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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEOn March 29, 2006, Vermont Governor James Douglas signed H 237. The bill, authored by Representative Harry Chen (D), a physician, allows a pharmacist to dispense emergency contraception under a protocol with a physician or other prescriber. An age restriction was discussed in the House Human Services committee hearing but was not included in the final bill. The Vermont Medical Society supported the bill, and Right to Life Vermont did not fight it. Representative Chen introduced a similar bill in the 2003-2004 Legislature, H 552, but the bill was not heard in the legislative session and quietly faded. After the August 2006 FDA ruling that allowed EC to be “over the counter”, it was determined that going forward with collaborative practice was still beneficial for Vermont women as some women still require a prescription despite over-the-counter status. The VT Department of Health led the rule making process which included a notice and public comment period. Final rules were submitted to the Vermont Legislative Committee on Administrative Rules (LCAR) and in late May 2007 LCAR approved the final EC-CP rules, effective June 25th. In June 2007, the Pharmacy Board approved a training for pharmacists, which meets the statutory requirement for pharmacists to complete before entering into the collaborative practice agreement. EC is also always available at Planned Parenthood Health Centers and at many pharmacies with a medical prescription. The first Vermont EC-CP training is scheduled for September 30th, 2007 in Burlington. The training, sponsored by the Vermont Pharmacists’ Association, will be led by Don Downing, a nationally recognized trainer on this subject. After attending this comprehensive EC training, pharmacists will be able to begin dispensing EC through a Collaborative Practice Agreement. The VT Department of Health, the VT Network against Domestic and Sexual Violence and Planned Parenthood of Northern New England (PPNNE) have provided information and resources for this training and sustained public awareness of EC and EC-CP. The University of Vermont Women’s Health Center has been an advocate for student access to EC.
CONTACTSJames Marmar, R.Ph. Emily Blistein Sally Kerschner Sarah Kenney
USEFUL LINKSVermont Board of Pharmacy The Vermont Legislature Planned Parenthood of Northern New England
PROTOCOL ENVIRONMENTOptimal Environment: No Revision to Authority Necessary Existing statutes and regulations would accommodate pharmacists’ initiation of emergency contraception, generally under a collaborative practice agreement (protocol) with a prescriber. Pharmacist initiation of EC requires:
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. VERMONT Board of pharmacy rules, but not the statute, define the practice of pharmacy to include drug administration, by any route of delivery, along with management of drug therapy. One or more pharmacists practicing in any setting may implement collaborative practice with one or more practitioners under written protocol prepared by the practitioners. In an institutional setting, the protocol is approved by the medical staff of the institution. The scope of practice is outlined in protocol and authorizes interpretation, evaluation and dispensing of prescription drugs or drug order, “management of drug therapy,” and the provision of information, but initiation of drug therapy is not authorized. Additionally, institutional pharmacists “may adjust medication doses if the order is part of a . . . protocol that has been approved by the medical staff of the institution.” There is no limitation on disease state management opportunities, nor any specific training, record-keeping or notification requirements related to administration. Statutory authority is defined within “practice of pharmacy” as the responsibility for advising, where necessary or where regulated, of therapeutic values, content, hazards and use of drugs or devices. Regulatory authority is defined through “drug therapy” and “scope of practice” that include provisions regarding drug therapy and collaboration. Statutory authority: Provided generally in definition of practice of pharmacy, Vt. Stat. Ann. Tit.26 § 2022(13-14) Regulatory authority: Provided in sections governing definitions, scope of practice, and under physician’s orders and related definitions, Vt. Code R. Sections 8, 14 and 19
VERMONT STATUTE VERMONT PHARMACY PRACTICE ACT 1897. 2022. Definitions … (13) “Practice of pharmacy” shall mean the interpretation and evaluation of prescription orders; the compounding, dispensing, labeling of drugs and devices (except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices); the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records therefor; the responsibility for advising, where necessary or where regulated, of therapeutic values, content, hazards and use of drugs and devices; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy. No rule shall be adopted by the board under this chapter that shall require the sale and distribution of nonprescription drugs by a licensed pharmacist or under the supervision of a licensed pharmacist or otherwise interfere with the sale and distribution of such medicines. (14) “Practitioner” shall mean a physician, dentist, nurse, veterinarian, scientific investigator or other person (other than pharmacists) licensed by this state or adjoining states or the province of Quebec and permitted by such license to dispense, conduct research with respect to or administer drugs in the course of professional practice or research in their respective state or province.
VERMONT REGULATIONS VERMONT BOARD OF PHARMACY REGULATIONS 04.OFFICE OF SECRETARY OF STATE 030.OFFICE OF PROFESSIONAL REGULATION 230. BOARD OF PHARMACY RULES Section 8. Abbreviations and Definitions 8.2.1 “Administer” means the direct application of a Drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means. … 8.2.5 “Collaborative Pharmacy Practice” is that Practice of Pharmacy whereby one or more Pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or more Practitioners under protocol whereby the Pharmacist may perform certain patient care functions authorized by the Practitioner or Practitioners under certain specified conditions and/or limitations. … 8.2.36 “Prescription Drug Order” means a lawful order from a Practitioner for a Drug or Device for a specific patient, including orders derived from Collaborative Pharmacy Practice, that is communicated directly to a Pharmacist in a licensed Pharmacy. … 8.2.27. Pharmaceutical care: Provision of drug therapy and other pharmaceutical patient care services intended to achiever outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. Section 19. Scope of Practice Pharmacy is that profession which is concerned with the art and science of preparing, from natural and synthetic sources, suitable and convenient materials for distribution and use in the treatment and prevention of disease. It embraces a knowledge of the identification, selection, preparation, preservation, combination, analysis, standardization of pharmacologic action, and therapeutic use of drugs and medicines. It also embraces the interpretation, evaluation, and dispensing of prescription drugs of drug orders in the patient's best interest; participation in drug and device selection, drug administration, drug regimen reviews and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for compounding and labeling of drugs and devices, proper and safe storage of drugs and devices and maintenance of proper records for them. It includes the management of drug therapy in collaboration with health care providers responsible for patient care and the research, consultation, selection of drugs under protocol, and recommendation or provision of information necessary for drug therapy. Section 14. Physician's Orders Drugs may be dispensed from the institutional pharmacy if: 14.1.1. Ordered by an authorized physician; 14.1.2. The drug order includes the name and location of the patient, name and dosage of the drug, directions for use, date of order, and signature of the physician or his or her authorized designee; 14.1.3. Telephone or verbal orders are taken only by a pharmacist, registered nurse, or licensed practical nurse, transcribed into the patient record, noted as a telephone or verbal order, and countersigned by the attending physician within 72 hours. The authority to receive telephone or verbal orders must be officially granted in the institution's rules and regulations or medical staff bylaws. A telephone or verbal order is a valid order when reduced to writing in the patient's medical record by the pharmacist, nurse, or other practitioner and may be regarded by nurses, or others as a valid order to be executed as if it had been written directly in the medical record by the prescriber. No telephone or verbal order may be transmitted to a third party to be recorded in the medical record by the third party. 14.1.4. All abbreviations and symbols used in written orders are approved for use by the institution. 14.1.5. Pharmacists may adjust medication doses if the order is part of a medication or dosing protocol that has been approved by the medical staff of the institution. This section should not be construed as giving prescribing privileges to pharmacists.
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