Abstract
Opioid-related overdose continues to be a significant contributor to mortality in the U.S. with over 80,000 opioid-related overdoses reported in 2021. Naloxone is available for layperson use; however, naloxone use in the community could be increased to save additional lives.
Participants were invited to participate in a survey-based study to assess potential barriers in obtaining naloxone. Candidates with prior professional training with naloxone were omitted. Questions evaluated potential barriers in obtaining or administering naloxone, particularly from a legal standpoint.
A total of 126 surveys were included in this study. Comparisons were completed to see how past and current experiences affect an individual’s ability to correctly identify how to obtain or use naloxone for an opioid overdose. In the comparison between participants with previous naloxone education (15.9%) versus no previous naloxone education (84.1%), those who had completed previous naloxone education were significantly more likely to be able to correctly identify how to obtain naloxone. Comparison between those who use or know someone who uses opioids (38%) versus those who do not (62%) found a significant difference between groups for only one question asking if anyone can obtain naloxone regardless of if they personally know someone who uses opioids.
More widespread and easily accessible education for laypersons may increase their willingness to obtain naloxone. There should be enhanced efforts to increase education among individuals who use or know someone who uses opioids.
Background
People dependent on opioids, especially those with reduced tolerance to opioids, are at the greatest risk of suffering an opioid overdose.1 Many other groups have an increased risk of overdosing on opioids including those who inject opioids, those who were prescribed high doses of opioids (greater than 50 milliequivalents of morphine), those with reduced clearance of opioids, those who use opioids in combination with other sedating substances and those who live with people in possession of opioids.1 Making naloxone readily available to laypersons in the community, including friends and family members of people taking opioids, allows for faster administration, which increases a victim’s chances of survival and minimizes the damage to their vital organs.1 Naloxone should be administered whenever opioid overdose is suspected, as naloxone administration is safe even if opioid overdose has not occurred.1,2
Naloxone has become more readily available to laypersons in the U.S. through various legislative advances. In California, a layperson can obtain naloxone from a pharmacist without a prescription, provided the dispensing pharmacist has completed the necessary training required by the California Board of Pharmacy.3 Every state has enacted similar laws allowing laypersons to obtain naloxone without a prescription, provided that certain conditions are met.4,5 In addition, all 50 states and the District of Columbia have enacted some form of the Good Samaritan law, which protects the person calling for emergency assistance from low-level drug offenses, such as use or possession for personal use of illicit drugs.6 Despite these legislative advances, drug overdose deaths continue to remain high. Drug overdose deaths rose from 2020 to 2021 with 106,699 drug overdose deaths reported in 2021 (most current data available).7 In the U.S., 68,630 people died in 2020 and 80,411 people died in 2021 specifically from an opioid-related overdose.7 Synthetic opioids (other than methadone) are currently the main driver of drug overdose deaths with 87.8% of opioid-involved overdose deaths involving synthetic opioids.7 Deaths involving synthetic opioids increased over 56% between 2019-2020 and are suspected to be driven by illicitly manufactured fentanyl, including fentanyl analogs.8 Though naloxone is readily available, many Americans still do not receive timely care during opioid overdose.
Most previously completed research has not addressed the layperson’s perspective regarding barriers to obtaining naloxone. Instead, this research primarily addresses the perspectives of health care professionals, emergency personnel, police officers and other related professionals.9-11 One study identified addressed patients’ perspectives on overdose education, naloxone distribution programs and naloxone itself.12 This study used four focus groups consisting of 21 patients chosen from a Veterans Affairs residential facility in California.12 Several barriers to obtaining and using naloxone were identified, including legal and ethical concerns, the need for more education on using naloxone and the uncertainty of naloxone adverse effects.12 The study was limited by the small study size and population including only patients in the Veterans Affairs system. In this system, treatment, insurance, affordability and policies for obtaining medications are often different compared with the general population. Another study, involving 66 people who inject drugs in the Skid Row area of Los Angeles, assessed participant understanding after a one-hour class related to opioid overdose and response.13 This study was limited by the small study size and did not address barriers in obtaining naloxone. Another limitation of this study was that it took place before naloxone became available to laypersons without a prescription and before the Good Samaritan law. The final study involved 10 people who formerly or currently used drugs at the time of the study from six different sites within the U.S.14 The participants were given a brief survey to address their naloxone and opioid overdose knowledge.14 One advantage of this study is it involved participants from multiple programs across the U.S. However, it was also limited by its small study size and did not address specific barriers to laypersons obtaining naloxone.
