August 5, 2016 David A. Sencabaugh, R.Ph. Executive Director Massachusetts Board of Registration in Pharmacy 239 Causeway Street Boston, MA 02114 RE: Regulations Adopted Jointly by the Department of Public health and the Board of Registration in Pharmacy for the Implementation of M.G.L. c. 94C; 105 CMR 721.000, Standards for Prescription Format and Security in Massachusetts, and 105 CMR 722.000, Dispensing Procedures for Pharmacists. Dear Executive Director Sencabaugh: CVS Health appreciates the opportunity to submit comments regarding the new proposed changes to 105 CMR 700.000 the Implementation of M.G.L. c. 94C. The goal of this communication is to provide the Department of Public Health (Department) and Board of Registration in Pharmacy (Board) with additional information regarding this proposal for their review and consideration. Comments: 700.001 Definitions Long-term Care Facility means any institution whether conducted for charity or profit, that is advertised, announced or maintained for the express or implied purpose of providing three or more individuals admitted thereto with long-term resident, nursing, convalescent or rehabilitative care; supervision and care incident to old age for ambulatory persons; or retirement home care for elderly persons. Long-term Care facility shall include convalescent or nursing homes, rest homes, infirmaries maintained in towns and charitable homes for the aged.  CVS Health believes an Assisted Living Residence (ALR) as defined in 651 CMR 12.02 and licensed by the Department of Public Health should be included in the definition of a Long-term Care Facility. Medication Order means a written order for a medication entered on a patient’s medical record maintained at a hospital, other health facility, or ambulatory health care setting and is dispensed for immediate administration to the ultimate user by an individual authorized by M.G.L. c. 94C to administer such medication.  CVS Health recommends the Department consider striking the word “written” specific to a medication order. Medication Orders can be prescriber, communicated and received by health care facilities in various formats to include, but are not limited to, written, verbal, facsimile, and electronic transmission based on prescriber and facility preference. Allowing the prescriber to leverage options when communicating a medication order, will improve the speed of initiation of therapy as well as documentation of medication administration. Written Prescription means a lawful order from a practitioner for a drug or device for a specific patient that is communicated directly to a pharmacist in a licensed pharmacy, including an electronic prescription; provided, however, that “written prescription” shall not include an order for medication which is dispensed for immediate administration to the ultimate user by a practitioner, registered nurse or practical nurse.  CVS Health recommends the Department amend the definition of a “written prescription” to be aligned with the current Board of Pharmacy definition of a “prescription” as referenced in 247 CMR 2.00.  247 CMR 2.00 states a “prescription means an order for a drug, chemical, device or combination thereof, either written, given orally or otherwise transmitted to a registered pharmacy by a practitioner or his or her expressly authorized agent, to be dispensed or compounded in a registered pharmacy and dispensed by a registered pharmacist to a patient or his or her agent with necessary and appropriate counseling.” 700.004(B)(6) A registered pharmacist and pharmacist intern may dispense by administration influenza vaccine and other immunizations designated by the Department to persons 9 years of age or older provided that (c) each pharmacy that provides immunizations shall follow Department guidelines to disclose whether it receives vaccines free of charge through the Massachusetts Immunization Program and shall notify patients that there may be a difference in cost between immunization services provided at a pharmacy and at a primary care provider’s office.  CVS Health supports the expansion of vaccine administration by a pharmacist intern.  CVS Health believes the proposed requirement to disclose whether a pharmacy receives vaccines free of charge through the Massachusetts Immunization Program will place an unnecessary burden on the pharmacist to provide information not relevant to the health of the patient.  In addition, we believe that providing notification to the patient regarding primary care providers located in the geographical area of the pharmacy, as well as the potential cost differential between immunization service provided by the pharmacy as compared to the provider’s office, will be an onerous task. This requirement, if promulgated, will create a significant challenge for the pharmacy staff to identify available providers in proximity to the pharmacy as well as understanding the scope of the cost of services provided. 700.005 Security Requirements (A) Physical Security Requirements. All applicants and registrants shall provide effective physical security controls against theft and other diversion of controlled substances. All applicants and registrants shall provide physical security controls which meet the conditions set forth in guidelines issued by the Department.  CVS Health respectfully requests the Department provide clarification specific to the enforcement of “guidelines” versus rules. Should it be necessary to amend the “guidelines” at some point in the future, will the Department share the proposal with the public and seek comment prior to implementing any further changes? We believe this is critical to ensure the public and licensees remain informed of the proposed changes as well as having the opportunity to provide feedback regarding any impending impact on their business practice. (B) Personnel Security Requirements. All applicants and registrants shall screen before employment new employees who may work in or around areas where controlled substances are handled. (1) Such screening shall be made solely for the purpose of determining whether the prospective employee is a reasonable person who can be trusted to work in and around controlled substances. Documentation of such screening shall be made available by applicants and registrants to the Commissioner upon his or her request.  CVS Health recommends the Department provide further clarification and direction to licensees regarding how an employer should objectively assess a potential candidate for hire regarding an acceptable of level of trust to be in and around controlled drug substances. 700.006 Requirements for Records, Inventories, and Reports (C) Central Record Keeping. Any registrant may keep central records if he or she holds a valid permit to keep central records issued by the Drug Enforcement Administration and notifies the Commissioner thereof. The registrant must keep records in a manner that makes them easily available for inspection upon request of the Commissioner.  CVS Health respectfully requests the Department further define the intended meaning of “easily available” for inspection. We recommend the Department consider the following language: “The registrant must keep records in a ready retrievable manner for inspection upon request of the Commissioner. Records will be deemed readily retrievable if provide within 72 hours of the request.” 721.060 Emergency Situations in Which Controlled Substances in Schedule II May Be Dispensed upon Oral Prescription.  CVS Health respectfully requests the Department to provide further clarification with respect to the proposed 72 hours timeframe that a prescriber is to provide a pharmacy with a written prescription designating the Authorization for Emergency Dispensing of a schedule II controlled drug substance.  This proposed requirement appears in conflict with 247 CMR 5.03(3) which states: “Within seven days after authorizing an emergency oral prescription, the prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the pharmacy which must have written on its face “ Authorization for Emergency Dispensing” and should comply with federal and state law.  CVS Health recommends the Department adopt the current language as noted in 247 CMR 5.03(3) to maintain consistent with respect to this requirement. In closing, CVS Health appreciates the opportunity to provide these comments to the Department of Public Health and the Board of Registration in Pharmacy for their review and consideration and is available to partner with the Board on a path to better health. Should you or the Department have any questions or require additional information, I can be reached directly at (603) 339-7846. Sincerely, Bill Irvin, R.Ph. Director, Pharmacy Regulatory Affairs CVS Health 13 Commerce Avenue Londonderry, NH 03053 (603) 339-7846 William.irvin@omnicare.com