INNOVATIONS in pharmacy

Prevalence, Scope and Quality of Extemporaneous Medications in Selected Healthcare Facilities and Implications for Pharmacy Practice

Grace Lovia Allotey-Babington — 2024-04-10

Background: Extemporaneous compounding is the preparation of medicines for individual patients when no commercially available authorized form exists. Unlike registered medications, these products are not subjected to various tests for quality by Regulatory Authorities. Data on compounded medications in Ghana is currently inadequate or unavailable. There is the need to collate data that can be used to influence policy and to regulate preparation of extemporaneous products.

Aim: To establish the prevalence, scope and quality of extemporaneously compounded medicines at selected hospitals in Accra, Ghana.

Methodology: Prescriptions presented at the pharmacies in selected hospitals were reviewed to determine the requests that needed to be extemporaneously prepared as well as the prevalence and the scope of formulations. Three of the most frequently compounded medications were procured and subjected to microbial contamination tests using the pour plate method followed by differential tests if microbes were present. Content analysis of the active ingredients was determined using High Performance Liquid Chromatography (HPLC).

Results: 641 requests comprising 49 different extemporaneous products were collated from the hospitals studied. Hydroxyurea, furosemide and spironolactone suspensions were the three most frequently prescribed. Patients aged from 0-2 years had majority of the prescriptions.

Conclusion: A population of patients still exist who depend on compounding for their drug needs. 49 different formulations were prepared at one of the hospitals visited. Samples of products analyzed were of good quality.

Factors that Influence Healthcare Professionals' Intentions towards Biosimilars

Mohammed Alqahtani — 2024-04-10

Background: Physicians often prescribe original biologic products to patients who have not used them before and are reluctant to switch to biosimilars. Biosimilars are highly similar versions of already-approved biologics, but healthcare professionals typically hesitate to transition patients from the original products to biosimilars. This study aims to investigate the factors that influence U.S. healthcare professionals' intentions to use biosimilars.

Methods: A cross-sectional study was conducted. 510 participants were eligible healthcare professionals (279 physicians and 231 pharmacists). The theory of planned behavior (TPB) is used to identify which factors affect healthcare professionals' intentions. Descriptive statistics, chi-square, and the logistic regression model tested the TPB constructs as predictors of intentions toward biosimilars.

Results: Among 279 physicians, most were aged 61 and above, with high (n = 142) and low (n = 137) intentions. Male physicians constituted 71% of the population. Attending physicians (66.3%) showed consistent perceptions towards biosimilars, primarily in the private sector (76.3%). Pharmacists (n = 231), a higher percentage of females demonstrated higher intentions compared to males (35.5% vs. 28.1%); the majority were community pharmacists. Associations between years of practice and intentions were significant. Positive correlations existed between beliefs and intentions, except for normative beliefs.

Conclusions: This study revealed diverse attitudes among healthcare professionals towards biosimilars in the USA. Pharmacists and physicians, especially those with limited experience, require ongoing education on biosimilar manufacturing pathways. This education supports the appropriate use of biosimilars and helps standardize federal and state legislation.

Development and Evaluation of a Reliable Medication Management Self-Assessment Checklist

Brian Isetts — 2024-03-18

An ability to effectively self-manage medications is the result of several factors influencing a person’s decision to take medications. The need for new approaches to medication self-management are evident in the persistent trends of ineffective and unfortunate medication use consequences, referred to as drug-related morbidity and mortality. Fortunately, pioneering initiatives have emerged to reshape our approach for developing a rational organizational paradigm so that patients can confidently self-manage medications.

Favorable outcomes of studies pertaining to the delivery of comprehensive medication therapy management services within the practice of pharmaceutical care prompts the question, ‘Can patients and family members apply the 4-step pharmacotherapy workup process to better organize their decision-making and confidence in medication self-management?’ To answer this question an Effective Medication Self-Management Toolkit based on this 4-step process, and a Medication Management Self-efficacy Checklist, were created and evaluated for feasibility, acceptability, and internal consistency reliability.

