Pharmacology and Drug Regulation Study Guide

Comprehensive flashcards covering pharmacology basics, clinical trial phases, drug schedules, pharmacokinetics, pharmacodynamics, insulin timings, legislation, and therapeutic drug therapeutic ranges.

Pharmacology

The study of the effects of chemical substances on living tissues.

Pharmacopeia

A reference for drug standards created in 1820.

Drug Standards

Criteria including therapeutic use, client safety, quality, purity, strength, packaging safety, and dosage form.

The United States Pharmacopia National Formalard (USP)

Official publication by the U.S. listing drugs that meet high standards set by the U.S. Federal, Food, Drug and Cosmetic Act (FDA).

USP Suffix

Denotes global recognition of high quality when placed behind a drug name.

Phase 1 Clinical Trials

Trials lasting about $1$ year involving $20$ to $80$ healthy volunteers.

Phase 2 Clinical Trials

Trials lasting about $2$ years involving $100$ to $300$ volunteer patients with disease processes.

Phase 3 Clinical Trials

Trials lasting about $2$ years involving $1000$ to $3000$ patients in hospitals and clinic agencies.

Schedule 1 Controlled Substances

Illegal drugs with a high potential for abuse and no currently accepted medical use in the U.S., such as heroin, LSD, marijuana, and ecstasy.

Schedule 2 Controlled Substances

Drugs with a high potential for abuse that may lead to severe psychological and physical dependence, including Adderall, Fentanyl, Morphine, and Percocet.

Schedule 3 Controlled Substances

Drugs with potential for abuse (less than Schedule 1 and 2) that are primarily combined drugs, such as Vicodin and Ketamine; may lead to moderate physical or high psychological dependence.

Schedule 4 Controlled Substances

Drugs with a low potential for abuse relative to Schedule 3, such as Xanax, Klonopin, and Valium; these are often identifiable by the suffixes -pam and -lam.

Schedule 5 Controlled Substances

Preparation drugs with limited amounts of narcotics, such as Robitussin, Lomotil, and Lyrica.

Prescription rules for Schedule 2 and 3

Requires a new prescription each time; narcotics and opioids must be sent and signed electronically.

Prescription refills for Schedule 3 and 4

Can be refilled $5$ times in $6$ months.

Narcan (Naloxone)

A drug that can reverse the effects of Schedule 1 and 2 substances; acts as an antagonist receptor.

Flumazenil

A drug that can reverse the effects of Schedule 3 and 4 substances.

Nonproprietary name

Also known as the generic name; there is only one per drug.

Proprietary name

Also known as the trade name; the generic name is typically listed under it.

Category A (Pregnancy)

Controlled studies show no risk to the unborn fetus.

Category C (Pregnancy)

Risk to the unborn fetus cannot be ruled out.

Category X (Pregnancy)

Contraindicated in pregnancy due to risks of structural defects.

Pharmacokinetics

The study of what the body does to the drug, consisting of absorption, distribution, metabolism, and excretion.

Absorption

The movement of the drug into body fluids, occurring in three ways and influenced by GI mucosa, motility, and food.

First Pass Effect

The process where a drug loses $20-40\%$ of its concentration while passing through the gut and liver during absorption.

Bioavailability

The amount of drug reaching systemic circulation, which is less than $100\%$ for oral administration ($PO$).

Distribution

The process of a drug becoming available to body fluids and tissues, influenced by blood flow, tissue affinity, and protein binding.

Protein Binding Effect

Occurs when a drug binds to a protein and is not floating freely; only unbound (free) drugs can reach target cells or be excreted.

Metabolism (Biotransformation)

The change of a substance's chemical structure to facilitate quicker elimination; the liver is the main site.

Excretion

The elimination of drugs from the body, with the kidneys being the most common site.

Pharmacodynamics

The study of drug concentration and its effects on the body.

Primary Effect

The desired therapeutic effect for which a drug is administered.

Secondary Effect

All effects of a drug other than the desired therapeutic effect.

Onset

The time it takes to reach the minimum effective concentration after administration.

Peak

The point when a drug reaches its highest blood or plasma concentration; drawn after medication is given.

Duration

The length of time a drug has a pharmacologic effect.

Half-life ($t_{1/2}$)

The amount of time it takes for a drug's active substance to reduce by half in the body.

Trough Level

The lowest serum concentration, drawn immediately before the next dose is given.

Loading Dose (Bolus)

A large initial dose used to achieve rapid minimum serum drug concentration, such as Digoxin or Heparin.

Agonist

Drugs that produce a response, such as Heroin, Morphine, and Oxycodone.

Antagonist

Drugs that block a response, such as Naloxone.

Rapid-Acting Insulin (Apidra, Humalog, Novolog)

Onset: within $16\,\text{min}$; Peak: $1-2\,\text{hr}$; Duration: $3-4\,\text{hr}$.

Regular Insulin (Short-Acting) SUBQ

Onset: $30\,\text{min}-1\,\text{hr}$; Peak: $2-4\,\text{hr}$; Duration: $5-7\,\text{hr}$.

Regular Insulin (Short-Acting) IV

Onset: $10-30\,\text{min}$; Peak: $15-30\,\text{min}$; Duration: $30-60\,\text{min}$.

NPH (Intermediate-Acting)

Onset: $2-4\,hx$; Peak: $4-10\,\text{hr}$; Duration: $10-16\,\text{hr}$.

Insulin Glargine (Long-Acting)

Onset: $3-4\,\text{hr}$; Peak: No Peak; Duration: $24\,\text{hr}$.

Food, Drug and Cosmetic Act of 1938

Regulates the production and sale of food, drugs, and cosmetics; focuses on safety and efficiency before marketing.

Durham-Humphrey Amendment of 1952

Distinguished between prescription and OTC drugs and authorized verbal prescriptions.

Kefauver-Harris Amendment of 1962

Requires manufacturers to prove drug effectiveness and disclose major side effects.

Controlled Substance Act of 1970

Federal policy regulating the manufacturing and distribution of regulated substances to fight drug abuse.

Warfarin Therapeutic Data

Range: INR $2-3.5$; Antidote: Vitamin K.

Digoxin Therapeutic Data

Range: $0.5-2$; toxicity occurs above $2.4$; Antidote: Digibind.

Phenytoin Therapeutic Data

Total range: $10-20$; Unbound range: $1-2$.