Diversion and Abuse of Buprenorphine: A Brief Assessment of ...

Diversion and Abuse of Buprenorphine:
A Brief Assessment of Emerging Indicators
Results of the Vermont Case Study
Submitted to the
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
Ray Hylton, Jr., R.N., M.S.N., Project Offi cer
Submitted by
JBS International, Inc.
Center for Health Services & Outcomes Research
Bonnie B. Wilford, M.S., Director
8630 Fenton Street, Ste. 1200
Silver Spring, MD 20910
Telephone: (301) 495 1080
E mail: bwilford@jbs.biz
Data Analysis by
Jane C. Maxwell, Ph.D.
Gulf Coast Addiction Technology Transfer Center and
Center for Excellence in Epidemiology
University of Texas at Austin
1717 West 6th Street
Austin, Texas 78703
Telephone: (512) 232 0610
E mail: jcmaxwell@sbcglobal.net
November 30, 2006

Results of the Vermont Case Study
2

CONTENTS
Summary 5
Background 5
Findings, Conclusions and Recommendations 7
Acknowledgements 19
Appendix A: Datasets Consulted for the Assessment 21
Appendix B: State and Federal Officials Consulted for the Assessment 23
Appendix C: Outside Experts Consulted for the Assessment 25
Appendix D: Vermont Buprenorphine Guidelines 27
Results of the Vermont Case Study
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3

Results of the Vermont Case Study
4

Diversion and Abuse of Buprenorphine:
Results of the Vermont Case Study
_________________________________________________________________
SUMMARY
This case study was undertaken by CSAT/SAMHSA in response to reports that availability of
Suboxone® and Subutex® for the treatment of opioid addiction has been accompanied by the
emergence of a small but persistent problem with diversion and abuse of those medications. This
is not unexpected, in that historical data show a period of experimentation following the
introduction of many drugs. Nevertheless, CSAT/SAMHSA determined that the problem
required further examination, and commissioned a case study in the State of Vermont that
involved analysis of all available data and interviews with key State officials.
Results of the case study suggest that buprenorphine diversion and abuse are not widespread, but
rather tend to be concentrated in certain small population groups within the state. This
phenomenon may reflect lack of access to addiction treatment, as some non­medical use appears
to involve attempts to self­medicate with buprenorphine when formal treatment is not available.
SAMHSA has provided the case study results to officials in Vermont and is prepared to assist
them in any actions they may wish to take to further assess and/or address the identified issues.
BACKGROUND
On October 17, 2000, the President signed into law the Drug Addiction Treatment Act of 2000
(DATA), Title XXXV, Section 3502 of the Children’s Health Act of 2000. DATA expanded the
clinical context of medication­assisted treatment by allowing qualified physicians to prescribe or
dispense specifically approved Schedule III, IV, and V medications for detoxification and
maintenance treatment of addiction. In addition, DATA reduced the regulatory burden on
physicians by permitting qualified physicians to apply for and receive waivers from the special
registration requirements defined in the Federal Controlled Substances Act.
DATA 2000 marks the first time in almost 40 years that pharmacotherapies for addiction can be
offered to patients in office­based settings. The act thus is designed to address the growing gap
between the number of persons in need of treatment for opiate addiction and the amount of
treatment available.
Two formulations of buprenorphine (which were approved by the FDA in October 2002) are the
first – and so far only – medications approved under DATA 2000 for the pharmacologic treatment
of addiction. One formulation (Subutex®) contains buprenorphine alone, while the other
(Suboxone®) is a combination of buprenorphine with naloxone, an opioid antagonist. (The
Buprenex® formulation is approved only for the treatment of pain, and no generic version has
been approved for use in the U.S.) Both Subutex and Suboxone, which are designed to be
administered sublingually, are available in 2 mg and 8 mg tablets. Both are classified as Schedule
III narcotics under the Federal Controlled Substances Act.
Results of the Vermont Case Study
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Indicators of a Potential Problem. Although none of the formal indicators used by the
manufacturer or the government signaled any adverse effects attending the introduction of
buprenorphine, in December 2005 SAMHSA/CSAT officials received several anecdotal reports of
buprenorphine diversion and abuse in Vermont. To address the reports, SAMHSA/CSAT
commissioned an independent assessment of buprenorphine diversion and abuse (the results of
which are described in a separate report). The assessment included a case study of the situation in
Vermont, which was undertaken in collaboration with Vermont officials. Using information
gathered from multiple sources, analysts set out to determine whether diversion and abuse of
buprenorphine were occurring in the state and, if so, to assess the nature, extent, and source of
the problem (if any) and to formulate recommendations for its amelioration.
The plan of action devised for the Vermont case study consisted of several steps:
1. Working in concert with Vermont officials, gather additional information about the
anecdotal reports of buprenorphine diversion and abuse.
2. Analyze all available information (Appendices A and B) to determine whether there is
evidence to support or refute the anecdotal reports.
3. Convene a panel of outside experts (Appendix C) to examine and interpret the information
gathered and to formulate recommendations for future action.
The results are summarized below.
FINDINGS, CONCLUSIONS AND RECOMMENDATIONS
The case study employed interviews with Vermont officials, as well as analysis of data from the
DEA’s Automation of Reports and Consolidated Orders System (ARCOS) and National Forensic
Laboratory Information System (NFLIS) reports, Vermont Medicaid records, SAMHSA’s
DAWNLive! medical examiner reports, treatment data from the Vermont Office of Drug and
Alcohol Programs and SAMHSA’s Treatment Episode Data Set (TEDS), the Northern New
England Poison Control Center, and the Vermont state police and corrections system.
ARCOS data show a rate of buprenorphine consumption in Vermont – as measured in grams per
100,000 population – that is more than ten times the national average: 583 grams per 100,000
population in Vermont, compared with a U.S. average of 56 grams per 100,000 population
(Exhibit 1).
Unfortunately, the data do not tell us the reasons for these rankings, which may reflect a problem
with diversion and abuse of buprenorphine but, equally plausibly, may suggest that Vermont
officials have been very effective in recruiting physicians to prescribe buprenorphine, and that a
consumption rate of 583 grams per 100,000 population indicates that the goals for office­based
treatment of opioid addiction are being met in the state.
Multiple explanations were tested through a detailed examination of the various datasets and
through information­collection interviews with State and Federal officials and other experts. The
results are summarized below.
Results of the Vermont Case Study
6

