Prescribing and Regulatory Issues

Definition of Controlled Substance Schedules

Controlled Substances Act (CSA) are divided into five schedules

Substances are placed in their respective schedules based on:

• currently accepted medical use

• relative abuse potential

• likelihood of causing dependence

Need a DEA number to prescribe

Schedule I Controlled Substances = Class I or C-I

no currently accepted medical use

a lack of accepted safety

high potential for abuse

Schedule II/IIN Controlled Substances (2/2N) = Class II or C-II

No refills are allowed. A new prescription must be written each time.

hydrocodone-based products (Norco®, Vicodin®, Lortab®)

Schedule III/IIIN Controlled Substances (3/3N) = Class III or C-III

Tylenol with Codeine®

Schedule IV Controlled Substances = Class IV or C-IV

tramadol (Ultram®, Ultracet®) –

Schedule V Controlled Substances = Class V or C-V

low potential for abuse

California’s Prescription Drug Monitoring Program (PDMP)

state-run electronic databases used to track the prescribing and dispensing of controlled prescription drugs to patients

CURES : database of Schedule II, III, IV and V controlled substance prescriptions dispensed in California.

LAYMAN’S LANGUAGE: I-M-D-A

I = Introduce and Indications (what the medication is)

M = Mechanism of action (the purpose of the medication is and how it works)

D = Dosage Regimen (Explain the directions for use)

A = Adverse Effects, Ask Questions, Anything Else? (potential interactions)

two basic categories, A or B

therapeutically equivalent or not