Submission to the Therapeutic Goods Administration regarding

Changes to accessing unapproved therapeutic goods through the

Authorised Prescriber (AP) and Special Access Schemes (SAS)

This joint submission is made by:

The Society of Hospital Pharmacists of Australia (SHPA)

SHPA is the national professional organisation with more than 4,400 pharmacists, pharmacist interns,

students, technicians and associates working across Australia’s health system and are supported by

Branches around the country. SHPA members lead the Pharmacy Departments at 29 of the principal referral

hospitals in Australia, as well as the vast majority of both Public Acute A and Public Acute B hospitals.

Council of Australian Therapeutic Advisory Groups (CATAG)

CATAG is an authoritative, expert, consensus-based collaboration of representatives from all Australian

State and Territory Therapeutic Advisory Groups or their jurisdictional committee equivalents

New South Wales Therapeutic Advisory Group (NSWTAG)

The New South Wales Therapeutic Advisory Group Inc. (NSW TAG) is an independent, not-for-profit

member-based organisation, comprised of clinical pharmacologists, pharmacists, nurses and clinicians

committed to advancing quality use of medicines (QUM) in NSW public hospitals and the wider community.

Victorian Therapeutic Advisory Group (VicTAG)

The Victorian Therapeutics Advisory Group (VicTAG) is an independent, not-for profit association. VicTAG

members are hospital pharmacists and medical specialists from Victorian hospitals. VicTAG ‘s purpose is to

promote quality use of medicines by sharing unbiased, evidence-based information about medication

therapy and to support the goals of, and facilitate the National Medicines Policy of access, quality, an d

safety in the use of medicines in Victorian hospitals.

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Introduction

On behalf of our members, SHPA, CATAG, VICTAG and NSWTAG welcome the opportunity to give advice on

proposed changes to the Authorised Prescriber (AP) Scheme and the Special Access Scheme (SAS) Category

B. Our members provide clinical care to the most complex and unwell patients as part of their daily

practice, and often rely on these access schemes to procure medicines (frequently of a specialised nature)

to provide the highest quality care.

Key Recommendations

Recommendations for Special Access Scheme

Changes to SAS Category B to allow notification only must specifically allow health service facilities

to procure stock in advance of expected usage (i.e. procurement not tied to a specific patient).

Transparency is required by the regulator in the decision-making process when medicine products

are both included and removed from the SAS Category B notification list.

Suitable unregistered products that can be supplied to meet a national medicine shortage should

be included on the SAS Category B notification list.

Medicines to treat potentially serious morbidity (i.e. loss of limb, blindness) should be included on

the SAS Category B notification list.

Medicines on the SAS B notification list must be accompanied by indication as there may be times

when a medicine may be eligible for SAS Category B notification for a certain indication but not for

other indications.

Where more than one unregistered product of the same medicine is available, it would be desirable

for the regulator to provide a comparative analysis and/or nominate a preferred product.

Comparative analysis would provide details of international regulator(s) evaluations and approvals,

and packaging, labelling and consumer medicines information (preference for English). This would

achieve objectives in the National Medicines Policy pertaining to access to medicines that meet

appropriate standards of quality, safety and efficacy, and quality use of medicines. The

responsibility best sits with the TGA as they have the expertise to undertake such an activity.

Due to concerns about counterfeit or sub-standard drugs entering into the Australian market via

the SAS scheme, guidance should be provided to allow healthcare professionals to obtain stock

from a reputable source.

Systematic communication of SAS approvals (whether automatic via notification list or via TGA

evaluation of application) to pharmacies/hospital pharmacy departments and Drug and

Therapeutic Committees (accessible portal and/or direct communication to relevant

pharmacies/hospital pharmacy departments and DTCs) is essential.

Further analysis of SAS Category A products is recommended as some may be more appropriate as

SAS Category B items.

Pharmacovigilance and data collection for effectiveness should be incorporated into the SAS and AP

scheme.

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Recommendations for Authorised Prescriber Scheme

The regulator should provide advice to HRECs and specialist medical colleges as to the quality of

evidence that would constitute appropriate endorsement of a prescriber under this scheme.

