Creating the Required Infrastructure

Best Practice: Develop documentation and patient education policies and procedures

Policies and procedures will help the pharmacy determine how they will obtain informed consent from the patient, document that the injection has been provided, and communicate with prescribers. Example informed consent questions include, but are not limited to:

1. I understand that injectable naltrexone is currently indicated and approved by the FDA for alcohol dependency and/or for the treatment of opioid dependency.
2. I understand that injectable naltrexone may cause liver injury and I need to notify my healthcare provider if I develop symptoms and/or signs of liver disease.

Community pharmacies already offering injectable naltrexone are excellent resources to obtain example informed consent documents.

Best Practice: Arrange for patient education materials and resources

Community pharmacies should develop concise, easy to read patient educational materials. These materials should:

• Provide general basic information about naltrexone injections, including who would be eligible, and its associated benefits as part of the overall treatment regimen for OUD.
• Include a description of the benefits of receiving the injection at a community pharmacy and general information about the injection process.
• Ideally, the materials should be one page (front and back) and written using simple and easy to understand language.

Individuals receiving a naltrexone injection are at risk for an adverse event if the patient has a health condition requiring administration of an opioid. Like alerts for individuals with diabetes, a community pharmacy offering injectable naltrexone should obtain physical educational resources (e.g., bracelets, or cards) to provide to the patient at the time of an injection. Educational materials, especially bracelets, are beneficial in informing first responders or other healthcare professionals that a person is being treated with injectable naltrexone.

Once developed, patient educational materials should be translated, as necessary, to meet the needs of patients in the pharmacy service area.

Best Practice: Establish policies and procedures related to injection delivery

The policies and procedures should focus on procurement of injectable naltrexone, including determining insurance coverage for injectable naltrexone from major insurers in the area, including Medicaid.

A pharmacy beginning to offer injectable naltrexone should order injectable naltrexone kits on an as-needed basis until the pharmacy can determine the actual demand that requires maintaining doses on-site. Most established pharmacies keep one or two kits on site for walk-in appointments. Otherwise, they work with the prescriber and/or the patient to schedule an injection appointment and then order the naltrexone 24 hours before the appointment.

Best Practice: Set aside a private consultation room

The private consultation room should be (a) located close to the pharmacy, (b) utilized only for clinical consultations and not shared or used for other purposes (e.g., office, stock room) in the pharmacy, and (c) ideally located near the pharmacy restroom if a rapid urine drug test will be conducted. A location close to the restroom eliminates the patient having to traverse the pharmacy to provide a urine sample. The room can also allow for behavioral health counseling to occur (via telehealth) and will provide a private space to consult with the patient prior to giving the injection.

Best Practice: Establish an adverse event plan

For a community pharmacist that is planning to or is currently offering injectable naltrexone, an adverse event plan will offer guidance related to questions or problems that may arise during the injection process.