Community Pharmacists' Knowledge and Perceptions of Buprenorphine for Patients with Opioid Use Disorder.

OBJECTIVES: The aims of the study are to evaluate community pharmacists' knowledge and perceptions regarding buprenorphine for opioid use disorder and their willingness to dispense buprenorphine and to identify opportunities for education. METHODS: An electronic survey of Michigan pharmacists (n = 11,123) assessed demographics, training, buprenorphine knowledge, dispensing, perceptions of stigma, diversion, and confidence in patient/provider interactions. Composite scores for knowledge, stigma, diversion, and confidence were calculated. Cross-tabulations and logistic regressions examined associations. RESULTS: There were 775 surveys returned (response 7%, n = 11,123) with 390 community pharmacists completing the survey. Twenty-five percent practiced in a rural area. Common practice sites were chain or independent pharmacies (30% each). Ninety-seven percent had buprenorphine training, 50% from Accredited Continuing Pharmacy Education. Eighty percent reported that their pharmacy dispensed buprenorphine with 90% of rural pharmacists compared with 71% urban responding yes. Composite knowledge scores did not differ between urban or rural location ( P > 0.05). Predictors of willingness to dispense buprenorphine were urban location (odds ratio, OR, 0.55; 95% confidence interval [CI], 0.34-0.91; P = 0.01), independent pharmacy (OR, 0.53; 95% CI, 0.30-0.94; P = 0.03), Accredited Continuing Pharmacy Education training (OR, 0.54; 95% CI, 0.34-0.87; P = 0.01), low stigma/diversion (OR, 0.51; 95% CI, 0.37-0.70; P = 0.00), and confidence in patient/provider interactions (OR, 0.14; 95% CI, 0.10-0.19; P = 0.00). CONCLUSIONS: Most survey pharmacists practice at pharmacies that dispense buprenorphine for opioid use disorder, with a larger proportion from rural pharmacies reporting availability. Pharmacists at independent pharmacies in urban locations have increased willingness to dispense buprenorphine, with urban pharmacists having lower perceptions of diversion compared with rural. Differences in buprenorphine availability, pharmacist willingness to dispense, and perceptions are opportunities for education. Limitations include one state, response bias, self-assessed competencies, and small samples.

Opioid Management of Dyspnea at End of Life: A Systematic Review.

Objective: The objective of this systematic review is to consolidate the existing evidence on opioid use, including administration, dosing, and efficacy, for the relief of dyspnea at end of life. The overarching goal is to optimize clinical management of dyspnea by identifying patterns in opioid use, improving opioid management of dyspnea, and to prioritize future research. Background: Opioids are commonly used in the management of dyspnea at end of life, yet specific administration guidelines are limited. A greater understanding of the effectiveness of opioids in relieving end-of-life dyspnea with consideration of study design, patients, and opioids, including dyspnea evaluation tools and outcomes, will leverage development of standardized administration and dosing. Methods: A PRISMA-guided systematic review using six databases identified quality studies of opioid management for patients with dyspnea at end of life. Results: Twenty-three references met review inclusion criteria, which included terminally ill cancer and noncancer patients with various diagnoses. Studies included two randomized controlled trials, and three nonrandomized experimental, three prospective observational, one cross-sectional, and one case series. Thirteen retrospective chart reviews were also included due to the limited rigorous studies rendered by the search. Thirteen studies evaluated morphine, followed by fentanyl (6), oxycodone (5), general opioid use (4), and hydromorphone (2). Routes of administration were parenteral, oral, combination, and nebulization. Dyspnea was evaluated using self-reporting and non-self-reporting evaluation tools. Sedation was the most reported opioid-related adverse effect. Discussion: Challenges persist in conducting end-of-life research, preventing consensus on standardization of opioid treatment for dyspnea within this specific palliative time frame. Future robust prospective trials using specific, accurate assessment with reassessment of dyspnea/respiratory distress, and consideration of opioid tolerance, polypharmacy, and comorbidities are required.

Pharmacists and opioid use disorder care during COVID-19: Call for action.