The Drug and Therapeutics Committee (DTC) of a health service should also be considered as an

alternate endorser of authorised prescriber in addition to HREC or specialist medical colleges.

Systematic communication of AP endorsement by HRECs and professional colleges to

pharmacies/hospital pharmacy departments and Drug and Therapeutic Committees (accessible

portal and/or direct communication to relevant pharmacies/hospital pharmacy departments).

Recommendations for online system

The online system should empower the TGA to improve the current level of oversight with respect

to surveillance, pharmacovigilance and compliance activities related to the SAS scheme, taking

advantage of its logistic capabilities, with the view to inform future policy.

The online system should provide the same level of oversight with respect to administration of the

AP Scheme, which should also have the capability for clinicians to upload documents from specialist

colleges/HRECs and supporting clinical information.

An online system should be built without delay. Integration into prescribing and dispensing

software should be considered as Phase 2 of the development. More important than

interoperability with prescribing and dispensing software is building electronic capability for

pharmacovigilance and effectiveness evaluation in TGA systems that manage unregistered

medicines via SAS and AP scheme. Linking with the My Health Record database is recommended.

Given the online system for Category B notification products will provide automated approval

(similar to the current streamlined PBS authority scheme), prescribers should be required to

acknowledge their compliance with SAS requirements. (Non-automated approval for all other

unregistered medicines obtained via the SAS scheme using the online system will also require

agreement to requirements).

Medicines procured and used under SAS Category B and eligible for notification via the online

system cannot be obtained without mandatory completion of each section. This will include details

of responsible senior treating doctor, indication, proposed duration of use, Drug and Therapeutics

Committee (DTC) and pharmacy/pharmacy department details.

For hospital use of an SAS product: As hospital/ district Drug and Therapeutics Committees (DTCs)

will continue their ongoing responsibility for formulary management and individual patient use

applications (via independent review), the online system should promptly and systematically

inform the responsible DTC of approvals through the SAS online system.

For hospital and community use of a SAS product: the online system should promptly and

systematically inform the relevant community pharmacy/hospital pharmacy department through

the SAS online system

The online system should consider mandatory provisions for clinicians to give feedback to the

regulator regarding patient outcomes and if the unregistered medicine was clinically useful.

The online system should automatically provide patient consent forms with pre-filled information

available through the application process.

The online system should have provision for registration for not only the clinicians involved, but

also the health service facility or hospital network, such that specific site reports cam be produced

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General comment regarding role and responsibilities of the Australian regulator for

unregistered medicines

We acknowledge and appreciate the expertise and robust activity undertaken by the TGA in its role as

Australia’s medicines and medical devices regulator. The TGA is largely a self-funded body that relies on

fees charged to pharmaceutical manufacturers and sponsors, which differ to other regulators such as the

Food and Drug Administration (FDA) and the European Medicines Agency (EMA) who receive specific

government funding. This means that regulatory activities for the public good such as regulation of

unregistered medicines via the SAS and AP scheme are cross-subsidised by other TGA activities and

potentially under-resourced. This is of particular concern given there is less safety and effectiveness

information about these products for the clinician and consumer. The current regulation activity for these

products represents a lost opportunity to collect information about unregistered medicines’ safety and

effectiveness.

Our organisations recommend that changes to the regulatory logistics for unregistered medicines should

advance the capabilities of the TGA to ensure improved effectiveness and safety with the use of these

medicines as outlined in this submission. It is proposed that resources currently allocated for functions that

will become obsolete once the online system is implemented, be diverted to enhancing pharmacovigilance

and surveillance activities.

Medicinal cannabis (currently accessible via the SAS Category B and AP scheme) provides an opportunity

for a pilot in which the TGA tests it capacity and processes in order to collect, analyse and report clinical

outcome and safety data and inform policymakers, clinicians and consumers about its effectiveness and

safety. Given the difficulties with blinded assignation in clinical trials of some forms of medicinal cannabis,

real world data regarding safety and effectiveness will be crucial for assessment. Such a pilot could provide

a business case for further pharmacovigilance and effectiveness evaluation activities by the TGA. This could

potentially dovetail into new pathways for the registration of therapeutic goods which are currently

considered as part of the wider Review of Medicines and Medical Devices Regulation (MMDR).

