Antiseizure medications and oral contraceptives: Impact of enzyme inducers on pregnancy outcomes and costs.

PURPOSE: To show the impact of drug-drug interactions (DDIs) associated with co-administration of enzyme-inducing (EI) antiseizure medications and oral contraceptives (OCs) on the annual number of unintended pregnancies, their outcomes, and their associated costs in the United States (US). METHODS: A Microsoft Excel pregnancy-outcomes model was developed to determine the impact of DDIs in women who take an OC as well as an EI antiseizure medication known to lower the effectiveness of the OC in preventing pregnancy. The model compared the number of unintended pregnancies, the expected pregnancy outcomes, and associated costs in women taking an OC and an EI medication with a matched cohort of women who took an OC and an enzyme-neutral (EN) antiseizure medication that is known not to interact with OCs. The model perspectives were patients and third-party payers in the US. Unintended pregnancy rates, pregnancy outcomes, and cost inputs for the model were taken from published studies. RESULTS: The results of the analysis showed an estimated increase in the annual number of unintended pregnancies in the US of 503 (a change from 1151 to 1654), an increase of 44.7%, for the estimated 71,922 women currently taking an OC plus an EI medication in the US when compared with a matched cohort taking an OC plus an EN medication. This resulted in an estimated annual healthcare cost increase of $3 million, which is an increase of 5.5% in the annual costs for contraception and pregnancy care. A scenario analysis showed that the annual number of unintended pregnancies could be lower (575 vs 1654) for a matched cohort of women taking EI medications and using a copper intrauterine device, a highly effective and nonhormonal form of contraception, rather than an OC. CONCLUSIONS: Physicians treating women of reproductive age for epilepsy who wish to avoid pregnancy should consider the potential for DDIs that might result in unintended pregnancies. Thus, physicians should alert women using EI medications for epilepsy control to the increased potential for unintended pregnancies if they use OCs for contraception.

Organizational values: Essential substrate for professional identity formation.

Core organizational values are essential for any organization, including academic institutions. Formal and informal leaders can have a positive, or negative, impact on shaping their culture through the core values. Members of an organization, including students, can be shaped by the organizational values in ways that strengthen, or impede, their professional identity formation. Here, we discuss the use of organizational values as vital substrates needed to shape the desired behaviors and attitudes that will help describe the organizational culture and identity. We define and discuss various types of core values, identify the benefits and challenges of core values alignment, and offer strategies for leaders at all levels to reflect on their own organization's core values and their current approach to their contribution to an effective and sustainable workplace that supports the professional identity formation of all members.

An assessment of patient experiences as teachers of cultural sensitivity in an interprofessional setting.

BACKGROUND AND PURPOSE: The importance of cultural sensitivity training in pharmacy education is well-recognized, though best practices are not well described. Traditional teaching approaches such as faculty lectures may result in overgeneralization, lack of nuance, or tokenization. Utilizing patients from diverse special populations as teachers of cultural sensitivity may mitigate these risks. However, faculty must ensure patients feel comfortable, empowered, valuable, and prepared to serve as partners in education. EDUCATIONAL ACTIVITY AND SETTING: Patients were used as teachers of cultural sensitivity in an interprofessional education panel activity at two colleges of pharmacy over two years. Patient experiences with training and preparation for the activity as well as their perceived benefits of partnering in student education were assessed. FINDINGS: Overall, patients reported that training was adequate, and the educational activity provided a sufficient platform for sharing their knowledge with students. Patients felt they provided meaningful contributions to student education, learned valuable information in the process, and formed sincere relationships with each other and faculty. SUMMARY: Faculty at other institutions may wish to adapt this activity to meet the needs of their own institution and empower patients to contribute to the education of health professions students. Practical recommendations are provided for promoting a positive patient experience. A comprehensive training program prepared and empowered patients to teach cultural sensitivity principles to an interprofessional group of health care students.

Defining and enhancing collaboration between community pharmacists and primary care providers to improve medication safety.

