Standardized indolent systemic mastocytosis evaluations across a healthcare system: implications for screening accuracy.

Timely diagnosis of systemic mastocytosis (SM) remains challenging due to care heterogeneity. We implemented a standardized approach for SM screening and diagnosis utilizing a novel healthcare system-wide international screening registry. A retrospective analysis assessed rates of SM, cutaneous mastocytosis (CM), and molecular diagnoses before and two years after care standardization. Accuracy of individual and combined SM screening tests - basal serum tryptase (BST) ≥11.5 and ≥20.0 ng/mL, REMA ≥2, monomorphic maculopapular CM, and elevated BST based upon tryptase genotype - was analyzed. Tryptase genotyping and high-sensitivity KIT p.D816V testing increased substantially two years following care standardization. SM diagnoses doubled from 47 to 94 and KIT p.D816V molecular diagnoses increased from 24 to 79. Mean BST and KIT p.D816V variant allele frequency (VAF) values were significantly lower in patients diagnosed after standardization. Hereditary-alpha tryptasemia prevalence was increased in SM prior to care standardization at 4/30 (13.3%) but reflected the general population prevalence two years later at 5/76 (6.6%). Elevated BST based upon genotype and BST ≥11.5 ng/mL had the highest sensitivities at 84.2% and 88.3%, respectively. Presence of monomorphic MPCM, elevated BST based upon tryptase genotype, and the combination of REMA ≥2 with elevated BST based upon tryptase genotype had specificities >90%. BST >20.0 ng/mL had low sensitivity and specificity and was not required to establish any indolent SM diagnosis. Care standardization increased SM diagnosis rates, particularly in patients with low BSTs. Stratifying BST based upon genotype had the best overall sensitivity and specificity of any indolent SM screening test and improved the REMA score specificity.

Exploring Knowledge, Skills, and Abilities Needed for Army Pharmacist Readiness Using the Nominal Group Technique.

INTRODUCTION: The purpose of this study was to conduct a general educational needs assessment to identify deficiencies in current Army pharmacy education while projecting future educational requirements based on changes in pharmacy practice and evolving demands of military medicine. MATERIALS AND METHODS: Twelve pharmacists participated in a facilitated discussion using the nominal group technique. Data were analyzed using quantitative and qualitative methods to establish consensus. Member checking was used to verify and validate the findings. RESULTS: Participants generated 190 knowledge, skill, and ability (KSA) statements over 3 sessions. Twenty-one statements achieved consensus. Four consensus statements were skills, 7 were knowledge, and 10 were abilities. KSAs were categorized into pharmaceutical care, military, logistics, or legal domain based on a thematic analysis. CONCLUSIONS: With modernized, relevant KSAs, the Army can measure and train a ready pharmacy force. Individual Critical Tasks augmented with KSAs are one potential approach we recommend as a strategy to improve Army pharmacist health profession education.

Identifying Risk Factors for Cardiovascular Events Among Active-Duty Service Members and Veterans Prescribed Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).

Background: Oral NSAIDs are widely used analgesic medications for the treatment of musculoskeletal and inflammatory conditions. NSAIDs are associated with adverse effects that arise from COX enzyme inhibition including cardiovascular events. The combined role of patient and prescription factors associated with NSAID use on cardiovascular risk is not well characterized. Objective: The purpose of this study is to identify the risk factors with cardiovascular events among NSAID users. Methods: This study is a retrospective, nested case-control study, within the DAVINCI database, among active-duty service members and veterans with at least one NSAID pharmacy claim between fiscal year (FY) 2015-FY2020. Inclusion criteria individuals ≥18 years of age received a prescription NSAID for ≥7-day supply and a duration ≥1 month overall. Cases experienced nonfatal myocardial infarction, nonfatal stroke, or new onset heart failure. Ten controls were selected per case. Risk factors were identified through logistic regression modeling. Results: The risk factors with strongest association to the primary outcome included age starting at 45 up to 75 and older, the first 90 days of NSAID exposure, cerebrovascular disease, cardiomyopathy, and history of myocardial infarction. Cox-selectivity and dose did not appear to be clinically significant in their association with cardiovascular events. Conclusion: The results of this study indicate that age, initial NSAID exposure, and comorbidities are more predictive than NSAID-specific factors such as COX-selectivity and dose. The results provide the framework for development of a risk score to improve prediction of NSAID-associated cardiovascular events.

