Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS STATE BOARD OF PHARMACY [ 49 PA. CODE CH. 27 ] Collaborative Management of Drug Therapy [45 Pa.B. 4911]
[Saturday, August 22, 2015]The State Board of Pharmacy (Board) amends §§ 27.1, 27.301 and 27.311 (relating to definitions; written protocol for the management of drug therapy in an institutional setting; and certification of professional liability insurance—written protocol) and adds §§ 27.302 and 27.312 (relating to collaborative agreement for management of drug therapy in a non-institutional setting; and certification of professional liability insurance—collaborative agreement) to read as set forth in Annex A.
Effective Date
The final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
The final-form rulemaking is authorized under sections 6(k)(9) and 9.3 of the Pharmacy Act (act) (63 P. S. §§ 390-6(k)(9) and 390-9.3).
Background and Purpose
In August 2002, section 9.1 of the act (63 P. S. § 390-9.1) was added to authorize pharmacists practicing in an institution setting to manage drug therapy by means of a written protocol. In August 2010, section 9.3 of the act was added to provide for collaborative drug therapy management in accordance with a written collaborative agreement between a physician and a pharmacist in a setting other than an institutional setting. This final-form rulemaking implements section 9.3 of the act.
Summary of Comments and Responses to Proposed Rulemaking
The Board published notice of proposed rulemaking at 43 Pa.B. 2439 (May 4, 2013), followed by a 30-day public comment period. The Board received comments from Patricia Epple, CEO of the Pennsylvania Pharmacists Association (PPA); joint comments from Jill McCormack, Regional Director, State Government Affairs, National Association of Chain Drug Stores (NACDS), and Janet Hart, RPh, President, Pennsylvania Association of Chain Drug Stores (PACDS); and comments from C. Richard Scott, MD, President, Pennsylvania Medical Society (PAMED). On June 13, 2013, the House Professional Licensure Committee (HPLC) voted to take no formal action on the proposed rulemaking until the final-form rulemaking is promulgated and to submit one comment to the Board. The Board did not receive comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC). On July 3, 2013, the Board also received comments from the Independent Regulatory Review Commission (IRRC) as part of their review of proposed rulemaking under the Regulatory Review Act (71 P. S. §§ 745.1—745.12a).
The comments were discussed at the public meeting of the Board on August 20, 2013. Present during the discussion of the comments were representatives from PPA, Target, CVS Caremark, Omnicare, Walgreens and Acme. These stakeholders did not offer additional comment during the discussion of the written comments.
The comments from PPA, NACDS and PACDS were supportive and did not offer changes to the proposed rulemaking. PAMED was supportive of the proposed rulemaking but suggested revisions.
PAMED recommended that controlled substances should be excluded from drug therapy management. The Board considered this recommendation and decided not to change this final-form rulemaking based on the fact that the parties involved, that is, the physician and the pharmacist, could limit the types of medication involved during the drug therapy management with an individual drug protocol. The Board felt it was better to leave this decision to the actual treatment providers involved with the specific drug therapy management protocol.
PAMED recommended that the agreements be placed on file with the respective physician licensing board. In response to this recommendation, the Board amended § 27.302(h) to include the requirement that the collaborative agreement shall be filed with the Bureau of Professional and Occupational Affairs (Bureau). Under section 810 of The Administrative Code of 1929 (71 P. S. § 279.1), the Commissioner of the Bureau has the power and duty ''[t]o be responsible for all administrative affairs of each of the professional and occupational examining boards and to coordinate their activities.'' Filing the written agreement with the Bureau relieves the parties from the requirement to file multiple copies with the applicable boards. Instead, Bureau staff will distribute the agreement to the applicable boards and place an electronic copy of the written agreement on file with each licensee's licensure record maintained by the Bureau.
PAMED further recommended that physicians should have access to the pharmacist's records for review. In response to this recommendation, the Board amended § 27.302(l)(2) to include the requirement that physicians who are parties to the collaborative agreement shall have access to the pharmacy records of the drug therapy patient.
PAMED also recommended that a change in drug therapy should be reported to the physician within 48 hours. The Board considered this recommendation and decided not to change the final-form rulemaking. The Board notes that the final-form rulemaking requires it to be reported as soon as practicable, but no longer than 72 hours after the change. The Board felt that 72 hours was an appropriate time frame regarding changes regardless of the practice setting.
PAMED recommended that the Board institute workload limitations on pharmacists performing drug therapy management. The Board considered this recommendation and decided not to change the final-form rulemaking. Physicians and pharmacists are both licensed professionals and are capable of determining their own workload limitations without the need of Board guidance.
