February 22, 2019

 

Caroline Juran, RPh

Executive Director

Virginia Board of Pharmacy

9960 Mayland Drive

Suite 300

Richmond, VA  23233-1463

Caroline.juran@dhp.virginia.gov

 

Re: CVS Health’s comments on Virginia Board of Pharmacy periodic review of regulations in chapter 20 and 50.

 

Dear Executive Director Juran:

 

I am writing to you in my capacity as Senior Director of Regulatory Affairs for CVS Health and its family of pharmacies. CVS Health, the largest pharmacy health care provider in the United States, is uniquely positioned to provide diverse access points of care to patients in the state of Virginia through our integrated offerings across the spectrum of pharmacy care. CVS Health appreciates the opportunity to submit comments on the Virginia Board of Pharmacy periodic review of regulations in chapter 20 and 50. Our suggested rule language changes are listed in red and italicized throughout this letter. We would also like to thank the Board for their vigilance to continuously improve the laws and regulations that guide pharmacists, pharmacy interns, and pharmacy technicians serving Virginia patients.

 

Supporting the Pharmacist

Community pharmacists provide high quality, accessible patient care services, including medication management, immunizations, preventive screenings, and chronic care management. Despite a growing need for increased access to patient care services, community pharmacists spend only 21% of their professional time performing patient care services that are not associated with dispensing prescriptions.1 To further enhance and optimize patient care services delivered at community pharmacies, leveraging and expanding current roles of the pharmacy technician should be considered in community pharmacies. This means working towards a unified vision for pharmacy technician practice, which includes removing antiquated supervision requirements and expanding technician roles related to dispensing medications and supporting patient care services.2 Increasing the scope of pharmacy technicians to include administrative and supportive tasks for pharmacist-provided patient care services will allow pharmacists to more effectively and efficiently provide for patients’ medication-related needs.3 Most importantly, some states have a patient safety track record of success with expanded pharmacy technicians roles that spans over four decades.4

 

• We request that the Board amend the definition of personal supervision in 18VAC110-20-10 to allow for emerging technology to safely assist pharmacists in the communication and observation of pharmacy technicians.5
• We request the that the Board follow the lead of the National Association of Boards of Pharmacy (NABP) Model Act and 21 other states to remove the ratio supervision requirements proposed in 18VAC110-20-112(A).6
• We request that the Board amend 18VAC110-20-360 to permit pharmacy technicians to transfer prescriptions.4

 

Suggested language:

18VAC110-20-10. Definitions.

"Personal supervision" means the pharmacist must be physically present and render direct, personal control over the entire service being rendered or act being performed. Neither prior nor future instructions shall be sufficient nor shall supervision rendered by telephone, written instructions, or by any mechanical or electronic methods be sufficient. or must be readily and immediately available through the use of real time, two-way technology communications between the pharmacist and technician(s).

1. A pharmacist using technology as an adjunct to assist in the personal supervision of the pharmacy technician shall make certain all applicable state and federal laws, including, but not limited to confidentiality, are fully observed when employing technological means of communication and observation.

2. If technology is being used to provide personal supervision of pharmacy technician(s), such technology shall be sufficient to provide the personal assistance, direction and approval required to meet the standard of practice for the delegated tasks.

 

Suggested language:

18VAC110-20-112. Supervision of pharmacy technicians.

A. A pharmacist shall determine the number of pharmacy interns, pharmacy technicians, and pharmacy technician trainees he can safely and competently supervise at one time.; however, no pharmacist shall supervise more than four persons performing the duties of a pharmacy technician at one time.

B. In addition to the acts restricted to a pharmacist in §54.1-3320 A of the Code of Virginia, a pharmacist shall provide personal supervision of compounding of extemporaneous preparations by pharmacy technicians.

 

Suggested language:

18VAC110-20-360. Issuing a copy of a prescription that can be filed or refilled.

A. Consistent with federal laws and regulations, a copy of a prescription shall be given upon request by one pharmacy to another pharmacy provided the drug can be filled or refilled pursuant to §§ 54.1-3410 and 54.1-3411 of the Code of Virginia and provided the patient has given permission for the transfer.

B. The transfer of original prescription information for a drug listed in Schedules III through VI for the purpose of dispensing is permissible between pharmacies if the transfer is communicated directly between the two pharmacies either orally by direct communication between the transferring pharmacist and the receiving pharmacist, or by facsimile machine or by electronic transmission, provided:

1. The transferring pharmacy:

a. Records the word "VOID" on the face of the invalidated prescription;

b. Records on the reverse of the invalidated prescription the name, address, and, except for a prescription for a Schedule VI drug, the DEA number of the pharmacy to which it was transferred, and, for an oral transfer, the name of the pharmacist or pharmacy technician receiving the prescription information;

c. Records the date of the transfer and, in the case of an oral transfer, the name of the pharmacist or pharmacy technician transferring the information; and

2. The receiving pharmacy:

a. Writes the word "TRANSFER" on the face of the transferred prescription.

b. Provides all information required to be on a prescription to include:

(1) Date of issuance of original prescription;

(2) Original number of refills authorized on the original prescription;

(3) Date of original dispensing, if applicable;

(4) Number of valid refills remaining and date of last dispensing;

(5) Pharmacy name, address, DEA registry number, except for Schedule VI prescriptions, and original prescription number from which the prescription information was transferred; and

(6) Name of transferring pharmacist, or pharmacy technician if transferred orally.