Medication Trends in the Military: A Comparative Analysis of Prescribing Patterns Among Service Members Seen by a Pharmacist and Implications for Medical Readiness.

INTRODUCTION: Medications play a critical role supporting the health of military service members. Little is known about the broad use of medications prescribed to this population. Active duty service members (ADSMs), while often younger and having fewer diagnosed comorbid conditions, face unique health challenges that benefit from pharmacotherapy. Understanding prescribing patterns is instrumental to illuminate potential areas for research and to guide education so that military health care professionals can maintain competency, improve outcomes, and support medical readiness. This study aimed to characterize commonly dispensed medications among ADSMs and to compare these prescriptions with those of the general population. MATERIALS AND METHODS: A retrospective, cross-sectional analysis using data extracted contained in the Military Health System Information Platform focused on ADSMs who consulted with a clinical pharmacist during the 2019 fiscal year. Descriptive statistics were used to summarize patient and prescription data. The 100 most frequently prescribed medications and 20 most frequently prescribed therapeutic classes were identified. Analyses were performed using Statistical Analysis System (SAS) software, and a non-metric multidimensional scaling plot was generated in R to illustrate the relationships between the 20 most frequently used therapeutic classes and the branches of service. RESULTS: The study analyzed 719,788 prescriptions for 30,012 service members, revealing a high prescription rate for pain, inflammation, and psychiatric condition treatments. Antidepressants and nonsteroidal anti-inflammatory drugs were among the most commonly prescribed across all military branches. Some medication uses varied, which may indicate distinct needs within different service branches. CONCLUSIONS: Understanding medication patterns among ADSMs may be able to help health care professionals proactively address pharmacological challenges and optimize pharmaceutical use in this unique population. This knowledge can also aid in the development of training modules focused on medication side effects, interactions, counseling, and implications on military deployment for the most commonly used medications. Future examination into prescribing cascades and medication use related to proton-pump inhibitors, docusate, benzonatate, and muscle relaxants may identify opportunities to provide better care or lower cost.

Development and Testing of a Chronic-Disease Patient Experience Mapping Toolbox.

BACKGROUND: Stakeholders increasingly expect research and care delivery to be guided by and to optimize patient experiences. However, standardized tools to engage patients to gather high-quality data about their experiences, priorities, and desired outcomes are not publicly available. The objective of this study was to develop and test a Toolbox with a disease-agnostic interview guide template and accompanying resources to assist researchers in engaging patients living with chronic disease in a dialogue about their experiences. METHODS: Guided by a multidisciplinary workgroup, a targeted literature review (PubMed) was conducted, followed by group discussions to identify/thematically organize patient experience concepts, development of a conceptual model, and drafting of an interview guide template and patient-facing visual. Materials were tested/refined via cognitive (n = 5) and pilot (n = 30) interviews conducted virtually with US patients diagnosed with chronic/potentially disabling conditions from December 2020 to April 2021. Patient-facing tools were reviewed by health literacy experts for applicability/accessibility. English-speaking adults who self-reported receiving a chronic condition diagnosis at least 6 months prior participated in a 60-90 min interview. RESULTS: Patient experience concepts were organized thematically under three domains: (1) life before a diagnosis, (2) experiences getting a diagnosis, and (3) experiences living with a diagnosis. A plain language consent sheet template, interview guide template, and patient experience conceptual model were developed and revised based on input from interviewees, interviewers, and the workgroup. CONCLUSIONS: A disease-agnostic patient-engagement Toolbox was developed and tested to capture patient experience data. These materials can be customized based on study objectives and leveraged by various stakeholders to identify opportunities to enhance the patient centricity of healthcare delivery and research.

Patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS).

