June27, 2017

Board of Registration in Pharmacy

Re:Comments to Proposed Rule 9.10 - Automated Pharmacy Systems

Dear Board of Pharmacy:

I am writing on behalf of Asteres Inc., a company that manufactures and distributes an automated pharmacy system that is used by pharmacies to facilitate patient access to prescription medications which have already been dispensed by pharmacy. Along with these comments, we are attaching our proposed language to amend Proposed Rule 9.10 (Automated Pharmacy Systems).

Asteres thanks the Board for recognizing the need to expand access to pharmacy services by allowing the use of Automated Pharmacy Systems ("APS") to allow patients to access prescription medications from locations outside of a licensed pharmacy. However, we are concerned that the proposed rule is too restrictive, and that a broader rule that would allow an APS to be operated as an extension of a pharmacy, in locations that are lawfully permitted to possess and store prescription drugs, would help increase access to pharmacy services, improve patient adherence to prescribed drug therapy, and improve outcomes for patients who may otherwise leave prescriptions unfilled at their local pharmacy. Specifically, the use of this technology inlocations outside of the pharmacy, including in hospitals, clinics, urgent care centers, and physician offices, will increase patient access to prescription medications and pharmacy services, while keeping pharmacies and pharmacists involved in the dispensing process.

The Asteres ScriptCenter is a type of APS that allows patients to pick up prescription medications that have been filled and verified at a pharmacy and placed into ScriptCenter by pharmacy personnel. The Board may view the Asteres system and see a demonstration of how it is used at The prescription pickup system uses sophisticated technology that is integrated with the dispensing pharmacy's information technology system to enhance secure receipt of the dispensed medications and improve patient care. Pharmacies in 25 states utilize the Asteres ScriptCenter to facilitate patient access to medications after the medications have been dispensed by the pharmacy. The pharmacy receives a prescription, performs drug utilization review and takes all other steps required to ensure that the prescription is lawful. After a pharmacist performs the final check to make sure the prescription has been filled properly, the medications are placed in an appropriate vial or other container for dispensing. The vial or container is labeled in accordance with applicable law. Only then is the medication dispensed from the pharmacy and delivered to the ScriptCenter. With the patient's consent, the pharmacy delivers the dispensed medication to a secure prescription pickup system.

The patient obtains the dispensed medications by entering personal identifying information in the prescription pickup system. The system's computer software which is integrated into the pharmacy's prescription management system maintains detailed records of all prescription pickups, and can produce a complete audit trail including a picture and signature of the person picking up the prescription. The patient has no access to any other medications in the prescription pickup system and all required counseling pursuant to MA ST 94C § 21A occurs before any prescriptions are picked up from ScriptCenter.

ScriptCenter has been in use in Massachusetts since 2010 and has safely and securely delivered more than 30,000 prescription under the existing Department of Public Health/Board of Registration in Pharmacy Joint Automated Pharmacy System guidelines. Asteres, in collaboration with Harvard University and Cambridge Health are requesting that Proposed Rule 9.10 be revised to allow for the expanded use of Automated Pharmacy Systems in Massachusetts. Harvard has been using the ScriptCenter to improve patient care since September 2016. The Harvard deployment complies with the existing APS joint guidelines, and services Harvard students and faculty for the pickup of their prescriptions and OTC's at the Harvard University Health Services building 24/7. Cambridge plans to deploy a ScriptCenter, also in compliance with existing APS joint guidelines, in July 2017. The planned deployment will allowCambridge Health employees to pick up prescriptions for themselves and their family members 24/7 at one of 3 convenient ScriptCenter locations located within Summerville, Everett, and Cambridge hospitals. Both of these deployments illustrate the utility of APS technology as a tool to expand access to pharmacy services. Both Harvard and Cambridge would benefit from an expansion of the deployment locations currently permitted in the joint guidelines, and are seeking revisions to Proposed Rule 9.10 to allow expanded deployment opportunities and locations.

