Abstract
Background:
Increasing access to naloxone, an opioid antagonist, can prevent opioid overdose among patients prescribed opioids. In 2016, the Centers for Disease Control and Prevention recommended co-prescribing naloxone with opioids; however, the extent to which this guideline influenced clinical practice remains unclear. In this study, we seek to describe trends in the rate of naloxone co-dispensing with opioid prescriptions from 2013 to 2023.
Methods:
This serial cross-sectional analysis utilized the IQVIA Longitudinal Prescription Database, which captures 92% of dispensed U.S. retail prescriptions, to examine opioid prescriptions dispensed to individuals aged 12 and older between 1/1/2013–9/30/2023. Naloxone co-dispensing was defined as naloxone dispensed within three days of the opioid dispensing date. Subgroup analyses included high-risk opioid prescriptions, long-term opioid therapy, and prior dispensing of buprenorphine for opioid use disorder.
Results:
From 2013 to 2023, 1,690,391,169 opioid prescriptions were dispensed, with naloxone co-dispensing occurring in 3,531,421 (0.2%) cases, increasing from 0.0% in 2013 to 0.9% in 2023. Naloxone co-dispensing increased from 0.0% to 1.3% among high-risk prescriptions, 0.0% to 0.7% for long-term opioid therapy, and 0.0% to 1.8% for prior buprenorphine recipients during the study period.
Conclusions:
In this analysis of a national prescription dispensing database, naloxone co-dispensing with prescription opioids increased for 2013 to 2023 but remained infrequent, even among individuals at elevated risk for opioid overdose. Although these data do not capture naloxone obtained through prior prescriptions or free distribution programs, these findings emphasize the need for targeted interventions to promote naloxone co-dispensing. Clinician education, policy measures, and continued community outreach may help increase naloxone uptake and improve access for at-risk patients.
Keywords: Opioids, Epidemiology, Public Health, Chronic Pain
INTRODUCTION
Since 1999, more than 500,000 opioid-related deaths have occurred in the United States.1 Among fatal drug overdoses in 2023, 75.6% involved any opioid and 12.3% involved prescription opioids.2,3 The timely administration of naloxone, a competitive opioid antagonist that is used to reverse opioid overdoses and prevent death, is a critical element of broader opioid harm reduction strategies.4 In recent decades, community and public policy efforts have focused on increasing the availability of naloxone to first responders and bystanders to prevent opioid-related death.5,6 Previous probabilistic analysis has suggested that expanding naloxone distribution could prevent 6% of opioid overdose deaths, or approximately 6,600 lives annually.2,7
To increase naloxone access among patients at high risk of opioid overdose, the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain recommended that clinicians co-prescribe naloxone when prescribing opioids to high-risk patients, including those with a history of opioid use disorder (OUD), patients using benzodiazepines, and patients receiving opioid doses greater than 50 morphine milligram equivalents (MME) per day. CDC recommendations were later updated in 2022 to recommend repeated evaluation of potential opioid-related harms at least every three months, regardless of the prescribed dose.8,9
Although the vast majority of opioid-related overdoses occur in the context of nonmedical use, misuse, and among individuals with OUD, opioid prescribing for acute and chronic pain remains common in the United States. Prior studies have demonstrated an increase in naloxone co-dispensing, with the most recent estimate reporting an increase in the average number of naloxone prescriptions per 100 high-dose (≥50 MME) from 0.002 in 2012 to 3.04 in 2019.10 However, little is understood regarding more recent trends in naloxone co-dispensing among patients at high risk of opioid overdose. Moreover, given the rising prevalence of OUD and other known risk factors for overdose in the U.S., education and guidelines regarding naloxone co-dispensing are critical to ensure safe opioid stewardship.
In this context, we sought to define recent trends in naloxone co-dispensing in the United States among adolescent and adults, given the rising rates of opioid use disorder across these age groups.11 We examined retail pharmacy claims in the U.S. between 2013 and 2023 to 1) describe current rates of naloxone co-dispensing with all opioid prescriptions and high-risk prescriptions; 2) determine the prescriber factors associated with naloxone co-dispensing, including prescriber specialty, age, and practice setting; and 3) determine the patient factors associated with naloxone co-dispensing, including age and whether patients were new to opioids or not. Understanding the current landscape of naloxone co-dispensing can facilitate the creation of targeted interventions for provider education about naloxone prescribing and dispensing, especially among patients with concomitant benzodiazepine use, high daily opioid doses, or those receiving medications for opioid use disorder (MOUD), such as buprenorphine.
