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PubMed1999

Formulary submission guidelines for Blue Cross and Blue Shield of Colorado and Nevada. Structure, application and manufacturer responsibilities.

From 1 January 1999, all requests by pharmaceutical manufacturers and others to Blue Cross and Blue Shield (BCBS) of Colorado and Nevada for the listing of new pharmaceutical products or any proposed change to the formulary status of an existing product must be accompanied by a submission which meets the informational and analytical standards set out in the BCBS Guidelines for Formulary Submissions for Pharmaceutical Product Evaluation. These submission requirements relate both to the anticipated therapeutic impact of a new product and to claims made as to its anticipated pharmacoeconomic impact. The guidelines have been developed because BCBS is concerned that decisions to admit a drug to formulary have been based in the past on incomplete information. In order to rectify this situation (and to meet quality control objectives), it has been decided that all submissions to BCBS should meet a common information standard that describes both the characteristics of the product and its expected impact in a disease or therapeutic area. Unlike guidelines that have been introduced in countries such as Australia and the Canadian Province of Ontario, these guidelines take an explicit systems approach to the case a manufacturer must make before a product is considered for formulary listing. While the notion of systems impact requirements is not new, this is the first time that a managed healthcare system in the US has adopted this explicit perspective and notified manufacturers that traditional pharmacoeconomic evaluations may not meet the information needs of drug purchasers. The purpose of this paper is to describe the BCBS formulary guidelines and to demonstrate how manufacturers are expected to meet the information needs of a systems impact perspective in submissions to the pharmacy and therapeutics committee.

Blue Cross Blue Shield Insurance Plans↗
PubMed1999

Formulary management of proton pump inhibitors.

The management of dyspepsia has been radically altered by the discovery of the role of Helicobacter pylori and the advent of proton pump inhibitors (PPIs). The use of PPIs alone as antisecretory agents and as part of triple therapy regimens for H. pylori eradication accounts for a significant percentage of any healthcare system's drug budget. Thus, it is important to take into account a variety of factors when devising a formulary and considering which PPIs to include. Consideration of 3 factors are particularly crucial in this process, namely therapeutic efficacy, tolerability and cost but several other clinical and economic parameters should also be considered. The mechanisms of action of all 4 PPIs currently available (omeprazole, lansoprazole, pantoprazole and rabeprazole) are very similar, with any small differences in pharmacological properties unlikely to be of clinical significance. Therapeutic efficacy in patients with acute reflux oesophagitis is again very similar for all 4 PPIs at their standard dosages; all agents are superior to H2-antagonists. Data on maintenance therapy for reflux oesophagitis also suggest similar efficacy for omeprazole and lansoprazole; data on pantoprazole and rabeprazole are awaited. For the treatment of H. pylori-related ulcers, the consensus at present is for PPI-based triple therapy. Again, all PPIs seem equally efficacious for this indication but pantoprazole and rabeprazole have yet to receive licences for H. pylori eradication therapy (HPET) in most countries. Drug tolerability is another critical issue to consider in formulary inclusion decisions. As a class, the PPIs are well tolerated. Minor drug interactions are reported for omeprazole, lansoprazole and rabeprazole but not for pantoprazole. However, whether or not this is significant in clinical practice is open to debate. Most of the pharmacoeconomic data in these indicators, to date, relate to omeprazole and, to a lesser extent, lansoprazole. Certainly, the studies on these 2 drugs confirm the superior cost effectiveness of PPIs over H2-antagonists in the treatment of reflux oesophagitis and peptic ulceration in both the short and long-terms. Although data are awaited, there is no reason to suggest that this will be any different for pantoprazole and rabeprazole. PPI-based triple therapy for H. pylori eradication appears to be the most cost-effective treatment option for H. pylori-related peptic ulcer disease. It is clear that PPIs are superior in several regards to previously used medications in the treatment of dyspepsia. Which PPI(s) to include in a particular formulary is a more difficult decision. On review of many criteria involved in formulary decisions, differences between the individual PPIs appear minimal. The relative acquisition costs of the PPIs vary nationally and internationally and this may be a critical factor in formulary inclusion decisions. However, one should not ignore non-economic factors, as these should form the basis of any sound drug policies.

Anti-Ulcer Agents↗
PubMed2006

Narrative review: the U.S. Pharmacopeia and model guidelines for Medicare Part D formularies.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 includes a provision directing the Secretary of the U.S. Department of Health and Human Services to request that the U.S. Pharmacopeia (USP) develop a list of categories and classes (the USP Model Guidelines) that can be used by prescription drug plans in developing their formularies for the Part D prescription drug benefit. The Centers for Medicare & Medicaid Services (CMS) used the Model Guidelines and USP's related listing, termed the Formulary Key Drug Types, to evaluate prescription drug plan formularies submitted by prescription drug plan sponsors intending to provide the new Part D benefit. This article recounts how USP's all-volunteer Model Guidelines Expert Committee developed the USP Model Guidelines and Formulary Key Drug Types, working under a cooperative agreement with CMS in response to the Secretary's request. The Model Guidelines and Formulary Key Drug Types are updated annually to reflect advances in evidence-based medicine, thereby offering timely guidance to CMS and to prescription drug plans based on USP's demonstrated expertise in setting standards.

