Agencies | Governor
Virginia Regulatory Town Hall

Emergency Text

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Action:
Pharmacy working conditions
Stage: Emergency/NOIRA
 
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 may, however, volunteer to work longer than 12 continuous hours. A pharmacist working longer than six continuous hours shall be allowed to take a 30-minute break. Breaks, including uninterrupted rest periods and meal breaks, shall be provided consistent with 18VAC110-20-113 B 5.

C. The 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 jurisdiction in the United States. The board may grant an exception to the minimum number of years of experience for good cause shown.

E. When the PIC ceases practice at a pharmacy or no longer wishes to be designated as PIC, he shall immediately return the pharmacy permit to the board indicating the effective date on which he ceased to be the PIC.

F. Although not required by law or regulation, an outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Schedules II through V controlled substances on hand on the date he ceases to be the PIC, unless the owner submits written notice to the board showing good cause as to why this opportunity should not be allowed.

G. A PIC who is absent from practice for more than 30 consecutive days shall be deemed to no longer be the PIC. Pharmacists-in-charge having knowledge of upcoming absences for longer than 30 days shall be responsible for notifying the board and returning the permit. For unanticipated absences by the PIC, which exceed 15 days with no known return date within the next 15 days, the owner shall immediately notify the board and shall obtain a new PIC.

H. An application for a permit designating the new PIC shall be filed with the required fee within 14 days of the original date of resignation or termination of the PIC on a form provided by the board. It shall be unlawful for a pharmacy to operate without a new permit past the 14-day deadline unless the board receives a request for an extension prior to the deadline. The executive director for the board may grant an extension for up to an additional 14 days for good cause shown.

I. Only one pharmacy permit shall be issued to conduct a pharmacy occupying the same designated prescription department space. A pharmacy shall not engage in any other activity requiring a license or permit from the board, such as manufacturing or wholesale-distributing, out of the same designated prescription department space.

J. Before any permit is issued, the applicant shall attest to compliance with all federal, state, and local laws and ordinances. A pharmacy permit shall not be issued to any person to operate from a private dwelling or residence after September 2, 2009.

18VAC110-20-113 Pharmacy working conditions

A. A pharmacy permit holder shall protect the health, safety, and welfare of patients by consulting with the PIC or pharmacist on duty and other pharmacy staff to ensure patient care services are safely provided in compliance with applicable standards of patient care. A permit holder's decisions shall not override the control of the PIC or other pharmacist on duty regarding appropriate working environments for all pharmacy personnel necessary to protect the health, safety, and welfare of patients.

B. To provide a safe working environment in a pharmacy, a permit holder shall, at a minimum:

1. Ensure sufficient personnel are scheduled to work at all times in order to prevent fatigue, distraction, or other conditions which interfere with a pharmacist's ability to practice with reasonable competence and safety. Staffing levels shall not be solely based on prescription volume, but shall consider any other requirements of pharmacy staff during working hours;

2. Provide sufficient tools and equipment in good repair and minimize excessive distractions to support a safe workflow for a pharmacist to practice with reasonable competence and safety to address patient needs in a timely manner;

3. Avoid the introduction of external factors, such as productivity or production quotas, or other programs to the extent that they interfere with the pharmacist's ability to provide appropriate professional services to the public;

4. Ensure staff are sufficiently trained to safely and adequately perform their assigned duties, ensure staff demonstrate competency, and ensure that pharmacy technician trainees work closely with pharmacists and pharmacy technicians with sufficient experience as determined by the PIC;

5. Provide appropriate opportunities for uninterrupted rest periods and meal breaks consistent with 18VAC110-20-110 and the following:

a. A pharmacy may close when a pharmacist is on break based on the professional judgment of the pharmacist on duty provided that it has complied with the 14-day notice to the public pursuant to § 54.1-3434 of the Code of Virginia and 18VAC110-20-135;

b. If a pharmacy does not close while the pharmacist is on break, the pharmacist must ensure adequate security of drugs by taking his break within the prescription department or on the premises. The pharmacist on duty must determine if pharmacy technicians or pharmacy interns may continue to perform duties and if the pharmacist is able to provide adequate supervision; and

c. If the pharmacy remains open, only prescriptions verified by a pharmacist pursuant to 18VAC110-20-270 may be dispensed when the pharmacist is on break. An offer to counsel any person filling a new prescription must be offered pursuant to § 54.1-3319 of the Code of Virginia. Persons who request to speak to the pharmacist shall be told that the pharmacist is on break and that they may wait to speak with the pharmacist or provide a telephone number for the pharmacist to contact them upon return from break. Pharmacists returning from break shall immediately attempt to contact persons who requested counseling and document when such counseling is provided;

6. Provide adequate time for a pharmacist to complete professional duties and responsibilities, including:

a. drug utilization review;

b. immunization;

c. counseling;

d. verification of prescriptions;

e. patient testing; and

f. all other duties required by §§ 54.1-3300 et seq. and 54.1-3400 et seq. of the Code of Virginia and 18VAC110-20-10 et seq; and

7. Ensure that pharmacy technicians shall never perform duties otherwise restricted to a pharmacist.

C. A pharmacy permit holder shall not override the control of the pharmacist on duty regarding all aspects of the practice of pharmacy, including a pharmacist's decision not to administer vaccines when one pharmacist is on duty and, in the pharmacist's professional judgment, vaccines cannot be administered safely.

D. Staffing requests or concerns shall be communicated by the PIC or pharmacist on duty to the permit holder using a form developed by the board.

1. Executed staffing forms shall be provided to the immediate supervisor of the PIC or pharmacist on duty, with one copy maintained in the pharmacy for three years, and produced for inspection by the board.

2. The PIC or pharmacist on duty may report any staffing issues directly to the board if the PIC or pharmacist on duty believes the situation warrants immediate board review.

3. Under no circumstances shall a good faith report of staffing concerns by the PIC, pharmacist on duty, or notification of such issues by pharmacy personnel to the PIC or pharmacist on duty result in workplace discipline against the reporting staff member.

E. Permit holders shall review completed staffing reports and shall:

1.Respond to reporting staff member to acknowledge receipt of the staffing request or concern;

2. Resolve any issues listed in a timely manner to ensure a safe working environment for pharmacy staff and appropriate medication access for patients;

3. Document any corrective action taken, steps taken toward corrective action as of the time of inspection, or justification for inaction, which documentation shall be maintained on-site or produced for inspection by the board within 48 hours of request; and

4. Communicate corrective action taken or justification for inaction to the PIC or reporting pharmacist on duty.