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Management and communication of medicine shortages and discontinuations in Australia

Guidance for sponsors and other stakeholder bodies

1 May 2019

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Steps: report, manage and communicate

Reporting a shortage to the TGA

There is a clear distinction between reporting to the TGA and publication of a medicine shortage.

Sponsors will need to report the shortage through the TGA's Business Services (eBS) portal. Further advice and instructions relating to making a medicine shortages notification will be provided in Medicine shortages user guide - Instruction for submitting and managing information in TGA Business Services (eBS), which will be available to sponsors prior to implementation of mandatory reporting.

While reporting is normally done by the sponsor of the medicine, the TGA may be contacted directly (by phone or email) by a different sponsor or healthcare provider and informed that the supply of a medicine is not likely to meet normal or projected demand. This information is then investigated and, if confirmed, the sponsor will be required to submit a notification to the TGA.

Mandatory reporting of shortages on a confidential basis to the TGA is necessary for all shortages of reportable medicines. For shortages of a reportable medicine that is on the Medicines Watch List, or is assessed as having critical patient impact, the sponsor must report any such known shortage to the TGA within 2 working days.

Ideally, the sponsor is able to complete the medicine shortages notification form with all the required information and submit it to the TGA within 2 working days of confirming the shortage. However, an initial report (Medicines Shortage Information Initiative notification with reduced mandatory fields) may be submitted within 2 working days containing a subset of the information that is required to be reported to the TGA. The sponsor then has another 3 working days in which to provide the remaining required information on the shortage.

The minimum information required to submit a notification form advising of a critical patient impact, current or anticipated shortage is:

  • impact of the shortage
  • nature of the shortage
  • sponsor name - auto-populated based on the person who logs in to eBS
  • sponsor address
  • Australian telephone number for public contact purposes
  • medical information email for public contact purposes
  • ARTG number - which will provide the ARTG name of the product in shortage
  • primary contact (auto-populated based on the person who logs in to eBS) which provides contact details of someone with whom the TGA can liaise
  • the date the shortage was known to the sponsor
  • estimated dates for the start and end of the shortage
  • availability
  • proposed date of publication on the TGA website.

Minimum mandatory requirements will be identified in the eBS Notification form by the presence of red asterisks next to the required fields.

For reportable medicines that will result in a medium or low patient impact, the sponsor has 10 working days in which to notify the TGA of the medicine shortage. In this case, completion of all fields in the notification form is mandatory. The TGA will then conduct an assessment of the shortage and its impact and where required will also consult expert clinicians. The reporting process is as follows:

  1. Product sponsor confidentially and mandatorily reports to the TGA of:
    1. an anticipated shortage to facilitate early investigation with proactive forecasting and management
    2. actual, unanticipated shortage for urgent investigation and management.
  2. Information from other parties may be used to inform the TGA such as:
    1. State and Territory health systems
    2. health care providers (pharmacists, prescribers, hospitals) or consumers may notify shortages directly to the TGA or other parts of the Department of Health
    3. we may obtain information about current or impending medicines shortages from international liaison activities.
  3. Where possible, the Technology Assessment and Access Division within the Department of Health will provide information to the TGA to assist with the management of supply shortages.

In examples 2 and 3 above, the TGA will verify the accuracy of the reported information with the sponsor of the medicine.

The TGA is able to publish information about medicine shortages under a legislative instrument under section 61 of the Act that provides the TGA with the authority to release information to the website regardless of consent where we have assessed there is a public health interest in doing so (see Specifications).

If the sponsor anticipates that there is going to be a shortage at any time in the next 6 months, they must submit a medicine shortage notification. If unsure about whether to submit a medicine shortage, the sponsor can contact the Medicine Shortages Section for assistance.

Reporting a discontinuation to the TGA

Permanent discontinuations of reportable medicines must be reported to the TGA. Where the discontinuation is likely to be of 'critical impact', the sponsor must report the discontinuation at least 12 months before the discontinuation is proposed to occur. If the sponsor is unable to comply with this timeframe, then it must be reported as soon as practicable after the decision to discontinue is made.

Where the discontinuation is not likely to be of 'critical impact', the sponsor must report the discontinuation at least 6 months before the discontinuation is proposed to occur. If the sponsor is unable to comply with this timeframe, it must be reported as soon as practicable after the decision is made.

The long lead time for reporting a permanent discontinuation which is of critical impact is needed because in many cases the sponsor may be the sole supplier of the medicine in Australia. The long lead time is designed to allow us to identify an alternative supplier of the product for the Australian market, which may include reviewing an application for registration of the alternative medicine on the ARTG.

