Proposal for Remote Dosing Program
1
PROPOSAL
FOR
REMOTE DOSING PROGRAM
By
Dr Clive Stack and Dr Gwenyth James
Humanitas Trust, Tasmania
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Proposal for Remote Dosing Program
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Table of Contents
ACKNOWLEDGEMENT ............................................................................ 2
1.
INTRODUCTION ........................................................................ 3
1.1
METHADONE TREATMENT IN AUSTRALIA .......................... 5
1.1.1 HISTORY OF METHADONE TREATMENT IN AUSTRALIA .... 5
1.1.2 THE AUSTRALIAN METHADONE PROGRAM ........................ 5
2.
PROBLEM IDENTIFICATION ................................................ 11
2.1
STATISTICAL ANALYSIS OF DRUG DEPENDENCE ....... 11
2.2
ECONOMIC ISSUES ............................................................... 14
2.3
COST TO PATIENT OF METHADONE MAINTENANCE
THERAPY ................................................................................ 17
2.4
SUPERVISION OF METHADONE TREATMENT .................. 17
3.
PROPOSED REMOTE DOSING PROGRAM .......................... 19
3.1
INTRODUCTION ..................................................................... 19
3.2
AIMS OF PROGRAM .............................................................. 19
3.3
PROCESS FOR REMOTE DOSING PROGRAM .................. 20
3.3.1 CRITERIA FOR INVOLVEMENT IN REMOTE DOSING
PROGRAM ............................................................................... 20
3.3.2 INITIAL ASSESSMENT ............................................................ 21
3.4
THE DOSING MACHINE ........................................................ 27
3.5
DUTIES OF PARTICIPATING PHARMACISTS ..................... 29
3.6
PATIENT AGREEMENT ......................................................... 29
3.7
COMPUTER NETWORK ........................................................ 31
3.8
ADVANTAGES OF REMOTE DOSING PROGRAM .............. 31
3.9
DISADVANTAGES OF REMOTE DOSING PROGRAM ........ 35
4.
PRELIMINARY RESEARCH ................................................... 36
4.1
TRIAL OF REMOTE ASSESSMENT TECHNOLOGIES ....... 36
4.2
TRIAL OF DOSING MACHINE ................................................ 37
5.
PROPOSED RESEARCH – PILOT STUDY .......................... 38
5.1
AIM........................................................................................... 38
5.2
METHODOLOGY ..................................................................... 38
5.3
RESOURCES .......................................................................... 40
5.4
PROPOSED BUDGET ............................................................. 40
6.
CLINICAL TRIAL ..................................................................... 41
7.
APPENDIX 1 – MEDICAL TERMS ........................................... 43
7.1
OPIOIDS .................................................................................. 43
7.2
METHADONE .......................................................................... 43
8.
APPENDIX 2 - LITERATURE REVIEW .................................... 45
REFERENCES ..................................................................................... 47
ACKNOWLEDGEMENT
The assistance of Dr Tim Gale, Department of Engineering, University of
Tasmania in development of the dosing machine, pupillometry goggles and
remote assessment software has been fundamental in the development of the
proposed remote dosing program.
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1. INTRODUCTION
Over the last 50 years, opioid dependence has been steadily increasing in
Australia. Drug replacement programs, or pharmacotherapy programs, are the
most common treatment for opioid dependence with guidelines for the
Australian Methadone Program being established in 1985. There are currently
over 41,000 people in pharmacotherapy programs for opioid dependency,
from illicit and, increasingly, also therapeutic origin. This number is rising
steadily. However, the Australian Methadone Program 1 imposes significant
costs on all participants: prescribing medical practitioners, dispensing
pharmacists and the participants themselves.
Under the current program, participants are usually required to attend a
dispensing centre (usually a pharmacy or a medical clinic) once a day where
they are assessed by the dispensing clinician (usually the pharmacist or
medical practitioner). The dispensing clinician is required to assess the patient
prior to them receiving their medication to ensure they do not display signs of
sedation (e.g. from other drug use) or withdrawal. They are also required to
dispense the medication and supervise the patient taking it. Depending on the
work load at the dispensing centre, it may take several hours for the patient to
receive their medication. Patient costs particularly relate to daily attendance at
the dispensing centre such as: travel, time spent waiting for medication and
issues relating to contact with other drug users also waiting to receive
medication at the dispensing centre.
Some patients who meet stability criteria are allowed to receive takeaway
medication doses from the pharmacy to be taken at a later time away from the
dispensing centre. The takeaway policy differs significantly between States
and Territories with the most liberal policy in Tasmania where 3 takeaway
doses a week may be authorised by the prescribing medical practitioner.
However, the takeaway dose system still imposes significant costs on the
prescribing medical practitioner/dispensing pharmacist particularly in relation
to investigating and instigating requests for changes to the takeaway dose
prescription. In addition, diversion of medication to the black market and
misuse of medication are significant problems.
The Remote Dosing Program has taken into consideration the issues with the
existing pharmacotherapy programs for opioid dependence, including the
methadone maintenance program, and proposes a new addition to the
program using innovative new technology. It is believed the pre-dose
assessment in the new program will be more rigorous than the current system
and the dose dispenser more secure. This will result in both cost savings to
1
Other forms of pharmacotherapy such as treatment with buprenorphine also follow the
guidelines of the Australian Methodone Program.
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doctors and pharmacists and a safer, more secure drug replacement program
that facilitates faster rehabilitation of drug dependent patients.
Regardless of the costs and issues with pharmacotherapy programs, they
have been found to be a cost-effective and safe way of managing opioid
dependence. There is substantial research indicating an extension of the
program is warranted particularly if the issues regarding diversion of takeaway
doses can be addressed.
Over a period of approximately 20 years Dr Clive Stack has accumulated
considerable clinical experience through work in the community including
treating patients in both hospital and private practice in Tasmania. During this
time, he has identified many shortcomings in the current programs to manage
and rehabilitate drug dependent patients. He has subsequently developed the
Remote Dosing Program to address these problems.
There are three major elements to the Remote Dosing Program. The
first is a remote objective, reproducible and cheap pre-dose
assessment of the patient to determine their level of stability. The
second is a secure dosing machine, continuously remotely monitored
to reduce the harm usually associated with home dosing. The third is
remote dispensing of medication and supervision of the patient by an
assessor to ensure the medication is taken correctly at the same time
as dispensed.
The program is aimed at people already stable on existing pharmacotherapy
programs for opioid dependence, and introduces new technology to remotely
assess patients and dispense medication. The technology relies on internet
web cameras to allow the dosing clinician to contact and observe the patient
as well as assess the patient using a simple reaction test and pupillometry
(which measures changes in the size and reactivity of the patient’s pupil to
light). If the patient passes the assessment, the medication is dispensed
through a dosing machine which can only be unlocked via an internet
connection with the dosing clinician.
It is anticipated the Remote Dosing Program will not only result in cost
savings to prescribing medical practitioners and dispensing clinicians but will
contribute also to a safer, more secure pharmacotherapy program for opioid
dependence. In addition, the Remote Dosing Program has significant
advantages for patients particular the potential to provide split dosing
throughout a day and to eliminating the need for daily visits to a dispensing
centre to receive medication. This may facilitate a more productive
contribution to the community. For example, the Remote Dosing Program will
accommodate the patient’s medication needs allowing them to return to
employment or study. In addition, the program can be extended to
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communities that are currently unable to access pharmacotherapy programs
such as remote or rural communities.
It should be noted that the development of the sedation assessment tools that
can be undertaken remotely has many other possible uses of great
community significance. For example, a simple, quick, objective and reliable
tool for assessing sedation has obvious uses in policing and in industries
where undetected sedation has safety implications such as flying planes,
driving or operating machinery.
1.1 METHADONE TREATMENT IN AUSTRALIA
1.1.1 HISTORY OF METHADONE TREATMENT IN AUSTRALIA
Methadone is a synthetic opioid that was first developed in Germany in 1937
for the relief of pain. It was first used to treat heroin dependency in the USA in
1964 and introduced into Australia for the same purpose in 1969. Methadone
maintenance was endorsed as an appropriate and useful method for treating
heroin dependency at the launch of the National Campaign Against Drug
Abuse in 1985.
In the 1980s concern about the spread of HIV/AIDS amongst injecting drug
users (and from them to the rest of the community) increased. Concurrently,
evidence emerged of the role of methadone in reducing the spread of
HIV/AIDS amongst those who use illegal opioids. From this time, there has
been a steady and substantial increase in the number of people receiving
methadone treatment in Australia. In addition, there has been an increasing
reliance on the private sector (medical practices and dispensing pharmacies)
for the provision of methadone services.
Currently, State, Territory and the Commonwealth Governments all contribute
to the funding of methadone treatment services. However, direct service
provision is a State/Territory responsibility.
1.1.2 THE AUSTRALIAN METHADONE PROGRAM
National guidelines for methadone treatment were first endorsed by the
Australian Health Ministers' Conference in 1985 and subsequently reviewed in
1987 and 1991. The guidelines were further reviewed in 1997. These
guidelines are the framework for policies and procedures for methadone
treatment throughout Australia.
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The objectives of methadone treatment, as identified in the National
Guidelines, are:

to reduce harmful opioid and other drug use

to improve the health of clients

to help reduce the spread of blood-borne communicable diseases
associated with injecting opioid use

to reduce deaths associated with opioid use

to reduce crime associated with opioid use

to facilitate and improve social functioning.
From this, it should be noted that the goal of methadone treatment in Australia
is to reduce the health, social and economic harm, associated with
unsanctioned opioid use, to individuals and the community. While abstinence
from all opioid use is seen as a desirable outcome of the methadone program,
it is not one of the objectives.
The national treatment protocols enable the majority of opioid dependent
people to be maintained safely on methadone. These protocols include the
following 6 steps.
1. Suitability for Methadone Treatment
Admission into a methadone treatment program is usually voluntary.
Methadone treatment is suitable for people who are opioid dependent as
indicated by:

neuroadaption as evidenced by tolerance and withdrawal on cessation
or sudden reduction in the use of opioids

the use of opioids or other drugs to avoid withdrawal

continued desire to use opioids regardless of persistent or recur rent
problems associated with their use

