MARK COLVIN: But first tonight, don't take your vitamins, and check
your other non-prescription drugs. Australia's medicine cabinets
tonight need a severe cleanout, after what appears to be the biggest
product recall in Australian medical history.
The Therapeutic Goods Administration, the Federal Government's
medicines watchdog, has ordered an urgent recall of 219 products
made and supplied by Pan Pharmaceuticals. Pan on its website
describes itself as the largest independent contract manufacturer of
ethical drugs and health supplements in the world.
It also claims to comply fully with the Therapeutic Goods
Administration Code of Good Manufacturing Practice for Therapeutic
Products. But now the TGA says the company has been systematically
and deliberately manipulating its quality control test data.
The company's products affected include herbal and complementary
medicines, but Pan also makes painkillers like paracetamol, and cold
and flu medicines, on licence to other companies.
Nick Grimm reports.
NICK GRIMM: Sydney-based drug manufacturer Pan Pharmaceuticals is
the nation’s largest contract manufacturer of complementary
medicines, such as vitamins, minerals and herbal and nutritional
supplements.
The company also produces over-the-counter pain relievers like
paracetamol and codeine, and cold and flu preparations such as
antihistamines and pseudoephedrine. Now a there's a list of 219
products, many carrying the Pan product name, which must not be
used.
Dr John McEwen is the principal medical adviser for the Therapeutic
Goods Administration.
JOHN MCEWEN: It’s important that we stress that we’re not talking
about prescription medicines. Up to this time no safety problems
have been identified with the prescription medicines on the
Pharmaceutical Benefits Scheme.
What we’re talking about are a range of over-the-counter and
particularly complementary medicines, herbal and vitamin products,
and similar products to that.
NICK GRIMM: The product recall is the result of an investigation
which began in January, when an anti-travel sickness tablet,
Travacalm, manufactured by Pan for another company, was itself
recalled. Faulty batches of the product had caused the
hospitalisation of 19 people, while 68 others suffered potentially
life threatening adverse reactions.
JOHN MCEWEN: It came to light initially because of problems with a
travel sickness remedy in January, and when we investigated that we
found there were manufacturing problems. Within a pack, some tablets
had no active ingredient, and within the same pack at least one
tablet had up to seven times the amount.
And what initially misled us was that the company had manipulated
some assay results. Since then we have had our auditors visit the
plant on a couple of occasions, and most recently spent nearly a
week there, and have come up with multiple quality control and
production failures, and we’ve reached the point where – in the
interest of public health – we must simply get their products out of
the marketplace.
NICK GRIMM: Is it the case there was a deliberate attempt to mislead
your investigators?
JOHN MCEWEN: I wouldn’t want to say that, because that conveys sort
of active diversion of the investigators. But, certainly, we found a
number of things which were quite worrying to us on this recent
audit.
NICK GRIMM: What’s likely to cause further confusion for the public
tonight is the further warning from the Therapeutic Goods
Administration that other products might also be affected.
Pan Pharmaceuticals has also manufactured products under licence for
other companies. But what those products and their brand names might
be, the Therapeutic Goods Administration isn’t saying yet.
John McEwen again.
JOHN MCEWEN: The great challenge for us is that Pan also are the
biggest contract manufacturer, and they occasionally, therefore,
make batches for other people and they will not be branded as Pan
product.
So we’re in touch with a wide array of other marketers of these
products, asking them to identify for us all of the batches of their
products which Pan has made in the last 12 months, and we have in
plan to publish that on our website and then in a second newspaper
advertisement late this week or early next week, to publish a much
broader list of those other products.
NICK GRIMM: The Therapeutic Goods Administration didn’t consider
pursuing that investigation first, before making this information
public. I mean, a lot of people are going to be confused tonight
about whether they can use the products that they will have at home,
because they don’t know if it’s been…
JOHN MCEWEN: We quite take that point. The Administration looked
very carefully at that. It’s simply because of the magnitude of the
task, and to delay at all would just leave us exposed to accusations
of doing nothing.
I think we can say that in the next little while, if people have got
medicines that, like vitamin products, mineral products that they
don’t need to take as an essential medicine, it would be sensible,
prudent to delay taking them until they’ve checked the numbers on
the label of them against the published lists in the newspapers.
NICK GRIMM: Now, the recall spells a major headache for pharmacists
and other retailers.
John Bronger is the National President of the Pharmacy Guild of
Australia.
JOHN BRONGER: I’m a bit stunned actually. I haven’t seen a recall of
this sort for, you know, for quite a number of years.
NICK GRIMM: How’s this going to impact on your members?
JOHN BRONGER: This will be quite a few products come back, and our
members will be involved in making sure that the public haven’t been
affected by it, and oh gee, it’s just a mess.
NICK GRIMM: This has got the potential for causing a lot of
confusion, hasn’t it? What’s your advice to members of the public
tonight?
JOHN BRONGER: Look, I would say that first of all to just read any
of the other medicine and the vitamins and pain area, and see
whether it’s been manufactured on the label by Pan Pharmaceuticals,
and if it has, and it’s within the date period, to take it back to
the pharmacist, and he’ll sort it out for them.
MARK COLVIN: John Bronger is the National President of the Pharmacy
Guild of Australia. Nick Grimm with that report.
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