Mass.Gov



4114800-1171576John N. Rocchio Director, Pharmacy Regulatory AffairsCell: 617-599-9091115 Fisher AveRoxbury, MA 0212000John N. Rocchio Director, Pharmacy Regulatory AffairsCell: 617-599-9091115 Fisher AveRoxbury, MA 02120Via electronic mailJuly 14, 2017David Sencabaugh, R.Ph. Executive Director Department of Public Health Office of Public Protection 239 Causeway Street, Suite 400 Boston, MA 02111RE: Proposed amendments and additions to 247 CMR Chapters 6.00, 9.00, 15.00, and 20.00Dear Executive Director Sencabaugh:I am writing to you in my capacity as Director of Regulatory Affairs for CVS Health and its family of pharmacies located across the United States. CVS Health appreciates the opportunity to submit comments on the proposed amendments to 247 CMR Chapter 6.00: Licensure of Pharmacies, Chapter 9.00: Professional Practice Standards, Chapter 15.00: Continuous Quality Improvement, and Chapter 20:00: Reporting. We recognize the considerable effort that the Board of Pharmacy “the Board” has undertaken in drafting extensive amendments with public wellbeing and patient safety at the heart of their intent. I hope that providing insight from my experience and understanding acquired in my roles as a Massachusetts Registered Pharmacist, Pharmacy Supervisor, Pharmacy Operations Manager of Quality Process Improvement, and Director of Regulatory Affairs for CVS Health will assist the Board in arriving at an optimal set of rules for the preservation of patient safety and pharmacy practice in the Commonwealth. 247 CMR Chapter 6.00: Licensure of PharmaciesRE: 6.03 (9): The Board may determine an applicant or licensee is not suitable to establish or maintain a pharmacy…An applicant, licensee, or interest holder has prescriptive privileges.CVS Health believes a modification to the prescriptive privilege language is warranted based on the expansion of prescriptive authority within the scope of practice of a pharmacist. CVS Health suggests the following amendment to the proposed language.Suggested language: An applicant, licensee, or interest holder has prescriptive privileges exceeding those permitted under the practice of pharmacy.RE: 6.09 (1)(a)(2): In support of an application for a license to operate a non-resident Drug Store Pharmacy, the applicant(s) shall submit…certificate of good standing from the state where the pharmacy is located issued within three months of the application submission dateCVS Health believes this places an unnecessary burden on the state licensing agency of the applicable pharmacy’s domicile state. We recommend striking this requirement and replacing it with an attestation by the applicant that a pharmacy is in good standing, supplemented with a screenshot of the current license status from the applicable board’s license verification site. Suggested language: certificate of proof of good standing from the state where the pharmacy is located issued dated within 3 months of the application submission date;RE: 6.09 (1)(a)(3); 6.09 (2)(b) and (3)(b): In support of an application for a license to operate a non-resident Drug Store Pharmacy, the applicant(s) shall submit… inspection report from a Board approved inspector, conducted within two years of the application submission date; andAn applicant shall achieve a satisfactory Board inspection of the proposed non-resident sterile compounding pharmacy prior to the issuance of a non-resident sterile compounding pharmacy license. The Board may require the inspection to be performed by an agent of the Board or by a Board approved inspector. All costs associated with third party inspectors shall be paid by the applicant. An applicant shall achieve a satisfactory Board inspection of the proposed non-resident complex non-sterile compounding pharmacy prior to the issuance of a non-resident sterile compounding pharmacy license. The Board may require the inspection to be performed by an agent of the Board or by a Board approved inspector. All costs associated with third party inspectors shall be paid by the applicant.CVS Health requests clarification on “Board approved inspector”. Many states face a backlog of inspections to complete for the purpose of non-resident renewals. We request that the Board defines accepted inspection agencies prior to the effective date of this rule to avoid potential delay in therapy for patients serviced by the permit requesting pharmacy.RE: 6.10 (2) (a): Change of Manager of Record: A licensee, or duly authorized representative of the licensee, and the proposed new Manager of Record shall sign an application for change of Manager of Record. A change of Manager of Record application shall include: (a) an attestation confirming the pharmacy performed an inventory of all controlled substances in Schedules II, III, IV, V, and VI and filed the inventory report with the pharmacy’s controlled substance records.CVS Health believes an inventory on legend drugs, Schedule VI, is unnecessary. A systemic balance on hand can be provided, which gives a reasonable estimate of the current non-federally controlled stock. In addition, a starting count is not provided as the biennial inventory is not required for legend drugs. We recommend striking Schedule VI from this requirement. 