DEA/OD/ODE
Introduction:
Hydrocodone diversion and
abuse has been escalating in recent years. In 2006, hydrocodone
was the most frequently encountered opioid pharmaceutical
(25,136 items) in drug evidence submitted to state and local
forensic laboratories as reported by the National Forensic
Laboratory Information System (NFLIS). According to the System
to Retrieve Investigational Drug Evidence (STRIDE), DEA forensic
laboratories analyzed 654 hydrocodone exhibits in 2006. Poison
control data, medical examiners’ reports, and treatment center
data all indicate that the abuse of hydrocodone is associated
with significant public health risks, including a substantial
number of deaths. The DEA is currently reviewing a petition to
increase the regulatory controls on hydrocodone combination
products from schedule III to schedule II of the Controlled
Substances Act (CSA).
Licit Uses:
Hydrocodone is an
antitussive (cough suppressant) and analgesic agent for the
treatment of moderate to moderately severe pain. Studies
indicate that hydrocodone is as effective, or more effective,
than codeine for cough suppression and nearly equipotent to
morphine for pain relief.
Hydrocodone is the most
frequently prescribed opiate in the United States with nearly
131 million prescriptions for hydrocodone-containing products
dispensed in 2006. There are several hundred brand name and
generic hydrocodone products marketed. All are combination
products and the most frequently prescribed combination is
hydrocodone and acetaminophen (Vicodin®, Lortab®).
Chemistry/Pharmacology:
Hydrocodone [4,5α-epoxy-3-methoxy-17-methyl-morphinan-6-one
tartrate (1:1) hydrate (2:5), dihydrocodeinone] is a
semi-synthetic opioid most closely related to codeine in
structure and morphine in producing opiate-like effects. The
first report that hydrocodone produces euphoria and habituation
symptoms was published in 1923. The first report of hydrocodone
dependence and addiction was published in 1961.
Illicit Uses:
Hydrocodone is abused for
its opioid effects. Widespread diversion via bogus call-in
prescriptions, altered prescriptions, theft and illicit
purchases from Internet sources are made easier by the present
controls placed on hydrocodone products. Hydrocodone pills are
the most frequently encountered dosage form in illicit traffic.
Hydrocodone is generally abused orally, often in combination
with alcohol.
As with most opiates,
abuse of hydrocodone is associated with tolerance, dependence,
and addiction. The co-formulation with acetaminophen carries an
additional risk of liver toxicity when high, acute doses are
consumed. Data suggests that some individuals who abuse very
high doses of acetaminophen-containing hydrocodone products may
be spared this liver toxicity if they have been chronically
taking these products and have escalated their dose slowly over
a long period of time.
User Population:
Every age group has been
affected by the relative ease of hydrocodone availability and
the perceived safety of these products by medical prescribers.
Sometimes viewed as a "white collar" addiction,
hydrocodone abuse has increased among all ethnic and economic
groups. Of particular concern is the prevalence of illicit use
of hydrocodone among school age children. In 2006, the
Monitoring the Future Survey (commonly referred to as the high
school survey) reported that 3%, 7% and 9.7% of 8th,
10th, and 12th graders, respectively,
reported non-medical use of Vicodin® in the previous
year.
Illicit Distribution:
Hydrocodone has been
encountered in tablets, capsules, and liquid form in the illicit
market. However, tablets containing acetaminophen are the most
frequently encountered products. Hydrocodone is not
clandestinely produced and diverted pharmaceuticals are the
primary source of the drug for abuse purposes. In 2006, the DEA
has documented the diversion of millions of dosage units of
hydrocodone from illicit Internet sources. Doctor shopping,
altered or fraudulent prescriptions, bogus call-in
prescriptions, diversion by unscrupulous physicians and
pharmacists, and drug theft are also major sources of the
diverted drug.
Control Status:
Congress placed
hydrocodone (bulk or single entity products) in schedule II of
the CSA and its products containing specified doses in
combination with specified amounts of isoquinoline alkaloid of
opium or one or more nonnarcotic substances in recognized
therapeutic amounts as schedule III products when the CSA was
enacted.
Comments and additional information are welcomed by the
Drug and Chemical Evaluation Section, FAX 202-353-1263 or telephone
202-307-7183.
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