Pharm Law Exam 2 Lecture 1 Flashcards
(26 cards)
What was the use of controlled substances like in the 1900s
Recreational and medical usage of opiates and cocaine was common and without regulation federally.
What was the first federal law involved in regulation of narcotics and controlled substances
The Harrison narcotic act of 1914
What did the Harrison narcotics act of 1914 require?
Required importers, manufacturers and distributors of cocaine and opiates (narcotics) to:
- register with the US treasury
- Pay special tax on these drugs
- Keep records of each transaction
Who was responsible for enforceing the harrison narcotics act? What effect did this have on physicians
Narcotic division of the IRS was responsible for enforcing this law and shutting down narcotic clinics (earned the nickname narcs)
Many physicians were jailed as maintenance with narcoitics was viewed as beyond the scope of practice of physicians so they stopped prescribing narcotics. Many users went to the black market.
Explain the 1920s and 30s in terms of alcohol and marijuana
The 18th amendment prohibited manufacture, sale or transportation of alcohol in 1919-1933. (prohibition)
During prohibition era, recreational marijuana became popular and attracted attention from law enforcement.
In 1930, Federal bureau of narcotics was established and their commissioner attacked marijuana use, claiming that marijuana incited violent behavior
What did the marihuana tax act of 1937 do?
Federal govt banned marijuana under this act by requiring a high-cost transfer tax stamp for every sale of marijuana
Federal govfernment was in control of these stamps, and they were VERY RARELY ISSUED
How did the DEA form?
In 1968: FBN combined with the bureau of drug abuse control to form the bureau of narcotics and dangerous drugs (BNDD), now under the department of justics. Merged with customs and changed to Drug enforcement agency (DEA)
What law established the 5 separate schedules of controlled substances
1970: Comprehensive drug abuse prevention and control act
What did title II of the 1970 comprehensive drug abuse prevention and control act establish
Established 5 separate schedules of controlled substances. Regulated the manufacture, distribution and dispensation of controlled substances
What is Title II more commonly referred to as
controlled substances act (CSA)
What is a controlled substance?
A controlled substance is a drug with dependence liability and/or abuse potential
What are 8 factors determining scheduling of controlled substances
- Its actual or relative potential for abuse
- Scientific evidence of its pharmacologic effect, if known
- The state of current knowledge regarding the drug or other substance
- Its history and current pattern of abuse
- Scope, duration and significance of abuse
- What, if any, risk there is to the public health
- Its psychic or physiological dependence liability
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter
What can the 8 factors for determining controlled substance be used for?
- scheduling a drug that was previously not scheduled
- Changing a drug from one schedule to another
- Removing a drug from schedules entirely
- Keeping a drug in its current position (Controlled/uncontrolled)
State the abuse potential, medical use, psychological and physical dependency of the different scheduled substances (EXAM)
Schedule I- High abuse potential, No medical use, Not defined for psychological or physiological dependency
Schedule II- High abuse potential, Yes medical use, Severe psychological and physical dependency
Schedule III- Abuse potential lower than I or II, yes medical use, High psychological dependency, moderate to low physical dependency
Schedule IV- Abuse potential lower than III, yes medical use, psychological and physical limited compared to III.
Schedule V- Abuse potential lower than than IV, Yes medical use, psychological and physical limited compared to IV
What schedule is the only schedule with no accepted medical use? Compare abuse potential of schedule 1 and 2?
Schedule 1 is the only schedule with no accepted medical use
schedule 2 has the same abuse potential as schedule 1
How are schedules 3, 4, 5 stratified
They are stratified based on abuse potential and or addiction potential
Can different dosage forms have different schedules?
Yes, dronabinol.
It is a derivative of marijuana. Liquid CII, gelatin capsule C III
Can different drug combinations have different schedules? Example (EXAM)
Yes.
Codeine by itself CII
Codeine with another drug (acetaminophen), CIII
Codeine in liquid formulation 200 mg/100 ml- C V
What to follow if federal schedules vs state schedules differ
Follow the stricter of the 2 schedules within whatever state you are practicing in
Can controlled substances classified as non prescription drugs be sold without a prescription? What is the most notable substance
Yes
Codeine/guafenesin liquid
What are 2 things we have to think about when selling CS OTC
- pharmacist must decide to sell medication and only to someone 18 years olf or older
- Sale is limited to 240 mo (8 fl. oz) or 48 dosage units (Tabs, caps) of any controlled substance containing opiom, or 120 mo (4 fl oz) or 24 dosage units of any other CS in a 48 hr eriod
What information must the pharmacist collect when selling controlled substances OTC? How to collect info?
- review a valid form of ID (Not required if pharmacist knows patient) and record information
- Name of purchase
- Name and quantity of CS purchased
- Date of each purchase
- Name or initials of pharmacist
ALL information must be recorded in a bound book (not electronically or on loose paper)
What are listed chemicals? Name them?
Products that are not controlled substances but are listed chemicals due to their ability to prioduce methamphetamine
pseudoephedrine
ephedrine
phenylpropanolamine
What is the federal limit to the listed substances?
3.6 grams/day and 9 grams in 30 days