Vermont
Maine
Exhibit 1. ARCOS Data: States With the Highest Per Capita
Consumption of Buprenorphine (in grams and dosage units
per 100,000 population), January – December 2005
Massachusetts
Rhode Island
Maryland
U.S. Average
Dosage Units Grams Per
Per 100,000 Pop. 100,000 Pop.
82,948 Vermont 583.56
53,573 Maine 324.02
37,642 Massachusetts 253.17
31,783 Rhode Island 204.27
20,588 Maryland 127.56
9,090 U.S. Average 56.73
Source: U.S. Drug Enforcement Administration: Automation of Reports and Consolidated
Orders System, ARCOS 2, Report 4, 01/01/2005 to 12/31/2005.
Hypothesis 1: Vermont has been unusually successful in recruiting primary care
physicians to prescribe buprenorphine, resulting in high levels of per capital consumption.
Relevant Information: Todd Mandell, M.D., Medical Director of the Vermont SSA, reported
that Vermont has a very small number of certified addiction medicine or addiction psychiatry
specialists (e.g., only six ASAM members and a similarly small contingent of members of AAAP
or AOAAM), so engaging non­specialist physicians in the use of buprenorphine to treat addiction
is a key strategy in increasing access to treatment.
In an effort to engage physicians in the use of buprenorphine to treat addiction, Vermont has
developed administrative and clinical guidelines for office­based practice (Appendix D) and
offered modest financial incentives. In addition, Dr. Mandell offers telephone consultations to
waivered physicians who have questions about buprenorphine dosing and other patient
management issues. Dr. Mandell encourages such physicians not to exceed 16­ to 20­mg dose
levels without obtaining outside consultation.
As a result of these efforts, Vermont has the highest rate of participating physicians in the U.S.
Conclusions: Experts consulted for the case study commended Vermont officials for their
efforts to recruit physicians to use buprenorphine in office­based treatment of opioid addiction.
Specifically, they were very supportive of the proposed incentive plan to expand the availability of
medication­assisted treatment in Vermont. The Vermont Legislature provided Medicaid with a
one­time fund of $500,000 for the incentive plan and a one­time fund of $350,000 to the Vermont
Office of Drug and Alcohol Programs for the purpose of training physicians and developing a
Results of the Vermont Case Study
7

system to coordinate care. Physicians who wish to participate in the incentive plan must agree to
work with a State­assigned Buprenorphine Coordinator. The Coordinator is to help the office
prepare for the treatment of opiate­addicted patients and to assure that every patient obtains all
recommended treatment services.
The SSA also is planning to develop a set of tools, including screening instruments and patient
contracts, for use by the Coordinators. Formal outcome measures will be used to measure the
effectiveness of the Coordinators and of the incentive program.
Recommendation: This may be an excellent model for other States.
Hypothesis 2: Buprenorphine is being widely used for the treatment of pain in Vermont.
Relevant Information: A sizeable number of Vermont physicians may be using Subutex and
Suboxone off­label for the treatment of pain. The outside experts consulted for this assessment
confirmed that many physicians prefer to use these oral formulation in treating pain patients rather
than Buprenex, which is labeled for pain, because Buprenex is available only in an injectable form.
The experts also suggested that some physicians may be using the Suboxone formulation in pain
management in an effort to avoid drug overdoses.
Analysts examined the distribution of buprenorphine within the State, as compared to the
distribution of physicians who hold waivers to prescribe the drug for office­based treatment of
opioid addiction (Exhibits 2a and 2b). The data not only showed wide variations in distribution of
buprenorphine from county to county, they also indicated that Suboxone and Subutex are being
dispensed in counties where there are no physicians who hold waivers to prescribe buprenorphine
for office­based treatment of opioid addiction.
Results of the Vermont Case Study
8

Exhibit 2a. Vermont Data: Distribution by County of Buprenorphine, in Number of Dosage Units
and Number of Prescriptions, and Distribution of Waivered Physicians, 2005
# Medicaid
Patients Total # DU per
Receiving # Waivered Subutex Subutex Suboxone Suboxone Dosage 10,000
Vermont County Buprenorphine Doctors 2.16 DU 8mg DU 2mg DU 8mg DU Units Population
ADDISON 18 0 1,320 300 60 9,150 10,830 3,011
BENNINGTON 29 6 960 5,280 3,090 14,370 23,700 6,406
CALEDONIA 24 9 270 1,140 2,550 15,300 19,260 6,484
CHITTENDEN 184 16 5,250 2,370 14,970 80,970 103,560 6,970
FRANKLIN 5 1 0 420 3,600 26,220 30,240 6,658
GRAND ISLE 4 0 0 0 0 90 90 101
LAMOILLE 28 4 1,350 2,100 9,060 26,250 38,760 16,683
ORANGE 18 1 30 690 90 1,650 2,460 872
ORLEANS 33 3 270 990 1,350 9,270 11,880 4,521
RUTLAND 149 13 450 4,770 3,780 61,680 70,680 11,148
WASHINGTON 79 22 2,940 1,860 8,880 57,180 70,860 12,209
WINDHAM 48 18 1,320 450 10,980 34,650 47,400 10,720
WINDSOR 46 8 180 810 1,350 10,920 13,260 2,309
TOTAL 665 101 14,340 21,180 59,760 347,700 442,980 82,948
Sources: U.S. Drug Enforcement Administration: Automation of Reports and Consolidated
Orders System; Vermont Medicaid Data; and Vermont SSA Data on Waivers.
Results of the Vermont Case Study
Exhibit 2b. Map of Vermont Counties
9

