Launched 10 years ago, the Fleetwood Project examines the impact of consultant pharmacist services on patient outcomes and healthcare costs in long-term care.

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or Medicare/Medicaid-certified nursing facilities, federal regulations require that each resident’s medication regimen be reviewed at least once a month by a pharmacist; that the pharmacist must report any “irregularities” to the attending physician and director of nursing (DON); and that these reports must be “acted on.”¹ This requirement created a distinct role for pharmacists in long-term care. In 1995, the American Society of Consultant Pharmacists (ASCP) Foundation launched the Fleetwood Project—a landmark, 3-phase initiative to demonstrate the impact of consultant pharmacist services on patient outcomes and healthcare costs in nursing facilities.

Fleetwood Phase I Quantifies Cost of Medication-Related Problems

       Fleetwood Phase I was the first pharmacoeconomic study to quantify the cost of medication-related problems in US nursing facilities, as well as the value of consultant pharmacist services in reducing medication-related problems. The study found that consultant pharmacist-conducted drug regimen review increases the number of patients experiencing an optimal therapeutic outcome by 43% and saves $3.6 billion annually in costs from avoided medication-related problems. Despite this cost saving, the study also reported that for every dollar spent on medications in nursing facilities, 2 dollars are spent treating medication-related problems.²
       Other studies examining medication-related problems in nursing facilities have shown similar results. The 1997 report from the US Department of Health and Human Services’ Office of the Inspector General on prescription drug use in nursing homes stated that “patients may be experiencing unnecessary adverse medication reactions as a result of inadequate monitoring of medications.”³ This report concluded that “[t]he Health Care Financing Administration [now known as the Centers for Medicare and Medicaid Services, or CMS] should require pharmacists’ direct input to achieving optimal clinical outcomes for residents.” More recent studies confirmed that adverse drug events (ADEs) occur frequently among nursing facility residents and that as many as half of ADEs are preventable.^4,5
       The Fleetwood Advisory Board recognized that the Fleetwood Project had to go beyond traditional retrospective drug regimen review, which has not been adequate, to prevent avoidable ADEs. A new model for long-term care pharmacy services was needed—a model that was prospective rather than retrospective and that focused on patients at highest risk for medication-related problems.

Fleetwood Phase II Tests Feasibility of New Model for Consultant Pharmacy

       The ASCP sought to develop and test a model for long-term care pharmacy services that could be utilized in the “real world” of pharmacy and relied on the skills and knowledge of pharmacists currently practicing in long-term care. The result was the “Fleetwood Model,” which has 4 main components: prospective medication review and intervention; direct communication between the pharmacist and prescriber; patient assessment by the consultant pharmacist; and formalized pharmaceutical care planning for patients at highest risk for medication-related problems.^6,7

Table 1

       Fleetwood Phase II found that the Fleetwood Model can be successfully implemented in long-term care pharmacy.⁸ The most significant operational findings are described in Table 1.

Fleetwood Phase III Targets Inappropriate Medications and ADEs

       Fleetwood Phase III is a 3-year, randomized trial to test the effectiveness of the Fleetwood Model in reducing potentially inappropriate medication use,

Table 2

ADEs, and the undertreatment of common diseases experienced by nursing facility residents in 26 nursing facilities in North Carolina (see Table 2).⁹ In addition, the study will quantify the impact of the Fleetwood Model on the efficiency, productivity, workload, and satisfaction of the participating pharmacists.¹⁰ The ASCP Foundation’s research partner for Fleetwood Phase III is the Center for Gerontology and Health Care Research at Brown University (Providence, RI). The Commonwealth Fund and The Retirement Research Foundation funded the project. The intervention phase was conducted January 1, 2004, through December 31, 2004. At press time, the results were scheduled to be published in late fall, 2005.

