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Presentation: Reporting of Medicine Shortages

TGA presentations given by the TGA at the 2019 ARCS Annual Conference, Sydney, 6-8 August 2019

10 September 2019

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These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Anna Nhan
  • Presented at: 2019 ARCS Annual Conference
  • Presentation date: 7 August 2019

Transcript

Reporting of Medicine Shortages

Anna Nhan
Medicine Shortages team, Risk Management Section
Pharmacovigilance and Special Access Branch, TGA

ARCS - August 2019

Slide 1 - Overview

  • Background
  • Definitions
  • Reporting requirements
  • Assessment & management
  • Section 19A
  • Compliance framework

Slide 2 - Background

  • Worldwide issue
  • Lack of a universally accepted definition of a "medicine shortage"
  • Varying degrees of patient impact
  • Medicine shortages are unavoidable and cannot be prevented in most cases
  • Need for timely communication of medicine shortages

Slide 3 - Causes of shortages

  • Unavailability of raw materials
  • Manufacturing/Quality related issues
  • Changes in product manufacturer
  • Commercial decision by sponsors
  • Unexpected fluctuations in demand

Slide 4 - Shortage reasons reported

Shortage reasons reported for 2017

Shortage reasons reported for 2018

Shortage reasons reported for 2019

Slide 5 - How shortages have been managed until now

  • Previously no consistent and co-ordinated approach to the communication and management of medicine shortages in Australia
  • Healthcare professionals and consumers left uninformed
  • Based on voluntary notifications from sponsors
  • Medicine Shortages Information Initiative (MSII) webpage was launched on 26 May 2014.

Slide 7 - Limitations

  • Voluntary scheme vs FDA and Health Canada where reporting of shortages is mandatory
  • Not all shortages notified
  • Health care professionals and patients aware of shortages before they were reported
  • Lack of accuracy of information
  • Information out of date

Slide 8 - Changes to how shortages are communicated and managed in Australia

  • End of 2017 - Health Minister requested change to current system
  • Issues considered:
    • definition of a medicine shortage
    • reporting obligations and timeframes for sponsors
    • introduction of the "Medicines Watch List" (MWL)
    • penalties for non-compliance

Slide 9 - Changes to how shortages are communicated and managed in Australia

  • Goals:
    • Improve management and communication of medicine shortages
    • Increase transparency
    • Early identification of alternative medicines where necessary
  • Therapeutic Goods Act 1989 amended
    • mandatory reporting for all "reportable medicine" shortages to the TGA to commence from 1 January 2019

Slide 10 - Overview

  • Mandatory reporting of all "Reportable medicines" (include all S4, S8 and some S3 medicines)
  • Mandatory publication on the MSII if Critical Impact
  • Critical Impact medicine shortages
  • Medicines Watch List
  • Reporting of critical impact shortages vs low/medium impact

Slide 11 -

  1. Notify

    Sponsors can notify the TGA when they become aware of a shortage. For prescription medicines and some over-the-counter medicines this is mandatory and must be done within specified timeframes

  2. Assess and respond

    The TGA works with sponsord to assess the impact of the shortage and agree on responses.

  3. Publish

    Standardised information is published on the TGA's Medicine Shortages Information Initiative website. For all shortages with a critical patient impact, publishing information is mandatory. Publication about other shortages is also hightly encouraged.

  4. Update

    Sponsors provide new information about shortages to the TGA when it becomes available and any details on the TGA website are updated.

Slide 12 - Definition - Medicine shortage

A medicine shortage is defined in the Act as:

a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

Slide 13 - Discontinuation - Legislated timeframes

The discontinuation of the supply of a medicine (a permanent shortage) must also be notified to the TGA as outlined in the legislation:

  1. if the discontinuation is likely to be of critical impact:
    1. at least 12 months before the discontinuation is proposed to occur; or
    2. if the person is unable to comply with subparagraph (i) - as soon as practicable after the decision is made; or
  2. in any other case:
    1. at least 6 months before the discontinuation is proposed to occur; or
    2. if the person is unable to comply with subparagraph (i) - as soon as practicable after the decision is made.

Slide 14 - Reportable medicines

Reportable medicines are defined in the legislation as:

  1. For the purposes of this Act, registered goods are a reportable medicine if:
    1. the goods are medicine; and
    2. either:
      1. the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard; or
      2. the medicine is determined in an instrument under subsection (2).
  2. The Minister may, by legislative instrument, determine medicine for the purposes of subparagraph (1)(b)(ii).

