PROPOSED RULEMAKING
STATE BOARD
OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Continuing Education
[38 Pa.B. 350]
[Saturday, January 19, 2008]The State Board of Pharmacy (Board) proposes to amend §§ 27.1 and 27.32 (relating to definitions; and continuing education) to read as set forth in Annex A.
Effective Date
The amendments will be effective upon final-form publication in the Pennsylvania Bulletin.
Statutory Authority
The proposed amendments are authorized under sections 3.1, 4(j) and 6(k)(1) and (9) of the Pharmacy Act (act) (63 P. S. §§ 390-3.1, 390-4(j) and 390-6(k)(1) and (9)).
Background and Need for Amendment
Pharmacists are required to certify proof of completion of continuing education hours on their biennial renewal forms. Every biennial renewal period the Board performs an audit of 5% of the licensee population. Through the course of past audits and resulting disciplinary actions for noncompliance with the regulations, it has come to the Board's attention that not all licensees understand that only courses offered by ACPE-accredited continuing education providers are acceptable continuing education. While § 27.32(h) does permit other non-ACPE accredited providers to apply to the Board for approval, to date the Board has not approved any other continuing education providers. In the past 5 years, the Board has not received an application for approval from a non-ACPE accredited provider of continuing education. Because ACPE is the National accrediting body for pharmacy-related continuing education, a vast majority of providers are ACPE-accredited. Therefore, the Board proposes to amend the current regulation to make it clear that, in general, only ACPE-accredited providers of continuing education are acceptable. In addition, the Board has reviewed the regulation and determined that other updates are needed, specifically with regard to requiring continuing education in the area of patient safety, requiring applications for program approval to be submitted at least 60 days prior to the start of the program, and requiring any deficiencies in continuing education hours to be made up within 6 months of notification by the Board.
Description of Proposed Amendments
The proposed amendments amend § 27.1 to reflect the change of name for ACPE from the American Council of Pharmaceutical Education to the Accreditation Council for Pharmacy Education. The proposal would also amend § 27.32to clarify that, with limited exceptions, the Board only accepts ACPE-accredited providers of continuing education. The proposal would further amend § 27.32 to delete the term ''approved'' after ACPE, as ACPE accredits providers instead of approving them.
The Board also proposes to add a requirement that 2 of the required 30 hours of continuing education be completed in courses under the ACPE topic designator ''Patient Safety.'' Recently ACPE introduced new topic designators, which will make it easier for licensees and the auditing agents to determine if a continuing education course falls under a certain topic. The Board is concerned about medication errors and believes that pharmacists benefit from completing continuing education specific to these types of errors. The public benefits from having pharmacists aware of common errors and ways to prevent them. ACPE has indicated that the topic designator ''Patient Safety'' includes the prevention of healthcare errors, and the elimination or mitigation of patient injury caused by healthcare errors.
The Board proposes to codify in this rulemaking its current practice that any pharmacist found to be in noncompliance with the continuing education requirement shall make up the deficiency within 6 months. This provision would not apply to licensees who indicate on the renewal form that they have not met the continuing education requirements, as their licenses would not be renewed until 30 hours of continuing education can be verified. Any pharmacist found to be noncompliant with the continuing education requirements, either through the audit or some other means, would be required to make up the deficiency within 6 months from the notice of deficiency from the Board, notwithstanding any disciplinary action taken for the violation of the continuing education requirements.
Finally, the Board proposes to require applications for approval from continuing education program providers that are not ACPE-accredited be submitted to the Board at least 60 days prior to the start of the program. The Board proposes to add this requirement to the regulation to give the Board ample time to review a program for equivalency to ACPE standards before the program takes place.
Fiscal Impact and Paperwork Requirements
The proposed amendments will not have an adverse fiscal impact on the Commonwealth or its political subdivisions, as the Board is self-supporting. The proposed amendments will not impose any additional paperwork requirements upon the Commonwealth or its political subdivisions.
Sunset Date
The Board monitors its regulations on an ongoing basis. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (act) (71 P. S. § 745.5(a)), on January 9, 2008, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the act, IRRC may convey any comments, recommendations or objections regarding the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria that have not been met. The act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations or objections raised.
Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding this proposed rulemaking to Melanie Zimmerman, Executive Secretary, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649, within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
EDWARD J. BECHTEL, R.Ph.,
ChairpersonFiscal Note: 16A-5417. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACPE--The [American Council of Pharmaceutical Education] Accreditation Council for Pharmacy Education.
* * * * *
RENEWAL OF PHARMACIST LICENSE AND PHARMACY PERMIT § 27.32. Continuing education.
(a) The Board will renew the license of a pharmacist who has completed a minimum of 30 contact hours (3 CEU) of continuing education during the preceding biennial renewal period. Beginning with the license period commencing on _____ (Editor's Note: The blank refers to the date of the first biennial renewal that occurs at least 2 years from the effective date of adoption of this proposed rulemaking.), 2 of the required 30 contact hours shall be completed in courses from the ACPE topic designator ''Patient Safety.'' [For] In addition, for licensees with authority to administer injectable medications, biologicals and immunizations in accordance with section 9.2 of the act (63 P. S. § 390-9.2) and [§ 27.301] § 27.401 (relating to qualifications for authority), at least 2 of the required 30 hours [shall] must concern the administration of injectable medications, biologicals and immunizations, including, but not limited to, disease epidemiology, vaccine characteristics, injection technique, emergency response to adverse events [,] and related topics. [Programs offered by providers accredited by the ACPE are approved by the Board.] Except as provided in subsection (h), only continuing education programs offered by ACPE-accredited providers of continuing pharmaceutical education targeted toward pharmacists are acceptable to the Board.
(b) A pharmacist shall prove compliance with [the requirements of] subsection (a) by completing and submitting a form provided to the pharmacist by the Board for that purpose with the renewal application. The certificates provided upon completion of an approved program shall be retained by a pharmacist for 2 years after renewal, and shall be produced upon demand by the Board or its auditing agents. The Board will utilize a random audit of 5% of renewals to determine compliance with [the requirements of] subsection (a), and may expand the audit if rates of noncompliance at 20% or more of the sample are revealed by the initial audit. Individuals selected for the audit will be required to produce certificates proving the information they provided to the Board on the form submitted with the renewal application. Notwithstanding any disciplinary action taken under subsection (i), a pharmacist found to be in noncompliance with the continuing education requirements shall make up the delinquent contact hours within 6 months of the notice of deficiency from the Board.
* * * * * (h) Continuing education program providers which are not ACPE [approved]-accredited may apply to the Board for approval, and shall make a showing of program accreditation substantially similar to ACPE accreditation standards. Requests for approval shall be submitted to the Board at least 60 days prior to the start date of the program. Retroactive requests for approval will not be considered. The Board will maintain a list of programs approved under this subsection.
* * * * *
[Pa.B. Doc. No. 08-92. Filed for public inspection January 18, 2008, 9:00 a.m.]
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