A Follow-Up Study on Delivery of Pharmacy Law Education Across Doctor of Pharmacy Programs.

OBJECTIVE: To present 2018-2019 data from an expanded investigation after an inaugural 2016 pilot survey, which previously reported on the delivery of pharmacy law education in doctor of pharmacy (PharmD) programs in the US. METHODS: Due to the limited scope of responses in the 2016 pilot study, the earlier survey was refined and readministered (Qualtrics, Provo, UT) utilizing branching logic to specifically identify characteristics of the pharmacy law content and its delivery in PharmD curricula. The follow-up study received an exempt status from the Institutional Review Board of Keck Graduate Institute. RESULTS: Of the 142 American Association of Colleges of Pharmacy member institutions in 2018, 97 provided complete responses to the survey, yielding a response rate of 68.3%. The survey results from this 2018-2019 further investigation examining the delivery of pharmacy law education in US PharmD programs indicate significant variations across respondent programs with respect to professional background of pharmacy law educators and assessment strategies used in pharmacy law courses, as well as variations in the structure and timing of the core pharmacy law course within the PharmD curriculum. CONCLUSION: The current data show PharmD curricula at surveyed institutions lack uniformity in pharmacy law content and sequencing of pharmacy law courses, supporting further investigation to identify the best practices in the delivery of pharmacy law education. Another deliberate focus should aim to more specifically determine how, if, and which specific modifications to delivery of pharmacy law education might ensure achievement of student learning outcomes and optimize PharmD graduates' performance on standardized jurisprudence exams.

Initiation of buprenorphine for opioid use disorder in the hospital setting: Practice models, challenges, and legal considerations.

PURPOSE: To provide health-system pharmacists with published examples of strategies utilized to offer buprenorphine to inpatients with opioid use disorder (OUD) along with information on challenges and legal considerations. SUMMARY: Hospitals and emergency departments (EDs) are a constant source of healthcare for patients with OUD. As a result, hospital practitioners can screen, diagnose, begin treatment, and facilitate transfer of care to the outpatient setting. Offering sublingual buprenorphine in the hospital can bridge the gap before outpatient care is established. Multiple studies have shown that initiating treatment in the ED or during inpatient hospitalization results in 47% to 74% of patients utilizing medication-assisted treatment at day 30 of follow-up, statistically superior to the rates achieved with brief interventions or referral alone. Moreover, initiating buprenorphine treatment in the ED has been shown to decrease healthcare costs. Despite the benefits of offering buprenorphine in the inpatient setting, several challenges must be solved by hospital administration, such as achieving clinician readiness to prescribe buprenorphine, developing relationships with outpatient providers of buprenorphine, and creating an efficient workflow. Treatment of OUD with buprenorphine is heavily regulated on the federal level. Pharmacists can participate in the development of these programs and ensure compliance with applicable laws. CONCLUSION: As health systems continue to care for patients with OUD, starting buprenorphine in the inpatient setting can improve the transition to outpatient treatment. Several institutions have developed programs with positive results. With an understanding of the typical barriers and relevant laws when initiating buprenorphine in the hospital setting, health-system pharmacists can assist in the development and operation of these initiatives.

A Pilot Study Regarding Pharmacy Law Education Across Doctor of Pharmacy Programs.

Objective. To describe the features of pharmacy law education in Doctor of Pharmacy (PharmD) programs in the United States. Methods. A review of the literature found no prior published data describing the delivery of pharmacy law education across PharmD programs in the United States. Members of the Pharmacy Law Educators Subcommittee of the American Society for Pharmacy Law (ASPL) developed questions for a survey. The survey was administered electronically to all 139 American Association of Colleges of Pharmacy (AACP) member institutions in the summer of 2016. A link to complete the 32-item online survey was distributed via email to the pharmacy law educator or associate dean at each AACP member institution. Results. Of the 139 PharmD programs surveyed, 49 completed the survey instrument, yielding a response rate of 35.2%. Variations between programs were found in the professional background of pharmacy law instructors and assessment strategies for pharmacy law courses, as well as in the structure and placement of the main pharmacy law course within the various curricula. Conclusion. This pilot study represents the first and only known attempt to examine delivery of pharmacy law education across colleges of pharmacy. The variations between programs found in this study highlight the need for further investigation into this area of pharmacy education.