In a further effort to determine the purposes for which buprenorphine is being prescribed in
Vermont, distribution data for various formulations and dose strengths were examined. This
showed that shipments of Buprenex, which is the formulation most frequently used in the
management of pain, is the formulation least widely distributed in Vermont (Exhibit 3).
400,000
350,000
300,000
250,000
200,000
150,000
100,000
Exhibit 3. ARCOS Data: Comparison of Various
Formulations and Dose Strengths of Buprenorphine
Shipped to Vermont, 2003 – 2005*
1295 5700
59760
195990
347700
50,000
32940 38850
0
3270
2785
1 900
14730 12420
210 330
6960
Buprenex Buprenorpine Suboxone 2mg Suboxone 8mg Subutex 8mg Subutex
*ARCOS Data Run of 2/3/06
Injectable 2.16mg
21180 14340
Source: U.S. Drug Enforcement Administration: Automation of Reports and Consolidated
Orders System.
Conclusion: The distribution of waivered physicians and the pattern of distribution of Subutex
and Suboxone do not support the hypothesis that buprenorphine is widely used to treat pain.
Recommendation: Based on data from the Vermont Medicaid program and the Vermont SSA,
the case study suggests that this factor is a minimal contributor to high per capita rates of
buprenorphine consumption in Vermont. However, a definitive determination requires further
examination and follow­up by State officials.
Relevant Information: Todd Mandell, M.D., Medical Director of the Vermont SSA, examined
the Medicaid drug claims data for buprenorphine. He found more than 100 claims for Subutex or
Suboxone prescribed by physicians who do not hold Federal waivers to use buprenorphine in
addiction treatment. This may reflect off­label use of buprenorphine to treat pain. However,
when interviewed by Dr. Mandell, some physicians denied having prescribed buprenorphine at all.
For example, some of the prescriptions bore the name of a gynecologist who, according to
Medicaid records, had prescribed buprenorphine to several men.
Conclusion: While the claims anomalies may represent simple coding errors at the time of data
entry, there are a sufficient number to warrant further examination. For example, if coding errors
do not explain all 100 claims, a logical next step would be to ask the Vermont Board of Pharmacy
to send investigators to examine the actual prescription forms at the pharmacies where
Results of the Vermont Case Study
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the prescriptions were dispensed. Dr. Mandell has committed to work with Scott Strenio, M.D.,
Medical Director of the Vermont Medicaid program, to clarify the situation.
Hypothesis 3: High rates of consumption of buprenorphine in Vermont and other New
England States may reflect correspondingly high levels of opioid abuse and addiction.
Relevant Information: Over the past several years, Federal data and anecdotal reports have
identified New England (and particularly Maine) as a “hot spot” for diversion and abuse of
OxyContin® and other prescription opioids. For example, SAMHSA’s Treatment Episode Data
Set (TEDS) collects information on all publicly funded treatment programs. TEDS data show
that the number of patients entering treatment who report Other Opiates (including oxycodone,
hydrocodone, and buprenorphine) as their primary drug of abuse is increasing nationally.
Similarly, in Vermont, treatment admissions related to Other Opiates show a steady upward trend.
In contrast, Vermont admissions related to heroin slowly trended upward from 1998 to 2002,
then dropped slightly in 2003 and 2004 (Exhibit 4). Moreover, Vermont treatment data for the
past two years also show that patients who reported Other Opiates as their primary drug of abuse
were more likely to use their primary drug on a daily basis than were those who reported heroin
as their primary drug.
Exhibit 4. TEDS Data: Vermont Treatment Admissions
Related to “Other Opiates” Compared to Heroin
and As a Percent of All Admissions, 1998 – 2004
12%
10%
8%
6%
4%
2%
0%
1998 1999 2000 2001 2002 2003 2004
Heroin
Other Opiates
Source: SAMHSA Office of Applied Studies: Treatment Episode Data Set.
Data gathered from medical examiners in Vermont who report to the DAWN Medical Examiner
system show that, in 2003 – the latest year for which data are available – the largest number of
drug­related deaths in Vermont involved oxycodone. In contrast, the largest number of drugrelated
deaths in Maine and New Hampshire involved methadone. In all three states, more deaths
were associated with prescription opiates than with heroin (Exhibit 5).
Results of the Vermont Case Study
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Exhibit 5. DAWN Medical Examiner Data:
Reports of Deaths Associated with Opioid Drugs
in Vermont, Maine and New Hampshire, 2003
50
45
40
47
35
30
7
3
24
0
6
Heroin
7
25
20
15
10
5
0
34
19
0
16
12
8
4
0
Hydrocodone
Methadone
Oxycodone
Buprenorphine*
Maine New Hampshire Vermont
NOTE: Special tests to identify buprenorphine were not run.
Source: SAMHSA Office of Applied Studies: Drug Abuse Warning Network, 2003.
Conclusion: The data available for this assessment suggest that opioids – and particularly
prescription opioids – account for a significant portion of all treatment admissions and drugrelated
deaths in Vermont. As discussed earlier, efforts to treat the relatively large number of
individuals who are dependent on opioids may be straining an already overtaxed opioid treatment
system, leading to heavy reliance on office­based treatment and thus to the use of buprenorphine.
Recommendation: This hypothesis should be further tested by the State SSA, as by examining
comparable data on the primary drug of abuse at treatment admission in Vermont compared to
similar data for the U.S. as a whole and for selected States with similar population demographics
and patterns of drug use.
Hypothesis 4. A significant number of patients from out of state are receiving opioid
treatment in Vermont, and a similarly significant number of Vermont residents are seeking
opioid treatment out of state.
Relevant Information: Because of the compact nature of the New England region, patients from
out of state may be obtaining addiction treatment in Vermont, while Vermont residents may be
receiving care – and prescriptions for buprenorphine – from physicians in adjoining States, but
having them filled in Vermont pharmacies. Both of these factors would distort consumption data
based on the State’s permanent population.
The buprenorphine distribution data shown in Exhibit 2b suggest some discontinuities between the
distribution of patients and the location of treatment services. For example, patients whose
physicians are located in one county (or State) may have their prescriptions filled in another
location – not an unexpected occurrence in a largely rural state.
Results of the Vermont Case Study
12

Moreover, an interview with Allan W. Graham, M.D., FASAM, formerly medical director of one
of the State’s largest opioid treatment programs, disclosed that his program treated large numbers
of patients from New York and other States (Graham, personal communication, April 27, 2006).
Dr. Graham added that other treatment programs in Vermont, both public and private, also were
seeing significant numbers of out­of­state patients. This is a very suggestive piece of information
to explain the high per capita rate of buprenorphine distribution in Vermont.
Conclusion: Based on preliminary data from the Vermont Medicaid program and the Vermont
SSA, as well as interviews with treatment experts, this factor appears to be an important
contributor to high per capita rates of buprenorphine consumption in Vermont.
Recommendation: To allow a definitive determination, officials of the State SSA could contact
their counterparts in adjoining States to determine how many Vermont residents are receiving
addiction treatment in other States. They also should contact Vermont treatment facilities and
waivered physicians who treat large numbers of patients to determine what proportion of their
patients are residents of other States.
Hypothesis 5: Insufficient capacity in traditional opioid treatment programs, coupled with
the presence of relatively few addiction medicine and addiction psychiatry specialists in the
State, requires heavy reliance on office­based treatment by primary care physicians, and
thus to the use of buprenorphine.
Relevant Information: Until recently, Vermont did not offer publicly funded methadone
maintenance treatment for addiction. Moreover, the State has very few physicians who are
certified specialists in addiction medicine or addiction psychiatry. As a result, Vermont
authorities have been highly proactive in recruiting non­specialist physicians to prescribe
buprenorphine – even offering special financial incentives to physicians who do so.
Peter Lee, Director of Treatment for the Vermont SSA, attributed the high level of buprenorphine
use to inadequate access to opioid treatment programs. In support of his contention, Mr. Lee
estimated that, at present, the State has 2,000 individuals in need of treatment for opiate addiction
who are not receiving such treatment.
In addition to turning to office­based primary practitioners for care, Mr. Lee suggested that some
of these individuals may be attempting to self­medicate with buprenorphine.
However, there was little statistical correlation between consumption of buprenorphine and of
methadone. Among the five States that ranked highest in per capita distribution of buprenorphine
in 2005, Vermont ranked 22 nd in distribution of methadone, Maine ranked 6 th , Massachusetts
ranked 32 nd , Rhode Island ranked 48 th and Maryland ranked 28 th (Exhibit 6).
Results of the Vermont Case Study
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Exhibit 6. ARCOS Data: State Rankings on Per Capita Consumption
of Buprenorphine and Methadone Compared,
January – December 2005
Vermont
(rank=1)
Maine
(rank=2)
Massachusetts
(rank=3)
Rhode Island
(rank=4)
Maryland
(rank=5)
U.S. Average
Buprenorphine
Grams Per
100,000 Pop.
Methadone
Grams Per
100,000 Pop.
583.56 Vermont 991.56
(rank=22)
324.02 Maine 1,973.83
(rank=6)
253.17 Massachusetts 800.05
(rank=32)
204.27 Rhode Island 422.77
(rank=48)
127.56 Maryland 878.66
(rank=28)
56.73 U.S. Average 929.95
Source: U.S. Drug Enforcement Administration: Automation of Reports and Consolidated
Orders System, ARCOS 2, Report 4, 01/01/2005 to 12/31/2005.
Conclusion: State officials believe that primary care physicians are using buprenorphine to treat
many patients who would be enrolled in opioid treatment programs if places were available, and
that some patients are attempting to self­medicate with buprenorphine while awaiting availability
of care. Based on information provided by state officials, this factor appears to be the most
significant contributor to high per capita rates of buprenorphine consumption in Vermont.
Recommendation: The outside experts consulted for the case study endorsed Vermont officials’
efforts to recruit and train additional physicians to use buprenorphine in office­based practice,
because knowledgeable officials strongly endorse the hypothesis that one factor in non­medical
use of buprenorphine is lack of access to adequate and appropriate addiction care. Thus, the
experts agreed that the answer to problems with buprenorphine (or methadone, or other opiates)
involves more – rather than less – access to these important therapies.
Finally, access to care would be enhanced if third­party payers would compensate physicians for
office­based treatment of addiction at parity with the fees paid for other physician services of
similar complexity. It also is important to eliminate distortions in the payment system, such as
policies that cover detoxification but not maintenance treatment with buprenorphine. Such
distortions may be an underlying cause of the relatively high proportion of Vermont patients who
are detoxified but do not receive the follow­up care necessary to achieve and sustain recovery.
Results of the Vermont Case Study
14

