting pharmacoeconomic projects are discussed. Although most formularies are viewed as cost-containment tools, formularies should not be a list of the 'cheapest' alternatives. Today's formulary should contain agents that optimise therapeutic outcomes while controlling cost. Pharmacoeconomic assessments of formulary decisions help to ensure that the agents promoted by our formularies yield the highest outcome per dollar spent. A discussion of the process for formulary action in a US hospital, the influence of pharmacoeconomics on US formularies, and strategies for incorporating pharmacoeconomics into formulary decision making are presented in this paper.     

Survey of formulary system policies and procedures.

A telephone survey was conducted to determine the policies and procedures of hospital formulary systems. Directors of pharmacy at a random sample of 150 community hospitals were interviewed, and letters were sent to each respondent requesting copies of the formulary and drug evaluation form. One hundred thirty hospitals completed the interview (gross response rate of 87%), and 35 evaluation forms and 49 printed formularies were received. Almost all hospitals had a formulary system and a printed formulary; the most frequently stated purposes were to decrease costs and to ensure appropriate therapy. Most formularies received were simple drug lists with no supporting information. The typical pharmacy and therapeutics committee consisted of 11 members, met every month, and reported to the executive committee. About 80% of the responding institutions had formal procedures for considering formulary additions. Less than half had standardized drug evaluation forms. Most hospitals have a formulary system and a printed version of the formulary; however, the formulary often serves primarily as a drug list, with no supporting information.     

Total formulary review--the easy way

In an effort to minimize drug costs, many hospital pharmacy services have limited their drug inventories through the development of a formulary. Evaluation of drug products for addition to the formulary is the responsibility of the Pharmacy and Therapeutics (P & T) Committee. The deletion of rarely used or outdated products is often overlooked. As a means to "clean up" the formulary, Hamot Medical Center (HMC) underwent a total formulary review. Drugs were separated into classes as defined by the American Hospital Formulary Service (AHFS). Approximately three drug classes were evaluated each month by the P & C Committee. Evaluation criteria was based on the following factors: current formulary status, usage statistics, negative comments appearing in six current publications, hospital acquisition cost, and number of formularies containing each product. A final compilation of all deletions and additions were distributed to all medical staff department and division chiefs. Following receipt of all their comments, a final draft of the formulary was made and prepared for publication. This system is a simple, uncomplicated means of either revising or beginning a formulary. It evaluates a drug based on efficacy, individual hospital usage, and cost of the drug while allowing for input of the medical staff. The end result is a formulary tailored to best fit each institution.     

Effect of Misalignment between Hospital and Provincial Formularies on Medication Discrepancies at Discharge: PPITS (Proton Pump Inhibitor Therapeutic Substitution) Study

Background

Medication discrepancies may occur on admission, transfer, or discharge from hospital. Therapeutic interchange within a drug class is a common practice in hospitals, and orders for specific proton pump inhibitors (PPIs) are often substituted with the hospital’s formulary PPI through therapeutic interchange protocols. Rabeprazole is the PPI on the formulary of the British Columbia PharmaCare program. However, different PPIs may appear on the formularies of the province’s hospitals. This misalignment and use of therapeutic interchange may lead to increased rates of medication discrepancies at the time of discharge.

Objective

To evaluate the effect of formulary misalignment for PPIs between St Paul’s Hospital in Vancouver and the British Columbia PharmaCare program and use of therapeutic interchange on the occurrence of medication discrepancies at discharge.

Methods

A cohort chart review was performed to compare discharge discrepancy rates for PPI orders between 2 periods: June 2006 to June 2008, when the same PPI appeared on the hospital and provincial formularies, and July 2008 to July 2010, when the designated PPIs differed between the hospital and provincial formularies. Data for the first study period were used to establish the baseline discharge discrepancy rate, and data for the later period represented the discharge discrepancy rate in the presence of misalignment between the hospital and PharmaCare formularies.

Results

The discharge discrepancy rate for PPIs was 27.3% (24/88) when the 2 formularies were aligned and 49.1% (81/165) when the formularies were misaligned. This represents an absolute increase of 21.8 percentage points in the risk of discharge discrepancies (95% confidence interval 9.8–33.9 percentage points; p < 0.001) when the hospital and provincial formularies were misaligned and the hospital’s therapeutic interchange protocol was used.

Conclusions

Misalignment between the PPIs specified in the hospital and provincial formularies, combined with use of therapeutic interchange, was associated with a significant increase in medication discrepancies at discharge.     

Hospital policies regarding herbal medicines.

