Pharma Exam 1 Flashcards
The Durham-Humphrey Amendment
designates drugs that must be prescribed by a licensed physician or nurse practitioner and dispensed by a pharmacist. The U.S. Food and Drug Administration (FDA) is charged with enforcing the law.
The Drug Enforcement Administration (DEA)
Enforces the Controlled Substances Act. Individual
people and companies legally empowered to handle controlled substances must register with the DEA, keep accurate records of all transactions, and provide for secure storage. The DEA assigns prescribers a number, which they must include on all prescriptions they write for a controlled substance.
Controlled Substances Act
Regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, and anabolic steroids and requires the pharmaceutical industry to maintain physical security and strict record keeping for these drugs and substances. The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act.
FDA role in approving new drugs
The FDA is responsible for ensuring that new drugs are safe and effective before approving the drugs and allowing them to be marketed. The FDA reviews research studies (usually conducted or sponsored by pharmaceutical companies) about proposed new drugs; the organization does not test the drugs.
Phases of testing new medication
Phase 1, a few doses are given to a certain number of healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity.
Phase 2, a few doses are given to a certain number of subjects with the disease or symptom for which the
drug is being studied, and responses are compared with those of healthy subjects.
Phase 3, the drug is given to different populations and different dosages and by using the drug in combination with other drugs. In Phase 4, the FDA allows the drug to be marketed and requires monitoring of the drug’s safety and effectiveness.
Pharmacokinetics
involves drug movement through the body (i.e., “what the body does to the
drug”)
Specific processes are absorption, distribution, metabolism, and excretion.
Pharmacodynamics
involves drug actions on target cells and the resulting alterations in cellular biochemical reactions and functions (i.e., “what the drug does to the body”).
Schedule I Drugs
Drugs that have no accepted medical use, have lack of accepted safety, and have high abuse potentials: heroin, lysergic acid diethylamide (LSD), 3,4methylenedioxymethamphetamine (MDMA or ecstasy), mescaline, and peyote
Schedule II Drugs
Drugs that are used medically and have high abuse potentials: opioid analgesics.
(e.g., codeine, hydromorphone, methadone, meperidine, morphine, oxycodone), central nervous system (CNS) stimulants (e.g., cocaine, methamphetamine), and barbiturate sedative–
hypnotics (e.g., pentobarbital).
Schedule III Drugs
Drugs with less potential for abuse than those in Schedules I and II, but abuse of which may lead to psychological or physical dependence: androgens and anabolic steroids, some depressants (e.g., ketamine, pentobarbital), some CNS stimulants (e.g., methylphenidate),
and mixtures containing small amounts of controlled substances (e.g., codeine, barbiturates not listed in other schedules). These drugs and substances have an accepted medical use in the United States.
Schedule IV Drugs
Drugs with an accepted medical use in the United States but with some potential for abuse: benzodiazepines (e.g., diazepam, lorazepam), other sedative–hypnotics (e.g., phenobarbital,
Schedule V Drugs
Products containing moderate amounts of controlled substances.
-dispensed by the pharmacist without a physician’s prescription but with some restrictions regarding amount.
Included are cough suppressants containing small amounts of codeine and antidiarrheal drugs, such as diphenoxylate and
atropine (Lomotil).
Medication oversight in Hospitals
Procurement, preparation, storage, distribution, and control of all drugs throughout a hospital is the responsibility of the Director of Pharmacy.
Medications shall be stored in hospitals in a secure manner to protect public health and safety, and to
promote patient care.
The generic name
(Official Name) is related to the chemical or official name and is independent of the manufacturer. The generic name often indicates the drug group (e.g., drugs with generic names ending in “cillin” are penicillins). The generic name often indicates the drug group (e.g., drugs with generic names ending in “cillin” are penicillins).
- Generic drugs are required to be therapeutically equivalent and are less expensive than trade-named drugs.
The brand Name
(trade) name is designated and patented by the manufacturer. For example, amoxicillin is manufactured by several pharmaceutical companies, some of which assign a specific trade name (e.g., Amoxil, Larotid) and several of which use only the generic name. In drug literature, trade names are capitalized, and generic names are presented in lowercase.
How do we warn patients about drugs
Adverse Effects and
Black Box Warnings
Patient Drug Rights
RIGHT DRUG
RIGHT DOSE
RIGHT PATIENT
RIGHT ROUTE
RIGHT TIME
right reason,
right documentation,
right patient education,
right evaluation
right to refuse the medication
half-life
Serum half-life, also called elimination half-life, is the time required for the serum concentration of a drug to decrease by 50%.
It is determined primarily by the drug’s rates of
metabolism and excretion. A drug with a short half-life requires more frequent administration than one with a long half-life.
steady-state concentrations
When a drug is given at a stable dose, four or five half-lives are required to achieve steady-state concentrations and to develop equilibrium between tissue and serum concentrations. Because
maximal therapeutic effects do not occur until equilibrium is established, some drugs are not fully effective for days or weeks. To maintain steady-state conditions, the amount of drug given must equal the amount eliminated from the body.
Absorption
The process that occurs from the time a drug enters the body to the time it enters the
bloodstream to be circulated. Onset of drug action is largely determined by the rate of absorption; intensity is determined by the extent of absorption. Numerous factors affect the rate and extent of drug absorption, including dosage form, route of administration, blood flow to the site of administration, GI function, the presence of food or other drugs, and other variables.
Distribution
transport of drug molecules within the body; after a drug is injected or absorbed into the bloodstream, it is carried by the blood and tissue fluids to its sites of action, metabolism, and excretion
Metabolism
or biotransformation, is the method by which drugs are inactivated or biotransformed by the body. Most often, an active drug is changed into inactive metabolites, which are then excreted.
Excretion
elimination of a drug from the body; effective excretion requires adequate functioning of the circulatory system and of the organs of excretion (kidneys, bowel, lungs, and skin)
older adults (65 years and older), physiologic changes may alter all pharmacokinetic processes.
Changes in the GI tract include decreased gastric acidity, decreased blood flow, and decreased motility. Despite these changes, however, there is little difference in drug absorption.
-Changes in
the cardiovascular system
include decreased cardiac output and therefore slower distribution.
-In the LIVER, blood flow and
metabolizing enzymes are decreased. -Drugs are metabolized more slowly, have a longer action, and are more likely to accumulate with chronic administration.
In the KIDNEYS-
decreased blood flow, decreased glomerular filtration rate, and decreased tubular secretion of drugs. Slow excretion and promote accumulation of drugs in the body.
