Dear Members and Staff of the Board of Pharmacy,

BrightView LLC would like to express it sincere appreciation for the opportunity to comment on Guidance Document 110-6, Guidance for Pharmacies Within Opioid Treatment Programs. We commend the Board on acknowledging some of the unique situations that arise in the operation of an OTP. We also understand the Board's efforts to maintain the integrity of the practice of pharmacy.

However, Virginia remains as one of only five states in the Union to subject OTPs to general pharmacy regulations. Opioid treatment programs are highly regulated by the Drug Enforcement Administration and Substance Abuse and Mental Health Services Agency. Also, each facility has a separate accreditation by the Joint Commission. This means every aspect of OTP operations are already regulated by a federal agency and private accreditation body. They keep a handful of medications on hand for the treatment of individuals with opioid use disorder and are highly specialized in this service. Therefore, the risk of diversion and provision of the correct dosages of medications is significantly reduced in comparison to the operation of a community retail pharmacy.

Our comments reflect what we believe would provide more efficient operation of the OTP pharmacy. Unnecessary regulatory burdens restrict the number of OTPs that could be in operation and thereby restricting access to care. This is counterproductive when the rate of opioid related deaths continues to increase at an alarming rate. Finally, we would recommend permanently placing these suggestions in regulation in addition to the waiver process already in place. 

Waive the requirement of allowing a pharmacist in charge to supervise no more than two pharmacies.

This strict limitation does not account for the volume of medications dispensed, carried in inventory, or number of patients served. Again, OTP pharmacies only carry a handful of drugs for the treatment of opioid use disorder and alleviation of symptoms associated with acute withdrawal upon the introduction of an opioid agonist. Federal law limits the number of patients each prescriber can treat and only those patients are allowed to receive medications from the pharmacy. This type of pharmacy operation does not require a full-time pharmacist and only a few personnel are allowed to administer or dispense the medications. 

BrightView also recommends, in lieu of a pharmacist in charge, to allow the designation of a pharmacy director for all OTP pharmacies within a particular program. This position would have ultimate responsibility for all pharmacy personnel, regulatory compliance, and proper handling of all medications. This position is already established in a medical director for the OTP under federal law and their responsibility is compliance and proper practice of all medical personnel.

Allow the storage of Schedule VI drugs administered to patients within the pharmacy enclosure or in a secured storage cabinet outside the pharmacy enclosure.

During the induction and initial dosing of an opioid agonist, BrightView will administer "comfort medications" to patients for abatement of acute withdrawal symptoms  brought about by the opioid agonist. All of these medications are non-narcotic drugs to treat nausea, headaches, and other symptoms that cause discomfort. They are at a low risk of diversion or harmful effects.

In order to stock and administer these medications, BrightView has been asked to apply for a controlled substances registration pursuant to 18 VAC 110-20-690. The registration carries its own separate storage obligations for a facility that is not open on a twenty-four hour basis. The regulation controlling storage, 18 VAC 110-20-710, requires the drugs to be stored "in a fixed or secured room, cabinet or area that has a security device for the detection of breaking."

This requirement is incongruent with the pharmacy permit held by the OTP and will not allow the storage of the Schedule VI medications within the pharmacy enclosure. the clinics have limited space to treat patients, and more unnecessary storage requirements take away from that space. BrightView locations are DEA certified facilities ands are compliant with all security measures. No practical reason exists to require these medications to be stored in a separate enclosure from the pharmacy , or in the alternative, in a cabinet with the proper security device that is not in another enclosure.

Waive the requirement of a pharmacist verification of all take home doses.

BrightView understands Va. Code 54.1-3320 requires the verification of a prescription by a pharmacist before the drug is dispensed to a patient. However, the healthcare field is experiencing unprecedented shortages of licensed providers, and the practice of pharmacy is no different. Filling a full-time pharmacist position has proven itself to be difficult at best. Further, the duties on an OTP pharmacist are limited and not attractive to most candidates due to a prohibition on administration of drugs and the use of only two medications. Therefore, BrightView is limited to employing a pharmacist on a part-time basis.

Traditionally, the OTP model uses methadone for treatment of patients with opioid use disorder. This model is more conducive to employing a pharmacist on a part-time basis because patients infrequently change their dosage. The dosage amounts for methadone remain stable because of the strict phasing requirements. Therefore, a pharmacist can be on duty at the OTP for only a few hours per day in the morning or evening when when patients pick up their doses. However, SAMSHA is currently in favor of amending federal regulations that will allow more take-home doses of methadone, which will require increased presence of pharmacists in OTPs that use primarily methadone.

BrightView is innovating the OTP model and uses primarily buprenorphine, which allows more take-home doses and increased frequency of change in dosages. When a pharmacist is only working part-time hours, and a patient's dosage changes they may have to daily dose and come back the next day or several days later when a pharmacist is on duty.

Unnecessary daily dosing presents a huge barrier to patient care due to inability to acquire stable transportation. Allowing a patient to have take-home doses from the OTP pharmacy greatly increases a patient's medication adherence and probability of successful treatment. Otherwise, patients will have to travel to an outside pharmacy, which often do not carry buprenorphine or will not fill the prescription.

This barrier only exists in Virginia and a handful of other states. Most states have removed the requirement of a pharmacist to verify take-home doses with no increase in medication errors or adverse events.

Until the statutory requirement changes, we recommend waiving the restriction of placing different medication strengths of the same drug in the same container and the OTP pharmacies be allowed to dispense take-home doses in a customized medication package that provides the patient's daily dose. This would allow for each container to hold two or more prescribed solid dosage forms of the same drug in different strengths to an equivalent of the daily dose. For example, allow two milligram and eight milligram buprenorphine solid doses in the same container. To make this a safer alternative the container will: (1) be labeled, or package designed, to indicate the day and time or period of time when the contents are to be taken by the patient; and (2) not be filled beyond its quantity capability to prevent damage to the dosage forms.