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REGULATORY IMPACT STATEMENT
Drugs, Poisons and Controlled Substances
Regulations 2006
This Regulatory Impact Statement has been prepared in
accordance with the requirements of the Subordinate Legislation
Act 1994. Its purpose is to inform interested parties regarding the
proposed new regulations.
Comments and submissions are invited by 6 March 2006 and
should be addressed as outlined in the Forward.
Prepared for the Department of Human Services, Melbourne
Victoria by Jaguar Consulting Pty Ltd ABN 56089 615636.
Published by the Victorian Government Department of Human
Services, Melbourne, Victoria.
© Copyright State of Victoria 2006.
This publication is copyright, no part may be reproduced by any
process except in accordance with the provisions of the Copyright
Act 1968.
This document may also be downloaded from the Department of
Human Services web site at:
www.health.vic.gov.au/dpu
Authorised by the State Government of Victoria, 120 Spencer
Melbourne, Victoria.
January 2006
Forward
Section 7 of the Subordinate Legislation Act 1994 provides that ‘unless an
exception certificate or an exemption certificate is issued in respect of a proposed
statutory rule, the responsible Minister must ensure that a regulatory impact
statement is prepared in respect of a proposed statutory rule’.
This Regulatory Impact Statement has been prepared with respect to the
proposed Drugs, Poisons and Controlled Substances Regulations 2006.
The Regulatory Impact Statement assesses the likely costs and benefits of the
proposed statutory rule and discusses possible alternatives.
The Minister for Health has given notice of the preparation of this Regulatory
Impact Statement in accordance with section 11 of the Subordinate Legislation
Act 1994. Interested organisations, health professionals and members of the
public are now invited to make comments and submissions.
Responses to the Regulatory Impact Statement or proposed regulations should be
addressed to:
Megan Smith
Drugs and Poisons Unit
Department of Human Services
GPO Box 4057
MELBOURNE VIC 3001
Email: [email protected]
The closing date for receipt of comments and submissions is 6 March
2006.
It should be noted that all comments and submissions received in
response to this Regulatory Impact Statement will be treated as public
documents.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
3
Summary
The proposed Drugs, Poisons and Controlled Substances Regulations 2006 will
replace the Drugs, Poisons and Controlled Substances Regulations 1995, which
are due to sunset 29 May 2006. The proposed regulations make only limited
amendments to the existing regulations. The regulations constitute the principal
regulations made under the Drugs, Poisons and Controlled Substances Act 1981
(the Act). The Act is itself the central piece of Victorian legislation seeking to
control the manufacture, supply, storage, prescription, possession and use of
drugs and poisons.
The Act seeks to control the possession and use of drugs and poisons, including
medicines, in the interests of minimising harms to public health. The drugs and
poisons subject to regulation are:
•
•
•
those that are subject to improper use ;
those that have a potential for harm if administered inappropriately and
thus must be taken on expert advice; and
those that require additional control because they have inherent dangers
(includes certain agricultural and industrial chemicals and animal and
human medicines).
The Act provides for regulations to impose specific controls on the drugs and
poisons industry, providers of health services and health professionals and other
appropriately trained individuals in relation to matters such as the manufacture,
sale, possession, administration, use, supply, distribution and storage of
potentially hazardous substances. Key controls include a licensing and permitting
system, secure storage requirements and controls on the right to possess and
prescribe drugs and poisons. The Act also covers packaging and labelling 1 , to
ensure members of public have access to information regarding safe use of
chemicals.
The controls provided in the regulations are intended to minimise both the risk of
diversion of drugs to illicit purposes (entailing drug abuse) and the risk of
inappropriate drug treatments occurring, leading to problems of lack of efficacy
and, potentially, harms to health.
As noted, the proposed regulations constitute a continuation, with some
refinements, of regulatory approaches to drugs and poisons that have been in
place for some decades.
There is a high degree of commonality in the
approaches to the regulation of drugs and poisons taken internationally and in
Australia. This reflects a clear consensus on the need for, and appropriate type
of, restrictions on the availability of drugs and poisons.
Drugs and poisons regulation inevitably intersects with other areas of regulation,
such as the regulation of a range of health professions. As well, there are
complex interactions between Federal and State regulation.
These factors,
together with the long history of drugs and poisons regulation and consequent
unavailability of an unregulated “control scenario” mean that it is not possible to
conduct a formal and complete benefit/cost analysis of the proposed regulations.
1
through incorporation of the Standard for the Uniform Scheduling of Drugs and
Poisons (SUSDP).
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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However, the case that the regulations will deliver net benefits to the community
can be established via qualitative arguments as to the merits of the regulatory
model employed, supported by evidence of the size of existing harms due to
misuse and abuse of drugs and poisons and inferences as to the extent to which
the regulations employed to date have been effective in minimising these harms.
Quantitative cost data have also been included in this Regulatory Impact
Statement in order to verify as far as possible that the costs imposed by the
regulations are not disproportionate to the benefits sought to be achieved.
It is difficult to attribute specific costs to the regulations per se. The major
compliance requirements are specified, at least in broad terms, in the enabling
Act, while the regulations provide the detail that allows implementation.
Moreover, in many cases, the regulations are “permissive” in nature: that is, in
their absence, the prohibitions and limitations on certain activities established by
the Act would be farther reaching than is the case with the regulations.
The regulations are supported by stakeholder groups and are not considered by
them to be unduly burdensome.
The regulations make only very limited
amendments to the sunsetting regulations which they will replace.
Thus,
stakeholders have substantial experience with the administration of these
regulations and fully understand their compliance obligations. Their support for
the regulations reflects this experience.
The nature of the broader regulatory structure in relation to drugs and poisons, at
State, Federal and International levels, is such that there are very few feasible
alternatives to the proposed regulations. One alternative has been identified and
involves relying to a far greater extent on professional regulations and
professional regulatory bodies to determine what drugs and poisons can be used
and supplied by particular groups of health professionals. This alternative could
be seen as having benefits deriving from the making of regulatory decisions at a
level closer to the issues of day-to-day practice and experience of individual
health professions. This could arguably lead to more appropriate decisions being
made and a more responsive regulatory structure generating and allowing greater
dynamic efficiency.
However, significant potential costs were identified. These included the fact that
this model would compromise, to some degree, the achievement of a consistent
and strategic approach to drug regulation. As well, professional regulatory bodies
are likely to lack specific skills in effective drug regulation. In instances where a
number of regulatory bodies needed to be involved, the lack of an overall coordinating regulatory body could also jeopardise the achievement of good
regulatory outcomes. Currently the Department of Human Services is able to
exercise regulatory control impacting across the spectrum of professional
organisations.
The combination of these considerations suggests that the
effectiveness of regulation overall would be likely to be significantly lower under
this alternative.
Given these factors, it is considered that the proposed regulations are likely to
yield greater net benefits to the society than the alternative.
In sum, the proposed regulations are expected to support effectively existing
systems of drug regulation that aim to:
•
•
Reduce to a practical minimum the incidence of drug abuse, by controlling
the availability of drugs subject to abuse;
Maximise the effectiveness of drug prescription for therapeutic purposes
and minimise the extent of “medication incidents” involving negative
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
5
•
outcomes, by restricting the right to prescribe and supply drugs to those
with appropriate expertise; and
Minimise the incidents of poisonings and other misuse of drugs, whether
accidental or not, again by limiting the supply of drugs and poisons.
Given the widespread prevalence of drug and poison use and abuse in society,
the system of regulation of which the proposed regulations form an integral part
yields very substantial benefits to society as a whole by effectively minimising the
size of the problems of drug misuse and abuse. By contrast, the identifiable costs
are relatively modest and the conclusion that the regulations can be expected to
entail net benefits is clear.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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Table of Contents
1. Introduction..............................................................................................................................9
1.1. Overview ...............................................................................................................................9
1.2. Regulatory context ............................................................................................................9
1.3. Victorian regulation.........................................................................................................10
2. Objectives of the proposed regulations .................................................................12
3. Authorising provisions......................................................................................................12
4. Nature and extent of the problem .............................................................................13
4.1. Overview .............................................................................................................................13
4.2. Explanation of the proposed measure, likely impact and enforcement
regime ..............................................................................................................................................17
4.3. Affected parties and enforcement .............................................................................19
5. Description of the proposed regulations ...............................................................21
5.1. General ................................................................................................................................21
5.2. The National Standard for the Uniform Scheduling of Drugs and Poisons.21
5.3. Summary of the proposed regulations ....................................................................22
6. Expected benefits of the proposed regulations .................................................32
6.1. Overview .............................................................................................................................32
6.2. Quantitative benefit estimates....................................................................................35
6.3. Benefits associated with proposed changes to the existing regulations.....39
6.4. Enforcement activity.......................................................................................................44
7. Expected costs of the proposed regulations .......................................................46
7.1. Overview .............................................................................................................................46
7.2. Summary of affected parties.......................................................................................48
7.3. Quantitative estimates...................................................................................................49
7.4
Fees Regulations ..............................................................................................................52
8. Alternatives to the proposed regulations..............................................................56
8.1. Alternatives and the regulatory context .................................................................56
8.2. Regulation by individual professional organisations...........................................57
9. Small business impacts....................................................................................................60
10. Conclusion: Comparison of proposed regulation and identified
alternatives .....................................................................................................................................61
11.
Evaluation strategy ........................................................................................................63
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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12.
Consultation........................................................................................................................64
13.
Statement of compliance with National Competition Policy ..................67
Appendix 1: Setting the proposed fees .........................................................................69
Appendix 1A: Salaries and operating costs......................................................................76
Appendix 1B: Administration costs .......................................................................................77
Appendix 1C: Total costs for new applications and renewals ...................................80
Appendix 2: Proposed Drugs, Poisons and Controlled Substances
Regulations 2006.........................................................................................................................85
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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1.
Introduction
1.1. Overview
The proposed Drugs, Poisons and Controlled Substances Regulations 2006 will
replace the current Drugs, Poisons and Controlled Substances Regulations 1995,
which are due to sunset due to the operation of the Subordinate Legislation Act
1994 2 . The proposed regulations make only limited amendments to the existing
regulations. The regulations constitute the principal regulations made under the
Drugs, Poisons and Controlled Substances Act 1981 (the Act). The Act is itself
the central piece of Victorian legislation seeking to control the manufacture,
supply, storage, prescription, possession and use of drugs and poisons.
1.2. Regulatory context
The context within which the regulations operate includes a range of international
treaties and Commonwealth/State agreements.
Many quite extensive and
specific obligations exist as a result of these international and national
obligations. At the international level, Australia is a signatory to international
treaties, including the Single Convention on Narcotic Drugs (1961), which aims to
combat drug abuse by coordinated international action. Under the reporting
requirements of the 1961 convention, Australia reports on domestic consumption
and stocks of controlled substances, including Schedule 8 poisons. This enables
Australia to identify potential diversions and stockpiling of narcotics. Drugs and
poisons regulations in each State and Territory assist in this process and enable
Australia to meet its reporting and monitoring obligations under the treaty.
Australia has a complex framework of Commonwealth, State and Territory
legislation that provides a suite of controls to provide for the safe and effective
use of potentially poisonous substances in the community. Commonwealth
legislation largely controls end use safety, quality and efficacy of therapeutic
medicines and agricultural products, whereas State and Territory legislation
imposes restrictions on Scheduled substances, including who may supply these
substances, to whom they may be supplied and under what circumstances.
The controls imposed by State and Territory legislation relate to where the
substances are listed in the Commonwealth Standard (i.e. the Schedule and
associated appendices as listed in the Standard for the Uniform Scheduling of
Drugs and Poisons), and may include additional State or Territory specific
controls. All States and Territories adopt the Schedules to the Commonwealth
Standard and because of this there is a high degree of uniformity with respect to
the legislation and regulatory controls across Australia.
The major National Competition Policy review of drugs, poisons and controlled
substances legislation in Australia conducted in 2000 (the Galbally Review) was
satisfied that most of the controls provided a net benefit to the community as a
whole, in relation to the potentially most harmful substances.
Given the
widespread use of drugs, poisons and controlled substances and the potential for
harm, the Galbally Review concluded that some degree of reduced competition
and higher costs were acceptable in some circumstances. It noted that the harm
2
Victorian regulations are automatically revoked ten years after being made,
unless sooner revoked. They must then be formally remade if required. This
ensures that the continuing case for regulation is established. Sunsetting is
therefore a fundamental regulatory review mechanism.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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to the community resulting from use of certain harmful substances would
increase in a significantly less regulated context.
The Galbally Review reports strong support from stakeholders for the objectives
of the current legislation, which was considered to provide a net benefit to the
community as a whole. Lack of national uniformity imposed the most costs.
In summary the Galbally Review found there were strong reasons for Australia to
have a comprehensive system of legislative controls that regulate drugs, poisons
and controlled substances. It recommended measures to improve regulatory and
administrative efficiency, and reduce the level of regulation. The majority of
these measures have been implemented or are being worked through by the
Commonwealth and States and Territories.
1.3. Victorian regulation
The Act seeks to control the possession and use of poisons and drugs, including
medicines, in the interests of minimising harms to public health. The drugs and
poisons subject to regulation are:
•
•
•
those that are subject to improper use ;
those that have a potential for harm if administered inappropriately and
thus must be taken on expert advice; and
those that require additional control because they have inherent dangers
(includes certain agricultural and industrial chemicals and animal and
human medicines).
As part of the system of controlling the possession and use of drugs and poisons,
the Act provides for regulations to impose specific controls on health professionals
and other appropriately trained individuals in relation to matters such as the
manufacture, sale, possession, administration, use, supply, distribution and
storage of potentially hazardous substances. Key controls include a licensing and
permitting system, secure storage requirements and controls on the right to
possess and prescribe drugs and poisons. The Act also covers packaging and
labelling 3 , to ensure members of public have access to information regarding safe
use of chemicals.
The regulations give effect to the Act in a number of ways:
•
•
•
they authorise particular classes of people, who would not otherwise be
authorised, to be in possession of drugs and poisons;
they establish consistent standards for equivalent functions carried out by
the range of health professionals; and
they set limits on the scope of lawful practice of health professionals in
relation to the use and prescription of drugs and specify that activity
outside this scope constitutes an offence.
The current regulations will sunset on 29 May 2006 as a result of the operation of
the Subordinate Legislation Act 1994. The proposed regulations will replace the
sunsetting regulations, with amendments aimed at improving the overall
effectiveness of regulation. Thus, they will continue the general approach to the
control of potentially harmful substances that has been in place in Victoria for
many decades, namely to restrict access to such substances to those who need
them and are properly equipped to handle them.
3
Through incorporation of the Standard for the Uniform Scheduling of Drugs and
Poisons.
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Access to drugs and poisons is controlled via a process of listing substances
within “Schedules”. The Schedule into which each substance is placed depends
on its toxicity and potential risk to the user, and the public’s need to have access
to the substance. The content of these Schedules is determined at a national
level, with the Act incorporating the Commonwealth standard, namely the
Standard for the Uniform Scheduling of Drugs and Poisons.
The regulations authorise individuals and others to possess poisons or controlled
substances and limit the purpose and extent of possession. The regulations
adopt a consistent approach to controls on access to poisons or controlled
substances for all those authorised to possess them. The specific controls adopted
vary in accordance with the poisons Schedule.
The Schedules for which
regulations are needed are Schedules 2,3,4,7 (certain poisons), 8 and 9.
Regulations are not needed to cover other Schedules, nor are they needed in
relation to non-scheduled poisons.
The key proposed changes proposed to the existing regulations are as follows:
Major changes
•
•
•
•
•
Additional persons will be authorised to possess Schedule 4 poisons under
specified conditions, including officers employed in ambulance services,
dental auxiliaries and orthoptists.
Provision has been made for the writing, sending, checking and retaining
of prescriptions, orders or instructions by electronic means (in accordance
with the Electronic Transactions (Victoria) Act 2000).
Current requirement that only nurses can administer drugs to residents in
aged-care services catering only to high-care residents will be removed. It
is intended that provisions requiring nurses to manage the administration
of drugs to high care residents in all aged care facilities will be inserted
into the Act to replace the existing regulation.
Drug storage requirements will be standardised, such that Schedule 8
poisons used in aged care facilities will no longer be required to be stored
in a Drug Cabinet. Moreover, impractical record keeping requirements in
aged care will be eliminated by removing the requirement to maintain a
drug register for Schedule 8 poisons when they are supplied fully labelled
by the pharmacist in tamper evident dose administration containers.
New licence and permit categories will be created to benefit small
businesses and new fees will be adopted that are better aligned with
administrative costs incurred in respect of different types of licence and
permit holders.
Other changes
•
•
•
The regulation restricting possession of Schedule 4 poison samples for
demonstration purposes by sales representatives to a maximum of one, is
removed. In accordance with the Galbally review, this activity is to be
regulated nationally, through an industry Code of Practice imposed as a
condition of manufacturing and wholesale licences.
The authorisation given to persons acting on behalf of others to possess
their Schedule 4, 8 or 9 poisons is clarified to include those persons
providing care.
Owners and custodians of herds and flocks of animals will be authorised to
possess prescribed animal medicines supplied in stockfeed directly from
manufacturers.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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•
•
•
•
•
•
•
2.
Remove repetitive labelling requirements for human and animal
medicines, and for bulk supplies of animal medicines where both the
manufacturer’s original label and additional written instructions are
provided.
Introduce consistencies in requirements for storage and access to
Schedule 4 poisons between pharmacies and other health professionals, to
recognise workplace requirements.
Medical officers acting under the instructions of warrant holders may now
use, supply or prescribe under the terms of the warrant and prescriptions
will need to contain the warrant holder’s name and number.
Restrictions on optometrists’ ability to issue repeat prescriptions are
removed.
The regulations will give clearer direction to pharmacists when they are
required to notify prescribers if they suspect oversupply of drugs of
dependence.
The regulations will relax storage requirements such that limited
emergency stocks of Schedule 8 poisons need not be stored in a Drug
Cabinet.
Authorise nurses and other registered health professionals to destroy the
remains of Schedule 8 and Schedule 9 poisons, supplied in sterile
containers such as ampoules, without a witness.
Objectives of the proposed regulations
The stated objectives of the regulations are to:
•
•
•
Facilitate and enhance the orderly sale, supply, prescribing, administration
and use of drugs, poisons and controlled substances by health
professionals, authorised persons, licensed or permitted persons and the
general public;
Prescribe fees relating to the provision of licences and permits under the
Act; and
Prescribe forms and other matters necessary to be prescribed for the
purposes of the Act.
More generally, however, the regulations are a mechanism by which the public is
provided with ongoing protection from the harmful effects of the misuse and
abuse of poisons and controlled substances.
3.
Authorising provisions
The proposed regulations are made under sections 129, 131, 132, 132A and 132B
of the Act.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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4.
Nature and extent of the problem
4.1. Overview
The problem that the proposed regulations seek to address is the inappropriate
use of drugs, poisons and controlled substances. The improper use of different
drugs and poisons can lead to differing kinds of harmful effects:
•
•
•
Poisoning: The most readily apparent results of inappropriate use are
poisoning of the user. The effects of poisoning can be observed in many
ways, ranging from mild pain and discomfort to severe illness and in
extreme cases, permanent incapacitation, birth defects and death.
Drug Dependence: The abuse of certain substances can also lead to
dependence, with its associated health effects and potential for anti social
and criminal behaviour.
Failures of effectiveness: Use of medicines inappropriately may also
result in lack of efficacy – that is, in a failure to treat the relevant malady
as effectively as is possible. This may not result in harm to the user per
se, but is associated with avoidable costs in terms of unnecessarily lost
work/school time, avoidable expenditures on the ineffective drugs and loss
of treatment options for example with the indiscriminate use of antibiotics
and the development of antibiotic resistance.
These problems may arise in the following ways:
Prescription of drugs: Inadequate control over the range of people authorised
to prescribe drugs would increase the incidence of the wrong drugs being
prescribed for a therapeutic purpose. This means that illnesses would not be
treated effectively and that negative health outcomes may occur due to adverse
reactions to medication (including negative interactions between different
medications).
Diversion of drugs: Inadequate controls on the manufacture and supply of
drugs would mean increased diversions of drugs to illicit purposes. This would
increase the incidence of drug dependence, with its various social and economic
costs. Those at greater risk would include both the general public and those
involved in the supply of drugs.
The regulations seek to address these problems by implementing mechanisms
that control public access to drugs, poisons and controlled substances, such that
those substances end up in the hands only of those who have a legitimate need
for them. The regulations also seek to limit opportunities for diversion that may
result in improper use of the substances and possible harmful effects.
The substances that are the subject of these regulations are human and animal
medicines and certain highly regulated toxic non-therapeutic chemicals. Certain
of these substances may end up in illicit use, while the majority would end up in
legitimate use for the treatment of illness and infection and the alleviation of
suffering. Inappropriate use of the latter substances has capacity for significant
harm, over both the short term and the longer term. As well, as noted above,
restrictions on the prescription and use of drugs can help improve efficacy and,
hence, the cost effectiveness of the use of medicines.
These potential harms have long been recognised. As long ago as 1857, concerns
were raised in Victoria over the widespread use and abuse of patent medicines
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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containing opiates. Children were considered to be particularly at risk because of
their low tolerance. Other poisons that were considered for control at the time
were arsenic and strychnine. The first legislation to be passed to deal with these
issues was the Poisons Act 1876, which established requirements for the proper
labelling of a range of drugs that were used in the treatment of illnesses and
infection and their sale by qualified persons.
