Implementing an automatic fluoroquinolone therapeutic interchange program in a community hospital

A community hospital developed an automatic therapeutic interchange program for fluoroquinolone antibiotics. After considering efficacy, available formulations, and cost, this P&T Committee selected ciprofloxacin (Cipro) as the class representative for formulary use. The steps taken to implement this automatic therapeutic interchange policy are presented.     

Experience with a two-tiered therapeutic interchange policy

A university hospital's formulary policy for therapeutic interchange is described in which pharmacists can routinely interchange some drugs but must contact the prescribers before interchanging other drugs. For drugs that are not automatically interchanged by the pharmacy, the formulary contains a "class representative," which pharmacy may change as relative prices of drug products change. When a non-formulary drug for which there is a designated class representative is prescribed, pharmacy contacts the prescriber. When a class representative for injectable histamine H2-receptor antagonists was being selected, previous positive and negative experiences with establishing therapeutic equivalence for antimicrobial agents were considered. The implementation of H2 antagonist therapeutic equivalence included the following steps: determining potential cost savings, reviewing the literature, consulting with specialty practitioners, presenting the information to the pharmacy and therapeutics committee, distributing formal bids, and educating hospital staff. Before cimetidine was designated the class representative, 84% of orders for injectable H2 antagonists were for ranitidine; one year later, 90% were for cimetidine. Orders for oral H2 antagonists also changed from predominantly ranitidine to predominantly cimetidine. The hospital's total costs for H2 antagonists decreased 8.4% in one year. The two-tiered approach to therapeutic interchange can reduce drug costs and increase the scope of agents deemed therapeutic equivalents in a manner that is acceptable to physicians and pharmacists.     

A multidisciplinary process to determine, communicate, and manage an antibiotic formulary

This article describes a collaborate process developed by the Pharmacy & Therapeutics Committee to define, determine, communicate, and manage an effective antibiotic formulary. Multiple professional disciplines represented by the antibiotic subcommittee evaluated each classification of antibiotics and recommended a preferred drug(s) for each classification. Decisions were based on relative safety, efficacy, and cost with minimal duplication of therapeutic equivalent antibiotics. A therapeutic interchange policy was unnecessary because extensive communication measures developed by the committee proved effective. The strategy used strengthened pharmacist/physician working relationships. This process permitted rationality and understanding by the medical staff, which resulted in unanimous formulary acceptance.     

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.     

The formulary decision-making process in a US academic medical centre

This article reviews and describes the formulary decision-making process in an academic medical centre. The pharmacy and therapeutics (P & T) committee is the organisational nucleus of the drug use control process in the institutional environment. Thomas Jefferson University Hospital (TJUH), a 720-bed academic medical centre in an urban locality in the US, is used as a model representative of how most of these committees function. Survey responses collected from 29 peer academic medical centres are presented to compare and contrast the structure and function of the P & T committee at TJUH with corresponding procedures in other university hospitals in the US. TJUH is typical of the institutions which comprise the University Hospital Consortium (UHC). The P & T committee of TJUH is composed of 29 members, meets once per month for 10 months of the year, and has a network of 13 subcommittees. TJUH has an intermediately controlled (mixed) formulary, and uses both restricted drugs and treatment guidelines. Of the 29 UHC member institutions responding to the survey, the average P & T membership is 18, the average meeting frequency is 11 times per year, and 83% of these committees have a network of subcommittees. None describe their formulary system as open, 86% have a closed formulary and 14% have a mixed formulary system. There is a restricted drug programme in 76% of the institutions, 79% utilise treatment guidelines, 76% practice therapeutic interchange and all employ generic substitution. Specific areas addressed in this review include the history of the formulary system, the structure and function of the P & T committee, types of formularies, cost containment and the formulary decision-making process, the impact of organisational culture on physician decision making, the role of the pharmacy department, the role of pharmaceutical sales representatives and their impact on prescribing habits, the impact of the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) Agenda for Change on the formulary process, and future challenges.     

