- Email: [email protected]
Availability of Naloxone in Pharmacies and Knowledge of Pharmacy Staff Regarding Dispensing Naloxone to Younger Adolescents
Journal of Adolescent Health xxx (2019) 1e4
www.jahonline.org Adolescent health brief
Availability of Naloxone in Pharmacies and Knowledge of Pharmacy Staff Regarding Dispensing Naloxone to Younger Adolescents David E. Jimenez a, Miriam R. Singer a, and Andrew Adesman, M.D. a, b, * a b
Division of Developmental and Behavioral Pediatrics, Steven and Alexandra Cohen Children’s Medical Center of New York, Lake Success, New York Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York
Article history: Received April 19, 2019; Accepted July 18, 2019 Keywords: Naloxone; Opioid crisis; Standing order; Narcan; Minors; Overdose prevention; Public health
A B S T R A C T
Purpose: This study assessed the immediate availability of naloxone in pharmacies and the knowledge of pharmacy staff regarding naloxone dispensing protocols, especially as it relates to younger adolescents. Methods: The primary sample included pharmacies in the 10 states with the highest number of opioid-related overdose deaths in 2016; in addition, pharmacies in the 2 states with the highest prevalence of opioid-related overdose deaths in 2016 were also contacted. Researchers simulated a routine conversation between pharmacy staff and a potential customer about the immediate availability of and requirements to purchase naloxone. Results: The primary sample included 120 pharmacies (82.5% chain pharmacies; 50.8% rural). The majority (80.3%) had at least one form of naloxone in stock. Pharmacy staff were knowledgeable about prescription and third-party purchasing requirements. However, almost half incorrectly responded that there was a minimum age requirement to purchase naloxone. Conclusion: This study reveals barriers to obtaining naloxone, including a lack of immediate in-store availability and a common misperception that naloxone cannot be dispensed to minors. Ó 2019 Society for Adolescent Health and Medicine. All rights reserved.
In 2017, approximately 67.8% of all drug overdose deaths in the U.S. were related to opioid use, representing a six-fold increase in opioid-related deaths since 1999 [1]. This increase is not limited to the adult population; the number of fatal opioid overdoses among youth nearly tripled from 1999 to 2016, with approximately 9,000 deaths during this interval [2]. Naloxone, an opioid antagonist, is effective at reversing opioid-induced overdoses. This life-saving drug has minimal side Conflicts of interest: The authors have no conflicts of interest to disclose. * Address correspondence to: Andrew Adesman, M.D., Division of Developmental and Behavioral Pediatrics, Steven and Alexandra Cohen Children’s Medical Center of New York, 1983 Marcus Avenue, Suite 130, Lake Success, NY 11042. E-mail address: [email protected] (A. Adesman). 1054-139X/Ó 2019 Society for Adolescent Health and Medicine. All rights reserved. https://doi.org/10.1016/j.jadohealth.2019.07.009
IMPLICATIONS AND CONTRIBUTION
Despite efforts to increase naloxone access, many pharmacies do not routinely stock naloxone and over half provided limited and/or inaccurate information regarding naloxone dispensing protocols. State policies regarding naloxone dispensing need to be refined and promulgated to enhance access to naloxone, especially for younger adolescents.
effects and does not possess potential for abuse [3]. Studies have demonstrated that increased access to naloxone is associated with a reduction in potentially fatal opioid overdoses [3,4]. Between 1996 and 2014, there were over 26,000 reported cases of opioid overdose reversals due to the administration of naloxone by laypersons that participated in naloxone access programs [4]. All 50 states have passed legislation designed to increase access to naloxone. These laws include “standing orders,” passed by 44 states, which allow pharmacists to dispense naloxone without a physician’s prescription when the individual meets the criteria dictated by the standing order protocol [5]. To date, research on the impact of these policies on naloxone access has focused on availability, cost, and third-party purchasing in two
2
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states (Texas and California) [6,7]. The present study has two objectives: to evaluate the immediate availability of naloxone and pharmacy employees’ knowledge about third-party purchasing in the states with the highest number of opioidrelated overdose deaths (ORODs) and to specifically examine pharmacy employees’ understanding of state protocols with respect to dispensing naloxone to youth.
Methods State selection The ten states (Table 1) with the highest total ORODs in 2016 were selected for primary analysis. In addition, the two states with the highest prevalence (per capita) of ORODs were also examined. Each state’s total number of ORODs was calculated based on the state’s OROD rate and population in 2016 [8,9].
