RULES AND REGULATIONS
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Drug Therapy and Injectable Medications, Biologicals and Immunizations
[36 Pa.B. 3237]
[Saturday, July 1, 2006]The State Board of Pharmacy (Board) amends §§ 27.1, 27.32 and 27.91 (relating to definitions; continuing education; and schedule of fees) and adds §§ 27.301, 27.311 and 27.401--27.407 to read as set forth in Annex A. The final-form rulemaking adds definitions, updates and adds additional requirements in § 27.32, adds two new fees to § 27.91 and provides regulations regarding drug therapy management and the administration of injectable medications, biologicals and immunizations.
Notice of proposed rulemaking was published at 34 Pa.B. 5598 (October 9, 2004). Publication was followed by a 30-day public comment period. The Board received comments from the Pennsylvania Pharmacists Association, Louis F. Pauzano, Jr. and the Pennsylvania Academy of Family Physicians (PAFP). The House Professional Licensure Committee (HPLC) submitted 14 comments to the proposed rulemaking on November 10, 2004. The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) made no comments. The Independent Regulatory Review Commission (IRRC) submitted seven comments to the proposed rulemaking on December 10, 2004.
Summary of Comments and Responses to Proposed Rulemaking
§ 27.1. Definitions.
The HPLC and IRRC commented that the Board should use the definition of ''institution'' in section 2 of the Pharmacy Act (act) (63 P. S. § 390-2) or reference the statutory definition. The Board declines to make this change. Section 2 of the act defines ''institution'' as a ''health care facility'' defined in section 103 of the Health Care Facilities Act (35 P. S. § 448.103) and adds the qualifier ''which offers care and medical treatment to patients who require food, board and overnight sleeping facilities.'' The Board included the definition of ''health care facility'' in section 103 of the Health Care Facilities Act with the qualifying language of the act's definition for ease of reference for pharmacists. Having the definition completely set forth in the regulations negates the necessity for pharmacists to refer to another act to understand the definition of ''institution.'' The Board did not alter the definition as found in the Health Care Facilities Act, but included the language as referenced in the act with the qualifier. The definition is not confusing and does nothing more than clarify the definition found in the act.
The HPLC and IRRC commented that the proposed rulemaking used the term ''order'' whereas ''drug order'' is defined and used in existing regulations. The HPLC and IRRC commented that if the Board meant ''drug order,'' that term should be used or the Board should add the a new definition of the term ''order.'' The term ''drug order'' is specific to institutions. In the proposed rulemaking, the Board is referring to any order from a physician within the context of management of drug therapy. Accordingly, the Board has added a definition of the term ''order.''
IRRC commented that the regulatory definition of ''practice of pharmacy'' was practically, but not completely, identical to the statutory definition. The Board added the last sentence of the definition of ''practice of pharmacy'' to the regulatory definition and it is now completely identical to the statutory definition.
The HPLC and IRRC recommended that the statutory definition of ''drug therapy management'' be added to the proposed regulations. The Board agrees and has added the definition.
§ 27.32. Continuing education.
Mr. Pauzano commented that the 2-hour continuing education requirement for the administration of injectable medications, biologicals and immunizations was not a sufficient number of hours. The Board disagrees. In drafting the rulemaking, the Board consulted several other states' regulations and the standard continuing education requirement for the administration of injectables was 2 hours per biennial renewal period. Pharmacists are required to complete at least a 10-hour course to apply for the authority to administer injectables, which will give sufficient knowledge to administer injectables. The Board is satisfied that the minimum 2-hour continuing education requirement is satisfactory and declines to make a change.
The HPLC commented that the Board is required to establish education and training standards for the administration of injectables and noted that the proposed rulemaking was silent as to these standards. With respect to continuing education, the Board disagrees. The Board added the requirement that for renewal of the authority to administer injectables, pharmacists must complete at least 2 hours of continuing education concerning administration of injectable medications, biologicals and immunizations, including disease epidemiology, vaccine characteristics, injections technique, emergency response to adverse events and related topics. With regard to the education needed to apply for the initial authority to administer injectables, the Board added § 27.407 (relating to education requirements) to the final-form rulemaking. Section 27.407 lays out in detail the requirements for the course of education and training necessary to apply for the initial authority to administer injectables.
