INNOVATIONS in pharmacy (Iip - E-Journal)
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ICER, ISPOR AND QALYs: A Tale of Imaginary Worlds
Full text linkPrevious commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the lack of credibility in modeled claims for cost-effectiveness and associated recommendations for pricing by the Institute for Clinical and Economic Review (ICER). The principal objection to ICER reports has been that their modeled claims fail the standards of normal science: they are best seen as pseudoscience. The purpose of this latest commentary is twofold: first, to review the latest report by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on standards and value claims for modeling imaginary cost-per-quality life year (QALY) worlds in health technology assessments and (ii) given ICER’s commitment to ISPOR standards, to consider the credibility of ICER’s QALYs. The concern is that ICER gives the impression that there is a common and agreed utility metric to support QALY constructs and that there is an agreed standard for creating QALYs within the imaginary reference case meme. The purpose of this commentary is to emphasize that there is no ‘gold standard’ QALY, let alone a ‘gold standard’ utility metric. A QALY is what you assume the QALY should be; it is an artificial construct which allows any number of competing QALYs to be generated for the same target population under different imaginary constructs. Similar objections apply to the application of willingness-to-pay thresholds to support ICER’s business case as the sole arbiter, in pole position, of health technology assessments to support pricing recommendations. In the US. A threshold has to be defined for the QALYs and costs captured, by assumption, within the model. Even for the same target patient population a $50,000 cost per QALY threshold will yield different pricing recommendations depending upon the assumptions driving the QALY estimate, such as choice of utility metric, time spent by stage of disease, frequency and severity of adverse events and costs. While this is an obvious point, it appears not to occur to those who, with a limited technical understanding of how the ICER model is constructed (and ICER is not given to extended technical explanations) take at face value the ICER imaginary construct and the QALY value judgements. Of course, it is also beside the point that the ICER reference case imaginary world was never intended to support empirical assessments of the claims made; we have no idea of whether it is right, if it is wrong and, over the lifetime perspective, we will never know and were never intended to know.
Article Type: Commentar
Innovative Partnership Between a Rural Mental Health Center and Community Pharmacy: Integration of a Mental Health Pharmacist
Full text linkPurpose: The purpose of this article is to describe how an innovative partnership between a rural community mental health center, community independent pharmacy and College of Pharmacy and integration of a mental health pharmacist lead to identification of medication therapy problems (MTP’s) and interprofessional team partnerships with center mental health professionals.
Methods: A contractual arrangement was initiated between Northern Pines Mental Health Center (NPMHC), GuidePoint Pharmacy Services GPS) and the University of Minnesota College of Pharmacy (UMN CoP) to place a PGY1 resident at NPMHC. The resident was assigned to work closely with the Chief Medical Officer and provide initial comprehensive medication management (CMM) services to individuals who were enrolled in Assertive Community Treatment (ACT). A retrospective chart review was conducted to evaluate the impact of services provided. Patient inclusion criteria included ACT enrollees 18 years or older, a diagnosis of SPMI, taking at least one psychotropic medication, and participation in at least one resident-led CMM visit. Additional findings included the relationship between the pharmacist, the psychiatric physician, and other members of the ACT team. Descriptive statistics were used to document the findings.
Findings: N = 30 met the inclusion criteria: 18 males and 12 females, age ranged from 24 - 69 with average of 44 years old. 110 MTPs were identified ranging from no MTPs to 10 MTPs per patient, with a mean of 4 MTPs/patient. There was an uneven distribution of MTPs between psychiatric and medical conditions, with a disproportionately high occurrence of “Needs Additional Drug Therapy” in medical conditions and “Adverse Drug Reaction” in psychiatric conditions. In addition, the services were valued by members on the ACT team.
Conclusion: Rural residents with SPMI in intensive community treatment have complex medication needs that require the training and skills of a clinical pharmacist. Despite the inclusion of a medication list as part of the ACT fidelity standards MTPs may go unrecognized and unresolved without the services of a clinical pharmacist conducting CMM. The pharmacist and psychiatric physician formed a collaborative partnership to address medication issues. We conclude that there is a need for integrating clinical pharmacist services into rural mental health centers.