6.13 (3): Closing a pharmacy…Notice to Patients. A licensee or a Manager of Record who intends to close a pharmacy licensed by the Board shall identify each patient who had a prescription filled at the pharmacy within preceding 90 days of the intended closure date. The licensee or a Manager of Record shall send notice of the pharmacy closure to each such patient no later than 14 days prior to the closure date, by first class mail or other Board approved method. The licensee or a Manager of Record shall also post notice in a conspicuous location at the pharmacy informing patients of the intended closure and procedure for requesting a transfer of patient file information.CVS Health believes documented notification by any form of technology would be sufficient, and advises against requiring notification with considerable cost to the permit owner of the closing pharmacy.Suggested language: … The licensee or a Manager of Record shall send provide documented notice notification of the pharmacy closure to each such patient no later than 14 days prior to the closure date, by telephone, first class mail or any technological pathway of communication other Board approved method.6.14 (2) (a): Transfer of closing pharmacy stock…On the date of the transfer, the transferor pharmacy shall take a complete inventory of all controlled substances in Schedules II through VI in accordance with federal and state law;CVS Health believes an inventory on legend drugs, Schedule VI, is unnecessary. A systemic balance on hand can be provided, which gives a reasonable estimate of the current non-federally controlled stock. CVS Health recommends limiting the inventory required to schedules II-IV. In addition, a starting count is not provided as the biennial inventory is not required for legend drugs. We recommend striking Schedule VI from this requirement.MA BOP Chapter 9.00: Professional Practice StandardsRE: 9.01 (3): A licensee shall adhere to the most current standards established by each chapter of the United States Pharmacopeia (“USP”).CVS Health supports this requirement; however, we recommend clarifying that only those USP Chapters under Chapter 1000 are required, as is consistent with current industry practices and guidelines. Every chapter above USP Chapter 1000 is a recommendation or best practice. These recommendations are not intended to be adopted by regulatory entities (i) based on certain pharmacy practice environments, (ii) conflicting federal and state laws, and (iii) as stated by USP.Suggested language: 9.01 (3): A licensee shall adhere to the most current standards established by each chapter of the United States Pharmacopeia (“USP”) numbered below USP General Chapter 1000.RE: 9.01 (15): A licensee may not provide any practitioner with prescription forms which refer to any pharmacist or pharmacy.CVS Health supports the Board’s intent to ensure a patient’s pharmacy freedom of choice is not compromised. However, pharmacies, specifically specialty pharmacies and patient assistance programs with limited distribution drugs, employ the use of forms to ensure that prescriptions are delivered timely and accurately. Many pharmacies utilize prescription forms with information fields so that prescribers can clearly convey the requested clinical and prescription information. In addition, institutional pharmacies (i.e., hospital, long-term care pharmacies, and home infusion pharmacies) may use prescription forms that assist in obtaining needed clinical information for a “medically complex” patient population.While CVS Health continues to honor and provide prescription medication pursuant to a patient’s choice through support of “freedom of choice” statutes and regulations, we believe the language of this requirement can be amended to maintain the Board’s intent, while enabling forms which may be necessary to safely conduct pharmacy services and provide medication in a timely manner.Suggested language: Excluding clinical prescription forms provided by a patient’s selected pharmacy, A licensee may not provide any practitioner with prescription forms which refer to any pharmacist or pharmacy. RE: 9.01 (16): General Practice Standards: Unless otherwise permitted by law or regulation, a licensee may not limit his or her services to a particular segment or segments of the general public.CVS Health seeks clarification of the intent of this rule. A segment of the general public could be defined as a group of individuals with the same disease state or medical care needs. It could also speak to the ethnicity, race, creed, or socioeconomic position of the general public. CVS Health does not believe the intent of this rule is to prevent pharmacies from specializing in a particular disease state; rather, it is to prevent discriminatory practices. Suggested language: Unless otherwise permitted by law or regulation, a licensee may not limit his or her services to a particular segment or segments of the general public based on race, gender, ethnicity, or creed.RE: 9.01(17): A licensee may not refuse to compound simple or moderate non-sterile compounded preparations customary to the community needs except upon extenuating circumstances or by a waiver of Board regulation.CVS Health opposes this requirement. We believe a pharmacy should not be forced to stock or supply any prescription medication. This would include simple or moderate compounds. We suggest revising the language of this proposed rule to encompass the requirement that enables a pharmacy to defer a compounded prescription to another pharmacy that can fulfill the patient’s order.Suggested language: In the event A a licensee may not refuse elects not to compound simple or moderate non-sterile compounded preparations customary to the community needs, the licensee must provide the patient with the name of a pharmacy that can fulfill the order. except upon extenuating circumstances or by a waiver of Board regulation.RE: 9.01 (20, 21) and 9.19 (8): The posting of licenses, registrations and certificatesCVS Health recommends removing the requirement to physically display permits, certificates and registrations. We recommend replacing the requirement to ensure these documents are readily retrievable at the time of inspection. This would encompass electronic storage or manual storage within the pharmacy. The documents would be available during an inspection and would not subject the pharmacy team to potentially dangerous identity matters that have arisen due to similar posting requirements. In addition, pharmacy support personnel and pharmacists are required to identify themselves and their current role on their name tag. This serves as a proper means of identification for patients interacting with pharmacy personnel. RE: 9.01 (23): A pharmacy may not allow any individual who is not a Massachusetts registered pharmacist to direct or supervise the practice of pharmacy.CVS Health requests clarification of this requirement. A pharmacy within Massachusetts is required to have a Massachusetts registered pharmacist on duty, supervising support personnel under the practice of pharmacy. The term “direct” is open for interpretation. It is unclear what would be encompassed under this term. RE: 9.02(2): A pharmacist shall verify that packing, shipping, and transportation processes do not adversely affect the integrity or stability of medications dispensed by mail.CVS Health requests clarification of this requirement and suggest a change to the proposed language. The term “verify” is readily used to indicate direct review of an action or product. We suggest changing “verify” to “ensure”. This would place the responsibility on the dispensing pharmacists to ensure policies and procedure are in place to maintain product integrity.Suggested language: A pharmacist The Manager of Record shall verify ensure that packing, shipping, and transportation processes do not adversely affect the integrity or stability of medications dispensed by mail.RE: 9.03 (2, 3 , 4): Advertisement of a prescription drug.CVS Health supports the Board’s effort to eliminate false or misleading advertising, by a pharmacy, of a prescription drug out of concerns for the general public. We believe the language of 9.03(1) provides sufficient authority to enforce violations of the rule. We suggest striking 9.03(2), 9.03(3), and 9.03(4) in their entirety. RE: 9.04(4): A pharmacy shall utilize computerized prescription scanning, barcode scanning, and product imaging technology or other technology approved by the Board.CVS Health supports the utilization of technology enhancements to aid pharmacists in the prescription filling process; however, we suggest enabling the licensee to determine the technologies they will utilize to support their safe workflow process identified in 9.04(2). Mandating specific technologies force licensees to operate out of compliance during downtime or during the process of producing orders that do not have accompanying technologies such as serial barcodes on the product. CVS Health suggests modifying the language of 9.04(4).Suggested language: A pharmacy shall may utilize computerized prescription scanning, barcode scanning, and product imaging technology or other technology approved by the Board.RE: 9.04 (5): Requirements for Dispensing and Refilling Prescriptions: A licensee shall ensure the label affixed to a prescription drug container is clearly printed by a computerized pharmacy system. In the event of printing or equipment failure, a prescription label may be legibly handwritten or typed during an emergency period not to exceed 48 hours. CVS Health supports the requirement enabling dispensing during an emergency, but we disagree with setting a 48 hour limitation. Extensive natural disasters can lead to an unexpected duration of downtime. It is our belief that the state of