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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEA survey of 41 Richmond-area pharmacies was conducted by the Virginia League for Planned Parenthood as part of the 2005 Back Up Your Birth Control Day. Results showed that 70% of the pharmacies stocked EC. The survey included chain and independent pharmacies, as well as pharmacies in discount department stores and grocery stores. Planned Parenthood found that in some cases, stocking was a corporate decision. In other cases, pharmacies did not stock EC because of lack of demand. During the 2004 session the state House approved a bill (HB 1414) sponsored by Robert Marshall (R) that prohibited (PDF-90K) student health centers at state colleges and universities from dispensing EC, but ultimately the bill died. Access to EC drew state and national attention around James Madison University’s Board of Visitors decision to stop dispensing EC at the campus health center in April 2003. The Attorney General, Jerry Kilgore, issued a statement (PDF-116K) in May 2003 that dispensing EC by a university health clinic does not violate Virginia’s informed consent abortion law, which requires women to wait 24 hours before having an abortion. This ruling reinforced the distinction that EC is not considered an abortion but is understood to prevent pregnancy. Other universities in the state including Old Dominion University, The University of Virginia, and the College of William and Mary continued to distribute EC. The James Madison University's Board of Visitors voted on January 9, 2004 to reverse (PDF-24KB) its earlier ban and now permit campus health centers to dispense EC. In 2003 a resolution (HB 611) was introduced that urged hospitals, health care facilities, health care providers, pharmacists, and pharmacies in the Commonwealth to provide patients and the public with complete, accurate, and objective information about the full range of contraceptives, including emergency contraception, to enable women to make responsible and informed health care decisions. The resolution was left in the House committee. A proactive stance to formally differentiate between contraception and abortion was taken in 2003 with a bill entitled the Family Planning Protection Act, SN1104. The bill stated that contraception, including EC, does not constitute abortion. It passed the Senate, went to the Health Committee of the House, and ultimately did not pass in a tie vote in the House Courts of Justice Committee. In 2002 a bill, HB 1741, was introduced to amend the existing conscience clause to specify the inclusion of pharmacists and contraceptive pills. This bill specified that pharmacists could refuse to dispense any contraception that they felt caused abortion. The bill was approved in the House of Delegates but ultimately defeated by the Senate Education and Health Committee. In 2001 HB 2782, sponsored by Planned Parenthood, was introduced to give prescribers the opportunity to dispense EC. In addition, it allowed pharmacists to prescribe and dispense EC under a protocol issued by a prescriber and approved by the Board of Medicine. The bill came within one vote but was killed in the House. In 2002, the bill was reintroduced, but also died in the House. In 2001 the Virginia Pharmacists Association (VPhA) did not have policy in favor of EC, but they did not oppose. In late 2001 VPhA House of Delegates voted in support of voluntary access to EC. In 2002 VPhA was more actively involved in supporting EC pharmacy legislation. VPhA is currently beginning to address this issue and educate others as a public health issue. The VA Department of Health requires all health districts to provide and dispense EC to their own patients and they sometimes also provide EC to the community at large. For press coverage in this state, click here.