Article Type: Original Researc
Updating the Model: The Case for Independent Pharmacy to Embrace Digital Health
Full text linkObjectives: To advocate for independent pharmacy to embrace digital health as a means to improve patient outcomes and compete more strongly in an increasingly competitive business environment.
Summary: Independent pharmacies are positioned to be at the forefront of adopting digital health tools for a variety of reasons. They often can make changes to their business model faster than a major retail chain, are often in rural locations where few other providers are located, and are already starting to offer the types of clinical services that can be greatly aided by digital health. This commentary presents the case for a change in the current model of pharmacy practice to one which embraces digital health. The role of the pharmacist would grow beyond exclusively medication management to incorporate tools such as wearable health trackers and mobile phone applications. By utilizing digital health, the pharmacist can obtain a greater amount of patient health data via an asynchronous electronic uploading process, and then use that data to further improve their ability to offer clinical services.
Conclusion: Digital health is a powerful tool that should be embraced by independent pharmacy. By leveraging digital health, pharmacies can improve both accessibility and quality of care, thus providing a competitive advantage in the retail marketplace.
Article Type: Commentar
Influential Factors of Successful Hepatitis C Treatment in Elderly Patients
Full text linkBackground: Chronic Hepatitis C virus (HCV) is an infection associated with an increased risk of cirrhosis, hepatocellular carcinoma (HCC), and morbidity and mortality. Treating HCV poses challenges in the elderly population due to the lack of evidence and complexity of patients.
Objective: This study aims to evaluate factors that influence HCV treatment success in elderly patients, especially those over age of 70, such as pill burden and comorbidities, in addition to drug interactions and adverse effects.
Methods: This was a retrospective chart review of patients treated at our urban academic institution from 2014-2016.
Results: Sixty-two patients over the age of 70 were included in this study. The sustained virologic response rate 12 weeks after the completion of treatment (SVR12) was 79%. In a multi-variate analysis, cirrhosis, age closer to 70, and longer duration of treatment were statistically significantly more likely to lead to treatment failure. Though not statistically significant, other factors that may negatively influence achievement of SVR12 were cognitive impairment, cardiovascular disease, multi-tablet HCV regimen, time to initiation of HCV treatment > 90 days, and prior treatment experience. Pill burden of other prescribed medications did not impact SVR12. Adverse events and drug interactions were common in the population.
Conclusions: Overall SVR12 rate in the elderly population was lower than that reported in the literature. Factors associated with lower treatment success, especially cirrhosis, should be considered when treating an elderly population. Further data is needed on the impact of other factors on SVR12 attainment in an elderly patient population.
Article Type: Original Researc
Credentialing in Pharmacy Practice: Examining Pharmacist Views and Perceptions
Full text linkIntroduction: Pharmacy practice has evolved to include direct patient care and interprofessional team models. Proper documentation of training and certification is required to verify eligibility for providing specialized services and for reimbursement.
Objectives: The objectives of this study were to assess pharmacists’ views and perceptions on credentialing with respect to (1) familiarity and perceived importance of credentialing; (2) satisfaction with current credentialing tracking systems; and (3) challenges in adopting a centralized credentialing platform.
Methods: This study used a cross-sectional, survey design to examine pharmacist perceptions of credentialing. The survey, distributed by the American Pharmacists Association from November 18, 2017 to December 2, 2017, consisted of 11 demographic items and 22 items about familiarity, importance, satisfaction and current systems of credentialing in pharmacy practice. Descriptive statistics were used to characterize the sample and outcome variables. Content analysis was conducted on freeform responses.
