Legal, Safe, & Rational Drug Selection

Vocabulary flashcards covering legal, safe, and rational drug selection principles, drug approval phases, DEA schedules, FDA regulations, and prescribing safety guidelines.

Rational Drug Prescribing Steps

The WHO-recommended process for selecting medication: 1. Define (Diagnose the patient's problem), 2. Specify (Set therapeutic objective/goal), 3. Choose (Make the best drug choice), 4. Start (Prescribe following safe/legal guidelines), 5. Educate (Provide administration instructions and side effects), 6. Monitor (Assess effectiveness).

Therapeutic Index

A ratio comparing the dose of a drug that produces an undesirable effect (toxicity) to the dose that achieves the desired therapeutic effect. A narrow index is harder to manage, while a wider index is safer and requires less monitoring.

Pharmacokinetics

The study of how your body processes a drug, from the moment it enters your system to the moment it leaves.

Pharmacodynamics

The relationship between drug exposure and pharmacological response and/or toxicity, which can be influenced by factors such as age-related physiological changes and receptor sensitivity.

Numbers Needed to Harm (NNH)

A metric indicating how many patients had to take a drug before harm occurs.

Numbers Needed to Treat (NNT)

An epidemiological measure where the ideal value is 1 (everyone improves with treatment and no one improves with control); a higher NNT indicates the treatment is less effective.

Rights of Medication Administration

The core safety standard requiring verification of: Dose, Drug, Indication, Time, Person, Route, and Documentation.

Teratogens

Substances or agents that cause miscarriages or fetal abnormalities.

MedWatch Report

An FDA program providing evidence-based safety and adverse-event reporting data regarding clinical trials and post-marketing surveillance.

U.S. Food and Drug Administration (FDA)

The regulatory entity that oversees new drug approval, official labeling, surveillance of adverse drug events, manufacturing/distribution methods, medical devices, and prescription drug advertising. It does NOT regulate prescribing.

Off-Label Prescribing

The legal practice of prescribing a drug for a use or indication NOT listed on its official FDA label.

"I Can Prescribe A Drug" Mnemonic

A decision-making tool standing for: Indication, Contraindications, Precautions, Cost/Compliance, Efficacy, Adverse Effects, and Dose/Duration/Direction.

Phase 1 Drug Testing

The clinical trial phase where a new drug is tested in healthy individuals.

Phase 2 Drug Testing

The clinical trial phase where a new drug is tested in subjects with 1 diagnosis.

Phase 3 Drug Testing

The clinical trial phase where a new drug is tested in subjects with multiple diagnoses.

Expedited New Drug Approval

FDA pathways to accelerate drug availability, including Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track.

U.S. Drug Enforcement Administration (DEA)

The agency that regulates the manufacture, prescribing, dispensing, registration, record keeping, and enforcement of controlled substances.

Schedule I Controlled Substances

Drugs with no acceptable medical use, the highest abuse potential, and illegal status at the national level, available only for registered research facilities (e.g., Heroin, LSD, Mescaline, Peyote, Marijuana).

Schedule II Controlled Substances

Drugs with high abuse potential requiring written or EHR prescriptions with no refills permitted and no telephone orders except in emergencies (e.g., Morphine, Oxycodone, Methadone, Cocaine, Amphetamine, Methylphenidate).

Schedule III Controlled Substances

Drugs whose prescriptions must be rewritten after 6 months or 5 refills and for which telephone orders are accepted in many states (e.g., Codeine combinations <= 90mg/tab, Hydrocodone <= 50mg/tab, Benzphetamine, Butobarbital).

Schedule IV Controlled Substances

Drugs subject to the same refill/ordering rules as Schedule III but carrying different legal penalties for illegal possession (e.g., Pentazocine, Benzodiazepines, Meprobamate).

Schedule V Controlled Substances

Prescription drugs with lower abuse potential that follow standard prescription rules and may be dispensed without a prescription unless regulated by state law (e.g., Loperamide, Diphenoxylate).

State Board of Nursing

The primary state entity responsible for regulating Nurse Practitioners' (NPs) prescriptive authority, degree of independence, and scope of controlled substance prescribing.

Patient-Centered Care

Healthcare delivery that incorporates the patient's values, preferences, needs, circumstances, and goals.

Dispense As Written (DAW)

An explicit instruction written on a prescription by a provider when generic substitution is not desired.

Hospital Medication Error Statistics

Data showing medication errors occur in approximately 1 in every 5 doses given in hospitals (one error per patient per day), causing ~1.3 million injuries and 7,000 deaths annually in the U.S., with drug-related morbidity and mortality costing $177 billion.