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ELECTRONIC RECORDING AND REPORTING OF CONTROLLED DRUGS
CONSULTATION PAPER
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PURPOSE OF CONSULTATION
The Commonwealth Department of Health and Ageing (the Department) and the Pharmacy
Guild of Australia (the Pharmacy Guild) are inviting submissions from interested parties to
assist in the development of the Electronic Recording and Reporting of Controlled Drugs
(ERRCD) initiative as part of the Fifth Community Pharmacy Agreement (Fifth Agreement).
This paper provides information on the scope and context of the initiative to assist in
informing submissions. Submissions may comment on any matters relevant to the initiative
and are not limited to issues canvassed in this paper.
Questions relating to the development of the ERRCD initiative are presented on pages 7 – 8
to stimulate initial thinking. Input is welcome on these questions as well as any other
relevant issues of interest.
CONTEXT
The Australian community has an expectation that therapeutic goods are safe and of high
quality, to a standard equal to that of comparable countries. The objective of the Therapeutic
Goods Act 1989 is to provide a national framework for the regulation of therapeutic goods in
Australia, so as to ensure their quality, safety, efficacy and timely availability.
Scheduling is a national classification system that controls how medicines and chemicals are
made available to the public. Medicines and chemicals are classified into Schedules
according to the level of regulatory control over the availability of the medicine or chemical,
required to protect public health and safety. This classification process takes into account a
substance's toxicity profile, pattern of use, indications, product formulation and dosage,
potential for abuse and need for access.
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is established
under Section 52D of the Therapeutic Goods Act 1989, and is the document through which a
uniform national approach to medicine availability, labelling and packaging is achieved. The
SUSMP is given legal effect through state and territory legislation.
Controlled drugs are those drugs listed in ‘Schedule 8’ of the SUSMP. Schedule 8 contains a
list of those substances which should be available for use but require restriction of
manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or
psychological dependence.
State and territory legislation also requires that Controlled Drugs Registers (Dangerous Drugs
Registers or “DD Books”) are kept and maintained for the receipt and supply of Controlled
(Schedule 8) Drugs. Currently, these registers are manually recorded and maintained within
the pharmacy and, in most jurisdictions, copies of the prescriptions are sent to State and
Territory Health Departments at regular intervals. The registers must be available for
inspection by State and Territory Health Departments and police.
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The mandatory recording and reporting of the storage and supply of Controlled Drugs is
intended to complement and support the suite of controls on access to scheduled substances.
At the pre-retail level it is mainly directed at minimising diversion and assisting in quality
assurance.
It is important, from the public health, safety and patient care perspectives, that the
opportunity for abuse/misuse of Controlled Drugs such as opioid pain relievers is minimised.
This includes chronic use by those who have developed addictions, illicit ‘recreational’ use,
and those engaged in diversion of these medicines to the black market. In the absence of
effective reporting and monitoring systems, individuals abusing/misusing Controlled Drugs
are potentially able to ‘doctor-shop’ and ‘pharmacy-shop’ to procure these medicines. This is
because, in most cases, a health professional has limited information regarding what
medicines have been obtained elsewhere. In an effort to minimise risk to patients and the
public, a variety of health bodies continue to call for real-time, confidential, integrated
electronic systems to record, report and monitor the prescribing and supply of these
medicines.
The Royal Australasian College of Physicians (RACP) in its Prescription Opioid Policy1
notes there are increasing concerns regarding problematic and/or unsanctioned use of
prescription and over-the-counter opioids. In some parts of Australia, prescription opioids
are the main opioid used illicitly, reflecting scarcity of heroin, poor regulatory control of
pharmaceutical opioids and/or inadequate provision of treatment for dependent opioid users.
Illicit use of pharmaceutical opioids entails risks of overdose, adverse events from injecting
pharmaceutical drugs and blood borne virus transmission. To address these issues the RACP
recommends a web-based, confidential real-time management system to enable prescribing
doctors and dispensing pharmacists to monitor prescriptions for Controlled Drugs.
Consistent with this, the National Pain Strategy2, which was the final outcome of the
National Pain Summit of March 2010, included the development of a real-time monitoring
and auditing system for opioid prescriptions and codeine containing medicines as one of its
‘high priority’ strategic actions. This broad approach has also received support from affected
parts of the medicines industry.