Since that time, the number of chemicals available has increased exponentially
and the uses to which they are put have also increased. As a result, the
prevalence of drugs, poisons and other dangerous chemicals has increased
substantially over time. The risk to human health and the environment has
evidently also increased with the greater proliferation and complexity of these
agents and their more widespread use. As the number of new chemicals has
increased, and their availability to the public has increased, regulatory controls
have needed to be continually upgraded in order to control the risk to human
health and the environment to acceptable levels for the community.
The Second National Report on Patient Safety, prepared by the Australian Council
for Safety and Quality in Health Care in 2002 (‘the Second Report’) estimated
that in any two-week period, 70 per cent of Australians will have taken at least
one medicine. This percentage is even higher – as high as 90 per cent – for older
members of the community who, moreover, often take more than one form of
medicine at a time. Therefore, the potential for harmful health effects due to
inappropriate and incorrect prescription, misuse and abuse is significant.
Moreover, the prevalence of therapeutic drugs in the community underlines the
need to control access by ensuring a secure “trail” from manufacture to supply.
Evidence of the size of the problem: incidence of poisoning
Even in the presence of the current regulatory controls over the supply and use of
drugs, there is a substantial incidence of poisoning. This indicates that, even
though the regulations are consistent with international practice and are
considered to be relatively effective, the prevalence of drug use in the community
is such that poisoning cannot be averted entirely. The following data on the
current size of the problem of poisoning are presented to allow the reader to infer
the probable size of these harms where controls such as those contained in the
regulations not maintained.
Poisoning, or ‘medication incidents’ that result in harm to the person receiving
health care, can occur wherever medicines are administered, for example in
hospitals, specialist clinics, day surgeries, and general practitioners, dentists and
authorised optometrists surgeries, as well as within aged care, community and
domestic settings. Factors that commonly lead to problems include the following:
•
•
•
•
•
•
•
•
Handwritten prescriptions that are difficult to read;
Selection of incorrect strength and / or dosage;
Medication names that sound alike;
Medication packages that look alike;
Medicine administered to the wrong patient;
Patient or carer misunderstands the directions;
Medication use is not adequately monitored; and
Potentially harmful medicine interactions are not recognised.
The Second Report estimated that between two and three per cent of all hospital
admissions in Australia in 1999/00 (approximately 140,000 admissions) related to
problems with medicines, such as an adverse reaction to a prescribed medicine or
the inadvertent ingestion of a dangerous substance, and their harmful effects.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
14
This indicates that problems with medicines constitute one of the most prevalent
causes of hospital admission: for example, the 140,000 admissions cited above is
more than double the 60,700 admissions for asthma recorded over the same
period. Moreover, to the extent that medication incidents also occur within the
hospital setting, this admission figure is likely to be an underestimate of the true
size of the problem: The Second Report cites one study that estimates that
approximately 40 per cent of adverse drug events that resulted in a hospital
admission were avoidable. Overall, the Second Report estimates the costs to the
public health system alone of these admissions due to medication incidents at
$380 million per annum.
Poisons Information Centre data
An additional source of data on the incidence of adverse impacts due to accidental
or deliberate misuse of drugs and poisons is the Victorian Poisons Information
Centre (PIC) 4 . The PIC is the main telephone advisory service for poisons
information. According to the PIC Annual Report, it received over 40,000 calls
during 2004, with 27,424, or around 75 per day, relating to an actual exposure to
a poison. Of this number, the main causes of exposure are as follows:
•
•
•
•
Accidental exposure: 85%
Deliberate exposure: 9%
Therapeutic error: 4%
Other: 2%
Table 1 shows the main substances generating calls to the PIC.
Table 1: Main substances generating PIC calls
Of the ten substances listed in Table 1, four (benzodiazepines, cough and cold
preparations, antidepressants and oral contraceptives) are substances that are
included within the scope of these regulations. These four substances accounted
for 2,824 incidences of poisoning.
Clearly, the regulations only operate up until the poisons or controlled substances
are in the hands of those persons who are legitimately able to possess them.
Thus, they do not have any direct bearing on the storage or use of those
medicines by those in possession of them, including where this is contrary to
instructions on the label. This means that they have little bearing on a number of
the underlying causes of the medication incidents and poisonings reported above.
However, it is apparent that, in the absence of the controls on the supply of drugs
imposed by the regulations the substances in question would be still more
4
See Annual Report 2004. Victorian Poisons Information Centre, pp4-7.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
15
widespread in the community and the incidence of such poisoning incidents would
inevitably be somewhat greater than that currently observed.
The cost of poisoning incidents is clearly significant. According to PIC data, of the
calls made 4,135 resulted in the caller being referred to a hospital while a further
2,494 resulted in the caller being referred to a general practitioner.
Other aspects of the problem
Aside from the deleterious health effects of the misuse of drugs and poisons,
there is a substantial potential for additional medical costs to be incurred, with
these costs being borne both by individuals and by the broader community via
the financing of the public health system.
Another significant problem for the community is the misuse and abuse of
Scheduled medicines, such as psychoactive pharmaceutical drugs. While they are
not deemed to be illicit drugs in themselves and can generate significant benefits
when prescribed for individual patient care and administered correctly, they
create problems for the community when they are illegally diverted and used
illicitly. These drugs include stimulants such as dexamphetamine, morphine
tablets and oxycodone tablets.
These substances can provide strong and
immediate pain relief but their misuse can have serious consequences,
particularly when combined with other substances. Another substantial problem
is with diversion of drugs that are not psychoactive themselves, but are used in
the manufacture of illicit drugs (eg pseudoephedrine).
The misuse of these drugs has obvious health implications for individuals.
However, an associated problem is that of criminal and anti social activity such as
prescription forgeries and thefts from pharmacies and doctors’ surgeries.
Dependent individuals may also become unable to hold a job and may suffer
homelessness and other social problems. In sum, their ability to function in
society may be substantially compromised.
All of these problems have
substantial potential costs to society attached to them.
A further type of problem is that of failure to treat maladies effectively due to
prescribing the wrong drugs, resulting in greater duration and potentially
complications of illness as well as additional costs associated with the
administration of more appropriate medications. Data on the incidence of these
problems are not readily available. However, in the absence of the clear set of
controls that exist in Australia over the training and professional registration of
individuals who can prescribe and dispense poisons or controlled substances,
there would be even greater scope for medication misadventure.
Summary
The above discussion indicates that, even in the presence of the current,
substantial set of legislative and regulatory controls, significant problems relating
to the misuse and abuse of drugs continue to be encountered. These problems
are, to some degree inevitable, given the widespread use of drugs and poisons in
society. However, it is apparent that even a small proportionate increase in such
problems would have substantial social and economic costs. The remaking of the
sunsetting regulations is essential to ensure firstly that health professionals and
others are able to be in possession of drugs and poisons, secondly that effective
controls on drugs, poisons and other toxic chemicals are maintained and thirdly
that both the incidence of adverse effects associated with their use and the
potential for adverse societal impacts resulting from diversion and misuse will
continue to be minimised.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
16
4.2. Explanation of the proposed measure, likely impact and
enforcement regime
The Act regulates the availability of drugs and poisons by:
•
•
Adopting Schedules 2 to 9 of the Commonwealth Standard (Standard for
the Uniform Scheduling of Drugs and Poisons 5 (SUSDP))) by reference,
with penalties for non-compliance with the provisions of the
Commonwealth Standard that relate to labelling, storage, packaging or
advertising; and
Establishing a system of authorising, licensing and permitting according to
profession or activity.
As noted above, it is not possible to completely eradicate all incidents of
inappropriate and harmful exposure to drugs, poisons and other controlled
substances. For example, despite best efforts, error may be made in prescribing
a particular drug or poison or a particular patient may react badly to a substance
even if there were no signs or genuine reason to suspect that they were going to,
given the available evidence.
Therefore, the regulations endeavour to minimise the extent of medication
incidents by requiring those entrusted with the right to possess and prescribe
such substances to implement appropriate safeguards and implement appropriate
systems to reduce the likelihood of such problems occurring.
The proposed regulations will continue a long history of regulation of access to
potentially harmful substances. Like the existing regulations they implement
agreed national approaches to regulation. Also like the current regulations, they
are performance-based, so appropriately trained medical professionals are
provided with some flexibility as to how they are to comply with the regulations.
This approach has been in place since 1995 and has had the effect of reducing
the length and complexity of the regulations and of reducing direct compliance
costs. In general, performance-based regulation can reduce compliance costs by
providing flexibility as to means of compliance. This means, for example,
allowing compliance strategies to take account of work practices and clinical
requirements.
In this specific context, the performance-based approach reinforces and
complements other legislative and regulatory instruments that require high
standards of education and training.
This applies to registered health
professionals authorised under section 13(1) of the Act to be in lawful possession
of poisons in the practice of their professions. Those authorised under section
13(1) of the Act are registered medical practitioners, pharmacists, veterinary
practitioners, dentists, nurse practitioners and registered optometrists endorsed
under section 11 of the Optometrists Registration Act 1996. In this Regulatory
Impact Statement (RIS) this group is referred to as “registered health
professionals”. In general, the regulations recognise the high level of training
and the professional ethics binding this group and, as a consequence, adopts the
approach that it is appropriate to allow registered health professionals to
determine compliance arrangements within a performance-based regulatory
framework.
5
The Standard is published by the Commonwealth Government under the
authority of the Therapeutic Goods Act 1989
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
17
Moreover, the introduction of the performance-based regulatory approach has
been supported by the publication of guidance material in the form of the Guide
First
to the Drugs, Poisons and Controlled Substances Regulations 1995 6 .
published in 1995, it has been updated as required and new guidance will be
provided for stakeholders to support the proposed regulations.
Difference between current and proposed regulations
The proposed regulations build on the approach of the current regulations but
make a range of amendments from minor administrative changes to those with
substantial impact, that reflect both the Department of Human Services (DHS)
experience over the previous ten years in implementing the current regulations
and the outcomes of consultation with interested parties. Stakeholders that have
been consulted include health professional registration boards, other Government
agencies and medical, dental, pharmaceutical, optometry, veterinary, nursing and
aged care organisations.
Major amendments include the addition of new groups of authorised persons who
are able to possess certain drugs and poisons in the practice of their professions
(ambulance services, dental auxiliaries and orthoptists), provisions that recognise
that it is not the intention of the regulations to preclude electronic prescriptions
when the electronic means used is consistent with the requirements of the
Electronic Transactions (Victoria) Act 2000, recognition of ongoing evolution in
the management of an ageing population by introducing changes to storage and
record keeping requirements for Schedule 8 poisons, and introduction of new
regulatory fees for issuing licences and permits.
Other amendments relate to existing provisions and aim to improve
understanding and compliance.
Amendments of relevance to veterinary
practitioners enable the direct supply of veterinary products from stockfeed
manufacturers to end users and introduce reduced labelling requirements for
animal medications supplied in bulk.
Storage of Schedule 4 poisons can now be treated consistently across the health
professions, in so far as these poisons may be stored in the treatment room
which may remain unlocked during day-to-day activities, as long as an authorised
person is present.
Some restrictions on prescribing are removed in the new regulations.
Optometrists will be able to issue repeat prescriptions. In addition a medical
practitioner acting under the direction of other medical practitioner who holds a
warrant to use certain highly regulated poisons, is able to maintain the supply of
that poison to specific patients.
The new regulations give clearer directions to pharmacists in responding to
suspected oversupply of drugs of dependence. This increases the capacity of
pharmacists to put a curb on “doctor shopping activity” by individuals.
Other amendments introduce practical solutions to poisons management. These
include relaxing the normal storage requirement of the Drug Cabinet for storage
of limited emergency stocks of Schedule 8 poisons, plus enabling nurses to
destroy the remaining contents of sterile solutions of Schedule 8 and Schedule 9
poisons, rather than requiring medical practitioners or pharmacists to do this task
and removing the requirement for a witness. An amendment also clarifies that a
6
See www.health.vic.gov.au/dpu/
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
18
person providing care of another person, is able to be in possession of their
prescribed medication.
The removal of the current regulation on possession of samples of Schedule 4
poisons by sales representatives, will allow for adoption of a national industry
Code of Practice and thereby allow for national consistency.
Other minor amendments are editorial and include for instance, removal of
unnecessary definitions.
A more detailed overview of the proposed changes to the existing regulations is
given in Section 5. This has been integrated into the broader description of the
regulations so that the changes can be better placed into context by the reader.
4.3. Affected parties and enforcement
A wide range of parties is affected by the proposed regulations. These include:
•
•
•
•
•
•
•
•
The medical, veterinary, dental, optometry, nurse practitioner and
pharmacy professions, as well as other allied health professionals such as
nurses, podiatrists, dental auxiliaries and orthoptists;
The pharmaceutical and chemical industries;
Educational and research organisations;
Organisations and bodies that provide health services, such as ambulance
services, medical clinics, day surgeries and hospitals and approved
providers of residential aged care;
Miscellaneous organisations with genuine need to possess poisons or
controlled substances, eg ship masters, yacht owners, qualified ski
patrollers, Director of State Emergency Services and Municipal Officers,
Environmental Health Officers and Immunisation Nurses;
The public
Certain poisons retailers; and
Animal owners.
At a broader level, it should be noted that the whole of society is materially
affected by the regulations, given the substantial externalities that are associated
with the misuse of drugs, poisons and chemicals, as discussed above.
The proposed regulations will be administered by the Drugs and Poisons Unit
(DPU) of DHS. The DHS budget for 2005-06 is $10.9 billion, of which $1.6 million
is devoted to the administration of the drugs and poisons legislation (i.e. the Act
and its associated regulations, of which the proposed regulations will constitute
the principal set).
The DPU is staffed by administrative and technical staff with training in the
medical, pharmacy, veterinary, science, nursing and legal fields. The DPU field
officers visit regulated groups including health professionals, manufacturers and
suppliers of drugs and poisons. The DPU also assesses applications from the
pharmaceutical and chemical industries and health service providers who wish to
obtain a licence to manufacture or wholesale drugs and poisons or a permit to
purchase drugs and poisons. Licences and permits are issued under the Act.
Assessment generally involves a site visit, the length and detail of which depends
on the nature and size of the organisation and the substance involved. The DPU
also conducts systematic monitoring and audit of persons and organisations
subject to the Act and investigation of complaints and alleged breaches of the
legislation and regulations.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
19
Monitoring often involves a review of a professional’s or organisation’s systems
for restricting access to controlled substances and ensuring they are, prescribed
and supplied appropriately. This includes a review of the adequacy and security
of storage facilities, record keeping practices and reconciliation to demonstrate
that substances are not diverted from their intended source.
Another key function of the DPU is the issue of warrants and treatment permits to
medical practitioners to allow for the controlled prescription and use of drugs with
the potential to cause significant harm to the population, if misused. Such drugs
are those with addictive or teratogenic effects (i.e. causing birth defects).
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
20
5.
Description of the proposed regulations
5.1. General
The regulations are made under the authority of Sections 129, 131 and 132 of
the Act. Section 129 authorises the making of regulations for the purpose of
preventing the improper use of both drugs of dependence and Schedules 1, 4, 8
and 9 poisons. To this end it authorises regulations to regulate or control the
manufacture, sale, possession, administration, use, supply, distribution and
storage of those substances. Section 131 authorises regulations to be made to
protect persons engaged in manufacture, sale, use or distribution or for the
protection of the public from regulated poisons. In particular, it authorises
regulations prohibiting manufacture, sale, supply etc, or restricting these
activities by requiring them to be carried out under certain conditions, including
licensing. It also authorises the making of regulations prescribing precautions to
be taken in regulating or controlling the manufacture, storage use or handling of
any such regulated poisons.
Pursuant to these powers, the regulations deal only with regulated poisons as
determined under the Act. These include drugs of dependence defined in
Schedule 11 of the Act, and poisons included in the Schedules of the
Commonwealth Standard, the SUSDP. The regulations deal with poisons listed in
Schedules 4 and Schedule 8 (prescribed poisons), certain Schedule 7 poisons with
high toxicity, Schedule 9 restricted poisons, and to a lesser extent Schedule 2 and
Schedule 3 poisons, generally supplied by pharmacists.
The regulations
recognise that Schedule 5 and Schedule 6 poisons and most Schedule 7 are
effectively regulated elsewhere.
The regulations put restrictions around
legitimate access to poisons or controlled substances, and establish fees for the
inspection of premises seeking to manufacture and supply or purchase poisons or
controlled substances.
5.2. The National Standard for the Uniform Scheduling of
Drugs and Poisons
Pursuant to inter-governmental agreements, Victoria adopts a nationally uniform
standard for scheduling drugs and poisons. This forms the basis for the controls
applied to various categories of drugs under the regulations. Victorian legislation
to adopt the Schedules to the SUSDP by reference was passed in September
1994. The SUSDP is produced and updated by the National Drugs and Poisons
Scheduling Committee, a sub committee of the Australian Health Ministers
Advisory Council (AHMAC) 7 .
The following outlines the Schedule’s classification of drugs and poisons and
provides examples under each Schedule:
•
•
•
Schedule 1. Blank
Schedule 2. Pharmacy Medicine – Substances, the safe use of which
may require advice from a pharmacist and which should be available from
a pharmacy or, where a pharmacy service is not available, from a licensed
person. Examples are cough and cold remedies and some pain relievers.
Schedule 3. Pharmacist Only Medicine – Substances, the safe use of
which requires professional advice but which should be available to the
7
As noted above, the Schedule is given authority by the Therapeutic Goods Act
1989.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
21
•
•
•
•
•
•
public from a pharmacist without a prescription. Examples are antifungal
creams, cough and cold medicines and bronchodilator sprays.
Schedule 4. Prescription Only Medicine, or Prescription Animal
Remedy – Substances, the use or supply of which should be by or on the
order of persons permitted by State or Territory legislation to prescribe
and should be available from a pharmacist on prescription. Examples are
antibiotics, diuretics, antihypertensive medicines, oral contraceptives,
stronger analgesics , prostaglandins, ovulatory stimulants, oral retinoids
and thalidomide and benzodiazepines.
Schedule 5. Caution – Substances with a low potential for causing harm,
the extent of which can be reduced through the use of appropriate
packaging with simple warnings and safety directions on the label.
Examples are household poisons such as methylated spirits and
turpentine.
Schedule 6. Poison – Substances with a moderate potential for causing
harm, the extent of which can be reduced through the use of distinctive
packaging with strong warnings and safety directions on the label.
Examples are agricultural and industrial chemicals such as strong acids,
alkalis and pesticides.
Schedule 7. Dangerous Poison – Substances with a high potential for
causing harm at low exposure and which require special precautions
during manufacture, handling or use. These poisons should be available
only to specialised or authorised users who have the skills necessary to
handle them safely.
Special regulations restricting their availability,
possession, storage or use may apply. Examples are chlorine, cyanide,
dangerous agricultural chemicals, strychnine and arsenic.
Schedule 8. Controlled Drug – 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.
Examples include morphine, pethidine, codeine, most
barbiturates, flunitrazepam and methadone.
Schedule 9. Prohibited Substance – Substances which may be abused
or misused, the manufacture, possession, sale or use of which should be
prohibited by law except when required for medical or scientific research
or for analytical, teaching or training purposes with
approval of
Commonwealth and / or State or Territory Health Authorities. Examples
are illicit, mind-altering drugs such as heroin, cannabis and lysergic acid.
5.3. Summary of the proposed regulations
This section briefly summarises the proposed regulations and highlights areas in
which substantive changes are made to the existing (sunsetting) regulations. The
full text of the regulations is attached as an appendix to this RIS.
Part 1
This part relates to preliminary matters such as the objectives of the regulations,
authorising provisions and definitions.
Part 2
This part relates to drugs of dependence and Schedule 4, 8 and 9 poisons.
Access to these substances is limited and they are only to be obtained via
prescription by a registered health professional, or under a licence, permit or
warrant, or under an approval granted by the Secretary of DHS. The divisions (1
to 9) within this part specify requirements with respect to possession, treatment,
supply, storage, records, administration, destruction (Schedule 8 and 9 poisons),
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
22
cultivation of narcotic plants, and warrants
prostaglandins, retinoids and thalidomide.
for
ovulatory
stimulants,
Division 1 - Possession
While maintaining broader restrictions on the possession and use of the relevant
poisons, the regulations in this section provide some flexibility and authorise
other persons to possess certain poisons or controlled substances for
administration in specific circumstances. These provisions recognise that in some
situations where the possession for administration of certain drugs is necessary, it
may be neither practical nor possible for a registered health professional to be
present.
These situations include when a person has had one of the poisons prescribed for
a medical condition, persons caring for or assisting such persons, and when a
carrier or messenger is delivering one of the poisons to a person who is
authorised to possess it, such as a registered health professional. As well, nurses
are authorised to possess poisons or controlled substances on the instruction of a
registered health professional, under the conditions of a health services permit
(eg in hospitals, including under standing orders), or where they have Secretary
approval to possess in defined circumstances (eg immunisation nurses). Other
persons who may be authorised include ambulance officers and paramedics
employed by regulated ambulance services, St John Ambulance members with
recognised level of training, ship owners, yacht owners or crew members when
they are involved in races conducted under Yachting Australia rules, registered
optometrists, podiatrists, orthoptists, dental auxiliaries, qualified ski patrollers,
State Emergency Services, municipal officers, environmental health officers and
immunisation nurses.
Division 2 - Treatment
This Division specifies the steps a registered health professional must take before
administering, prescribing, selling or supplying various poisons or controlled
substances 8 . Registered health professionals must take steps to ensure that the
poison or controlled substance is for medical treatment and that there is a
therapeutic need for the poison or controlled substance. Additional steps are
needed to identify persons before supplying Schedule 8 or 9 poisons. The
prescriber or supplier needs to be as sure as they can be by taking reasonable
steps, that the person is who they say they are. In effect, if the prescriber or
supplier does not already know the person, they would be expected to ask to see
common forms of identification, for example a Drivers Licence, Medicare Card or
Health Concession Card.