Special Access Scheme Category B policy changes

We are pleased to see Recommendation 24 of the MMDR progressed to enable access to certain

unapproved therapeutic goods through a notification process.

Enabling streamlined access to a specific list of unregistered therapeutic goods via a SAS Category B

notification process, to reduce administrative burden and maintain an appropriate level of regulation, is

welcome. The proposal is a reasonable solution to the current application process, which is burdensome for

clinicians and the TGA as the regulator, as well as having potential adverse impact on the quality of patient

care. The introduction of a medicines notification list would alleviate the delay in treatment for those

patients, particularly when requiring importation of medicines, thereby reducing potential patient harm.

At present, pharmaceutical companies will not supply SAS Category B medicines without prior approval by

the TGA, which means health service facilities are unable to pre-emptively stock SAS Category B medicines.

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To ensure Australians can access timely and appropriate treatment, products on the SAS B notification list

should be able to be purchased by health service facilities prior to specific patient need in quantities

commensurate to their anticipated use.

Is the proposed criterion suitable for identifying unapproved therapeutic goods that are suitable for

notification? Are there any amendments to the proposed criterion that would enhance the process?

Any criterion established to identify an unregistered therapeutic good as eligible for notification, needs to,

at a minimum, maintain the current level of oversight with regard to safety and efficacy. The points listed

on Page 7 of the consultation paper are all appropriate safety concerns and considerations in deciding

which medicines are eligible for notification. Medicines on the SAS Category B list should be linked to

indication(s) and the indication and (maximum) duration of therapy should be specified in the notification.

All Category B medicines on the notification list should have details regarding evaluation and registration by

international regulators. When it is deemed that there is more than one suitable product of a medicine (in a

similar formulation) this should also be reported on the notification list, preferably with a comparative

assessments. As the TGA progresses the move towards an online system, it is envisaged that capacity for

pharmacovigilance and compliance activities will be built into the system’s capability.

There are currently 13 SAS medicines listed in the NSW Life Saving Drugs Register, many of which are first-

line antidotes for their respective poisonings. We recommend that a criterion that enables any SAS

medicine on a jurisdictional lifesaving drugs list (for use in poisonings/deliberate self-poisonings) be

included in the SAS Category B notification list. Such a listing would enable hospitals to pre-emptively stock

these medicines. (Please refer to NSW TAG and VicTAG Life Saving Drug Registers for listings:

http://www.ciap.health.nsw.gov.au/nswtag/pages/life-saving-drugs-register.html and

http://www.victag.org.au/register-of-emergency-and-life-saving-medicines

Another group of unregistered medicines that could be included on the Category B notification list are

medicines used to treat serious morbidity e.g. loss of limb. Currently they do not fit the criteria for

Category A (lifesaving) to keep on-hand, but the urgency of the condition means current Category B

protocols are inappropriate.

We recommend that when a medicine is removed from the notification list, the rationale for the decision is

communicated to clinicians, health service facilities and patients. More broadly, it would be helpful to all

stakeholders if the TGA provided transparency on the listing (and de-listing) process for Category B SAS

medicines and provided detail regarding the threshold for removal (and addition) to the notification list.

The regular TGA email update can be one way of providing updates to clinicians about SAS Category B

notification listings.

Proactive and periodic review of the criteria by the TGA will be required. All medicines on the SAS Category

B notification list should also be reviewed for their eligibility periodically and earlier reviews could be

triggered if newer clinical evidence emerges or if there is disruption to supply of the medicine from

overseas.