The first evaluation established the preliminary acceptability and feasibility of the toolkit using a convenience sample of 39 residents of independent living facilities in focus group sessions. All participants indicated they perceive that the 4-step process can help individuals successfully self-manage medications. At the conclusion of the focus group sessions, all 39 participants completed the 7-item post-session checklist. This paper presents the second evaluation to establish the internal consistency reliability of the toolkit’s Medication Management Self-efficacy Checklist using Cronbach’s alpha. There was good internal consistency of the self-efficacy checklist with a Cronbach’s alpha value of 0.82.

This investigation of a novel approach for applying the 4-step pharmacotherapy assessment process by patients suggests that it is feasible and acceptable to use, and that the medication self-efficacy checklist provides a reliable and useful measure of a patient’s confidence in self-managing medications.

Clinical and Financial Outcomes of a Pilot Pharmacist-Led Continuous Glucose Monitoring Clinic

Leigh Ballard — 2024-04-19

Abstract

Purpose: What are the clinical and financial benefits of patients using a continuous glucose monitor (CGM) as part of a pilot pharmacist-led service in a Federally Qualified Health Center (FQHC)?

Methods: This single-center, prospective cohort conducted in a FQHC from October 2022 to September 2023 was submitted to IRB for review [EXMT-P-22-F-17]. Patients were seen by a pharmacist in collaboration with an attending physician during diabetes specific visits. Follow-up visits were scheduled in-person every 3 months to obtain a hemoglobin A1c (HbA1c). Reimbursement rates were analyzed to determine financial outcomes of the pharmacy service.

Results: Pharmacists saw 15 patients for their initial CGM visits, with 8 patients returning for follow-up. The average HbA1c at the first visit was 10% + 2.49 and improved at the last follow-up to 8.05% + 0.29. Time in range (TIR) was obtained for 8 patients through the CGM device or online data monitoring. The average TIR 2 weeks after the first pharmacist visit was 39.625% + 23.19 and increased to 48.75% + 11.41 at the completion of the project. A total of 39 visits were conducted, with a total reimbursement rate of $5,978.54.

Conclusion: This pharmacist-led pilot CGM clinic showed improvements in clinical outcomes and provided financial reimbursement for diabetes management in addition to typical office visit revenue. Further research should focus on clinical impact of pharmacist-led continuous glucose monitor clinics in larger patient populations, as well as financial sustainability of the service in both physician clinics and FQHC’s.

Community-Based Pharmacist Anticoagulation Clinic Outcomes Compared with Physician Management

Iryna Kurochka — 2024-04-17

Background: Warfarin has many indications; however, it is the only anticoagulant that is indicated for mechanical mitral value and antiphospholipid syndrome. Management may be conducted by pharmacists in medical clinic settings.

Objectives: To evaluate the percentage difference in the international normalized ratio (INR) target range when managed by a community-based pharmacist with a collaborative practice agreement (CPA) versus a physician and to analyze patient satisfaction of an anticoagulation clinic when managed by a community-based pharmacist with a CPA versus a physician.

Practice Description: Independent community-based pharmacy. Practice Innovation: Community-based pharmacist managed anticoagulation clinic. Pharmacist provides anticoagulation services under a collaborative practice agreement or conducts INR testing and reporting with physician management of anticoagulation.

Methods: Quasi-experiment study design with retrospective and prospective evaluation of warfarin management and patient satisfaction. A retrospective chart review was conducted of patients enrolled in the anticoagulation clinic from January 1^st, 2020 to June 30^th, 2022. Patients, 18 years or older with an indication for warfarin and attendance of at least 3 anticoagulation appointments were included. The Time in Therapeutic Range (TTR) was determined using the traditional method. TTR differences across the two groups were reported using descriptive, bi-variate, and multivariate statistics. All statistical tests were conducted using SAS 9.0. Patient satisfaction was collected for 6 months using a survey created by the investigators. Survey consisted of 18 questions using a 3-point Likert scale. Survey was assessed using descriptive statistics.