Slide 15 - Reportable medicines

Non-prescription medicines:

  • critical to the ongoing health of the patient (e.g. salbutamol inhalers)
  • inclusion of the medicines is critical for public health (e.g. naloxone injections)

Slide 16 - Therapeutic Goods (Reportable Medicines) Determination 2018

Slide 17 - Critical impact vs Low/Medium

  • A risk assessment framework
  • Nature and size of the population affected
  • Availability of alternative products
  • Assists in determining patient impact - critical, medium or low

Slide 18 - Impact assessment framework

Slide 19 - Medicines Watch List (MWL)

Slide 20 - Reporting a shortage - Timeframes

Critical impact

  • If on the Medicines Watch List, or assessed as having critical patient impact - must report to the TGA within 2 working days.
  • Either complete all fields and submit to the TGA within 2 working days
  • OR
  • Submit initial report within 2 working days containing certain information that is required. Submit remaining information within 3 working days

Slide 21 - Reporting a shortage - Timeframes

Critical impact

  • minimum information required:
    • impact of the shortage
    • nature of the shortage
    • sponsor details
    • ARTG number - which will provide the ARTG name
    • primary contact for TGA to liaise with
    • 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

Slide 22 - Reporting a shortage - Timeframes

Low/Medium impact

  • sponsor has 10 working days to notify TGA
  • completion of all fields in the notification form is mandatory

Slide 23 - New Medicine Shortage Notification

Slide 24 - Manage

Investigation of alternative products

  • Identify products that may be available for substitution
  • Same pharmaceutical substance, dose form and strength but sourced from another supplier
  • Different substance but in the same therapeutic class
  • Suitable products may be sourced from overseas

Slide 25 - Communicate

Critical impact

  • Mandatorily published on the Medicines Shortage Information Initiative website.
  • Sponsor to undertake the following communications as appropriate:
    • hospital medicines
    • community/retail pharmacy medicines
    • PBS medicines
    • National Immunisation Program vaccines
    • National Blood Authority plasma components (registered medicines)

Slide 26 - Communicate

Low/Medium impact

  • Highly encourage to be published on the Medicines Shortage Information Initiative website.
  • Sponsor to notify other stakeholders as required, eg supply chain
  • Minimise lack of publicly available information creating difficulties in the community

Slide 27 - Role of TGA

  • Manages the medicines shortage information initiative website
  • Review the sponsor's initial risk assessment of the shortage and communicate the shortage as needed
  • Approve temporary supply of a substitute medicine during a shortage
  • May undertake additional communication activity where necessary

Slide 28 - Role of sponsors

  • Maintain continuity of supply for a medicine through various business processes
  • Assess supply and demand gaps and develop a response
  • Implement management activities to secure supply
  • Implement communication activities to the supply chain

Slide 29 - TGA Home page - Medicine shortages

Slide 30 - Medicine Shortages Information Initiative

Slide 31 - Active ingredient - medicine shortage information

Slide 32 - Medicine Shortages Guidance and Resources

Slide 33 - Medicine shortages guidance documents and fact sheets

Slide 34 - Number of new notifications

New medicine shortages notifications in 2018

Slide 35 - Number of new notifications

New medicine shortages notifications January to June 2019

Slide 36 - Number of total notifications

Number of total notifications for 2018

Slide 37 - Number of total notifications

Number of total notifications for January to June 2019

Slide 38 - Section 19A

Slide 39 - Section 19A

  • Allows a sponsor to import and supply a medicine not on the ARTG because:
    • The Australian registered medicine is in shortage or unavailable
    • The medicine is needed in the interest of public health
      • availability of other treatments
      • consequences of discontinued treatment or changing treatment
      • projected demand for the product

Slide 40 - Section 19A

  • Included in Schedule 10 to the Therapeutic Goods Regulations 1990
  • Approvals are granted for a specified period of time
  • Subject to any relevant conditions

Slide 41 - Suitable substitutes - what to consider

  • Identify and assess suitability of all potential substitutes included in the ARTG
  • Availability of substitutes included in the ARTG
  • Suitability of s19A product:
    • how close it is to ARTG product in shortage/unavailable
    • how appropriate it is to use the substitute in the intended patient population
    • how appropriate is the dosage form