In closing, Asteres requests that the proposed APS Rule be revised to allow for expanded use of APS technology. The enclosed proposed revised language would expand access to pharmacy services and lead to improved patient care. We thank you for providing us with the opportunity to make public comment, and can be available to answer any questions or to provide additional information as the Proposed Rule is being finalized.

Sincerely,

Shawn Orr

Vice President of Global Operations

Asteres Inc.

858-777-8602

4110 Sorrento Valley Blvd San Diego, CA 92121 Tel 858-777-8600 Fax 858-866-0669

Proposed rules regarding automation:

9.10: Automated Pharmacy Systems

(1) A pharmacy may dispense Schedule VI controlled substances for refill prescriptions from

an Automated Pharmacy System (“APS”) to a patient or a patient’s agent during or after

pharmacy hours of operation provided the following requirements are met:

(a) The APS is located within 20 feet of the operated as an extension of a pharmacy.

(b) The APS is secured against or within a wall or floor in a manner that prevents unauthorized access and removal.

(c) The location where the APS is monitored by continuous, recordable video surveillance.

(d) When used to dispense new prescriptions, the APS must utilize technology, such as telephone access to a pharmacist, to ensure compliance with MA ST 94C § 21A.__

(e) When used to dispense schedule II through V controlled substances, the pharmacy that operates the APS shall comply with all state and federal laws and regulations applicable to the dispensing of controlled substances.

(df) The pharmacy notifies the Board in writing of its intent to use an APS. The notification shall include:

1. the name and address of the pharmacy;

2. APS hours of operation;

3. type of APS system; and

4. a description of how the APS system is to be used;. and

5. if intended to be used in a location that is remote from the operating pharmacy, a description of location and security measures used at the location to prevent unauthorized access and removal.

(e) The APS or the pharmacy that operates the APS maintains the following electronic data for each prescription it dispenses:

1. name of the pharmacy;

2. name of the patient;

3. name of the prescriber;

4. prescription number;

5. name, strength, dosage form, and quantity of the drug dispensed;

6. date and time of dispensing;

7. identity of the pharmacist who verified the prescription; and

8. identity of the person to whom the drug was released.

(f) The pharmacy provides the patient an opportunity for a pharmacist consultation during all hours that the APS is in operation for dispensing.

(g) The pharmacy allows the patient to choose whether or not to use an APS.

(2) A pharmacy with an APS shall maintain policies and procedures that include:

(a) the name and address of the pharmacy where APS is used;

(b) the APS manufacturer's name, model, serial number, and other identifying information;

(c) a description of how the APS is used by the pharmacy;

(d) quality assurance procedures;

(e) APS operation, safety, security, accountability, accuracy, patient confidentiality, and access;

(f) procedures to be followed in the event of a malfunction, including that any malfunction is immediately reported to the pharmacist on duty;

(g) procedures to identify, analyze, and report each dispensing error, in accordance with 247 CMR 15.00; and

(h) stocking the APS.

(3) A pharmacy shall ensure the stocking and return of all prescription medications in the

APS occurs in the following manner:

(a) a pharmacist, pharmacy intern, or certified pharmacy technician stocks and returns prescription medications;

(b) the APS, pharmacist, pharmacy intern, or certified pharmacy technician records all stocking and return activities, including the identification of each person who accessed the APS;

(c) the pharmacy may not stock medications in an APS that require refrigeration or reconstitution unless the pharmacy that operates the kiosk utilizes a method that ensures that the drug will be stored at the appropriate temperature, including, without limitation, refrigeration technology or the use of cold packs;

(d) the APS utilizes two separate verifications, such as bar code verification, electronic verification, weight verification, radio frequency identification (RFID), or another similar process, to ensure that the proper medication is dispensed from the system. If the APS is used to store and dispense medications that have been filled and verified by a pharmacist prior to being placed in the APS, only one method of verification shall be required.

4110 Sorrento Valley Blvd San Diego, CA 92121 Tel 858-777-8600 Fax 858-866-0669