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
Schedule III narcotics: Abuse potential, Examples and Handling.
Abuse Potential: Moderate
Examples: Codeine, Hydrocodone
Handling: Rx can be phoned in, no more than 5 refills in less than 6 months
Schedule IV narcotics: Abuse potential, Examples and Handling:
Abuse Potential: Less
Examples: Diazepam
Handling: Rx can be phoned in, no more than 5 refills in less than 6 months
Schedule V narcotics: Abuse potential, Examples and Handling
Abuse Potential: Lease
Examples: Some codeine cough syrups
Handling: Can be OTC in some states
Purpose of Prescription writing is __?
- Saves time-don’t need to clarify
- Decrease in mistakes
- Originally in Latin
- Recent years-simplified
Which measurement system:
- Has calculations are based on 10
- Language of scientific measurement
a. Kilogram-weight
b. Liter- volume - Solid drugs dispensed by weight
- Liquid drugs dispensed by volume
Metric
1 kilogram =
1000g
1 gram =
1,000,000 micrograms
The process of manipulating DNA and RNA and recombining genes into hybrid molecules that can be inserted into living organisms and repeatedly reproduced. (ex: E. Coli)
Biotechnology
name given to a drug designed by manufacturers.
Brand/ Trade Name
Drugs that are categorized my federal law according to therapeutic usefulness and potential for abuse.
Controlled substance
Drugs are classified according to there effect on particular body systems, therapeutic use, and their chemical characteristics.
Drug classifications
related to the chemical or official name of the drug; independent of the manufacturer and often indicates the drug group
Generic name
drugs available with out a prescription
Over-the-counter (OTC) drugs
involves the cost of drug therapy including cost of purchasing, dispensing, storage, administration, lab and other tests used to monitor patient responses and loses due to expiration
Pharmacoeconomics
an inactive substance similar in appearance to the actual drug
Placebo
access to threapeutic drugs order for medication is written by a licensed health care provider.
Prescription Drugs
an example of a group of drugs often the first one of the group to be developed
Prototype
drugs that are absorbed by the body circulates through the bloodstream to their sites of action in various body tissues, and eventually are eliminated from the body
Systemic effects
is the study of drugs
pharmacology
alter functions of living organisms
Chemicals
Drug therapy use,drugs to ,prevent diagnoses treat signs and symptoms and disease
pharmocotherapy
helps with qulity of life
medications
out side body topical,
local effects
inside body, curculates threw the blood stream most drugs r give thew systemic effects
systemic effects
historicaly meds are from
plants, animals,minerals
medication now
synthetic compounds manufacterd in labs
importent source of drugs, manipulating DNA,&RNA then recombinding genes into hybrid molecules(colones) that can be inserted into living organisms hybrid molecules colones for example escherichia coli bacteria
Biotechnology
individual drugs that represent groups of drugs
prototypes
opioid Analgeics
morphine (prototype)
antibotics
penicillen(prtotype)
related to chemical of offical name and is indeprndent of manufactors always lowercase, less expensive but equal to brand
generic drugs
Brand or ,trade name
capitalized
involve cost of drugs and all who help docter, nureses techs goals are to identify drug therapy provid benifet and is cost effective
pharmaconomics
regulates manfactures distribution advertising & labeling of drugs
food drug and cosmetic Act 1938
must be prescribed Lincience Physical
Durham-Humphrey Amendment
Enforces the law
Food Drug Adminisrations (FDA)
Regulates vaccines & other biological pruducts
Public Health
can supress misleading advertiment of non-prescriptios drugs
Federal Trade commission
Specific body systems
Therapeutic uses
Chemical characteristics
Classifications
Title II: Controlled Substances Act
Regulates manufacturing and distribution of
Narcotics, depressants
stimulants, hallucinogens
Anabolic steroids
Approves many new drugs annually
Both prescription and OTC
May change status from prescription to OTC
Potential advantages and disadvantages
Food and Drug Administration (FDA) (cont.)