Opioid overdoses are on the rise in the U.S., with synthetic opioid-related overdose becoming increasingly common.15 As a result, many legislative advances have offered protection to bystanders seeking help for an overdose and have made it easier for laypersons to obtain naloxone. Additionally, it is crucial to identify and address barriers to laypersons acquiring and administering naloxone, as family, friends and bystanders can potentially administer naloxone much sooner and prevent permanent organ damage and death.
Objectives
The objectives of this study were to identify layperson knowledge and perspectives regarding barriers to obtaining naloxone and to compare differences in responses based on demographic measures, prior naloxone training and current personal, relative and/or close friend use of opioids.
Methods
Survey Design
Researchers at California Northstate University College of Pharmacy developed a survey to assess laypersons’ perceptions of barriers to obtaining and administering naloxone for the prevention of opioid overdose-related deaths. This study was approved by the California Northstate University Institutional Review Board. The Standards for Reporting Qualitative Research (SRQR) guidelines were followed to ensure quality research.16
Participants
Recruitment and consent was done in person at two health fairs in Cloverdale and Elk Grove, California, and additionally through a shareable survey link on social media. Survey participation was voluntary, and participants provided consent prior to participating in the study. Participants did not receive any incentives to participate in the survey.
Participants were excluded if they were less than 18 years old or did not currently live in the U.S. Participant responses were also excluded if they answered “yes” to being a health care professional because this study aimed to determine barriers from a layperson’s perspective.
Assessments
The survey consisted of 25 questions, with two collecting consent to participate, six collecting demographics (Table 1) and three assessing if the person was a health care professional, was currently prescribed or knows someone prescribed an opioid or had any prior naloxone training. Though the details of participants’ previous naloxone training were not collected, this could have included anyone trained when picking up a prescription for naloxone at a pharmacy, provided education from a physician or other health care provider or trained through part of a basic life support course taught at a place of employment or volunteer organization. The remaining questions evaluated potential barriers to obtaining or administering naloxone such as cost, lack of awareness of where or how it can be obtained, pharmacist’s refusal to fill naloxone, worries about being stigmatized for obtaining naloxone, lack of training on naloxone use and worries about legal implications of administering naloxone (Table 2). At the end of the survey, a free response question was asked: “What are some additional barriers that might still keep you from obtaining naloxone from a pharmacist or administering naloxone in the unfortunate case of an opioid overdose?”
Data Analysis
Primary objectives were to identify layperson knowledge and perspectives regarding barriers to obtaining or administering naloxone and to compare differences in responses based on demographic measures, prior naloxone training and current personal, relative and/or close friend use of opioids.
Descriptive analysis and qualitative analysis were completed. Each of the 14 questions assessing knowledge of naloxone and barriers to obtaining or administering naloxone were compared based on responses to the following: demographics, prior naloxone training and if the person was prescribed opioids or knows someone who takes opioids. Categorical variables were assessed using Pearson’s chi-squared test, and Fisher’s exact test, when appropriate. The alpha level was set at 0.05.
Incomplete submissions of respondents were conducted utilizing listwise deletion, omitting responses with missing data and analyzing only the remaining data. Listwise deletion is commonly utilized as a data preprocessing method when missing data is present.
Text mining methods were used to analyze the comments of the free-response question (Figure 1). All free responses that were left blank were removed from the analysis, and all English stop words such as “the,” “a,” “an,” etc. were removed as those words did not contribute to the meaning of the response themes. A program script was written in R language to analyze the text and extract the main themes of the responses (positive versus negative knowledge, Figure 2A). In addition, a word cloud of the free responses was then produced (Figure 2B).
Results
Of the 160 study participants, 126 responses were evaluated after excluding health care professionals because they would not likely offer a true representation of a layperson’s perspective. Most participants were female (71.9%), white (82.5%) and had high school diplomas or equivalent (i.e., General Education Development test or GED) (98.8%) (Table 1).
