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: Over the past century, a worldwide system for the control of drugs with abuse potential has developed through the adoption of a series of international treaties. The important multilateral conventions currently in force are the United Nations Single Convention on Narcotic Drugs, 1961 (Single Convention), the United Nations Convention on Psychotropic Substances, 1971 (Psychotropic Convention) and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988. From the beginning, the aim of these drug control treaties has been to control the abuse and trafficking of substances with abuse potential while assuring that the availability of these drugs for medical and scientific purposes is not unduly restricted. There is activity in the World Health Organization and the International Narcotics Control Board to determine whether the international control of buprenorphine, a partial mu-opioid agonist used as an analgesic and for the treatment of opioid addiction, should be changed from the Psychotropic Convention to the Single Convention. This change would result in the classification and regulation of buprenorphine as a narcotic drug rather than a psychotropic substance. Such a move is unwarranted medically and scientifically and would provoke increased controls on buprenorphine that would fundamentally disrupt the medical practice of pain management and opioid replacement therapy around the world. The negative impact of inappropriate regulatory controls when licensed medicines come under such scrutiny are described.Human Psychopharmacology Clinical and Experimental 07/2004; 19(4):215-24. · 2.10 Impact Factor
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ABSTRACT: Buprenorphine is a potent mu-receptor partial agonist and is widely used as an analgesic drug. It is also increasingly considered to be an alternative to methadone in the maintenance and eventual detoxification of heroin addicts, and also in the treatment of cocaine addiction. So far, buprenorphine has been available as a sublingual tablet and as a solution for IV injection. Recently, a new transdermal formulation of buprenorphine in slow-release matrix patches has been introduced (Transtec) for the treatment of intermediate to severe pain. The aim of this paper is to review, from a preclinical perspective, the current status of what is known about the behavioral pharmacology of buprenorphine, with a particular emphasis on the issues of reward, addiction, and dependence. It will also point to open questions that should be addressed in the future to improve our understanding of the effects and the mechanisms of action of this drug. Since buprenorphine is a potent opioid drug, the issue of addiction and dependence in this context is an important one. Although there are still some gaps in the behavioral pharmacological characterization of buprenorphine, the general conclusion that can be drawn from the reviewed literature is that despite the high affinity of buprenorphine for the mu receptor it appears to be a remarkably safe drug, with a benign overall side effect profile and low addictive and dependence-inducing potential. This favorable side effect profile appears to be due, to a large extent, to the partial agonistic properties of the drug, in combination with its particular receptor kinetics (i.e. very slow dissociation from the mu receptor after binding).Psychopharmacology 05/2002; 161(1):1-16. · 4.06 Impact Factor
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ABSTRACT: The US Food and Drug Administration (FDA) approved buprenorphine or Subutex for the treatment of opiate dependence in October 2002. Buprenorphine is a partial agonist of the mu-opioid receptor; although initial animal research suggested a low abuse potential for buprenorphine, it was subsequently shown to have an abuse potential similar to that of morphine or hydromorphone. The objectives of this study were to establish the sociodemographic profile and help-seeking behaviour of buprenorphine abusers attending the deaddiction treatment clinics of the Community Addictions Management Programme. One hundred and twenty subjects, all buprenorphine abusers fulfilling the diagnostic criteria for opiate dependence, who consented to the study, completed an interviewer-administered questionnaire. The mean age of those participating in the study was 39.2 [standard deviation (SD) 8.0] years. The majority of the participants were male (90%), 52.5% were currently employed and 98% had at least primary education. A family history of drug abuse was reported by 27% of the subjects. Illicit drug abuse occurred at an early age with mean age of onset of illicit drug abuse being 16.9 (SD 4.8) years with gateway drugs like marijuana and glue. It is vital for our medical profession to be aware of the trend in the local population to move from the abuse of illicit substances, to the abuse of prescriptive medications. It makes it necessary to increase the understanding of addictions both amongst our practising medical fraternity, and amongst those training to enter the profession. At the hospital level, it necessitates a higher level of vigilance among our emergency room physicians and those treating infectious diseases.Annals of the Academy of Medicine, Singapore 08/2006; 35(7):451-6. · 1.36 Impact Factor
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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