OPIOID

REPLACEMENT
THERAPY
PHARMACY
BUSINESS
MODEL
 INTRODUCTION
With the implementation of Real Time Monitoring databases the
identification of patients who have an opioid dependence issue will
become easier. Due to this pharmacy needs to be prepared for an
increased number of patients potentially needing opioid
replacement therapy.

The following model and resources gives an example of how opioid

replacement therapy may be implemented into current pharmacy
practice in a financially viable manner.

The spreadsheet included on the USB allows for you to change the
figures to suit your own personal circumstances, costs and charges.

For further information please contact:

Western Victoria Primary Health Network – Opioid Management
Team

Phone: 5222 0809

Email: Pene.wood@westvicphn.com.au
Opioid Replacement Therapy
Business Plan

Prepared By West Vic PHN Opioid management team in

conjunction with Norman Thurecht (Pitcher Partners)
Business Plans Contents

1 Executive Summary one 5 Implementation Plan

2 Business Summary 6 Appendix

3
Product

4 Marketing Plan

1.0 Executive Summary

1.1 Objective one

The objective of this business plan is to understand the viability of providing an opioid replacement service within the community pharmacy environment.
 This is achieved through understanding the business operations and ongoing management together with understanding the financial outcomes of
delivering the service.

1.2 Mission one

The mission is to build a scalable and profitable opioid replacement service within the community pharmacy environment.

1.3 Keys to success

The keys to success are:

1. Maintaining a good relationship with the doctors that prescribe opioid replacement therapy and the drug and alcohol service if one exists in
the area;
2. Maintaining and managing the patient relationship ;
3. Implementing efficient systems and processes that make the contact time with patients short but effective and therefore controlling the
pharmacist’s time and labour cost in the dispensing process;
4. Ensure an effective and efficient software management system is in place to ensure safety and quality processes to comply with the
regulation around dispensing controlled drugs (S8’s).

2.0 Business Summary

2.1 Description of the Business one
• There are a number of drivers underpinning growth in demand for pharmacy products and services. As an average across the industry, IBISW orld
estimates that these drivers will support growth in revenue of 1.1% per annum, to reach an estimated $12.5 billion by financial year 2020.

• With greater pressure on the health care system, pharmacists are increasingly becoming a key participant in primary health care and are an
important point of reference for community health concerns and their management. Consumer researchers have found pharmacists represent a
 popular source of medical information, second only to GPs. They are recognised by 76% of the population for their provision of excellent advice
about medicine and ways to treat minor illnesses.

• Historically some pharmacies have not been interested in extending their services into opioid replacement therapy services to patients due to the
perceived customer base it attracts. Therefore opportunity exists for pharmacies to extend their services into the opioid replacement therapy
program by providing methadone / buprenorphine dosages to patients in certain locations. It is possible that these patients already exist in the
demographics surrounding pharmacies and represent not only additional services to existing patients but also additional patients to those
pharmacies.

• If a community pharmacy takes a total patient care approach to the business of opioid replacement therapy, it is possible for additional revenue
streams to be generated via those patients bringing all of their scripts to the one pharmacy, additional Government funding and the opportunity for
other retail health solution sales to those customers.

• The pattern in which the pharmacy acquires these patients can be described as a stepped model (i.e. The total potential customer cohort will not
present in the first month but should grow steadily however there is some attrition from time to time). Given the patients are referred by a medical
practitioner, referral service or by word of mouth it will take some time before the patient capacity is reached.
2.0 Business Summary
2.1 Description of the Business (cont’d)ne

Below is a graphical representation of the expectation of patient growth. The expectations will vary depending on location and willingness of
the pharmacy and referring doctor to participate.

Customers
100
90
80
70
60
50
40
30
20
10
0

Customers
2.0 Business Summary
2.1• Description of the Business one

• The retail pharmacy industry comprises four primary types of pharmacies:

 Discount Pharmacy
 Shopping Centre Pharmacy
 Medical Centre Pharmacy
 Community Strip Pharmacy

• Before deciding to implement an opioid replacement therapy service factors about the type and location of pharmacy need to be taken into consideration including:

– Discount Pharmacies are generally large in size with proportionally less staff, often do not provide private consultation rooms/spaces and are sometimes located
in inconvenient locations. This at times does not allow for privacy/discretion when patients are consuming their dose and may make it difficult for patients to visit
the pharmacy if they do not have their own form of transport.

– Shopping Centre Pharmacies are located in high traffic areas surrounded by other retailers and consumers. It is possible that the shopping centre
management may place restrictions on pharmacies to prevent them providing this service due to the perceived particular clientele.

– Medical Centre Pharmacies are an appropriate style of pharmacy to provide this service to patients. These types of pharmacies are in close proximity to doctors
should the patient require assistance and for referral. In addition, the size of the pharmacy is smaller and therefore easier to manage the customer.

– Community Strip Pharmacies are an appropriate type of pharmacy to provide the service due to their location, convenience for the customer and potential for a
higher level of community involvement. Patients are able to easily access these pharmacies due to their convenient locations being generally close to public
transport and/or parking. These pharmacies have the flexibility to provide private consultation rooms and areas for the provision of pharmacotherapy service to
patients while also forming strong relationships which promotes loyalty.

• The medications used for opioid replacement therapy (methadone and buprenorphine) are classified as controlled drugs and therefore at the end of each day the
pharmacist must allow time to write up all the doses in the Controlled Drug Book. Any spillages should be noted and accounted for.

• It is recommended a separate department and category be set up in the point of sale system in the pharmacy to record the opioid replacement therapy sales.
2.0 Business Summary
2.2 Start – Up Summary

• In providing the opioid replacement therapy service to patients, the pharmacy will need to consider whether they have or are willing to
acquire the following:

1. Gain an understanding of how many patients exist within the catchment area requiring the service - with the assistance of The
Opioid Management Team, Western Victoria PHN.

2. Ensure a private consultation space exists in the pharmacy or can be procured so that the patients can receive and consumetheir
dose privately and discreetly;

3. Implementation of either a manual or automated dose system for dispensing the correct doses. If the manual dose system
ischosen, additional software may be required for dose administration. The three automated dosing machines/software programs
available to pharmacies are further explained in appendix 1 and their respective costs are included in the financial model;

4. Purchase of the consumable items necessary to dose the patients (e.g. Bottles, cups, labels etc);

5. Order the methadone from the pharmacy wholesaler and keep it in the safe in the pharmacy as it is an S8 (controlled drug).
Noting that the pharmacy does not pay for the drug (there is no cost of goods sold for the pharmacy, this is government subsidised);

6. The marketing is based on referral from the prescribers, self referral, or referral agencies;

7. Patients need to be set up in the pharmacy’s system with photo to identify them on each visit and their details entered into the
software before dosing can commence.
2.0 Business Summary
• The specific inputs into the financial model are outlined at Appendix 2.
3.0 Product Procedure
• Opioid replacement therapy is used to reduce the withdrawal symptoms of people who are dependent on licit and illicit opioid medications. As part of
the opioid replacement therapy treatment program, methadone/buprenorphine is used to treat pain and aid in detoxification.

• In order for a patient to obtain an opioid replacement therapy dosage, the patient must have first been to a GP who is willing and able to prescribe
methadone or buprenorphine. On a needs basis, the doctor will then provide a script specifying the medication and dosage required to manage the
patient outcome.

• The patient must provide a paper script to the pharmacist before dosing can commence. Most customers will initially be on a daily dosage. It is possible
that some customers may be able to access take-away doses once stabilised and this is usually decided upon consultation and collaboration between
the prescriber and the pharmacist/s.

• Upon entering the pharmacy, the patient will be identified by photo identification which the pharmacy has taken/received when first setting the patient up
on the system. The pharmacist will then bring up the patient’s personal information on the computer with the dosing details.

• For methadone, dependent on whether a pharmacist manually doses or engages an automatic dosing method, the pharmacist will retrieve the
methadone from the safe (all methadone must be kept in a safe) and dose the patient. Methadone comes in a liquid form that can be provided as a daily
dose or as a takeaway.

• For certain patients, scripts will allow for doses to be dispensed as a takeaway. These patients are typically those who are in full time employment with
low dependency.

• The pharmacy receives the supply of methadone/buprenorphine direct from a wholesaler at no cost. The price the pharmacy charges to its patients
varies between $5 to $7.50 per dose. Historically, the more rural and remote the pharmacy’s location is, the higher price per dose can be charged.

• Servicing 90-100 patients per day equates to approximately 2-3 litres of methadone required per day. Methadone can be ordered from the wholesaler
and be delivered within 24-48 hours. The pharmacy should therefore at any one time hold at least 2 days worth of methadone supply.
 4.0 Marketing Plan
4.1 SWOT Analysis
Strengths
1. Doctor, clinic, self-referral,
DirectLine referral process so a
low cost of marketing.
2. Very loyal customer base (a
new pharmacy charging a
lower price can open but a high
percentage of patients will
remain at original pharmacy).
3. Patients do not seem to be very
price sensitive.
Weaknesses
1. Difficult to market directly to
the patient.
2. Type of customer requiring the
service is not always the typical
pharmacy customer
3. Management of the customer
payment arrangements if paying
cash. Pharmacy cannot afford for a
debtor to build up.
Opportunities
1. Each opioid replacement 1.
therapy patient may have
approximately 2-4 other scripts
per month.
2. Opportunity to pack other 2.
medications in a DAA & receive
additional remuneration.
3. Opportunity for additional 3.
government funded revenue
from Meds Checks and home
medication reviews.
4. Centrepay (if patients are on 4.
Centrepay this ensures the
pharmacist will get paid).
5. Revenue from other retail
purchases in the pharmacy.
Threats
Possible issues/management of
patients.
Patients falls behind on
payment. Once debt is $50 or
more very unlikely to be
recovered.
Patients may not be receptive
to these professional services
Administration fee charged by
Centrelink.
4.0 Marketing Plan
4.1 Market Segmentation 4.2 Target Market

Opioid replacement therapy patients can be broken down into two
different groups, dosed daily and takeaways.
Dosed Daily: These patients are required to visit the pharmacy
daily, 7 days a week, to receive their opioid replacement therapy
dose. These patients are usually new to the program or do not hold
down full time jobs or have other valid reasons for a takeaway dose.
They may sometimes have takeaways for the weekends if the
pharmacy is not open but this decided in collaboration with the
prescriber. The prices of these takeaways on the weekends should
remain the same as the daily dose.
The flow chart below outlines how a pharmacy acquires a patient with a
prescription for opioid replacement therapy. Ideally the patient is treated in
the community by their community GP and then by their community
pharmacy. Sometimes more complex patients need to treated at a specialist
drug and alcohol service. They are either referred by GPs or self-referral. A
pharmacist can also refer a patient for opioid replacement therapy.
The pharmacy should be contacted by the patient /prescriber to identify if
they have the capacity and are willing to accept the patient into their
program. The prescriber will provide the patient with a script for opioid
replacement therapy. The patient then goes to the pharmacy with their script
detailing the exact dosage and frequency to receive their opioid replacement
therapy
Once a patient is referred to and connected to a pharmacy, they tend to be
very loyal patients and will rarely change to another pharmacy.

Takeaways: These patients receive their opioid replacement

therapy doses as takeaways that do not need to be consumed in
the pharmacy. The frequency in which these patients visit the Provide
Patient GP Script Pharmacy
pharmacy to pick up their supply of takeaways is wholly dependent
on the doctor’s script (at least weekly). These patients often are in
full time employment.