Opioid use disorder (OUD) is a chronic relapsing condition characterized by problematic opioid use causing significant impairment in daily life. Medication for opioid use disorder using buprenorphine, methadone, and naltrexone with behavioral therapy reduces illicit opioid use and risk of overdose death. Despite evidence and decades of experience, barriers limit access to treatment and care for individuals with OUD. Barriers include a lack of treatment centers particularly in rural areas, regulations on buprenorphine prescribing, and stigma from the community and health care professionals. While many barriers are longstanding, the coronavirus disease 2019 (COVID-19) pandemic-forced isolation and associated stress has exacerbated challenges for individuals with mental health conditions such as OUD. Pharmacists are well-positioned to bridge existing gaps in OUD care, particularly during the COVID-19 pandemic. Roles for pharmacists include OUD risk identification and screening, referral of patients to treatment and support programs, ensuring medication access, expanding naloxone access, and advocacy initiatives. This review article identifies barriers to care for patients with OUD during the COVID-19 pandemic and explores opportunities and resources for pharmacists to improve OUD care during the pandemic and beyond.

Commercial and public payer opioid analgesic prescribing policies: a case study.

BACKGROUND: One strategy to address the high number of U.S. opioid-related deaths is to restrict high-risk or inappropriate opioid analgesic prescribing and dispensing. Federal and state laws and regulations have implemented restrictions but less is known about commercial and public payers' policies aside from clinician anecdotal reports that these policies are increasing. To assess the number and types of policies with temporal trends, we examined commercial and public (Medicaid) payer policies in one state, Michigan, that has high opioid-related deaths and implemented opioid analgesic prescribing laws. METHODS: Policies for seven large commercial payers and the public payer for 2012-2018 were reviewed and categorized by actions. Joinpoint regression was used to summarize temporal trends on number of policies for all payers and subgroups. RESULTS: Across the 7 years, there were 529 action policies (75.57 (95% confidence intervals (CI) 35.93, 115.22) actions per year) with a range of 36 to 103 actions by payer. Limitations on number of days for initial prescriptions and prior authorizations were the most frequently implemented policy. The temporal trend showed a decline in new policies from 2012 to 2013 but a steady increase from 2014 to 2018 (average annual percent change or AAPC=29.6% (95% confidence intervals 13.2, 48.5%)). The public payer (n=47 policies) showed no increase in number of policies over time (AAPC=2.9% (95% CI -41.6, 61.6%). CONCLUSIONS: The eight commercial and public payers implemented many new policies to restrict opioid analgesic prescribing with a steady increase in the number of such policies implemented from 2014 to 2018. This case study documented that at least in one state with high opioid-related deaths and multiple commercial payers, new and different policies were increasingly implemented creating barriers to patient care. The impact of these policies is understudied, complicating recommendation of best practices.

Pharmacists' knowledge, support, and perceived roles associated with providing naloxone in the community.

INTRODUCTION: Prior to the Michigan naloxone standing order legislation, a sample of Michigan pharmacists was surveyed to (1) identify gaps in knowledge regarding naloxone: (2) assess supportive attitudes towards the standing order and; (3) determine perceived pharmacist roles when providing naloxone. METHODS: A 37-item survey was emailed to Michigan Pharmacist Association members (n = 2757), July to August 2016. Responses to knowledge, supportive attitude, and perceived roles items were analyzed using descriptive statistics and logistic regression. Significance set at p < 0.05. RESULTS: The useable response was 8% (n = 211), 92% white, 54% female, aged 46.5 ± 14.6 years. Knowledge: Eighty-five percent (179/211) agreed laypersons can administer naloxone. Sixty-four percent could identify an opioid overdose and 74% agreed with required pharmacist naloxone education; yet 20% had education. Supportive attitude: Eighty-seven percent (184/211) supported the standing order. Perceived role: Fifty-six percent agreed with responsibility for following patients after providing naloxone. Predictors of agreement were rural practice location (OR = 2.5; 95% CI 1.2-5.0, p = 0.01), and requiring naloxone education (OR = 3.0; 95% CI 1.3-6.8, p = 0.007). Having a Doctor of Pharmacy versus a Bachelor of Science Pharmacy degree decreased odds of agreement by 43.5% (OR = 0.435; 95% CI 0.221-0.857, p = 0.016). DISCUSSION: Timing of survey may explain the low number of trained respondents. The increased willingness of BS Pharmacists to follow patients may reflect longer practice and closer community ties. Limitations include low generalizability and small sample. CONCLUSION: A small representative sample of Michigan pharmacists is knowledgeable regarding naloxone and has supportive attitudes towards the standing order.

