Abuse of Buprenorphine in the United States:
Meredith Y. Smith, PhD
J. Elise Bailey, MS
George E. Woody, MD
Herbert D. Kleber, MD
ABSTRACT. This study examines trends in the reported abuse of two sublingual buprenorphine
tained from 18 regional poison control centers (PCCS) for 2003-2005. Seventy-seven abuse cases
average quarterly ratio of abuse cases per 1,000 prescriptions dispensed was 0.08 (SD ± 0.09) for
Subutex®, and 0.16 (SD ± 0.08) for Suboxone®. Findings suggest that these sublingual bu-
prenorphine formulations have a low rate of abuse based on toxico-surveillance data. doi:10.1300/
J069v26n03_12 [Article copies available for a fee from The Haworth Document Delivery Service: 1-800-
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KEYWORDS. Sublingual buprenorphine, Subutex®, Suboxone®, opioid analgesics, prescription
drug abuse, opioid dependence, buprenorphine-naloxone, substitution therapy
Buprenorphine, a partial μ opioid agonist,
has been used as a pain medication for several
2002, two new sublingual buprenorphine for-
mulations, Subutex®and Suboxone®(Reckett
Meredith Y. Smith is affiliated with Purdue Pharma L.P., Stamford, CT.
J. Elise Bailey is affiliated with the Rocky Mountain Poison Control Center, 777 Bannock Street, Mail Code
0180, Denver, CO 80204.
George E. Woody, Treatment Research Institute, 600 Public Ledger Building, 150 South Independence Mall,
West, Philadelphia, PA 19129.
Riverside Drive, New York, NY 10032.
Address correspondence to: Meredith Y. Smith, PhD, MPA, Director, Risk Management & Health Policy,
Purdue Pharma L.P., One Stamford Forum, Stamford, CT 06901-3431 (E-mail: firstname.lastname@example.org)
This work was supported by Purdue Pharma L.P., Stamford, Connecticut.
Journal of Addictive Diseases, Vol. 26(3) 2007
Available online at http://jad.haworthpress.com
© 2007 by The Haworth Press, Inc. All rights reserved.
the Drug Addiction Treatment Act of 2000.2
chloride product, was intended for use during
the initiation phase of substitution therapy
while Suboxone®, a buprenorphine-naloxone
Buprenorphine’s partial agonist properties,
coupled with its slow rate of dissociationfrom
a Schedule III drug with lower abuse potential
medical availability of buprenorphine, how-
ever, concerns have mounted regarding its
abuse potential.1Internationally, cases of
buprenorphine misuse and abuse-related mor-
bidity and mortality have been documented in
numerous countries where the drug has been
approved for use in opioid dependence treat-
ment.5-10In Finland, where both single entity
buprenorphine and buprenorphine-naloxone
use, intravenousabuse of thesedrugs has been
reported among untreated intravenous users
the abuse of these sublingual buprenorphine
products in the U.S. To address this issue, we
assessed trends in the reported abuse of
buprenorphine and buprenorphine-naloxone
combination using data from regional toxico-
Study data consisted of calls received be-
tween 4th quarter, 2003 through 4th quarter,
2005 by 18 regional poison control centers
(PCCs) covering a total of 103.1 million indi-
teria specified that (a) the exposure resulted
a substance with an attemptto get “high,” pro-
duce euphoria, or other psychotropic effect
(defined as “Abuse” per PCC rating criteria);
fied by a Specialist in Poison Information
(SPI), a professional trained in nursing and/or
pharmacology. Clinician review has shown
algesic cases categorized as “abuse” and stan-
and dependence.12As a proxy for legitimate
use, data were obtained on the estimated num-
ber of prescriptions dispensed for Subutex®
prescriptionsdispensed for eachdrug by quar-
ter for the nine quarter study period. We also
to 1,000 prescriptions dispensed.
Table 1 presents the number of abuse cases
and prescriptions dispensed for each drug by
calendar quarter. Seventy-seven PCC abuse
cases were reported for the two drugs com-
and 92.2 percent involved Suboxone®. The
mean number of abuse cases per quarter was
0.66 (standard deviation± 0.71) for Subutex®,
108JOURNAL OF ADDICTIVE DISEASES
TABLE 1. Number of abuse cases and estimated
number of prescriptions dispensed on an outpa-
tient basis for Suboxone®and Subutex®by quarter
in the United States (US), 4th quarter 2003-4th
and 7.88 (standard deviation ± 5.68) for Sub-
Of the estimated 474,860 prescriptions dis-
pensed for the 2 drugs, 15.7 percent were for
Subutex®; and 84.3 percent were for Sub-
oxone®. The number of prescriptions dis-
pensed for each product rose during the study
period. The change was most pronounced for
Suboxone®, which showed a 402 percent in-
during the nine quarter period compared to a
261 percent increase for Subutex®.
Figure 1 presents the ratio of abuse cases to
1,000 prescriptions dispensed per quarter by
of abuse cases per 1,000 prescriptions dis-
pensed was 0.08 (SD ± 0.090), while for
steadily in the U.S. between 4th quarter, 2003
proximately 84 percent of the total number of
prescriptions dispensed for both drugs during
themajority(92 percent)of the77 abuse cases
of dispensing of these two drugs, the ratio of
abuse cases was slightly higher on average for
son to similar data on opioid analgesic abuse.
Zacny and colleagues calculated the ratio of
five opioids for the period 1994-2001.14Hy-
dromorphone had the highest average ratio
(1.80 ED mentions per 1,000 prescriptions
dispensed), while fentanyl had the lowest
(0.013 ED mentions per 1,000 prescriptions
RAPID COMMUNICATIONS 109
Ratio of PCC Abuse Cases to Prescription Dispensed
4Q2003 1Q2004 2Q2004 3Q2004 4Q2004 1Q2005 2Q2005 3Q2005 4Q2005
FIGURE 1. The ratio of Suboxone®and Subutex®abuse cases to 1,000 prescriptions dispensed as re-
ported to participating poison control centers by quarter, 4th quarter, 2003-4th quarter 2005.
Our finding that Suboxone®had a higher
abuse ratio than Subutex®is intriguing. One
possible explanation is that the degree of pa-
supervised administrationshould be limitedto
Suboxone®, in contrast, is recommended for
use in all 3 phases of treatment, including
array of patients.15
Information concerning the route of bu-
prenorphine administration used by abusers
would have aided us in interpreting our study
results. Data show that, in non-dependent
opioid abusers, the opioid agonist effects of
sublingually administered Suboxone®closely
it has been demonstrated that, when adminis-
ade of buprenorphine’s action is only partial
and short-lived in nature.17A recent study of
untreated intravenous abusers in Finland re-
vealed that 68 percent reported abusing Sub-
oxone intravenously.11Moreover, 66 percent
that they had abused it at least once subse-
quently, or even regularly thereafter, despite
describing the effect as a “bad experience.”
acteristics of buprenorphine abusers in more
detail and explore whether and to what extent
route of administration varies by type of
istration,our study was limitedby the fact that
the geographical coverage of participating
PCCs was not nationally representative. It is
important to note, however, that all major re-
gions of the U.S. were included.
and Suboxone®are being abused in the post-
marketing context, the level of such abuse is
thy in light of the fact that both these products
are prescribed for use in a population at high
risk for drug abuse. Ongoing monitoring of
whether these trends will continue.
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