Controlled Substances Act & DEA

Controlled Substances Act (1970)

• Passed due to widespread drug use.
• Regulates drugs likely to be abused, initially focused on those causing physical addiction.
• Now includes substances like anabolic steroids, even without strong physical addiction potential.

Drug Enforcement Administration (DEA)

• Enforcement agency created by the Controlled Substances Act.
• Commonly called "narcs."
• Operates under the U.S. Department of Justice, separate from the FDA.

Drug Schedules

• Establishes five schedules of controlled substances.
• Schedules are based on potential for dependency or abuse and therapeutic usefulness.
• Schedule examples are detailed in A6 and A7.

DEA Registration for Prescribers

• Physicians, dentists, and other prescribers must register with the DEA.
• Registered prescribers receive a DEA number for tracking prescriptions.
• DEA number typically found on prescription forms, especially for narcotics prescribed by dentists for pain relief.

Schedule One Substances

• Illegal in the United States.
• Cannot be prescribed.
• Not listed in the United States Pharmacopeia (USP).
• High potential for dependency and no accepted therapeutic use.
• Examples include heroin and LSD (though heroin is prescribable in Canada).

Schedule Two Substances

• Can be prescribed but have a high potential for dependency.
• Accepted therapeutic uses in the United States.

Security Prescription Forms for Schedules Two and Three

• Special tamper-resistant prescription forms required for Schedules 2 & 3.
• DEA number is pre-printed on the form.
• "Void" appears upon photocopying to prevent replication.
• Prescriber checks off the quantity of pills within a range to prevent alteration.
• Refills not allowed for Schedule Two.
• New prescription required for each refill.
• Quantity cannot exceed a 30-day supply.
• Cannot be phoned in or faxed.

Examples of Schedule Two Substances

• Narcotic pain relievers: morphine, codeine, Demerol.
• Stimulants: cocaine, dexedrine, Adderall (used for ADD).
• Sedatives: barbiturate sedatives like pentobarbital and Seconal.

Schedule Three Substances

• Requires the special security prescription forms
• Are a little less strictly regulated compared to Schedule Two.
• Refill instructions are permitted (up to five refills every six months if noted).
• Can be phoned in or faxed.
• Include narcotics combined with non-narcotics.

Examples of Schedule Three Substances

• Tylenol with codeine.
• Vicodin (hydrocodone with acetaminophen).
• Anabolic steroids (due to abuse potential, especially in sports).

Schedule Four Substances

• Regular prescription forms are acceptable (though tamper-resistant forms can also be used). Examples: Valium, Xanax, Ambien, Meridia.

Schedule Five Substances

• Lowest level of controlled substances.
• Little potential for abuse.
• No real refill limitations.
• Regular form is adequate.
• DEA number still required.

Examples of Schedule Five Substances

• Robitussin AC (cough medicine with codeine).
• Lomotil (anti-diarrheal, contains a weak narcotic for constipating effects).

1984 Federal Law

• Requires generic drugs to meet the same efficacy standards as brand-name drugs.
• Aims to ensure generics work as well as brand names.

Overlapping Responsibilities of FDA and DEA

• Vicodin: FDA requires a prescription (legend drug), DEA classifies it as a Schedule Three controlled substance.
• Amoxicillin: FDA requires a prescription, but DEA does not regulate.
• Advil (ibuprofen): FDA allows over-the-counter sales, DEA has no regulations.

Potential Lawsuits Against Healthcare Providers

• Dental hygienists, like other healthcare professionals, can theoretically be sued.
• Lawsuits against doctors and dentists are more common due to their higher earning potential.

Types of Civil Actions (Torts)

• Misfeasance: Making a mistake while doing something within your license.
• Nonfeasance: Failing to do something that should have been done according to your license.
• Malfeasance: Doing something wrong that is outside your licensed scope of practice.

Sources of Drug Information

• United States Pharmacopeia (USP): Official drug listing by generic name.
• Physician's Desk Reference (PDR): Compendium of package inserts provided by drug manufacturers; useful for identifying drugs by various criteria, but information is not objective.

Prescription Writing: The Heading

• Contains information about the prescriber (name, address, phone number).
• Contains information about the patient (name, date of prescription, address, age).

Prescription Writing: The Body

• Begins with "Rx" (recipe).
• Three lines:
  • The name of the drug and its dosage.
  • Dispense (disp) and the number of pills.
  • Sig (signa) and the directions to the patient.

Prescription Writing: The Closing

• Signature of the prescriber.
• Refill instructions.
• DEA number.
• Instructions on whether a generic drug can be substituted.

Abbreviations in Prescription Writing

• Often used but not required.
• Examples: bid (twice a day), tid (three times a day), qid (four times a day).
• q6h (every six hours), ac (before meals), hs (at bedtime), PRN (as needed), po (by mouth).

Liquid Medications

• Dosages are generally written in the metric system(milliliters)
• 5 milliliters is approximately one teaspoon.

Old Apothecary System: Grains

• Unit of measurement formerly used, especially for drugs.
• 1 grain = 60 milligrams.
• Used commonly for aspirin and codeine dosages.

Codeine Dosage

• "Number Four" pill: 60 mg or one grain.
• "Number Three" pill (Tylenol with Codeine #3): half a grain or 30 mg of codeine.
• Based on the old system.

Additional Notes For Schedule 2 Drugs

• Terminally Ill patients have an exception
• Still regulated and need special consideration and approval
• Can't be fotocipied and require a specific form.