Calvin H. Knowlton

Establishing community pharmacy-based anticoagulation education and monitoring programs.

OBJECTIVE To determine the process for establishing community pharmacy-based anticoagulation education and monitoring programs using fingerstick capillary whole blood testing. DESIGN Pilot community-based intervention study using convenience sample of patients. SETTING Three community pharmacies with pre-established health education centers and laboratories certified for moderate complexity. PARTICIPANTS 26 patients were referred to the clinics by 2 primary care physicians for each pharmacy, most with a diagnosis of atrial fibrillation. INTERVENTION Patient assessment, including adherence to prescribed regimens; changes in medication use, including prescription and nonprescription medications, vitamins, health foods, and nutrition supplements; changes in diet and ethanol consumption; assessment of adverse experiences; and needed changes in warfarin dosage. MAIN OUTCOME MEASURES Percentage of international normalized ratio (INR) values within therapeutic range, major bleeding events, and thrombotic events. RESULTS A total of 21 patient charts were available for analysis. More than 80% of patients had INR values within their targeted range (+/- 0.2) 60% or more of the time, comparable with values reported for anticoagulation clinics. Of the 235 INR values obtained during the study, 75% were within the individualized targeted therapeutic range (e.g., 2 to 3 +/- 0.2). One patient experienced a major bleeding event related to an underlying cancer. None of the patients experienced a thrombotic event. CONCLUSION Community pharmacies can effectively implement an anticoagulation education and monitoring program.

Community pharmacists help HMO cut drug costs.

Twenty-seven independent community pharmacies that were preferred providers for a health maintenance organization (HMO) were enrolled in a study to determine the effect of increased intervention activities on the cost of a drug benefit in a managed care environment. Pharmacists from nine pharmacies were trained to initiate changes in medication prescriptions to contain costs, to enhance communication with patients and prescribers, and to intervene in drug-related problems. Their intervention activities during the nine-month study period were compared with activities of nine pharmacies assigned to a control group and nine pharmacies assigned to a comparison group. Patients who visited the intervention pharmacies had a 6.5% lower prescription mean ingredient cost; a 6.0% higher generic substitution rate; an 8.3% lower average patient drug cost per month; and no difference in the days supply, the average number of prescriptions per patient, or the aggregate hospital admission rate. The pharmacists in the intervention group spent more time with patients before preparing prescriptions (2.4-fold increase); initiated more requests for prescribers to change prescriptions (2.5-fold increase); intervened more often to reduce the cost of drug therapy (3.7-fold increase); and suggested medication changes more often for better quality of care (1.9-fold increase). In this study, community pharmacists altered their practice procedures and settings to foster communication with patients and prescribers. Also, the prospective drug regimen review changed prescribing patterns: physicians permitted increased use of generic medications, which reduced monthly prescription expenditures.

Are newer, more expensive pharmacotherapy options associated with superior symptom control compared to less costly agents used in a collaborative practice setting?