Using MyDispense to simulate validation of controlled substance prescriptions in a pharmacy law course.

BACKGROUND AND PURPOSE: MyDispense is an innovative, web-based program which simulates a community pharmacy. Use of this software may assist students' comprehension of validating controlled substance prescriptions by determining if prescriptions contain errors or omissions. EDUCATIONAL ACTIVITY AND SETTING: Fourteen MyDispense practice exercises were created and implemented into a required second-year pharmacy law course. Completion of the MyDispense exercises and performance on the pharmacy law midterm exam were recorded. A questionnaire was administered to students to receive feedback on the exercises. FINDINGS: There were complete data on all 94 student pharmacists enrolled in the didactic course. Thirty-five students (37%) completed all MyDispense exercises, 15 students (16%) completed some of the exercises, and 44 (47%) did not complete any of the exercises. Linear regression results indicate that students who completed more MyDispense exercises were significantly more likely to score higher on the midterm than those who completed fewer exercises (ß = 0.28, p = 0.02). Students reported moderate to high exercise value and a willingness to use the software in preparation for future pharmacy law examinations. SUMMARY: MyDispense provided a platform for students to apply controlled substance laws to the prescription validation process in the community pharmacy setting. Completion of practice exercises in MyDispense was shown to positively impact student performance on a pharmacy law midterm. Students valued the innovative simulation tool and were willing to access the tool again to prepare for future examinations.

Predictors of performance on the North Carolina Multistate Pharmacy Jurisprudence Examination.

INTRODUCTION: To evaluate an expanded set of variables and determine their association with Wingate University School of Pharmacy (WUSOP) graduates' scores on the North Carolina (NC) Multistate Pharmacy Jurisprudence Examination (MPJE). METHODS: Demographic, pre-admission, pharmacy school, and licensing preparation variables were collected for WUSOP graduates who attempted the NC MPJE for the first time in 2017. Bivariate correlations between student-pharmacist characteristics and the MPJE score were performed. RESULTS: Several variables were found to have a statistically significant association with the NC MPJE score, including prerequisite grade point average, pharmacy coursework, Pharmacy Curriculum Outcomes Assessment performance, and completion of MPJE practice questions. There were no significant associations between NC MPJE scores and demographic characteristics, previous paid pharmacy employment, receipt of undergraduate degree, or Pharmacy College Admission Test scores. CONCLUSION: This exploratory analysis identified characteristics of WUSOP graduates that were associated with performance on the NC MPJE. The results of this study will be communicated with future graduates to enhance their success on the jurisprudence examination.

Drug updates and approvals: 2019 in review.

In 2019, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: risankizumab-rzaa (Skyrizi); halobetasol and tazarotene (Duobrii); dolutegravir and lamivudine (Dovato); romosozumab-aqqg (Evenity); brexanolone (Zulresso); solriamfetol (Sunosi); aclidinium and formoterol (Duaklir Pressair); and siponimod (Mayzent).

Do more opioid policies reduce opioid dispensing in traditional medicaid?: A national analysis.

BACKGROUND: Several Medicaid programs have implemented approaches to ensure the appropriateness of opioid utilization and decrease opioid dispensing. OBJECTIVE: To evaluate whether Medicaid opioid harm reduction strategies (OHRS) resulted in a decrease in opioid claims, costs, or units reimbursed per beneficiary. METHODS: The number of OHRS was determined for each state's fee-for-service (FFS) Medicaid program according to previously published data. Publically available FFS Medicaid data were tabulated by state for opioid claims, costs, and units reimbursed in state fiscal years 2016 and 2017. Multivariable generalized estimating equation (GEE) models were utilized to analyze the data. RESULTS: GEE results indicated that OHRS intensity or change in OHRS did not impact opioid claims or units reimbursed in Medicaid FFS programs. A significant finding on reduction in beneficiary-adjusted opioid costs was observed for states with two OHRS compared to states with no OHRS. There were no significant differences in opioid claims, units reimbursed, and costs based on states with 3 or fewer OHRS versus those with four or more. When examining the differential effect of each individual type of OHRS, there were no significant differences in opioid claims, units reimbursed, nor medication costs. CONCLUSIONS: The number of OHRS may not be associated with opioid dispensing or utilization in FFS Medicaid programs. Other factors may have led to the decrease in opioid claims for Medicaid.