OBJECTIVE: This study aims to assess the patient-centeredness and psychometric properties of the Defense and Veterans Pain Rating Scale 2.0 (DVPRS) as a patient-reported outcome measure (PROM) for pain assessment in a military population. DESIGN: A critical evaluation of the DVPRS was conducted, considering its fit-for-purpose as a PROM and its patient-centeredness using the National Health Council's Rubric to Capture the Patient Voice. SETTING: The study focused on the use of the DVPRS within the Department of Defense (DoD) and Veterans Health Administration (VA) healthcare settings. SUBJECTS: The DVPRS was evaluated based on published studies and information provided by measure developers. The assessment included content validity, reliability, construct validity, and ability to detect change. Patient-centeredness and patient engagement were assessed across multiple domains. METHODS: Two independent reviewers assessed the DVPRS using a tool/checklist/questionnaire, and any rating discrepancies were resolved through consensus. The assessment included an evaluation of psychometric properties and patient-centeredness based on established criteria. RESULTS: The DVPRS lacked sufficient evidence of content validity, with no patient involvement in its development. Construct validity was not assessed adequately, and confirmatory factor analysis was not performed. Patient-centeredness and patient engagement were also limited, with only a few domains showing meaningful evidence of patient partnership. CONCLUSIONS: The DVPRS as a PROM for pain assessment in the military population falls short in terms of content validity, construct validity, and patient-centeredness. It requires further development and validation, including meaningful patient engagement, to meet current standards and best practices for PROMs.

Racialized and beneficiary inequities in medication to treat opioid use disorder receipt within the US Military Health System.

BACKGROUND: Medication for opioid use disorder (MOUD) can be critical to managing opioid use disorder (OUD). It is unknown the extent to which US Military Health System (MHS) patients diagnosed with OUD receive MOUD. METHODS: Healthcare records of MHS-enrolled active duty and retired service members (N = 13,334) with a new (index) OUD diagnosis were included between 2018 and 2021, without 90-day pre-index MOUD receipt were included. Elastic net logistic and Cox regressions evaluated care- and system-level factors associated with 1-year MOUD receipt (primary outcome) and time-to-receipt. RESULTS: Only 9% of patients received MOUD 1-year post-index; only 4% received MOUD within 14 days. Black patients (OR for receipt 0.38, 95% CI 0.30-0.49), Latinx patients (OR for receipt 0.44, 95% CI 0.33-0.59), and patients whose race and ethnicity was Other (OR for receipt 0.52, 95%CI 0.35, 0.77) experienced lower MOUD access (all p < 0.001). Retirees were more likely to receive MOUD relative to active duty service members (OR for receipt 1.81, 95%CI 1.52, 2.16, p <0.001). CONCLUSIONS: Institutional racism in MOUD prescribing, combined with the overall low rates of MOUD receipt after OUD diagnosis, highlight the need for evidence-based, multifaceted, and multilevel approaches to OUD care in the Military Health System. Without clear Defense Health Agency policy, including the designation of responsible entities, transparent and ongoing evaluation and responsiveness using standardized methodology, and resourced programming and public health campaigns, MOUD rates will likely remain poor and inequitable.

Benzonatate Safety and Effectiveness: A Systematic Review of the Literature.

OBJECTIVE: To review the available literature regarding the treatment effects and efficacy of benzonatate needed to better inform patients, providers, and regulators evaluating its role in modern medical therapies. DATA SOURCES: Comprehensive literature searches were conducted in PubMed, Embase (Elsevier), Cochrane Library, and Scopus for original research articles evaluating the effectiveness, tolerability, and safety profile of benzonatate from January 1956 through August 2022. STUDY SELECTION AND DATA EXTRACTION: The identified studies were screened for relevance and then assessed for inclusion through a full-text review, data extraction, and quality assessment by multiple reviewers using the online software Covidence. DATA SYNTHESIS: The selection process resulted in 37 articles consisting of 21 cohort studies, 5 experimental studies, and 11 case studies and series. Initial clinical studies exploring potential therapeutic benefits collected data from very small populations and limited clinical settings. Safety is primarily assessed in terms of toxicity due to overdose or inappropriate use. Quality assessment raised concerns for high degrees of biases primarily related to the limited sample size, data collection, generalizability, and study design. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This review reveals substantial limitations within existing evidence pertaining to the safety and clinical effectiveness of benzonatate and thus, a need for large observational studies or randomized trials to better characterize its role and value in modern medical practice. CONCLUSIONS: Rising safety concerns should bring closer scrutiny upon the prescription of benzonatate whose approval is founded upon evidence that would not stand up to current regulatory review.