Hypothesis 6: Significant levels of buprenorphine diversion and abuse are occurring in
Vermont.
Relevant Information: Dr. Mandell first began to receive reports of buprenorphine abuse in early
2005. Because the reports were entirely anecdotal, he has used the limited data available to him –
as well phone consultations with prescribing physicians and other sources of information – to try
to clarify the situation.
Peter Lee of the Vermont SSA reported that some buprenorphine diversion and abuse is
occurring in Vermont. Mr. Lee confirmed that he has received anecdotal reports of
buprenorphine tablets being crushed and injected. However, he described this as “horizontal”
diversion within the addicted population – who rent pills for pill checks, for example, or sell part
of their supply of buprenorphine to a friend who cannot access treatment – rather than “vertical”
diversion into the general population.
An official of the Vermont Department of Corrections reported that buprenorphine was being
smuggled into the State’s correctional institutions, and said that the amount exceeded that of
methadone or oxycodone. He also described buprenorphine as easy to obtain on the street, as
compared to oxycodone, which he described as not widely used in Vermont (however, this
anecdotal report is not consistent with the DAWN medical examiner data).
Several other corrections officials suggested that buprenorphine was being smuggled into
correctional facilities to sell to inmates who wanted to “get high” or to help inmates withdraw
from heroin. Officials said some inmates who were addicted to heroin reported stockpiling
buprenorphine prior to their incarceration.
On the other hand, Gretchen Feussner of DEA’s Office of Diversion Control confirmed that the
DEA field office for Vermont had not received any reports of buprenorphine diversion.
The head of the Vermont State Police Laboratory reported that, in all of 2004 and 2005,
buprenorphine had been seized in only eight cases. In every case, the formulation involved was
Suboxone. Five seizures involved one tablet each, one seizure involved two tablets, and one
involved three tablets. Thus, the Vermont State Police laboratory does not consider diversion of
buprenorphine to be a significant problem at this time.
Multiple datasets were examined in an effort to determine whether and to what degree
buprenorphine was cited as either a primary or secondary drug of abuse by individuals entering
addiction treatment in Vermont. While SAMHSA’s Drug Abuse Warning Network (DAWN)
provides data on adverse events associated with a large number of drugs, no hospital emergency
departments in Vermont report to DAWN. Boston is the closest metropolitan area with
reporting hospitals. Interestingly, Boston also reports more emergency department visits related
to buprenorphine than any other metropolitan area in the DAWN system (Exhibit 7).
Results of the Vermont Case Study
15

Exhibit 7. DAWNLive! Data: Emergency Department
Visits Related to Buprenorphine, by Continuously Reporting
Metro Area, 2003 – 2005*
Bos
Chi
Den
Det
Hou
Mia
Minn
NO
NY
Phx
SanD
Sfo
SEA
200
180
160
140
120
100
80
60
40
20
0
Exhibit 8. Northern New England Poison Control Center
Data: Information Calls
Related to Buprenorphine, 2003­2005*
23
8
0 10 20 30 40 50 60 70 80
*The unweighted data are from all U.S. EDs reporting to DAWN. All DAWN cases are reviewed for
quality control. Based on this review, cases may be corrected or deleted, and, therefore, are subject to
change.
SOURCE: SAMHSA Office of Applied Studies: Drug Abuse Warning Net work
(downloaded 2/12/2006)
Another indicator of drug diversion and abuse is found in the number of calls – for information or
to report human exposure – received by the Northern New England Poison Control Center (which
covers Vermont, Maine and New Hampshire). The number of information calls increased from 36
in 2003 to 203 in 2005. Of 464 human exposure case reports related to buprenorphine, 435
involved Suboxone, 3 involved Subutex and, in 25 cases, the formulation was unknown. The
largest group of case reports involved persons between the ages of 20 and 29 (Exhibit 8).
Results of the Vermont Case Study
82
22
144
35
13
1
43
21
9
17
43 2003 ME 2004 ME 2005 ME 2003 VT 2004 VT 2005 VT 2003 NH 2004 NH 2005 NH
*2005 data may not be complete as it was retrieved on 1/9/2006
Source: Northern New England Poison Control Center
16
5
Information
Human Exposure
16

Buprenorphine is not reported separately in data collected by the Vermont SSA’s Client Data
System, or in SAMHSA’s Treatment Episode Data Set (TEDS). Rather, it is included in the
Other Opiate category, with oxycodone and hydrocodone. As noted in Exhibit 8, treatment
admissions related to Other Opiates as a primary drug of abuse have been trending steadily
upward in Vermont, as they have nationally. However, the Vermont treatment data show little
change in the use of Other Opiates as a secondary drug of abuse (Exhibit 9).
80%
70%
60%
50%
40%
30%
20%
10%
0%
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Exhibit 9. Vermont SSA Data: Secondary Drug of
Abuse Reported by Patients Entering Addiction
Treatment Who Reported Other Opiates as Their
Primary Drug of Abuse, 2004 and 2005
24% 24%
12%
10%
13% 18%
3%
2%
17% 15%
23% 23%
2004 2005
Source: Vermont Client Data System
Exhibit 10. Vermont SSA Data: Route of
Administration Reported by Treatment Clients
Whose Primary Drug is Other Opiates,
1999­2005
% Inhale % inject % oral
1999 2000 2001 2002 2003 2004 2005
Source: Vermont Client Data System.
Marijuana/Hashish
Heroin
Cocaine/Crack
Benzodiazepine
Alcohol
No Secondary
The predominant route of administration reported by Vermont patients who cited Other Opiates
as their primary drug of abuse is shifting from “oral” to “inhaling” and “injecting” (Exhibit 10).
Such a shift to injection drug use not only indicates an increasingly intensive pattern of use, it also
is of concern because of its implications for transmission of hepatitis and HIV.
Law enforcement agencies also capture data that are useful in identifying prescription drug abuse
and diversion. However, in a situation similar to the one encountered with the DAWN ED
reporting system, Vermont does not report to the DEA’s National Forensic Laboratory
Results of the Vermont Case Study
17