§ 27.301. Written protocol.
The HPLC commented that the Board should state that drug therapy management may only take place in an institutional setting. The Board declines to make the change. The act already states in both the definition of ''drug therapy management'' and section 9.1 of the act (63 P. S. § 390-9.1) that drug therapy management can only take place in an institutional setting. Stating this again in § 27.301 would be redundant and unnecessary. Moreover, § 27.301 concerns the parameters of the written protocol, not the requirements to enter into a written protocol as these are already stated in the act.
The HPLC, IRRC and the PAFP commented that the notification provisions for drug therapy management under a written protocol gave a pharmacist up to 72 hours to notify a physician of a change in drug therapy and 72 hours for the pharmacist to document a change in the medical records and questioned the appropriateness of that time frame. The Board notes that 72 hours set the outside limit for notification. The pharmacist and physician would be free to agree to a shorter time frame in drafting the written protocol. To address the concerns raised, the Board added language to the final-form rulemaking for notification and documentation to occur as soon as practicable, but no later than 72 hours after the change or intervention. The HPLC also asked for the Board's rationale for choosing the 72-hour time frame. The Board's rationale for choosing 72 hours is twofold. First, the General Assembly already set the maximum time for notification in section 9.1(e)(9) of the act, the Board simply adopted that. Second, the 72 hours allowed for a period of time when the physician may not have been available (for example, over a weekend).
The HPLC commented that the act requires that the written protocol be available to representatives of the State Board of Medicine, the State Board of Osteopathic Medicine and the State Board of Pharmacy and that § 27.301(b)(5) should include these entities. These entities are already covered by § 27.301(b)(5). The Board specifically chose to use the term ''Bureau'' instead of listing the individual boards because a specific board does not employ the inspectors and investigators. Because the Bureau of Professional and Occupational Affairs encompasses all the professional licensing boards, using the term ''Bureau'' covers all the boards named in the act. Use of the term ''Bureau'' is consistent with other collaborative practice agreement regulations. See the certified registered nurse practitioner regulations in § 21.285(a)(7) (relating to collaborative agreement).
§ 27.311. Certification of professional liability insurance.
The HPLC commented that the proposed rulemaking is silent as to the professional liability insurance requirement. The HPLC commented that the rulemaking should at least require proof of insurance be submitted to the Board. The Board has added a section to the final-form rulemaking that requires certification of professional liability insurance to the Board when filing the written protocol.
§ 27.401. Qualifications for authority.
The HPLC commented that the Board had not established education and training standards for the administration of injectables. IRRC commented that the Board needed to identify the specific minimum education and training requirements that must be included in an approved course. In the proposed rulemaking, the Board intended to establish education and training guidelines by accepting any course that was Accreditation Council for Pharmacy Education (ACPE) (formerly called American Council of Pharmaceutical Education) approved and included the current guidelines and recommendations regarding the administration of injectable medications, biologicals and immunizations of the Centers for Disease Control and Prevention and offered by providers accredited by the ACPE. However, in response to these comments, the Board added § 27.407 which lays out specific requirements for the education needed to apply for the authority to administer injectables. With respect to the treatment guidelines, these are addressed in a new subsection added to § 27.403 and in § 27.404 (relating to authority and requirements), which establish the guidelines for injectable administration.
IRRC further commented that the proposed rulemaking was silent as to how a course provider would apply for approval by the Board. The Board has added to § 27.407(b) that preapproves courses offered by ACPE-accredited providers and education institutions that meet the course criteria in § 27.407(a). The Board will only accept ACPE-accredited courses, as the ACPE is the accreditation body for pharmacy education and continuing education. With the new section added to the final-form rulemaking, the Board has removed the option to approve other course providers.
§ 27.402. Application and renewal procedures.