Investigation - assessment and verification

What dose forms and strengths are in shortage?

The definition of what 'medicine' is in shortage should be further defined by molecule, strength and route of administration, rather than molecule alone, so that it is understood which formulations and strengths of a molecule are in shortage.

Sponsors, wholesalers and other stakeholders will work with the TGA to determine whether or not supply will meet demand, especially when there is more than one supplier of that molecule/strength/route of administration.

The TGA will ask a sponsor to confirm and assess the availability of their product(s) suspected to be in shortage, and will ask other sponsors who sponsor a similar product about the availability of their products. The TGA will also be asking for information about therapeutic alternatives and their current status.

A risk assessment will be conducted as per the matrices in this guidance which may include undertaking a clinical review to support the management option, for example endorsing a section 19A alternative product.

How long will the product be in shortage?

Any supply disruption must be reported because it is not feasible to prescribe a standard minimum period of inability to supply that will not be of significant consequence to patients. For example, inability to supply an antibiotic used in life-threatening situations, or particular antivenoms for as little as 24 hours could be deemed critical shortages in certain circumstances.

Nature of the product in shortage

The approach outlined in Table 1 - Impact assessment framework will be used to assess the effect of the type of product in shortage on the impact of the shortage.

If the product is on the Medicines Watch List, a confirmed shortage is automatically deemed to have a critical patient impact. A risk assessment framework will be applied to all other medicines, in which the nature and size of the population affected is assessed together with the availability of alternative products, before determining whether a particular shortage is of low, medium, or critical patient impact.

The Medicines Watch List is derived from a consensus review of existing State Hospital Emergency and Life Saving Drug Lists and the WHO's Model List of Essential Medicines that are included in the ARTG. The list will be reviewed annually to ensure it remains current and appropriate.

Medicines included on the Medicines Watch List are those where lack of access in Australia could result in significant morbidity in patients, or the death of one or more patients.

The list includes antibiotics used in critically ill patients, antidotes for poisonings, some emergency and critical care products and critical vaccines included on the National Immunisation Program, as well as some anticoagulants and antivenoms.

A number of other classes of medicines have been associated with clinically serious medicines shortages, such as:

  • inhaled anaesthetics, anticonvulsants, antipsychotics, antidepressants, opioids, steroids - however alternatives in these classes may potentially be interchangeable; likewise
  • specific oncology medicines - which require individual patient assessment as to whether alternatives are appropriate and switching of the patient is possible.

Shortages of these medicines will be assessed on a case-by-case basis.

The assessment framework identifies the potential impact of any shortage by applying a mechanism that assesses the impact on the size of patient populations affected through measures of the prevalence of use in the population alongside the availability of alternatives (refer Table 1 and Table 2).

An example of a critical patient impact is an unexpected shortage of heparin-based products. This product has no therapeutic alternative, and the post-surgical population group may experience life-threatening impacts if this medicine was not available.

An example of a medium patient impact is a shortage of an ACE Inhibitor for hypertension, where a doctor may be able to prescribe another ACE inhibitor, or other anti-hypertensive medicine. In these cases, publicly available information for doctors and pharmacists is recommended.

An example of a low patient impact is a shortage of a generic amoxicillin 250 mg oral product, where another generic product (either tablet or capsule) is easily substitutable with little, if any, effect on the consumer's health outcomes and where the doctor and/or pharmacist are not required to undertake significant additional effort. In this case, information is still recommended as it will inform and assist doctors and pharmacists if queries are received about availability.

For further examples, see Appendix 3: Example scenarios for sponsors

Table 1 - Impact assessment framework
Substitute medicine ranking (refer Table 2)
Patient Population Affected Exact alternative available Similar alternative available Appropriate alternative available Possible alternative available No alternative available

Rare

< 9 per 100,000 population

Uncommon

> 9 and < 100 per 100,000 population

Low Low Medium Medium Critical

Common

> 100 per 100,000 population

Low Medium Medium Critical Critical
Table 2 - Assessing and ranking substitutes/alternatives
Substitute medicines or therapeutic alternatives

Determined by taking into account:

  • Types of substitute medicines or therapeutic alternatives that exist
  • The approved indications for the substitute medicines or therapeutic alternatives
  • Likelihood of available substitute medicines or therapeutic alternatives being available in quantities to meet demand

Note: When ranking a medicine shortage, consideration is also given to the feasibility of the medicine being substituted in the context of the patient population and the care setting

EXACT - same medicine (active ingredient, strength and route of administration)
SIMILAR - same active ingredient but different strength

APPROPRIATE

Different active ingredient but same pharmacological class and adverse reaction profiles when administered to patient in therapeutically equivalent doses.

