Natalie A. DiPietro Mager

Women’s involvement in clinical trials: historical perspective and future implications

The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women’s response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women’s inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.

Global Health Education in Doctor of Pharmacy Programs.

The objective of this Review is to characterize content related to global health in didactic and experiential curricula of doctor of pharmacy (PharmD) programs in the United States. The review was completed through a systematic website search of 133 US PharmD programs accredited or currently in the process of obtaining accreditation to identify global health dual degrees, minors/concentrations, required and elective courses, and experiential opportunities. Programs’ course catalogs were referenced as needed to find more specific course listings/descriptions. More than 50 programs offered an elective course related to global health; eight had a required course; eight offered a minor or certification for global health; three offered dual degrees in pharmacy and global health. Fourteen institutions had a center for global health studies on campus. More than 50 programs offered experiential education opportunities in global health including international advanced pharmacy practice experiences or medical mission trips. Inclusion of and focus on global health-related topics in US PharmD programs was widely varied.

Pharmacists' perceptions of advancing public health priorities through medication therapy management

Background: Public health priorities can be addressed by pharmacists through channels such as medication therapy management (MTM) to optimize patient and population outcomes. However, no studies have specifically assessed pharmacists’ perceptions of addressing public health priorities through MTM. Objective: The objective of this study was to assess pharmacists’ opinions regarding the feasibility and appropriateness of addressing seven areas of public health priority through MTM services to impact public health in direct patient care settings. Methods: An anonymous 37-question electronic survey was conducted to evaluate Ohio pharmacists’ opinions of advancing seven public health priorities identified from Healthy People 2020 (family planning, preconception care, smoking cessation, immunizations, nutrition/biometric wellness assessments, point-of-care testing, fall prevention) through MTM activities; to identify potential barriers; and to collect demographic information. The cross-sectional survey was sent to a random sample of 500 pharmacists registered with the Ohio State Board of Pharmacy. Results: Seventy-six pharmacists responded to the survey, resulting in a 16% response rate. On average, it took respondents 5-10 minutes to complete the survey. The majority of respondents thought that each of the seven public health priorities were “important” or “very important” to patient health; the most commonly identified areas included smoking cessation, immunizations, and fall prevention (97.5%). When asked to indicate which of the seven areas they thought they could potentially have a role to provide services through MTM, on average pharmacists picked 4 of the priority areas. Only 6.6% indicated there was no role for pharmacists to provide MTM services for any of the listed categories. Staffing, time, and reimbursement represented the most commonly perceived barriers for pharmacists in providing MTM services. Fifty-seven percent indicated an interest in learning more about MTM, with 98% of responders selecting continuing education as the preferred source. Conclusion: The majority of pharmacists indicated they could make an impact on public health priorities through MTM services.

Fulfilling an Unmet Need: Roles for Clinical Pharmacists in Preconception Care

Preconception care refers to a set of interventions that identify and address biomedical, behavioral, and social risks to a womans health that may negatively impact a future pregnancy. A great need for preconception care currently exists in the United States, and womens attitudes about discussions with health care providers about healthy and safe pregnancies are positive. Clinical pharmacists are well positioned to work with other health care and public health professionals to ensure that all women of childbearing potential have access to preconception care. As part of the collaborative health care team, clinical pharmacists can directly provide services or support and referrals to other members of the health care team or to community resources through clinical‐community linkages. Specifically, clinical pharmacists can provide education, counseling, and/or services to women to address family planning, medication and disease state management, immunizations, screenings, health promotion, and substance use. Clinical pharmacists can also impact preconception care through drug information services, advocacy, and research. Preconception care services can be incorporated into daily pharmacy practice, and there are potential means for reimbursement. Multiple roles exist for clinical pharmacists to fulfill unmet needs in preconception care.

The Importance of Public Health in Pharmacy Education and Practice.

