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:

December 3, 2019 - 9:10 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 4, Richmond, VA 23233

Public Comment Deadline: January 10, 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: Section 54.1-2400 of the Code of Virginia provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. Section 54.1-3307 of the Code of Virginia authorizes the board to regulate the dispensing of prescription drugs.

Purpose: The purpose of the proposed regulatory action is to address patient safety concerns relating to brown bagging and white bagging. Specific requirements for notification and patient information to the receiving pharmacy or alternative delivery site of the shipment will better ensure appropriate coordination of patient care in white bagging. Requiring appropriate storage and security for a shipped product will protect public health and safety. The prohibition on delivering drugs to a patient's residence for administration, if the drug requires special storage, reconstitution, or compounding, will protect patients and the entities responsible for the integrity of the drug administered.

Substance: At the 2016 annual meeting of the National Association of Boards of Pharmacy (NABP), the membership authorized a study of "white bagging" and "brown bagging." A copy of the report may be viewed at https://nabp.pharmacy/wp-content/uploads/2018/04/White-Bagging-and-Brown-Bagging-Report-2018_Final.pdf.

Based on the NABP report and the expertise of pharmacist members of the board and the pharmacy benefits manager workgroup, the board proposes regulations:

1. Requiring the specialty pharmacy participating in white bagging to notify the receiving pharmacy or alternative delivery site of the shipment to ensure appropriate coordination of patient care;

2. Requiring the pharmacy to provide to the receiving pharmacy an estimated arrival date, to provide the name of the patient to whom the drug has been dispensed, and to provide the exact address where the product has been shipped;

3. Requiring appropriate storage and security for a shipped product; and

4. Prohibiting delivery to a patient's residence of any drug that requires special storage, reconstitution, or compounding prior to administration is intended and that will be subsequently transported by the patient for administration.

Issues: The advantage to the public is less risk of a drug that requires special storage or has a short shelf life will be delivered to a pharmacy or other entity without preparations in place to receive that drug. There are no disadvantages.

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. Under specified circumstances, the Board of Pharmacy (Board) proposes to ease burdens related to the delivery of prescription drugs from a pharmacy to an alternative delivery site. The alternative delivery site may be another pharmacy, a practitioner of the healing arts licensed to practice pharmacy or to sell controlled substances, or an authorized person or entity holding a controlled substances registration. The Board also proposes to prohibit delivering dispensed drugs to a patient's residence that are intended to be subsequently transported by the patient or patient's agent to a hospital, medical clinic, prescriber's office, or pharmacy for administration if the drugs require special storage, reconstitution or compounding prior to administration.

Result of Analysis. The benefits likely exceed the costs for one or more proposed changes. For other amendments, whether the benefits exceed the costs depend on the policy views of the observer.

Estimated Economic Impact.

Background:

In addition to direct hand delivery to a patient or patient's agent or delivery to a patient's residence, under specified conditions 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.

When the delivery is to another pharmacy, the two pharmacies must 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 (including counseling, return of any prescription medications not delivered to the patient, etc.), and the manner in which each pharmacy will comply with all applicable federal and state law. When the delivery is to a practitioner of the healing arts licensed by the Board to practice pharmacy or to sell controlled substances or another authorized person or entity holding a controlled substances registration authorized for this purpose, there must be a written contract or agreement between the two parties describing the procedures for such a delivery system and the responsibilities of each party. According to the Department of Health Professions, sometimes this is impractical or causes delay in the delivery of a medication that a patient needs. If a specialty drug is needed, the pharmacy benefits manager or insurer may require that the drug be obtained from a specialty pharmacy or the pharmacy to which the prescription is sent may not carry that drug.

Proposals:

The Board proposes to permit deliveries from a pharmacy to an alternative delivery site without the detailed written contract or same ownership if the alternate delivery site does not routinely receive deliveries from the pharmacy and producing and agreeing to the contract and paperwork details would create a delay in delivery that may result in potential patient harm. The pharmacy would be required to notify the alternate delivery site of the anticipated arrival date of the shipment, the exact address to where the drug was shipped, the name of the patient for whom the drug was dispensed, and any special storage requirements. Similar to current requirements, 1) the pharmacy would have to provide counseling or ensure a process is in place for the patient to receive counseling, 2) prescriptions delivered to the alternate delivery site would have to 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, and 3) the pharmacy would have to provide a procedure for the return of any prescription drugs not delivered or subsequently administered to the patient.

