Current through February, 2024
(a) Each arrangement between a licensed
pharmacist and a licensed physician relating to the distribution to a patient
of emergency contraception drugs shall be documented in a signed collaborative
agreement in accordance with the form attached hereto as Exhibit A entitled
"Emergency Contraception Drug Therapy Collaborative Agreement" dated December
2004, located at the end of this chapter and made a part of this chapter. The
agreement shall be delivered to the board by the licensed pharmacist within ten
days of the execution of the agreement by the pharmacist and the
physician.
(b) Before a pharmacist
may participate in the collaborative agreement, the pharmacist shall have
completed an emergency contraception training course approved by the ACPE,
curriculum-based programs from an ACPE-accredited college of pharmacy,
applicable state or local health department programs, or programs recognized by
the board of pharmacy. Training shall include procedures listed in Exhibit A,
entitled, "Emergency Contraception Drug Therapy Collaborative Agreement", dated
December 2004 and located at the end of this chapter, the management of the
sensitive communications often encountered in emergency contraception,
providing service to minors, quality assurance, referral for additional
services, and documentation.
(c) By
executing the collaborative agreement, both the physician and pharmacist agree
and acknowledge that:
(1) They accept the
responsibility for the distribution of the emergency contraception drugs and
that the licensed pharmacist shall dispense only certain drugs approved for
emergency contraception by the United States Food and Drug Administration. Some
of the currently approved drugs are listed in the attached Exhibit B entitled
"Brands and Doses", dated August 2004, located at the end of this chapter and
made a part of this chapter however, drugs approved for emergency contraception
are not limited to this list. Other drugs listed in Exhibit B entitled "Brands
and Doses", dated August 2004 and located at the end of this chapter, may be
dispensed instead of Plan B® in the following circumstances:
(A) Plan B® is unavailable;
(B) Plan B® is not covered under the
patient's health insurance plan and another drug listed in Exhibit B is
covered; or
(C) The patient chooses
another listed drug after the pharmacist advises the patient that side effects
are usually less with Plan B®.
The list of approved drugs in Exhibit B also shall include
adjunctive drugs for treatment of nausea and vomiting that may be associated
with emergency contraceptives;
(2) The licensed pharmacist shall provide the
patient with drug information concerning dosage, potential adverse side
effects, and follow-up contraceptive care;
(3) The collaborative agreement shall be
effective for a period of at least two years from the date of its delivery to
the board, unless rescinded in writing by either the physician or the
pharmacist, with written notice to the other and the board, or unless the
pharmacy board invalidates the agreement or changes the terms of the agreement.
After the two year period, the agreement shall continue to be valid from month
to month unless rescinded, invalidated, or changed as provided herein. The
licensed pharmacist or the licensed physician, who rescinds the agreement,
shall notify the board within three business days of the rescission. At the
time the collaborative agreement is rescinded, the licensed pharmacist shall
not have prescriptive authority to dispense emergency contraceptives until
another collaborative agreement with a physician is completed and received by
the board; and
(4) Each drug
therapy prescription authorized by the physician and dispensed by the
pharmacist shall be documented in a patient profile.
(d) Additionally, the collaborative agreement
between the licensed pharmacist and licensed physician shall include:
(1) The name, address, and phone number of
the licensed pharmacist and pharmacy and the signature of the licensed
pharmacist;
(2) The name, address,
and phone number of the licensed physician and the signature of the licensed
physician;
(3) The purpose of the
collaborative agreement, which is to permit emergency contraception drug
therapy within one hundred twenty hours of the patient having unprotected
sexual contact and to ensure that the patient receives appropriate information
from the licensed pharmacist regarding the drug therapy;
(4) The procedures, delineated in Exhibit A,
to be followed by the licensed pharmacist when the patient requests drug
therapy, including any applicable referrals;
(5) Any limitation agreed upon by both the
licensed pharmacist and the licensed physician including but not limited to
approved drugs that may not be prescribed to the patient or whether the
licensed pharmacist's or the licensed physician's decision shall control in the
event of a disagreement on the prescription for a patient;
(6) A provision that the licensed pharmacist
shall refer the patient to a licensed physician;
(7) A statement that the label placed on the
drug therapy product shall contain the names of both the pharmacist and the
physician signers of this agreement;
(8) An informed consent, included in Exhibit
A, to be used by the licensed pharmacist to inform the patient about the
emergency contraception drug therapy. The informed consent shall be signed by
both the licensed pharmacist and the patient; and
(9) A screening checklist for emergency
contraception pills, included in Exhibit A, to be filled in by the patient and
signed by both the licensed pharmacist and the patient.
(e) Any modification to an existing
collaborative agreement previously delivered to the board shall be submitted to
the board by the licensed pharmacist at least ten working days prior to the
intended implementation of the changed collaborative agreement.
(f) The board shall have the authority to
reject a collaborative agreement if the board determines that the collaborative
agreement is not in compliance with this section or is not in the best
interests of the patient.
(g) The
form of the collaborative agreement, the informed consent form, and the
screening checklist for emergency contraception drugs attached as Exhibit A
hereto, shall be made available by the board to licensed pharmacists and
licensed physicians.