Professional and governmental organizations continue to acknowledge the profound impact of pharmacists on public health,1-5 and the academy is no exception. It has long recognized the importance of preparing pharmacy students to assume roles in public health. Topics related to public health have been a fundamental component of each iteration of the Center for the Advancement of Pharmaceutical Education (CAPE) Educational Outcomes.6-9 For example, in the 2013 Outcomes, 1.1 (Learner), 2.1 (Patient-centered Care), 2.3 (Health and Wellness), 2.4 (Population-based Care), 3.2 (Educator), 3.3 (Patient Advocacy), 3.5 (Cultural Sensitivity), 3.6 (Communication), 4.1 (Self-awareness) and 4.2 (Leadership), support the need to include public health concepts in the doctor of pharmacy curriculum.9 In addition, the American Association of Colleges of Pharmacy (AACP) is a member of the Healthy People Curriculum Task Force, convened by the Association for Prevention Teaching and Research, which developed a Clinical Prevention and Population Health Curriculum Framework.10 Moreover, many pharmacy faculty members are involved and interested in public health, as evidenced by the robust membership in the Public Health Special Interest Group (SIG) of AACP. The group is currently the sixth largest among AACP’s 21 SIGs. Eight active subcommittees comprise the SIG, with areas of focus that include tobacco control, emergency preparedness and response, caring for the underserved, and global public health pharmacy.11 In this theme issue of the Journal, we present five diverse examples of ways colleges and schools of pharmacy are engaging their students and faculty members in public health inside and outside of the classroom. We include four areas where pharmacists may contribute to public health activities and principles, but enumerable examples exist beyond these. Also contributing to the issue is Georges Benjamin, MD, executive director of the American Public Health Association (APHA), which has one of the most comprehensive policy statements outlining opportunities for pharmacists in public health.3 A Pharmacy Special Primary Interest Group also has been recently established within the organization.12,13 Importantly, Benjamin distinguishes between public health and population health, the latter a term also used in the CAPE 2013 Outcomes and Accreditation Council for Pharmacy Education (ACPE) 2016 Standards.9,14 Pharmacists may contribute to both, in that public health may be considered local activities of a public health department to improve health, and population health may be considered the activities (medical care or public health activities) focused to improve the health of populations. In two articles, pharmacy faculty members provide examples of efforts that consider emergency preparedness, an area that public health organizations such as the National Association of County and City Health Officials have highlighted as needing pharmacy involvement.15 This topic has been specified as a necessary entry-level competency for pharmacists.14 For example, it is critical that pharmacists consider how individuals obtain their medications during emergencies when pharmacies may be flooded or transportation limited. Ford and colleagues share the results of a comprehensive analysis of pharmacy legal documents from US states and commonwealth territories to estimate the degree of pharmaceutical emergency preparedness, and Hannings and colleagues provide a guide to designing, implementing, and assessing an introductory pharmacy practice experience focused on emergency preparedness. Based on their findings, the profession may need to focus explicitly on this important public health activity, particularly in areas with a high risk of devastating events such as earthquakes, tornados, and floods. The remaining three papers present the variety of activity in which pharmacists may participate in public health and generally represent the theme of caring for underserved or vulnerable populations. Potential roles for pharmacy students as tuberculosis screeners are explored by McKennon and Arnold, significant because it represents a novel screening certification specifically created for and delivered to pharmacy students. Clarke and colleagues present the effect of a poverty simulation exercise on pharmacy students’ attitudes toward poverty, an important consideration as pharmacy students must be familiar with social determinants of health.9 This type of activity is important for pharmacy students in terms of CAPE Outcomes such as 2.1 (Patient-centered Care), 2.3 (Health and Wellness), 2.4 (Population-based Care), 3.5 (Cultural Sensitivity), 3.6 (Communication) and 4.1 (Self-awareness).9 It can be easy to find oneself in a judging mode after several years of practice—activities such as this may ameliorate such attitudes. Finally, Karwa and colleagues detail the construct and impact of an international residency program in global health, which is increasingly becoming a national priority16,17 and is included in Healthy People 2020 as a new topic area.18 Access to medications and their best use is a critical need, and pharmacists can help in this regard. The academy must continue to ensure that students are well-equipped to assume roles in public health and population health management. The papers presented here provide specific examples that can be implemented. However, the topics are not exhaustive; there are many other ways and opportunities for schools of pharmacy to incorporate principles of public health in didactic and experiential curricula, co-curricular or extracurricular activities, and postgraduate training. For example, members of the Public Health SIG have assisted faculty members at schools of pharmacy to adopt official policies to reduce the health burden associated with tobacco.19 Recent SIG webinars have explored subjects such as expedited partner therapy, quality improvement, and interprofessional collaborations in public health.20 As faculty members continue to develop and revise programs, especially in light of the updated CAPE Outcomes and ACPE Standards, we hope that this theme issue calls attention to the importance of public health in pharmacy education and practice. We also hope that faculty members who do not yet participate in the AACP Public Health SIG but who provide instruction or have an interest in public health consider joining the group in order to facilitate a continued sharing of ideas and strategies to best prepare pharmacy students in these areas.

