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Puzantian T, Gasper JJ. Provision of Naloxone Without a Prescription by California Pharmacists 2 Years After Legislation Implementation. JAMA. 2018;320(18):1933–1934. doi:10.1001/jama.2018.12291
Layperson access to the opioid overdose reversal medication naloxone can reduce mortality.1,2 Legislation in California has allowed trained pharmacists to furnish naloxone without a physician’s prescription since January 27, 2016.3 Under a Board of Pharmacy protocol, naloxone is available by patient request or pharmacist suggestion. A furnishing pharmacist is required to screen and educate patients on opioid overdose prevention, recognition, and response. With patient consent, the pharmacist must notify the primary physician that naloxone was furnished. We estimated the availability of pharmacist-furnished naloxone 2 years after implementation.
The Office for Human Research Protections at Claremont Graduate University deemed this study nonhuman research. An anonymous telephone survey of a 20% random sample of California community pharmacies was conducted between January 23 and February 28, 2018. The California State Board of Pharmacy website was accessed on January 2, 2018, to identify all licensed California pharmacies, excluding pharmacies with canceled, revoked, probationary, or restricted licenses and hospital, correctional, or specialty pharmacies. Thirty trained interviewers posed as potential customers. Using a standardized script, they asked any pharmacy staff: “I heard that you can get naloxone from a pharmacy without a prescription from your doctor. Can I do that at your pharmacy?” If the response was affirmative, they asked what formulations were available, the cash price, and whether naloxone could be billed to insurance. Additional unsolicited information was recorded.
Proportions with 95% confidence intervals, medians with interquartile ranges (IQRs), and χ2 tests comparing differences in availability by urbanity (census tract designation) and pharmacy type (independent or chain, defined as ≥5 locations) were estimated using Stata version 15.1 (StataCorp). With a power of 85% and α = .05, the sample size required to detect an effect size of 0.1 in χ2 tests comparing differences in availability by urbanity and pharmacy type was n = 898. Statistical significance was set at a 2-tailed P < .05.
Of 6962 California pharmacies, 6047 were eligible, 1209 were surveyed, and data were collected from 1147 (93.3%). Most pharmacies were urban (98.7%) and part of a chain (66.2%) (Table 1). Pharmacist-furnished naloxone was available at 23.5% (95% CI, 21.0%-26.0%) of pharmacies. Differences by urbanity were not statistically significant, although rural pharmacies were underrepresented. There was a significant difference by pharmacy type, with 31.6% (95% CI, 28.3%-35.1%) of chain pharmacies compared with 7.5% (95% CI, 5.1%-10.6%) of independent pharmacies furnishing naloxone (P < .001).
Among pharmacies furnishing naloxone (n = 269), 225 (83.6%) offered a nasal formulation (Table 2). Fourteen (5.2%) offered combination buprenorphine-naloxone tablets used for treatment of opioid use disorder, not opioid overdose. Of pharmacies furnishing naloxone, 50.6% had nasal naloxone in stock. Chain pharmacies were significantly more likely to have nasal naloxone in stock (52.3%; 95% CI, 46.3%-59.4%) compared with independents (31.0%; 95% CI, 15.3%-50.8%) (P = .03). Regarding insurance billing, 59.9% of pharmacies replied correctly that pharmacist-furnished naloxone could be billed, with no significant difference by pharmacy type. The median cash price of nasal naloxone (pack of 2) at chain pharmacies was $136 (IQR, $120-$143.50) compared with $150 (IQR, $138.50-$170) (P = .04) at independents.
A number of erroneous statements were made by respondents, including that naloxone was a controlled substance, that a tablet formulation was available, and that injectable formulations not appropriate for layperson use were available.
Two years after implementation, only 23.5% of a representative sample of California retail pharmacies were furnishing naloxone to patients without a physician prescription. Reasons the practice was not being implemented may include lack of knowledge of legislation, lack of required training, stigma about substance use disorder, and time.4,5 With only 50.6% of pharmacies stocking nasal naloxone, patients may face a delay in access to the drug.
Limitations include low rural pharmacy representation, inclusion of nonpharmacist respondents, absence of data on reasons why pharmacies were not furnishing naloxone, and restriction to California, although most states have some form of pharmacy-based naloxone distribution. Over the last 2 years, the Board of Pharmacy has provided naloxone training to more than 700 of California’s 40 000 pharmacists. Whether naloxone will become more available with training of additional pharmacists and implementation of standardized policies by pharmacy chains needs to be studied.
Accepted for Publication: July 31, 2018.
Corresponding Author: Talia Puzantian, PharmD, BCPP, Keck Graduate Institute School of Pharmacy, 535 Watson Dr, Claremont, CA 91711 (firstname.lastname@example.org).
Author Contributions: Drs Puzantian and Gasper had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Both authors.
Acquisition, analysis, or interpretation of data: Both authors.
Drafting of the manuscript: Puzantian.
Critical revision of the manuscript for important intellectual content: Both authors.
Statistical analysis: Puzantian.
Administrative, technical, or material support: Both authors.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Additional Contributions: We thank Chris Lim, BS, Howard Park, BS, and Rachita Sumbria, PhD, all from Keck Graduate Institute, for performing statistical analyses, a role for which they did not receive compensation; and Ramisha Ali, BS, Inet Amirian, BS, Kofi Atta-Boateng, BS, BSc, Priscilla Arteaga, BS, Winnie Chan, BS, Allen Chung, BS, Anthony Costy, BS, Nour Dabbas, BS, Sirun Gasparyan, BS, Marina Girgis, BA, Dominic Goria, BS, Shana Henderson, BS, Amandeep Kaur, BS, Tanya Lengvilas, BS, Chris Lim, BS, Mark Lua, BS, Hollie Maguire, BS, Dominique Miller, MS, Conor Moldowan, BS, Amarachi Okafor, BS, Rupangi Patel, MS, Tiffany Samouha, BS, Patricia Sedlock, BS, Sara Sheik, BA, Michael Soliman, BA, Taguhi Tagakchyan, BS, Emily Tat, BA, Danielle Tessier, BS, Peter Tran, BS, and Rebekah Trules, MPH, all from Keck Graduate Institute, for conducting telephone interviews, a role for which they did not receive compensation.