Therapeutic substitution in the health maintenance organization outpatient environment

Health maintenance organizations (HMO) are growing in number as a cost-effective way of providing health care. In some, stringent formulary management policies including programs authorizing therapeutic substitution are practiced. Under this concept a drug that has been previously determined to be therapeutically equivalent to a second drug, even though it is not chemically equivalent to the prescribed drug, is automatically dispensed without contacting the prescriber. This study was undertaken to learn the extent and conditions under which therapeutic substitution is being practiced in the HMO setting. A survey was sent to all HMO in the U.S. inquiring into the operation of the pharmacy services. Specific focus was on the operation of the formulary and the policies and procedures being followed. The main goal was to learn how many programs authorize therapeutic substitution, what drugs are allowed, and what procedures are followed once the substitution is made. Of the 481 surveys sent out, 192 (40 percent) usable responses were received. Results indicate that 30.5 percent of HMO pharmacy plans allow therapeutic substitution. These programs were most likely to be of the staff-model or the group-model and least likely to be of the independent practice association type. HMO with an inhouse pharmacy more frequently had policies allowing therapeutic substitution than those using outside pharmacy services.     

Rule-based standardised switching of drugs at the interface between primary and tertiary care

Introduction Changes in drug treatment are frequently mandatory with hospital admission and discharge because hospital drug formularies are generally restricted to about 3000 drugs as compared to the many times this number – 62,000 in Germany – that are commercially available. Without computerised support, the process involved with switching drugs to a corresponding generic or a therapeutic equivalent is time-consuming and error-prone. Methods We have developed and tested a standardised interchange algorithm for subsequent implementation into a computerised decision support system that switches drugs to the corresponding generic or a therapeutic equivalent if they are not listed on the hospital drug formulary. Results The algorithm was retrospectively applied to the medication regimens of 120 patients (774 prescribed drugs containing 886 active ingredients) at their time of admission to surgical wards. Of the prescribed drugs, 52.8% (409/774) were part of the hospital drug formulary, thereby rendering a switch unnecessary. The 365 drugs not listed consisted of 392 active ingredients that were successfully switched to a corresponding generic (84.7%) or a therapeutic equivalent (10.2%). No specific switching procedures were defined for only 2.3% (20/886) of the active ingredients. In these cases, the drugs were either discontinued (4/20) or special drug classes, current diseases or co-medication required manual switching (8/20), or the drugs were continued unchanged and ordered from a wholesaler (8/20). Conclusion Using a standardised interchange algorithm, pre-admission drug regimens can successfully be switched to drugs on a hospital drug formulary. These findings suggest that a computerised decision support system will likely be useful to support this important practice.     

Organization and operation of P & T Committees in the state of Florida: a survey

To determine the structure and function of P & T Committees in Florida, a survey was initiated. Questionnaires were mailed to all 289 hospitals in the state. Topics addressed included hospital demographics (type of service provided, institution ownership, hospital size), P & T Committee structure (size of the committee, membership breakdown by specialty, chairman specialty, number of meetings per year), formulary additions (personnel authorized to request drug additions, process for adding drugs to the formulary, monitoring new drug use), and formulary systems (prevalence of therapeutic interchange programs, methods of communicating formulary changes). Overall survey response rate was 71.5%. In general, P & T Committees in Florida appear to be functioning at a relatively high level. Since there is little current information about the composition and operation of P & T Committees in hospitals around the country, it is hoped that this survey will be useful to P & T Committees that wish to upgrade or expand their activities.     

The expanding role of pharmacy and therapeutics committees. The 1990s and beyond

Traditionally, pharmacy and therapeutics (P&T) committees have been responsible for overseeing the drug use process, using formulary systems to control drug costs. Primarily, these committees act in an advisory capacity as policy-recommending bodies within healthcare systems, for the specific purpose of promoting rational drug therapy. Methodologies utilised by these committees include drug use evaluation, medical staff education, continuous quality improvement, formulary restriction and therapeutic interchange. Future roles of P&T committees will include the evaluation of clinical outcomes information, including quality-of-life issues, to establish policies governing the use of drugs at all levels and in all types of healthcare.     

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.     