Drug Prescriptions↗
PubMed1995

Diffusion of innovation II: Formulary acceptance rates of new drugs in teaching and non-teaching British Columbia hospitals--a drug development perspective.

Diffusion theory was used to examine differences in adoption rates of new drugs by British Columbia teaching and non-teaching hospitals. Surveys were mailed in September 1990 to 41 hospital pharmacies (response rate = 88%), requesting hospital pharmacy directors to provide formulary inclusion dates of 29 study drugs marketed between July 1987 and March 1990. Of the 36 initial responses, 31 were suitable for further analysis and these were surveyed again in April 1993 (response rate = 100%) as to the formulary status of drugs not initially approved. The second survey ensured that all study drugs would have at least 36 months on the Canadian market when determining formulary acceptance times. Of the 29 study drugs, six were not approved for use in any of the 31 study hospitals. The six teaching hospitals had a median formulary approval time of 8.0 months compared to 12.8 months in the 25 non-teaching hospitals for the 23 study drugs. Although 21 of 23 study drugs were approved for use earlier in teaching hospitals than non-teaching hospitals, only alfentanil was found to be adopted significantly earlier (U = 11, n1 = 5, n2 = 19, alpha = 0.05). Variations in formulary approval times for new drugs have a bearing on patient care, Pharmacy and Therapeutics Committees, hospital budgets, and pharmaceutical firm revenues.

British Columbia↗
PubMed1995

Results of our national survey. Current formulary decision-making strategies and new factors influencing the process.

Formulary recently conducted a survey of 2,000 of its readers to uncover what forces are at play in their formulary decision-making processes. Topics included general philosophies toward formulary decision making, philosophies toward adding and deleting products, influences on the process, trends related to product reviews, formulary management strategies, drug information educational strategies, and new approaches to the formulary decision-making process. Some 295 surveys (14.75%) were returned. Highlights and analyses of the survey findings are presented for your review and comparison with your practice setting's approaches.

Attitude of Health Personnel↗
PubMed1995

Developing and implementing a statewide formulary system: one state's experience.

Prior to the Pennsylvania Department of Public Welfare (DPW) implementing a statewide formulary for its 21 mental health hospitals and mental retardation facilities, each facility had its own drug use policy. In many facilities, drugs were ordered with little or no cost-containment or drug-management consideration. To change drug purchasing and usage policies, a task force was created to develop a state formulary system. The task force appointed a formulary subcommittee to research and make recommendations on issues such as drug selections, formulary substitutions, and nonformulary drug use. The step-by-step process of developing and implementing the Pennsylvania DPW state formulary--including pitfalls and successes--is presented.

Drug Costs↗
PubMedDate not supplied

Pharmacy formularies in integrated health systems.

Formulary management implications are described for an Oklahoma integrated health system comprising 14 acute care facilities, numerous owned medical practices, and a fledgling HMO. A systemwide pharmacy director has yet to be appointed; however, the position of pharmacy operations management for the Oklahoma City area has been created. A physician group has been formed that is expected to address system-wide pharmacy and therapeutics (P&T) committees and formulary strategies. Currently P&T committee activities take place at the individual hospital level. The hospitals do not have restrictive formularies. An overall formulary system would likely be patterned after the largest hospital's system, including a formal approval process in which a P&T subcommittee reviews drug use outside established guidelines and the P&T committee asks the appropriate medical department to address the problem. For ambulatory care, the HMO has contracted with a pharmacy benefit manager (PBM), and there is no coordination of formulary efforts between the PBM and health system entities. Although this and other problems remain to be resolved, some standardization of drug use has begun. Also, all entities in the system use the same purchasing group and plan to use the same information system. Drug use among hospitalized patients in this integrated health system is influenced by the usage guidelines established at the largest hospital, and drug use among ambulatory managed care patients is influenced by an external PBM.

Ambulatory Care↗
PubMed1981

A survey of selective administration procedures in formulary maintenance.