METHODS
Data Source
We conducted a retrospective longitudinal analysis of the IQVIA Longitudinal Prescription Database from January 1, 2013, to September 30, 2023, which includes 92% of prescriptions dispensed from U.S. retail pharmacies and the majority of prescriptions from long-term and mail-order pharmacies. We concluded the analyses on 9/30/2023, as these were the most recent data available at the time of analysis. Prescriptions for opioids (excluding opioids approved for OUD and opioid cough-and-cold medications), benzodiazepines, medications approved for OUD, and naloxone were identified using the IQVIA market definitions. Because data were de-identified, the University of Michigan Medical School Institutional Review Board exempted this study from human subjects review; informed consent was not required. This study follows the STROBE guidelines for reporting cross-sectional studies.
Study Population
We identified valid (days supplied between 1 and 90, no missing data for quantity, and quantity≥1) non-parenteral and non-topical opioid prescriptions written by U.S. prescribers and dispensed between 1/1/2013–9/30/2023 to patients aged 12 and over residing in one of the 50 U.S. states or the District of Columbia. Children and adolescents younger than 12 years old were excluded, as weight-based dosing is used for opioid prescribing in this population.12 Index opioid prescriptions were excluded if any of the following were true: 1) missing prescriber specialty; 2) invalid opioid prescriptions in the year prior to the day of index prescription; 3) another opioid prescription for parenteral or topical opioid prescriptions written on the same day as the index prescription; 4) an invalid benzodiazepine prescription written or dispensed in the prior 90 days; 5) invalid MOUD prescription dispensed in the year prior to the index prescription; 6) an invalid naloxone prescription dispensed within three days of index prescription; 7) more than one state associated with the patient for the index prescription; 8) a prescriber aged 80 or older.
Opioid prescriptions dispensed on the same day were all considered to represent one index prescription. If there were opioid prescriptions dispensed on the same date from multiple providers with different specialties, prescriber specialty was assigned to the specialty of prescriber with the higher total dosage, as measured in MME. If total MMEs were the same, the specialty was assigned based on the prescription written by a prescriber in the same state as the patient. Otherwise, random assignment was used.
Covariates
Patient covariates included patient age, sex, payment method (including cash), year of dispensing, and prior opioid status. Prior opioid status consisted of 1) opioid naive, defined as the absence of an opioid prescription dispensing in the 365 days prior to the index opioid prescription; 2) long-term opioid therapy, defined as having greater than 120 days supplied or 10 or more opioid prescriptions in the year prior to the index date13; 3) use of MOUD defined as the occurrence of a dispensed prescription for MOUD in the year prior to the index date; 4) low/intermittent opioid use, defined as opioid therapy that is not long-term and not on MOUD.
Prescriber-level covariates included age, region of practice (categorized as Northeast, Midwest, South or West), urban or rural practice location (determined based on Rural-Urban Continuum Codes), and specialty, which was categorized as addiction medicine, anesthesiology/pain medicine, dentistry, emergency medicine, medical subspecialties, obstetrics and gynecology, pediatric subspecialties, pediatric primary care, primary care, psychiatry, surgery, or other.14
To classify an opioid prescription as high-risk, we used previously described definitions.9,15 Briefly, index opioid prescriptions were considered high-risk if the prescription met any of 3 criteria: 1) the prescription was for ≥ 90 MME per day; 2) there was concurrent benzodiazepine use, defined as a benzodiazepine prescription dispensed on the same day as the index opioid prescription or during the prior 90 days; or 3) prescriptions for different opioid types were filled on the same day.
Outcomes
The outcome was naloxone co-dispensing, defined as the occurrence of a dispensed naloxone prescription on or within 3 days of the dispensing date of the index opioid prescription.