emergency should be sufficient for enabling the use of a hand-written prescription label, in the best interest of continuity of care. We recommend striking “not to exceed 48 hours” from the rule. RE: 9.04 (16): A prescription for a Schedule VI medication is valid for one year from the date of issue. A licensee may not refill a Schedule VI prescription after one year. In the event that a prescription expires and the pharmacist is unable to obtain authorization in a timely manner the pharmacist in his or her professional judgment may dispense a quantity not to exceed seven days.CVS Health recognizes the Board’s intent to ensure continuity of care for a patient. We suggest amending the language to encompass manufacturer unit of use packaging that may be in excess of 7 days. For example: Albuterol inhalers, oral contraceptives etc. Suggested Language: A prescription for a Schedule VI medication is valid for one year from the date of issue. A licensee may not refill a Schedule VI prescription after one year. In the event that a prescription expires and the pharmacist is unable to obtain authorization in a timely manner the pharmacist in his or her professional judgment may dispense an additional refill, quantity not to exceed seven days.RE: 9.05(2): Oral Prescriptions. Upon receiving an oral prescription for a brand name drug product, a pharmacist shall in ascertain whether or not the prescriber wishes “no substitution” to be marked on the prescription and record this information with all other required information in the computerized pharmacy system.CVS Health opposes placing the onus of identifying “no substitution” on the receiving pharmacy personnel. The prescriber or prescriber’s agent calling in the prescription should have the responsibility of providing this status to the pharmacy. It is feared that asking an agent of the prescriber if no substitution is requested will lead to inadvertent “no substitution” authorizations, leading to a higher cost to the patient and insurer. We recommend striking subsection 9.05(2) in its entirety. RE: 9.06(2)(a): A pharmacy located in a high overdose area shall maintain a standing order and a continuous supply of naloxone rescue kits or other Board approved opioid antagonists readily available for dispensing.CVS Health supports expansion of naloxone related initiatives in an effort to save the lives of those exposed to a potentially lethal dose of opiates. We offer our full support to expand the authority of a pharmacist to prescribe or furnish Naloxone without the need for a standing order or other authority from a traditional prescriber. With respect to the proposed language of this requirement, we caution the mandate requiring a continuous supply of naloxone or Board approved opioid antagonists readily available, as this does not provide exceptions due to supply chain limitations. Suggested language: A pharmacy located in a high overdose area shall make a reasonable effort to maintain a standing order and a continuous supply of naloxone rescue kits or other Board approved opioid antagonists readily available for dispensing.RE: 9.06(7): A pharmacy that assembles opioid antagonist rescue kits shall affix a label to the outer package noting “Opioid Antagonist Rescue Kit” and the expiration date, which shall be based on the expiration dated of the included naloxone hydrochloride unit.CVS Health agrees with the importance of identifying the potentially life-saving product, as well as the expiration date. We recommend modifying the language to state, “Naloxone Rescue Kit”, as this has become a commonly understood name of the product. We believe the term opioid antagonist may not be comprehended by a significant portion of the population. Also, the distributed version of the rule had a grammatical error, which has been rectified in our suggested language. Suggested language: A pharmacy that assembles opioid antagonist rescue kits shall affix a label to the outer package noting “Opioid Antagonist Naloxone Rescue Kit” and the expiration date, which shall be based on the expiration dated of the included naloxone hydrochloride unit.RE: 9.08: Specialty PackagingCVS Health generally agrees with the proposed language, and believes these standards generally comport with applicable pharmacy industry practice and USP guidelines. That said, CVS Health would like to include several potential revisions to enhance patient safety through medication administration in institutional settings, access to medications, and reduce confusion in the industry. CVS Health recommends that the Board consider changing “specialty packaging” to “compliance packaging” and define the term broadly. This would avoid confusion between specialty medication and “specialty packaging”. To define the term broadly would enable pharmacy and patient innovations to support new packaging technology. For reference, the Virginia Board of Pharmacy defines its “specialty packaging” as, “"Compliance packaging" means packaging for dispensed drugs that is comprised of