The survey attempts to examine various Pharmacy and Therapeutics (P & T) Committees' activities for indications of a rational and objective approach to drugs and the hospital formulary. The objectives were: 1) to gain insight as to how drug products attain formulary listing by examining select P & T Committee's reasons for adding and deleting drugs; 2) to determine whether P & T Committees are attempting to follow generally accepted guidelines for the operation of the formulary system; and 3) to determine how the hospital pharmacist is responding to the rational and/or irrational drug selection by the P & T Committee. The results showed that the hospitals studied appeared to be acting in agreement with the guidelines presented. Definitive statements concerning the activities of the pharmacist and the rational approach of the P & T Committee to the hospital formulary could not be made. The author recommends that P & T Committees begin documenting the methods they utilize to promote and maintain the formulary system in hospitals. This information should be used as an educational tool by the P & T Committee.

Formularies, Hospital as Topic↗
PubMed1984

Perspectives on the hospital formulary.

The hospital formulary system will become increasingly important in future years with the transition to target-rate third party reimbursement. This paper provides an overview of the hospital formulary and its management. A brief history of the formulary system is provided along with some key definitions. The potential benefits and actual effectiveness of a formulary system are described. Various potential problems in managing a hospital formulary are identified along with recommendations to minimize their occurrence.

Formularies, Hospital as Topic↗
PubMed1988

Formulary decision making: identifying factors that influence P&T committee drug evaluations.

This study identifies outcomes related to hospital formulary decision making and estimates the importance of 16 specific types of data to five P & T Committees during the formulary decision making process. The two most important outcomes, according to the Committee members involved in this study, were the effects of the potential formulary addition on the quality of drug treatments available in the hospital followed by its impact on hospital costs. Information about the therapeutic advantage of the potential drug addition, the relative adverse effect profile, and cost information were viewed as especially important. On the other hand, promotional literature provided by pharmaceutical companies and letters of evaluation from respected physicians at hospitals other than their own, were not viewed as important. By understanding the factors involved in hospital formulary decision making, strategies encouraging optimal formulary decisions may be developed.

Data Collection↗
PubMed1983

A method for familiarizing nurses with the hospital formulary.

A slide-tape audiovisual program was developed by a university-based drug information center for the purpose of familiarizing the nursing staff with our institution's formulary. The formulary contains useful information on medications stocked by our pharmacy, including costs, dosage forms, policies and procedures governing the pharmacy department, and many useful tables and figures. It was felt that the nursing staff was not aware of these components and thus, was not optimally utilizing the formulary. Nurses taking a test after the slide-tape presentation scored higher on the average than nurses from similar nursing stations who had not seen the presentation. These results, as well as the positive subjective responses from the individual nurses regarding the presentation, indicate that the slide-tape format is an effective means of acquainting the nursing staff with the hospital formulary. It is anticipated that this new awareness of the formulary will result in its more efficient use and further promote the pharmacy department as an information provider.

Audiovisual Aids↗
PubMed1999

Selective contracting and patient outcomes: a case study of formulary restrictions for selective serotonin reuptake inhibitor antidepressants.

OBJECTIVES: Many health maintenance organizations (HMOs) have selected 1 or 2 selective serotonin reuptake inhibitors (SSRIs) as their preferred drug for treating depression. This study investigated the effect of "single-drug" formulary restrictions on the likelihood of drug therapy completion for new patients, controlling for initial SSRIs used and other factors. METHODS: Prescription drug and medical record data for 187 patients who were newly prescribed SSRIs were retrieved from a single California group practice consisting of 22 board-certified primary care physicians. The group practice contracted with 2 independent practice association-model HMOs with different SSRI formulary restrictions. A multivariate analysis of drug therapy completion was conducted and 2 sensitivity analyses were performed. Completed therapy was based on the patient having achieved 6 months of uninterrupted therapy at a minimum therapeutic dose. RESULTS: Patients from the HMO with a single preferred SSRI (paroxetine) were 80% less likely to complete therapy than were patients from the HMO with 2 preferred SSRIs (fluoxetine and paroxetine) (odds ratio [OR] = 0.200, 95% confidence interval [CI] = 0.083-0.430). This formulary effect was independent of the initial drug used to treat the patient. Drug selection was also found to affect completion rates. Patients treated with sertraline were significantly less likely to complete therapy than were patients treated with fluoxetine (OR = 0.319, 95% CI = 0.105-0.968). Similar results were found for patients taking paroxetine relative to fluoxetine (OR = 0.357, 95% CI = 0.149-0.853). CONCLUSION: These results suggest that the use of single-product formularies may have unintended consequences on patient completion rates, independent of whether or not the most effective product is selected for preferred formulary status.

Adult↗
PubMedDate not supplied

The effect of a closed formulary on prescription drug use and costs.

This study examines the effect of a closed formulary on pharmaceutical use and spending. We compared an employer plan that implemented a closed formulary in July 1997 to a control group with an open formulary, for the nine months preceding and following implementation of the formulary. When controlling for age, gender, and chronic disease score, the closed formulary was associated with significantly lower increases in utilization and expenditures, a higher prior authorization rate, and a reduced rate of continuation with chronic medications in the nine months following its implementation. These findings have implications for the design of prescription drug benefits.

