Prescriptive Authority and Drug Regulations

Questions and Answers

What is full prescriptive authority?

The legal right to prescribe only in emergency situations.

The legal right to prescribe only Schedule 1 drugs.

The legal right to prescribe only certain medications.

The legal right to prescribe independently without limitation. (correct)

The FDA looks at the cost of production for approval of all drugs.

False

What are the two criteria that the FDA looks at for approval of drugs?

safety and efficacy

Drugs with a high potential for abuse and potential to create severe psychological and/or physical dependence are classified as Schedule ______________.

1 Signup and view all the answers

Match the following drug schedules with their characteristics:

Schedule 2 = High potential for abuse, potentially leading to severe psychological or physical dependence. Schedule 3 = Moderate to low potential for physical and psychological dependence. Schedule 4 = Low potential for abuse and low risk of dependence. Schedule 5 = Lower potential for abuse than Schedule 4. Signup and view all the answers

What is the main reason why refills are not allowed for Schedule 1 drugs?

Due to their high potential for abuse Signup and view all the answers

True or False: Prescribing for friends and family is always acceptable.

False Signup and view all the answers

What are the three elements of a bona fide patient-provider relationship?

physical examination, documentation of findings and treatment plan, complete medical history Signup and view all the answers

In Phase 1 of FDA human drug studies, the drug is given to _______________ healthy volunteers to evaluate pharmacokinetics.

40-50 Signup and view all the answers

Match the following FDA phases of human drug studies with their descriptions:

Phase 1 = Evaluate pharmacokinetics Phase 2 = Evaluate safety and efficacy Signup and view all the answers

Study Notes

Prescriptive Authority

Full prescriptive authority refers to the legal right to prescribe independently without limitation.
Prescriptive authority for APRNs and CNMs is determined by the laws in the state of practice.
Some states grant full prescriptive authority, while others enforce restrictions.

FDA Drug Approval Criteria

The FDA evaluates drugs based on two criteria: safety and efficacy.

Drug Classifications

Over-the-counter medications: drugs sold directly to consumers without a prescription, generally safe and effective when used as directed.
Prescription medications: drugs that require a valid prescription from a healthcare prescriber, classified into controlled substances or scheduled medications.
Controlled substances/scheduled medications: classified into five schedules based on acceptable medical use and abuse or dependence potential.

Scheduled Medications

Schedule 1: high potential for abuse, no accepted medical use, and high potential for severe psychological and/or physical dependence (e.g., LSD, marijuana, ecstasy).
Schedule 2: high potential for abuse, potentially leading to severe psychological or physical dependence (e.g., cocaine, methamphetamine, methadone).
Schedule 3: moderate to low potential for physical and psychological dependence (e.g., codeine, testosterone, ketamine).
Schedule 4: low potential for abuse and low risk of dependence (e.g., xanax, soma, darvon, valium, ativan).
Schedule 5: lower potential for abuse than Schedule 4, used for anti-diarrheal, antitussive, analgesic purposes.

Controlled Substance Prescribing

Refills allowed on Scheduled drugs, except for Schedule 1 (no refills, no accepted medical use).
Schedule 2: no refills, new prescription required.
Schedule 3 and 4: refillable up to 5 times within 6 months.
Schedule 5: refills as authorized by the prescriber.

DEA Number

Required for prescribers to prescribe controlled/scheduled drugs.
Every prescription must include a valid DEA number.

Bona Fide Patient-Provider Relationship

A treating or consulting relationship with a complete assessment of the patient's medical history and current medical condition.
Elements of a bona fide patient-provider relationship: physical examination, documentation of findings and treatment plan, complete medical history.

Off-Label Prescribing

Legal if it benefits the patient and is based on scientific evidence, not illegal, contraindicated, or investigational.

Ethical and Legal Prescribing Concerns

Prescribing for friends and family is acceptable with a bona fide patient-provider relationship.
Provide a reasonable standard of care, including aspects of care typically included in an office visit for the same complaint.

FDA Phases of Human Drug Studies

Phase 1: 40-50 healthy volunteers take the drug to evaluate pharmacokinetics and safety.
Phase 2: drug given in increasing doses to a small number of patients (10-100) in controlled clinical trials with the target disease or disorder.

Description

Learn about the legal aspects of prescribing medications, including full prescriptive authority, state laws, and FDA drug approval criteria. Understand drug classifications, including over-the-counter medications.