PROPOSED RULEMAKING
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Administration of Injectable Medications, Biologicals and Immunizations
[50 Pa.B. 5844]
[Saturday, October 24, 2020]The State Board of Pharmacy (Board) proposes to amend §§ 27.12, 27.401—27.407 and add § 27.408 (relating to professional liability insurance) to read as set forth in Annex A.
Effective Date
This proposed rulemaking will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
This proposed rulemaking is authorized under sections 4(j), 6(k)(1) and (9) and 9.2 of the Pharmacy Act (act) (63 P.S. §§ 390-4(j), 390-6(k)(1) and (9) and 390-9.2).
Background and Need for the Amendment
Section 9.2 of the act permits the Board to regulate a pharmacist's ability to administer injectable medications, biologicals and immunizations. This proposed rulemaking would amend Chapter 27 (relating to State Board of Pharmacy) to conform to amendments made by the act of June 26, 2015 (P.L. 29, No. 8) (Act 8 of 2015). Act 8 of 2015 amended section 9.2 of the act to allow a pharmacist to administer influenza immunizations by injectable or needle-free delivery methods to children 9 years of age or older but under 19 years of age. Additionally, section 9.2 now allows a qualified and authorized pharmacy intern to administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age and administer influenza immunizations by injectable or needle-free delivery methods to children 9 years of age or older but under 19 years of age. Section 9.2 also requires pharmacists authorized to administer injectable medications, biologicals and immunizations to maintain professional liability insurance a minimum of $1 million per occurrence or claims made.
Description of the Proposed Amendments
Section 27.12 (relating to practice of pharmacy and delegation of duties) is proposed to be amended to add subsection (c)(4) allowing a pharmacy intern under the direct, immediate and personal supervision of a pharmacist to administer injectable medications, biologicals and immunizations provided the pharmacy intern and the pharmacist each hold an active authorization to administer injectable medications, biologicals and immunizations issued by the Board.
Section 27.401 (relating to qualifications for authority) is proposed to be amended to add language allowing a pharmacy intern to apply for the authority administer injectable medications, biologicals and immunizations.
Section 27.402 (relating to application and renewal procedures) is proposed to be amended to rename the heading of the section to ''Application, renewal and reactivation procedures'' to fully reflect the amendments made in this section. In § 27.402(a), the Board proposes amendments that include pharmacy interns in the application process for authority to administer injectable medications, biologicals and immunizations. In § 27.402(b), the proposed amendments make clear that only pharmacists are required to renew the authority to administer injectable medications, biologicals and immunizations. Under § 27.402(b)(2), pharmacy intern authority to administer injectable medications, biologicals and immunizations is valid so long as their intern certificate is valid under § 27.26 (relating to pharmacy internship). Under § 27.26, pharmacy intern certificates are valid for 6 years and may not be renewed. In addition, the Board proposes to add subsection (c) pertaining to lapse and subsection (d) pertaining to reactivation. Subsection (d)(1) would allow a pharmacist to renew the authority to administer injectables after a brief lapse (less than 2 years) without having to retake the required education and training in § 27.407 (relating to education requirements). However, if a pharmacist's authority to administer injectable medications, biologicals or immunizations is lapsed for 2 or more years, subsection (d)(2) would require the pharmacist to retake and successfully complete the required education. Subsection (c) and (d) serve to codify the Board's current procedures.
Section 27.403 (relating to conditions for administration) is proposed to be amended to add language to allow a pharmacist or pharmacy intern to provide influenza immunizations by injectable or needle-free delivery to persons 9 years of age or older and to allow a pharmacy intern to administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age. Section 27.403(d) requires a pharmacist's direct, immediate and personal supervision of a pharmacy intern who administers injectable medications, biologicals and immunizations.
Further, the Board proposes to amend § 27.404(a) (relating to authority and requirements) to add language allowing a pharmacy intern to administer injections under an order or written protocol.
To conform with the amendments to section 9.2 of the act regarding parental consent, § 27.405 (relating to recordkeeping) is proposed to be amended to add language requiring documentation of written parental consent for minors who receive injections and to add a requirement to record the name or initials of a pharmacy intern and the supervising pharmacist if the pharmacy intern administered the injectable medication, biological or immunization.
The Board proposes to amend § 27.406 (relating to notification requirements) to reduce the notification timeline from 72 hours to 48 hours in conformity with amendments to section 9.2 of the act, and to apply notification requirements to the administration of injectable medications, biologicals and immunizations by pharmacy interns. In addition, this section is proposed to be amended to clarify which physician is to be notified when the administration has occurred under an order or a written protocol and who to notify if there is an adverse reaction, because there has been some confusion among the licensee population.
