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Home > State Profiles > Montana State Profile

Montana State Profile

EC PHARMACY UPDATE

Montana has an optimal environment for allowing pharmacists initiation of EC. A physician in Bozeman, Montana has expressed interest in entering into EC collaborative practice agreements, but no pharmacists have come forward as yet. The Montana Pharmacy Association has offered EC certification and pharmacist education, with active participation from the University of Montana, School of Pharmacy. Most family planning organizations have arrangements with local pharmacies, which dispense EC under prescriptions.

The pharmacist’s role in providing EC was featured in an article (PDF-40K) in The New Montana Pharmacist, July 2003.

General work around EC access has been grassroots and led by the State Health Department. A separate Statewide Reproductive Rights Coalition was formed around 1993, and formalized around 1998. The coalition includes: American Civil Liberties Union (ACLU), Blue Mountain Clinic, National Abortion Rights Action League NARAL Pro-Choice Montana, InterMountain Planned Parenthood, Montana Women’s Lobby, Montana Women’s Vote Project, Business & Professional Women’s (BPW), American Association of University Women (AAUW), Human Rights Network, and Working for Equality and Economic Liberation (WEEL).

The NARAL Pro-Choice Montana Foundation has worked on educational and organizing projects to encourage pharmacists to develop a collaborative agreement with a physician to dispense EC. The Foundation also works to ensure that local EC providers are listed (PDF-36K) on various websites and hotlines and to increase awareness and availability of EC through student health centers. They also have developed an EC pharmacy survey (DOC24K) and sent letters to pharmacists (DOC-28K) thanking them for stocking EC.

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CONTACTS

Jim Smith
Executive Director
Montana Pharmacy Association
34 W. 6th Street 2E
Helena, MT 59601
406-449-3843
Fax: 406-443-1592
jimesmith@mt.net
www.rxmt.org

Allyson Hagen
Executive Director
NARAL Pro-Choice Montana
P.O. Box 279
Helena, MT 59624
406-443-0276
prochoice@mt.net
www.prochoicemontana.org

Raquel Castellanos Miller
Blue Mountain Clinic
610 North California
Missoula, MT 59802
406-721-1646
raquelcm@montana.com
www.bluemountainclinic.com

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USEFUL LINKS

Montana Board of Pharmacy
www.discoveringmontana.com/dli/bsd/license/bsd_boards/pha_board/board_page.htm

Montana State Legislature
leg.state.mt.us/css/default.asp

Blue Mountain Clinic
www.bluemountainclinic.com

NARAL Pro-Choice Montana
www.prochoicemontana.org

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PROTOCOL ENVIRONMENT

Optimal 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.

Regulations would require filing a copy of the protocol with the Board of Pharmacy. Pharmacist initiation of EC requires would require development of a protocol and securing prescriber authorization.

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PHARMACY PRACTICE ACT

Pharmacy 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.

MONTANA

One or more pharmacists may enter into patient-specific “collaborative pharmacy practice agreements” with one or more prescribers to engage in “drug therapy management”, a broad term that is not defined by regulation. The agreement, which must be filed with the Board, shall set forth the types of decisions, procedures and activities the pharmacist may engage in pursuant to a protocol, including initiating or modifying drug therapy, and administering drugs, under certain conditions or limitations authorized by the prescriber. The agreement “may” also include the specific diseases and drugs involved, decision criteria and plan.

The agreement must also set forth:

  • the method for documentation, which must be completed within 24 hours and maintained for seven years
  • how feedback and adverse events will be reported to the prescriber and the way the pharmacist will be monitored, and
  • the process for obtaining patient consent.

The Board reserves the right to approve standard protocols for interested parties to use to then be placed on file.

The Board’s regulations define pharmacies in family planning clinics and similar entities as Class IV facilities which may only dispense “oral contraceptives; injectable long-term contraceptives; progestational drugs; diaphragms; contraceptive jellies; creams, and foams; IUD's; condoms; vaginal creams, ointments, and suppositories used in the routine treatment of vaginal disorders.”

Statutory authority: Provided in definitions related to collaborative and pharmacy practice, Mont Code Ann. § 37-7-101

Regulatory authority: Provided in rules governing administration of vaccines, Mont. Admin. Reg. 24.174.503, and collaborative practice, Mont. Admin. Reg. 24.174.524.