Impact of an Online Educational Program on Pharmacy Students’ Knowledge of Folic Acid and Neural Tube Defects

Purpose: Pharmacy students must receive adequate training regarding folic acid for the prevention of neural tube defects (NTDs). Pharmacy students’ knowledge should be evaluated and effective methods utilized to improve it, if needed. The objective of this study was to assess baseline knowledge among third-year students in a 0-6 Doctor of Pharmacy program and to evaluate the impact of an online educational video. Methods: Baseline knowledge was assessed by a pretest adapted with permission from the March of Dimes (MOD). Students watched a 30-minute MOD video and completed a posttest. Nine months later, students completed a longitudinal posttest. Analysis of variance was used to assess differences in the percentage of correct responses to each question. Results: A total of 133 (90.5%) students completed the educational program and 105 (78.9%) completed the longitudinal test. Statistically significant improvements in knowledge from baseline were seen for 9 of 10 questions on the posttest and for 6 of 10 questions on the longitudinal test. Conclusion: Online videos are tools to teach pharmacy students key information regarding folic acid and NTD; however, material should be reinforced in experiential education as well. Counseling women of childbearing potential about folic acid fulfills an important public health need.

Partners in Public Health: Public Health Collaborations With Schools of Pharmacy, 2015:

To collect data on public health collaborations with schools of pharmacy, we sent a short electronic survey to accredited and preaccredited pharmacy programs in 2015. We categorized public health collaborations as working or partnering with local and/or state public health departments, local and/or state public health organizations, academic schools or programs of public health, and other public health collaborations. Of 134 schools, 65 responded (49% response rate). Forty-six (71%) responding institutions indicated collaborations with local and/or state public health departments, 34 (52%) with schools or programs of public health, and 24 (37%) with local and/or state public health organizations. Common themes of collaborations included educational programs, community outreach, research, and teaching in areas such as tobacco control, emergency preparedness, chronic disease, drug abuse, immunizations, and medication therapy management. Interdisciplinary public health collaborations with schools of pharmacy provide additional resources for ensuring the health of communities and expose student pharmacists to opportunities to use their training and abilities to affect public health. Examples of these partnerships may stimulate additional ideas for possible collaborations between public health organizations and schools of pharmacy.

