HRT HRT Legal, Ethical & Documentation Standards

Question 1

Which federal agency oversees compounding pharmacies that produce HRT preparations and issued guidance distinguishing traditional vs. outsourcing facility compounding?

Accepted Answer

U.S. Food and Drug Administration (FDA)

Answer

Drug Enforcement Administration (DEA)

Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

Health Resources & Services Administration (HRSA)

Question 2

Informed consent for HRT must include which core elements to be legally valid?

Accepted Answer

Explanation of risks, benefits, alternatives, and confirmation that the patient understands and agrees voluntarily

Answer

Physician signature only

Answer

Patient's insurance ID number

Answer

Pharmacist's approval

Question 3

HIPAA regulations require HRT practitioners to protect patient hormone therapy records in which fundamental way?

Accepted Answer

Limit disclosure of protected health information (PHI) to the minimum necessary for treatment, payment, or operations

Answer

Share all records with any requesting provider

Answer

Store all records only on paper

Answer

Destroy records after 1 year

Question 4

When prescribing compounded HRT, a practitioner's documentation should include which element to satisfy medical necessity requirements?

Accepted Answer

Documentation of why an FDA-approved product is inadequate for the patient's specific clinical need

Answer

A note stating the patient preferred compounded products

Answer

Pharmacy's convenience as the reason

Answer

Price comparison to FDA products

Question 5

Which professional body publishes the most authoritative clinical practice guidelines for menopause management in the United States?

Accepted Answer

The Menopause Society (formerly NAMS — North American Menopause Society)

Answer

American Heart Association

Answer

CDC

Answer

NIH Office of Dietary Supplements

Question 6

Testosterone is a Schedule III controlled substance in the United States. What does this classify it as?

Accepted Answer

A drug with accepted medical use but moderate potential for dependence and abuse

Answer

An over-the-counter supplement

Answer

A Schedule II narcotic

Answer

An unregulated herbal product