Analysis was completed for the 14 questions assessing knowledge of naloxone and barriers to obtaining or administering naloxone (Table 2). There were no statistical differences for the demographic characteristics except for responses based on the state the participant lived in at the time of questionnaire completion; therefore, only data for the responses based on the state of residence are included. A majority of survey participants (n = 105) claimed residence in California, Indiana, and Massachusetts. Due to a low number of participants from other states (n = 21), responses from those states outside California, Indiana and Massachusetts were not included in the state of residence comparison.
Comparison of Participants With Previous Naloxone Education Versus No Previous Naloxone Education
A total of 20 (15.9%) of the respondents previously had naloxone training or education. For the comparison of participants with previous naloxone training versus no previous naloxone training (column one in Table 2), there was a statistical difference between groups for the following questions:
If you are not prescribed an opioid (by a doctor, nurse practitioner or physician assistant), would you still be able to buy naloxone (p = 0.002; 45%)?
Can a person buy naloxone if it will be used for someone else (for example, can a friend or family member buy naloxone for someone they worry may overdose on an opioid) (p = 0.018; 50%)?
Can you buy naloxone without a prescription (p < 0.001; 60%)?
Can a person with no known friends or family members who use opioids buy naloxone just in case they come across someone who may have overdosed (p < 0.001; 55%)?
Can you buy naloxone from a pharmacy without your doctor knowing (p < 0.001; 50%)?
Are you familiar with the Good Samaritan law in your state which may protect those who administer naloxone to others (p < 0.001; 75%)?
Are there programs available to help cover the costs of naloxone if you do not have insurance or your insurance does not cover naloxone (p < 0.001; 55%)
For each of these seven questions above, participants with no previous naloxone training were more likely to select “unsure” or “no” for the question, while a majority of participants with previous naloxone training were able to accurately select “yes” for each of the seven questions.
For each of the three following questions, a majority of participants in both groups selected “no;” however, there was still a statistical difference between the groups:
Does your insurance cover naloxone (p = 0.001; 55%)?
Have you seen an advertisement anywhere in your community or on TV or social media educating you about naloxone (p = 0.002)?
Are you worried about buying or administering naloxone to another person for legal reasons (p = 0.025)?
On the questions regarding naloxone insurance coverage and advertisements, more participants in the group with previous naloxone training chose “yes;” however, for the question about being worried about the legal implications, more participants without prior naloxone training chose “yes.”
Comparison of Participants With Current Personal Use of Opioid or Knowing Someone Taking Opioid Versus No Personal Use or Knowledge of Personal Contact With Someone Taking Opioids
A total of 48 participants (38%) reported current use of opioids or knowing someone who was taking opioids. Only one question showed statistical significance between groups for this comparison: Can a person with no known friends or family members who use opioids buy naloxone just in case they come across someone who may have overdosed (p=0.034)? A majority of the responses for both groups were “unsure,” however, more participants in the group taking opioids or knowing someone taking opioids selected “no” (8.3% versus 0%, respectively).
Comparison Among States
For the state comparisons, 105 responses were included in the analysis, including 63 (60%) in California, 19 (18%) in Indiana and 23 (22%) in Massachusetts. Four of the 14 questions had statistically significant differences between groups including the following:
If you are not prescribed an opioid (by a doctor, nurse practitioner or physician assistant), would you still be able to buy naloxone? (p = 0.005) in which more participants from Indiana (21.1%) and Massachusetts (34.8%) were likely to choose “yes” compared to only 6.3% in California while the majority for all three states chose “unsure.”
Can a person buy naloxone if it will be used for someone else (for example, can a friend or family member buy naloxone for someone they worry may overdose on an opioid) (p = 0.002)? in which over half of participants (56.5%) in Massachusetts chose “yes” while only 26.3% in Indiana and 17.5% in California chose “yes.”
Can you buy naloxone without a prescription (p = 0.025)? in which more participants in Massachusetts (34.8%) chose “yes” and more participants (36.8%) in Indiana chose “no” while the majority for all three states chose “unsure.”
