Safety & Regulations
Food and Drug Act
•First attempt to establish consumer protection in drug and food manufacture
•Required drugs to meet minimal standards of strength, purity, and quality
•Demanded labeling for preparations containing dangerous ingredients
•Established United States Pharmacopeia (USP) and National Formulary (NF)
Schedule IV
Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol
Drug Characteristics
–Therapeutic uses
–Most common side effects
–Precautions/Contraindications
–Interactions
–Common product names, usual dosages, and comments on administration
Drug Indications
List of medical conditions or diseases for which the drug is meant to be used
OTC
Over the counter
Local vs. Systemic Effect
•A common characteristic of all drugs
•Affect body function: cellular changes (drug actions), followed by some physiological change (effects of drugs)
•Systemic effect: reaches widespread areas of the body
•Local effect: limited to the area of the body where it is administered
Routes of Administration
•Routes of administration: selected based on speed, cost, or safety
•Enteral or GI tract routes
•Parenteral routes
Food, Drug, and Cosmetic Act
•FDA established under the Department of Health and Human Services (DHHS)
•Established more specific regulations for preventing adulteration of (tampering with) drugs, foods, and cosmetics
–Example: “Warning” labels must be present on certain preparations: “May cause drowsiness,” “may cause nervousness,” “may be habit-forming,” etc.
Schedule II
Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are: combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin
Generic vs Brand Names
Generic names are lower cased
Trade names are capitalized and can be trademarked with ®
Drug Actions
Description of the cellular changes that occur as a result of the drug
Legend Drug
Prescription drug: determined unsafe for over-the-counter purchase because of possible harmful side effects if taken indiscriminately
Drug Processing by the body
Absorption, Distribution, Metabolism, Excretion
Unexpected Drug Responses
•Tolerance: decreased response to a drug that develops after repeated doses are given
•Dependence: acquired need for a drug that may produce psychological or physical symptoms of withdrawal when discontinued
•Hypersensitivity: immune response (allergy) to a drug may vary
•Anaphylactic reaction: severe, possibly fatal, allergic (hypersensitivity) response
Controlled Substances Act
•Established the Drug Enforcement Administration (DEA)
•Set tighter controls on a specific group of drug: those being abused by society. These include depressants, stimulants, psychedelics, narcotics, and anabolic steroids
•Provided guidelines for five schedules of controlled (designated by a capital C) substances ( C I, II, III, IV, and V)
Schedule III
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are: products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone
Chemical Name
Exact molecular formula
Drug Contraindications
List of conditions for which the drug should not be given
Drug Interactions
List of other drugs or foods that: May alter the effect of the drug and usually should not be given during the same course of therapy
Absorption
•Site of absorption of drugs varies according to the physical properties of each drug
•pH (acid or alkaline)
•Lipid (fat) solubility
•Presence or absence of food in the stomach tends to slow absorption
Adverse Drug Reactions (ADRs)
•Adverse drug reactions (ADRs): unintended side effects from medications that cause a negative reaction
•Teratogenic effect: maternal drug administration causes development of physical defects in a fetus
•Idiosyncratic reaction: unique, unusual, and unexpected response to a drug
•Paradoxical reaction: opposite effect from that which is expected
FDA vs. DEA
•Food and Drug Administration (FDA)
–Oversees drug testing before release
–Inspects plants where foods, drugs, medical devices or cosmetics are made
–Reviews new drug applications for food additives
–Investigates/removes unsafe drugs from the market
–Ensures labeling of foods, cosmetics, and drugs
–Concerned with general safety standards in the production of drugs, foods, and cosmetics
–Responsible for the approval and removal of products on the market
----------------------------------------------------
•Drug Enforcement Administration (DEA)
–Concerned only with controlled substances
–Enforces laws against drug activities (illegal drug use, dealing, and manufacturing)
–Monitors need for changing the schedules of abused drugs
–Created as the need for better control of addictive drugs became urgent
–Handles all the needs and safety controls for the more dangerous drugs
Schedule V
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are: cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin
Official Name
Official name used in USP/NF
Drug Cautions
List of conditions or types of patients that warrant closer observation for specific side effects when given the drug
Drug Sources
•Plants
•Minerals
•Animals
•Synthetics
Distribution
•Also affected by specific drug properties
•Ability to cross a lipid membrane
•Selective distribution: an affinity, or attraction, of a drug to a specific organ or cells
•Distribution speed
Drug Interactions: Synergism, Potentiation, Antagonism
•Drug interactions: can be desirable or undesirable
•Synergism: drugs work together to produce desired effect that neither could produce alone
•Potentiation: drugs oppose each other to increase/prolong effect
•Antagonism: drugs oppose each other to decrease/cancel effect
•Examples given in text
These are Drug Standards set to assure consumers that they are getting what they pay for
All preparations with the same drug name must be of uniform strength, quality, and purity
Schedule I
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
Look-Alike and Sound-Alike
Recognize look-alike and sound-alike medications
Drug Side effects/Adverse reactions
List of possible unpleasant or dangerous secondary effects, other than the desired effect
Chemoinformatics
•Applies computer technology, statistics, and mathematics to study molecules: Examines molecular structure, properties, and activities
•Probably the most actively pursued source of drugs by major companies
Metabolism
•Biotransformation
•Drug transformed in the liver is broken down and altered to more water-soluble by-products (metabolites)
•May be more easily excreted by the kidneys
•Prodrugs: inactive when administered and only become active when metabolized by the liver
•Altered by interaction between drugs and food and drugs and disease states
Excretion: cumulative effect, toxicity, therapeutic range
•Most drugs are excreted by the kidneys via urine: some may be eliminated through lungs, perspiration, feces, bile, or breast milk
•Cumulative effect: Increased effect of a drug demonstrated when repeated doses accumulate in the body
•Toxicity: Condition resulting from exposure to either a poison or a dangerous amount of a drug that is normally safe when given in a smaller amount
•Therapeutic range: Range of drug levels in the blood that will give the desired effect without causing serious side effects