CONTACTSRebecca Snead, RPh Barbara E. Parker, RN, MPH Mira Signer
USEFUL LINKSVirginia Board of Pharmacy Virginia Pharmacists Association Virginia General Assembly Planned Parenthood of Virginia Planned Parenthood Advocates of Virginia DC Campaign to Prevent Teen Pregnancy Planned Parenthood of Southeastern Virginia Virginia League for Planned Parenthood Planned Parenthood of the Blue Ridge Planned Parenthood of Metropolitan Washington NARAL Pro-Choice Virginia
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. VIRGINIA Pharmacists practicing in any setting may participate in collaborative practice under patient-specific written agreements or protocols approved by the physician. The practitioner must initiate implementation of collaborative drug therapy through an order for the individual patient. Pharmacist initiation of drug therapy is not allowed. The protocol requires patient consent and is valid for two years. The protocol agreement, physician orders and patient consent form must be kept by the pharmacist with a copy of the medical record. The pharmacist and the physician may both designate alternates to the agreement. The Boards of Medicine and Pharmacy must approve the protocol no protocol exists that is clinically accepted as the standard of care to manage or treat a condition or disease state in that facility. A collaborative agreement is not required for management of patients of an inpatient facility. The scope of practice is defined within the protocol to include:
There is no limitation on disease state management opportunities. The order, protocol and consent form must be added to the patient’s record. Authority to participate in collaborative practice expires on July 1, 2004 unless extended by the legislature. A separate section governing professional use by practitioners authorizes pharmacists to initiate and administer immunizations to adults, via any route of delivery, pursuant to a protocol approved by the Board of Nursing Statutory authority: Provided in sections establishing and governing collaborative practice authority and related definitions, VA Code Ann. § 54.1-3300, 3300, 3320, 3408 Regulatory authority: Provided in joint regulations establishing collaborative practice authority, 18 Va. Admin. Code §110-20-270, §110-40-10 et.seq.
VIRGINIA STATUTE CODE OF VIRGINIA Title 54.1 SUBTITLE I.- GENERAL PROVISIONS RELATING TO REGULATORY BOARDS. Chapter 33. - Pharmacy. Article 1. -General Provisions. § 54.1-3300. (Effective until July 1, 2004) Definitions. “Collaborative agreement” means a voluntary, written arrangement between one pharmacist and his designated alternate pharmacists involved directly in patient care at a location where patients receive services and a practitioner of medicine, osteopathy, or podiatry and his designated alternate practitioners involved directly in patient care which authorizes cooperative procedures with respect to patients of such practitioners. Collaborative procedures shall be related to treatment using drug therapy, laboratory tests or medical devices, under defined conditions or limitations, for the purpose of improving patient outcomes. A collaborative agreement is not required for the management of patients of an inpatient facility. * * * “Practice of pharmacy” means the personal health service that is concerned with the art and science of selecting, procuring, recommending, administering, preparing, compounding, packaging and dispensing of drugs, medicines and devices used in the diagnosis, treatment, or prevention of disease, whether compounded or dispensed on a prescription or otherwise legally dispensed or distributed, and shall include the proper and safe storage and distribution of drugs; the maintenance of proper records; the responsibility of providing information concerning drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease; and the management of patient care under the terms of a collaborative agreement as defined in this section. § 54.1-3300. (Effective July 1, 2004) Definitions As used in this chapter, unless the context requires a different meaning: “Dispense” means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for delivery. * * * “Practice of pharmacy” means the personal health service that is concerned with the art and science of selecting, procuring, recommending, administering, preparing, compounding, packaging and dispensing of drugs, medicines and devices used in the diagnosis, treatment, or prevention of disease, whether compounded or dispensed on a prescription or otherwise legally dispensed or distributed, and shall include the proper and safe storage and distribution of drugs, the maintenance of proper records and the responsibility of providing information concerning drugs and medicines and their therapeutic values and uses in the treatment and prevention of disease. § 54.1-3300.1. (Effective until July 1, 2004) Participation in collaborative agreements; regulations to be promulgated by the Boards of Medicine and Pharmacy. A pharmacist and his designated alternate pharmacists involved directly in patient care may participate with a practitioner of medicine, osteopathy, or