Slide 42 - Specified foreign countries

  • S19A(1): Medicine must be registered and marketed in at least 1 of 9 specified countries
    • Canada
    • France
    • Germany
    • Netherlands
    • New Zealand
    • Sweden
    • Switzerland
    • United Kingdom
    • United States of America
  • S19A(1A): Medicine is registered and marketed in a country other than the above

Slide 43 - Conditions of approval

  • Current GMP
  • Labelling in English (at least easily identifiable)
  • Product information in English
  • Dear Health Care Professional Letter
  • Over-label with Australian sponsor’s name and address
  • Adverse event reporting
  • Reporting on supply

Slide 44 - Multiple applications

  • Usually only grant one approval
  • Consider granting approval to subsequent application(s) if supply cannot be met and where appropriate
  • An effective application is one that:
    • has been completed in full
    • provides all relevant attachments

      AND

    • meets the criteria for approval.

Slide 45 - Accessing medicines during a medicine shortage

Slide 46 - Compliance framework

Slide 47 - Reporting requirements - recap

  • A medicine is in 'shortage' if its supply in Australia will not, or will not likely, meet the demand for it at any time in the next 6 months, for all the patients in Australia who take it or who may need to take it
  • 'Critical impact' shortage - no later than 2 working days
  • Any other shortage - within 10 working days
  • Discontinuation of 'critical impact' - at least 12 months
  • Any other discontinuation - at least 6 months

Slide 48 - Information gathering powers

  • Power to require a person to provide information or documents in relation to:
    • whether or not there is a shortage of the medicine in Australia;
    • if there is a shortage of the medicine in Australia - the shortage, or
    • any decision of the person to permanently discontinue the supply of the medicine in Australia

Slide 49 - Medicine shortage reporting non-compliance

  • Compliance obligations and penalties commenced on 1 July 2019
  • In accordance with the TGA's Regulatory Compliance Framework.
  • Graduated, risk-management approach to compliance
  • TGA's response to non-compliance guided by:
    • whether there is a potential for detriment to the health of consumers, and
    • sponsor's behaviour prior to and in relation to the non-compliance with their reporting obligations.

Slide 50 - Regulatory compliance and enforcement tools

  • Legal obligations letter
    • informs a sponsor that their reporting may not be compliant
    • provides educational and guidance material
    • does not seek a response
  • Formal warning letter
    • sponsor is aware of reporting obligations but have not met them
    • requires the sponsor to respond to the TGA
    • TGA will publish the names of sponsors who do not comply

Slide 51 - Regulatory compliance and enforcement tools

  • Infringement notice
    • may be given where a sponsor has, within 12 months, contravened a civil penalty provision of the Act for non-compliance with their reporting obligations relating to medicine shortages or discontinuations.
  • Enforceable undertaking
    • a promise able to be enforced by a court
  • Civil penalty litigation in the Federal Court
    • can result in large fines being imposed on the alleged sponsor

Slide 52 - Compliance risk

Low Medium High Extreme

Help and support

  • Make ongoing compliance easy through clear education and guidance material

Inform and advise

  • Direct education and guidance in a legal obligations letter to help the sponsor become and stay compliant

Correct non-compliant behaviour

  • Send a formal warning letter and giving notice of available compliance and enforcement options available to the TGA
  • Publish names of non-compliant sponsors

Enforce penalties

  • Civil penalties
  • Infringement Notices
  • Enforceable Undertakings

Voluntary compliance

  • Effective compliance systems in place
  • Management is compliance oriented

Accidental or opportunistic non-compliance

  • Ineffective compliance and/or developing compliance systems
  • Management is compliance oriented but lacks capability

Regular non-compliance

  • Resistant to compliance
  • Management is not compliance oriented

Intentional non-compliance

  • Deliberate non-compliance
  • No or ineffective compliance systems
  • Reckless attitude towards reporting obligations
"Committed to doing the right thing" "Try to comply but don’t always succeed" "Don't want to comply but will if made to" "Conscious decision to be non-compliant"

Slide 53 - Publication of outcomes

  • Details about the sponsor and action undertaken by the TGA may be published on the TGA website:
    • formal warning letter
    • infringement notices
    • enforceable undertaking
    • civil penalties
  • Transparency of the TGA’s compliance handling processes

Slide 54 - Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framwork (to be implemented on 1 July 2019)

Slide 55 - END SLIDE

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