Revisiting pharmacy-based naloxone with pharmacists and naloxone consumers in two states: 2017 perspectives and evolving approaches

Abstract

Objectives:

Pharmacies provide accessible sources of naloxone to caregivers, patients taking opioids, and individuals using drugs. While laws permit expanded pharmacy naloxone access, prior work identified barriers like concerns about stigma of addiction and time constraints that inhibit scale-up. We sought to examine similarities and differences in experiences obtaining naloxone at the pharmacy over a one-year period in two states, and to explore reactions from people with opioid use disorder, patients taking opioids for chronic pain, caregivers of opioid users, and pharmacists to communication tools and patient outreach materials designed to improve naloxone uptake.

Design:

Eight focus groups held December 2016 to April 2017 in Massachusetts and Rhode Island.

Setting and participants:

Participants were recruited from pharmacies, health clinics, and community organizations; pharmacists were recruited from professional organizations and pharmacy colleges.

Outcome measures:

Focus groups were led by trained qualitative researchers using a topic guide and prototypes designed for input. Five analysts applied a coding scheme to transcripts. Thematic analysis involved synthesis of coded data and connections between themes, with comparisons across groups and to first-year findings.

Results:

A total of 56 individuals participated: patients taking opioids for chronic pain (n=13), people with opioid use disorders (n=15), caregivers (n=13), and pharmacists (n=16). Fear of future consequences and stigma in the pharmacy was a prominent theme from the previous year. Four new themes emerged: experience providing pharmacy naloxone, clinician-pharmacist partnered approaches, naloxone co-prescription, and fentanyl as motivator for pharmacy naloxone. Prototypes for prompting consumers about naloxone availability, materials facilitating naloxone conversations, and posters designed to address stigma were well received.

Conclusion:

Experiences dispensing naloxone are quickly evolving, and a greater diversity of patients are obtaining pharmacy naloxone. Persistent stigma-related concerns underscore the need for tools to help pharmacists offer naloxone, facilitate patient requests, and provide reassurance when getting naloxone.

Introduction

In 2017, there were an unprecedented 70,237 overdose deaths, 67.8% (47,600) of which involved opioids, both illicit and prescription (1). Overdose deaths rose 12% from 2016 to 2017, with the largest increase in synthetic opioid-involved overdoses (45.2%), indicating fentanyl’s rapid spread (1). One evidence-based intervention to reduce mortality is broad community-wide access to the opioid antagonist naloxone, which reverses the respiratory depression that causes overdose, with minimal risk.

Many creative legal and regulatory processes have been implemented to expand community naloxone access, including standing orders to permit naloxone to be accessed directly at the pharmacy (2) or at community-based programs like syringe service programs (3). In December 2018, the US Department of Health and Human Services began explicitly encouraging the prescribing of naloxone to individuals at risk of experiencing or able to respond to overdose (4).

Despite the positive impact of naloxone availability (5–8), barriers to accessing it still exist in community healthcare settings. Prescriber barriers include a lack of knowledge about naloxone, discomfort in treating addiction and patients with substance use disorders in general, and a fear of increased risky behaviors in patients prescribed naloxone (9); whereas patient barriers include fear of being identified as misusing medications and restricted access to pain medications (10, 11). The stigmatization of drug use, and subsequently naloxone, presents further barriers to pharmacists providing and people asking for naloxone (12–14). In prior work (11, 15), we found that pharmacists are primarily concerned with offending patients when talking about overdose with them. Patients and caregivers (i.e., family, friends) of people who use opioids are also worried about perception, specifically about pharmacists altering their attitudes towards them if they asked for naloxone and the potential of future stigma (11). Cost and uncertain insurance coverage of naloxone (10, 16) impede access regardless of the consumer group.

A prominent theme featured in our prior work focused on practical solutions for the pharmacy and addressing barriers to naloxone provision (11, 17). For instance, caregivers sought tools that made the process of obtaining naloxone easier and more confidential; people who use illicit drugs preferred messages about naloxone that were simple, non-verbal and required less time at the pharmacy counter to discuss; and patients with chronic pain taking opioids wanted the opportunity to understand what naloxone is and to discuss its utility in their opioid regimen. All groups wished for a universal offer of naloxone at the pharmacy, or something that “started the conversation.” Tailoring materials and how they are delivered to the different, potential pharmacy naloxone consumer populations may improve the prospects of obtaining naloxone there.