Innovative approaches to care may be necessary to provide the most effective symptom management to hospice patients. One approach is prescribing newer pharmacotherapy options with the potential to improve symptom management in hospice. Such therapies are sometimes prescribed outside of Food and Drug Administration indications and are typically more costly than older agents usedfor the same symptoms. Another approach is the collaborative practice (CP) care model, whereby clinical pharmacists are given prescriptive authority according to evidence-based protocols and algorithms within boundaries approved by a physician. The agents typically included in CPprotocols are those with wide therapeutic indices and with substantial evidence to support their use. The purpose of this study was to examine both approaches to management ofpain, insomnia, and nausea, comparing symptom scores for those patients who received noncollaborative drug therapies (transdermal fentanyl, zolpidem, and ondansetron) to those who received agents under CP (oral sustained-release opioids, temazepam, andprochlorperazine). The object of the study was to investigate outcomes associated with newer drug therapy options as compared to older agents for the management of pain, insomnia, and nausea. A secondary goal is to compare symptom outcomes for patients receiving pharmaceutical care under CP and non-CP models. The study design was retrospective with a cohort. A total of 50 patients were randomly selected for each cohort of the pain and insomnia study arms. Only 45 patients prescribed oral ondansetron met inclusion criteriafor the nausea group; 45 patients prescribed prochlorperazine were randomly selected as the comparator group. Patients were compared on their degree of response to the prescribed therapy. Response was classified as complete, partial, no improvement from baseline, worsened, or unknown. A complete response was defined as the symptom score improving to a 0 of 10, regardless of the previous value documented. A partial response was defined as any improvement in score that did not result in a 0 of 10. No improvement from baseline reflected a lack of overall change in score throughout the series of data points collected. A worsened response was any score found to be higher than the score documented at the time of dispense. The unknown category reflects any set of scores that had an “NIA” documented at the time of medication dispense or when documented for both attempts subsequent to dispensing the medication. A complete response was present in 14 of 50 (24 percent) of the patients prescribed fentanyl as compared with 12 of 50 (28 percent) of those prescribed oral therapy (p = .82). Responses defined as partial, no improvement over baseline, worsened, and unknown were also comparable between the two cohorts. A complete response was seen in 26 patients prescribed temazepam (52 percent), whereas only 11 (22 percent) of patients initially prescribed zolpidem achieved the same response (p = .003 7). Both groups had a similar distribution of partial, no improvement over baseline, and worsened responses. For the nausea arm of the study, a difference was found in the number of complete responses, favoring prochlorperazine (22 of 45, 48.9 percent for prochlorperazine, 12 of 45, 26.7 percent for ondansetron, p =. 0504), as well as an increased number of worse responses seen with ondansetron patients (p = .0513); however, neither difference was statistically significant. Newer pharmacotherapy options for the management of pain, insomnia, and nausea were not found to be superior when compared to older agents prescribed under CR

Toward evidence-based prescribing at end of life: A comparative review of temazepam and zolpidem for the treatment of insomnia

A comparative review of temazepam and zolpidem use in managing insomnia in the hospice patient was undertaken to determine whether treatment with temazepam is a more cost-effective approach for this patient population. A MEDLINE search was conducted to identify pertinent literature, including clinical trials and reviews that involved temazepam or zolpidem. Published data was used as background information and provided in the discussion. This retrospective analysis, conducted from June 2002 through November 2002, focused on the prescribing patterns of temazepam and zolpidem in our hospice practice setting. We examined the reasons for discontinuation of each agent, along with the frequency of therapeutic change from temazepam to zolpidem. The top 10 ICD-9 codes associated with each treatment modality were investigated to determine any prescribing patterns. A total of 4,752 participants were prescribed either temazepam or zolpidem during this six-month period. Of the 4,065 patients prescribed temazepam 9.9 percent had the agent discontinued, whereas, 13.0 percent of those taking zolpidem (n = 687) terminated therapy. Reasons for discontinuation included change in dose, incomplete efficacy, change in patient status, adverse drug reaction, cultural/social issues and “other.” Analyses of prescribing patterns and the reasons for termination of each drug therapy were completed and compared with results found in the primary literature. Due to the limited financial resources available for hospice care, our goal is to provide the most clinically appropriate and cost-effective agents for hospice patients. With the lack of data pertaining to the hospice patient, physicians often are faced with challenges in deciding the most appropriate therapy. They may prefer one agent over another based on current medical opinion rather than sound clinical evidence. After review of the primary literature and the prescribing patterns in our setting, there is currently no evidence in our patient population to support that zolpidem is superior to benzodiazepines for the treatment of insomnia.

Cross-Sectional Study of the Ethics of Pharmacy Students

The importance of ethics in pharmacy education and practice has recently received increased attention. Previous studies have addressed occupational orientation and personality traits as well as the nature of attitudes and values. Many unanswered questions remain. This cross-sectional study was designed to compare the attitudes and value priorities of pharmacy students in preprofessional and professional years of study and to evaluate a modified questionnaire. The 495 students who completed the questionnaire were representative of the 835 pharmacy students enrolled in this “0/5” undergraduate pharmacy program. The survey results indicated that honesty and full disclosure are preferences held by preprofessional students, whereas what may be described as professional judgment predominates in students during their final two professional years. Most students felt they had an idealistic or humanistic orientation. The differences among the classes may be due to any of a number of factors including curricula, normal maturation, or chance differences in the students within each class.