narrowed repertoire of behaviours associated with or fixated on opioid
use

repeated unsuccessful attempts to reduce or stop opioid use

priority of opioid use over other life activities.
2. Assessment for Methadone Treatment
A person is only admitted into the methadone program after an approved
medical practitioner has assessed them as being appropriate for treatment.
The assessment examines the client's needs, determines their suitability for
treatment and the setting in which this is best to take place (e.g. a dispensing
pharmacy or specialist dispensing setting) and establishes a treatment plan. It
includes the collection of relevant medical, social and personal details
including drug use history, risk taking behaviours associated with drug use,
observation of clinical symptoms related to drug use including intoxication or
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Proposal for Remote Dosing Program
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withdrawal and examination for the purposes of detecting evidence of drug
use. In addition, the person's identity must be confirmed.
Following the assessment, the person is eligible for entry into the program.
However, entry into a methadone program is predicated on this being the best
treatment for the patient’s condition and social circumstances. If this is
agreed, entry into the program occurs as quickly as possible. Research
indicates that successful commencement and continuation of treatment is
improved by prompt access to programs.
3. Induction into Treatment
The medical practitioner who conducts the assessment is responsible for
providing each client with information about the purpose, methods, demands,
risks and inconveniences of methadone treatment. Information is also
provided on:

the policies and procedures of the treatment program

addictive qualities, side effects and drug interactions of methadone

hazards and problems associated with the use of methadone (e.g. risk
of excessive sedation in early stages of the program)

information about any other health risks identified such as
management of hepatitis or HIV/AIDS

alternatives to methadone treatment.
4. Dosing
Usually, methadone is dispensed as a syrup. Physeptone tablets are
dispensed in exceptional circumstances instead of syrup. The medical
practitioner who undertakes the initial assessment prescribes the dosage of
methadone and prescribes the way in which it will be delivered to the patient
(e.g. all supervised doses). The aim of treatment is to arrive at an effective
maintenance dose where drug elimination and the rate of drug administration
are balanced, using safe dose increments. The dose of methadone is
increased slowly until the effective maintenance dose is identified unless the
medical practitioner identifies signs of toxicity or intoxication.
The initial dose of methadone is based on the person's history of opioid use
including quantity, frequency, and route of administration. A person maybe
considered for a supplementary dose if they re-present with withdrawal
symptoms at least 4 hours after the initial dose on the first day of treatment.
However, cases for supplementary treatment need to be assessed by a
medical practitioner. Generally, the initial dose of methadone is 20 -30mg but it
is often gradually increased to 60mg (or more). It has been found that people
receiving 60mg (or more) are less likely to use other opioids and remain in the
treatment program than people receiving a lower dose of methadone.
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Once the maintenance dose of methadone has been established, i t can only
be changed by a prescribing medical practitioner. Each time a prescription for
methadone is provided or renewed, the prescribing medical practitioner must
assess the patient's progress.
Supervised dosing is an essential component of the methadone program.
Usually, methadone is taken each day at a location approved by the State of
Territory jurisdiction under direct supervision. Generally, the location is an
approved dispensing pharmacy under the direct supervision of the pharmacist
but a medical practice may also be approved with supervision provided by the
practice nurse or general practitioner.
If a patient misses a methadone dose, it may be an indicator of instability.
This instability could take the form of using other drugs to alleviate their
discomfort. This action could result in a memory disturbance or significant
sedation so patient does not get to the dispensing pharmacy for their usual
dose. Alternatively, there may be social factors preventing the patient from
getting to the dispensing pharmacy (e.g. car breakdown). Therefore, it is
necessary to assess the person for stability and intoxication before dosing
recommences. This is usually done by the dispensing pharmacist. However, if
the patient does not take their methadone for three consecutive days, they
cannot recommence the program until assessed by a medical practitioner.
This assessment is necessary as the patient’s tolerance to methadone may
be reduced and their stability needs to be reassessed to ensure the best
dosing arrangements for their wellbeing.
5. Monitoring of Drug Use (Other than Methadone)
Concurrent use of other drugs by people in the methadone program is
common. These drugs may include heroin, amphetamines, alcohol or
prescribed medication. It is necessary to attempt to detect and monitor the
use of other drugs as the use of other drugs may lead to toxicity or indicate
that the patient is at risk of diverting their methadone dose for payment. Such
actions can put other people at risk (i.e. by making prescription medication
available on the black market). Detection and monitoring of other drug use is
done at the time of supplying methadone by the dispensing clinician (through
observing the person) as well as by the prescribing medical practitioner
(through case history, physical examination, blood and urine tests etc).
6. Takeaway Methadone Doses
Where a patient meets certain criteria, the prescribing medical practitioner
may authorise either a single or regular dose of methadone to be taken and
consumed away from the dispensing location (takeaway doses). Takeaway
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doses are an intervention to assist in rehabilitation and normalisation of the
patient’s lifestyle (e.g. so they can attend work or further education).
There are significant risks associated with takeaway doses including:

methadone diversion and involvement in drug trafficking

injection of the dose with the risk of overdose, toxicity (methadone
syrup contains sorbitol which may be toxic if injected), bacterial
infection or spread of blood-borne viruses

injection of the dose which may result in increased tolerance to the
medication

accidental overdose/death of the person (if they take the doses too
close together) or other people (if accidentally taken by other people
such as children).
Therefore, to be eligible to receive takeaway doses, the patient must meet
stability criteria including:

the patient has been in continuous methadone treatment for 2 months
where all doses of methadone have been consumed under
supervision

takeaway doses should be the same dose normally dispensed

the patient is assessed as stable in that they:
o are not engaged in continuing, hazardous use of opioids,
benzodiazepines, alcohol and/or psychostimulants
o have regular, reliable contact with the clinic and pharmacy and
comply with the requirements of the methadone program
o have functioning social behaviours


the patient has not shown any of the following contraindicators for
takeaway doses:
o
o
diversion of methadone doses
recent injection of methadone
o
serious psychiatric illness
the prescribing medical practitioner has assessed the patient, their
past performance and progress in methadone treatment and their
reason for requesting takeaway doses.
Patients who meet the stability criteria are considered “stable”. Those who do
not meet one or more of the criteria are considered “unstable”. It should be
noted there are often significant difficulties in distinguishing stable patients
from unstable patients and an objective, easy to administer and cheap test
that can be applied in every situation is not always available.
Each takeaway dose is supplied in a separate, child-resistant container. If a
patient reports a takeaway dose has been lost, stolen or damaged it will only
be replaced at the prescribing medical practitioner's discretion. If the
prescribing medical practitioner has reason to believe the dose has been
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already consumed or sold, they may choose to require the patient to return to
supervised dosing.
A patient who is approved for takeaway doses will gradually have the number
of takeaway doses they may receive increased in response to their level of
stability. In addition, the prescribing medical practitioner will consider whether
takeaway doses assist the achievement of a stable lifestyle particularly in
relation to whether the takeaway doses will support the patient’s normalisation
of their social functioning. Initially they may get one takeaway dose per week
to be taken on a particular day. As patient demonstrates their ability to
manage their medication, their takeaway privileges can be increased until
they have full privileges: 3 takeaway doses per week to be taken on any day.
(On the days they do not have a takeaway dose they must attend a pharmacy
or dispensing clinic and received a supervised dose).
Patients may request takeaway doses if travelling overseas. Generally,
takeaway doses will only be provided for the shortest possible time f or the
patient to reach their destination. Physeptone (methadone) tablets rather than
syrup is provided in some states. The following guidelines apply to takeaway
doses for overseas travel:

if a methadone program is available at the destination, transfer t o that
program is preferable to takeaway doses

the destination country must allow entry to people in possession of
prescribed methadone medication

the State/Territory jurisdiction must approve the provision of the
takeaway doses giving consideration to public and personal safety
issues.
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2. PROBLEM IDENTIFICATION
2.1 STATISTICAL ANALYSIS OF DRUG
DEPENDENCE
Opioid dependence includes people dependent on prescribed opioids, such
as morphine, as well as illicit drugs such as heroin. It is estimated that 40 % of
people who suffer chronic pain are dependent on opioid medication. In
Australia, people with opioid dependence have been treated using opioid
pharmacotherapy. The number of pharmacotherapy patients has been
steadily increasing since 2006 but an increase of approximately 2,500
patients in 2008 was more than in any of the previous three years. At 30 June
2008 there were 41,347 patients in Australia receiving some form of
pharmacotherapy treatment for opioid dependence.
In Australia, the pharmacotherapies for opioid dependency currently used
include:

Methadone Hydrochloride – This drug has been used as a
pharmacotherapy since 1969. It is a synthetic opioid agonist primar ily
used in maintenance therapy. Methadone is taken orally usually on a
daily basis.

Buprenorphine – This drug has been used as a pharmacotherapy
since the 1980s. It is a partial opioid agonist with high receptor affinity
and has actions similar to full agonist drugs in that it can prevent
withdrawal effects. The major benefit of using buprenorphine is that
an increase in the dose of buprenorphine does not correspondingly
increase the side effects such as respiratory suppression or sedation.
This is significantly different to methadone where the side effects
continue to increase with increases in dosage levels. This often allows
buprenorphine to be dosed every second or third day rather than daily
as the body can be safely loaded with the drug so its duration of effect
can be extended. Buprenorphine is taken sublingually.