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Further SAS policy considerations

To further improve governance of the SAS, prescribers and other clinicians should be cognisant that the SAS

product may not have been manufactured to the high quality standards that would normally be required

for marketing authorisation. Due to concerns about counterfeit or sub-standard drugs entering into the

Australian market via the SAS scheme, guidance should be provide to allow healthcare professionals to

obtain stock from a reputable source or from jurisdictions with comparable regulators. This information can

be disseminated via the proposed online system.

Currently there are approximately 40,000 SAS Category A applications per year. The intent of SAS Category

A is to enable use of unregistered medicines for imminent life-threatening conditions where there is no

suitable medicine alternative registered in Australia. Because of the burdensome nature of the current

system, it is likely that some workarounds have been used to enable timely access to unregistered

medicines in serious but not imminently life-threatening situations. It is envisaged that the Category B

notification system will reduce the administrative burden for both SAS Category A and B medicines. To

achieve this, it is recommended that an analysis of SAS Category A medicines is undertaken and

consideration of whether some of these medicines are better placed on the SAS Category B notification list

be made.

Health funds are becoming more reluctant to reimburse fund members for SAS medications despite there

being valid reasons for their use, and despite being reimbursed in the past. For example:

Increasing reluctance by health funds to reimburse patients for urokinase, the most appropriate

medicine to treat peripheral vascular occlusion at various stages of the condition. This medicine

costs approximately $2,000 per course.

Another potentially unaffordable medicine that can be caught that in this funding gap includes

mexiletine used as ongoing therapy for various uncommon myopathies when other antiarrhythmics

have failed.

Reimbursement for levosimendan use in acute on chronic heart failure is now frequently refused

despite previous reimbursement practices.

Increasingly health funds consider that they should be part of the clinical decision-making with regard to

medicines reimbursement and request clinical information to inform reimbursement approvals. It should

also be noted that there is reimbursement variation for various medicines between health funders. A better

understanding of the SAS scheme and the choices facing clinicians and patients should be advocated to

health funders by the TGA and health and consumer organisations. Clarity about why individual medicines

are available via SAS would be helpful in this regard. For example, a medicine may have robust supporting

evidence but if the pool of eligible patients is small in Australia, a pharmaceutical company may decide not

to market the medicine in Australia, and thus it is appropriate for health funds to fund such medicines. A

failure to reimburse such medicines does not align with the principles of Australia’s National Medicines

Policy.

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Implications for medicines shortages

Medicine shortages are a significant issue, and cause difficulties for clinicians, patients, health service

facilities and regulators. Although drug shortages are multifactorial in nature, an increasingly global

perspective to manufacture and supply is being adopted by pharmaceutical companies. The incidence and

prevalence of drug shortages is increasing and having a significant impact on patient care. The SAS and

other procurement methods for unregistered drugs are increasingly used to fill medicine supply gaps

related to drug shortages.

When medicines shortages occur, many hospital pharmacy managers are required to use the SAS as a

potential solution. We suggest the TGA considers a method to alleviate significant administrative burden of

medication shortages in the context of SAS when adjusting the policy parameters regarding the regulatory

management of unregistered medicines. The alternative product(s), if unregistered, should be included in

the SAS Category B notification list. This is especially important as obtaining medicines via Section 19A of

the Therapeutic Goods Act 1989, whether triggered by the sponsor of the medicine in shortage or not,

takes some weeks to be organised. Once the product is available under Section 19A, it could be removed

from the SAS B notification list.

TGA should consider making it mandatory that manufacturers provide timely ‘out of stock’ notifications to

the regulator as part of the registration requirements. The current voluntary system is of limited benefit

and provides inadequate information for health care professionals to make decisions around patient care. It

also leads to replication of activity in multiple sites across Australia.

There have been recent examples where there has been delayed access to urgent medicines (e.g.

intravenous antimicrobials) due to short supply under Section 19A. When the stock was supplied from an

overseas source, it required relabelling to meet Australian requirements, this further delayed access to

these lifesaving medicines.

Communication

In addition to publishing the notification listing on the TGA website, how else could we make

stakeholders aware of what therapeutic goods are on the SAS Category B notification list?

In addition to publishing information on the TGA website, how else could we communicate the changes

to the SAS B scheme to stakeholders?