Objectives

Given the urgency of the opioid crisis, it is important to iteratively assess changes in naloxone access and improve upon implementation approaches. To do so, this study sought the perspectives of participants representing four key consumer groups and providers of pharmacy naloxone. The study aimed first to examine consistencies and changes in experiences obtaining naloxone at the pharmacy over a one-year period and, second, to explore reactions to practical, pharmacy-based tools and patient outreach materials designed to improve naloxone uptake.

Methods

Our prior methods entailed conducting four focus groups (FGs) in two states (11). The current study used an identical approach, inviting different constituents of the same four populations involved in pharmacy naloxone uptake or provision: (1) people in recovery (short- or long-term, medication-centered or not) or actively using illicit opioid drugs; (2) patients with chronic pain who are prescribed opioid analgesics; (3) caregivers and family members of illicit and/or prescription opioid consumers; and (4) licensed pharmacists who have been trained in and/or have dispensed naloxone. The eight FGs were conducted in Massachusetts (MA) and Rhode Island (RI). These two states were early adopters of pharmacy-based naloxone laws, permitting anyone seeking naloxone to obtain it at a pharmacy without having to first see a prescriber. Rhode Island’s first collaborative pharmacy practice agreement for naloxone was approved in 2012 and was superseded by a standing order for naloxone in 2014. As part of an April 2014 emergency declaration due to the rising overdose deaths, Massachusetts permitted pharmacy naloxone access under a standing order, which then expanded to a statewide standing order in 2018.

Recruitment

Informational flyers were posted throughout MA and RI in health care settings (e.g., state pharmacist associations, pharmacy colleges, pain clinics) and community-based organizations (e.g., syringe service programs, recovery centers, family support groups) inviting people to a focus group about opioid safety and naloxone. Potential participants were screened for eligibility (≥18 years of age, English speaking). Participants provided informed consent to participate and were offered a $50 gift card at the conclusion of the focus group. Patient participants were also offered a $25 transportation stipend (pharmacist FGs were held at a conference that all were attending). Institutional review boards of Boston University Medical Campus and Rhode Island Hospital approved the study protocols.

Data collection

From December 2016 to April 2017, two female, doctoral-trained moderators (ED, DB) conducted eight FGs (one in each of the four broad categories in each state). Each FG was held in a private, community location (e.g., community health clinic, syringe service program, conference space) and lasted 45 to 60 minutes. A second investigator (JDB, JB, TG) was also present at each FG as well as a research assistant who took notes.

Semi-structured interview guides (Supplemental Appendices) used open-ended questions and probes to explore the following topics adapted from year one (Y1): (1) beliefs and experiences associated with naloxone; (2) naloxone products; (3) communicating about naloxone in the pharmacy; and (4) responses to stimuli: hypothetical scenarios (e.g., various circumstances when pharmacists may offer naloxone). In between the FGs of Y1 (December 2015) and year two (Y2) (December 2016 to April 2017), the Northeast experienced a large surge of illicitly manufactured fentanyl in the drug supply (1) and a concomitant massive, sustained increase in fentanyl-involved fatal overdoses (18). Toward the end of the interview guide, we posed a question about fentanyl and how its presence influenced their naloxone use or provision, if at all. A final topic explored reactions to newly developed materials (found on prevent-protect.org), including display pads for the pharmacy counter, stickers for use during purchase of nonprescription syringes, and professional posters designed to raise awareness about the availability of naloxone at the pharmacy. The posters were harvested from an annual overdose awareness and naloxone access poster contest hosted by the Boston Medical Center Injury Prevention Center as part of the parent research study. All materials were drafted or adapted by the research team with community and stakeholder input subsequent to FG Y1 findings to directly address barriers to getting naloxone articulated by the FGs of Y1.

Data analysis

All FGs were audio-recorded and transcribed verbatim without personal identifiers to protect confidentiality. Research staff read the transcripts and met to conduct content analysis, incorporating the principles of the immersion-crystallization method (19). This qualitative approach consists of all coders individually reviewing the FG recordings and transcriptions, then discussing the data as a group to determine emerging themes. As the prior year’s FG with similar populations had found many salient themes, we revisited the described themes for discrepancy, affirmation, and further clarity, as well as identified new ones. The same research team members developed and refined the codebook (LD, TG, BK, AT). We used NVivo qualitative data coding software (QSR International, v. 10) to manage and sort data. Research staff coded the data independently before meeting to discuss applied codes. Any coding discrepancies that emerged during meetings were discussed and resolved; in all cases of coding discrepancies, the team was able to collectively determine a final code. Group meetings continued until no new themes emerged. Results are presented in two parts: the revisited and new themes (Part 1) and feedback on practice-based solutions (Part 2).