Section 27.407 (relating to education requirements) is proposed to be amended to apply the education requirements to pharmacy interns. Subsection (a)(1) would amend the education requirements by changing the evidence-based course time frame from 2 years to 3 years prior to application to accommodate the influx of students applying for the authorization, without disrupting the pharmacy schools' education curriculum. The Board pro-poses to delete subsection (a)(2)(xii) as a required course topic as it is not necessary for the performance of administering injectable medications.
The Board proposes to add § 27.408 (relating to professional liability insurance) to implement the amendments to section 9.2 of the act that require maintenance of professional liability insurance in the minimum amount of $1 million dollars per occurrence or claims made. Subsection (a) requires a pharmacist applying for authority to administer injectable medications, biologicals and immunizations to certify the maintenance of professional liability insurance coverage in the amount of $1 million dollars per occurrence or claims made. Subsection (b) provides that only pharmacists who maintain the required professional liability insurance may engage in the practice of administering injectable medications, biologicals and immunizations and may supervise the administration by a pharmacy intern. Finally, subsection (c) provides that the pharmacist shall, upon request, make available to the Board all records relating to the pharmacist's maintenance of professional liability insurance.
Fiscal Impact and Paperwork Requirements
This proposed rulemaking will have minimal fiscal impact on the Commonwealth and no fiscal impact on its political subdivisions. This proposed rulemaking will impose additional paperwork requirements upon the Board in the form of creating and processing applications for pharmacy interns; however, costs for processing applications would not adversely impact the Board because costs associated with processing applications are borne by the licensees through application fees. To implement Act 8 of 2015 and the proposed regulations, the Board created new forms and revised some existing forms which had minimal fiscal impact to the Board.
This proposed rulemaking will have some financial impact in the form of fees and education for pharmacy interns who elect to apply for the authorization to administer injectable medications, biologicals and immunizations. The Board has no way of knowing how many pharmacy interns will apply for authorization to administer injectables, but using the same percentage of pharmacists that applied for the authorization to administer injectables (44%), the total costs incurred for applications in fiscal year 2020-2021 would be approximately $65,160. Since most pharmacy schools have incorporated the required education into the curriculum, most pharmacy interns should not incur additional costs in education. Even assuming all applying pharmacy interns would either be required to take the initial education or would be required to repeat the training, the cost of education for the 44% of pharmacy interns would be $868,800. For subsequent years, the Board estimates an average annual cost to new pharmacy interns of $36,000 (the cost associated with the fee).
For pharmacists, because Act 8 of 2015 expanded the ability of pharmacists to perform immunizations to minors, pharmacists engaging in this activity already have the required training and equipment and no additional costs will be incurred by pharmacists. The Board estimates the total cost per pharmacist to be as follows: $400 for the approved Pharmacy-Based Immunization Delivery course, an application fee of $30 and the cost to obtain professional liability insurance in the amount of $1 million ($415). The only new cost associated with Act 8 of 2015 and this proposed rulemaking is the cost of professional liability insurance. Assuming the Board continues to receive 1,100 new applications from pharmacists seeking the authority to administer injectables each year, the fiscal impact to pharmacists would be $456,000 annually.
This proposed rulemaking will impose additional paperwork requirements for licensees, including submission of forms to the Board (applications for authority to administer injectables and reactivation forms), recordkeeping (documentation of the pharmacy intern and supervising pharmacist for each administration), parental consent documentation, notification requirements to primary care providers and professional liability insurance coverage record disclosure requirements.
Sunset Date
The Board continuously monitors the effectiveness of its regulations. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on October 8, 2020, 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 Regulatory Review Act, IRRC may convey comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria which have not been met. The Regulatory Review 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, suggestions or objections regarding this proposed rulemaking to Juan A. Ruiz, Counsel, State Board of Pharmacy, by mail at P.O. Box 69523, Harrisburg, PA 17106-9523, or by e-mail at RA-STRegulatoryCounsel@pa.gov, within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin. Reference No. 16A-5429 (Injectable Medication, Biologicals and Immunizations), when submitting comments.
THERESA M. TALBOTT, RPh,
ChairpersonFiscal Note: 16A-5429. 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
STANDARDS § 27.12. Practice of pharmacy and delegation of duties.
* * * * * (c) Pharmacy interns.
(1) A pharmacy intern may work only under the direct, immediate, personal supervision of a pharmacist in accordance with subsection (b)(2).
(2) A pharmacy intern may neither enter nor be in a pharmacy if a pharmacist is not on duty.