Results: Thirty-seven patients met the inclusion criteria, 26 were in the pharmacist management group with 609 appointments, and 11 patients were in the physician management group with 123 appointments. There was no statistical significance for the time in the therapeutic range between the pharmacist-managed group (60.7%) and the physician-managed group (59.4%); p-value of <0.829. Results of the satisfaction survey suggest that patients slightly prefer management by a pharmacist over a physician.

Conclusion: Community-based pharmacist warfarin management of time in therapeutic range was equivalent to physician management and with similar patient satisfaction.

Development of a Continuous Glucose Monitoring Service by Clinical Pharmacists in a Medically Underserved Population

Sara Lingow — 2024-04-22

Background: Continuous glucose monitoring (CGM) is an evolving technology that provides a wealth of information to aid in managing diabetes. Professional CGM (ProCGM) is recommended when personal CGM is not desired or available. Patients in medically underserved areas may have limited access to personal CGM devices, thus ProCGM devices can be used for short-term monitoring and medication adjustment. Clinical pharmacists are well-positioned to help set up and establish personal and professional CGM management services.

Objectives: To determine the effect of ProCGM in patients with persistently uncontrolled type 2 diabetes in a medically underserved population (MUP).

Methods: Pre-post intervention analysis of a single cohort of patients in a public health center. Patients with persistently uncontrolled (A1c > 9%) and taking at least one daily dose of insulin were included. Included participants wore a ProCGM sensor and met with the clinical pharmacist at least once for ProCGM data interpretation and education. The primary analysis evaluated patients who achieved an A1c <9% 1-6 months after intervention. The change in A1c was also evaluated. Participants completed a pre- and post-survey about their experience.

Results: Twenty-two patients were included in the final analysis. Ten patients achieved an A1c <9% (45%). The mean A1c pre- and post-ProCGM was 11.0% and 9.8% respectively, with a decrease of -1.2% (p=0.055) overall and a decrease of -1.7% for patients who wore the sensor for at least 10 days (p=0.012; n=15). Using the CGM data 91% of participants had a change to their medication regimen and 45% achieved an A1c <9%. Six participants experienced hypoglycemia per the CGM report, but only two were aware of it. After reviewing their glucose report with the pharmacist, 95% of the respondents agreed or strongly agreed to feeling more knowledgeable about blood sugar patterns after reviewing the report with a pharmacist.

Conclusion: Almost half of the patients in the study achieved an A1c <9%. This study demonstrated glycemic benefit in patients in a MUP who wore a ProCGM for at least 10 days and met with a clinical pharmacist. Data from ProCGM enabled patients to better understand glucose patterns in those with persistently uncontrolled type 2 diabetes.

Implementation of a Tenecteplase Protocol for Treatment of Acute Ischemic Stroke in a Health System

Alexis Pace — 2024-04-17

Purpose. Alteplase is the standard of care for intravenous thrombolytic treatment of acute ischemic stroke, but recent evidence suggests that tenecteplase may be as safe and efficacious. The purpose of this study was to evaluate the direct cost savings, safety, and efficacy outcomes following the implementation of a tenecteplase protocol for acute ischemic stroke in the emergency departments within a health system.

Methods. A multicenter retrospective medical record review was performed for 4 months prior to protocol implementation on patients who received alteplase and for 4 months post-implementation on patients who received tenecteplase. The primary outcome was the direct cost difference associated with tenecteplase. Secondary outcomes included reduction in National Institutes of Health Stroke Scale 24 hours after thrombolytic therapy, door-to-needle time, symptom onset to intravenous thrombolysis time, incidence of adverse effects, and death.

Results. Pre-implementation, 102 received alteplase and post-implementation, 117 received tenecteplase. Four months of utilization of tenecteplase resulted in direct cost savings of $209,476.80 for the health system, which translates to roughly $2,000 per patient. Reduction in the National Institutes for Health Stroke Scale were similar between the two groups with -3.96 in alteplase and -3.18 in tenecteplase (p = 0.952). Median door-to-needle time was 44.5 minutes in alteplase and 49 minutes in tenecteplase. Adverse events occurred in 19 patients in alteplase and 19 in tenecteplase (p = 0.573). Death occurred in 9 patients in alteplase and 14 patients in tenecteplase (p = 0.376).

