NOTICES
INDEPENDENT REGULATORY REVIEW COMMISSION
Notice of Comments Issued
[51 Pa.B. 249]
[Saturday, January 9, 2021]Section 5(g) of the Regulatory Review Act (71 P.S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b).
The Commission has issued comments on the following proposed regulations. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
Reg. No. Agency/Title Close of the Public
Comment PeriodIRRC
Comments
Issued16A-5429 State Board of Pharmacy
Administration of Injectable Medications, Biologicals and Immunizations
50 Pa.B. 5844 (October 24, 2020)
11/23/20 12/23/20 16A-7103 Bureau of Professional and Occupational Affairs
Schedule of Civil Penalties—Crane Operators
50 Pa.B. 5850 (October 24, 2020)
11/23/20 12/23/20
State Board of Pharmacy Regulation # 16A-5429 (IRRC # 3272)
Administration of Injectable Medications, Biologicals and Immunizations
December 23, 2020 We submit for your consideration the following comments on the proposed rulemaking published in the October 24, 2020 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P.S. § 745.5a(a)) directs the State Board of Pharmacy (Board) to respond to all comments received from us or any other source.
1. Section 27.402. Application, renewal and reactivation procedures.—Protection of the public health, safety and welfare; Reasonableness.
Under this section, a pharmacist who is the holder of the authority to administer injectable medications, biologicals and immunizations (injectables) must renew the authority every two years along with the pharmacist's license to practice pharmacy. As part of that renewal process, a pharmacist must complete two hours of continuing education related to injectables and provide proof of current CPR certification.
Subsection (b)(2) of this section states that a pharmacy intern's authority to administer injectables, ''is valid so long as the intern remains registered under § 27.26 (relating to pharmacy internship) and may not be renewed.'' Section 27.26(c) provides that a pharmacy intern registration is valid for six years. We are concerned that a pharmacy intern can administer injectables for this time frame without current training on the topic and question whether this is adequately protective of the health, safety and welfare of the citizens of the Commonwealth. In the Preamble to the final-form regulation we ask the Board to explain why it is reasonable to allow a pharmacist intern to administer injectables for a period of up to six years without updated training or education on the topic. In addition, how can the Board ensure that pharmacy interns are current with their CPR certification?
We suggest that the final-form regulation be amended to include provisions to ensure pharmacy interns, similar to pharmacists, are up-to-date on the most recent information regarding injectables and also current with their CPR certification.
2. Section 27.403. Conditions for administration.—Clarity.
Subsection (e) states that injectable immunizations shall be administered, ''in accordance with treatment guidelines established by the Centers for Disease Control and Prevention and which have been approved by the Board.'' Act 8 of 2015 (Act 8) recently amended Section 9.2(a)(3) of the Pharmacy Act (Pharmacy Act (63 P.S. § 390-9.2(a)(3)) to require administration of injectables to be administered in accordance with guidelines established by a physician and ''the Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices Guidelines or another competent authority.'' (Emphasis added.) We suggest that the final-form regulation be amended to more accurately reflect the language of statute.
3. Section 27.406. Notification requirements.—Clarity.
Paragraph (1) requires pharmacists or pharmacy interns administering injectables to notify the ''ordering prescriber and the patient's primary care provider, if known, as soon as practicable, but no longer than 48 hours after the administration of certain information. Similarly, Paragraph (2) requires notification of ''the patients primary care provider, if known and the par- ticipating/protocol physician'' within the same time frame. Paragraph (3) requires notification within 24 hours to the primary care provider and the participating/protocol physician when a patient experiences an adverse event or reaction. We have two concerns.
First, as noted by a commentator, how is a patient's primary care provider to become known to the pharmacist and/or the pharmacy intern? The commentator also seeks additional guidance on the notification requirements for pharmacists when an injectable was administered by an intern under their supervision. We ask the Board to clarify these issues in the Preamble and the final-form regulation.
Second, we believe the clarity of the rulemaking could be improved by defining what a ''participating/protocol physician'' is or including a reference to the section of the Board's regulation that address protocol agreements between physicians and pharmacists.