Provide
Referral DAS* Script
Patient GP Pharmacy

* DAS = Drug and alcohol service

DAS* Provide
Patient script Pharmacy
4.0 Marketing Plan
4.3 Total Customer Opportunity

• Many patients receiving opioid replacement therapy may also require a further 2-4 scripts to be
filled per month for other medications such as antipsychotics, antidepressants, antibiotics,
nonopioid pain medications and short-term benzodiazepines. If compliance is an issue an
opportunity exists to pack these other medications in a DAA and receive additional government
funding through MedsChecks and home medication reviews.

• Patients receiving Centrelink payments can choose to have the cost of their opioid replacement
therapy doses deducted from their payments and paid directly to the pharmacy using Centrepay
(Centrepay charges a fee of $0.99 per payment). This method ensures the pharmacy will
consistently receive payment for each opioid replacement therapy dose it supplies.

• Patients do not appear to be as price sensitive when paying via Centrepay, therefore giving the
pharmacy the ability to charge $7.50 per dose as opposed to $5 per dose.

• The patient is also likely to spend a additional $10 to $20 per month on other retail items which
could be health related or consumables such as lollies and water.
5.0 Implementation Plan
5.1 Marketing Strategy
Marketing directly to the patient is extremely difficult. Incentives such as
providing a discount if paying for 1-2 weeks up front could be trialled.
SMS reminders to existing patients who are not fully compliant can ensure
patient retention.
It is important for the pharmacy/pharmacist to have a strong relationship
with the prescribing clinic/doctors in the area.
5.2 Customer Payment Methods
Patients will pay for their opioid replacement therapy doses using either
cash or through Centrepay. It is best practice with patients paying via
cash to have them paid 2 weeks in advance. If a patient is behind in
payment and owes more than $50, it is very unlikely that money will be
recovered.
Patients on Centrepay have the cost of their opioid replacement therapy
doses deducted directly from their Centrelink payment (this may be
weekly or fortnightly) and paid directly to the pharmacy. The pharmacy
will incur a $0.99 fee for each payment it receives from Centrepay.
If there is an issue with payment the pharmacotherapy mediation and
advocacy service (PAMS) can act as a mediator.
5.3 Milestones
Measuring the scalability will be highly dependent on the method the
pharmacy uses to dispense the methadone dose, i.e. if they dose
manually or automatically and the type of medication predominantly
dispensed i.e. methadone or buprenorphine.
5.4 Personnel Plan
The medications used in opioid replacement therapy are classified as
controlled drugs and must be dosed by a qualified pharmacist. Due to the
some of the complex issues and comorbidities of some of these patients,
the pharmacy must have a pharmacist who is willing to manage the various
issues that may arise from servicing these patients. Training in mental
health or mental health first aid would be an advantage. The pharmacist
must be able to build relationships with the patient as to retain their loyalty,
while managing social issues such as inability to pay.
5.5 Layout & Design
A pharmacy providing an opioid replacement therapy service must have a
private consultation space. This is to allow for the opioid replacement
therapy patient who is consuming the medication in store to do so in a
private and discreet manner.
6.0 Additional income opportunities
Additional opportunities exist to obtain income from the following pharmacy
programs / professional services that complement an opioid replacement
therapy service:

• Naloxone supply

• Needle syringe program

• Daily dispensing service

• Clinical interventions

• Dose administration aid service

Appendix 1
Three Types of dispensing software
1. Meth. D. A 2. Autodose

 Robust software management system that replaces the paper

base recording for dispensing methadone, subutex and
suboxone.
 Helps streamline processes to improve efficiency and safety and
quality process.
 Built in reporting and accounting functionality  Australian designed precision pumping system with locally build software that
 Optional Accessories (to be used with Meth.D.A) is fully integrated.
 Label Printer  Accurately, precisely dispenses methadone and bidone.
 Prints takeaway labels  Helps comply fully with statement regulations
 Signature Pad  Automatically record patient history and allow a complete DD register record
 Allows patients to sign for their doses electronically. Digitally  Empty you DD cabinet of bottles and allows consolidated record of your
records signatures and recognises and alerts if this does not inventory
seem correct
 20-160 clients daily
 Scanner
 Complete turn key system that includes:
 Scan original scripts and attached to patient records
 Report Printer
 Electronic Pump
 Attaching the electronic pump to MethDA allows the pump to  Costs: $740 for automatic pump
automatically dispense the correct dose based of patient records $305 per month licence fee
 Digital Camera
 To take photos of patients to attached to client
 Costs: $2,250 for automatic pump
 $5 per patient per month fee
3. Idose

 System is completely modular – can be operated as a simple recording system (with accounts management) ,on a standalone
workstations and hardware can be added such as:
 Scientific pump device
 Iris recognition technology
 Printing of thermal labels (for pre-dispensed doses)
 On-screen digital images for patient identification
 Printing of reports including controlled drug register reports.
 From 10-several hundred patients per day

 Costs: $750 per quarter for software & support

$5,000 Iris scanner
$5,000 automated pump system
Appendix 2
Inputs to the financial model
1. Initial patient numbers

2. Expected cap on patient numbers

3. Growth rate – to understand expected time to reached patient cap

4. Patient attrition rate (if any)

5. In-Store and takeaway dosing per week

6. Amount to charge the patient per dose

7. Pharmacists hourly pay rate (ex super)

8. Number of patients where Centrepay is utilised to manage customer payments

9. Estimate of Medschecks v HMRs and as a % of opioid replacement therapy

patients

10. Method of dosing the patient – manual or automatic options

11. Number of additional scripts from the patient per month

12. Estimate of additional retail sales per month per patient

13. Cost of setting up consultation area

Appendix 3
Financial model example 2
Financial model example 1 The following assumes the following:
The following assumes the following:

1. Patient opportunity is 80 over 18 months

1. Patient opportunity is 50 over 12 months
2. 5% attrition rate
2. 10% attrition rate
3. 5 days of in-store dosing and 2 takeaways for the weekend on average
3. 5 days of in-store dosing and 2 takeaways for the weekend on average
4. $7.50 charge to customer per day
4. $5 charge to customer per day
5. 50% of customers on Centrepay
5. 20% of customers on Centrepay
6. $45 hourly rate for the pharmacist labour
6. $35 hourly rate for the pharmacist labour
7. Idose system used for dosing patients
7. Autodose system used for dosing patients
8. 10 MedsChecks and 5 HMRs
8. No MedsChecks or HMRs
9. 2 additional scripts per patient per month on average
9. 2 additional scripts per patient per month on average
10. $20 retail sales per pateint per month
10. $30 retail sales per patient per month
11. $5,000 set up of consulting space
11. $2,500 set up of consulting space
RESOURCES
 OPIOID RELACEMENT
THERAPY POLICY
To be reviewed: (insert date)

OPIOID RELACEMENT Insert Pharmacy Name

THERAPY POLICY
To be reviewed: (insert date)
Table of Contents
QCPP requirements .............................................................................................................................................. 27
Training ............................................................................................................................................................. 27
Resources.......................................................................................................................................................... 27
Premise and equipment ................................................................................................................................... 28
Records ............................................................................................................................................................. 28
Procedure for supply of methadone and buprenorphine doses .......................................................................... 29
Establishing a new or transferred patient record ............................................................................................. 29
New Patient .................................................................................................................................................. 29
Transferred patient (including discharge from hospital and release from prison)....................................... 29
Dosing ............................................................................................................................................................... 29
Recording .......................................................................................................................................................... 29
Preparing take-away doses ............................................................................................................................... 30
Methadone take-away doses ....................................................................................................................... 30
Communication with prescribers ..................................................................................................................... 30
Dosing errors .................................................................................................................................................... 30
Excess dose methadone ............................................................................................................................... 30
Excess dose buprenorphine .......................................................................................................................... 31
APPENDIX 1 ........................................................................................................................................................... 32
Opioid Replacement Therapy Program (Methadone / Suboxone) Agreement Between Client and Pharmacy
.......................................................................................................................................................................... 32
APPENDIX 2 ........................................................................................................................................................... 35
Client review /stability report (CONFIDENTIAL) ............................................................................................... 35
APPENDIX 3 ........................................................................................................................................................... 37
Missed dose report ........................................................................................................................................... 37
APPENDIX 4 ........................................................................................................................................................... 39
Department of health self-assessment............................................................................................................. 39
Appendix 5 ............................................................................................................................................................ 58
Withdrawal Vs Intoxication/overdose .............................................................................................................. 58
QCPP requirements

Training
The following pharmacists have completed pharmacotherapy training (Stage 1)

Name Date training Signature

completed

* Store certificates documenting completion with this policy

The following pharmacist have completed pharmacotherapy training (Stage 2)

Name Date training Signature

completed

* Store certificates documenting completion with this policy

Resources

The current policy for maintenance therapy for opioid dependence can be found here:
https://www2.health.vic.gov.au/getfile/?sc_itemid=%7B2467D7C8-6C90-486E-8265-
6FC3E47ACDD1%7D&title=Policy%20for%20maintenance%20pharmacotherapy%20for%20opioid%20depende
nce

Additional resources can be found:

 (please insert other resources and their location)

Referral and advice services include:

 Drug and Alcohol Clinical Advisory Service (DACAS), 1800 812 804 – Free 24 hour service for health
professionals to obtain clinical advice
 Pharmacotherapy, Advocacy Mediation and Support (PAMS), 1800-443-844 - If problems with client
behaviour or disputes
 DirectLine, 1800 888 236 – Counselling and service finder service
 (add own local area services)

Premise and equipment

 Only use measuring devices capable of measuring to the degree of accuracy required i.e. syringes and
pumps. Do not use conical measures.
 Only use single use disposable cups. Do not reuse cups.
 Ensure patients have access to drinking water.
 Take away doses MUST be in child resistant packaging and made up to 200mL with water suitable for
drinking.
 Methadone and buprenorphine are kept in an appropriate locked safe
 Doses are to be done in a discreet area in a discreet manner

Equipment calibration/service record

Equipment piece Date calibrated / Signature

serviced

Records
All records for each patient are to include:

 A certified photograph of the patient

 A signed treatment agreement form
 Details of the prescriber and other relevant health care workers
 Significant communications with prescribers
 Important notes about the patient
 A record of each supply
 Whether a dose has been withheld or declined and the reason
 When a patient has failed to attend

Any issues with patients, prescribers doses etc. should be clearly recorded in the clinical
notes/communications book (or pharmacy’s preferred means of communication).
Procedure for supply of methadone and buprenorphine doses

(Add pharmacy’s own extra requirements as necessary)

Each pharmacist that provides pharmacotherapy must complete the department of health self-assessment
checklist (APPENDIX 4) and store with this policy.

Establishing a new or transferred patient record

New Patient
 Verify patient identity by viewing prescriber verified photograph
 Do not dose before receiving a prescription for the patient, verbal orders are accepted in an
emergency situation as long as it is verified that the person is a prescriber.
 Ensure the patient signs a treatment agreement form
 Verify the prescription is legal and in date and from a known prescriber

Transferred patient (including discharge from hospital and release from prison)
Same as for a new patient including:

 Establish what the last dose was and when it was taken by contacting the last dosing point to avoid
doubling up of dosing.

