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|Steps to Beginning a Pharmacist-Provided Hormonal Contraceptives Practice
- Become familiar with state law and Tennessee Board of Pharmacy rules surrounding pharmacist-provided contraceptives in Tennessee.
- Complete the Tennessee Pharmacists Association’s Pharmacist-Provided Hormonal Contraceptive Training Program, or another approved training by the Tennessee Department of Health. Other approved trainings can be found on the Tennessee Board of Pharmacy website.
- An equivalent curriculum-based training program completed in or after the year 2017 from a school or college of pharmacy recognized by the Board or a training program recognized by the Board shall satisfy the requirement of training.
- A certificate of completion of the training must be permanently maintained by the pharmacist at their place of practice, and the pharmacist shall make the certificate available to the Board of Pharmacy upon request.
- Training programs, at a minimum, shall provide information pertaining to the types and pharmacology of hormonal contraceptives which may be prescribed, the risks and benefits of each hormonal contraceptive, and any side effects or contraindications associated with hormonal contraceptives. Training programs shall provide the prescribing pharmacist with a minimum level of proficiency regarding proper prescribing of hormonal contraceptives.
- Set up a collaborative pharmacy practice agreement.
- Develop a relationship with a prescriber with whom to enter into a collaborative pharmacy practice agreement. Different from a typical collaborative pharmacy practice agreement, patients do not have to have a relationship with the prescriber.
- A sample collaborative practice agreement can be found here. Please note that this is just an example, and each agreement should be tailored to your pharmacy practice. You could consider adding additional services such as Plan B prescribing, pregnancy tests, and prenatal care.
- Executed collaborative pharmacy practice agreements should be sent to the Tennessee Board of Pharmacy within 30 days.
|Laws and Regulations for Pharmacist-Provided Hormonal Contraceptives Practice
There are two sets of laws and regulations that you need to be familiar with: State law and Tennessee Board of Pharmacy regulations.
- Tennessee state law, as codified into Tennessee Code Annotated 63-10-219, can be found here. These are the laws around the provision of hormonal contraceptives in Tennessee by pharmacists.This law, which was passed in 2016, was supported by the Tennessee Pharmacists Association. TPA believes that this legislation will expand patient access to an important class of medications and promote continued collaboration between pharmacists and other members of the multidisciplinary patient care team to increase patient access to self-administered hormonal contraceptives, while addressing safety concerns, resulting in a reduction in the number of unintended pregnancies in Tennessee. Please see the full position statement of TPA as this bill was being discussed by the Tennessee legislature.
- Tennessee Board of Pharmacy rules were promulgated in collaboration with the Board of Medical Examiners and the Board of Osteopathic Examination, and can be found online here under Chapter 1140-15, Prescribing and Dispensing of Hormonal Contraceptives.
|Procedural Mandates from the Tennessee Board of Pharmacy
- Pharmacists may provide hormonal contraceptives to individuals who are:
- 18 years of age or older; or
- Under 18 years of age, if the individual is an emancipated minor.
- Each new patient must complete a self-screening risk assessment, which the pharmacist will use to assess her candidacy for a hormonal contraceptive. Returning patients must complete the assessment at least every 12 months. This is the Tennessee Department of Health (TDH)-produced standardized self-screening risk assessment tool discussed in the Board of Pharmacy rules. The assessment tool can be incorporated into a pharmacy’s management system software in order to be made electronic. A record of this completed form shall be maintained by the pharmacy practice site for a period of ten years.
- The pharmacist must review each patient’s self-screening assessment tool and clarify responses as needed, before using his/her professional judgment to determine whether or not to prescribe a hormonal contraceptive. The Tennessee Pharmacist-Provided Hormonal Contraceptives Algorithm can be used as an aid when determining whether or not a patient should be prescribed contraceptives. This algorithm is discussed during TPA’s Pharmacist-Provided Hormonal Contraceptive Training Program and is available only to TPA members and to pharmacists who participate in the TPA training.
- If the patient is eligible for a hormonal contraceptive, dispense the medication or refer the patient to a pharmacy that can dispense the medication as soon as practicable after making the determination that the patient is eligible. If the patient is deemed not to be eligible for a hormonal contraceptive, refer them to another provider.
- At the time the medication is prescribed and dispensed, counsel the patient using the guidelines outlined in Responsibilities for Pharmaceutical Care in the rules of the Tennessee Board of Pharmacy. Patient counseling shall cover matters that the pharmacist deems significant, including:
- The name and description of the medication;
- The dosage form, dose, route of administration, and duration of drug therapy;
- Special directions and precautions for preparation, administration, and use by the patient;
- Common side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
- Techniques for self-monitoring drug therapy;
- Proper storage;
- Prescription refill information; and
- Action to be taken in the event of a missed dose.
- Provide the patient with the FDA-required patient product information document that is included with the hormonal contraceptive, as well as a factsheet similar to this one. The factsheet should include but is not limited to the following:
- Indications and contraindications for the medication
- Appropriate method for using the drug
- The importance of medical follow up
- Other appropriate information
- Advise the patient to follow up with her primary care or women’s health practitioner. Documentation of this is encouraged, and could be included on a referral and visit summary.
- Provide the patient with a list containing contact information for primary care or women’s health practitioners. If this cannot be done at the time of prescribing and dispensing, it should be done within 72 hours of the contraceptive being prescribed. A sample list has been developed, which includes local health departments and clinics.