Ensuring Best Practice in the
Notification of Prescription Medical
Product Discontinuations
TGA and Medicines Australia Conjoint
Best Practice Guidelines
October 2007
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Ensuring Best Practice in the
Notification of Prescription Medical
Product Discontinuations
TGA and Medicines Australia
Conjoint Best Practice Guidelines
October 2007
Discontinuing a medicine is a decision that most pharmaceutical companies will
take at some point. The Therapeutic Goods Administration (TGA) and Medicines
Australia want to ensure that the impact of such a decision on patients is
minimised. Therefore we have developed these best practice guidelines, which
are an adaptation of the equivalent guidelines adopted by the Association of the
British Pharmaceutical Industry (ABPI) and the UK Department of Health.
The guidelines are designed to ensure best practice in managing the phase out
of products, especially the timing and recipients of notifications of the deletion.
They make recommendations about who to tell, when and what information will
be needed. The emphasis is very much on early timing and information exchange
and dissemination. To help companies and health professionals further, a central
contact point has been established within the TGA; the details are on the proforma in these guidelines.
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These guidelines have been adopted jointly by the Therapeutic Goods
Administration and Medicines Australia. We believe they will establish good
practice across the industry and the wider health community, and allow
discontinuations to be managed with as little inconvenience and worry as
possible for patients. We very much hope that you will adopt them within your
company.
The usefulness of these guidelines will be reviewed in 12 months’ time. If you
have any comments on this document, please contact either Medicines Australia
or the TGA (contact details are at the end of the document).
Introduction
Every product has a limited medical or economic life cycle and the decision to
delete a product can be made for a variety of reasons including:
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Change in medical practice and availability of newer and better drugs
Change in marketing strategy
Commercial decisions
Parent company decisions
Manufacturing capacity restraints
Revision of quality, regulatory or compliance requirements
Problems in procurement of active ingredient
In recognition of the National Medicines Policy, of which a responsible and viable
medicines industry is one of the four pillars, pharmaceutical companies strive to
take a responsible approach to the discontinuation of medicines to ensure that
appropriate medicines are available to the Australian community.
Before the decision is made to discontinue a medicine, a company should have
carried out a risk assessment, taking into account the current therapeutic use,
and whether there are therapeutic alternatives available.
Where a product is being withdrawn and there is no therapeutic alternative, the
company should seek a meeting with the Therapeutic Goods Administration
(TGA) at least 12 months before the product is discontinued. The meeting with
TGA will be informal and confidential, and focus on exchanging information. The
reasons for deletion should be discussed and TGA may want to explore options
for continued production, such as using another manufacturer or importation. At
this stage, TGA will not share any information outside the Department of Health
and Ageing, including the Pharmaceutical Evaluation Branch, without the
agreement of the company.
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If a product is being withdrawn for reasons of safety, quality or efficacy,
companies will be aware of their legal obligations to notify the TGA.
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Risk Assessment
Before the decision is made to discontinue a medicine, a company should
undertake a risk assessment. The key guiding principles are:
1. Take into account the impact of the product discontinuation on the
“customers”; and
2. ensure the level of communication is proportionate to the level of impact
on “customers”.
The risk assessment should include consideration of:
• The seriousness of the disease the medicine is used to treat
• Any unlicensed uses of the medicine, including paediatric use, and their
extent
• Whether alternative medicines are available
• Whether an alternative supplier or manufacturer is available – in Australia or
overseas
• The timeframe for which no medicine may be available
• Options for managing available stock to ensure appropriate distribution and
avoidance of stock piling
To ensure that the discontinuation of a product does not cause unnecessary
problems for patients and prescribers, it is important that sufficient notice is given
so that alternative sources of supply can be located, or patients switched to
alternative therapies safely and effectively.