Dosing
 Only one patient is to be dosed at a time.
 If unfamiliar with the patient confirm the patient’s identity by referring to endorsed photograph or
(enter other methods as appropriate i.e. fingerprint or iris recognition)
 Before dosing the patient assess whether they may be intoxicated by alcohol or other drugs (see
APPENDIX 5) If found to be intoxicated withhold dose.
 Check that the prescription is current and in date
 Double check with the prescription and the previous dose to ensure the correct dose is being supplied
 Confirm with the dosing record that the patient has not been dosed already on that day and it has
been at least 8 hours since their previous dose
 Confirm in the dosing record that they have not missed FOUR consecutive days (Methadone or
buprenorphine) . If missed withhold dose and contact prescriber.
 Check/monitor the patient for any signs of adverse reactions
 At regular periods discuss with the patient their treatment progress and refer to other health
professionals as necessary.
 Confirm that the dose has been taken before allowing the patient to leave the pharmacy

Recording
Ensure the required information is recorded.
All records for each patient are to include:
 A certified photograph of the patient
 A signed treatment agreement form
 Details of the prescriber and other relevant health care workers
 Significant communications with prescribers
 Important notes about the patient such as irregular attendance, behavioural issues, changes in their
condition
  A record of each supply including: date, time, pharmacist who supplied, whether the dose was taken
in the pharmacy or a take-away dose, dose taken in mgs
 Whether a dose has been withheld or declined and the reason
 When a patient has failed to attend
 The dose must be recorded in the daily dosing / DD register (delete inappropriate) after supply

Preparing take-away doses

 Ensure patient is entitled to take-away dose as per the prescription and the maximum for that week
have not been exceeded.
 Prepare and record dose as for in-pharmacy supply with the following extra requirements:
o Dose must be labelled in a way that states the name of the patient, the medication details
including strength, the quantity in mg, initials of the dispensing pharmacist, date of
dispensing and the directions for taking the medication including the date the dose is to be
consumed.
o Container must have Label 1 attached and the words “May cause death or injury if taken by
another person”
Methadone take-away doses
 Dose is supplied in a sterilised child-resistant 200mL amber container
 Dose must be made up to 200mL with drinking water (do not add cordial or other additives)

Communication with prescribers

 If any issues arise with the dose amount, suspected diversion, vomited dose, the amount of take-
away doses, missed more than the recommended doses etc. the prescriber should be contacted
immediately. Do not dose the patient until you are satisfied that you have been able to discuss the
situation with the prescriber.
o Any issues where a prescriber cannot be reached i.e. after hours, prescriber away etc the
pharmacist should contact DACAS for advice
 The prescribers should be advised weekly of patients that have missed doses. This is done by sending
through a weekly report. See template (APPENDIX 3)
 Patients whose scripts are getting close to their expiry date should have a review report sent through
to their prescriber prior to their next appointment (APPENDIX 2)
 Record significant communication with the prescriber or others as above.

Dosing errors
If there has been a dosing error the following procedures should be followed:

Excess dose methadone

 If the patient is in their first 2 weeks of treatment and is showing signs of intoxication:
o The patient must attend the emergency department – pharmacist should contact the ED and
advise that the patient is coming in and what dose they have been given
o Advise the patients prescriber of what has happened.
o Record all the details of the incident.
o If necessary contact PDL

 If the patient has been in treatment for longer than 2 weeks and:
o If the dosing error is less than 50% over their usual dose
 Alert the patient to the signs and symptoms of overdose (APPENDIX 5)
 Advise the patient to present to the emergency department if any of these
symptoms develop.
  Warn then not to use alcohol or other drugs as this will increase their risk of an
overdose
 Warn them to not drive or operate machinery as they are at an increased risk of side
effects especially sedation
 Advise the prescriber of the incident
 Record all the details of the incident.
o If the dosing error results in a dose more than 50% over their usual dose
 Contact the prescriber immediately. If they are not available contact the Drug and
Alcohol Clinical Advisory Service (DACAS) 1800 1800 812 804
 If hospitalisation is required, contact hospital or ambulance to alert staff to
circumstances.
 Record all the details of the incident.
 If necessary contact PDL

Excess dose buprenorphine

 Explain the consequences to the patient- increased sedation for several hours.
 Warn against additional drug or alcohol use as this increases their risk of overdose.
 Warn them to not drive or operate machinery as they are at an increased risk of side effects especially
sedation.
 Notify the prescriber of the incident.
 Record all the details of the incident.
 The patient should be monitored for at least 6 hours by a trained health professional or the
emergency department it they:
o Experiences sedation and drowsiness following the dose.
o Are new to pharmacotherapy i.e. within the first 2 weeks
o Are given an incorrect dose that is more than 32mg (regardless of their normal daily dose).
If the patient has left the pharmacy after the dosing error has been realised every effort should be made to
contact the client. If you are unable to contact the client or their family / carer in the case of an overdose
contact the police and ask them to perform a “welfare check”.

Further information on supplying pharmacotherapy can be found at:

https://westvic.healthpathways.org.au/
Login: westvic
Password: p4thways
Mental Health; Alcohol and Drugs; Opioid Replacement Therapy Dispensing - Information for Pharmacists
APPENDIX 1
Opioid Replacement Therapy Program (Methadone / Suboxone) Agreement
Between Client and Pharmacy
Insert pharmacy name & address
Opening Hours: ?? to ??
Client Contact Details
Name:
Residential address:
Phone Number:
Date of Birth:

Welcome to the (insert pharmacy name) pharmacotherapy program. We look forward to working with you
for all of your health needs. We are committed to providing a comprehensive professional service to our
clients, which includes advice on medication and health matters. This program is a partnership between
yourself, your doctor and our pharmacists. The section overleaf briefly outlines the main points of our
program and is designed to be informative and to clarify any issues or queries you may have. We hope that
our association will be a positive experience for all involved and you will achieve the outcomes that you
want from this program.

We uphold the principles of the Consumer rights charter as outlined below.

Client rights charter

This Charter is designed to provide guidance to both clients and service providers in ensuring a relationship
of mutual respect and consideration. Furthermore, it is designed to aid conflict resolution to the mutual
benefit of both clients and service providers. While the rights detailed below are for the benefit of the
client, they should also treat their providers and other program participants with consideration and
respect.

The following is a statement of rights that all clients participating in a program to receive methadone,
buprenorphine or other pharmacotherapy, can expect from their pharmacist providers.
 Quality pharmacy service.
 Considerate care that respects privacy and dignity.
 Adequate information on appropriate aspects of service provided or treatments available, in terms
that can be understood.
 Non-judgmental treatment that is unassuming and non-discriminatory and is fair and equitable.
 Information about the treatment and participation in decision making which relates to their
program and their general health.
 Access to information from their pharmaceutical records, unless specifically directed otherwise by
their prescribing doctor and accurate and honest responses to questions relating to their
treatment.
 Discreet and confidential service and confidential handling of their pharmaceutical records.
 The right to consent to, or refuse treatment.
 The right to make a complaint and receive a fair hearing and to have their concerns heard without
fear of repercussions.
 Where the pharmacy supplies clean injecting equipment, the right to obtain this equipment,
without this having any influence on their program.

If the client feels that they have been treated in a way that is contrary to these conditions, they can lodge a
complaint in the first instance to the pharmacist-in-charge and subsequently the Pharmacotherapy
advocacy, medication & support (PAMS) service. If a satisfactory outcome is still not reached they can
contact the health services commissioner or the pharmacy board in that state or territory.
Procedure for getting dose:

 Outline expected procedure when come into the pharmacy here e.g.
o When you come into the pharmacy go to the register and pay for your dose/s if required
 If alternative arrangements have been made i.e. Centrepay, paid in advance (outline
expected procedure)
o Take a seat in the waiting area and the pharmacist will attend to you once finished serving any
customers who were already in the pharmacy before you
o When the pharmacist calls your name approach the dosing bench to receive your dose

Fee: ?? per dose or $ ?? per week

 This pharmacy does not give credit to any customer. NO PAY NO DOSE. Under NO CIRCUMSTANCES
will credit be given so please DO NOT ASK. It is your responsibility to ensure there is enough credit in
your account or that you have enough money for the number of doses you require, including take
away doses. If you are having trouble finding the money for your dose please ask the pharmacist about
community support options that may be able to assist.

 To enable us to dose you safely we request that you not wear your sunglasses inside the pharmacy – if
you are wearing your sunglasses we will not be able to dose you.

 Due to the risk of overdose, for your safety, we may not be able to dose you if you attend the
pharmacy in an intoxicated state. If this occurs you may be asked to leave the pharmacy and return
later when you are not under the influence of any substances.

 Your prescription is YOUR responsibility – Make sure it is in date, the correct dose, correct number of
take away doses etc. We will try to remind you when your prescription is running out but ultimately it is
your responsibility.

 It is a legal requirement that any changes to regular dosing, for example increases in the number of
take away doses, increase in dose, wanting to get doses early etc. MUST go through the prescriber

 Doses that are to be consumed under supervision, must be taken in view and under the supervision of
the pharmacist.

 In order for this program to be as successful as it possibly can be for you, regular attendance is
suggested. There are specific Department of Health rules around how many doses can be missed, see
below:

FOUR day rule for Methadone: It is a drugs and poisons regulation that if four doses in a row are missed
your prescription is no longer valid therefore under no circumstances can you be dosed without you having
made arrangements with your prescriber for a new prescription.

FOUR day rule for Suboxone: It is a drugs and poisons regulation that if four doses in a row are missed
your prescription is no longer valid therefore under no circumstances can you be dosed without you having
made arrangements with your prescriber for a new prescription.

We are committed to ensuring everyone that attends this pharmacy are treated fairly and with respect at
all times including all customers and staff.

I, …………………………………………..
 Have read the information supplied to me and understand my responsibilities with regard to the
program.

 I understand that if my behaviour is not to a standard that can be expected from any customer that I
may be placed on an individual contract that outlines my specific behaviour requirements or my
position on the program may be terminated

Client’s signature……………………… Date…………………………

Pharmacist’s signature………………………. Date…………………………

APPENDIX 2
Client review /stability report (CONFIDENTIAL) Date:
Insert pharmacy details

Prescribers name:

Client name: DOB:

Address:

Treatment with:

Dose: Takeaways per week:

Other medications:

Assessment Outcome Comments

Number of missed doses

Erratic behaviour

Up-to-date payment

Intoxicated presentation

Recent diversion attempts

Concerns over stability

Dose changes

Presentation of potential
adverse effects i.e. drowsiness,
sleep disturbance, aches &
pains, dental issues, reduced
libido & other sexual
dysfunction, sweating
 Still using other opioids or
illicit drugs

Known health or social issues

I am happy to continue providing pharmacotherapy for this client Yes No

Do you think the number of takeaways provided is appropriate? Yes No

Comments:

Signed: Pharmacist Date:

APPENDIX 3
Missed dose report
WEEKLY MISSED DOSES REPORT METHADONE CLIENTS
Insert Pharmacy details here

Dr……………………………………………………………… Fax / email:………………………………………….

Dates……………………………………………………………

Patient Dates Missed Comments

WEEKLY MISSED DOSES REPORT SUBOXONE CLIENTS

Dr……………………………………………………………… Fax / email:………………………………………….

Dates……………………………………………………………

Patient Dates Missed Comments

APPENDIX 4
Department of health self-assessment

Self-Assessment Form for Pharmacists

Opioid-Replacement Therapy 1st
September 2016

Pharmacy Name: ………………………………………………………………………………………………………

This document has been prepared by Drugs and Poisons Regulation (DPR) to assist
pharmacists in assessing their compliance with key regulatory and policy requirements
associated with the safe, appropriate and lawful provision of opioid-replacement therapy (ORT).
Note: This document does not address all aspects of the requirements; pharmacists should
refer to the Drugs, Poisons and Controlled Substances Regulations 2006
(www.legislation.vic.gov.au) and Victoria’s Policy for maintenance pharmacotherapy for opioid
dependence (the Policy) (www2.health.vic.gov.au/public-health/drugs-and-
poisons/pharmacotherapy) for full details.