INTRODUCTION: Over 4 billion prescriptions are dispensed each year to patients in the United States, with the number of prescriptions continuing to increase. There is a growing recognition of pharmacists' potential in improving medication safety in community settings, in collaboration with primary care providers (PCPs). However, the nature of collaboration has not been well defined, and barriers and strategies are not articulated. AREA COVERED: For this narrative review, published studies were retrieved from PubMed between January 2000 and December 2020. Search terms included "patient safety," "medication safety," "collaboration," "primary care physician," and "community pharmacy." Resulting articles were categorized as follows: defining collaboration, types of collaboration, and barriers and solutions to collaboration. EXPERT OPINION: It is important to understand the factors within a community pharmacy setting that limit or facilitate community pharmacists' participation in medication safety activities. Strategies such as medication review are a common form of collaboration. Barriers to collaboration include misconceptions regarding roles and differences in access to clinical information and community pharmacy practice variability. Future recommendations include increasing training and utilization of pharmacists/PCP teams, increasing community pharmacists' practice in emerging roles, and expanding the community pharmacist role in transitions of care from the hospital to the community.

Development of a pharmacoeconomic registry: an example using hormonal contraceptives.

BACKGROUND: Disease-specific registries, documenting costs and probabilities from pharmacoeconomic studies along with health state utility values from quality-of-life studies could serve as a resource to guide researchers in evaluating the published literature and in the conduct of future economic evaluations for their own research. Registries cataloging economic evaluations currently exist, however they are restricted by the type of economic evaluations they include. There is a need for intervention-specific registries, that document all types of complete and partial economic evaluations and auxiliary information such as quality of life studies. The objective of this study is to describe the development of a pharmacoeconomic registry and provide best practices using an example of hormonal contraceptives. METHODS: An expert panel consisting of researchers with expertise in pharmacoeconomics and outcomes research was convened and the clinical focus of the registry was finalized after extensive discussion. A list of key continuous, categorical and descriptive variables was developed to capture all relevant data with each variable defined in a data dictionary. A web-based data collection tool was designed to capture and store the resulting metadata. A keyword based search strategy was developed to retrieve the published sources of literature. Finally, articles were screened for relevancy and data was extracted to populate the registry. Expert opinions were taken from the panel at each stage to arrive at consensus and ensure validity of the registry. RESULTS: The registry focused on economic evaluation literature of hormonal contraceptives used for contraception. The registry consisted of 65 articles comprising of 22 cost-effectiveness analyses, 9 cost-utility analyses, 7 cost-benefit analyses, 1 cost-minimization, 14 cost analyses, 10 cost of illness studies and 2 quality of life studies. The best practices followed in the development of the registry were summarized as recommendations. The completed registry, data dictionary and associated data files can be accessed in the supplementary information files. CONCLUSION: This registry is a comprehensive database of economic evaluations, including costs, clinical probabilities and health-state utility estimates. The collated data captured from published information in this registry can be used to identify trends in the literature, conduct systematic reviews and meta-analysis and develop novel pharmacoeconomic models.

Naloxone Prescribing and Education in Outpatient Pain Management and Palliative Care.

Over the past two decades, opioid use and overdose have increased substantially. Naloxone, an opioid overdose reversal agent, has been one of many risk mitigation strategies for preventing mortality due to overdose. Most literature describing naloxone utilization has been about populations of illicit drug users and patients in hospitals, primary care, and pharmacies. There is limited information regarding naloxone prescribing and training for opioid users in specialty pain management clinics. Furthermore, there are no known publications concerning patients receiving palliative care services and overdose prevention. Pain and palliative care patients are commonly at risk of opioid overdose. In an interdisciplinary outpatient pain and palliative care clinic, pharmacists implemented naloxone prescribing and education. Eleven patients at increased risk for overdose were prescribed naloxone and educated on overdose risk factors, recognition, and management. Seven patients reported picking up their naloxone prescription from the pharmacy, and none reported using it within two weeks of the initial education. This intervention was deemed successful within the clinic, but small sample size and the pharmacist role may not be replicable within other pain and palliative care settings. It encourages further research of overdose risk and prevention in pain management and palliative care.

Quantifying the economic burden of unintended pregnancies due to drug-drug interactions with hormonal contraceptives from the United States payer perspective.

