Mandatory reporting of shortages looms

empty shelves

The Pharmacy Guild and Medicines Australia have both welcomed the introduction of legislation for mandatory reporting of medicine shortages

Health Minister Greg Hunt has introduced the Therapeutic Goods Amendment (2018 Measures No.1) Bill 2018, which amends the Therapeutic Goods Act 1989.

The Amendment is aimed at implementing a mandatory reporting scheme for medicine shortages, to better address the public health implications of such shortages, Mr Hunt said.

“Medicine shortages have become an increasing problem in recent years, not just in Australia but around the world,” he said.

“A shortage of a critical medicine places patients’ lives at risk. This bill responds to concerns raised by patients, their carers and health professionals as well as many representations from members of parliament on behalf of often-distressed patients seeking information about a shortage of a critical medicine.”

He cited the recent EpiPen auto-injector shortage, as “a case in point”.

“The current voluntary scheme for reporting medicine shortages by medicine sponsors, which has been in place since 2014, has, unfortunately, proven to be ineffective,” the Minister said.

“A significant number of medicine shortages of critical patient impact have not been reported to the TGA or not reported in a timely manner.

“As these voluntary arrangements do not oblige sponsors to report, the TGA is not always able to alert the Australian public to a shortage, give them timely advice about steps for alleviating its effects or, significantly, inform health practitioners so they can work with patients to minimise a shortage’s impact.”

He said that a working group, including the Medicines Partnership of Australia, the AMA and the SHPA, chaired by the Department of Health, responded to these concerns to develop a “revised approach”.

“In particular it will be mandatory for companies to report all shortages to the TGA. The TGA will principally publish information about those shortages that are of particular impact on patients, so that prompt action can be taken to address the needs of affected patients.

“The bill would ensure that the new mandatory reporting scheme is properly targeted to higher risk medicines—principally prescription medicines, but other non-prescription medicines that are registered in the Australian Register of Therapeutic Goods may also come within the scheme.

“Examples of products that may be included in this way may be EpiPens and Ventolin inhalers.”

The Bill stipulates time frames in which sponsors must report shortages: for those of critical patient impact, a sponsor will be expected to report as soon as possible but in no more than two working days after they first know, or ought to have reasonably known, about the shortage, Mr Hunt said.

“Under the bill, a ‘shortage’ will exist if its supply in Australia will not, or will not likely, meet the demand for it at any time in the next six months, for all the patients in Australia who take it or who may need to take it.

“This takes a balanced approach by focussing on the overall situation for a medicine’s availability in Australia, meaning instances of short supply that only occur at particular locations would not be shortages under the bill—avoiding the over-reporting of events that may turn out not to be widespread shortages.”

To allow forward planning of patient care, sponsors will also be required to notify the Secretary of any decision to permanently discontinue supplying a medicine to the Australian market, the Minister said.

“For such discontinuations of critical impact the sponsor must notify the Secretary at least 12 months before the proposed discontinuation or, if this is not possible, as soon as practicable after the decision is made.

“For all other discontinuations, the Secretary must be told at least six months before the proposed discontinuation or as soon as practicable after the decision.”

A Medicines Watch list is set to be established as a legislative instrument, he said.

“This list will set out those medicines that, if in shortage, would have a critical impact on patient care.

“A shortage or permanent discontinuation of a medicine not in the Medicines Watch List may still be of critical patient impact if certain criteria in the bill are met—for example, if the shortage could have a life-threatening or serious impact on affected patients.

“Meeting these criteria will trigger the mandatory reporting obligations for critical impact shortages or discontinuations.”

There will be civil penalties for sponsors who do not require with these requirements in time. However, the TGA would work with sponsors to ensure awareness of the scheme and how to comply with it, and take a graduated approach to instances of non-compliance.

Mr Hunt thanked Medicines Australia, the wholesalers, the Pharmacy Guild, AMA and SHPA for their input into the new regime, and their support and advocacy for the bill.

The TGA is seeking comments from stakeholders about the proposal.

The Guild welcomed the move, agreeing that a shortage of a critical medicine places patient lives at risk.

“The Pharmacy Guild fully supports the move to a mandatory reporting regime which will significantly improve communication around medicine shortages for the benefit of patients and health professionals,” it said in a statement.

“Timely communication about medicine shortages and any available alternatives is vital to providing the best level of care for patients.

“Too many times in the past, community pharmacists have been affected by shortages with no warning or readily available information. This legislation will significantly reduce the likelihood of sub-standard patient care arising from unforeseen and un-notified medicine shortages.”

Medicines Australia said that the legislation will “go a long way to ensuring there is timely and relevant information available on the supply of medicines, which will assist patients and their doctors (and other health care providers) to manage their treatment plans to receive uninterrupted care”.

“Minister Hunt’s approach for sponsors to report information about those shortages that are of particular impact on patients, so that prompt action can be taken to address the needs of affected patients, is sensible and factors in the diverse needs of the supply chain,” it said.

“The legislation takes a balanced approach by focusing on the overall situation for a medicine’s availability in Australia.”

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