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EC PHARMACY UPDATEThere is currently no known activity promoting direct pharmacy access to EC. The Clara Bell Duvall Project of the ACLU, the Pennsylvania Coalition Against Rape (PCAR) and the Pennsylvania Pharmacists Association worked together to develop a 1.5 hour CE program on EC at the PA Pharmacists Association annual conference in July 2004. In addition, the advocates offered to write an article on EC for their bimonthly pharmacy journal. In the coming year, the Duvall Project plans to work with the PCAR to help build linkages between pharmacists and coalitions against rape to help ensure that pharmacies carry dedicated EC products and to increase pharmacist awareness and sensitivity around issues of EC and rape victims. The Pennsylvania Pharmacists Association believes that increasing pharmacist awareness of EC is the most important strategy for increasing access to EC at the moment. The Duvall Project has also been very active on other EC issues. The Pennsylvania Coalition to Prevent Teen Pregnancy (PCPTP) is training school nurses about EC with a grant they received from Advocates for Youth. PCPTP is also surveying Pennsylvania school nurses to measure their knowledge, attitudes, and school policies concerning EC and contraception in general. State funded family planning clinics are distributing EC prophylactically to family planning clients. The Family Planning Council is also involved in research funded by the National Institute of Child Health and Human Development (NICHD), comparing clinics that give EC proactively and those that do not. Wendy Bennet, MD, MPH conducted a survey (PDF-16K) of 320 pharmacists in Pennsylvania to determine the knowledge and attitudes of pharmacists about emergency contraction and to determine the percentage of pharmacists able and willing to dispense EC. The findings suggest there was a positive association between knowledge about EC and stocking it and encouraged targeting EC educational campaigns toward the pharmacy community.
CONTACTSPatricia Epple Carol Petraitis Joe Fay Dorothy Mann
USEFUL LINKSPennsylvania State Board of Pharmacy Pennsylvania Pharmacists Association Pennsylvania General Assembly Pennsylvania Coalition Against Rape Maternal and Family Health Services Family Health Council of Central Pennsylvania Family Health Council, Inc. Planned Parenthood Association of Bucks County Planned Parenthood of the Susquehanna Valley Planned Parenthood of Southeastern Pennsylvania Planned Parenthood of Western Pennsylvania Planned Parenthood of North East Pennsylvania Planned Parenthood of Chester County Planned Parenthood of Central Pennsylvania Pennsylvania NARAL Family Planning Council
PROTOCOL ENVIRONMENTPossible Environment: Revision to Existing Authority Required This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community. Pharmacist initiation of EC would require:
PHARMACY PRACTICE ACTPharmacy Practice Act Regulatory and Statutory Authority Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003. PENNSYLVANIA Under amendments to the Pharmacy Practice Act adopted in June 2002, pharmacists serving patients in institutional settings may now enter into a patient-specific written agreement or protocol for the management of drug therapy as authorized by the physician. The protocol is effective for two years. The pharmacist is required to obtain and maintain professional liability insurance coverage that is satisfactory to the board of in the minimum amount of one million dollars per occurrence or claim made. Regulations are to be adopted by the Board within 18 months that establish requirements for written protocols to include:
Management of drug therapy may occur without these requirements if the medical staff of the institution approves the managing protocol. Statutory authority: Provided in the newly amended Pharmacy Act through definitions for practice of pharmacy, managing drug therapy, institution, drug administration, and protocol; and through separate sections on drug therapy protocols and authority to administer injectable medications, Pa. Cons. Stat. § x Act No. 102 (June 29, 2002) Regulatory authority: Not yet promulgated
