Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy.

In the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD. The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes. Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.

Healthcare professionals' knowledge, confidence and perceptions of pharmacogenomics in primary care and pain management.

Aim: To assess knowledge, confidence and perceptions of healthcare professionals specializing in primary care and pain management at Brigham and Women's Hospital, related to clinical pharmacogenomics (PGx). Methods: A 25-question online survey was distributed to 328 Brigham and Women's Hospital clinicians for analysis. Results: Thirty-four clinicians completed the survey. Respondents had minimal experience with PGx and limited awareness of PGx resources. Although respondents expressed belief that PGx has utility to improve medication-related patient outcomes, many lack confidence to apply PGx results to their practice. For clinical drug-gene questions relevant to primary care and/or pain management, respondents scored poorly. Conclusion: More clinician education is needed for appropriate utilization of PGx in clinical practice as it pertains to primary care and pain management.

Results of a Team Objective Structured Clinical Examination (OSCE) in a Patient with Pain.

PURPOSE: As rates of chronic pain and opioid use disorder continue to rise, improved pain education is essential. Using an interprofessional team objective structured clinical examination (OSCE) simulation, this study evaluates whether prior exposure to a case-based learning module improves students' assessment and treatment planning of a standardized patient prescribed chronic opioids presenting with acute pain. METHODS: A quasi-experimental mixed method approach using convenience sampling was employed to evaluate student performance and the impact of the educational intervention. RESULTS: Fourteen (intervention) and 16 (control) nurse practitioner, physician assistant, medical, pharmacy, and dental students in the final pre-licensure program years completed the team OSCE. Demographics, OSCE learning scores, Interprofessional Attitudes Scale scores, and pain management plans did not differ between groups. All students evaluated the activity highly. Qualitative analysis did not demonstrate differences between groups, but did identify similar themes: students missed opportunities to establish patient-provider rapport and educate across disciplines; opioid use disorder was assumed with chronic opioid therapy; team discussions improved treatment plans; moderators variably influenced team discussion. CONCLUSIONS: This novel approach to interprofessional training in pain management using a team OSCE is promising, with modifications suggested. A case-based learning module without structured education prior to the OSCE did not improve students' assessment and pain management skills compared to a control group. Nonetheless, important themes emerged including biases towards the standardized patient. Additional research is needed to develop effective curricular initiatives to foster and improve interprofessional collaboration in assessing and managing a standardized patient with acute and chronic pain.

Attitudes of Primary Care Practitioners in Managing Chronic Pain Patients Prescribed Opioids for Pain: A Prospective Longitudinal Controlled Trial.

OBJECTIVE: There is increasing concern among primary care practitioners (PCPs) regarding medication misuse and noncompliance among chronic pain patients prescribed opioids for pain. This study investigated the benefits of interventions designed to track potential opioid misuse and to improve practitioner confidence in managing patients with chronic pain through the use of risk assessment, monthly monitoring of compliance, and specialty support. METHODS: Fifty-six PCPs and 253 chronic pain patients were recruited into the study. All patients were assessed for risk and called once a month for 6 months to monitor pain and opioid compliance. Practitioner knowledge about opioids, concerns about analgesic prescriptions, practice behavior, and attitudes of managing chronic pain patients were assessed and questionnaires were repeated after 1 year. Practitioners in the experimental group received monthly patient summary reports that consisted of pain, mood, activity levels, healthcare utilization, and results of the Opioid Compliance Checklist, while practitioners in the control group did not receive the monthly reports. RESULTS: After 1 year all the PCPs reported improvement in identifying patients at risk for misuse (P < 0.05), perceived confidence in prescribing opioids for pain (P < 0.05) and increased satisfaction with communication with pain specialists (P < 0.05). The patients reported greater compliance with their opioid medication and felt that the monthly monitoring was beneficial. Despite modest improvements, many PCPs still lacked confidence in managing pain patients and reported reluctance to prescribe opioids for chronic noncancer pain, especially among younger practitioners. This study demonstrates the benefits of careful monitoring of chronic pain patients and need for pain management support within primary care.

Implementation of a collaborative care management program with buprenorphine in primary care: a comparison between opioid-dependent patients and patients with chronic pain using opioids nonmedically.

OBJECTIVE: To implement a collaborative care management program with buprenorphine in a primary care clinic. DESIGN: Prospective observational study. SETTING: A busy urban academic primary care clinic affiliated with a tertiary care hospital. PARTICIPANTS: Opioid-dependent patients or patients with chronic pain using opioids nonmedically were recruited for the study. A total of 45 participants enrolled. INTERVENTIONS: Patients were treated with buprenorphine and managed by a supervising psychiatrist, pharmacist care manager, and health coaches. The care manager conducted buprenorphine inductions and all follow-up visits. Health coaches offered telephonic support. The psychiatrist supervised both the care manager and health coaches. MAIN OUTCOME MEASURES: Primary outcomes were treatment retention at 6 months, and change in the proportion of aberrant toxicology results and opioid craving scores from baseline to 6 months. After data collection, clinical outcomes were compared between opioid-dependent patients and patients with chronic pain using opioids nonmedically. Overall, 55.0 percent of participants (25/45) remained in treatment at 6 months. Primary care physicians (PCPs)' attitudes about opioid dependence treatment were surveyed at baseline and at 18 months. RESULTS: Forty-three patients (95.6 percent) accepted treatment and 25 (55.0 percent) remained in treatment at 6 months. The proportion of aberrant urine toxicology results decreased significantly from baseline to 6 months (p < 0.01). Craving scores significantly decreased from baseline to 6 months (p < 0.01). Opioid-dependent patients, as opposed to patients with chronic pain using opioids nonmedically, were significantly more likely to complete 6 months of treatment (p < 0.05). PCPs' confidence in treating opioid dependence in primary care increased significantly from baseline to 18 months postimplementation (p < 0.01). CONCLUSION: Collaborative care management for opioid dependence with buprenorphine may be feasible in a primary care clinic. More research is needed to understand the role of buprenorphine in managing patients with chronic pain using opioids nonmedically.