OR

Same active ingredient but different dose form that may require consideration of care setting implication.

POSSIBLE - different active ingredient but comparable pharmacological class or mode of action
NONE - unique pharmacology, no substitute medicine or alternative treatment options exist.
Table 3 - Activities by shortage impact level
IMPACT LEVEL ACTIVITY STEPS
NOTIFY
Low

Yes

Mandatory reporting regardless of shortage status

Medium

Yes

Mandatory reporting regardless of shortage status

Critical

Yes

Mandatory reporting regardless of shortage status

ASSESS
Low

Yes

by Medicine Shortages Section

Medium

Yes

by Medicine Shortages Section with 'quick touch review' if necessary - See Fig. 1

Critical

Yes

by Medicine Shortages Section with input from Medicine Shortages Action Group where necessary

RESPOND
Low

Anticipated

communication of information through the website

Current

communication of information through the website

Discontinuation

communication of information through the website

Medium

Anticipated

clinical guidance on substitute medicines or therapeutic alternatives linked from the website, in addition to direct communication by sponsors

Current

clinical guidance on substitute medicines or therapeutic alternatives linked from the website, in addition to direct communication by sponsors

Discontinuation

clinical guidance on substitute medicines or therapeutic alternatives linked from the website, in addition to direct communication by sponsors

Critical*

Anticipated

Collaboration with TGA, specialists and sponsors to agree on management which may include escalation for public health responses as required

Current

Collaboration with TGA, specialists and sponsors to agree on management which may include escalation for public health responses as required

Discontinuation

Collaboration with TGA, specialists and sponsors to agree on management which may include escalation for public health responses as required

PUBLISH
Low

Anticipated

Optional

strongly encouraged

Current

Optional

strongly encouraged

Discontinuation

Optional

strongly encouraged

Medium

Anticipated

Optional

strongly encouraged

Current

Optional

strongly encouraged

Discontinuation

Optional

strongly encouraged

Critical

Anticipated

Yes

mandatory

Current

Yes

mandatory

Discontinuation

Yes

mandatory

UPDATE
Low

Yes

regardless of Shortage status

Medium

Yes

regardless of Shortage status

Critical

Yes

regardless of Shortage status

Investigation of alternative products

As part of the assessment and management of a shortage reported to the TGA, an investigation will be undertaken to identify products that may be available for substitution. These could be:

  • the same pharmaceutical substance, dose form and strength but sourced from another supplier; or
  • the same pharmaceutical substance at a different strength or different dose form; or
  • a different substance but in the same therapeutic class.

In cases where no suitable products are available in Australia are identified (particularly where the same pharmaceutical substance is not available in sufficient quantities), suitable products may be sourced from overseas to address a shortage.

Following the risk assessment which includes public interest considerations determining a finding of critical impact, where there are no suitable direct or similar alternatives identified or in a situation where obtaining a substitute is delayed (such as needing to be sourced from overseas) a Medicines Shortages Action Group may be convened if required.

A Medicines Shortages Action Group will identify strategies to continue patient management that could include rationing options and alternative therapies to support management of patients affected by the shortage.

Response

When a decision has been made that the shortage has a critical patient impact, the shortage will be communicated via publication on the Medicines Shortage Information Initiative website. The sponsor and other relevant authorities will be notified of the decision by the TGA and asked to implement particular communication and management strategies.

The sponsor will be expected to undertake the following communications as appropriate:

  • hospital medicines -the sponsor will notify State and Territory Health Departments; and wholesalers marketing into private hospitals; and the Society of Hospital Pharmacists of Australia
  • community/retail pharmacy medicines - the sponsor will notify the Pharmaceutical Society of Australia; the Pharmacy Guild of Australia; and wholesalers and pharmacies
  • PBS medicines -the sponsor will notify the Technology Assessment and Access Division, who in turn will notify Community Service Obligation Distributors
  • National Immunisation Program vaccines - the sponsor will notify the Office of Health Protection
  • National Blood Authority plasma components (where they are registered medicines) - the sponsor will notify the National Blood Authority and the Office of Health Protection.

For medicines of critical patient impact, the TGA's Medicine Shortages Section will notify the Deputy Secretary and Chief Medical Advisor of the Health Products Regulation Group (HPRG) and the Department of Health's Chief Medical Officer.

For shortages with medium/low patient impact, the TGA and the sponsor will notify other stakeholders as required, noting that while such shortages can be published on the Medicines Shortage Information Initiative website at the discretion of the TGA, it is expected that the sponsor will notify those in the supply chain about the details of the shortage. For example, where a sponsor does not wish to publish their shortage but the lack of publically available information is creating significant difficulties in the community, the TGA may take the decision to publish the information on the Medicine Shortages Information Initiative website in the interest of public health. Where this occurs, the sponsor will be notified by the TGA.

