The first government attempt to establish consumer protetion in the manufacture of drugs and foods. Required all drugs marketed in the US to meet minimal standards of strength, purity, and quality. Demanded that drug preparations containing dangerous ingrediants have a labeled container indicating the ingredient. Originally there were 11 "dangerous" ingredients, such as morphine.
What are the responsibilities of the FDA?
Concerned with general safety standards in the production of drugs, foods, and cosmetics. To ensure that some basic standards would be followed including: Overseeing testing of all proposed new drugs before they are released into the U.S.market, Inspecting plants where foods, drugs, Medical devices, or cosmetics are made, Reviewing new drug applications and petitions for food additives, Investigating and removing unsafe drugs from the market, ensuring proper labeling of foods, cosmetics, and drugs.
What are the responsibilities of the DEA?
Concerned only with controlled substances. Handles all the needs and safety controls for the more dangerous drugs. Enforces laws against drug activities, including illegal drug use, dealing, and manufacturing. Monitors need for changing the schedules of abused drugs.
How many drug schedules are there and which is the most restrictive?
Five schedules of Controlled Substances C-I, II, III, IV, and V. The most restrictive would be C-1. (Which includes such drugs as heroin, LSD, mescaline, ecstasy).
The agency that requires you to keep a record of each controlled substance transaction is the?
Drug Enforcement Administration.
Prescriptions for schedule C-___ drugs may be phoned in by the health care practitioner.
An inventory record of each controlled substance transaction at an office must be kept for
Responsibilities of the FDA include?
inspecting plants where food, drugs, or cosmetics are made; reviewing new drug applications and petitions for food additives; investigating and removing unsafe drugs from the market; assuring proper labeling of foods, cosmetics, and drugs.
C-___ scheduled drugs are prescription drugs with a low potential for abuse (e.g., cough suppressants and diarrhea preparations).
Securing controlled substances at an office should be done by?
double-locking by using a locked security box inside a locked cupboard.
If a patient calls to request a refill of a Percodan (C-II) prescription, the patient must?
pick up a new written prescription from the physician, or the physician may fax the prescription, but the original prescription must be handed in when the prescription is picked up.
The 1983 Orphan Drug Act allowed?
drugs to be provided for small patient populations that might not be profitable for drug companies.
The first major U.S. drug law was passed in the year 1906 and was called?
The Pure Food and Drug Act.
USP stands for _________ and is the title of one of the original references that specified the official U.S. standards for making each drug.
Physician’s Desk Reference (PDR); United States Pharmacopeia/Dispensing Information (USP/DI); AHFS Drug Information (American Health-System Formulary Service).
Explain the difference between these two medication orders: Give two Tylenol, PO. and Give one Tylenol No #2 PO.
Give two Tylenol, PO means give two tablets of Tylenol.,Give one Tylenol #2, PO means give one tablet of Tylenol #2 (with codeine).
An older adult male was found unconscious in his bedroom with several pink and blue pills beside his bed, but no labeled pill bottle can be found. He is rushed to the emergency department for treatment. What drug reference source will be most helpful in this situation?
The PDR is best because it has color photos of the drugs.
The alkaloid named morphine is named after what Greek god of sleep?
The study of drugs and their origin, nature, properties, and effects on living organisms
The ________ creates the candidate compound?
The ________ tests the candidate compound for physiologic activity?
A promising compound is investigated by what other scientists after the pharmacologist has documented a potential therapeutic effect?
Toxicologists, Microbiologists, Clinicians.
What are the main tasks of pharmacologists in the search for and development of new medicines?
Screening for desired activity, determining mode of action, and quantifiying drug activity when chemical methods are not available.
When was synthetic organic chemistry born and by whom?
In 1828 by Friedrich Wholer
Pharmacology is held to have emerged as a separate schience only when ?
The first university chair was established. According to Walter Sneader, this occured in 1847, when Rudolf Buchheim was appointed professor of pharmacology at the University of Dorpat in Estonia. (Then part of Russia).
Who is generally recognized as the founder of modern pharmacology?
This professor of pharmacology showed that muscarine evoked the same effect on the heart as electrical stimulation of the vagus nerve, he published a classic text, Outline of Pharmacology, and he introduced urethan as a hypnotic?
Who was the first chair in pharmacology in the U.S. at the University of Michigan?
John Jacob Abel.
Who can be accredited with the following major accomplishments, the isolation of histamine from pituitary extract, the preparation of pure crystalline insulin?
John Jacob Abel
Who discovered acetylcholine in adrenal extracts in 1906?
Factors that may affect the passage of drugs through the body: Process Absorption, what is (a) the primary site of this process and (b) conditions hampering process?
a. Mucosa of the stomach, mouth, small intestine, or rectum; blood vessels in the muscles or subcutaneous tissues; dermal layers - b.Incorrect administration may destroy the drug before it reaches the bloodstream or its site of action (e.g., some drugs should be given on an empty stomach)
Factors that may affect the passage of drugs through the body: Process Distribution, what is (a) the primary site of this process and (b) conditions hampering process?
a. Circulatory system, through capillaries and across cell membranes - b.Poor circulation may prevent drug from reaching tissues
Factors that may affect the passage of drugs through the body: Process Metabolism, what is (a) the primary site of this process and (b) conditions hampering process?
a. Liver - b. Hepatitis, cirrhosis of liver, or a damaged liver may prevent adequate breakdown of drug, thus causing a buildup of unmetabolized drug
Factors that may affect the passage of drugs through the body: Process Excretion, what is (a) the primary site of this process and (b) conditions hampering process?
a. Kidneys, sweat glands, lungs, or intestines b.Renal damage or kidney failure may prevent passage of drug waste products, thereby causing an accumulation of the drug in the body
If circulation is poor, metabolism faulty, or excretion inadequate, drugs may build up in the system, leading to ___________ effects, causing poisonous, or ________, levels of the drug.
cumulative - toxic
Variables affecting the efficiency of drug action include?
age, weight, sex and psychological status.
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