Implementation of a Standardized Medication Therapy Management Plus Approach within Primary Care

Purpose: The purpose of this study was to implement a clinical pharmacist-led medication therapy management (MTM) service within a primary-care setting that is enhanced by 1) a clinical decision support system (CDSS) that includes a unique combination of medication risk mitigation factors, which aids the pharmacist in interpreting the medication profile, and 2) pharmacogenomics (PGx) testing. Methods: This was a service implementation study, whereby Medicare beneficiaries were eligible if they were patients of Elmwood Family Physicians, a private family, primary care practice with 2 locations in New Jersey, and were on at least 7 medications. Patients had a medication reconciliation completed by a pharmacist and performed a PGx buccal swab. Patient information was run through a CDSS to aid the pharmacist with screening for multidrug interactions and assessing patient’s medication-related risks. The output of the CDSS was used to create recommendations and provide a consult to the physicians. Recommendations were followed up by return of the consult. Results: Enrolled patients used a mean (± standard deviation) of 12.1 (± 4.6) medications. The turnaround time for the MTM Plus consults was 11.7 (± 6.2) days. During the consults, the pharmacist identified 138 medication-related problems (MRPs). The most common MRPs were drug-drug interactions (29.0%) and drug-gene interactions (DGIs; 24.6%). Conclusion: Implementing a clinical pharmacist-led MTM Plus service in the primary care setting is feasible. This study highlights that DGIs are common in older adults in family practice and indicates that PGx testing identifies additional MRPs that may otherwise go unnoticed in these patients. The experiences we shared can aid other clinicians in establishing successful MTM Plus services. Future studies should also measure the impact of such personalized medicine services on economic, clinical, and humanistic outcomes. This study has been registered with ClinicalTrials.gov (study No. NCT02748148).

Dynamic Competition as an Exploratory Model of Healthcare Policy for the Antihypertensive Market

SummaryDynamic competition based on innovation, rather than classical competition based on price, may better explain the research-intensive pharmaceutical market. In an exploratory comparison of these models, economic indicators of annual change in price and price elasticity of demand were tested in a repeated-measures design by analysis of variance.Between 1990 and 1992, updated US prescribing guidelines for hypertension provided a framework in which the contrast between 2 newer classes and 2 older classes of first-line therapies served as a marker for innovation. The principal hypothesis was that newer classes would be less elastic than older classes, but with such innovation-based differences eroding over time. Although temporarily greater inelasticities for newer classes supported dynamic competition, initially extreme inelasticities for newer classes indicated a market distortion or a shifting demand curve.These exploratory results, although requiring substantiation, point toward using dynamic competition in crafting healthcare policy for the pharmaceutical market.

C22. Evaluation of community pharmacy-based anticoagulation clinics

Famotidine is a specific, long-acting histamine 2 -receptor antagonist. It is indicated for the treatment of duodenal ulcer, gastric ulcer, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. Since its introduction for the treatment of acid-related disorders in 1985, an estimated 18.8 million patients worldwide have been treated with famotidine. We present a comprehensive safety profile of oral famotidine, incorporating data from investigational trials, postmarketing studies, and reports of marketed use. The excellent tolerability profile of famotidine observed during investigational trials has remained substantially unchanged during postmarketing experience. Famotidine does not notably bind to cytochrome P-450 or gastric alcohol dehydrogenase and therefore has not been associated with clinically significant drug interactions. It is generally well tolerated in patients with cardiovascular, renal, or hepatic dysfunction or with Zollinger-Ellison syndrome who have tolerated doses up to 800 mg daily.

Physicians as Pharmacists

One may tend to think of biomedical ethics issues from a noneconomic perspective, i.e., rights and responsibilities, life and death, situational “oughts.” Yet, as an interdisciplinary forum, biomedical ethics at times rubs shoulders with business ethics in its quest to explore patient care dilemmas and health-policy issues.