Abuse of buprenorphine in the United States: 2003-2005.
ABSTRACT This study examines trends in the reported abuse of two sublingual buprenorphine products, Subutex and Suboxone, in the United States. Quarterly counts of abuse cases were obtained from 18 regional poison control centers (PCCS) for 2003-2005. Seventy-seven abuse cases were reported, of which 7.8 percent involved Subutex and 92.2 percent involved Suboxone. The 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 buprenorphine formulations have a low rate of abuse based on toxico-surveillance data.
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ABSTRACT: Objective: To develop effective programs for people who are opioid dependent and to impact the opioid epidemic in New York City, it is crucial to monitor attitudes about opioid addiction treatments among opioid users who have experienced barriers to engagement and retention in addiction treatment. Design: The authors conducted a qualitative study using focus groups. Methods: Six focus groups in three needle exchanges in New York City were audio recorded, transcribed, and systematically coded. The authors report on the main themes related to the study objectives. Participants: Participants of each needle exchange who were opioid dependent and had some knowledge of both methadone and buprenorphine were eligible. Results: There were four main findings. Participants felt the following: 1) buprenorphine is an appropriate option for those heroin users who are motivated to stop using, 2) they have less control over their addiction treatment with methadone than they would have with buprenorphine, 3) buprenorphine treatment is not accessible to many New York City residents who would benefit from this treatment, and 4) lack of access to buprenorphine treatment is a cause of treatment-related diversion. Conclusions: Both methadone maintenance and buprenorphine treatment opportunities are necessary to address the diverse treatment needs of opioid-dependent people in New York City. However, the current medical model of buprenorphine treatment may be too restrictive for some opioid-dependent people and may be contributing to the use of illicit buprenorphine. New models to deliver buprenorphine treatment may address these problems.Journal of opioid management 9(2):111-119.
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ABSTRACT: To review current evidence on buprenorphine-naloxone (bup/nx) for the treatment of opioid-use disorders, with a focus on strategies for clinical management and office-based patient care. Medline and the Cochrane Database of Systematic Reviews were searched. Consensus reports, guidelines published, and other authoritative sources were also included in this review. Apart from expert guidelines, data included in this review constitute level 1 evidence. Bup/nx is a partial μ-opioid agonist combined with the opioid antagonist naloxone in a 4:1 ratio. It has a lower abuse potential, carries less stigma, and allows for more flexibility than methadone. Bup/nx is indicated for both inpatient and ambulatory medically assisted withdrawal (acute detoxification) and long-term substitution treatment (maintenance) of patients who have a mild-to-moderate physical dependence. A stepwise long-term substitution treatment with regular monitoring and follow-up assessment is usually preferred, as it has better outcomes in reducing illicit opioid use, minimizing concomitant risks such as human immunodeficiency virus and hepatitis C transmission, retaining patients in treatment and improving global functioning. Bup/nx is safe and effective for opioid detoxification and substitution treatment. Its unique pharmaceutical properties make it particularly suitable for office-based maintenance treatment of opioid-use disorder.Neuropsychiatric Disease and Treatment 01/2014; 10:587-598. · 2.00 Impact Factor
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ABSTRACT: The use of prescription opioid drugs has the potential to lead to patient abuse of these medications, addiction, and diversion. Such an abuse is associated with increased costs because of excessive healthcare utilization. Finding ways to minimize the risk for abuse and addiction can enhance patient outcomes and reduce costs to patients and to payers.American Health and Drug Benefits 03/2011; 4(2):107-14.
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-
HAWORTH. E-mail address: <email@example.com> Website: <http://www.HaworthPress.
com> © 2007 by The Haworth Press, Inc. All rights reserved.]
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
1Q051 10,4459 54,253
Total6 74,686 71400,174
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
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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Drug, and Cosmetic Act. (Act) 21 U.S.C.§ 360, Section
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