listened Minnesota Hormonal Contraception Prescribing Protocol Study Notes

General Considerations for the Minnesota Prescribing Protocol

Resource Access: The official protocol can be accessed via the Minnesota Board of Pharmacy website at: https://mn.gov/boards/pharmacy/resourcesfaqs/prescribingprotocols.jsp
Physical Documentation Requirement: A copy of the prescribing protocols must be maintained on-site at the pharmacy location.
Pharmacist Education: Pharmacists are required to have specific education on the prescribing of the approved medications before they can participate.
Documentation and Records: Documentation of the prescription is mandatory. Pharmacists must refer to individual protocols for specific details. Prescription records must follow standard dispensing, documentation, and record-keeping requirements as per Minn Stats. $151.01, subd 16a$.
Prescriber of Record: * The authorized pharmacist acts as the prescriber of record. * Delegation: The pharmacist may not delegate the authority to prescribe to pharmacy interns.

Criteria and Summary for MN Pharmacists Prescribing Protocol

Scope of Products: Pharmacists may only prescribe self-administered hormonal contraceptives (e.g., oral pills, transdermal patches, vaginal rings, and injections).
Age and Eligibility Requirements: * New Prescriptions: Patients must be $18$ years of age or older to receive a new prescription from a pharmacist. * Minors (< 18 years old): A pharmacist may prescribe only if the contraceptive was previously prescribed by another health care provider (MD, PA, or APRN).
Clinical Visit Requirements for Refills: For refills to be prescribed by a pharmacist, the patient must have been seen by a health care provider within the last $3$ years.
Intended Use Limitation: Pharmacists may only prescribe a self-administered contraceptive if the intended use is strictly for contraception.
Refill Policy for Patients $\ge 18$ : For patients over $18$ years old, an initial prescription can be provided by the pharmacist without refills if there is no confirmation of a clinical visit with an MD, PA, or APRN in the last $3$ years.

Key Procedural Steps and Mandatory Screening

Hormonal Contraceptive Self-Screening Questionnaire: * Patients must complete a self-screening questionnaire. * Frequency: This questionnaire must be repeated every $12$ months. * Pharmacist Role: The pharmacist must review the patient's answers on the self-screening form.
Blood Pressure (BP) Monitoring: * Blood pressure must be measured and recorded for all Combined Hormonal Contraceptive (CHC) prescriptions.
Application of Guidelines: Pharmacists must apply the CDC Medical Eligibility Criteria (MEC) guidelines to the specific patient situation.
The Prescribing Algorithm: * Pharmacists must complete the full algorithm to ensure there are no contraindications. * If contraindications are present, the pharmacist must refer the patient to a Primary Care Provider (PCP), clinic, or hospital.
Educational Requirements: * Pharmacists must educate the patient on the proper use of the prescribed product. * A fact sheet must be provided to every patient.
Patient Record: The patient must be provided with a written record of the contraceptive prescribed and a summary of the visit.

Detailed Breakdown of the Self-Screening Questionnaire

Demographic and Background Information: * Name, Date of Birth, Age ( $Age$ ), Weight ( $Weight$ ), Date. * Insurance status (Yes/No). * Date of last women's health clinical visit. * Allergies to medications (Yes/No; list if applicable).
Method Preference: * Daily pill * Weekly patch * Vaginal ring * Injectable (every $3$ months) * Other (e.g., IUD, implant).
General Health Questions: * 1. Possible pregnancy: "Do you think you might be pregnant now?" * 2. Menstrual cycle: "What was the first day of your last menstrual period?" * 3. History of use: Previous use of pills, patch, ring, or injection. Previous prescription by a pharmacist. History of bad reactions to hormonal birth control. * 4. Professional warnings: "Have you ever been told by a medical professional not to take hormones?" * 5. Smoking status: "Do you smoke cigarettes?"
Medical History Questions: * 6. Vaginal bleeding changes. * 7. Postpartum status: "Have you given birth within the past $21$ days?" * 8. Breastfeeding status. * 9. Diabetes. * 10. Migraine headaches: Specifically looking for migraines with aura (flashes of light, blind spots, tingling in hand/face) that disappear before the headache starts. * 11. Inflammatory Bowel Disease (IBD). * 12. Conditions: High blood pressure, hypertension, or high cholesterol (even if controlled). * 13. Cardiovascular history: Heart attack, stroke, or heart disease. * 14. Blood clot history. * 15. Risk for blood clots. * 16. Surgery: Recent major surgery or planned surgery in the next $4$ weeks. * 17. Immobility: Long-term immobility (e.g., long airplane trips). * 18. Gastric surgery: Bariatric surgery or stomach reduction. * 19. Breast cancer history. * 20. Organ transplant: Solid organ transplant history. * 21. Liver/Gallbladder: Hepatitis, liver disease, liver cancer, gallbladder disease, or jaundice. * 22. Autoimmune/Blood disorders: Lupus, rheumatoid arthritis, or other blood disorders. * 23. Medication interactions: Medications for seizures, tuberculosis (TB), fungal infections, or HIV. * 24. General medications: Other medical problems, seasonings, herbs, or supplements.

