John Sisto
Express Scripts Holdings
330 New Jersey Ave. NW
Washington DC 20001
July 10, 2017
David Sencabaugh
239 Causeway Street
Boston, Massachusetts 02114.
Executive Director Sencabaugh,
I am writing this letter in my capacity as Senior Director of Regulatory Affairs for Express Scripts to include Express Scripts Home Delivery, Accredo Health and Freedom Fertility. I would like to thank the Board for the opportunity to comment on the proposed changes to the Board’s rules.
To begin, I would support the commentators at the June 28th Hearing regarding 6.04 (2)(a)1. This section refers to a requirement for a Massachusetts registered Manager of Record (MOR) for various pharmacy license, to include nonresident pharmacies. Based on the phrase “as applicable in the statute, it appears that the requirement for a Massachusetts registered pharmacist does not apply in all cases. However if the Board decides to require a Massachusetts registered pharmacist for all nonresident applications then Express Scripts strongly suggests that an additional section should be added to account for a change in MOR in nonresident licensees. Many nonresident licensees will need to have the new MOR apply for Massachusetts registration which can be a time consuming process. A section that allows for a transition period while the proposed MOR moves through the registration process would prevent a disruption to patient care that could occur if the nonresident licensee was required to suspend dispensing during the transition period.
In addition to the above, we offer the comments on the following sections:
6.09: Applications for Non-Resident Drug Store Pharmacy, Non-Resident Sterile Compounding Pharmacy, and Non-Resident Complex Non-Sterile Compounding Pharmacy Licenses
(1) Non-Resident Drug Store Pharmacy
(a) In support of an application for a license to operate a non-resident Drug Store Pharmacy, the applicant(s) shall submit:
1. all documentation identified in 247 CMR 6.04(2);
2. certificate of good standing from the state where the pharmacy is located issued within three months of the application submission date;
Express Scripts suggests that section 6.09(1)(a) 2 be eliminated. This information can be retrieved through NABP or the resident Board’s website. Many State Boards are having their resources stretched and adding additional paperwork requests would create an unnecessary burden. Experience has shown that these types of requests often are given low priority which can unnecessarily delay licensure of a nonresident pharmacy.
6.10 6.10: Change of Manager of Record
(2) 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.
This section would require an inventory of all legend (Schedule VI) drugs in conjunction with a change in MOR. This appears unnecessary since this is not required in other sections of the rules and would not have any previous record to compare against in many situations.
9.01: General Practice Standards
(6) Unless otherwise permitted by law or regulation, a licensee may not dispense, package, label, or compound any medication that was previously processed or dispensed by another pharmacy. Unless otherwise permitted by law or regulation, a drug store pharmacy may not accept or store any medication that was previously processed or dispensed by another pharmacy.
Express Scripts suggests that the word processed be removed from the language. This could contradict any rules the Board could promulgate concerning central fill/processing that the Board was mandated to consider in the Pharmacy Act.
9.01: General Practice Standards
(16) 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.
Many pharmacies have begun to specialize in their practices, such as diabetes or hemophilia. This rule would force a pharmacy to carry products that they would not need in the ordinary course of the specialized practice to be able to comply. If the intent is to prohibit discrimination then that should be what the rule says, otherwise Express Scripts suggests that it be removed.
9.01 General Practice Standards
(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.
Compounding requires specific skills, knowledge and facilities to be performed properly and pharmacists who do not compound regularly may not have the expertise or confidence to perform these tasks sporadically. The Board should not mandate the provision of a service that the pharmacist may not be comfortable or proficient in delivering. The Board should change the language to read: A licensee may not refuse to compound a preparation for a patient if the pharmacy compounds similar products in the regular course of business except upon extenuating circumstances.
9.02: Prescriptions by Mail
(2) A pharmacist shall verify that packing, shipping, and transportation processes do not adversely affect the integrity or stability of medications dispensed by mail.
Express Scripts suggest that “verify” be replaced with ensure. The pharmacist will need to rely on input from experts to certify that the packaging will meet the requirements for the drug, ambient temperature and transit time. It should be the pharmacist’s responsibility to ensure that these studies have been done, not to verify the accuracy of experts.
9.04: Requirements for Dispensing and Refilling Prescriptions
(14) A pharmacy may not dispense any medication that was processed or verified outside its licensed pharmacy premises unless said process and verification was performed by an on-site Massachusetts registered pharmacist or performed in a pharmacy licensed by the Board.
Express Scripts suggests that “on-site” be removed. Preventing a pharmacist from processing a prescription from a remote site places significant limitations on innovation in the future and limits the available work force unnecessarily. As pharmacists expand to other areas of practice outside the traditional pharmacy, rules should not be limiting. Availability of remote pharmacists allows pharmaceutical services to be provided during hours a pharmacy might not otherwise be staffed. In addition, technology allows pharmacists who for various reasons, such as disabilities or living in rural locations, to be included in the work force.
9.04: Requirements for Dispensing and Refilling Prescriptions
(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.
Express Scripts would suggest adding: or the smallest available unit of use package .
9.14: Transfer of Prescriptions
(1) 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:
(a) 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
Express Scripts suggests eliminating Section (a). Currently, the DEA is considering rules to allow for the transfer of unfilled controlled substance prescriptions to accommodate multiple conditions resulting from e-prescribing. Any rules should be broad enough to accommodate any Federal changes.
9.19: Pharmacy Operation
(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.
Express Scripts does not agree with the exclusion of NTI drugs in compliance programs. The very nature of these drugs makes automatic refills an important part of therapy to avoid any interruption in therapy of drugs with a narrow safety profile.
I would like to thank you this opportunity to share our comments. If the Board has any additional questions please feel free to contact me at 717-609-7361.
Sincerely,
John Sisto
Sr. Director of Regulatory Affairs
Express Scripts