This Division also specifies that pharmacists may only supply certain poisons
under specific circumstances, such as on the prescription or order of a registered
health professional or other authorised person.
The regulations allow the
pharmacist to supply in an emergency, on copies of prescriptions and on
prescriptions issued in other States and Territories. Where it becomes apparent
that someone has obtained poisons or controlled substances under false
pretences, a registered health professional must notify the Secretary of DHS and
a member of the Victoria Police.
8
For example, a dentist must ensure that the drug or poison is for the dental
treatment of a person under his or her care, that they have taken all reasonable
steps to ascertain the identity of the individual and that all reasonable steps have
been taken to ensure a therapeutic need exists for that drug or poison.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
23
This Division also requires registered health professionals other than in specified
circumstances to hold permits prior to treating individuals with drugs of
dependence, such as methadone.
Division 3 - Supply
This Division specifies who is able to prescribe the poisons in question (registered
health professionals with the exception of pharmacists) and the style and
particulars required for prescriptions.
The strictest requirements apply to
Schedule 8 poisons and Schedule 9 poisons.
The regulations also specify
requirements for the supply of poisons in emergency situations (by oral
instruction for example), details that must be verified prior to supply on a
prescription (for example that the prescription was written by the purported
prescriber) and the required labelling for poison containers. The regulations
define circumstances under which prescriptions must not be supplied, including if
the prescription has exceeded its allowable lifespan, if the quantities specified on
the prescription would be exceeded or have previously been supplied, or if the
pharmacist suspects the prescription has been forged or altered. Supplied
prescriptions for Schedule 8 or Schedule 9 poisons must be retained intact by the
registered health professional making the supply for 3 years.
The proposed regulations differ from the current regulations. For example, in
recognition of the Electronic Transactions (Victoria) Act 2000, the regulations
allow for an electronic signature as well as the handwritten signature on a
prescription. Where a person is prescribed a drug of dependence or Schedule 8
or 9 poison and a pharmacist has reason to believe that a similar prescription
may have been issued recently, the pharmacist must take reasonable steps to
inform the current prescriber of the earlier supply. Such steps aim to promote
the rational supply and use in particular of drugs of dependence, and curb
tendencies by certain individuals to obtain excessive amounts of these poisons by
“doctor shopping”.
One important change to the requirements for labelling affects veterinary
practitioners supplying in bulk for flock or herd treatment of animals. Under
these circumstances, the veterinary practitioner need not label each container
(this may be a lengthy and onerous task), provided each container contains the
manufacturer’s label and the veterinary practitioner provides written instructions
containing information consistent with what would be required on a label.
Division 4 - Storage
This Division specifies the steps that must be taken to ensure that Schedule 4, 8
and 9 poisons are stored safely and securely and as a result, inappropriate access
is denied. Requirements relate to the dimensions and security of storage facilities
and ongoing obligations to ensure a storage facility remains locked and secured.
The most stringent storage requirements relate to Schedule 8 and 9 poisons
where, in most circumstances, these poisons must still be stored in a drug cabinet
that complies with minimum required security standards.
Some flexibility has been incorporated into the new regulations. For example,
registered medical practitioners and veterinary practitioners may now choose to
store Schedule 4 poisons within the treatment room, as opposed to a “lockable
storage facility”, as long as this room is locked to prevent access to unauthorised
persons when the medical practitioner is not present. This change is desirable as
it brings medical practitioners and veterinary practitioners in line with existing
practice in pharmacies, and enables the treatment room to remain unlocked
during day-to-day activities, as long as the medical practitioner or veterinary
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
24
practitioner is present. More importantly, this change is being made because the
increase in security risk that it entails is considered to be very small in relation to
the much more important benefits in terms of ready access in case of emergency
and greater flexibility and convenience in the day to day running of these
practices. In this context, it is emphasised that the medical and veterinary
practitioners in question will be on the premises at all times and will be using the
room in which the drugs are stored as part of their normal activities.
Other regulations allow Schedule 8 poisons used in residential aged care to be
stored in lockable rooms or lockable fixed storage facilities rather than requiring
them to be stored in a drug cabinet. Other new regulations allow for storage of
minimal volumes (up to 6 ampoules) of Schedule 8 or Schedule 9 poison to be
stored in a lockable facility other than a drug cabinet, when set aside for
emergency use. Finally, application may be made to the Secretary of DHS to
store substances other than Schedule 8 and 9 poisons together with these
poisons in the storage facility.
Division 5 - Records
This Division outlines who is obliged to keep records of the manufacture,
preparation, use, transfer within and between premises, administration, sale,
supply, disposal or destruction of Schedule 4, 8 or 9 poisons. Such parties are
required to keep such details as the date of a particular event relating to that
poison, the name and quantity of the poison and the names and details of the
parties involved. These regulations ensure that transactions involving these
poisons are accountable and any diversion, via illegal means, for example, can be
identified. The most stringent records apply to Schedule 8 and 9 poisons where
an accurate balance for each poison must be kept (i.e. via the drug register).
The new regulations allow for records of Schedule 8 and 9 poisons to be kept
electronically provided that they cannot be altered, obliterated, deleted or
removed without detection. In addition, an adjustment to normal record keeping
requirements for Schedule 8 poisons has been made for prescribed medication for
persons in residential aged care. In the case of high care residents receiving
medication from tamper-evident dose administration containers fully labelled by
the registered health professional for the individual, the requirement to maintain
the drug register is waived.
Division 6 - Administration
This Division states that a poison or controlled substance supplied by a registered
health professional may only be administered to the person or animal for whom it
was supplied.
Secondly, the regulations specify the process that must be
followed when a Schedule 4, 8 or 9 poison is to be administered to a patient. For
example, a registered health professional who instructs a nurse to administer the
medication, must provide a written instruction in a legible and durable form and
confirm that order with a signature. The new regulations more clearly allow the
Electronic Transactions (Victoria) Act 2000 to prevail in the case of electronically
transmitted instructions. As is currently the case, the proposed regulations
prohibit self-prescribing of drugs of dependence, or Schedule 4, 8, or 9 poisons.
This means it is unlawful for a registered health professional to prescribe or
supply one of these poisons to themselves.
The most substantial change in administration relates to the administration of
medication to high care residents in residential aged care which will be dealt with
through legislative change. The new regulations will not include the current
requirement that, in residential aged care services catering only for “high care”
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
25
residents, only a nurse is able to administer medication. Instead, it is proposed
that a provision be inserted in the Act requiring that nurses manage the
administration of medication to high care residents in all residential aged care
services. This change will enable consistent requirements to apply across all
aged care services with high care residents, while also providing greater flexibility
in the use of staff resources and a more appropriate level of supervision.
Division 7 – Destruction of Schedule 8 and Schedule 9 poisons
Regulations specify the circumstances under which Schedule 8 and 9 poisons may
be destroyed and prohibit their wilful destruction. Controls on destruction of
these poisons form one part of the safeguards contained in the regulations
against diversion of Schedule 8 and 9 poisons to illicit uses. These poisons can
be destroyed by registered health professionals in the presence of specified
witnesses and records kept.
A new regulation enables nurses and other registered health professionals to
destroy the unused contents of previously sterile containers without a witness.
The existing safeguards requiring a record of destruction remain.
Division 8: Cultivation of narcotic plants
The regulation relates to section 72 of the Act and enables the Secretary of DHS
to authorise the cultivation of narcotic plants for non-therapeutic use. This allows
for limited use of narcotic plants in research.
Division 9: Warrants for ovulatory stimulants, prostaglandins, retinoids and
thalidomide
This Division requires that registered medical practitioners hold warrants for the
purchase, use, supply and prescription of ovulatory stimulants, a prostaglandin, a
retinoid or thalidomide.
These substances require additional controls because of their high potential to
cause adverse effects if not handled responsibly. The reasons for restricting
supply are described below:
Ovulatory stimulants: use is confined to Fellows of the Royal Australasian
College of Obstetricians and Gynaecologists with expertise in reproductive
medicine, because of the risk of multiple pregnancies.
Prostaglandins: used during late pregnancy to facilitate labour, but can
cause uterine overactivity that may cause foetal distress or lead to uterine
rupture. Controls restrict use to a limited number of medical practitioners
with specialist qualifications at hospitals with facilities to monitor foetal
welfare during labour.
Retinoids: used to treat severe acne, and can cause birth defects if taken
during pregnancy.
Restricting use to dermatologists and physicians
encourages familiarity with the risk, and prevention of use during
pregnancy, and optimal use of non-retinoid treatment of severe acne, thus
optimising the overall use of retinoids.
Thalidomide: used to treat a limited range of serious medical conditions,
and can cause birth defects if taken during pregnancy. Restricting use to a
limited number of specialists ensures that they are familiar with the risk,
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
26
and use it appropriately in the context of optimal non-thalidomide
treatment.
A new clause is included to allow a warrant holder to instruct another doctor to
use, supply or prescribe a drug in accordance with the existing warrant. This
means that established treatment in hospitals and clinics can continue if the
original warrant holder is absent. In addition, both the warrant number and
warrant holder’s name will be required on any prescription written for a relevant
poison.
Part 3 - Prescribed Poisons for Categories of Nurse Practitioner
Refers to the various categories of nurse practitioner and the lists of poisons or
controlled substances they are authorised to possess, use, sell or supply.
Part 4 – Schedule 3 Poisons
This Part applies to registered health professionals and licence and permit
holders. It places the conditions on treatment with, and storage, display and
supply of, Schedule 3 poisons (i.e. non-prescription medicines that are normally
supplied only from a pharmacy). Registered health professionals must take all
reasonable steps to ensure that a therapeutic need exists for the poison before it
is supplied. In addition, these poisons must be stored in a way as not to enable
self-selection by the public. It is an offence for anyone to supply a Schedule 3
poison merely to support drug dependence.
Part 5 – Schedule 7 Poisons
This Part specifies that only those authorised or permitted under the Act or the
regulations may manufacture, sell, supply, purchase or obtain, possess or use a
listed regulated Schedule 7 poison. Retailers must also store Schedule 7 poisons
in such a way as to deny or supervise public access.
Special Schedule 7 substances are defined in the regulations as those substances
listed as special Schedule 7 substances in Part 2 of Chapter 1 of the Poisons
Code, and further described as those listed in Appendix C of Part 5 of the
Commonwealth Standard. They are of such danger to health as to warrant
prohibition of sale, supply and use. The regulations restrict possession and use to
persons holding a licence, permit or warrant has been issued under the Act or
regulations.
Part 6 – General Requirements
This Part imposes a number of conditions relating to all poisons or controlled
substances, irrespective of the specific conditions contained in other sections of
these regulations. A person who sells or supplies a poison by wholesale or retail
must ensure it is in its original unopened pack. A member of the Victoria Police
or the Secretary of DHS must be notified of the theft or loss of a poison.
Part 7 – Licences and Permits Issued Under the Act
This Part prescribes the regulatory fees for licences and permits issued under the
Act. It lists fees for new applications, renewals and amendments, which operate
across Schedules 2,3,4,7,8 and 9 (other than heroin). Licence fees relate to
manufacture and/or sale or supply by wholesale, retail (Schedules 2 and 7).
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
27
Permits enable industry, educational and research facilities and health services to
purchase or obtain poisons or controlled substances (other than by prescription or
from a pharmacy). In accordance with the Commonwealth Standard, licences to
retail Schedule 2 poisons are not issued unless the premises are more than 25
kilometres from the nearest pharmacy business.
Proposed changes to the range of licence and permit fee categories will align the
extent of the regulatory requirements more closely with the scale and scope of
the intended operations of the applicant. This will have the effect of reducing the
administrative costs of applying for and obtaining a licence or permit, as well as
licence and permit fees, for significant numbers of smaller businesses.
Licences and permits have a 12-month duration, in accordance with the
requirements of Section 21 of the Act.
Fees
The Act provides for fees to be charged for the issue of licences to manufacture
and/or sell or supply by wholesale, or retail and permits to purchase or otherwise
obtain poisons and controlled substances. This function is separate from other
aspects of the proposed regulations. Typically, those organisations that apply for
licences are involved in chemical and pharmaceutical manufacture and wholesale
distribution. Organisations that apply for permits to purchase or otherwise obtain
poisons or controlled substances include industry, educational and research
organisations (university and hospital research departments, research facilities)
and organisations providing health services, such as ambulance services, day
clinics, aged care facilities and hospitals.
The issue of licences and permits allows for restricted poisons and controlled
substances to be possessed in specific circumstances. Mandatory inspections and
compliance audits of premises relating to licences and permits, helps to ensure
that poisons are handled effectively and securely. Therefore, the licensing regime
requires licence and permit holders to establish and maintain appropriate storage,
security and record keeping systems, as they are accountable for the responsible
handling of the poisons.
The regulatory fee for licences and permits relates solely to the administration of
that system. It covers costs involved in mandatory inspections, ongoing audits,
reviews of new and amended Poisons Control Plans, minor amendments and
providing specialist advice to existing and potential licence and permit holders.
The regulatory fee does not encroach on areas where it is established
Government policy that costs are funded by consolidated revenue in the public
interest. This includes administration of the Schedule 8 treatment permit system,
the warrant system for certain listed regulated poisons, the Pharmacotherapy
Program, monitoring the activities of and providing advice to registered health
professionals supplying poisons or controlled substances on prescription to the
general public and conducting compliance investigations and prosecutions.
Therefore, regulatory fee revenue does not recover DHS total costs for
administering the Act and regulations, but rather that proportion which is
incurred in relation to licence and permit holders.
Legislation has provided for fees to be charged for the issue of licences and
permits since 1983, and fees have been set at a level that recovers the direct
costs described above since 1995.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
28
The proposed fees for each type of licence or permit are outlined in Table 2.
Where possible, the current fees are presented in parentheses for comparison.
However, as discussed in the footnotes, some categories of licences have been
changed from those applied under the current regulations. This renders direct
comparison impossible in many cases. In the regulations the fees are presented
as fee units, with the value of a fee unit being $10.49 as of 1 July 2005.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
29
Table 2: Proposed licence and permit fees for manufacture, supply, and
purchase of poisons
Type of Licence or Permit
MA
MP 4
MP
2,3,7
MPR 7
WA
WP 4
WP
2,3,7
WA
Indent
WP4
Indent
WP
2,3,7
Indent
GDL
Permit
8,9
Manufacture and sale or supply by
wholesale of any Schedule 8 or 9
poison, other than heroin
Manufacture and sale or supply by
wholesale Schedule 4 poisons
Manufacture and sale or supply by
wholesale Schedules 2, 3 or 7
poisons
Manufacture and sale or supply by
retail any Schedule 7 poison (other
than a Schedule 7 poison included in
the Poisons Code in the list of
substances that are not for general
sale by retail)
Sale or supply by wholesale any
Schedule 8 or 9 poison other than
heroin
Sale
or
supply
by
wholesale
Schedule 4 poisons (together with
any Schedule 2, 3 or 7 poisons)
Sale
or
supply
by
wholesale
Schedule 2, 3 or 7 poisons
Sale or supply by wholesale any
Schedule 8 or 9 poison other than
heroin – by Indent
Sale
or
supply
by
wholesale
Schedule 4 poisons (together with
any Schedule 2, 3 or 7 poisons) – by
Indent
Sale
or
supply
by
wholesale
Schedule 2, 3 or 7 poisons – by
Indent
Sale or supply by retail any
Schedule 2 poison
Permit to purchase or obtain or use
any Schedule 8 or 9 poison, or any
Schedule 8 or 9 poison plus any
Schedule 2, 3, 4 or 7 poison for
industrial, educational or research
purposes
Proposed Fees (existing fees)
Application
Renewal
Amendment
$1128.37
$773.94
$55
($1147.60)
($1,088.90) ($55.60)
$826.66
($844.50) 9
$597.24
($844.50)
$404.65
($501.40)
$210.98
($501.40)
55
($55.60)
55
($55.60)
$517.30
($544.40)
$194.99
($350.40)
55
($55.60)
1128.37
($1147.60)
$773.94
($1,088.9)
55
($55.60)
$826.66
($778.40)
$404.65
($464.70)
55
($55.60)
597.24 10
($778.40)
517.30
210.98
($464.79)
350.89
55
($55.60)
55
517.30
238.11
55
517.30
194.99
55
353.13
($446.90)
501.83
($660.90)
147.62
($251.80)
191.89
($346.20)
55
($55.60)
55
($55.60)
9
Categories of licences to manufacture and sell by wholesale have been revised
from the current regulations. Thus, while licence MA is unchanged, separate
licence fees for MP4 and MP2,3,7 are provided to enable a lower fee to be
charged for inspections where S4 poisons are not involved
10
Wholesale sale and supply licence categories have changed, to cover supply by
indent and to provide a separate and lower fee where inspection of S4 poisons is
not involved.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
30
Table 2: continued
Permit
Permit to purchase or obtain and use 459.71
162.86
55
($312.60)
($55.60)
2,3,4,7
any Schedule 2, 3, 4 or 7 poisons for ($560.20)
industrial, educational or research
purposes
Health Services Permit – to purchase or obtain and use any poisons or controlled
substances for the provision of health services
Type A
Type A – single site, no beds
379.77
151.43
55
($560.20)
($312.60)
($55.60)
Type B
Type B – residential aged care, 581.76
214.81
55
($312.60)
($55.60)
single storage facility (no bed limit) ($560.20)
OR single site of 1 to 30 beds
Type C
Type C – multiple sites and no beds 800.02
358.67
55
($642.00)
(339.90)
($55.60)
OR 31 to 100 beds
Type D
Type D – multiple sites OR more 1135.23
506.48
55
($909.50)
($429.00)
($55.60)
than 100 beds
NB: Indent refers to supply of drugs where the licence holder does not take
possession
A detailed explanation of each of these steps for estimating the cost of receiving,
assessing, approving and monitoring licence and permit applications and the
subsequent justification for setting the fees at the proposed level is included in
Appendix 1.
SCHEDULES
Schedule 2 contains the FORMS and Schedule 3 contains the prescribed poisons
that various categories of nurse practitioner (e.g. wound management, intensive
care unit liaison, young people’s health and palliative care) are authorised to
obtain, have in their possession and use, sell or supply.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
31
6. Expected
regulations
benefits
of
the
proposed
6.1. Overview
6.1.1. Best practices in drug regulation
As noted above, there is a high degree of commonality in the approaches to drug
regulation taken internationally. This reflects the substantial degree of consensus
that exist as to the nature and extent of the problems associated with the misuse
and abuse of drugs and, importantly, the appropriate controls. The World Health
Organisation (WHO) has set out the key elements that must be contained within
a complete and fully effective system of drug regulation.
In general, drug legislation must:
•
•
•
•
•
•
•
•
•
•
Define the categories of medicinal products and activities to be regulated;
State the missions and goals of drug regulation;
Create the administrative bodies necessary for implementing drug
regulation, and define their structural and functional relationships;
Define the qualifications and standards required for those handling drugs;
Create mechanisms to ensure that all responsible parties are licensed and
inspected and ensure compliance with drug legislation and with the
standards and specifications laid down for persons, premises and
practices;
Define the norms, standards and specifications necessary for ensuring the
safety, efficacy and quality of drug products, as well as the
appropriateness and accuracy of product information;
State the terms and conditions for suspending, revoking or cancelling
licences to import, manufacture, export, distribute, sell, supply or promote
drugs;
Establish the administrative measures and legal sanctions that will be
applied if drug legislation provisions are violated;
Create mechanisms for ensuring the transparency and accountability of
drug regulatory authorities to the government, the public and consumers;
Create mechanisms for ensuring government oversight 11 .
The centrality of the current regulations to drug legislation can be seen in the fact
that they deal with seven of the ten key elements of drug legislation identified
above by WHO. The elements of an effective regulatory system to which the
proposed regulations contribute are underlined above.
WHO concludes that Australia’s system of drugs regulation includes all of the
necessary elements cited above. However, it also points to the substantial
difficulties involved in attempting to measure the effectiveness of regulatory
systems within countries in controlling the misuse of drugs and in making
meaningful comparisons between countries. The WHO findings point to the
difficulties inherent in providing comprehensive estimates of the benefits of the
existing regulations and, by extension, the benefits of the proposed regulations.
However, a number of partial indicators of the likely benefits are highlighted in
this section.
11
Ratanawijitrasin, S & Wondemagegnehu, E, Effective Drug Regulation: A
Multicountry Study. World Health Organisation, (2002), pp 128-9.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
32
6.1.2. Overview of major benefits attributable to the proposed
regulations
As noted in Section 4, there are several broad categories of benefits attributable
to the regulations. These relate to the minimisation of the following adverse
outcomes:
•
•
•
Poisoning: Due to accidental or intentional ingestion of poisons or
harmful chemicals or to ingestion of inappropriate drugs or drugs in
inappropriate quantities;
Drug dependence: Due to the abuse of certain substances, leading to
adverse health and social consequences, including criminal behaviour; and
Failures of effectiveness: Use of medicines inappropriately leading to a
lack of efficacy – that is, in a failure to treat the relevant malady as
effectively as is possible, leading to increased pain and suffering and
economic losses.