Statistical Analysis
Descriptive statistics were used to characterize the proportion of opioid prescriptions across the study period with naloxone co-dispensing. This analysis was repeated among the following subgroups of opioid prescriptions: 1) high-risk opioid prescriptions; 2) opioid prescriptions for patients on long-term opioid therapy; and 3) opioid prescriptions for patients with MOUD dispensing in the prior 180 days. For the pooled sample of opioid prescriptions from 2013 to 2023, we used logistic regression models, adjusting for the aforementioned covariates, with standard errors clustered at the patient level to identify characteristics associated with naloxone co-dispensing. In the logistic regression model, we included a term for continuous rather than categorical year to calculate the year-over-year change in the rate of naloxone co-dispensing. We repeated these models and calculations in each of the subgroups described above. We converted coefficients from logistic regression models to average marginal effects to facilitate interpretation as absolute percentage-point changes in probability. Analyses were conducted using 18.0/MP (StataCorp, College Station, TX). P values were two-tailed and were deemed statistically significant at p<0.05.
RESULTS
Sample Characteristics
The database included 1,703,677,832 non-parenteral and non-topical opioid prescriptions dispensed to U.S. patients ages 12 and older between 2013–2023. Of these, 13,286,663 (0.8%) were excluded, with 58.8% of exclusions resulting from prescriptions written by providers aged 80 or older. Our final study sample included 1,690,391,169 opioid prescriptions dispensed during the study period.
Among opioid prescriptions dispensed during the study period, 518,139,918 (30.7%) were to patients ages 65 and older (average 54.8; SD 16.2), 997,220,034 (59.0%) were dispensed to female patients, and 853,742,485 (50.5%) were dispensed to individuals with long-term opioid therapy (Table 1).
Table 1.
Characteristics of dispensed naloxone co-dispensings for all opioid prescriptions and high-risk opioid prescriptions from U.S. providers, 2013–2023.
| Characteristic | Category | Total opioid prescriptions (thousands) n=1,690,391 | Naloxone co-dispensings for all opioid prescriptions (thousands) (%)a n=3,531,421 | High-risk opioid prescriptions (thousands) n=533,895 | Naloxone co-dispensings for high-risk opioid prescriptions (thousands) (%)b n= 1,540 |
|---|---|---|---|---|---|
|
| |||||
| Patient age (yrs) | 12–17 | 18,707 | 22 (0.1%) | 2,108 | 7.1 (0.1%) |
| 18–34 | 205,612 | 305 (0.1%) | 41,287 | 101 (0.1%) | |
| 35–44 | 218,452 | 448 (0.2%) | 68,949 | 195 (0.2%) | |
| 45–54 | 317,964 | 677 (0.2%) | 113,555 | 316 (0.2%) | |
| 55–64 | 411,517 | 991 (0.2%) | 148,113 | 461 (0.2%) | |
| ≥65 | 518,140 | 1,088 (0.2%) | 159,882 | 460 (0.2%) | |
| Patient sex | Female | 997,220 | 2,097 (0.2%) | 334,733 | 949 (0.3%) |
| Male | 690,430 | 1,433 (0.2%) | 198,293 | 590 (0.3%) | |
| Unknown | 2,741 | 1.1 (0.0%) | 868 | 0.6 (0.1%) | |
| Opioid exposure status | Opioid naive | 338,507 | 687 (0.2%) | 44,018 | 198 (0.4%) |
| Low/intermittent | 488,939 | 939 (0.2%) | 118,677 | 359 (0.3%) | |
| Chronic | 853,742 | 1,855 (0.2%) | 366,731 | 957 (0.3%) | |
| MOUD | 9,203 | 51 (0.6%) | 4,469 | 25 (0.6%) | |