a series of containers for solid oral dosage forms and designed to assist the user in administering or self-administering the drugs in accordance with directions for use.” 18 VAC 110-20-10.RE: 9.08 (1)(f): A pharmacist shall visually inspect and verify the contents of each specialty package prior to dispensing.CVS Health opposes this restrictive language, as it does not account for technologies with a higher safety profile than human intervention, such as barcode scanning verification. In addition, limiting the non-clinical activity, such as verifying a medication matche with an image, to a pharmacist will reduce the time a pharmacist could be dedicating to clinical patient care. CVS Health urges the Board to incorporate enhanced patient safety technology and expanded technician capabilities into rule..RE: 9.08(2)(a): A licensee may not dispense a medication in an oral-liquid-single-dose package unless the package has a child proof safety cap.CVS Health believes this requirement is in potential conflict with the federal Poison Prevention Act of 1970; more specifically, the federal law and enforcement standards allow for a waiver of child-resistant packaging. CVS Health recommends revising the language accordingly.Suggested Language: A licensee may must not dispense a medication in an oral-liquid-single-dose package unless the package has with a child proof safety cap mechanism, unless the patient or the patient’s agent has requested to waive this requirement.RE: 9.11(1)(b): Pharmacy Processing Automation: “a pharmacist verifies the stocking of the PPA;”CVS Health requests removal of this requirement as it excludes additional safe practice methods of verification. In a system that leverages barcode verification of stocking, requiring a pharmacist to verify a product adds an additional human element to the automated process. A pharmacy should have the option to leverage technology to advance the safe practice of pharmacy, while still placing the responsibility on the individual verifying the final product. CVS Health recommends striking 9.11(1)(b) in its entirety. RE: 9.11(1) (g): “lot numbers are not comingled in a single cell.”CVS Health opposes this requirement. Manufacturer packages arrive from the wholesaler from an array of lots. The benefits of automation in terms of patient safety becomes weakened at every human intervention. Limiting the contents of an automated cartridge, cell, or container leads to additional human intervention for replenishment. It is CVS Health’s belief that the language of this subsection is intending to ensure recalled medication is not distributed to the public. This same end result can be maintained by the practice of destroying all medication that could contain the impacted lot number in the event of a recall. This would include product in automation, as well as product in returned stock vials.Suggested language: if lot numbers are not comingled in a single cell, a policy and procedure must be in place to quarantine the contents of the cell for reverse distribution. RE: 9.11(c): the PPA, pharmacist, pharmacy intern, or certified pharmacy technician records all stocking and return activities, including the identification of each person who accessed the PPA; and 9.11 (f): the PPA prevents unauthorized access by utilizing passwords, biometric scanning, or other coded identification;CVS Health reminds the board that the physical access to a PPA is not limited by the software of all PPA systems. The request for medication is tracked and access controlled with respect to the software system, but the physical access is maintained by a manual locking doors, if at all. Policies and procedures must be put in place to limit access to authorized individuals. Suggested language: 9.11(c): the PPA, pharmacist, pharmacy intern, or certified pharmacy technician records all stocking and return activities, including the identification of each person who accessed requested product from the PPA; and 9.11 (f): the PPA prevents unauthorized access product requests by utilizing passwords, biometric scanning, or other coded identification;RE: 9.12 (5): A pharmacist, pharmacy intern, or certified pharmacy technician shall verify the inventory provided for loading or loaded into the ADD is correct.CVS Health requests that the Board consider permitting other licensed health care professionals to replenish ADDs. Licensed health care professionals already have access to the ADDs and are adequately trained and licensed to administer and handle medication. ADD replenishment and removal of product is a real time adjudication that tracks each user ID in the system. The pharmacy is aware of personnel that open the unit, at what time, and for what purpose. In short, ADDs are secure and auditable. Finally, half of all states today allow a nurse or another qualified individual to replenish prescription medication in an automated medication system. Suggested language: A pharmacist, pharmacy intern, or certified pharmacy technician shall verify the