Results

Fifty-six participants took part in eight FGs , including people living with chronic pain prescribed opioid analgesics (n=13), people actively using illicit opioid drugs or in early recovery (n=15), caregivers of people using any opioids (n=13), and pharmacists / pharmacists-in-training (n=16). The overall median age was 42.5 years (range 23-63 years), 71% of participants were female, and 79% identified as white (Table 1).

Table 1:

Demographic characteristics of the year two focus group participants

	Patients living with chronic pain (n=13)	People who use illicit drugs or who are in recovery (n=15)	Caregivers of people who consume opioids for chronic pain or who use illicit drugs (n=12)	Pharmacists/pharmacists-in training (n=16)	Total (n=56)
Rhode Island	8 (62%)	6 (40%)	6 (50%)	7 (44%)	27 (48%)
Massachusetts	5 (39%)	9 (60%)	6 (50%)	9 (56%)	29 (52%)
Gender
Male	7 (54%)	7 (47%)	1 (8%)	2 (13%)	17 (30%)
Female	6 (46%)	8 (53%)	11 (92%)	14 (88%)	39 (69%)
Age, median (min, max)	56 (53-62)	42 (23-63)	55 (25-63)	34 (23-62)	42.5 (23-63)
Race
White/Caucasian	9 (69%)	11 (73%)	11 (92%)	12 (75%)	43 (77%)
Black/African American	4 (31%)	0	1 (8%)	0	5 (9%)
Asian	0	0	0	4 (25%)	4 (7%)
Ethnicity
Hispanic	2 (15%)	4 (27%)	0	0	6 (11%)

Part 1: Revisited and new discussion themes

Revisiting Y1 theme: Fear of future consequences, stigma, and discomfort

Several themes from the Y1 FGs persisted and evolved, but new themes also emerged. Fear of future consequences when requesting naloxone remained a prominent theme, compounded by perceived stigma and discomfort. The Y2 data mainly showed a fear of future consequences to be present in the two consumer groups – chronic pain patients and people who use illicit opioids -- specifically around issues of possible scrutiny by health professionals if obtaining naloxone:

“What if I’m not even getting it for myself? I could not even be a user; and I go in there and grab it. Then, ‘boom!’, you’re flagged in the computer as somebody grabbing Narcan and all of a sudden you’re red-flagged as a user. And you get hurt, and now you’re screwed; you can’t have any pain meds.” – Illicit use/recovery group, MA

This fear was echoed by a chronic pain patient from Rhode Island:

“Yeah. If you fill a script for Narcan, the doctor’s probably going to make a note and say, hey, no more pain medicine.”

Caregivers generally expressed less concern about getting naloxone at the pharmacy than in the FGs Y1, except for when considering doing so in smaller towns where there was less anonymity. In these environments, caregivers and people who use drugs both shared that they were less likely to go to their personal, local, pharmacy and ask for naloxone, as one FG participant shared:

“I grew up in [town]. I know everybody in that town, so there’s like four people in the store I already know. And now my parents are hearing about this [getting naloxone at the pharmacy], and my grandparents even about this.”—Illicit use/recovery group, MA

In the pharmacist focus groups, there was a greater awareness of and encouragement of practice adaptations that were responsive to community overdose risk and consumer safety. For instance, one pharmacist in the Massachusetts FG described spearheading their team’s efforts to expand overdose response safety capacity at their store:

“Pharmacist 1: We were talking about leaving one [naloxone kit] in the office at the store, for when the pharmacy’s not open. The store previously has had someone overdose in the bathroom. So, and it was when the pharmacy was closed, so there wouldn’t have been access to a pharmacist with Narcan sitting on the shelves.

Moderator: So you could have filled one [a prescription in the pharmacist’s own name] and left it in the front store office?