Background: In the United States of America (USA), nearly 10 million women use oral contraceptives (OCs). Concomitant administration of certain medications can result in contraceptive failure, and consequently unintended pregnancies due to drug-drug interactions (DDIs). The objective of this analysis was to estimate the economic impact of unintended pregnancies due to DDIs among women of reproductive age using an OC alone or in combination with an enzyme inducer co-medication in the USA from a payer perspective. Methods: A Markov model using a cohort of 1,000 reproductive-age women was developed to estimate costs due to contraceptive failure for OC alone versus OC with concomitant enzyme inducer drugs. All women were assumed to begin an initial state, continuing until experiencing an unintended pregnancy. Unintended pregnancies could result in birth, induced abortion, spontaneous abortion, or ectopic pregnancy. The cohort was analyzed over a time horizon of 1 year with a cycle length of 1 month. Estimates of costs and probabilities of unintended pregnancy outcomes were obtained from the literature. Probabilities from the Markov cohort trace was used to estimate number of pregnancy outcomes. Results: On average, enzyme inducers resulted in 20 additional unintended pregnancies with additional unadjusted and adjusted costs median (range) of USD136,304 (USD57,436-USD320,093) and USD65,146 (USD28,491-USD162,635), respectively. The major component of the direct cost is attributed to the cost of births. Considering the full range of events, DDIs with enzyme inducers could result in 16-25 additional unintended pregnancies and total unadjusted and adjusted costs ranging between USD46,041 to USD399,121 and USD22,839 to USD202,788 respectively. Conclusion: The direct costs associated with unintended pregnancies due to DDIs may be substantial and are potentially avoidable. Greater awareness of DDI risk with oral contraceptives among payers, physicians, pharmacists and patients may reduce unintended pregnancies in at-risk populations.

Incorporating Pharmacometrics into Pharmacoeconomic Models: Applications from Drug Development.

Pharmacometrics is the science of quantifying the relationship between the pharmacokinetics and pharmacodynamics of drugs in combination with disease models and trial information to aid in drug development and dosing optimization for clinical practice. Considering the variability in the dose-concentration-effect relationship of drugs, an opportunity exists in linking pharmacokinetic and pharmacodynamic model-based estimates with pharmacoeconomic models. This link may provide early estimates of the cost effectiveness of drug therapies, thus informing late-stage drug development, pricing, and reimbursement decisions. Published case studies have demonstrated how integrated pharmacokinetic-pharmacodynamic-pharmacoeconomic models can complement traditional pharmacoeconomic analyses by identifying the impact of specific patient sub-groups, dose, dosing schedules, and adherence on the cost effectiveness of drugs, thus providing a mechanistic basis to predict the economic value of new drugs. Greater collaboration between the pharmacoeconomics and pharmacometrics community can enable methodological improvements in pharmacokinetic-pharmacodynamic-pharmacoeconomic models to support drug development.

Pharmacy and Nursing Students' Perceptions Regarding the Role of Spirituality in Professional Education and Practice.

Objective. To compare first-year student pharmacists and nursing students with respect to their spirituality and perceptions of the role of spirituality in professional education and practice. Methods. This was a five-year, cross-sectional study. All first-year student pharmacists and nursing students were invited to participate in the survey during the first week of the fall semester in 2012 through 2016. Descriptive and inferential statistics were used to analyze the data. Results. A total of 1,084 students participated, including 735 student pharmacists and 349 nursing students. Significant differences in baseline demographics were noted between the groups. Students in both groups reported having frequent spiritual experiences. A significantly larger percentage of nursing students reported these experiences compared to student pharmacists. Furthermore, compared with student pharmacists, nursing students were more likely to anticipate that spirituality would play a role in their academic course work (76% vs 58%) and professional practice (90% vs 74%). Conclusion. Student pharmacists and nursing students reported having frequent spiritual experiences, and both groups anticipated that spirituality would be incorporated into their education and professional practice.

Appropriateness of Term Limits for Administrative Appointments in Pharmacy Programs.

The appropriateness of term limits for administrative appointments is a subject of much discussion, not just within pharmacy programs, but in organizations of all types. The prospect of term limits for involves a wide variety of important organizational issues, including succession planning, institutional memory, strategic decision-making, and concepts regarding leadership styles overall. This paper examines both sides of the debate regarding the appropriateness of term limits for administrative appointments. Arguments supporting term limits include the ability for strategic changes in the diversity of leaders as well as a more focused effort on continuous quality improvement. The arguments against term limits focus around the need for stability and the time involved in the development of effective leaders.