Pharmacy selection and eligibility
A semistructured questionnaire was developed to simulate a routine telephone conversation between a pharmacy employee and a potential customer about the immediate availability of and requirements to purchase naloxone. Researchers (D.J., M.S.) individually contacted pharmacies in December 2018 and June 2019; before data collection, the researchers were trained by completing multiple phone calls to pharmacies to familiarize themselves with the questionnaire and possible responses from pharmacy employees. The accuracy of the respondent’s answers to knowledge-based questions was determined by referencing each state’s specific naloxone standing order protocol. If the standing order protocol was not publicly available, other resources, such as state legislation, were referenced. If a questionnaire item was not explicitly addressed in (nor clearly inferable from) the reference material, researchers directly contacted the appropriate state government department/program for clarification. Statistical analysis
All pharmacies contacted were participating in their state’s naloxone standing order program. These included both nonchain pharmacies (fewer than four locations) and chain pharmacies. The three pharmacy chains chosen for inclusion were CVS, Walgreens, and Walmart because they are the three largest pharmacy chains in the U.S. with respect to the number of pharmacists and because all three have publicly committed to participating in naloxone standing orders when available [10e13]. Nonchain pharmacies in three states (FL, IL, WA) were excluded from analysis as their participation in their state’s naloxone standing order could not be verified. A stratified sampling approach was implemented to ensure a comparable distribution of pharmacies with respect to characteristics such as population density.
Table 1 Characteristics of a sample of 120 pharmacies in the 10 states with the highest estimated number of opioid-related overdose deaths
Chain status Nonchain Chain CVS Walgreens Walmart Population density Rural Urban Respondent occupation Pharmacist Pharmacy technician State California Florida Illinois Maryland Massachusetts Michigan New York Ohio Pennsylvania Washington
Assessing respondent’s knowledge
N
(%)
21 99 33 33 33
(17.5) (82.5) (27.5) (27.5) (27.5)
61 59
(50.8) (49.2)
91 29
(75.8) (24.2)
12 8 10 13 13 10 11 22 12 9
(10.0) (6.7) (8.3) (10.8) (10.8) (8.3) (9.2) (18.3) (10.0) (7.5)
For the ten states with the highest ORODs, differences in responses between subgroups were assessed using the chisquared test of independence and Fisher’s exact test when appropriate. For interchain comparisons, Tukey’s test was applied to adjust for multiple comparisons. Human subjects The study protocol was reviewed by the institutional review board of Northwell Health and deemed to be exempt from review. Results The primary sample consisted of 120 pharmacies (99 chain pharmacies, 21 nonchain pharmacies). Further characteristics of this sample can be found in Table 1. The majority (80.3%) of pharmacies had at least one form of naloxone in stock (66.7% only spray; 11.9% both spray and injector; 1.7% injector only). A significant difference was found across the three chain pharmacies with regard to having naloxone in stock (p < .001). Specifically, Walmart and Walgreens were significantly more likely to have naloxone in stock than CVS (both p < .001). The majority of pharmacy employees (88.1%) correctly answered that no prescription was required. Similarly, the majority (87.4%) correctly stated that third-party purchasing was allowed. However, only 52.0% of pharmacy employees correctly communicated that there was no minimum age required to purchase naloxone. Moreover, less than half (44.2%) of pharmacy staff questioned were able to correctly answer all questions asked regarding dispensing requirements. The remaining pharmacies (55.8%) either provided incorrect information or were unable to answer all questions asked. Further information regarding immediate availability and pharmacy staff knowledge for this primary sample can be found in Table 2. Among the pharmacies in West Virginia (n ¼ 9) and New Hampshire (n ¼ 9)dthe states with the two highest OROD rates per capita in 2016d4 of 18 (22.2%) pharmacies did not have any naloxone in stock. In addition, 15 of 18 (83.3%) correctly stated a doctor’s prescription was not needed, and 15 of 17 (88.2%)
