health care systems lecture 12

Schedule I (C-I)

Schedule I (C-I): High abuse potential, no medical use, not available in pharmacies (e.g., heroin, most marijuana products).

Schedule II (C-II)

Schedule II (C-II): High abuse and misuse potential, high dependence risk (e.g., morphine, oxycodone, methylphenidate)

Schedule III (C-III)

Schedule III (C-III): Moderate abuse and dependence potential (e.g., Tylenol #3, ketamine, testosterone).

Schedule IV (C-IV)

Schedule IV (C-IV): Low abuse potential, limited dependence risk (e.g., diazepam, lorazepam, sedatives).

Schedule V (C-V)

Schedule V (C-V): Lowest abuse potential (e.g., cough meds with limited codeine, Lomotil); in some states, may be sold OTC under strict requirements

Regulatory Role of the DEA

The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act of 1970, regulating manufacturing, distribution, dispensing, storage, and record-keeping of controlled substances.

Requires entities (pharmacies, prescribers, manufacturers) to register and possess a DEA number

DEA Form 222

to order Schedule II drugs

DEA Form 106

to report theft or significant loss

Labeling Requirements for Prescription Drugs Manufacturer Package

Must display the DEA schedule designation ("C" + schedule number) if applicable, "Rx only", National Drug Code (NDC), name/address of manufacturer/packer/distributor, drug name, strength, dosage form, expiration date, lot number, package size, warnings, and legibility/formatting standards. Must be accompanied by FDA-approved prescribing information/package insert

Labeling Requirements for Prescription Drugs Patient Outpatient Container

Must bear the federal transfer warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

FDA Requirements for Labeling of Drugs Package Insert (Healthcare Professionals)

Requires sections for indications, dosage/administration, adverse reactions/warnings/precautions, contraindications, preparation, pharmacology, storage, and package sizes/NDCs.

FDA Requirements for Labeling of Drugs Patient Information

Consumer Medication Information (CMI): Not routinely FDA-reviewed or approved.

Patient Package Insert (PPI): FDA-approved; required for specific drugs like oral contraceptives and estrogens.

Medication Guide: FDA-approved; required for select high-risk medications and drug classes

FDA Requirements for Labeling of Drugs Over-the-Counter (OTC) Drugs

Over-the-Counter (OTC) Drugs: Requires a standardized Drug Facts section (active/inactive ingredients, uses, warnings, directions), drug name, quantity, manufacturer info, dosage/frequency, side effects, lot number, and expiration date

Purpose of Prescription Monitoring Programs (PMPs)

Purpose: Electronic state-level programs used to identify potential prescription drug diversion and abuse by patients, pharmacies, or prescribers, identify individuals who need drug abuse treatment, and serve as a clinical tool.

Function of Prescription Monitoring Programs (PMPs)

Function: Pharmacies periodically report filled controlled substance prescriptions electronically to state databases

Role of Key Federal Laws Related to Drug Safety Controlled Substances Act (1970)

Establishes the legal framework to regulate all aspects of controlled substance handling

Role of Key Federal Laws Related to Drug Safety Poison Prevention Packaging Act (1970)

Mandates child-resistant packaging for medications (with consumer opt-out options and exemptions like sublingual nitroglycerin and birth control pills).

Role of Key Federal Laws Related to Drug Safety Combat Methamphetamine Epidemic Act of 2005 (CMEA)

Regulates OTC sales of pseudoephedrine/ephedrine (methamphetamine precursors) by requiring products to be behind the counter, logbook signatures, and sales limits (3.6 g/day, 9 g/30 days)