The major mechanisms employed by the Act and regulations to minimise these
harms are restrictions on the right to manufacture and sell drugs by wholesale,
restrictions on the right to possess and supply drugs and restrictions in relation to
the storage and destruction of drugs. In general terms, the links between these
controls and the achievement of the benefits noted above are as follows:
Restriction on right to manufacture and sell by wholesale (the Act)
Licensing of manufacturers provides an important mechanism for allowing the
quality of drugs being manufactured to be monitored and controlled. Quality
control helps ensure the effectiveness of the therapeutic use of drugs while
minimising the risk of poisoning due to substances contaminating drugs. It also
helps to ensure that drugs cannot be diverted to illicit uses by helping to enable a
system of tracking of all drug manufacture and supply to be adopted. Reducing
the incidence of drug diversion is an important means of minimising the risk of
illicit use and consequent drug dependence.
Restriction on the right to prescribe and supply drugs and circumstances
of prescribing and supply (the Act and regulations).
Restricting the right to prescribe drugs to persons with appropriate medical
qualifications 12 ensures that sound clinical judgements are made with respect to
the appropriate drug to treat particular conditions and that adverse outcomes due
to negative drug interactions and drug intolerance are avoided. These controls
therefore assist in maximising the effectiveness of drug use and minimising
poisoning (broadly defined).
Restrictions relating
(regulations)
to
the
storage
and
destruction
of
drugs
These restrictions are aimed at minimising the risk of drugs being diverted to
illicit purposes by either theft or illicit supply. They form part of a broader system
of accountability for the movement of drugs throughout their “lifecycle” from
production (or production of precursor chemicals in some cases) to use or
12
Essentially medical practitioners, but also a range of allied health professionals
to a limited degree, involving a narrow range of drugs.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
33
destruction. As noted above, minimising illicit use of drugs will minimise the risks
of both poisonings and of drug dependence.
6.1.3. Other benefits attributable to the regulations
Performance-based standards
The regulations also represent a performance-based approach that seeks to
minimise compliance costs while maintaining necessary controls. This approach
was first applied in 1995 when the current regulations were made. It has not
only reduced the size of the regulations but enables health professionals to
determine the most effective and efficient way to comply with the regulations
consistent with their own work practices. For example, previous prescription in
relation to the required design and installation of drug safes was replaced by
performance based requirements whereby a particular design of cabinet set the
minimum security standard and installation was defined by minimum times for
which facilities could resist hand and power tool attack.
Therefore, the proposed regulations reinforce and complement other legislative
and regulatory instruments in relation to the training and professional standards
for medical practitioners, dentists, veterinarians and pharmacists. They rely on
the high standards imposed on these professionals in terms of professional
qualifications.
Conversely, the regulations ensure that those without the
necessary professional qualifications, training or legitimate need are prevented
from accessing dangerous substances.
National uniformity benefits
Finally, the proposed regulations satisfy commitments made by the Victorian
Government to enact national standards for the control of drugs and poisons,
such as the SUSDP. Reliance on national standards, nationally agreed codes of
practice and a consistent approach across jurisdictions can be expected to
enhance understanding of the rationale for, and application of, the standards by
health professionals and therefore assist compliance.
This also applies to
manufacturers and distributors, particularly those that operate across a number
of jurisdictions. Manufacturers also reap important cost savings in relation to
packaging and labelling as a result of the establishment of uniform standards in
respect of these requirements. It should be noted that these national uniformity
issues are essentially in the province of the Act and that the regulations are
simply instrumental in implementing supporting matters, for example in relation
to storage requirements.
Refining the regulations over time
The regulations have been continuously refined and improved in response to
emerging issues and improved knowledge.
This has allowed the costs of
maintaining high levels of control over drug use to be minimised and, in some
cases, has led to improvements in the effectiveness of the regulations. The
following section provides some specific examples of the beneficial outcomes of
recent regulatory changes in order to demonstrate the capacity for even small
improvements in the regulatory environment to yield substantial benefits to the
community.
•
The existing regulations place a substantial check on “doctor shopping” by
individuals seeking to obtain multiple prescriptions for drugs of
dependence or Schedule 8 poisons from different medical practitioners
within the same time period (defined as 8 weeks). If an individual
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
34
presents a prescription from a different medical practitioner to the
pharmacist, and the pharmacist recognises that earlier supply has
occurred, the pharmacist is obliged to inform the current prescriber of that
fact.
This mechanism enables communication between the medical
practitioners and the pharmacist to determine the most appropriate action.
It reduces the potential for individuals to fraudulently obtain prescriptions
for Schedule 8 poisons. This regulation is extended in the new regulations
such that a pharmacist only needs to have “reason to believe” that an
earlier supply was made, and is to take “all reasonable steps” to inform
the current prescriber
•
The capacity of the regulations to cater for computer generated
prescriptions that include the handwritten signature of the prescriber,
without each registered medical practitioner being individually approved,
means that computer generated prescriptions are widely adopted and the
doctors instructions are more likely to be accurately interpreted by the
pharmacist and relayed on the pharmacist label.
•
Electronic monitoring of access to storage systems of Schedule 4 and 8
poisons within certain ambulance services now allows the ambulance
officers to restock their ambulances from the nearest ambulance station.
This promotes efficiency, as well as accountability and security.
•
Existing regulations no longer specify the exact manner in which poisons
transactions need to be recorded. Earlier regulations detailed specific
recording requirements for ward-to-ward transfers of poisons within
hospitals. The existing regulations enable hospitals to use electronic
poisons management systems.
•
Earlier regulations required that Schedule 8 records and cumulative totals
be kept manually to identify alterations to records, while other records
could be maintained electronically. This meant for example that relevant
wholesalers maintained a manual and an electronic recording system. The
existing regulations allow new technologies in stock control that also track
alterations to records.
These systems are now adopted by major
wholesalers, and are starting to be seen within pharmacies.
•
Earlier regulations specified the construction of the drug cabinet, including
detail on how the cabinet should be attached to the floor or walls, that was
needed to store drugs of dependence. The current regulations do not
specify how the cabinet should be attached to the floor and walls but
require that it should resist manual or power tool attack for certain
specified times.
6.2. Quantitative benefit estimates
It is inherently difficult to quantify or attach a monetary value to many of the
benefits that the proposed regulations will generate as strict controls on the use
of drugs, poisons and harmful chemicals have been a place in Victoria for a long
period of time. Thus, it is difficult to infer the degree of effectiveness of the
regulations by reference to the characteristics of an estimated unregulated
scenario.
That the likely benefits are substantial is indicated by the very great prevalence
of the drugs in question. For example, it was noted above that, in any two-week
period, approximately 70 per cent of Australians will take at least one form of
medicine. The widespread use of pharmaceuticals within society highlights the
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
35
prevalence of the risks that are associated with accidental or deliberate misuse.
Such misuse can have severe health consequences, up to and including death, as
well as contributing to a range of other social problems, including criminal
behaviours.
Furthermore, this RIS has previously noted that a large number of hospital
admissions and cases treated in general practice are due to the adverse effects of
drugs and poisons. It has been estimated that across Australia 140,000 hospital
admissions annually are due to adverse drug events while an additional 400,000
cases are treated in general practice. One authority estimates that such events
are the fifth most common cause of death among hospitalised patients 13 . It was
noted that a large proportion of these incidents were potentially avoidable.
In the context of Schedule 4, 8 and 9 drugs (i.e. medicines), the causes of
medication incidents, where inappropriate exposure to particular substances
causes harm to a patient receiving health care can be attributed to a number of
factors, such as:
•
•
•
•
•
•
•
Errors in the administration where the patient did not receive prescribed
medicine at the right time or received an incorrect dose;
Errors in prescription where medical records are incorrectly transcribed;
Errors in dispensing where the incorrect medicine is dispensed from a
hospital pharmacy;
Errors in medication records where previous adverse reactions or allergies
were not properly documented;
Errors in the review of medical records;
Communication problems either between health professionals or between
a health professional and a patient, due to problems of legibility or the
completeness of records;
Errors in pharmacies where an incorrect or inappropriate medicine or
dosage is provided or if a prescription is incorrectly interpreted. These
problems often occur when product names look or sound similar or if
packaging is similar.
More generally, many of these incidents can be attributed to failures
appropriate systems or procedures for the control of the possession and use
potentially harmful substances, a failure on the part of health professionals
adhere to proper procedures or misuse by patients (either deliberately
inadvertently).
of
of
to
or
To the extent that failure to comply with the existing drugs and poisons
regulations contributes to the overall impact of medication incidents, it is
apparent that, in the absence of the controls provided for in the regulations, a
substantially greater incidence of these adverse incidents would be expected. In
principle, the benefits of the regulations are found in the reduction in adverse
impacts related to drugs and poisons vis-à-vis what would be expected in an
unregulated scenario.
Some examples of the mechanisms by which the proposed regulations will
contribute to a reduction in the rate of misuse of drugs and poisons are as
follows:
13
Use of potentially inappropriate medications among elderly common in some
European countries Fialova, D., et al. Journal of the American Medical
Association, Vol 293, No. 11, March 2005.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
36
•
•
•
•
Regulation 25 ensures that only those with appropriate training and
qualifications are legally able to write a prescription. A person other than
a medical practitioner, nurse practitioner, veterinary practitioner, dentist
or optometrist is prohibited from writing a prescription for a Schedule 4, 8
or 9 poison. This restriction substantially reduces the likelihood that
medicines will be illegally supplied or prescribed inappropriately and
thereby minimises adverse health outcomes due to adverse drug
reactions, including deleterious combinations of drugs. It also increases
the likely cost-effectiveness of drug prescription;
Regulation 26 ensures that those able to prescribe certain poisons must
communicate the range of specified instructions clearly to the pharmacist
in terms of the substance and the patient to receive the substance. This is
done either in legible handwriting or in a manner approved by the
Secretary that is secure and legible. Details to be included relate to the
prescriber, the patient, the date of the prescription and directions for the
precise dose and frequency of administration. These provisions reduce the
likelihood that the pharmacist will supply the incorrect poison for a person
or include the incorrect instructions on the label. This in turn will reduce
the risk that the incorrect person will take incorrect poison or dosages,
which would result in reduced efficacy and, potentially harm to health;
Regulation 35 ensures that Schedule 8 and 9 poisons are stored securely
by specifying that they must be held in a lockable storage facility subject
to certain minimal structural requirements. This requirement reduces the
capacity for break-ins and consequently the incidence of theft of drugs,
particularly by drug dependent persons or those supplying the illegal drug
trade, and thus minimises the incidence of self-harm due to misuse of
drugs and societal costs; and
Regulation 40 ensures that complete, accurate and durable records are
kept of transactions involving controlled substances which in turn, assists
the identification of any diversion from their intended to source. This is
done by requiring people involved in the transaction to record details such
as the date on which it occurred, the name, form, strength and quantity of
the substance and details of other parties to the transaction. These
provisions also reduce the expected incidence of misuse of drugs.
In general, it is clear that the regulations help to reduce the number of
“medication incidents” that arise due to several causes. Equally, other causes of
medication incidents are beyond the scope of the regulations and they will not
have any effect on the number of incidents that are attributable to these causes.
This factor – i.e. that observed harms relate to many causes, only some of which
are affected by the regulations – contributes further to the difficulties of
quantification cited above. Moreover, it must be recalled that Victoria is already
operating in a regulated environment and has done for decades past. Therefore,
baseline information on the harms that can be expected to occur in a similar, but
non-regulated, environment is impossible to obtain.
Given this, one approach to estimating the likely benefits of the current
regulatory restrictions on drugs and poisons is to review the available evidence on
harms currently resulting from the abuse of drugs and poisons or from their
inappropriate use and to infer the additional harms that might be expected to
occur in the absence of an effective regulatory regime. In effect, data on the size
of the harms that persist in the presence of the current regulatory arrangements
provide an indication of the scale of the problem, while adopting a range of
estimates on the probable effectiveness of the existing regulatory structure would
allow inferences to be drawn as to how much greater these harms would likely be
in the absence of regulation. The difference then constitutes a measure of the
probable benefits of the regulatory structure.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
37
Such an approach is highly approximate. Moreover, it does not allow us to
separate the likely impacts of the proposed regulations from those of the Act and
of other interlocking elements in the broader Federal and State regulatory
structure.
A further issue to be considered is that the environment within which the
regulations operate is one in which the prescribing of medication in general and
drugs of dependence in particular, has escalated dramatically.
The more
widespread use of drugs, for both licit and illicit purposes, necessarily means that
the size of the potential harms associated with drug misuse and abuse are also
increasing substantially. This suggests that even relatively static trends in terms
of actual harms reported can be considered as constituting evidence of improved
effectiveness when set against the background of increasing potential harms.
Cost of medication incidents
As noted above, a key purpose of the regulations is to ensure that medications
are used effectively and that adverse outcomes from the use of medication area
avoided. However, despite the substantial controls imposed by legislation and
regulation there remains a significant incidence of adverse impacts due to
medication use. For example, the Second Report estimated that medication
incidents where there is harm to a patient receiving health care accounted for
approximately 2 to 3 per cent (or 140,000) of all hospital admissions in Australia
each year. The Report suggested that as many as 40 per cent of these incidents
were preventable.
More recent data are available from ABS 14 and broadly confirm these estimates.
These show that, across all hospital types, 3.8% of principal diagnoses leading to
admissions relate to “injury, poisoning and certain other consequences of external
causes”. A substantial proportion of these admissions would relate to adverse
medication incidents.
ABS data 15 provides average cost data for public hospital stays. These data
show that the average cost per patient day (Australia wide) is $1,115, with an
average stay of 4.0 days. These data can be combined with the above estimates
of admissions due to medication incidents to obtain some indication of the
aggregate costs involved. As noted above, around 40 per cent of the 140,000
annual admissions due to this cause were considered to be avoidable. This
amounts to 56,000 avoidable admissions due to medication incidents per annum.
Applying the average stay of 4 days and average daily rate of $1,115 to these
data provides the following estimate:
56,000 x $1,115 x 4 = $249.8 million per annum.
That is, even in the presence of the regulations, avoidable medication incidents
still cost around $250 million per annum Australia-wide. In present value terms,
this cost is equal to $1.93 billion over ten years. By no means would all of these
admissions relate to matters that are covered by the proposed regulations:
indeed, probably a minority of cases would fit within this category. However,
these estimates clearly indicate that a significant problem remains even in the
presence of longstanding regulatory controls. The implicit benefit of having these
controls in place, in terms of avoidance of substantially greater harms due to
medication incidents, is thus apparent.
14
15
See ABS 4390.0 Private Hospitals Australia 2003-04.
ABS 1301.0 2005 Health care delivery and financing
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
38
Efficiency benefits.
ABS data in relation to the Pharmaceutical Benefits Scheme (PBS) 16 show that, in
2003-04, 165.4 million PBS prescriptions were issued, equal to an average of 8.2
prescriptions per person. The cost of these prescriptions to the Australian
Government was $5.6 billion, while patients also paid a substantial further
amount in co-contributions.
The size of these expenditures underscores the importance of ensuring that drugs
are only prescribed in circumstances in which they can confidently be expected to
generate positive clinical outcomes and, indeed, that they represent the most
efficient and effective available drug.
Clearly, the regulations contribute
substantially to ensuring that this is the case by requiring that drugs only be
obtained from a regulated health professional on a valid prescription. If it is
speculated that PBS expenditures might otherwise be, say, 50 per cent higher,
due to lower efficiency of prescription, the additional costs to government alone
would be around $2.8 billion per annum. This is equivalent to $21.6 billion over
ten years in present value terms. Again, this projected benefit (i.e. avoidance of
these additional expenditures as a result of effective regulatory controls) excludes
the gain due to lower patient co-contributions.
6.3. Benefits associated with proposed changes to the
existing regulations
RIS in respect of sunsetting regulations are required to analyse benefits and costs
against a notional unregulated alternative scenario. The above discussion adopts
this perspective. However, where the sunsetting regulations are to be replaced
with largely similar regulation, it is also important to clarify the purpose of the
proposed changes and to highlight the benefits and costs associated with them.
This section provides detail on these issues.
6.3.1. Dental auxiliaries to become authorised for possession
As noted in Section 4.3, the proposed regulations would allow the Secretary of
DHS to authorise dental auxiliaries (i.e. dental hygienists and dental therapists)
to possess certain Schedule 4 poisons, such as local anaesthetics.
Dental auxiliaries administer local anaesthetic as part of their clinical practice.
This enables them to perform the range of tasks specified in the Dental Practice
Board of Victoria’s (DPBV) Code of Practice, which was promulgated in April 2002.
Tasks include ‘local anaesthesia for dental procedures’.
Dental auxiliaries are appropriately trained to be able to administer local
anaesthetics competently and are registered through the professional body.
Dental therapists may be employed by Dental Health Services Victoria (DHSV)
and other external organisations, and dental hygienists are mostly employed in
the private sector.
Under current arrangements (i.e. without the separate
authorisation the proposed regulations will provide) a dental auxiliary would need
to be acting under the supervision of a dentist, or the organisation utilising the
skills of the dental auxiliary would need to hold Health Services Permit in order
for a dental auxiliary to be able to possess local anaesthetics. These options
could be costly for dental organisations.
16
Ibid.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
39
The new authorisation provides a clear recognition that dental auxiliaries need to
be in possession of certain Schedule 4 poisons in the conduct of their profession.
It allows greater efficiency in the day-to-day activities of dental auxiliaries and
introduces greater flexibility and cost effectiveness in their movement throughout
the dental workforce.
There are no costs associated with this amendment.
6.3.2. Orthoptists to become authorised for possession
The proposed regulations would also allow orthoptists to be authorised by the
Secretary to possess certain Schedule 4 poisons, such as eye drops.
Orthoptists are degree-qualified allied health care practitioners specialising in the
clinical application of ocular physiology and optics. According to the Orthoptists
Association of Australia approximately three quarters of orthoptists work in
conjunction with ophthalmologists either in public hospital settings or in
sponsored private practices. Orthoptists form an important part of the eye health
team providing investigative testing of diseases such as glaucoma, assessment
and management of eye movement disorders and rehabilitation of persons with
sight loss due to eye diseases such as age-related macular degeneration. They
have adequate training to possess and administer eye drops, and will be
practicing under the direction of a registered medical practitioner or authorised
optometrist.
The proposed change to allow separate authorisation for persons registered as
orthoptists with the Australian Orthoptic Board to possess Schedule 4 poisons
that are local anaesthetics and cycloplegics in topical eye preparations. The
change reflects that made in New South Wales in 1996, whereby orthoptists can
administer restricted substances (Schedule 4 eye drops) on the direction of a
medical practitioner, in public hospitals and community health centres.
The change will promote the efficient use of trained resources and help to
minimise costs and improve access to services.
There are no costs associated with this amendment.
6.3.3. Administration of drugs in aged care services
As noted above, the existing requirement that only nurses are able to administer
drugs in high care residential aged care services will be removed.
New
requirements will be inserted into the Act. These will apply controls to the
administration of medication to all aged care services regulated by the Aged Care
Act 1997 (Commonwealth), while introducing a more flexible regime requiring
nurses to make a professional judgement as to who should administer medication
to high care residents according to guidelines established by the Nurses Board of
Victoria. The change is consistent with the Aged Care Act 1997 (Commonwealth),
where nurses are required to develop care plans for aged care residents. The
proposed requirements will ensure that medication management is included in
care plans.
Changes in storage and record keeping requirements for Schedule 8 poisons are
proposed to introduce a uniform standard for storage and record keeping for all
aged care services where there is at least one high care resident. The proposed
regulations require that Schedule 8 medications be locked away, but not
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
40
necessarily within a Drug Cabinet. In addition, they no longer make it essential
to maintain a drug register for Schedule 8 poisons that are prescribed for specific
residents, supplied in tamper-evident dose administration containers and labelled
by the pharmacist. To maintain such a register (which means maintaining an
ongoing drug balance) when medication is supplied in dose administration
containers would be onerous and impractical.
The changes enable all poisons or controlled substances for all residents in aged
care services to be handled consistently and with the same degree of security.
This means that approved providers and their staff do not need to manage
different storage and record keeping systems that depend upon the resident
category and the poison Schedule. In aged care facilities that currently do not
have a Drug Cabinet, there will be no requirement to purchase one. Given that
most medications will be prescribed for the individual residents, and that most
would be Schedule 4 rather than Schedule 8, and that some medications at least
would be provided in tamper evident dose administration containers, the
opportunities for diversion of Schedule 8 poisons are assessed as low under the
new regulations. Diversion from tamper evident dose administration containers
would be immediately apparent and could be quickly investigated.
If the
residential aged care facilities did need to hold stocks of poisons or controlled
substances (i.e. other than medication prescribed and dispensed for a specific
patient), then they would need to obtain a Health Services Permit and the stricter
storage and record keeping requirements would apply.
6.3.4 Ambulance officers and paramedics to be authorised to
possess certain drugs
The proposed regulations will allow ambulance officers and paramedics employed
in regulated ambulance services, as well as appropriately qualified members of St
John Ambulance Australia (Vic) to be in possession of the poisons or controlled
substances listed in the Health Services Permit of their employing organisation.
In effect, these officers are already permitted to possess the relevant poisons or
controlled substances, since this is the effect of the employing organisations’
Health Services Permits. However the new regulations make it transparent that
officers from these organisations are in legal possession of certain poisons or
controlled substances to use for emergency treatment of the public. The benefit
of this change is in removing any uncertainty as to the position of these officers.
6.3.5 Electronic transactions
It is the intention of the proposed regulations to more clearly provide for the
writing, sending, checking and retaining of prescriptions, orders or instructions by
electronic means, provided the methods used meet the requirements of the
Electronic Transactions (Victoria) Act 2000.
This means that where handwritten signatures were specified, signatures are now
required. A signature can be a handwritten signature, or where electronic
transactions are used, a signature that can be achieved by a method that meets
the requirements of the Electronic Transactions (Victoria) Act 2000.