Therapeutic decision-making: a model for formulary evaluation

A systematic approach of evaluating medications for a hospital formulary is discussed. The hospital formulary is a program of objective evaluation, selection, and use of medicinal agents in the hospital. In light of the ever-increasing numbers of new and/or improved therapeutic agents, formulary decisions must be made with an eye to the future. Therefore, it appears that the best means of choosing a medication for formulary addition, both clinically and economically, is to choose an agent based on its clinical indication(s). Examples of such indications are presented. Selecting formulary agents by indication rather than by simple drug cost or pharmacologic class should ensure the most effective utilization of therapeutic agents and hopefully a diminution of overall costs.     

Prevalence and cost savings of therapeutic interchange among U.S. hospitals.

The prevalence and cost savings of therapeutic interchange (TI) among teaching, nonteaching, and investor-owned hospitals in the United States was studied. A survey was sent to all directors of pharmacy at hospitals listed in the 1999 American Hospital Association directory as having more than 100 beds; 463 (29.8%) hospitals responded. The survey elicited data about hospital demographics, the policies and personnel involved in TI, and the estimated cost savings incurred by the use of TI. Eighty-eight percent of teaching, 89% of nonteaching, and 100% of investor-owned hospitals reported having established TI policies and procedures; 88% of responding hospitals reported the use of TI as a means of formulary management. Individuals involved in the decision-making process for TI policies included physicians, pharmacists, and pharmacy and therapeutics committee members. Most responding hospitals reported having an automatic interchange procedure, and few required physician consent before the substitution was made. The most commonly substituted medication classes were histamine H2-receptor antagonists, proton-pump inhibitors, antacids, and quinolones. Differences in TI procedures and the medication classes commonly substituted were not significant between teaching and nonteaching hospitals. The annual dollar savings was estimated by 36% of teaching, 38% of nonteaching, and 50% of investor-owned hospitals and determined by record keeping in 18% of teaching, 20% of nonteaching, and 40% of investor-owned hospitals. Eighty-eight percent of teaching, 89% of nonteaching, and 100% of investor-owned hospitals have established TI policies. Significant variation in cost savings occurred when hospitals attempted to estimate the annual dollar savings, as no adequate commercially available software exists to perform this task.     

Therapeutic substitution: has its time arrived?

Therapeutic substitution refers to substitution by the dispenser of a drug product that is not chemically identical but is therapeutically equivalent to the product prescribed, pursuant to guidelines established by the hospital P & T Committee. Until recently, the extent to which this concept has been adopted by hospitals across the country was unknown. Late in 1980, we conducted a nationwide survey of hospital pharmacies to learn more about therapeutic substitution. This paper reviews some of the issues involved, some of the findings of our study, and the pros and cons of therapeutic interchange. It also provides an update as to some of the recent changes that are occurring in therapeutic substitution procedures.     

Building a better online formulary.

The history of and improvements made to the University of Michigan Health System (UMHS) inpatient online formulary are described. The current formulary at UMHS is the third version of the Web-based formulary. The original effort in 1997 consisted of converting word-processing documents to HTML format and exporting this information to the university's intranet. There was no mechanism to search for formulary items, no therapeutic class cross-referencing, and no cost information. Documents and their conversion had to be manually maintained. The second version incorporated a series of automatic daily computer downloads from the inpatient pharmacy computer system. Web pages were built to dynamically display the formulary information from the database based on users' requests. The formulary enabled searching by brand or generic names, provided therapeutic category cross-references, listed the location of products within automated dispensing cabinets, provided accurate cost information, and was always up-to-date. Maintenance efforts drastically decreased. The current version has incorporated additional logic to meet users' needs. If no matches are found, the system expands its search by automatically linking to UMHS's inpatient pharmacy system repository of all drugs, finding matches to what the user entered, and then returning the names of therapeutically similar formulary agents to the user. A cross-index feature allows the system to return all the drugs that fall under the searched therapeutic category. Dramatic improvements have been made to UMHS's inpatient online formulary in the past two years. The current formulary provides a very low-cost, easily maintainable, and effective means to access the formulary and clinically relevant and timely information specific to each medication.     

