Clarification on Take-Home Naloxone
Dear Editor,
We applaud EM Resident (June/July 2017) cover and related review on “Take-Home Naloxone.” We would like to provide clarification on content to avoid confusion and/or misperceptions. Naloxone is available in a variety of dosage forms (see Table 1).
While many states have taken steps to increase access to naloxone, it would be inaccurate to describe this medication as “Over-the-Counter” (OTC), despite this use by some media outlets. OTC traditionally implies that a medication is available without a prescription and located on the shelf of a pharmacy. Naloxone is currently by prescription only; however, many states have enacted laws/regulations that no longer require an individualized or traditional prescription.
- Statewide Standing Order — written order by the state's Physician General that permits designated individuals (usually pharmacists) to distribute naloxone
- Entity Specific Standing Order — written order by physician/provider that allows specific designated individuals to distribute naloxone
- Pharmacist Prescriptive Authoity — allows pharmacists to initiate prescriptions
- Collaborative Practice Agreements — Formal relationships between pharmacists and physicians (or other providers) that allow specific pharmacists to provide to patients.
These standing orders or collaborative practice agreements may be written for one dosage form or multiple dosage forms including the “off label” generic prefilled syringe with a nasal adapter.
Table 1. Forms of Naloxone
| Product | Strength | FDA approved | Cost (AWP– Redbook.com) | Use as “Take Home” |
| Solution, Injection (Vial — as pictured on the cover) | 0.4 mg/mL (1 mL) 4 mg/10 mL (10 mL) | Yes — IM, IV, Subcutaneous | $13-24/ 1mL | Unlikely as a volumetric syringe is required for use. |
| Solution, Prefilled Syringe | 2 mg/2 mL (2 mL) | Yes — IM, IV, SQ
Off Label — | $20/ unit plus cost of intranasal adapter | Unlikely with luer lock syringe (IM/IV, subcutaneous use) Yes with nasal adapter option |
| Liquid, Nasal (Narcan ®) | 4 mg/0.1 mL 2 mg/0.1mL | Yes — intranasal | $75 per unit (packaged with two units) | Yes as no assembly is required |
| Solution, Auto-injector Injection ( Evzio ®) | 0.4 mg/0.4 mL (0.4 mL) AND 2 mg/0.4 mL (0.4 mL) | Yes — IM/Subcutaneous | $2250 — $2460/ unit (Packaged with 2 units plus a trainer device) | Yes as voice prompted instructions |
This clarification is important, as we share the authors' concerns that designating naloxone as an OTC product may result in a lack of proper training among individuals purchasing this medication. Fortunately, even though naloxone may be perceived as an OTC product because of its increased availability through the mechanisms described above, current laws still require a prescription and in turn counseling from a licensed pharmacist. This ensures an opportunity to provide each individual with appropriate training and instructional materials. Most importantly, this training should include the importance of calling 911 and not delaying the activation of emergency medical services. In some cases, individuals experiencing an overdose caused by long acting opioids or new synthetic opioids may require additional doses or continuous infusion of naloxone over an extended period of time to fully reverse the respiratory depressive effects caused by these substances.
Sincerely,
Daniel Ventricelli, PharmD, MPH
Assistant Professor of Clinical Pharmacy
Department of Pharmacy Practice and Pharmacy Administration
Philadelphia College of Pharmacy/University of the Sciences
Katherine F. Koffer, BS, PharmD, CDE
Assistant Professor of Pharmacy Practice
Department of Pharmacy Practice and Pharmacy Administration
Philadelphia College of Pharmacy/University of the Sciences