chapter 1 information, etc. Flashcards
What are the 4 different sources of information for drugs?
- Explain Discuss
- Reference Texts
- Association Journals
- Internet
When a drug is being investigated & identified by chemical structure it is known as __?
chemical name
Proprietary name is also known as the __?
trade name
Another name for trade name is the __?
brand name
What are the 4 requirements of Drug substitution?
- The FDA requires that the active ingredient of the generic enters the bloodstream at the same rate as the trade name
- Chemically equivalent
- Biologically equivalent
- Therapeutically equivalent
This act was created in 1914 and provides federal control over narcotics and required registration of those giving an rx.
Harrison Narcotic Act
This act was created in 1906 & was the 1st fed law to regulate interstate commerce of drugs
Food & Drug Act
FDA functions are __?
- Part of the health and human services,
- Grants approval so drugs can be marketed
- Determines drugs to be safe & effective
- Decides which drugs or OTC or Rx
FTC functions are __?
- Regulates trade practices of drug companies
2. Prohibits false advertising of fodds, OTC drugs & cosmetics
DEA functions are __?
- Part of the Dept of Justice
- Administers the controlled substances act of 1970
- Regulates the manufacture/districution of substances with abuse potential
Omnibus Budget Reconciliation Act
This act was created in 1990 and states that phamacists MUST provide patient counseling
Phase I in the clinical evaluation of a new drug consists of __?
- Small doses
- Given to a limited number of people
- Determines:
a. Biological effects
b. Metabolism
c. Safe dose range
d. Toxic effects of the drug
Phase II in the clinical evaluation of a new drug consists of __?
- Given to a large number of people
2. Determines: Effectiveness
Phase III in the clinical evaluation of a new drug consists of __?
- Given to a larger number of people who have the condition for which the drug is indicated
- Determines:
a. Safety
b. Efficacy
c. Dosage
Phase IV in the clinical evaluation of a new drug consists of __?
Phase IV in the clinical evaluation of a new drug consists of __?
What does Phase I treatment determine about a new drug?
- Biological effects
- Metabolism
- Safe dose range
- Toxic effects of the drug
What does Phase II treatment determine about a new drug?
Effectiveness
What does Phase III treatment determine about a new drug?
- Safety
- Efficacy
- Dosage
What does Phase IV treatment determine about a new drug?
- Drug toxicity
This act was created in 1952 and Amends Food, Drug, Cosmetic Act of 1938. It requires Rx for certain drugs to be sold
The Durham-Humphrey Law of 1952
This Amendment required that manufacturers must demonstrate drug effectives, follow rules in testing, & to submit reports of adverse effects
The Drug Amendments of 1962
This amendment accounts for drugs with abuse potential
Drug Abuse Control Amendments of 1965
This amendment sets current requirements for writing prescriptions for drugs
The Controlled Substance Act of 1970-
What are some of the specific details involving the controlled substance act of 1970?
- Any Rx for controlled substance requires DEA #
- Schedule II through IV requires Rx
- Sch. II Rx-written in pen or typed-The RDH may write but the DDS must sign
- Sch. II Rx-cannot be phoned in; exception-emergency
- Sch. II- no refills; obtain new Rx
- State requirements-duplicate; triplicate-DDS gets 1, pt gets 2nd, RPH sends 1 to state board.
- Sch. III & IV-can phone in; refilled no more than 5 times in 6 months-if so, noted on Rx
Schedule I narcotics: Abuse potential, Examples and Handling
Abuse Potential: Highest
Examples: Heroin, LSD, Pot
Handling: No accepted medical use; experimental only
Schedule II narcotics: Abuse potential, Examples and Handling.
Abuse Potential: High
Examples: Oxycodone, Morphine, amphetamine
Handling: Written RX with provider’s signature, no refills