|
||||||||||||||||||
| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
 |
|
|||||||
|
EC PHARMACY UPDATEIn February 2005, EC pharmacy access bills, SB 541 and HB 1145, were introduced in the Maryland Legislature. SB 541 was approved in the Senate Education Health and Environmental Affairs Committee with amendments, but did not pass in the Senate in a close vote. A few legislators cited access to EC to young teens as the concern. In January 2006, Senator Sharon Grosfeld (D) introduced SB 297 and Delegate James Hubbard (D) introduced HB 828 in February 2006 again to authorize licensed pharmacists to dispense EC to women who do not have an advance prescription. Several EC pharmacy access bills were introduced in the 2004 Maryland Legislature. Two bills, HB 203 and SB 247, allowed pharmacists to provide EC under a protocol with a physician. Two others, HB 204 and SB 248, allowed pharmacy access to EC by setting up an emergency contraception dispensing program in the Department of Health and Mental Hygiene. A similar program exists in the DHMH where pharmacists may administer epinephrine for bee stings. SB 247 and SB 248 were heard in the Senate Committee on Education, Health and Environmental Affairs where the Maryland Pharmacists Society and Planned Parenthood of Maryland testified in support. In spite of over 30 sponsors for each bill, the two bills died upon the adjournment of the legislative session. In 2003, EC pharmacy access bills HB 615 and SB 354 were introduced. The House bill passed by one vote but it failed in the Senate Committee. The position of the Governor on EC pharmacy access is unknown. The Department of Health did not have a position on the 2003 bills. On June 9, 2003 the Maryland Pharmacists Association adopted a resolution (DOC-20K) on EC supporting voluntary expanded access through pharmacist/physician protocols. A number of local and national groups supported the proposed pharmacy access legislation including American Civil Liberties Union (ACLU), American Academy of Pediatrics, Maryland Chapter Sierra Club, Planned Parenthood of Maryland, Planned Parenthood of Metro DC, National Abortion Rights Action League (NARAL), Alan Guttmacher Institute (AGI), Reproductive Health Technologies Project (RHTP), and Maryland Coalition Against Sexual Assault (MCASA). The State Medical Society chose not to take a position on the bill. In 2001/2002 a bill mandating provision of EC in hospital emergency rooms was introduced but did not make it out of committee. As an issue, EC has been fairly visible in the state. Foundations have provided funding for marketing EC and advertising Maryland’s EC Hotline. Maryland launched a large EC awareness campaign. Part of the outreach campaign, designed by Miles Ahead Marketing, was a grassroots effort in local neighborhoods. There were radio ads on morning radio, posters, billboards, wallet cards, nail files, pens, mirrors, coasters and magnets. Outreach occurred in convenience stores, liquor stores, hair salons, laundromats, bathrooms, restaurants, bars, and clubs. University Reporter, a paper serving 30 colleges ran EC ads. Publicly funded family planning clinics in Maryland provide Plan B to clients in need of emergency contraception. The Maryland State Family Planning Program Clinical Guidelines were amended on October 2003 with an addendum that specifically stated that both Plan B tablets should be taken at the same time and that the time limit was extended to 120 hours. EC is covered in two pharmacy classes at the University of Maryland School of Pharmacy. The Association of Reproductive Health Professionals (ARHP) provided training on EC for medical audiences and Planned Parenthood provided some training at grand rounds upon request. For press coverage in this state, click here.
CONTACTSVirginia Ginger Apyar, R.Ph. Jennifer Lee, CNM, MSN Howard Schiff, R.Ph. Wendy Royalty, MSW Kathy Rogers, MPH, MD Cathy Allen
USEFUL LINKSMaryland Board of Pharmacy Maryland Pharmacists Association Maryland General Assembly Maryland Center for Maternal and Child Health Planned Parenthood of Maryland Planned Parenthood of Metropolitan Washington NARAL Pro-Choice Maryland
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. MARYLAND Under authority established by legislation passed in 2002, a pharmacist practicing in any setting may enter into a “physician-pharmacist agreement” with an individual physician that is patient and disease-state specific, specifies the protocols to be used, demonstrates that the parties have “adequate training,” and has been approved by the Board of Pharmacy and the Board of Physician Quality Assurance. Such agreements are valid for a maximum of two years and must be renewed annually. Upon this approval, the pharmacist and physician may enter into a Therapy Management Contract that is patient-specific and:
The pharmacists must have a PharmD or equivalent training established in regulations. The physician must maintain the patient record, and the pharmacist must update the record in a “timely manner” as provided for in the physician-pharmacist agreement. The contract is good for one year. Pharmacists working in institutional facilities (not including nursing homes) do not require a contract for management of patients. This law became effective on October 1, 2002 and expires on May 31, 2008. The Board of Pharmacy and the Board of Physician Quality Assurance must report to Governor on its effect by October 1, 2006. Also, the Department of Health and Mental Hygiene must conduct a study on the outcomes achieved by drug therapy agreements. Finally, current law does not authorize pharmacists to administer immunizations or any other drug, such as contraceptives. Draft Collaborative Practice Regulations The law also required the Board of Pharmacy and the Board of Physician Quality Assurance to jointly develop regulations related to the criteria for the physician-pharmacist agreements, and guidelines for the use, approval, modification, continuation and disapproval of protocols. On August 23, 2002 the two Boards published a very complex, 19-page draft regulation implementing this collaborative practice authority. The Boards received significant public comment and expect to move forward with finalizing the regulations. As of June 15, 2003, the rules were still in draft form. The draft regulations cover the following: Protocols: Must contain ten enumerated elements, and may authorize modifying or discontinuing drug therapy, ordering lab tests, and “other patient care management measures related to . . . improving outcomes. . .” Content of Physician-Pharmacist Agreements: Must contain eight enumerated elements, including protocols to be followed, documentation requirements, etc. Approval of Pharmacist: The Board has set forth significant advanced training requirements Approval of Protocol and Agreement: The Board has set forth a complex process for reviewing and approving protocols and agreements, including submission of a $300 review fee. The Board must review and approve these two documents annually, at a cost of $250 per submission. Therapy Management Contract: In addition to a written protocol and a physician-pharmacist agreement, the two practitioners must also cosign a therapy management contract with the patient which must contain several elements. Statutory authority: Provided in the subtitle on “Therapy Management Contracts,” Md. Code Ann. Health Occ. § 249-12-101, 6A Regulatory authority: Draft regulations proposed on August 2, 2002.