| Payment method | Commercial | 827,730 | 1,282 (0.2%) | 247,077 | 558 (0.2%) |
| Medicaid | 206,501 | 742 (0.4%) | 60,704 | 267 (0.4%) | |
| Medicare | 546,829 | 1,342 (0.2%) | 195,084 | 624 (0.3%) | |
| Cash | 103,521 | 143 (0.1%) | 27,503 | 71 (0.3%) | |
| Multiple | 3,353 | 23 (0.7%) | 2,807 | 20 (0.7%) | |
| Unknown | 2,457 | 0.1 (0.0%) | 720 | 0.05 (0.0%) | |
| Year of prescription | 2013 | 186,667 | 0.25 (0.0%) | 64,829 | 0.17 (0.0%) |
| 2014 | 195,381 | 1.2 (0.0%) | 67,663 | 0.84 (0.0%) | |
| 2015 | 189,690 | 3.0 (0.0%) | 66,622 | 2.1 (0.0%) | |
| 2016 | 182,880 | 26 (0.0%) | 63,416 | 17 (0.0%) | |
| 2017 | 169,957 | 96 (0.1%) | 56,689 | 64 (0.1%) | |
| 2018 | 151,966 | 263 (0.2%) | 47,622 | 155 (0.3%) | |
| 2019 | 139,461 | 445 (0.3%) | 40,354 | 223 (0.6%) | |
| 2020 | 130,296 | 484 (0.4%) | 36,384 | 225 (0.6%) | |
| 2021 | 128,507 | 564 (0.4%) | 34,478 | 238 (0.7%) | |
| 2022 | 124,672 | 834 (0.7%) | 32,675 | 321 (1.0%) | |
| 2023 | 90,914 | 817 (0.9%) | 23,164 | 295 (1.3%) | |
| Prescriber age | <40 | 247,860 | 619 (0.2%) | 63,921 | 234 (0.4%) |
| 40–49 | 393,962 | 685 (0.2%) | 120,314 | 290 (0.2%) | |
| 50–59 | 422,412 | 649 (0.2%) | 140,403 | 299 (0.2%) | |
| 60–79 | 371,773 | 583 (0.2%) | 132,024 | 299 (0.2%) | |
| Unknown | 254,384 | 995 (0.4%) | 77,232 | 417 (0.5%) | |
| Practice region | Northeast | 225,025 | 470 (0.2%) | 77,664 | 221 (0.3%) |
| Midwest | 375,487 | 577 (0.2%) | 114,266 | 250 (0.2%) | |
| South | 745,921 | 1,406 (0.2%) | 235,120 | 647 (0.3%) | |
| West | 343,958 | 1,078 (0.3%) | 106,845 | 421 (0.4%) | |
| Prescriber Rurality (RUCC) | Urban | 1,582,841 | 3,398 (0.2%) | 500,478 | 1,478 (0.3%) |
| Rural | 106,403 | 131 (0.1%) | 33,094 | 61 (0.2%) | |
| Unknown | 1.1 | 2.2 (0.2%) | 322 | 0.76 (0.2%) | |
| Prescriber specialty | Addiction Medicine | 1,005 | 2,221 (0.2%) | 497 | 1.4 (0.3%) |
| Anesthesiology and pain medicine | 143,718 | 473 (0.3%) | 61,013 | 217 (0.4%) | |
| Dentistry | 135,598 | 34 (0.0%) | 17,923 | 13 (0.1%) | |
| Emergency medicine | 78,520 | 153 (0.2%) | 12,663 | 41 (0.3%) | |
| Medical subspecialties | 296,046 | 518 (0.2%) | 110,215 | 258 (0.2%) | |
| OBGYN | 35,058 | 52 (0.1%) | 5,474 | 14 (0.3%) | |
| Pediatric subspecialties | 6,704 | 13 (0.2%) | 2,130 | 6.0 (0.3%) | |
| Pediatrics | 2,300 | 3.7 (0.2%) | 579 | 1.8 (0.3%) | |
| Primary care | 691,229 | 1,675 (0.2%) | 231,484 | 739 (0.3%) | |
| Psychiatry | 3,271 | 5.6 (0.2%) | 2,091 | 3.7 (0.2%) | |
| Surgery | 206,083 | 361 (0.2%) | 51,675 | 128 (0.2%) | |
| Other | 90,859 | 240 (0.3%) | 38,151 | 116 (0.3%) | |
Percentages refer to the proportion of total opioid prescriptions with naloxone co-dispensing
Percentages refer to the proportion of high-risk opioid prescriptions with naloxone co-dispensing
A plurality (49.0%) of opioid prescriptions were paid for by commercial insurance plans (827,730,222 prescriptions). Medicare coverage was used for 546,828,859 (32.3%) prescriptions, followed by Medicaid (206,500,775; 12.2%) and cash (103,521,218; 6.1%) (Table 1). The most commonly prescribed opioid was hydrocodone (686,253,577; 40.6%), followed by oxycodone (403,569,848; 23.9%) and tramadol (317,783,219; 18.8%). The mean prescription size was 879.3 (SD 2361.6) MMEs, equivalent to approximately 176 tablets of 5 mg hydrocodone. The mean days supplied was 19.0 (SD 18.6) (Supplemental Table 1).