podiatry and his designated alternate practitioners involved directly in patient care in collaborative agreements which authorize cooperative procedures related to treatment using drug therapy, laboratory tests or medical devices, under defined conditions and/or limitations, for the purpose of improving patient outcomes. No patient shall be required to participate in a collaborative procedure without such patient's consent. Collaborative agreements may include the modification, continuation or discontinuation of drug therapy pursuant to written, patient-specific protocols; the ordering of laboratory tests; or other patient care management measures related to monitoring or improving the outcomes of drug or device therapy. No such collaborative agreement shall exceed the scope of practice of the respective parties. Any pharmacist who deviates from or practices in a manner inconsistent with the terms of a collaborative agreement shall be in violation of § 54.1-2902; such violation shall constitute grounds for disciplinary action pursuant to §§ 54.1-2400 and 54.1-3316. Collaborative agreements may only be used for conditions which have protocols that are clinically accepted as the standard of care, or are approved by the Boards of Medicine and Pharmacy. The Boards of Medicine and Pharmacy shall jointly develop and promulgate regulations to implement the provisions of this section and to facilitate the development and implementation of safe and effective collaborative agreements between the appropriate practitioners and pharmacists. The regulations shall include guidelines concerning the use of protocols, and a procedure to allow for the approval or disapproval of specific protocols by the Boards of Medicine and Pharmacy if review is requested by a practitioner or pharmacist. Nothing in this section shall be construed to supersede the provisions of § 54.1-3303. § 54.1-3307.2. Approval of innovative programs. A. Any person who proposes to use a process or procedure related to the dispensing of drugs or devices or to the practice of pharmacy not specifically authorized by Chapter 33 (§ 54.1-3300 et seq.) of this title or by a regulation of the Board of Pharmacy may apply to the Board for approval to use such process or procedure. The application under this section may only include new processes or procedures, within the current scope of the practice of pharmacy, that relate to the form or format of prescriptions, the manner of transmitting prescriptions or prescription information, the manner of required recordkeeping, the use of unlicensed ancillary personnel in the dispensing process, and the use of new technologies in the dispensing process. The authority granted the Board under this section shall not authorize expansion of the current scope of practice for pharmacists and shall not interfere with the requirement that pharmacists only dispense drugs in accordance with instructions from a prescriber, as defined in § 54.1-3401. B. The application to the Board shall address safety to the public regarding the new process or procedure, any potential benefit to the public, promotion of scientific or technical advances in the practice of pharmacy, compliance with prescriber's instructions for any drug dispensed, any impact the new process may have on the potential for diversion of drugs, maintenance in the integrity of and public confidence in the profession of pharmacy and of the drugs dispensed, impact on cost to the public and within the health care industry, means of monitoring the new process or procedure for any negative outcomes or other problems, and the reporting of such outcomes to the Board. C. An informal conference committee, composed of not less than two members of the Board and in accordance with § 2.2-4019, shall receive and review the application and any investigative report requested by the committee. The committee shall have the authority to grant or deny approval of the request. The committee may grant approval of the request unconditionally or may impose conditions on the approval as follows:
D. If an applicant does not agree with the decision of the committee, the applicant may request a hearing before the Board or a panel of the Board, in accordance with § 2.2-4020. E. Application under this section shall be on a form provided by the Board and shall be accompanied by a fee determined by the Board. (2000, c. 876.) § 54.1-3320. Acts restricted to pharmacists. A. Within the practice of pharmacy as defined in § 54.1-3300, the following acts shall be performed by pharmacists, except as provided in subsection B:
B. A pharmacy intern may engage in the acts to be performed only by a pharmacist as set forth in subsection A for the purpose of obtaining practical experience required for licensure as a pharmacist, if the supervising pharmacist is directly monitoring these activities. C. Consistent with patient safety, a pharmacist shall exercise sole authority in determining the maximum number of pharmacy technicians that he shall supervise; however, no pharmacist shall supervise more than four pharmacy technicians at one time. (2001, c. 317.)
