Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-90, 18VAC110-20-106).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: April 19, 2017.

Effective Date: May 5, 2017.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia authorizes the Board of Pharmacy to promulgate regulations to administer the regulatory system with a specific mandate enacted by Chapter 82 of the 2016 Acts of Assembly to include provisions for the satisfaction of board-required continuing education through the delivery of health care services, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those health services.

Purpose: The purpose of the amended regulation is compliance with the mandate of the General Assembly and to provide an incentive for licensees to volunteer professional services to free clinics or public health centers. While a licensee can satisfy up to two hours of continuing education with six hours of volunteer service, he is still required to have 13 hours of approved continuing education necessary to acquire new knowledge and skills. For pharmacy technicians, one hour of continuing education may be credited for three hours of providing volunteer services. Therefore, public health is served by a potential increase in badly needed volunteer service for pharmacy services, but public safety is not sacrificed by eliminating most or all of the continuing education hours required for renewal.

Rationale for Using Fast-Track Rulemaking Process: The allowance of hours for volunteer service to be counted towards the continuing education requirement is a mandate of the General Assembly. A licensee is not required to provide volunteer service but may be credited with continuing education hours for doing so. The provisions are permissive and neither is controversial.

Substance: The board has adopted amended regulations to allow pharmacists to count up to two hours of the 15 hours required for annual renewal to be satisfied through delivery of pharmacy services, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those services. One hour of continuing education may be credited for three hours of providing such volunteer services, as documented by the health department or free clinic. Pharmacy technicians are allowed to count up to one hour of continuing education for three hours of volunteer service.

Issues: The advantage to the public is the incentive given for pharmacists and pharmacy technicians to volunteer their services in exchange for credit towards meeting continuing education requirements. 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. Pursuant to Chapter 82 of the 2016 Acts of Assembly,¹ the Board of Pharmacy (Board) proposes to allow six hours of volunteer work to be substituted for up to two hours of continuing education annually for pharmacists and three hours of volunteer work to be substituted for up to one hour of continuing education annually for pharmacy technicians.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Chapter 82 of the 2016 Acts of Assembly requires all health boards to promulgate regulations to accept volunteer work provided to low-income individuals through local health departments or free clinics in lieu of the required continuing education. Pursuant to the legislative mandate, the Board proposes to accept three hours of volunteer work in satisfaction of one hour of continuing education from pharmacists and pharmacy technicians. The limit on the continuing education hours that can be satisfied by volunteer work is two hours for pharmacists and one hour for pharmacy technicians every year. Currently, pharmacists and pharmacy technicians are required respectively to take 15 and 5 hours of continuing education every year for annual renewal of their licenses and registrations.

The proposed change will allow affected practitioners to substitute volunteer work for continuing education. The educational value of volunteer services may vary depending on each person's experience. However, the proposed limits on the continuing education hours that can be gained through this method are a relatively small portion of the annually required hours.

Also, it is not clear whether the ratio of required three hours per continuing education hour is sufficient by itself to provide enough incentives to offer volunteer service. It appears easier for affected practitioners to spend one hour acquiring continuing education than to spend three hours providing free services. However, it is reasonable to expect that the additional incentive provided by the proposed regulation would lead to increased volunteer hours by convincing affected practitioners who are indecisive at the margin about providing such services. The proposed regulation will also help those practitioners who have already been providing volunteer services at the qualified locations by allowing them to earn continuing education credit for their charity work.

In any event, the proposed regulation allows substitution of volunteer work for continuing education, but does not mandate it. A practitioner choosing to do volunteer work in lieu of the continuing education reveals that he or she benefits more from doing so.

Businesses and Entities Affected. Currently, there are 14,210 pharmacists and 14,373 pharmacy technicians with current licenses and registrations in Virginia. According to data provided by the Virginia Employment Commission, there are 1,529 establishments in the industry category of the affected entities. All of the 1,529 establishments in that category satisfy the small business criteria. However, most of these establishments are chain stores owned by non-small businesses. The number of continuing education providers is not known.

Localities Particularly Affected. The proposed changes apply statewide.