Trends in Naloxone Co-Dispensing
During the study period, naloxone co-dispensing occurred with 3,531,421 (0.2%) of opioid prescriptions (Table 1). The number of opioid prescriptions with naloxone co-dispensing increased from 250 (0.0%) opioid prescriptions in 2013 to 816,709 (0.9%) opioid prescriptions in 2023 (adjusted year-over-year change: 0.093%; 95% CI: 0.093–0.093) (Figures 1 & 2). In subgroup analyses, 533,894,541 (31.6%) of opioid prescriptions were high-risk (Table 1). Among high-risk prescriptions, 230,137,050 (43.1%) had daily doses greater than or equal to 90 MME (Table 2).
Figure 1.
Total opioid prescriptions, high-risk opioid prescriptions, and total naloxone prescriptions, 2013–2023.
Figure 2.
Total naloxone co-dispensings and naloxone dispensings associated with high-risk opioid prescriptions, 2013–2013.
Table 2.
Characteristics of high-risk opioid prescriptions from U.S. providers, 2013–2023.
| High-risk opioid prescriptions | Naloxone co-dispensings for high-risk opioid prescriptions | Rate of naloxone co-dispensings within each characteristic | |
|---|---|---|---|
|
| |||
| MME per day ≥ 90 | 230,137,050 | 762,539 | 0.3% |
| Concomitant benzodiazepine prescription (≥ 50 only) | 402,691,330 | 1,007,438 | 0.3% |
| Multiple types of opioids prescribed (≥ 50 only) | 67,337,991 | 298,078 | 0.4% |
Naloxone co-dispensing occurred in 0.3% (1,539,571) of all high-risk opioid prescriptions. This proportion increased from 0.0% in 2013 to 1.3% in 2023 (adjusted year-over-year change: 0.124%; 95% CI: 0.124–0.125%) (Table 1; Supplemental Table 2). A total of 853,742,485 (50.5%) opioid prescriptions were for patients with long-term opioid therapy. Of these prescriptions, naloxone co-dispensing occurred in 0.2%. This proportion increased from 0.0% in 2013 to 0.7% in 2023 (adjusted year-over-year change: 0.081%; 95% CI: 0.081–0.081%) (Supplemental Table 3). A total of 9,202,519 (0.5%) opioid prescriptions were for recent MOUD dispensing. Of these prescriptions, naloxone co-dispensing occurred in 0.6%. This proportion increased from 0.0% in 2013 to 1.8% in 2023 (adjusted year-over-year change: 0.23%; 95% CI: 0.22–0.23%) (Supplemental Table 4).
Providers in the South accounted for 44.1% of opioid prescriptions and 39.8% of prescriptions with naloxone co-dispensing (naloxone co-dispensing rate: 0.2%). Providers in the West accounted for 20.3% of opioid prescriptions and 30.5% of prescriptions with naloxone co-dispensing (naloxone co-dispensing rate: 0.3%) (Table 1). Primary care providers were responsible for 40.9% of opioid prescriptions and 47.4% of opioid prescriptions with naloxone co-dispensing (naloxone co-dispensing rate: 0.2%) (Table 1). No specialty demonstrated a naloxone co-dispensing rate greater than 0.3% (Table 1).
DISCUSSION
In this analysis of national prescription dispensing data, we examined trends in naloxone co-dispensing with prescription opioids from 2013 to 2023. During the study period, naloxone co-dispensing only occurred with 0.2% of opioid prescriptions despite CDC guidance recommending naloxone co-prescription with opioids. Although there was a modest increase over time, the rate of naloxone co-dispensing remained low, including among patients with high-risk opioid prescriptions, those on long-term opioid therapy, and those with recent MOUD dispensing. Together, these findings highlight a need to enhance awareness regarding the role of naloxone in harm reduction when prescribing opioids to individuals with known risk factors for overdose and to implement strategies that promote naloxone co-dispensing where appropriate.