Buprenorphine/Naloxone –The combination of two the drugs,
buprenorphine/naloxone is also taken sublingually. The naloxone is
not absorbed if taken this way and therefore has little impact on the
users when taken as prescribed. However, if the combination is illicitly
injected, the naloxone will attenuate the effects of the buprenorphine
and other opioids. Therefore, the addition of naloxone to
buprenorphine will help to discourage the injection of the drug
combination and so reduce the harm related to such injection.
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Proposal for Remote Dosing Program
The number of people receiving pharmacotherapy treatment for opioid
dependence has only shown a slight increase over the last 3 years, as
indicated by the figures below. This compares with an increase of over 50% in
patients accepted into treatment between 1998 and 2004.
Table 1 – Number of People Receiving Pharmacotherapy Treatment
for Opioid Dependence in Australia 2005-2008
YEAR
NSW
VIC
QLD
WA
SA
TAS
ACT
NT
AUSTRALIA
2005
16,460
10,753
4,470
2,883
2,857
588
764
183
38,937
2006
16,355
10,736
4,637
2,888
2,823
602
790
134
38,965
2007
16,348
11,051
4,309
2,822
2,834
600
765
114
38,843
2008
17,168
11,821
4,899
2,908
3,052
588
786
125
41,347
When the mode of pharmacotherapy treatment is disaggregated, it is found
that methadone was the most common form of pharmacotheraphy treatment
in 2008. Over 60% of patients in most States/Territories are prescribed
methadone alone with methadone being the pharmacotherapy treatment most
likely to be prescribed in TAS, NSW and the ACT.
Figure 1 – Comparison of Pharmacotherapy Treatment for Opioid
Dependence in Australia: 2008
In addition, VIC, QLD and WA indicated that Buprenorphine/Naloxone was
administered more often than Bupronorphrine alone. (NSW did not record any
buprenorphine/naloxone as these figures were included in the buprenorphine
only figures.)
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Figure 2 – Comparison of Pharmacotherapy Treatment for Opioid
Dependence by State/Territory: 2008
The place where a patient receives treatment (dosing point sites) is also
significant. In 2008, pharmacies dispensed treatment to nearly 70% of
patients. In addition, nearly 87% of patients receiving buprenorphine/naloxone
in 2008 received their treatment from a pharmacy compared with only 66% of
people receiving methadone treatment. (In Figure 3, “Other” includes
correctional settings.)
Figure 3 – Dispensing Location for Pharmacotherapy Treatment
for Opioid Dependence in Australia: 2008
Each jurisdiction has a registration process which authorises a medical
practitioner to prescribe pharmacotherapy drugs. In 2008, there were 1,393
practitioners nationally authorised to prescribe pharmacotherapy drugs.
However, it is significant to note that over 65% of patients received treatment
from a private practitioner (i.e. working in private practice rather than a
government funded setting such as a hospital or clinic).
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The geographical coverage of the dispensing centre is also critical. In the
USA it was found that 85% of heroin addicts did not have access to legal
methadone. While the exact figures in Australia are unknown, it would be
reasonable to assume that there are insufficient authorised medical
practitioners to fully cover all Australian communities with remote or rural
areas most likely not to have access to pharmacotherapy programs for opioid
dependence.
2.2 ECONOMIC ISSUES
Opiate dependence imposes a significant economic burden on society in
terms of costs related to treatment and prevention services, other health
costs, work absenteeism of addicts, productivity losses from premature death
of addicts and social welfare expenditure. The National Policy on Methadone
Treatment identifies the following issues associated with illegal opioid use
which contribute to health, social and economic costs to the individual and
community:

significant risk of dying from overdose

quantifiable costs relating to illicit drug use in Australia were estimated
at $1,700M in 1992 while the tangible social costs of drug use in
Australia in 1998-99 were estimated to be $18.3B (or approximately
5.5% of the gross domestic product)

law enforcement costs relating to illegal drugs were estimated at
$450M in 1992

infectious diseases such as HIV/AIDS and hepatitis B and C are
readily transmitted through shared injecting equipment. The estimated
lifetime treatment costs to Australian public funds for treatment care,
social security etc of HIV/AIDS was estimated as $250,000 in 2006
while the lifetime costs per person infected with hepatitis C was
approximately $46,000 per person in 2005.

50-70% of injecting drug users are infected with hepatitis C which will
place demands on the health system with approximately 20% of
infected people progressing to liver cirrhosis within 20 years and up to
10% developing liver cancer within another 5-10 years.
In addition, once a person becomes dependent on opioids, particularly heroin,
the cost of maintaining the habit contributes to an escalating involvement in
income-generating crime, such as trafficking drugs, property crime or
prostitution, to support the habit. In 1998-99, it was estimated that the total
social costs of alcohol, tobacco and illicit drugs was $34,440M of which nearly
20% was due to illicit drugs.
Economic evaluation of opioid dependence interventions is complex as post treatment outcomes affect both the drug dependent person and society as a
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whole. In addition, economic evaluation of certain outcomes such as the
duration of medical problems is difficult. Despite this, there is a growing
number of studies which show the benefit of maintenance programs e xceed
the costs. In particular, studies between 2001 and 2004 showed for each
additional healthcare dollar spend on a methadone maintenance program,
$15 of crime-related expenditure was saved. In addition, a 2002 study found
the benefits of dependence intervention for participants after being included in
the program for one year included a 83% reduction in criminal activity, an 11%
increase in employment earnings and a 6% reduction in health services
utilisation.
Significant costs are associated with the treatment of opiod dependence. A
study of the methadone program in 2001 found significant differences in the
costs of the program depending on whether it was delivered as an outpatient
service or residential treatment with the cost of the labour involved in
delivering the treatment responsible for up to 88% of the cost. While the
labour costs associated with delivery of a methadone program is significant,
other costs include testing to ensure the dosage and frequency of treatment is
appropriate. These tests include urine and blood test. Other tests such as
pupillometry, which involves measurement of the diameter of the pupil, are
being investigated for use in treatment programs. The costs as well as the
advantages and disadvantages of these tests are shown in Table 2 (on Page
16).
Studies of methadone maintenance programs have indicated that their
expansion is cost-effective and decreasing barriers to access generates
significant health benefits for the community. In addition, a 2003 study in
Sydney, Adelaide and Brisbane found that treatment with methadone was less
expensive and more effective than treatment with buprenorphine.
Despite these findings, expansion of the methadone maintenance program is
dependent on governments funding treatment places and the availability of
prescribing medical practitioners and dispensing pharmacists. As stated in a
1999 study, funding shortages require more efficient and less expensive ways
of delivering treatment.
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Table 2 – Comparison of Drug Tests
TEST
COST PER TEST
TIME/
ADVANATAGES
RESOURCES TO
ADMINISTER
DISADVANTAGES
Urine
 Approximately
$30 plus the cost
of labour to
administer and
analyse the test
 Approximately
5 minutes
 Tests for other drugs
of dependence
 May detect drugs
that have been in a
the body for up to a
week
 Fast
 Immediate results so
can act to modify
treatment protocol if
necessary
 Diuretics and other
drugs can mask
 Needs to be done
in a medical clinic
 Too expensive to
do every day
Blood
 Approximately
$30 plus the cost
of labour to
administer and
analyse the test
 Approximately
3 days
 Tests for other drugs
of dependence
 Not easily confused
by other drugs
 Unreliable – only
tells what is
present in the
body at time of test
 Needs to be done
in a medical clinic
 Too expensive to
do every day
 Not able to get
immediate results
Pupillometry
(as proposed
in this project)
 Only the cost of
labour to
administer and
analyse the test
 5 minutes
 Uncomplicated
 Accurate
 Immediate results so
can act to modify
treatment if
necessary
 New protocols are
not easily confused
by other drugs
 Maybe able to tell if
multiple drugs of
dependency are
being used
 Can be remotely
administered
 Still being
researched and
developed
 Initial start up cost
– over $200
 Goggles not yet
commercially
available
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Proposal for Remote Dosing Program
17
2.3 COST TO PATIENT OF METHADONE
MAINTENANCE THERAPY
Patients who undertake methadone maintenance therapy may experience a
number of expenses including 2:

The cost of daily transport to and from the dispensing pharmacy or
medical centre (either cost of petrol, maintenance of car, taxi or bus
fare)

Lost productivity for employed patients who have to leave work to
receive their medication

The stress of keeping the details of their methadone maintenance
therapy away from employers, family and friends so they do not lose
their jobs or experience prejudice

Personal safety issues related to being in contact with other drug
users at the dispensing pharmacy or medical centre as some of these
people may intimidate or threaten other patients to gain access to
their doses

Personal safety issues related to loss of resolve towards stability
when exposed to low stability patients, or drug dealers who have
ready access to other drugs of dependence

Personal safety issues relating to loss of privacy due to other, less
stable, patients attending the same pharmacy or dispensing centre
who may discover personal information (e.g. place of residence,
access to takeaway doses)

Loss of personal dignity when having to queue at the pharmacy (often
for extended periods such as hours), in view of other customers
(which can lead to involuntary disclosure of their participation in the
program), as people on the methadone program are often the last to
be served

Lost family time spent obtaining their daily medication (e.g travel time,
dosing time)

Difficulty travelling (for both work and on holidays) due to perceived or
real restrictions in arranging supervised dosing (e.g. dispensing
centres may not be available in remote areas).
2.4 SUPERVISION OF METHADONE TREATMENT
Generally, people who are part of a methadone program (and other opiod
pharmacotherapy program) are required to take their medication in front of a
pharmacist or a medical practitioner. The exceptions to this rule are people
2
Most of the expenses of methadone maintenance therapy also apply to people on other forms of
opioid pharmacotherapy programs.
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Proposal for Remote Dosing Program
18
who are considered stable and are therefore approved to take medic ation
home (known as takeaways).
There is substantial evidence from a range of studies which indicates
diversion and misuse (e.g. taking medication early, overdosing, injecting) is
an integral risk in prescribing opioids (including methadone) either for
management of dependence or management of pain. Much of the diverted
opioids find their way to the black market where it is sold to be ingested orally
or intravenously. In these circumstances the dosage and frequency of
methadone taken by the person becomes uncontrolled. Diversion of
prescribed opioids is associated with many adverse consequences including
fatal overdose, an increased incidence of addiction, and the compromise of
the public acceptance of treatment programs.
As the methadone program expanded rapidly in the 1990s, there was an
increase in methadone-related deaths. Approximately 75% of these deaths
occurred as a consequence of diversion of methadone to people not in the
methadone program. A study in Sydney in 1995 found an active black market
in methadone with 88% of the drug sourced from diverted takeaway doses. A
further study in 2002 found diversion of the drug to the black market
increased proportionally with unsupervised treatment while a 2005 study
found that the restrictiveness of takeaway policies, the market availability of
heroin, and the dose dilution of takeaway doses, all also impact on the
amount of methadone diverted.
Making treatment accessible, affordable and attractive to potential patients
needs to be balanced against the need to minimise diversion and maximise
safety of the patient and the community. While supervision of treatment has
been clearly shown to decrease diversion of medication, people in regular
employment or studying may find daily attendance at the dispensing
pharmacy disrupts the lifestyle stability they are trying to achieve.
Although there is significant therapeutic value in the methadone program, supervising
the program effectively imposes a significant cost on both the prescribing medical
practitioner and the dispensing pharmacist. These costs include the time taken to
consider all the issues surrounding requests for early, extra, replacement and
takeaway doses and to take any necessary action (e.g. changing prescriptions). In
particular, it is necessary to differentiate between stable and unstable patients. Stable
patients will generally have a valid reason for requesting early, extra, replacement or
takeaways doses (e.g. travelling for work). The prescribing medical practitioner and
dispensing pharmacist are often aware that the consequences of denying the request
may destabilise the patient (e.g. may lose job as cannot travel and then become
depressed and unstable). In comparison, a request which is found to be invalid may
be an early indication of instability requiring prompt attention to prevent rapid
escalation of their instability. Therefore, validating requests and following up on
potentially unstable patients, although time consuming, is an essential part of the
patient’s rehabilitation and the continued safe provision of the methadone program.
© STACK & JAMES 2010
Proposal for Remote Dosing Program
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3. PROPOSED REMOTE DOSING PROGRAM
3.1 INTRODUCTION
The proposal for the Remote Dosing Program is the accumulation of
approximately 20 years community and clinical experience both in hospital
and private medical practice. During this time, opioid dependency due to the
use of prescription and illicit drugs was observed to be a significant problem
within the community. Shortcomings in the current programs to rehabilitate
drug dependent patients were also identified. The Remote Dosing Program
was developed by Dr Clive Stack to address a number of the problems and
issues involved in the treatment and rehabilitation of drug dependent patients.
The program is aimed at patients who are stable on the existing opioid
pharmacotherapy programs and introduces new technology to facilitate
remote location dosing. This has the potential to enhance rehabilitation
through increased social integration. As in existing opioid pharmacotherapy
programs such as the methadone maintenance program, the interaction
between the prescribing medical practitioner, dispensing pharmacist and
patient is still pivotal. However, daily contact and assessment of the patient
will be undertaken by a new Central Dosing Service using internet technology
to assess the patient and dispense the medication. This will allow the patient
to access medication at locations remote to a dispensing pharmacy or
medical centre.
Prototypes of the new technology for assessment of the patient and
dispensing medication have been developed through collaboration between
Dr Clive Stack and Dr Tim Gale of the University of Tasmania. These
prototypes have been tested in preliminary trials that indicate further
investigation is warranted.
3.2 AIMS OF PROGRAM
The aims of the Remote Dosing Program are to:

