Women in oncology pharmacy leadership: A white paper.

Gender disparity exists in leadership roles within healthcare. While the majority of the healthcare workforce is comprised of women, significantly fewer women occupy leadership positions, particularly at executive and board levels. As the field of oncology pharmacy continues to rapidly expand and evolve, an assessment of the current state of women in oncology pharmacy leadership roles is vital to the growth and development of the profession. In the fall of 2017, the Hematology/Oncology Pharmacy Association (HOPA) hosted a summit to explore leadership issues facing women in oncology pharmacy which have the potential to affect our membership and our profession. This meeting included invited participants from across the fields of oncology and pharmacy and was part of HOPA's strategic leadership initiative developed through the work of the HOPA Leadership Development Committee in 2016. This promotes a primary goal of HOPA, which is to support oncology pharmacists as they assume leadership roles within their practices and within healthcare to assure oncology pharmacy is integrated into cancer care. The purpose of this white paper is to (1) summarize key issues that were identified through a membership survey; (2) review ongoing efforts to address the needs of female oncology pharmacists in leadership development; (3) serve as a call to action for individuals and professional organizations to assist with and disseminate these efforts and highlight available resources, and (4) to provide practical steps to meet the needs of individuals, training programs, and institutions/employers.

Community-Based Services by Pharmacists: A Systematic Review of Cost-Utility Analyses.

OBJECTIVES: To conduct a systematic review of cost-utility studies of community-based services provided by pharmacists and to examine their reporting and methodological quality. METHODS: A comprehensive literature search was performed in February 2019 using a replicable search strategy in bibliographic databases MEDLINE, EMBASE, and the NHS Economic Evaluations Database from their inception onwards. Two reviewers independently screened the literature, abstracted data from full-text articles, and assessed reporting and methodological quality using the Consolidated Health Economic Evaluation Reporting Standards and Quality of Health Economic Studies checklists. RESULTS: Twenty studies were included in this review, representing the healthcare systems of the United Kingdom, Spain, France, The Netherlands, Belgium, Italy, Canada, the United States of America, and Brazil. Descriptions of the context in which the studies were done, justification of data sources on patient and process outcomes, choices of model, and generalizability of study findings were often inadequately reported. Seven studies (35%) were deemed of high methodological quality, 11 studies (55%) of fair quality, and 2 studies (10%) of poor quality. In addition, various methodological issues related to the randomized controlled trials and observational studies used to generate effectiveness estimates were identified. CONCLUSIONS: In view of the lack of standardized definitions of expanded services, heterogeneity in study objectives, settings, comparators, methodology, outcomes, and the variable quality of these studies, the value of these services (in terms of costs) compared with quality-adjusted survival remains inconclusive.

Survey of guidelines and current practices for safe handling of antineoplastic and other hazardous drugs used in 24 countries.

PURPOSE: A survey of guidelines and current practices was conducted to examine the safe handling procedures for antineoplastic and other hazardous drugs that are used in 24 countries including the Americas, Europe, the Mideast, Far East, and Australia. METHODS: Subject experts were asked to complete a brief survey regarding safe handling guidelines and practices for hazardous drugs in their countries. Questions addressed practices for handling monoclonal antibodies, the use of closed-system transfer devices, medical surveillance practices, and measurements of compliance with existing guidelines. RESULTS: Responses from 37 subject experts representing 24 countries revealed considerable variation in the content and scope of safe handling guidelines and pharmacy practices among the participating countries. Guidelines in the majority of countries used the term "cytotoxics," while others referred to "hazardous" or "antineoplastic" drugs. The International Society of Oncology Pharmacy Practice standard was cited by six countries, and five cited the National Institute for Occupational Safety and Health Alert. Others cited international guidelines other than International Society of Oncology Pharmacy Practice, or they have created their own guidelines. Approximately half reported that their guidelines were mandatory under federal, state, or provincial legislation. Only 11 countries reported that monoclonal antibodies were covered in their guidelines. Closed-system drug-transfer devices are widely used, but were not specifically recommended in four countries, while one country required their use. Medical surveillance programs are in place in 20 countries, but only in The Netherlands is surveillance mandatory. Nine countries reported that they have completed recent updates or revisions of guidelines, and the measures for their adoption have been initiated. CONCLUSIONS: Although the overall goals in the participating countries were similar, the approaches taken to assure safe handling of hazardous drugs varied considerably in some cases.

Drug Repositioning by Integrating Known Disease-Gene and Drug-Target Associations in a Semi-supervised Learning Model.