Conclusion. A tenecteplase protocol was successfully implemented in the healthcare system resulting in direct cost savings with no significant differences in adverse events.

Implementation and evaluation of a learner-driven leadership initiative for pharmacy students and pharmacy residents.

Molly Corder — 2024-03-18

Introduction: Leadership training is a crucial component of the pharmacy education curriculum. ACPE standards 4 & 9 emphasize and encourage the use of different leadership initiatives while universities employ different tactics with varying levels of success. Leadership theory debates if leadership can be learned or if it is a natural born skill. This article explores learned leadership and describes a small study deployed to different levels of pharmacy learners to foster leadership confidence and self-awareness.

Educational Context and Methods: Second- and third-year didactic students in a leadership elective, fourth-year APPE students on an ambulatory care rotation, and PGY1 pharmacy residents were included in this initiative. Each cohort facilitated a leadership book club discussion and completed professional development activities over the course of their experience. Learners’ perspectives on leadership were surveyed utilizing a pre-post survey study, administered prior to beginning the initiative and after completing the initiative.

Findings and Discussion: Results demonstrated learners’ perceived confidence and self-awareness in their leadership skills increased from pre-survey to post-survey. Evaluation of qualitative responses exhibited that participants found value in adding more leadership development to their pharmacy training. Most participants noted leadership book discussion facilitation as the most valuable part of the initiative and posited they would utilize skills gained through these discussions nearly every day in their careers. Results suggest PGY1’s showed the most significant increase in their scores from pre- to post-study, while didactic students showed the least significant increase.

Implications: Our findings suggest learner-driven leadership initiatives, specifically learner-facilitated book club discussions, are beneficial to incorporate into both didactic and experiential coursework. Implementation of these discussions could be applied in many aspects of the curriculum with minimal resources and a reasonable expectation of perceived benefit to student leadership development.

Babcock L, Peyser B, Vesterlund L, Weingart L. The No Club, Putting a Stop to Women’s Dead-End Work. Simon and Schuster; 2022. ISBN-13: 978-1982152338.

Alisha Halver — 2024-04-10

This book review of The No Club, Putting a Stop to Women’s Dead-End Work, would serve anyone struggling with burnout or lack of promotion. Supervisors can gain a better understanding of how to distribute non-promotable tasks (NPTs) as well as how to properly and fairly ask their employees to complete NPTs. The hope is that by promoting better understanding of NPTs, both individuals and organizations would see a benefit by preventing burnout, achieving higher promotability, and equitable allocation of workload.

Lecanemab: A Second in Class Therapy for the Management of Early Alzheimer’s Disease

Connie Yoon — 2024-03-18

The Food and Drug Administration granted traditional approval of lecanemab for the treatment of Alzheimer’s disease (AD). Lecanemab is a humanized anti-amyloid monoclonal antibody directed towards Aβ protofibrils. Lecanemab is the only drug that targets Aβ soluble protofils and has shown statistical differences in mild AD or mild cognitive impairment. In its landmark phase III trial, lecanemab was shown to slow the progression of clinical decline, and a reduction in amyloid protein accumulation. The difference in mean CDR-SOB score improvement between the treatment and placebo groups was -0.45, of which the clinical significance could be argued. Amyloid burden was also considerably reduced as well, but the true clinical consequence of this reduction remains to be seen. This beneficial impact on daily living is offset by rare but serious side effects including amyloid-related imaging abnormalities (ARIA) causing cerebral edema (ARIA-E) or cerebral microhemorrhages or hemosiderin deposits (ARIA-H). Benefits of therapy must be considered against the risk of cerebral microhemorrhages and edema. Affordability must also be taken into consideration. The current estimated yearly cost for twice monthly lecanemab infusion is $26,500. In addition to the significant cost challenges, the frequent infusions may pose concerns related to access. Additional agents within this class are in the pipelines with possibly increased efficacy or decreased adverse events.