D.E. Jimenez et al. / Journal of Adolescent Health xxx (2019) 1e4
3
Table 2 Availability of naloxone and pharmacy staff knowledge regarding dispensing protocol across pharmacy characteristics in a sample of 120 pharmacies in the 10 states with the highest estimated number of opioid-related overdose deaths Overall
Chain status Nonchain All chains
Immediate availability (%)a Neither spray nor injector 19.7 25.0 n ¼ 117 n ¼ 20 Spray only 66.7 70.0 n ¼ 117 n ¼ 20 Injector only 1.7 .0 n ¼ 117 n ¼ 20 5.0 Both spray and injector 11.9 n ¼ 117 n ¼ 20 Pharmacy staff knowledge of dispensing protocol Age requirement 52.0 46.7 n ¼ 98 n ¼ 15 Prescription needed 88.1 77.8 n ¼ 109 n ¼ 18 Third-party purchasing 87.4 85.7 n ¼ 95 n ¼ 14
Specific chain p CVS value
18.5 .788 n ¼ 97 66.0 n ¼ 97 2.1 n ¼ 97 13.4 n ¼ 97 (% Correct)b 52.4 1.000 n ¼ 84 89.0 .089 n ¼ 91 87.7 1.000 n ¼ 81
Population density
Walgreens Walmart p value
Rural
Urban
Respondent occupation
p Pharmacist Pharmacist value technician
45.5 n ¼ 33 48.5 n ¼ 33 .0 n ¼ 33 6.0 n ¼ 33
9.4 n ¼ 32 62.5 n ¼ 32 6.2 n ¼ 32 21.9 n ¼ 32
.0 n ¼ 32 87.5 n ¼ 32 .0 n ¼ 32 12.5 n ¼ 32
<.001 18.3 n ¼ 60 70.0 n ¼ 60 1.7 n ¼ 60 10.0 n ¼ 60
21.1 .893 n ¼ 57 63.2 n ¼ 57 1.7 n ¼ 57 14.0 n ¼ 57
46.2 n ¼ 26 86.2 n ¼ 29 84.0 n ¼ 25
51.7 n ¼ 29 84.4 n ¼ 32 93.1 n ¼ 29
58.6 n ¼ 29 96.7 n ¼ 30 85.2 n ¼ 27
.641 46.0 n ¼ 50 .619 89.1 n ¼ 55 .073 87.2 n ¼ 47
58.3 .987 n ¼ 48 87.0 .740 n ¼ 54 87.5 .363 n ¼ 48
p value
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
48.7 n ¼ 78 86.2 n ¼ 87 87.0 n ¼ 77
60.0 n ¼ 20 90.9 n ¼ 22 88.9 n ¼ 18
.484 1.000 1.000
NA ¼ not applicable. a n ¼ 117 for availability status because a pharmacy technician at 1 location was unsure of the formulation type and pharmacy technicians at 2 other locations were unsure if naloxone was in stock. b The number of pharmacies for these 3 rows is not consistent because in some cases, one or more questions could not be asked because the pharmacy staff were too busy to answer all questions or the conversational flow did not lend itself.
correctly responded that third-party purchasing was allowed. Only 6 of 16 (37.5%) correctly stated that no age requirement existed.
Discussion Despite efforts to increase naloxone access in recent years, this study suggests that barriers still exist that may prevent individuals from obtaining naloxone. Of the 120 pharmacies in the primary sample, approximately 20% did not have any form of naloxone in stock. This may be related to cost; some pharmacies may choose to minimize carrying costs by reducing their overall inventory and prioritizing certain medications over others [14]. Nevertheless, given that naloxone has a shelf life of 18e24 months and given that the opioid epidemic has been classified as a national public health emergency, pharmacies participating in naloxone standing order programs should prioritize keeping naloxone in stock for immediate availability [15]. While the majority of pharmacy employees surveyed were aware that naloxone can be dispensed without a physician’s prescription and that it can be dispensed to friends and family members of those at risk of an overdose, approximately 48% of pharmacy employees incorrectly stated that there was a minimum age requirement. This finding is particularly concerning because the increase in opioid overdose deaths in the U.S. includes a significant rise in overdose deaths among minors. Between 2000 and 2009, adolescents aged 15e19 years experienced a 91% increase in fatal poisonings, which was primarily due to a rise in prescription drug overdoses [16]. Furthermore, this age group saw a 165% rise in hospitalizations due to prescription opioid poisonings from 1997 to 2012 [17]. Misconceptions regarding naloxone purchasing age requirements, which were prevalent among pharmacy staff, may prevent minors who are at risk of an overdose or in close contact with individuals at risk of an overdose from being able to access this life-saving medication.
