Arcangelo Chapter 1 - Issues for the Practitioner Flashcards
Application to the FDA for investigational use of a drug is made only after this portion of research is completed
A pre-clinical trial
Clinical trials consist of ____ clinical phases and may last up to ____ years
Four
Nine
This is the clinical phase in which healthy people are tested and concentrates on pharmacokinetics
Phase I
In this clinical phase patients with the disease are tested for drug effects
Phase II
Double-blind research is used to compare an effective drug with a new one in this clinical phase
Phase III
Once on the market, a drug enters this clinical phase and everyone who takes it is monitored
Phase IV
These drugs have a high potential for abuse and are not available for routine therapeutic use (heroin, LSD)
Schedule 1 drugs
These drugs have a valid medical use but have a high potential for abuse, both physiologically and psychologically (amphetamines, barbiturates)
Schedule 2 drugs
These drugs have a lower potential for abuse and contain controlled and non-controlled substances (narcotics such as codeine, non-barbiturate sedatives)
Schedule 3 drugs
These drugs have a low potential for abuse but may cause psychological dependence (non-narcotic analgesics, anti-anxiety agents such as Ativan)
Schedule 4 drugs
These drugs have the least potential for abuse and are used mainly as antitussives and antidiarrheals
Schedule 5 drugs
Prescriptions for this level of drug may be prescribed by telephone only in an emergency and must be backed by a written proscription within 72 hours
Schedule 2 drugs
Prescriptions for these drugs cannot be refilled
Schedule 2 drugs
A verbal order may be given to the pharmacy for these drugs and the prescription may be refilled up to five times in six months
Schedule 3 drugs
What must be included on the prescription for a controlled substance for the prescription to be valid
The US Drug Enforcement Agency (DEA) number
What is used to uniquely identify a health care provider in standard transactions such a s health care claims and was created by CMS
The National Provider Identifier (NPI)
What drugs approved by the FDA, are legally obtained without a prescription, are often self-prescribed, and may delay the diagnosis of potentially serious problems
OTC
What drugs must demonstrate therapeutic equivalence to a brand name drug before being released for use
Generic drugs
The AUC values obtained for a generic drug must be within ___% to ___% of those obtained for the brand name drug
80, 125
What is found on the label of herbal products
The effect of the product on the body and a statement that the product has not been reviewed by the FDA
Prescribing practices of practitioners are regulated by whom
The state in which the practitioner practices
What type of practice has no requirements for physician collaboration or supervision
Independent
What type of practice requires a formal agreement with a physician
Collaborative
What type of practice is overseen or directed by a supervisory physician
Supervised
