respiratory

Tough new rules for pharma companies to notify medication shortages


Pharmaceutical companies will be forced to report medication shortages within strict time frames or face financial penalties, under new laws that come into effect in January 2019.

The Therapeutics Goods Amendment Bill was passed in parliament on 10 September in response to concerns raised by medical groups about large numbers of essential medicines going out of stock at short notice and with little information being provided by manufacturers.

The new law gives companies two days to report to the TGA shortages that will have a “severe” impact on patients and 10 days for others. It replaces the current voluntary reporting scheme, which federal health Minister Greg Hunt said many companies had been ignoring.

In the last year Australia has been hit by shortages of products including EpiPens, vaccines for hepatitis and meningococcal disease and diabetes drugs such as metformin.

In a submission to the TGA, the Cancer Council of Australia gave examples of where a shortage of cancer agents could have or did lead to a significant disruption to patient care, including vinblastine, dacarbazine, etoposide phosphate, mitomycin and doxorubicin.

“Implications of shortages often go beyond a simple change in therapy that may be possible in other disciplines and may involve the use of regimes where data is less robust or older, or impact on other services such as radiotherapy, if combined modality treatment is involved,” it said.

While the new mandatory reporting rules won’t necessarily avert shortages, they may allow for arrangements to be made to source an alternative supply, the Senate was told when debating the legislation.

“The TGA can also work with a sponsor to identify and authorise the supply of a suitable substitute medicine. Public health authorities can also prepare advice on alternatives for patients, and in extreme circumstances, supplies can be rationed,” ALP Senator Helen Polley told the Senate.

However the AMA said that simply improving communication about medicine shortages did not go far enough, and there was a need for the Department of Health to take pro-active steps to ensure supplies of PBS-subsidised alternatives in times of shortages rather than rely on industry to act.

“There is no point in announcing a shortage if patients cannot access appropriate alternative medicines on the PBS because of price or restricted indications,” it said in a submission.

“There needs to be a mechanism to rapidly and temporarily substitute either a medicine that is on the PBS but at a higher price, for one not available due to shortage, or temporarily alter PBS indications/restrictions for medicines so they may be used for additional indications where the preferred medicine is not available. The Department of Health should take this initiative, not medicine sponsors.”

Under the new rules manufacturers must also give a minimum of 12 months’ notice to the Department of Health before taking a critical drug off the market.

Companies found to be no compliant could face fines of up to $210,000 per infringement and court action.