Are you embarrassed to ask your pharmacist or doctor about how to get a prescription for naloxone (p = 0.045)? in which only Indiana had 100% responses for “no”
Are you worried about buying or administering naloxone to another person for legal reasons? (p = 0.010) in which the majority of participants in Indiana (63.2%) chose “yes” while the majority in Massachusetts (52.2%) and California (73%) chose “no.”
Free Response
For the free-response text analysis, investigators asked: “What are some additional barriers that might still keep you from obtaining naloxone from a pharmacist or administering naloxone in the unfortunate case of an opioid overdose?” Investigators counted the word frequency of the survey data shown in Figure 1. The word “unsure” was the most commonly used, followed by “lack,” “stigma,” and “fear.” This can be interpreted that most of the participants lack knowledge on how to obtain and administer naloxone and fear of stigma when trying to obtain naloxone.
Figure 2 shows the contrast of frequencies among negative words (lack of knowledge) versus positive words (has knowledge) of the survey responses. It shows a dominant-negative trend of the responses (lack of knowledge) in obtaining and administering naloxone of participants. The word cloud of the survey responses illustrated in Figure 2B displays the word “unsure” located in the middle of the cloud. This implies that most of the participants lacked the knowledge of obtaining and administering naloxone which is consistent with the word frequency data in Figure 1.
To gain more insight, investigators further re-encoded the comments using different categories to understand how participants obtained and administered naloxone. For example, the response “How to use?” is labeled as “lack of knowledge” while “Price” is labeled as “Cost,” and so on. The encoding process is manually implemented and checked by the investigators. Figure 3 shows the number of responses in percentages in the different categories. As illustrated, the “lack of knowledge” category accounted for about 50% of the responses followed by “cost” as key barriers in obtaining and administering naloxone. Participants indicating sufficient knowledge accounted for only about 11.4% of the responses. It was also identified that “stigma,” “legal issue” and “safety” are also barriers preventing participants from obtaining and administering naloxone.
Discussion
This study examined the layperson perspective on obtaining naloxone. In the three states where data were primarily obtained, there was a state protocol for pharmacists to dispense naloxone without a physician’s prescription when survey responses were collected.
Within the study data, it was found that the most significant potential barriers to obtaining naloxone included lack of knowledge and training, cost, legal issues, stigma and safety. Interestingly, despite the opioid epidemic in the United States and increased accessibility to naloxone, only 15.9% of participants had previous naloxone training or education. The majority of those with previous naloxone training answered many of the questions that pertained to obtaining naloxone correctly. This included answering “yes” to the survey questions in the above section “Comparison of Participants With Previous Naloxone Education Versus No Previous Naloxone Education.” Additionally, those who have had previous naloxone training answered favorably, answered “no,” to survey questions 6, 7 and 10 in Table 2, indicating they are not embarrassed or worried about the legal implications of obtaining or administering naloxone.
Within the comparison between those with and without previous naloxone training, there was statistical difference between groups for questions 1, 2, 3, 8, 9, 10, 11, 12, 13 and 14. For these questions, those participants without previous naloxone training were much more likely to select “no” or “unsure” indicating that they were not as aware of how to obtain naloxone. This analysis reveals that those with prior training are more aware of how to obtain naloxone and of the laws that protect them in situations where naloxone might have to be used. Additionally, many of those with previous naloxone training have overcome the barriers of stigma associated with obtaining naloxone.
Within the comparison between those who know someone who uses opioids or they themselves use opioids compared to those who do not, survey results showed there was little difference between groups. The majority of responses in both groups showed “unsure” for most survey questions with regard to barriers on obtaining naloxone including buying naloxone without a provider’s prescription, buying naloxone for use on someone other than themselves, buying naloxone without their doctor knowing, questions about buying naloxone from a pharmacy, knowing if their insurance covers the cost of naloxone and regarding programs available to help cover the cost of naloxone (Table 2). It is concerning that those who are closest to those using opioids or using opioids themselves are unaware of how to obtain naloxone.
For the comparison between states, questions 1, 2, 3, 6 and 10 showed statistical differences between groups; however, a large majority of participants indicated “unsure” for questions 1, 2, 3 and 6. For question 10, which aimed to asses participants’ concerns about buying or administering naloxone to another person due to legal reasons, a majority of participants from Indiana indicated they were concerned while a majority from California and Massachusetts indicated they were not concerned. This implies that better education is needed in Indiana about the Good Samaritan laws that protect an individual who has chosen to administer naloxone to someone in need.
