Publications

Disease-modifying therapies for multiple sclerosis (MS) are effective, but frequently cost $70,000+/year and can predispose patients to serious infections. This retrospective cohort analysis (N = 3,204) compared rates of infections over a 24-month period by MS medication route of administration and antimicrobial use. Infection rates were: 38.7% (oral), 37.3% (infused), and 36.8% (injectable). Of those infections, antimicrobials were prescribed in 86.5% (oral), 84.3% (infused), and 85.5% (injectable) cases. We found differences within bacterial and herpes zoster infection rates (and antimicrobial use) among new users by medication route of administration. Our findings suggest that pharmacovigilance may inform the shared-decision processes when choosing MS medications.

BACKGROUND: Given efforts to reduce opioid use, and because marijuana potentially offers a lower-risk alternative for treating chronic pain, there is interest in understanding the public health impact of marijuana legalization on opioid-related outcomes.

OBJECTIVE: Assess the impact of recreational and medical marijuana legalization on opioid utilization among patients receiving pharmacotherapy for pain.

DESIGN: Retrospective claims-based study of commercially insured patients continuously eligible for pharmacy and medical benefits from July 8, 2014 to June 30, 2017. Index pain prescription period was defined between January 8, 2015 and June 30, 2015, and longer-term opioid use examined during 2-year follow-up. Marijuana state policy on July 1, 2015, was assigned: none; medical only; or medical and recreational.

PARTICIPANTS: Patients aged 18-62 without cancer diagnosis.

MAIN MEASURES: Patient receiving (1) opioid at index; (2) > 7 days' supply of index opioid; (3) opioid during follow-up; and (4) ≥ 90 days' opioid supply during follow-up. Multivariable regression assessed associations between opioid utilization and state marijuana policy, adjusting for age, gender, overall disease burden, mental health treatment, concomitant use of benzodiazepine or muscle relaxant, and previous pain prescription.

KEY RESULTS: Of 141,711 patients, 80,955 (57.1%) resided in states with no policy; 56,494 (39.9%) with medical-only; and 4262 (3.0%) with medical and recreational. Patients in states with both policies were more likely to receive an index opioid (aOR = 1.72, 95% CI = 1.61-1.85; aOR = 1.90, 95% CI = 1.77-2.03; P < 0.001) but less likely to receive > 7 days' index supply (aOR = 0.84, 95% CI = 0.77-0.91; aOR = 0.76, 95% CI = 0.70-0.83; P < 0.001) than patients in states with no policy or medical-only, respectively. Those in states with both policies were more likely to receive a follow-up opioid (aOR = 1.87, 95% CI = 1.71-2.05; aOR = 2.20, 95% CI = 2.01-2.42; P < 0.001) than those in states with no policy or medical-only, respectively, and more likely to receive ≥ 90 cumulative follow-up opioid days' supply (aOR = 1.18, 95% CI = 1.07-1.29; P < 0.001) than those in states with no policy.

CONCLUSIONS: Our analysis does not support the supposition that access to marijuana lowers use of chronic opioids for pain.

OBJECTIVE: The objective of this study was to describe national changes in utilization and associated costs of antidiabetic medications in the United States from 2014 to 2019, across different drug classes and insurance plans.

RESEARCH DESIGN AND METHODS: This retrospective, cross-sectional study examined administrative claims from a large national pharmacy benefits manager from January 1, 2014, to December 31, 2019. Patients aged 18 years and above enrolled in commercial, Medicare, or Medicaid health plans who filled ≥1 prescription claim for an antidiabetic medication(s) during the 6-year period were included. Utilization was examined as the total number of 30-day adjusted prescription fills per user per month (PUPM). Gross costs were calculated as the sum of plan costs (net of rebates) and member out-of-pocket costs. Differences in mean utilization and costs PUPM between 2014 and 2019 for each medication class were calculated.