Use of targeted medication reviews to deliver preconception care: A demonstration project

OBJECTIVES To demonstrate the ability of a statewide network of community pharmacists to provide preconception care services with the use of targeted medication reviews (TMRs). Community pharmacists are well qualified and well positioned to assist in this public health priority; however, there are no documented case studies of pharmacists providing preconception care with the use of TMRs. METHODS Through the demonstration project, pharmacists provided educational TMRs focused on 3 elements of preconception care to women aged 15 to 45 years enrolled in a nonprofit managed care plan: (1) medications that may cause fetal harm (category D/X); (2) folic acid use; and (3) immunizations. TMRs were generated and released to the individual pharmacy where that patient had prescriptions filled. Any practicing pharmacist in Ohio participating in the medication therapy management platform with a patient in the sample received a TMR notification. The pharmacists documented and billed for the service through this commercially available platform. RESULTS Nineteen weeks after implementation of the TMRs, 1149 individual pharmacists from 818 different pharmacies had completed at least 1 TMR. Pharmacists completed 33% of all TMR opportunities with a 65% success rate. CONCLUSION Establishing new services that were focused on preconception care resulted in rapid integration into existing medication therapy management processes in hundreds of pharmacies across Ohio. These results may help to provide justification for additional payers to reimburse for similar services. Through demonstrating the impact on preconception care, the role of the community pharmacist may continue to expand to include provision of additional preventive care services following the model developed in this initiative.

Pharmacist and student pharmacist perspectives on providing preconception care in the United States

OBJECTIVES The primary objective was to assess pharmacist and student pharmacist current involvement and interest in providing preconception care services. Secondary objectives were to assess comfort in providing these services to various subpopulations in addition to training and resource needs. METHODS A cross-sectional online survey was conducted in the United States and its territories from August 26 to October 14, 2016. Pharmacists and student pharmacists were recruited via a Facebook advertisement to participate in a self-administered survey assessing experiences, interest, and comfort in providing preconception care services in addition to training and resource needs. RESULTS Three hundred thirty-two responses were included in the final analysis from the United States and its territories. Most respondents were female (72%) and pharmacists (65%). Respondents reported providing preconception care services, from routine immunizations (54%) to sexually transmitted disease (STD) and HIV screening and management (13%). Respondents also expressed strongest interest in providing new services for STD and HIV screening and management (68%) and minimizing risk of medication teratogenicity (62%). Respondents were most comfortable providing services to female adults (88%) and female adolescents (65%) compared with male adults (61%) and male adolescents (32%). Respondents indicated that tools, such as patient medical records (67%), patient educational materials (66%), and clinical guidelines (60%), would facilitate adoption of preconception care services. CONCLUSION This study provides the first insights on the involvement, interest, and comfort of pharmacists and student pharmacists in the United States and its territories related to preconception care. Most respondents indicated that they are currently providing or are interested in providing preconception care services. Tools and resources should be developed to facilitate pharmacist provision of preconception care services.

Utility of reproductive life plans in identification of potentially teratogenic medication use: A pilot study

BACKGROUND Teratogenic medications increase risks of miscarriage, fetal death, and/or birth defects. It is important to identify whether women of childbearing potential are taking these medications and to minimize exposure to these agents through change in drug therapy before conception and/or use of effective contraception to prevent conception. OBJECTIVE To determine the utility of reproductive life plans as tools to identify women using potentially teratogenic medications. METHODS A retrospective review was conducted on reproductive life plans completed by women receiving services as part of the Toledo-Lucas County Healthy Start program. The medication section of the reproductive life plan was reviewed to determine: if it was completed; categories of medications reported (prescription, over-the-counter, vitamin/herbal); potentially teratogenic medications listed; contraception use and method. RESULTS Medication lists were completed for 437 of the 580 reproductive life plans reviewed (75%). Thirty-five women (8%) reported use of a potentially teratogenic medication; most commonly reported agents included blood pressure medications and antidepressants. Only 10 women taking a potentially teratogenic medication (29%) reported using some form of contraception, half of which reported use of a less effective method such as condoms. CONCLUSION The reproductive life plan can be a useful tool to identify women of childbearing age who require intervention due to use of potentially teratogenic medications. Efforts are needed to ensure complete and accurate reporting of medication use in reproductive life plans, and to promote effective contraceptive use among women taking potentially teratogenic medications.