inventory provided for loading or loaded into the ADD is correct. ADD systems that incorporate electronic validation of product added to the unit may be loaded by facility personnel approved by the Manager of Record. RE: 9.13(1)(a): Return to Stock. “A pharmacy may not return a medication to the manufacturer’s stock bottle or PPA…”CVS Health opposes this language out of concern for patient safety. Impeding a pharmacy’s ability to return product from a previously processed but not dispensed amber vial to a PPA creates a bifurcated process leading to an increased chance of error. If a system has the ability to validate the product from the previously processed amber vial, the re-addition to the automation system should be enabled. CVS Health recommends striking “or PPA” from this subsection.RE: 9.13(1)(b): “A pharmacist shall verify any return to stock performed by a pharmacy intern or pharmacy technician.”CVS Health believes technologically aided verification of return to stock product with the corresponding return to stock label surpasses the accuracy of a pharmacist’s human intervention. We recommend adding language to encompass technological validation of return to stock by a pharmacy technician or intern without requiring human intervention by the pharmacist. It is important to note that upon ultimate dispensing of a previously returned to stock product, the dispensing individual is responsible for ensuring the correct product is dispensed.Suggested language: A pharmacist shall verify any return to stock performed by a pharmacy intern or pharmacy technician, unless barcode scanning or equivalent technologies are in place to verify the proper label is affixed to the return to stock product. RE: 9.14(1)(a): Transfer of Prescriptions: A pharmacy shall transfer a prescription to another pharmacy, at the request of a patient or his/ or her agent, in a timely manner so as not to delay patient therapy, if the following conditions are met: the pharmacy has not yet dispensed the initial prescription for Schedule VI medication or refills remain on a prescription for Schedule III, IV, V, or VI medication;CVS Health recommends deferring the ability to transfer an unfilled Schedule III-V prescription to Federal Law. There has been guidance provided from federal agencies on this topic, and any future changes could be impeded within Massachusetts due to this requirement. Suggested language: A pharmacy shall transfer a prescription to another pharmacy, at the request of a patient or his/ or her agent, in a timely manner so as not to delay patient therapy, if the following conditions are met: the pharmacy has not yet dispensed the initial prescription for schedule VI medication or refills remain on a prescription. for schedule III, IV, V, or VI medication;;RE: 9.14(6): A licensee may not transfer a Schedule III, IV, or V prescription if that prescription was previously transferred. CVS Health requests the existing Federal and State exemption for pharmacies operating under a common database. Pharmacies linked by a common database should have the ability to transfer Schedule III-VI prescriptions multiple times, based on the needs of the patient. Suggested language: A licensee may not transfer a Schedule III, IV, or V prescription if that prescription was previously transferred, unless the pharmacies share a common database enabling the electronic transmission of the prescription transfer. RE: 9.15(1): A pharmacist who is eligible to register for the Massachusetts Prescription Monitoring Program (“PMP”) shall register with and maintain login information for PMP. CVS Health recommends modifying the language of this requirement to exempt Massachusetts registered pharmacists that do not dispense medications reported to the PMP. Suggested language: A pharmacist who dispenses medications reported to is eligible to register for the Massachusetts Prescription Monitoring Program (“PMP”) shall register with and maintain login information for PMP.RE: 9.17(4): Prospective Drug Utilization Review: “The DUR shall include a review of the patient’s active prescription medication profile within the preceding (12) months.”CVS Health agrees with the importance of a relevant Drug Utilization Review (DUR). When evaluating the relevance of previously dispensed medication, it is important to encompass the active medication that may have an interaction, while limiting the number of irrelevant notifications for medications that would not factor in the current therapy profile for the patient. Unnecessary prompts lead to alert fatigue, which causes the human operator to miss potentially serious prompts. For the purpose of this rule, we suggest striking, “within the previous (12) months.” This would express the clinical intent of the language, without creating excessive, irrelevant alerts.RE: 9.19(4)(b, c, e and f) The prescription area shall provide for the arrangement and storage of drugs, supplies, and equipment that is calculated to prevent their accidental misuse and that:… stores