Medicine Shortages Changes to the Communication and Management of Medicine Shortages in Australia Dr Tony Gill Director Medicine Shortages Section, Pharmacovigilance and Special Access Branch ARCS Annual Conference 23 August 2018
Background • Medicine shortages are a global public health issue affecting rich and poor countries alike • Complex issue where there is a lack of a universally accepted definition of a “medicine shortage” • Varying degrees of patient impact – e.g. a shortage of a generic amoxicillin 250 mg oral product = LOW IMPACT – e.g. unexpected batch failure of heparin-based products which has NO therapeutic alternative = CRITICAL IMPACT • Medicine shortages are unavoidable and cannot be prevented in most cases • However the timely communication of medicine shortages informs: - The development of mitigation strategies - Healthcare professionals in the management of their patient’s treatment 1
Causes of shortages • Disruption to manufacturing processes • Unavailability of raw materials • Manufacturing/Quality related issues • Diversity of regulatory requirements • Changes in product formulation • Changes in product manufacturer • Commercial decision by sponsors • Unexpected fluctuations in demand • Lack of timely communication regarding supply/demand 2
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 • Subsequent decision to have an organised approach • Joint initiative established • Medicine Shortages Information Initiative (MSII) webpage was launched on 26 May 2014. • http://apps.tga.gov.au/prod/MSI/search/ 3
Joint Initiative
Australian protocol • Founded on a commitment to improve the communication and management of medicine shortages in Australia • Key document highlighting the roles and responsibilities of all stakeholders in the event of a medicine shortage and the subsequent actions required • Based on voluntary notifications from sponsors • Medicine Shortages Information Initiative Protocol is available on the TGA website • http://www.tga.gov.au/publication/medicine-shortages-information-protocol 5
Benefits of a medicine shortage database • Consolidated • Role clarity “source of truth” • Efficient • Confidence of Mechanisms to Consumers TGA updates “close the loop” • Information to • Standardised support continuity • Information to assessment/ • Role clarity of care support discussions Consistent • Streamlined with HCP responses systems Sponsors Health professionals
MSII website 8 http://apps.tga.gov.au/prod/MSI/search
Information available on the website • Sponsor name and contact details • Product active ingredient and trade name, strength, dose form and ARTG number • Reason for shortage (provided by sponsor from drop down menu) • Estimated duration of the shortage • Shortage type – anticipated, current, resolved, discontinuation • Additional supply details about the medicine as appropriate • Information about substitute medicines or therapeutic alternatives as appropriate and available 9
Limitations • Voluntary scheme vs FDA and Health Canada where reporting of shortages is mandatory • Not all shortages notified and reasons for which include: – Perceived commercial risk with future contracts – Perceived commercial risk that lose share of markets if generic products available • Timelines – Variable timeliness of notification – tend to hear from other sources and then speak to sponsor to request notification – Accuracy of information shortage commenced but not notified and available on MSII duration of expected shortage under estimated Information integrity– sponsors forget to update current information once published 10
Statistics • In 2017 224 notifications to the TGA • Society of Hospital Pharmacists of Australia in June 2017 – Commercial changes – 5 reported on a survey of medicine shortages on a – Discontinuations – 26 particular day in hospitals across Australia. – Manufacturing issues – 103 – 1577 medicines – Unexpected increase in demand – 36 – 154 substances/API – Other - 54 – 14.8% on MSII website • As of 22 August 2018 Australia had 214 current notifications on the MSII and 428 notifications in total (includes current, anticipated, resolved and discontinued notifications) 11
Statistics – 2015, 2016 & 2017 Unexpected Shortage Reasons 2017 Commercial Increase in Changes Demand 2% 16% Discontinuation 12% Other 24% Manufacturing 46% • Discontinuations are classified as permanent shortages
Breakdown of notifications • Notifications are classified by high level descriptors • Various contains all notifications resulting from the shortages of allergens Notifications by ATC Code 2016 Various Respiratory system Musculo-skeletal system Antiinfectives for systemic use Genito-urinary system and sex hormones Cardiovascular system Alimentary tract and metabolism 0 5 10 15 20 25 30 35 40
Notifications by ATC Code 2017 Various Sensory organs Respiratory system Nervous system Musculo-skeletal system Antineoplastic and immunomodulating agents Antiinfectives for systemic use Systemic hormonal preparations, excluding sex hormones and insulins Genito-urinary system and sex hormones Dermatologicals Cardiovascular system Blood and blood forming organs Alimentary tract and metabolism 0 5 10 15 20 25 30 35 40 45 50 14
Changes to how shortages will be communicated and managed in Australia • Public consultation held from 28 March to 30 April • All stakeholders acknowledged the need for a better system • Issues under consideration included: the definition of a medicine shortage, the reporting obligations and timeframes for sponsors, introduction of the “Medicines Watch List” (MWL) and penalties for non-compliance • Definition of a medicine shortage: if the supply of that medicine in Australia will not, or will not be likely to meet the demand for the medicine at any time in the next 6 months for all patients in Australia who take, or who may need to take, the medicine • The Bill has been introduced into Parliament and subject to the passage of legislation, the introduction of mandatory reporting for all “reportable medicine” shortages to the TGA will commence from 1 January 2019 15
Changes to how shortages will be communicated and managed in Australia (contd) • “Reportable medicines” include all S4, S8 and some S3 medicines • Mandatory publication on the MSII website for medicine shortages assessed to be of Critical Impact • Critical Impact medicine shortages include instances where there are no reasonable substitutes available or if the shortage has the potential to have a life threatening impact on patients who need or may need to take it • Medicines Watch List: a subset of medicines identified to assist in simplifying and speeding up decision- making when deciding if a medicine shortage has critical patient impact • Sponsors will have to report critical impact medicine shortages within 2 working days of becoming aware of the shortage with certain information including: name of the sponsor, product and estimated duration of shortage. All other required information to be reported within the following 3 working days 16
Changes to how shortages will be communicated and managed in Australia (cont.) • All other shortages to be reported within 10 days of becoming aware of the shortage • Discontinuations will also have to be reported • Critical impact medicine discontinuation- 12 months notice required or as soon as the sponsor is made aware of the decision to discontinue • All other discontinuations- 6 months notice required or as soon as the sponsor is made aware of the decision to discontinue • TGA takes a graduated, risk-based approach to compliance and will assess reports of non-compliance on a cases by case basis 17
Changes to how shortages will be communicated and managed in Australia (cont.) • Penalties for demonstrated and deliberate non-compliance will include civil penalties (fines) with a maximum of 100 penalty units for an individual and 1000 penalty units for a sponsor • TGA will also publish the names of sponsors who have been non-compliant on the MSII • Further stakeholder engagement and communication activities planned for 2018 to ensure all stakeholders are aware of their roles and responsibilities (including the publication of a revised protocol) 18
Recommend
More recommend