(3) A pharmacy intern working under the direct, immediate, personal supervision of a pharmacist may perform procedures which require professional skill and training. Examples of these procedures include: verifying ingredients, weighing ingredients, compounding ingredients and other similar processing of ingredients.
(4) A pharmacy intern working under the direct, immediate and personal supervision of a pharmacist may administer injectable medications, biologicals and immunizations if the pharmacist and the pharmacy intern each hold an active authorization to administer injectable medications, biologicals and immunizations issued by the Board, in accordance with §§ 27.401—27.408.
(d) Pharmacy technicians.
* * * * *
ADMINISTRATION OF INJECTABLE MEDICATIONS, BIOLOGICALS AND IMMUNIZATIONS § 27.401. Qualifications for authority.
A pharmacist or pharmacy intern may apply to the Board for authority to administer injectable medications, biologicals and immunizations. A candidate for authority to administer injectable medications, biologicals and immunizations shall meet the following requirements:
(1) The pharmacist holds an active license to practice pharmacy or the pharmacy intern holds an active intern registration in this Commonwealth.
(2) The pharmacist or pharmacy intern has completed a course of education and training which meets the requirements of § 27.407 (relating to education requirements).
(3) The pharmacist or pharmacy intern holds a current basic cardio-pulmonary resuscitation (CPR) certificate issued by the American Heart Association, American Red Cross or a similar health authority or professional body approved by the Board.
§ 27.402. Application [and], renewal and reactivation procedures.
(a) Application. An applicant for authority to administer injectable medications, biologicals and immunizations shall submit the following to the Board:
(1) An application obtained from the Board along with the fee required by § 27.91 (relating to schedule of fees).
(2) Certification that the [pharmacist] applicant has completed the required education and training in § 27.407 (relating to education requirements).
(3) Certification that the [pharmacist] applicant holds an acceptable, current CPR certificate.
(b) Renewal.
(1) A pharmacist who is the holder of the authority to administer injectable medications, biologicals and immunizations shall renew the authority every 2 years along with the pharmacist's license to practice pharmacy. Renewal requires completion of a form provided to the pharmacist by the Board in advance of the renewal period, payment of the fee specified by § 27.91, certification of completion of 2 hours of continuing education required by section 9.2 of the act (63 P.S. § 390-9.2) and § 27.32 (relating to continuing education), and proof of a current CPR certificate.
(2) A pharmacy intern's authority to administer injectable medications, biologicals and immunizations is valid so long as the intern remains registered under § 27.26 (relating to pharmacy internship) and may not be renewed.
(c) Lapse. A pharmacist who intends to allow the authority to administer injectable medications, biologicals and immunizations to lapse shall notify the Board on the pharmacist's biennial license renewal form.
(d) Reactivation.
(1) A pharmacist who has had a lapsed authority for less than 2 years and seeks reactivation of the authority to administer injectable medications, biologicals and immunizations shall complete a form provided to the pharmacist by the Board, pay the renewal fee specified by § 27.91, complete 2 hours of continuing education required by section 9.2 of the act and § 27.32, and provide proof of a current CPR certificate.
(2) A pharmacist who has had a lapsed authority for 2 years or more and seeks reactivation of the authority to administer injectable medications, biologicals and immunizations shall complete a form provided to the pharmacist by the Board, retake and successfully complete the required education set forth in § 27.407, pay the renewal fee specified by § 27.91 and provide proof of a current CPR certificate.
§ 27.403. Conditions for administration.
(a) A pharmacist or pharmacy intern who is granted authority may administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age. A person is more than 18 years of age on the day following the person's 18th birthday.
(b) A pharmacist or pharmacy intern who is granted authority may administer influenza immunizations by injectable or needle-free delivery methods to persons 9 years of age or older.
[(b)] (c) A pharmacist may not delegate the administration of injectable medications, biologicals and immunizations to another person.
(d) A pharmacy intern who has been authorized by the Board to administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age and influenza immunizations by injectable or needle-free delivery methods to persons 9 years of age or older under § 27.401 (relating to qualifications for authority) may do so only under the direct, immediate and personal supervision of a pharmacist who holds an active authority to administer injectable medications, biologicals and immunizations.
[(c)] (e) A pharmacist or pharmacy intern shall administer injectable immunizations in accordance with treatment guidelines established by the Centers for Disease Control and Prevention and which have been approved by the Board.
§ 27.404. Authority and requirements.
(a) A pharmacist or pharmacy intern authorized by the Board to administer injectable medications, biologicals and immunizations may only do so under either an order or written protocol.
* * * * * § 27.405. Recordkeeping.
(a) A pharmacist who administers an injectable medication, biological or immunization or who supervises the administration by a pharmacy intern shall maintain the following records regarding each administration for a minimum of 2 years:
(1) The name, address and date of birth of the patient.
