Exam 2 lecture 9 Flashcards
Controlled substances in 1900
recreational and medical use of opiates, cocaine and other medications known as controlled were common
1914: The Harrison Narcotics Act
First federal law involved in regulation and control of certain drugs
Required importers, manufacturers, and distributors of cocaine and opiates (narcotics) to:
- Register with US Treasury
- Pay a special tax on these drugs
- Keep records of each transaction
Allowed practitioners to prescribe opiates/cocaine in practice
The effect of the Harrison Narcotics Act
Treasury viewed patient drug maintenance with narcotics beyond the scope of practice
The Narcotic Division of the Internal Revenue Bureau was responsible for enforcing this “Narcs”
As a result, physicians stopped prescribing narcotics
1920-30s: Prohibition and Marijuana
18th amendment prohibited alcohol in 1919 and was repealed by 21st amendment in 1933
1930, Federal Bureau of Narcotics was established within the Treasury. First commissioner attacked marijuana use
The Marihuana Tax Act
Federal government banned marijuana under this act by requiring a high-cost transfer tax stamp for marijuana sale
Federal government was in control of these stamps, and they were VERY RARELY ISSUED
Following this, all states made possession of marijuana illegal
Substance control laws
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 Justice.
Merged with Customs and changed to the Drug Enforcement Agency (DEA)
Comprehensive Drug Abuse Prevention and Control Act
Title 1: instituted rehab programs for controlled substance use disorder
Title 2: Established 5 separate schedules of controlled substances. Regulated the manufacture, distribution, and dispensation of controlled substances.
Title 3: Addressed import and export of controlled substances
Title 2: Comprehensive Drug Abuse Prevention and Control Act
Commonly referred to as the Controlled Substances Act (CSA)
controlled substance schedules
registration with DEA
inventory requirements
recordkeeping requirements
ordering requirements for controls
prescription requirements
dispensing requirements
security requirements
transfer or disposal of controls
What is a controlled substance?
A controlled substance is a drug with a dependence liability and/or abuse potential
What are the factors determining scheduling of controlled substances?
- Its actual or relative potential for abuse
- Scientific evidence of its pharmacological effect, if known
- The state of current knowledge regarding the drug or other substance
- Its history and current pattern of abuse
- The scope duration, and significance of abuse
- What, if any, risk there is to the public health
- Its psychic or physiological dependence
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter
Scheduling/changing of schedule
The eight factors for determining controlled substance scheduling allow for:
1. Scheduling a drug that was previously not scheduled
2. Changing a drug from one schedule to another
3. Removing a drug from the schedule entirely
4. Keeping a drug in its current position (controlled/uncontrolled)
We don’t always anticipate how drugs will be used/abused. These factors allow for scheduling fluidity.
Schedule 1
Abuse potential: high
Medical use: no
Psychological dependency: not defined
Physical dependency: not defined
Schedule 2
Abuse potential: High
Medical use: Yes
Psychological dependency: Severe
Physical dependency: Severe
Schedule 3
Abuse potential: Lower than 1 or 2
Medical use: Yes
Psychological dependency: High
Physical dependency: Moderate to Low
Schedule 4
Abuse potential: Lower than 3
Medical use: Yes
Psychological dependency: limited compared to 3
Physical dependency: limited compared to 3
Schedule 5
Abuse potential: Lower than 4
Medical use: Yes
Psychological dependency: limited compared to 4
Physical dependency: limited compared to 4
Key points: controlled substance schedules
- Schedules are in decreasing order of abuse potential or dependence issues
- Schedule 1 is the only schedule with no accepted medical use
- Schedule 2 has the same abuse potential as schedule 1
- Schedule 3, 4, and 5 are stratified by abuse potential and/or addiction potential
- Not all schedules are intuitive (meth, cocaine)
- Different dosage forms have different schedules (dronabinol)
- Different drug combos may have different schedules (codeine)
Federal Schedules vs. State Schedules
State schedules can and will differ. You need to follow the stricter of the two schedules within whatever state you are practicing
Some states have begun regulating or rescheduling products. We will focus on federal and IN scheduling
OTC controlled substances
If a controlled substance is classified as a nonprescription drug, it may be sold w/o a prescription.
Codeine/guaifenesin liquid –> meet this criteria
Selling Controlled Substances OTC
- A pharmacist must decide to sell the medication, only to someone who is 18 years old or older
- Sale is limited to 240mL or 48 dosage units (tabs, caps) of any substance containing opium, or 120 mL or 24 dosage units of any other controlled substance in a 48-hour period.
- Pharmacist must verify patient and record info:
- Review valid form of ID
- Name of purchaser
- Name and quantity of controlled substance
- Date of each purchase
- Name or initials of pharmacist
All info must be recorded in a bound book (not electronic or loose papers)
OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine amount
The CSA limits the sale of “listed chemicals” due to their ability to produce methamphetamine:
pseudoephedrine
ephedrine
phenylpropanolamine
Federal law limits: 3.6g/day, and 9g in 30 days,
no more than 7.5g imported or mail
Many states have additional and/or stricter limits on these products
OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine requirements
- Sellers must maintain a written or electronic sales record which contains
- Name, address, and signature of purchaser
- Date and time of sale
- Name and quantity of product purchased - Purchaser must present valid form of ID, containing a photo, is nonexpired, and issued by state or federal government
Controlled substance labeling
are required to have a symbol prominently displayed on the label of the commercial container
the symbol denotes the schedule of the substance