allow the provision of multiple doses over a day to assist in the
tailoring of the program to match the individual's need (e.g. pain
management where a number of smaller doses are required
throughout the day)

to assist and support reduction and termination of treatment by
providing multiple, smaller doses throughout the day (as when the
dose is reduced, a single daily dose is often insufficient to prevent
withdrawal symptoms)
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Proposal for Remote Dosing Program
20

reduce the potential harm of takeaway doses such as diversion,
overdosing, other people taking dose (e.g. children)

increase the flexibility of dosing to aid in the integration back into
normal society (e.g. to make it easier for participants to undertake
employment or study)

allow investigation of other replacement programs utilising shorteracting medications

help increase safer treatment options for other programs using other
drugs of dependence (dexamphetamines, benzodiazapines)

decrease the amount of drugs of dependence finding their way onto
the black market from licit sources (i.e. diversion)

increase the availability of the opioid replacement program to the
community by removing the emotional, financial and time cost burden,
created by the provision of takeaway doses, on the prescribing
medical practitioner and dispensing pharmacist

reduce the potential for instability caused by taking the takeaway dose
inappropriately (e.g. intravenously or excessive amounts) which may
result in the patient not having enough medication for each day

reduce the health burden of increasing daily dose which is a natural
consequence of the patient presenting to the prescribing medical
practitioner as though the dosage is not maintaining them (e.g. with
physical or emotional symptoms of withdrawal) requesting and
seeming to need their dose increased

hasten recovery from drug dependence through the ability to more
effectively manage an individual's program due to the early discovery
and treatment of instability.
The process consists of 3 steps:

Meeting the criteria for consideration of entry into the Remote Dosing
Program and referral to the Remote Dosing Program

Initial assessment by the Remote Dosing Program

Daily assessments and medication dispensing.
3.3 PROCESS FOR REMOTE DOSING PROGRAM
3.3.1 CRITERIA FOR INVOLVEMENT IN REMOTE DOSING PROGRAM
The patient will be initially assessed for entry into the Remote Dosing
Program by the clinical staff from the Central Dosing Service in conjunction
with the prescribing medical practitioner and dispensing pharmacist. A patien t
will only be considered for the Remote Dosing Program if they are eligible for
takeaway doses and display objective signs of a stable lifestyle within the
preceding year. These include:
© STACK & JAMES 2010
Proposal for Remote Dosing Program
21

Assessed as stable by prescribing medical practitioner

Assessed as stable by their regular dispensing pharmacist

Regular attendance to prescribing medical practitioner for medication
and review

No unexplained and/or unsubstantiated missed or lost doses of
medication

No unexplained and/or unsubstantiated requests for earl y or extra
take away doses

No request for dose to cover an unexplained or unsubstantiated
specific activity (e.g a patient would need to produce receipt to show
they have gone to funeral to get take away dose for that activity)

No dosage escalation

No escalation of other drugs of dependence

No other illicit drug use including no needle puncture marks

Regular job attendance or demonstrated ability to successfully
undertake study (e.g. at TAFE or university)

Financial stability

Regular or stable housing (for security reasons associated with
storage of medication in the Remote Dosing Program, the patient
cannot be in a caravan)

No unavoidable association with unstable drug users.
3.3.2 INITIAL ASSESSMENT
The patient will initially be assessed for entry into the Remote Dosing
Program by clinical staff in the Central Dosing Service in conjunction with the
prescribing medical practitioner. The prescribing medical practitioner will be
largely responsible for identifying patients who meet the criteria for
involvement in the Remote Dosing Program as outline above. The Central
Dosing Service ensures a consistent standard for entry into the Remote
Dosing Program is maintained firstly by verifying the patient meets the entry
criteria and then by further assessing the patient.
The Central Dosing Service assessment consists of the following:

Confirming patient’s identity and recording identification pictures and
demographic data

Full urine screens – These provide an overall screen for drugs of
dependence and will show if the patient is using drugs of dependence
other than opioids

A simple reaction test – The person is comfortably seated facing a
computer monitor holding a mouse in one hand. When the computer
monitor screen changes from grey to green, the person clicks the left
button on the mouse as quickly as possible. This is done a number of
© STACK & JAMES 2010
Proposal for Remote Dosing Program
22
times to acquaint the person with the test as they will initially decrease
their response time but after they have done the test a number of
times, their reaction time will stabilise.

Pupillometry – Five aspects of pupil physiology (the size and
reactivity of the pupil) change with the methadone level in opioid
dependent people. Unlike a number of other physiological effects
caused by opioids, these changes do not adapt as the person
continues to take opioids. Pupillometry can record these 5 changes
which makes it a reliable test regardless of the duration of drug use.
These aspects of pupil physiology can be recorded by a high
resolution camera in response to changing light levels (i.e. a
pupillogram).The pupillometry test is conducted with the patient
wearing a pair of goggles fitted with computer controlled light emitting
diodes (LED) and an infrared camera linked to a USB webcam. An
infrared LED is used to illuminate the pupil for the camera while a
white LED is used to create the pupil reaction. The USB webcam
records the pupil reaction to the changes in the light which is then
used to measure the five changing aspects of pupil physiology.
Image 1 – Prototype of Pupillometry Goggles
The information from these assessments forms the baseline data for each
patient. Information gathered during the daily assessments will be compared
to this baseline data before medication is dispensed through the dosing
machine.
A person who has an eye disease or who is totally blind may not be able to
participate in the Remote Dosing Program as they may not be able to be
monitored using pupillometry. In addition, people with poor upper limb
dexterity such as quadriplegics may not be able to participate in the Program
© STACK & JAMES 2010
Proposal for Remote Dosing Program
23
as they may not be able to manipulate the equipment or undertake the simple
reaction test.
During the assessment process, the patient's medical practitioner will also be
contacted to advise of the patient's current medication regime including the
dosage and frequency of taking medication. Details of the medication regime
will be held on file at the Central Dosing Service and medication will only be
authorised in accordance with this regime. The patient's medical p ractitioner
will also be connected to the Central Dosing Service and can record any
variation in the medication regime determined as a result of any contact with
the patient directly onto the Central Dosing Service files. Only the patient's
prescribing medical practitioner can make changes to medication dosages
and frequency as the Central Dosing Service will neither prescribe medication
nor change medication regimes. In addition, only the patient's medical
practitioner can read the patient's file held by the Central Dosing Service. The
Central Dosing Service will use the same encrypted secure internet
technology and protocols currently used between doctors when transferring a
patient’s file to ensure the patient's confidentiality and privacy are maintained.
After the initial assessment has been undertaken and the patient is accepted
into the Remote Dosing Program, arrangements are made with the pharmacy
that usually dispenses the patient's medication for their inclusion in the
program. This includes inducting the pharmacist into the program, training the
pharmacist in how to load medication into the dosing machine, providing the
pharmacist with codes to allow access to the Central Dosing Service , and
providing the pharmacist with the hardware and software to participate in the
program.
3.3.3 DAILY ASSESSMENTS AND MEDICATION DISPENSING
The remotely monitored medication system will be set up to dispense tablet or
liquid forms of medication after assessment of the patient by a clinician at the
Central Dosing Service. While the initial assessment and prescription of a
medication regime must be conducted by the patient’s medical practitioner,
the clinician who assesses the patient before medication is dispensed each
day does not need to be a medical practitioner as they are comparing specific
behaviours displayed by the patient at the time of dosing to the baseline data
previously recorded.
The dosing machine is linked to a computer, which has communication and
data acquisition software loaded, cameras to monitor the dispensing of the
medication, and a pupillometry device for patient assessment. The computer
has a high speed secure internet connection which links the patient with the
Central Dosing Service.
© STACK & JAMES 2010
Proposal for Remote Dosing Program
24
The patient can only access the dosing program through a password which is
authenticated each time. The clinician at the Central Dosing Service also
confirms the patient's identity each time the patient accesses the program by
comparing their video image with images taken of the patient during their
initial assessment and stored in their file.
Figure 4 – Computer Connections Between Patient and Central
Dosing Service
Web cameras
Pupillometry
goggles
Patient’s computer
Communication and
data acquisition
software
Remote
dispenser
Secure Internet
connection
Central Dosing
Service Computer
Web cameras
Communication and
data acquisition
software
Establishment of connection with the Central Dosing Service, including visual
and audio communication, is required as part of the daily assessment
process. Each dosing machine has its own code. When a connection is
established with the Central Dosing Service over the secure internet, it will
read the code on the patient's dosing machine and confirm the medication
contained is correct according to information provided by the dispensing
pharmacist when the machine was loaded. In addition, the location of the
dosing machine will be confirmed by GPS.
Images of the client, the doses within the dosing machine plus audio
information will be sent to the Central Dosing Service both before and after
the medication is dispensed. The pre-medication assessment consists of:
© STACK & JAMES 2010
Proposal for Remote Dosing Program

25
Observation of facial expressions/of the patient – the clinician
notes a number of aspects including: blink rate, closing eyes (as if
falling asleep), nodding, losing context in sentence (forgetting what
they’re saying.)