Explanatory notes and terminology

Examples of commonly accepted procedures have been included for guidance and clarification;
they are not intended to represent the only manner in which compliance might be achieved.
Where ‘Yes/No’ responses are required, bold text is used to indicate the ‘correct’ or ‘preferred’
response.
Where methadone is mentioned in this document, the reference may be applied to either of the
two available formulations, which both contain 5 mg/mL of methadone hydrochloride. Methadone
Syrup (Aspen) contains preservatives and other excipients; Biodone Forte ® contains colouring and
purified water.
References to buprenorphine in this document may be applied to either of the available
formulations - unless the brand name or type of formulation is specified.
In addition to medical practitioners, references to prescribers are equally applicable to nurse
practitioners whose registration endorsement and scope of practice are applicable to prescribing
opioid-replacement therapy.

The Regulations
Regulatory requirements associated with ORT are the same as for other Schedule 8 poisons under
the Drugs, Poisons and Controlled Substances Regulations 2006 (the Regulations). Failure to
comply with the Regulations renders a person liable to prosecution. In this document, the term
‘must’ is used to emphasise regulatory requirements.

The Policy
The Policy has been developed in accordance with input from health practitioners with expertise in
treating opioid-dependent patients to minimise the risks associated with ORT. It should be read in
conjunction with the National Guidelines for Medication-Assisted Treatment of Opioid Dependence.
The Policy contains general advice, which is intended to assist health practitioners manage patients
in a safe, appropriate and lawful manner. However, the Policy cannot address every clinical
situation and is not intended to replace professional judgement in individual cases.
It is expected that pharmacists will generally act in a manner consistent with the Policy and will
vary from it only if there is sufficient justification in an individual case.

A pharmacist is not obliged to vary from the Policy and must not vary from regulatory
requirements simply because a prescriber gives instructions to do so.
In determining whether there is sufficient justification to vary from the Policy, or when dealing with a
situation that is not specifically addressed in the Policy, pharmacists are advised to consider the
“Principles of Pharmacotherapy Administration” (contained in Appendix 7 of the Policy) and to
document reasons for any actions that are not consistent with the Policy. Pharmacists might also
consider whether their actions are likely to satisfy the scrutiny of the Coroner in a worse-case
situation.

Recent changes to the Policy

The current version of the Policy, which took effect in September 2016, is similar to previous
versions of the Policy. Four key amendments have been highlighted in this document by yellow
background shading rather than green. If this document has been printed in black and white, please
refer to the website version (location) to identify the sections with yellow background shading.
.

Self-assessment issues
Reference material
The Policy and the National Guidelines for Medication-Assisted Treatment of Opioid
Dependence may be accessed on the department’s website at: www2.health.vic.gov.au/public-
health/drugs-and-poisons/pharmacotherapy
Many useful contact details are contained in Appendix 2 of the Policy, including:
 The Drug and Alcohol Clinical Advisory Service (DACAS) for urgent clinical advice (1800
812 804)
 The Pharmacotherapy Advocacy and Mediation Service (PAMS) for advice and
assistance in dealing with client-related issues that might arise (Tel: 1800 443 844)
Does your pharmacy have internet access, with the above website bookmarked YES / No
for ready access by pharmacists, OR are printed versions of the corresponding
reference material readily available?

Are you confident that all pharmacists at your pharmacy are aware of and are YES / No
able to readily access the emergency contacts listed in Appendix 2 of the
Policy?
Awareness by all pharmacists
ORT has inherent risks, associated with the vulnerability of the patients as well as the potential
toxicity of the drugs – especially methadone. Those risks can be minimised when all pharmacists
are fully aware of the key principles of treatment but can be heightened if some pharmacists are
not fully aware.
The Policy contains a Certification Document (Appendix 7) that contains a concise summary of
key principles, for ready reference by all pharmacists, including locums.

Are you confident that all pharmacists at your pharmacy are fully aware of and YES / No
are complying with the Policy?

Have all relevant pharmacists completed a Certification Document to confirm YES / No

that they are familiar with the Policy?

Are copies of the Certification Document available for reference by all YES / No
pharmacists?

Varying from the Policy

The Policy is not intended to replace professional judgement in individual cases. If a variation
from the Policy is considered to be justified in an individual case, pharmacists are strongly
advised to document fully the reasons for the variation. (Refer to the disclaimer on page 3 of the
Policy)

Have all pharmacists been advised that, if a prescriber requests or directs them YES / No
to vary from the Policy, the pharmacist is required to make a professional
judgement and to be satisfied that the requested variation is safe, appropriate
and lawful before agreeing to implement the proposed variation?

Have all pharmacists been advised to record any variations from the Policy in a YES / No
prominent, consistent manner and in a form that can be readily retrieved if
called upon to justify decisions to authorities? (e.g. Drugs and Poisons Officers,
Coroner)

Patient identification
Before administering ORT, a pharmacist must be able to confirm the patient is the same person
for whom treatment was prescribed. This is commonly achieved by reference to a photograph,
which looks like the patient and which has been certified by the prescriber, to confirm the
person’s identity.

Commonly accepted examples:

 Photographs are securely attached to, or contained in, patients’ attendance records.
 Photographs are scanned and displayed on the pharmacy computer.
 Computer software scans of irises and/or fingerprints are used to confirm identities.
 Replacement photographs are obtained if a patient’s appearance changes significantly.
Are certified photographs, which actually look like the patient, or alternative YES / No
identification standards held for all current patients?

Information for patients commencing Opioid Replacement Therapy

Appendix 1 of the Policy contains an information leaflet to explain key aspects and risks associated with the
commencement of ORT. The leaflet is available in a range of languages.
The leaflet also contains references to the use of naloxone injections, which might be prescribed by the ORT
prescriber, especially where methadone is the drug selected.
Note: Buprenorphine is generally safer than methadone during the induction phase, but the risks of poly-drug
use and precipitated withdrawal still require caution during the induction period and while the maintenance
dose is being established.

Have all pharmacists been made aware of the information leaflet and its contents? YES / No
Note: Additional information about the use of naloxone injections is available on page 20
of the Policy.

Patients commencing or recommencing methadone treatment

During the initial stabilisation period, methadone blood levels take some days to plateau. There is a
significantly greater risk of toxicity due to lack of recognition of the long half-life of methadone and the
possibility of concurrent poly-drug use.
If the initial prescribed dose exceeds 40 mg daily, the prescriber should be consulted before administration. If
there are concerns, the pharmacist and/or prescriber may need to discuss the case with the DACAS (tel:
1800 812 804).
Note: Buprenorphine is generally safer than methadone during the induction phase, but the risks of poly-drug
use and precipitated withdrawal still require caution during the induction period and while the maintenance
dose is being established.

Have all pharmacists been informed of the need to communicate with prescribers if a YES / No
patient appears to be commencing or recommencing ORT with a methadone dose that
exceeds 40 mg daily?

New OR returning patients

In addition to the risks associated with a patient commencing treatment with higher doses of
methadone, deaths associated with ORT have been attributed to multiple dosing (with or without
take-away doses), when patients are transferring between dosing points. Multiple dosing is more
likely if there is miscommunication or no communication between the dosing points involved in
the transfer.
Similarly, when a patient returns to a pharmacy after an absence and dosing resumes on the
basis of a prescription from a previous (or new) prescriber, the reason for the absence (e.g.
 hospital treatment, prison term, illicit drug use) might be known to the prescriber, the pharmacy,
both or neither.
It is not acceptable to make assumptions. To ensure the patient’s safety; precise details of the
magnitude and timing of the most recent dose need to be determined and documented before a
dose is administered. The possibility of take-away doses and/or an interim prescription, which
might have been issued by prison health service provider, should also be considered.

Have all pharmacists been informed that they should always communicate with YES / No
the prescriber (to determine whether a patient is commencing (or
recommencing) ORT or transferring from another dosing point) before
administering methadone or buprenorphine to a patient who is new to your
pharmacy?

Have all pharmacists been informed that they should always communicate with YES / No
the previous dosing point (to determine precisely when the previous dose
was given; the magnitude of the actual dose; and whether any take-away
doses were supplied) before administering methadone or buprenorphine to a
patient who is transferring to your pharmacy?

Prescriptions from prescribers in another state or territory

Victorian legislation requires prescribers in Victoria to obtain permits before prescribing ORT but
it has no jurisdiction over prescribers in other states or territories, whose prescriptions may still
be valid in Victoria.
To prevent the possibility of a concurrent Schedule 8 treatment permit being issued to a Victorian
prescriber, a pharmacist, who undertakes to provide ORT to a patient on the basis of a
prescription issued in another jurisdiction, should notify DPR using the form “Notification of a
temporary interstate transfer of a patient on opioid-replacement therapy (ORT) to a Victorian
pharmacy”, which may be downloaded from the DPR website at: www2.health.vic.gov.au/public-
health/drugs-and-poisons/pharmacotherapy/pharmacotherapy-transfers-into-victoria.

Have all pharmacists been informed of the need to provide relevant details of YES / No
the patient and the prescriber to DPR when they undertake to provide ORT on
the basis of a prescription issued in another jurisdiction?

Patient attendance records

Attendance records are required to ensure that a patient cannot receive multiple doses on the
same day and to assist pharmacists in reviewing a patient’s regularity of attendance.

Commonly accepted examples:

 Patients are required to sign for each dose in a designated exercise book.
 Patients are required to sign for each dose on loose-leaf pages in a designated binder.
 Patients are required to sign for each dose on loose-leaf pages that are kept in
designated drop folders.
 Patients’ signatures or attendances are recorded electronically using computer software.
NOTE:
 1. The administering pharmacist must be identified on each occasion – unless he/she is
identified in the pharmacy’s Administration Records (see below).
2. If the administering pharmacist is identified in the attendance records, rather than in the
pharmacy’s administration records, the attendance records must be retained for three
years.

Dose administration records

A pharmacist must make a true and accurate record of all transactions, including the
administration or supply of ORT. Suggested formats are contained in Appendices 8 to 12 of the
Policy

Commonly accepted examples:

 Manual records on computer-generated day sheets

 Computer spread sheet
 Commercially developed computer software
 Manual records in a bound book with consecutively numbered pages
 Manual records in a Schedule 8 Drug Register (practical only for small numbers of
patients)

Is the unit of measurement of methadone (mg or mL) clearly recorded to YES / No

prevent misinterpretation by pharmacists?

Is the supply of take-away doses recorded in a consistent and unambiguous YES / No

manner that may be readily identified by all pharmacists?

Are administration records kept in a manner that preserves patient YES / No

confidentiality and ensures they may not be viewed by other patients?

Recording & reconciling the balance of Schedule 8 poisons

With Schedule 8 poisons, including methadone and buprenorphine, a pharmacist must record
the balance remaining after each transaction in a manner that ensures the record cannot be
altered, obliterated, deleted or removed without detection.
NOTE: The minimum standard required to comply with this requirement involves recording the
calculated balance in an appropriate form (e.g. Drug Register) at least daily.