Patients as Teachers of Cultural Sensitivity in Pharmacy Education.

INTRODUCTION: Cultural sensitivity training among pharmacy students is required by the Accreditation Council for Pharmacy Education, but little data exists on effective practices for teaching these concepts. The goal of this case study was to describe the process and determine if integration of a patient-led Cultural Sensitivity Panel into the required didactic curriculum impacts pharmacy student perceptions of their own cultural competence. DESCRIPTION OF CASE: A special population was defined based on the CAPE competencies requiring students demonstrate sensitivity and responsiveness to culture, race/ethnicity, socioeconomic status, gender, sexual orientation, spirituality, disability, and other aspects of diversity and identity. Patients representing various special populations, such as veterans, the Deaf and hard of hearing population, the LGBT community, were invited to participate in a Cultural Sensitivity Panel for two consecutive years. Panelists shared information they wish future healthcare professionals understood about the population they represented and participated in a question and answer session. Pre- and post-surveys were conducted to assess the impact of the panel on student perceptions of cultural competence. RESULTS: Over two years, 138 students completed surveys. More than 95% of students agreed or strongly agreed that a cultural sensitivity panel is a worthwhile experience, and that the panel would help them change behaviors that may be culturally insensitive. Student perceptions of their own cultural competence significantly improved between the pre- and post- surveys; ethnicity, age and gender significantly impacted responses (p<.05). Key themes of responses to open-ended questions included learning about effective communication (64%), new resources for diverse patient populations (28%), addressing barriers to care (21%), the importance of patience and empathy (18%), and incorporating a patient's background into their care (18%). EXPLORATION OF CASE IMPACT: Use of a cultural sensitivity panel provides patients with their own voice in discussing barriers to the provision of health care and thus mitigates the inherent bias and limitations of faculty members teaching about cultures and populations they do not represent. CONCLUSION: This novel approach of integrating a Cultural Sensitivity Panel into the didactic curriculum positively impacted student perceptions of their own cultural competence and may improve culturally competent provision of care among pharmacy students.

An Elective Course in Lesbian, Gay, Bisexual, and Transgender Health and Practice Issues.

Objective. To design, implement and assess a lesbian, gay, bisexual, and transgender (LGBT) health and practice elective course for second- and third-year Doctor of Pharmacy (PharmD) students. Methods. The course focused on health promotion, health care barriers, disease prevention, and treatment throughout an LGBT person's lifespan. The course included topic discussions, reading assignments, various active-learning activities, an objective structured clinical examination (OSCE) with a transgender person, and guest speakers from the LGBT community. Five quizzes were administered during the course that were mapped to specific session learning objectives and course learning outcomes. Students completed an anonymous pre- and post-course survey on the seven course learning outcomes to assess their knowledge and skills regarding the health of LGBT people. Results. Students exhibited significant learning with improvement in the seven course learning outcomes. The two most improved course learning outcomes were the medications used for LGBT people and summarizing health care resources available to LGBT people. The content of student portfolios included general themes of discrimination, health care access problems, advocacy, inclusive pharmacy environments, and desire to be a better practitioner. More than 91% of the students actively engaged the guest speakers from the LGBT community. Student performance on quizzes and in the OSCE activity was excellent. The capstone presentations covered a variety of topics including LGBT in Islam. Conclusion. Students demonstrated knowledge of the unique health care issues among the LGBT community. This elective course provides a framework for other pharmacy programs to incorporate LGBT health topics into the curriculum and to engage with their local LGBT community.

Successful Remediation of an Advanced Pharmacy Practice Experience for an At-risk Student.