Randomized placebo-controlled trial of sucrose analgesia on neonatal skin blood flow and pain response during heel lance.

OBJECTIVES: To evaluate the effect of oral sucrose on skin blood flow (SBF; perfusion units; PU) measured by Laser Doppler Imager (LDI) in term newborns and pain response (Neonatal Infant Pain Scale score; NIPS score) during heel lance; (2) determine SBF changes during heel lance; and (3) the relationship between SBF and NIPS. MATERIALS AND METHODS: Term infants ≤7 days old (n=56) undergoing routine heel lance were randomized to pretreatment with 2.0 mL oral 24% sucrose (n=29) or sterile water (n=27) in a double-blinded, placebo-controlled trial. SBF was assessed by LDI scans and NIPS scores at 10 minutes before lance, immediately after lancing, and 5 minutes after blood extraction. Mean SBF and median NIPS scores were compared between groups using General Linear Model or Kruskal-Wallis. Regressions examined the relationship between SBF immediately after heel lance and NIPS score. RESULTS: Mean SBF and median NIPS scores immediately after heel lance were lower in sucrose-treated infants (167.9±15.5 vs. 205.4±16.0 PU, P=0.09; NIPS 1 [interquartile range 0 to 4] vs. NIPS 3 [interquartile range 0 to 6], P=0.02), although no significant difference in mean SBF. During heel lance NIPS score was predictive of SBF. An increase of 1 in NIPS score was associated with 11 PU increase in SBF (R=0.21; P=0.09) for sucrose, and 16 PU increase for placebo-treated infants (R=0.20; P=0.014). CONCLUSIONS: Increased SBF assessed by LDI is a pain response among term neonates after routine heel lance, which was not completely attenuated by oral sucrose administration. Increased SBF is associated with NIPS scores. Sucrose analgesic efficacy evidenced by decreased NIPS scores for the sucrose group. Association of SBF with NIPS scores suggests that LDI is potentially useful for assessing newborn procedural pain.

Incidence and costs of adverse drug reactions in a tertiary care pediatric intensive care unit.

Adverse drug reactions (ADRs) increase morbidity, mortality, and hospital costs in children treated in the Pediatric Intensive Care Unit (PICU). Few studies have reported the incidence and risk factors of ADRs in PICU. Our study aimed to evaluate incidence, risk factors, and economic burden of ADRs in PICU. An intensive ADR surveillance was conducted at the PICU of Children's Hospital of Michigan between November 1, 2010 and May 31, 2011. A trigger list was used to screen for suspected ADR cases. Of the 697 consecutive PICU admissions reviewed, 13.1% experienced at least one episode of ADR. The ADR incidence was 22% in patients with cardiovascular (CV) surgery and 11.5% in other patients. The most frequently detected ADR was electrolyte imbalance associated with diuretic exposure. Mean age at admission was 4 years (interquartile range: 9 months-13 years). Risk factors for ADR included young age (<1 year), Pediatric Risk of Mortality (PRISM) score upon admission ≥3, and administration of ≥16 medications. ADRs increased total ICU costs by 3.5-fold and length of ICU stay by 3.8-fold. Increased ADR surveillance of high risk patients in conjunction with early intervention may reduce drug related morbidity and costs in the PICU.

Fluctuations of anti-Xa concentrations during maintenance enoxaparin therapy for neonatal thrombosis.

AIM: To evaluate fluctuations in anti-Xa concentrations in infants treated with enoxaparin for thrombosis and describe clinical outcomes. METHODS: A retrospective chart review was performed on infants treated with enoxaparin in the Neonatal Intensive Care Unit, and data on enoxaparin doses, anti-Xa concentrations, clinical characteristics and outcomes were abstracted. RESULTS: Our cohort (n = 26) had a median gestation of 36 (range, 23-41) weeks, birthweight of 2522 (510-3912) grams and 5-min Apgar score of 8(4-9). Fifteen (57.7%) infants were males. Thromboses was diagnosed at a median age of 22 (range, 1-97) days; enoxaparin was initiated at 27.5 (range, 4-98) days at a mean (SD) dose of 1.4 (0.3) mg/kg every 12 h. Therapeutic anti-Xa concentrations (0.5-1 U/mL) were achieved at a mean (SD) dose of 2.1 (0.6) mg/kg at 12.5 (12.2) days of treatment. Of the 143 anti-Xa concentrations, 39 (27%) were within the therapeutic range. During maintenance therapy following initial therapeutic anti-Xa concentration, 40% concentrations were therapeutic. Minor bleeding was noted in four infants and intracranial bleed in one infant; four infants died. During treatment, thrombocytopenia, renal and hepatic impairment during treatment were noted in 7, 2 and 4 infants, respectively. Clot resolution was observed in 21 (81%) infants. CONCLUSIONS: Anti-Xa concentrations fluctuate during maintenance enoxaparin therapy, with therapeutic levels being achieved only sporadically in young infants. Despite this, enoxaparin appears efficacious in thrombosis resolution. Further studies on the impact of stringent control of concentrations on outcomes in this population are warranted.