Information System. (NFLIS systematically collects drug chemistry analysis results and other
information from law enforcement cases analyzed by Federal, State, and local forensic
laboratories.) Also like the DAWN data, among the States that do report, the largest number of
forensic cases related to buprenorphine was reported by Massachusetts (Exhibit 11).
400
350
300
250
200
150
100
50
0
AK
AL
AR
AZ
Exhibit 11. Buprenorphine Items Analyzed by Forensic Laboratories By State and
Reported to NFLIS: 2002­2005
CA
CO
CT
DC
DE
FL
GA
HI
IA
2002 2003 2004
ID
IL
IN
KS
KY
LA
MA
MD
ME
MI
MN
MO
MS
MT
NC
NE
NJ
Source: Drug Enforcement Administration: National Forensic Laboratory Information System (NFLIS).
Conclusions: ARCOS data for Vermont show wide variations in distribution of buprenorphine from
county to county, and also indicate that Suboxone and Subutex are being dispensed in counties where there
are no physicians who hold waivers to prescribe buprenorphine for office­based treatment of opioid
addiction.
Distribution data for various formulations and dose strengths of buprenorphine show that
shipments of Buprenex, which is the formulation most frequently used in the management of pain,
is the formulation least widely distributed in Vermont. The formulation that is most widely
distributed is Suboxone 8 mg., typically used in office­based treatment of opioid addiction.
Data from the Northern New England Poison Control Center (which covers Vermont, Maine and
New Hampshire) show that the number of information calls related to buprenorphine increased
from 36 in 2003 to 203 in 2005. Of 464 human exposure case reports related to buprenorphine,
435 involved Suboxone, 3 involved Subutex and, in 25 cases, the formulation was unknown.
An official of the Vermont SSA confirmed that he had received reports of buprenorphine tablets
being crushed and injected.
An official of the Vermont Department of Corrections reported that buprenorphine was being
smuggled into the State’s correctional institutions, in amounts that exceed those of methadone or
oxycodone.
An expert in DEA’s Office of Diversion Control reported that the DEA field office for Vermont
had not received any reports of buprenorphine diversion as of February 2006.
Results of the Vermont Case Study
2005
NM
NV
NY
OH
OK
OR
PA
PR
SC
SD
TN
TX
UT
VA
WQ
WI
WV
WY
t
18

Based on all of the information examined, it appears that while there are episodes of
buprenorphine diversion and abuse in Vermont, there is not an identifiable pattern of widespread
abuse. Nevertheless, the situation bears continued close monitoring by state officials.
Recommendation: A number of the assessment findings require additional examination. The
outside experts commended the Vermont SSA and other State officials for their willingness to
engage in such self­study, as well as SAMHSA/CSAT’s willingness to assist the State with a
strategic approach that engages public and private sector stakeholders in the needed collaborative
efforts.
ACKNOWLEDGEMENTS
The case study was conducted under the direction of Bonnie B. Wilford, M.S., Director of the
Center for Health Services & Outcomes Research at JBS International, Inc. The data analysis was
led by Jane C. Maxwell, Ph.D., an epidemiologist at the University of Texas at Austin and a
consultant to the Center for Health Services & Outcomes Research. Dr. Maxwell heads the
University’s Center for Excellence in Epidemiology within the Gulf Coast Addiction Technology
Transfer Center. She also is a long­time member of NIDA’s Community Epidemiology Work
Group who specializes in gathering and analyzing data on drugs of abuse, including
buprenorphine and methadone.
The case study team acknowledges with gratitude the collaboration and multiple contributions of
Vermont State officials, particularly SSA Director Barbara Cimaglio and her staff. We are grateful
as well for the many contributions of the expert panel and the staff of SAMHSA/CSAT –
particularly Center Director H. Westley Clark, M.D., J.D., M.P.H., CAS, who provided overall
direction; Robert Lubran, M.S., M.P.A., Director of CSAT’s Division of Pharmacologic
Therapies, who offered insightful observations and suggestions; and Government Project Office
Ray Hylton, Jr., R.N., M.S.N., who provided ongoing support and guidance. All were essential to
successful completion of this assignment.
Results of the Vermont Case Study
19

Results of the Vermont Case Study
20

APPENDIX A
INFORMATION SOURCES CONSULTED FOR THE CASE STUDY
_________________________________________________________________
DATASETS
Automation of Reports and Consolidated Orders System (ARCOS)
Drug Abuse Warning Network (DAWN) – Emergency Department Data
Drug Abuse Warning Network (DAWN) – Medical Examiner and Coroner Dataset
National Forensic Laboratory Information System (NFLIS)
DEA Theft and Loss Reports (106 Forms)
New England Poison Control Center
Vermont Treatment Program Data
Vermont Medicaid Claims Data
State and Local Law Enforcement and Laboratory Data
OTHER INFORMATION
Vermont Buprenorphine Guidelines
Interviews with State Officials
Medicaid Claims Data
Results of the Vermont Case Study
21

Results of the Vermont Case Study
22

APPENDIX B
STATE OFFICIALS CONSULTED FOR THE CASE STUDY
_________________________________________________________________
The active participation and many contributions of the following State and Federal officials are
acknowledged with gratitude:
• Eric Buel, Vermont Department of Public Safety
• Barbara Cimaglio, Director, Division of Alcohol & Drug Abuse Programs, Vermont
Department of Health
• Peter Lee, Chief of Treatment, Division of Alcohol & Drug Abuse Programs, Vermont
Department of Health
• Todd Mandell, M.D., Medical Director, Division of Alcohol & Drug Abuse Programs,
Vermont Department of Health
• Linda Piasecki, Division of Alcohol & Drug Abuse Programs, Vermont Department of
Health
• Karen Simeon, Northern New England Poison Control Center
• Scott Strenio, M.D., Medical Director, Office of Vermont Health Care Access
• Anne Van Donsel, Division of Alcohol & Drug Abuse Programs, Vermont Department of
Health
Results of the Vermont Case Study
23

Results of the Vermont Case Study
24

APPENDIX C
OUTSIDE EXPERTS CONSULTED FOR THE CASE STUDY
Gretchen K. Feussner
Drug Enforcement Administration
Drug and Chemical Evaluation Section
Office of Diversion Control
600 Army­Navy Drive
Arlington, VA 22202
Fax: 202­353­1079
GKFeussner@aol.com
Howard A. Heit, M.D., FACP, FASAM
Assistant Clinical Professor
Georgetown School of Medicine, and
Private Practice of Pain and Addiction Medicine
8316 Arlington Blvd., Suite 232
Fairfax, VA 22031­5216
Tel: 703­698­6151
Howard204@aol.com
David E. Joranson, M.S.W.
Director, Pain & Policy Studies Group
WHO Collaborating Center
University of Wisconsin ­ Madison
406 Science Drive, Suite 202
Madison, WI 53711­1068
Tel: 608­263­8448
joranson@wisc.edu
Jane C. Maxwell, Ph.D.
Research Professor
Addiction Research Institute
Center for Social Work Research
University of Texas
1717 West 6th Street
Austin, Texas 78703
Tel: 512­232­0610
jcmaxwell@sbcglobal.net
Results of the Vermont Case Study
Patrick L. McKercher, Ph.D.
Center for Medication Use,
Policy & Economics
University of Michigan
College of Pharmacy
428 Church St.
Ann Arbor, MI 48109­1065
Tel: 734­657­5790
PMcKerch@aol.com
Richard K. Ries, M.D., FASAM
Univ. of Washington Medical School, and
Harborview Medical Center
325 Ninth Ave., Box 359911
Seattle, WA 98104­2420
Tel: 206­341­4216
Fax: 206­731­3236
RRies@u.washington.edu
Martha J. Wunsch, M.D., FAAP
Associate Professor and
Chair of Addiction Medicine
Virginia College of Osteopathic Medicine,
and Medical Director, Pantops OTP
2265 Kraft Drive
Blacksburg VA 24060
Tel: 540­231­4477 office
Fax: 540­231­5252
mwunsch@vcom.vt.edu
25