During the risk assessment, it is important to consult with groups and
organisations that might be affected by the product discontinuation, and who
could provide advice on the therapeutic importance of the medicine. These
groups may include:
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Royal Australasian College of Physicians (RACP)
Specialist colleges/associations in the therapeutic area
Royal Australian College of General Practitioners (RACGP)
Pharmaceutical Society of Australia (PSA)
Society of Hospital Pharmacists of Australia (SHPA)
State Therapeutic Advisory Groups (TAGs)
National Prescribing Service
Relevant Health Consumer Organisations (HCOs)
Consumers’ Health Forum (CHF)
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Notification of Product Deletions
Date of Deletion from Market
Once a company has made the decision to delete a product, they should assess
how much stock of the product remains within the company and how long this is
likely to last, based on current usage patterns and PBS listing status. This will
determine the Deletion from Market Date. The Deletion from Market Date is the
date that the company will no longer supply the product. It does not affect the
stock that may already be in the distribution chain in wholesalers and
pharmacies.
Once a Deletion from Market Date has been agreed, stock levels should be
closely monitored. If it appears that there will be a change in the proposed
deletion date due to a reduction or increase in ex-factory sales, the impact on the
notification schedules should be considered urgently.
Timetable
At least 12 months prior to Deletion from Market Date
Initiate discussions with the TGA and Pharmaceutical Evaluation Branch (PEB)
(for PBS listed products) on products for which there are no therapeutic
alternatives.
At least 3-6 months prior to Deletion from Market Date
The TGA and PEB (for PBS listed products) should be formally notified of the
proposed deletion 3-6 months prior to the Deletion from Market Date.
The pro-forma attached to these guidelines should be used. Six months notice
would be ideal although it is recognised that this may not always be possible due
to factors outside the Australian company’s control; three months should be
taken as the minimum notice period.
The information that the TGA and PEB requires is:
• company details and contact;
• product details;
• which formulations or presentations are being deleted and which will
remain;
• licensed and significant unlicensed uses:
• the proposed timing;
• the reason for deletion;
• possible alternative therapies;
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whether or not the deletion is just for Australia or world-wide; and
whether or not the product will be removed from the Australian Register of
Therapeutic Goods. *
At this stage, following discussion between the company and TGA and PEB, it
will be assumed that this information can be shared widely, including relevant
stakeholders and specialist groups, the Royal Colleges, groups with an interest
(e.g. patient groups) and other companies, unless the company specifies
otherwise. The TGA or PBB will not communicate with these other parties prior
to discussion with the company. The TGA will contact the company with any
feedback they receive regarding the deletion. This will enable the company to
target the notifications more effectively.
Two to three months prior to Deletion from Market Date
State Medicines Information Centres
The State Medicines Information Centres, State Therapeutic Advisory Groups
(TAGs), National Prescribing Service Therapeutic Advice and Information Service
(TAIS) and Medicines Line should be notified of the proposed deletion three
months prior to the Deletion from Market Date. The letter should include:
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the proposed timing of the deletion;
whether the deletion is for Australia or world-wide; and
alternative therapies.
This information will then be disseminated via the usual communication channels.
Specialist Groups
Feedback from the TGA together with internal company knowledge will enable
notifications to be targeted at specific specialist groups (eg doctor, pharmacist,
patient) depending on the product being deleted. A letter, similar to that sent to
the State Medicines Information Centres, should be sent to the specialist groups
with a particular interest. For example, discontinuation of a diabetes product
would be notified to Diabetes Australia and the Endocrinology Society.
State Government Departments
If the product to be deleted is supplied under contract to a State or Territory
government department, the relevant departments should be notified of the
proposed deletion.
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It is preferable to maintain the registration of the product on the ARTG to facilitate the transfer of
the registration if an alternative sponsor is identified.
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Specialist medical and pharmacy media
The company should issue a press release or letter regarding the product
deletion. In timing this, the company needs to consider the Deletion from Market
Date and what stock remains in the distribution chain. The press release should
be sent to the following media depending on the market concerned:
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The Australian Prescriber (e-version);
Journal of Pharmacy Practice and Research;
The Australian Journal of Pharmacy;
medical press as appropriate;
professional bodies/organisations including RACP, RACGP, SHPA,
PSA, TAG’s).