Assessing the impact of a didactic lecture for student pharmacists on legislative advocacy.

BACKGROUND AND PURPOSE: Advocacy has been defined as "the essential competence". Literature describes and assesses the impact of elective, extracurricular, and co-curricular advocacy experiences, but there is a deficiency of literature that describes and assesses core curricular advocacy experiences. EDUCATIONAL ACTIVITY AND SETTING: An electronic pre- and post-survey was administered to second-year student pharmacists who attended a didactic lecture on advocacy within a pharmacy law course. All responses were anonymous and matched via self-generated code. Wilcoxon signed rank tests analyzed matched data. FINDINGS: Pharmacy students were generally unaware of their legislative representation and did not know what to expect when meeting with legislators. A small percentage (24%) had previously contacted their legislator regarding pharmacy topics. All three knowledge items and seven of eight attitudes showed statistically significant improvement after the lecture. Following the lecture, 85% of students agreed/strongly agreed they were more prepared to be an advocate for pharmacy, with 76% reporting increased commitment. DISCUSSION: This study shows that a brief didactic educational intervention may improve student pharmacists' knowledge of and commitment to political advocacy, addressing previously noted limitations of models to prepare student pharmacists for advocacy efforts. The skill of advocating was not addressed by this intervention. SUMMARY: A brief didactic lecture at one institution showed a short-term positive influence on pharmacy students' knowledge and attitudes towards legislative advocacy. Introduction of advocacy within the core didactic curricula may provide a method to increase the prevalence of advocates within the profession of pharmacy, but this requires further assessment and identification of best practices.

Drug updates and approvals: 2018 in review.

In 2018, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy); doxylamine succinate and pyridoxine hydrochloride (Bonjesta); erenumab-aooe (Aimovig); lofexidine hydrochloride (Lucemyra); tezacaftor and ivacaftor (Symdeko); and tildrakizumab-asmn (Ilumya).

Association between the North Carolina Medical Board opioid guideline update and opioid prescriptions in Medicare Part D beneficiaries.

OBJECTIVE: To examine if North Carolina (NC) opioid prescribing guidelines were associated with changes in opioid prescribing. METHOD: Retrospective secondary analysis of the Medicare Provider Utilization and Payment Data: Part D Prescriber datasets from 2013 to 2015. PARTICIPANTS: Providers who prescribed at least one opioid from 2013 to 2015 and paid by Medicare Part D. MAIN OUTCOME MEASURE: Per-prescriber Medicare-population adjusted number of analgesic opioid claims and per-prescriber average day supply. Generalized estimating equations (GEE) were used to analyze the data. RESULTS: There were significantly higher per-prescriber Medicare adjusted opioid claims in 2014 compared to 2015 (p < 0.001) but no difference between 2013 and 2015 (p = 0.584). GEE results also indicated that there was a significant increase in 2015 in per-prescriber average day supply, compared to 2013 and 2014 (both p < 0.0001). CONCLUSIONS: State opioid prescribing guidelines published in mid-2014 may have slowed the escalation of numbers of opioid prescriptions in NC. Future research should examine whether the guidelines were associated with changes in morphine equivalent dosing in NC during the same timeframe.

Emergency Providers' Opioid Prescribing Behaviors Among Medicare Part D Beneficiaries in North Carolina, 2013-2014: Medication Utilization and Costs.