Pharmacist 1: Well, we were trying to figure out what the legality of that was. And like, company policy and such. But we were going to fill one and leave the kit in the office, so if I billed it for myself and obviously that would be for any of the rest of the employees in the store.” – MA, Pharmacist

Revisiting Y1 theme: Concerns about pharmacy practice

More frequent dispensing engendered increased comfort with the billing and insurance side of providing naloxone, thereby reducing some of the logistical barriers to naloxone provision that pharmacists had identified in Y1. Furthermore, the single-step nasal naloxone product (Narcan, approved November 2015, broadly marketed in 2016) was an improvement upon the multi-step nasal spray(20), and simplified pharmacy naloxone provision, insurance billing, and patient education:

“Yeah, we switched to that one [nasal Narcan]. I think that when patients are approaching you, that’s an easier counsel. The Narcan spray that’s already assembled, it doesn’t look as medical as the other box. People had this horrified look on their face when you showed them the box and piece [multistep nasal spray]. And then they would be fine by the time they left, but I think it takes away that initial shock of the counselling.” – RI, Pharmacist

Similar to Y1 findings, a general under-preparedness for naloxone provision in the pharmacy persisted in the pharmacist FGs. Pharmacists expressed a desire for further education, as they still felt uncomfortable engaging in discussions about naloxone, and this was true even among pharmacists with dispensing experience and prior naloxone training:

”I was very uncomfortable the first couple times, because I felt like I… I knew how to process the standing order and package it up for them and hand it to them but I didn’t feel like I knew what to explain to them. I actually did the Narcan trainer learning thing [from a local organization]. And that was amazingly helpful.” – MA, Pharmacist

From the perspective of pharmacists and patients, technicians also lacked sufficient awareness and training. Patients primarily interact with technicians and expressed frustration with those interactions, which contributed to a distrust of the pharmacy and technicians when obtaining naloxone. Pharmacists recognized the crucial role of technicians and some felt they could be trained to participate in naloxone provision. Other pharmacists echoed concerns about involving technicians further, stating: “I don’t trust any of my technicians to do that [provide naloxone]”-- MA, Pharmacist

Y2 emergent theme: Experience providing naloxone

Different from Y1, multiple Y2 pharmacist FG participants had dispensed naloxone. Their experience gave rise to several notable shifts in the group discussion of pharmacy naloxone provision. For instance, some pharmacists articulated greater awareness of the need for anonymity and attention to patient privacy, and had adjusted practices accordingly:

“Privacy is part of that conversation too, I mean, I’m in a small town pharmacy, and we have a little sign up that says ‘Please stand back for privacy’, but people are standing right there, and they all know each other, and they’re all neighbors and they can hear, so you’ve got to be discreet and try to walk them to the other end of the counter to have a conversation [about naloxone].” – RI, Pharmacist

Pharmacist-specific concerns about naloxone appeared to shift from fears about offending or undermining care plans and billing issues in Y1 to a more nuanced understanding of the prescriber’s role in obtaining naloxone in Y2 FGs.

Y2 emergent theme: Clinical and pharmacy provider partnered approach

The Y2 FG pharmacist participants exhibited more extensive experience in providing naloxone to patients via the standing order and by prescription than the Y1 FG pharmacists. This gave insight into the actual implementation of the two legal mechanisms of pharmacy naloxone access:

“So I have dispensed naloxone through a standing order in Rhode Island and Massachusetts. I very rarely see a prescription come through for it, from a physician, I would say nine times out of 10 it’s through the standing order. I’ve had family members request on behalf of, you know, their concerned family members. I’ve had patients come in themselves. More recently I’ve had people coming in in groups, so I’ll see two or three people at a time and they’re all requesting Naloxone together, so I would say definitely as increased awareness and increased access is improving I see definitely more people requesting in general and more patients and family members in general.” – RI, Pharmacist

Overall, pharmacists in the FGs expressed less concern in Y2 than in Y1 about upsetting patients and harming existing customer relationships when providing naloxone and offering it directly. Different from Y1 FGs, where some pharmacists articulated a resistance to direct provision of naloxone in the pharmacy and a preference for medical prescribers to do this, the Y2 FGs indicated a tendency for pharmacists to see themselves as part of a ‘team’ with medical providers in naloxone provision. As one MA pharmacist put it: “I’ll do my part, but they had to do theirs [co-prescribing naloxone].” – MA, Pharmacist

Y2 emergent theme: Naloxone co-prescription

The emphasis on the prescriber’s role from the perspective of the pharmacist was further highlighted in the FGs when discussing naloxone co-prescribing for patients taking high risk medications like high opioid doses or opioid-benzodiazepine combinations. The pharmacists believed it was essential to collaborate with the medical providers to support and promote naloxone distribution, thereby ensuring the best treatment, and safety. One pharmacist captured this sentiment well, saying:

“We need to work together, we need to work as a team…I think if doctors and pharmacists and nurses, like the healthcare professionals who all deal with the patients, we all have the same mindset and we all see these things and work like, as soon as a doctor writes up prescription he invites the conversation at the office. And that conversation gets carried to the pharmacy, it becomes less threatening” – MA, Pharmacist

A consistent, partnered approach to naloxone provision could ease the discomfort that some patients with chronic pain still felt regarding obtaining naloxone, where recommendations of their prescriber echo those from the pharmacy counter:

Participant 1: “Yeah, but if it’s not coming from my doctor, I’m still going to say no [if offered at the pharmacy]”

Participant 2: “I wouldn’t either. If it’s not from my doctor then I wouldn’t feel comfortable…” – RI, Pain Patients

Of note, these spontaneous discussions or suggestions regarding clinical and pharmacy provider collaborations did not emerge with regards to patients who use illicit drugs, nor did they extend to include caregivers of people consuming opioids.

Y2 emergent theme: Fentanyl motivating obtaining pharmacy naloxone

In Y2, awareness of fentanyl emerged as a motivator to obtaining naloxone at the pharmacy for opioid consumers and caregivers, though pharmacists were less knowledgeable of this shift in overdose trends. In neither focus group did pharmacists spontaneously discuss illicitly manufactured fentanyl. Instead, pharmacists in both states were more apt to discuss measures to address problems with prescribed fentanyl medications (e.g., “we now have like a hard stop at the register before we can sell fentanyl”) than use of illicitly manufactured fentanyl and thus did not identify fentanyl as a motivating factor for pharmacy naloxone provision, even with prompting by the moderator in the interview guide. For example, one pharmacist from Massachusetts summarized:

Fentanyl has been provided, you know, commercially-available for us to dispense in the patches and all that- it’s always been pretty much going- but, like you [moderator] said, I think it’s [illicitly manufactured fentanyl] on the streets, it’s happening more. So it’s heartbreaking because it’s definitely killing a lot more people but I don’t think it’ll make much of a difference on our end.

However, the FGs with chronic pain patients, caregivers, and, especially, people who use drugs viewed fentanyl in the illicit drug supply as a key driving force for getting naloxone in the community, including the pharmacy. For the non-pharmacist groups, discussion of fentanyl occurred without prompting and early in the focus group session.

One FG with younger participants shared how fentanyl’s presence influenced the availability and proximity of naloxone in their social networks, as shared in this group discussion:

Participant 1: I always have it. My mom has one and I have one.

Participant 2: My family has – my father has it.

Participant 1: Friends know I have it, so that if they have a situation and I’m around; and they’ve called me and asked me. And I’ve saved lives that way.

Participant 2: I keep one next to my bed even just in case…

Participant 3: I think a few years back, was like, didn’t have access to it. Maybe even just a year ago” – MA, Illicit use/recovery groups

Patients with chronic pain, too, identified the need for more available naloxone due to fentanyl:

Moderator: Do you think it [fentanyl] changes how people think about Narcan? About naloxone. About having it around.

Participant 1: They need it more. They need it more and more. “– MA, Pain Patients

While it was unknown where the majority of FG participants and their family and friends had obtained naloxone in Y1 or Y2, the pharmacy was a source discussed by many Y2 FGs members. For them, the fear of fentanyl may have motivated getting naloxone at the pharmacy, as this discussion between several participants in the FG with people who use drugs illustrated:

“Moderator: “What motivated you to go [to the pharmacy for naloxone] when you saw the information?”

Participant 1: “Because I was afraid with the… what is it called, Participant 2?”

Participant 2: “What is it?”

Participant 3: “The Fentanyl?”

Participant 2: “Fentanyl”

Participant 1: “Yeah, I was afraid with the Fentanyl” – RI, Illicit use/recovery group

Part 2: Reactions to Practice-based solutions

Feedback on the patient-facing materials designed for use at the pharmacy gave insight into ways to better educate patients, reduce stigma, and improve the logistics of accessing pharmacy naloxone.

Figure 1 depicts the proposed practice-based solutions for addressing some of the barriers to naloxone in the pharmacy identified in Y1 FGs. The creation of these materials was motivated by the clear need for stigma reduction, so that, in the words of one pharmacist participant, “[naloxone at the pharmacy] becomes more of a transaction, so the people who are less likely to come ask for it are more willing.”