hazardous drugs in a designated… separates ophthalmic from otic medications… identifies high alert high risk drugs and look alike sound alike drugs as identified by ISMP…and separates internal from external use medications.CVS Health believes the intent of this rule is to reduce the likelihood of dispensing an incorrect product to a patient. The layout of a pharmacy should be organized to enable for adequate spacing of drug product to maintain accurate inventory and assist in the dispensing process. Requiring a particular product or type of product to occupy specific sections of a pharmacy limits the ability of the Manager of Record to arrange the pharmacy stock in the best possible manner based on the layout of the pharmacy. In addition, requiring a specific section for a product would not ensure the product is placed back on the proper shelf. This would create a confirmation bias during the production of the misplaced product, which would heighten the chance of error.CVS Health recommends maintaining the onus of organization on the Manager of Record, and removing the prescriptive language of product placement. Safe prescription processing is aided by establishing a proper prescription workflow which includes human validation of the correct product at production and product verification. This process is bolstered by technological enhancements such as barcode accuracy scanning.RE: 9.19(5): A pharmacy shall store medications in the manufacturer’s stock bottles or in containers that are clearly labeled with the product name, strength or concentration, NDC number, manufacturer or supplier, lot number, expiration date, and date that the medication was transferred out of its original stock bottle. CVS Health supports this requirement with respect to repackaged products; however, we request that a clear exemption is made for products returned to stock. A product that has been processed for dispensing, but not dispensed, will be in a container that has the drug name, manufacturer, and expiration date of the stock utilized or a year from the date processed, whichever comes first. These return to stock containers will not have a lot number, as this is not a requirement of dispensing.Suggested language: A pharmacy shall store medications in the manufacturer’s stock bottles or in containers that are clearly labeled with the product name, strength or concentration, NDC number, manufacturer or supplier, lot number, expiration date, and date that the medication was transferred out of its original stock bottle. Products processed for dispensing that have not been dispensed, and have subsequently been returned to stock are exempt from the lot number portion of this requirement. RE: 9.19 (13): A pharmacy shall obtain and document consent from a patient or patient’s agent prior to enrolling that patient in an automatic refill program. A pharmacy may not include any drug with a Narrow Therapeutic Index in an automatic refill program.CVS Health opposes the exclusion of Narrow Therapeutic Index medications from automatic refill programs. We believe the intent is to prevent multiple doses of the same medication from being dispensed to the patient; however, we feel the exclusion of NTI medications will lead to an interruption in care for patients on multiple chronic medications. Automated refill programs have shown demonstrable improvements in patient adherence and medical outcomes. The onus to dispense the proper dosage of all medications should be placed on the pharmacist performing the prospective Drug Utilization Review. We recommend striking the NTI drug exclusion from the requirement. RE: 9.20: Non-Resident Pharmacies…A non-resident pharmacy shall comply with all Massachusetts laws and regulations governing the practice of pharmacy when filling, dispensing, or shipping medications into Massachusetts.CVS Health opposes this proposed rule. More specifically, this proposed rule will (i) undermine current compliant practices in other jurisdictions, (ii) create confusion among pharmacies and legitimate conflicts of law, (iii) create substantial administrative burden for pharmacies and the Board with limited patient safety benefit, and (iv) may be contrary to the authority of its implementing statute, M.G.L.A. 112 § 39J.Nearly all states have non-resident pharmacy regulations in place, and this proposed regulation is restrictive. CVS Health encourages a robust rule to ensure that the Board has jurisdiction and authority over non-resident pharmacy practices, but cautions the Board to use reasonable discretion with the scope of its implementing statute when crafting this proposed rule.CVS Health supports regulations for non-resident pharmacies in terms of the shipment of prescription medication into the state as it relates to prescription monitoring requirements, recordkeeping requirements, and Board investigations or inquiries. However, to include a comprehensive rule which requires compliance with all applicable laws is untenable for the above mentioned reasons. For