The prevalence and content of herbal policies and herbal formularies in the hospital setting were studied. Drug information centers affiliated with hospital pharmacies were surveyed by telephone. Hospitals with policies on herbal products were asked to provide detailed information about the policies. Of 70 hospitals included in the analysis, 53 (76%) had policies and procedures on the use of herbal products. Three hospitals (4%) reported having an herbal formulary. A majority of the existing policies required a physician order for an herbal product to be used inhouse. Many of the policies also required pharmacists to verify labeled product ingredients. Product administration, patient consent, and drug interaction screenings were addressed by some hospitals. Most hospitals reported having policies on the use of herbal products, but herbal formularies were rare.     

Should medical students learn to develop a personal formulary?

Objective

This study was performed to determine whether students who are trained in developing a personal formulary become more competent in rational prescribing than students who have only learned to use existing formularies.

Methods

This was a multicentre, randomised, controlled study conducted in eight universities in India, Indonesia, the Netherlands, the Russian Federation, Slovakia, South Africa, Spain and Yemen. Five hundred and eighty-three medical students were randomised into three groups: the personal formulary group (PF; 94), the existing formulary group (EF; 98) and the control group (C; 191). The PF group was taught how to develop and use a personal formulary, whereas e the EF group was taught how to review and use an existing formulary. The C group received no additional training and participated only in the tests. Student’s prescribing skills were measured by scoring their treatment plans for written patient cases.

Results

The mean PF group score increased by 23% compared with 19% for the EF group (p?p?Conclusion Training in development and use of a personal formulary was particularly effective in universities with a classic curriculum and with traditional pharmacology teaching. In universities with a general problem-based curriculum, pharmacotherapy teaching can be based on either existing or personal formularies.     

Evaluation of the introduction of an antimicrobial drugs formulary in a general hospital in Slovenia

Objective: To analyse the consumption of antimicrobials in a general hospital prior and after implementation of a drug formulary and the economic evaluation of the implementation.Method: Data were obtained from medical documentation collected over a one-month period for all in-patients in four major hospital departments prior to and after the implementation of a drug formulary. The ATC/DDD methodology was used to analyse consumption of antimicrobials. Patients were grouped in therapeutic groups according to their disease and the clinical and economic outcome of the implemented intervention was estimated. Retrospectively, pharmacoeconomical cost–effectiveness analysis was undertaken from the hospitals point of view.Results: The overall use of antimicrobials after implementation in DDD/100 bed-days increased by 16.8%. However, the drug formulary was successfully implemented in 1999, saving 33.7% DDD/100 bed-days of antimicrobials restricted by the formulary. At the same time, treatment time was shortened by 26.5%, with an overall saving of 35.1% per patient.Conclusions: The importance of a drug formulary for antimicrobials was demonstrated in terms of its clinical and economic outcome. A practical case of co-operation between physicians and clinical pharmacists in such a project was also revealed.     

ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing--2004.

PURPOSE: Results of the 2004 ASHP national survey of pharmacy practice in hospital settings that pertain to prescribing and transcribing are presented. METHODS: A stratified random sample of pharmacy directors at 1183 general and children's medical-surgical hospitals in the United States was surveyed by mail. SMG Marketing Group, Inc., supplied data on hospital characteristics; the survey sample was drawn from SMG's hospital database. RESULTS: The response rate was 41.7%. Compared with the results of the 2001 survey, the number of times pharmacy and therapeutics committees met increased, suggesting an increase in efforts to monitor and manage medication use in hospitals. There was an increase in the use of quality-of-life information to make formulary decisions, indicating a shift away from cost-based formularies. There was a decrease in the rates of formulary compliance, but an increase in the use of evidence-based clinical practice guidelines, suggesting the emergence of more comprehensive approaches to improving prescribing. The use of medication-use evaluations increased in smaller hospitals, suggesting greater use of best practices is occurring in these institutions. The use of drug information services continues to decline, as the use of more efficient and easily accessible online sources of drug information increases. Reading back oral orders to improve accuracy dramatically increased since 2001. The adoption of computerized prescriber-order-entry systems continues to be slow, with fewer than 5% of hospitals reporting their use. CONCLUSION: The 2004 ASHP survey results indicate that pharmacists are continuing to improve medication use at the prescribing and transcribing steps of the medication-use system.     

Medicaid formularies: a critical review of the literature.

Studies on the impact of restricted Medicaid formularies were reviewed to assess whether other drugs on the formulary were substituted for restricted drugs, the cost of the substitutes, whether the substitutes were therapeutically appropriate, whether restricted drugs continued to be prescribed, what incremental administrative costs accompanied restrictions, what indirect costs occurred and how the cost-effectiveness of pharmaceuticals impinged on the total cost of illness. The assumption that restriction of specific drugs results in savings in the drug costs proportional to prior usage was shown to be questionable, numerous studies found alternate formulary drugs to the restricted drugs being prescribed, or patients were paying out-of-pocket for denied drugs. There was a tendency for alternate drugs to be more expensive. Little information exists as to the incremental administrative costs of restricted formularies or the therapeutic appropriateness of substituted drugs. One study suggests that major shifts in costs occur due to restrictive formularies through substitution of more expensive services such as hospitalization in lieu of pharmaceuticals. It is concluded that restricting formularies leads to dynamic changes in the total Medicaid program of a complex and often costly nature. Plans to implement formulary restrictions require considerable careful thought.     