We intend to notify the State and Territory Health Departments as soon as possible, most likely via an email, following notification of an imminent shortage of critical impact. This is to allow jurisdictions to begin to manage stock levels and make alternative arrangements where necessary, even if the comprehensive risk assessment has not been completed.

When notified of a shortage with critical patient impact, the HPRG Chief Medical Adviser (or in some cases the Department of Health's Chief Medical Officer) will work with the impacted sponsor with regard to the following activities:

  • coordinate action on rationing of the products following clinical review with relevant bodies (for example Clinical Colleges, medical and pharmacy professional organisations, States and Territories, Council of Australian Therapeutic Advisory Groups)
  • when there is not a supply of an alternative similar product, it may be necessary to provide advice to doctors on appropriate therapeutic alternatives or what measures need to be undertaken in view of the shortage, which can be provided by the Chief Medical Officer, States and Territories, or clinical colleges (the TGA will support the decision-making process and assist in promulgating information on alternatives)
  • where appropriate, work with supply chain stakeholders on rationing of supplies and signposting to alternatives available in Australia, including different suppliers, different dose forms, or different products in the same therapeutic class
  • advise of the option and relative importance of obtaining alternative products from overseas.

Communication involving multiple sponsors

It is important to note that the above discussions only occur on a voluntary, one-on-one basis between the TGA and individual sponsors (and do not involve any group or 'round table' discussions). In conversations with individual sponsors, the TGA will not pass on information about a sponsor's commercial operations (for example volumes, prices, production capabilities or difficulties) to other sponsors.

Where there are multiple sponsors supplying the market of a medicine that has fallen into shortage, the first issue for the TGA to determine is the market share of the different sponsors' products and usually the different sponsors have a good idea of their own market share. The TGA will contact sponsors individually to request this information, and information about how a shortage may affect each sponsor. A shortage might only affect one sponsor's product initially, however depending on their market share, a shortage of a particular medicine where the sponsor has a significant market share might lead to shortages of all sponsors' products and hence a shortage of the product overall.

The TGA may receive information about the different market shares and how all sponsors are affected by a shortage in the same medicine market. Communication between the TGA and each sponsor on a one-on-one basis will allow improved management of the shortage. The TGA may speak further to individual sponsors to identify if sponsors might be able to increase supply during the shortage, to minimise the effects of the shortage on patients. The same principle applies for products to be or being imported under section 19A of the Act to either enable importation or minimise over-importation in addressing a shortage. In conversations with individual sponsors, we will not pass on information about a sponsor's commercial operations (for example, volumes, prices, production capabilities or difficulties) to other sponsors.

Other useful activities are the ability to 'ration' supply of all sponsors' products when there is a shortage to minimise stock piling of products and reduce the risk of increasing the shortage of like products. It also allows supply to those who might most need it, for example oncology drugs to finish a course rather than having new patients commence a course but not be able to complete it.

The sponsor, with the support of the TGA, will coordinate communications about confirmed shortages. This enables consistent clinical advice for communication to pharmacists, prescribers and hospitals to enable management of the shortage and mitigate risks to patient care. Where appropriate the TGA will:

  • notify peak consumer organisations to manage patient expectations
  • notify the Technology Assessment and Access Division who in turn will notify Community Service Obligation Distributors to ensure currency of their information
  • update the Medicines Shortage Information Initiative website with management actions.

Regulatory options for sourcing medicines from overseas

The TGA regulates the import and supply of unregistered medicines for use by individual patients through the Special Access Scheme [section 18(1) and section 19(1) of the Act] and the Authorised Prescriber scheme [section 19(5)].

The TGA can consent to the importation and supply of medicines that do not comply with a standard that are otherwise applicable (section 14).

The TGA can grant approval to a sponsor to import and supply an unregistered medicine that could substitute for a registered medicine that is in short supply (section 19A).

Information on section 19A is available on the TGA website - Accessing medicines during a medicines shortage.

Coordinated communications about confirmed shortages

All shortages of critical patient impact will be published on the TGA website. These shortages will appear on the landing page on the medicine shortages website. They will be listed under one of the following sub-categories: current, anticipated or discontinued. There will also be a list of resolved critical shortages.

In certain cases, information may be published on the TGA website, including information on alternative products where appropriate. Links to other websites (sponsor, State and Territory, clinical college) will also be provided. Information on products approved to be imported under section 19A as alternative products to Australian-registered medicines that are experiencing a shortage are now available on the TGA website.