IRRC commented that § 27.402 was silent as to the professional liability coverage required to manage drug therapy. However, § 27.402 does not pertain to managing drug therapy; it pertains to the authority to administer injectable medications, biologicals and immunizations. Professional liability insurance is not required to administer injectables. Therefore, the Board has not addressed it in this section. Professional liability insurance for managing drug therapy is addressed in section 9.1(d)(1) of the act and § 27.301 (relating to written protocol).
§ 27.403. Conditions for administration.
The HPLC remarked in a comment concerning § 27.401 (relating to qualifications for authority) that the education and training standards and practice guidelines that the Board must establish must include a ''definitive set of treatment guidelines established by a physician and approved by the board.'' The Board has added language to this section with respect to immunizations. Treatment guidelines are also dealt with in § 27.404.
§ 27.404. Authority and requirements.
The HPLC asked for an explanation with regard to subsection (c) and asked if the Board intended to address drug therapy management under section 9.1(f) of the act. In this section, the Board is detailing what must be in a written protocol for the administration of injectable medications, biologicals and immunizations. This section is unrelated to § 27.301 or section 9.1(f) of the act, which concerns management of drug therapy in an institution under a medical order by a licensed physician approved by the medical staff of the institution. Therefore, § 27.404(c) does not need to track the language of section 9.1(f) of the act.
§ 27.405. Recordkeeping.
The HPLC recommended that the Board remove the words ''or identifiable initials'' from subsection (a)(5). The Board declines to make this change. Under § 27.18 (relating to standards of practice), prescription records kept on file in the pharmacy must be identified with the name or initials of the dispensing pharmacist. The Board is being consistent with existing regulations in allowing initials to be placed on the administration records. There have been no reported problems with identifying a pharmacist by his or initials and patient safety is not compromised with placing the pharmacist's initials on the pharmacy records. The HPLC also recommended that the Board remove the words ''of provision'' from subsection (a)(6). The Board has changed the final-form rulemaking accordingly.
The PAFP commented that the Board should adopt the 7-year recordkeeping requirement applied to medical records because the administration of injectables implicates the patient's medical condition. IRRC also commented that the Board should make this change in the final-form rulemaking or justify the 2-year requirement. The purpose of the 2-year requirement is to maintain the current recordkeeping standards in pharmacies. Therefore, the Board declines to make the suggested change. Every administration done by a pharmacist must be reported to the patient's physician who records this information in the patient's medical file. Inasmuch as the physician is maintaining this information for 7 years, it is not necessary for the pharmacy to also maintain the record of administration for 7 years. The PAFP's rationale that the administration of drugs implicates the patient's medical condition fails to consider that when pharmacists dispense any drug for the patient's consumption it implicates the patient's medical condition as well. The only difference is the route of administration. Therefore, the Board does not see the need to retain records for more than the standard 2 years.
§ 27.406. Notification requirements.
The PAFP commented that the 72-hour notification requirement for injections done under an order and 14 days for injections done under a written protocol was not consistent with good medical care. IRRC echoed the PAFP's comment. The Board has amended the final-form rulemaking to require notification as soon as practicable, but no longer than 72 hours after administration of the injectable. This change requires the pharmacist to notify the physician as soon as practicable, but allows for up to 72 hours in case the physician is unavailable, such as over a weekend when many physicians' offices are closed. The HPLC and IRRC recommended that the Board change the wording to require a pharmacist to notify the physician of an adverse reaction as soon as practicable. The Board has changed the final-form rulemaking by adding paragraph (3) pertaining to adverse reactions and requiring notification as soon as is practicable, and in no event later than 24 hours after learning of the adverse event or reaction.
§ 27.407. Education requirements.