Computational drug repositioning has been proven as a promising and efficient strategy for discovering new uses from existing drugs. To achieve this goal, a number of computational methods have been proposed, which are based on different data sources of drugs and diseases. These methods approach the problem using either machine learning- or network-based models with an assumption that similar drugs can be used for similar diseases to identify new indications of drugs. Therefore, similarities between drugs and between diseases are usually used as inputs. In addition, known drug-disease associations are also needed for the methods as prior information. It should be noted that those associations are still not well established due to the fact that many of marketed drugs have been withdrawn and this could affect the outcome of the methods. In this study, we propose a novel method named RLSDR (Regularized Least Square for Drug Repositioning) to find new uses of drugs. More specifically, it relies on a semi-supervised learning model, Regularized Least Square, thus it does not require definition of non-drug-disease associations as previously proposed machine learning-based methods. In addition, the similarity between drugs measured by chemical structures of drug compounds and the similarity between diseases which share phenotypes can be represented in a form of either similarity network or similarity matrix as inputs of the method. Moreover, instead of using a gold-standard set of known drug-disease associations, we construct an artificial set of the associations based on known disease-gene and drug-target associations. Experiment results demonstrate that RLSDR achieves better prediction performance on the artificial set of drug-disease associations than that on the gold-standard ones in terms of area under the Receiver Operating Characteristic (ROC) curve (AUC). In addition, it outperforms two representative network-based methods irrespective of the prior information of drug-disease associations. Novel indications for a number of drugs are also identified and validated by evidences from a different data resource.

Establishment of a research pharmacy to support Ebola clinical research in Liberia.

OBJECTIVE: This article describes the establishment of a research pharmacy to support the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) vaccine study for Ebola virus disease. SETTING: This article describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia, in 2014 and 2015. PRACTICE INNOVATION: The need for the rapid establishment of infrastructure to support the Liberia-United States joint clinical research partnership in response to the emerging Ebola virus disease provided the opportunity for collaboration among Liberian and U.S. pharmacists. PRACTICE DESCRIPTION: Resource austere and research naïve. EVALUATION: Research pharmacy prepared and randomized 1500 vaccinations in support of PREVAIL. RESULTS: Experiences of the Liberian and U.S. pharmacists involved in the program are described. CONCLUSION: The partnership was successful in the conduct of the study. More importantly, the capacity for Liberian pharmacists to support clinical research was established. In addition, the U.S. team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks.

Utilization patterns for oral oncology medications in a specialty pharmacy cycle management program.

BACKGROUND: The cycle management program (CMP) was implemented in 2008 at a national specialty pharmacy with a focus on providing specialized counseling and monitoring for patients on select oral oncology medications. The program now includes nine medications: bexarotene, dasatinib, erlotinib, everolimus, nilotinib, pazopanib, sorafenib, sunitinib, and vorinostat. Patients receive frequent assessments to encourage adherence, identify adverse events, and track discontinuations through a pharmacist outreach at the initiation of therapy, day 10 and 20 of the first month, then monthly thereafter. The use of oral agents is increasing in cancer patients, shifting away from regimens exclusively involving intravenous chemotherapy. This offers advantages for patients in terms of convenience, but introduces risk as patients become more responsible for the administration and monitoring of the medications. PURPOSE: To evaluate utilization patterns of the oral oncology medications in the CMP including adverse event occurrence, medication discontinuations, and adherence markers. METHODS: This study is a retrospective review of patient-reported data from the CMP assessments completed in 2013. Data collected include adverse events and grades, adherence markers, and discontinuation rates. A total of 1163 assessments were reviewed from 557 patients. The assessments included in the analysis were the initial assessment, 10-day assessment, 20-day assessment, and the first monthly follow-up assessment, which encompasses the first two months of therapy. RESULTS: A total of 1453 adverse events were reported. Adverse events were cited as the reason for 39% of discontinuations and 28% of missed/held doses. A total of 101 discontinuations were reported across the nine CMP medications based on the first two months of data. Missed or held doses were reported in 130 assessments. CONCLUSIONS: Patient engagement and pharmacist interventions, through programs such as the CMP, are important to help patients manage these complex, high-risk medications.

A survey of manufacturing and handling practices for monoclonal antibodies by pharmacy, nursing and medical personnel.