(2) The date of the administration and site of the injection.
(3) The name, dose, manufacturer, lot number and expiration date of the medication, biological or immunization.
(4) The name and address of the patient's primary health care provider, as identified by the patient.
(5) The name or identifiable initials of the administering pharmacist. If the administration was performed by a pharmacy intern, the name or identifiable initials of the pharmacy intern and the supervising pharmacist.
(6) Documentation of informed consent for administration of injectable medications, biologicals and immunizations, and in the case of influenza immunizations administered to patients under the age of 18, documentation of written parental consent.
(7) The nature of an adverse reaction and who was notified.
(b) A pharmacist who administers an immunization or supervises the administration by a pharmacy intern shall also maintain the following records regarding each administration for a minimum of 2 years:
(1) An identification of the Vaccine Information Statement (VIS) that was provided.
(2) The date of publication of the VIS.
(3) The date and to whom the VIS was provided.
(c) In an institution, the information required to be maintained in subsections (a) and (b) may be maintained in the patients' medical records.
§ 27.406. Notification requirements.
A pharmacist or pharmacy intern administering injectable medications, biologicals or immunizations shall meet the following notification requirements:
(1) When administration has occurred under an order, the pharmacist or pharmacy intern shall notify the ordering prescriber and the patient's primary care provider, if known, as soon as practicable, but no longer than [72] 48 hours after administration of the following:
(i) The identity of the patient.
(ii) The identity of the medication, biological or immunization administered.
(iii) The route of administration.
(iv) The site of the administration.
(v) The dose administered.
(vi) The date of administration.
(2) When the administration has occurred under a written protocol, the pharmacist or pharmacy intern shall notify the [participating physician] patient's primary care provider, if known, and the participating/protocol physician, as soon as practicable, but no longer than [72] 48 hours after administration of the following:
(i) The identity of the patient.
(ii) The identity of the medication, biological or immunization administered.
(iii) The site of the administration.
(iv) The dose administered.
(v) The date of administration.
(3) In the event of any adverse event or reaction experienced by the patient either under an order or a written protocol, the pharmacist or pharmacy intern shall notify the patient's [physician] primary care provider and the participating/protocol physician, if applicable, as soon as practicable, [and in no event later] but no longer than 24 hours after learning of the adverse event or reaction.
§ 27.407. Education requirements.
(a) To apply for the authority to administer injectable medications, biologicals and immunizations, a pharmacist or pharmacy intern shall meet the following education requirements:
(1) Complete within the [2-year] 3-year period prior to application an evidence-based course that meets the following criteria:
(i) Includes study material.
(ii) Includes hands-on training and techniques for administration.
(iii) Requires testing with a passing score.
(iv) Provides a minimum of 10 hours of instruction and experiential training.
(v) Complies with current guidelines and recommendations by the Centers for Disease Control and Prevention, ACPE or a similar health authority or professional body.
(2) The course must provide instruction on the following topics:
(i) Basic immunology and the human immune response.
(ii) Mechanics of immunity, adverse effects, dose and administration schedule of available vaccines.
(iii) Response to an emergency situation as a result of the administration of an injectable medication, biological or immunization.
(iv) Administration of subcutaneous, intradermal and intramuscular injections.
(v) Disease epidemiology.
(vi) Standards for immunization practices.
(vii) Vaccine-preventable diseases.
(viii) Recommended immunization schedules.
(ix) Vaccine storage and management.
(x) Biohazard waste disposal and sterile techniques.
(xi) Informed consent.
[(xii) Authority and recordkeeping requirements as provided in this chapter.]
(b) The Board approves courses offered by ACPE-accredited providers and educational institutions that meet the criteria and provide instruction on the topics listed in subsection (a).
(Editor's Note: The following text is proposed to be added and printed in regular type to enhance readability.)
§ 27.408. Professional liability insurance.
(a) To qualify for authority to administer injectable medications, biologicals and immunizations, a pharmacist must certify the maintenance of professional liability insurance coverage in the minimum amount of $1 million per occurrence or claims made.
(b) A pharmacist who does not maintain the required professional liability insurance in the minimum amount of $1 million may not engage in the practice of administering injectable medications, biologicals and immunizations and may not supervise the administration by a pharmacy intern.
(c) A pharmacist shall, upon request, make available to the Board or its agents all records relating to the pharmacist's maintenance of professional liability insurance, including policies, cancelled checks, receipts or other proofs of premium payment.
[Pa.B. Doc. No. 20-1450. Filed for public inspection October 23, 2020, 9:00 a.m.]
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