"You've got to care to carry this stuff" Community implications from take-home naloxone use: A qualitative study.

BACKGROUND: In New Mexico, drug overdose rates have been among the highest in the nation for the past two decades, with 332 overdose deaths involving opioids in 2017. While interventions aimed at enhancing distribution and uptake of take-home naloxone (THN) have identified people who use opioids as viable candidates, there exists a gap in applying these findings to underserved, ethnic minority women. METHODS: We conducted qualitative interviews with participants recruited from a parent study which recruited 395 women diagnosed with OUD who participated in a two year study (April 2016-May 2018) during which they received opioid overdose education and two free THN kits for their use. RESULTS: Findings characterize the social dynamics of persistent opioid exposure, accidental overdose, and take home naloxone use to reverse overdose, and we identified three overarching themes: 1) Crisis management and community responsibility; 2) Complex social networks as informal channels for family to family and peer to peer naloxone distribution and education; and 3) Participant preferences and strategies for THN distribution and education. CONCLUSIONS: Participants in the ASAP program demonstrated an unquestionable willingness to distribute naloxone when they had access to it, and the ability to replace it. Further research is warranted to apply these findings in interventional contexts to refine strategies toward prioritizing distribution of THN, enhance training tools and optimize community locations for engagement.

Barriers to and recommendations for take-home naloxone distribution: perspectives from opioid treatment programs in New Mexico.

BACKGROUND: Naloxone is a safe and effective medication to help reverse opioid overdose. Providing take-home naloxone to patients in opioid treatment settings is a critical step to reducing opioid overdose deaths. In New Mexico, a US state with one of the highest rates of opioid overdose deaths, legislation was passed in 2017 (House Bill 370) to support take-home naloxone, and followed by naloxone training of Opioid Treatment Program staff to increase distribution. METHODS: Naloxone training was offered to all New Mexico Opioid Treatment Programs along with a baseline survey to assess current practices and barriers to take-home naloxone distribution. Focus groups were conducted approximately 1 year post-training with staff at a subset of the trained Opioid Treatment Programs to assess the impact of the legislation and training provided. RESULTS: Baseline survey results show most Opioid Treatment Program staff were unfamiliar with House Bill 370, reported conflicting understandings of their agency's current take-home naloxone practices, and reported a number of barriers at the patient, agency, and policy level. Follow-up focus groups revealed support for House Bill 370 but persistent barriers to its implementation at the patient, agency, and policy level including patient receptivity, cost of naloxone, staff time, and prohibitive pharmacy board regulations. CONCLUSIONS: In spite of targeted legislation and training, provision of take-home naloxone at remained low. This is alarming given the need for this lifesaving medication among the Opioid Treatment Program patient population, and high opioid death rate in New Mexico. Locally, important next steps include clarifying regulatory guidelines and supporting policy/billing changes to offset costs to Opioid Treatment Programs. Globally, additional research is needed to identify the prevalence of take-home naloxone distribution in similar settings, common barriers, and best practices that can be shared to increase access to this vital lifesaving medication in this critical context.

Association of Take-Home Naloxone and Opioid Overdose Reversals Performed by Patients in an Opioid Treatment Program.

Importance: The US opioid crisis was deemed a public health emergency in 2017. More than 130 individuals in the US die daily as a result of unintentional opioid overdose deaths. Objective: To measure use of take-home naloxone for overdose reversals performed by study participants with opioid use disorder receiving treatment at an opioid treatment program. Design, Setting, and Participants: In a year-long cohort study, between April 4, 2016, and May 16, 2017, 395 study participants enrolled at the University of New Mexico Addiction and Substance Abuse Opioid Treatment Program, an outpatient clinic treating substance use disorders. Inclusion criteria included all patients enrolled at University of New Mexico Addiction and Substance Abuse Opioid Treatment Program during the study enrollment period; positive history of opioid use disorder treated with methadone, buprenorphine, or naltrexone; and age 18 years or older. Exclusion criteria included allergy to naloxone and age younger than 18 years. The study closed 1 year after enrollment, on May 17, 2018. Data analysis was performed from May 2018 to July 2019. Exposure: Two doses of take-home naloxone combined with opioid overdose education were provided to study participants. Main Outcomes and Measures: The primary outcome was to measure the association of take-home naloxone with overdose reversals performed by patients with opioid use disorder enrolled in an opioid treatment program. Results: We enrolled 395 study participants (270 female [68.4%]; mean [SD] age, 35.4 [12.6] years; 260 [65.8%] with Hispanic white race/ethnicity) in the 1-year prospective trial. Sixty-eight female participants (25.2% of all female participants) were pregnant at the time of enrollment. Seventy-three of the 395 study participants (18.0%) performed 114 overdose reversals in the community. All community reversals were heroin related. Most study participants (86.8%) stated that the person on whom they performed an overdose reversal was a friend, relative, acquaintance, or significant other. In the year before enrollment, only 18 study participants (4.5%) had been prescribed naloxone. Conclusions and Relevance: Take-home naloxone as part of overdose education and naloxone distribution provided to patients in an opioid treatment program may be associated with a strategic targeted harm reduction response for reversing opioid overdose-related deaths. Policy makers may consider regulations to mandate overdose education and naloxone distribution in opioid treatment programs.