RESULTS: The final analytic sample increased from 745,290 patients in 2014 to 1,596,006 in 2019. Antidiabetic medication utilization increased by 8.8% from 2014 to 2019, driven by increases in sodium-glucose cotransporter 2 inhibitor (48.7%; P<0.001), glucagon-like peptide 1 receptor agonist (11.8%; P<0.001), insulin (8.1%; P<0.001), and metformin (2.9%; P<0.05) utilization. Average costs PUPM rose 47.5% (P<0.001), from $126.52 in 2014 to $186.58 in 2019. Sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and combination drugs contributed significantly to these increased costs, with 6-year cost differences of 57.3%, 46.9%, and 47.2%, respectively (all P<0.001).

CONCLUSION: Our study demonstrates a shift in antidiabetic medication class utilization from 2014 to 2019, where associated costs net of rebates significantly increased to a disproportionately greater extent than the significant increase in utilization PUPM.

BACKGROUND: Most states have recently passed laws requiring prescribers to use prescription drug monitoring programs (PDMPs) before prescribing opioid medications. The impact of these mandates on discontinuing chronic opioid therapy among Veterans managed in the Veterans Health Administration (VA) is unknown. We assess the association between the earliest of these laws and discontinuation of chronic opioid therapy in Veterans receiving VA health care.

METHODS: We conducted a comparative interrupted time-series study in the 5 states mandating PDMP use before August 2013 (Ohio, West Virginia, Kentucky, New Mexico, and Tennessee), adjusting for trends in the 17 neighboring control states without such mandates. We modeled 25 months of prescribing for each state centered on the month the mandate became effective. We included Veterans prescribed long-term outpatient opioid therapy (305 of the preceding 365 d). Our outcomes were discontinuation of chronic opioid therapy (primary outcome) and the average daily quantity of opioids per Veteran over the following 6 months (secondary outcome).

RESULTS: We included 250 monthly cohorts with 225,665 unique Veterans and 3.4 million Veteran-months. Baseline discontinuation rates before the PDMP mandates were 0.4%-2.7% per month. Kentucky saw a discontinuation increase of 1 absolute percentage point following its PDMP mandate which decreased over time. The other 4 states had no significant association between their mandates and change in opioid discontinuation. There was no evidence of decreasing opioid quantities following PDMP mandates.

CONCLUSION: We did not find consistent evidence that state laws mandating provider PDMP use were associated with the discontinuation of chronic opioid therapy within the VA for the time period studied.

BACKGROUND: The 2017 Food and Drug Administration Reauthorization Act established a new category of hearing aids to be available over the counter to increase accessibility and affordability of hearing aid devices. To prepare for increased consumer demand, pharmacists must be ready to meet the needs of the millions of adults eligible to seek over-the-counter hearing aids at the community pharmacy. To date, no organization has proposed competency statements to describe a pharmacist with the knowledge, skills, and abilities aligning with safe and effective use of over-the-counter hearing aids to be sold at community pharmacies.

OBJECTIVES: The objective of this study was to establish competencies needed for pharmacists to safely and effectively assist patients seeking over-the-counter hearing aids at the community pharmacy.

METHODS: The Delphi technique was selected to achieve group consensus for competency statements. The project began with a kickoff meeting in July 2019 and continued with a brainstorming round followed by 3 rounds of surveys ending in March 2020. Each survey presented competency statements for panelists to review, rate their agreement, and offer revisions. Statements that reached consensus to accept (≥80% agreement) were advanced to the final list. Statements that did not reach consensus were advanced to subsequent survey rounds.

RESULTS: A total of 14 individuals representing pharmacy, audiology, hearing aid manufacturers, and persons with hearing loss participated. In total, 26 competency statements were accepted by consensus, 2 statements were rejected by consensus, and 11 statements did not reach consensus. All 26 accepted statements were mapped to the Pharmacists' Patient Care Process before final approval by the stakeholder panel.

CONCLUSION: Pharmacists will likely play new interprofessional roles in the delivery of hearing health care as over-the-counter hearing aids come to market. With professional competency statements, pharmacists will have a framework for the knowledge, skills, and abilities needed to safely assist patients seeking over-the-counter hearing aids at the community pharmacy.