There are a variety of existing networks which can be utilised to communicate changes, such as Pharmacy

Board of Australia (PBA) communiques, as well as PBA’s database of all registered health practitioners. The

network of Chief Medical Officers and Chief Pharmacists in the jurisdictions are also an important

engagement tool. Professional societies such as the Society of Hospital Pharmacists of Australia, also have a

major role in informing our members with respect to any regulatory changes. The various Therapeutic

Advisory Groups and their national organisation, CATAG, have close links with the public hospital networks

and Drug and Therapeutic Committees. NSWTAG has a weekly newsletter, TAGMail, which highlights

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weekly updates from the TGA. NPS MedicineWise may also have a role communicating information via

their website and activities as well as via Australian Prescriber journal. The organisations mentioned above

may also be able to provide information about the new regulatory system for unregistered medicines via

continuing education. It is recommended that the TGA develop a presentation regarding the changes,

perhaps in a similar way as it has done with Adverse event reporting - online learning modules for health

professionals. This also could be done in collaboration with NPS MedicineWise and include education

regarding medicines evaluation and regulation. It is also envisaged that the TGA would already have a

database of all practitioners who have made applications to TGA to seek approval for importing

unregistered medicines, which would also be a useful tool for disseminating information.

We believe it may be also appropriate to hold some stakeholder workshops or forums across Australia, and

given the geographical barriers, online streaming and/or recordings for viewing on demand of the

forums/workshops should be made available.

Once the online system is implemented, it is anticipated that its portal will also serve as a repository for all

information and updates to both programs. The online system presents an opportunity for the TGA to

identify suppliers, manufacturers and place of manufacture and to guide the ‘most appropriate option’ of a

particular medicine in terms of labelling, consumer and product information, through comparative analysis,

in order to ensure availability in English and information regarding the overseas regulator(s), e.g. whether it

has been evaluated/approved by a comparable overseas regulator which would be consistent with the

suite of recommendations made by the Expert Panel Review of Medicines and Medical Devices Regulation.

These would address concerns held by hospitals regarding where SAS products are manufactured. The

appraisal conducted by the TGA in its approval of SAS products is unclear to hospitals and clinicians, and the

development of the online system is an opportunity to address this. For example, the literature used in the

appraisal, such as comparative information about the quality of manufacture may be useful for hospital

clinicians when they are sourcing products.

Even in a digital world locating SAS products is frequently challenging because the products cannot be

marketed. Furthermore they are often costly as there may be minimal competition between suppliers. For

example, SAS products used to fill a medicine shortage may be five times the cost of the registered product.

The time and resources used by hospital pharmacies to identify various products and their costs is

excessive, and this work is potentially replicated in every hospital. Hospitals are also often required to

spend significant time changing hospital-based treatment protocols for the new product and consider the

safe use of the alternative product(s). Although these are not strictly regulatory issues, the TGA could assist

by sharing relevant information to reduce this burden of information gathering, verifying and authorising. .

The increased transparency regarding the information and literature used in the TGA’s appraisal of the non-

registered would be useful for Australian clinicians to ensure safe prescribing, dispensing, administration

and ongoing monitoring.

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What information is needed by HRECs and colleges to clarify any changes in roles and responsibilities for

the Authorised Prescriber Scheme? Are general guidance documents from the TGA the best mechanism

for conveying the information?

In addition to guidance on the TGA website, what else could we do to provide information to HRECs and

colleges on the changes to AP? What further guidance/information would be useful to HRECs and

colleges to assist them when they are considering documents submitted to them by an AP?

It is appreciated that as part of its aim of reducing red tape and bureaucratic oversight, and improving

efficiency the TGA will no longer need to approve the clinical justification of products through the

Authorised Prescriber (AP) Scheme, as this is already simultaneously undertaken by a Human Research

Ethics Committee (HREC) or specialist medical college through their endorsement.