Both the original and transferred prescription shall be maintained for a period of two years from the date of last refill.

C. Nothing in this chapter shall prevent the giving of a prescription marked "For Information Only" to a patient.

D. In lieu of recording the required information in subsection B of this section on a hard copy prescription, a pharmacy may record all required information in an automated data processing system used for storage and retrieval of dispensing information in accordance with 18VAC110-20-250.

E. For prescriptions transferred between pharmacies using a common database, the pharmacy receiving the prescription shall not be required to maintain a hard copy pursuant to 18VAC110-20-240 B provided that the system used is capable of generating a hard copy of the transferred prescription upon request or except as required by federal law.

 

Supporting the Community

There are a variety of situations or natural disasters that can directly effect the temporary closing of community pharmacies across Virginia. In these events, patients can lose critical access to pharmacy services resulting in a fragmentation of their prescription medication management care. Mobile and temporary pharmacies have played a key role in other jursidictions in aiding patients to maintain or stabilize their health as they recover from the disaster’s impact on other areas of their lives.7-8

 

• We request the Board amend 18VAC110-20-150(A) and (C) to permit pharmacies to aid Virginia communities with temporary pharmacy services during emergency situations.

 

Suggested Language:

18VAC110-20-150. Physical standards for all pharmacies

A. The prescription department shall not be less than 240 square feet allow for adequate space to perform the practice of pharmacy. The patient waiting area or the area used for counseling, devices, cosmetics, and proprietary medicines shall not be considered a part of the minimum 240 square feet. The total area shall be consistent with the size and scope of the services provided.

B. Access to stock rooms, rest rooms, and other areas other than an office that is exclusively used by the pharmacist shall not be through the prescription department. A rest room in the prescription department, used exclusively by pharmacists and personnel assisting with dispensing functions, may be allowed provided there is another rest room outside the prescription department available to other employees and the public. This subsection shall not apply to prescription departments in existence prior to November 4, 1993.

C. The pharmacy shall be constructed of permanent and secure materials. Trailers or other moveable facilities or temporary construction shall not only be permitted in a declared emergency pursuant to §54.1-3307.3 of the Code of Virginia.

 

Dispensing of Prescriptions

CVS Health commends the Board for the proposed changes in in 18VAC110-20-270(D) and (F). We support all efforts  that increase patient access to pharmacy services by allowing patients to utilize a drop box at their local pharmacy for the collection of written prescriptions and refill requests. We support the Board allowing pharmacists to use their professional judgment when determining whether or not to refuse to return forged prescriptions to patients. We believe the proposed changes align with the Drug Enforcement Admininstration (DEA) guidance publication to pharmacists on prescription fraud.9 Empowering pharmacists to engage in all aspects of the prescription adaptation process can lead to improved medication management while promoting efficiencies between pharmacists and prescribers.10-11 As the pharmacist’s role in community pharmacies continues to transition to delivering a higher order of clinical care, it is vital to allow pharmacists the professional judgment to determine what practice models of the dispensing process best assist the needs of our patients.1

 

• We recommend the Board amend the title of 18VAC110-20-270 to remove supervision of pharmacy technicians, as the proposed supervision of pharmacy technician rule now rests in 18VAC110-20-112.
• We request the Board amend 18VAC110-20-270(B) for alignment with the DEA signature requirements for written prescriptions.10
• We request the Board amend proposed rule 18VAC110-20-270(E)(1-4) allowing adaptation of an existing prescription when, in the pharmacist professional judgment, the action is intended to optimize the therapeutic outcome of patient treatment.11-12
• We request the Board continue requiring both data entry verification and prospective drug utilization review as required by 18VAC110-20-270(F), but request that the Board amend the rule to allow for technical workflow efficiencies for on-hold prescriptions that increase pharmacists ability to spend time with patients.
• We request the Board strike 18VAC110-20-110(D) as is there is no published evidence that suggests a pharmacist graduating from an ACPE accredited college of pharmacy is not prepared and professionally capable to safely fulfill the duties of a PIC immediately upon passing the MPJE jurisprudence exam and licensure.

 

Suggested Language:

18VAC110-20-270. Dispensing of prescriptions; certification of completed prescriptions.; supervision of pharmacy technicians.

A. In addition to the acts restricted to a pharmacist in § 54.1-3320 A of the Code of Virginia, a pharmacist shall provide personal supervision of compounding of extemporaneous preparations by pharmacy technicians.