Class-wide REMS for extended-release and long-acting opioids: potential impact on pharmacies.

OBJECTIVES: To provide an update on the recently approved class-wide risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids and to discuss the potential impact on pharmacy practice. DATA SOURCES: In mid-2011, the Food and Drug Administration notified drug manufacturers that a single, class-wide REMS would be required for ER and LA opioids. This regulation was the result of a multiyear process that incorporated input from government, drug manufacturers, medical associations, and other stakeholders. SUMMARY: The goal of the class-wide REMS for ER/LA opioids is to reduce addiction, unintentional overdose, and death resulting from inappropriate prescribing, misuse, and abuse. To accomplish these goals, this REMS focuses on physician education on safe and appropriate prescribing and patient counseling on the risks of opioids. Although voluntary, a movement to require physician education to obtain or renew Drug Enforcement Administration licensing is occurring. Pharmacists are not included in the class-wide REMS per se. Pharmacists play an important role in overall risk reduction and are critical to the success of the class-wide REMS. CONCLUSION: Although the changing requirements for prescribing ER/LA opioids will not have a direct effect on pharmacist workflow, the pharmacist-patient interaction remains critical for overall risk reduction with this class of medication.

The role of dose reduction with NSAID use.

Effective pain relief with use of nonsteroidal anti-inflammatory drugs (NSAIDs) may come at the cost of an increased risk for serious cardiovascular (CV), gastrointestinal (GI), and renal complications. Research has shown that these adverse events are more likely to occur with higher NSAID dosing and in individuals with a preexisting risk for CV and GI complications. To minimize the potential risk for an adverse event, numerous regulatory bodies and medical societies recommend using the lowest effective NSAID dose for the shortest time necessary. One potential strategy is to offer patients lower doses of standard NSAID formulations. However, efforts to modify physician prescribing behavior may be challenging because of concerns regarding the potential for suboptimal pain management. Another strategy has emerged through use of new technology that produces submicron NSAID formulations. This new technology is also an approach that could provide effective pain relief at low doses. This article reviews the role of dose and duration in the risk for NSAID-associated adverse events, and discusses the potential benefits associated with new low-dose submicron NSAID formulations.

Meta-analysis of drug-induced adverse events associated with intensive-dose statin therapy.

BACKGROUND: Randomized trials evaluating intensive dose statin therapy have found enhanced protection against cardiovascular (CV) events compared with moderate-dose statin therapy in patients with acute coronary syndromes (ACS) or stable coronary artery disease (CAD). However, the potential for an increase in the risk of drug-induced adverse events with such therapy has not been quantified. OBJECTIVE: This meta-analysis was performed to compare the incremental risks associated with intensive- and moderate-dose statin therapy. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from 1995 to 2006 using the following terms: acute, coronary syndrome, stable coronary artery disease, atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, and fluvastatin. Prospective, randomized controlled trials evaluating intensive- and moderate-dose statin therapy for the reduction of CV events were included in the review. The safety end points examined were elevations in creatine kinase (CK) >or= 10 times the upper limit of normal (ULN), elevations in alanine or aspartate aminotransferase >or=3 times the ULN, rhabdomyolysis, drug-induced adverse events requiring discontinuation of therapy, and any drug-induced events. The efficacy end points examined were all-cause mortality, CV death, nonfatal myocardial infarction (MI), and stroke. Each analysis compared the effect of intensive- or moderate-dose statin therapy on statin-induced adverse events and clinical efficacy outcomes. Simple absolute risk, the number needed to treat, and the number needed to harm were also calculated to quantify the incremental benefit or harm associated with intensive-dose statin therapy. RESULTS: Four trials were included in the analysis.Together, they included 27,548 patients with ACS or stable CAD followed for a mean of 3.4 years, representing 108,049 patient-years of clinical-trial experience. Intensive-dose therapy with atorvastatin or simvastatin 80 mg was associated with a significant increase in the risk for any adverse event (odds ratio [OR] = 1.44; 95% CI, 1.33-1.55; P < 0.001) and adverse events requiring discontinuation of therapy (OR = 1.28; 95% CI, 1.18-1.39; P < 0.001). Intensive-dose therapy also was associated with an increased risk for abnormalities on liver function testing (OR = 4.48; 95% Cl, 3.27-6.16; P < 0.001) and elevations in CK (OR = 9.97; 95% CI, 1.28-77.92; P = 0.028). The benefits of intensive-dose statin therapy included reductions in CV death (OR = 0.86; 95% CI, 0.75-0.99; P = 0.031), MI (OR = 0.84; 95% CI, 0.76-0.93; P < 0.001), and stroke (OR = 0.82; 95% CI, 0.72-0.94; P = 0.004). CONCLUSIONS: Although intensive-dose statin therapy was associated with a reduced risk for important CV events, it was also associated with an increased risk for statin-induced adverse events. Therefore, moderate-dose statin therapy may be the most appropriate choice for achieving CV risk reduction in the majority of individuals, whereas intensive-dose statin therapy may be reserved for those at highest risk.