In response to comments from the HPLC and IRRC, the Board has added this section to address the education and training requirements required to apply for the authority to administer injectable medications, biologicals and immunizations. In drafting this section, the Board looked at several other states' regulations, including North Dakota, South Dakota, Iowa, Oregon, Texas, Nevada, Ohio and Delaware, and adopted standards similar to those of these states. Pharmacists will have to complete a course within the 2-year period prior to applying for the authority to administer injectables. The course must be an evidence-based course that includes study material, includes hands-on training and techniques for administration, requires testing with a passing score, provides a minimum of 10 hours of instruction and experiential training, and complies with the current guidelines and recommendations by the Centers for Disease Control and Prevention, the ACPE or a similar health authority or professional body. The course must provide instruction on: basic immunology and the human immune response; mechanics of immunity, adverse effects, dose and administration schedule of available vaccines; response to an emergency situation as a result of the administration of an injectable medication, biological or immunization; administration of subcutaneous, intradermal and intramuscular injections; disease epidemiology; standards for immunization practices; vaccine-preventable diseases; recommended immunization schedules; vaccine storage and management; biohazard waste disposal and sterile techniques; informed consent; and authority and recordkeeping requirements. The Board approves courses offered by ACPE-accredited providers and educational institutions that meet these criteria.
General Comments
Mr. Pauzano commented that the Board should address emergency situations, such as a smallpox outbreak, and promulgate regulations that would enable pharmacists to administer injectables without a physician order in an emergency situation. The Board notes that in an emergency situation, under the appropriate emergency declaration from the Governor, the Board may suspend enforcement of its regulations. In the case of a smallpox outbreak, the Board would look at suspending the requirement of a physician order to administer injectables. However, the Board declines to promulgate specific regulations concerning emergency situations at this time.
The HPLC requested an explanation from the Board regarding its discussions with the Insurance Commissioner regarding self-insurance. In late 2002/early 2003, the Board's legal counsel contacted the Insurance Department (Department) concerning what kind of regulations would be necessary for self-insurance by pharmacists. Counsel was referred to the Department's regulations for self-insurance evaluation by the Department in 31 Pa. Code Chapter 243 (relating to medical malpractice and health-related self-insurance plans). At that time, the decision was made to reference the Department's regulations in the Board's proposed rulemaking. At a later time, the issue of pharmacists not being a health care provider as defined by the Department's regulations was raised. Board counsel again contacted the Department to inquire further about self-insurance regulations. At that time, the Department identified several issues with reviewing self-insurance plans that the Board and Department must work out before regulations can be promulgated. As the Board does not anticipate that many pharmacists who engage in drug therapy management will self-insure, the Board decided that this issue could be taken up at a future time and removed the self-insurance language from the proposed rulemaking.
Statutory Authority
The final-form rulemaking is authorized under section 9.1(d)(3) and (e) of the act and sections 4(j), 6(k)(1) and (9) and 9.2(a) of the act (63 P. S. §§ 390-(4)(j), 390-6(k)(1) and (9) and 390-9.2(a)).
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have a fiscal impact on the Board in that there will be revenue to the Board through the licensure and renewal fees for the authority to administer injectable medications, biologicals and immunizations. The final-form rulemaking requires the Board to develop an application for the authority to administer injectable medications, biologicals and immunizations. The Board will also have to revise the pharmacist license renewal form to allow for the renewal of the authority to administer injectable medications, biologicals and immunizations.
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 the notice of proposed rulemaking, published at 34 Pa.B. 5598, 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 Department has considered all comments from IRRC, the HPLC and 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 May 2, 2006, the final-form rulemaking was approved by the HPLC. On May 17, 2006, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on May 18, 2006, and approved the final-form rulemaking.
Additional Information
Individuals who need information about the final-form rulemaking should contact Melanie Zimmerman, R.Ph., Executive Secretary, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649.
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) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking is necessary and appropriate for the administration of the act.
(4) The amendments to this final-form rulemaking do not enlarge the original purpose of the proposed regulation published at 34 Pa.B. 5598.
Order
The Board orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by amending §§ 27.1, 27.32, 27.91 and by adding §§ 27.301, 27.311 and 27.401--27.407 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Board shall submit this order and a copy of 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) This order shall take effect upon publication in the Pennsylvania Bulletin.