A data-driven quality-score system for rating drug products and its implications for the health care industry.

The quality of drug products in the United States has been a matter of growing concern. Buyers and payers of pharmaceuticals have limited insight into measures of drug-product quality. Therefore, a quality-score system driven by data collection is proposed to differentiate between the qualities of drug products produced by different manufacturers. The quality scores derived using this proposed system would be based upon public regulatory data and independently-derived chemical data. A workflow for integrating the system into procurement decisions within health care organizations is also suggested. The implementation of such a quality-score system would benefit health care organizations by including the consideration of the quality of products while also considering price as a part of the drug procurement process. Such a system would also benefit the U.S. health care industry by bringing accountability and transparency into the drug supply chain and incentivizing manufacturers to place an increased emphasis on the quality and safety of their drug products.

Naloxone Prescribing Associated With Reduced Emergency Department Visits in the Military Health System.

PURPOSE: The aim was to determine the association between the receipt of naloxone and emergency department (ED) visits within 60 days after the receipt of an opioid. METHODS: A retrospective cohort of individuals 18 years of age or above, enrolled in TRICARE, and were dispensed an opioid at any time from January 1, 2019, through September 30, 2020 was identified within the United States Military Health System. Individuals receiving naloxone within 5 days of the opioid dispensing date were propensity score matched with individuals receiving opioids only. A logistic regression was used to estimate the odds of an ED visit in the 60-day follow-up period after the index opioid dispense event among those co-dispensed naloxone and those receiving opioids only. RESULTS: Of the 2,136,717 individuals who received an opioid prescription during the study period, 800,071 (10.1%) met study inclusion criteria. Overall, 5096 (0.24%) of individuals who received an opioid prescription were co-dispensed naloxone. Following propensity score matching, those who received naloxone had a significantly lower odds of ED utilization in the 60 days after receiving an opioid prescription (odds ratio: 0.74, 95% CI: 0.68-0.80, P<0.001). CONCLUSION: This study highlights the importance of expanding access to naloxone in order to reduce ED utilization. Future research is needed to examine additional outcomes related to naloxone receipt and develop programs that make naloxone prescribing a routine practice.

Variation by default: cesarean section discharge opioid prescription patterns and outcomes in Military Health System hospitals: a retrospective longitudinal cohort study.

BACKGROUND: To examine factors associated with post-Cesarean section analgesic prescription variation at hospital discharge in patients who are opioid naïve; and examine relationships between pre-Cesarean section patient and care-level factors and discharge morphine equivalent dose (MED) on outcomes (e.g., probability of opioid refill within 30 days) across a large healthcare system. METHODS: The Walter Reed Institutional Review Board provided an exempt determination, waiver of consent, and waiver of HIPAA authorization for research use in the present retrospective longitudinal cohort study. Patient records were included in analyses if: sex assigned in the medical record was "female," age was 18 years of age or older, the Cesarean section occurred between January 2016 to December 2019 in the Military Health System, the listed TRICARE sponsor was an active duty service member, hospitalization began no more than three days prior to the Cesarean section, and the patient was discharged to home < 4 days after the Cesarean section. RESULTS: Across 57 facilities, 32,757 adult patients had a single documented Cesarean section procedure in the study period; 24,538 met inclusion criteria and were used in analyses. Post-Cesarean section discharge MED varied by facility, with a median MED of 225 mg and median 5-day supply. Age, active duty status, hospitalization duration, mental health diagnosis, pain diagnosis, substance use disorder, alcohol use disorder, gestational diabetes, discharge opioid type (combined vs. opioid-only medication), concurrent tubal ligation procedure, single (vs. multiple) births, and discharge morphine equivalent dose were associated with the probability of an opioid prescription refill in bivariate analyses, and therefore were included as covariates in a generalized additive mixed model (GAMM). Generalized additive mixed model results indicated that non-active duty beneficiaries, those with mental health and pain conditions, those who received an opioid/non-opioid combination medication, those with multiple births, and older patients were more likely to obtain an opioid refill, relative to their counterparts. CONCLUSION: Significant variation in discharge pain medication prescriptions, as well as the lack of association between discharge opioid MED and probability of refill, indicates that efforts are needed to optimize opioid prescribing and reduce unnecessary healthcare variation.

