Around The Globe

Medicines Shortages Down Under

Richard Day
Professor of Clinical Pharmacology
University of New South Wales

G

lobal Forum: Mandatory reporting of medicines shortages is to commence on January 1, 2019? Can you give the background?

John Skerritt: There have been recent shortages and discontinuations of a number of important medicines such as the EpiPen (epinephrine) auto-injector, MIN-I-JET naloxone injection syringes, glyceryl trinitrate sublingual tablets, hepatitis B vaccine recombinant injections, BCG vaccine, trifluoperazine tablets, metronidazole intravenous infusions, adrenaline injection ampoules, SLOW-K potassium chloride tablets, flumazenil (benzodiazepine antidote), and zoledronic acid injections.

We have relied on information being supplied voluntarily by industry sponsors on the Medicine Shortages Information Initiative (MSII) website hosted by TGA. There are 236 current, 19 anticipated, and 96 discontinued notifications as of October 15, 2018. Despite these numbers, there are many more shortages but reporting is quite inconsistent and so timely action has often not been possible.

GF: What’s behind these large numbers of disruptive discontinuations and shortages?

JS: Disruption to manufacturing processes, unavailability of raw materials, manufacturing difficulties, changes in product formulation or manufacturer, commercial decisions by sponsors, industry consolidation, and unexpected increases in demand due to disease outbreak or new clinical practice all contribute.

GF: How would more timely and complete notifications to TGA make a difference to patients and their healthcare providers?

JS: TGA will be able to provide access for medicines that are registered but discontinued, unavailable or in short supply in Australia but, however, are registered and available in markets such as the US, Canada, UK, Europe and New Zealand, and supply access at short notice. Supply of the medicine will no longer require special individual patient approvals.

GF: What if supplies of a product cannot be secured from overseas?

JS: A Medicine Shortage Action Group will work together to prioritize use of any remaining product stocks, and identify and communicate therapeutic alternatives during the period of the shortage.

GF: What are the key features of the legislation enacted by the Australian Parliament on September 21, 2018?

JS: Sponsors will be required to report shortages for all prescription and some non-prescription medicines. Shortages of critical medicines must be initially reported within two working days, with all relevant related information provided within five working days. Non-critical shortages must be reported within ten working days. The TGA will also have greater powers to penalize sponsors who deliberately fail to comply.

Discontinuations of “critical impact for the patients prescribed these drugs” must be reported at least twelve months before the discontinuation would occur or, if this is not possible, as soon as practicable after the sponsor’s decision. Any other discontinuation must be reported at least six months before the discontinuation would occur or, if this is not possible, as soon as practicable after the decision.

GF: What steps will TGA take to disseminate important information about discontinuations?

JS: TGA will prominently publish information about all current and anticipated shortages of critical patient impact. Information about current shortages that are assessed as having low or medium patient impact may also be published, when sponsors agree to this.

GF: What about shortages of critical medicines?

JS: TGA will work actively with healthcare professionals, including state and territory Chief Health Officers and/or clinical colleges, to identify alternative therapies in a more timely manner. We will also work with industry using existing mechanisms to facilitate the temporary import of suitable medicines that have been registered in comparable international markets.

GF: A Medicines Watch List is proposed? What is this and how will it help?

JS: The legislative instruments supporting the new scheme, including the Medicines Watch List which details medicines considered to be of critical impact, will be published in November 2018 along with guidance material that is undergoing targeted consultation prior to publication. Education and further communication activities will commence in December.

GF: What has been the response to the Legislation and other changes so far?

JS: It has generally been very positive from industry, health practitioner associations, NPS MedicineWise and other groups.