Shortcut update on drug supply
The medicines regulator has lifted restrictions on the supply of a common anaesthetic just days after the launch of a system to alert hospitals, health professionals and patients of medicine shortages.
Supplies of the widely used intravenous anaesthetic propofol began to flow freely early this month after the Therapeutic Goods Administration withdrew precautionary restrictions put in place following a contamination scare.
While the cause of the contamination, in which several patients developed sepsis after receiving the drug, is yet to be determined, the TGA said the outcome of extensive testing made it confident that the product was safe for use.
The watchdog said both it and three external laboratories had conducted tests for sterility and the presence of bacterial endotoxins on 25 batches of propofol 1 per cent emulsion, involving 1680 vials, and “all samples passed the criteria”.
However, in a caveat, the TGA said tests on the outer surface of vial rubber stoppers and the inside of lids had found microbial contamination in a “low number” of cases.
The regulator said that, based on these results and other information, it was “confident that supply restrictions are not necessary”.
While the supply restrictions were in place, hospitals and practitioners were directed to avoid using propofol manufactured and supplied by Provive and Sandoz. Instead, they were instructed to secure alternative supplies or, where that was not possible, assess the cost and benefits of using the product.
The decision to lift the supply restriction came soon after the launch, following sustained AMA lobbying, of a website notifying practitioners and patients about medicine shortages.
The AMA has made numerous representations on the need for arrangements to ensure there were clear, consistent and coordinated systems for the timely notification and management of medicine shortages. Immediate-part AMA Vice President Professor Geoffrey Dobb held several meetings with the ministers from both the current and former Federal Governments to press action on the issue.
Announcing the establishment of a website to notify of drug shortages in late May, Assistant Health Minister Fiona Nash said episodes such as the propofol shortage highlighted the importance of getting timely information about supplies of medicines out to the medical community as quickly and clearly as possible.
Senator Nash said it was for this reason that the TGA, in partnership with Medicines Australia and the Generic Medicines Industry Association, had set up a website (http://www.tga.gov.au/hp/information-msi.htm) to alert practitioners and consumers when drugs come into short supply and suggest medicine substitutes or alternative therapies.
Professor Dobb flagged earlier this year that the AMA would have preferred a mandatory notification system for “high impact” medicine shortages, the current voluntary arrangement was still “a considerable improvement on the current ad hoc and uncoordinated approach”.
The Minister said shortages can be caused by something as simple as a disruption in manufacturing through to a spike in demand caused by a disease outbreak.
“Whether the shortage affects thousands, hundreds or a small number of people, it can be difficult for the individuals involved,” Senator Nash said. “For patients who regularly take a medicine, and then cannot get that medicine, change can have significant implications, even if there is an alternative.
“Up-to-date and consistent communication about medicine shortages is crucial to allow continuity of care.”
The website not only provides a single source of information for doctors, pharmacists and patients, but also cuts red tape for drug companies, which will now be able to report shortages by simply completing an online firm.
The Medicine Shortages Information Initiative website is at: http://www.tga.gov.au/hp/information-msi.htm