Our findings align with previous studies that describe the lags in naloxone co-dispensing in the United States, particularly among individuals with risk factors for overdose. Previous investigation has highlighted geographic variation in naloxone dispensing rates, ranging from 0.2 per 100 persons in Georgia, New Hampshire, South Dakota, and Texas to 1.7 per 100 persons in Arkansas.10 In our study, the rate of naloxone co-dispensing was 0.2% in the U.S. South and Midwest.
Prior work has also demonstrated variation in naloxone co-dispensing among different specialties. A previous study found that from 2012–2018, psychiatrists demonstrated the highest rate of naloxone prescriptions at 12.9 co-dispensings per 100 high-dose opioid prescriptions. In contrast, surgeons had the lowest naloxone co-dispensing rate at 0.2 per 100 high-dose prescriptions.16 In contrast, in our sample, the rate of naloxone co-dispensing was so limited that significant differences in co-dispensing patterns between specialties were not apparent. No medical specialty had a naloxone co-dispensing rate greater than 0.3%, even when considering high-risk opioid prescriptions.
Several factors may contribute to low rates of naloxone co-dispensing. Stigma related to OUD continues to be a challenge for effective harm reduction strategies; previous work has demonstrated that the association of naloxone with OUD may drive reduced rates of naloxone uptake among patients.17 Furthermore, some prescribers may believe that high-risk drug use can increase with the availability of naloxone, despite the lack of strong supporting evidence for this idea.17 Independent pharmacies have also demonstrated diminished comfort dispensing naloxone when compared to primary and grocery pharmacies, possibly contributing to lower rates of co-dispensing.18 In addition, increased out-of-pocket costs remain a persistent barrier to naloxone access. Chua et al. demonstrated that an increase in cost-sharing of $10 was associated with a 3.1 percentage point increase in the probability of prescription abandonment among patients with commercial insurance and a 2.3 percentage point increase among Medicare patients.19
Naloxone co-prescribing to every patient with an opioid prescription may reduce the stigma associated with naloxone, but the benefits of blanket co-prescription remain unclear. In many instances, naloxone co-prescribing may not be logistically feasible or cost-effective, especially if a patient does not meet any of the high-risk criteria outlined above. However, the low rate of naloxone co-dispensing with high-risk opioid prescriptions suggests that opportunities to prevent opioid-related adverse events are potentially being missed.
There were several limitations to our study. We were unable to capture naloxone provided in contexts outside of a prescription, such as naloxone provided through community distribution programs. The IVQIA database also lacked information on indications for opioid prescription and patient comorbidities. Finally, the database did not capture methadone dispensing in opioid treatment programs, meaning there was misclassification in the subgroup analysis of patients with recent MOUD use.
Conclusions
In summary, rates of naloxone co-dispensing with prescription opioids remain very low, even among patients with risk factors for opioid overdose. Further investigation is needed to better understand the longitudinal impact of the availability of over-the-counter naloxone on the rate of co-dispensing and to identify which interventions can most effectively increase naloxone co-dispensing to high-risk patients, thus potentially mitigating their risk of opioid overdose.
Supplementary Material
KEY MESSAGES.
What is already known on this topic:
Naloxone can prevent opioid overdose, and clinical guidelines recommend its co-prescription for high-risk patients, but recent national data on dispensing trends have been limited.
What this study adds:
This study demonstrates that naloxone co-dispensing with opioid prescriptions increased slightly from 2013 to 2023 but remains rare, even among high-risk groups.
How this study might affect research, practice, or policy:
These findings reveal a gap between clinical recommendations and real-world practice. Targeted interventions, including clinician education, stigma reduction, and supportive policy measures, are needed to improve naloxone access and uptake.
Acknowledgments
Funding:
This work was supported by the National Institute on Drug Abuse, grant number R01DA057284 (JFW, KPC).
Footnotes
Conflicts of Interest: CMB is a consultant for Vertex Pharmaceuticals and Merck Pharmaceuticals, and he provides expert medical testimony. KPC has received consulting fees from the U.S. Department of Justice for unrelated work.
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