Drug product management in health maintenance organizations.

A national mail survey of drug product management in health maintenance organizations (HMOs) is described. The survey covered 570 HMOs--502 by questionnaires mailed to pharmacy directors at individual independent and multistate HMOs and 68 represented by six executives of multistate HMOs who agreed to report aggregate data for their HMO operations. Responses for 180 individual HMOs were received (36% response rate); four of the six multistate HMO executives returned aggregate data. Individual HMO respondents reported using the following methods of drug product management: formularies, 66% (of these, 60% reported using a restrictive formulary or a restrictive formulary with exceptions); MACs, 54%; prior authorization, 44%; contracts for co-marketed and single-source drug entities, 46% for each. Almost all HMOs with contracts also had exclusive or preferred status for dispensing or reimbursement of some drug products. Most HMOs received discounts, manufacturer's value-added services, price protection, rebates based on market share, and rebates based on use as contract incentives; discounts and rebates based on use were chosen as the most preferred incentives. Established methods of drug product management, such as formularies and MACs, were most commonly reported by HMOs; however, nearly half reported using new approaches, including contracts with manufacturers, incentives, such as discounts and rebates based on use, and exclusive or preferred status.     

Literature review on the structure and operation of Pharmacy and Therapeutics Committees

Aim of the review To review the literature on the structure and operation of hospital Pharmacy and Therapeutics Committees from an international point of view and examine the factors that influence decision-making of these committees. Method We performed a literature search in the Medline and Embase databases from 1997 to January 2009 with the search terms: formulary system decision making, pharmacy and therapeutics committee, formularies hospital, drug formulary, survey, drug selection and outcome assessment health care. Inclusion criteria were the following: studies analyzing Pharmacy and Therapeutics Committees published in English or Spanish from 1997 to January 2009. Exclusion criteria were: publications which were editorials or opinion pieces, studies relating to one hospital, and studies where full text could not be attained. The analysis was divided into structural/organizational data and data on factors affecting the decision-making process. Results Seventeen studies met the inclusion criteria. Pharmacy and Therapeutics Committees and formularies were present in more than 90% of the hospitals in four of the five countries examined. Therapeutic interchange programs existed only in two of these countries. The mean number of committee members ranged between six and eight. More than 89% of the committees included a pharmacist. Standard operating procedures were implemented by 89% of the committees. The most influential factors in the decision-making were clinical trial results or drug costs rather than pharmacoeconomic studies. Other local organization-dependent factors were also important. Conclusions The structure and operating procedures of Hospital Pharmacy and Therapeutics Committees are similar in select Western countries. Information from clinical trials is the most influential factor in the decision-making process.     

美国药品成本管理策略对我国医疗机构药品费用控制启示

目的：为控制我国药品费用的不合理增长和促进医疗机构药学服务提供参考。方法：分析美国卫生系统药师协会制定的药品成本管理策略，对比我国医疗机构卫生现状，从而提出完善医疗机构药学工作，进行药品控费的建议。结果：美国药品成本管理策略建议医疗机构基于往年采购量（或金额）和使用量（或金额）开展药品预算管理；规范临床药师素质及临床药学服务质量的同时常态化开展交互治疗；成立药师参与临床治疗且获取医务人员支持的治疗小组；制定药品处方集并将成本较低、效果明显的药品纳入电子处方管理系统；建立药品使用替换制度，严格规范药品替换流程。结论：我国医疗机构可以开展药品预算研究来控制药品使用金额；通过提升临床药师技能来增强药师职业认知；加强药师医师沟通以明确两者职能分工；注重药师处方集制定并管控药品不合理使用；完善药品替换制度来规范药品使用管理。     

浅谈处方集发展的历史、现状与构建原则

目的探讨在我国建立和推行处方集制度的问题。方法借鉴国外的相关政策和经验,就其医疗机构药品处方集系统的历史、现状、构建原则作简要介绍。结果面对不断增加的医疗费用,世界上许多国家的健康保险机构和卫生保健系统已经采取了一系列措施抑制药品费用,包括由消费者承担费用比例的增加和对开处方者采用限制性处方集。结论我国医院处方集的编制还处于探索阶段,希望国外的经验能对在我国推行处方集制度起到一定的积极作用。     

The Tennessee medication therapy management program: A hybrid type 2 effectiveness-implementation trial study protocol