Results of the Vermont Case Study
26

Results of the Vermont Case Study
APPENDIX D
VERMONT BUPRENORPHINE GUIDELINES
27

Vermont Buprenorphine
Practice Guidelines
On October 17, 2000, “The Children’s Health Act of 2000” (HR 4365) was signed into federal law.
Section 3502 of that Act sets forth the “Drug Addiction Treatment Act of 2000” (DATA). This
legislation is of particular interest to state medical boards because it provides for significant
changes in the oversight of the medical treatment of opioid addiction. For the first time in almost a
century, physicians may treat opioid addiction with opioid medications in office-based settings.
These opioid medications, Schedules III, IV, and V opioid drugs with Food and Drug Administration
(FDA) approved indication for the treatment of opioid dependence, may be provided to patients
under certain restrictions. This new treatment modality makes it possible for physicians to treat
patients for opioid addiction with these Schedules III-V narcotic controlled substances specifically
approved by the FDA for addiction treatment in their offices without the requirement that they be
referred to specialized opioid treatment programs (OTP’s) as previously required under federal law.
Physicians who consider office-based treatment of opioid addiction must be able to recognize the
condition of drug or opioid addiction and be knowledgeable about the appropriate use of opioid
agonist, antagonist, and partial agonist medications. Physicians must also demonstrate required
qualifications as defined under and in accordance with the “Drug Addiction Treatment Act of 2000”
(DATA) (Public Law 106-310, Title XXXV, Sections 3501 and 3502) and obtain a waiver from the
Substance Abuse and Mental Health Services Administration (SAMHSA), as authorized by the
Secretary of HHS.
The Vermont State Medical Board is obligated under the laws of the State of Vermont to protect
the public health and safety. The Board recognizes that inappropriate prescribing of controlled
substances, including opioids, may lead to drug diversion and abuse by individuals who seek them
for other than legitimate medical use. Physicians must be diligent in preventing the diversion of
drugs for illegitimate and non-medical uses.
Practitioner Requirements for a Waiver:
Must be licensed in the state of Vermont plus meet one or more of the following:
-ABPN Added Qualification in Addiction Psychiatry
-Certified in Addiction Medicine by ASAM
-Certified in Addiction Medicine by AOA
-Investigator in buprenorphine clinical trials
-Has completed 8 hours of training provided by ASAM, AAAP, AMA, AOA, APA or
other designated organizations. Web sites are: www.aaap.org or www.apa.org.
-Training/experience as determined by state medical licensing board
-Other criteria established through regulation by the Secretary of Health and Human
Services
- Physicians who are seeing patients under the DEA number of an Opiate Treatment
Program do not have to apply for the waiver, nor are they required to take the 8 hour
training course.
2

Once training is completed, the physician registers at SAMHSA
(http://buprenorphine.samhsa.gov/howto.html) to obtain a waiver. A certificate will be sent to
the physician with a special DEA license number amendment. This must be put on all
prescription. Prescribing without this number is a violation.
The “qualifying physician” must have the capacity to refer patients for appropriate
counseling and other services that might be needed in conjunction with buprenorphine
treatment. These include:
-Different levels of chemical dependency treatment services 1
-Psychiatric consultation
-Consultation for medical co-morbidities 2
-12 Step program
-Staff and patient education/training program 3
-Urine screening, either onsite or in conjunction with certified laboratory
-Coverage with knowledge and experience using buprenorphine and office policies
and procedures
-Medication security and storage
No more than 30 patients to be treated at one time per physician
As of July 2005 Congress passed legislation to adjust the 30-patient limit for physician
group practices that dispense buprenorphine in an office-based setting to individuals with
opioid dependence. Now, each physician in a group practice will be allowed to treat 30
patients with buprenorphine
3

Buprenorphine
Buprenorphine is used for both long-term maintenance and for medically supervised
withdrawal/detoxification from opiates. It has been found to be safe and effective in minimizing
withdrawal symptoms as well as blocking the effects of illicit opiates. It is a partial opioid agonist:
at low doses, it acts as an agonist and at high doses as either an agonist or antagonist depending
on the circumstance. Unlike morphine or other full agonist, Buprenorphine’s effects are not linear
with increasing doses and it exhibits a “ceiling effect”. The significance of the ceiling effect is on the
respiratory system and that an individual who takes too much is less likely to die from overdose.
Buprenorphine Preparations Available:
Both of the following are pill preparations that are dissolved sublingually.
Subutex: Mono-therapy containing only buprenorphine. Available from pharmaceutical
house in small supply to be kept in MD’s offices.
May be used for induction but is not necessary for this.
Suboxone: Combination therapy. This preparation contains a combination of
buprenorphine and naloxone. The naloxone has been added to avoid the
possibility of diversion and abuse IV. This is the recommended preparation for
induction, detox and maintenance.
Patient Assessment/Screening:
Treatment Setting:
Office Based Treatment
The initial screening for addiction should consist of a combination of
interviews, objective screening
instruments and laboratory evaluations. (see attached examples of screening
tools)
Within practice care:
Single Practitioner with training and flexibility to provide clinical evaluation,
buprenorphine induction, maintenance and follow up including consultation
and referrals as needed with Primary Care Providers and Medical Specialists.
A practitioner may be able to provide all of the services on their own ie. An
addictions psychiatrist with Buprenorphine training.
Integrated network of care: “Hub and Spoke Model”
Definition: A treatment network that consists of providers with necessary
training and education to provide a continuum of services for opiate dependent
patients.
The Vermont Department of Health, Division of Alcohol and Drug Abuse
Programs (ADAP), proposes that “Hubs” of services be established in the
various regions of the state. These Hubs would provide patient entry into
available services through assessment, buprenorphine induction and referrals
back to “Spokes” i.e., primary care physicians for maintenance once stabilized,
as well as to substance abuse and dual diagnosis treatment. Referral for entry
into a Hub may come from a Primary Care Physician, Psychiatrist, Counselor,
Emergency Room or the patient may self refer. There may be a certain
population of patients who receive all of their services in such a Hub
4

Screening/Intake:
depending on the availability of services in an area or specific patient needs.
Representation from ADAP will be available for consultation for all of the state
providers especially as more appropriate patients are identified and started in
treatment. Please note that one such “hub and spoke model” is in the process
of being piloted in the Central Vermont area using Central Vermont Substance
Abuse Services as the primary Hub. Details about this will be available at a
later date.
Confidentiality and flow of information will be particularly challenging and
important to be certain that all treatment providers are aware of specific issues
that pertain to a given patient as well as the type of specific treatment that is
being proposed. All information sharing must conform to current 42cfr part2
and HIPPA standards for a release of information form
Opiate Treatment Program
Recent legislation as determined that buprenorphine in either the single
(Subutex) or combination form (Suboxone) can be given at OTPs with the
same exact regulations for methadone (42CFR part 8). This includes the takehome
schedule: buprenorphine is to be dispensed from the window and no
prescriptions are given. Due to the long acting nature of buprenorphine,
dosing need only occur two to three times per week. Buprenorphine will be
part of the program’s DEA’s registration, not the individual physician’s, so that
physicians working in OTPs do not have to seek a waiver or take the 8 hour
training. The program is exempt from the 30 patient limit.
Exceptions for take homes and other issues such as a “clinic closed” day can
be submitted for buprenorphine as has been the case with methadone.
Link for the exception form:
http://www.samhsa.gov/centers/csat/content/dpt/Exception168Final.pdf
Link to get Instructions for completing the exception form:
http://www.samhsa.gov/centers/csat/content/dpt/instructions168Final.pdf
1. Medical history with attention paid to liver and cardiac status and medications
2. Psychiatric history with attention to current compliance with medications
3. Substance abuse history and treatment history to identify if patient was ever on
Buprenorphine and to insure that patient is not currently on Methadone but meets criteria for
Opiate Dependence (see DSM-IV-TR based criteria)
4. Social, work, and family circumstances history
5. Physical exam, mental status exam
6. Lab screening for ALT, AST, Hep B,C, HIV, Gonorrhea, Chlamydia, Syphilis, TB test
7. Urine screen (witnessed) with attention to opiates (including Methadone) and
benzodiazepines.
8. If urine is negative for opiates (which may occur with synthetic opiates) you will need to rely
on evidence of IV puncture marks on the skin and evidence of withdrawal symptoms in
various stages such as:
Runny eyes, sniffling, yawning, tremor, sweating, gooseflesh, vomiting, abdominal
cramps, muscle aches, pupil dilation. A CINA scale can be very useful (see enclosed)
5

