Reporting of Medicine Shortages Anna Nhan Medicine Shortages team, - - PowerPoint PPT Presentation

Reporting of Medicine Shortages

Anna Nhan Medicine Shortages team, Risk Management Section Pharmacovigilance and Special Access Branch, TGA ARCS – August 2019

Overview

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

1

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

2

Causes of shortages

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

3

Shortage reasons reported

3% 9% 46% 26% 16%

2017

2% 14% 50% 16% 1% 17%

2018

22% 46% 17% 1% 14%

2019

Commercial changes Discontinuation Manufacturing Other Product recall Unexpected increase in demand

4

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.

5

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• Information out of date

6

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

7

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

8

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

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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,

• r who may need to take, the medicine.

11

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

12

Reportable medicines

Reportable medicines are defined in the legislation as: (1) For the purposes of this Act, registered goods are a reportable medicine if: (a) the goods are medicine; and (b) either: (i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard; or (ii) 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).

13

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 (eg naloxone injections)

14

15

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

16

Impact assessment framework

17

Medicines Watch List (MWL)

18

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

19

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

20

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

21

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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

23

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)

24

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

25

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

26

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

27

ARTG name: AUST R: Active ingredients: Sponsor: Phone:

active ingredient - m edicine shortage inform ation

30

32

Number of new notifications

20 40 60 80 100 120 140 160 180 200 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018

33

Number of new notifications

50 100 150 200 250 300 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018 2019

34

Number of total notifications

50 100 150 200 250 300 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018

35

Number of total notifications

100 200 300 400 500 600 700 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018 2019

36

Section 19A

37

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

38

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

39

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

40

Specified foreign countries

• S19A(1): Medicine must be registered and marketed in at least 1 of 9 specified countries
• S19A(1A): Medicine is registered and marketed in a country other than the above

Canada Sweden France Switzerland Germany United Kingdom Netherlands United States of America New Zealand

41

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

42

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.

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Compliance framework

45

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

46

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

47

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.

48

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

49

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

50

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

• bligations 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

• pportunistic 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

• bligations

“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”

51

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

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