Shortages protocol mooted

empty shelves

A proposed protocol for managing and communicating medicines shortages has the backing of the SHPA

Under the changes suggested by the TGA, medicine suppliers would be required to report all medicines shortages in confidence to the TGA and, under a new classification system, all medicines shortages deemed to carry “extreme” or “high” patient impact would be mandatorily published on the public Medicines Shortages Information Initiative on the TGA website.

Professor Michael Dooley, SHPA Federal President says the proposed protocol – which has been informed by data gathered by SHPA members at a grassroots level – will provide important protections for Australian patients.

“The adoption of a patient-oriented definition of medicine shortages, which describes the impact of the shortage on a scale from ‘low’ to ‘extreme’, is welcomed,” he says.

“SHPA is pleased to see the proposed mandatory requirement that sponsors notify the TGA of shortages as soon as they are known or anticipated. This will reducing the burden of hospitals addressing systemic shortages on a case-by-case basis, as currently occurs.

“Quickly distributing this medicine-specific knowledge to hospital pharmacists, will mean less time chasing replacement stock or devising alternative medicine regimens and more time spent caring for patients.”

Professor Dooley says it is important the proposed protocol prioritises medicines used to treat acutely ill patients in hospitals, through a Medicines Watch List, which will enable shortages of these medicines to be recognised as a high priority in managing and resolving.

“Working primarily in the hospital setting, SHPA members manage the medicines of the most unwell patients, so it is crucial the new protocol focuses on ensuring supply of these medicines, which can be difficult, expensive and time-consuming to replace.

“Through advice from SHPA’s collective Specialty Practice groups, SHPA has made further suggestions for additions to the Medicines Watch List which are critical to treating life-threatening conditions, such as intravenous antimicrobials and anaesthetics for mass casualty events and public health emergencies.

“In addition, SHPA supports the revision of legislation to ensure that medicine sponsors are incentivised to report shortages likely to have a clinical impact, and that widespread compliance is mandated.”

Kristin Michaels, SHPA Chief Executive, says the proposed protocol is a very positive response to a 2017 report information gathered by SHPA members on the scope of the issue, again at a grassroots level.

“In June 2017, SHPA released Medicines Shortages in Australia, containing data from a snapshot survey of members revealing shortages were more prevalent than previously thought, only flagged by pharmaceutical suppliers 15% of the time and negatively affected patient treatment in one third of cases,” she says.

“It has been a very constructive process partnering with the Federal Department of Health and other key stakeholders to develop this evidence-based approach that rightly reflects the community’s expectation that, in reasonable circumstances, the most appropriate medicines for their treatment should be reliably available in Australia.”

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