The purpose of this project was to evaluate the impact of a comprehensive medication adherence packaging (RxMAP) service on patient medication-taking behaviors and patient-centered outcomes. Adult patients who utilized a single independent community pharmacy, enrolled in the RxMAP service for at least two consecutive cycles, and managed their own medications were eligible. The RxMAP service consists of multi-dose blister packaging in 28-day cycles, medication synchronization, monthly touchpoint calls, and delivery/mailing. A 13-item telephonic survey was administered, and patients' verbal responses were captured by audio-recording and detailed note taking. Descriptive statistics were used to quantify the results and illustrative quotes representing the interview domains were selected. There were 42 patients who completed the survey: 88% reported they missed fewer doses compared to before using RxMAP; 71% were more likely to take their medications on time each day; 86% were more confident with managing their medications; and 74% were more independent. Finally, 64% of patients stated their overall quality of life was better now compared to before using the packaging service. These results demonstrate that medication adherence packaging services can positively impact patients' medication-taking behaviors, increase their confidence in medication management, and improve perceived quality of life.

With increasing patient interest in and access to pharmacogenomic testing, clinicians practicing in primary care are more likely than ever to encounter a patient seeking or presenting with pharmacogenomic test results. Gene-based prescribing recommendations are available to healthcare providers through Food and Drug Administration-approved drug labeling and Clinical Pharmacogenetics Implementation Consortium guidelines. Given the lifelong utility of pharmacogenomic test results to optimize pharmacotherapy for commonly prescribed medications, appropriate documentation of these results in a patient's electronic health record (EHR) is essential. The current "gold standard" for pharmacogenomics implementation includes entering pharmacogenomic test results into EHRs as discrete results with associated clinical decision support (CDS) alerts that will fire at the point of prescribing, similar to drug allergy alerts. However, such infrastructure is limited to the few institutions that have invested in the resources and personnel to develop and maintain it. For the majority of clinicians who do not practice at an institution with a dedicated clinical pharmacogenomics team and integrated pharmacogenomics CDS in the EHR, this report provides practical tips for documenting pharmacogenomic test results in the problem list and allergy field to maximize the visibility and utility of results over time, especially when such results could prevent the occurrence of serious adverse drug reactions or predict therapeutic failure.

BACKGROUND: Nearly 300 medications contain pharmacogenomic information in their labeling approved by the U.S. Food and Drug Administration. As this number continues to grow, community pharmacists will be called on to use available pharmacogenomic data at the point of dispensing.

OBJECTIVE: This qualitative study aimed to describe how pharmacists envision the integration of pharmacogenomic data into the current workflows of community pharmacy practice.

METHODS: Community pharmacists from a regional supermarket chain pharmacy in the greater Pittsburgh area were interviewed using a semistructured interview guide. Participating pharmacists were presented with 3 clinical scenarios, followed by questions, to gain insight into how they envisioned the integration of pharmacogenomic data into community pharmacy workflow. The interview transcriptions were transcribed and coded. The content was analyzed to deduce the final themes. Supporting quotes were selected to illustrate each theme.

RESULTS: Ten community pharmacists from 3 different pharmacy locations participated in the study. A thematic analysis produced 6 themes: (1) integrating pharmacogenomic data into the dispensing software, (2) receiving an alert for pharmacogenomic information within the dispensing software, (3) accessing pharmacogenomic clinical guidelines to guide drug-decision-making, (4) contacting the prescriber by adding a task to the call queue, (5) placing a mandatory counseling alert on medications that were adjusted using pharmacogenomic data, and (6) counseling the patient on the first refill of a medication that was adjusted using pharmacogenomic data.

CONCLUSION: This study describes how pharmacists envisioned the integration of pharmacogenomic data into community pharmacy workflow. The participants sought the integration of pharmacogenomic data into existing dispensing software, alerts for actionable prescribing changes using patient-specific pharmacogenomic data when available, and access to clinical decision support. In addition, the participants preferred to engage prescribers and receive alerts to counsel patients at prescription pick-up. These findings are key to integrating pharmacogenomic data into community pharmacy practice.