IRRC expressed concern regarding § 27.1 in that ''non-institutional setting'' used in § 27.302 was not specifically defined. In response to this concern, the Board defined ''non-institutional setting'' along with amending the definition of ''institution.''
IRRC and the HPLC also recommended that the written agreements be placed on file with the appropriate boards. In response to this recommendation, the Board amended § 27.302(h) to include the requirement that the collaborative agreement must be filed with the Bureau. This new provision is identical to the existing requirement in § 27.301(d) pertaining to written protocols for the management of drug therapy in institutional settings. The Bureau will ensure that the agreements are distributed to the applicable boards, and are copied and placed on file with each licensee's electronic licensure record. This process will eliminate the unnecessary filing of the same documents with multiple boards by multiple parties and is consistent with the Commissioner's authority under section 810 of The Administrative Code of 1929.
IRRC was supportive of PAMED's recommendation concerning physician access to the pharmacist's records. As previously noted, in response to this recommendation, the Board amended § 27.302(l)(2) to include the requirement that physicians who are parties to the collaborative agreement shall have access to the pharmacy records of the drug therapy patient.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking will have minimal fiscal impact on the Board or the regulated community. The licensees' obligations regarding certification to the Board of professional liability insurance to practice under a collaborative agreement would be similar to those of licensees practicing in institutional settings under a written protocol.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 22, 2013, the Board submitted a copy of the notice of proposed rulemaking, published at 43 Pa.B. 2439, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on July 8, 2015, the final-form rulemaking was deemed approved by the HPLC and the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on July 9, 2015, and approved the final-form rulemaking.
Additional Information
Persons who require additional information about the final-form rulemaking should submit inquiries to Board Counsel, State Board of Pharmacy, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7200, st-pharmacy@state.pa.us.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) and regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) The amendments to this final-form rulemaking do not enlarge the scope of proposed rulemaking published at 43 Pa.B. 2439.
(4) The final form rulemaking adopted by this order is necessary and appropriate for the administration of the act.
Order
The Board, acting under the act, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 27, are amended by adding §§ 27.302 and 27.312 and by amending §§ 27.1, 27.301 and 27.311 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of Attorney General and the Office of General Counsel for approval as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) The final-form rulemaking shall take effect upon publication in the Pennsylvania Bulletin.
JANET GETZEY HART, RPh,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 45 Pa.B. 4123 (July 25, 2015).)
Fiscal Note: Fiscal Note 16A-5425 remains valid for the final adoption of the subject regulations.
Annex A TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS PART I. DEPARTMENT OF STATE Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS CHAPTER 27. STATE BOARD OF PHARMACY GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACPE—The Accreditation Council for Pharmacy Education.
Act—The Pharmacy Act (63 P. S. §§ 390-1—390-13).
Automated medication system—
(i) A process that performs operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing and distribution of medications, and which collects, controls and maintains all transaction information.
(ii) The term does not include an automatic counting device or unit-based dispensing cabinet.
Automatic counting device—A device used in a pharmacy to automatically count medication for dispensing.
Board—The State Board of Pharmacy.
Bureau—The Bureau of Professional and Occupational Affairs of the Department.
CEU—Continuing education units—The unit of measuring contact hours of continuing education provided by ACPE accredited providers. Ten contact hours are equivalent to 1.0 CEU.
Central fill pharmacy—A pharmacy engaging in centralized prescription processing by filling and refilling prescriptions, which includes the preparation and packaging of the medication. A central fill pharmacy may also be the originating or delivering pharmacy.
Central processing center—A pharmacy operated under the direction of a pharmacist that processes information related to the practice of pharmacy and that engages solely in centralized prescription processing but from which drugs are not dispensed.
Centralized prescription processing—The processing, under the direction of a pharmacist, of a request to fill or refill a prescription, to perform functions such as refill authorizations, interventions or other matters related to the practice of pharmacy for subsequent delivery to the delivering pharmacy.
Commissioner—The Commissioner of Professional and Occupational Affairs in the Department.
Contact hours—Continuing education units of measure equivalent to 50 to 60 minutes of participation in an approved organized learning experience, including home study with approved educational materials.
Continuing education—Professional education obtained to maintain, improve or expand current skills or knowledge, or to develop new skills or knowledge.
DEA—The Federal Drug Enforcement Administration.
Delivering pharmacy—The pharmacy that receives the processed prescription or the filled or refilled prescription for delivering to the patient or the patient's authorized representative. A delivering pharmacy may also be an originating or central fill pharmacy.