For products where there is no therapeutic alternative, it is also suggested that
the company has a list of Q&As regarding the product deletion, which can be
used to respond to any telephone queries. A copy of the Q&A should be sent to
TGA.
Product Information Compendiums
The company should ensure that the following annual compendium entries are
updated to remove Product Information for deleted products:
• MIMS Australia (CMPMedica Australia Pty Limited)
• PP Guide (Australian Pharmaceutical Publishing Company)
• Australian Medicines Handbook
It may be appropriate to keep the Product Information in these compendiums for
up to 12 months following the product deletion, after which the information would
no longer be required.
GP Databases, Prescribing and Dispensing Software suppliers
In Australia most GPs have electronic clinical management systems and use the
computer during a consultation and to produce the prescription. To ensure that a
deleted product is removed from the GP database, a letter should be sent to the
prescribing software distributors who will then include the information in the
update discs that are issued to the GP system suppliers. The process of having a
product removed from a GP database can take anything from eight to twelve
weeks depending on the cut-off date for the inclusion of new information on the
discs that are issued.
Alternatively, a company could notify each GP system supplier individually, which
may speed up the process. Again in timing this, the company needs to consider
the Deletion from Market Date and what stock remains in the distribution chain.
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Dispensing software is updated monthly, and any monthly updates to the
Pharmaceutical Benefits Schedule will be included automatically.
One Month Prior to Deletion from Market Date
Wholesalers
Wholesalers should be notified of the deletion one month prior to the Deletion
from Market Date. This notification is left until one month prior to the deletion date
to ensure that the product is not removed from the wholesalers’ computer
systems prematurely which would prevent the wholesalers from ordering further
product from the company.
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Pro-forma for Product Discontinuation
Send to:
(For all products):
(For products listed on the PBS):
By e-mail: TGA (Head of relevant clinical unit)
By e-mail:
By fax:
02 6232 8145
By fax:
By post:
Director,
Drug Safety and Evaluation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
By post: Mr Axel Godeck
axel.godeck@health.gov.au
02 6289 8633
Pharmaceutical Evaluation Branch
Department of Health and Ageing
GPO Box 9848
CANBERRA ACT 2601
Company details
Company name:............................................................................................................
Company contact:.........................................................................................................
Contact telephone number:...........................................................................................
Contact fax number:......................................................................................................
E-mail address: .............................................................................................................
Product Details
Product name:.........................................................................................................
ARTG Number:........................................................................................................
Will the product be deleted from the ARTG? 1..........................................................
Active Ingredient(s):...................................................................................................
Licensed/unlicensed uses:........................................................................................
Presentation:............................................................................................................
Presentations remaining on the market:..................................................................
Proposed date of discontinuation:............................................................................
(3-6 month’s notice if possible, 12 months if there is no therapeutic alternative)
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It is preferable to maintain the registration of the product on the ARTG to facilitate the
transfer of the registration if an alternative sponsor is identified.
Proposed date to inform prescribers, pharmacists and medical/pharmaceutical press:
.......................................................
Reason for Discontinuation
(Please tick any that apply)
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Raw material/sourcing difficulty
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Manufacturing plant closure/transfer
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Manufacturing capacity issues
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Safety issues
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Low volume product
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Other (please state):………………………………………………………….
Possible alternative product(s):..................................................................................
Interim arrangements (if applicable):..........................................................................
eg Special Access Scheme (SAS)
Market(s) Affected
(Please tick)
□ Australia only
□ World-wide
If the discontinuation relates to safety, quality or efficacy
Date of notification to TGA:............................................................................................
Name of contact at TGA:................................................................................................
