Integrating real-world skills and diabetes lifestyle coach training into a revised health promotion and communications course.

BACKGROUND AND PURPOSE: Effective communication skills are essential for all pharmacists, regardless of practice setting. An implicit need in pharmacy education is to emphasize direct application of these skills to future healthcare practice prior to experiential rotations. The aim of this article is to describe how we revised a required first professional year (P1) doctor of pharmacy course to achieve two main goals: 1) improve the course relevance by connecting content to real-world skills; and 2) qualify all pharmacy students at our institution as certified National Diabetes Prevention Program (DPP) lifestyle coaches upon course completion. EDUCATIONAL ACTIVITY AND SETTING: Lifestyle coach training approved by the Centers for Disease Control and Prevention (CDC) was integrated into a P1 communications course consisting of 14 modules that include: review of diabetes pathophysiology, group facilitation skills, social determinants of health, food tracking, action planning, participant retention and program administration. This content serves as a direct application of pre-existing course objectives related to knowledge (evidence-based theory) and skills (technical and counseling) required for effective communication with patients, families, and health professionals. FINDINGS: Between 2019 and 2022, the redesigned course was offered to 373 P1 students. Course evaluations during this time were consistently positive. The average evaluation score since DPP activities were integrated into the course was 3.41 (on a 4-point scale). Based upon course evaluations, students appreciated three main benefits of incorporating lifestyle coach certification into the pharmacy curriculum: 1) a certified skill that can differentiate them in the job market; 2) practice of skills on real patients under faculty supervision in the community setting; 3) early exposure to pharmacy patient care topics, thus contributing to professional identity. SUMMARY: Integration of lifestyle coach training into an existing core P1 pharmacy course increased application and assessment of communications skills and allowed wider availability of trained coaches to deliver DPP in the community.

Longitudinal medication adherence group-based trajectories of aging adults in the US: A retrospective analysis using monthly proportion of days covered calculations.

BACKGROUND: It is thought that half of the patients with chronic conditions are not adherent to their medications, which contributes to significant health and economic burden. Many studies estimate medication non-adherence by implementing a threshold of ≥80% of Proportion of Days Covered (PDC), categorizing patients as either adherent or non-adherent. Healthcare quality metrics pertaining to medication use are based on this dichotomous approach of medication adherence, including the Medicare Part D Star Ratings. Among others, the Medicare Part D Star Ratings rewards part D plan sponsors with quality bonus payments based on this dichotomous categorization of beneficiaries' medication adherence. OBJECTIVES: Describe the longitudinal adherence trajectories of adults ≥65 years of age covered by Medicare for 3 classes of drugs in the Part D Star Ratings: diabetes medications, statins, and select antihypertensives. METHODS: This study used Medicare healthcare administrative claims data linked to participants from the Health Retirement Study between 2008 and 2016. Group-based trajectory models (GBTM) elicited the number and shape of adherence trajectories from a sample of N = 11,068 participants for the three pharmacotherapeutic classes considered in this study. Medication adherence was estimated using monthly PDC. RESULTS: GBTM were estimated for the sample population taking antihypertensives (n = 7,272), statins (n = 8,221), and diabetes medications (n = 3,214). The hypertension model found three trajectories: high to very high adherence (47.55%), slow decline (32.99%), and rapid decline (19.47%) trajectories. The statins model found 5 trajectories: high to very high adherence (35.49%), slow decline (17.12%), low then increasing adherence (23.58%), moderate decline (12.62%), and rapid decline (11.20%). The diabetes medications model displayed 6 trajectories: high to very high adherence (24.15%), slow decline (16.84%), high then increasing adherence (25.56%), low then increasing (13.58%), moderate decline (10.60%), and rapid decline (9.27%). CONCLUSIONS: This study showed the fluid nature of long-term medication adherence to the medications considered in the Medicare Part D Star Ratings and how it varies by pharmacotherapeutic class. These challenge previous assumptions about which patients were considered adherent to chronic medications. Policy and methodological implications about medication adherence are discussed.

Cost minimization analysis of short-duration antiviral prophylaxis for hepatitis C positive donor kidney transplants.