We have received feedback from members that the AP Scheme has become more unworkable as the

requirements are increasingly analogous to requirements for the conduct of a clinical trial of a medicine

We recommend that the TGA provides advice to HRECs and specialist medical colleges as to the quality of

evidence that would constitute appropriate prescriber endorsement. This could be done via a template or

checklist produced by the TGA, with the view that it will be adapted into the online platform in order to

notify HRECs/specialist medical colleges when an application is received and is accessible to them. This not

only will improve the quality of AP applications presented to the TGA and public safety, but also improve

governance mechanisms for both HRECs and specialist medical colleges who bear an implicit risk in

endorsing prescribers of medicinal products which are not registered in Australia. Once an authorised

prescriber is approved by these organisations, notification should be provided to the DTC and hospital

pharmacy department/pharmacy regarding the details of the authorised prescriber approval.

We recommend that the Drug and Therapeutics Committee (DTC) of a health service be considered an

alternate endorsers of authorised prescribers in addition to HREC or specialist medical colleges. This has the

advantage of removing unnecessary duplication and delay. DTCs are comprised of clinical specialists and

experts in assessing the safety and efficacy of drug therapy and are the body responsible for approving drug

therapy within health service facilities. Generally, the DTC will be required to review the medicine in the

context of hospital formulary and management, and individual patients in a manner that is commensurate

to that of HRECs and specialist medical colleges.

It is expected that the administration of the AP Scheme will be built into the online system and have the

capability for clinicians to upload documents from specialist colleges/HRECs and supporting clinical

information. An online system linking prescriber applicant, HREC/specialist medical college and TGA needs

to be developed for the AP scheme. Authorised prescribers should be required to acknowledge their

compliance with AP scheme requirements. Availability of patient consent forms (when relevant i.e. non-

routine off-label use) would assist streamlining the tasks associated with use of the medicine by the

Authorised Prescriber.

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Compliance

What information is required to assist in complying with the SAS and AP Schemes?

As described above, further information from the TGA on the quality of evidence and supporting

documentation required in applications will improve compliance with both schemes.

Given the online system for Category B notification products will provide automated approval (a model

similar to the current streamlined PBS authority scheme could be considered), prescribers should be

required to acknowledge their compliance with SAS requirements. (Non-automated approval for all other

unregistered medicines obtained via the SAS scheme using the online system will also require prescribers to

comply with requirements). An online system linking prescriber applicant, HREC/specialist medical college

(or DTC if above recommendation accepted) and TGA needs to be developed for the AP scheme.

Authorised prescribers should be required to acknowledge their compliance with AP scheme requirements.

Systematic communication of SAS notifications/approvals (whether automatic via notification list or via

TGA evaluation of application) and AP approvals must occur to pharmacies/hospital pharmacy departments

and Drug and Therapeutic Committees (accessible portal and/or direct communication to relevant

pharmacies/hospital pharmacy departments and DTCs).

For hospitals’ use of SAS products: As hospital/district Drug and Therapeutics Committees (DTCs) will

continue their ongoing responsibility for formulary management and individual patient use applications and

undertake independent review of the unregistered medicine in the hospital environment, the online

system should promptly and systematically inform the responsible DTC of approvals/notifications through

the SAS online system.

For hospitals’ and community use of SAS products: the online system should promptly and systematically

inform the relevant community pharmacy/ hospital pharmacy department through the SAS online system.

Medicines procured and used under SAS Category B and eligible for notification via the online system

cannot be obtained without mandatory completion of each section. This will include details of responsible

senior treating doctor, indication, proposed duration of use, DTC and pharmacy/pharmacy department

details. A commitment to providing outcome information should be made at the time of application and

automated follow-up occur. Consideration to actions that could occur if the prescriber fails to meet their

commitment to provide outcome data needs to be considered by the TGA. Such actions should not place

current and future patients in harm. Incentivised reporting rather than punishment would be a preferred

course of action.

Would it be useful to have a standardised template for reporting to assist in complying with the TGA

requirements?

Yes. As described above, having a standardised template will improve the consistency and quality of

applications, ensure appropriate approval, and improve the governance overall for prescribers, the TGA,

DTCs (when relevant) and pharmacists.

