Reading 8

Question 1

What is the Federal Controlled Substance Act?

Answer 1

• Created more control around drugs that could be misused and lead to substacne use disorders

Question 2

What was the new category created by the Controlled Substance Act?

Answer 2

• “Controlled Substances”

Question 3

What are the eight factors that determine the scdeduling or removal from schedules?

Answer 3

• Potential Abuse
• Pharmacologic Effect [if known]
• Current knowledge of drug
• History of abuse
• Scope of abuse
• Risks to public health
• Psychicro Physiological Liability
• Precusor of controlled substance

Question 4

When evaluating the eight factors of scheduling, what are one of the four things is can lead too?

Answer 4

• Become schedule when it wasnt
• Changes to a different schedule
• Removed from schedule early
• Remains the same schedule

Question 5

What are the Five schedules of Controlled substances?

Answer 5

• C-I
• C-II
• C-III
• C-IV
• C-V

Question 6

What is important to know about determining what a C-I is?

Use? Abuse? Dependency?

Answer 6

• Medical Use: NO
• Abuse: HIGH
• Dependency: NOT DEFINED [Psycological/Physical]

i.e.: Ecstasy, Marijuana, Herion, Peyote, Psilocybin

Question 7

What is important to know about determining what a C-II is?

Use? Abuse? Dependecny?

Answer 7

• Medical Use: Yes
• Abuse: HIGH
• Dependency: SEVERE [both psychological/physical]

i.e: Adderal, Cocaine, Fentanyl, Methamohetamine

Question 8

What is important to know about determining what a C-III is?

Use? Abuse? Dependency?

Answer 8

• Medical Use: YES
• Abuse: Lower than I or II
• Dependency: HIGH/LOW to MOD [psyhological/physical respectively]

i.e.: Steroids, Buprenophine, Ketmine, Xyrem, Marinol

Question 9

What is important to know about determining what a C-IV is?

Use? Abuse? Dependency?

Answer 9

• Medical Use: YES
  Abuse: Lower than III
  Dependency: LIMITED [both psyhocological/physical]

i.e.: Alprazolam, Chlordiazepoxide, Phenobarbital, Tramadol, Diaepam, modafinil, Zolpidem

Question 10

What is important to know about determining what is a C-V is?

Use? Abuse? Dependency?

Answer 10

• Medical Use: YES
• Abuse: Lower than IV
• Dependency: LIMITED [both psyhcological/physical]

i.e.: Lomotil, Pregabalin, Lacosamide, Robitussin AC

Question 11

What are some of the things that must be done to sell an OTC-controlled substances WITHOUT a prescription?

Answer 11

• Make decision to sell and ONLY to some +18yo
• Limits within 48 hours [NO more than 240ml (8oz) or 48 units if opium & 1/2 within 48h]
• Verify the patient and record the sale

Question 12

What is some of the things that the Pharmacist must record when selling a OTC-controlled substance?

Answer 12

• Name of patient
• Name of Controlled Substance & Quantity
• Date
• Name of Pharmacist
• MUST be in a bound notebook

Question 13

What is the limit of the amount of Pseudoephedrine, Ephedrine, and Phenylpropanolamine that you can get in a day?

Answer 13

• NO MORE then 3.6g per day & 9g per month
• NO MORE then 7.5g imported

Question 14

What must the manufacturer put on a controlled substance bottle?

Answer 14

• C with what ever schedule it is

Question 15

What does the DEA do?

Answer 15

• Tasked with enforcing controlled substance laws and regulation of the US, which means it administers all parts of the CSA

Question 16

Practice Question 1

A drug’s recent abuse history is sufficient information to require scheduling?

a. True
b. False

Answer 16

• b. False

Question 17

Practice Questions 2

An NDA is being reviewed by the FDA for approval. The product is used to treat pain and has been found to meet the factors for scheduling. The drug has a higher dependence liability than Pregabalinm and it has a greater addiction potential than tesosterone. Which of the following schedules is the most appropriate for its future schedule?

a. Schedule I
b. Schedule II
c. Schedule III
d. Schedule IV
e. Schedule V

Answer 17

• b. Schedule II

Question 18

Practice Question III

Select all of the following that are factors when deciding wheter a drug should be scheduled>

a. Actual potential for abuse
b. Evidence of the pharmacologic effect of the drug
c. Likelihood for use by practitioners
d. Ease of access
e. Psychologic or Physiologic Dependence

Answer 18

• A, B, E