Consequently, where a handwritten signature is no longer provided on an
electronically transmitted document, the new regulations require a person to take
reasonable steps to verify the prescription was written by the purported
prescriber. In the case of electronically transmitted prescriptions, reasonable
steps would be expected to include confirming that the process used by a
purported prescriber complied with the provisions of the Electronic Transactions
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
41
(Victoria) Act 2000. It is intended that DHS will be active in working with medical
and pharmacy organisations to give guidance on this issue.
The Electronic Transactions (Victoria) Act 2000 recognises the importance of
developments in information technology. It provides a framework for using
electronic transactions, including in dealings with government and promotes
confidence in electronic transactions. Consequently there are benefits for the
regulations not to stand in the way of introducing more flexible and efficient
electronic transactions, as long as equivalence in identity and security are
maintained.
6.3.6 Other changes
The remaining changes to the proposed regulations largely introduce refinements
and efficiencies into the current system. They are designed to facilitate drugs
and poisons transactions while operating within the safeguards of the current
regulatory framework.
Samples of medicines
The proposed regulations do not include a restriction on possession of Schedule 4
poisons samples by sales representatives (being agents of drugs and poisons
licence holders). This facilitates the adoption in Victoria of the new national
industry Code of Practice, which allows more flexible arrangements for industry.
Adherence to the code will become a condition of the drugs and poisons licence.
Veterinary medicines
The proposed regulations will allow owners and custodians of herds and flocks of
animals to possess prescribed medications in stockfeed when supplied directly
from the stockfeed wholesaler. This practical change means that bulk medicated
stockfeed can legally be transported directly from the wholesale supplier to the
animal owner, instead of being supplied from the supplier, to the veterinary
practitioner and on to the animal owner. There are no costs to this change, and
existing safeguards apply because the medicated stockfeed can only be lawfully
supplied on the order of a veterinary practitioner.
Labelling requirements
The proposed regulations introduce efficiencies in labelling of containers of drugs
and poisons beyond the manufacturer’s label. The proposed regulations will allow
a veterinary practitioner not to separately label each container of Schedule 4
medication supplied in bulk, as long as each container retains the manufacturer’s
original label and the veterinary practitioner supplies written instructions. This
change enables the practical and efficient use of resources, as long as safeguards
are in place.
There has also been a slight change in the wording for labelling requirements to
allow writing on the labelling panels of starter packs of medicines.
Storage requirements
The proposed regulations reduce inconsistencies in requirements for storage and
access to Schedule 4 poisons as they apply to different health professionals.
Currently, Schedule 4 poisons need to be locked away unless access is needed.
However, this requirement does not apply in pharmacies, where Schedule 4
poisons are not locked away but are stored in open shelves under the continual
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
42
supervision of the pharmacist. The change will allow Schedule 4 poisons stored in
the treatment room of medical and veterinary practices to be accessible in a
similar manner. The room will not need to be continually locked and unlocked
throughout the day, but may remain unlocked during busy times as long as an
authorised person, i.e. a medical practitioner is present to supervise. The room is
to remain locked when the authorised person is otherwise occupied or absent.
The change allows medical practices to determine efficient and secure working
arrangements around any Schedule 4 poisons stored (and used) in the treatment
room.
Similarly, the proposed regulations relax storage requirements for Schedule 8
poisons stored in limited stocks (up to six divided doses) for emergency use.
These stocks will not need to be stored in a Drug Cabinet, and consequently can
be mobilised quickly and easily in an emergency. This would relate to emergency
poisons stored in a Crash Trolley. The emergency supply needs to remain locked,
to ensure emergency supplies are present when needed, however the security
level is reduced. Reduced security would provide easier illegal access to these
poisons, however given the limited stocks involved and the benefits of emergency
treatment for patients, there overall benefit is assessed as outweighing the cost.
Prescription of Schedule 8 and 9 drugs
The proposed regulations enable medical practitioners acting under the
instructions of other medical practitioners who hold a warrant to use certain
highly regulated human therapeutics (specialists), to continue to supply that
medication. This enables continuity of care of the patient if the warrant holder is
absent, or if the patient does not have ready access to the warrant holder (eg
lives some distance from the specialist).
As an additional safeguard, any
prescriptions or orders written by the subordinate medical practitioner are to
include the name of the warrant holder.
Prescription by optometrists
The proposed regulations remove a current restriction on the issuing of repeat
prescriptions by optometrists. The practical change recognises that optometrists
may need to treat patients with long-term eye complaints.
Over-supply of drugs of dependence
The proposed regulations give clearer directions to pharmacists on how to deal
with instances where they suspect patients are seeking oversupply of drugs of
dependence and Schedule 8 or Schedule 9 poisons (“doctor shopping” behaviour).
Under the existing regulations the pharmacist must have supplied the patient
previously. Under the proposed regulations, the pharmacist may know or suspect
that the patient was previously supplied from another pharmacist.
The
pharmacist is to take reasonable steps to inform the current prescriber that the
patient has obtained prescriptions from other prescribers. This highly beneficial
regulation aims to bring the prescribers together, to devise strategies to curb
irrational patient behaviour if needed.
Destruction of Schedule 8 and 9 drugs
The proposed regulations enable nurses and other registered health professionals
to destroy the remains of Schedule 8 and Schedule 9 poisons supplied in sterile
containers without a witness. As with other legitimate destructions, the activity
must be recorded. The change enables timely and efficient destruction of waste
contents in hospital theatres and wards, to prevent the containers being
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
43
inadvertently reused or diverted, and when containers cannot be safely resealed
and transferred to the pharmacy for disposal.
6.4. Enforcement activity
While there is substantial voluntary compliance with many forms of regulation,
data on enforcement activity constitutes one important indicator of the extent to
which the regulations are ensuring behavioural changes in practice.
The DPU internal database records 95 successful prosecutions against since 1995,
or an average of 9.5 per annum. Of these, slightly more than two thirds (66)
involved medical practitioners, another 23 involved pharmacists and four involved
veterinary practitioners.
Medical practitioners were most commonly prosecuted for offences under the Act:
•
•
•
Failure to notify DHS that they have reason to believe that a patient is a
drug dependent person (Section 33);
Prescribing a person a Schedule 8 drug with out the required permit
(Section 35); and
Obtaining drugs of dependence by false representation (Section 78).
These Sections 33, 35 and 78 were represented in 26 (39%), 34 (52%) and 27
(41%) of cases, respectively.
Prosecutions of medical practitioners under the following existing regulations
most commonly occurred in relation to their own drug abuse:
•
•
•
•
Failure to establish a therapeutic need existed for the drug (Regulation 7);
Included false or misleading particulars on a prescription (Regulation 23);
Administering a drug obtained on a prescription in the name of a patient to
themselves (Regulation 44); and
Self-administering a drug that was not prescribed for them (Regulation
47).
Prosecutions under regulations 7, 23, 44 and 47 were represented in 13 (20%),
10 (15%), 25 (38%) and 28 (42%) of cases, respectively. The drug most
frequently self-administered by medical practitioners was the Schedule 8 drug,
pethidine, and to a lesser extent the Schedule 4 drug, codeine compound tablets.
Pharmacists were most commonly prosecuted for supplying anabolic steroids or
other drugs of dependence without prescriptions and dispensing forged
prescriptions where complying with the regulations would have identified the
forgeries presented.
More recently pharmacists have been detected and
prosecuted for offences associated with their drug abuse.
Offences most commonly prosecuted:
•
•
•
•
Sale or supply of drugs without a prescription (Regulation 12).
Failing to verify the authenticity of a Schedule 8 prescription with the
purported prescriber when not familiar with the prescriber’s handwriting
(Regulation 25).
Failing to notify a prescriber that the patient had obtained a similar
prescription from another prescriber within the previous eight weeks
(Regulation 29).
Failing to record the supply of Schedule 4 or 8 drugs (Regulation 39).
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
44
Some pharmacists were also prosecuted for offences under the Act, Section 36,
failing to notify the Department when called upon to supply greater quantities of
or more frequently than appears reasonably necessary, or in a few cases
obtaining by false representation, Schedule 4 or 8 drugs. Six of 23 cases
involving pharmacists (26%) involved Section 36.
Breaches of Regulations 12, 25, 29 and 39 were cited in 13 (56%), 7 (30%), 6
(26%) and 7 (30%) prosecutions of pharmacists, respectively.
Veterinarians have mainly been prosecuted for supplying Schedule 4 drugs, drugs
of dependence, especially anabolic steroids, not for the treatment of animals but
for illegal use.
DHS, through the DPU, adopts a risk-based approach to compliance activity and
enforcement. Some investigations are resolved quickly following an interview
with the person concerned. Other cases are complex and require efforts over
months to piece together a brief of evidence. Cases involving professional
misconduct are referred to the respective professional registration boards.
Departmental resources are targeted to cases with potentially the most severe
impact on public health or confidence in the public health system. Usually the
DPU follows minor breaches with a warning and education of responsibilities.
Investigations are finalised or reassessed as progressively more information
becomes available.
Penalties
The penalties applicable to breaches of the provisions of the regulations are
described in Section 129 (1) (h), Section 131 (g), Section 132 (oa) and Section
132 (x) of the Drugs, Poisons and Controlled Substances Act 1981 and Section
129(2) of the Drugs, Poisons and Controlled Substances Act 1981. The former
Sections establish that any contravention of regulations made under the Act is
liable to a penalty of up to 100 penalty units.
However, Section 129(2)
establishes that a registered medical practitioner, registered optometrist, nurse
practitioner, veterinary practitioner, dentist or pharmacist who contravenes the
regulations is guilty of an indictable offence and can be liable to a penalty of up to
200 penalty units, up to 5 years imprisonment, or both.
These penalties are substantial, but reflect the fact that significant responsibilities
lie with highly trained health professionals and that they relate to the misuse of
dangerous drugs and poisons.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
45
7. Expected
regulations
costs
of
the
proposed
7.1. Overview
The proposed regulations effectively remake the current regulations and more
importantly, maintain an approach to regulation that has been in place in Victoria
for many decades. As such, the proposed regulations create very few additional
obligations for those that currently apply to affected parties. In fact, the
proposed regulations have been drafted to overcome some of the more
problematic aspects of the current regulations, in relation to compliance costs,
particularly by seeking to accommodate current work practices and administrative
arrangements.
That said, it is clear that the regulations and, more broadly, the legislative
structure of which they form an integral part, impose substantial costs on a wide
range of parties in society. Broadly speaking, these costs include:
•
•
•
•
•
•
Costs to consumers of medicines of the prescription supply system,
including the requirement to attend a doctor or other relevant professional
to obtain a prescription.
Costs to health service providers including hospitals, day surgeries,
ambulance services, medical clinics and individual health practitioners in
implementing the storage, records and security requirements of the
regulations and in paying regulatory fees for health services permits.
Costs to manufacturers, wholesalers and suppliers of poisons or controlled
substances in implementing the storage, records and security
requirements of the regulations and in paying the regulatory fee for the
licence to possess these poisons.
Costs to industry, educational and research establishments needing to
purchase or obtain poisons or controlled substances, in implementing the
storage, records and security requirements of the regulations and in
paying the regulatory fee for the permit.
Costs in time to registered medical practitioners in making applications for
Schedule 8 treatment permits, pharmacotherapy permits and making
applications for warrants to prescribe and supply certain restricted
poisons; associated costs for DHS in administration, monitoring and
compliance of the treatment permit system, warrant system and
pharmacotherapy program; and
Costs to DHS in administering the Act and Regulations.
Attribution of costs – regulation vs private interests
A fundamental difficulty in estimating the size of these costs arises from the
conceptual problem of the extent to which costs incurred in complying with a
range of requirements can reasonably be attributed to the regulations. It is
probable that, in the absence of the legislative and regulatory controls imposed
under the Act, quite similar arrangements would, in any case, exist in most areas.
To the extent that this is so, the costs attributable to the regulations are very
much smaller than at first glance seems to be the case. Some examples of areas
in which other factors would be expected to lead to arrangements similar to those
required in the regulations are as follows:
•
Secure storage. The regulations impose requirements to store drugs
securely on a wide range of parties. However, there are clearly other
reasons why most or all such parties would choose to ensure that drugs
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
46
•
•
were securely held in the absence of a regulatory requirement. Most
notably, while the regulatory requirements seek to prevent theft in the
interests of minimising drug abuse, the owners of drugs have clear private
interests in preventing theft – both in order to minimise monetary losses
and in order to minimise disruption to their activities. Clearly, the costs of
secure storage arrangements are not primarily attributable to the
regulations.
Record-keeping requirements. The regulations require records to be
kept as to drug movements, again largely in order to ensure that drugs
are not diverted to illicit purposes. For manufacturers, suppliers and
health professionals, there are clear private interests served by keeping
sound records. From the point of view of manufacturers and suppliers, all
businesses require sound information to function efficiently and
information on input and stock flows is clearly fundamental to this.
Similarly, health professionals have clear management based incentives to
undertake detailed record-keeping.
Prescription requirements. The requirement for Schedule 4, 8 and 9
drugs to be supplied only on prescription aims to ensure that effective
drug therapies are supplied and that ineffective drugs or those to which
there could be adverse reactions are not supplied. While consumers have
some tendency toward “self-prescription”, particularly where a drug has
previously been supplied to them, all accept the general logic of requiring
an expert to make a judgement as to appropriate treatments. Thus,
relatively few consumers would seek access to drugs other than on the
advice of medical practitioners, even in the absence of regulatory
restrictions 17 . The exception is those whose intention is to abuse drugs.
The prescription system would, however, be required even in the absence
of a need to limit opportunities for drug abuse. Thus, the costs of the
prescription system are only attributable in small part to the regulations.
As well, it should be noted that many of the compliance costs associated with the
proposed regulations would be incurred by health professionals, regardless of the
nature of the regulatory framework applying to the possession and use of drugs,
poisons and other controlled substances. It is expected that the nature of the
training and their membership of professional associations would encourage the
appropriate treatment and handling of these substances, irrespective of the
obligations created by these regulations.
By contrast, one area in which costs are clearly attributable directly to the
legislation and regulations is that of the costs of licence and permit requirements
and of DHS monitoring and enforcement activities. These costs are quantified as
far as possible in the following section.
Attribution of costs – legislation vs regulations
The above discussion has discussed costs associated with both the Act and the
proposed regulations. This reflects the fact that, in many areas, it is difficult to
disaggregate these costs and attribute them simply to the Act or to the
regulations.
This difficulty of disaggregation arises from the fact that the
regulations largely give effect to requirements that are, in the first instance,
established in the Act itself. In fact, as noted elsewhere, the impact of the
regulations in many areas is permissive: that is, they allow certain things to be
17
There are, necessarily, questions of judgement at the margin as to which drugs
should be restricted to prescription only supply. However, this discussion focuses
on the issue of having a prescription system, rather than the specific issues of
how broadly or narrowly it should operate.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
47
done by certain groups of people, whereas these things would otherwise be
prohibited by virtue of the provisions of the Act. To this extent, the provisions of
the regulations can be considered to be cost reducing, since they create flexibility
and lower the costs associated with making drugs available in a controlled
environment, vis-à-vis the general requirements established under the Act itself.
7.2. Summary of affected parties
This section identifies the main affected parties and provides data on the numbers
of companies, other entities or individuals in each group. This information
provides a general overview of the extent of the application of the regulations and
supports the quantitative cost data provided in Section 7.3., below.
Those who are directly affected by the regulations are, in the main, required to
hold licences or permits to manufacture, supply, sell, purchase or possess drugs.
As of 1 September 2005, the number of premises that were regulated under the
licence and permit system was 1217. Table 3 provides a breakdown of this total
into the main categories of licences and permits
Table 3: Licences and permits on issue as at September 2005
Licence/permit type
Number
Total licences to manufacture and sell or supply by
wholesale:
Licence to manufacture and sale or supply by wholesale of 10
any Schedule 8 or 9 poison, other than heroin
Licence to manufacture and sale or supply by wholesale 134
Schedules 2, 3, 4 or 7 poisons
Total licences to sell or supply by wholesale
Licence to sell or supply by wholesale any Schedule 8 or 9
poison other than heroin
Licence to sell or supply by wholesale Schedule 2, 3, 4 or 7
poisons
Licence to sell or supply by retail any Schedule 2 poison
Total permits to purchase, obtain or use
28
Permit to purchase or obtain or use any Schedule 2, 3, 4,
7, 8 or 9 poison for industrial purposes
Permit to purchase or obtain or use any Schedule 2, 3, 4,
7, 8 or 9 poison for educational and research purposes
Health services permit all types
275
Total (%)
144
(12%)
279
(23%)
222
29
383
(31.6%)
108
Total
411
(34%)
1,217
Table 3 shows that licences and permits can be broken into four broad types:
licences to manufacture, licences to supply by wholesale, permits to purchase,
obtain or use, and health services permits. The total of the two former categories
– representing the drugs and poisons industry – is 423 licences, or 35 per cent of
the total. Permits to purchase, obtain and use poisons or controlled substances
of all types (including health services permits) account for 794 permits, or 65 per
cent of the total number of licences and permits. Of these, health services
permits are the most common, with 411, or slightly more than one third of all
licences and permits being of this type. Most if not all of the private and public
hospitals and day treatment centres in Victoria would hold a health services
permit.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
48
A total of 47 new licences and 78 permits were issued during 2005. This
constitutes slightly more than 10 per cent of the total number of licences and
permits currently on issue. New licences and permits were issued in all of the
above categories.
Within the health community, a very large number of health professionals,
premises and organisations are affected by the drugs and poisons regulations.
According to the 2003-2004 published Annual Reports for the respective
registration boards, in 2004, almost 110,000 individuals would have needed to
deal with drugs and poisons regulations. These include:
•
3,628 registered dental care providers (including 2,288 dentists, 312
dental specialists, 288 dental prosthetists, 211 dental therapists, 122
dental hygienists, and 363 dental students) (Annual Report of the Dental
Practice Board of Victoria 1 July 2003 to 30 June 2004)
•
18,016 medical practitioners (including 397 provisional registrations)
(Medical Practitioners Board of Victoria Annual Report 2004)
•
2,499 medical students (Medical Practitioners Board of Victoria Annual
Report 2004)
•
77,144 nurses (Nurses Board of Victoria Annual Report 2003/2004)
•
947 optometrists (plus 155 endorsed therapeutic optometrists)
(Optometrists Registration Board of Victoria Annual Report to the Minister
for Health Year ended 30 June 2004)
•
5,040 pharmacists (Pharmacy Board of Victoria 128th annual report 2004)
•
2,023 veterinary practitioners (Veterinary Practitioners Registration Board
Victoria Annual Report 2003-2004)
In addition, in 2004 there were 1,160 approved community pharmacies, 63
pharmacy departments and 36 pharmacy depots (Pharmacy Board of Victoria
128th annual report 2004) and 135 private hospitals (ABS 4390.0 Private
Hospitals 2003-04). Currently in 2005 there are 121 public hospitals, including
49 Melbourne Metropolitan Hospitals and Health Services Locations and 72 Rural
Public Hospitals, Multipurpose Services and Rural Public Health Services
(Department of Human Services Victorian Government Health Information,
current as of 21 September 2005).
7.3. Quantitative estimates
Section 7.1., above, has indicated that many of the costs associated with the
proposed regulations are unquantifiable and that there are substantial issues of
attribution of costs, even where quantification can be attempted. Given this, the
following material must be seen simply as an attempt to quantify impacts
associated with the regulations wherever possible and, thereby, to provide some
“order of magnitude” estimates of key costs associated with the regulations.
7.3.1. Costs to the Department of Human Services
The responsibility for the administration of the Act and the proposed regulations
lies with the DPU of the DHS. Approximately $1.6 million of the DHS budget for
2004-2005 is assigned to the direct administration costs of the Act and associated
regulations.
Adding overhead costs including accommodation expenses,
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
49
departmental corporate costs and database depreciation costs brings the total
cost of the DPU to approximately $2.4 million per annum. In present value
terms, this is equal to $18.5 million over the assumed ten-year life of the
regulations.
Approximately 23% (5.2/23 FTE) of DPU full time equivalent staff are engaged in
licence and permit related activities, suggesting that this function costs
approximately $550,000 per annum. This cost is almost entirely recouped from
licence and permit-holders through fee payments: the revenue obtained from
licences and permits in 2004-2005 was approximately $540,000.
7.3.2. Costs to regulated parties
Licence and permit related costs
As noted above, licence and permit fee revenue in 2004-05 totalled $540,000.
This represented full recovery of the costs of those activities of the DPU that are
directly related to the administration of the licence and permit system, as noted
above. Section 7.4., below, discusses the nature of the changes being made to
the system of licences and permits, involving changes to the categories of licence
and permit that will be available, and discusses the consequent changes being
made to the fee structure.
The revenue from the revised fee structure is expected to be equal to the
currently collected aggregate revenue.
This reflects the fact that full cost
recovery is currently being achieved and that there are not expected to be any
net increases in administrative cost arising from the implementation of the new
fee structure. Further information on the calculation of the new fee structure is
also contained at Appendix 1.
The expected fee revenue under the proposed regulations will therefore remain at
approximately $540,000 per annum. This constitutes a direct cost to licence and
permit holders. This cost is equivalent to $4.2 million per annum in present value
terms over the ten-year life of the regulations.
Data on the costs borne by licence and permit holders in undertaking licensing
activity are not available. However, in general, it is expected that the compliance
costs borne by licensees simply in preparing and submitting licence applications,
facilitating inspections and undertaking related tasks are of the order of one to
three times the costs borne by the regulatory agency. Applying this “rule of
thumb” multiplier suggests that the licence and permit requirements of the
regulations may cost the drugs and poisons industry and health service providers
in the vicinity of $540,000 - $1.62 million per annum. Over the assumed tenyear life of the regulations, this is equivalent to between $4.2 and $12.5 million in
present value terms.