INTRODUCTION: There is a paucity of data available to assess the occupational health and safety risk associated with exposure to monoclonal antibodies. Industry standards and published guidelines are conflicting or outdated. Guidelines offer contrary recommendations based on an array of methodological approaches. This survey aimed to describe current practices, beliefs and attitudes relating to the handling of monoclonal antibodies by Australian medical, nursing and pharmacy clinicians. METHODS: An electronic survey was distributed between June and September 2013. Respondents were surveyed on three focus areas: institutional guideline availability and content, current practices and attitudes. Demographic data relating to respondent and primary place of practice were also collected. RESULTS: A total of 222 clinicians completed the survey, with representation from all targeted professional groups and from a variety of geographic locations. 92% of respondents reported that their institution prepared or administered monoclonal antibodies, with 87% specifically handling anti-cancer monoclonal antibodies. Monoclonal antibodies were mostly prepared onsite (84-90%) and mostly within pharmacy clean-rooms (75%) and using cytotoxic cabinets (61%). 43% of respondents reported access to institutional monoclonal antibody handling guidelines with risk reduction strategies including training and education (71%), spill and waste management (71%), procedures for transportation (57%) and restricted handling (50%). Nurses had a stronger preference towards pharmacy manufacturing than both doctors and pharmacists for a range of clinical scenarios. 95% of all respondents identified that professional or regulatory body guidelines are an important resource when considering handling practices. CONCLUSION: Monoclonal antibodies are most commonly handled according to cytotoxic drug standards and often in the absence of formal guidelines.

[Modern order of rationing of medical property for military medical and pharmaceutical organizations in peacetime].

Modern order of rationing of medical property for military medical and pharmaceutical organizations in peacetime. The characteristic of the new rules of medical supply for medical and pharmaceutical institutions of the Armed Forces in peacetime are presented, approved and put into effect by the order of the Minister of Defence of the Russian Federation. New standards of medical supply logistics adapted to the current organizational structure of the military healthcare and pharmaceutical organizations. Their use in practice will improve the quality of primary specialized healthcare, as well as specialized and high-tech medical care to military personnel and other categories of citizens who are entitled to health care through the Ministry of Defence.

Migraine attacks in the pharmacy: a gender subanalysis on treatment preferences.

In 2014 our group published the results of a survey conducted in Piedmont, Italy, on the patterns of use and dispensing of drugs in patients requesting assistance from pharmacists for relief of a migraine attack. Epidemiological studies on migraine have consistently shown that migraine is far more common among women than men. This gender difference is also reflected in the higher percentage of women visiting a pharmacy to obtain treatment or advice for headache attacks. In this study, we further explored gender differences in healthcare-seeking behavior and use of migraine medications. The aim of the study was to determine whether women made better selective use of migraine medications and whether visiting a headache center for consultation and treatment reflected awareness of how best to manage their condition. Among the drugs usually taken for relieving head pain, there was no statistically significant difference between men and women in the routine use of NSAIDs (55.6 vs. 51.6 %) or ergot derivatives (8.7 vs. 9.3 %). Statistically significant differences emerged between men and women (27.9 vs. 35.4 %) in the use of triptans (p = 0.003; OR 1.41, 95 % CI 1.12-1.78) and in the use of combined medications (8.5 vs. 12.2 %) (p = 0.029; OR 1.49, 95 % CI 1.04-2.14) but not in the use of simple OTC non-NSAIDs. Less men than women sought professional medical care for managing migraine (65.7 vs. 72.4 %) (p = 0.003; OR 0.71, 95 % CI 0.57-0.89); more women than men sought treatment at a headache center (21.7 vs. 17.4 %) (p = 0.044; OR 1.31, 95 % CI 1.07-1.72).

Pharmacist addition to the post-ED visit review of discharge antimicrobial regimens.

OBJECTIVE: Our objective was to evaluate whether pharmacist addition to the postvisit review of discharged adult emergency department (ED) visits' prescriptions/cultures would reduce the prevalence of revised antimicrobial regimen inappropriateness. METHODS: We conducted a retrospective observational study of discharged adult ED visits to a single center with positive cultures requiring antimicrobial regimen revision (May 1 to October 31, 2012, nurse process; February 1 to July 31, 2013, nurse/pharmacist process). Investigators abstracted cohorts' medical records for demographic, ED diagnosis, original/revised antibiotic regimen, culture result, medical history, medications, and patient instruction data and determined whether the revised regimen was inappropriate based on Infectious Diseases Society of America/Centers for Disease Control and Prevention and clinical guidelines. We used the large sample z-test to compare the prevalence of revised antimicrobial regimen inappropriateness between the 2 cohorts. RESULTS: In the prepharmacist cohort, there were 411 positive ED discharge cultures. Seventy-three (17.8%; 95% confidence interval [CI], 14.1%-21.5%) required antimicrobial regimen revision; 34 of these met 1 or more level of inappropriateness (46.6%; 95% CI, 35.1%-58.0%). In the postpharmacist cohort, there were 459 positive ED discharge cultures. Seventy-five (16.3%; 95% CI, 13.0%-19.7%) required revision; 11 of these met 1 or more level of inappropriateness (14.7%; 95% CI, 6.7%-22.7%; z = 4.2; P < .0001 for comparison). CONCLUSION: In this single-center study, pharmacist addition to the postvisit review of discharged adult ED patients' prescriptions/cultures reduced the prevalence of revised antimicrobial regimen inappropriateness.

Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective.

This document is meant to complement Part B of the EANM 'Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals' issued by the Radiopharmacy Committee of the European Association of Nuclear Medicine, covering small-scale in-house preparation of radiopharmaceuticals with automated modules. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals, which are not intended for commercial purposes or distribution.

Rediscovering community--reflections after Hurricane Sandy.

Hoboken, New Jersey, is a town of 50,000 residents located across the Hudson River from New York City. Most of Hoboken's infrastructure was compromised during Hurricane Sandy as a result of flooding and power outages that rendered many businesses inoperable, including all of the pharmacies in town. Despite a focus on emergency preparedness since Hurricane Katrina and 9/11, there were no contingencies in place to facilitate and assess the medication needs of the community in the event of a natural disaster. This essay describes how the author rediscovered the meaning of community, and through working with colleagues in other health care disciplines and non-health care volunteers, provided care to patients in suboptimal circumstances.

Public health in pharmacy: improving vitamin D status in the U.S. population.

OBJECTIVES: To summarize the problem of vitamin D inadequacy in the United States and discuss how pharmacists can help improve vitamin D status in the population. SUMMARY: Vitamin D inadequacy has proven skeletal health effects and potential effects on other chronic conditions. The condition is present in many Americans. Adequate vitamin D intake is currently emphasized to prevent vitamin D inadequacy. However, overall dietary vitamin D intake and use of vitamin D supplements is relatively low in the United States. Pharmacists' health knowledge and placement in communities make them ideal resources for raising awareness on the benefits of vitamin D and providing nutrition information to prevent vitamin D inadequacy. However, pharmacists' ability to provide these services may be impeded in part by current limitations on compensation for health promotion activities. CONCLUSION: Health care reform is likely to expand pharmacists' scope of practice and services eligible for reimbursement. By promoting vitamin D in the communities they serve, pharmacists can take a lead role among health professionals in addressing vitamin D inadequacy.

Virtual medication therapy management: the cornerstone to a pharmacy renaissance.

OBJECTIVES: To introduce an innovative clinical service that can be used to reduce medication errors and improve quality of care in the rural environment, in order to assist in eliminating or alleviating disparities in health based on geographical location. SUMMARY: Virtual medication therapy management (MTM) will be a tool to assist underserved populations, specifically residents of rural communities. It will use videoconferencing software to provide MTM services to populations that lack access to care. For virtual MTM to be effective, specific measures must be implemented to comply with the Health Insurance Portability and Accountability Act, and state regulations must be established to standardize the practice. CONCLUSION: The virtual MTM model is a feasible and promising model for advancing MTM services. With commitment and cooperation from various health care fields, virtual MTM could be the cornerstone of a health care renaissance.

Methodology for conducting a comprehensive product review in managed care.

The high degree of complexity of the product-review process and differences in procedures between organizations have resulted in a need for best practices and an overall product-review process to create efficiencies for health care decision makers. In an effort to streamline product-review concepts, this article outlines the different components of the review process, including clinical and economic review, formulary placement determination, and evaluation of alternatives within a drug class. The article also details opportunities for the near future, as technology continues to advance and alignment between medical and pharmacy benefits is desired. DISCLOSURES: Drs Linnerooth, Penley, Ha, and Craven report employment with Xcenda, which provided funding for the manuscript. Drs Sauvageau and Hydery report employment Xcenda, which provided funding for the manuscript, and stock holdings with AmerisourceBergen. Dr Feeney reports support for attending meetings and/or travel provided by Highmark, Inc. Dr Thomas reports receipt of consulting fees from ActiveRADAR, board member roles with ActiveRADAR and RoundtableRx, an adjunct professor role with the University of Minnesota, and stock options and pensions with Eli Lilly and Aetna/CVS. Dr Watkins reports payment or honoraria from ISPOR and for articles written for Value and Outcomes Spotlight, and support for attending meetings and/or travel by AMCP.