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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.
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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
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.
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.
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.
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
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.
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