Key Components of Intervention

       There are several key components of intervention, including the following.
       Risk screen. A risk screen was integrated into the pharmacy’s software system to identify patients at highest risk for ADEs and those receiving potentially inappropriate medications. The risk screen was adapted from published research on risk factors for preventable ADEs in nursing facilities.¹¹
       Prospective intervention. The dispensing pharmacists review the medication profile of high-risk patients and those receiving potentially inappropriate medications during order verification prior to dispensing the prescription. They intervene prospectively to address medication problems identified. The pharmacists communicate directly with the prescriber to resolve medication problems. All interventions are documented in the pharmacy system.
       Web-based pharmaceutical care software. This software was developed and serves as the repository for the documentation of all interventions made by dispensing and consultant pharmacists, as well as the main conduit of information exchange between pharmacists. This shared system allows the dispensing and consultant pharmacists to work from the same patient information and see all interventions and outcomes.

Figure 1

       Treatment algorithms. Algorithms for alternatives to potentially inappropriate medications (see Figure 1) and intervention letters for specific drugs, which were faxed to prescribers with recommendations for suitable alternatives, were developed for use by the dispensing pharmacists.¹²
       Nursing alert cards for inappropriate medications. Alert cards were developed for propoxyphene and medications with anticholinergic effects to foster early recognition of potential adverse drug effects. The alert cards contain recommendations for monitoring for potential ADEs that should be observed for and reported, as well as risk assessment protocol (RAP) problems that may be caused or aggravated by the medication effects. The cards are sent with the medication order and placed on the front of the patient’s medication administration record. The goal is to reduce new orders for inappropriate medications, increase monitoring for ADEs, and provide documentation for the survey process. The consultant pharmacist conducted an in-service for nursing facility staff when these procedures were implemented.
       Although not specified in the list of inappropriate medications in the nursing facility regulations, propoxyphene was targeted because of its prevalence of use, high risk for adverse effects, and lack of superiority over more appropriate analgesic medications. Propoxyphene has been identified by geriatric experts as potentially inappropriate for use by adults aged 65 and older, due to its opioid-related adverse effects and questionable efficacy.^13-15 Propoxyphene’s active metabolite has cardiotoxic, proarrhythmic effects and central nervous system (CNS) toxicities, as well as a long elimination half-life (30–36 hours), which poses a high risk of accumulation if given repeatedly; older adults are especially prone to increased serum concentrations or reduced elimination.

Figure 2

       Propoxyphene’s CNS-related side effects of dizziness, sedation, and lightheadedness may increase the risk of falls; research has identified propoxyphene use as a risk factor for hip fractures.^16,17 In addition, several studies have demonstrated that propoxyphene is no more effective than and may even be inferior to acetaminophen, aspirin, codeine, or ibuprofen in reducing pain (see Figure 2).^18-22 The lack of advantage of propoxyphene over other analgesics in clinical efficacy, together with its potential for opioid-related adverse effects, has resulted in widespread recommendations against its use in the elderly population.^23-25
       For all new orders for propoxyphene products, a letter with the aforementioned information is faxed to the prescriber with a recommendation for alternative therapy based on the nature and severity of the patient’s pain. In general, the response from prescribers has been positive. For all refills, the nursing alert card is sent with the medication. Anecdotal reports from the pharmacists indicate that the prescriber letter is useful in changing prescribing habits and that the propoxyphene alert card enlists nurses in the effort to reduce the use of these products.
       Many of the medications inappropriate for use in the elderly are implicated due to their anticholinergic effects. However, for some of these medications, there may be no reasonable alternatives or efforts to prevent their use may not be successful. The anticholinergic alert card is intended to foster early recognition of the adverse effects of these medications so that problems can be avoided, managed, or reversed.

Summary

       The Fleetwood Phase III intervention phase was completed December 31, 2004, and researchers are currently analyzing data. They do know that involving the dispensing pharmacist in identifying medication problems and drug therapy decision making has already had positive results on the pharmacists’ perceived job satisfaction; the web-based pharmaceutical care software has enabled the dispensing and consultant pharmacists to work together, rather than in isolation, to improve patient care; and the propoxyphene and anticholinergic alert cards have changed prescribing habits and improved monitoring for potential adverse drug effects.

       (Acknowledgement: The Fleetwood Phase III study is funded by The Commonwealth Fund and The Retirement Research Foundation.)