 

MONTANA STATUTE

TITLE 37. PROFESSIONS AND OCCUPATIONS

CHAPTER 7. PHARMACY

37-7-101. Definitions. As used in parts 1 through 7 of this chapter, the following definitions apply:
(1)

(a) “Administer” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means.
(b) The term does not include immunization by injection for children under 18 years of age.

(4) “Collaborative pharmacy practice” means the practice of pharmacy by a pharmacist who has agreed to work in conjunction with one or more prescribers, on a voluntary basis and under protocol, and who may perform certain patient care functions under certain specified conditions or limitations authorized by the prescriber.

(5) “Collaborative pharmacy practice agreement” means a written and signed agreement between one or more pharmacists and one or more prescribers that provides for collaborative pharmacy practice for the purpose of drug therapy management of patients.

(21) “Pharmaceutical care” means the provision of drug therapy and other patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of disease process.

(26) “Practice of pharmacy” means:

(a) interpreting, evaluating, and implementing prescriber orders;

(b) administering drugs and devices pursuant to a collaborative practice agreement
and compounding, labeling, dispensing, and distributing drugs and devices, including patient counseling;

(c) properly and safely procuring, storing, distributing, and disposing of drugs and devices and maintaining proper records;


(d) monitoring drug therapy and use;
(e) initiating or modifying drug therapy in accordance with collaborative pharmacy practice agreements established and approved by health care facilities or voluntary agreements with prescribers;
(f) participating in quality assurance and performance improvement activities;

(g) providing information on drugs, dietary supplements, and devices to patients, the public, and other health care providers; and

(h) participating in scientific or clinical research as an investigator or in collaboration with other investigators.

* * *

History: En. Sec. 2, Ch. 175, L. 1939; amd. Sec. 1, Ch. 33, L. 1951; amd. Sec. 2, Ch. 241, L. 1971; amd. Sec. 148, Ch. 350, L. 1974; amd. Sec. 1, Ch. 439, L. 1977; R.C.M. 1947, 66-1502; amd. Sec. 7, Ch. 22, L. 1979; amd. Sec. 3, Ch. 379, L. 1981; amd. Sec. 1, Ch. 247, L. 1983; amd. Sec. 1, Ch. 219, L. 1991; amd. Sec. 36, Ch. 429, L. 1995; amd. Sec. 3, Ch. 388, L. 2001; amd. Sec. 116, Ch. 483, L. 2001.

 

MONTANA REGULATIONS

Dept. of Labor and Industry

Chapter 174 - Board of Pharmacy

24.174.524 COLLABORATIVE PRACTICE AGREEMENT REQUIREMENTS

(1) Prior to initially engaging in collaborative practice, a pharmacist must provide the board with an executed written and electronic copy of the collaborative practice agreement.

(2) The collaborative practice agreement must include:

(a) the identification and signature of individual practitioner(s) or a facility’s chief of staff or their designee authorized to prescribe drugs and responsible for the delegation of drug therapy management;

(b) the identification and signature of individual pharmacist(s) authorized to dispense drugs and engage in drug therapy management;

(c) the types of drug therapy management decisions that the pharmacist is allowed to make which may include:

(i) a specific description of the types of diseases and drugs involved, and the type of drug therapy management allowed in each case; and

(ii) a specific description of the procedures and methods, decision criteria and plan the pharmacist is to follow.

(d) a detailed description of the procedures and patient activities the pharmacist is to follow in the course of the protocol, including the method for documenting decisions made and a plan or mechanism for communication, feedback and reporting to the practitioner concerning specific decisions made. Documentation shall be recorded within 24 hours following each intervention and may be recorded on the patient medication record, patient medical chart, or a separate log book. Documentation of drug therapy management must be kept as part of the patient's permanent record and shall be considered confidential information;

(e) a method by which adverse events shall be reported to the practitioner;

(f) a method for the practitioner to monitor clinical outcomes and intercede when necessary;

(g) a provision that allows the practitioner to override protocol agreements when necessary;

(h) a provision that allows either party to cancel the agreement by written notification;

(i) the effective date of the protocol. The duration of each protocol shall not exceed one year;

(j) the annual date by which review, renewal and revision, if necessary, will be accomplished;

(k) the addresses where records of collaborative practice are maintained; and

(l) the process for obtaining the patient's written consent to the collaborative practice agreement.

(3) Patient records shall be maintained by the pharmacist for a minimum of seven years and may be maintained in an automated system pursuant to ARM 24.174.818(3)..

