PROPOSED RULEMAKING
STATE BOARD
OF PHARMACY
[49 PA. CODE CH. 27]
Drug Therapy and Injectable Medications, Biologicals and Immunizations
[34 Pa.B. 5598] The State Board of Pharmacy (Board) proposes to amend §§ 27.1, 27.32 and 27.91 (relating to definitions; continuing education; and schedule of fees) and to add §§ 27.301 and 27.401--27.406 to read as set forth in Annex A.
Effective Date
This proposed rulemaking will be effective upon publication as final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
The amendments are authorized under sections 4(j), 6(k)(1) and (9), 8.2(a), 9.1(d)(3) and (e) and 9.2(a) of the Pharmacy Act (act) (63 P. S. §§ 390-4(j), 390-6(k)(1) and (9), 390-8.2(a), 390-9.1(d)(3) and (e) and 390-9.2(a)).
Background and Purpose
In August 2002, the act was amended to add sections 9.1 and 9.2, as well as to modify and add several definitions to the act. The additional sections authorize pharmacists to manage drug therapy by means of a written protocol as well as administer injectable medications, biologicals and immunizations. This proposed rulemaking is required to implement the new provisions of the act.
Description of Proposed Rulemaking
The Board proposes to amend § 27.1 by adding the definition of ''Bureau'' to define the term as it is used in the regulations. The Board also proposes to amend § 27.1 by changing the definitions of ''institution'' and ''practice of pharmacy'' to correspond with the definitions in the act.
The Board proposes to amend § 27.32 to remove obsolete portions of the regulation and add the continuing education requirements necessary to renew the authority to administer injectable medications, biologicals and immunizations.
The Board proposes to amend § 27.91 to add the fees necessary for pharmacists to apply for and renewal the approval to administer injectable medications, biologicals and immunizations.
Proposed § 27.301 (relating to written protocol) sets out the requirements for the drug therapy management written protocol. Proposed § 27.301 incorporates the requirements under section 9.1 of the act and adds a section that requires the protocol to identify the types of drug therapy management decisions that the pharmacist is authorized to make, the ailments or diseases involved in the physician's scope of practice and types of drug therapy management authorized. The act also requires the Board to promulgate regulations with regard to self-insurance for pharmacists engaging in drug therapy management by means of a written protocol. The Board has deferred proposing regulations for self-insurance until the details of the regulations can be worked out with the Insurance Commissioner.
Proposed § 27.401 (relating to qualifications for authority) lists the qualifications that a pharmacist must have to be granted the authority to administer injectable medications, biologicals and immunizations. A pharmacist must hold an active license to practice pharmacy in this Commonwealth; complete a course of education and training related to the administration of injectable medications, biologicals and immunizations offered by an approved provider; and hold a current basic cardio- pulmonary resuscitation (CPR) certificate from an approved provider.
Proposed § 27.402 (relating to application and renewal procedures) outlines the application and renewal process for the authority to administer injectable medications, biologicals and immunizations. An applicant for the initial authority shall certify that the applicant has completed the educational requirement and that the applicant holds an acceptable CPR certificate. A pharmacist may renew the authority along with the biennial pharmacist license renewal. To renew the authority, the pharmacist must certify that a minimum of 2 continuing education hours in the administration of injectable medications, biologicals and immunizations were completed. Lastly, the pharmacist must submit proof of a current CPR certificate.
Proposed § 27.403 (relating to conditions for administration) details the conditions for administration of injectable medications, biologicals and immunizations. Pharmacists may only administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age. The proposed rulemaking defines what ''more than 18 years of age'' means. The proposed rulemaking also mandates that the administration of injectable medications, biologicals and immunizations shall not be delegated to another person.
Proposed § 27.404 (relating to authority and requirements) sets forth the scope of authority and requirements for administering injectable medications, biologicals and immunizations. A pharmacist with the authority to administer injectable medications, biologicals and immunizations may do so only under an order or written protocol. This section details the requirements for the order and written protocol.
Proposed § 27.405 (relating to recordkeeping) sets forth the recordkeeping requirements for pharmacists who administer injectable medications, biologicals or immunizations. All of the records shall be kept for a minimum of 2 years. Additionally, the proposed rulemaking lists the additional information that shall be maintained when an immunization is administered.
Proposed § 27.406 (relating to notification requirements) details the notification requirements when a pharmacist administers an injection. The notification requirements are different depending on whether the administration is done under an order or a written protocol. The notification requirement when the administration is done under an order places a shorter timeframe within which the pharmacist shall notify the prescriber. When the administration is done under a written protocol the pharmacist has a longer period of time to notify the prescriber.
The Board reviewed and considered all comments and suggestions received from interested parties during the regulatory development process.
