TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
BOARD OF PHARMACY
Proposed Regulation
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to "unprofessional conduct" was repealed and those activities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.
VA.R. Doc. No. R08-1341;
Filed August 10, 2009, 9:54 a.m.