Ford Research Group
In making the decision to begin offering an injectable naltrexone service, best practices dictate that a community pharmacy should (1) train staff, (2) create an infrastructure, (3) establish lab protocols, and (4) establish referral relationships. By doing so, community pharmacists will be better informed, prior to making their decision, about the requirements and associated best practices necessary to establish an injectable naltrexone service in their community.
Beyond any logistics, community pharmacists currently offering injectable naltrexone services highlighted that one of the most important factors is creating a no-judgement zone. Fostering a no-judgement zone promotes pharmacy staff understanding about why the service is being offered, that they are there to help individuals with an OUD as they move forward with their lives, and to provide a safe and supportive environment for these individuals.
Prior to offering injectable naltrexone services, a pharmacist must undergo appropriate training.
Two training courses are available through the Division of Pharmacy Professional Development at the University of Wisconsin-Madison School of Pharmacy. Note: There is a fee associated with both courses. Please refer to the websites for cost information.
The course provides an overview of the regulations associated with providing non-vaccine injections.
The course is designed to meet the non-vaccine injection requirements for Wisconsin. Pharmacists who successfully complete this training will be able to perform intermuscular injections, including naltrexone.
This YouTube video, developed by the Providers Clinical Support System, can serve as a reminder of how to prepare a naltrexone injection for delivery
As part of the pharmacy training efforts, two best practices were identified.
The benefits of multiple trained pharmacists, front-end staff, and pharmacy residents (if possible) is that it lessens disruptions to the pharmacy’s workflow by scheduling patients for the injection. In turn, the pharmacist can focus on activities such as reviewing medications or preparing and delivering the injection. The handing-off of duties can be especially beneficial if the pharmacy has walk-in clients.
By engaging front-end staff, they can complete such tasks as calling to remind the patient of their appointment, checking in the patient, conducting a benefits investigation, billing insurance, scheduling the initial or following injection appointment with the patient or obtaining a urine sample from the patient. In addition to preparing and delivering the naltrexone injection, trained residents could fulfill many of the front-end staff activities and help with the coordination of resources between recovery coaches or counseling providers, whenever possible.
Although giving a naltrexone injection is like giving other injections (although it may take a little longer), additional activities are needed for this injection. Four best practices were identified that relate to efforts within the pharmacy to create the required infrastructure to offer injectable naltrexone.
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:
Community pharmacies already offering injectable naltrexone are excellent resources to obtain example informed consent documents.
Community pharmacies should develop concise, easy to read patient educational materials. These materials should:
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.
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.
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.
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.
Five best practices were identified that relate to the establishment of lab protocols prior to offering naltrexone injections.
A urine drug testing policy and procedure should outline (a) how the urine drug test will be conducted, (b) who will be responsible for conducting the test, (c) who will be responsible for confirming the results prior to providing the injection, (d) steps needed if the results are positive, and (e) how the results will be communicated to the patients’ prescriber. In addition, the pharmacist needs to ensure that urine drug testing equipment is in stock in the pharmacy.
A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is required if a pharmacy is going to administer any lab tests, including a rapid urine drug test, as part of the process to provide injectable naltrexone.
More information can be found at How to Obtain a CLIA Certificate of Waiver. Note: there may be fees associated with obtaining a CLIA certificate. Please refer to the CLIA Certificate Fee Schedule for more information.
After the pharmacy conducts the urine drug test, the results obtained in the pharmacy should be sent to an outside pharmacy for confirmation. To accomplish this goal, the pharmacy should establish a relationship with an external lab where the UDS sample could be sent to the lab to confirm the findings in the pharmacy. In doing so, it may be necessary for the patient to sign a permission for the urine drug test results to be forwarded to an outside lab.
A rapid urine drug test should be done to check for recent opioid use immediately prior to administering naltrexone. While some pharmacists rely on test results performed by the prescriber, this does not represent best practice since a patient could use opioids in the time between leaving the prescriber’s office and arriving at the pharmacy. It is essential to ensure that a patient is clean of opioids prior to being given the injection to avoid precipitating opioid withdrawal.
According to FDA Vivitrol prescribing information, a person must be opioid-free for a minimum of 7-10 days before starting naltrexone treatment.
Health systems can be an important initial collaborator for providing telehealth-supported naltrexone injection services. Regardless of whether a health system is involved, it is important to identify the need for opioid use disorders services within the community and establish referral relationship to support the naltrexone injection service within the pharmacy. To accomplish this goal, the pharmacist should focus on activities related to marketing & outreach and building referral relationships.
Best practices are critical to building trusting and supportive relationships with practitioners.
Pharmacists who offer injectable naltrexone should develop educational materials for potential referral sources and marketing purposes. The informational handout should describe the benefits of pharmacy-provided injectable naltrexone and identify the process associated with offering this service in the pharmacy. Important components of that messaging are convenience, flexibility, accessibility, and trust.
Once the messaging has been created, the pharmacist should identify approaches (word of mouth, website, faxes, and e-mails) to promote that the pharmacy now offers naltrexone injections. Promotion strategies could include leveraging existing community relationships (local opioid coalition or community organizations) to reach target audiences (see above).
While some counties may be in a healthcare shortage area, the prevailing perception among pharmacists interviewed was that the lack of access to prescribers might be associated with: (1) a predominance of practitioners who are unwilling to prescribe naltrexone or (2) an unawareness of existing prescribing practitioners, or clinics or facilities, that can serve as referral sources for patients with an opioid use disorder and who need MOUD. It is, therefore, incumbent on pharmacists to seek out sustainable referral sources for patients who are viable candidates for injectable naltrexone treatment.
To accomplish this best practice, the pharmacy must identify the key target audiences. These relationships could include:
1To determine if your pharmacy is in an identified healthcare shortage area for primary care or mental health services, please visit Health Professional Shortage Area Find to search by county or by address.