BACKGROUND: Trials describing 4-12 week courses of direct-acting antiviral drugs (DAAs) to treat hepatitis C virus (HCV) transmission from infected donors to uninfected kidney transplant recipients (D+/R-transplants), may be limited in application by costs and delayed access to expensive DAAs. A short prophylactic strategy may be safer and cost-effective. Here, we report a cost minimization analysis using the health system perspective to determine the least expensive DAA regimen, using available published strategies. OBJECTIVES: To conduct cost-minimization analyses (CMAs) from the health system perspective of four DAA regimens to prevent and/or treat HCV transmission from D+/R-kidney transplants. METHODS: CMAs comparing 4 strategies: 1) 7-day prophylaxis with generic sofosbuvir/velpatasvir (SOF/VEL), with 12-week branded glecaprevir/pibrentasvir (G/P) for those with transmission; 2) 8-day branded G/P prophylaxis, with 12-week branded SOF/VEL/voxilaprevir for those with transmission; 3) 4-week perioperative generic SOF/VEL prophylaxis, with 12-week branded G/P for those with transmission; and 4) 8-week branded G/P "transmit-and-treat." We included data from published literature to estimate the probability of viral transmission in patients who received DAA prophylaxis, and assumed a 100% transmission rate for those who received the "transmit-and-treat" approach. RESULTS: In base-case analyses, strategies 1 (expected cost [EC]: $2326) and 2 (expected cost: $2646) were less expensive than strategies 3 (EC: $4859) and 4 (EC: $18,525). Threshold analyses for 7-day SOF/VEL versus 8-day G/P suggested that there were reasonable input levels at which the 8-day strategy may be least costly. The threshold values for the SOF/VEL prophylaxis strategies (7-day vs. 4- week) indicated that the 4-week strategy is unlikely to be less costly under any reasonable value of the input variables. CONCLUSIONS: Short duration DAA prophylaxis using 7 days of SOF/VEL or 8 days of G/P has the potential to yield significant cost savings for D+/R- kidney transplants.

The cost-effectiveness of pharmacist-physician collaborative care models vs usual care on time in target systolic blood pressure range in patients with hypertension: a payer perspective.

BACKGROUND: Hypertension is highly prevalent in the United States, affecting nearly half of all adults (43%). Studies have shown that pharmacist-physician collaborative care models (PPCCMs) for hypertension management significantly improve blood pressure (BP) control rates and provide consistent control of BP. Time in target range (TTR) for systolic BP is a novel measure of BP control consistency that is independently associated with decreased cardiovascular risk. There is no evidence that observed improvement in TTR for systolic BP with a PPCCM is cost-effective. OBJECTIVE: To compare the cost-effectiveness of a PPCCM with usual care for the management of hypertension from the payer perspective. METHODS: We used a decision analytic model with a 3-year time horizon based on published literature and publicly available data. The population consisted of adult patients who had a previous diagnosis of high BP (defined as office-based BP ≥ 140/90 mmHg) or were receiving antihypertensive medications. Effectiveness data were drawn from 2 published studies evaluating the effect of PPCCMs (vs usual care) on TTR for systolic BP and the impact of TTR for systolic BP on 4 cardiovascular outcomes (nonfatal myocardial infarction [MI], stroke, heart failure [HF], and cardiovascular disease [CVD] death). The model incorporated direct medical costs, including both programmatic costs (ie, direct costs for provider time) and downstream health care utilization associated with acute cardiovascular events. One-way sensitivity and threshold analyses examined model robustness. RESULTS: In base-case analyses, PPCCM hypertension management was associated with lower downstream medical expenditures (difference: -$162.86) and lower total program costs (difference: -$108.00) when compared with usual care. PPCCM was associated with lower downstream medical expenditures across all parameter ranges tested in the deterministic sensitivity analysis. For every 10,000 hypertension patients managed with PPCCM vs usual care over a 3-year time horizon, approximately 27 CVD deaths, 29 strokes, 21 nonfatal MIs, and 12 incident HF diagnoses are expected to be averted. CONCLUSIONS: This is the first study to evaluate the cost-effectiveness of PPCCM compared to usual care on TTR for systolic BP in adults with hypertension. PPCCM was less costly to administer and resulted in downstream health care savings and fewer acute cardiovascular events relative to usual care. Although further research is needed to evaluate the long-term costs and outcomes of PPCCM, payer coverage of PPCCM services may prevent future health care costs and improve patient cardiovascular outcomes. DISCLOSURES: No funding was received for the completion of this research. The authors have nothing to disclose. Study results were presented as an abstract at the AMCP 2021 Virtual, April 12-16, 2021.

Cost-effectiveness of syringe service programs, medications for opioid use disorder, and combination programs in hepatitis C harm reduction among opioid injection drug users: a public payer perspective using a decision tree.