Adult↗
PubMed2002

Effects of restrictive formularies in the ambulatory care setting.

OBJECTIVE: To determine the consequences of restrictive formularies in the ambulatory care setting in 4 areas: overall drug expenditures, overall healthcare spending, changes in the quality of prescribing, and health outcomes. STUDY DESIGN: A MEDLINE search was conducted for English and French language articles, published between 1977-1999, that presented results in quantitative terms. Only articles from industrialized countries were used. METHODS: Information was extracted from each article in the following areas: time period of the study, geographic location and group of patients involved, outcome measurement(s), intervention, study design, and results. RESULTS: Poor methodologic quality made definitive conclusions difficult to draw in most areas. Prior authorization may be effective in controlling drug costs without increasing costs in other areas. Both desirable and undesirable therapeutic substitutions may take place when drugs are delisted from formularies. CONCLUSIONS: The use of restrictive formularies in the ambulatory care setting requires more rigorous research. Before changes are made in formularies, money needs to be set aside for research into short-term and long-term consequences of using restrictive formularies.

Ambulatory Care↗
PubMed2003

Attitudes of physicians toward formularies and services provided by pharmacists.

This study was undertaken to evaluate the attitudes of physicians toward formularies as well as services provided by the pharmacy department in a large integrated delivery system (IDS) with a multispecialty group practice. Surveys were sent to all 282 practitioners in the IDS, requesting information on their use of and satisfaction with the existing printed "Formulary Quick List" (FQL), their satisfaction with pharmacy services, and their attitudes toward formularies in general. A five-point rating scale was used. The response rate was 32%, with the majority from staff physicians. Results indicated that practitioners were very satisfied with the services offered by the pharmacists. Their attitudes toward the FQL were very positive. However, their attitudes toward formularies in general were very negative. There was a significant, negative correlation between attitudes toward formularies in general and attitudes toward pharmacy services, as well as toward the FQL.

Attitude of Health Personnel↗
PubMed2004

Consumer knowledge and perceptions of formularies.

A study was undertaken to determine consumer knowledge and perceptions of formularies. A prevalidated survey containing 11 scored items was administered to 714 consumers waiting to receive prescription medications at 72 community pharmacies in Houston. Overall, these consumers were satisfied with their prescription insurance plans, but their attitudes toward formularies were negative, and the negative perceptions were significantly correlated with satisfaction scores. However, only 25% of the surveyed population had a copy of the formulary, so that a large majority had no knowledge of their formulary or the types of drugs it covered. Efforts to educate patients may reduce the difficulty faced by pharmacists in explaining formulary issues to consumers.

Adolescent↗
PubMed2005

Spillover effects of restrictive drug formularies: a case study of PacifiCare in California.

BACKGROUND: A restrictive drug formulary may influence how physicians treat other, unaffiliated patients, a phenomenon known as the "spillover effect." In a previous study we found significant spillover effects from Maine's Medicaid formulary. OBJECTIVE: To determine whether similar spillover effects exist for private insurers with less restrictive formularies and less dominant market presence. STUDY DESIGN: We treated PacifiCare's formulary changes for proton pump inhibitors (PPIs) as a natural experiment and studied whether these changes spilled onto non-PacifiCare patients in California. Rabeprazole and pantoprazole are the newly preferred PPI products. METHODS: We analyzed the physician-level before-and-after changes in prescribing of rabeprazole and pantoprazole for PacifiCare and non-PacifiCare patients. We also estimated the effect of PacifiCare share of practice on spillover effects using linear regressions. RESULTS: The number of rabeprazole and pantoprazole prescriptions increased simultaneously for non-PacifiCare patients and the increase was positively associated with PacifiCare share of practice. For non-PacifiCare prescriptions, a 10% increase in PacifiCare share of practice led to a 3.3% share increase for rabeprazole and a 1.6% share increase for pantoprazole, respectively (both P < .001). CONCLUSIONS: PacifiCare's PPI formulary changes generated significant spillover effects onto non-PacifiCare patients in California.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

[Dilemmas of the pharmacist, 7th edition of Hungarian National Formulary in practice].

Most important event of year 2004 of the history of Hungarian pharmacy was the release of the 7th edition of the National Formulary. The general part of the new formulary expanded, remarks on the preparations are more detailed and dispensing technologies are more elaborated. Knowledge base on pharmaceutical substances and incompatibility is inserted as novelty. Following the principles of modern pharmacy practice the new National Formulary excludes pills, though it is still accepted as an alternative dosage form. Usage of tablets, hard gelatine capsules and medication stick as a new dosage forms are introduced. The aim of my study was to prepare and examine some new compositions of the new edition of the National Formulary to help the pharmacist's work. Results confirmed the novel solutions of the new National Formulary.

Formularies as Topic↗