Regulations

Why are drug regulations important for public safety and health?

They ensure drug safety, efficacy, proper labeling, and protect the public from harmful or ineffective medications.

How have drug regulations evolved over time?

They have become stricter by requiring proof of safety, effectiveness, accurate labeling, and post-marketing surveillance.

Which agencies primarily regulate drugs and controlled substances in the United States?

The FDA regulates drugs and the DEA regulates controlled substances.

What was the purpose of the U.S. Pharmacopeia (USP) established in 1820?

It established standards for all drug products.

What was the purpose of the National Formulary (NF) established in 1852?

It established standards for drug ingredients.

What occurred in 1975 regarding USP and NF?

They merged to form the USP-NF.

What did the Pure Food and Drug Act of 1906 require?

Accurate labeling of ingredients and prohibition of adulterated or misbranded drugs.

What did the Food, Drug, and Cosmetic Act of 1938 mandate?

Pre-market approval of all new drugs and regulation of cosmetics and medical devices.

What did the Kefauver-Harris Amendment of 1962 require?

Proof of drug safety and effectiveness and informed consent in clinical trials.

What is the purpose of the Controlled Substances Act (1970)?

To categorize drugs into five schedules based on abuse potential and medical use.

Define dependence.

CNS adaptation to repeated drug use.

Define addiction.

Compulsive drug use despite harmful consequences.

Define withdrawal.

Physical and psychological symptoms that occur when stopping a drug.

Who must register with the DEA to handle controlled substances?

Hospitals, pharmacies, and prescribers.

What record-keeping is required for controlled substances?

All quantities purchased and sold must be documented; drugs must be locked and counted every shift.

What must providers monitor regarding controlled substances?

Misuse and diversion.

Which schedule has the highest abuse potential and no accepted medical use?

Schedule I.

Give examples of Schedule I drugs.

Heroin and LSD.

What characterizes Schedule II drugs?

High abuse potential and severe dependence risk.

Give examples of Schedule II drugs.

Opioids, stimulants, cocaine, and barbiturates.

What characterizes Schedule III drugs?

Moderate to low dependence risk.

Give an example of a Schedule III drug.

Acetaminophen with codeine.

What characterizes Schedule IV drugs?

Low abuse potential.

Give an example of a Schedule IV drug.

Benzodiazepines.

What characterizes Schedule V drugs?

Lowest abuse potential.

Give an example of a Schedule V drug.

Antitussives.

What is required to prescribe controlled substances?

DEA registration.

Why must providers follow evidence-based guidelines?

To ensure safe and appropriate prescribing.

How does scope of practice vary?

It varies by state law and licensure.

What is a nurse’s responsibility regarding medications?

Safe administration and patient education.

What is MassPAT?

Massachusetts Prescription Awareness Tool that tracks controlled substance prescribing.

When must providers check MassPAT?

Before prescribing Schedule II or III drugs.

What is required for Massachusetts providers to prescribe controlled substances?

A controlled substance license.

When was the FDA established under HHS?

1988.

When were Black Box Warnings introduced?

1997.

What is a Black Box Warning?

The FDA’s strictest warning highlighting severe or life-threatening drug risks.

What is the purpose of a Black Box Warning?

To increase awareness and prevent serious adverse outcomes.

What does the Center for Biologics Evaluation and Research (CBER) regulate?

Vaccines and blood products.

What does the Center for Food Safety and Applied Nutrition (CFSAN) regulate?

Food safety and nutrition products.

What does NCCIH focus on?

Complementary and integrative health practices.

What occurs during preclinical investigation?

Lab and animal testing to assess safety, activity, and efficacy.

What is studied in Phase I clinical trials?

Safety and dosage in healthy volunteers.

What is studied in Phase II clinical trials?

Efficacy and safety in patients.

What is studied in Phase III clinical trials?

Large-scale confirmation of efficacy and monitoring of side effects.

What is an NDA?

New Drug Application submitted to the FDA for approval.

What happens during post-marketing surveillance?

Monitoring long-term safety, rare side effects, and effectiveness.

What are risks of purchasing drugs online?

Counterfeit drugs, lack of quality assurance, and misuse.

Which agencies monitor internet drug sales?

FDA and DEA.

What are the five pregnancy risk categories?

A, B, C, D, and X.

Which pregnancy category is considered safest?

Category A.

Which pregnancy category shows proven fetal harm and is contraindicated?

Category X.

What does Category D indicate?

Evidence of fetal risk in humans but may be used in life-threatening situations.

What did the 2008 pregnancy labeling update provide?

More detailed pregnancy risk information.

How do drug regulations apply to nursing practice?

They ensure legal, ethical medication administration and patient safety.

Why must nurses understand drug regulations?

To maintain compliance and protect patients.