BACKGROUND: The hepatitis C virus (HCV) prevalence rate among injection drug users (IDUs) in North America is 55.2%, with 1.41 million individuals estimated to be HCV-antibody positive. Studies have shown the effectiveness of syringe service programs (SSPs) alone, medications for opioid use disorder (MOUD) alone, or SSP+MOUD combination in reducing HCV transmission among opioid IDUs. OBJECTIVE: To evaluate the cost-effectiveness of SSP alone, MOUD alone, and SSP + MOUD combination in preventing HCV cases among opioid IDUs in the United States. METHODS: We used a decision tree analysis model based on published literature and publicly available data. Effectiveness was presented as the number of HCV cases avoided per 100 opioid IDUs. A micro-costing approach was undertaken and included both direct medical and nonmedical costs. Cost-effectiveness was assessed from a public payer perspective over a 1-year time horizon. It was expressed as an incremental cost-effectiveness ratio (ICER) and an incremental cost savings per HCV case avoided per 100 opioid IDUs compared with cost savings with "no intervention." Costs were standardized to 2019 U.S. dollars. RESULTS: The incremental cost savings per HCV case avoided per 100 opioid IDUs compared with no intervention were as follows: SSP + MOUD combination = $347,573; SSP alone = $363,821; MOUD alone = $317,428. The ICER for the combined strategy was $4,699 compared with the ICER for the SSP group. Sensitivity analysis showed that the results of the base-case cost-effectiveness analysis were sensitive to variations in the probabilities of injection-risk behavior for the SSP and SSP + MOUD combination groups, probability of no HCV with no intervention, and costs of MOUD and HCV antiviral medications. CONCLUSIONS: The SSP + MOUD combination and SSP alone strategies dominate MOUD alone and no intervention strategies. SSP had the largest incremental cost savings per HCV case avoided per 100 opioid IDUs compared with the no intervention strategy. Public payers adopting the SSP + MOUD combination harm-reduction strategy instead of SSP alone would have to pay an additional $4,699 to avoid an additional HCV case among opioid IDUs. Although these harm-reduction programs will provide benefits in a 1-year time frame, the largest benefit may become evident in the years ahead. DISCLOSURES: This research had no external funding. The authors declare no financial interests in this article. Ijioma is a Health Economics and Outcomes Research (HEOR) postdoctoral Fellow with Virginia Commonwealth University and Indivior. Indivior is a pharmaceutical manufacturer of opioid addiction treatment drugs but was not involved in the design, analysis, or write-up of the manuscript.

Medication Adherence Trajectories: A Systematic Literature Review.

BACKGROUND: Traditional adherence measures such as proportion of days covered (PDC) and medication possession ratio (MPR) are limited in their ability to explain patient medication adherence over time. Group-based trajectory modeling (GBTM) is a new methodological approach that visually describes the dynamics of long-term medication adherence and classifies adherence behavior into groups. OBJECTIVES: To describe and compare trajectories of medication nonadherence reported in the medical literature, including identifying consistent trends in adherence trajectories and disease and patient characteristics that predict trajectory group membership. METHODS: A systematic literature review was conducted in April 2020 in PubMed and CINAHL using MeSH terms and key words in appropriate combinations. Citations were screened for relevance using predefined inclusion and exclusion criteria and evaluated according to variables associated with group-based trajectory models. RESULTS: 21 articles met the study criteria and were reviewed. Generally, studies identified 4 to 6 trajectory groups that described longitudinal medication adherence behavior. Most commonly identified trajectories were labeled as (a) consistent, high adherence, (b) declining adherence, (c) early and consistent nonadherence, and (d) initial nonadherence followed by an increase. Several predictors, including socioeconomic status, disease characteristics, and therapy initiation were routinely associated with group membership. CONCLUSIONS: This review suggests that adherence trajectories and predictors of specific group membership may be similar across diverse disease states. GBTM describes longitudinal, dynamic patterns of medication adherence that may facilitate the development of targeted interventions to promote adherence. Implications for value-based payment systems are discussed in this review. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to declare.

Pharmacy patronage and service utilization: Associations with patient sociodemographic and health characteristics.