Figure 1:

Developed materials tested in Year Two focus groups (found at prevent-protect.org)

Display pad

The display pad (Figure 1a) received a positive reaction from all Y2 FGs. These foam-board backed tear-offs allow for increased privacy and alleviate patients and caregivers having to ask aloud for naloxone, which both saved time for the pharmacy team and reduced the shame of verbalizing the ask:

“I like that it says ‘To get naloxone, present this to the pharmacy staff’, because it takes away the need for them to come explain themselves and a lot of them feel the need to explain some long, involved story with a million pieces of information that really make no difference in the scenario. Like, it’s a great conversation but they could just as easily hand this to me and not have to tell me any embarrassing details, not have to tell me that it’s their sister, brother, wife, mom… it would be much more anonymous.” – MA, Pharmacist

It is important to note that while the display pads can affirm and provide discretion for those seeking naloxone, it also serves those that are “desperate” and in need of naloxone regardless of the stigma:

“Caregiver 1: If somebody really, really feels they need naloxone they’re gonna do whatever to do it. I mean, screw the stigma, excuse me, but you know, I mean some people, when they get to that point, they’re gonna go in and they’re gonna say, I don’t care what people think, you know, I’m desperate.

Caregiver 2: But we’re trying to encourage people who aren’t desperate

Caregiver 1: [overlap] but that’s where I was going to go after that. But you know, then we have to reach out to the people that, you know, have the blinders up and, you know, that kind of stuff…”

Naloxone sticker

The sticker, designed for placement on the packaging for nonprescription syringe sales (Figure 1b), received a positive response from FGs in both states with illicit use groups and those in recovery. They liked that the stickers spoke—silently but directly—to people who use drugs, pointing out the awareness-raising intent, but also suggesting the opportunity created by the sticker, for additional conversation at the pharmacy counter:

Moderator: So, if you go, and this was on it [shows the sticker]. What would you do? What would you think?

Participant 1: Now I know. Now I know it’s available.

Participant 2: If I need it, then I’m going to ask for it.

Participant 3: And now we know it’s at the pharmacy. Like he said.

Participant 1: I think more people might be more tempted to ask a question, if you don’t know. --MA, Illicit use/recovery group

Pharmacists, too, saw the stickers, when placed on the packages of non-prescription syringes, could be helpful by “giv[ing] them more room to discuss”:

“I think that’s like, a really cost-effective way to really increase awareness of naloxone availability because some patients might not know, and then it’s kind of like advertisement almost, where they might be buying syringes currently, like, every single week from you, and if they just keep seeing that sticker then it just sticks to them and then the next time they might have the initiative from themselves to ask for naloxone.” – MA, Pharmacist

Multiple FGs wrestled with the concern that people who do not inject drugs who also buy syringes at the pharmacy might be offended by receipt of the sticker, but all converged upon a consensus sentiment, articulated best by one participant: “Who cares if they’re upset? Who cares? If it saves a life, who cares?” – RI, Illicit use/recovery group

Posters

The most discussed posters were those entitled ‘breathe easy’, ‘step up’, ‘monsters’, and ‘pediatric poison’, each designed to reach different populations affected by the opioid crisis and urge them to get naloxone (Table 2). While the effectiveness of the posters had yet to be tested in public or in the pharmacy at the time of the FG, the participants overall thought highly of many of the posters and provided rich input. The positive, and negative, responses were beneficial in determining the accessibility, tone, intended messaging audience, and ideal location for each poster. Subsequently, one large retail chain pharmacy selected the ‘step up’ poster for placement in all of their pharmacies in Massachusetts and Rhode Island; the Rhode Island Department of Health selected both the ‘pediatric poison’ and ‘monsters’ posters for their public service announcements and printed them for all pharmacies in the state; and the Massachusetts Department of Public Health adapted another winning poster (not shown here) for their public awareness campaign encouraging people to obtain naloxone at the pharmacy.