DESCRIPTION
The ERRCD initiative is one of a number of professional programs to be implemented under
the Fifth Agreement. A system will be implemented to collect and report data relating to
Controlled Drugs to help address problems of forgery, abuse and doctor shopping. Initially,
the system will be designed for state and territory monitoring purposes only, with the
capacity for utilising the data collected for intervention purposes in the future.
The integrity of the system is vital to ensure it does not present a barrier to access, and
balances the needs of legitimate users of Controlled Drugs. In latter stages of the initiative,
access to the database could potentially be widened to include prescribers and pharmacists.
Consumer consent, privacy concerns and links to electronic health records will be important
considerations of program development.
1 See RACP
http://www.racp.edu.au/page/policy-and-advocacy/public-health-and-social-policy
2 See National Pain Strategy
http://www.painsummit.org.au/
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The initiative will be have a two-phased approach:
Phase 1: Electronic recording of Controlled Drugs to act as a register process along with
electronic reporting to State and Territory Health Departments.
Definition: Establishment of an electronic system to enable nationally consistent recording
and reporting of Controlled Drugs in all states and territories. This will assist
State and Territory Health Departments to undertake their current monitoring of
Controlled Drugs. Wherever possible this system will be designed to interface
with any existing State or Territory Health Department monitoring and reporting
systems. The system will enable real-time, secure reporting of Controlled Drugs
within each jurisdiction. It is envisaged that the system will be designed with the
capacity to allow monitoring of Controlled Drugs across states and territories in
the future.
Key Points:
• Currently it is a legislative requirement to record all stock movements for Controlled
Drugs (including receipt from supplier), balances and reconciliation of Controlled Drugs
including in section 90 (community) and section 94 (public hospital and private hospital)
pharmacies. The automatic recording of Controlled Drugs in an electronic register
already occurs in some states and territories.
• The development of a system to seamlessly interface with existing dispensing software
will enable real-time reporting of Controlled Drugs within jurisdictions. This will assist
states and territories to monitor the prescribing and dispensing of these medications, as
required by legislation.
• In those states and territories that do not yet have an electronic register, the system will
provide this, assisting pharmacists to more easily meet their statutory obligations to
maintain records of Controlled Drugs. The electronic register will also assist in
identifying errors or omissions.
• The electronic system will be accessible in real-time by State and Territory Health
Departments. This would assist State and Territory Controlled Drugs Units to monitor
misuse/abuse of Controlled Drugs and to track the movements of Controlled Drugs
within their jurisdictions.
• The system will allow notification to pharmacies of stolen prescription stationery,
cancelled prescriptions, expired authorisations, and prescribers with limited prescribing
rights. This functionality would be further enhanced in Phase 2 by allowing real-time
alerts.
Phase 2: Prescriber Real-Time Monitoring and Pharmacy Real-Time Monitoring
Definition: A real-time electronic decision support tool for prescribers of Controlled Drugs,
where the prescriber is able to voluntarily access a secure database to view the
dispensing history for patients.
A mandatory, real-time, electronic decision support tool for all community,
public hospital and private hospital pharmacies when dispensing Controlled
Drugs. The system would provide the pharmacist with real-time information
from a database regarding previous dispensing episodes.
Key points:
• The system will automatically create an audit trail for all records viewed, without the
need for prescribers and pharmacists to record details.
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• A real-time electronic decision support tool will assist the pharmacist to confirm the
authenticity and patient history when presented with a prescription for a Controlled
Drug.
• The system will be integrated into all prescribing and dispensing software packages.
Current technology available in pharmacies will allow the system to operate in all
dispensary software packages without major modifications to current dispensing
software programs.
NOTE: Phase 1 will be developed with the capacity to add on the features of Phase 2.
Funding under the Fifth Agreement is limited to the development and implementation of
Phase 1. If possible, Phase 2 will be implemented following the successful implementation
of Phase 1.
