Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-275).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information:

March 24, 2020 - 9 a.m. - Department of Health Professions, Board Room 4, Perimeter Center, 9960 Mayland Drive, Suite 201, Henrico, VA 23233.

Public Comment Deadline: April 3, 2020.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of Chapter 24 of Title 54.1 of the Code of Virginia. Section 54.1-2400 provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific authority for the board to regulate the dispensing of prescription drugs is found in § 54.1-3307 of the Code of Virginia.

Purpose: The purpose of the proposed regulatory action is to respond to a petition for rulemaking from CVS Health to eliminate a requirement for a pharmacy that is only holding a prescription for pick-up or delivery to a consumer to be identified on the prescription label. The petitioner noted that identification of multiple pharmacies is confusing; the dispensing pharmacy is best able to answer questions and respond to problems or concerns by a patient about the patient's medication. The board believes an amendment to its regulation will safeguard patient health and safety by ensuring that a prescription label has pertinent information.

Substance: An amendment to 18VAC110-20-275 would specify that a unique identifier on the prescription label is not required to identify a pharmacy that is solely involved in the holding of a prescription for pick-up or further delivery when that pharmacy has not shared in other filling or dispensing functions.

Issues: Some commenters, such as Rx Partnership, believe the amendment is advantageous to the public, especially many low-income and uninsured patients who experience transportation challenges and would be able to receive medications at a preferred pharmacy rather than the pharmacy where the prescription was filled.

Others have expressed concern that patients, particularly senior citizens, might want the information about the pharmacy where the prescription was being picked up, as well as the pharmacy where it was filled. To address those concerns, letters were sent directly to consumer groups and senior advocacy groups explaining the possible amendment and requesting comment. None was received. The groups were: Virginia Citizens Consumer Council, Virginia Association of Area Agencies on Aging, Virginia Navigators, Senior Connections, and AARP Virginia.

There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to amend 18VAC110-20 Regulations Governing the Practice of Pharmacy (regulation) in order to clarify the Board's interpretation of the labeling requirements in response to a petition for rulemaking filed by Joseph Lavino, Legal Counsel of Pharmacy Regulatory Affairs for CVS Health in September 2017.² Specifically, the Board seeks to amend 18VAC110-20-275 by adding that, "A unique identifier on the prescription label is not required to identify a pharmacy solely involved in the holding of a prescription for pick-up or further delivery when that pharmacy has not shared in other filling or dispensing functions."³ The proposed addition would reduce the amount of detailed information that pharmacies are currently expected to include on limited prescription label space, making it easier for pharmacies to comply with the labeling requirements.

Background. In response to the petition for rulemaking, the Board seeks to clarify that a unique identifier on the prescription label is not required to identify a pharmacy solely involved in holding a prescription for pick-up or further delivery when that pharmacy does not share in other filling or dispensing functions. As per current regulation, pharmacies are required to (i) formulate their own policy regarding their prescription labels, including a procedure to identify "all pharmacies involved in filling and dispensing the prescription," (ii) administer the policy via a current "policy and procedure manual" and (iii) maintain adherence to their own policies and procedures as laid out in their manual.⁴

According to the Department of Health Professions (DHP), the Board heretofore interpreted 18VAC110-20-275 as applying to every pharmacy involved in "drug delivery." As a result, the Board expected that pharmacies that only receive and hold a prescription for the consumer to pick up would be identified, not just pharmacies that fill and dispense the prescription.⁵ However, the petitioner noted that identification of multiple pharmacies is confusing and that the dispensing pharmacy is best able to answer questions and respond to patients' questions or concerns.⁶

Estimated Benefits and Costs. As of this writing, CVS Health operates 344 pharmacy locations in Virginia and relies on the size of their network to optimize inventory management: some prescriptions are filled by CVS' specialty pharmacies and then sent to local CVS pharmacies. This allows customers to pick up their medications at a store location that suits their convenience, while also having the address and phone number of the dispensing pharmacy should they have any questions or concerns.⁷ The proposed amendment would allow CVS to continue filling and delivering prescriptions without having to change their labeling procedures. They would also not risk being cited during routine pharmacy inspections for not meeting the Board's labeling requirements. Thus CVS and their customers would benefit from maintaining the status quo without having to incur any additional costs. Further, other pharmacy chains that may have been found to be in violation of the labeling requirements for not identifying the delivering pharmacy on their labels would also benefit from not having to make changes. Independent pharmacies or pharmacies belonging to local chains may not be affected by the proposed amendment if they fill prescriptions which are picked up at the same location.⁸

Pharmacies that have currently been including information to identify both the dispensing as well as the delivering pharmacy on their labels would not be affected, as the proposed amendment would not require them to change their labeling procedures. However, they may choose to discontinue including identifying information about the delivering pharmacy, which could benefit their customers if it makes the label easier to read and less confusing.