Commonly accepted examples:

 The cumulative total, of doses administered or supplied during the day, is calculated in
the Administration Records and transcribed to a manual Schedule 8 Drug Register with
the remaining balance calculated and recorded each day.
 The computer software automatically calculates the remaining balance as each dose is
recorded and records the balance in a computer file, which cannot be altered without
making a separate record.
  The daily total is calculated and recorded in the Administration Records, which are in a
bound book with consecutively numbered pages. The remaining balance is calculated
each day and recorded in the same book.
 Each dose, administered or supplied during the day, is recorded in the Schedule 8 Drug
Register with the remaining balance calculated and recorded after each dose (practical
only for small numbers of patients).

To ensure the recorded balance is true and accurate, it should be reconciled with the actual
balance on a regular basis.

Commonly accepted examples:

 Weekly or fortnightly physical stock checks are performed, with a separate entry made
when it is necessary to adjust the recorded balance to show the actual balance.
 Physical stock checks are conducted when new stock is received, with a separate entry
made when it is necessary to adjust the recorded balance to show the actual balance.

NOTE: Any discrepancies in a Schedule 8 poison must be investigated immediately with any
unresolved discrepancies reported promptly to DPR.

Prescriptions
A pharmacist must have lawful instructions from a prescriber before administering a Schedule 8
poison. Accordingly, the prescriber must provide instructions in writing or (in an emergency)
verbally, with written confirmation of verbal instructions to be provided as soon as practicable. A
faxed document should be used only to confirm verbal instructions.

When receiving verbal instructions from a prescriber (to authorise administration YES / No
in an emergency), is it your pharmacy’s policy to request that the prescription is
faxed to confirm those instructions?

Following verbal instructions, is it your pharmacy’s policy to seek further YES / No

instructions from the prescriber, before administering further doses, if a
prescription is not provided promptly?

It is an offence for a pharmacist to administer a Schedule 8 poison without lawful instructions

from a prescriber but such occurrences are not rare. In some cases, pharmacists have been
found to have administered ORT for months after the prescription had expired and in
circumstances where the patient had ceased consulting the prescriber.

Common examples of how prescription expiry dates are prominently recorded so that
pharmacists and/or patients are aware of the need to obtain new prescriptions in a timely
manner:
  The expiry date of the current prescription is prominently highlighted in the patient’s
attendance record so that both patient and pharmacist are aware that the expiry date is
approaching.
 The current prescription is attached to the patient’s attendance record with the expiry
date prominently recorded. Pharmacists routinely remind patients that the expiry date is
approaching (and make a note that they have done so), to allow the patient ample time
to obtain a new prescription.
 The expiry date of the current prescription is prominently displayed on the computer
screen when a patient attends. Pharmacists routinely remind patients that the expiry
date is approaching (and make a note that they have done so), to allow the patient
ample time to obtain a new prescription.

All prescriptions for Schedule 8 poisons must be retained for 3 years in a manner that enables
them to be produced on demand.

Commonly accepted examples:

 Prescriptions that have expired (or that have been superseded by a subsequent
prescription) are filed in clearly marked bundles on a regular basis (e.g. monthly) and are
kept separate from prescriptions for other Schedule 8 poisons so that they are easier to
locate if required.
 Prescriptions that have expired (or that have been superseded by a subsequent
prescription) are retained in the designated file or drop folder for the corresponding
patient; care is taken to ensure that the current prescription is clearly distinguished from
earlier prescriptions.

Storage
ALL methadone and buprenorphine must be stored in a safe or Schedule 8 drug cabinet when
not actually required for administration and always at the end of the day.

Does your pharmacy have sufficient storage capacity to accommodate all ORT YES / No
drugs – including the methadone-dispensing container?

Some pharmacies have experienced situations where a person has reached over or around a
dispensary barrier to snatch a bottle of methadone solution or packets of buprenorphine
preparations.

During the working day, are the methadone dispensing container and the “in- YES / No
use” buprenorphine preparations located where a person cannot reach them or
walk to them without obstruction to affect an opportunistic theft?

Stability of buprenorphine preparations

Buprenorphine sublingual preparations are packed under nitrogen, to ensure the stability and
integrity of the drug. Tablets and Films should remain in the manufacturer’s immediate
packaging until immediately prior to administration.
Are buprenorphine preparations left in the manufacturer’s immediate packaging YES / No
until it is time to prepare a dose for administration?

Methadone dispensing container

Where pharmacies dispense methadone doses from a container other than the manufacturer’s
original container, most use the solution in its original 5 mg/mL concentration; some choose to
dilute the solution to a 1 mg/mL concentration. To avoid errors, it is essential that the dispensing
container is labelled to identify its contents plus the strength of those contents accurately and
prominently.

IF dispensed from other than its original container, is the container labelled to YES / No
identify its contents prominently - including the concentration of the
methadone solution?

Doses prepared in advance (if applicable)

The department recommends that each ORT dose is prepared by the pharmacist who is to
administer the dose when the patient attends to receive the dose.

Do pharmacists at your pharmacy prepare doses prior to patients’ attendance? Yes / NO

(If the answer is ‘no’, you need not complete the rest of this sub-section)

Where a pharmacy chooses to prepare doses in advance of patients’ attendance, additional

matters should be considered to minimise the risk of errors.

Are pre-prepared doses placed in containers that have a secure closure? YES / No

Are pre-prepared doses placed in containers that are clearly & unambiguously YES / No
labelled with the identity of the patient?

Do the pharmacy records clearly identify the pharmacist who prepared the dose YES / No
in addition to the pharmacist who administers the dose?

Are pre-prepared doses of methadone diluted prior to the patient’s attendance? Yes / NO
(This practice is not recommended because it precludes the possibility of re-
checking the dose)

Administering methadone & anti-diversion strategies

Is each supervised dose of methadone diluted with water or cordial before YES / No
administration?

Is the administration of each methadone dose supervised to ensure that the YES / No
patient has consumed the dose?

Are all pharmacists aware that methadone is fully absorbed within 20 to 30 YES / No
minutes of ingestion and that a dose might have been substantially absorbed if
a patient claims to have vomited a dose after leaving the pharmacy?
Administering buprenorphine & anti-diversion strategies
To address widespread reports of diversion and injection of Subutex ®, naloxone was added to
the formulation to deter injection and pharmacists were instructed to break tablets into smaller
pieces to reduce the times required for absorption and supervision. Suboxone ® Films were
subsequently developed to further reduce the times of absorption and supervision. Suboxone®
tablets are no longer registered for use.
For administration of Suboxone® Films, each sachet should be torn to allow the patient to
remove (peel off) the strips and place one strip under each side of the tongue without
overlapping. Some patients will be able to administer four doses concurrently, with the extra two
Films being administered in the buccal cavities.

Have all pharmacists and patients been advised that buprenorphine YES / No
preparations are to be administered sublingually and that Suboxone® Films
should not overlap?

Are patients supervised until the sublingual dose of buprenorphine tablets has YES / No
been substantially absorbed or Suboxone® Films have adhered to the mucous
membrane?

The Policy states that Subutex® tablets should be broken into small pieces (resembling
granules) and administered directly under the patient’s tongue. Note: Crushing tablets into a fine
powder may cause pasting in the mouth and actually slow absorption.
DPR recommends providing the dose of broken tablets to the patient in a dry disposable cup. If
patients complain about the taste, bread is reported to be quite effective in eliminating the taste
and, if it is a particular concern, patients can be advised to bring a slice of bread to eat once the
tablets have been absorbed.

To minimise the possibility that Subutex® tablets might be diverted, are the YES / No
tablets routinely broken into small pieces or granules before administration to
each patient?

Some prescribers have directed pharmacists not to crush Subutex® tablets for specific patients.
The department advises that this instruction is probably best interpreted as an instruction to not
crush the tablets into a fine powder, an action that might affect the extent to which a dose is
absorbed.

Commonly accepted options:

 If the pharmacist agrees that it is safe and appropriate to vary from the recommended
process in relation to an individual patient, the reasons for the variation should be
documented in the patient’s records. In such cases, the sublingual tablets should be
broken into smaller pieces and additional time should be allotted to supervise the patient
in order to prevent diversion.
 If a prescriber is unable to satisfy the pharmacist that it is safe and appropriate to vary
from the recommended process in relation to an individual patient, the pharmacist
 should inform the prescriber that he/she is not willing to agree to the variation. In such
cases, the prescriber and the patient could be invited to transfer to another pharmacy.
 Suboxone® sublingual films may be suggested to the prescriber as an alternative
formulation.

Administration containers
For reasons of hygiene, it is recommended that disposable containers are used for the
administration of both methadone and buprenorphine.

Commonly accepted options:

 Disposable containers are used and are discarded into a designated waste container.
 Re-usable containers, labelled for specific patients, are thoroughly cleaned and sanitised
after each use.

Authorisation of take-away doses

The supply of take-away doses is a significant clinical decision that requires thorough
consideration of the risks and benefits of a patient having the privilege of take-away doses; see
pages 30 to 42 of the Policy for a broad discussion of the many variables that should be
assessed and considered.
Appendix 4 contains a check list to assist prescribers in assessing whether authorisation for
take-away doses might be considered; it divides the numerous issues into four categories:
1. Absolute contra-indications: Take-away doses should not be supplied
2. Relative contra-indications
3. Reasonable need
4. Continuous period of stability
Note: Before authorising take-away doses, prescribers should communicate with pharmacists to
confirm that patients fulfil the criteria for the supply of take-away doses; to ensure that
pharmacists are not aware of any contra-indications; and to confirm or establish the duration of
continuous, stable treatment – a key factor in determining the frequency with which take-away
doses may be supplied.

Have all pharmacists been made aware of the relative importance of the four YES / No
categories that are associated with the supply of take-away doses?
Is a copy of Appendix 4 readily available (hard copy or bookmarked) for ready
YES / No
reference by pharmacists?

Have all pharmacists been informed of the need to alert prescribers if the YES / No
conduct of patients who have been receiving take-away doses, represents a
contra-indication to the ongoing supply of take-away doses?

Have all pharmacists been informed that, where a prescriber requests or directs YES / No
them to provide take-away doses other than in accordance with the Policy, the
pharmacist is also required to make a professional judgement about the safety
and appropriateness of the variation?

Have all pharmacists been advised that take-away doses that are claimed to YES / No
have been lost or stolen must not be replaced unless the prescriber’s written
authorisation has been obtained; and that pharmacists should exercise
professional judgment about the safety and appropriateness of providing
replacement doses even if authorised to do so?

Take-away doses - secure storage by patients

The absence of a safe, secure storage facility is one of four absolute contra-indications to the
supply of take-away doses because of the significant risk if doses are consumed by someone
other than the patient for whom they were supplied. This risk is magnified in the case of children,
people who lack tolerance for the drug and people who are concurrently using other drugs. In a
number of inquests into deaths from ingesting take-away doses of methadone, the Coroner has
raised concerns about the safe storage of take-away doses. To minimise these risks, it is
essential that take-away doses are stored securely by patients.
Note: Take-away doses of methadone do not need to be refrigerated and doing so might
increase the risk of a dose being taken by children or other household members.

Are patients periodically questioned about the manner in which they store take- YES / No
away doses and reminded of the need to ensure that take-away doses are
stored securely, where they cannot be located or accessed by others,
especially children?

Take-away doses of methadone

A schedule, showing the recommended maximum number of methadone take-away doses
following continuous periods of stability in treatment, is included in Appendix 4 of the Policy.