Fiscal Impact and Paperwork Requirements
The proposed rulemaking would have a fiscal impact on the Board in that there would be revenue to the Board through the licensure and renewal fees for the authority to administer injectable medications, biologicals and immunizations. The proposed rulemaking would require the Board to develop an application for the authority to administer injectable medications, biologicals and immunizations. The Board would also have to revise the pharmacist license renewal form to allow for the renewal of the authority to administer injectable medications, biologicals and immunizations.
Sunset Date
The Board reviews the effectiveness of its regulations on an ongoing basis. 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 September 29, 2004, 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 Carole Clarke, Counsel, 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.
MICHAEL J. ROMANO, R.Ph.,
ChairpersonFiscal Note: 16A-5412. 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:
* * * * * Bureau--The Bureau of Professional and Occupational Affairs of the Department of State of the Commonwealth.
* * * * * Institutions--[Extended care facilities, nursing homes, nursing care facilities, convalescent homes, resident care facilities, hospitals or another place which offers medical treatment to patients who require food, board and overnight sleeping facilities and care.]
(i) A health care facility that offers care and medical treatment to patients who require food, board and overnight sleeping facilities and provides clinically related services, including, a general or special hospital, including psychiatric hospitals, rehabilitation hospitals, ambulatory surgical facilities, long term care nursing facilities, cancer treatment centers using radiation therapy on an ambulatory basis, and inpatient drug and alcohol treatment facilities, both profit and nonprofit and including those operated by an agency or State or local government.
(ii) The term also includes a hospice that offers care and medical treatment to patients who require food, board and overnight sleeping facilities.
(iii) The term does not include an office used primarily for the private or group practice by health care practitioners where no reviewable clinically related health service is offered, a facility providing treatment solely on the basis of prayer or spiritual means in accordance with the tenets of any church or religious denomination or a facility conducted by a religious organization for the purpose of providing health care services exclusively to clergy or other persons in a religious profession who are members of the religious denominations conducting the facility.
* * * * * Practice of pharmacy--[The practice of that profession concerned with the art and science of preparing, compounding and dispensing drugs and devices, whether dispensed on the prescription of a medical practitioner or legally dispensed or sold directly to the ultimate consumer. The term includes the proper and safe storage and distribution of drugs, the maintenance of proper records therefor and the responsibility of relating information as required concerning the drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease.] The provision of health care services by a pharmacist, which includes:
(i) The interpretation, evaluation and implementation of medical orders for the provision of pharmacy services or prescription drug orders.
(ii) The delivery, dispensing or distribution of prescription drugs.
(iii) Participation in drug and device selection.
(iv) Drug administration.
(v) Drug regimen review.
(vi) Drug or drug-related research.
(vii) Compounding.
(viii) Proper and safe storage of drugs and devices.
(ix) Managing drug therapy in an institutional setting consistent with the institution's assignment of clinical duties.
(x) Maintaining proper records.
(xi) Patient counseling.
(xii) Acts, services operations or transactions necessary or incident to the provision of these health care services.
* * * * *
RENEWAL OF PHARMACIST LICENSE AND PHARMACY PERMIT § 27.32. Continuing education.
(a) [Beginning with 1988 renewals, the] The Board will renew the license of a pharmacist who has completed [the required hours of continuing professional education.
(1) For 1988 renewals, a pharmacist shall have completed a minimum of 25 contact hours (2.5 CEU) of programs offered by providers approved by the ACPE.
(2) For 1990 renewals and thereafter, a pharmacist shall have completed] a minimum of 30 contact hours (3 CEU) of continuing education during the proceeding biennial renewal period. 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 and 27.302 (relating to qualifications for authority; and application and renewal procedures), at least 2 of the required 30 hours shall concern the administration of injectable medications, biologicals and immunizations, including 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.
* * * * *
FEES § 27.91. Schedule of fees.
An applicant for a license, certificate, permit or service shall pay the following fees at the time of application:
* * * * * Application for approval to administer
injectables. . . . . . . . . .$30Biennial renewal of approval to administer injectables. . . . . . . . . .$30
DRUG THERAPY MANAGEMENT § 27.301. Written protocol.
(a) The written protocol for drug therapy management between licensed physicians and pharmacists shall contain:
(1) A statement identifying the physician responsible for authorizing drug therapy management.
(2) A statement identifying the pharmacist authorized to perform the drug therapy management.
(3) A statement requiring that drug therapy regimens be initiated by a licensed physician for patients referred to a pharmacist for drug therapy.
(4) A statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make, including a statement of the ailments or diseases involved within the physician's scope of practice, and types of drug therapy management authorized.
(5) A statement of the functions and tasks the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation of each intervention must occur within 72 hours in the patient medical record and must also be recorded in the pharmacist's records.
(6) A statement that establishes an appropriate time frame, not to exceed 72 hours, within which the licensed pharmacist must notify the licensed physician of any changes in dose, duration or frequency of medication prescribed.