As a general overview, a majority of responders indicated they had not seen an advertisement anywhere in their community, on TV or on social media educating about naloxone. This was an unanticipated low number. More advertisements and education in the layperson community on how to obtain naloxone and prevent opioid overdose could decrease stigma and thus increase laypersons’ abilities to obtain naloxone.
Conversely, it was encouraging to see that access through pharmacists was not a significant barrier. Of the 29 participants who had previously tried to buy naloxone from a pharmacy, only one participant indicated they were told the pharmacist was not able to provide the naloxone (for example, they do not carry this medication or it was out of stock). Additionally, when asked if a pharmacist had ever refused to provide the naloxone, there were no responses that indicated “yes.” It was also encouraging that 111 participants indicated “no” and only 15 participants indicated “yes” to the question asking if they were embarrassed to ask their pharmacist or doctor about how to get a prescription for naloxone.
To our knowledge, this is the first study investigating barriers to accessing naloxone in the layperson population. These results shed some light on the barriers that prevent laypersons from obtaining naloxone including lack of knowledge, cost, legal implications, stigma and safety concerns. There is a scarcity of research that identifies the perspectives of laypersons on naloxone. The studies discussed previously survey laypersons after naloxone education; however, they do not discuss how to obtain naloxone in the community from a prescription source, which is the focus of our study. More studies should be done to validate these results. Of note, naloxone nasal spray has been approved for OTC use since the completion of this study. Despite decreased barriers to access with the recent OTC status, we suspect laypersons may still face barriers to accessing naloxone including simply just being aware that it will now be available OTC and barriers with cost if insurance does not cover OTC medication. Once naloxone becomes readily available OTC, it will be pertinent to conduct future studies to observe the impact to laypersons. This research could help health care professionals, public health administrators and policymakers identify knowledge gaps of laypersons in obtaining naloxone. This could be useful in their design of future education programs and public service announcements.
Limitations
Some potential limitations of this study include the small sample size and having a majority of surveyed participants from only three states in the United States. A larger sample size would help to ensure that the data were representative of populations in other states or countries. Because individual state health departments have contributed to naloxone education, it is pertinent to identify possible state-dependent barriers to adequately target the right population in each state. Additionally, due to this study being self-reported data, we know that there may be a source of data bias.
Conclusions
With the increasing frequency of fentanyl-laced illicit substances, the opioid epidemic is not expected to be resolved in the near future and there could be an increase in overdose deaths among people who use drugs, such as in people who use opioids, stimulants or benzodiazepines that are laced with fentanyl. Individuals who have completed naloxone education are more likely to understand how to obtain and administer naloxone, thus more outreach and training needs to be done within our communities. Better education and understanding of barriers with obtaining and administering naloxone from a layperson perspective could decrease stigma and increase access to this life-saving medication. In particular, there should be more efforts to increase education among individuals who use or know someone who uses opioids. Community outreach training events and advertisements can be tailored to focus on these identified barriers, such as educating about where people can obtain naloxone, that they can obtain naloxone even if they do not take opioids themselves and on state laws that protect those who administer naloxone to those who have overdosed. As you desensitize and educate the community about the risk of opioid overdose, even for those without a substance use disorder, this may decrease the stigma associated with opioid use and increase the use of naloxone, possibly leading to more lives being saved.
References
The authors declare no relevant conflicts of interest or financial relationships. Erika Titus-Lay was awarded a small grant from ASHP and honoraria for the BCPP Review Book chapter on Substance Use Disorders, both of which were awarded after completion of this research project. Jennifer Courtney was awarded a small grant from the Team Based Learning Collaborative (TBLC) which was awarded after completion of this research project
Credit author statement: Jennifer Courtney: conceptualization, methodology, writing - original draft; Amy Ferrarotti: investigation, resources, data curation, writing - original draft; Tuan Tran: formal analysis, data curation, writing - original draft; and Erika Titus-Lay: conceptualization, methodology, formal analysis, resources, writing - original draft, supervision, funding acquisition
Funding: Internal seed grant from the California Northstate University College of Pharmacy.