4. Section 27.408. Professional liability insurance.—Implementation procedures; Clarity.
Act 8 amended the Pharmacy Act to require pharmacists to maintain professional liability insurance. This section of the proposal implements that requirement. We have two questions. First, does the insurance cover negligent supervision by a pharmacist that is supervising a pharmacist intern that has authorization to inject? Second, since the pharmacy intern is not required to maintain professional liability insurance by this section, is there any insurance coverage if the pharmacist's supervision is proper, but the pharmacy intern is negligent in administering the injection? We ask the Board to explain how this provision will be implemented in the Preamble to the final-form regulation.
Bureau of Professional and Occupational Affairs Regulation # 16A-7103
(IRRC # 3273)
Schedule of Civil Penalties—Crane Operators
December 23, 2020 We submit for your consideration the following comments on the proposed rulemaking published in the October 24, 2020 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P.S. § 745.5a(a)) directs the Bureau of Professional and Occupational Affairs (Bureau) to respond to all comments received from us or any other source.
Section 43b.28. Schedule of civil penalties—crane operators.—Clarity; and the Protection of the public health, safety and welfare.
In the Preamble to the proposed regulation, the Bureau and the State Board of Crane Operators (Board) write:
''Operating a crane without a license is a serious infraction of both section 501(a) of the act (63 P.S. § 2400.501(a)) and the Board's regulation at § 6.41(a) (relating to unlicensed crane operation). An unlicensed individual who has not been properly trained to operate a crane could cause extensive damage to property as well as cause bodily harm to individuals at a construction site.''We concur with the Bureau and the Board on the importance of properly trained crane operators in protecting the public health and safety and avoiding costly damage to property. With this in mind, we ask the Bureau and Board to address the following issues when the final version of this rulemaking is submitted.
First, did the Bureau and Board consider qualifying the use of this civil penalty section for the offenses of operating a crane without a license or employing an unlicensed individual to operate a crane? If the violation for either of these two offenses mentioned results in bodily harm or substantial property damage, we question whether a civil penalty should even be available for consideration. We ask the Bureau and Board to explain their rationale and how violations that result in bodily harm or extensive property damage will be treated. The explanation should describe how the approach protects the public health and safety and deters violations of statutory and regulatory requirements.
Second, a license to operate a crane is valid only in conjunction with certification if the licensee maintains a current certification in the specialty for which the crane operator is certified. 63 P.S. § 2400.501(f). Depending on the specialty or the accrediting organization, certifications are valid for two, three or five years. As such, there may be times when a crane operator's certification will expire during the biennial licensing renewal period.
The act and the Board's regulations require crane operators to have a current valid certification at all times. To assure that crane operators maintain their certification, the Board requires licensees to submit evidence of certification renewal before their current certification expires. Under both the act and the Board's regulations, a licensee who has failed to maintain certification or submit evidence of re-certification is subject to disciplinary action. 63 P.S. 2400. 502(b) and 49 Pa. Code 6.32(a)(2). Since certification is integral to licensure, did the Board consider and reject establishing a civil penalty for failure to maintain certification or provide evidence of certification renewal? If so, the Bureau and Board should include a revised Preamble to the final-form regulation that explains the reason and rationale for excluding these offenses from the schedule of civil penalties.
Finally, the proposed schedule distinguishes between ''operating a crane without a license'' and ''operating a crane on a lapsed or expired license.'' For clarity, we recommend the Title/Description of the offense for ''holding oneself out as being able to operate a crane or using the title ''licensed crane operator'' or the abbreviation ''L.C.O.'' without a license'' be revised to cover an individual with a lapsed or expired license who holds themselves out as authorized to operate a crane. The Bureau and Board should revise the Title/Description accordingly or explain why it is unnecessary to do so.
GEORGE D. BEDWICK,
Chairperson
[Pa.B. Doc. No. 21-62. Filed for public inspection January 8, 2021, 9:00 a.m.]
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