A simple reaction test – the patient is requested to click the left side
of their computer mouse when a square changes colour on their
computer screen. The test is done five times and the results
averaged.

Pupillometry – the patient will be required to put on a set of
pupillometry goggles and the pupillometry assessment, as previously
described, will be undertaken.
Upon receiving this data, the clinician at the Central Dosing Service can
compare it to baseline information obtained during the initial assessment. This
comparison is necessary to ensure over-medication of the patient is not
occurring and the patient is stable enough to be receiving remote dosing. If
the patient looks sedated or any of their assessment does not conform to the
baseline information, the assessment will be failed. When this occurs, the
patient will need to be immediately reviewed by their prescribing me dical
practitioner. A medical practitioner at the Central Dosing Service may do the
review if the patient cannot get in to see their prescribing medical practitioner.
The patient will not receive their dose of medication until this review occurs.
The Central Dosing Service may arrange transport to either the medical
practitioner or the Central Dosing Service office if it is required. As part of the
review, the patient will immediately have to undergo an assessment including
breathalyser test, urine/drug screen, pupillometry and reaction tests to
determine if they have been overdosed, taken other drugs or substances
which have interfered with their behaviour or reactions or have another
medical problem which must be addressed. If the patient is found to be
unstable, they may be excluded from the Remote Dosing Program and may
have to return to daily visits to the dispensing pharmacy to get their
medication. After a period of time (e.g. 6 months but the exact length of time
will be determined by the nature of the instability and the danger to the patient
or community as a result of their instability) the patient may apply to be again
included in the Remote Dosing Program.
If the patient passes the pre-medication assessment and the doses contained
in the dosing machine match the contents indicated on file, the Central Dosing
Service initiates dispensing of the medication. The details of the medication
including the type, dose, date and time of dispensing are recorded. When the
dose is authorised, the lock on the machine is automatically disengaged. The
patient must follow predetermined protocols for where they are to stand and
how they are to hold the dosing machine to ensure the cameras can fully
record the medication being taken. When the medication is dispensed, the
© STACK & JAMES 2010
Proposal for Remote Dosing Program
26
cameras must have direct vision of it leaving the machine and being taken by
the patient. The patient must then follow a set of protocols allowing the
cameras clear vision of their mouth to show the medication has been taken
correctly (e.g. if it’s been swallowed, placed under the tongue) Every protocol
must be followed every time the patient gets medication from the dosing
machine. If any protocol is not followed (e.g. the patient turns their head away
from the cameras at the time of swallowing the medication, which could
indicate the patient is spitting it out), the patient will be assessed with possible
immediate exclusion from the Remote Dosing Program by the Central Dosing
Service clinician. If this occurs, the patient will have to return to daily visits to
the dispensing pharmacy to get their medication. After a period of time (e.g. 6
months, but the exact time period will be determined by the nature of the
breach) the patient may apply to be again included in the program.
It will take approximately 3 minutes for the pre-medication assessment to be
undertaken and the medication dispensed. Another 5-15 minutes will be
needed for medication dissolution depending on the form of medication
dispensed (eg buprenorphine takes up to 15 minutes to dissolve under the
tongue).
If a patient does not contact the Central Dosing Service for a scheduled
medication dose (e.g. does not contact the Service for 24 hours) they will be
immediately investigated. If it is found there is no reasonable explanation for
the patient failing to make contact (e.g. the patient has taken other illicit
drugs) they will be excluded from the Remote Dosing Program and will have
to return to daily visits to the dispensing pharmacy to get their medication.
After a period of time (e.g. 6 months, but the exactly length of time will be
determined by the nature of the instability and the danger to the patient or
community as a result of their instability) the patient may apply to be again
included in the Remote Dosing Program.
Figure 5 – The Dosing Process
Patient log-in
Client side
Staff
Server side
Authentication
Server Connection
& Authentication
Connection Established
Webcam on
Audio On
Visual, Pupillometry and
Reaction Time Assessment
Appropriate Medication Delivery
Data Stored
© STACK & JAMES 2010
Proposal for Remote Dosing Program
27
The audio and video communication plus the software required for monitoring
of the patient require 3.5G wireless technology to be available to both the
patient and the Central Dosing Service.
3.4 THE DOSING MACHINE
The dosing machine, which contains the medication, will be a metal tube
which holds tablets or a liquid form of medication. Depending on the patient's
prescription, there may be multiple doses of medication in a single dosing
machine or the patient may need to have multiple dosing machines each
containing a single dose. Each dosing machine has a unique computerised
serial number. The dispensing pharmacist assigns one or more specific
dosing machines to each patient by its serial number. A record of the patient
and the serial number on machines they are allocated is made by the
dispensing pharmacist at the time the machine is filled and forwarded to the
Central Dosing Service over the secure internet. The patient must keep the
dosing machine in an accessible place which has mobile phone coverage and
cannot move the dosing machine through areas which do not have mobile
phone coverage except with prior approval from the Central Dosing Service.
The dosing machine is connected to the Central Dosing Service via the
patient's computer. When connected, it will send its serial number which will
then be confirmed by the Central Dosing Service as being allocated to a
machine assigned to the patient. The dose contained in the machine will be
checked through an internal camera against the records from the dispensing
pharmacy to ensure they are the same. The Central Dosing Service can
unlock the dosing machine via the internet connection to allow the medication
to be received. When this occurs, a retractable tube will ex tend from the
dispenser and the patient places their mouth over the tube to receive their
medication. The time of ejection of the medication is controlled by the patient
using a push-button mounted on the dosing machine. When medication in the
dosing machine is insufficient for the next dose, the patient will get a message
telling them it needs to be refilled.
© STACK & JAMES 2010
Proposal for Remote Dosing Program
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Image 2 – Prototype of the Dosing Machine
It is not possible for the patient to unlock the dosing machine without breakin g
into it. Each dosing machine will have internal GPS acquisition technology,
light and pressure sensors which will be activated if the machine is moved,
opened or breached by an unautherised person. The dosing machine will
have a mobile phone facility which will send a SMS if movement or a break-in
occurs. It also has its own software that records video/audio data as soon as
the machine is moved or the light or pressure sensors are activated. This is to
assist in identification of the circumstances and people who steal or break into
the machine. This data will be sent to the Central Dosing Service if the
machine is in mobile phone range or sent as soon as the machine comes
back into mobile phone range. There will be an alarm on the Dosing Machine
but it will not be audible. The alarm will alert the Central Dosing Service which
will immediately respond to it or any other signal of unautherised movement of
the dosing machine, breach or break-in. This is necessary to reduce morbidity
and mortality that might result from any unauthorised use of the medication. If
it is found that the patient is responsible or involved in the theft or break-in,
they will be excluded from the Remote Dosing Program and will have to return
to daily visits to the dispensing pharmacy to get their medication. After a
period of time (e.g. at least 12 months) the patient may reapply to be included
in the program.
When a patient is approved for inclusion in the Remote Dosing Program, they
will be provided with a safe in which to keep their dosing machine. The safe,
which will be set into a concrete block, will be delivered to the patient’s home
address by the Central Dosing Service. The safe must be kept outside the
patient’s house so there is no risk to the patient or their family if somebody
decides to steal or break into it. In addition, the safe must be in an area which
can be accessed by the Central Dosing Service in the case event of an
emergency (e.g. the dosing machine alarm is activated).
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Proposal for Remote Dosing Program
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3.5 DUTIES OF PARTICIPATING PHARMACISTS
The duties of the dispensing pharmacists in the Remote Dosing Program will
be different to their duties under the current opioid pharmacotherapy such as
the methadone maintenance program. While they will still be required to
dispense medication, the method in which they do this will be significantly
different. In addition, they will not be required to dose the patient.
The pharmacist will dispense medication via the dosing machine provided to
them by the Central Dosing Service. To dispense the medication th ey must
access the machine by plugging it into the computer terminal that connects
them to the Central Dosing Service. Once the Central Dosing Service has
confirmed the dosing machine is fully functional through a remote diagnostic
check of the machine they will authorise its loading. This will allow the dosing
machine to be opened without activating the alarm systems. The pharmacist
will then load the machine with the patient’s medication in accordance with
the prescription provided by the prescribing medical practitioner. At the time
this is done, the Central Dosing Service will be advised (via the internet
connection) of the dosage and type of medication being provided to the
patient. The dosing machine being loaded is also identified by serial number.
At times, the Central Dosing Service may require the dispensing pharmacist
to replace a dosing machine (e.g. if a machine requires repair or to be
updated). In addition, the dispensing pharmacist may be requested to keep
the dosing machine rather than refill it and refer the patient back to their
prescribing medical practitioner. This may be necessary if the pre- or postassessments undertaken by the Central Dosing Service indicate the patient’s
medication level needs to be reviewed. Finally, if the patient has breached a
condition of the Remote Dosing Program (i.e. turned away from the web cam
camera while taking a dose of medication), the dispensing pharmacist may
keep the dosing machine and refer the patient to the Central Dosing Service
who will explain both why they are being excluded from the program and the
duration of their exclusion. Patients who are excluded from the Remote
Dosing Program will still be able to access their medication by going to the
dispensing pharmacy each day.
Pharmacists who participate in the Remote Dosing Program will be provided
with the training and software to undertake their responsibilities under the
program.
3.6 PATIENT AGREEMENT
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Proposal for Remote Dosing Program
30
Before the patient is included in the Remote Dosing Program, they must enter
into an agreement to abide by the conditions of the Remote Dosing Program
and acknowledge repercussions may apply where conditions are breached.
This agreement will be in writing and patients may seek advice from other
people (e.g. a legal representative) before entering into the agreement.
The conditions in the agreement with the patient will include:

Not to break into, tamper with or in any other way breach the dosing
machine

To immediately notify the Central Dosing Service if they become
aware the dosing machine is breached, tampered with or stolen

Except when in use, to keep the dosing machine in the safe provided

Not to give access to the dosing machine safe, including not providing
anybody else with the combination code or leaving details of the
combination code where somebody else may find it

To immediately notify the Central Dosing Service if the safe is
breached or stolen

If the dosing machine alarm is activated at the Central Dosing Service
indicating that the machine has been breached or tampered with, to
provide the staff of the Central Dosing Service access to their home to
ensure the safety of all household members (i.e. that nobody has
taken an overdose)

To follow the set protocols for dosing when using the dosing machine
(e.g. face the web cam)

To give permission for the Central Dosing Service staff to view data
on their dosing event and analyse the data

To accept any consequences for a breach of the conditions which may
be applied (e.g. exclusion from the Remote Dosing Program for a
period of time)

To notify the Central Dosing Service if they wish to move the Dosing
Machine from the area of the safe such as when taking an overnight
trip away or when returning the machine to the pharmacy to be
reloaded.
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Proposal for Remote Dosing Program
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3.7 COMPUTER NETWORK
Figure 6 – The Computer Network
Prescribing
Medical
Practitioner
Dispensing
Pharmacy
Central Dosing
Service
Patient’s
Dosing
Machine
Patient
3.8 ADVANTAGES OF REMOTE DOSING
PROGRAM
The advantages of the Remote Dosing Program include:

Increasing the rigour of pre-dose assessments which in this program
are more onerous than current pre-dose assessments conducted by
dispensing pharmacies. The Remote Dosing pre-dose assessments
are objective, based on physiological reactions which cannot be
controlled by the patient. They are more likely to objectively detect
signs of intoxication, overdosing or the possibility of other drugs
consumption. Conversely, they may identify signs of withdrawal. This
makes the system safer for the patient and also for the public.
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Proposal for Remote Dosing Program

32
Decreasing the risk of unstable patients receiving takeaway dose s of
medication as the patient will only have access to medication through
an automatic dispenser controlled via the computer network if the pre medication assessment is passed. The patient cannot manipulate or
intimidate the assessor into providing medication as they do not hav e
direct or physical access to the assessor.