Table 2:

Responses to Posters tested during Year Two Focus Groups

	a. Breathe easy	a. Step up	c. Monsters	d. Pediatric poison
Positive	“Yeah, ‘cause it’s telling you just not, heroin users. It could be anyone. That part of the… I like that.” – MA, Chronic Pain Patient group	“That [poster] says what I said earlier, opiate overdose can happen to anyone, anywhere, anytime… I think everybody and their mamma should have it, Narcan…” – MA, Illicit use/recovery group	“Well, in view of the fact that that is how my son started with a friend in a medicine cabinet… To me any parent would stop in their tracks. And if they hadn’t thought about it, they’d be like, wow, that’s true.”– RI, Caregiver group	Participant 1: Really gets the message. It’s really in your face versus something else when it’s a child…Very relatable.” – MA, Pharmacist group
Negative	Participant 1: … Too many words Participant 2: Too much information Participant 1: Too much information – MA, Chronic Pain Patient group	Participant 1: Not at all… it might confuse a lot of people. Participant 2: Unless you already know what it is… – RI, Chronic Pain Patient group	Participant 1: It’s too stigmatized. Participant 2: It doesn’t catch me at all. – RI, Caregiver group	“I think that it’s kind of misleading because I have trouble taking the top off of my bottles, so to have the pain medicine, and a child could take the top off? To me, I think it’s kind of misleading, but then it gets the point across.” – RI, Chronic Pain Patient group
Likely Target Audience	Young people People who use pain medications “I think that this one might go for, like, younger kids in college or something, you know” – MA, Illicit use/recovery group	People who use drugs People knowledgeable about naloxone Parents/grandparents/caregivers “Parents, kids’ parents.” – RI, Illicit use/recovery group	Parents/grandparents/caregivers “I do like it for parents.” – MA, Pharmacist group	Parents/grandparents/caregivers “Or a grandparent, you know, for me if you’re a grandparent you’re like, oh, my God, I’m picking up my monthly Percocet’s… that would prompt me as a grandparent to be like, what is Naloxone, can I get one of those?” – RI, Pharmacist group
Ideal Location	Healthcare settings Colleges, venues where young people congregate Targeted online advertisements for demographic Participant 1: But I think this one could go in a doctor’s office. Participant 2: Doctors office. That’s a doctor’s office. – MA, Caregiver group	Any location, public or private Participant 1: Everywhere. Participant 2: In a…bar. Buses, schools. Participant 3: Doctor’s offices, pharmacies – MA, Caregiver group	Healthcare settings Venues where parents/grandparents congregate Targeted online advertisements for demographic Participant 1: Pediatrician Offices. Participant 2: YMCAs, pediatrician offices, where you’re going to have parents, day cares. – MA, Pharmacist group	Healthcare settings Venues where parents/grandparents congregate Targeted online advertisements for demographic “I think this is a good thing to hang in the pharmacy because people are like hanging around like waiting…” – RI, Pharmacist group

RI=Rhode Island

MA=Massachusetts

Discussion

The results from the focus groups suggest that a “tipping point” has been reached with respect to naloxone availability in our study states. Emergent themes in Y2 indicated that, for people who use drugs, the fear of fentanyl is beginning to surpass the fear of future consequences and perceived stigma in obtaining naloxone at a pharmacy. Although some people who use drugs and chronic pain patients prescribed opioid medication expressed concerns of stigma from pharmacists, fear of fentanyl and opioid overdose served as a motivating force to obtain naloxone from the pharmacy. For pharmacists in Y2, direct experience with dispensing naloxone increased their comfort levels in talking about, offering and counseling on naloxone. Pharmacists reported more nuance in understanding the naloxone transaction, noting patient concerns instead of worrying about patients’ reactions to being offered naloxone. Other states may be experiencing similar shifts (21), and may benefit from further qualitative study.

Still, the persistent concerns from patients and pharmacists about fear of future consequences are not unfounded. Recent actions of several life insurance companies to deny coverage to applicants with no documented substance use disorder, based on their obtaining naloxone to administer in the case of witnessing an overdose (22), indicate the depth of misinformation surrounding naloxone and the lack of parity for behavioral health conditions. While these life insurance denials have since been dismissed and two states, Rhode Island and New York, have passed laws forbidding such naloxone-based denial reoccurrence, there remains a clear need for pharmacists to reassure patients of the confidentiality of their protected health information and to be knowledgeable of alternative, nearby community-based sources for anonymous naloxone.

Nearly all states in the country have a naloxone access law to legally permit naloxone distribution through pharmacies (2), and their expansion creates a pathway for practice norms to be adopted and refined. In Y2 findings, another emerging theme is the tendency of some pharmacists to adopt a more comprehensive medical model, envisioning naloxone as part of a broader set of clinician-pharmacist partnered healthcare interventions, and emphasizing the importance of co-prescription, not just co-dispensing. More explicit involvement of pharmacy technicians in naloxone provision or boosting technician trainings on the subject were raised in Y2 focus groups. Recent research suggests high willingness and capacity for technician involvement in naloxone provision at pharmacies (23). Another practice shift raised in the Y2 focus groups was the possibility of more explicitly involving pharmacy technicians in naloxone provision, as well as the current need for technician training. The pharmacist’s reflections may help explain how states with naloxone co-prescription laws are evolving and achieving lower community opioid-related harm (24).