Less than 3 months  No take-away doses

3 to 6 months  Not more than 2 take-away doses per week
More than 6 months  Not more than 4 take-away doses per week
 Not more than 3 take-away doses on any occasion
Take-away doses of methadone represent a significant risk if consumed by someone other than
the patient for whom they were supplied. This risk is magnified in the case of children, people
who lack tolerance for the drug and people who are concurrently using other drugs.
To minimise these risks and to deter injection, each methadone take-away dose should be
diluted with water to a volume of 200 mL and supplied in a container with a child-resistant
closure. Take-away doses should not be diluted with cordial, as doses prepared in this manner
may develop microbial growth.

Is each methadone take-away dose diluted to a volume of 200 mL? YES / No

Is each methadone take-away dose supplied in a container with a child- YES / No

resistant closure?
The department sometimes receives complaints alleging that pharmacists have re-used
containers that were previously used for methadone take-away doses but have not been
adequately cleaned and sanitised before being re-used and/or that tap water has been used to
dilute take-away doses.
These issues relate to professional pharmacy standards rather than regulatory requirements but
DPR offers the following information for consideration.
The use of tap water in diluting methadone take-away doses may be acceptable but pharmacists
should consider the quality of local tap water and the fact that the concentration of preservatives
in Methadone Syrup will also be diluted. Accordingly, the use of tap water for dilution of
methadone take-away doses represents a minor risk that might be elevated if a take-away dose
is not stored appropriately or consumed until several days after preparation.
The risks associated with the use of tap water might be less significant than the provision of
methadone take-away doses in containers that have not been thoroughly cleaned and sanitised.

Have all pharmacists been informed of the need to ensure that containers used YES / No
for take-away doses are not to be re-used for anyone other than the same
patient and then only if they have been thoroughly cleaned and sanitised ?

Have all pharmacists been advised to consider the proposed duration and YES / No
conditions of storage of methadone take-away doses when determining
whether tap water may be used to dilute take-away doses?

Take-away doses of buprenorphine

Subutex® should not be authorised for take-away doses unless the patient is pregnant or
breastfeeding; has a clinically documented allergy to naloxone (or to an excipient in Suboxone®);
or where it is necessary to supply the 0.4 mg tablet to achieve a dose that is less than 2.0 mg.
Where take-away doses of Suboxone® are authorised, the patient should be transferred to
Suboxone® for all doses, including the days when doses are supervised.

Have all pharmacists been informed that the Policy makes no provision for YES / No
routine take-away doses of Subutex® and that take-away doses of Suboxone®
should be limited as indicated other than as indicated above?

A schedule, showing the recommended maximum number of Suboxone® take-away doses

following continuous periods of stability in treatment, is included in Appendix 4 of the Policy.

Less than 2 weeks  No take-away doses

2 weeks to 2 months  Not more than 2 take-away doses per week
2 months to 6 months  Not more than 5 take-away doses per week
More than 6 months  Not more than 6 take-away doses per week

Minimal Supervision Regimens of Suboxone®

A small percentage of very stable, low-risk patients may be considered for provision of
Suboxone® for longer periods than listed under low-level supervision - up to a maximum of 28
days’ supply. Such permits, which will be different to other ORT permits, will generally be issued
 only to Fellows of the Australasian Chapter of Addiction Medicine (FAChAM) or prescribers with
supporting advice from a Fellow.

Suboxone® take-away doses might be packaged and labelled as individual doses OR as

multiple doses with different strengths in different containers. In either case, labelling must be
accurate and unambiguous (see sample labels on the final pages of this document).
Suboxone® Films are to be retained in the manufacturer’s immediate packaging - see page 53 of
the Policy for related information

Take-away doses - labelling

Ad hoc reviews by DPR of labels on containers of take-away doses have revealed that a
significant number of pharmacists failed to label containers in accordance with the Regulations
or the Policy. Extracts from the Policy, showing sample labels for take-away doses have been
included on the final pages of this document.

Have all pharmacists been made aware of the packaging and labelling YES / No
requirements for take-away doses?

Note: Pharmacists should use their professional judgment about the appropriateness of
including other authoritative recommendations, including those contained in the Australian
Pharmaceutical Formulary (APF), which recommends including the warning “Do not inject”.

Irregular dosing
Are all pharmacists aware of the need to inform the prescriber when a patient’s YES / No
attendance becomes irregular – regardless of whether take-away doses have
been authorised?

When not to administer ORT

The symptoms of methadone toxicity are similar to those of alcohol intoxication and may indicate
that a patient has administered other drugs.

Have all pharmacists been informed that ORT is not to be administered if a YES / No
patient appears to be intoxicated?

If a patient has ceased receiving ORT for a period, there is a risk that his/her tolerance to the
drug might have diminished or that he/she has used other drugs. In such cases, the prescriber
should consider reducing the recommencement dose.

Have all pharmacists been informed that neither methadone nor YES / No
buprenorphine is to be administered, without the prescriber’s expressed
authorisation, if a patient has missed doses on four or more consecutive days?
Have all pharmacists been informed that, if a patient recommences ORT after YES / No
having missed doses on four or more consecutive days, safety precautions
should be similar to those that apply when a patient initially commences ORT?
Refer to pages 3 and 4 of this document for details of issues relating to
commencing or recommencing ORT.

Transfers & temporary absences

Deaths associated with ORT have been attributed to multiple dosing (with or without take-away
doses), when patients are transferring between pharmacies. Multiple dosing is more likely if
there is miscommunication or no communication between the two pharmacies involved in the
transfer.
Similarly, when a patient returns to a pharmacy after an absence and dosing resumes on the
basis of a prescription from a previous or new prescriber, the reason for the absence (e.g.
hospital treatment, prison term, illicit drug use) might be known to the prescriber, the pharmacy,
both or neither.
It is not acceptable to make assumptions. To ensure the patient’s safety; precise details of the
magnitude and timing of the most recent dose need to be determined and documented before a
dose is administered. The possibility of take-away doses and/or an interim prescription, which
might have been issued by prison health service provider, should also be considered.

Have all pharmacists been informed that they should always communicate with YES / No
the prescriber (to determine precisely what has transpired) before
administering methadone or buprenorphine to a patient who is returning to your
pharmacy after missing doses on four or more consecutive days?

Have all pharmacists been informed that they should always communicate with YES / No
the previous dosing point (to determine precisely when the previous dose
was given; the magnitude of the actual dose; and whether take-away
doses were provided) before administering methadone or buprenorphine to a
patient transferring to your pharmacy?

Contemporaneous notes
ORT has inherent risks associated with the vulnerability of the patients as well as the potential
toxicity of the drugs – especially methadone. Those risks can be minimised when all pharmacists
are fully aware of key issues relating to the management of a patient but can be heightened if
some pharmacists are not fully aware, which is more likely if aspects of a patient's treatment rely
on what is known by just one pharmacist. Readily retrievable contemporaneous notes, which are
maintained in a consistent manner and location, are needed to address this issue.

Commonly accepted options:

 Contemporaneous notes are recorded in a designated section of each patient’s

attendance records – in a location that is not available for the patient to peruse.
 Contemporaneous notes are recorded in a designated section of each patient’s file or
folder – where the patient cannot peruse them.
 Contemporaneous notes are recorded in a computer file for each patient.
All pharmacists should be aware of the need to make contemporaneous notes of the following:

 Communications with prescribers in relation to variations from the Policy

 Communications with prescribers in relation to dose variations
 Communications with prescribers in relation to proposed & authorised take-away doses
 Communications with prescribers in relation to absences or irregular attendance
 Communications with other pharmacies where transfers are involved and where doses
are to be administered from multiple dosing points
 Communications with DACAS in relation to the receipt of clinical advice
 Communications with prescribers or PAMS in relation to unacceptable behaviour or
suspected diversion of doses
 Communications with DPR in relation to issues of concern, including suspected or
confirmed diversion of doses

Prescribers who have not completed training and assessment

In recognition of the lesser risk of diversion and less complicated pharmacokinetics of
Suboxone® use, any prescriber may prescribe Suboxone® (only) for up to 5 patients without
completing the training or assessment required to prescribe other ORT drugs or formulations.
Prescribers who have not completed training and assessment should seek advice from an
‘approved prescriber’ (preferably in the same practice) or from DACAS before prescribing to a
patient.

Have all pharmacists been made aware of the possibility of Suboxone® YES / No
prescriptions from prescribers who have not completed training and
assessment and who might not be familiar with all aspects of the Policy and
relevant legislation?

Prescribers who have not completed training and assessment may also deputise for an
‘approved prescriber’ to continue the treatment of a stable patient if the following circumstances
are met:
 the deputising prescriber is practising at the same practice as the usual treating
prescriber, and
 the usual treating prescriber holds a current permit, and
 the deputising prescriber is not re-starting treatment of a patient with pharmacotherapy
(including where a patient has missed doses on four or more consecutive days), and
 the duration of the prescription is limited to the expected period of absence of the usual
prescriber, and
 the prescription is endorsed to show that the prescriber is temporarily deputising for the
usual prescriber

Sample labels for take-away doses

Each methadone take-away dose bottle should only contain a single dose of methadone.
The following example includes the key requirements for labelling a methadone take-away
dose of 40 mg daily.

METHADONE SOLUTION containing 40 mg in 200 mL

This bottle contains a single daily dose of methadone to be

taken on 15 June 2016 by John Citizen.

Prepared on 14 June 2016

KEEP OUT OF REACH OF CHILDREN

Pharmacy Name
Address & Phone Number
Pharmacist ID

“This medication may cause drowsiness and may increase

the effects of alcohol. If affected do not drive a motor vehicle
or operate machinery.” (commonly on an ancillary label)

“May cause death or injury if taken by another person”

(on an ancillary label or the main label)

Buprenorphine/naloxone take-away doses may be packaged individually to contain only a

single dose of buprenorphine. The following example includes the key requirements for
labelling a buprenorphine/naloxone take-away dose as a single dose of 22 mg daily.

BUPRENORPHINE/NALOXONE FILM

This container contains a single daily dose of 22 mg of

buprenorphine to be taken by John Citizen. Take the contents
of this container as a single dose dissolved under the tongue
on 15 June 2016.

Prepared on 14 June 2016

KEEP OUT OF REACH OF CHILDREN

Pharmacy Name
 Address & Phone Number
Pharmacist ID

“This medication may cause drowsiness and may increase

the effects of alcohol. If affected do not drive a motor vehicle
or operate machinery.” (commonly on an ancillary label)

“May cause death or injury if taken by another person”

(on an ancillary label or the main label)

***
Alternatively, buprenorphine/naloxone take-away doses may be packaged for multiple days of
unsupervised dosing. However, if the patient is required to take different strengths of
preparation (i.e. a combination of the 2 mg and 8 mg films), the different strengths of films must
be packaged separately. Ensure that the patient is aware of the dosing instructions for both
strengths of film to achieve the correct daily dose of buprenorphine.
The following example includes the key requirements for the labelling of
buprenorphine/naloxone take-away doses of 22 mg daily packaged in two separate containers
for multiple days of unsupervised dosing.

