6.2 Self-Administered Hormonal Contraception: Standing Order & Pharmacist Prescribing

6.2 Self-Administered Hormonal Contraception: Standing Order & Pharmacist Prescribing

Utah's pharmacist-provided hormonal contraception program rests on three layers of law:

1. Statute: Title 26B, Chapter 4, Part 5 (§§ 26B-4-503 to -507), the "Treatment Access" provisions, and § 58-17b-502(1)(n);
2. DHHS rule and standing order: R433-200 and the Utah Statewide Standing Order for Pharmacist Dispensing of Hormonal Contraception; and
3. DOPL rules and guidance: R156-17b-610(8), R156-17b-621b, and the Utah Guidance for Self-Administered Hormonal Contraceptives incorporated through R156-17b-627 (pharmacist prescribing under § 58-17b-627).

Who and what

• Who may provide it: a pharmacist or pharmacy intern licensed under the Pharmacy Practice Act who has completed the required training (§ 26B-4-504; R156-17b-621b).
• Patient age: 18 years or older (§ 26B-4-504(1); DOPL guidance). Utah has no pharmacist pathway for minors, even with a prior prescription.
• Covered products: FDA-approved oral hormonal contraceptives, the hormonal vaginal ring, and the hormonal contraceptive patch. Excluded are any drug intended to induce an abortion, and methods that are not self-administered (injectable medroxyprogesterone, implants, IUDs).
• Participation is voluntary. The statutes create no duty or standard of care to prescribe or dispense (§ 26B-4-503).

Standing order mechanics (§ 26B-4-505; R433-200)

• A physician (including a DHHS physician or a local health department medical director) may issue a standing order under a protocol that identifies authorized dispensers by license number, requires the physician to review their dispensing practices at least annually, requires dispensing records, and is approved by DHHS rule.
• R433-200-3 requires records of each patient's age and ZIP code, the NDC dispensed, and an annual count of self-screening assessments evaluated.
• The physician who issues the standing order is not liable for civil damages from dispensing under it (§ 26B-4-507).

Training, enrollment, and CE

The encounter (§ 26B-4-506; R156-17b-610(8); standing order)

1. Self-screening questionnaire. Obtain the patient's completed Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire (English and Spanish versions are available) before dispensing. Use the Standard Procedures Algorithm and the CDC's U.S. Medical Eligibility Criteria (US MEC). The algorithm includes a blood pressure check.
2. If unsafe, don't dispense. If the evaluation shows dispensing would be unsafe, the pharmacist or intern may not dispense and must refer the patient to a primary care or women's health practitioner.
3. Initial dispensing. The standing order allows up to 12 months at the initial dispensing.
4. Counseling (§ 26B-4-506(2)). At a minimum: administration and storage, side effects and risks, the need for backup contraception, when to seek emergency care, and the risk of STIs and ways to reduce it.
5. Written information (§ 26B-4-506(1)(d)). Explain the importance of seeing a primary care or women's health practitioner for recommended tests and screening, and the effectiveness and availability of long-acting reversible contraceptives (LARC). Give the patient a copy of the encounter record, including the completed self-assessment and a description of what was dispensed or why nothing was dispensed.
6. Abuse concerns. The DOPL guidance directs pharmacists to refer any patient who may be subject to abuse to an appropriate social services agency.

Continuing therapy

• Statute: a pharmacist or intern may not continue dispensing for more than 24 months after the initial prescription without evidence the patient has consulted a primary care or women's health practitioner during the preceding 24 months (§ 26B-4-506(1)(c)).
• Standing order schedule: re-evaluate at 12, 24, 36, and 48 months, then every 12 months. The 36- and 48-month reviews require evidence of a clinician consult within the last 24 months. If an enrolled pharmacist isn't on site, no standing-order dispensing may occur.

Records and reporting

• Records: keep a record of each person seeking the medication (name and age, NDC, dispensing dates, completed self-assessment, counseling given, and any referral) for seven years at the pharmacy where the patient received care (standing order).
• Annual reporting: each enrolled pharmacist or intern reports to DHHS within 10 business days after each enrollment year ends. A report is due even if nothing was dispensed. Reports cover dispensing date, contraceptive type and brand, patient age, and ZIP code.
• Confidentiality: information collected is confidential "health data" (R433-200-4).
• Discipline: failing to follow the Treatment Access statutes when dispensing under a standing order is unprofessional conduct (§ 58-17b-502(1)(n)).

Exam traps

• A 17-year-old requesting pills: refer. Utah requires patients to be 18 or older.
• Depo-Provera, implants, and IUDs: not self-administered, so not covered.
• A 36-year-old who smokes 15 or more cigarettes a day: estrogen-containing methods are US MEC Category 4. Follow the algorithm (consider a progestin-only pill if appropriate) or refer.