OBJECTIVES: This study describes associations between patient sociodemographic and health characteristics, pharmacy patronage, and service utilization. DESIGN: Cross-sectional survey. SETTING: United States. PARTICIPANTS: A Qualtrics research panel was used to obtain a sample of American adults (N = 741) who had filled at least one prescription at a community pharmacy in the last 12 months. Surveys were completed electronically in January 2017. MAIN OUTCOME MEASURES: Primary pharmacy patronage (chain, independent, grocery, mass merchandiser, or mail order) and utilization of pharmacy services. RESULTS: Respondents most commonly patronized chain pharmacies (51.6%), followed by mass merchandiser (17.1%), grocery (14.4%), and independent (11.0%) pharmacies. In multivariable analysis, geographic factors and age were the primary predictors of pharmacy patronage. Approximately one third (35.1%) of patients stated that their pharmacist knew their name. Being known by their pharmacists was significantly associated with patronage of independent pharmacies, long-term medication use, caregiving activities, and use of medication synchronization or adherence packaging services. Automatic refill (57.9%), e-mail or text reminders (37.4%), and influenza immunizations (26.7%) were the most commonly used pharmacy services surveyed. Younger patients were significantly more likely to report the use of medication synchronization and smartphone apps, whereas use of pharmacist-administered vaccination increased with age. Use of medication synchronization, home delivery, and adherence packaging services was higher among independent pharmacy patrons compared with chain pharmacy patrons. CONCLUSION: This study identified several sociodemographic and health-related predictors of pharmacy patronage and service utilization. Independent pharmacy patronage, caregiving activities, and utilization of some pharmacy services were associated with having an established patient-pharmacist relationship, as indicated by having a pharmacist who knew the patient's name. Future research should explore how patient characteristics affect the use of pharmacy services and combinations thereof to facilitate targeted marketing of expanded pharmacy services to different populations.

Resource-based theory of competitive advantage - a framework for pharmacy practice innovation research.

A growing body of research demonstrates the effectiveness of evidence-based pharmacy practice, but too many practice innovations fail to survive past the initial implementation and study phase. This paper presents the resource-based theory of competitive advantage as a framework for describing, understanding, and predicting the adoption and dissemination pharmacy service innovations into routine practice. The theory argues that the sustainability of any business innovation (e.g., pharmacy service) is based upon (1) the internal resources of the firm offering it, (2) the firm's capabilities in using those resources, (3) the competitive advantage to the firm of its resources and capabilities, (4) the attractiveness of the market in which it competes, and (5) the innovation's contribution to financial performance of the firm. This paper argues that the resource-based theory of competitive advantage provides a foundation for comparing findings from different research frameworks and studies relating to innovations in services, service processes, and service business models. The paper also poses a number of research questions related to the theory that can be used to further the literature about pharmacy practice innovations. Finally, it makes a case that competition is a fundamental aspect of pharmacy practice and the resource-based theory of competitive advantage can serve as a general theory for studying innovations in pharmacy practice and in the social and administrative sciences.

Understanding Business Models in Pharmacy Schools.

The objectives of this article are to define business models, contrast the business models in pharmacy schools, and discuss issues that can arise from misunderstandings about whom pharmacy schools serve and how they do so.

Cost-benefit of appointment-based medication synchronization in community pharmacies.

OBJECTIVES: To evaluate the cost-benefit of appointment-based medication synchronization (ABMS) offered in community pharmacies for patients taking chronic medications to prevent negative outcomes associated with hyperlipidemia, hypertension, and diabetes. STUDY DESIGN: Decision-tree analysis based on published literature and publicly available data. METHODS: Program benefits were based on linking published findings of improvements in medication adherence due to the implementation of an ABMS program to a claims-based study of disease-related medical costs associated with different levels of adherence. The direct cost of the program-increased medication utilization as a result of improved adherence-was calculated from publicly available prescription pricing data. Benefit-cost ratios were assessed from a payer perspective over a 1-year time frame. RESULTS: Additional medication expenditures due to improved adherence associated with ABMS enrollment were offset by lower disease-specific medical costs. Medical savings per additional dollar spent on medications ranged from approximately $1 to $37 depending on the medication and medication class considered. ABMS was most cost-beneficial for metformin and statins. Sensitivity analyses showed that cost-benefit was significantly impacted by medication costs and any service fees associated with ABMS. CONCLUSIONS: ABMS programs have been shown to increase medication adherence in patients taking chronic medications. These programs were shown to have a significant cost-benefit for healthcare payers by reducing medical utilization and costs. Payers should consider supporting the provision of these programs in community pharmacies.

Analysis of costs to dispense prescriptions in independently owned, closed-door long-term care pharmacies.