Rigorous assessment every time medication is dispensed allows a
clear record of the patient to be maintained and quicker detection of
instability. Where instability is suspected, appropriate measures can
be instigated to resolve problem before it escalates into a situation
that is harder to address.

Potentially increases access to drug substitution programs (e.g. the
methadone maintenance program) as it reduces the workload on
prescribing medical practitioners and dispensing pharmacists through
a reduced workload related to responding to requests from patients for
take away doses.

Facilitates implementation of opioid reduction programs as smaller
doses can be provided more frequently to deal with the problem of
doses being too small to last for the whole 24 hours which affects
compliance with the reduction process.

Allows for the use of short acting/short half-life medications in drug
replacement programs such as amphetamines or short half -life
opioids. Currently, these cannot be used because of a lack of
available of programs or inability to suitably supervise multi-dosing
throughout a day.

Eliminates the possibility of the patient taking more than one dose at a
time. This in turn decreases the risk of overdosing or death.

May create an environment of greater stability by preventing a
“bouncing” phenomenon where the patient takes too much medication
then has insufficient medication in their next dose to stop withdrawal
so requests or takes a higher does when medication becomes
available again

Eliminates the possibility of other people (e.g. children) accidentally
taking the medication and overdosing or dying

Allows for immediate detection of interference with doses through
alarm systems fitted to the dosing machine
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Reduces black market availability of prescribed medication as the
dosing machine is more secure than current arrangements for
takeaway doses

Facilitates the expansion of opioid pharmacotherapy programs as will
allow greater participation by those people currently excluded due to
their location or employment situation

Allows people on the program to travel because they only need to be
connected to the internet service to be dosed. Current programs are
restrictive as the person must be approved for takeaway doses or
attend a designated dispensing pharmacy or medical practice to
receive their medication. If they travel within Australia, arrangements
can be made for their medication to be transferred to another
pharmacy or medical practice. However, the person must make travel
arrangements around attendance at the designated location. This may
be particularly onerous for people who are required to travel as part of
their employment

Allows people to work or live in rural and remote areas (providing they
have 3G coverage) to access opioid pharmacotherapy programs.
Currently, the access to opioid pharmacotherapy programs for people
in rural and remote areas is restricted by the number of and distance
to doctors or pharmacies participating in a program and whether the
patient can attend the pharmacy or medical practice on a daily basis

Allows shift workers access to the opioid pharmacotherapy programs.
Some shift workers are restricted in accessing opioid
pharmacotherapy programs as their availability to attend dispensing
pharmacies or medical practices may not coincide with the hours they
are open.

Reduces discrimination against people participating in the opioid
pharmacotherapy programs as the likelihood of their drug treatment
being detected is reduced. If these people are observed going to
pharmacies to get their daily medication, it may result in discrimination
both personally and professionally with a significant loss of
productivity to the community

Reduces discrimination against people “in the public eye” participating
in the opioid pharmacotherapy programs as these people often cannot
take part in the current program due to the likelihood of their drug
treatment being detected
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Reduces the risks of harassment or discrimination by other people in
the pharmacy (e.g. other people on opioid pharmacotherapy programs
or pharmacy customers)

Reduces centralisation of drug users in one area (i.e. the pharmacy
where they receive their medication) which may lead to inappropriate
networking (e.g. discussion of how to get more medication) or black
market pressure (e.g. intimidation to divert medication)

Allows people with a combination of drug dependence and pain issues
to be given supervised doses of medication suitable for pain control.
Many of these patients often have reduced mobility so daily travel to a
dispensing pharmacy is not practicable. In addition, people with this
combination of issues often require multi-dosing through the day
which is not currently possible if they have reduced mobility or
restricted access to a dispensing pharmacy (e.g. limited access to
public transport)

Allows participants to explore family or academic or work options that
are not currently available due to the restrictions of the existing
program imposed by pharmacy hours, time taken to travel to/from
pharmacy, cost of transport, child care issues (e.g. sick children and
nobody to care for them while go to pharmacy)

Reduces the cost to the community of daily dosing as the patient will
only need to be assessed by a medical practitioner if they fail the predosing assessment.
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3.9 DISADVANTAGES OF REMOTE DOSING
PROGRAM
The disadvantages of the Remote Dosing Program include:

Some costs are associated with the implementation of the system
including production of dosing systems (dosing machine and
pupillometry goggles), implementation of software and training doctors
and pharmacists in the new software

Costs are associated with the implementation of the Central Dosing
Service including costs of its establishment and staffing and
implementation of emergency teams

Many patients currently using takeaway doses will not like the
intensity of assessment as it will detect instability more quickly than
the current system. Some unstable patients have a vested interest in
the retention of the existing takeaway dose system as the opportunity
for medication abuse through diversion is increased

The process must be controlled by a non-government organisation as
it must not be able to be challenged on the grounds of discrimination
(e.g. by people on opioid pharmacotherapy programs contacting
members of parliament or ombudsmen to complain about their
exclusion from the program). The proposed program will actively
discriminate to exclude patients who are unstable or who have been
found not to comply with the guidelines. This is necessary to ensure
the safety of the program. It would be inappropriate for patients to
have access to a complaint or appeal procedure if they are excluded.
(It should be noted these patients will not be excluded from the opioid
pharmacotherapy program – just the Remote Dosing Program. They
will still be able to receive medication through dispensing pharmacies
or medical practices.) However, monitoring of the program to ensure
guidelines are being applied in a non-discriminatory and consistent
way is appropriate and will occur.
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4. PRELIMINARY RESEARCH
In 2009, two preliminary trials relating to the Remote Dosing Program were
undertaken: the first to assess remote assessment technology by comparing
pupillary reactions and simple reaction time to the blood methadone levels,
and the second to trial the dosing machine. The dosing machine, pupillometry
goggles and software for the remote assessment were developed by the
Department of Engineering, University of Tasmania in consultation with Dr
Clive Stack.
Both trials where undertaken as a collaboration between Dr Clive Stack and
Dr Tim Gale of the University of Tasmania. The trials were subject to rigorous
assessment and authorisation by the Tasmania Scientific Research Advisor y
Committee and the Tasmania Health and Medical Human Research Ethics
Committee. The Therapeutic Goods Administration, Department of Health and
Aging (Cmth) was also notified of the trials in compliance with the Clinical
Trial Notification (CTN) scheme, pursuant to Schedule 4 of Regulation 7.1 of
the Therapeutic Goods (Medical Devices) Regulations 2000.
4.1 TRIAL OF REMOTE ASSESSMENT
TECHNOLOGIES
This trial was designed to investigate whether or not the pupillometry system,
including the custom designed goggles, and simple reaction time test could be
used as pre-dose assessment tools in the Remote Dosing Program. If it could
be shown that a person’s pupil and physical reactions changed in response to
methadone levels, these measures could be used to indicate whether or not
that person was unstable through already having non-prescribed opioids or
other drugs of dependence in their body or if that person was, potentially, in
withdrawal.
The trial consisted of 9 stable patients currently undertaking the metha done
maintenance program and 2 people not taking methadone or any other drugs.
All 11 people were given the full initial assessment (pupillometry, reaction
time test, urine drug screen). In addition, the 9 people on the methadone
program had their blood taken before the trail commenced for an initial
measurement of blood methadone level.
The people who were already taking methadone were then given their
prescribed dose of medication. Each hour after this, over a 6 hour period,
blood methadone levels were measured via blood tests and at the same time
pupillary reactions to various levels of light stimulation were recorded. A
computer controlled pupillometer was used to take the pupillograms and
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ensured the pupillometry was undertaken in a consistent manner. Participants
also undertook a simple reaction test each hour and breath alcohol tests. The
2 people who did not take methadone undertook all assessments except the
blood tests. All participants in the trial also had urine drug screens performed
after testing was completed at the end of the 6 hour period.
The trial was undertaken in a single clinic. No dosing or assessment was
carried out at a location remote to the clinic.
The trial found there were at least 5 distinct aspects of pupil physiology and
one aspect of the reaction time test that changed significantly with the
methadone level in opioid dependent people. These characteristics were not
observed in the two people who did not take methadone. The trial also found
a strong correlation between blood methadone levels and the 5 aspects of
pupil physiology as well as a strong correlation between blood methadone
levels and the simple reaction time test. These results suggest that the
pupillometry and the reaction time test are worth further investigation as
assessment tools for the Remote Dosing Program.
The results of this trial are in preparation for publication.
4.2 TRIAL OF DOSING MACHINE
The trial was designed to test both the dosing machine and the software
developed for the dosing machine.
Two drug dependent patients currently on buprenorphine participated in the
trial. They were placed in a room with the dosing machine linked to the
controlling clinician in another room over an intranet via control and
communication software build specifically for the program. This process
allowed contemporaneous visual and auditory communication between the
clinician and the patient. (This was necessary to monitor the patient as they
took the medication and to ensure they did not divert it.)
Verification of the successful delivery of the medication was demonstrated by
the dosing machine delivering a dose of medication and images provided by
the software (computer control of dosing machine and webcam footage). The
patients filled in post-dosing questionnaires related to their perception of the
functionality and usability of the dosing machine.
The trial resulted in successful acceptable remote delivery of the medication
directly into the patient’s mouth confirming the functionality of the system.
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5. PROPOSED RESEARCH – PILOT STUDY
5.1 AIM
It is proposed to implement the dosing machine together with supporting
software in a pilot study to show the equipment and assessment protocols are
effective and provide a safe remote dosing system.
5.2 METHODOLOGY
This pilot study will be the first remote test of the procedure, equipment and
software. It will have two components: the development and production of
equipment and technology followed by a clinical pilot of the equipment and
technology.
The production of equipment and technology will take approximately 6 months
and will include:

Production of dosing machine with the inclusion of security and
control devices (e.g. sensing capabilities) to detect and prevent
tampering

Development of patient's software for dosing machine

Development of Central Dosing Service software and server

Development of software for interpretation of pupillograms (Neural
Network Software)

Production of pupillometry goggles
The clinical component of the pilot study will include approximately 8 patients
currently receiving takeaway doses on an opioid pharmacotherapy program
and residing in the south of Tasmania. Participants will be identified and
selected by the participating prescribing medical practitioner who has been
monitoring their progress on the opioid pharmacotherapy program. All
participants will be identified as meeting the criteria for stability and have met
this criteria for at least 1 year (i.e. are very stable). It is likely they will be
recruited from the patients who were involved in the preliminary research.
The patients will be provided with a computer system linked to a Central
Dosing Service, pupillometry goggles and dosing machine. This will allow the
software for pre- and post-dosing assessment to be piloted as well as all
necessary record-keeping for the Central Dosing Service.
Patients will also be provided with a safe in which to keep the dosing machine
when not in use. The safe will be modified by being set into a concrete block
to deter theft and will be placed in the grounds of the patient’s home but
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outside the house. The Central Dosing Service will install the computer which
will be used with the dosing machine in the patient's home after the area
where the dosing machine is to be used has been inspected and has pas sed
criteria for functionality and security. These criteria include ensuring that the
area where the dosing machine is to be used is not easily accessible to the
outside or to other people living in the residence, there is suitable, adequate
lighting, and the webcam affords a clear view of the patient and surrounding
area such that any attempt to divert medication in the dosing process will be
noticed on the webcam. In addition, the Central Dosing Service may need to
access to the computer located in the patient's home as well as the dosing
machine and pupillometry goggles during the clinical pilot if there is a need to
update or repair software or hardware.
In addition to the pre- and post-dose assessments, participants will be
required to participate in random urine drug screens, blood methadone level
tests and physical assessments throughout the pilot study. In addition to
checking for illicit drug use, these tests will allow the results of the
pupillometry testing to be assessed and confirmed.
The dispensing pharmacists who fill the dosing machine and the prescribing
medical practitioner who supervise the participants’ medication prescription
will be linked to the Central Dosing Service and will pilot the relevant
software. The dispensing pharmacists who will be involved in the pilot will be
recruited from the pharmacies that have already been involved in the
preliminary research.
Participants will be encouraged to investigate ways in which pre - and postassessments can be circumvented or dosing machines can be manipulated or
breached. Participants who are successful will receive a cash bonus if they
provide detailed advice as to how they achieve this and will not incur other
consequences for such breaches. Patients will be monitored to ensure they
do not take other drugs or non-approved medication or engage in any other
harmful activity in attempts to circumvent assessments or tamper with dosing
machines. Any patient who is found to have otherwise tampered with or
breached a dosing machine, taken other drugs or non-approved medication,
or engaged in any other harmful activity will be immediately excluded from the
pilot study.
The pilot study will run for approximately 1 year. The development of the
infrastructure (software, dosing machines, server) will take approximately 7-8
months. The final stages of this development will overlap with implementation
of the clinical phase which will take approximately 6 months. Prior to the
implementation of the clinical phase, a number of single day trials will be
conducted using different pharmacotherapy drugs to further test the
reproducibility of the results of the assessment tools. Implementation manuals
will be written during the clinical implementation.
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5.3 RESOURCES
The pilot study will require the following resourcing:

development of software to link participants, medical practitioner,
pharmacy and Central Dosing Service

production of dosing machine

production of pupillometry goggles

purchase and installation of computer equipment including webcams
for participating patients and the Central Dosing Service

provision of training for participating dispensing pharmacists and
Central Dosing Service clinician.
It is envisaged the following staffing will be required:

two part-time research assistants who will undertake data entry,
analyse results, deliver training and develop training manuals for the
Central Dosing Service

a part-time dosing clinician (3 hours a day, 7 days a week) who will
undertake pre- and post-dosing assessment and monitor/assess the
effectiveness of assessment protocols

a part-time project manager (4-8 hours a week) who will oversee the
budget, purchasing, resource allocation and project reporting

a full-time medical practitioner/chief researcher who will be
responsible for the pilot study’s implementation, monitoring and
assessment of all aspects of the pilot study’s design, supervising the
analysis of results and identifying trends, developing new policy and
an implementation strategy for extension of the program. This person
will also be available for any medical emergency such as in the case
of an overdose, unauthorised movement of dosing machine and to
provide urgent assessment if additional drug use is suspected plus
oversee medication prescriptions and random urine/blood tests

various contractors and consultants who will develop, install and
maintain the software, undertake the production of pupillometry
goggles, implement the computer systems, and develop and
implement any necessary training.
In addition, the research assistants and Central Dosing Service clinician will
have responsibility for emergency call-out if the dosing machine is breached.
5.4 PROPOSED BUDGET
The budget for the trial has yet to be confirmed however, it is anticipated to be
in the order of $500,000.
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6. CLINICAL TRIAL
Following the pilot study and any adjustment to the technology and software,
a larger clinical trial will be undertaken. This trial will extend the pilot
parameters to include more people (medical practitioners, pharmacies and
patients), more variables (e.g. patients at different levels of stability so will
increase the risk of problems occurring such as tampering with dosing
machine) and a larger geographical spread. The intention of the trial is to test
the procedures, equipment and software to show that the equipment and
assessment protocols are effective and to provide a safe remote dosing
system that is suitable for wider scale implementation with people on opioid
pharmacotherapy programs.
The participants in this trial will be a combination of very stable and relatively
stable patients. There will be 30-40 participants in the trial each of whom must
meet the criteria for inclusion in the Remote Dosing Program as well as the
following criteria:

Returned negative random urine drug screen for non-prescription
drugs at initial screening

Returned negative breathalyser test at initial screening.
The trial will be run over 2 years and will have two components: development
of assessment technology and implementation of the clinical trial.
The development of the assessment technology will take approximately 1 year
and will include:

Review and improvement of design of dosing machine in light of the
results of the pilot study, research and inclusion of safety and control
devices (e.g. sensing capabilities) to detect tampering

Review and improvement of patients’ software for dosing machine

Extension and improvement of Central Dosing Service software and
server

Review and improvement of pupillometry goggles

Development of software to analyse pupillometry and reaction time
data, using modelling techniques, to facilitate automation of some of
the processes. This will allow some assessment work in routine, low
risk situations to be undertaken by people with less training (e.g.
technicians) leaving non-routine, high risk situations to be assessed
and managed by clinicians.
The implementation of a larger clinical trial will follow from the improvements
in the technology. The preparation for the clinical trial will include:

Production of dosing machines and goggles as well as purchase of
computers for patients to be involved in the project

