INNOVATIONS in pharmacy https://pubs.lib.umn.edu/index.php/innovations Inspiring Inquiry and Improvement in Pharmacy Practice, Education, and Policy. A quarterly publication featuring case studies, clinical experiences, commentaries, idea papers, original research, review articles, and student projects that focus on leading edge, novel ideas for improving, modernizing, and advancing pharmacy practice, education, and policy. INNOVATIONS in pharmacy. en-US <p>Copyright of content published in <em>INNOVATIONS in pharmacy</em>&nbsp;belongs to the author(s).</p> schom010@umn.edu (Jon Schommer, Ph.D.) libpubs@umn.edu (Emma Molls) Wed, 22 Sep 2021 14:54:43 -0500 OJS 3.3.0.7 http://blogs.law.harvard.edu/tech/rss 60 Where Ignorance Is Bliss: The Institute for Clinical and Economic Review (ICER), The University of Washington, College of Pharmacy CHOICE Institute and Simulation Pricing and Access Recommendations for Atopic Dermatitis https://pubs.lib.umn.edu/index.php/innovations/article/view/4329 <p>It has been demonstrated conclusively that value and utility preference scores have only ordinal properties. This means, as has been pointed out on numerous occasions that the quality adjusted life year (QALY) is a mathematically impossible construct. The implications are profound: some 30 years of health technology assessment is rendered worthless due to a failure to recognize the well documented limitations imposed by the axioms of fundamental measure. Yet these are ignored in favor of persevering with the QALY as though it has mystical measurement properties, a ratio scale in disguise that allows QALYs to be imagined. This denial of the relevance of these axioms by the Institute for Clinical and Economic Review (ICER) has been the long-standing position and in the case of the just published ICER final evidence report on JAK Inhibitors and monoclonal antibodies (released on 17 August, 2021), shared by its contracted model builders at the College of Pharmacy, CHOICE Institute at the University of Washington, Seattle. The fact that an academic center should support ICER’s denial of fundamental measurement and the construction of evidence should come as no surprise as professional groups such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) are equally complicit in this denial. Interestingly, this denial appears to extend to ignoring peer reviewed studies that have considered alternative frameworks for evaluating quality of life in atopic dermatitis. This applies to the Quality of Life Index of Atopic Dermatitis (QoLIAD) and the Parents’ Index of Quality of Life in Atopic Dermatitis (PIQoL-AD) instrument. These are the only two quality of life instrument in atopic dermatitis that meet the required axioms of fundamental measurement. . The purpose of this commentary is to address once again ICER’s (and the CHOICE Institute’s) failure to understand the difference between science and pseudoscience, irrespective of numerous critiques of the denial and misuse of preference scales. The creation of mathematically impossible simulations continues; driven by assumption without credible and evaluable claims for therapy response. ICER is operating in an analytical dead end; a basis for creating pricing and access recommendations that should be rejected out of hand. Yet, ICER perseveres. Truly, ignorance is bliss.</p> Paul C Langley Copyright (c) 2021 Paul C Langley https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4329 Tue, 05 Oct 2021 00:00:00 -0500 Self-Medication in Africa during COVID-19 Pandemic https://pubs.lib.umn.edu/index.php/innovations/article/view/4234 <p>Self-medication is known as “the usage of drugs, herbs or home remedies on one’s own initiative, or on the advice of another person, without consulting a doctor’<strong>. </strong>In Africa, self-medication has reached a critical stage, with people using and taking any drug regardless of how poisonous the material may be as long as unprofessional suggestions advocate it as a solution to their health problem. In this article, we looked at the consequences, effects, and recommendations for reducing the use of self-medication as a habit among Africans.</p> Zainab Ismail, Anmol Mohan, Christophe Ngendahayo, Abdullahi Tunde Aborode , Arooj Abid, Ana Carla dos Santos Costa, Shoaib Ahmad, Mohammad Yasir Essar Copyright (c) 2021 Zainab Ismail, Anmol Mohan, Christophe Ngendahayo, Abdullahi Tunde Aborode , Arooj Abid, Ana Carla dos Santos Costa, Shoaib Ahmad, Mohammad Yasir Essar https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4234 Wed, 22 Sep 2021 00:00:00 -0500 Evaluation of Hospital-Based Acute Care Utilization by Uninsured Patients Enrolled in Free or Low-Cost Pharmacy Programs https://pubs.lib.umn.edu/index.php/innovations/article/view/3998 <p><strong>Background</strong>: Research is warranted to define the role of affordable pharmacy programs in optimizing healthcare utilization for uninsured patients.</p> <p><strong>Methods</strong>: This was a pre-post study including uninsured patients from an internal medicine residency clinic who enrolled in free or low-cost pharmacy programs with clinical pharmacist support.