Effect of patient notification of formulary change on formulary adherence

OBJECTIVE: To evaluate the impact of patient notification of impending formulary changes on formulary adherence. METHODS: This pilot program in a large, Midwest-based health insurer utilized a randomized controlled trial research design. A list of 30 chronic-use medications that were to change formulary status were selected for the pilot. A review of adjudicated pharmacy claims records was performed to identify patients receiving one or more of the formulary change medications on the list. Members of 112 individual health plans of this large health insurer, all of whom were subject to the same drug formulary, were randomized to either the intervention (letter) or control arm. Patients in the intervention arm were sent a targeted communication that described the patient.s formulary change medication(s) and provided therapeutic option(s) for the formulary change medication(s). Pharmacy claims for patients in both arms were examined at 110 days after the date of the mailing to determine if there was a switch to a formulary alternative. Multivariate regression modeling was performed to adjust for baseline differences between the arms. RESULTS: A total of 7,247 unique formulary change medication regimens were identified (3,817 in the control arm and 3,430 in the letter arm) for 6,518 subjects (3,387 in the control arm and 3,131 in the letter arm). A higher proportion of formulary change medication regimens in the intervention arm were switched to a formulary alternative compared with the control arm (19.2% vs. 12.0%, P<0.001). After adjustment for baseline differences, regression modeling indicated that subjects in the intervention arm were 1.33 times more likely to switch to a formulary alternative (P<0.001). CONCLUSION: A letter-based, formulary change notification program is a pragmatic and effective strategy to increase drug formulary adherence. Such a program does not restrict access to medications but, rather, provides education and personalized information that may allow patients to participate more actively in their pharmacotherapy decision making.     

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.     

How to develop a proactive formulary system

To develop a quality formulary system, a proactive approach is necessary. This approach incorporates a prospective product and concurrent product analyses. A prospective product analysis, in turn, involves a review of current formulary agents, those likely to enter the marketplace shortly, and the formation of an expert review panel. This panel's tasks are to examine therapeutic, economic, and humanistic aspects of therapy and to set initial parameters for appropriate and cost-effective use of accepted products. Keys to a successful formulary system are to continuously monitor drug use and compliance with criteria and to work collaboratively with all institutional professionals in the development, implementation, and monitoring of the system.     

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.     

Therapeutic interchange of ampicillin-sulbactam for cefoxitin.

A therapeutic interchange program based on microbial patterns within an institution is described. A change in anaerobic susceptibility patterns, increased prevalence of enterococcal infections, and cost factors provided the rationale for the therapeutic interchange of ampicillin-sulbactam for cefoxitin. Ampicillin-sulbactam was recommended for prophylaxis in intraabdominal or gynecological surgery as well as for treatment for gynecological infections. Cefoxitin was restricted to penicillin-allergic patients and women who were pregnant or breast-feeding. The transition from cefoxitin to ampicillin-sulbactam proceeded smoothly as a result of preliminary education of pharmacists and physicians. Pharmacists participated in continuing-education programs and received concise guidelines for the interchange and follow-up instructions; physicians learned of the program from the drug newsletter published by the pharmacy department. Three months after the program began, only one physician was resistant to the interchange. After the program began, 11 antimicrobials, including cefoxitin, were used less frequently and ampicillin-sulbactam use increased. No adverse clinical consequences from the interchange were detected. A therapeutic interchange program based on institution-specific microbial patterns and educational efforts by the pharmacy department produced a change in physician prescribing.     

Controlling financial variables--changing prescribing patterns

Techniques of formulary management, pharmacy and therapeutics committee intervention, and the use of clinical pharmacy services to change prescribing patterns and contain costs in hospital pharmacy departments are reviewed. Methods of using the formulary to contain costs include deletion of generic and therapeutic equivalents, inclusion of therapeutic categories and cost codes, and regular reviews and updates of its contents. Drug monographs for formulary evaluation prepared for the P & T committee should include a comparative review of other drugs in the therapeutic category and a cost impact statement. The P & T committee can help contain costs by developing policies for automatic stop orders and restricted drug use. Clinical pharmacy activities that can result in cost savings include physician education (focused on prescribing), target drug programs, target disease programs, pharmacist participation on TPN and i.v. therapy teams, and patient training programs for home care. A matrix for evaluating cost-containment activities is presented. By tailoring the described methods to departmental personnel resources and hospital needs, the pharmacy can be effective in controlling costs.