The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.

This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. Participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors (target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Study Population:

• Eligible pharmacies
• Patients prescribed chronic opioid therapy

Inclusion Criteria for pharmacies:

• Stock naloxone for outpatient dispensing.
• Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
• Pharmacy leadership willing to be randomized to order of implementation.
• Have or can implement a naloxone standing order.

Exclusion Criteria for pharmacies:

• None

Inclusion Criteria for patients:

• Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol
• Receive medications at participating pharmacies
• Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
• (for surveys)18 years of age or greater

Exclusion Criteria:

• (for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order