Comments received at the NOIRA stage pointed out the potential benefits of dispensing with the requirement to identify pharmacies that are merely holding a prescription for pick-up. A comment made on behalf of CVS Health noted that the Institute for Safe Medication Practices, which has published guidelines for medication labels, suggests that "maximizing the use of white space on a label would improve medication adherence and reduce inadvertent medication errors."⁹ Older adults and adults with visual impairments have reported a strong subjective preference for larger print size and the use of uppercase letters to denote numeric information on prescription labels.¹⁰ This is especially relevant given that 80 percent of older adults in the U.S. (and 90 percent of Medicare beneficiaries) take at least one daily prescription.¹¹ Hence, the proposed amendment could benefit older adults and adults with visual impairments to the extent that a reduction in the amount of information required on the label leads pharmacies to design labels that are easier to read.

Another commenter in support of the Board's action pointed out that mail order pharmacies sometimes put a customer service number on the label, rather than the number of the pharmacy. While it can be confusing to the consumer to have multiple phone numbers on the prescription label, the commenter recommended prioritizing information regarding where the prescription was filled and how to contact the pharmacist directly.¹² Rx Partnership (a nonprofit working to increase medication access) commented in support of the initial petition saying it would increase efficiency and make it easier to provide prescriptions for individuals who need a convenient location for pick-up that may not be where the prescription was filled.¹³ Hence, consumers of prescription medications stand to benefit as long as the proposed amendment would at least preserve, if not increase, the clarity of information regarding whom to contact with questions, while also enabling more efficient delivery systems and convenient pick-up locations.

Businesses and Other Entities Affected. The proposed amendment would affect pharmacies that are either operated as part of larger chains or belong to pharmacy networks, to the extent that prescriptions filled at one pharmacy are delivered to the customer at a different pharmacy. The proposal would not increase costs for any entities.

Localities¹⁴ Affected.¹⁵ The proposed amendments do not introduce new costs for local governments and are unlikely to affect any locality in particular.

Projected Impact on Employment. The proposed amendments are unlikely to have any impact on employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to affect the use and value of private property. Real estate development costs are not affected.

Adverse Effect on Small Businesses:¹⁶ The proposed amendments are unlikely to have an adverse impact on any small business. As mentioned previously, independent pharmacies are unlikely to be affected at all, unless they participate in contractual arrangements with other pharmacies to fill and deliver prescriptions across multiple locations, in which case they would benefit from the greater flexibility allowed by the proposed amendment.

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²See https://townhall.virginia.gov/L/viewpetition.cfm?petitionid=262

³See https://law.lis.virginia.gov/admincode/title18/agency110/chapter20/
section275/

⁴18VAC110-20-275 B 2 currently states that "Each pharmacy using such a drug delivery system shall maintain and comply with all procedures in a current policy and procedure manual that includes the following information" with subdivision d requiring "The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription." (https://law.lis.virginia.gov/admincode/title18/agency110/
chapter20/section275/)

⁵DHP provided this explanation regarding "the Board's interpretation" via phone communication.

⁶See p. 3 https://townhall.virginia.gov/l/GetFile.cfm?File=30\5093\8779\
AgencyStatement_DHP_8779_v2.pdf

⁷DHP also helpfully pointed out that customers do not need the location of the pharmacy where they picked up the prescription to be on the label, because they just went there to pick it up.

⁸However, if they participate in any prescription networks or have any reciprocal contracts with other pharmacies and have only been identifying the pharmacy that fills the prescription, they too would benefit in the same way as CVS and other pharmacy chains.

⁹The commenter also noted that there would still be an audit trail to track the prescription, and information provided to the patient to answer any questions or provide any counseling. See p.7 of the ABD, https://townhall.virginia.gov/l/GetFile.cfm?File=30\5093\8779\AgencyStatement_DHP_8779_v2.pdf.

¹⁰See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4860753/.

¹¹See https://bemedwise.org/health-education-resources/older-adults and https://bemedwise.org/documents/must_factsheet.pdf.