(History: 37-7-101, 37-7-201, MCA; IMP, 37-7-101, 37-7-201, MCA; NEW, 2002 MAR p. 794, Eff. 2/1/02.)

24.174.503 ADMINISTRATION OF VACCINES BY PHARMACISTS

(1) A pharmacist may administer vaccines to persons 18 years of age or older provided that:

(a) the pharmacist has successfully completed an accredited course of training provided by the centers for disease control, the American council on pharmaceutical education or other authority approved by the board;

(b) the pharmacist holds a current basic cardiopulmonary resuscitation certification issued by the American heart association or the American red cross;

(c) the vaccines are administered in accordance with an established protocol; and

(d) the pharmacist has a current copy of the centers for disease control reference “Epidemiology and Prevention of Vaccine-Preventable Diseases”.

(2) The pharmacist must give the appropriate vaccine information statement to the patient or the patient's legal representative with each dose of vaccine covered by these forms and counsel the patient accordingly.

(3) The pharmacist must maintain written policies and procedures for disposal of used or contaminated supplies.

(4) The pharmacist must report any adverse events to the primary care provider identified by the patient and to the CDC.

(5) A pharmacist administering any vaccine shall maintain the following information in the patient's medical records for a period of at least three years:

(a) the name, address and date of birth of the patient;

(b) the date of administration;

(c) the name, manufacturer, dose, lot number and expiration date of the vaccine;

(d) the vaccine information statement provided;

(e) the site and route of administration;

(f) the name and address of the patient's primary health care provider;

(g) the date on which the vaccination information was reported to the patient's primary health care provider under the provisions of the national vaccine injury compensation program;

(h) the name of the administering pharmacist; and

(i) any adverse events encountered.

(6) The authority of a pharmacist to administer immunizations may not be delegated.

(7) The pharmacist must provide a certified true copy of the certificate to the board for endorsement on their pharmacist license.

(History: 37-7-101, 37-7-201, MCA; IMP, 37-7-101, 37-7-201, MCA; NEW, 2002 MAR p. 794, Eff. 2/1/02.)

24.174.813 CLASS IV FACILITY

(1) A Class IV facility shall be administered in compliance with the following standards:

(a) that any legend drugs dispensed shall first have been packaged, labeled, and otherwise prepared by a registered pharmacist holding a current license in Montana. The pharmacist is to be recorded with the board and the board shall be notified of any change of the pharmacist in charge.

(i) a legend drug is defined as one that is controlled by federal law and carries the legend “Federal Law Prohibits Dispensing Without a Prescription”.

(b) that the registered pharmacist in charge shall provide this service to said facility at regular periods and that these periods be posted at said facility.

(c) that adequate locked storage be provided for all drugs referred to in these rules. Only the pharmacist may have access to the legend drug stock. However, the person in charge, or his or her designee, may obtain a product that has been properly prepared by the pharmacist for delivery to the recipient.

(d) that records for all legend drugs dispensed and to whom be kept at the facility for the purpose of accounting for these drugs. These records would include present stock and all shipments received thereafter.

(e) that these drugs be delivered to the recipient at no cost for the drug.

(f) that the dispensing of drugs by M.D.'s not be restricted except as defined in 37-2-104 and 37-7-103, MCA.

(g) that nothing in these rules authorizes the dispensing of any drugs and devices other than the following:

(i) oral contraceptives; injectable long-term contraceptives; progestational drugs; diaphragms; contraceptive jellies; creams, and foams; IUD’s; condoms; vaginal creams, ointments, and suppositories used in the routine treatment of vaginal disorders.


(h) that all non-legend contraceptive devices and products be dispensed in accordance with the contraceptive drug or device law, Title 45, chapter 8, 45-8-204, MCA.

(i) that each family planning center must apply for a license from the board and submit the required fee for a Class IV facility. This license is to be displayed in a conspicuous place at the facility.

(History: 37-7-201, MCA; IMP, 37-7-201, 37-7-321, MCA; NEW, Eff. 3/21/71; AMD, Eff. 8/4/76; AMD, Eff. 1/31/77; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1983 MAR p. 344, Eff. 4/29/83; TRANS, from Commerce, 2002 MAR p. 904.)

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The state comparison information above was adapted from a study conducted by the American Pharmacists Association and commissioned by the Pharmacy Access Partnership.

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