The Center for Drug and Alcohol Programs (CDAP) at the Medical University of South Carolina (MUSC) focuses on research and clinical services for substance use disorders. CDAP is comprised of both inpatient and outpatient services. Outpatient services include an intensive program with daily group meetings and an individualized treatment program where patients are able to take part in one-on-one counseling. Approximately 1200 outpatients are seen in the CDAP clinics annually, 300 of which are in the intensive outpatient program. The patients seen in CDAP have a range of substance use disorders which include alcohol and opioid dependence, among others. Given the patient population, there is a significant demand for extended-release intramuscular naltrexone (ERIN), but the CDAP clinics are neither staffed nor structured for medication administration or storage. A previously established pharmacist-run clinic exists at MUSC for the purpose of administering long-acting injectable antipsychotics and monitoring the patients who receive them. An explanation of the financial impact of the antipsychotic injection clinic to our institution is described by Phan and Vandenberg.1 With the increasing patient and physician demand, a protocol was developed to allow pharmacists to administer ERIN in the pharmacist-run clinic.

At MUSC, any pharmacist providing collaborative drug therapy management (CDTM) services must be credentialed by the Department of Pharmacy Services. They must meet the minimal competencies required for their practice area and demonstrate continued competency annually. To educate pharmacists who will provide services in the ERIN clinic, an online PowerPoint-style module was created using the FDA-approved prescribing information and medication guide for extended-release intramuscular naltrexone (Vivitrol®) and through consultation with nurses in a local clinic who previously administered ERIN (Appendix 1).2,3 Pharmacists seeking credentialing under the ERIN protocol must complete the module and pass a test. Credentialed pharmacists must complete the module and pass the exam annually in order to maintain credential. Currently, four credentialed psychiatric pharmacists provide services in the ERIN clinic.

The protocol is limited to adult outpatients who have a referral to the ERIN clinic. In order to be referred to the clinic, patients must voluntarily wish to participate in treatment and sign an informed consent, agree to carry emergency identification (wallet card, bracelet, or necklace/“dog tags”), and be 18 years or older. They must also meet criteria for treatment with ERIN as described by the manufacturer (be opioid free for at least 7 days, have tolerated PO naltrexone, and have liver transaminase levels less than three times the upper limit of normal). Referrals may only be made by university credentialed attending psychiatrists who have a signed CDTM agreement for ERIN with a credentialed pharmacist. Referrals may be made while a patient is admitted as an inpatient or while outpatient, but the patient must have outpatient status at the time of the clinic visit. The protocol requires the referring physician to provide the clinic with the indication for naltrexone (either alcohol dependence or opioid dependence), treatment goals for the patient, a current medication list, a list of comorbid disease states, and most recent liver transaminase levels and urine drug screen. The physician must complete a referral note in our institution's electronic medical record.

Once a patient is referred to the pharmacist-run ERIN clinic, a CDAP administrative assistant completes the initial drug procurement forms via the manufacturer's support services program.4 ERIN is shipped from specialty pharmacies which vary based upon the patient's insurance provider. Once insurance approval has been granted, a pharmacist from the ERIN clinic contacts the patient directly to schedule an appointment and works with the specialty pharmacy to arrange shipment of the medication. At this point the clinic appointments are scheduled to fit in to the daily schedule of the pharmacist and the patient and there are not designated days or times that the clinic is open.

Each ERIN clinic appointment lasts approximately 15–30 minutes. The credentialed pharmacist discusses the following information with the patient during each ERIN clinic visit:

Additionally, during clinic visits the pharmacist may check vital signs and complete a visual inspection to monitor for signs of hepatotoxicity and injection site reaction. After the injection is given, patients are observed for 15 – 30 minutes prior to leaving the clinic. According to patient-specific factors and other recent laboratory results, the pharmacist is authorized to order comprehensive metabolic panels, urine drug screens, and complete blood counts. Liver transaminases and urine drug screens must be collected at least quarterly. The pharmacist will contact the referring physician upon discovery of any suspected medication-related adverse effects, abnormal laboratory results, or if it is discovered that the patient has a relapse to alcohol or opioids to determine if treatment with ERIN should proceed.

All patient encounters are documented in the electronic medical record and notes sent to the referring provider for co-signature. A facility charge ticket is completed by the pharmacist for each encounter and submitted to the insurance company for reimbursement. Follow-up visits are scheduled approximately every 4 weeks based on the dosing interval for ERIN. If an appointment is missed, it is rescheduled as soon as possible to resume therapy. Patients are seen by a MUSC psychiatrist approximately every 12 weeks.

The creation of the CDTM protocol for ERIN provides a service to patients at MUSC that was previously unavailable. The purpose of the service is to provide continuity of care to patients who require ERIN, and enhance care through education, monitoring, and close follow-up. Potential benefits of the pharmacist-run clinic are that injections are given in the same location as the CDAP clinic and the patient will see the same pharmacist providers each visit. However, there are also several barriers that were anticipated when developing the clinic, some of which proved to be true barriers, and others which did not. The potential barriers included medication procurement, issues with billing and reimbursement, and optimizing referral volume. Working with the ERIN manufacturer's support services program has been beneficial as the program coordinators assist with prior authorization and initial communication with the specialty pharmacies, so medication procurement, billing, and reimbursement have not been significant issues as were initially anticipated. However, all requests for subsequent drug shipments and appointment scheduling are managed by clinic pharmacists to ensure doses are obtained on time for each patient's next clinic appointment. This method of clinic management requires time and organization on the part of the pharmacist, but it is currently the same process followed by the antipsychotic injection clinic at our facility. The most significant barrier encountered thus far is maintaining an appropriate referral volume. The ERIN manufacturer does not offer patient assistance to uninsured patients, so self-pay clients are typically not referred to the pharmacist-run clinic. Due to the issues with treatment of acute pain in emergency situations, some potential patients are deterred from initiating treatment with ERIN. In other cases patients do not view ERIN as a long-term treatment option and, therefore, decide to stop therapy with the medication after they have achieved abstinence for a certain period of time. Lastly, patients may have legal issues pertaining to their substance use that interrupts their participation in the pharmacist-run clinic. In most situations, however, the patients in the ERIN clinic have reported success with the medication and find it a beneficial tool for maintaining sobriety/abstinence. In the future a survey may be incorporated to assess patient satisfaction with the pharmacist-run ERIN clinic.

After 10 months of seeing patients in the ERIN clinic, MUSC has demonstrated that a pharmacist-run injection clinic is a viable option for patients who need to receive ERIN.

If you would like a copy of the clinic protocol, informed consent document, pharmacist credentialing module, or comprehension questions for the credentialing module, please contact Amy Hebbard.

1.
Phan
SV
,
Vandenberg
AM.
Financial impact of a pharmacist-managed clinic for long-acting injectable antipsychotics
.
Am J Health Syst Pharm
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Vivitrol®: Highlights of prescribing information; [revised 2013 July; cited 2013 Aug 8]; [2p.]. Available from http://www.vivitrol.com/Content/pdf/prescribing_info.pdf
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Vivitrol®: Medication Guide; [revised 2013 July; cited 2013 Aug 8]; [2p.]. Available from http://www.vivitrol.com/Content/pdf/medication_guide.pdf
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TouchpointsSM: Enroll your patients in TouchpointsSM Support Services; 2013 [cited 2013 Nov 1]; [about 1 screen]. Available from http://www.vivitrol.com/HCP/VivitrolResources/Touchpoints
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