¹²See https://townhall.virginia.gov/l/viewcomments.cfm?commentid=68800.

¹³See https://townhall.virginia.gov/l/viewcomments.cfm?commentid=63283.

¹⁴"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹⁵§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

¹⁶Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget.

Summary:

The proposed amendments specify that a unique identifier on the prescription label is not required to identify a pharmacy solely involved in the holding of a prescription for pick-up or further delivery when that pharmacy has not shared in other filling or dispensing functions. The amendments are in response to a petition for rulemaking from December 11, 2017.

18VAC110-20-275. Delivery of dispensed prescriptions.

A. Pursuant to § 54.1-3420.2 B of the Code of Virginia, in addition to direct hand delivery to a patient or patient's agent or delivery to a patient's residence, a pharmacy may deliver a dispensed prescription drug order for Schedule VI controlled substances to another pharmacy, to a practitioner of the healing arts licensed to practice pharmacy or to sell controlled substances, or to an authorized person or entity holding a controlled substances registration issued for this purpose in compliance with this section and any other applicable state or federal law. Prescription drug orders for Schedule II through Schedule V controlled substances may not be delivered to an alternate delivery location unless such delivery is authorized by federal law and regulations of the board.

B. Delivery to another pharmacy.

1. One pharmacy may fill prescriptions and deliver the prescriptions to a second pharmacy for patient pickup pick-up or direct delivery to the patient provided the two pharmacies have the same owner, or have a written contract or agreement specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which each pharmacy will comply with all applicable federal and state law.

2. Each pharmacy using such a drug delivery system shall maintain and comply with all procedures in a current policy and procedure manual that includes the following information:

a. A description of how each pharmacy will comply with all applicable federal and state law;

b. The procedure for maintaining required, retrievable dispensing records to include which pharmacy maintains the hard-copy prescription, which pharmacy maintains the active prescription record for refilling purposes, how each pharmacy will access prescription information necessary to carry out its assigned responsibilities, method of recordkeeping for identifying the pharmacist or pharmacists responsible for dispensing the prescription and counseling the patient, and how and where this information can be accessed upon request by the board;

c. The procedure for tracking the prescription during each stage of the filling, dispensing, and delivery process;

d. The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription. A unique identifier on the prescription label is not required to identify a pharmacy solely involved in the holding of a prescription for pick-up or further delivery when that pharmacy has not shared in other filling or dispensing functions;

e. The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information;

f. The policy and procedure for ensuring accuracy and accountability in the delivery process;

g. The procedure and recordkeeping for returning to the initiating pharmacy any prescriptions that are not delivered to the patient; and

h. The procedure for informing the patient and obtaining consent for using such a dispensing and delivery process.

3. Drugs waiting to be picked up at or delivered from the second pharmacy shall be stored in accordance with subsection A of 18VAC110-20-200.

C. Delivery to a practitioner of the healing arts licensed by the board to practice pharmacy or to sell controlled substances or other authorized person or entity holding a controlled substances registration authorized for this purpose.

1. A prescription may be delivered by a pharmacy to the office of such a practitioner or other authorized person provided there is a written contract or agreement between the two parties describing the procedures for such a delivery system and the responsibilities of each party.

2. Each pharmacy using this delivery system shall maintain a policy and procedure manual that includes the following information:

a. Procedure for tracking and assuring security, accountability, integrity, and accuracy of delivery for the dispensed prescription from the time it leaves the pharmacy until it is handed to the patient or agent of the patient;

b. Procedure for providing counseling;

c. Procedure and recordkeeping for return of any prescription medications not delivered to the patient;

d. The procedure Procedure for assuring confidentiality of patient information; and

e. The procedure Procedure for informing the patient and obtaining consent for using such a delivery process.

3. Prescriptions waiting to be picked up by a patient at the alternate site shall be stored in a lockable room or lockable cabinet, cart, or other device that cannot be easily moved and that shall be locked at all times when not in use. Access shall be restricted to the licensed practitioner of the healing arts or the responsible party listed on the application for the controlled substances registration, or either person's designee.

D. The contracts or agreements and the policy and procedure manuals required by this section for alternate delivery shall be maintained both at the originating pharmacy as well as the alternate delivery site.

E. A controlled substances registration as an alternate delivery site shall only be issued to an entity without a prescriber or pharmacist present at all times the site is open if there is a valid patient health or safety reason not to deliver dispensed prescriptions directly to the patient and if compliance with all requirements for security, policies, and procedures can be reasonably assured.