Correction: Implementation Documentation and Process Assessment of the PharmNet Intervention: Observational Report.

[This corrects the article DOI: 10.2196/54077.].

Implementation Documentation and Process Assessment of the PharmNet Intervention: Observational Report.

BACKGROUND: The number of overdose deaths in the United States involving opioids continues to exceed 100,000 per year. This has precipitated ongoing declarations of a public health emergency. Harm reduction approaches, such as promoting awareness of, ensuring access to, and fostering willingness to use naloxone to reverse opioid overdose, are a key component of a larger national strategy to address the crisis. In addition, overdose reversal with naloxone directly and immediately saves lives. Because of pharmacies' ubiquity and pharmacists' extensive clinical training, community pharmacies are well-positioned, in principle, to facilitate naloxone access and education. OBJECTIVE: In 2022, a single-site pilot study of PharmNet, a community pharmacy intervention incorporating naloxone distribution, awareness building, and referral, showed promising outcomes for both naloxone and resource distribution in the community. As a next step, this study was intended to be a pilot randomized controlled trial of PharmNet in 7 pharmacies. However, due to circumstances outside of the study team's control, data collection was unable to be fully completed as planned. In keeping with open research standards, we transparently report all available data from the study and discuss trial barriers and processes. We do so both to provide insights that may inform similar studies and to avoid the "file-drawer" (publication bias) problem, which can skew the aggregated scholarly literature through nonpublication of registered trial results or selective publication of findings affirming authors' hypotheses. METHODS: This paper reports an in-depth implementation study assessment, provides the available observational data, and discusses implementation considerations for similar studies in independent (eg, nonchain) community pharmacies. RESULTS: Retrospective assessment of study outcomes and fidelity data provided for robust discussion around how resource differences in independent community pharmacies (vs well-resourced chain pharmacies), as well as high demands on staff, can affect intervention implementation, even when leadership is highly supportive. CONCLUSIONS: Community pharmacies, particularly independent community pharmacies, may require more support than anticipated to be successful when implementing a new intervention into practice, even if it might affect estimates of real-world effectiveness. Further implementation science research is needed specific to independent community pharmacies. All study elements are outlined in the International Registered Report Identifier (IRRID) PRR1-10.2196/42373. Although this paper reports results associated with that registration, results and conclusions should not be given the weight assigned to findings from a preregistered study. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42373.

Elucidating determinants of medication disposal programs at retail pharmacies in North Carolina.

BACKGROUND: Pharmacy-based medication disposal programs is one approach to prevent diversion of unused prescription opioids. OBJECTIVE(S): The objective of this study was to assess the extent to which disposal programs have been implemented by retail pharmacies and identify determinants of implementation using the Consolidated Framework for Implementation Research. METHODS: A sequential mixed-method design was used to examine implementation of medication disposal programs at pharmacies in Pitt County, NC. We conducted environmental scans of all retail pharmacies that served community members (N = 31) to assess the extent to which disposal programs had been implemented. Then, we conducted interviews with pharmacists (n = 15; 48.4%) to identify determinants of implementation. The following pharmacy types were represented in the completed interviews: corporate chain (n = 10), small chain (n = 1), independently owned and operated (n = 1), medical (n = 2), and government (n = 1). RESULTS: We found that 32.3% of pharmacies (n = 10) had a medication disposal box and 12.9% (n = 4) had posted a flyer on medication disposal. Pharmacists perceived that patients benefit from disposal boxes and medication disposal is in their purview. Determinants of implementation included the cost of sustaining the intervention, polices of corporate and regional management, variable local control in the decision-making process to implement a disposal box, and experience with having a medication disposal box. CONCLUSION: Our findings highlight one way in which pharmacists can have a vital role in preventing diversion of opioid analgesics and associated consequences. There is a need to expand disposal boxes at pharmacies to increase community member accessibility and use. Future research is needed to determine the cost-effectiveness of expanding the scale of disposal box implementation in community pharmacies.

