RULES AND REGULATIONS
Title 49—BUREAU OF PROFESSIONAL AND OCCUPATIONAL AFFAIRS
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Continuing Education
[40 Pa.B. 842]
[Saturday, February 13, 2010]The State Board of Pharmacy (Board) amends §§ 27.1 and 27.32 (relating to definitions; and continuing education) to read as set forth in Annex A.
Description and Need for the Rulemaking
Section 3.1 of the Pharmacy Act (act) (63 P. S. § 390-3.1) authorizes the Board to require licensees to complete continuing education and to promulgate regulations to enforce that requirement. The Board has done so by promulgating § 27.32 (relating to continuing education). However, the Board determined that its regulation should be updated and in January of 2008, the Board published proposed rulemaking to make certain updates.
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, this rulemaking amends the current regulation to make it clear that, in general, only ACPE-accredited providers of continuing education are acceptable. In addition, the Board 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 no less than 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.
This rulemaking amends § 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 rulemaking also amends § 27.32 to clarify that, with limited exceptions, the Board only accepts ACPE-accredited providers of continuing education. The rulemaking further amends § 27.32 to delete the term ''approved'' after ACPE, as ACPE accredits providers instead of approving them.
This rulemaking adds a requirement that 2 of the required 30 hours of continuing education be completed in courses under the ACPE topic designator ''Patient Safety.'' This change will go into effect beginning with the license period commencing on October 1, 2011. 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. Recently ACPE introduced new topic designators, which make it easier for licensees and the auditing agents to determine if a course falls under a certain topic. 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 rulemaking codifies the Board's 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 will 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, will 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. The Board cannot simply let licensees make up deficient continuing education in place of disciplinary action, for that would encourage licensees to avoid the continuing education obligation until being discovered in an after-the-fact audit and then complete the required continuing education without consequence.
Finally, the rulemaking requires that any application for approval from a continuing education program provider that is not ACPE-accredited be submitted to the Board no less than 60 days prior to the start of the program. This requirement is necessary to give the Board ample time to review a program for equivalency to ACPE standards before the program takes place.
Summary of Comments and Responses to Proposed Rulemaking
The Board published notice of proposed rulemaking at 38 Pa.B. 350 (January 19, 2008) with a 30-day public comment period. The Board received comments from the Pennsylvania Pharmacists Association (PPA), but from no other members of the public. The Board received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) as part of their review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12). The Board did not receive any comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC).
The PPA supported the proposed rulemaking. Other than a language format question that has been resolved by the Legislative Reference Bureau in accordance with standards of the Pennsylvania Code & Bulletin Style Manual, the HPLC had no comment.
IRRC questioned what the penalty would be for a licensee who failed within 6 months to make up delinquent contact hours of continuing education, as required in proposed § 27.32(b), and whether such a penalty should be included in the rulemaking. Existing § 27.32(i) provides that a pharmacist who fails to comply with the continuing education requirements, for example, upon request failing to provide proof of completion of the required amount of continuing education during the biennial period, is subject to disciplinary action. Under § 27.32(b), a licensee who failed to complete the required amount of continuing education shall make up the deficiency within 6 months, regardless of any other sanction imposed. The Board may revoke or suspend the license of a pharmacist who has violated the act or regulations of the Board. Section 5(a)(6) of the act (63 P. S. § 390-5(a)(6)). The Board may impose a civil penalty of up to $1,000 on any licensee who has violated the act. Section 8(15.1) of the act (63 P. S. § 390-8(15.1)). The result is that a pharmacist who does not complete continuing education when required or does not make up the deficiency timely will be subject to disciplinary action, with the possibility of a suspension of the pharmacist's license and the imposition of a civil penalty. The Board is considering whether it should standardize the amount of a civil penalty for failure to complete continuing education timely. Because a civil penalty may be levied through issuance of a citation under a schedule promulgated by the Commissioner of Professional and Occupational Affairs, the Board will consider doing so in a separate rulemaking.
The Board has not found a need to revise its rulemaking in response to the comments. However, in the course of reviewing these comments, the Board noticed that § 27.32(b) referred to producing certificates upon demand of its ''auditing agents'' and determined that this should be upon demand simply of the Board's ''agents.''
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have no adverse fiscal impact on the Commonwealth or its political subdivisions and will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
Effective date
The final-form rulemaking will become effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
The final rulemaking is authorized under section 3.1 and section 6(k) of the act (63 P. S. § 390-6(k)).
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 9, 2008, the Board submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 350, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments received from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on November 18, 2009, the final-form rulemaking was approved by the HPLC. On December 9, 2009, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on December 10, 2009, and approved the final-form rulemaking.
Additional Information
Persons who require additional information about the final-form rulemaking should submit inquiries to Regulatory Unit Counsel, Department of State, by mail to P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7156, or st-pharmacy@state.pa.us.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2 (relating to notice of proposed rulemaking required; and adoption of regulations).
(2) A public comment period was provided as required by law and all comments were considered.
(3) The amendments to this final-form rulemaking do not enlarge the scope of proposed rulemaking published at 38 Pa.B. 350.
(4) The final-form rulemaking adopted by this order is necessary and appropriate for the administration of the act.
Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending §§ 27.1 and 27.32 to read as set forth in Annex A, with ellipses refering to the existing text of the regulations.
(b) The Board shall submit this order and Annex A to the Office of Attorney General and the Office of General Counsel for approval as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) The final-form rulemaking shall take effect upon publication in the Pennsylvania Bulletin.
MICHAEL A. PODGURSKI, RPh
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 7272 (December 26, 2009).)
Fiscal Note: Fiscal Note 16A-5417 remains valid for the final adoption of the subject regulations.
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 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 October 1, 2011, 2 of the required 30 contact hours shall be completed in courses from the ACPE topic designator ''Patient Safety.'' 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 § 27.401 (relating to qualifications for authority), at least 2 of the required 30 hours 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. 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 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 agents. The Board will utilize a random audit of 5% of renewals to determine compliance with 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.
(c) Both live and correspondence courses will be accepted by the Board as long as they are offered by approved providers.
(d) An excess of completed contact hours in one renewal period will not be carried over into the next renewal period.
(e) A newly graduated licensee will be exempt from the requirements in subsection (a) for the license renewal immediately following licensure. A reciprocally licensed pharmacist will be required to show compliance with the requirements in subsection (a), but will have the number of hours required to be completed prorated, on a quarterly basis, from the date of licensure to the next date of renewal. For this purpose, each quarter will consist of 3 months, and will be credited for 3.75 contact hours (.375 CEU). The pharmacist will be required to begin accumulating contact hours at the beginning of the next quarter following licensure.
(f) A pharmacist whose license has been suspended or revoked for disciplinary reasons shall comply with continuing education requirements during the period of suspension or revocation, if the pharmacist wants to resume practice or petition for licensure reinstatement at the conclusion of the disciplinary period.
(g) The Board will consider renewing a license without timely filing of the required hours of continuing education on a case by case basis, upon a showing of incapacity, acute illness or other circumstances which reasonably precluded timely compliance. Pharmacists whose licenses are renewed under this subsection will be required to make up the missing hours of continuing education on a schedule determined by the Board, and to pay applicable fees and fines.
(h) Continuing education program providers which are not ACPE-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.
(i) A pharmacist who fails to comply with this section, or who submits fraudulent contact hour reports, will be subject to disciplinary action.
[Pa.B. Doc. No. 10-274. Filed for public inspection February 13, 2010, 9:00 a.m.]
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