Basic Pharmacology Concepts - Controlled Substances

BASIC PHARMACOLOGY CONCEPTS

Controlled Substances

• The Federal Controlled Substances Act (CSA) regulates drugs with potential for abuse.

  • These drugs can be prescribed by physicians but are subject to strict regulations due to the risks associated with their misuse by patients or others.
  • The Drug Enforcement Administration (DEA) is responsible for enforcing regulations regarding:
  • Storage of controlled substances
  • Record keeping
  • Safekeeping of these substances

• Controlled substances are also referred to as Schedule Drugs.

  • They are categorized by schedule based on their potential for abuse:
  • Schedule I Substances (C-I): Considered the most dangerous regarding abuse potential.
  • Schedule II Substances (C-II): High potential for abuse but also accepted for medical use with severe restrictions.
  • Schedule III Substances (C-III): Moderate to low potential for physical and psychological dependence.
  • Schedule IV Substances (C-IV): Low potential for abuse relative to C-III.
  • Schedule V Substances (C-V): Lowest potential for abuse with minimal risk of dependency.

• Record Keeping and Management:

  • Physicians and pharmacists are required to:
  • Account for all controlled substances.
  • Maintain accurate records regarding their purchase and management for a period of two years.
  • Specific procedures include:
  • Storing controlled substances in a locked box, separate from patient charts.
  • Counting the substances with two staff members present when keys are transferred.
  • Ensuring substances are available for inspection by DEA personnel at any time.

• Documentation Requirements:

  • When a controlled substance is administered:
  • Must log the following information:
    • Date of administration
    • Time of administration
    • Patient name
    • Dosage given
    • Amount dispensed
  • This information must be documented in the patient's chart.

• Discrepancy Policies:

  • Investigate any discrepancies between documentation and physical inventory in the physician's office.
  • Any missing controlled substances must be reported immediately to authorities.
  • Expired or unused drugs must be returned to a pharmacist for proper disposal.

Scheduling Overview

• Schedule I - V Breakdown:
  • Schedule I Substances (C-I): Highest abuse potential, no accepted medical use.
  • Schedule II Substances (C-II): High abuse potential, accepted for medical use, severe restrictions.
  • Schedule III Substances (C-III): Moderate abuse potential, accepted for medical use.
  • Schedule IV Substances (C-IV): Lower abuse potential compared to C-III, accepted for medical use.
  • Schedule V Substances (C-V): Lowest abuse potential, low risk of dependency.