July 14, 2017

Monica Bharel, MD, MPH

Commissioner

Massachusetts Department of Public Health

250 Washington Street

Boston, MA 02108 – 4619

Re: Proposed Amendment to 247 CMR 6.00, 9.00, 15:00 & 20.00

Dear Commissioner Bharel:

On behalf of the 984 chain pharmacies operating in the Commonwealth of Massachusetts, the National Association of Chain Drug Stores (NACDS) writes to share our numerous concerns regarding the proposed amendments to 247 CMR 6.00, 9.00, 15:00 & 20.00. Our concerns are outlined below.

247 CMR 6.02: License Requirements

We believe that requiring multiple licenses for compounding is unnecessary and recommend sterile & drug store pharmacy licenses. Sterile compounding is a subset of compounding which poses public risk and USP <800> has solved for employee protection. Requiring an application for Complex Compounding License in MA is a burden for pharmacies and does not provide public or employee protection. As such, specific licensure to perform complex compounding is a burden on the healthcare system.

Furthermore, a 12-month license is too short as it can be affected by construction in the pharmacy or the pharmacy’s policies and procedures. We recommend that the reapplication should be widened to 3 years.

247 CMR 6.03: Suitability of Applicant, Licensee, and Interest Holder

6.03(9): This section states that if an applicant, licensee, or interest holder has prescriptive privileges, the Board may determine that he/she is not suitable to establish or maintain a pharmacy. We urge the Board to consider the possibility of pharmacist-given prescriptive privileges in Massachusetts. As the profession progresses, states are granting prescriptive authority to pharmacists. We urge the Board to strike this language from the proposed amendment or making an exception for pharmacists.

247 CMS 6.04: General Application Requirements

6.04(2)(c): This section requires a separate registration for controlled substances. We believe this is duplicative and burdensome given that all prescription drugs are controlled substances in Massachusetts. Therefore, we recommend removing this requirement.

6.04(2)(f): Submitting a certified blueprint is burdensome for the Board to review and is an unnecessary requirement for the pharmacy. We recommend removing this requirement.

6.04(2)(h): CMR 9.01(17) indicates that a pharmacy may not refuse to compound simple or moderate non-sterile compounded preparations. We believe that the attestation created in 6.04(2)(h) does not provide any further public safety and is an administrative burden. We recommend removing this requirement.

247 CMR 6.09: Applications for Non-Resident Drug Store Pharmacy, Non-Resident Sterile Compounding Pharmacy, and Non-Resident Complex Non-Sterile Compounding Pharmacy Licenses

6.09(1)(a)(2): This section requires non-resident drug stores to produce a certificate of good standing to the Board. We believe this is a duplicative requirement as the license “free and clear” information is readily available on the home state Board of Pharmacy’s website. We recommend removing this requirement.

6.09(3): This section requires an inspection report from a Board approved inspector. We are concerned that the inspection process in other states may be behind and urge the Board to allow an opportunity to schedule inspections. Additionally, we request clarification on who qualifies as a Board approved inspector.

247 CMR 6.11 (1) - Transfer of Ownership

This section will require the pharmacy licensee to notify the Board of Pharmacy within at least 30 days prior to the sale of a pharmacy.

We believe the 30-day time period can be too long in many special circumstances. It is not uncommon for the time frame between the final contractual agreement to sell a pharmacy and the actual transfer of the business operations to occur within a 14-day period of time. There have been transactions where the selling party required the purchaser to close on the transaction within 14 days. There also may be fact patterns where the sole owner of a pharmacy may want to close and transfer their pharmacy on an expedited basis and may not be able to absorb the cost to keep the store operating for the 30-day time period. Also, if a sole practitioner unexpectedly passes away, the store could remain closed for a month in order to comply with this provision. We would recommend this time period be reduced from 30 days to 15 days or in the alternative, a process be made available where both parties can petition the Board for a shorter time period in which to make this required notification.

247 CMR 6.13: Closing of a Pharmacy

6.13(1)(e): Since the closing and notification requirements are already included in the Board’s rules, we believe the steps outlined in this section are burdensome for both the Board and the pharmacy staff.