OBJECTIVES
This initiative will initially focus on the development and implementation of Phase 1,
outlined above. The system could, in the future, be expanded to allow access of information
between jurisdictions and/or to include other medicines prone to misuse/abuse. For example,
in the Australian Capital Territory (ACT), the Voluntary Undertaking – Protocol for
Management for Benzodiazepines is a voluntary agreement entered into by a patient with
their doctor. As part of this agreement the patient agrees to attend only one identified doctor
or practice to receive their prescriptions for benzodiazepines and to attend only one identified
pharmacy to have their prescriptions for benzodiazepines dispensed. The ACT Health
Department sends (via facsimile) a list of these voluntary undertakings to all pharmacies in
the ACT and the pharmacy makes a note in the patient’s file. This cumbersome system may
benefit from a real-time online management system; however, it is not in the scope of this
Fifth Agreement initiative.
This initiative will be consistent with a range of policies relating to Controlled Drugs, such
as, but not limited to:
• Various State and Territory Legislation regarding Controlled Drugs;
• National Medicines Policy 2000;
• National Pharmaceutical Drug Misuse Strategy;
• RACP’s Prescription Opioid Policy;
• National E-Health Transition Authority (NEHTA) standards for electronic transmission
of prescriptions; and
• Quality Use of Medicines (QUM).
BACKGROUND
The five year Fifth Agreement between the Australian Government and the Pharmacy Guild
of Australia commenced on 1 July 2010. It recognises the integral part that is played by
community pharmacy in primary health care.
The Fifth Agreement includes $5 million to develop a system to collect and report data
relating to Controlled Drugs (Schedule 8) to address the problems of forgery, abuse and
doctor shopping.
Current controls for Controlled Drugs are set out in relevant state and territory medicines
legislation. Common across all jurisdictions is a requirement of the pharmacist to record the
receipt and supply of all Controlled Drugs and some notifiable medicines in a manually
maintained register. Some jurisdictions have extended this requirement to apply to some
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Schedule 4 medicines, for example alprazolam in Tasmania. The Controlled Drugs register
includes the quantity, strength and balance of each Controlled Drug, the patient name and
address and prescriber details as well as date of supply and prescription number. The
Controlled Drugs register must be available for inspection by the state or territory’s chief
pharmacist or equivalent officer. In addition to this, jurisdictions require regular reporting of
all supplies by the pharmacy to the State or Territory Health Department. The monitoring of
compliance by these authorities, and the investigation of issues such as inappropriate use of
Controlled Drugs, prescribing by more than one doctor/practice to a patient and escalating
doses are all significantly dependent on the receipt of dispensing reports from pharmacies.
Manual recording and non-real time reporting mechanisms slow this process down and are
open to errors and omissions.
A move from manual to electronic recording and then to real-time electronic reporting will
increase the capacity to not only monitor the prescribing of these medicines but to ensure
appropriate prescribing. Real-time access to accurate dispensing information will increase
the capacity of State and Territory Health Departments to identify potential problems and to
make clinically significant interventions to promote best practice and improve public health
outcomes. When data is analysed up to 6 to 8 weeks after an event, as may currently occur in
some jurisdictions, the clinical significance of the intervention is compromised. The best
time for intervention is when a prescriber is about to write a prescription or a pharmacist is
about to dispense a Controlled Drug.
The ERRCD initiative will be implemented from 1 July 2012.
CONSULTATION PROCESS
The implementation of the ERRCD initiative will affect a wide range of stakeholders,
organisations and individuals. The translation of this initiative into practice must align with,
and maintain, the quality use of medicines principles.
This consultation paper is designed to stimulate thinking around the processes, tools,
guidelines and communication required to implement this change. The consultation process
will involve written submissions and meetings with affected organisations and representative
bodies. All stakeholders are encouraged to provide written submissions, including references
to standards, guidelines and legislation where appropriate.
Effective public consultation is important in ensuring comprehensive and informed decisions
are made in the development of this initiative. A range of issues and questions are provided
below. All stakeholders are encouraged to respond to these issues, and also to raise and
respond to any other issues which have not already been identified.
CONTENT OF SUBMISSIONS
Written comment is sought from stakeholders, including prescribers, pharmacists and consumer
groups.
Your submissions should include:
• name and full contact details (including email address), company name (where applicable)
and position (if applicable);
• comment on the questions set on pages 7 – 8 of the Consultation Paper;
• any other relevant information (for example technical, economic or business information, or
research based evidence supporting the view being expressed); and
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• identification and discussion of any perceived omissions in the Consultation Paper or
alternative approaches.