BACKGROUND: The need for accurate calculation of long-term care (LTC) pharmacies' costs to dispense (CTD) has become more important as payers have moved toward reimbursement models based on pharmacies' actual acquisition cost for drug products and the Centers for Medicare Medicaid Services (CMS) has implemented requirements that LTC pharmacies must dispense prescriptions for certain branded drugs in 14-day-or-less quantities. OBJECTIVES: To (a) calculate the average cost that the typical independently owned, closed-door LTC pharmacy currently incurs to dispense and deliver a prescription to the resident of a client LTC facility and (b) estimate how CMS-mandated changes to a 14-day-or-less dispensing cycle would affect the typical LTC pharmacy's average CTD. METHODS: The data requirements and measurement model were developed by academic researchers in consultation with an industry advisory committee of independent LTC pharmacy owners. A survey instrument was constructed to collect financial and operating data required to calculate the CTD. Surveys were distributed via 3 dissemination channels to approximately 1,000 independently owned, closed-door LTC pharmacies. The National Community Pharmacists Association mailed surveys to their LTC members; 3 major national wholesalers distributed surveys to their LTC customers through their newsletters; and 3 LTC group purchasing organizations distributed the surveys to their members through emails, newsletters, mailings, and/or regional meetings. Each pharmacy's CTD was calculated by dividing total LTC dispensing-related costs by the total number of prescriptions dispensed. Dispensing-related costs included costs incurred to physically dispense and deliver prescriptions (e.g., dispensing pharmacists' and technicians' salaries and costs of medication containers) and costs incurred to support the dispensing function (e.g., salaries of delivery and medical records personnel). A model based on dispensing-related fixed, variable, and semivariable costs was developed to examine the impact of shorter dispensing cycles on LTC pharmacies' CTD. A prescription volume increase of 19% was assumed based on converting only solid oral branded drugs to short-cycle dispensing. RESULTS: A diverse sample of 64 closed-door LTC pharmacies returned usable surveys. Sales from dispensing to LTC facilities accounted for more than 98% of total sales. Respondents indicated that they currently dispensed 23% of total doses in 14-day-or-less cycles and 76% in 28-31 day cycles. Most pharmacies used automated medication packaging technology, heat and cold package sealers, bar code systems, sterile compounding hoods, LTC printers or labelers, and electronic prescribing. The median CTD was $13.54 with an interquartile range (25th to 75th percentiles) of $10.51 to $17.66. More than half of dispensing-related costs were from personnel expense, of which pharmacists and managers accounted for more than 40%. The results of the fixed and variable cost modeling suggested that converting solid oral brand-name drugs from 30-day to 14-day dispensing cycles would lower the median per prescription CTD to between $11.63 and $12.54, depending on the assumptions made about the effects of semivariable costs. However, this decrease in per prescription dispensing cost is dwarfed by an increase in total dispensing cost incurred by pharmacies that results from doubling the monthly volume of short-cycle prescriptions that must be dispensed. The result is that the typical LTC pharmacy in our sample incurred a CTD of $13.54 if the medication is dispensed in a 30-day cycle or $23.26 if the medication is dispensed in two 14-day cycles (at a cost of $11.63 for each cycle dispensed). CONCLUSIONS: Our results indicated a median CTD of $13.54 for the typical independently owned, closed-door LTC pharmacy. Moving to a shorter cycle would reduce pharmacies' average per-prescription CTD but would increase the number of prescriptions dispensed per month. Our results indicated that transitioning solid oral branded products to 14-day cycles would reduce the median CTD to a minimum of $11.63 but would increase total dispensing costs because each sold oral branded prescription would require twice the number of monthly dispensing events.

The economic burden of opioid-related poisoning in the United States.

OBJECTIVE: To estimate the yearly economic burden of opioid-related poisoning in the United States. BACKGROUND: Rates of opioid poisoning and related mortality have increased substantially over the past decade. Although previous studies have measured the costs of misuse and abuse, costs related specifically to opioid poisoning have not been quantified. This study quantifies the economic burden of opioid poisoning in the United States to help evaluate the economic case for efforts to reverse or prevent opioid poisoning and its associated morbidity and mortality. METHODS: Mean costs and prevalence estimates were estimated using publically available datasets. A societal perspective was assumed and accordingly estimated direct medical and productivity costs. Direct medical costs included treatment for opioid poisoning in the emergency department (ED) and inpatient settings, along with emergency transport and drug costs. Productivity costs were estimated using the human capital method and included lost wages due to mortality and absenteeism costs from ED visits and hospitalizations. All costs were inflated to 2011 U.S. dollars. RESULTS: In 2009, total costs were estimated at approximately $20.4 billion with indirect costs constituting 89% of the total. Direct medical costs were approximately $2.2 billion. ED costs and inpatient costs were estimated to be $800 million and $1.3 billion, respectively. Absenteeism costs were $335 million and lost future earnings due to mortality were $18.2 billion. CONCLUSION: Opioid-related poisoning causes a substantial burden to the United States each year. Costs related to mortality account for the majority of costs. Interventions designed to prevent or reverse opioid-related poisoning can have significant impacts on cost, especially where death is prevented.

Estimating the economic burden of food-induced allergic reactions and anaphylaxis in the United States.