Misconceptions regarding dispensing naloxone to minors may be, in part, due to the ambiguity of many standing order protocols surrounding age requirements. There were no explicit age specifications for purchasing naloxone within the standing order protocol for any of the states included in this study. When contacted about this issue, some health officials were unable to provide a clear answer. A Florida Boards of Pharmacy & Department of Health representative responded to a written inquiry that “there is no specific answers to your questions from an age standpoint.” A Pennsylvania Opioid Command Center representative replied that Pennsylvania “did not set an age limit,” but pharmacy staff “would have to make a judgement call related to the minor’s maturity and ability to administer the naloxone”; Ohio’s Board of Pharmacy’s web site provides similar guidelines without specifying a minimum age [18]. Thus, this ambiguity may help explain pharmacy employees’ inaccurate responses surrounding age requirements for purchasing naloxone. In terms of limitations, the fact that we only sampled approximately a dozen pharmacies per state in a total of 12 states (each of which had a high prevalence or high absolute number of ORODs) may limit the generalizability of our findings. Sample limitations (e.g., the small number of nonchain pharmacies and pharmacy technicians) may have also reduced the potential to detect differences between subgroups. In terms of state selection criteria, we chose to focus our primary analyses on the ten states with the highest number of ORODs since these accounted for the majority (53.2%) of all ORODs in 2016. We had originally considered focusing on the 10 states with the highest prevalence of ORODs; however, these states only accounted for approximately 30% of all OROD’s in the U.S. in 2016. When we subsequently reached out to pharmacies in the two states with the highest prevalence (not number) of ORODs, we found similar issues regarding immediate availability of naloxone and lack of pharmacy employee knowledge with respect to age restrictions for dispensing naloxone. This suggests that these issues extend beyond the ten states that were in the primary analysis. Although
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we cannot generalize our findings to states with a low number or prevalence of ORODs, it is unlikely that naloxone is more readily available in states where this is a less common problem. In summary, a notable percentage of pharmacies participating in naloxone standing order programs do not have naloxone immediately in stock. Moreover, many pharmacy employees are unaware of the current naloxone dispensing protocol requirements as they relate to minimum age requirements, and this may further interfere with the ability of minors to access naloxone. Given that the opioid epidemic affects those of all ages, public health efforts should focus on increasing the immediate availability of naloxone. Although the Food and Drug Administration is committed to making naloxone available “over the counter,” state legislators should revise standing order legislation to explicitly state that no age restrictions exist until this change occurs [19].
Acknowledgments The findings in this study were presented at the Pediatric Academic Societies meeting in April, 2019. References [1] Understanding the epidemic. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 12, 2019. [2] Gaither JR, Shabanova V, Leventhal JM. US national trends in pediatric deaths from prescription and illicit opioids, 1999-2016. JAMA Netw Open 2018;1:e186558. [3] Giglio RE, Li G, DiMaggio CJ. Effectiveness of bystander naloxone administration and overdose education programs: A meta-analysis. Inj Epidemiol 2015;2:10. [4] Wheeler E, Jones TS, Gilbert MK, Davidson PJ. Opioid overdose prevention programs providing naloxone to laypersonsdUnited States, 2014. MMWR Morb Mortal Wkly Rep 2015;64:631e5. [5] The Network for Public Health Law. Legal interventions to reduce overdose mortality: Naloxone access and overdose good Samaritan laws. Available at: www.networkforphl.org/_asset/qz5pvn/legal-interventions-to-reduceoverdose.pdf. Accessed February 8, 2019. [6] Evoy KE, Hill LG, Groff L, et al. Naloxone accessibility without a prescriber encounter under standing orders at community pharmacy chains in Texas. JAMA 2018;320:1934e7.
[7] Puzantian T, Gasper JJ. Provision of naloxone without a prescription by California pharmacists 2 Years after legislation implementation. JAMA 2018;320:1933e4. [8] National Institute on Drug Abuse. Opioid summaries by state. Available at: https://www.drugabuse.gov/drugs-abuse/opioids/opioid-summaries-bystate. Accessed November 5, 2018. [9] U.S. Census Bureau. State population totals and components of change: 2010-2018. Available at: https://www.census.gov/data/tables/time-series/ demo/popest/2010s-state-total.html#par_textimage_1574439295. Accessed November 5, 2018. [10] Becker’s Hospital review. 