(7) A provision for execution of the agreement when any licensed physician or licensed pharmacist may be temporarily absent from a practice setting or temporarily unavailable to participate in its execution.
(8) A provision for notification of the role of the pharmacist by a licensed physician to each referred patient whose drug therapy management may be affected by the agreement and providing an opportunity for the patient to refuse drug therapy management by a pharmacist.
(9) The signatures of the licensed physicians and licensed pharmacists who are entering into the written protocol, and the dates signed.
(10) A statement allowing for the termination of the agreement at the request of any party to it at any time.
(b) The written protocol must be available as follows:
(1) At the practice site of any licensed physician who is a party to the agreement.
(2) At the practice site of any licensed pharmacist who is a party to the agreement.
(3) At the institution where a written agreement or protocol is in place.
(4) To any patient whose drug therapy management is affected by the agreement.
(5) Upon request, to representatives of the Bureau and the Department of Health.
(c) The written protocol must be filed with Bureau.
(d) The written protocol must be effective for a period not to exceed 2 years from the date of execution. At the end of the 2-year period, or sooner, the parties shall review the agreement and make a determination as to its renewal, necessary modifications or termination.
ADMINISTRATION OF INJECTABLE MEDICATIONS,
BIOLOGICALS AND IMMUNIZATIONS § 27.401. Qualifications for authority.
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 in this Commonwealth.
(2) The pharmacist has completed a course of education and training which includes the current guidelines and recommendations related to the administration of injectable medications, biologicals and immunizations of the Centers for Disease Control and Prevention or a similar health authority or professional body approved by the Board offered by providers accredited by the ACPE or a similar health authority or professional body approved by the Board.
(3) The pharmacist 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 procedures.
(a) 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 has completed the required education and training.
(3) Certification that the pharmacist holds an acceptable, current CPR certificate.
(b) A holder of the authority to administer injectable medications, biologicals and immunizations shall renew the authority every 2 years along with the 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.
§ 27.403. Conditions for administration.
(a) A pharmacist 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 may not delegate the administration of injectable medications, biologicals and immunizations to another person.
§ 27.404. Authority and requirements.
(a) A pharmacist authorized by the Board to administer injectable medications, biologicals and immunizations may only do so under either an order or written protocol.
(b) The order from a licensed prescriber must be written, received electronically or if received orally be reduced to writing, and contain at a minimum the following:
(1) The identity of the licensed prescriber issuing the order.
(2) The identity of the patient to receive the injection.
(3) The identity of the medication, immunization or vaccine, and dose, to be administered.
(4) The date of the original order and the date or schedule, if any, of each subsequent administration.
(c) An authorized pharmacist may enter into a written protocol, either approved by a physician or authorized by the medical staff of an institution, governing the administration of injectable medications, biologicals and immunizations for a specific period of time or purpose. The written protocol may be valid for a time period not to exceed 2 years. The protocol must include the following:
(1) The identity of the participating pharmacist and physician or institution.
(2) The identification of the medication, biological or immunization, which may be administered.
(3) The identity of the patient or groups of patients to receive the authorized injectable medication, biological or immunization.
(4) The identity of the authorized routes and sites of administration allowed.
(5) A provision establishing a course of action the pharmacist shall follow to address emergency situations including adverse reactions, anaphylactic reactions and accidental needle sticks.
(6) A provision establishing a length of time the pharmacist shall observe an individual for adverse events following an injection.
(7) The identity of the location at which the pharmacist may administer the authorized medication, biological or immunization.
(8) Recordkeeping requirements and procedures for notification of administration.
(9) A provision that allows for termination of the protocol at the request of any party to it at any time.
§ 27.405. Recordkeeping.
(a) A pharmacist who administers an injectable medication, biological or immunization 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.
(6) Documentation of provision of informed consent for administration of injectable medications, biologicals and immunizations.
(7) The nature of an adverse reaction and who was notified.
(b) A pharmacist who administers an immunization 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 administering injectable medications, biologicals or immunizations shall meet the following notification requirements:
(1) When administration has occurred under an order, the pharmacist shall notify the ordering prescriber within 72 hours of the following:
(i) The identity of the patient.
(ii) Identity of the medication.
(iii) Biological or immunization administered.
(iv) The route of administration.
(v) The site of the administration.
(vi) The dose administered.
(vii) The date of administration.
(viii) The nature of any adverse events or reactions experienced by the patient.
(2) When the administration has occurred under a written protocol, the pharmacist shall notify the participating physician within 14 days of the following:
(i) The identity of the patient.
(ii) The identity of the medication.
(iii) The biological or immunization administered.
(iv) The site of the administration.
(v) The dose administered.
(vi) The date of administration.
(vii) The nature of any adverse events or reactions experienced by the patient.
[Pa.B. Doc. No. 04-1855. Filed for public inspection October 8, 2004, 9:00 a.m.]
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