Department—The Department of State of the Commonwealth.
Drug order—
(i) An oral or written order issued by a medical practitioner which is either written on or entered by computer into the medical record of a patient in an institution for the dispensing of a drug or device for administration to the patient.
(ii) The term does not include an order for a drug for a patient in an institution which the patient will self-administer which will be considered a prescription.
FDLE—Federal Drug Law Examination.
Institution—A health care facility as defined in section 103 of the Health Care Facilities Act (35 P. S. § 448.103) which offers care and medical treatment to patients who require food, board and overnight sleeping facilities.
Licensed person—A person holding a license issued by the Board.
Long-term care facility—A nursing home, retirement care, mental care or other institution that provides extended health care to resident patients.
MJPE—Multistate Pharmacy Jurisprudence Examination.
Management of drug therapy—
(i) Any of the following processes performed under a written protocol as set forth in section 9.1 of the act (63 P. S. § 390-9.1) or under a collaborative agreement as set forth in section 9.3 of the act (63 P. S. § 390-9.3):
(A) Adjusting a drug regimen.
(B) Adjusting drug strength, frequency of administration or route.
(C) Administration of drugs.
(D) Ordering laboratory tests and ordering and performing other diagnostic tests necessary in the management of drug therapy.
(E) Monitoring the patient's vital signs.
(F) Providing education and training to the patient that is related to the management of the drug therapy.
(ii) The term excludes medication therapy management services in the practice of pharmacy provided under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. No. 108-173, 117 Stat. 2066).
Medical practitioner—A physician, dentist, veterinarian or other individual authorized and licensed by law to prescribe drugs.
Non-institutional setting—A setting other than an institution as defined in the act and this section.
Nonproprietary drug—A drug containing any quantity of a controlled substance or a drug which is required by an applicable Federal or state law to be dispensed only by prescription.
Order—Any directive from a medical practitioner.
Originating pharmacy—
(i) The pharmacy that receives the patient's or prescribing practitioner's request to fill or refill a prescription and performs functions such as the prospective drug review.
(ii) The term includes a central processing center or a central fill pharmacy if the prescription was transmitted by the prescriber directly to the central processing center or central fill pharmacy or if the patient requested the refill from that pharmacy.
PDR—Prospective drug review performed to assure that a drug dispensed under a prescription is not likely to have an adverse medical result by attempting to identify potential drug therapy problems that might result from therapeutic duplication, drug-drug interactions, incorrect dosage, incorrect duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse.
Pharmacist manager—The pharmacist named in the permit to operate a pharmacy who is in charge of a pharmacy and responsible for operations involving the practice of pharmacy under section 4 of the act (63 P. S. § 390-4).
Pharmacy—The place licensed by the Board where the practice of pharmacy is conducted.
Pharmacy intern—A person registered by the Board as a pharmacy intern under section 3(e) of the act (63 P. S. § 390-3(e)) and § 27.26 (relating to pharmacy internship).
Pharmacy technician—
(i) An unlicensed person working in a pharmacy to assist a pharmacist in the practice of pharmacy in accordance with § 27.12 (relating to practice of pharmacy and delegation of duties).
(ii) The term does not include a pharmacy intern, or clerical or housekeeping personnel.
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) Management of drug therapy under a written collaborative agreement as set forth in section 9.3 of the act or, if in an institutional setting, consistent with the institution's assignment of clinical duties under a written protocol as set forth in section 9.1 of the act.
(J) Maintaining proper records.
(K) Patient counseling.
(L) Acts, services, operations or transactions necessary or incident to the provision of these health care services.
(M) Drug therapy management, including services provided under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
(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).
Prescription—A written, electronic or oral order issued by a licensed medical practitioner in the course of professional practice for a controlled substance, other drug or device, or medication which is dispensed for use by a consumer.
Prescription area—
(i) That area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy.
(ii) The term does not include waiting counters or display space attached to the waiting counters.
Proprietary drug—A nonprescription, nonnarcotic medicine or drug which may be sold without a prescription and which is prepackaged for use by the consumer and labeled in accordance with the requirements of Federal and State statutes and regulations.
Satellite pharmacy—
(i) A pharmacy in an institution which provides specialized services for the patients of the institution and which is dependent upon the centrally located pharmacy for administrative control, staffing and drug procurement.
(ii) The term does not include a pharmacy serving the public on the premises of the institution nor does it include a pharmacy located off premises from the centrally located pharmacy of the institution regardless of whether the pharmacy is owned by the same person or entity which owns the institution.