10 largest retail pharmacies in America. Available at: https://www.beckershospitalreview.com/lists/10-largest-retail-pharmacies-in-america.html. Accessed November 5, 2018. [11] CVS Health. CVS health expands efforts to educate patients about naloxone. Available at: https://cvshealth.com/newsroom/press-releases/cvs-healthexpands-efforts-educate-patients-about-naloxone. Accessed December 10, 2018. [12] Walmart. Walmart supports state of emergency declaration on opioids. Available at: https://news.walmart.com/2017/10/26/walmart-supportsstate-of-emergency-declaration-on-opioids. Accessed December 10, 2018. [13] Walgreens. Walgreens expands availability of naloxone without a prescription to 33 states and Washington D.C. Available at: https://news.walgreens.com/ press-releases/general-news/walgreens-expands-availability-of-naloxonewithout-a-prescription-to-33-states-and-washington-dc.htm. Accessed December 10, 2018. [14] Ali AK. Inventory management in pharmacy practice: A review of literature. Arch Pharm Pract 2011;2:151þ. Available at: https://link.galegroup.com/ apps/doc/A342178177/AONE?u¼googlescholar&sid¼AONE&xid¼374219c7. Accessed March 2, 2019. [15] North Carolina harm reduction coalition. Naloxone 101. Available at: http://www.nchrc.org/programs-and-services/naloxone-101/. Accessed March 2, 2019. [16] Centers for Disease Control and Prevention. Vital signs: Unintentional injury deaths among persons aged 0e19 Years d United States, 2000e 2009. MMWR Morb Mortal Wkly Rep 2012;61:270e6. [17] Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National trends in hospitalizations for opioid poisonings among children and adolescents, 1997 to 2012. JAMA Pediatr 2016;170:1195e201. [18] State of Ohio Board of Pharmacy. Dispensing of naloxone by pharmacists and pharmacy interns without a prescription. Available at: https://www. pharmacy.ohio.gov/Documents/Pubs/Naloxone/Pharmacist/Guidance% 20Document%20-%20Dispensing%20of%20Naloxone%20without%20a% 20Prescription.pdf. Accessed March 2, 2019. [19] Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths. Available at: https://www.fda.gov/newsevents/press-announcements/statement-fda-commissioner-scott-gottliebmd-unprecedented-new-efforts-support-development-over. Accessed March 2, 2019.
www.jahonline.org Adolescent health brief
Availability of Naloxone in Pharmacies and Knowledge of Pharmacy Staff Regarding Dispensing Naloxone to Younger Adolescents David E. Jimenez a, Miriam R. Singer a, and Andrew Adesman, M.D. a, b, * a b
Division of Developmental and Behavioral Pediatrics, Steven and Alexandra Cohen Children’s Medical Center of New York, Lake Success, New York Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York
Article history: Received April 19, 2019; Accepted July 18, 2019 Keywords: Naloxone; Opioid crisis; Standing order; Narcan; Minors; Overdose prevention; Public health
A B S T R A C T
Purpose: This study assessed the immediate availability of naloxone in pharmacies and the knowledge of pharmacy staff regarding naloxone dispensing protocols, especially as it relates to younger adolescents. Methods: The primary sample included pharmacies in the 10 states with the highest number of opioid-related overdose deaths in 2016; in addition, pharmacies in the 2 states with the highest prevalence of opioid-related overdose deaths in 2016 were also contacted. Researchers simulated a routine conversation between pharmacy staff and a potential customer about the immediate availability of and requirements to purchase naloxone. Results: The primary sample included 120 pharmacies (82.5% chain pharmacies; 50.8% rural). The majority (80.3%) had at least one form of naloxone in stock. Pharmacy staff were knowledgeable about prescription and third-party purchasing requirements. However, almost half incorrectly responded that there was a minimum age requirement to purchase naloxone. Conclusion: This study reveals barriers to obtaining naloxone, including a lack of immediate in-store availability and a common misperception that naloxone cannot be dispensed to minors. Ó 2019 Society for Adolescent Health and Medicine. All rights reserved.
In 2017, approximately 67.8% of all drug overdose deaths in the U.S. were related to opioid use, representing a six-fold increase in opioid-related deaths since 1999 [1]. This increase is not limited to the adult population; the number of fatal opioid overdoses among youth nearly tripled from 1999 to 2016, with approximately 9,000 deaths during this interval [2]. Naloxone, an opioid antagonist, is effective at reversing opioid-induced overdoses. This life-saving drug has minimal side Conflicts of interest: The authors have no conflicts of interest to disclose. * Address correspondence to: Andrew Adesman, M.D., Division of Developmental and Behavioral Pediatrics, Steven and Alexandra Cohen Children’s Medical Center of New York, 1983 Marcus Avenue, Suite 130, Lake Success, NY 11042. E-mail address: [email protected] (A. Adesman). 1054-139X/Ó 2019 Society for Adolescent Health and Medicine. All rights reserved. https://doi.org/10.1016/j.jadohealth.2019.07.009
IMPLICATIONS AND CONTRIBUTION
Despite efforts to increase naloxone access, many pharmacies do not routinely stock naloxone and over half provided limited and/or inaccurate information regarding naloxone dispensing protocols. State policies regarding naloxone dispensing need to be refined and promulgated to enhance access to naloxone, especially for younger adolescents.