Objective. To describe a successful remediation for an Acute Care Medicine advanced pharmacy practice experience (APPE) in a student with multiple learning deficits. Methods. A literature review of pharmacy and medical experiential remediation was conducted to identify best practices to implement prior to designing the remediation for our student case. Based on this search and experience as preceptors, a three-phase remediation was designed: one week for assessment, two weeks for development of learning skills and strategies and six weeks for an on-campus APPE. Success of the remediation was determined by student performance, as defined by the APPE preceptor, in all relevant 2013 Center for the Advancement of Pharmacy Education (CAPE) educational outcomes. Results. Baseline assessment indicated that the student was below minimal competency in six of 13 relevant 2013 CAPE educational outcomes. Upon completion of the three-part remediation, the student repeated the Acute Care Medicine APPE, achieving better than minimal competency in all 13 outcomes. The student demonstrated significant improvement in nine of 13 CAPE educational outcomes. Conclusion. This student case provides a novel and successful blueprint for remediation of APPE. However, more evidence-based literature is needed to guide educators in experiential remediation.

Establishing a Multidisciplinary Framework to Study Drug-Drug Interactions of Hormonal Contraceptives: An Invitation to Collaborate.

Hormonal contraceptive agents (HCAs) are widely used throughout the world, and women taking HCAs are likely to take other medications. However, little is known about the clinical effect of most drug-drug interactions (DDIs) associated with HCAs. A team of interdisciplinary outcomes and pharmacometric researchers from academia and industry jointly engage in a research project to (i) quantitatively elucidate DDI impacts on unintended pregnancies and breakthrough bleeding, and (ii) establish a DDI-prediction framework to inform optimal use of HCAs.

First-year Student Pharmacists' Spirituality and Perceptions Regarding the Role of Spirituality in Pharmacy Education.

Objective: To measure student pharmacists' spirituality utilizing validated survey instruments and to determine perceptions regarding the anticipated role of spirituality in academic course work and professional practice. Methods: This was a cross-sectional, descriptive study. The survey was offered to all first-year student pharmacists during the first week of the fall semester (2012-2015). Descriptive and inferential statistics were used to analyze data. Results: A total of 580 students (98%) participated. The majority of students reported having each of the spiritual experiences on most days of the week or more frequently (58% to 89% based on individual item). Furthermore, 57% of students anticipate that matters of spirituality would be significant components of academic course work and 75% anticipate they would be incorporated into eventual professional practice settings. These perceptions were positively correlated to measures of spirituality and religiosity. Conclusion: These findings suggest that faculty should evaluate current and future incorporation of topics related to spirituality and health in pharmacy curriculum.

Hospital and Health Plan Partnerships: The Affordable Care Act's Impact on Promoting Health and Wellness.

BACKGROUND: The Affordable Care Act (ACA) healthcare reforms, centered on achieving the Centers for Medicare & Medicaid Services (CMS) Triple Aim goals of improving patient care quality and satisfaction, improving population health, and reducing costs, have led to increasing partnerships between hospitals and insurance companies and the implementation of employee wellness programs. Hospitals and insurance companies have opted to partner to distribute the risk and resources and increase coordination of care. OBJECTIVE: To examine the ACA's impact on the health and wellness programs that have resulted from the joint ventures of hospitals and health plans based on the published literature. METHOD: We conducted a review of the literature to identify successful mergers and best practices of health and wellness programs. Articles published between January 2007 and January 2015 were compiled from various search engines, using the search terms "corporate," "health and wellness program," "health plan," "insurance plan," "hospital," "joint venture," and "vertical merger." Publications that described consolidations or wellness programs not tied to health insurance plans were excluded. Noteworthy characteristics of these programs were summarized and tabulated. RESULTS: A total of 44 eligible articles were included in the analysis. The findings showed that despite rising healthcare costs, joint ventures prevent hospitals from trading-off quality and services for cost reductions. Administrators believed that partnering would allow the companies to meet ACA standards for improving clinical outcomes at reduced costs. Before the implementation of the ACA, some employers had wellness programs, but these were not standardized and did not need to produce measurable results. The ACA encouraged improvement of employee wellness programs by providing funding for expanded health services and by mandating quality care. Successful workplace health and wellness programs have varying components, but all include monetary incentives and documented outcomes. CONCLUSION: The concurrent growth of hospital health plans (especially those emerging from vertical mergers and partnerships) and wellness programs in the United States provides a unique opportunity for employees and patient populations to promote wellness and achieve the Triple Aim goals as initiated by CMS.