6.13(3): We believe that mailing notification to patients is burdensome and patient safety is not impacted as long as the pharmacies properly transfer files as outlined in the regulations and have applicable signage indicated the new location of the patients’ prescription files. We recommend removing this requirement.

247 CMR 6.15: Application for Remodeling, Change in the Configuration, or Change in Square Footage of a Pharmacy

6.15(1): We recommend that it should be “notification” as opposed to “application” for changes to the physical space of a pharmacy. An application creates an unnecessary burden on both the licensee and the Board staff. Any concerns with the notification can be remedied by sending an inspector to the site. Accordingly, we do not believe that a certified blueprint is necessary for changes to the pharmacy and the requirement in 6.15(3)(a) should be removed.

247 CMR 6.16: Application for Relocation of a Pharmacy to a New Address

We do not believe that a certified blueprint of the new pharmacy location is necessary and recommend removing this requirement. Additionally, for 6.16(3), we do not believe a written plan to maintain security of controlled substances during transportation is necessary as the pharmacy will employ professional judgment to transport controlled substances. The written plan adds an administrative burden for both the Board and the pharmacy.

247 CMR 9.01: General Practice Standards

9.01(6): We recommend striking the term “processed or” as it can be confusing based on various pharmacy models. This may also hinder certain business models or if remote order processing is occurring.

9.01(17): We believe this regulation involves business models and the business of pharmacy. Mandating pharmacies to fill certain prescriptions should not be decided by a board regulation, but rather by the pharmacy model.

9.01(18): We believe the intent of this rule is for pharmacists to be compliant with the Health Insurance Portability and Accountability Act (HIPAA). However, this rule does not permit the proper disclosure of confidential information that is permitted under HIPAA, such as to other health care providers and third-party payers. We would recommend adding language to indicate that pharmacists must comply with HIPAA rules.

9.01(19): We recommend striking “and the licensee documents the extenuating circumstance”. The documentation on the licensee is burdensome on the pharmacist and something that can easily be overlooked in the course of day-to-day practice.

9.01(21): We believe this is an antiquated requirement as the ability to check licensure of an individual electronically is readily available. We recommend that an individual must have their personal registration readily retrievable.

9.01(23): This section provides that a pharmacy may not allow any individual who is not a Massachusetts registered pharmacist to direct or supervise the practice of pharmacy.

In most chain pharmacies, the pharmacy department is a separate division of the store which engages in the sale of non-prescription products. The structure of the business has a reporting hierarchy that typically requires all department managers to discuss with and report information to non-pharmacist store managers relative to the overall performance of their department. This is particularly true for pharmacies located within a supermarket.

We recommend that this section be amended to clarify that communications between the pharmacy manager and a store manager relative to the overall operation and performance of the pharmacy department shall not be the subject of this regulation if those communications do not result in the non-pharmacist manager engaging in directing or supervising the practice of pharmacy.

247 CMR 9.04: Requirements for Dispensing and Refilling Prescriptions

9.04(5): We urge the Board to reconsider the phrase “not to exceed 48 hours” as emergency periods may sometimes last longer than 48 hours, especially when considering natural disasters or other events that maybe unpredictable.

9.04(6): The term “attestation” under 9.04 8(d) indicates a statement of some kind and would be an onerous task for a pharmacist to undertake during the work day. If this is not the boards intent, we would recommend moving subsection (d) into the heading under (8) as follows: “(8) A pharmacist who refills a prescription for a controlled substance in Schedules III through VI shall refill controlled substance prescriptions in accordance with 21 CFR s. 1306.22 and record the following information in the computerized pharmacy system or on the written prescription:”

9.04(14): We recommend removal of “on-site Massachusetts registered pharmacist” to permit for workload balancing models or remote processing locations.

9.04(15): We recommend that the Board permit pharmacies to follow DEA Controlled Substances Security Manual guidelines regarding storage of Schedule II medications including hydrocodone products. We urge the Board to consider that with CII-cabinet space limitations, Managers of Record decide how best to identify suitable locations for these and other Schedule II products based on DEA guidelines. Additionally, we have concerns regarding the approval process for this written warning. Such a process can prevent proper patient care during the interim period. We would instead recommend that this process be left to the discretion of the pharmacy to use proper professional and clinical judgment in providing such documentation.