Seven states have new laws and regulations requiring prescribers to co-prescribe naloxone when writing a prescription for opioids to people who may be at risk of overdose, and the FDA recommends naloxone co-prescription with opioids along with labeling changes to encourage co-prescription. While results from our Y2 focus groups suggest the importance of co-prescription, the emphasis on this mechanism of distribution appears to offer another kind of barrier, by overlooking people who use drugs who may benefit from pharmacist offers of naloxone. Considering ways to address pharmacists’ discomfort with dispensing naloxone in the absence of a co-prescription encounter will be critical to increasing distribution of naloxone to all people at risk of overdose.

Our preliminary, Y1 work helped inform the creation of several practice-based solutions, all proposed specifically to increase pharmacy naloxone uptake and reduce stigma for the potential consumer. Intentionally designing consumer outreach pharmacy materials where stigma and the concerns of chronic pain patients, caregivers, and people who use drugs are centrally considered stands to benefit all. This approach of user experience-driven, patient-centered, community participatory research is critical to effectively reach vulnerable populations about naloxone. Moreover, such an approach is common in HIV prevention (25, 26), sexual health (27), disability design (28), and novel safer injection interventions (29) like consumption spaces. Future work should rigorously test the inclusion of patient education and consumer outreach materials at the pharmacy counter, and if and how they can expand harm reduction services at the pharmacy.

Limitations

Focus group participants were not randomly selected but recruited purposefully from clinics, the study pharmacies, and community-based organizations. Consequently, respondents are not representative of all populations of people who use drugs or who are in recovery, patients living with chronic pain, caregivers of people who use opioids, or pharmacists practicing in Massachusetts and Rhode Island. While all data analysis can be subject to error, several measures were undertaken to assure trust in the analysis and our findings. Specifically, the analysis team was comprised of four experienced qualitative researchers and seven research staff who were trained to analyze qualitative data. Moreover, focus group guides were developed in an iterative process and reviewed after each group by co-investigators to ensure fidelity to emerging theory, and core questions, such as the scenarios and prototypes, were held constant across all groups to ensure confirmation of previous responses. In addition, focus group facilitators were observed by at least one co-investigator and process notes were written after each focus group noting any issues with the group. Finally, analysis was conducted by multiple well-trained investigators, and discussions between investigators resolved differences in interpretation and coding. Taken together, these measures bolster our confidence and trust in the dependability of the results.

Conclusion

Experiences dispensing naloxone are quickly evolving, and a greater diversity of patients are obtaining naloxone from the pharmacy. Persistent stigma-related concerns about getting naloxone underscore the need for tools to help pharmacists consistently and thoughtfully offer naloxone, facilitate non-judgmental patient naloxone requests, and provide reassurance to patients that getting naloxone is safe, without consequence, and good public health. Several practical, pharmacy-based resources and patient outreach materials can be designed to improve naloxone uptake and warrant further study.

Key points.

Background

1. Laws permitting pharmacy-based access to the opioid overdose antidote naloxone have spread quickly across the United States, but barriers like stigma associated with addiction hinder widespread uptake of the medication by consumers.

2. Our prior work identified several themes influencing naloxone uptake in pharmacies as well as possible approaches and educational materials to addressing them.

Findings

1. Pharmacists, opioid consumers (individuals using illicit opioids and patients with chronic pain prescribed opioids) and their caregivers continue to struggle with fear of negative consequences of getting naloxone at the pharmacy and the stigma of addiction, however, access and availability of naloxone are rapidly improving.

2. Compared to one year prior, focus group participant pharmacists in Massachusetts and Rhode Island articulated refinements in practice such as a more collaborative clinical and pharmacy provider partnered approach to naloxone provision, including co-prescription of naloxone for high risk opioid doses or medication combinations, but they struggled to reach patients at highest overdose risk: people who use illicit drugs.

3. Materials were designed to help encourage asking for naloxone at the pharmacy, increase the likelihood of accepting a pharmacist-initiated offer of naloxone, reduce the stigma of naloxone, and were well-received by pharmacists, opioid consumers, and their caregivers.