</p> <p><strong>Results</strong>: In the period following program enrollment (N=116), there was a mean decrease of 0.23 acute care encounters (hospitalizations and emergency department [ED] visits) per patient (p=0.0210, 95% CI 0.04-0.43). The mean decrease for hospitalizations was also statistically significant (0.17, p=0.0052, 95% CI 0.05-0.28), but the mean decrease for ED visits was not (0.06, p=0.3771, 95% CI -0.08-0.21). Using the national average hospitalization cost of $10,700, the decrease in hospitalizations represents an estimated savings of $246,100.</p> <p><strong>Conclusions</strong>: Enrollment in affordable pharmacy programs was found to be associated with decreased acute care encounters.</p> Jessica Stickel, Jennifer Kim Copyright (c) 2021 Jessica Stickel, Jennifer Kim https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/3998 Wed, 22 Sep 2021 00:00:00 -0500 Why Nigeria Must Strengthen its Local Pharmaceutical Manufacturing Capacity https://pubs.lib.umn.edu/index.php/innovations/article/view/4208 <p>With over 115 registered pharmaceutical manufacturers, Nigeria still depends on other countries for the supply of active pharmaceutical ingredients and excipients. Significant attention has not been paid to the local production of raw materials, pharmaceutical dosage formulations, or processing equipment, which has resulted in a decline in the country's pharmaceutical manufacturing capacity. Owing to the overall importance of the pharmaceutical industry, it is, therefore, essential to pay close attention to developmental issues affecting this sector. In this commentary, we explore why Nigeria must boost its local pharmaceutical manufacturing capacity.</p> Melody Okereke, Adebowale Adekunbi, Yusuf Ghazali Copyright (c) 2021 Melody Okereke, Adebowale Adekunbi, Yusuf Ghazali https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4208 Wed, 22 Sep 2021 00:00:00 -0500 COVID Vaccine Transport, Storage, and Distribution: Cold Chain Management to Ensure Efficacy https://pubs.lib.umn.edu/index.php/innovations/article/view/4225 <p>The Vaccines for Children Program (VFC) is a federally funded program in the United States, providing vaccines to children who lack health insurance or who otherwise cannot afford the vaccination cost. The VFC program was created in 1993 and is required to be a new entitlement of each State's Medicaid plan. The program was officially implemented in October 1994 and served eligible children in all United States (US). Other countries, the United Nations (UN), and the World Health Organization (WHO), have similar programs.</p> <p> A critical aspect of these programs is the guidance surrounding the environmental monitoring of the materials. To best maintain the integrity of these products, specific storage parameters are required. It is necessary to store most vaccines at refrigeration or freezing temperatures. To best assure the efficacy of the vaccines, monitoring standards and equipment are specified. The technology and methodologies may be adequate for these programs' materials; these same methods are not for the COVID vaccine.<sup>[1]</sup></p> <p> When reviewing the guidance recommendations worldwide, one may observe commonalities in the program. Each guidance calls for the use of digital data loggers (DDL), sampling rates of 15 to 30 minutes, daily check-in (during business hours), and the use of a temperature buffer, each without specificity.<sup>[2]</sup></p> <p>The inadequacies of the VFC program monitoring methodologies fall far short when monitoring COVID vaccines. Herein considerations for the transport, storage, and distribution of the COVID vaccine cold chain will be discussed.</p> Michael Rusnack Copyright (c) 2021 Michael Rusnack https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4225 Wed, 06 Oct 2021 00:00:00 -0500 Low Prevalence of Thrombosis Prophylaxis Dose Adjustments Highlights Implications for Patient Safety https://pubs.lib.umn.edu/index.php/innovations/article/view/4288 <p><strong>Background</strong>: Pharmacologic thromboprophylaxis (PTP) is the mainstay prevention strategy for venous thromboembolism (VTE). PTP agents traditionally dosed, like unfractionated heparin (UFH) and enoxaparin (ENOX), are associated with failure and bleeding in obese and underweight patients, respectively.</p> <p><strong>Objectives</strong>: This study aimed to describe the prevalence of unadjusted ENOX and UFH dosing for PTP based on anthropometric measures.</p> <p><strong>Patients/Methods</strong>: This was a post-hoc, multicenter, cross–sectional analysis of critically ill adults receiving PTP with ENOX or UFH. The primary outcome was the prevalence of unadjusted PTP based on body mass index (BMI) and total body weight (TBW). Definitions for dose adjustments were developed based on existing literature. A secondary outcome was to identify factors associated with unadjusted dosing per BMI and TBW using multivariable generalized linear mixed-effect models.