PENNSYLVANIA STATUTE Approved by the Governor, June 29, 2002 Act No. 102 House Bill No. 751 Session 2001 AN ACT - Amending the act of September 27, 1961 (P.L.1700, No.699),entitled “An act relating to the regulation of the practice of pharmacy, including the sales, use and distribution of drugs and devices at retail; and amending, revising, consolidating and repealing certain laws relating thereto,” further providing for definitions; and providing for drug therapy protocol. * * * (11) “Practice of pharmacy” means the [practice of that profession concerned with the art and science of the evaluation of prescription orders and the preparing, compounding and dispensing of drugs and devices, whether dispensed on the prescription of a medical practitioner or legally dispensed or provided to a consumer, and shall include the proper and safe storage and distribution of drugs, the maintenance of proper records, the participation in drug selection and drug utilization reviews, and the responsibility of relating information as required concerning such drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease:] provision of health care services by a pharmacist, which includes the interpretation, evaluation and implementation of medical orders for the provision of pharmacy services or prescription drug orders; the delivery, dispensing or distribution of prescription drugs; participation in drug and device selection; drug administration; drug regimen review; drug or drug-related research; compounding; proper and safe storage of drugs and devices; managing drug therapy in an institutional setting consistent with the institution's assignment of clinical duties; maintaining proper records; patient counseling; and such acts, services, operations or transactions necessary or incident to the provision of these health care services. [Provided, however, That] The “practice of pharmacy” shall not include the operations of a manufacturer or distributor as defined in “The Controlled Substance, Drug, Device and Cosmetic Act.” * * * (14) “Managing drug therapy” means any of the following processes which shall be performed in an institutional setting only: Adjusting a drug regimen; adjusting drug strength, frequency of administration or route; administration of drugs; and 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. Managing drug therapy shall be performed pursuant to a written agreement or protocol as set forth in section 9.1 of this act. (15) “Institution” means a health care facility as defined in section 103 of the act of July 19, 1979 (P.L.130, No.48), known as the “Health Care Facilities Act,” which offers care and medical treatment to patients who require food, board and overnight sleeping facilities (16) “Drug administration” means the direct introduction of or the application of a drug into or on the body of a patient by injection, inhalation, ingestion or any other means, and where required by law, shall occur only pursuant to a medical order. … (18) “Protocol” means a written document that describes the nature and scope of the drug therapy management to be carried out by the pharmacist. Section 2. The act is amended by adding sections to read: Section 9.1. Drug Therapy Protocols.— (a) A pharmacist shall be permitted to enter into a written agreement or protocol with a licensed physician authorizing the delegation of the management of drug therapy in an institutional setting (b) The licensed physician who is a party to a written agreement or protocol authorizing the delegation of the management of drug therapy shall be in active practice and the delegation written agreement or protocol shall be within the scope of the licensed physician's current practice. (c) Participation in a written agreement or protocol authorizing the delegation of the management of drug therapy shall be voluntary, and no licensed physician, pharmacist or institution shall be required to participate. (d)
(e) Within eighteen months of the effective date of this section, the board shall adopt regulations establishing the parameters of written agreements or protocols authorized by this section. Such parameters shall include, but not be limited to, the requirement that written agreements or protocols:
(f) Managing drug therapy within an institutional setting may occur without the requirements of subsection (e) provided it is pursuant to a medical order by a licensed physician for managing drug therapy protocol or guideline approved by the medical staff of the institution. TITLE 63. PROFESSIONS AND OCCUPATIONS (STATE LICENSED) CHAPTER 11. PHARMACISTS PHARMACY ACT Section 390- 9.2. Authority to Administer Injectable Medications, Biologicals and Immunizations.— (a) Within eighteen months from the effective date of this section, the board shall by regulation establish education and training standards and practice guidelines pursuant to which pharmacists shall be authorized to administer injectable medications, biologicals and immunizations to persons who are more than eighteen years of age. Such standards and guidelines shall include, but not be limited to, the following:
(b) A pharmacist's authority to administer injectable medications, biologicals and immunizations shall not be delegated to any other person. Section 3. This act shall take effect in 60 days.
PENNSYLVANIA REGULATIONS Not yet promulgated
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