The PharmNet Harm Reduction Intervention for Community Pharmacies: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: The overdose epidemic in the United States has continued to worsen despite substantial efforts to mitigate its harms. The opioid antagonist naloxone has been identified as a key means of reducing the prevalence of fatal overdoses. An important evidence-based approach to optimizing naloxone's impact is to seed it throughout the community, because bystanders are often able to reverse overdoses more quickly than first responders and sometimes are the only possible means of overdose reversal. As part of a multipronged approach to distributing naloxone nationwide, community pharmacies have been identified as ideal venues for naloxone dispensing, especially under standing orders. However, dispensing rates remain surprisingly low, and there is a need to understand how best to engage community pharmacies in naloxone-based harm reduction services. OBJECTIVE: The objective of this trial is to determine whether a tailored, pragmatic pharmacy intervention (PharmNet) results in greater naloxone dispensing relative to baseline (the prior 3 months) compared to a control condition. This pilot trial is intended to determine whether it is appropriate to invest the substantial resources that would be required to conduct a full-scale, randomized controlled study of PharmNet. METHODS: We will conduct a 3-month randomized controlled pilot trial consisting of 2 parallel groups with a 4:3 allocation ratio. A group of 7 independent pharmacies from rural areas in Indiana will be randomly assigned to either the PharmNet intervention arm (n=4) or the control arm (n=3). The primary outcome will be overall naloxone dispensing (both at cost and free), and secondary outcomes will include the distribution of referral cards and multiple variables at the level of individual staff members. Dispensing data will be collected for the 3 months prior to the intervention and the 3 months of the intervention, and all other data will be collected using a pretest-posttest design. The primary analysis will be a generalized linear mixed model with a Poisson distribution with fixed effects for group, time, and their interaction and a random effect for pharmacy ID to account for repeated measures within pharmacies. RESULTS: This study was approved by the Indiana University institutional review board in 2 phases (August 2, 2021, and April 26, 2022) and was funded by the Indiana University Grand Challenge: Responding to the Addictions Crisis. CONCLUSIONS: If this study produces evidence that the PharmNet intervention results in increased naloxone dispensing relative to control pharmacies, it will be both appropriate and important to study it in a large, full-scale randomized controlled trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42373.

"The gatekeepers in prevention": Community pharmacist perceptions of their role in the opioid epidemic.

Background: Community pharmacists are at the frontline of patient care, yet their role in the opioid epidemic remains unclear. This qualitative study examines the perception of community pharmacists about their role in the opioid epidemic and challenges to fulfilling this role. Methods: A secondary analysis of cross-sectional survey data from an Indiana census of community managing pharmacists was conducted. Qualitative data were coded using a priori and emergent themes. A priori categories included the perceived role of pharmacists in the opioid epidemic and perception of practice barriers. Results: A total of 215 Indiana community managing pharmacists participated in this study. Pharmacists understood themselves as gatekeepers in preventing opioid misuse and overdose. Reported pharmacy practices included providing patient education and communicating with prescribers. Challenges to fulfilling this role included pharmacy structure and operation, lack of patient and provider clarity about pharmacist scope of practice, and pharmacist perception that that there is no available discretionary time to support additional services. Conclusion: Pharmacists believe they have a vital role in combatting opioid misuse and overdose but are hampered by structural aspects of pharmacy practice and lack of recognition of their role. Pharmacy associations and policy partners are encouraged to identify opportunities to address these barriers.

Naloxone availability and dispensing in Indiana pharmacies 2 years after the implementation of a statewide standing order.

OBJECTIVES: This study examined changes in rates of pharmacy naloxone stocking and dispensing in Indiana between 2016 and 2018 and explored supplemental variables and factors that may have affected observed differences. METHODS: Researchers used data from 2 existing datasets that were collected from managing pharmacists who responded to statewide pharmacy censuses in 2016 and 2018. After identifying all cases in which a pharmacy's managing pharmacist responded in both 2016 and 2018 censuses, researchers conducted a nonparametric statistical comparison of naloxone stocking and dispensing rates in 107 Indiana pharmacies. Additional descriptive data regarding naloxone-related pharmacy policies and educational programs during those years were collected in 2019 from pharmacy corporations operating food stores or chain pharmacies in Indiana and from the Indiana Pharmacists Association. RESULTS: Pharmacy stocking and dispensing in Indiana increased from 2016 to 2018. In 2016, 57% of pharmacies reported stocking naloxone compared with 92.5% in 2018 (P < 0.001). Similarly, 23.4% of pharmacies reported dispensing naloxone in 2016 compared with 76.6% of pharmacies in 2018 (P < 0.001). All responding pharmacy corporations and the state pharmacy association reported offering self-directed volunteer-training programs regarding naloxone since 2016. In addition, they reported that company policy and procedures regarding naloxone were put into place in response to the 2016 statewide standing order. CONCLUSION: Pharmacy naloxone stocking and dispensing increased in the 2 years after the statewide standing order was issued. The effect of the order itself was likely moderated or mediated by corporate responses to the law. Research examining the impact of naloxone-availability policies on pharmacy practice and patient incomes should longitudinally examine data after policy implementation and with covariates that include type of pharmacy (e.g., chain or independent), location, and opioid overdose-associated mortality rates.