Recruitment and training of pharmacies and medical practitioners
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Recruitment and training of Central Dosing Service staff.
Following these preparations, a full clinical trial will be run for approximately 1
year. This will provide sufficient time to collect data on implementation
problems, investigate and implement possible solutions, and identify and
implement improvements to the technology or the program. After this trial, the
technology and program will be assessed to determine if it is economically
feasible and socially practicable to extend the program further.
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7. APPENDIX 1 – MEDICAL TERMS
7.1 OPIOIDS
Opioids are a class of compounds that are endogenous (e.g. endorphins) or
naturally occurring (e.g. morphine or codeine) or synthetically produced
(pethidine, methadone, and heroin). Opioids act by binding to the opioid
receptors mainly in the central nervous system and gastrointestinal tract.
There are many different classes of opioid receptors. Most opioids will bind to
a number of different opioid receptors. Opioids can have a number different
actions on receptors including fully or partially blocking or activating them.
The combination of the binding strength, stimulation type of a particular opioid
and the specific receptors with which it binds are responsible for many of the
differences in the effects of different opioids on the human body.
The human body creates endogenous opioids such as endorphins in response
to a number of stimuli including pain. These bind to specific opioid receptors
to decrease the perception of pain which, in turn, leads to greater pain
tolerance. A feeling of euphoria may also result from the release of
endorphins which can act to impress certain behaviours in the brain. Other
opioids act in a similar manner when taken: binding to the naturally occurring
opioid receptors to do similar things including decreasing the perception of
pain and sometimes creating a feeling of euphoria.
Tolerance, due to neuroadaption (i.e. the change in the body’s sensitivity to
the drug through reduction in receptor number and/or sensitivity) can occur
resulting in a reduced drug effect. As a result higher doses of the opioid are
required to achieve the same effect.
Dependency is characterised by withdrawal symptoms when opioid use is
discontinued. Dependency is not the same as addiction. Addiction occurs
when there is a physical and psychological dependency on the opioid.
However, it should be noted that withdrawal symptoms may reinforce the
addiction.
7.2 METHADONE
Methadone (also known as Physeptone) is a synthetic opioid used medically
as an analgesic, antitussive and maintenance anti-additive for use in patients
dependent on opioids. Although chemically unlike morphine and heroin, it acts
on the opioid receptors in the brain and produces many of the same effects.
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Methadone is also used in managing chronic pain. This use is due to a
number of factors such as its long half life (i.e. the time it takes for the b lood
level of the drug to reduce by one half). It also has a much lower cost than a
number of other prescription medications. In 2004, a month supply of
methadone was $120 compared to an equivalent analgesic amount of
meperidine at $240 or $500 or more for hydromorphone, morphine, fentanyle
or oxycodone.
Methadone is useful in the treatment of opioid dependence – for both illicit
and prescription opioids. Its duration of effect is longer than many other
opioids and it has cross-tolerance with other opioids including heroin and
morphine. This means methadone can be used to mitigate withdrawal
symptoms. In addition, higher doses of methadone can block the euphoric
effects of heroin, morphine or other similar drugs. As a result, properly dosed
methadone patients can stop or reduce their use of these other substances.
It should be noted that methadone will not always help reduce the use of non narcotic substances such as cocaine, methamphetamine or alcohol.
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8. APPENDIX 2 - LITERATURE REVIEW
At 30 June 2008 there were 41,347 patients in Australia receiving
pharmacotherapy treatment for opioid dependence (AIHW). The
pharmacotherapies for opioid dependency currently used include: methadone,
buprenorphine and buprenorphine/naloxone. When the mode of
pharmacotherapy treatment is disaggregated, it is found that methadone was
the most common form of pharmacotheraphy treatment in 2008 with over 60%
of patients prescribed methadone alone (AIHW).
There are a growing number of studies which show that the benefits of
methadone maintenance programs exceed their costs. In particular, studies
between 2001 and 2004 showed for each additional healthcare dollar spen t
on a methadone maintenance program, $15 of crime related expenditure was
saved (Godfrey, Gossop). In addition, a 2002 study found the benefits after
being included in the program for one year included a 83% reduction in
criminal activity, an 11% increase in employment earnings and a 6% reduction
in health services utilisation (French). Studies of methadone mainten ance
programs have indicated that their expansion is cost-effective and decreasing
barriers to access generates significant health benefits for the community
(Doran, Connock, Zaric). However, it is significant to note that while there is a
need for more efficient and less expensive ways to deliver methadone
maintenance programs (Ward) the benefits of the programs are dependent on
the quality of the treatment (Bell).
Generally, people who are part of a methadone program are required to take
their medication in front of a pharmacist or a medical practitioner. The
exceptions to this rule are people who are considered to be stable and are
therefore approved to take medication home (known as takeaways). A study
of the methadone treatment programs in the USA in 2001 found significant
differences in the costs of the program depending on whether it was delivered
as an outpatient service or residential treatment with the cost of the labour
involved in delivering the treatment responsible for up to 88% of the cost.
(Roebuck) While the labour costs associated with the delivery of a methadone
maintenance program are significant, other costs include testing (such as
urine and blood tests) to ensure that the dosage and frequency of treatment
are appropriate.
Pupillometry is being increasingly investigated as a reliable, low-cost screen
for drug use. The accuracy of measurement of pupil parameters from digital
images has been proven (Iskander) showing that specialised ophthalmic
instruments are unnecessary. Research has shown pupillometry to be
effective in verifying concomitant drug use in methadone maintained patients
(Murillo). A clear correlation between pupillary changes and methadone
detoxification has been shown (Grunberger) as well as the use of pupillometry
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to objectively measure the intensity of opiate withdrawal in patients (Rosse).
There is a clear relationship between sedation and pupillary function which
may be linked to a reduction in central sympathetic activity caused by
sedating drugs (Hou). Preliminary research into the assessment of opioid
dependent patients using a combination of pupillometry, reaction time and
speech slurring or reaction time testing alone have also been undertaken
(Patil) and warrants further investigation.
Supervision of medication dosing is a significant issue in the methadone
maintenance program. There is substantial evidence from a range of studies
which indicates that diversion and misuse (e.g. taking medication early,
overdosing, injecting) are integral risks in the prescription of opioids (including
methadone) (Bell). A study in Sydney in 1995 found an active black market in
methadone with 88% of the drug sourced from diverted takeaway doses
(Darke). A subsequent study in 2002 found diversion of the drug to the black
market increased proportionally with unsupervised treatment (Darke). An
analysis of policy differences regarding takeaway doses of methadone found
that States/Territories with the most restrictive policies reported the lowest
incidence of methadone injecting (Ritter). However, the same study also
noted that the availability of heroin and dose dilution of takeaway doses
impacted on the amount of methadone diversion (Ritter).
Takeaway doses of methadone could be more widely prescribed if there was
an adequately secure medication dispenser that could also facilitate
assessment of the patient. Current medication dispensers have poor security
(i.e. there is no check that the medication is properly dispensed or taken by
the patient) and lack the ability to assess the patient’s need for medication.
While work has been done on remote monitoring of medication dispensation,
the prototypes require the patient to load the machine themselves (Hayes,
Hassuji). Preliminary research has been undertaken into the development of a
dispensing machine with appropriate security protocols to be used for opioid
dependent patients and utilising a remote monitoring system to assess
patients (Bajracharya, Ho).
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REFERENCES
AIHW (Australian Institute of Health and Welfare) (2009). National Opioid
Pharmacotherapy Statistics Annual Data Collection: 2008 Report . Bulletin No.
72. Cat no AUS 115. Canberra: AIHW
Bajracharya, A., Gale, T.J., Stack, C.R., Turner, P. (2008). 3.5G Based Mobile
Remote Monitoring System. Conf Proc IEEE Eng Med Biol Soc., 783-786
Bell, J. (Ed.) (2007). The Role of Supervision of Dosing in Opioid Maintenance
Treatment.
Available at:
http://www.who.int/substance_abuse/activities/supervision_dosing.pdf
Bell, J., Zador, D., (2000). A Risk-Benefit Analysis of Methadone Maintenance
Treatment. Drug Safety, 22:3, 179-190
Connock, M., Juarez-Garacia, A., Jowett, S., Frew, E., Liu, Z, Taylor, R.J., FrySmith, A., Day, E., Lintzeris, N., Roberts, T., Burls, A., Taylor, R.S. (2007).
Methadone and Buprenorphine for the Management of Opioid Dependence: A
Systematic Review and Economic Evaluation.
Available at: http://www.hta.ac.uk/execsumm/summ1109.htm
Darke, S., Ross, J., Hall, W (1995). The Injection of Methadone Syrup, Australia.
In Bell, J. (Ed.) (2007). The Role of Supervision of Dosing in Opioid
Maintenance Treatment.
Available at:
http://www.who.int/substance_abuse/activities/supervision_dosing.pdf
Darke, S., Topp, L., Ross, J. (2002). The Injection of Methadone and
Benzodiazepines Amongst Sydney Injecting Drug Users 1996-200. In Bell, J.
(Ed.) (2007). The Role of Supervision of Dosing in Opioid Maintenance
Treatment.
Available at:
http://www.who.int/substance_abuse/activities/supervision_dosing.pdf
Doran, C. (2007). Economic Evaluation of Interventions for Illicit Opioid
Dependency: A Review of Evidence.
Available at:
http://www.who.int/substance_abuse/activities/economic_evaluation_intervent
ions.pdf
French, M.T., Salome, H.J., Carney, M. (2002). Using the DATCAP and ASI to
Estimate the Costs and Benefits of Residential Addiction Treatment in the
State of Washington. Social Science and Medicine. 55(12), 2267-2282
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48
Godfrey , C., Steward, D., Gossop, M. (2004). Economic Analysis of Costs and
Consequences of the Treatment of Drug Misuse: 2-year Outcome Data from
the National Treatment Outcome Research Study (NTORS). Addiction, 99(6),
697-707
Gossop, M., Marsden, J., Steward, D., Treacy, S. (2001). Outcomes after
Methadone Maintenance Reduction Treatments: Two-Year Follow-Up Results
from the National Treatment Outcome Research Study. Drug and Alcohol
Dependence, 79(3), 295-302
Grunberger, J., Linzmayer, L., Fodor, G.,Presslich, O., Praitner, M., Loimer, N.
(1990). Static and Dynamic Pupillometry for Determination of the Course of
Gradual Detoxification of Opiate-Addicted Patients. Eur Arch Psychiatry Clin
Neurosci, 240, 109-112
Hassuji, A., Miljkovic, J., Sivananthan, T., Sivasubramaniam, V. (2007). Medical
Dispenser including Adverse Drug Reaction Detection. Proceedings of ENGG
3100: Design III Projects, 53-54
Hayes, T.L., Hunt, J.M., Adami, A., Kaye, J.A. (2006). An Electronic Pillbox for
Continuous Monitoring of Medication Adherence. IEEE EMBS Annual
International Conference, New York City: USA, 6400-6403
Ho, V., Gale, T.J., Stack, C.R. (2009). Medical Dispenser Design for Narcotic
Rehabilitation Patients. IEEE EMBC Annual Conference. Minnesota: USA
Hou, R.H., Scaife, J., Freeman, C., Langley, R.W., Szabadi, E., Bradshaw, C.M.
(2006), Relationship Between Sedation and Pupillary Function: Comparison of
Diazepam and Diphenhydramine. Br J Clin Pharmacol, 61:6, 752-760
Iskander, D.R., Collins, M.J., Mioschek, S., Trunk, M. (2004). Automatic
Pupillometry from Digital Images. IEEE Transaction on Biomed Eng, 51:9,
1619-1627
Murillo, R., Crucilla, C., Schmittner, J., Hotchkiss, E., Pickworth, W.B. (2004).
Pupillometry in the Detection of Concomitant Drug Use in Opioid-Maintained
Patients. Methods and Findings in Exper and Clin Pharmacol, 26:4, 271-275
Patil, S.G., Gale, T.J., Stack, C.R. (2007). Design of Novel Assessment
Techniques for Opioid Dependent Partients. Conf Proc IEEE Eng Med Biol
Soc. 3737-40
Patil, S.G, Gale, T.J., Stack, C.R. (2009). A Test for the Assessment of Reaction
Time for Narcotic Rehabilitation Patients. 13th International Conference on
Biomedical Engineering, 23, 769-773
© STACK & JAMES 2010
Proposal for Remote Dosing Program
49
Ritter, A., Di Natale, R. (2005). The Relationship Between Take-Away Methadone
Policies and Methadone Diversion. Drug Alcohol Rev, 244, 347-352
Roebuck, C., French, M.T., McLellan, T. (2003). DATSats: Results from 85
Studies Using the Drug Abuse Treatment Cost Analysis Program (DATCAP).
J Sub Abuse Treatment, 25, 51-57
Rosse, R.R., Johri, S., Goel, M., Rahman, F., Jawor, K.A., Deutsch, S.I. (1998).
Pupillometric Changes During Graduate Opiate Detoxification Correlate with
Changes in Symptoms of Opioid Withdrawal as Measured by the Weak Opiate
Withdrawal Scale. Clinical Neuropharm, 21:5, 312-315
Ward, J., Hall, W., Mattick, R.P. (1999). Role of Maintenance Treatment in Opioid
Dependence. The Lancet, 353, 221-226
Zaric, G.S., Barnett, P.G., Brandeau, M.I. (2000). HIV Transmission and the CostEffectiveness of Methadone Maintenance. Am Jn of Public Health, 90:7, 11001111
© STACK & JAMES 2010