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.
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.
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.
Paregoric, a common remedy for digestive ailments, was
compounded from opium, alcohol, camphor, anise oil, benzoic acid and glycerin.
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.
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
• 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.