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Online system and processes

What are your views about moving solely to an online system for SAS and AP Scheme applications and

notifications?

A TGA-managed portal accessible to prescribers, pharmacists and hospitals providing information about

Authorised Prescribers, medicines on CAT B notification list, and general SAS product information including

wholesale suppliers is strongly recommended. A registration process could be used to ensure only

appropriate personnel access the information.

Our organisations are supportive of the move to an online system for SAS and AP Scheme applications and

notifications. An online system offers an opportunity to better balance resource activity in the management

of unregistered medicines in order to reduce administrative burden, and provide useful information to

clinicians and policymakers. Further to advantages touched on in previous sections of this submission, an

online system will vastly improve the workload, resourcing and governance responsibilities for prescribers,

pharmacists, DTCs and the TGA.

An online system will also provide a convenient platform to enable the TGA to collate data for analysis

which can inform any future medicines policy. For example, analysis will enable identification of prescribing

patterns, medicines use specific to certain indications, frequently used products, and which

diseases/conditions require unregistered products. Such analysis can be automated; however resources will

be required to report and act upon the lessons analysis will offer.

We recommend that the TGA considers improving the current level of oversight and surveillance and

compliance activities related to the SAS scheme that an online system can provide:

take advantage of the logistic capability of the online system; inform future policy related to unregistered medicines and their use; supplement pharmacovigilance activities; and support appraisal of effectiveness of unregistered medicines.

If designed appropriately and resourced adequately the online system has the potential to significantly

enhance future policy considerations as well as curate an evidence base for medicines for which evidence is

sparse. It will be important that sufficient detail is provided in the applications and mandatory outcome

information is obtained to support these pharmacovigilance and effectiveness evaluation functions. The

online system should consider mandatory provisions for clinicians to give feedback to the regulator

regarding patient outcomes and if the unregistered medicine was clinically useful. Linking to the existing or

future Adverse Drug Reporting system as well as My Health Record should be considered.

Details of the treating physician (not the junior medical officer or registrar) i.e. a senior doctor responsible

for acute and/or ongoing care need to be clearly identified in the online application as well as the

indication, and planned duration of use. Activities ensuring compliance with the ‘approved’ but non-

registered indication(s) should be managed and enabled by the regulator. A certificate of ‘approved’

duration of therapy should be able to be printed as well as sent online to relevant

individuals/committees/departments. Compliance with indication and therapy duration could be managed

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by providing notification to the pharmacy procuring/supplying the medicine, when notification/approval is

triggered in the online system.

If therapy is long-term, the maximum duration of approval for a Category B medicine should be no longer

than 12 months (aligning with validity period of Schedule 4 prescriptions). A change in prescriber and/or

pharmacy should necessitate a new application. Such a system will be easier to manage once online.

Is there a time by which you think a paper-based system would no longer be needed?

The move to the online system should be as soon as practicable, but only after the policy parameters are

agreed to by majority of stakeholders, and sufficient industry engagement and communication has been

undertaken to inform stakeholders of these changes. It may also be prudent for the TGA to have a

transition period of 12 months, where both online system and paper-based systems are used

simultaneously for a defined period to aid this transition.

Would integration into existing clinical software systems (such as prescribing and dispensing) be an

important element of the new process?

Interoperability with current and anticipated electronic medical records, prescribing and dispensing

software would be ideal; however, this should not impeded the process to move to an online system as

integration is likely to be complex given the multiple software available in Australia and may extend the

transition period more than necessary. Interoperability should be actioned in the future and considered

‘Phase 2’ of the online system implementation. We note that the online system would need to integrate

with all products and any updates rely on the software vendors implementing the changes. We recommend

that linkage to My Health Record be included in the electronic system developed by the TGA. This will assist

pharmacovigilance activities related to the use of the unregistered medicine. It will also provide a means by

which other clinicians can ensure appropriate continuity of care, as appropriate.

Would you be interested in participating in the targeted consultation on the online system?

Yes. All four organisations would be interested in participating in a consultation of the online system.