This proposed amendment may substantially reduce delays in some patients receiving needed medications. Consequently, it may produce large health benefits. Given the safety procedures accompanying the proposal, it seems unlikely that there would be an increase in health risk. Thus, the benefits very likely exceed the costs.

The Board also proposes to prohibit delivering dispensed drugs to a patient's residence that are intended to be subsequently transported by the patient or patient's agent to a hospital, medical clinic, prescriber's office, or pharmacy for administration if the drugs require special storage, reconstitution or compounding prior to administration. The proposed language includes an exception for patients with hemophilia who may require emergent blood factor treatment.

When drugs require special storage, reconstitution or compounding, there is increased risk that they may become ineffective or dangerous if not handled properly. Prohibiting the delivery of such drugs to a patient's residence that are intended to be subsequently transported as described above would likely reduce the occurrences where drugs that become ineffective or dangerous due to mishandling are administered to patients. This is beneficial. On the other hand, there may be circumstances where such delivery is the most practical way for certain patients to quickly receive needed treatment. The Board has recognized this by providing the exemption for patients with hemophilia. There may be other patients for which this is true who are not exempted by the proposal. In addition, some individuals may believe that they should not be prevented from taking their own informed risks.

Businesses and Entities Affected. The proposed amendments potentially affect the 1,813 pharmacies, practitioners of the healing arts licensed to practice pharmacy or to sell controlled substances, authorized persons or entities holding a controlled substances registration, and patients.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to substantially affect employment.

Effects on the Use and Value of Private Property. The proposal to permit deliveries from a pharmacy to an alternative delivery site without a detailed written contract may reduce costs for small firms involved. This may modestly increase their value.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant 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."

Costs and Other Effects. The proposal to permit deliveries from a pharmacy to an alternative delivery site without a detailed written contract may reduce costs for small firms involved.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments do not adversely affect businesses.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

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 (i) require the specialty pharmacy participating in white bagging to notify the receiving pharmacy or alternative delivery site of the shipment to ensure appropriate coordination of patient care; (ii) require the pharmacy to provide to the receiving pharmacy an estimated arrival date, to provide the name of the patient to whom the drug has been dispensed, and to provide the exact address where the product has been shipped; (iii) require appropriate storage and security for a shipped product; and (iv) prohibit delivery to a patient's residence of any drug that requires special storage, reconstitution, or compounding prior to administration is intended and that will be subsequently transported by the patient for administration.

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 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;

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 for assuring confidentiality of patient information; and

e. The 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.

F. The pharmacy and alternate delivery site shall be exempt from compliance with subsections B through E of this section if (i) the alternate delivery site is a pharmacy, a practitioner of healing arts licensed by the board to practice pharmacy or sell controlled substances, or other entity holding a controlled substances registration for the purpose of delivering controlled substances; (ii) the alternate delivery site does not routinely receive deliveries from the pharmacy; and (iii) compliance with subsections B through E of this section would create a delay in delivery that may result in potential patient harm. However, the pharmacy and alternate delivery site shall comply with following requirements:

1. To ensure appropriate coordination of patient care, the pharmacy shall notify the alternate delivery site of the anticipated arrival date of the shipment, the exact address to where the drug was shipped, the name of the patient for whom the drug was dispensed, and any special storage requirements.

2. The pharmacy shall provide counseling or ensure a process is in place for the patient to receive counseling.

3. Prescriptions delivered to the alternate delivery 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 prescriber, pharmacist, or either person's designee.

4. The pharmacy shall provide a procedure for the return of any prescription drugs not delivered or subsequently administered to the patient.

G. A pharmacy shall not deliver dispensed drugs to a patient's residence that are intended to be subsequently transported by the patient or patient's agent to a hospital, medical clinic, prescriber's office, or pharmacy for administration and that require special storage, reconstitution or compounding prior to administration. An exception to this requirement may be made for patients with hemophilia who may require emergent blood factor treatment.