MANAGEMENT OF DRUG THERAPY § 27.301. Written protocol for the management of drug therapy in an institutional setting.
(a) The management of drug therapy under section 9.1 of the act (63 P. S. § 390-9.1) shall be performed under a written protocol consistent with the institution's assignment of clinical duties. Ordering of laboratory tests and ordering or performing other diagnostic tests necessary in the management of drug therapy shall be consistent with the testing standards of the institution.
(b) The written protocol for management of drug therapy between physicians and pharmacists must contain:
(1) A statement identifying the physician responsible for authorizing management of drug therapy.
(2) A statement identifying the pharmacist authorized to perform management of drug therapy.
(3) A statement requiring that regimens for the management of drug therapy be initiated by a physician for patients referred to a pharmacist for management of drug therapy.
(4) A statement identifying the types of decisions regarding the management of drug therapy 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 management of drug therapy authorized.
(5) A statement of the functions and tasks the pharmacist shall follow in the course of exercising management of drug therapy, 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's 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 no longer than 72 hours after the change.
(7) A provision for implementation of the written protocol when a physician or pharmacist who is a party to the protocol is temporarily unavailable to participate in its implementation.
(8) A provision for notification of the role of the pharmacist by a physician to each referred patient the management of whose drug therapy may be affected by the written protocol and providing an opportunity for the patient to refuse management of drug therapy by a pharmacist.
(9) The signatures of the physicians and pharmacists who are entering into the written protocol, and the dates signed.
(10) A statement allowing for the termination of the written protocol at the request of any party to it at any time.
(c) The written protocol must be available as follows:
(1) At the practice site of each physician who is a party to the written protocol.
(2) At the practice site of each pharmacist who is a party to the written protocol.
(3) At the institution where a written protocol is in place.
(4) To any patient the management of whose drug therapy is affected by the written protocol, upon request of the patient.
(5) Upon request, to representatives of the Bureau and the Department of Health.
(d) The written protocol shall be filed with the Bureau.
(e) 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 written protocol and make a determination as to its renewal, necessary modifications or termination.
§ 27.302. Collaborative agreement for management of drug therapy in a non-institutional setting.
(a) Before practicing the management of drug therapy in a non-institutional setting, a pharmacist shall enter into a written collaborative agreement with a physician authorizing the management of drug therapy for diseases or for conditions or symptoms of diseases.
(b) The collaborative agreement must be between a physician and a pharmacist.
(c) A pharmacist may not provide economic or other incentives, inducements or benefits to a physician for the purpose of entering into a collaborative agreement for the management of drug therapy.
(d) A pharmacist who is employed by a physician under a collaborative agreement for the purpose of management of drug therapy may not engage in retail dispensing while in the health care practice or within the context of employment.
(e) Participation in a collaborative agreement authorizing the management of drug therapy is voluntary. A physician or pharmacist is not required to participate.
(f) The collaborative agreement must contain:
(1) A statement identifying the physician responsible for authorizing the management of drug therapy.
(2) A statement identifying the pharmacist authorized to perform the management of drug therapy.
(3) A statement requiring that regimens for the management of drug therapy be initiated by a physician for patients referred to a pharmacist for management of drug therapy.
(4) A statement identifying the types of decisions regarding the management of drug therapy that the pharmacist is authorized to make within the physician's scope of practice and types of management of drug therapy authorized.
(5) A statement identifying the terms under which a pharmacist providing the management of drug therapy is permitted to: adjust the drug regimen, the drug strength and the frequency of administration or the route of administration; administer drugs; order laboratory tests; and order and perform other diagnostic tests necessary in the management of drug therapy without prior written or oral consent by the collaborating physician. This paragraph does not provide prescriptive authority to a pharmacist.
(6) A statement of the functions and tasks the pharmacist shall follow in the course of exercising management of drug therapy, 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, and be recorded in the pharmacist's records.
(7) A statement that requires notification to the authorizing physician of changes in dose, duration or frequency of medication prescribed as soon as practicable but no longer than 72 hours after the change.
(8) A provision for implementation of the collaborative agreement when a physician or pharmacist who is a party to the agreement is temporarily unavailable to participate in its implementation.
(9) A provision for notification of the role of the pharmacist by a physician to each referred patient the management of whose drug therapy may be affected by the collaborative agreement and providing an opportunity for the patient to refuse management of drug therapy by a pharmacist.