Submissions close at 5pm on Monday 4 April 2011.
CONFIDENTIALITY OF SUBMISSIONS
The Department of Health and Ageing may share the content of your submission with
relevant Government Departments, Government Agencies and the Pharmacy Guild of
Australia to inform the development of the initiatives funded as part of the Fifth Agreement.
If you wish any information contained in your submission to be treated as confidential please
clearly identify such information, and outline the reasons why the information should be
treated confidentially. Note that general disclaimers in covering emails will not be
interpreted as specific requests for submissions to be treated confidentially. The Department
will, however, use its best endeavours to ensure that any information identified as sensitive is
treated in confidence.
In addition, where submissions focus on issues specifically relevant to state and territory
governments, this information may be forwarded to the relevant jurisdiction(s) to inform
jurisdictional consideration of issues relating to the implementation of these programs.
ADDRESS FOR SUBMISSIONS
Submissions can be emailed to
[email protected] or sent by post to:
Governance and Strategic Co-ordination Section
Department of Health and Ageing
MDP 901
GPO Box 9848
Canberra ACT 2601
QUESTIONS RELATING TO SUBMISSIONS
Any comments or questions about the consultation process should be directed to (02) 6289 9232
or
[email protected]
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ELECTRONIC RECORDING AND REPORTING OF CONTROLLED DRUGS
CONSULTATION
SUBMISSION INFORMATION
NAME / COMPANY /ORGANISATION:
ADDRESS :
CONTACT INFORMATION: (BH)
(EMAIL)
ISSUES FOR DISCUSSION
Stakeholders are invited to provide comment on the following issues:
1. State and territory legislation requires that the receipt and supply of Controlled Drugs
(including quantities of medicine supplied and personal patient information) is recorded
and maintained in the Controlled Drugs Register. There may be differences across the
jurisdictions in regard to the specific information that must be recorded. For example, in
Queensland, date of birth is recorded.
a. What mandatory information is collected in your state or territory?
b. What mandatory information should be consistently collected by all states and
territories to ensure the usefulness of the data in reducing the problems of forgery,
abuse and doctor shopping of Controlled Drugs?
c. What additional information would you deem useful to record?
d. At later stages of program development, data may be able to be accessed across
jurisdictions. In this instance, should only the mandatory data be able to be
accessed by authorised persons of other jurisdictions?
2. Guidelines will be developed to assist pharmacists in determining the need for
intervention when a client presents who is identified by the electronic system as meeting
the requirements to decline supply of a Controlled Drug.
a. Are there any requirements that you consider to be important in developing
guidelines for pharmacists?
3. The ERRCD software system (to be developed) will ensure that any data recorded in a
dispensing event is encrypted securely to protect patient privacy. Initially, the data will
be automatically inputted during a dispensing event and only the relevant State and
Territory Health Department and the police will be able to inspect the recorded
information, as currently occurs. In the future, accessibility to this information may be
expanded to other relevant, authorised persons such as prescribers and pharmacists.
a. Are there any other relevant health care providers who should be authorised to
access this information and, why?
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b. Should all pharmacists, prescribers and health departments be able to access the
information recorded by other states and territories?
c. Where should the recorded information be stored?
4. Evidence into practice and policy is one of the five priority areas currently being
implemented by the National Medicines Policy advisory structure. In this context,
activity is currently being undertaken to identify specific action areas to address issues
relating to opioid analgesics (one of the identified current evidence practice gaps in
medicines use). Data collected by the electronic register could potentially be used to
inform future policy decisions such as identifying areas where there may be gaps in the
prescribing practice of Controlled Drugs for licit purposes.
a. Should recorded (deidentified) data be made accessible to the Commonwealth
Department of Health and Ageing having the potential to be used to inform future
policy development for Controlled Drugs?
b. Should accessibility of access to recorded (deidentified) data be expanded to include
other agencies / organisations? For example, the Australian Federal Police or the
Australian Customs and Border Protection Service.
c. If so, who else should have access and how could this (deidentified) data be used to
help address problems of forgery, abuse and doctor shopping of Controlled Drugs.
Stakeholders are also invited to provide any additional comment and/or references around the
processes, protocols, standards, guidelines and communication required to implement the
Electronic Recording and Reporting of Controlled Drugs initiative.