BUPRENORPHINE/NALOXONE FILM 8 BUPRENORPHINE/NALOXONE FILM 2

mg (Qty 6) mg (Qty 9)

Dissolve under the tongue TWO films each
day.
To be taken on 15 June, 16 June and 17
June 2016 by John Citizen.
(Please note: buprenorphine/naloxone 2
mg films are packaged separately)
Prepared on 14 June 2016
KEEP OUT OF REACH OF CHILDREN
Pharmacy Name
Address & Phone Number
Pharmacist ID
“This medication may cause drowsiness
and may increase the effects of alcohol. If
affected do not drive a motor vehicle or
operate machinery.” (commonly on an
ancillary label)
“May cause death or injury if taken by
another person” (on an ancillary label or
the main label)
Dissolve under the tongue THREE films
each day.
To be taken on 15 June, 16 June and 17
June 2016 by John Citizen.
(Please note: buprenorphine/naloxone 8
mg films are packaged separately)
Prepared on 14 June 2016
KEEP OUT OF REACH OF CHILDREN
Pharmacy Name
Address & Phone Number
Pharmacist ID
“This medication may cause drowsiness
and may increase the effects of alcohol. If
affected do not drive a motor vehicle or
operate machinery.” (commonly on an
ancillary label)
“May cause death or injury if taken by
another person” (on an ancillary label or
the main label)
For information relating to induction, education and program
development
Department of Health & Human Services (DHHS)
Harm Reduction and Pharmacotherapy Services
Maureen Chesler
Pharmacotherapy Development Officer
GPO Box 4057
Melbourne 3001

Phone: 03 9096 5057

Mobile: 0418 221 452
Fax: 03 9096 9170
Email: maureen.chesler@dhhs.vic.gov.au

For further information relating to matters of compliance

Department of Health & Human Services (DHHS)
Drugs and Poisons Regulation
GPO Box 4057
Melbourne 3001

Tel: 1300 364 545

Fax: 1300 360 830
Email: dpcs@dhhs.vic.gov.au
Web: www2.health.vic.gov.au/dpcs

To receive this publication in an accessible format contact Drugs and Poisons Regulation on 1300 364
545. Authorised and published by the Victorian Government, 1 Treasury Place, Melbourne.
Appendix 5

Withdrawal Vs Intoxication/overdose

It is very important when pharmacists are dosing pharmacotherapy to be able to identify if a patient
is withdrawing from an opioid OR if their dose is too high, they have other opioids on board, or if
they are using poly substances. This is especially important if they are just starting on a
pharmacotherapy program as this is when they are at highest risk of overdosing.

See the below table to help distinguish between the signs of withdrawal and intoxication/overdose if
this is not usual behaviour for the patient. Not all of these signs and symptoms need to be present. If
unsure withhold dose and contact the prescriber.

Signs of withdrawal Signs of intoxication/overdose

Anxiety Drowsiness

Muscle tension Nausea and vomiting

Muscle and bone ache Shallow breathing

Muscle cramp Pinpoint pupils (pupil constriction)

Sleep disturbance Hypotension

Hot and cold flushes Dizziness

Yawning Slowed or slurred speech

Lacrimation Unsteady gait

Rhinorrhoea Confused state

Abdominal cramps Disinhibition

Nausea and vomiting Drooling

Diarrhoea Itching or scratching

Palpitations Hypoventilation

Dilated pupils
Opioid Management

Pharmacist mentoring
The opioid management team provides a pharmacist mentoring service for pharmacists
across the Barwon and South West region that would like support in opioid management
including opioid replacement therapy (ORT). This service is available to pharmacists new to
the area of ORT or established services wanting additional advice and support.
The pharmacy mentoring service can offer advice and support with:

 Starting an ORT program in your  Starting patients new to ORT

pharmacy
 Signs of overdose
 Suspected diversion
 What to do if a patient has vomited
their dose
 Managing intoxicated patients
 Communicating with patients
 Missed doses
 Temporary transfers and holidays
 Supervision of doses
 Signs of withdrawal
 Irregular attendance
 Safety and dosing in pregnancy &
breastfeeding
 Split doses
 Switching therapies
 Prison transfers
 Acute pain
 Managing OTC codeine

Accessing mentoring
Mentoring can be provided by telephone, email or pharmacy visit depending on the level
required. Access mentoring by contacting:
Pene Wood, Clinical Advisor: pene.wood@westvicphn.com.au 5222 0809

For further opioid management information:

Specialist opioid management support and advice contacts

Geelong Office: 5222 0800 Warrnambool Office: 5564 5888

Dr Mark Davies Amy Collins:

mark.davies@westvicphn.com.au amy.collins@westvicphn.com.au
Rob Kenna:
rob.kenna@westvicphn.com.au

Not sure who to contact? All opioid management team members will be able to assist or
connect you to the most appropriate team member.
Opioid Management
HealthPathways
HealthPathways is a clinical tool that enables GPs, specialists and other health professionals
to meet and work through medical and health issues that are important for our local area.
These are accessible via an online information portal. HealthPathways is designed to be
used at the point of care and provides information on how to assess and manage medical
conditions and health problems, and how to refer patients to local specialists and services in
the timeliest way.
Available Pathways
The opioid management team has worked alongside the Western Victoria Primary Health
Network HealthPathways team and various subject matter experts in developing pathways
relevant to opioid dependence, pain management and opioid replacement prescribing and
dispensing, these include:

 Opioid dependence  Opioid replacement

pharmacotherapy
 Prescribing naloxone  Chronic Pain
 Medications in chronic pain  Referral for pain management
services
 Opioid Pharmacotherapy  Combination Analgesics Containing
Dispensing - Information for Codeine Dependence
Pharmacists  Prescription shopping
 Patient Requests for Combination
Analgesics Containing Codeine
(CACC)

Who Can Use The HealthPathways Portal?

Only GPs, Pharmacists and other health practitioners can access HealthPathways. The
portal is not designed to be used by patients or general community members. Access to the
portal is by using a secure login and password.

https://westvic.healthpathways.org.au
Login: westvic
Password: p4thways

For further opioid management information:

Specialist opioid management support and advice contacts

Geelong Office: 5222 0800 Warrnambool Office: 5564 5888

Pene Wood: Amy Collins:

pene.wood@westvicphn.com.au amy.collins@westvicphn.com.au

Dr Mark Davies Rob Kenna:

mark.davies@westvicphn.com.au rob.kenna@westvicphn.com.au

Not sure who to contact? All opioid management team members will be able to assist or
connect you to the most appropriate team member.

Daily
Queue
See a list of patients due to
dose each day. Select and dose
in a few clicks.
Records all details and
automatically applies any
pre-loaded discounts.
Prescripti
ons
Checks the script is current, with
automatic alerts before expiry.
Photo storage of scripts for added
confidence and convenience.
Reporting
Generates and instantly emails
health department and other
reports from stored data, covering:
Stock levels, Patient details,
Doctors, Dosage history including
missed dosages, Payments.
Ensures security with photo ID or
fingerprint ID of script-holders.
A digital signature pad is also
available.
Print takeaway labels on your
existing dispensary label printer.
EasyDose will save you and your
staff time in dosing, recording,
dispensing and client
management.
Every staff member has their own EasyDose log in, so it’s
easy to keep track of every transaction by date, time,
patient, dose, doctor and more.

Fast, intuitive, simple and secure, EasyDose can be quickly

and easily downloaded and installed on any PC running
Windows 7 to 10.

Contextual online help means you can introduce

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Every effort has been made to present all information accurately. Penington Institute accepts no liability for, and does not indemnify against, any loss or damage that may result from
any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
 COMMUNITY OVERDOSE PREVENTION AND EDUCATION (COPE) | INFORMATION SHEET
64

Every effort has been made to present all information accurately. Penington Institute accepts no liability for, and does not indemnify against, any loss or damage that may result from
any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
 COMMUNITY OVERDOSE PREVENTION AND EDUCATION (COPE) | INFORMATION SHEET
65

Every effort has been made to present all information accurately. Penington Institute accepts no liability for, and does not indemnify against, any loss or damage that may result from
any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
 C PE

Establishing COPE in Victoria loved ones. Agencies who are considering

implementing COPE are advised to engage
The establishment of COPE has been and collaborate with other local healthcare
overseen by a high-level Reference providers, including pharmacists.
Group and a Clinical Sub-Group with As a result, pharmacies may be approached
representation from a range of peak by local service providers, including GPs,
bodies and organisations to develop requesting them to stock naloxone in order
for them to refer people to pharmacies to
training, information and an opioid
have naloxone prescriptions filled after the
overdose response plan for people at person has received naloxone training on how
risk of overdose and potential to recognise and respond to overdose
overdose witnesses. The Pharmacy including the administration of naloxone.
Guild, Victoria Branch and the
Alternatively, pharmacists may
Pharmaceutical Society of Australia,
decide to implement COPE on their
Victoria were represented on the
own, particularly if they already
groups.
deal with individuals who are
COPE encourages the collaboration of many deemed to be “at risk”, such as
organisations and services (including GPs and people on pharmacotherapy or
pharmacists) working with people who are at
risk of overdose and other potential overdose
those on prescription opioids for
witnesses such as their families, friends and chronic pain

Verification of naloxone training

training
It is recommended that all services not prohibit an individual from patients. Making the option of
delivering naloxone training provide obtaining a naloxone prescription naloxone prescription available is
or having it filled.
all individuals with a “Verification of adding to and enhancing the
Overdose deaths can and do
naloxone Training” card or the like involve methadone, and, within overall pharmacotherapy
upon completion of training. This will the “Victorian Policy for program in Victoria.
allow pharmacists to identify maintenance pharmacotherapy for Furthermore, pharmacotherapy
individuals who have been trained in opioid dependence”, it is a patients may have partners, family
COPE. requirement of pharmacotherapy or friends who still use opioids and
providers (both prescribers and wish to be prepared in the event
However, an absence of dispensers) that overdose risk that an overdose occurs.
“Verification of naloxone avoidance is discussed with
Training” written advice should

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any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
 Naloxone priority groups and risk factors for opioid overdose
» are on any opioid prescription and have
With proper education, patients on long-term known or suspected:
opioid therapy and others at risk for overdose may • smoking history, Chronic Obstructive
benefit from having a naloxone prescription to use
in the event of an overdose. Pulmonary Disease (COPD),
emphysema, asthma, sleep apnoea or
other respiratory system disease;
Patients who may be considered as “high • renal or hepatic disease;
risk” for opioid overdose include those who:
• alcohol use;
» have had recent medical care for opioid • concurrent benzodiazepine use;
poisoning/intoxication/overdose; and/or
» have a suspected or confirmed history of • concurrent antidepressant
heroin or non-medical opioid use; prescription.
» are at high risk for overdose because of a
legitimate medical need for analgesia,
It also may be advisable to suggest that the atrisk
coupled with a suspected or confirmed
patient create an “overdose plan” to share with
history of substance abuse, dependence or friends, partners and/or caregivers. Such a plan
non-medical use of prescription or illicit would contain information on the signs of
opioids; overdose, how to respond to overdose including
administering naloxone, providing emergency
» are being prescribed high doses of opioids care (for example, by calling 000) and where the
for long-term management of chronic patient plans to store their naloxone so it can
easily be found in the case of an emergency.
malignant or non-malignant pain
(≥100 mg/day morphine equivalence);
» have recently been released from prison;
» have been recently released from drug
withdrawal or rehabilitation program; Opioid dependence can be diagnosed by
considering the well-established criteria
» are being inducted onto a methadone or (DSM V).
buprenorphine maintenance program (for
Please see box on the following page:
addiction or pain);

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Every effort has been made to present all information accurately. Penington Institute accepts no liability for, and does not indemnify against, any loss or damage that may result from
any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
 The Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-V) defines
opioid use disorder as a problematic pattern of opioid use leading to clinically significant
impairment or distress, as manifested by at least two of the following, occurring within a 12-
month period:

» Taking larger amounts of opioids or taking opioids over a longer period than was intended

» Experiencing a persistent desire for the opioid or engaging in unsuccessful efforts to cut
down or control opioid use.