Results: Data were analyzed from 446 (7.3%) completed surveys of the 6,144 distributed. Respondents were primarily represented by pharmacists from chain stores (29.6%), outpatient clinics (16.6%), and academic settings (15.2%). Job titles included staff pharmacist (33.9%), clinical pharmacist (21.3%), and manager positions (18.3%). Nine of 10 pharmacists reported familiarity with credentialing and considered credentialing as important to the pharmacy profession. Majority agreed with the importance of having a centralized online platform to store credentialing information (96.1%) and to obtain reimbursement (97.1%). Poor integration of data among different platforms (16%) was a common reason for dissatisfaction with current tracking systems. Most respondents (96.5%) were willing to provide information necessary for credentialing; however, over half were concerned about security of the information.
Conclusions: This study was among the first to examine pharmacist perceptions of credentialing. Pharmacists in this study were familiar with and responsive to participating in credentialing process. They were also supportive of having a centralized credentialing system, but held reservations about security of information.
Article Type: Original Researc
Community Pharmacy Enhanced Dispensing Model to Improve Medication Access for Rural Patients Living with HIV
Full text linkObjective: To demonstrate the utility of a community pharmacy-centric workflow for improving access to medications for high-risk, rural persons living with HIV (PLWH) in partnership with a Federally Qualified Health Center (FQHC).
Setting: University-sponsored independent community pharmacy and rural FQHC providing care to PLWH.
Practice Description: Patient-centered Pharmacy Program is a service designed to improve access to HIV medications for PLWH in rural Idaho. The service is delivered in partnership with a 340B-covered entity (FQHC).
Practice innovation: The workflow for the service in the community pharmacy is described in detail, including time assessments and descriptions of tools and forms developed for rollout.
Evaluation: Quality improvement initiatives over three years are described.
Results: This service ensures medication access for rural PLWH and is sustainable for the community pharmacy. Expansion of services is feasible for the future.
Conclusion: This partnership may be one that could be implemented at other rural, independent community pharmacies seeking to have outreach to rural patients with chronic medication needs.
Article Type: Clinical Experienc
Impact of an Advanced Practice Pharmacist Type 2 Diabetes Management Program: A Pilot Study
Full text linkBackground: The purpose of this study was to describe the impact of an Advanced Practice Pharmacist (APh) on lowering hemoglobin A1c (HbA1c) in patients with type 2 diabetes within a patient centered medical home (PCMH) and to classify the types of therapeutic decisions made by the APh.
Methods: This was a retrospective study using data from electronic health records. The study evaluated a partnership between Chapman University School of Pharmacy and Providence St. Joseph Heritage Healthcare that provided diabetes management by an Advanced Practice Pharmacist in a PCMH under a collaborative practice agreement. Change in the HbA1c was the primary endpoint assessed in this study. The type of therapeutic decisions made by the APh were also evaluated. Descriptive analysis and Wilcoxon signed rank test were used to analyze data.
Results: The study included 35 patients with diagnosis of type 2 diabetes mellitus managed by an APh from May 2017 to December 2017. Most of the patients were 60-79 years old (68.5%), 45.7% were female, and 45.7% were of Hispanic/Latino ethnicity. The average HbA1c was 8.8%±1.4% (range=6.0%-12.4%) and 7.5%±1.4% (range=5.5%-12.4%) at the initial and final APh visit, respectively (p<0.0001). Therapeutic decisions made by the APh included drug dose increase (35.5% of visits), drug added (16.4%), drug dose decrease (6.4%), drug switch (5.5%), and drug discontinuation (1.8%).
Conclusion: The Advanced Practice Pharmacist’s interventions had a significant positive impact on lowering HbA1c in patients with type 2 diabetes mellitus in a PCMH. The most common therapeutic decisions made by the APh included drug dose increase and adding a new drug.
Article Type: Pharmacy Practic
Opioid Prescribing Habits in a Family Medicine Residency Program for the Management of Non-Cancer Pain
Full text linkObjectives: 1. List components of the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain, 2. Describe the prescribing habits of medical residents and attending physicians within a family medicine residency program, 3. Discuss the direction of future research
Methods: A report was generated for all patients with opioids listed as a medication at Christ Health Center family medicine clinic from July 2016 to June 2017. A total of 153 patients were identified with prescriptions written for chronic non-cancer pain indications. Clinical management via a retrospective chart review was completed utilizing a standardized data collection form centered around four of twelve recommendations within the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain: (1) Avoid concurrent opioid and benzodiazepine prescribing; (2) evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy; (3) perform urine drug testing before starting opioids and consider at least annually; and (4) offer/prescribe medication for opioid use disorder for all patients taking chronic opioids.