9. In some cases the use of 1 cc of naloxone (Narcan) (0.4 mg/ml) must be injected
subcutaneously and the patient observed for up to 30 minutes for evidence of precipitated
withdrawal, which would aid in diagnosing dependence. Naltrexone (ReVia) would not be
used in this circumstance due to the protracted withdrawal syndrome that it causes.
10.There are some circumstances when the patient has been detoxed from opiates and will
show no evidence of withdrawal symptoms but is presenting for treatment due to high risk of
using again despite multiple treatment attempts. Examples would be released from prison,
voluntary or involuntary withdrawal from opiates, etc. Consultation with a substance abuse
counselor or addiction specialist is encouraged in these cases.
11.Once this is completed, a consent form and a contract should be reviewed and signed by
the patient and the physician (see enclosed). One copy goes in the chart and one goes to
the patient. A copy of the contract should be sent to the pharmacy.
12.Release of information forms should be completed for the Substance Abuse Counselor and
the pharmacy that will be dispensing. Any other agencies such as the VNA, SRS,
Psychiatrist, referring treatment center, etc, should also have releases signed and placed in
the chart.
Factors that indicate that a patient is LESS likely (not hard and fast “rules”) to be an
appropriate candidate for office based buprenorphine treatment
Dependence of high doses of benzodiazepines, alcohol, or other CNS depressants
Significant psychiatric co-morbidity
Active or chronic suicidal or homicidal ideation or attempts
Multiple previous treatments and relapses
Non-response to buprenorphine in the past
High level of physical dependence (risk for severe withdrawal)
High relapse risk
Pregnancy
Current medical conditions that could complicate treatment
Poor support systems
Patient needs cannot be addressed with existing office-based resources
Buprenorphine- Induction:
1. Prescriptions should be written for one day at a time. * The special DEA number must be
written on the prescription.
2. Inductions should begin early in the week, unless the office is open 7 days a week.
3. Patient takes the script to the pharmacy and brings it back to the office.
4. Patient’s last reported use should have been at least 6 hours prior to induction.
5. MAKE SURE THAT THE PATIENT IS NOT ON METHADONE.
6. Patient takes the tablet and crushes it in the mouth and then lets it dissolve under the
tongue.
Patients NOT physically dependent on opioids ie coming out of incarceration or otherwise
high risk for relapse:
First dose: 2mg sublingual buprenorphine
Monitor for 2+ hours
Gradually increase the dose over several days
6

Patients dependent on SHORT ACTING opioids
Instruct patient to abstain from any opioid use for 12-24 hours so that they are in mild
withdrawal at time of first buprenorphine dose.
Note: If patient is not in withdrawal, have them wait and reassess, revisit their use or
abstinence over past 12-24 hours or return another day
First Dose: 2mg sublingual Suboxone (combination therapy)
Monitor in office for up to 2-4 hours
Re-dose in 2-4 hours if withdrawal subsides than reappears
Maximum dose for first day: 4 mg
Second Day: Adjust dose dependent on patient’s experiences on first day ie
withdrawal symptoms or excess sedation. Target dose 12-16 mg daily
Patients dependent on LONG ACTING opioids
Doses of methadone or LAAM should be decreased to a stable state of 30mg of
methadone or equivalent:
Methadone 40 mg = Buprenorphine 6 mg
Methadone 60 mg = Buprenorphine 12 mg
Methadone 80 mg = Buprenorphine 16-18 mg
Begin induction 24 hours after last methadone or 48 hours after last LAAM. No
additional methadone or LAAM given after induction
First Dose: 2mg sublingual Suboxone (combination therapy)
Monitor in office for up to 2-4 hours
Re-dose in 2-4 hours if withdrawal subsides than reappears
Maximum dose for first day: 4 mg
Second Day: Adjust dose dependent on patient’s experiences on first day ie
withdrawal symptoms or excess sedation. Target dose 12-16 mg daily
* Please note in terms of prescription practice, that some patients may have insurance plans that
require a co-payment for each prescription. Therefore, daily prescription writing may turn out to be
an excessive cost for the patient as opposed to a prescription for a larger number of pills.
Alternatively, a practice may obtain supplies of Subutex as indicated above.
Buprenorphine-Stabilization and Follow up:
Patient should receive daily dose until stabilized. Then patient can be shifted to alternate day
dosing, by increasing the dosing day by amount not received on the intervening days.
1. Urine screens should be done twice a week.
2. Non-attendance for counseling for more than two sessions in a row should trigger an
automatic call from the counselor. Schedule an office visit with the physician to make sure
that the patient understands that failure to follow through with counseling jeopardizes their
treatment and puts them outside of “good standing”.
3. Write 7 days worth of medication at a time for 2-3 months.
4. Once patient has remained compliant with counseling and physician visits, has not had any
mishaps with the Suboxone, and feels ready to do so, extend the scripts to 14 days.
7

5. A patient may choose to take Suboxone every 2 or 3 days. The dose is doubled or tripled,
depending on the time frame, and taken all at once. This is very effective in controlled
settings such as family member dispensing or clinic dispensing or just patient preference.
6. After a period of time that varies with each patient but should reflect the compliance with
treatment a script for 30 days may be written. Pill counts may be a useful monitoring tool at
this point.
7. At the present time, there is no indication that actually testing for the presence of
buprenorphine in the patient’s system as might be done for Methadone, is necessary. Such
a test may become available in the future but would only likely be used in specific cases
when compliance is questioned and the clinical picture does not provide sufficient
information.
Buprenorphine-Detoxification:
Rapid detox: (Three days or less)
Procedure is effective in suppressing withdrawal better than clonidine
Long term efficacy not well documented
Should only be done when there is a particularly compelling reason that the patient
must be detoxed quickly i.e., out of country travel, imminent incarceration
Low doses of buprenorphine given 2-3 times daily
Moderate detox: 4-30 days
Few studies of buprenorphine for this time period
Better tolerated than clonidine
Long detox: more than 30 days
Not well studied but suggested that this is more efficacious than the more brief
approaches
Staff Education/Training:
The use of agonist treatment, either methadone or buprenorphine is new to Vermont
patients and providers. The abstinence-based treatments that have out of necessity been
the state of the art treatment for opiate dependence are in many ways not compatible with
agonist treatment. There are also not such extensive training requirements prior to MD’s
being able to prescribe new antidepressants or other psychotropic medications or
antihypertensives, as there are for buprenorphine. Having buprenorphine as an office based
treatment option is also new to Vermont as treatment as typically been provided at
treatment centers.
This new set of circumstances offers Vermont providers an opportunity to move away from
“abstinence based treatment as always” and into the use of research grounded therapies.
MD’s should have a clear expectation that clinicians to whom they refer their buprenorphine
treated patients, will have been trained in evidence based therapies such as Cognitive
Behavioral Therapy, Motivation Enhancement Therapy, DBT-S etc. Training and orientation
to such therapies must include the patient for whom such treatment approaches may be
new, or difficult to accept initially. Please use the ADAP office for assistance as well as the
SAMSA website for additional assistance for this training.
Funding:
Insurance medication precertification is required prior to starting a patient on buprenorphine
State program approval does not automatically mean that programs will be funded. State
program approval does not automatically mean that programs will be funded. Approval will
be based on program’s demonstration of staff experience and/or training in agonist
treatments and evidence based program focus on moving patients as needed through a
continuum of services and to independent functioning.
Attached is a copy of the preauthorization form for PATH.
8