BACKGROUND: Food allergy is reported to affect 4% to 6% of children and 1% to 2% of adults in the United States. Every year, allergic reactions result in visits to physicians, emergency departments, and hospitals. However, the economic burden of food-induced allergic reactions is unknown. OBJECTIVE: We sought to estimate the direct medical costs and indirect costs of food-induced allergic reactions and anaphylaxis in the United States. METHODS: Costs were estimated with a bottom-up approach from a societal perspective: the average cost of illness per patient was calculated and multiplied by reported prevalence estimates. Patients with an inpatient admission, emergency department admission, office-based physician visit, or outpatient visit for a food-induced allergic reaction were identified from a list of federally administered 2006 and 2007 databases by using International Classification of Diseases, ninth revision, codes. Indirect costs were quantified by estimating lost productivity in terms of lost earnings caused by absenteeism and mortality of patients or caregivers. Sensitivity analyses were conducted to measure the robustness of the estimates. RESULTS: For 2007, direct medical costs were $225 million, and indirect costs were $115 million. Office visits accounted for 52.5% of costs, and the remainder was split between emergency visits (20%), inpatient hospitalizations (11.8%), outpatient visits (3.9%), ambulance runs (3%), and epinephrine devices (8.7%). Simulations from probabilistic sensitivity analyses suggested mean direct medical costs were $307 million and indirect costs were $203 million. CONCLUSIONS: The economic burden of allergic reactions caused by food and anaphylaxis was an estimated half a billion dollars in 2007. Ambulatory visits accounted for more than half of the costs.

Media coverage of off-label promotion: a content analysis of US newspapers.

BACKGROUND: Promotion of drugs for off-label use is newsworthy, because it is an illegal but all too common strategy used by pharmaceutical companies. The print media are an important source of information about coverage of off-label promotion of drugs and devices and can influence public perceptions of the practice. OBJECTIVES: Print media coverage of off-label promotion during the years 1990-2008 were described and quantified. The primary themes and general tones relating to off-label promotion articles were evaluated. General concerns associated with off-label promotion and complaints about specific brand name drugs were also identified. METHODS: Content analyses of the top 6 US newspapers were conducted over the period of 1990-2008 to analyze the media coverage given to off-label promotion of drugs and devices. Headlines and full text of articles were analyzed for primary themes and tones of the coverage. Intercoder reliability tests were performed on all the study variables. RESULTS: One hundred and one articles were identified meeting the study inclusion criteria. Coverage varied by newspaper. The Wall Street Journal had the most coverage on the topic (45%), and USA Today and Chicago Tribune had the least coverage (5%). Overall, most of the stories sampled were deemed to have a negative tone in coverage (77%), focusing mainly on lawsuits against drug companies for promoting their drugs for off-label uses. Pfizer's Neurontin(®) (Pfizer Inc., New York, NY 10017, USA) and Johnson & Johnson's Retin-A(®) (Orthoneutrogena, Los Angeles, CA 90045, USA) received the most media attention. CONCLUSION: The news media helps shape public understanding of promotional practices of pharmaceutical companies and their potential benefits and harms. This study suggests that print media coverage is generally negative about off-label promotion, focusing on legal actions taken against drug companies and the negative consequences of such promotional practices.

Cost-effectiveness analysis of anticoagulation strategies in non-ST-elevation acute coronary syndromes.

BACKGROUND: Contemporary studies document the outcomes of unfractionated heparin (UFH), enoxaparin, fondaparinux, and bivalirudin in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). It remains unclear which anticoagulant regimen is the most cost-effective. OBJECTIVE: To perform a cost-effectiveness analysis comparing 4 anticoagulant regimens in NSTE-ACS. METHODS: A decision analysis was conducted from a healthcare provider perspective. Data sources included the SYNERGY, OASIS-5, and ACUITY trials, including 2 subgroup analyses. A decision tree model was created incorporating the outcomes associated with 4 antithrombotic approaches: UFH with eptifibatide, enoxaparin with eptifibatide, bivalirudin alone, and fondaparinux with eptifibatide. The percentage of eptifibatide use in each arm was consistent with clinical trials. Probabilities of complications (eg, myocardial infarction, revascularization, major/minor bleeding at 30 days) were calculated. Costs were assigned to each outcome, incorporating the cost associated with diagnosis-related group and/or current procedural terminology codes, drug acquisition, and red blood cell infusions. Multiple sensitivity analyses were performed. RESULTS: The base case analysis showed bivalirudin monotherapy to be the least costly regimen ($1131 per average course), and it dominated enoxaparin plus eptifibatide ($1609) and UFH plus eptifibatide ($1739) in cost-effectiveness. The total average cost of fondaparinux with eptifibatide ($1184) was higher than bivalirudin alone, but the combination was more effective, resulting in an incremental cost of $2569 per each additional patient treated without complication. Sensitivity analyses showed the model's results to be sensitive to drug acquisition cost and complication probabilities. Probabilistic sensitivity analyses favored neither bivalirudin nor fondaparinux; however, when 2 or more vials of bivalirudin were necessary, bivalirudin was no longer a cost-effective alternative. CONCLUSIONS: Bivalirudin is the least costly agent in moderate- to high-risk NSTE-ACS patients managed with an early invasive approach, if its use is consistent with the ACUITY trial. Fondaparinux is the preferred agent in patients undergoing a conservative treatment strategy.