Relationship Between Substance Use and the Onset of Spinal Cord Injuries: A Medical Chart Review.

Background: Opioid misuse is a leading health care concern within the United States. In many cases, opioid misuse and opioid use disorder are associated with pain, a secondary health condition affecting individuals with spinal cord injury (SCI). Further, substance use is a known risk factor for SCI, resulting in the potential for a substance-related risk trajectory running from pre- to post-SCI. However, little research has examined substance use prior to SCI since the opioid epidemic began, and so the relative risk of opioids to patients with SCI is unclear. Objective: To determine whether individuals with SCI tested positive for substance use at the time of injury and identify the primary substances used at the time of injury. Methods: This study retrospectively reviewed all medical charts of individuals ages 18 and older who had sustained an SCI during an identified 18-month period and received medical care at a selected level 1 trauma center in the Midwest. Results: Data revealed an 80% combined positive toxicology and/or self-report of substance use immediately prior to the onset of the SCI. Twenty-five percent of males were positive for more than one substance at time of injury. Substances used prior to injury, listed most to least prevalent, were opioids (37.5%), alcohol (25%), marijuana (25%), methamphetamines (12.5%), benzodiazepines (12.5%), followed by cocaine (6.25%) and synthetic cathinone (6.25%). Conclusion: Although opioids were the most common substance used prior to SCI, none of the individuals positive for opioids at the time of injury were identified by the reviewing medical professional as having pain as a secondary health condition either prior to or after injury. However, pain is commonly listed as the primary health concern among individuals living with SCI, and the possibility of opioid use prior to injury likely warrants pain management planning that includes careful pharmacological and nonpharmacological interventions.

I could take the judgment if you could just provide the service: non-prescription syringe purchase experience at Arizona pharmacies, 2018.

BACKGROUND: Community pharmacies are important for health access by rural populations and those who do not have optimum access to the health system, because they provide myriad health services and are found in most communities. This includes the sale of non-prescription syringes, a practice that is legal in the USA in all but two states. However, people who inject drugs (PWID) face significant barriers accessing sterile syringes, particularly in states without laws allowing syringe services programming. To our knowledge, no recent studies of pharmacy-based syringe purchase experience have been conducted in communities that are both rural and urban, and none in the Southwestern US. This study seeks to understand the experience of retail pharmacy syringe purchase in Arizona by PWID. METHODS: An interview study was conducted between August and December 2018 with 37 people living in 3 rural and 2 urban Arizona counties who identified as current or former users of injection drugs. Coding was both a priori and emergent, focusing on syringe access through pharmacies, pharmacy experiences generally, experiences of stigma, and recommendations for harm reduction services delivered by pharmacies. RESULTS: All participants reported being refused syringe purchase at pharmacies. Six themes emerged about syringe purchase: (1) experience of stigma and judgment by pharmacy staff, (2) feelings of internalized stigma, (3) inconsistent sales outcomes at the same pharmacy or pharmacy chain, (4) pharmacies as last resort for syringes, (5) fear of arrest for syringe possession, and (6) health risks resulting from syringe refusal. CONCLUSIONS: Non-prescription syringe sales in community pharmacies are a missed opportunity to improve the health of PWID by reducing syringe sharing and reuse. Yet, current pharmacy syringe sales refusal and stigmatization by staff suggest that pharmacy-level interventions will be necessary to impact pharmacy practice. Lack of access to sterile syringes reinforces health risk behaviors among PWID. Retail syringe sales at pharmacies remain an important, yet barrier-laden, element of a comprehensive public health response to reduce HIV and hepatitis C among PWID. Future studies should test multilevel evidence-based interventions to decrease staff discrimination and stigma and increase syringe sales.