MARYLAND STATUTES Article - Health Occupations Section 12-6A-01 through 12-6A-10 “Subtitle 6A. Therapy Management Contracts” 12-6A-101. (a) In this title the following words have the meanings indicated. (m) “Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed. (p)(1) “Practice pharmacy” means to engage in any of the following activities:
Subtitle 6a. Therapy Management Contracts. 12-6a-01. (a) in this subtitle the following words have the meanings indicated. (b) (1) “institutional facility” means a facility other than a nursing home whose primary purpose is to provide a physical environment for patients to obtain inpatient or emergency care. (2) “institutional facility” does not include an urgent care facility that is not part of a facility. (c) “licensed physician” means an individual who is licensed to practice medicine under title 14 of this article. (d) “physician-pharmacist agreement” means an approved agreement between a licensed physician and a licensed pharmacist that is disease-state specific and specifies the protocols that may be used. (e) “protocol” means a course of treatment predetermined by the licensed physician and licensed pharmacist according to generally accepted medical practice for the proper completion of a particular therapeutic or diagnostic intervention.
12-6a-02. A therapy management contract is not required for the management of patients in an institutional facility. 12-6a-03. (a) a licensed physician and a licensed pharmacist who wish to enter into therapy management contracts shall have a physician-pharmacist agreement that is approved by the board of pharmacy and the board of physician quality assurance. (b) the board of physician quality assurance and the board of pharmacy may not approve a physician-pharmacist agreement if the boards find there is:
(c) a physician-pharmacist agreement shall be valid for 2 years from the date of its final approval by the board of physician quality assurance and the board of pharmacy unless renewed in accordance with established regulations adopted under this subtitle. 12-6a-04. A pharmacist is authorized to enter into a physician-pharmacist agreement if the pharmacist: (1) is a licensed pharmacist; (2) has a doctor of pharmacy degree or equivalent training as established in regulations adopted under this subtitle; (3) is approved by the board to enter into a physician-pharmacist agreement with a licensed physician in accordance with this subtitle; and (4) meets the requirements that are established by regulations adopted under this subtitle. 12-6a-05. (a) subject to the regulations adopted under this subtitle, a licensed pharmacist may enter into a therapy management contract initiated by a licensed physician. (b) a licensed pharmacist may not employ or provide economic incentives to a licensed physician for the purpose of entering into a physician-pharmacist agreement or a therapy management contract. 12-6a-06. (a) A protocol under this subtitle:
(b) a protocol shall prohibit the substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the physician, unless permitted in the therapy management contract. 12-6a-07. (a) a therapy management contract shall apply only to conditions for which protocols have been approved by the board of physician quality assurance and the board of pharmacy under the regulations adopted under this subtitle. (b) a therapy management contract shall terminate one year from the date of its signing, unless renewed by the licensed physician, licensed pharmacist, and patient. (c) a therapy management contract shall include:
(d) any party to the therapy management contract may terminate the contract at any time. (e) fees paid to the board of physician quality assurance and board of pharmacy related to therapy management shall be established in regulations. 12-6a-08. (a) the physician shall maintain complete patient records with respect to the therapy management contract. (b) the licensed physician's patient record shall be fully updated in writing by the licensed pharmacist in a timely manner, as provided in the physician-pharmacist agreement. 12-6a-10. (a) subject to subsection (b) of this section, the board of pharmacy, together with the board of physician quality assurance, shall jointly develop and adopt regulations to implement the provisions of this subtitle. (b) the regulations adopted under subsection (a) of this section shall include provisions that:
MARYLAND REGULATIONS In draft form as of June 15, 2003.
|