These costs are essentially administrative in nature and do not include the costs
of complying with any substantive requirements of the regulation (beyond
licensing itself). However, it should be noted that this is an area in which the
question of attribution of costs arises, since the licensing system is largely set out
in the Act, while the regulations simply give effect to the Act’s intentions.
Secure storage costs
One area in which some specific quantitative data has been obtained in relation to
substantive compliance costs relates to the cost of the secure drug storage
devices (drug cabinets) required under the regulations. Quotes for the provision
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
50
of suitable devices were obtained from two manufacturers, with the following
results:
•
•
One company quotes prices ranging from $665 to $4275 to supply various
sized units constructed from 10mm steel plate with a 6 lever pick resistant
key lock, consistent with the regulation requirements.
A second company quoted prices of $725 to $1180 for drug cabinets of
varying size, also constructed of 10mm steel plate and 6 lever key locks.
These estimates suggest that the minimum cost of a drug cabinet is in the vicinity
of $700, while most sizes arguably cost between $700 and $1,200. Clearly,
however, large users may incur costs up to, and beyond, $4,000.
Quotations were also sought for the supply of a lockable refrigerator: a device of
this type would conform to regulatory requirements for the storage of Schedule 4
poisons (these are simply required to be stored in a locked facility). This may
include a lockable refrigerator. A current price range from one supplier for a
variety of sized lockable and temperature monitored laboratory refrigerators is
$1,900 to $2,840 (GST exclusive). A less expensive option is to purchase a
domestic refrigerator and install a lock.
While these costs are non-trivial, it is clear that drug cabinets have a long
expected lifespan, probably measured in terms of several decades. A lockable
refrigerator would also be expected to have a substantial lifespan.
Many
premises have had such equipment in place for many years. Given this, the
equivalent annual cost of a drug cabinet would clearly be small, perhaps being in
the range of $100 - $300 per annum for most operators.
Moreover, it was noted above that only a proportion of this cost can reasonably
be attributed to the regulations, given that there are clear commercial and/or
professional incentives for them to ensure that drugs are safely stored.
Expansion of the scope of the regulations in the aged care context
As noted in Section 6.3.3., the scope of the regulations is to be expanded to
include all aged care services, rather than simply “high care” services, as at
present. There is a cost to implementing this change in respect of aged care
services where there are high care residents. Facilities that have not been
regulated by Victorian drugs and poisons legislation before (mixed care facilities
comprised of low care facilities and hostels that have high care residents) will now
need to comply with the regulations. However, the modifications to storage and
record keeping regulations for Schedule 8 poisons used in aged care services
essentially allow the status quo to be maintained for most of those services.
That is, requirements in relation to drug storage for aged care services, applying
under proposed Regulation 36, are less stringent than those currently applied to
high-care services. Such services will not need to have a drug cabinet to store
Schedule 4 and 8 poisons, but will simply be required to store these items either
in a locked storage room or in a locked cabinet which, in the case of Schedule 8
poisons, will be required to be affixed to a wall or to the floor. It is expected that
most of these services will already have similar arrangements in place, since
there is a clear commercial and professional need to ensure that inappropriate
access to drugs is prevented. Hence, it is not believed that there will be any
additional substantive costs generated as a result of this change. For new “highcare” services, the removal of the current requirement to purchase a drug cabinet
will lead to cost savings.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
51
There will be an additional regulatory cost for the DHS because additional aged
care services as above will fall under Victorian drugs and poisons legislation.
There will be a cost involved in maintaining audit, monitoring, compliance and
enforcement activities. Experience with the current regulation of nursing homes
suggests that this cost should not be great, however some activity is expected
especially in the early stages of implementation.
Changes to the regulation of administration of drugs in the aged care
context
As discussed above, the proposed regulations will not include the current
requirement that only nurses administer drugs in high-care residential aged care
services.
However, it is expected that alternative requirements for the
administration of drugs to high care residents in all aged care services will be
adopted in the Act itself. These provisions are being adopted in the primary
legislation because matters required to be specified, such as provision of a
definition of “manage the administration of drugs” have been determined to be
beyond the scope of the regulations.
7.4
Fees Regulations
Table 2, above outlines the proposed fees that would be applied to organisations
or individuals applying for or varying a licence or permit to manufacture and sell,
supply, purchase, obtain or uses poisons and controlled substances.
The
proposed fees have been set at levels that are expected to fully recover the direct
costs associated with the administration of the licence and permit requirements.
That is, fee revenue will recover the costs associated with assessing and
approving licence and permit applications. This is consistent with current practice
and with government fees and charges guidelines and economic efficiency
considerations more generally.
The specific fees have been developed following a detailed examination of the
time, and therefore, cost of each step associated with the consideration and
ongoing administration of each application. The costs of assessing various
applications vary significantly, particularly in relation to the Schedules of the
poisons for which a licence or permit is sought: more dangerous poisons or those
with a greater propensity for abuse clearly justify the imposition of stricter
security requirements and more extensive inspection and approval arrangements.
Other factors causing variation in the size of the assessment task include the size
of the applicant and complexity of their operations.
The methodology used to estimate the costs involved in considering and
approving an application for a licence or permit is based on the following:
•
Determining the tasks, officer classification level and time needed to
deliver the licence and permit system. Tasks include audit procedures and
the provision of advice at the outset and on an ongoing basis;
•
Calculating hourly rates, including salaries, salary on-costs, operating
costs and indirect operating costs for each officer classification level;
•
Allocating charges according to the actual cost of the time of the officer
involved; and
•
Assigning a records management cost across all active licences and
permits.
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Appendix 1 contains a detailed description of the methodology for estimated the
cost involved with each category of licence or permit and therefore, the basis for
the fee.
Overview of inspection and assessment procedures
Typically, DHS visits an applicant in response to an application for a licence or
permit.
The application includes a Poisons Control Plan developed by the
applicant, designed to show that they understand their responsibilities under the
regulations. The applicant is required to nominate a suitably trained person to
ensure that the applicant fulfils their obligations. The inspection will determine
whether the applicant’s premises are suitable, sanitary and adequately equipped
(as required by the Act) which includes confirmation that the substances are not
accessible to persons who are not equipped to handle them appropriately. All
new applications require inspection of the premises; applications for renewal are
made annually and the process for subsequent approvals depends on the type of
licence or permit.
Inspectors will also consider records and manufacturing procedures to ensure
they are safe and that adequate reconciliation is undertaken to prevent
unintended diversion of the substance. Other factors include that the applicant
understands the labelling and packaging requirements of poisons and engages
personnel with the necessary qualifications and experience..
Following a visit to the applicant, field staff prepare an inspection report and
submit a report to a Senior Officer for review and to initiate any action that may
be needed. For most applications for renewal, a site visit is not required.
The size of the fee that is charged depends on the substance in question and the
nature of the applicant (such as number of beds in the case of an organisation
such as a hospital that provides health care services).
Specific fees proposed
The proposed fees for each type of licence or permit are given in Table 2. Where
possible, the current fees are presented in parentheses for comparison. However
the categories of licences have been changed from those applied under the
current regulations. This renders direct comparison impossible in some cases.
The purpose of the changes to the licence categories is to improve the fairness of
the fee structure. Six new licence categories have been created. These are for
new applications and renewals for the wholesale sale or supply of Schedule
2,3,4,7,8,or 9 poisons by indent. These fees are generally lower and reflect the
fact that supply by indent does not involve holding stock of the poisons being
sold. This, in turn, means that stock security issues are not required to be
addressed as for wholesale suppliers generally and that the assessment and
approval task is, concomitantly, less complex.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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Comparison of current and proposed fees
There are 35 separate fees (covering new applications, renewals and the
amendment fee) in the new regulations. Of these, 27 separate fees are carried
over from the existing fees, and eight are new fees. The eight new fees
correspond to applications and renewals for three new licence types for wholesale
sale or supply of Schedule 2,3,4,7,8,or 9 poisons by indent, and one new Health
Services Permit (Type A) specifically introduced for single site premises without
overnight beds, in particular general medical practice premises.
The expected revenue from the proposed fees is equal to that raised by the
existing fees. However, there have been changes in specific fee levels.
Of the 27 fees relating to existing licence types:
•
5 fees are higher than at present, with the increases ranging from 6% to
25%. The largest change is for new applications for Type C and Type D
Health Services Permits, designed to cater for organisations with multiple
sites requiring inspections, or for the largest hospitals. Renewal fees for
Type C and Type D permits are increased by 6% and 8%, respectively.
•
17 fees, almost two thirds of the total, are lower than at present, with the
proposed fee levels calculated at 44% to 95% of existing fees. The most
substantial reductions are for new applications and renewals of licences for
manufacture and/or wholesale sale or supply where Schedule 4 poisons
are not involved (down to 71% of the existing fee for new applications and
42% for renewals), general dealer licences (79% and 59% of the existing
fee for applications and renewals, respectively) and applications and
renewals for permits to purchase poisons or controlled substances for
industrial, educational and research purposes.
•
5 fees have been amended by amounts equal to less than 5% of the
existing fee. This includes the amendment fee in all categories.
The new Type A Health Services Permit fee for applications and renewals is set at
68% and 48%, respectively of the existing fee (also Type A Health Services
Permit). The new fees represent a substantial saving for services, in particular
general medical practices, choosing to utilise this category.
As noted above, the proposed fees are the result of a substantial exercise aimed
at accurately modelling the average costs associated with the review and
approval of each specific type of licence and permit application. The proposed
fees will therefore achieve a better matching between costs and revenues for
individual application types than at present. Substantially larger numbers of fees
have been reduced than have been raised.
Explanation of changes to licence/permit categories and likely impacts
The introduction of new licence and permit categories is unlikely to affect the total
number of licences, since the scope of activities requiring licences and permits to
be held is effectively unchanged. Thus, there will be movement between licence
and permit categories, but a similar total number of licence and permit holders.
As noted above, the purpose of the changes is to provide clearer distinctions
between different types of activities and to ensure that assessment arrangements
and associated fee levels reflect the scope and nature of activities being
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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undertaken. In addition to the introduction of new licences for wholesale supply
by indent, changes have been made in relation to health services permits, as
follows:
•
A new Type A Health Services Permit is proposed to cater for medical
practices and day surgeries. The category was created following requests
from general practice organisations. Uptake is untested but anticipated to
be favourable. General practice organisations and DHS plan to develop
guidance to assist with implementation of the new regulations, for general
practitioners.
•
Type B Health Services Permits have been restructured to accommodate
changes in the application of the regulations to residential aged care
facilities and small hospitals. These would have been included in the
previous Health Services Permit Type A (non-residential and residential up
to 30 beds), so no substantial change in numbers is expected.
•
Type C Health Services Permits have been restructured to accommodate
services with multiple distribution points such as ambulance services, and
medium sized hospitals, as in the existing regulations.
•
Type D Health Services Permits have been restructured to accommodate
hospitals with multiple sites necessitating additional DHS resources for
travel, inspection and reporting, and large public and private hospitals.
Assessment of the proposed changes to the structure of licence and
permit fees
As discussed above, the proposed changes to licence and permit fees have been
designed to ensure a closer linkage between the fees paid and the resources used
by DHS in assessing licence and permit applications and undertaking related
functions. The revised licence and permit structure has also been designed to
ensure that licence and permit categories distinguish appropriately between
businesses in terms of the scale and scope of their operations.
These changes will clearly improve the efficiency and the equity of the licence and
permit arrangements. No basis can be identified, in the current context, for
departing from the basic fee-setting assumption of ensuring cost recovery. Thus,
by ensuring a better rapport between costs and revenues at the level of individual
licence types, these changes will maximise the net benefits associated with this
aspect of the regulatory structure.
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8.
Alternatives to the proposed regulations
8.1. Alternatives and the regulatory context
The range of feasible alternatives to the proposed regulations is closely
constrained by a number of factors. Firstly, international approaches to the
regulation of drugs and poisons are substantially harmonised. As part of this
harmonisation, Australia is a signatory, along with most other countries, of
international treaties that require the implementation of substantial efforts to
restrict the availability of drugs across their entire “lifecycle”, from manufacture
to use or disposal.
In particular, as noted above, Australia is a signatory to the Single Convention on
Narcotic Drugs (1961), which aims to combat drug abuse by coordinated
international action. Under the reporting requirements of the 1961 convention,
Australia reports on domestic consumption and stocks of controlled substances,
including Schedule 8 poisons. This enables Australia to identify potential
diversions and stockpiling of narcotics. Drugs and poisons regulations in each
State and Territory assist in this process and enable Australia to meet its
reporting and monitoring obligations under the treaty. Thus, any alternative to
the proposed regulations would need to incorporate many of their features via
alternative mechanisms to ensure continued adherence to the treaty. Practically
speaking, the treaty requirements therefore significantly limit the range of
regulatory options available.
In addition, the introductory sections of this RIS have noted that there is a
substantial degree of national harmonisation of regulation governing drugs and
poisons. These derive in part from the fact that there are both Federal and State
government areas of responsibility that interact in a complex manner and in part
reflect the reality of a nationally focussed industry. This national regulatory
harmonisation also substantially limits the extent to which any alternative
regulatory approaches can be considered to be practical and feasible.
Finally, account must be taken of the terms of the Act under which the proposed
regulations are made. The Act establishes in broad terms most of the regulatory
arrangements in place, while the regulations largely give effect to the Act by
specifying particular elements of the broad regulatory approach set out in the Act.
For example the Act establishes that:
•
•
•
The supply of any poisons or controlled substances other than as
authorised or licensed under the Act and its regulations is illegal;
Authorised health professionals can possess, use and supply drugs in the
lawful practice of their professions. If the regulations did not define lawful
practice, the professions could traffic in drugs of dependence with
impunity.
Possession of Schedule 4, Schedule 8 and Schedule 9 poisons without
being licensed under the Act or authorised under the Act or regulations is
illegal.
In particular, it can be noted that the form of the Act in many places is to prohibit
certain things except to the extent that they are specifically authorised by the
regulations. To this extent, the regulations can be seen as permitting, rather
than prohibiting, various matters in connection with drugs and poisons.
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If the regulations did not exist, then the only persons able to obtain, possess and
to use, sell or supply any poison or controlled substance or drug of dependence
would be a registered medical practitioner, pharmacist, veterinary practitioner,
dentist or nurse practitioner (certain poisons) and registered optometrist (certain
poisons). The Act envisages, however, that regulations may authorise others
outside the professions to be in lawful possession of poisons in certain defined
circumstances. For example, if the regulations did not exist, individual persons,
carers, helpers, nurses, animal owners, delivery van drivers, couriers, ambulance
officers, ship and yacht crew members, certain optometrists, podiatrists, dental
auxiliaries, ski patrollers, municipal officers, immunisation nurses and emergency
workers could not legally possess restricted poisons or controlled substances. It
is difficult to envisage an alternative system that would allow possession under
controlled circumstances, as effectively as the regulatory system that has evolved
and that the new regulations seek to continue.
If the regulations did not exist, persons would still be able to apply for and be
issued with licences to manufacture, sell and supply by wholesale poisons, and
sell or supply by retail (certain poisons) and obtain a permit to purchase or
otherwise obtain poisons or controlled substances, or a warrant to purchase or
otherwise obtain or use regulated poisons. The Act requires an inspection of
premises and payment of a prescribed fee. Without the regulations there would
be no prescribed fee, or baseline criteria for inspections. Alternative systems
would need to be devised.
Medical practitioners would still need to apply for permits to treat persons with
drugs of dependence, but there would be no uniform procedure for making the
application, as the regulations prescribe the Forms needed.
Thus, within the framework set out by the Act, as well as the broader political and
legislative environment, there are few options other than the making of
regulations of the form proposed. The major identifiable alternative is considered
below.
8.2. Regulation by individual professional organisations
As noted above, the form of the Act is such that the making of some variant of
the proposed regulations is, in each sector, an inescapable necessity. That said,
it is possible to envisage an alternative form of the regulations that was
substantially less specific in relation to the obligations of members of registered
health professions in relation to the possession, storage, prescription and supply
of drugs and poisons and the range of drugs and poisons to which they would
have access in the course of undertaking their professional roles.
The most plausible alternative to the regulations’ approach of setting out these
matters in a single body of regulation would be to provide a substantial role for
the relevant professional regulatory bodies in determining what drugs, if any, are
required within the scope of practice of a particular profession and what
restrictions should apply in respect of a particular profession’s use of those drugs.
As noted, an alternative along these lines would still require regulations to be
made under the Act. The key difference would be that significant substantive
elements currently covered under the regulations would, instead, be covered
under individual professional Acts and Regulations.
In relation to possession and supply of drugs and poisons, the Act states that this
can only be done by professionals in the lawful practice of their professions.
Therefore regulation must define the scope of that lawful practice. However, it is
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
57
not necessarily the case that this definition must be within the proposed
regulations.
Moreover, it is possible that requirements in respect of prescription, supply,
storage and record keeping, could be set out either in regulations relating to
individual professions or else in quasi-regulatory or self-regulatory instruments
such as codes of practice, guidance notes and the like. Such an approach would,
however, inevitably lead over time to substantial inconsistencies in the
requirements that were applicable to the different professions. Moreover, there
are likely to be substantial problems in respect of monitoring and the
enforcement of sanctions under this alternative, particularly where offences went
beyond the scope of professional misconduct and moved in the direction of
criminal activity (for example, the trafficking of drugs.).
Even where the
requirements in relation to prescription, supply, storage and record keeping were
incorporated into professional registration Acts or associated regulations (i.e.,
rather than self-regulatory or co-regulatory alternatives), this would imply the
substitution of a number of separate regulatory systems, with no overall
coordination or standards setting, for the current situation of one efficient and
independent form of regulation. While this would be safer for the community
than self-regulation, it is unlikely to be as efficient or effective overall as the
current system. This approach is considered to be feasible but not desirable.
Expected benefits of the alternative
The main benefit of this alternative would be that decisions as to the appropriate
scope of practice within which drugs and poisons could be possessed or
prescribed by a particular profession would be made by the board responsible for
the regulation of that profession. These boards generally have a detailed and
specific understanding of the nature and scope of the profession’s practice and
the role or potential role of particular drugs within it. They can also be expected
to have a more thorough understanding of the nature and extent of the training
undertaken by members of the profession and the extent to which this adequately
equips them to make decisions concerning the use of certain drugs.
These factors could be seen as providing for better decision-making regarding
appropriate access to drugs, since decisions would be made at a level that is
closer to the individual professions involved. This accords with the general
principle of subsidiarity which suggests that regulatory effectiveness and
efficiency are enhanced if decision-making occurs as close to the regulated
parties as possible.
A particular area in which this approach might be seen to have benefits vis-à-vis
that of the proposed regulations relates to the dynamic evolution of the
regulations: that is, in ensuring that they are amended in a timely manner in
response to changes in available drugs and, perhaps more importantly, changes
in the nature and scope of practice of particular professions. Thus, the regulators
of an individual profession are arguably more likely to become aware of the need
for changes to regulations relating to drugs to be used by that profession in a
timely fashion and to implement those changes. This could have potentially
significant benefits in efficiency terms due to better utilisation of a profession’s
expertise.
Expected costs of the alternative
A potentially significant cost of the alternative relates to the fact that there would
be no baseline to ensure that uniform standards applied across the professions.
There would possibly be a need to establish an independent body of oversight, to
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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monitor and compare the effectiveness of the separate bodies. Regulatory (and
quasi-regulatory) responses to regulation would likely become a two-tiered
process, and would be expected to be less efficient, and less effective in applying
consistent and uniform standards.
A further issue relates to the incentives that would arguably exist if the regulators
of individual professions had responsibility for determining issues of access to
drugs. As these bodies are generally closely aligned to the regulated profession,
it is arguable that they would be under constant pressure to broaden the scope of
practice within which access to drugs and poisons was sanctioned. This is
consistent with the frequently observed trend for professional regulatory bodies
to generally favour extension of the scope of operation and enhancements to the
perceived status of the profession they are regulating. Continuing pressure of
this kind, especially on a body that could be perceived as not independent from
the profession, could be seen as inconsistent with the underlying purpose of the
regulations which is to ensure that the supply of drugs is tightly controlled and
that they are only made available where they are clearly required for therapeutic
purposes.
A further concern would relate to the level of relevant skills possessed by
professional regulatory bodies. It is likely that many would lack sufficient specific
understanding of issues related to drug regulation to ensure that sound decisions
were made systemically. This could potentially mean co-opting other expertise
onto regulatory boards in order to acquit these responsibilities. These issues
clearly raise an additional question as to whether the alternative would be
capable of achieving regulatory outcomes that were as high quality as those
currently being achieved.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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9.
Small business impacts
Victorian Government policy acknowledges that regulation tends to have
disproportionate impacts on small business, particularly because they lack
economies of scale (i.e., in the presence of fixed elements among regulatory
costs, the relative cost of compliance is necessarily larger) and, in most cases,
the ability to deploy specific expertise to manage compliance issues. Given this
issue, specific consideration should be given to the issue of whether regulatory
requirements are likely to impose unreasonable burdens on small business and, if
so, whether regulatory redesign is required.
The proposed regulations have been assessed in terms of their impacts on small
business and have been found, in general, to be appropriately structured to avoid
undue impacts on small businesses. Specific small business impacts of particular
importance arising as part of this assessment are as follows:
•
•
•
18
The restructuring of licence and permit categories will provide greater
flexibility for licence applicants.