Analysis of empiric antimicrobial strategies for cellulitis in the era of methicillin-resistant Staphylococcus aureus.

BACKGROUND: The rise in community-onset methicillin-resistant Staphylococcus aureus (MRSA) infections potentially complicates the empiric management of cellulitis. The threshold at which drugs active against MRSA, such as clindamycin and trimethoprim/sulfamethoxazole (TMP/SMX), should be incorporated into empiric therapy is unknown. OBJECTIVE: To evaluate the cost-effectiveness of using cephalexin, TMP/SMX, or clindamycin for outpatient empiric therapy of cellulitis, given various likelihoods of infection due to MRSA. METHODS: A decision analysis of the empiric treatment of cellulitis was performed from the perspective of a third-party payer. The model included initial therapy with cephalexin, clindamycin, or TMP/SMX, followed by treatment with linezolid in cases of clinical failure. Probability and cost estimates were obtained from clinical trials, epidemiologic data, and publicly available cost data and were subjected to sensitivity analysis. RESULTS: Under the base-case scenario (37% probability of infection by S. aureus and a 27% MRSA prevalence), cephalexin was the most cost-effective option. Clindamycin became a more cost-effective therapy at MRSA probabilities from 41-80% when the probability of staphylococcal infection was greater than 40%. TMP/SMX was cost-effective only at very high likelihoods of MRSA infection. Variables with the most influence in the model were probability of S. aureus being methicillin-resistant, cost of linezolid, probability of a cure with cephalexin for a non-MRSA infection, and probability of infection due to S. aureus. CONCLUSIONS: Cephalexin remains a cost-effective therapy for outpatient management of cellulitis at current estimated MRSA levels. Cephalexin was the most cost-effective choice over most of the modeled range of probabilities, with clindamycin becoming more cost-effective at high likelihoods of MRSA infection. TMP/SMX is unlikely to be cost-effective for treatment of simple cellulitis. Further studies of the microbiology of cellulitis, the epidemiology of MRSA, and the clinical effectiveness of clindamycin and TMP/SMX in skin and soft tissue infections are needed.

Cost-effectiveness analysis of antithrombotic therapy in nonurgent percutaneous coronary intervention.

STUDY OBJECTIVE: To perform a cost-effectiveness analysis comparing three treatment approaches during nonurgent percutaneous coronary intervention (PCI): bivalirudin with provisional glycoprotein (GP) IIb-IIIa inhibitor therapy, unfractionated heparin (UFH) with eptifibatide, and UFH with abciximab. DESIGN: Literature-based decision model from an institutional perspective. DATA SOURCE: Patient data from the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 study and three other randomized controlled trials that included UFH and routine GP IIb-IIIa inhibitor (eptifibatide or abciximab) therapy. All included studies were comparable based on patient population, procedural techniques, and general treatment approaches. MEASUREMENTS AND MAIN RESULTS: We included patient populations undergoing contemporary nonurgent PCI to identify probabilities of success or complications (myocardial infarction, urgent revascularization, thrombocytopenia, and major or minor bleeding at 30 days). Costs were assigned to each outcome by incorporating diagnosis-related group-- and/or Current Procedural Terminology--associated costs, institutional drug acquisition costs, and unit replacement costs of platelets and red blood cells. In the base-case analysis, the use of bivalirudin with provisional GP IIb-IIIa inhibitor therapy dominated the UFH and planned GP IIb-IIIa inhibitor approach: UFH with eptifibatide was 74 US dollars more expensive and 1.2% less effective, and UFH with abciximab was 777 US dollars more expensive and 2.3% less effective. Sensitivity analyses indicated that the model results were robust, but also revealed that bivalirudin lost its cost-effectiveness, resulting in UFH with eptifibatide becoming more cost-effective, when two or more vials of bivalirudin were necessary in greater than 27% of cases or when the use of provisional GP IIb-IIIa inhibitor therapy exceeded 20%. CONCLUSION: This analysis indicates that bivalirudin with provisional GP IIb-IIIa inhibitor therapy is the most cost-effective antithrombotic treatment strategy in nonurgent PCI when its use and dosing are consistent with the REPLACE-2 trial.