While not mandatory, sponsors will be strongly encouraged to publish other (medium/low patient impact) shortages on the Medicines Shortage Information Initiative website. These will also be under one of four sub-categories: current, anticipated, resolved or discontinued and will appear on the consolidated medicine shortages page.

For critical patient impact shortages, communication plans need to be developed to ensure the sponsor can work effectively with a range of stakeholders, including the TGA, to conduct the following steps:

  • finalise specific communication messages, channels, schedule and overall communication plan
  • where appropriate, notify peak consumer organisations - to manage patient cohort expectations
  • provide consistent clinical advice for communication to health care providers (pharmacists and prescribers) and hospitals to manage shortage and mitigate any patient risks
  • decide on additional information for publishing on the TGA website to support patient care
  • monitor and respond to shortage status changes and issues that emerge, for example to follow up with distributors to ensure currency of their information.

For low or medium patient impact shortages, communication plans will only need:

  • sponsors to develop and implement their routine communication activities based on the impact assessment; and if applicable decide on the website publication date (that aligns with the commencement of supply chain communication) and to notify the TGA of updates as required
  • the TGA to validate the assessment, and manage the publication of the shortage information if agreed (including updates) in accordance with the sponsors nominated publication date, as well as working with the sponsor to implement any agreed regulatory response.

From time to time, health professional and public media outlets are interested in reporting on specific medicine shortages. In developing the response, sponsors and the TGA will have considered this and decided on appropriate action. It is normally the sponsor's role to discuss the details of their products and the specific reasons for the shortages with the media.

Medicines Shortage Information Initiative website

The website provides health professionals and consumers with information about medicine shortages. The site includes information about medicines that are:

  • prescription medicines included in Schedule 4 or 8 to the current Poisons Standard; or
  • OTC medicines determined in an instrument under section 31EH(1)(b)(ii) of the Act which include medicines such as adrenaline auto-injectors and salbutamol inhalers.

Information on availability of other OTC medicines or on medicines that are usually obtained through the Special Access Scheme or Authorised Prescriber scheme is not included.

The information available will include:

  • medicines currently in shortage or anticipated to be in short supply or medicines that are to be permanently discontinued
  • for critical patient impact shortages, information will be posted on the medicine shortages landing page dedicated to only critical impact shortages as well as on the consolidated list of shortages
  • for low or medium impact shortages, information notified to the TGA and potentially included in the website as part of their communication and management activities, will appear in a consolidated list of shortages and discontinuations.

The information available on the website for each medicine shortage is:

  • sponsor name and contact details
  • product active ingredient and trade name, strength, dose form and ARTG number
  • reason for the shortage
  • estimated duration of the supply disruption
  • status (current, anticipated, resolved, or discontinued)
  • patient impact rating
  • additional supply details about the medicine as appropriate
  • information about substitute medicines or therapeutic alternatives as appropriate
  • TGA management actions.

By subscribing to the alert service, subscribers can elect to receive email or RSS feed notification of new and updated medicines shortage information.

Medicine shortage information relating to medicines with a critical patient impact will be mandatorily published on the TGA website. For medium and low patient impact medicine shortages the information will normally be published on the TGA website with the consent of the sponsor.

It is recognised that there may be situations where consent is not given or is not possible. The TGA is able to publish information about medicine shortages under a legislative instrument under section 61 of the Act which provides the TGA with authority to release information to the website regardless of this consent and in cases where the TGA believes there is a public health interest in the information being publicly available (see Specifications). For example, where a sponsor has not published their shortage and the lack of publically available information is creating significant difficulties in the community, the TGA may take the decision to publish the information on the Medicine Shortages Information Initiative website.

Compliance and enforcement

Compliance measures in relation to these new reporting obligations are outlined in the Medicine Shortages in Australia - Reporting obligations and the TGA's compliance framework which is in accordance with the TGA's Regulatory Compliance Framework.

We take a risk-based approach to compliance and will develop appropriate strategies to prevent non-compliance. This will include activities to raise awareness and understanding of the new scheme, which will allow us to respond proportionally to the varied types of non-compliant behaviour.

New regulatory measures available to the TGA under the Act can be used to address breaches. These measures range from publishing the names of sponsors who do not comply with the new requirements (in accordance with s61 of the Therapeutic Goods Act 1989), to issuing infringement notices and, in the most serious cases or where there is repeated non-compliance, initiating civil penalty proceedings. Civil penalties can result in maximum fines of 100 penalty units for an individual and 1000 penalty units for a body corporate.

In most cases, civil penalty action would only be used where other steps, such as awareness raising and warnings, have previously been used and there is a history of repeated non-compliance.

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