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Contact details for some key organisations
Australian Medicines Handbook Pty Ltd
Level 8, 10 Pulteney Street
ADELAIDE SA 5000
Phone: (08) 8303 6977
Fax: (08) 8303 6980
E-mail: amh@amh.net.au
Website: www.amh.net.au
Australian Prescriber
Suite 3, 2 Phipps Close
DEAKIN ACT 2600
Phone: (02) 6202 3100
Fax: (02) 6282 6855
Email: info@australianprescriber.com
HealthLinks.net Pty Ltd
PO Box 6593 Silverwater
Sydney NSW 2128
Phone (02) 9744 4444
Fax (02) 9744 4499
E-mail contact@healthlinks.net.au
MIMS Australia
Locked Bag 3000
ST LEONARDS NSW 1590 Australia
Phone: 61 2 9902 7700
Fax: 61 2 9902 7701
Email: editorial@mims.com.au
National Pharmaceutical Services Association
Locked Bag 5061
PARRAMATTA NSW 2124
Phone: (02) 8844 2000
Fax: (02) 8844 2400
Email: cheryl.nichols@api.net.au
National Prescribing Service Ltd (includes National Prescribing Service
Therapeutic Advice and Information Service (TAIS) and Medicines Line)
PO Box 1147
Strawberry Hills NSW 2012
Phone: 02 8217 8700
Fax: 02 9211 7578
E-mail: info@nps.org.au
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Pharmaceutical Society of Australia
PO Box 21
CURTIN ACT 2605
Phone: (02) 6283 4777
Fax: (02) 6285 2869
Email: psa.nat@psa.org.au
Australian Pharmaceutical Formulary and Handbook (Address as above)
Australian Pharmacist (Address as above) australian.pharmacist@psa.org.au
inPHARMation (Address as above) inpharmation@psa.org.au
Pharmaceutical Evaluation Branch
Department of Health and Ageing
PO Box 9848
CANBERRA ACT 2600
PP Guide & Australian Journal of Pharmacy
Australian Pharmaceutical Publishing Company
40 Burwood Road,
Hawthorn VIC 3122
Phone: (03) 9810 9900
Fax: (03) 9819-1706
Email: admin@pdlappco.com.au
State Therapeutic Advisory Groups (TAGs)
NSW
Executive Officer
NSW Therapeutic Advisory Group
Level 5, 376 Victoria St, Darlinghurst NSW 2010
PO Box 766, Darlinghurst 2010, NSW
VIC
Executive Officer
Victorian Therapeutic Advisory Group
PO Box 423
Carlton South VIC 3053
WA
Chairman, Western Australian Drugs & Therapeutics Committee
c/- Internal Medicine
Kirkman House, RPH
PO Box 2213, GPO
Perth WA 6847
QLD
Director, Pharmaceutical Advisory Unit
Queensland Hospitals Drug Advisory Committee
Queensland Health
147 – 163 Charlotte Street
Brisbane 4000
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Therapeutic Goods Administration
Drug Safety and Evaluation Branch
PO Box 100
WODEN ACT 2606
The Society of Hospital Pharmacists of Australia (includes State Medicines
Information Centres)
PO Box 1774
COLLINGWOOD VIC 3066
Phone: (03) 9486 0177
Fax: (03) 9486 0311
Email: shpa@shpa.org.au
Journal of Pharmacy Practice and Research Email: jppr@shpa.org.au.
Consultation
In developing this Best Practice Guideline, the following organisations were consulted:
Therapeutic Goods Administration
Pharmaceutical Benefits (now Evaluation) Branch
Sponsors
Wholesalers (through NPSA)
Prescribers (RACGP, RACP, AMA, ADGP)
Pharmacists (PSA, SHPA, Pharmacy Guild)
Prescribing software suppliers
Dispensing software suppliers
Hospitals (through SHPA and TAGs)
Publishers (AMH, MIMS, PPGuide, TGL, AJP, Aust Pharmacist, Aust Prescriber,
Medical Observer, Australian Doctor Weekly)
National Prescribing Service
State Medicines Information Centres
Consumers (through CHF)
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