Predictors of noncompliance with warfarin therapy in an outpatient anticoagulation clinic.

STUDY OBJECTIVES: To test variables associated with the Health Belief Model, the Patient Satisfaction Model, and patient demographics in predicting compliance with warfarin therapy. DESIGN: Descriptive study using chart and pharmacy database review as well as patient questionnaires. SETTING: Outpatient anticoagulation clinic in an academic medical center. PATIENTS: Seventy-five patients who had received warfarin therapy over the previous 6 months. MEASUREMENTS AND MAIN RESULTS: Clinicians interviewed patients using a subscale of the Beliefs About Anticoagulation Survey and a Patient Satisfaction Model. Perceived barriers to compliance with warfarin therapy and marital status explained 21.7% of the variance in calculations of refill adherence (p<0.001). Compliance with warfarin therapy was assessed using a validated compliance self-report survey and outpatient pharmacy dispensing data. Perceived barriers and current living conditions explained 33.2% of the variance in self-reported noncompliance (p<0.001). Logistic regression analysis, conducted to attempt to predict patients with an 80% refill adherence threshold, correctly classified compliance 85.3% of the time. CONCLUSION: This investigation provided some insight into the factors predictive of noncompliance in a low-income, outpatient population. Perceived barriers, marital status, living arrangements, and drug regimen played significant roles in warfarin noncompliance. Our results provide more evidence supporting the use of refill adherence and patient self-report as measures of noncompliance. This linkage helps validate compliance as a useful surrogate of patient health outcomes. This study also offers a model that can help clinicians identify patients at significant risk of noncompliant behavior.

Using buzz marketing to promote ideas, services, and products.

OBJECTIVE: To (1) discuss buzz marketing, contrast it with traditional forms of promotional communications, and provide guidelines for use and (2) describe a successful buzz-marketing program used by Sentara Healthcare to decrease overuse and inappropriate use of antibiotic medications. DATA SOURCES: An English-language-only literature search of ABI Inform, Lexus-Nexus, InfoTrac, and university library databases from 1980 to the present using the keywords buzz, word of mouth, opinion leader, and thought leader. Articles and books were cross referenced for other works of interest. STUDY SELECTION: Performed by the author for their contribution to an exploratory analysis of this topic. DATA EXTRACTION: Performed by the author. DATA SYNTHESIS: Buzz marketing is an indirect communications method that has been used successfully in the promotion of a wide variety of products, services, and ideas. By identifying and cultivating nonmedia opinion leaders, the technique generates word-of-mouth communications between these early adopters of products and services and the early and late majority of people who tend to follow their lead. Opinion leaders can be categorized as ordinary or extraordinary, technical or social, and specialist or generalist, depending on the nature of their communications, expertise, and range of knowledge. Buzz marketing is most useful for ideas that are memorable, produce small changes in behavior that have big effects over time, and have the potential to reach a "tipping point" in terms of momentum among a target population. Pharmacists can use buzz marketing for promoting innovative services such as pharmaceutical care. A case study is presented on the use of buzz marketing by a health system for decreasing antibiotic resistance through lessening of public demand for antibiotics and support of physicians in prescribing the agents appropriately. CONCLUSION: Buzz marketing is a potent force in the promotion of pharmaceuticals and can be used by pharmacists. It works best when patients perceive the benefits of innovations. Providing samples and demonstrations of the innovation will foster positive perceptions. Innovations also spread better when they are compatible with the needs, desires, and preferences of individuals and can be adapted to the unique situation of the adopter.

A comparison of the costs of manufacturer unit-dose and repackaged unit-dose in seven-day dispensing systems.

OBJECTIVE: To compare the costs associated with manufacturer unit-dose and repackaged unit-dose in seven-day unit-dose dispensing systems to guide purchasing decisions. DESIGN: Retrospective observational economic evaluation. SETTING: Central Virginia long-term care pharmacy provider servicing 2,020 beds in 13 unit-dose facilities. MAIN OUTCOME MEASURES: Costs of manufacturer unit-dose and repackaged unit-dose for the 146 most frequently dispensed drugs. RESULTS: Total costs over six months for manufacturer unit-dose were found to be $1,428,248. This was $14,726 less than repackaged unit-dose at $1,442,974. The major factor contributing to the difference was the cost of inventory destroyed. Sensitivity analyses indicated that the manufacturer unit-dose system was less expensive as long as the acquisition cost of unit-dose drugs was no more than 5.1% higher than that of drugs purchased in bulk bottles. CONCLUSION: Manufacturer unit-dose was associated with a 1.0% cost-savings over repackaged unit-dose. Lower costs of inventory destroyed outweighed higher acquisition costs.