18VAC110-20 Regulations Governing the Practice of Pharmacy

REGULATIONS

Vol. 32 Iss. 7 - November 30, 2015

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Chapter 20

Proposed Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-110).

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

Public Hearing Information:

December 1, 2015 - 9 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2, Richmond, VA 23233

Public Comment Deadline: January 29, 2016.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone [phone], FAX [phone], or email [e-mail].

Basis: Regulations are promulgated under the general authority of Chapter 24 (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia. Section 54.1-2400 of the Code of Virginia provides the Board of Pharmacy the authority to promulgate regulations that are reasonable and necessary to administer effectively the regulatory system. Such regulations shall not conflict with the purposes and intent of Chapter 24 or of Chapter 1 (§ 54.1- 100 et seq.) and Chapter 25 (§ 54.1-2500 et seq.) of Title 54.1. The specific statutory authority for the Board of Pharmacy to regulate the practice of pharmacy including regulations pertaining to the safety and integrity of drugs is found in § 54.1-3307 of the Code of Virginia.

Purpose: While the board is not aware of studies documenting the error rate for pharmacists working extensive hours continuously, every pharmacist who spoke to the board and members of the board are aware that fatigue and lack of concentration can and do lead to errors in filling, reviewing for drug interactions, and dispensing prescription drugs. For other professions who rely on mental acuity, such as airline pilots, there is a limitation on continuous hours of work. Therefore, the board believes it is essential for public health and safety that some reasonable limitation be instituted on continuous hours of work without any breaks for pharmacists in Virginia.

Regulation is necessary to prevent, to the extent possible, prescription errors due to fatigue and lack of concentration by pharmacists in the important task of assuring the accuracy and integrity of controlled substances.

Substance: The proposed regulation provides that, except in an emergency, a pharmacy cannot require a pharmacist to work longer than 12 continuous hours in any work day without being allowed at least six hours of off-time between consecutive shifts. A pharmacist working longer than six continuous hours must be allowed to take a 30-minute break.

Issues: The primary advantage to the public would be greater assurance of safety in prescription medications dispensed by pharmacists who are not overly-fatigued from excessive hours of work without any break. Pharmacists would have the option of continuing with a patient beyond the prescribed hours or remaining on duty if a replacement pharmacist is not available, so patients would not be neglected. There are no disadvantages to the public.

There are no advantages or disadvantages to the 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 provide in these regulations that, except in an emergency, a pharmacy cannot require a pharmacist to work longer than 12 continuous hours in any work day without being allowed at least six hours of off-time between consecutive shifts. A pharmacist working longer than six continuous hours must be allowed to take a 30-minute break.

Result of Analysis. The proposed amendments are beneficial for some entities and are costly for others.

Estimated Economic Impact. The proposal was initially brought forth through a petition for rulemaking by a practicing Virginia pharmacist. According to the petitioner, there are hundreds of retail pharmacists in Virginia who are required to work more than 12 continuous hours (often up to 14 hours) per day, and a large percentage of them are not allowed to leave the pharmacy for at least a 30 minute meal break. Under the proposed language a pharmacist can agree to work longer than 12 continuous hours in a work day without at least six hours of off-time between consecutive shifts or work longer than six continuous hours without taking a break, but cannot be required to do so. Thus, the proposed amendments will be beneficial for pharmacists who object to such work requirements.

Also, the peer reviewed literature does indicate that fatigue contributes to pharmacist dispensing errors.¹ Working numerous hours without a break and working long shifts with little time off in between surely does contribute to fatigue. Thus, the proposed amendments have the potential to reduce dispensing errors. Of note, the peer-reviewed literature appears to imply that high workload per hour is an even greater source of pharmacist dispensing error than a high quantity of consecutive hours worked.²

As demonstrated by the petition for rulemaking, there are pharmacists who are currently required to work longer than 12 continuous hours in a work day without at least six hours of offtime between consecutive shifts or work longer than six continuous hours without taking a break. Thus, the proposed prohibition on requiring such work hours will likely cause some pharmacies to increase staffing or redeploy existing staff in a less profit-maximizing manner.

Businesses and Entities Affected. The proposed amendments potentially affect the 12,011 pharmacists and 1,776 pharmacies currently licensed in the Commonwealth. According to the Department of Health Professions, most of the licensed pharmacies are owned by national chain drug stores and would not be considered small businesses.

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

Projected Impact on Employment. The net effect of the proposed amendments on total employment is uncertain. On the one hand, the proposed limitation on requiring certain work hours may cause some pharmacies to increase staffing to cover all hours of operation. On the other hand, the prohibition will increase costs for affected pharmacies. Such pharmacies may choose to operate for fewer hours in response and effectively employ fewer hours of pharmacist labor.

Effects on the Use and Value of Private Property. The proposed amendments will likely cause some pharmacies to increase staffing or redeploy existing staff in a less profit-maximizing manner.

Small Businesses: Costs and Other Effects. Most of the affected businesses are part of large chain pharmacies. Those small pharmacies which are currently requiring staff pharmacists to work longer than 12 continuous hours in a work day without at least six hours of off-time between consecutive shifts or work longer than six continuous hours without taking a break may incur higher staffing costs or be forced to be open fewer hours due to the proposed amendments if their staff do not voluntarily agree to work such hours.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There is not an apparent alternative method that achieves the same policy goal at a lower cost.

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

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¹Schaheutle EI, Seston EM, Hassell K. "Factors influencing pharmacist performance: A review of the peerreviewed literature." Health Policy: 102 (2011) 178-192.

²Ibid

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

Summary:

The proposed amendments establish that (i) except in an emergency, a pharmacy cannot require a pharmacist to work longer than 12 continuous hours in any work day without being allowed at least six hours of off-time between consecutive shifts and (ii) a pharmacist working longer than six continuous hours is allowed to take a 30-minute break.

Part IV
Pharmacies

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 without being allowed 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.

B. C. The pharmacist-in-charge (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.

C. D. 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.

D. E. Although not required by law or regulation, an outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Schedule 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.

E. F. 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.

F. G. 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.

G. H. 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.

H. I. 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.

VA.R. Doc. No. R12-19; Filed November 9, 2015, 1:10 p.m.