Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (adding 18VAC110-20-25).

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

Public Hearing Information:

September 2, 2009 - 9 a.m. - Department of Health Professions, 9960 Mayland Drive, Perimeter Center, 2nd Floor Conference Center, Richmond, VA

Public Comments: Public comments may be submitted until 5 p.m. on October 30, 2009.

Agency Contact: Elizabeth Scott Russell, 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 scotti.russell@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.

Purpose: The 2007 General Assembly amended the statutes relating to grounds for denial or disciplinary action against a license by the Board of Pharmacy. The previous, very narrowly defined section relating to "unprofessional conduct" was repealed and those activities specifically listed in § 54.1-3316 (11) and (12) as grounds for disciplinary action. In addition, § 54.1-3316 (4) was expanded to include unprofessional conduct specified in regulations promulgated by the board. The intent of this action is to promulgate such regulations.

After utilizing regulations from other boards and a compilation of unprofessional conduct regulations from other states to determine those provisions that should be set out in Virginia regulation, the board developed regulatory language to ensure that it has the necessary authority to protect the public health and safety from unprofessional conduct or substandard care.

Substance: The board has added 18VAC110-20-25, which provides that certain practices shall constitute unprofessional conduct within the meaning § 54.1-3316 of the Code of Virginia.

Issues: The primary advantage of this proposal is greater protection for the public by having clearer, more definitive language about behaviors and actions that may constitute unprofessional conduct in a pharmacy.

There are no disadvantages of these provisions to the agency or the Commonwealth; more specific provisions in regulation to supplement those stated in the Code of Virginia will allow more explicit charges in a disciplinary notice, which will be beneficial to both the agency and the respondent. The board does not anticipate more than a four or five additional disciplinary proceedings or notices of disciplinary action, because it currently manages to state the charges for such conduct under general provisions of the Code of Virginia. There are no other pertinent matters.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to 2007 General Assembly House Bill 2649, the Board of Pharmacy (Board) proposes to add a new section to these regulations to establish the types of behavior that constitute unprofessional conduct. HB 2649 repealed the previous, narrowly-defined Code section relating to "unprofessional conduct" and replaced it with language that expanded Virginia Code § 54.1-3316 by stating that unprofessional conduct would include that which is "specified in regulations promulgated by the Board."

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

Estimated Economic Impact. The proposed regulation would specify the following as grounds for unprofessional conduct: 1) a violation of patient privacy or other provisions in the Health Records Act, 2) willful or negligent breaching of patient confidentiality, 3) failure to maintain the confidentiality of information received from the Prescription Monitoring Program, obtaining such information for reasons other than to assist in determining the validity of a prescription to be filled, or misusing information received from the program, 4) engaging in disruptive or abusive behavior that interferes with or adversely affects patient care, 5) engaging in conduct constituting a boundary violation that would include a situation in which the licensee is in a position to take advantage of a patient or his family, 6) failure to maintain adequate safeguards against the diversion of controlled substances, 7) failure to appropriately respond to a known dispensing error, 8) delegating a task to someone not adequately trained to perform that task, 9) failure by the pharmacist in charge to ensure that pharmacy interns and pharmacy technicians are currently registered, and 10) failure to exercise professional judgment in determining whether a prescription meets the requirements of law prior to dispensing.

According to the Department of Health Professions (DHP), specifying the types of behavior that constitute unprofessional conduct will allow more explicit charges in a disciplinary notices, but will not cause a large increase in the number of disciplinary actions conducted since the Board currently manages to state the charges for such conduct under general provisions of the Code. In calendar year 2008 the Board received 301 disciplinary cases and closed 426. Out of the 426 cases closed by the Board of Pharmacy in calendar year 2008, 221 were closed as "no violation" or "undetermined." The rest were closed with some type of finding, or by confidential consent agreement. The Board estimates that specifying unprofessional conduct in regulation will in practice produce no more than 4 or 5 additional cases annually.

Specifying what constitutes unprofessional conduct will be beneficial for pharmacy professionals and the public in that there will be less uncertainty and fewer misunderstandings concerning what conduct is subject to discipline. There are no obvious costs associated with the proposed specificity.

Businesses and Entities Affected. The proposed amendments affect the 9964 pharmacists, 1396 pharmacy interns, 9502 pharmacy technicians, 1688 resident pharmacies, and 544 non-resident pharmacies regulated by the Virginia Board of Pharmacy.

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

Projected Impact on Employment. The proposal amendments do not significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments do not significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments do not significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not significantly affect small businesses.

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

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget on proposed amended regulations for 18VAC110-20, Regulations Governing the Practice of Pharmacy relating to regulations for unprofessional conduct.

Summary:

The proposed regulatory action adds a section on unprofessional conduct to address certain issues and licensee conduct that have been problematic and to supplement the statutory provision in § 54.1-3316 of the Code of Virginia that establishes grounds for disciplinary action based on unprofessional conduct specified in regulations promulgated by the board. The amendments include, but are not limited to, patient confidentiality, unethical behavior, sexual misconduct, failure to report a known dispensing error in a manner that protects the public, and inappropriate delegation of pharmacy acts to subordinates.

18VAC110-20-25. Unprofessional conduct.

The following practices shall constitute unprofessional conduct within the meaning of § 54.1-3316 of the Code of Virginia:

1. Failing to comply with provisions of § 32.1-127.1:03 of the Code of Virginia related to the confidentiality and disclosure of patient records or related to provision of patient records to another practitioner or to the patient or his personal representative;

2. Willfully or negligently breaching the confidentiality of a patient unless otherwise required or permitted by applicable law;

3. Failing to maintain confidentiality of information received from the Prescription Monitoring Program, obtaining such information for reasons other than to assist in determining the validity of a prescription to be filled, or misusing information received from the program;

4. Engaging in disruptive or abusive behavior in a pharmacy or other health care setting that interferes with patient care or could reasonably be expected to adversely impact the quality of care rendered to a patient;

5. Engaging or attempting to engage in a relationship with a patient that constitutes a professional boundary violation in which the practitioner uses his professional position to take advantage of the vulnerability of a patient or his family, including but not limited to sexual misconduct with a patient or a member of his family or other conduct that results or could result in personal gain at the expense of the patient;

6. Failing to maintain adequate safeguards against diversion of controlled substances;

7. Failing to appropriately respond to a known dispensing error in a manner that protects the health and safety of the patient;

8. Delegating a task within the practice of pharmacy to a person who is not adequately trained to perform such a task;

9. Failing by the PIC to ensure that pharmacy interns and pharmacy technicians working in the pharmacy are registered and that such registration is current; or

10. Failing to exercise professional judgment in determining whether a prescription meets requirements of law before dispensing.