the aforementioned reasons CVS Health respectfully suggests the following revisions based on common non-resident language in other jurisdictions with patients services by Massachusetts pharmacies. A non-resident pharmacy shall: maintain at all times a valid, unexpired license, permit, or registration to operate the pharmacy in compliance with the laws of the state in which the pharmacy is located and from which the prescription drugs shall be dispensed;follow all applicable pharmacy and drug rules and laws of the state in which the pharmacy is physically located; comply with all lawful directions and requests for information from the regulatory or licensing agency of all states in which it is licensed as well as with all requests for information made by the Board pursuant to this section;respond directly to all communications from the Board concerning emergency circumstances arising from errors in the dispensing of medicinal drugs to the residents of this Commonwealth;maintain its records of medicinal drugs dispensed to patients in this commonwealth so that the records are readily retrievable from the other business records of the pharmacy and from the records of other medicinal drugs dispensed; andduring its regular hours of operation but not less than 6 days per week, for a minimum of 40 hours per week, a toll-free telephone service shall be provided to facilitate communication between patients in this commonwealth and a pharmacist at the pharmacy who has access to the patient’s records. This toll-free number must be disclosed on the label affixed to each container of dispensed medicinal drugs.247 CMR Chapter 15.00: Continuous Quality Improvement ProgramRE: 15.03 (2) (a): QRE Documentation…A QRE shall be initially documented by the pharmacist who has discovered or been informed of the QRE on the same day the QRE is discovered by or described to the pharmacist. CVS Health supports the expedited documentation of an event after assisting the patient and contacting the prescriber when applicable. We suggest modifying this requirement to provide the discovering pharmacist 24 hours to document the event. Same day documentation may place an unnecessary hardship on a pharmacist-on-duty, which could precipitate in additional patient safety compromising events.Suggested language: A QRE shall be initially documented by the pharmacist who has discovered or been informed of the QRE on the same day within 24-hours after the QRE is discovered by or described to the pharmacist. 247 CMR 20.00: ReportingRE: 20.02 (1): A Manager of Record of a pharmacy shall report to the Board any improper dispensing of a prescription drug that results in serious injury or death within seven business days of discovery of the improper dispensing.CVS Health recommends changing the language of the requirement to mandate reporting within seven business days of the report of serious injury or death rather than the discovery of the improper dispensing. Adverse effects of an event may not be known at the discovery point of the improper dispensing. Suggested language: A Manager of Record of a pharmacy shall report to the Board any improper dispensing of a prescription drug that results in serious injury or death within seven business days of discovery of serious harm or death due to a dispensing incident the improper dispensing.RE: 20.07 (2)(b) and (c): The designated pharmacist in charge of a non-resident pharmacy shall submit the following to the Board… a letter or documentation from the in-state Board of Registration in Pharmacy certifying that the pharmacist in charge is in good standing with the in-state board of registration…a letter or documentation from the in-state Board of Registration in Pharmacy certifying that the non-resident pharmacy maintains a current, unrestricted license, permit, or registration to operate the pharmacy;CVS Health believes this places an unnecessary burden on the state licensing agency of the applicable pharmacy’s domicile state. We recommend striking these requirements and replacing them with an attestation by the applicant that the pharmacist-in-charge and the pharmacy is in good standing, supplemented with a screenshot of the current license status from the applicable board’s license verification site. CVS Health appreciates the opportunity to provide comments to the Massachusetts Board of Pharmacy for review and consideration and welcomes the opportunity to work with the Board as an available partner to serve the patients of Massachusetts on a path to better health. We believe our comments and suggested language for the proposed amendments and additions to 247 CMR Chapters 6.00, 9.00, 15.00 and 20.00 will lead to an enhanced level of patient care and services provided to the patients of Massachusetts. If you have any questions or need additional information, please contact me directly at 617-599-9091.Sincerely, John N. Rocchio PharmD. R.Ph.Director, Pharmacy Regulatory Affairs ................
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