How to Keep Your DEA Number Safe

Cary L. Clarke, MD

October 15, 2004

Lecture Overview

• History of Controlled Substances

• History of Regulation

• Principles in Practice

History of Controlled Substances

Controlled substances have been a part of human culture since people figured out how to ferment fruit, smoke herbs, snort powders, or spin around in circles until they

fell down.

Native Americans were using hallucinogens long before the

appearance of Europeans.

Opium and its derivatives made their largest appearance in the 1850s with the arrival of the

Chinese who labored on the new rail roads and in the mines.

As the need for laborers increased, the Chinese and their

habits spread east.

By the 1870s, opium dens were frequented by gamblers, actors

and prostitutes.

By the 1890s, opium dens were commonplace throughout the

country.

Opium den on lower Wazee Street

In 1859, Italian physician, Paolo Mantegazza touts the medicinal properties of coca and cocaine.

In 1863, Italian Chemist, Angelo Mariani becomes intrigued with

the commercial potential of Mantegazza’s work, and markets a coca-infused wine called Vin

Mariani.

Medical applications of narcotics came in the form of patent

medications and more legitimate tinctures.

A commonly prescribed tonic for pain of various sorts, Laudenum, was alcohol infused with opium.

Paregoric, a common remedy for digestive ailments, was

compounded from opium, alcohol, camphor, anise oil, benzoic acid and glycerin.

In 1879, cocaine was endorsed as a treatment for morphine

addiction.

In 1880, the chemical compound, cocaine, is isolated from coca

leaves.

In 1884, the Germans begin using cocaine as a local anesthetic.

In 1885, Parke Davis begins selling various forms of cocaine,

promising its products would “supply the place of food, make

the coward brave, the silent eloquent, and ...render the

sufferer insensitive to pain.”

With a limited armamentarium, physicians were grateful to have

something to relieve their patients’ suffering.

History of Regulation

1875—San Francisco passes the first antidrug laws in the nation

At the turn of the century, the level of moral and social anxiety was running high. Suffragettes, Prohibitionists and the forebears

of the civil rights movement were becoming vocal.

The Pure Food and Drug Act of 1906

1903—American Journal of Pharmacy characterizes cocaine users as “bohemians, gamblers, high- and low- class prostitutes,

night porters, bell boys, burglars, racketeers, pimps, and casual

laborers.”

1914—Dr. Christopher Kent’s testimony in favor of regulation

before the passage of the Harrison Narcotics Tax Act of

1914 elevated racial innuendo to the explicit.

The Harrison Narcotics Tax Act of 1914

• Championed by famed missionary and Prohibitionist Wm Jennings Bryan

• Was a nod to international relations (esp. China, battling rampant opium industry)

• Was an instrument of revenue• Was the first instance of registering practioners,

manufacturers, distributors, etc.• Was the foundation for laws regulating

manufacture and distribution of narcotics, vestiges of which exist today

Registration and enforcement is overseen by the Bureau of Internal Revenue under the

Department of the Treasury from 1915-1927

• 1922—Cocaine as a narcotic is officially outlawed

• 1929—the last year that Coca Cola contains cocaine as an additive

From 1927-1930 a new agency enforces the regulations under the

DOT, known as the Bureau of Prohibition

1925, 1931 and 1936 saw international agreements,

including participation by the League of Nations, to regulate

international trade and manufacture of narcotics.

Narcotics are limited to legitimate medical uses.

After the repeal of Prohibition, the DOT designates a new

agency, the Bureau of Narcotics to control marijuana,cocaine and

opiates from 1930-1968

Regulation = Criminalization

By WWII, heroin and cocaine were all but eliminated and drugs were viewed as a largely solved

social ill.

With the social upheaval of the 1960s, narcotics once again

become fashionable, and research into mind altering drugs and their legitimate applications emerges.

In response, under the FDA and the Department of Health,

Education & Welfare,the Bureau of Drug Abuse Control emerges to control dangerous drugs such as depressants, stimulants and

hallucinogens.

In 1968, LBJ merges these two bureaus into the Bureau of

Narotics & Dangerous Drugs, placing this authority under the

Department of Justice.

Four more agencies evolve from this, but bitter rivalries develop. In an effort to fortify regulation

and enforcement, the DEA is launched under the banner of the Department of Justice in 1973.

Principles in Practice

What are You Prescribing--Drug Schedules

• Set by the Attorney General with input from

• Secretary of Health and Human Services,

• Secretary of State

• Secretary Genereal of the United Nations, with input from the World Health Organization

Schedule I

• Drug or other substance with high abuse potential

• No currently accepted medical use in the US

• Lack of accepted safety for use under medical supervision

• Examples: Heroin, cocaine, MDMA/XTC

Schedule II

• High abuse potential

• Has a currently accepted medical use in the US, or use with severe restrictions

• Abuse may lead to severe psychological or physical dependence

• Examples: Dilaudid, methadone, Oxycontin

Schedule III

• Less abuse potential than I or II drugs• Has a current accepted medical use in the

US• Abuse leads to moderate or low physical

dependence or high psychological dependence

• Examples: Amphetamine, methylphenidate, anabolic steroids

Schedule IV

• Lower potential for abuse than I-III

• Has an accepted medical use in the US

• Limited physical or psychological dependence

• Examples: Phenobarbital, barbital, Xanax

Schedule V

• As before, but even LESS so

• Any compound, mixture, or preparation containing limited quantities of narcotics– for instance, not more than 200mg of codeine per 100ml or per 100 gm

• Examples—some cough suppressants, Lamotil

Who Needs a DEA Number

• Anyone prescribing, dispensing, manufacturing or distributing Scheduled Substances

• Some health insurance companies require their providers to have a DEA number

• Some retail pharmacies require DEA numbers to use as identification of providers

SAFETY M EASURES

• Don’t have your prescription pad publisher print your DEA number on your pads

• Write a pager or phone number on the “DEA Number” line of your pad for new or unknown patients

• If you dispense controlled substances from your office, you must maintain them in a locked cabinet in a secured area of the office per DEA requirements

• Maintain a log of dispensed narcotics for two years, including the patient’s address

• Keep prescription pads in a safe place, not easily accessible in rooms or at your nurse’s station

• Use prescription pads with duplicates or photocopy originals

• Document extensively in your patient encounter form what was given, how many, etc. This record must be maintained for a period of two years.

• Log all re-fills• Do not refill Schedule II medications

• Do not prescribe for family, friends, or self• Request old records before continuing a new patient’s

previous regimen• Have patient return unused portions when changing to a

new agent because the previous was “not working”• Prescribe generic whenever possible (lower street

value)• Familiarize yourself with the rules and regulations of

your state (some states require a separate narcotics license at the state level, without which your DEA license is suspended

• Report suspected diversion/abuse as soon as you become aware of it. This applies to patient misuse, staff abuse, peer use, and pharmacist malfeasance. Failure to do so will reflect as liability on you. Report to Law Enforcement and to the DEA Diversion Office in your area.

• Do not phone out prescriptions after hours or on weekends when you can’t access patient records. (Fake patient phone ins is one of the most common means of diversion.)

• Respect the pharmacist who calls to double check• Ask pharmacist to fax copy of questionable prescription.

• FYI—Pharmacists are subject to “corresponding liability,” meaning they are just as responsible for misuse issues as we are.

• There is no magic number which triggers an investigation or audit by the DEA.

• Use of methadone or other scheduled drugs for Narcotic Treatment Programs requires separate specific registration with the DEA.

• Refer to deadiversion.usdoj.gov and 21 CFR (code of fed regulations) 1300 for more information regulations applicable to prescription writing.