Opioid overdose response training in pharmacy education: An analysis of students' perception of naloxone use for opioid overdose prevention.

BACKGROUND AND PURPOSE: Pharmacists in New Mexico have prescriptive authority to prescribe naloxone. However, no formal naloxone training has been provided for students at the University of New Mexico College of Pharmacy. EDUCATIONAL ACTIVITY AND SETTING: Training was incorporated into a pharmaceutical care laboratory course. First-year (P1) (n = 63) and third-year (P3) (n = 78) pharmacy students were asked to answer a pre- and post-training survey. The survey was designed to assess students' self-rated knowledge, clinical-type skills related to naloxone and opioids, and attitude toward prescribing naloxone. In class students reviewed the epidemiology of opioid overdose and risk assessment methods for patients, and the students practiced using an intranasal spray and an auto injector. FINDINGS: The pre-survey showed that P3 students had higher confidence levels in regards to naloxone therapy compared with P1 students. However, educational materials significantly increased confidence levels in drug knowledge, clinical-type skills, and patient counseling in both cohorts. The P3 cohort tended to be more likely to disagree with advertisements about the availability of naloxone therapy by pharmacists as compared to the P1 cohort. SUMMARY: P1 and P3 students demonstrated improved knowledge, skills, and attitudes in regards to naloxone therapy and dispensing. Naloxone training is essential to increase pharmacy students' knowledge about opioid overdose and naloxone benefits. Although the training helped increase students' confidence level, additional practical training and longitudinal instruction in a pharmacy curriculum would be valuable so that students could transfer the knowledge into practice as a pharmacist.

Characteristics of Patients With Opioid Use Disorder Associated With Performing Overdose Reversals in the Community: An Opioid Treatment Program Analysis.

OBJECTIVE: The primary outcome of this study is to identify characteristics of study participants in a large opioid treatment program (OTP) for opioid use disorder (OUD) who used take-home naloxone to perform 1 or more opioid overdose (OD) reversal(s) in the community. METHODS: This 6-month prospective cohort study provided take-home naloxone and opioid OD education for 287 study participants with OUD. Characteristics associated with use of the take-home naloxone were determined from among 16 variables using multivariable logistic regression. RESULTS: The study participants who had greater odds of using the take-home naloxone to perform OD reversals, compared to those who did not use the take-home naloxone, (a) received emergency room care themselves for OD (OR = 4.89, 95% CI 1.54-15.52, P = 0.007), (b) previously witnessed someone else OD (OR = 5.67, 95% CI 1.24-25.87, P = 0.025), (c) tested positive for 2 or more illicit substances at their 6-month urine analysis (OR = 5.26, 95% CI 1.58-17.54, P = 0.007) or were missing their 6-month urine analysis (OR = 3.46, 95% CI 1.42-8.43, P = 0.006). In addition, they had greater odds of being (d) less than 30 years old (OR = 2.80, 95% CI 1.02-7.66, P = 0.045), and (e) Hispanic (OR = 3.98, 95% CI 1.41-11.21, P = 0.009). CONCLUSIONS: This study prospectively identified several characteristics of patients enrolled in an OTP with increased odds of using take-home naloxone in their social networks. Future harm reduction efforts may benefit by using targeted characteristics to identify those most likely to use naloxone in their communities.

Assessment of components included in published societal perspective or QALY outcome economic analyses for antiepileptic drug treatment in chronic epilepsy.

INTRODUCTION: Antiepileptic drug (AED) treatments seek to control seizures with minimal or no adverse effects, effects which can substantially impact costs and outcomes for patients, caregivers, and third party payers. The First and Second Panel on Cost-Effectiveness in Health and Medicine recommend inclusion of a societal reference case, even in studies conducted from a healthcare sector perspective, for comparability of findings across studies. Cost and outcome evaluation components include direct medical, non-direct medical-related (e.g. patient-time and transportation costs for treatment) and non-healthcare sectors (e.g. lost productivity). AREAS COVERED: Guided by Second Panel recommendations, this review developed an overall impact inventory and detailed adverse effect impact inventory to assess the scope and methods in published economic evaluations of AED treatments for adults with chronic epilepsy. Societal perspective evaluations or evaluations that utilized quality-adjusted life-years (QALYs) as an outcome were reviewed. The majority of reviewed articles were healthcare sector perspective studies, methods for estimating QALYs varied widely, and a minority considered specific AED treatment adverse effects. EXPERT COMMENTARY: Only considering a healthcare sector perspective fails to provide full information for patients on AED treatments. Using an impact inventory to guide study scope and design will facilitate full reporting of costs and benefits.

An Innovative Model for Naloxone Use Within an OTP Setting: A Prospective Cohort Study.