BACKGROUND This study sought to quantify utilization and costs associated with opioid prescribing by emergency providers for Medicare Part D beneficiaries in North Carolina and the United States from 2013 to 2014.METHODS This was a retrospective examination of the Medicare Provider Utilization and Payment Data: Part D Prescriber datasets from 2013-2014. The main variables of interest were total number of prescription claims and total Medicare Part D medication costs for opioid analgesic medications. Generalized estimating equations were used to analyze the data.RESULTS Excluding North Carolina, there were 2,030,108 (678.49 per 100,000) opioid claims in the United States in 2013, costing more than $28.3 million. In 2014, also excluding North Carolina, there were 2,061,992 (689.15 per 100,000) claims for opioids, costing almost $35.8 million. In North Carolina, there were 67,570 (708.62 per 100,000) opioid claims from emergency providers in 2013 and 72,881 (764.31 per 100,000) opioid claims in 2014 for Part D beneficiaries. Total Part D drug costs associated with opioids from North Carolina increased from $545,574 to $764,016, more than a 40% increase. In North Carolina, there was a statistically significant increase in costs (P < .001), but not a significant increase in numbers of claims (P = .051).LIMITATIONS This study did not examine patient-level data and could not examine diagnoses leading to opioid prescriptions, or opioid misuse or overdoses.CONCLUSION Almost 1 out of every 4 Part D prescriptions from emergency department providers in North Carolina was for an opioid medication. Given the recent focus on controlling opioid prescribing, future research should examine if the new opioid-prescribing guidelines reduced opioid prescription by these providers.

Drug updates and approvals: 2017 in review.

In 2017, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: brodalumab (Siliq), dapagliflozin and saxagliptin (Qtern), dupilumab (Dupixent), oxymetazoline (Rhofade), safinamide (Xadago), and sarilumab (Kevzara).

What do PAs need to know about prescription drug monitoring programs?

As controlled-substance abuse continues to increase in the United States, clinicians find themselves on the front lines of this epidemic. State-operated prescription drug monitoring programs are a valuable resource that prescribers can use to see patients' controlled substance history. Despite some limitations, these programs have been shown to be an effective method in reducing overdose deaths and the supply of controlled substances in the community.

Treating skin and soft tissue infections.

New guidelines have been released for the treatment of skin and soft tissue infections. The updates include recommendations on when to prescribe antibiotics and which antibiotics are effective for each infection. This article will highlight the important changes to practice and provide additional antibiotic clinical pearls.

Drug updates and approvals: 2016 in review.

In 2016, the FDA approved several new drugs for use in primary care. These drugs include amphetamine extended-release orally disintegrating tablets (Adzenys XR-ODT), elbasvir and grazoprevir (Zepatier), emtricitabine and tenofovir alafenamide (Descovy), glycopyrrolate and formoterol (Bevespi Aerosphere), insulin degludec injection (Tresiba), and ixekizumab (Taltz).

5-Day versus 10-Day Course of Fluoroquinolones in Outpatient Males with a Urinary Tract Infection (UTI).

INTRODUCTION: Current guidelines classify urinary tract infections (UTIs) in males as complicated and recommend longer treatment than for UTIs in females. The objective of this study is to demonstrate that males with UTIs may be successfully treated with an outpatient 5-day course of levofloxacin. METHODS: Data were obtained from a previously conducted clinical trial (www.clinicaltrials.gov identifier NCT00210886), a multicenter, double-blind, randomized, noninferiority study comparing levofloxacin 750 mg intravenously/by mouth once daily for 5 days and ciprofloxacin 400/500 mg intravenously/by mouth twice daily for 10 days in complicated UTI (cUTI). The current study was a post hoc, subgroup analysis of male and female subjects with cUTI. Subjects were stratified into groups based on sex and antibiotic received. The subjects were analyzed at the end of therapy (EOT) and post therapy (PT) for clinical success rates, defined as no further need for antimicrobial treatment. RESULTS: Totals of 427 patients (224 male, 203 female) and 350 patients (189 male, 161 female) were included in the modified intent-to-treat (mITT) population and microbiologically evaluable (ME) populations, respectively. Clinical success rates between males and females were not statistically different between antibiotic groups in either the mITT or ME populations at EOT or PT. CONCLUSION: This study demonstrates that males with UTI may be treated with a shorter course of antimicrobial therapy for UTI than previously recommended.

Researchers' Experience with Clinical Data Sharing.

The topic of transparency in industry-sponsored clinical trials has gathered the attention of researchers in medicine. Patient-level data from recently completed clinical trials is now available for investigators to reanalyze or perform new analyses. In this Special Communication, the authors discuss their experience using this type of research and provide recommendations for success.