Results: A total of 153 prescriptions were written for chronic indications. The most common indications were chronic back pain (32.0%), unspecified chronic pain (31.4%), and osteoarthritis (9.8%). Average duration of therapy was 26.6 months. Forty-two (27.5%) patients were concurrently receiving benzodiazepine therapy. Eighteen (11.8%) patients performed a drug test before or during therapy. Twenty-two (14.4%) patients had documented discussion with their prescriber evaluating the benefits and harms of their opioid regimens. No patients were prescribed medication for opioid overdose.
Conclusion: Prescribing habits did not align with the four-guideline recommendations evaluated. The need for provider-focused education on current pain management practice guidelines was identified.
Article Type: Student Projec
Assessing the State of Comprehensive Medication Management in a Sample of Primary Care Clinics
Full text linkOverviewComprehensive medication management (CMM) is an important tool to address medication-related morbidity and mortality and reduce health care costs. Medication therapy problems (MTPs) are a significant and costly barrier to improving patient outcomes1 and with more than half of all Americans taking at least one prescription drug,2 the need to manage and optimize patients’ medications is greater than ever.
This report examines select practice and practitioner characteristics of the primary care clinics that participated in the research project, Enhancing Performance in Primary Care Medical Practice through Implementation of Comprehensive Medication Management. To be eligible to participate, sites had to have: established relationships with care team providers, a way of electronically identifying patients most in need of CMM, reporting processes in place for CMM data, read/write access in the electronic medical record, and an established CMM practice or a commitment to providing CMM. Because of these inclusion criteria, most participating clinics had CMM services in place for several years and were mature in their design and delivery of services.
Site characteristics around the following areas were assessed: pharmacist and clinic demographics, delivery of pharmacy services, collaboration, billing and payment for CMM, and measuring CMM outcomes. The results of this report shed light on how CMM is being delivered in a sample of established CMM practices and therefore may provide benefit to those practitioners interested in building their own CMM practice.
Article Type: Original Researc
A Practice Based Chronic Pain Management Registry (CPMR): Structure and Content of Proposed Patient and Patient/Provider Platforms
Full text linkPrevious commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the difficulties of establishing the credibility of trial-based and modeled claims for therapy interventions. Claims for interventions in the management of chronic pain are no exception. To meet this challenge, the Chronic Pain Management Registry (CPMR) has been designed to provide an evidence base for physician practices and health care decision makers to evaluate the impact of pain management interventions. The purpose of this commentary is to detail the development, structure and content of the CPMR in two versions: (i) a patient response version and (ii) a combined patient/provider response version. The CPMR has a potentially critical role to play in providing a framework for the effective auditing of practice compliance in the prescribing and monitoring of opioids in the management of chronic pain. The CPMR tracks, with on-line input from the patient and the treating physician, the process and outcomes of therapy interventions. These reports cover the overall pain experience of patients as well as pain intensity and functional status by eleven specific pain locations, covering both pharmacological and non-pharmacological interventions. Prior to each practice visit patients complete reports which are entered to the CPMR with a summary transmitted to the physician practice. Over time, these reports track the cumulative response to therapy as well as the perception of the patients as to whether or not the therapy has led to any substantive improvement in activity limitations, symptoms and quality of life. A particular focus of the CPMR is on monitoring and evaluating the experience with, and impact of opioid medications, to include the effectiveness of opioid formulations on reducing pain intensity and improving functional status, including an intensive assessment of the potential for and experience of opioid substance abuse for individual patients. The CPMR can also support monthly reports to the practice to summarize patient throughput, the response to care by target pain patients and profiles of opioid use and abuse. The CPMR can be customized to meet the needs of individual practices.
Article Type: Commentar