Pharmacists' perceived knowledge and expertise in selected pediatric topics.

OBJECTIVES: The purpose of this study is to determine pharmacists' perceived knowledge and expertise required to make recommendations regarding selected pediatric topics. METHODS: A questionnaire was distributed to 400 pharmacists practicing in community, hospital, and home care settings. This instrument explored their perceived knowledge, expertise, and comfort in providing recommendations related to 38 pediatric topics. The impact of responder demographics on differences in perceived knowledge and expertise for each topic were evaluated. RESULTS: Ninety-five of 400 (24%) questionnaires were returned completed or partially completed. Forty-seven and 36 of responders practiced in the community or inpatient hospital setting, respectively. Seventy percent of responders reported that ≤ 40% of their patients were children. In general, responders believed they had the knowledge and expertise to make recommendations for the frequently occurring conditions or topics but not for the less familiar. Formal pediatric training was the most influential responder characteristic with a larger proportion having training that they believed enables them to have knowledge and expertise to make recommendations. Although less impressive, experience of more than 5 years and a community-based practice were also important factors. CONCLUSION: Additional training is beneficial in increasing the perceived knowledge and comfort of pharmacists making recommendations regarding pediatric patients.

Summary proceedings from the neonatal pain-control group.

Recent advances in neurobiology and clinical medicine have established that the fetus and newborn may experience acute, established, and chronic pain. They respond to such noxious stimuli by a series of complex biochemical, physiologic, and behavioral alterations. Studies have concluded that controlling pain experience is beneficial with respect to short-term and perhaps long-term outcomes. Yet, pain-control measures are adopted infrequently because of unresolved scientific issues and lack of appreciation for the need for control of pain and its long-term sequelae during the critical phases of neurologic maturation in the preterm and term newborn. The neonatal pain-control group, as part of the Newborn Drug Development Initiative (NDDI) Workshop I, addressed these concerns. The specific issues addressed were (1) management of pain associated with invasive procedures, (2) provision of sedation and analgesia during mechanical ventilation, and (3) mitigation of pain and stress responses during and after surgery in the newborn infant. The cross-cutting themes addressed within each category included (1) clinical-trial designs, (2) drug prioritization, (3) ethical constraints, (4) gaps in our knowledge, and (5) future research needs. This article provides a summary of the discussions and deliberations. Full-length articles on procedural pain, sedation and analgesia for ventilated infants, perioperative pain, and study designs for neonatal pain research were published in Clinical Therapeutics (June 2005).

Changing patterns of drug utilization in a neonatal intensive care population.

Newborns in the neonatal intensive care unit (NICU) typically are exposed to a large number of drugs and are especially vulnerable to adverse drug reactions. It is important to review changes in drug use patterns periodically in the NICU to identify newly introduced drugs as well as drugs with increasing use. The objective of this study was to determine the changes in drug utilization patterns over a 7-year period in an NICU population. Drug utilization of 2332 neonates treated at an intramural NICU between January 1, 1997 and December 31, 1998, and 2691 neonates between January 1, 2001 and June 30, 2004 was analyzed using chi-square tests, T tests, and linear regression. There was an increased utilization of antibiotics, central nervous system drugs, endocrine agents, cardiovascular and gastrointestinal drugs, and a decreased utilization of ophthalmic drugs. No changes in nutritional, biological, renal, and pulmonary drugs were observed. Some individual drug changes include an increased use of vancomycin, cefepime, caffeine, and a decreased use of morphine. Significant changes in drug utilization patterns in an NICU were observed during a 7-year period. These data are useful in monitoring drug resistance patterns, adverse drug reactions, and prioritizing areas of relevant therapeutic research and educational programs.