9.04(f): The pharmacist reviews the patient's history on the online Prescription Monitoring Program (PMP) and documents the results. Furthermore, we recommend striking “documents the results”. Documentation is unnecessary and creates administrative burdens. We would recommend that pharmacists utilize their professional judgment to review the patient’s history and the online PMP.

247 CMR 9.05: Interchangeable Drugs

9.05(2): We recommend striking this section. If the prescriber intends for a brand name to be indicated, that should be indicated on the prescription, and as such, the pharmacist will not need to provide any clarifying questions. Our concern would be a misunderstanding between office staff and the pharmacist during this oral exchange if this question is asked with a “yes or no” response.

9.05(4): Mandating the use of the word “interchange” on the label is too prescriptive. We instead recommend that “interchange” or “generic for or other suitable phrase” be used as examples, as long as it’s clear that a generic substitution has taken place. Patients may not understand what the phrase interchange means, while the term “generic” is widely known. Additionally, pharmacies would likely require software changes to make changes to a label, which may require lengthy programming changes and would be extremely burdensome with no extra patient benefit.

247 CMR 9.06: Opioid antagonists

9.06(2): We believe that the term “high overdose area” is vague and pharmacists may not know if they are in a high overdose area. We request the Board more clearly define “high overdose area”.

Additionally, with short expiration dates, it may be quite costly to maintain a supply of naloxone if there is a lack of demand from the public. Furthermore, unless there is a state-wide standing order from a surgeon general or similar other public physician, obtaining a standing order requires a recurring cost. This cost may not be recouped through the sales of naloxone and may lead to the Board getting involved in the business of pharmacy. Therefore, we would recommend that the board not mandate standing orders or a continuous supply of naloxone

9.06(3): We recommend that the Manager of Record or “pharmacy permit holder” be permitted to file the standing order. This would decrease the administrative burden on the Manager of Record without diminishing patient safety.

9.06(7): We recommend not using the phrase “opioid antagonist rescue kit”, as this name may very easily get lost in translation with the public. Instead, we urge the Board to allow pharmacies to use the names such as Opioid Overdose Rescue Kit, Naloxone Rescue Kit or Narcan Rescue Kit as alternatives, which are much more widely known.

247 CMR 9.11: Pharmacy Processing Automation

9.11(1)(d): Given the high cost of equipment, having two types of electronic verification may be cost prohibitive. We urge the Board to consider “pharmacist verification” be included as one of the types of verification for the PPA.

9.11(1)(g): We recommend tracking of what is entered into the cell for the last 30 days, and if there is a possibility of contamination, the pharmacy must quarantine all of that product.

247 CMR 9.13: Return to Stock

9.13(b): If the contents of the vial or label on the vial do not change, we do not believe there is a reason to engage the pharmacists time in this process. We recommend an exception if the return to stock process keeps the original label or there is a barcode process to prevent any type of return to stock a quality related event.

247 CMR 9.14: Transfer of Prescriptions

9.14(1): We request the Board to defer to the DEA guidance dated June 2008[1] and March 2010[2] that states that it is permissible to transfer electronic CIII-CV prescriptions.

9.14(6): We recommend adding an exception for pharmacies under common ownership as allowed by Federal law.

247 CMR 9.15: Verifying a Practitioner's Prescriptive Authority

9.15(3): Since pharmacists are bound by DEA regulations, we recommend revising subsection (3) to remove the requirement to maintain a policy and procedure and instead, indicate that, “the pharmacist shall ensure that a practitioner's prescriptive authority is verified prior to dispensing.” Accordingly, this section should be moved above subsection (2) which identifies the times that a pharmacist may not fill a prescription.

247 CMR 9:16 (6): Maintenance of Prescription Files

This section directs the pharmacist to make a reasonable effort to obtain the patient’s gender. We would recommend that an exception be allowed for those circumstances where the Federal law allows for the patient to declare no gender, both genders, and an alternative.

247 CMR 9.17: Prospective Drug Utilization Review (DUR)