16 Del. Admin. Code § 4110-5.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4110-5.0 - Procedures

5.1 Screening and eligibility

5.1.1 Patients shall be provided with a self-screening tool to complete.

5.1.1.1 A copy of the completed self-screening tool shall be securely stored within the originating pharmacy or healthcare facility for a period of at least 3 years from the date of dispensation or administration of the contraception.

5.1.1.2 The patient shall complete the self-screening tool annually at minimum.

5.1.2 If combined hormonal contraceptives are dispensed, a seated blood pressure measurement is recorded.

5.1.3 A pharmacist shall use the screening tool to determine eligibility for contraceptive use.

5.2 Product selection, dispensation, and administration

5.2.1 The pharmacist, in consultation with the patient, may dispense any non-hormonal contraceptive.

5.2.2 The pharmacist, in consultation with the patient, may dispense any hormonal contraceptive listed in the current USMEC for individuals with:

5.2.2.1 Conditions for which there is no restriction for the use of the contraceptive method ("Category 1"); or

5.2.2.2 Conditions for which the advantages of using the method generally outweigh the theoretical or proven risk ("Category 2").

5.2.3 The pharmacist may administer injectable hormonal contraceptives prescribed by healthcare practitioners or dispensed by a pharmacist.

5.2.4 The pharmacist must dispense the contraceptive or dispense and administer the contraceptive as soon as practicable after the pharmacist determines that the patient meets the requirements under the written standing order created by the Department of Health and Social Services.

5.3 Information provided to patient. The pharmacist shall provide the patient with:

5.3.1 A record of the encounter, including the patient's self-screening tool;

5.3.2 A record of the contraceptive dispensed or dispensed and administered or the basis for not dispensing or dispensing and administering a contraceptive; and

5.3.3 Written information about the importance of seeing the patient's healthcare practitioner to obtain recommended tests and screenings.

5.4 Referrals and follow-up care. A pharmacist shall refer the patient for appropriate follow-up care to the patient's healthcare practitioner or clinic in the following circumstances:

5.4.1 Upon dispensing a contraceptive to the patient; or

5.4.2 Upon determining ineligibility for contraception.

5.5 Documentation

5.5.1 Each contraceptive dispensed or administered by a pharmacist pursuant to this regulation shall be documented in a patient record and securely stored within the originating pharmacy or healthcare facility for a period of at least 3 years from the dispensed date.

5.5.2 A patient medication record shall be maintained in an automated data processing or manual record mode such that the required information under subsection 5.5.1 of this regulation is readily retrievable during the pharmacy's or facility's normal operating hours.

16 Del. Admin. Code § 4110-5.0

27 DE Reg. 609( 2/1/2024) (Final)