OBJECTIVES: Unintentional opioid overdose deaths are a public health crisis, and naloxone is the most effective harm reduction tool to curb many of these deaths. There is growing evidence that take-home naloxone can prevent opioid overdose in targeted populations. The goal of this study is to measure the opioid overdose reversal rate with take-home naloxone among participants with a diagnosis of opioid use disorder (OUD) in an opioid treatment program (OTP) setting. METHODS: Patients enrolled in an outpatient OTP program were eligible for this prospective cohort study between April 4, 2016 and July 4, 2016. Two hundred forty-four study participants received overdose education, instruction on how to use naloxone, and were provided with 2 doses of a take-home naloxone auto-injector kit. They were subsequently followed for 3 months. RESULTS: Thirty-one study participants reported overdose reversals using naloxone auto-injector kits on 38 community members. All overdose reversals were heroin-related. Eighty-seven per cent of the community members reversed with naloxone were friends or relatives of the study participants. CONCLUSIONS: This study validates that naloxone is not commonly used on the index study participant, but is often used on a secondary target among people who inject drugs. The large number of overdose reversals reported in this prospective study suggests that this novel model for naloxone use may be replicated at other OTP settings to reduce opioid overdose deaths.

Debriefing to Improve Student Ability to Assess and Plan for the Care of Persons With Disability.

INTRODUCTION: Although recent literature suggests that students should be trained in the care of persons with disability (PWDs) as a form of cultural sensitivity (CS), healthcare professionals may receive limited experience during their formal training. After pharmacy students in 2 previous years of testing failed to adequately assess and plan for the care of a standardized patient's chief complaint and disability in an Objective Structured Clinical Examination (OSCE), the investigators added debriefing to the OSCE to determine if it would improve student's ability to assess and plan for the care of PWD. METHODS: Two sequentially enrolled second-year pharmacy school student cohorts participated in this study (control n = 90; intervention n = 82). During the OSCE, students interviewed and examined a standardized patient with a simulated physical disability and other chronic disease states. Students were then instructed to develop a care plan considering the patient's disability and other disease states. The intervention cohort received debriefing; the control did not. Students documented the care plan in a subjective, objective, assessment, and plan (SOAP) note. Investigators assessed SOAP note score (general ability of students to write a SOAP note) and CS score (specific ability to care for PWD) to determine the effectiveness of the debriefing. RESULTS: The intervention group showed a significantly higher percent mean CS score than the control group (93.6% ± 19% and 61.1% ± 30.7%, respectively, P < 0.001), translating to a mean of 56.2/60 points earned for the intervention group and 36.7/60 points earned for the control group. Scores ranged from 0 to 60 points for both intervention and control groups. Students in the intervention group had an absolute improvement in pass rates (those students scoring ≥70% on the OSCE) of 59.4% with 92.7% of the students passing in the intervention group versus 33.3% of the students passing in the control group (P < 0.001). The overall SOAP note scores were no different between the 2 cohorts (P = 0.353). CONCLUSIONS: Debriefing added to an OSCE improved students' performance in developing care plans for disabled patients. Ideally, longitudinal studies should be completed to determine if these skills transfer from debriefings to clinical practice. Development of effective training and assessment methods is essential for students to obtain adequate skills and knowledge to care for persons with disabilities.

Co-prescription of naloxone as a Universal Precautions model for patients on chronic opioid therapy-Observational study.

BACKGROUND: The epidemic of lethal prescription opioid overdose is one of the most pressing public health problems in the United States. In an ambulatory clinic setting, current practice guidelines suggest that health care providers should screen patient's aberrant drug-related behaviors. Given the difficulty of predicting which patients on chronic opioid therapy (COT) will experience opioid overdose, a new paradigm of harm reduction is called for. In previous studies, naloxone, an opioid antagonist, was given only to high-risk patients. However, if naloxone is co-prescribed in a Universal Precautions manner for all patients receiving COT, this may have a significant impact on intentional and unintentional opioid overdose deaths. METHODS: Adult patients treated with COT for chronic noncancer pain are eligible study participants at the University of New Mexico Pain Center. The primary goal of this 1-year study was to develop an efficient Universal Precautions model for co-prescribing of naloxone with COT in the ambulatory clinic setting. Outcome measures included demographic data, detailed medical and substance use history, current morphine equivalent dose (MED), other "high-risk" medications used, and opioid misuse risk. RESULTS: One hundred and sixty-four patients were enrolled in this study. All subjects were educated about the risks of opioid overdose and provided naloxone rescue kits. No overdoses occurred in the study population. Follow-up data illustrated that approximately 57% of the cohort had depressive disorder, the median MED was 90 mg/day, and the median Current Opioid Misuse Measure score (COMM) was 5.0. CONCLUSIONS: The ambulatory co-prescribing of naloxone in a Universal Precautions model for all patients prescribed COT can be adopted as a useful public health intervention. This study illustrates a model that can be used to educate patients, caregivers, and an interdisciplinary team of health care professionals in an academic medical center.