(10) The signatures of the physicians and pharmacists who are entering into the collaborative agreement and the dates signed.
(11) A statement allowing for the termination of the collaborative agreement at the request of a party to it at any time.
(g) The collaborative agreement must be available:
(1) At the practice site of each physician who is a party to the collaborative agreement.
(2) At the practice site of each pharmacist who is a party to the collaborative agreement.
(3) To any patient the management of whose drug therapy is affected by the agreement, upon request of the patient.
(4) Upon request, to representatives of the Bureau and the Department of Health.
(h) The collaborative agreement shall be filed with the Bureau.
(i) The collaborative agreement must be maintained on the premises of the pharmacy for review during inspection by or upon request of representatives of the Bureau and the Department of Health.
(j) The collaborative agreement must be effective for no more than 2 years from the date of execution. At the end of the 2-year period, or sooner, the parties shall review the collaborative agreement and make a determination as to its renewal, necessary modifications or termination.
(k) A pharmacist who is party to a collaborative agreement authorizing the management of drug therapy shall:
(1) Utilize an area for in-person, telephonic or other approved electronic consultations regarding the management of drug therapy that ensures the confidentiality of the patient information being discussed.
(2) Initiate the management of drug therapy only upon a written referral to the pharmacist from the physician. The written referral must include the minimum frequency in which the pharmacist shall conduct the management of the drug therapy in person.
(3) Confirm that the physician who is a party to the collaborative agreement holds an active and unrestricted license and that the terms of the collaborative agreement are within the scope of the physician's current practice at the time of the execution of the collaborative agreement.
(l) Patient records regarding the management of drug therapy may be maintained in a computerized recordkeeping system which meets the requirements for Federal and State-certified electronic health care records, subject to the following:
(1) The pharmacist who is a party to the collaborative agreement shall have access to the records of the patient who is the recipient of the management of drug therapy.
(2) The physician who is a party to the collaborative agreement shall have access to the pharmacy records of the patient who is the recipient of the management of drug therapy.
(3) The handling of patient records by the pharmacist providing the management of drug therapy shall comply with the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191, 110 Stat. 1936), the Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5, Div. A, Title XIII, Div. B, Title IV, 123 Stat. 226, 467), and associated rules and regulations.
PROFESSIONAL LIABILITY INSURANCE § 27.311. Certification of professional liability insurance—written protocol.
(a) A licensee who engages in management of drug therapy under a written protocol shall maintain professional liability insurance in the minimum amount of $1 million per occurrence or claims made. The Board will accept from a licensee as satisfactory evidence of insurance coverage any of the following:
(1) Personally purchased professional liability insurance.
(2) Professional liability insurance coverage provided by the individual licensee's employer.
(3) Similar insurance coverage acceptable to the Board.
(b) A licensee who engages in management of drug therapy under a written protocol shall certify compliance with subsection (a) on a form available from the Board. The licensee shall submit the completed certification form to the Board with the written protocol.
(c) A licensee who engages in management of drug therapy under a written protocol shall, upon request, make available to the Board or its agents a certificate of insurance regarding the licensee's maintenance of professional liability insurance.
(d) Failure to maintain insurance coverage as required under the act and this section will subject the licensee to disciplinary action under section 5(a)(6) of the act (63 P. S. § 390-5(a)(6)).
§ 27.312. Certification of professional liability insurance—collaborative agreement.
(a) A licensee who is a party to a collaborative agreement authorizing the management of drug therapy shall obtain and maintain a level of professional liability insurance coverage in the minimum amount of $1 million per occurrence or claims made. The Board will accept from a licensee as satisfactory evidence of insurance coverage any of the following:
(1) Personally purchased liability insurance.
(2) Professional liability insurance coverage provided by the individual licensee's employer.
(3) Similar insurance coverage acceptable to the Board.
(b) A licensee who engages in the management of drug therapy under a collaborative agreement shall provide an affidavit to the Board that the licensee has obtained professional liability insurance in accordance with subsection (a) on a form available from the Board. The licensee shall submit the completed affidavit form to the Board with the collaborative agreement.
(c) A licensee who engages in the management of drug therapy under a collaborative agreement shall, upon request, make available to the Board or its agents a certificate of insurance regarding the licensee's maintenance of professional liability insurance.
(d) Failure to maintain insurance coverage as required under the act and this section will subject the licensee to disciplinary action under section 5(a)(6) of the act (63 P. S. § 390-5(a)(6).
[Pa.B. Doc. No. 15-1536. Filed for public inspection August 21, 2015, 9:00 a.m.]
