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Original Research |

Nonrandomized Intervention Study of Naloxone Coprescription for Primary Care Patients Receiving Long-Term Opioid Therapy for PainNaloxone Coprescribing in Primary Care Clinics

Phillip O. Coffin, MD, MIA; Emily Behar, MA; Christopher Rowe, MPH; Glenn-Milo Santos, PhD, MPH; Diana Coffa, MD; Matthew Bald, MD; and Eric Vittinghoff, PhD
[+] Article, Author, and Disclosure Information

This article was published at www.annals.org on 28 June 2016.


From San Francisco Department of Public Health and University of California, San Francisco, San Francisco, California.

Disclaimer: The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the San Francisco Department of Public Health.

Acknowledgment: The authors thank Michele Geier and the site leads at each clinic (Soraya Azari, Barbara Wismer, Jan Gurley, and Keith Seidel) for participation in coordination of this project.

Grant Support: By National Institutes of Health grant R21DA036776.

Disclosures: Drs Vittinghoff and Santos reports grants from NIH during the conduct of the study. Dr. Coffin reports grants from NIH during the contact of the study and has led studies that received donated medications from Alkermes (naltrexone, 2014-2015) and Gilead (ledipasvirsofosbuvir, 2016-present). Neither of these relationships is related to the submitted publication. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2771.

Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.

Reproducible Research Statement:Study protocol: Not available. Data set: Available from Dr. Coffin in the context of agreed-upon use and human subjects approval. Statistical code: Available from Dr. Coffin (phillip.coffin@ucsf.edu).

Requests for Single Reprints: Phillip Coffin, MD, MIA, San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102; e-mail, phillip.coffin@ucsf.edu.

Current Author Addresses: Drs. Coffin and Santos, Ms. Behar, and Mr. Rowe: San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 500, San Francisco, CA 94102.

Dr. Coffa: University of California School of Medicine, 1001 Potrero Avenue, SFGH 80, San Francisco, CA 94110.

Dr. Bald: Kaiser Permanente San Francisco, 2425 Geary Boulevard, M160, San Francisco, CA 94115.

Dr. Vittinghoff: University of California, 550 16th Street, San Francisco, CA 94158.

Author Contributions: Conception and design: E. Behar, D. Coffa, P.O. Coffin, G. Santos.

Analysis and interpretation of the data: P.O. Coffin, C. Rowe, G. Santos, E. Vittinghoff.

Drafting of the article: M.R. Bald, E. Behar, P.O. Coffin, C. Rowe, G. Santos, E. Vittinghoff.

Critical revision for important intellectual content: E. Behar, P.O. Coffin, C. Rowe, G. Santos, E. Vittinghoff.

Final approval of the article: M.R. Bald, E. Behar, D. Coffa, P.O. Coffin, C. Rowe, G. Santos, E. Vittinghoff.

Provision of study materials or patients: E. Behar, D. Coffa.

Statistical expertise: C. Rowe, E. Vittinghoff, G. Santos.

Obtaining of funding: P.O. Coffin, G. Santos.

Administrative, technical, or logistic support: M.R. Bald, E. Behar, D. Coffa, G. Santos.

Collection and assembly of data: M.R. Bald, E. Behar, P.O. Coffin.


Ann Intern Med. 2016;165(4):245-252. doi:10.7326/M15-2771
© 2016 American College of Physicians
Text Size: A A A

Background: Unintentional overdose involving opioid analgesics is a leading cause of injury-related death in the United States.

Objective: To evaluate the feasibility and effect of implementing naloxone prescription to patients prescribed opioids for chronic pain.

Design: 2-year nonrandomized intervention study.

Setting: 6 safety-net primary care clinics in San Francisco, California.

Participants: 1985 adults receiving long-term opioid therapy for pain.

Intervention: Providers and clinic staff were trained and supported in naloxone prescribing.

Measurements: Outcomes were proportion of patients prescribed naloxone, opioid-related emergency department (ED) visits, and prescribed opioid dose based on chart review.

Results: 38.2% of 1985 patients receiving long-term opioids were prescribed naloxone. Patients prescribed higher doses of opioids and with an opioid-related ED visit in the past 12 months were independently more likely to be prescribed naloxone. Patients who received a naloxone prescription had 47% fewer opioid-related ED visits per month in the 6 months after receipt of the prescription (incidence rate ratio [IRR], 0.53 [95% CI, 0.34 to 0.83]; P = 0.005) and 63% fewer visits after 1 year (IRR, 0.37 [CI, 0.22 to 0.64]; P < 0.001) compared with patients who did not receive naloxone. There was no net change over time in opioid dose among those who received naloxone and those who did not (IRR, 1.03 [CI, 0.91 to 1.27]; P = 0.61).

Limitation: Results are observational and may not be generalizable beyond safety-net settings.

Conclusion: Naloxone can be coprescribed to primary care patients prescribed opioids for pain. When advised to offer naloxone to all patients receiving opioids, providers may prioritize those with established risk factors. Providing naloxone in primary care settings may have ancillary benefits, such as reducing opioid-related adverse events.

Primary Funding Source: National Institutes of Health.

Figures

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Appendix Figure 1.

Checklist for clinic staff to train patients receiving naloxone.

CPR = cardiopulmonary resuscitation.

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Appendix Figure 2.

E-mail template to remind providers about naloxone prescribing.

ECW = eClinicalWorks; LCR = lifetime clinical record.

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Appendix Figure 3.

Naloxone for opioid safety patient brochure.

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Appendix Figure 4.

Informational sheet for pharmacists on ordering, dispensing, counseling, and billing for naloxone.

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Appendix Figure 5.

Expected number of opioid-related ED visits per month by receipt of naloxone prescription, by clinic.

ED = emergency department.

* Expected number of ED visits per month in 2 patients (1 who received a naloxone prescription and 1 who did not), both with mean values of all covariates and stratified by clinic.

† For both trajectories, time was uniformly centered on April 2014, the median time of receipt of naloxone prescription during the study period among patients who received naloxone.

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Appendix Figure 6.

Expected opioid dose by receipt of naloxone prescription, by clinic.

MEQ = morphine equivalent.

* Expected MEQ daily dose in milligrams in 2 patients (1 who received a naloxone prescription and 1 who did not), both with mean values of all covariates and stratified by clinic.

† For both trajectories, time was uniformly centered on April 2014, the median time of receipt of naloxone prescription during the study period among patients who received naloxone.

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Figure 1.

Expected number of opioid-related ED visits per month, by receipt of naloxone prescription.

ED = emergency department.

* Expected number of ED visits per month calculated for 2 patients (1 who received a naloxone prescription and 1 who did not), both with mean values of all covariates.

† For both trajectories, time was uniformly centered on April 2014, the median month of receipt of naloxone prescription during the study period among patients who received naloxone.

Grahic Jump Location
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Figure 2.

Expected opioid dose, by receipt of naloxone prescription.

MEQ = morphine equivalent.

* Expected MEQ daily dose in milligrams in 2 patients (1 who received a naloxone prescription and 1 who did not), both with mean values of all covariates.

† For both trajectories, time was uniformly centered on April 2014, the median month of receipt of naloxone prescription during the study period among patients who received naloxone.

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