B. A pharmacist shall determine the number of pharmacy interns, pharmacy technicians, and pharmacy technician trainees he can safely and competently supervise at one time; however, no pharmacist shall supervise more than four persons acting as pharmacy technicians at one time requirements in §54.1-3408.01 of the Code of Virginia for an oral prescription or written prescription, including those transmitted via facsimile or electronically, a prescription shall include a quantity, or duration of the order by which the pharmacist can calculate the authorized quantity using directions for use.  Except for prescriptions transmitted electronically in compliance with 18VAC110-20-285, written prescriptions for controlled substances shall also include the prescriber's manual signature.

C.B. After the prescription has been prepared and prior to the delivery of the order, a pharmacist shall inspect the prescription product to verify its accuracy in all respects, and place his initials on the record of dispensing as a certification of the accuracy of, and the responsibility for, the entire transaction. If more than one pharmacist is involved in verifying the accuracy of the prescription product, a record shall be maintained identifying the date of dispensing, each pharmacist involved in the process, and the individual task for which he is responsible for verifying the accuracy. Such record showing verification of accuracy shall be maintained on a pharmacy record and, if necessary, an alternate record consistent with 18VAC110-20-255 for the required time period of two years, unless otherwise specified in regulation. If the dispensing involves central or remote processing, records of pharmacist verification shall be maintained in a manner consistent with 18VAC110-20-276 and 18VAC110-20-515.

D.C. If a pharmacist declines to fill a prescription for any reason other than the unavailability of the drug prescribed, he shall record on the back of the prescription the word "declined"; the name, address, and telephone number of the pharmacy; the date filling of the prescription was declined; and the signature of the pharmacist.

E.D. If a pharmacist determines from a prescriber or by other means, including the use of his professional judgment, that a prescription presented for dispensing is a forgery, the pharmacist shall not may refuse to return the forged prescription to the person presenting it. The forged prescription may be given to a law-enforcement official investigating the forgery; or it shall be retained for a minimum of 30 days before destroying it, in the event it is needed for an investigative or other legitimate purpose.

E. Upon patient consent, a pharmacist using professional judgement and acting in the best interest of patient care may adapt a prescription as specified in this rule, provided the drug is not for a controlled substance, and provided that the prescriber has not indicated by any means necessary that adaptation is not permitted.

1. A pharmacist may change the quantity, dosage, dosage form, or direction of medication dispensed if it meets the intent of the prescriber.

2. A pharmacist may complete missing information on a prescription if there is sufficient evidence to support the change.

3. A pharmacist may extend a maintenance drug for the limited quantity necessary to coordinate a patient’s refills in medication synchronization program.

4. A pharmacist who adapts a prescription in accordance with these rules must document the adaptation in the patient’s record.

F.E.F. An on-hold prescription shall be entered into the automated data processing system if such system is employed by the pharmacy, and the pharmacist on-duty shall verify the accuracy of the data entry at that time. The pharmacist subsequently dispensing the on-hold prescription on a future date shall, at a minimum, and conduct a prospective drug review consistent with § 54.1-3319 A of the Code of Virginia. If an on-hold prescription is returned to a patient prior to the initial dispensing of the drug, the pharmacist shall delete the entry in the automated data processing system.

F.G. A pharmacy may utilize a drop box for the collection of written prescriptions and refill requests.  The drop box shall be located in a visible area within the permitted facility and shall be locked at all times with access to the items placed in the drop box restricted to pharmacists practicing at the pharmacy or an authorized pharmacy technician practicing at the pharmacy when a pharmacist is on duty.  The drop box shall be constructed in a manner to prevent the theft or loss of a written prescription or confidential information and shall be bolted to the floor or a fixed structure.  Pharmacists shall in some manner inform the public that containers left in a drop box for refill should not contain unused drugs.

 

18VAC110-20-110. Pharmacy permits generally.

A. A pharmacy permit shall not be issued to a pharmacist to be simultaneously in charge of more than two pharmacies.

B. Except in an emergency, a permit holder shall not require a pharmacist to work longer than 12 continuous hours in any work day and shall allow at least six hours of off-time between consecutive shifts. A pharmacist working longer than six continuous hours shall be allowed to take a 30-minute break.

C. The pharmacist-in-charge (PIC) PIC or the pharmacist on duty shall control all aspects of the practice of pharmacy. Any decision overriding such control of the PIC or other pharmacist on duty shall be deemed the practice of pharmacy and may be grounds for disciplinary action against the pharmacy permit.

D. A pharmacist shall not be eligible to serve as PIC until after having obtained a minimum of two years of experience practicing as a pharmacist in Virginia or another U.S. jurisdiction.  The board may grant an exception to the minimum number of years of experience for good cause shown.

 

 

(Comment 1 of 2) 

Sincerely, 

Mark Johnston, PharmD

Senior Director, Pharmacy Regulatory Affairs

CVS Health

200 Highland Corporate Drive

Woonsocket, RI 02895

(401)601-1968

Mark.Johnston@CVSHealth.com