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
3% Shortage reasons reported 9% 16% 2017 2019 Commercial changes 14% 26% 22% 1% Discontinuation 46% Manufacturing 2% 17% Other 2018 17% 14% Product recall 1% Unexpected increase in demand 16% 46% 50% 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professionals and patients aware of shortages before they were reported • Lack of accuracy of information • Information out of date 6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: o definition of a medicine shortage o reporting obligations and timeframes for sponsors o introduction of the “Medicines Watch List” (MWL) o penalties for non-compliance 7
Changes to how shortages are communicated and managed in Australia • Goals: o Improve management and communication of medicine shortages o Increase transparency o Early identification of alternative medicines where necessary • Therapeutic Goods Act 1989 amended o 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 9
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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, or 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
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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: o impact of the shortage o nature of the shortage o sponsor details o ARTG number – which will provide the ARTG name o primary contact for TGA to liaise with o date the shortage was known to the sponsor o estimated dates for the start and end of the shortage o availability o 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: o hospital medicines o community/retail pharmacy medicines o PBS medicines o National Immunisation Program vaccines o 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
active ingredient - m edicine shortage inform ation ARTG name: AUST R: Active ingredients: Sponsor: Phone: 30
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Number of new notifications 200 180 160 140 120 100 80 60 40 20 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018 33
Number of new notifications 300 250 200 150 100 50 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018 2019 34
Number of total notifications 300 250 200 150 100 50 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2018 35
Number of total notifications 700 600 500 400 300 200 100 0 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: o The Australian registered medicine is in shortage or unavailable o 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: o how close it is to ARTG product in shortage/unavailable o how appropriate it is to use the substitute in the intended patient population o how appropriate is the dosage form 40
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