The Standard Procedures Algorithm and Screens

1) Health and History Screen

Guideline: Refer to CDC USMEC ( $2016$ ).
Categories: * $1$ or $2$ (Green boxes): Hormonal contraception is indicated; proceed. * $3$ or $4$ (Red boxes): Hormonal contraception is contraindicated; refer the patient.

2) Pregnancy Screen

The patient must answer "YES" to at least one of the following and be free of symptoms to proceed: * a. Baby < 6 months ago, fully/nearly-fully breastfeeding, AND no period since delivery. * b. Baby in the last $4$ weeks. * c. Miscarriage or abortion in the last $7$ days. * d. Last period started within the past $7$ days. * e. Abstained from intercourse since last period/delivery. * f. Reliable contraceptive used consistently and correctly.
If "NO" to all, pregnancy cannot be ruled out; refer the patient.

3) Medication Screen

High-Risk Medications (Require Referral): * Carbamazepine * Felbamate * Griseofulvin * Lumacaftor/Ivacaftor * Primidone * Oxcarbazepine * Phenobarbital * Rifampin / Rifabutin * Topiramate * Lamotrigine * Phenytoin * Fosamprenavir (when not combined with ritonavir)

4) Blood Pressure Screen

Threshold: BP < 140/90.
Actions: * If BP < 140/90: Proceed. * If $BP \ge 140/90$ : Refer or consider Progestin-Only Pills (POP). The pharmacist may choose to take a second reading if the initial one is high.

Treatment Selection and Counseling

5) Contraception Selection

New Therapy: Choose based on patient preference, adherence, and history. Prescribe up to $12$ months.
Existing Therapy: Continue current form if no changes are necessary, or alter based on side effects. Prescribe up to $12$ months.
Refill Rule: Do not prescribe refills unless there is evidence of a clinical visit with a physician, PA, or APRN within the preceding $3$ years.

6) Initiation and Counseling Strategies

Quick Start: Instruct the patient she can start today. Use a backup method (e.g., condoms) for $7$ days.
Side Effects: Discuss management and expectations regarding bleeding irregularities, nausea, etc.
Adherence: Discuss the importance of daily use (if applicable) and follow-up expectations.
Referral/Summary: Encourage routine health screenings and STI prevention. Provide a written summary.

CDC USMEC Data and Risk Factors (Selected Data)

Smoking Profile for CHC (Pill/Patch): * Age < 35: Category $1$ (Initiating/Continuing). * Age > 35, < 15 cigarettes/day: Category $3$ (Initiating), Category $1$ (Continuing). * Age > 35, > 15 cigarettes/day: Category $4$ .
Postpartum and CHC: * < 21 days: Category $4$ (Initiating). * $21$ to $42$ days with VTE risk factors: Category $3/4$ . * $21$ to $42$ days without VTE risk factors: Category $2$ . * > 42 days: Category $1$ .

Clinical Scenarios and Practical Applications

Case 1 (Minor Patient): A $16$ -year-old female requests a prescription. She has a history of an OCP prescription from $8$ months ago (EE $20\, ext{mcg}$ /levonorgestrel $0.1\, ext{mg}$ ). Her $BP$ is $123/82\,mmHg$ . * Application: Since she has a previous prescription on file from a health care provider, the pharmacist can prescribe birth control despite her being under $18$ . * Legal Note: Minors can give consent for contraception under Minn. Stat. Ann. $\S 144.343(1)$ .
Case 2 (Switching for Side Effects): A $33$ -year-old female switching from DMPA to a pill for acne. She takes minocycline ( $100\, ext{mg}$ BID). Her $BP$ is $113/74\,mmHg$ . * Outcome: Yasmin/Ocella/Syeda (EE/drospirenone $30\, ext{mcg}/3\, ext{mg}$ ) is an option to help with acne. She can be prescribed a $12$ -month supply if she has seen a provider within $3$ years.
Case 3 (Drug Interaction): A $22$ -year-old on Nortrel (EE/norethindrone $35\, ext{mcg}/0.5\, ext{mg}$ ) suffering from headaches and nausea. She takes bupropion XL ( $300\, ext{mg}$ ) and lamotrigine ( $150\, ext{mg}$ ). * Major Clinical Concern: Refer to PCP because estrogen may decrease the effectiveness of lamotrigine.

Long-term Follow-Up and Monitoring

Encouraged Visits: Annual visits for cervical cancer or STI screening are encouraged but not required to provide contraception.
Initial Check-in: A check-in at $3$ months is reasonable to verify tolerability and address side effects.
Routine Follow-up Actions (per CDC): * Assess Satisfaction: Check if the patient is happy with the method. * Health Status Changes: Screen for new medications or conditions (USMEC Category $3/4$ ). * IUD Check: Examination for IUD strings. * Weight Counseling: Address concerns regarding weight changes. * Blood Pressure: Essential for users of Combined Hormonal Contraceptives (CHC).