1 Levels of care range from ambulatory, 1:1 substance abuse counseling in conjunction with 12
Step or other community based recovery support (least restrictive) to inpatient, medically managed
acute treatment (most restrictive). See ASAM level of care placement guidelines.
2
Medical co-morbidities that may affect use of buprenorphine
Hepatitis B, C
Buprenorphine inhibits hepatic mitochondrial function at high concentrations
May cause elevation of transaminases, but no documentation of fulminant liver failure
due solely to buprenorphine
Monitor liver enzymes levels in patients with Hepatitis, especially those on
Buprenorphine/Naloxone
Warn patients not to use Buprenorphine IV
Renal Failure
Few studies available
No significant difference in kinetics of buprenorphine in patient with renal failure vs
controls
No significant side effects in patients with renal failure
Medication Interactions
Cytochrome P450 3A4 Interactions
3A4 Inhibitors May Raise Buprenorphine levels
e.g.. Fluoxetine (Prozac) Fluvoxamine (Luvox), nefazodone (Serzone)
cimetidine (Tagamet) and possibly antiretrovirals ie ritonavir
3A4 Substrates may raise Buprenorphine levels
e.g. Trazodone (desyrel), alprazolam (Xanax), Diazepam (Valium), buspirone
(Buspar), zolipidem (Ambien) caffeine, haloperidol (Haldol), pimozide (Orap),
erythromycin, nifedipine, oral contraceptives
3A4 Inducers may lower buprenorphine levels
e.g. crabamazepine, Phenobarbital, phenytoin, barbiturates, primidone, St.
John’s Wort, rifampin protease inhibitors (nelfinavir, lopinavir) non-nucleoside
Rtis (nevirapine, efavirenz)
A complete list of substrates, inhibitors and inducers: www. druginteractions.com
3 Staff and patient education/training program
Staff Education
Treating patient with substance abuse disorders
The disorder of opiate dependence
Role and importance of medication in treatment of opioid dependence
Maintenance of confidentiality
Treatment philosophy
Providing medication
Role of non-pharmacological treatments
Universal precautions
Patient Information
Informed consent
Treatment agreements
9

Appendix
DSM-IV Diagnosis of Opiate Dependence
-Maladaptive pattern of use, leading to significant impairment or distress, as manifested by 3 or
more of the following, occurring at any time in the same 12-month period.
1.Tolerance, as defined by decreased effect with same amount or increased amount needed to
achieve same effect.
2.Withdrawal, as defined by characteristic syndrome for the substance when withdrawn or closely
related substance taken to relieve the syndrome.
3.An increase in the amount or the duration from what was intended.
4.Persistent desire or unsuccessful attempts to cut down or control use.
5.Spending a great deal of time in activities needed to obtain or use the substance or recover from
the effects of it.
6.Giving up social, occupational, or recreational activities because of use.
7.Continuing the use despite knowing that it is causing or worsening a persistent or recurrent
psychological or physical problem.
Ten Factor Office Based Criteria Check List
In general, 10 factors help determine if a patient is appropriate for office-based
buprenorphine treatment. Check off “yes” or “no” next to each factor.
Factor Yes No
Does the patient have a diagnosis of opioid dependence?
Is the patient interested in office-based buprenorphine
treatment?
Is the patient aware of the other treatment options?
Does the patient understand the risks and benefits of
buprenorphine treatment and that it will address some
aspects of the substance abuse, but not all aspects?
Is the patient expected to be reasonably compliant?
Is the patient expected to follow safety procedures?
Is the patient psychiatrically stable?
Are the psychosocial circumstances of the patient stable
and supportive?
Are resources available in the office to provide appropriate
treatment? Are there other physicians in the group
practice? Are treatment programs available that will accept
referral for more intensive levels of service?
Is the patient taking other medications that may interact
with buprenorphine, such as naltrexone, benzodiazepines,
or other sedative-hypnotics?
Information for the above guidelines was obtained in part from the following
BUPRENORPHINE CLINICAL PRACTICE GUIDELINES FIELD REVIEW DRAFT
November 17, 2000
Use of Buprenorphine in Pharmacologic Management of Opioid Dependence
Course Director: Elinore F. McCance-Katz, MD. PhD; Medical College of Virginia
Thanks to John Ross Brooklyn, MD and Todd Mandell, M.D.
10

~ BUPRENORPHINE ~
Prior Authorization Work Sheet
Vermont Medicaid has established criteria for prior authorization of Buprenorphine. These criteria are based on concerns about safety and the potential for abuse
and diversion. For beneficiaries to receive coverage for this drug, prescribers must telephone First Health or complete and fax or mail this form to the First Health
Services Corp at the address noted at the bottom of this page. Please complete this form in its entirety, sign and date. Incomplete requests will be returned for
additional information.
Prescribing physician (use stamp or print): Beneficiary (please print):
Name: Name:
Phone #: Medicaid ID #:
Fax #: Date of Birth: Sex:
Diagnosis: Dose:
Pharmacy (if known): Phone: &/or FAX:
QUALIFICATIONS
Prescribers must have a special ‘X’ DEA license in order to prescribe. Prescribers must also have the
MDs capacity to refer patients to an evidenced-based substance dependency counseling and monitoring
program, and have no more than 30 patients on Buprenorphine.
Patients must have a diagnosis of opiate dependence confirmed. Patients must also have been advised of
Patients other Rx options, and have signed an informed consent form or treatment contract.
PROCESS
Has MD prescribed Buprenorphine before?
Is this a new patient without any special considerations?
Yes No
(Special considerations include: hepatitis, pregnancy, CAD/ dual diagnosis/ psych med/ Hx
suicidal ideation/ continued substance use (Benzo/ETOH)/ Hx of treatment failure, incarceration,
or poor psychosocial-supportive environment)
Yes No
Is this an established patient who has been compliant with MD
appointments?
Is this an established patient who has been referred to an evidenced-based substance
dependency counseling and monitoring program?
Yes No
Yes No
You must page Dr. Strenio (741-7975) for Prior Authorization if any of the
above answers is “NO.”
If Agent, please print name:
Prescriber/Agent Signature: Date of request:
FOR FIRST HEALTH USE Approved Changed Denied Pending Add’l Info
Comments: MAP RPh/Tech:
NDC:
Date of Decision:
Submit requests via phone, fax or mail to: First Health Services Corp., MAP Dept.
4300 Cox Road, Glen Allen, VA 23060
tel: (866) 435-1199 fax: (888) 603-7696
Faxed requests are responded to within 24 hrs. For urgent requests, please use telephone. OVHA/Buprenorphine
7/17/03
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