effects and does not possess potential for abuse [3]. Studies have demonstrated that increased access to naloxone is associated with a reduction in potentially fatal opioid overdoses [3,4]. Between 1996 and 2014, there were over 26,000 reported cases of opioid overdose reversals due to the administration of naloxone by laypersons that participated in naloxone access programs [4]. All 50 states have passed legislation designed to increase access to naloxone. These laws include “standing orders,” passed by 44 states, which allow pharmacists to dispense naloxone without a physician’s prescription when the individual meets the criteria dictated by the standing order protocol [5]. To date, research on the impact of these policies on naloxone access has focused on availability, cost, and third-party purchasing in two
2
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states (Texas and California) [6,7]. The present study has two objectives: to evaluate the immediate availability of naloxone and pharmacy employees’ knowledge about third-party purchasing in the states with the highest number of opioidrelated overdose deaths (ORODs) and to specifically examine pharmacy employees’ understanding of state protocols with respect to dispensing naloxone to youth.
Methods State selection The ten states (Table 1) with the highest total ORODs in 2016 were selected for primary analysis. In addition, the two states with the highest prevalence (per capita) of ORODs were also examined. Each state’s total number of ORODs was calculated based on the state’s OROD rate and population in 2016 [8,9].
Pharmacy selection and eligibility
A semistructured questionnaire was developed to simulate a routine telephone conversation between a pharmacy employee and a potential customer about the immediate availability of and requirements to purchase naloxone. Researchers (D.J., M.S.) individually contacted pharmacies in December 2018 and June 2019; before data collection, the researchers were trained by completing multiple phone calls to pharmacies to familiarize themselves with the questionnaire and possible responses from pharmacy employees. The accuracy of the respondent’s answers to knowledge-based questions was determined by referencing each state’s specific naloxone standing order protocol. If the standing order protocol was not publicly available, other resources, such as state legislation, were referenced. If a questionnaire item was not explicitly addressed in (nor clearly inferable from) the reference material, researchers directly contacted the appropriate state government department/program for clarification. Statistical analysis
All pharmacies contacted were participating in their state’s naloxone standing order program. These included both nonchain pharmacies (fewer than four locations) and chain pharmacies. The three pharmacy chains chosen for inclusion were CVS, Walgreens, and Walmart because they are the three largest pharmacy chains in the U.S. with respect to the number of pharmacists and because all three have publicly committed to participating in naloxone standing orders when available [10e13]. Nonchain pharmacies in three states (FL, IL, WA) were excluded from analysis as their participation in their state’s naloxone standing order could not be verified. A stratified sampling approach was implemented to ensure a comparable distribution of pharmacies with respect to characteristics such as population density.
Table 1 Characteristics of a sample of 120 pharmacies in the 10 states with the highest estimated number of opioid-related overdose deaths
Chain status Nonchain Chain CVS Walgreens Walmart Population density Rural Urban Respondent occupation Pharmacist Pharmacy technician State California Florida Illinois Maryland Massachusetts Michigan New York Ohio Pennsylvania Washington
Assessing respondent’s knowledge
N
(%)
21 99 33 33 33
(17.5) (82.5) (27.5) (27.5) (27.5)
61 59
(50.8) (49.2)
91 29
(75.8) (24.2)
12 8 10 13 13 10 11 22 12 9
(10.0) (6.7) (8.3) (10.8) (10.8) (8.3) (9.2) (18.3) (10.0) (7.5)