This will mean that some smaller
businesses will be able to obtain licences that are more appropriately
tailored to the nature and scale of their activities and which, as a result,
involve both lower licence/permit fees and lower compliance costs
generally due to reduced requirements for verification of applications,
inspections and the like 18 ;
More flexible drug storage requirements will reduce the costs of storage
cabinets for some small businesses, while also providing for greater
operational flexibility for small general practitioners in particular;
Some small aged care providers will incur additional costs by virtue of
being brought within the ambit of the regulations for the first time (see
Section 7). This will largely entail a requirement to store drugs in locked
rooms or cabinets. However, it is not considered that this will entail
substantive costs, since most affected businesses are expected currently
to be adopting complying arrangements, or to be able to bring themselves
into compliance with only minor changes.
See Section 7.4. and Appendix 1 for further detail.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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10. Conclusion: Comparison of proposed
regulation and identified alternatives
The proposed regulations constitute a continuation, with some refinements, of
regulatory approaches to drugs and poisons that have been in place for some
decades. There is a high degree of commonality in the approaches to the
regulation of drugs and poisons taken internationally and in Australia. This
reflects a clear consensus on the need for, and appropriate type of, restrictions on
the availability of drugs and poisons. These restrictions cover virtually the whole
“lifecycle” of the drug, from manufacture through to wholesale supply, storage
and retail sale to disposal.
Drugs and poisons regulation inevitably intersects with other areas of regulation,
such as the regulation of a range of health professions. As well, there are
complex interactions between Federal and State regulation.
These factors,
together with the long history of drugs and poisons regulation and consequent
unavailability of an unregulated “control scenario” mean that it is not possible to
conduct a formal and complete benefit/cost analysis of the proposed regulations.
That said, the decision criterion employed in assessing the proposed regulations
and comparing them with the identified alternatives is, in effect, one of
maximising the expected net benefits of the regulatory structure to be adopted.
The contention that the regulations will deliver net benefits to the community is
largely based on qualitative arguments as to the merits of the regulatory model
employed, supported by evidence of the size of existing harms due to misuse and
abuse of drugs and poisons and inferences as to the extent to which the
regulations employed to date have been effective in minimising these harms.
Quantitative cost data has also been included in order to verify as far as possible
that the costs imposed by the regulations are not disproportionate to the benefits
sought to be achieved.
In this context, it should be noted that it is difficult to attribute specific costs to
the regulations per se. The major compliance requirements are specified, at least
in broad terms, in the enabling Act, while the regulations provide the detail that
allows implementation.
Moreover, in many cases, the regulations are
“permissive” in nature: that is, in their absence, the prohibitions and limitations
on certain activities established by the Act would be farther reaching than is the
case with the regulations.
The regulations are accepted by stakeholder groups and are not considered by
them to be unduly burdensome. The National Competition Policy review of the
Act and regulations (the Galbally Review) found that there was strong support
from stakeholders for the objectives of the legislation and that they uniformly
considered that it provides a net benefit to the community as a whole. The
regulations make only very limited amendments to the sunsetting regulations
which they will replace. Thus, stakeholders have substantial experience with the
administration of these regulations and fully understand their compliance
obligations. Their acceptance for the regulations reflects this experience.
The nature of the broader regulatory structure in relation to drugs and poisons, at
State, Federal and International levels, is such that there are very few feasible
alternatives to the proposed regulations. One alternative has been identified and
was discussed in the preceding section. This involved relying to a far greater
extent on professional regulations and professional regulatory bodies to
determine what drugs and poisons could be used and supplied by particular
groups of health professionals. This alternative could be seen as having benefits
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
61
deriving from the making of regulatory decisions at a level closer to the issues of
day-to-day practice and experience of individual health professions. This could
arguably lead to more appropriate decisions being made and a more responsive
regulatory structure generating and allowing greater dynamic efficiency.
However, significant potential costs were identified. These included the fact that
this model would compromise, to some degree, the achievement of a consistent
and strategic approach to drug regulation and that the effectiveness of regulation
overall may suffer as a result. Moreover, many professional regulatory bodies
would be likely to lack specific skills in relation to the issues arising in the context
of drug regulation and some questions could therefore arise over their ability to
make appropriate decisions, and their perceived independence.
Finally, requiring decisions to be made by numerous regulatory boards is likely to
entail higher regulatory costs than is the case under a more centralised approach.
Given these factors, it is considered that the proposed regulations are likely to
yield greater net benefits to the society than the alternative.
In sum, the proposed regulations are expected to support effectively existing
systems of drug regulation that aim to:
•
•
•
Reduce to a practical minimum the incidence of drug abuse, by controlling
the availability of drugs subject to abuse;
Maximise the effectiveness of drug prescription for therapeutic purposes
and minimise the extent of “medication incidents” involving negative
outcomes, by restricting the right to prescribe and supply drugs to those
with appropriate expertise; and
Minimise the incidents of poisonings and other misuse of drugs, whether
accidental or not, again by limiting the supply of drugs and poisons.
The above analysis has established the widespread prevalence of drug and poison
use and abuse in society and thus the potential costs of not continuing with
existing systems to restrict supply of such drugs. It can therefore readily be
inferred that the system of regulation of which the proposed regulations form an
integral part yields very substantial benefits to society as a whole. By contrast,
the identifiable costs are relatively modest and the conclusion that the regulations
can be expected to entail net benefits is clear.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
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11. Evaluation strategy
Government policy is that regulation should be evaluated periodically to ensure
that it is meeting its stated objectives and that its impacts are in line with initial
expectations.
As discussed elsewhere in this RIS, the proposed regulations represent a
refinement of currently existing regulations.
The current regulations are,
themselves, the latest iteration of a regulatory structure that has been in place to
achieve the same set of underlying objectives for very many decades. This broad
context means that there is substantial experience with the implementation of
regulations of the form proposed and that there is little reason to believe that the
implications of making these new regulations will be at odds with current
expectations.
That said, it must be recognised that regulatory environments change over time
and that regulatory structures must continue to evolve and adapt in response to
these changes. The DHS has a continuing and substantive dialogue with a wide
range of stakeholders affected by these regulations. In addition, substantial data
are habitually collected in relation to matters of relevance to the regulations, as
discussed in other parts of this RIS. As a consequence, regulations in this area
are kept under constant review and, as a result, amendments are frequently
made in response to emerging issues. This represents a process of “continuing
evaluation”, which is expected to continue following the implementation of the
proposed regulations.
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12. Consultation
A first round of consultation in respect of the proposed regulations was
commenced at the end of 2003. At that time, DPU wrote to approximately 90
stakeholders requesting suggestions for improvements to the existing drugs and
poisons regulations. Stakeholders included:
•
•
•
•
organisations representing medical professionals in the pharmacy,
medical, veterinary, nursing, aged care, dental, chemical, optometry,
podiatry and ambulance fields;
hospital organisations;
industry bodies and professional registration bodies;
government bodies including the Victorian Department of Human Services,
Health Insurance Commission , Local Government and health departments
in other States and Territories and the Commonwealth.
In addition, consultation was undertaken with Victoria Police, the Victorian
Farmers Federation, Emergency Services, forensic services, hospital clinical
departments and security organisations.
A second round of consultation commenced in August 2004 with the
circulation for comment of a Consultation Draft of the proposed regulations to the
same list of approximately 90 stakeholders. Thirty-two written responses were
received. All key stakeholder groups are generally supportive of the remaking of
the regulations in broadly their existing forms. Specific issues were raised,
however, in relation to several areas. The main stakeholder comments received
are summarised in Table 4, below. It should be noted that, where grouped
responses are provided, not all comments may have come from all groups.
Organisations that responded with “no comment”, were largely supportive,
sought clarification or provided comment beyond the scope of the regulations are
not included.
Table 4: Summary of issues raised in consultation and DHS responses
Key issues raised
Response in proposed regulations
Medical Organisations
(Responses were received from: Medical Practitioners Board Victoria (MPBV),
Australian Medical Association (Vic) (AMAV), Royal Australian College of General
Practitioners/General Practice Divisions Victoria (RACGP/GPDV))
That the regulations enable electronic
transmission of prescriptions
That the regulations enable more
flexible poisons access, storage and
record keeping arrangements, to reflect
a clinic based approach to poisons
management and accountability
Schedule 4 and Schedule 8 poisons
Regulations amended to do this
More flexible storage incorporated for
medical practices, together with greater
accessibility to a Health Services Permit
for medical practices
Not included, on security grounds 19
19
Schedule 8 poisons are recommended to be stored separately from Schedule 4
poisons because many Schedule 8 poisons are highly sought after for illegal
purposes. In general Schedule 4 poisons need to be accessed more frequently
than Schedule 8 poisons, and were they stored together, persons who rarely if
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
64
Key issues raised
Response in proposed regulations
should be able to be stored together
except for provision that S4 poisons
that are also classified as drugs of
dependence may be stored with S8
poisons.
Regulations do not prohibit storage of
Schedule 8 poisons in a dedicated
drawer of a safe
Devised a separately costed category
for Health Services Permits for medical
practices
Current regulation to be replaced with
provisions in the Act to enable nurses
to manage administration of medication
to high care residents in nursing homes
and other residential aged care
services, rather than being required to
actually administer every dose.
Schedule 8 poisons should be able to
be stored in a multi purpose safe
More accessible Health Services Permit
for general practitioners
Supported the current regulation that
nurses only are able to administer
prescribed medication in nursing homes
Introduces
equity
in
medication
administration
for
all
high
care
residents across aged care services,
and allows for greater utilisation of
nursing skills.
Medical
organisations
supported this approach.
subsequently
Aged Care Organisations
(Responses were received from: Victorian Association for Health and Extended
Care(VAHEC), Aged Care Association of Victoria (ACAV))
Did not support the current regulation
that nurses only are to administer
prescribed medication in residential
aged care
Current regulation to be replaced with
provisions in the Act to enable nurses
to manage administration of medication
to high care residents in nursing homes
and other residential aged care
services, rather than being required to
actually administer every dose.
Nursing Organisations
(Responses were received from: Australian Nursing Federation (ANF), Royal
District Nursing Service (RDNS), University of Melbourne School of Nursing and
Head of General Practice, Victorian Council of Peak Nursing Organisation
(VCPNO))
Supported the current regulation that See above.
nurses
only
are
to
administer
prescribed medication health services,
including residential aged care
Requested
nurses
be
required
to
See above.
ever needed to access the Schedule 8 poisons would nevertheless have ready
access to them when they went to collect the Schedule 4 poisons.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
65
Key issues raised
Response in proposed regulations
administer medication to all high care
residents in aged care services, not just
those in nursing homes.
Veterinary Organisations
(Australian Veterinary Association (Vic)(AVAV), Department of Primary Industries
(DPI), Veterinary Practitioners Board Victoria (VPBV))
Requested tighter wording to identify Regulations amended to do this
the animals involved on prescriptions
for livestock poisons
Proposed
to
reduce
labelling Regulations amended to do this
requirements for veterinary poisons
provided for bulk treatment
Supported changes allowing future Regulations amended to do this
activity in electronic transmission of
prescriptions
Other comments
The Australian Podiatry Association Victoria sought clarification on how to compile
and have approved a list of poisons for podiatrists to possess. This did not relate
to the regulations.
St John Ambulance Victoria requested authorisation to possess poisons for use in
ambulance services. The regulations are amended to allow for this.
A third round of consultation was conducted in November and December 2004
and January 2005.
DHS visited all major stakeholders who had provided
substantial comment on the August 2004 Consultation Draft as part of this
process. DHS organised meetings with RDNS, medical organisations (MPBV,
AMAV, RACGP/GPDV), veterinary organisations (AVAV, DPI, VPBV) and the
Australian Podiatrists Association (Vic). DHS also consulted with Aged Care
organisations in February 2005.
A final major round of consultation was conducted in June – July 2005.
These focused on demonstrating how the proposed regulations had addressed the
respective issues of concern raised in earlier consultation.
During this round of consultations, medical, pharmacy and veterinary
organisations indicated that they were largely supportive of the proposed
regulations. The ANF remained concerned with the specific issue of regulating the
administration of prescribed medication in aged care, including the fact that the
proposed regulations do not require nurses, as opposed to personal care workers,
to administer medication to high care residents in aged care, and changes to
storage and record keeping requirements for certain medication used in aged
care.
Throughout 2005 DHS consulted on a continuing basis with major nursing
organisations in an endeavour to resolve differences and find common ground on
the issue surrounding the administration of medication in aged care and wider
community services. DHS held an Information Session for stakeholders in the
aged care industry and nursing organisations on 21 July 2005, to explain
background and proposed regulations of relevance to those sectors.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
66
13. Statement of compliance with National
Competition Policy
The National Competition Policy Agreements (“NCPA”) set out specific
requirements with regard to all new legislation adopted by jurisdictions that are
party to the agreements. Clause 5(1) of the Competition Principles Agreement
sets out the basic principle that must be applied to both existing legislation,
under the legislative review process, and to proposed legislation:
The guiding principle is that legislation (including Acts, enactments,
Ordinances or Regulations) should not restrict competition unless it can be
demonstrated that:
The benefits of the restriction to the community as a whole outweigh the
costs; and
The objectives of the regulation can only be achieved by restricting
competition.
Clause 5(5) provides a specific obligation on parties to the agreement with regard
to newly proposed legislation:
Each party will require proposals for new legislation that restricts
competition to be accompanied by evidence that the restriction is
consistent with the principle set out in sub-clause (1). 20
Accordingly, every regulatory impact statement must include a section providing
evidence that the proposed regulatory instrument is consistent with these NCP
obligations.
While the proposed regulations clearly impose substantial limits on competition in
the supply of drugs, these can be seen as the minimum necessary to ensure
harm minimisation, as indicated by the fact that similar provisions are in place
not only Australia wide but in most other Western countries. In this context, it
should be noted that there are no specific limits on the numbers of persons who
can undertake any of the regulated activities and that the discussion of cost
impacts included in this RIS indicates that the costs involved are not likely to
constitute a barrier to entry to any of the relevant occupations or businesses.
It should also be emphasised that the regulations remake, largely without
substantive amendment, the existing regulations. These regulations, together
with the authorising Act were subjected to a National Competition Policy
assessment in 2000.
This review reported strong support from stakeholders for the current legislation
and found there were strong reasons for Australia to have a comprehensive
system of legislative controls that regulate drugs, poisons and controlled
substances. Some recommendations as to measures to improve regulatory and
administrative efficiency, and reduce the level of regulation were made and the
20
Clause 5, Competition Principles Agreement, 11 April 1995 accessed at
www.ncc.gov.au/pdf/PIAg-001.pdf
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
67
majority of these have been implemented or are in the process of being
implemented by the Commonwealth and States and Territories.
The Galbally Review’s assessment that the existing legislation is in compliance
with the NCP was subsequently accepted by the National Competition Council. No
substantial changes to the regulatory environment over the past five years have
been identified that would warrant revisiting these conclusions.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
68
Appendix 1: Setting the proposed fees
Methodology
The methodology used to develop the proposed new fees regulations involved the
following:
•
•
•
•
determining the tasks, officer classification level and times needed to
deliver and permit system;
calculating hourly rates, including salaries, salary on-costs, operating costs
and indirect operating costs for each officer classification level:
allocating charges according to the actual costs of the time(s) of the
officer(s) involved; and
assigning a records management cost across all active licences and
permits.
Description of Tasks, Times and Classification Levels
a)
Administrative tasks
Administrative tasks cover all non-inspection related activities. Tasks include
checking applications for completeness and accuracy, record keeping, preparation
of licence and permit documents and correspondence. Table 5 describes the
administrative and inspection tasks (described in b) conducted on applications for
a new or amended licence or permit, the time taken and classification of the
officer performing the task.
Table 5:
Tasks, times and officer classification associated with
assessment of applications for new or amended licences or permits
requiring inspection
Task
Administration check of the application
to ensure all required documentation is
present
Senior Officer allocates the application
to appropriate Field Officer
Field
Officer
pre-screens
the
application and arranges to inspect the
premises
Field Officer travels to the premises,
conducts the inspection, assesses the
Poisons Control Plan and prepares the
inspection report
Input
Admin
Time (hr)
0.3
Classification
VPS-4
Inspection
0.4
VPS-5
Inspection
0.25
VPS-4
Inspection
VPS-4
Senior Officer reviews the inspection
report
Inspection
From 2.5
to
14.5
(depending
on
categories
of
substances
involved –
Table 8)
From 0.5
to
2.0
(depending
on
VPS-5
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
69
Task
Input
Classification
Inspection
Time (hr)
complexity
of
premises
and report
–
see
Table 8)
0.3
Senior
Officer
prepares
the
recommendations for the delegate
Report
with
recommendations
is
finalised
The delegate approves the issue of the
licence or permit
Preparation
and
checking
of
licence/permit document
Licence/permit sent to applicant and
Depart records updated
Admin
0.1
VPS-2
Admin
0.1
VPS-6
Admin
0.6
VPS-4
Admin
0.3
VPS-2
VPS-5
Administration tasks do not include the costs of pre-screening and assessing the
application, inspecting premises, writing the inspection report and review of the
inspection report and writing the recommendations by a Senior Officer.
Administration tasks, time and cost associated with renewals for licences and
permits are provided in Table 6.
Table 6: Administration tasks, times and officer classification associated
with renewal of licences and permits
Task
Time
(hr)
0.1
Prepare renewal report forward renewal notice to
licence or permit holder
Check applications for renewal and pass to Senior 0.1
Officer to deal with significant amendments
Processing of Poisons Control Plan amendments
0.4*
Prepare and check renewed licence or permit 0.3
document and forward to the holder
*Estimated to take an average of 1.2hrs every three years.
Classification
VPS-4
VPS-4
VPS-4
VPS-4
Administration tasks, time and officer classifications involved in processing minor
amendments to licences and permits are provided in Table 7.
Table 7: Administration tasks, times and officer classification associated
with amendments
Task
Review of application/recommendation
Update records/prepare new document
Check for accuracy
Forward to client
Time
(hr)
0.3
0.4
0.3
0.2
Classification
VPS-5
VPS-2
VPS-4
VPS-2
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
70
b)
Inspection procedure
A Field Officer reviews the information provided in the application, conducts a
physical inspection of the premises and compiles the inspection report. A Senior
Officer
reviews
the
report
and
makes
recommendations,
including
recommendations for further action if needed. Activities include assessment of
application information, including the new Poisons Control Plan or amendments to
an existing Poisons Control Plan and carrying out any supplementary checks.
Licences and permits are linked to the one specified premises. Time taken to
check the Poisons Control Plan varies with the type of application and ranges from
0.5 hour to 2 hours. Inspections are conducted of the premises for all new
applications for licences and permits, at the predetermined re-inspection
frequency for applications for permits and licence renewals, and when the existing
licence or permit holders advises they are moving to new premises.
Physical inspection of premises involves the following activities:
•
Examination of records of purchase, supply, use and/or disposal of the
poisons or controlled substances referred to in the licence or permit. In
the case of permits for the provision of health services, inspection includes
examination of patient medication records and reconciliation of
purchases/orders with the administration records.
•
Examination of security, so that poisons or controlled substances are not
accessible to persons who are not adequately equipped to deal with them
or who may wish to misappropriate them.
•
Examination of premises to ensure that they are suitable, sanitary and
adequately equipped. This examination is to help ensure that mistakes
are minimised and that products are true to label and of satisfactory
quality.
•
Assessment of responsible persons to ascertain that they are capable of
complying with the legislation and other standards and that the persons in
charge are fit and proper and appropriately qualified or experienced for
their responsibilities.
•
Examination of labelling and packaging to assess capacity to comply with
legislative standards designed to protect the public and provide safe use
information.
Currently there are 4.8 FTE Field Officers servicing approximately 1250 active
licences and permits. To make most efficient and effective use of inspection
capacity, the timing and frequency of inspections and the time allocated to
conduct inspections are related to the perceived public risk. Inspections of
premises for new licences or permits are high priority, followed by inspections of
new premises for existing licence or permit holders and re-inspections tied to
licence or permit renewals. Inspectors are assigned geographical areas, and to
allow efficiency in travel costs, lower priority inspections are batched. Resources
use din the inspection reflect the size of the premises, the security controls
required, the extent of the hazard (toxicity) of the substances, and the activities
of the licence or permit holder (e.g. manufacturing compared with sale or use).
Consequently, inspection of a major hospital or premises dedicated to the
manufacture and wholesale of Schedule 8 and Schedule 9 poisons occupy the
most resources, estimated at 16.7 and 16.45 hours, respectively, whereas
inspection of premises for a general dealer occupies an estimated 3.95 hours.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
71
Inspection of premises engaged in wholesale or supply of indent stock involves a
visit and record check only.
Estimated inspection times for each type of licence and permit used to calculate
the respective fees are shown in Table 8. The inspection includes the time for the
pre-screening and assessing the Poisons Control Plan, travelling to and
conducting the inspection and writing and review of the inspection report and
recommendations.
Table 8: Total time spent for inspections, including pre-screen, travel,
physical inspection, check of the poisons control plan and preparation
and review of the inspection reports and recommendations.
