Transcript How to Keep Your DEA Number Safe

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.