Military Health System Opioid, Tramadol, and Gabapentinoid Prescription Volumes Before and After a Defense Health Agency Policy Release.

BACKGROUND: Clinical practice guidelines (CPGs) and health system policies to mitigate inappropriate opioid prescribing practices may have an extended impact on low-dose opioid (e.g., tramadol) and non-opioid (e.g., gabapentinoid) pain medication prescribing practices. OBJECTIVE: To evaluate changes in opioid, tramadol, and gabapentinoid prescribing rates from January 2016 to February 2020 within the Military Health System, including the degree to which prescribing rates changed after release of a US Defense Health Agency Procedural Instruction. METHODS: In this observational health services research study, opioid, tramadol, and gabapentin prescription dispense events of US Military Health System beneficiaries enrolled in care at military treatment facilities prior to US Defense Health Agency Procedural Instruction release (January 2016-May 2018) were used to forecast values from the post-intervention period (June 2018-February 2020). RESULTS: The median opioid and tramadol prescribing rates decreased from January 2016 to February 2020, aside from tramadol prescribing in Surgery Clinics, which increased. Gabapentinoid prescribing rate changes were mixed. In Bayesian time series models, the forecasted proportion of patients receiving each of the three medications, regardless of age group or clinic type, did not significantly vary from the actual prescribing rates in the post-intervention period. CONCLUSION: Overall, CPGs and policies targeting opioid prescribing practices may have provided the maximal impetus for providers to re-evaluate their prescribing practices, as the policy did not appear to change the slope in prescribing rates. However, it is unclear whether the policies mitigated the likelihood of plateaus in prescribing rates. Further work is needed to assess the degree to which providers simultaneously altered other non-opioid pain medication prescribing practices, self-management recommendations, and non-pharmacological therapy referrals.

Evaluation of an Opioid Overdose Composite Risk Score Cutoff in Active Duty Military Service Members.

OBJECTIVE: To evaluate the current cutoff score and a recalibrated adaptation of the Veterans Health Administration (VHA) Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose (RIOSORD) in active duty service members. DESIGN: Retrospective case-control. SETTING: Military Health System. SUBJECTS: Active duty service members dispensed ≥ 1 opioid prescription between January 1, 2018, and December 31, 2019. METHODS: Service members with a documented opioid overdose were matched 1:10 to controls. An active duty-specific (AD) RIOSORD was constructed using the VHA RIOSORD components. Analyses examined the risk stratification and predictive characteristics of two RIOSORD versions (VHA and AD). RESULTS: Cases (n = 95) were matched with 950 controls. Only 6 of the original 17 elements were retained in the AD RIOSORD. Long-acting or extended-release opioid prescriptions, antidepressant prescriptions, hospitalization, and emergency department visits were associated with overdose events. The VHA RIOSORD had fair performance (C-statistic 0.77, 95% CI 0.75, 0.79), while the AD RIOSORD did not demonstrate statistically significant performance improvement (C-statistic 0.78, 95% CI, 0.77, 0.80). The DoD selected cut point (VHA RIOSORD > 32) only identified 22 of 95 ORD outcomes (Sensitivity 0.23), while an AD-specific cut point (AD RIOSORD > 16) correctly identified 53 of 95 adverse events (Sensitivity 0.56). CONCLUSIONS: Results highlight the need to continually recalibrate predictive models and to consider multiple measures of performance. Although both models had similar overall performance with respect to the C-statistic, an AD-specific index threshold improves sensitivity. The calibrated AD RIOSORD does not represent an end-state, but a bridge to a future model developed on a wider range of patient variables, taking into consideration features that capture both care received, and care that was not received.

Naloxone prescribing practices in the Military Health System before and after policy implementation.