ID
Type of Licence or Permit
MA
Manufacture and sell by wholesale any
Schedule 8 or Schedule 9 poison other
than heroin
Manufacture and sell or supply by
wholesale Schedules 4 poison
Manufacture and sell or supply by
wholesale Schedules 2, 3 or 7 poisons
Manufacture and sell or supply by retail
any Schedule 7 poison (other than a
Schedule 7 poison included in the Poisons
Code in the list of substances that are not
for general sale by retail)
Sell or supply by wholesale any Schedule
8 or Schedule 9 other than heroin
Sell or supply by wholesale Schedule 4
poisons
Sell or supply by wholesale Schedule 4
poisons
Sell or supply by indent only any
Schedule 2, 3, 4, 7 and 8 poisons and
Schedule 9 poison other than heroin
Sell or supply by retail any Schedule 2
poison
Permit to purchase or obtain and use
poisons any Schedule 8 or 9 poisons, or
any Schedule 8 or 9 poison plus any
Schedule 2, 3, 4, 7 poison for industrial,
educational or research purposes
Permit to purchase or obtain and use
poisons any Schedule 2, 3, 4, 7 poisons
for industrial, educational or research
purposes
Permit to purchase or obtain and use any
poisons or controlled substances for the
provision of health services
Type A
Type B
Type C
Type D
MP4
MP 2,3,7
MPR 7
WA
WP 4
WP 2, 3, 7
WA/WP
Indent
GDL
Permit 8, 9
Permit
3, 4, 7
HSP
2,
VPS-4
time
(hr)*
13.75
VPS-5 time
(hr)**
9.25
1.7
6.75
1.7
5.25
1.7
13.75
2.7
9.25
1.7
6.75
1.7
5.25
1.7
2.75
1.2
5.25
1.45
4.75
1.2
3.25
6.75
8.75
14.75
1.2
1.45
1.7
1.95
2.7
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
72
*includes 0.25 hour for pre-screening and arranging the visit to the premises
**includes 0.7 hour for allocation and compiling recommendations
The level of public risk is also factored into the frequency of re-inspections for
licence and permit renewals for existing holders. Re-inspection frequencies are
established at practical levels and designed to provide an acceptable level of
compliance monitoring. Re-inspections are scheduled to occur between every 1.5
years to every 7 years, depending on the public risk. The highest frequency of
re-inspection is reserved for premises dealing with drugs of dependence, for
example premises to be used for the manufacture and/or wholesale of Schedule 8
poisons. In addition, Victoria is required to monitor the use of Schedule 8 poisons
as part of Australia’s responsibilities under international treaties to which it is a
signatory.
The cost of the re-inspection includes the annual cost for administration and
provision of advice, and the cost of re-inspection. Licence and permit holders are
expected to amend the Poisons Control Plan as often as necessary, and to provide
the amended plan to the Department for review. The renewal fee builds in costs
to cover an average of one review or assessment of amendments to the Poisons
Control Plan every 3 years. Renewal costs are annualised to account for the
three-yearly review of the Poisons Control Plan (annualising factor of 0.33) and
the other various re-inspection frequencies as defined in Table 9.
Table 9: Re-inspection frequency for licence or permit renewal
Licence or permit
Type
MA
MP 4
MP 2, 3, 7
MRP 7
WA/Indent
WP 4/Indent
WP 2, 3, 7/Indent
GDL
Permit 8, 9
Permit 2, 3, 4, 7
Permit for health
services
Type
Type
Type
Type
c)
A
B
C
D
Poisons Control Plan
Review
Average rate of once
every:
3 years
3 years
3 years
3 years
3 years
3 years
3 years
3 years
3 years
3 years
Rate – once
every:
1.5 years
3 years
5 years
5 years
1.5 years
3 years
5 years
7 years
5 years
7 years
Annualising
factor
0.67
0.33
0.2
0.2
0.67
0.33
0.2
0.143
0.2
0.143
3
3
3
3
7
5
4
3
0.143
0.2
0.25
0.33
years
years
years
years
Re-inspection
years
years
years
years
Provision of advice
Clients frequently contact the Drugs and Poisons Unit at DHS for advice about the
Act and Regulations, the status of their existing licence or permit, with requests
for application or amendment forms and with queries on the implementation of
legislative and other standards and the scheduling of drugs and poisons. In
addition, Field Officers conduct ad hoc visits to pharmacies during which they
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
73
answer questions and raise awareness as well as monitoring prescribing trends in
particular for drugs of dependence, and conduct any necessary follow up.
The advisory service is provided through Field Officers conducting such ad hoc
visits and the daily Duty Officer in the Office who is usually assisted by other
trained and experienced officers. Field Officers spend at least one day per week
as Duty Officer and with the assistance of others as required, respond to
telephone and written enquiries clients across the range of licence and permit
holders, health professionals and the public.
The total cost of providing the advisory service is based on the input cost of the
various officers providing the advice and is expressed as a percentage of FTE.
Across all levels, DHS allocates 1.4 FTE to provide advice, of which an estimated
0.9 FTE is related to licences and permit matters. The time involved in providing
the advisory service for licence and permit holders is shown in Table 10.
Table 10: Time spent in provision of advice
Classification
VPS-5
VPS-5
VPS-4
VPS-4 Administration
Time (% of FTE)
30% x 1
6% x 2
6% x 3
30% x 1
The expected number of active licences and permits for 2005-06 is 1250. The
total cost of providing the advisory service is $102,262.20, and is apportioned
across low input and high input licence and permit types as defined in Table 11.
Low input licence and permit types (Tier 1) are estimated to account for 25% of
advice costs, while high input licence and permit types (Tier 2) are estimated to
account for 75% of advice costs. This corresponds to an advice cost of $48.10 for
Tier 1 and $144.30 for Tier 2 licences and permits. These costs are incorporated
into the new application and annual renewal fees.
Table 11: Advice Input – Tier 1 and Tier 2
Tier 1
Low Input
MP 2, 3, 7
MRP 7
WP 2, 3, 7
WA/Indent
WP 4/Indent
WP 2, 3, 4, 7
GDL
Permit 8, 9
Permit 2, 3, 4, 7
Health Services Type A
Health Services Type B
d)
Tier 2
High Input
MA
MP 4
WA
WP4
Health Services Permit Type C
Health Services Permit Type D
Rationale for calculation of fees
New Applications
Fees for new licences or permits are calculated to cover costs for administration
(including record keeping), full inspection and provision of advice. In calculating
the fee for a new licence or permit application, the following formula is used.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
74
Application Fee = Administration costs + Inspection costs + Provision of advice.
Renewals
In the case of renewals of licences and permits, a slightly more complex
calculation is required, and the following formula is used:
Renewal Fee = Administrative costs (including record keeping) + Annualised
Inspection costs (including annualised Poison Control Plan amendment costs) +
Provision advice.
Providing Advice
In calculating a fee for providing advice, the total cost of time spent by all officers
in providing advice on licence and permit functions of the Drugs and Poisons Unit
is apportioned across low input (Tier 1) and high input (Tier 2) licence and permit
types.
Amendments
Amendment fees are calculated as follows:
i.
ii.
Amendment with inspection – the fee is the same as for new applications
Amendment without inspection – the fee reflects the administrative cost.
Database Depreciation Costs
Database depreciation costs are estimated at $62,500 per year. This is derived
by assuming the replacement development cost would be the same as the
original development costs, i.e. $500,000 and that the database would be
replaced in 2011, i.e. after 8 years of operation. An estimated 30% of Database
usage is dedicated to licences and permits. The Database services an estimated
1250 active licences and permits per year. The depreciation cost at 30% of total
cost is $18,750 per year (noting that maintenance costs are not included). This
corresponds to $15 per active licence or permit per year. This is added into the
Administration costs for initial application and renewal. Note that the cost of a
replacement database is uncertain at this time.
Costs are calculated in Appendices 1A, 1B, and 1C
Fees are converted to fee units valid for 2005-2006.
APPENDICES
Appendix 1A
Appendix 1B
Appendix 1C
Salaries and operating costs
Administration costs
Total costs for new applications and renewals
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
75
Appendix 1A: Salaries and operating costs
Table 12: Resource cost per hour – salaries and salary on-costs, direct
and indirect operating costs and corporate costs
Salaries mid
level
1 Oct 2005
Salary, plus
salary
oncosts
(19.57%)(1)
Salary costs
plus all other
on-costs
$
(2)
Total
resource
cost
per
hour $ (3)
VPS-6
VPS-5
VPS-4
VPS-3
VPS-2
$94,055
$72,474
$60,670
$51,818
$40,672
$112,462
$86,657
$72,543
$61,959
$48,632
$145,975
$122,726
$105,661
$84,913
$68,800
$73.62
$61.90
$53.29
$42.83
$34.70
(1) Salary and salary on-costs (salaries selected at mid level and includes
salary increase of 1 October 2005 (Victorian Public Service Agreement
2004))
(2) Includes (1) plus accommodation cost, operating expenses, other indirect
costs, corporate support and motor vehicle cost (Field Officers only) (as
provided in Table 13).
(3) Hourly rate calculated as total cost/365.25x14/76.
Table 13:
Additional costs – salary on-costs, direct and indirect
operating costs, accommodation and corporate costs
Payroll tax 5.72%
Workcover 1.00%
Superannuation 9.00%
Holiday loading 1.35%
Long
Service
Leave
2.50%
Accommodation
Operating expenses (1)
Other indirect costs (2)
Corporate support (3)
Motor vehicles
$10,000
10% direct salary
5% direct salary
10% direct salary
$7,950
Database Charge (4)
$18,750 per year
Total = 19.57%
Per Officer
Per Field Officer (VPS-5
and VPS-4)
Amalgamated into Admin
costs
for
initial
application or renewal, at
$15.00 per active licence
or permit
DHS Planning and Resources Branch provided all direct and indirect costings
(1)
(2)
(3)
(4)
Section operating budget – eg travel and accommodation, stationery, telephone,
printing, postage, staff development and training, depreciation on computers and
office machines
Desktop licences, fringe benefits tax, IT data line payments
Library, legal, administration and financial services
Database depreciation costs – assume a replacement cost equal to the original
development cost of $500,000, replacement within 8 years, development costs
for licences and permits at 30% of total costs, corresponds to depreciation of
$18,750 per year, and over 1250 active licences and permits corresponds to $15
per licence or permit.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
76
Appendix 1B: Administration costs
Table 14:
Administration costs for new applications, renewals and
amendments
New Applications
Classification
Time taken in all
steps (hr)
VPS6
0.10
VPS5
0.00
VPS4
0.90
VPS3
0.00
VPS2
0.40
Database
Cost per hour
$
73.62
61.90
53.29
42.83
34.70
Total
Total cost
$
7.36
0.00
47.96
0.00
13.88
15.00
84.20
Renewals
VPS6
VPS5
VPS4
VPS3
VPS2
0.00
0.00
0.90
0.00
0.00
Database
73.62
61.90
53.29
42.83
34.70
Total
0.00
0.00
47.96
0.00
0.00
15.00
62.96
73.62
61.90
53.29
42.83
34.70
TOTAL
0.00
18.57
15.99
0.00
20.82
55.38
Amendments
VPS6
VPS5
VPS4
VPS3
VPS2
0.0
0.3
0.3
0.0
0.6
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
77
Table 15:
reports
Costs of inspections, including preparation of inspection
Type of Licence or Permit
MA
MP 4
MP
2,3,7
MPR 7
WA
WP 4
WP
2,3,7
WA/WP
Indent
GDL
Manufacture and sale or supply
by wholesale of any Schedule 8
or 9 poison, other than heroin
Manufacture and sale or supply
by wholesale Schedule 4 poisons
Manufacture and sale or supply
by wholesale Schedules 2, 3 or 7
poisons
Manufacture and sale or supply
by retail any Schedule 7 poison
(other than a Schedule 7 poison
included in the Poisons Code in
the list of substances that are
not for general sale by retail)
Sale or supply by wholesale any
Schedule 8 or 9 poison other
than heroin
Sale or supply by wholesale
Schedule 4 poisons (together
with any Schedule 2, 3 or 7
poisons)
Sale or supply by wholesale
Schedule 2, 3 or 7 poisons
Proposed Fees
VPS-4
time (hr)
13.75
VPS-5
(hr)
2.7
time
Total
cost $
899.87
9.25
1.7
598.16
6.75
1.7
464.94
5.25
1.7
385.00
13.75
2.7
899.87
9.25
1.7
598.16
6.75
1.7
464.94
5.25
1.7
385.00
Sale or supply by retail any 2.75
1.2
220.83
Schedule 2 poison
Permit
Permit to purchase or obtain or 5.25
1.45
369.53
8,9
use any Schedule 8 or 9 poison,
or any Schedule 8 o 9 poison
plus any Schedule 2, 3, 4 or 7
poison for industrial, educational
or research purposes
Permit
Permit to purchase or obtain and 4.75
1.2
327.41
2,3,4,7 use any Schedule 2, 3, 4 or 7
poisons
for
industrial,
educational or research purposes
Health Services Permit – to purchase or obtain and use any poisons or controlled
substances for the provision of health services
Type A
Type A – single site, no beds
3.25
1.2
247.47
Type B
Type B – residential aged care, 6.75
1.45
449.46
single storage facility (no bed
limit) OR single site of 1 to 30
beds
Type C
Type C – multiple sites and no 8.75
1.7
571.52
beds OR 31 to 100 beds
Type D Type D – multiple sites OR more 14.75
1.95
906.73
than 100 beds
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
78
Table 16: Time and Cost for provision of advice
Classification
VPS-5
VPS-5
VPS-4
VPS-4 Admin
Time (% of FTE)
30% x 1
6% x 2
6% x 3
30% x 1
Total FTE 0.9
Cost (% total cost)
$36,817.80
$14,727.12
$19,018.98
$31,698.30
$102,262.20
Advice costs are apportioned across licence and permit types according to
estimate resource inputs.
Tier 1 licence and permit types account for
approximately 65% of the total number of active licences and permits but are
estimated to account for 25% of resource inputs. Tier 2 licence and permit types
account for approximately 35% of the total number of active licences and permits
but are estimated to account for 75% of resource inputs. Accordingly, for an
estimated 1250 active licences and permits, Tier 1 types are costed at $48.10
and Tier 2 types are costed at $144.30.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
79
Appendix 1C: Total costs for new applications and renewals
Table 17: New Applications - Total administration, inspection and advice
costs
Type of Licence or Permit
MA
MP 4
MP
2,3,7
MPR 7
WA
WP 4
WP
2,3,7
WA/WP
Indent
GDL
Manufacture and sale or supply
by wholesale of any Schedule 8
or 9 poison, other than heroin
Manufacture and sale or supply
by wholesale Schedule 4 poisons
Manufacture and sale or supply
by wholesale Schedules 2, 3 or 7
poisons
Manufacture and sale or supply
by retail any Schedule 7 poison
(other than a Schedule 7 poison
included in the Poisons Code in
the list of substances that are
not for general sale by retail)
Sale or supply by wholesale any
Schedule 8 or 9 poison other
than heroin
Sale or supply by wholesale
Schedule 4 poisons (together
with any Schedule 2, 3 or 7
poisons)
Sale or supply by wholesale
Schedule 2, 3 or 7 poisons
Admin
Cost $
84.20
Inspection Cost $
899.87
Advice
cost $
144.30
Total
cost $
1128.37
84.20
598.16
144.30
826.66
84.20
464.94
48.10
597.24
84.20
385
48.10
517.30
84.20
899.87
144.30
1128.37
84.20
598.16
144.30
826.66
84.20
464.94
48.10
597.24
84.20
385
48.10
517.30
Sale or supply by retail any 84.20
220.83
48.10
353.13
Schedule 2 poison
Permit
Permit to purchase or obtain or 84.20
369.53
48.10
501.83
8,9
use any Schedule 8 or 9 poison,
or any Schedule 8 o 9 poison
plus any Schedule 2, 3, 4 or 7
poison for industrial, educational
or research purposes
Permit
Permit to purchase or obtain and 84.20
327.41
48.10
459.71
2,3,4,7 use any Schedule 2, 3, 4 or 7
poisons
for
industrial,
educational or research purposes
Health Services Permit – to purchase or obtain and use any poisons or controlled
substances for the provision of health services
Type A
Type A – single site, no beds
84.20
247.47
48.10
379.77
Type B
Type B – residential aged care, 84.20
449.46
48.10
581.76
single storage facility (no bed
limit) OR single site of 1 to 30
beds
Type C
Type C – multiple sites and no 84.20
571.52
144.30
800.02
beds OR 31 to 100 beds
Type D Type D – multiple sites OR more 84.20
906.73
144.30
1135.23
than 100 beds
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
80
Table 18: Renewals - total administration, inspection and advice costs for
licences and permits
Type of Licence or Permit
MA
MP 4
MP
2,3,7
MPR 7
WA
WP 4
WP
2,3,7
WA
Indent
WP4
Indent
WP
2,3,7
Indent
GDL
Permit
8,9
Permit
2,3,4,7
Manufacture and sale or supply
by wholesale of any Schedule 8
or 9 poison, other than heroin
Manufacture and sale or supply
by wholesale Schedule 4 poisons
Manufacture and sale or supply
by wholesale Schedules 2, 3 or 7
poisons
Manufacture and sale or supply
by retail any Schedule 7 poison
(other than a Schedule 7 poison
included in the Poisons Code in
the list of substances that are
not for general sale by retail)
Sale or supply by wholesale any
Schedule 8 or 9 poison other
than heroin
Sale or supply by wholesale
Schedule 4 poisons (together
with any Schedule 2, 3 or 7
poisons)
Sale or supply by wholesale
Schedule 2, 3 or 7 poisons
Sale or supply by retail any
Schedule 2 poison
Permit to purchase or obtain or
use any Schedule 8 or 9 poison,
or any Schedule 8 o 9 poison
plus any Schedule 2, 3, 4 or 7
poison for industrial, educational
or research purposes
Permit to purchase or obtain and
use any Schedule 2, 3, 4 or 7
poisons
for
industrial,
educational or research purposes
Admin
Cost $
Advice
cost $
Total
cost $
62.96
Annualised
Inspection Cost $
566.68
144.30
773.94
62.96
197.39
144.30
404.65
62.96
99.92
48.10
210.98
62.96
83.93
48.10
194.99
62.96
566.68
144.30
773.94
62.96
197.39
144.30
404.65
62.96
99.92
48.10
210.98
62.96
239.83
48.10
350.89
62.96
127.05
48.10
238.11
62.96
83.93
48.10
194.99
62.96
36.56
48.10
147.62
62.96
80.83
48.10
191.89
62.96
51.80
48.10
162.86
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
81
Health Services Permit – to purchase or obtain and use any poisons or controlled
substances for the provision of health services
Type A
Type A – single site, no beds
62.96
40.37
48.10
151.43
Type B
Type B – residential aged care, 62.96
103.75
48.10
214.81
single storage facility (no bed
limit) OR single site of 1 to 30
beds
Type C
Type C – multiple sites and no 62.96
151.41
144.30
358.67
beds OR 31 to 100 beds
Type D Type D – multiple sites OR > 100 62.96
299.22
144.30
506.48
beds
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
82
Table 19: Proposed licence fees for manufacture and supply of poisons,
expressed in fee units 21
Type of Licence or Permit
MA
MP 4
MP
2,3,7
MPR 7
WA
WP 4
WP
2,3,7
WA
Indent
WP4
Indent
WP
2,3,7
Indent
GDL
Permit
8,9
Permit
2,3,4,
7
Manufacture and sale or supply by
wholesale of any Schedule 8 or 9
poison, other than heroin
Manufacture and sale or supply by
wholesale Schedule 4 poisons
Manufacture and sale or supply by
wholesale Schedules 2, 3 or 7
poisons
Manufacture and sale or supply by
retail any Schedule 7 poison (other
than a Schedule 7 poison included
in the Poisons Code in the list of
substances that are not for general
sale by retail)
Sale or supply by wholesale any
Schedule 8 or 9 poison other than
heroin
Sale or supply by wholesale
Schedule 4 poisons (together with
any Schedule 2, 3 or 7 poisons)
Sale or supply by wholesale
Schedule 2, 3 or 7 poisons
Sale or supply by wholesale any
Schedule 8 or 9 poison other than
heroin – by Indent
Sale or supply by wholesale
Schedule 4 poisons (together with
any Schedule 2, 3 or 7 poisons) –
by Indent
Sale or supply by wholesale
Schedule 2, 3 or 7 poisons – by
Indent
Sale or supply by retail any
Schedule 2 poison
Permit to purchase or obtain or
use any Schedule 8 or 9 poison, or
any Schedule 8 o 9 poison plus
any Schedule 2, 3, 4 or 7 poison
for
industrial,
educational
or
research purposes
Permit to purchase or obtain and
use any Schedule 2, 3, 4 or 7
poisons for industrial, educational
or research purposes
Proposed Fees – Fee Units
Application
Renewal Amendment
107.6
73.8
5.3
78.8
38.6
5.3
56.9
20.1
5.3
49.3
18.6
5.3
107.6
73.8
5.3
78.8
38.6
5.3
56.9
20.1
5.3
49.3
33.4
5.3
49.3
22.7
5.3
49.3
18.6
5.3
33.7
14.1
5.3
47.8
18.3
5.3
43.8
15.5
5.3
21
Table calculated on the basis of the current value of a fee unit of $10.49, as
published in the Government Gazette of 14 April 2005
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
83
Health Services Permit – to purchase or obtain and use any poisons or controlled
substances for the provision of health services
Type
Type A – single site, no beds
36.2
14.4
5.3
A
Type
Type B – residential aged care, 55.5
20.5
5.3
B
single storage facility (no bed
limit) OR single site of 1 to 30
beds
Type
Type C – multiple sites and no 76.3
34.2
5.3
C
beds OR 31 to 100 beds
Type
Type D – multiple sites OR more 108.2
48.3
5.3
D
than 100 beds
NB: Indent refers to supply of drugs where the licence holder does not take
possession.
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
84
Appendix 2: Proposed Drugs, Poisons and
Controlled Substances Regulations 2006
Regulatory Impact Statement: Drugs, Poisons and Controlled Substances Regulations 2006
85