For the ten states with the highest ORODs, differences in responses between subgroups were assessed using the chisquared test of independence and Fisher’s exact test when appropriate. For interchain comparisons, Tukey’s test was applied to adjust for multiple comparisons. Human subjects The study protocol was reviewed by the institutional review board of Northwell Health and deemed to be exempt from review. Results The primary sample consisted of 120 pharmacies (99 chain pharmacies, 21 nonchain pharmacies). Further characteristics of this sample can be found in Table 1. The majority (80.3%) of pharmacies had at least one form of naloxone in stock (66.7% only spray; 11.9% both spray and injector; 1.7% injector only). A significant difference was found across the three chain pharmacies with regard to having naloxone in stock (p < .001). Specifically, Walmart and Walgreens were significantly more likely to have naloxone in stock than CVS (both p < .001). The majority of pharmacy employees (88.1%) correctly answered that no prescription was required. Similarly, the majority (87.4%) correctly stated that third-party purchasing was allowed. However, only 52.0% of pharmacy employees correctly communicated that there was no minimum age required to purchase naloxone. Moreover, less than half (44.2%) of pharmacy staff questioned were able to correctly answer all questions asked regarding dispensing requirements. The remaining pharmacies (55.8%) either provided incorrect information or were unable to answer all questions asked. Further information regarding immediate availability and pharmacy staff knowledge for this primary sample can be found in Table 2. Among the pharmacies in West Virginia (n ¼ 9) and New Hampshire (n ¼ 9)dthe states with the two highest OROD rates per capita in 2016d4 of 18 (22.2%) pharmacies did not have any naloxone in stock. In addition, 15 of 18 (83.3%) correctly stated a doctor’s prescription was not needed, and 15 of 17 (88.2%)
D.E. Jimenez et al. / Journal of Adolescent Health xxx (2019) 1e4
3
Table 2 Availability of naloxone and pharmacy staff knowledge regarding dispensing protocol across pharmacy characteristics in a sample of 120 pharmacies in the 10 states with the highest estimated number of opioid-related overdose deaths Overall
Chain status Nonchain All chains
Immediate availability (%)a Neither spray nor injector 19.7 25.0 n ¼ 117 n ¼ 20 Spray only 66.7 70.0 n ¼ 117 n ¼ 20 Injector only 1.7 .0 n ¼ 117 n ¼ 20 5.0 Both spray and injector 11.9 n ¼ 117 n ¼ 20 Pharmacy staff knowledge of dispensing protocol Age requirement 52.0 46.7 n ¼ 98 n ¼ 15 Prescription needed 88.1 77.8 n ¼ 109 n ¼ 18 Third-party purchasing 87.4 85.7 n ¼ 95 n ¼ 14
Specific chain p CVS value
18.5 .788 n ¼ 97 66.0 n ¼ 97 2.1 n ¼ 97 13.4 n ¼ 97 (% Correct)b 52.4 1.000 n ¼ 84 89.0 .089 n ¼ 91 87.7 1.000 n ¼ 81
Population density
Walgreens Walmart p value
Rural
Urban
Respondent occupation
p Pharmacist Pharmacist value technician
45.5 n ¼ 33 48.5 n ¼ 33 .0 n ¼ 33 6.0 n ¼ 33
9.4 n ¼ 32 62.5 n ¼ 32 6.2 n ¼ 32 21.9 n ¼ 32
.0 n ¼ 32 87.5 n ¼ 32 .0 n ¼ 32 12.5 n ¼ 32
<.001 18.3 n ¼ 60 70.0 n ¼ 60 1.7 n ¼ 60 10.0 n ¼ 60
21.1 .893 n ¼ 57 63.2 n ¼ 57 1.7 n ¼ 57 14.0 n ¼ 57
46.2 n ¼ 26 86.2 n ¼ 29 84.0 n ¼ 25
51.7 n ¼ 29 84.4 n ¼ 32 93.1 n ¼ 29
58.6 n ¼ 29 96.7 n ¼ 30 85.2 n ¼ 27
.641 46.0 n ¼ 50 .619 89.1 n ¼ 55 .073 87.2 n ¼ 47
58.3 .987 n ¼ 48 87.0 .740 n ¼ 54 87.5 .363 n ¼ 48
p value
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
48.7 n ¼ 78 86.2 n ¼ 87 87.0 n ¼ 77
60.0 n ¼ 20 90.9 n ¼ 22 88.9 n ¼ 18
.484 1.000 1.000
NA ¼ not applicable. a n ¼ 117 for availability status because a pharmacy technician at 1 location was unsure of the formulation type and pharmacy technicians at 2 other locations were unsure if naloxone was in stock. b The number of pharmacies for these 3 rows is not consistent because in some cases, one or more questions could not be asked because the pharmacy staff were too busy to answer all questions or the conversational flow did not lend itself.
correctly responded that third-party purchasing was allowed. Only 6 of 16 (37.5%) correctly stated that no age requirement existed.