VIRGINIA REGULATIONS VIRGINIA PHARMACY PRACTICE REGULATIONS 18 VAC 110-20-10 et seq. PART I. General Provisions 18 VAC 110-20-270. Dispensing of prescriptions; acts restricted to pharmacists; certification of completed prescriptions. A. Te following acts shall be performed by a pharmacist, or by a pharmacy intern, provided a method for direct monitoring by the pharmacist of such acts is provided:
Regulations Of The Joint Boards Of Pharmacy And Medicine VAC 110-40-10. et. seq. Regulations Governing Collaborative Practice Agreements 18 VAC 110-40-10. Definitions. “Agreement” means a collaborative practice agreement by which practitioners of medicine, osteopathy or podiatry and pharmacists enter into voluntary, written agreements to improve outcomes for their mutual patients using drug therapies, laboratory tests, and medical devices, pursuant to the provisions of § 54.1-3300.1 of the Code of Virginia. * * * “Committee” means an Informal Conference Committee, comprised of two members of the Board of Pharmacy and two members of the Board of Medicine. * * * “Pharmacist” means a pharmacist who holds an active license to practice pharmacy from the Virginia Board of Pharmacy and who is a signatory to a collaborative practice agreement. “Practitioner” means, notwithstanding the definition in § 54.1-3401 of the Code of Virginia, a doctor of medicine, osteopathy, or podiatry who writes the order and is directly and ultimately responsible for the care of a patient being treated under an agreement and who holds an active license to practice from the Virginia Board of Medicine. 18 VAC 110-40-20. Signed authorization for an agreement. A. The signatories to an agreement shall be a practitioner of medicine, osteopathy, or podiatry involved directly in patient care and a pharmacist involved directly in patient care. The practitioner may designate alternate practitioners, and the pharmacist may designate alternate pharmacists, provided the alternates are also signatories to the agreement and are involved directly in patient care at a location where patients regularly receive services. B. An agreement shall only be implemented for an individual patient pursuant to an order from the practitioner for that patient and only after written informed consent from the patient has been obtained by the practitioner who authorizes the patient to participate in the agreement. A copy of the informed written consent from the patient shall be provided to the pharmacist.
18 VAC 110-40-30. Approval of protocols. A. If a practitioner and a pharmacist intend to manage or treat a condition or disease state for which there is not a protocol that is clinically accepted as the standard of care, the practitioner and pharmacist shall submit a proposed protocol for approval. The committee shall, in accordance with § 9-6.14:11 of the Code of Virginia, receive and review the proposed treatment protocol and recommend approval or disapproval to the boards. B. For a proposed treatment protocol in which practitioner oversight increases from that which is the accepted standard of care, approval by the committee is not required. C. In order to request a protocol review by the committee, the practitioner and the pharmacist shall submit:
VAC 110-40-40. Content of an agreement and treatment protocol. A. An agreement shall contain treatment protocols that are clinically accepted as the standard of care within the medical and pharmaceutical professions. B. The treatment protocol shall describe the disease state or condition, drugs or drug categories, drug therapies, laboratory tests, medical devices, and substitutions authorized by the practitioner. C. The treatment protocol shall contain a statement by the practitioner that describes the activities the pharmacist is authorized to engage in, including:
D. An agreement shall be valid for a period not to exceed two years. The signatories shall implement a procedure for reviewing and, if necessary, revising the procedures and protocols of a collaborative agreement at least every two years. 18 VAC 110-40-50. Record retention. A. Signatories to an agreement shall keep a copy of the agreement on file at their primary places of practice. B. An order for a specific patient from the prescribing practitioner authorizing the implementation of drug therapy management pursuant to the agreement shall be noted in the patient’s medical record and kept on file by the pharmacist. C. A copy of the informed written consent from the patient shall be maintained in the patient’s medical record and kept on file along with the practitioner’s order by the pharmacist in a readily retrievable manner. 18 VAC 110-40-60. Rescindment or alteration of the agreement. A. A signatory may rescind or a patient may withdraw from an agreement at any time. B. A practitioner may override the collaborative agreement whenever he deems such action necessary or appropriate for a specific patient. 18 VAC 110-40-70. Compliance with statutes and regulations. Any collaborative agreement or referral under an agreement governed by this chapter shall be in compliance with the requirements of the Practitioner Self-Referral Act (§ 54.1-2410 et seq. of the Code of Virginia) and with Chapters 29 (§ 54.1-2900 et seq.), 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and regulations promulgated pursuant thereto. Effective 1/17/2001
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