MICHAEL J. ROMANO, R.Ph.,
Chairperson(Editor's Note: The proposal to add §§ 27.311 and 27.407 was not included in the proposed rulemaking at 34 Pa.B. 5598. For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 36 Pa.B. 2781 (June 3, 2006).)
Fiscal Note: Fiscal Note 16A-5412 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:
* * * * * Bureau--The Bureau of Professional and Occupational Affairs of the Department of State of the Commonwealth.
* * * * * Drug therapy management--Any of the following processes performed in an institutional setting pursuant to a written agreement, protocol or order as set forth in section 9.1 of the act (63 P. S. § 390-9.1):
(i) Adjusting a drug regimen.
(ii) Adjusting drug strength, frequency of administration or route.
(iii) Administration of drugs.
(iv) Ordering laboratory tests and ordering and performing other diagnostic tests necessary in the management of drug therapy, consistent with the testing standards of the institution.
* * * * * Institutions--
(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 health 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.
* * * * * Order--Any directive from a medical practitioner.
* * * * * Practice of pharmacy--
(i) The provision of health care services by a pharmacist, which includes:
(A) The interpretation, evaluation and implementation of medical orders for the provision of pharmacy services or prescription drug orders.
(B) The delivery, dispensing or distribution of prescription drugs.
(C) Participation in drug and device selection.
(D) Drug administration.
(E) Drug regimen review.
(F) Drug or drug-related research.
(G) Compounding.
(H) Proper and safe storage of drugs and devices.
(I) Managing drug therapy in an institutional setting consistent with the institution's assignment of clinical duties.
(J) Maintaining proper records.
(K) Patient counseling.
(L) Acts, services, operations or transactions necessary or incident to the provision of these health care services.
(ii) The term does not include the operations of a manufacturer or distributor as defined in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-144).
* * * * *
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. 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 pharmacy intern certificate $30 Application for pharmacist license $40 Certification of examination scores or internship hours $25 Verification of licensure $15 Assistant pharmacist biennial renewal $120 Registered pharmacist biennial renewal $150 Registered pharmacist late renewal penalty $25 New pharmacy permit application $100 Reinspection of new pharmacy after failure at first inspection $90 Pharmacy permit change without inspection $30 Pharmacy permit change when inspection
required$95 Change in pharmacy ownership or Board of Directors $30 Verification of permit $15 Biennial renewal of pharmacy permit $100 Pharmacy permit late renewal penalty $25 Application for approval to administer injectables $30 Biennial 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 must 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 shall occur as soon as practicable, but no later than 72 hours after the intervention in the patient medical record and shall also be recorded in the pharmacist's records.
(6) A statement that requires notification to the authorizing physician of any changes in dose, duration or frequency of medication prescribed as soon as practicable but not longer than 72 hours after the change.
(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 shall 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.
PROFESSIONAL LIABILITY INSURANCE § 27.311. Certification of professional liability insurance.
(a) A licensee who engages in drug therapy management under a written protocol shall maintain professional liability insurance in the minimum amount of $1,000,000 per occurrence or claims made.
(b) A licensee who engages in drug therapy management under a written protocol shall certify compliance with subsection (a) on a form provided by the Board. The form shall be provided with the written protocol.
(c) A licensee who engages in drug therapy management under a written protocol shall upon request make available to the Board or its agents all records, relating to the licensee's maintenance of professional liability insurance, including policies, cancelled checks, receipts or other proofs of premium payment.
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 meets the requirements of § 27.407 (relating to education requirements).
(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 in § 27.407 (relating to education requirements).
(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.
(c) A pharmacist 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 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, but not limited to, 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 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 as soon as practicable, but no longer than 72 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 shall notify the participating physician as soon as practicable, but no longer than 72 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 shall notify the patient's physician as soon as is practicable, and in no event later 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 shall meet the following education requirements:
(1) Complete within the 2-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).
[Pa.B. Doc. No. 06-1200. Filed for public inspection June 30, 2006, 9:00 a.m.]
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