Introduction: Despite public health campaigns, policies, and educational programs, naloxone prescription rates among people receiving opioids remains low. In June 2018, the U.S. Military Health System (MHS) released 2 policies to improve naloxone prescribing. Objectives: The objective of this study was to examine whether the policies resulted in increased naloxone coprescription rates for patients who met the criteria for 1 or more risk indicators (eg, long-term opioid therapy, benzodiazepine coprescription, morphine equivalent daily dose ≥50 mg, and elevated overdose risk score) at the time of opioid dispense. Methods: Prescription and risk indicator data from January 2017 to February 2021 were extracted from the MHS Data Repository. Naloxone coprescription rates from January 2017 to September 2018 were used to forecast prescribing rates from October 2018 to February 2021 overall and across risk indicators. Forecasted rates were compared with actual rates using Bayesian time series analyses. Results: The probability of receiving a naloxone coprescription was higher for patients whose opioid prescriber and pharmacy were both within military treatment facilities vs both within the purchased-care network. Bayesian time series results indicated that the number of patients who met the criteria for any risk indicator decreased throughout the study period. Naloxone prescribing rates increased across the study period from <1% to 20% and did not significantly differ from the forecasted rates across any and each risk indicator (adjusted P values all >0.05). Conclusion: Future analyses are needed to better understand naloxone prescribing practices and the impact of improvements to electronic health records, decision support tools, and policies.

Development, implementation, and evaluation of a clinical decision support tool to improve naloxone coprescription within Military Health System pharmacies.

PURPOSE: To describe the development, implementation, and evaluation of a pharmacy clinical decision support tool designed to increase naloxone coprescription among people at risk for opioid overdose in a large healthcare system. SUMMARY: The Military Health System Opioid Registry and underlying presentation layer were used to develop a clinical decision support capability to improve naloxone coprescription at the pharmacy point of care. Pharmacy personnel use a patient identification card barcode scanner or manually enter a patient's identification number to quickly visualize information on a patient's risk for opioid overdose and medical history related to pain and, when appropriate, receive a recommendation to coprescribe naloxone. The tool was made available to military treatment facility pharmacy locations. An interactive dashboard was developed to support monitoring, utilization, and impact on naloxone coprescription to patients at risk for opioid overdose. CONCLUSION: Initial implementation of the naloxone tool was slow from a lack of end-user awareness. Efforts to increase utilization were, in part, successful owing to a number of enterprise-wide educational initiatives. In early 2020, the naloxone tool was used in 15% of all opioid prescriptions dispensed at a military pharmacy. Data indicate that the frequency of naloxone coprescription to patients at risk for opioid overdose was significantly higher when the naloxone tool was used than when the tool was not used.

Variability among Online Opioid Conversion Calculators Performing Common Palliative Care Conversions.

Introduction: Online opioid conversion calculators (OOCCs) are commonly used to aid conversion between opioids to overcome tolerance, reduce adverse effects, or challenges related to administration. The purpose of this study was to describe and characterize variability among OOCC used by health care practitioners when converting common opioids and doses encountered in the hospice and palliative care setting. Methods: We collected 58 quantitative surveys and performed sentiment analysis on 62 qualitative responses from adult learners primarily practicing in the palliative care setting and enrolled in an online palliative care Master of Science program through the University of Maryland, Baltimore, who were asked to perform opioid conversion calculations using realistic patient cases. Results: OOCC have substantial variability leading to a wide range of outputs, which may put patients at risk for opioid-related harm. Assessing participant sentiment toward OOCC showed most participants held a "Negative Sentiment" toward these calculators after the activity. Conclusion: Overall, findings reveal that given the same information, clinicians can come to widely different opioid doses and these differences can be amplified by OOCC. These differences can be particularly dangerous given the higher opioid doses commonly used in the palliative care setting. Considering the significant harm that can arise from an error when converting between opioids, clinicians should avoid the routine use of OOCC in real-world patient care settings. If an OOCC is used, organizations should endorse a specific calculator, provide training and education about the algorithm that supports the calculations, and encourage clinicians to use it only after their own manual calculation, which should be documented in the medical record.

Procedural Benzodiazepine and Post-Vasectomy Opioid and Nonopioid Prescribing Variation in a Large Health Care System.