BackgroundPharmacist-led medication therapy management (MTM) programs are considered evidence-based and have clearly defined core components. Despite this, MTM programs are often implemented without fidelity due to notable implementation barriers, such as physician-pharmacist relationships and pharmacist access to patient medical records. To improve MTM implementation, the Tennessee Medicaid program developed a MTM intervention that incorporates implementation strategies to address some of the known barriers to implementation (e.g., formalizing pharmacist-physician relationships through collaborative practice agreements, ensuring pharmacists’ access to medical records).ObjectivesThe purpose of this hybrid type 2 effectiveness-implementation study is to (1) assess the effectiveness of the MTM pilot program in Tennessee (e.g., medication adherence, healthcare utilization, quality and cost of care) and (2) assess the implementation of the MTM pilot program (e.g., feasibility, appropriateness, acceptability, penetration).MethodsThe Tennessee MTM pilot program is being assessed as a hybrid type 2 effectiveness-implementation study with a quasi-experimental design. A mixed methods approach (QUAN + QUAL) for the purpose of complementarity (e.g., answering related research questions). Data will include surveys, interviews, MTM platform encounter information, and medical and pharmacy claims. Initial analyses will include data between January 2018 and December 2019.ConclusionThe study will further add to the evidence base of MTM interventions by testing an intervention that addresses known barriers to implementation and simultaneously collecting data on effectiveness and implementation to speed up MTM translation. The Tennessee MTM program is expected to serve as a guide to other states seeking to expand pharmacist-delivered clinical services to their Medicaid members, particularly those intending to incorporate MTM into programs seeking to improve primary care delivery. Further, by improving the implementation of MTM, the pilot program is expected to improve the reliability of MTM program benefits including healthcare quality and cost and patient outcomes.     

Pharmacy involvement in formulary development: community pharmacists' views

A postal survey was carried out in the Eastern health and social services board in Northern Ireland to evaluate the views of community pharmacists (n= 100) on pharmacy involvement in formulary development. There was one mailing, with a response rate of 66 per cent. Most respondents (78.7 per cent) agreed or strongly agreed that pharmacist involvement in formulary development was important. Almost two thirds of responding pharmacists said they would be prepared to approach a GP in relation to such collaborative work and 27 per cent had had previous contact with GPs on the subject. Respondents considered that their input would be particularly useful in improving prescribing, providing cost advice and developing a closer working relationship with GPs. Evaluation of current levels of interprofessional liaison in relation to prescribing issues showed that 33.3 per cent of the pharmacists were already contacted by a GP regularly and 45.4 per cent contacted a GP regularly. Most (80 per cent) rated their working relationship with the GP as useful or very useful. The results suggest that community pharmacists in the Eastern health and social services board are willing to become involved in formulary development, thereby extending the use of practice formularies in general practice and integrating community pharmacy more fully into the primary health care team.     

Survey of hospital policies regarding low-molecular-weight heparins.

Hospital policies regarding the use of low-molecular-weight heparins (LMWHs) were studied. A questionnaire addressing the formulary status of LMWH products, the use of prescribing guidelines, programs for therapeutic interchange, and policies to promote alternatives to LMWHs when appropriate was prepared. The questionnaire was mailed in January 2001 to pharmacy directors at 70 hospitals located in 19 states. All the hospitals were members of a national group purchasing organization. Forty-nine usable responses were received, for a response rate of 70%. Enoxaparin and dalteparin were the LMWH products most likely to be on the respondents' formularies (98% and 29% of hospitals, respectively). About 29% of the hospitals reported having guidelines on the use of LMWHs. Among hospitals that did not, most indicated that they were considering or would like to implement such guidelines. The most commonly cited barrier to the development and implementation of guidelines was lack of pharmacy personnel. Ten percent of the respondents reported having therapeutic-interchange programs for LMWHs. Cited barriers to therapeutic interchange programs included lack of therapeutic equivalence among products and lack of comparable labeled indications. Policies to promote alternatives to LMWHs were reported by 18% of the respondents. A multihospital survey showed that many hospitals wanted but relatively few had prescribing guidelines for LMWHs.     

Superior hospital formularies: a critical analysis

The drug monograph section of eight superior hospital formularies was examined to (1) determine the type of pharmaceuticals, including dosage forms, listed, (2) delineate patterns of concurrence and divergence in drug acceptance, and (3) ascertain quantitative benchmarks by therapeutic category that may suggest optimum formulary size. The survey also undertook a comparative analysis of marginal drugs and reviewed the role of pharmacy personnel in supporting formulary administration. The critique of pharmaceutical preparations revealed significant patterns of similarity, heterogeneity, perplexity, and redundancy. The investigation also documented problems in dosage form selection and formulary publication. The report concludes that there is a need for more comprehensive studies that incorporate alternative quality assurance methods and focus on the more intangible factors of professional leadership and integrity.