Projected Impact on Employment. The proposed regulation may lead to a decrease in demand for continuing education services. However, the proposed limits on the continuing education hours that can be gained through this method is a relatively small portion of the annually required hours. In addition, the substitution of voluntary work for continuing education hours is voluntary and may not be exercised by all practitioners.

Effects on the Use and Value of Private Property. The potential impact on the asset value of continuing education providers is not known with certainty, but appears to be small.

Real Estate Development Costs. No impact on real estate development costs is expected.

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. Most if not all of the pharmacy establishments are small businesses. However, most are owned by non-small businesses. The proposed amendments do not impose costs on them. Most providers of continuing education services are probably small businesses. The proposed regulation may decrease the demand for their services by a small amount.

Alternative Method that Minimizes Adverse Impact. There is no known alternative that minimizes the potential small adverse impact on providers of continuing education services while achieving the same goals.

Adverse Impacts:

Businesses. The proposed amendments do not have an adverse impact on non-small businesses.

Localities. The proposed amendments will not adversely affect localities.

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

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¹ http://leg1.state.va.us/cgi-bin/legp504.exe?161+ful+CHAP0082

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

Summary:

Pursuant to Chapter 82 of the 2016 Acts of Assembly, the amendments allow pharmacists to substitute six hours of volunteer work for two hours of continuing education and pharmacy technicians to substitute three hours of volunteer work for one hour of continuing education annually.

18VAC110-20-90. Requirements for continuing education.

A. A pharmacist shall be required to have completed a minimum of 1.5 CEUs or 15 contact hours of continuing pharmacy education in an approved program for each annual renewal of licensure. CEUs or hours in excess of the number required for renewal may not be transferred or credited to another year.

B. A pharmacy education program approved for continuing pharmacy education is:

1. One that is approved by the Accreditation Council for Pharmacy Education (ACPE);

2. One that is approved as a Category I Continuing Medical Education (CME) course, the primary focus of which is pharmacy, pharmacology, or drug therapy; or

3. One that is approved by the board in accordance with the provisions of 18VAC110-20-100.

C. The board may grant an extension pursuant to § 54.1-3314.1 E of the Code of Virginia. Any subsequent extension shall be granted only for good cause shown.

D. Up to two hours of the 15 hours required for annual renewal may be satisfied through delivery of pharmacy services as a pharmacist, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those services.  One hour of continuing education may be credited for three hours of providing such volunteer services, as documented by the health department or free clinic.

D. E. Pharmacists are required to attest to compliance with CE requirements in a manner approved by the board at the time of their annual license renewal. Following each renewal period, the board may conduct an audit of the immediate past two years' CE documents to verify compliance with requirements. Pharmacists are required to maintain, for two years following renewal, the original certificates documenting successful completion of CE, showing date and title of the CE program or activity, the number of CEUs or contact hours awarded, and a certifying signature or other certification of the approved provider. Pharmacists selected for audit must provide these original documents to the board by the deadline date specified by the board in the audit notice.

18VAC110-20-106. Requirements for continued competency.

A. A pharmacy technician shall be required to have completed a minimum of 0.5 CEUs or five contact hours of approved continuing education for each annual renewal of registration. Hours in excess of the number required for renewal may not be transferred or credited to another year.

B. An approved continuing education program shall meet the requirements as set forth in subsection B of 18VAC110-20-90 or subsection B of 18VAC110-20-100.

C. Upon written request of a pharmacy technician, the board may grant an extension of up to one year in order for the pharmacy technician to fulfill the continuing education requirements for the period of time in question. The granting of an extension shall not relieve the pharmacy technician from complying with current year requirements. Any subsequent extension shall be granted for good cause shown.

D. Up to one hour of the five hours required for annual renewal may be satisfied through delivery of pharmacy services as a pharmacy technician, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those services. One hour of continuing education may be credited for three hours of providing such volunteer services, as documented by the health department or free clinic.

D. E. Original certificates showing successful completion of continuing education programs shall be maintained by the pharmacy technician for a period of two years following the renewal of his registration. The pharmacy technician shall provide such original certificates to the board upon request in a manner to be determined by the board.