Discussion Despite efforts to increase naloxone access in recent years, this study suggests that barriers still exist that may prevent individuals from obtaining naloxone. Of the 120 pharmacies in the primary sample, approximately 20% did not have any form of naloxone in stock. This may be related to cost; some pharmacies may choose to minimize carrying costs by reducing their overall inventory and prioritizing certain medications over others [14]. Nevertheless, given that naloxone has a shelf life of 18e24 months and given that the opioid epidemic has been classified as a national public health emergency, pharmacies participating in naloxone standing order programs should prioritize keeping naloxone in stock for immediate availability [15]. While the majority of pharmacy employees surveyed were aware that naloxone can be dispensed without a physician’s prescription and that it can be dispensed to friends and family members of those at risk of an overdose, approximately 48% of pharmacy employees incorrectly stated that there was a minimum age requirement. This finding is particularly concerning because the increase in opioid overdose deaths in the U.S. includes a significant rise in overdose deaths among minors. Between 2000 and 2009, adolescents aged 15e19 years experienced a 91% increase in fatal poisonings, which was primarily due to a rise in prescription drug overdoses [16]. Furthermore, this age group saw a 165% rise in hospitalizations due to prescription opioid poisonings from 1997 to 2012 [17]. Misconceptions regarding naloxone purchasing age requirements, which were prevalent among pharmacy staff, may prevent minors who are at risk of an overdose or in close contact with individuals at risk of an overdose from being able to access this life-saving medication.
Misconceptions regarding dispensing naloxone to minors may be, in part, due to the ambiguity of many standing order protocols surrounding age requirements. There were no explicit age specifications for purchasing naloxone within the standing order protocol for any of the states included in this study. When contacted about this issue, some health officials were unable to provide a clear answer. A Florida Boards of Pharmacy & Department of Health representative responded to a written inquiry that “there is no specific answers to your questions from an age standpoint.” A Pennsylvania Opioid Command Center representative replied that Pennsylvania “did not set an age limit,” but pharmacy staff “would have to make a judgement call related to the minor’s maturity and ability to administer the naloxone”; Ohio’s Board of Pharmacy’s web site provides similar guidelines without specifying a minimum age [18]. Thus, this ambiguity may help explain pharmacy employees’ inaccurate responses surrounding age requirements for purchasing naloxone. In terms of limitations, the fact that we only sampled approximately a dozen pharmacies per state in a total of 12 states (each of which had a high prevalence or high absolute number of ORODs) may limit the generalizability of our findings. Sample limitations (e.g., the small number of nonchain pharmacies and pharmacy technicians) may have also reduced the potential to detect differences between subgroups. In terms of state selection criteria, we chose to focus our primary analyses on the ten states with the highest number of ORODs since these accounted for the majority (53.2%) of all ORODs in 2016. We had originally considered focusing on the 10 states with the highest prevalence of ORODs; however, these states only accounted for approximately 30% of all OROD’s in the U.S. in 2016. When we subsequently reached out to pharmacies in the two states with the highest prevalence (not number) of ORODs, we found similar issues regarding immediate availability of naloxone and lack of pharmacy employee knowledge with respect to age restrictions for dispensing naloxone. This suggests that these issues extend beyond the ten states that were in the primary analysis. Although
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we cannot generalize our findings to states with a low number or prevalence of ORODs, it is unlikely that naloxone is more readily available in states where this is a less common problem. In summary, a notable percentage of pharmacies participating in naloxone standing order programs do not have naloxone immediately in stock. Moreover, many pharmacy employees are unaware of the current naloxone dispensing protocol requirements as they relate to minimum age requirements, and this may further interfere with the ability of minors to access naloxone. Given that the opioid epidemic affects those of all ages, public health efforts should focus on increasing the immediate availability of naloxone. Although the Food and Drug Administration is committed to making naloxone available “over the counter,” state legislators should revise standing order legislation to explicitly state that no age restrictions exist until this change occurs [19].
Acknowledgments The findings in this study were presented at the Pediatric Academic Societies meeting in April, 2019. References [1] Understanding the epidemic. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 12, 2019. [2] Gaither JR, Shabanova V, Leventhal JM. US national trends in pediatric deaths from prescription and illicit opioids, 1999-2016. JAMA Netw Open 2018;1:e186558. [3] Giglio RE, Li G, DiMaggio CJ. Effectiveness of bystander naloxone administration and overdose education programs: A meta-analysis. Inj Epidemiol 2015;2:10. [4] Wheeler E, Jones TS, Gilbert MK, Davidson PJ. Opioid overdose prevention programs providing naloxone to laypersonsdUnited States, 2014. MMWR Morb Mortal Wkly Rep 2015;64:631e5. [5] The Network for Public Health Law. Legal interventions to reduce overdose mortality: Naloxone access and overdose good Samaritan laws. Available at: www.networkforphl.org/_asset/qz5pvn/legal-interventions-to-reduceoverdose.pdf. Accessed February 8, 2019. [6] Evoy KE, Hill LG, Groff L, et al. Naloxone accessibility without a prescriber encounter under standing orders at community pharmacy chains in Texas. JAMA 2018;320:1934e7.
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