INTRODUCTION: Our goal was to describe variation in procedural benzodiazepine and post-vasectomy nonopioid pain and opioid prescription dispense events, and multilevel factors associated with the probability of an opioid refill. METHODS: Patients (40,584) undergoing vasectomies in the U.S. Military Health System between January 2016-January 2020 were included in this observational retrospective study. The main outcome was the probability of being dispensed an opioid prescription refill within 30 days post-vasectomy. Bivariate analyses examined the relationships between patient- and care-level characteristics, prescription dispense and 30-day opioid prescription refill. A generalized additive mixed-effects model and sensitivity analyses examined factors associated with opioid refill. RESULTS: There was wide variation in procedural benzodiazepine (32%) and post-vasectomy nonopioid (71%) and opioid (73%) prescription dispense patterns across facilities. Only 5% of the patients dispensed opioids received a refill. Probability of an opioid refill was associated with race (White), younger age, opioid dispense history, documented mental health or pain condition, lack of post-vasectomy nonopioid pain medication dispense events and higher dispensed post-vasectomy opioid prescription dose; albeit the effect of dose did not replicate in sensitivity analyses. CONCLUSIONS: Despite the wide variation in vasectomy-related pharmacological pathways across a large health care system, most patients do not require an opioid refill. Significant variation in prescribing practices indicated racial inequities. Given the low rates of opioid prescription refill, combined with the wide variation in opioid prescription dispense events and American Urological Association recommendations for conservative opioid prescribing after vasectomy, intervention to address excessive opioid prescribing is warranted.

The U.S. medicine chest: Understanding the U.S. pharmaceutical supply chain and the role of the pharmacist.

The U.S. capacity to manufacture key essential medications has diminished. The U.S. pharmaceutical supply chain (USPSC) has diversified and now relies on international sources of active pharmaceutical ingredients and finished drug products (FDPs). Despite years of effort raising concerns about the USPSC, pharmacists and pharmacy technicians continue to spend a substantial amount of time and energy responding to, and mitigating the impact of, medication shortages, drug recalls, and the adverse outcomes related to low-quality medications. The extent of U.S. reliance on foreign sources of medications is largely unknown. Pharmacists do not have a reliable way to determine the country of origin (i.e., source), capacity, or geographic location of pharmaceutical manufacturers, limiting our ability to anticipate challenges or mitigate risks to our Nation's drug supply. The U.S. Food and Drug Administration's task of regulating quality and safety is challenging and will likely require additional safeguards and resources. In addition to pharmacists' engagement, solutions will likely need to leverage a mix of policy, economic incentives, and expanded objective surveillance testing. The U.S. pharmaceutical supply chain is complex, global, and goes beyond FDPs. The 2020 American Pharmacists Association House of Delegates has rightly asserted that "The quality and safety of pharmaceutical and other medical products and the global pharmaceutical and medical product supply chain are essential to the United States national security and public health." Pharmacy professionals on the front line engage with patients, identify medication-related issues, and engage in drug-procurement decisions. Pharmacists are essential to our nation's overall health and must be engaged in the development and implementation of strategies to safeguard the USPSC.

Exploring the Use of State Medical Cannabis Legislation as a Proxy for Medical Cannabis Use Among Patients Receiving Chemotherapy.

OPINION STATEMENT: The use of medical cannabis is expanding in the USA. Due to conflicting, low-quality evidence, many oncologists may not feel confident to recommend it to patients. Given the potential for legal and financial risks when conducting clinical trials with medical cannabis, the use of observational data should be explored. Observational data that directly capture medical cannabis use in relation to prescription medications and track the prevalence and patterns of cannabis use is sparse. To gain insights into the role medical cannabis plays in the pharmaceutical landscape, proxies such as cannabis legislation need to be explored. In the context of recommendation-nonadherent antiemetic prescribing among patients experiencing chemotherapy-induced nausea and vomiting, medical cannabis may be a suitable alternative to an antiemetic in states that allow medical cannabis. Findings suggest that legislation may impact the use of certain antiemetics in states with cannabis legislation in place. The presence or absence of legislation regarding medical cannabis use may serve as an early, observable surrogate marker of medical cannabis use in the community. In light of the paucity of clinical trials and observational datasets that capture cannabis use, there remains a tremendous need for the development of methodologies or standardized datasets that appropriately and reliably capture the use of medical cannabis to facilitate research into its clinical application and effect on prescription medication use. Standardizing the reporting and destigmatizing use could eliminate the dependence upon proxy measures as a substitute for more extensive data and go a long way in improving data capture, thus allowing us to generate knowledge and hypotheses from observational data until research conditions improve and allow for expanded clinical trials involving medical cannabis.