» Spending a great deal of time in activities necessary to obtain, use or recover from the
effects of the opioid.

» Craving, or a strong desire or urge to use opioids.

» Using opioids in a fashion that results in a failure to fulfil major role obligations at work,
school, or home.

» Continuing to use opioids despite experiencing persistent or recurrent social or

interpersonal problems caused or exacerbated by the effects of opioids.

» Giving up or reducing important social, occupational, or recreational activities because of

opioid use.

» Continuing to use opioids in situations in which it is physically hazardous.

» Continuing to use opioids despite knowledge of having persistent or recurrent physical or

psychological problems that are likely to have been caused or exacerbated by the
substance.

» Tolerance, as defined by either a need for markedly increased amounts of opioids to

achieve intoxications or desired effect, or a markedly diminished effect with continued
use of the same amount of an opioid.

» Withdrawal, as manifested by either the characteristic opioid withdrawal syndrome, or

taking opioids to relieve or avoid withdrawal symptoms.
Tolerance and withdrawal criteria are not considered to be met for individuals taking opioids
solely under appropriate medical supervision. Opioid use disorder can be classified by severity
as mild, moderate, or severe
Source: American Psychiatric Association. (2013). Diagnostic Statistical Manual of Mental Disorders
(5th ed.) Arlington, VA: American Psychiatric Publishing.

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Every effort has been made to present all information accurately. Penington Institute accepts no liability for, and does not indemnify against, any loss or damage that may result from
any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
Patient information sheets
Two information sheets are available to provide to patients. They are a fact
sheet entitled “Recognising and responding to an opioid overdose including the
administration of naloxone” and a one-page pictorial opioid overdose response
plan that can be printed off and provided to patients by GPs when prescribing
naloxone and/or by the pharmacist upon dispensing a naloxone script.

Product patient Information is available at:

http://www.medicines.org.uk/emc/medicine/4937/PIL/

Useful information and contacts

COPE Program at Penington Institute – 03 9650 0699
Directline – 1800 888 236 Metro; 1800 858 584 Rural

Drugs & Poisons Controls in Victoria – 1300 364 545, including links to
Victorian policy on maintenance pharmacotherapy for opioid dependence
and training programs for prescribers and dispensers
– http://www.health.vic.gov.au/dpcs/pharm.htm; for health practitioners

Drug and Alcohol Clinical Advisory Service (DACAS) – 1800 812 804;
http://www.dacas.org.au/

COMMUNITY OVERDOSE PREVENTION AND EDUCATION (COPE) | INFORMATION SHEET

69

Every effort has been made to present all information accurately. Penington Institute accepts no liability for, and does not indemnify against, any loss or damage that may result from
any actions taken based on the information contained in this document. Copyright © 2014 Penington Institute
 Needle and Syringe Program (NSP)
Steps for establishing an authorised program

1. Before any formal processes begin, your organisation is asked to undertake some
internal consultation and planning with staff and management to:
o consider your organisation’s values and how the NSP fits with these;
o consider the client groups associated with your organisation and what impact
(both negative and positive) a NSP may have on these client groups; and
o identify staffing and organisational resources for long-term support of the
program.
If you have not already done so, it is recommended that you to contact and visit
other NSPs to gain a full understanding of the day-to-day operation of NSP services,
the various models of service delivery and the benefits.
2. To ensure your organisation is successful in the establishment and ongoing operation
of a NSP, it is important to identify and address any concerns of local stakeholders
through stakeholder consultation. This consultation process should occur
irrespective of the zoning of the area (i.e., residential, commercial, etc.).
o First and foremost, we recommend that you discuss your intentions with, and
confirm support from, local government and police. There may be local
government planning and permit requirements to be met and it is always
advisable to maintain good relations with local police.
o Consultation should then be conducted with other stakeholders as
appropriate. This might include nearby service providers and traders,
residents or community groups. The aim is not to seek permission, but to
ensure that concerns are addressed at the outset. This includes valid
concerns as well as those arising from misconceptions or misinformation
about the NSP, its purpose and function, and its clients.
A word of caution: the right balance must be found between consulting
stakeholders in close proximity or with a clear interest and unnecessarily
raising concern by casting the net too wide.
3. Complete an Application for Registration form, providing:
o the name, address and operating hours of the site where the NSP will operate
(please complete a separate application form for each site to be established);
o in the case of outreach services, the local government areas to be covered;
and
o details on the stakeholder consultation(s) undertaken.
4. Along with your application, a letter of support from the management/board of the
organisation needs to be submitted.
5. Harm Reduction and Pharmacotherapy Services will assess the application for
registration and process an authorisation via Order in Council* on the
recommendation of the Minister for Mental Health.
6. New authorisation details take affect at the time they are published in the Victorian
Government Gazette. Your organisation will be authorised to provide NSP services as
managed by the Department of Health from this date.
7. Once authorisation is granted, written confirmation will be sent to your organisation,
along with relevant operational instructions.

See over for information on who can help...

* The Drugs, Poisons and Controlled Substances Act 1981 provides the legislative basis for NSPs. It is an offence under
Section 80 of the Act, which deals with the offence of aiding and abetting the administration of a prohibited
substance, to distribute needles and syringes without authorisation. Individuals and organisations are exempt from
prosecution under the act if authorised by Order in Council.
Sept 2011 Enquiries: 1300 365 482
 Who can help?

The Association for Prevention and Harm Reduction

Programs Australia (Anex)
Anex is the peak body representing NSP services and advocating for
the NSP sector. It is highly recommended that you contact Anex for:
 Help organising visits to other NSP sites.
 Guidance on strategies to gain management/board support.
 Advice and assistance with stakeholder consultations.
Phone 9486 6399
Email info@anex.org.au
Further information on Anex can be found at www.anex.org.au.

Department of Health
Harm Reduction and Pharmacotherapy Services (HRPS)
HRPS officers can assist you throughout the registration process and
provide advice on the Victorian NSP and other harm reduction initiatives.
NSP HelpLine 1300 365 482

Regional Departmental
Alcohol and Other Drug (AOD) Coordinators
AOD Coordinators can provide advice and assistance with local and
regional information on a range of alcohol and drug issues.

DHS Region Contact Phone

Barwon South West Mary Spencer 5226 4661
Eastern Metropolitan Cathy Keenan 9843 1708
Kerri Scanlan 5177 2601
Gippsland
Abby Gannon 5177 2576
Grampians Allison Doodt 5333 6033
Hume Sheila Burns 5722 0612
Loddon-Mallee Region Anne Ketterer 5434 5536
Bernadette Lane 9412 5407
North & West Metropolitan
Amanda Soogun 9412 5440
Southern Metropolitan Elzbieta Zorska 8710 2821

Sept 2011 Enquiries: 1300 365 482

Needle & Syringe Program (NSP)
DRUGS, POISONS AND CONTROLLED SUBSTANCES ACT 1981
AUTHORITY TO SELL OR SUPPLY HYPODERMIC NEEDLES AND SYRINGES

APPLICATION FOR REGISTRATION

The legislative basis for NSP operations in Victoria is provided in the Drugs, Poisons and Controlled
Substances Act 1981. Distribution of needles and syringes without authorisation may result in
prosecution under Section 80 of the Act, which deals with the offence of aiding and abetting.

Under this legislation, pharmacists and pharmacy staff are permitted to sell or supply needles and
syringes. All other agents or agencies must be authorised by Order in Council.

Applications to register and operate a new NSP service are processed by Harm Reduction and
Pharmacotherapy Services. Applications from organisations not currently authorised by Order in
Council must be submitted to Governor in Council on the recommendation of the Minister for
Mental Health.

Please refer to the Steps for Establishing a Needle & Syringe Program before proceeding
with this application.

ORGANISATION DETAILS
Organisation Name

Location of proposed NSP operation

Please complete a separate form for each site to be registered

Site Name:

Address:

Suburb/Town/Locality: Postcode:

Phone: Fax:

Email:

Website:

Local Government Area (LGA)/Local Council:

REGISTRATION CONTACT PERSON

Harm Reduction and Pharmacotherapy Services will liaise with the following person regarding this
Application for Registration.

First Name: Surname:

Telephone No.: Mobile:

Email Address:
SERVICE/S
Agency Listing* (please tick)

Public Private

* Public NSP is open to the general public and may be identified as such to the public through information
services such as DirectLine. Private NSP is only available to formal clients of the host agency.
Under the Act, it is a requirement that a full list of authorised NSP providers be publicly available. For further
information, please contact Harm Reduction and Pharmacotherapy Services on 1300 365 482.

Service type/s* (please tick all that apply)

Fixed site - staffed

Fixed site – client self serve

x Offsite (mobile/outreach) – vehicle (please advise areas to be covered below)

x Offsite (mobile/outreach) – foot patrol (please advise areas to be covered below)

* For further information service delivery models, please contact Harm Reduction and Pharmacotherapy
Services on 1300 365 482.

Local Government Areas (LGAs) to be covered by offsite operation

Hours of operation
Fixed site service:

Offsite service:

ADDRESS & PHONE DETAILS

Postal Address
Same as site address

Address:

Suburb/Town/Locality: Postcode:

Delivery Address for NSP stock

Same as site address Same as postal address

Address:

Suburb/Town/Locality: Postcode:
CONTACTS
Please provide the main contacts for your proposed NSP

NSP Coordinator (required)

This will be the person responsible for the overall operation of the proposed NSP.

First Name: Surname:

Telephone No.: Mobile:

Email Address:

Other applicable NSP

NSP Orders Outreach worker
role/s

NSP Orders (required)

This will be the person responsible for ordering consumables for your proposed NSP. All
consumable and resource order forms will display this person’s name and deliveries will be
marked for the attention of this person.
Same as NSP Coordinator

First Name: Surname:

Telephone No.: Mobile:

Email Address:

Other applicable NSP

Outreach worker Other:
role/s

Other contacts

First Name: Surname:

Telephone No.: Mobile:

Email Address:

NSP Outreach
Role Receptionist Admin officer
Worker Worker+

First Name: Surname:

Telephone No.: Mobile:

Email Address:

NSP Outreach
Role Receptionist Admin officer
Worker Worker+

First Name: Surname:

Telephone No.: Mobile:

Email Address:

NSP Outreach
Role Receptionist Admin officer
Worker Worker+
+
Please ensure a mobile number is provided for outreach worker staff.

If there are other contact people, please attach a separate sheet.

Further contact list attached

ENDORSEMENTS AND SUPPORT
Pre-registration steps undertaken

Internal consultation and planning undertaken

Local government and police support confirmed

Stakeholder consultation conducted as appropriate* (Please provide further detail below)

Letter of support from management/board obtained* (Please attach)

* All applications must indicate appropriate stakeholder consultation AND the support of management/board
before an application can proceed. Please refer to Steps for Establishing a Needle & Syringe Program for
further information, or contact Harm Reduction and Pharmacotherapy Services on 1300 365 482.

Stakeholder consultation
Please detail what stakeholder consultation has taken place regarding your proposed NSP
service.

Coordinator’s signature

Date

Completed forms are to be submitted to:

NSP Registrations, Harm Reduction and Pharmacotherapy
Services
PO Box 4541, Melbourne 3001
Fax*: 9096 9170
*Please send original in the mail as well.

All enquiries regarding registrations can be directed to:

Harm Reduction and Pharmacotherapy Services
1300 365 482