</p> <p><strong>Results</strong>: The nested cohort included 172 patients (ENOX=46, UFH=126). Unadjusted PTP was observed in 118 patients (68.6%) based on BMI and 74 (43%) per TBW. When comparing UFH to ENOX, more patients who received UFH had doses unadjusted by BMI (78.6% vs. 41.3%, p&lt;0.05) but not TBW (43.7% vs. 41.3%). Factors independently associated with unadjusted PTP per BMI were receipt of UFH (OR 6.93, 95% CI 1.06-8.77) or a BMI underweight or overweight/obese (OR 10.45, 95% CI 4.38-24.92). Having a TBW &lt;50kg or &gt;100kg (OR 4.85, 95% CI 2.15-10.96) were independently associated with unadjusted PTP based on TBW.</p> <p><strong>Conclusions</strong>: Unadjusted dosing of PTP occurs frequently in critically ill adults receiving ENOX or UFH. This was seen in body size extremes by both BMI and TBW.</p> W. Anthony Hawkins, Susan E. Smith, Tia M. Stitt, Aliya Abdulla, Trisha N. Branan, Ronald G. Hall Copyright (c) 2021 W. Anthony Hawkins, Susan E. Smith, Tia M. Stitt, Aliya Abdulla, Trisha N. Branan, Ronald G. Hall https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4288 Fri, 08 Oct 2021 00:00:00 -0500 Antiviral and antiretroviral drug shortages amidst COVID-19: How Africa is struggling https://pubs.lib.umn.edu/index.php/innovations/article/view/4328 <p>Antiviral drugs are of paramount importance in the accomplishment of the vision of zero new cases of COVID-19 globally, through sustainable retaliation against viral diseases. However, several challenges currently exist in Africa which include insufficient infrastructure, deteriorating health systems, and rising costs of healthcare delivery with concomitant rising inequity with regards to access to health services amid the COVID-19 pandemic. The pandemic itself has stimulated an increased use of phytotherapy in Africa as a result of essential drug shortages that have been attributed to a plethora of contributing factors such as travel restrictions, reduced per capita income as well as increased expenditure on transport. As a result, the paucity of antiviral along with antiretroviral drugs used to combat COVID-19 as well as several other endemic viral diseases in Africa has created a worrisome state. This article therefore discusses and aims to underscore the causes, effects, and implications of antiviral and antiretroviral shortages amid COVID-19 in Africa.</p> Sudhan Rackimuthu, Zohra Kazmi, Osman Kamal Osman Elmahi, Reem Hunain, Behram Khan Ghazi, Zain Ali Zaidi, Ana Carla dos Santos Costa, Shoaib Ahmad, Mohammad Yasir Essar Copyright (c) 2021 Sudhan Rackimuthu, Zohra Kazmi, Osman Kamal Osman Elmahi, Reem Hunain, Behram Khan Ghazi, Zain Ali Zaidi, Ana Carla dos Santos Costa, Shoaib Ahmad, Mohammad Yasir Essar https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4328 Fri, 08 Oct 2021 00:00:00 -0500 An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems https://pubs.lib.umn.edu/index.php/innovations/article/view/4294 <p>The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the world. Rapid detection, exchange, prioritization, and assessment of safety signals based on available real-world data, surveillance of Adverse events following immunization<strong> (</strong>AEFI), and adverse event of special interest (AESI) by studying the observed/expected cases. Enhanced collaboration, and availability of resources, tools, and methods will add to the lessons learned from previous experiences.</p> Manal Mohammed Younus, Ali Azeez Al-Jumaili Copyright (c) 2021 Manal Mohammed Younus, Ali Azeez Al-Jumaili https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4294 Tue, 12 Oct 2021 00:00:00 -0500 Role of Pharmacist in Disaster Management: A Quantitative Content Analysis Approach https://pubs.lib.umn.edu/index.php/innovations/article/view/4359 <p><strong>Background:</strong> Little attention has been given to characterizing the roles of pharmacists in disasters even though the importance of pharmacists’ involvement is widely acknowledged.</p> <p><strong>Objective:</strong> We amid to review a broad range of pharmacists roles in disasters and their response by numerous reports in the literature.</p> <p><strong>Method:</strong> A quantitative content analysis technique was used to gather data consisting of words and phrases from literature regarding pharmacists’ roles and their response in disasters.</p> <p><strong>Results: </strong>A total of 106 reports were reviewed and screened based on titles and abstracts. Of these, only 20 studies were determined to meet the eligibility criteria for discussion. A total of 7 natural disasters (pandemics, tornadoes, fires, earthquakes, floods, hurricanes and storms) were found in the literature. Roles were classified using the Setlak classification scheme, which includes descriptors such as pharmaceutical supply, patient management, policy coordination, and response integration. Pharmaceutical supply was remains the pharmacists’ preferred role.</p> <p><strong>Conclusion: </strong>It is evident from the literature that pharmacists are uniquely positioned during disasters to provide healthcare continuity and medication.</p> <p><strong> </strong></p> Muhammad Ahmer Raza, Shireen Aziz, Misbah Noreen, Shahid Masood Raza Copyright (c) 2021 Muhammad Ahmer Raza, Shireen Aziz, Misbah Noreen, Shahid Masood Raza https://creativecommons.org/licenses/by-nc/4.0 https://pubs.lib.umn.edu/index.php/innovations/article/view/4359 Fri, 15 Oct 2021 00:00:00 -0500