Healthy Skepticism Library item: 5872

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Publication type: news

Rumble C.
Urgent call on pharmacy drug labs
The Age (Melbourne) 2006 Aug 13
http://www.theage.com.au/news/national/urgent-call-on-pharmacy-drug-labs/2006/08/12/1154803145320.html?page=fullpage#contentSwap1

Full text:

Urgent call on pharmacy drug labs

http://www.theage.com.au/news/national/urgent-call-on-pharmacy-drug-labs/2006/08/12/1154803145320.html?page=fullpage#contentSwap1

Chantal Rumble
August 13, 2006

A LOOPHOLE in regulation has fostered a rise in potentially unsafe
drug-making in pharmacies, prompting calls for urgent intervention.

Regulators and experts have called on the Therapeutic Goods
Administration (TGA) to develop a national policy to protect patients
from the risks associated with medicines prepared by “compounding chemists”.

Stephen Marty, registrar of the Pharmacy Board of Victoria, said it was
up to the Commonwealth to regulate the practice. “There should be
nationally consistent regulation in place,” he said. “Snake oil is very
much alive and well.”

The Therapeutic Goods Act, established in 1989, includes exemptions for
compounding, the traditional role of pharmacists to make medicines for
individual patients when no commercial product was available. At the
time, compounding was rare and public health risks were deemed very small.

But a small nexus of pharmacists, doctors and marketers used the
loophole to sell expensive “hand-made” drugs, which are promoted as
natural. The drugs are made by chemists in their own pharmacies. The
process is legal but poorly regulated.

According to a report commissioned by the TGA, the practice “has grown
out of all proportion” in a small number of pharmacies in Australia.
“This is part of an international trend and appears to be accelerating
rapidly.” While exact numbers are not known, the report estimates a
small number of specialty pharmacies in each jurisdiction and up to 50
others with some level of involvement.

So-called natural hormone replacement therapy is one of the biggest
sectors of the emerging industry, riding on the wave of fear caused by
contested claims in 2002 that conventional hormone therapies increased
the risk of cancer. Anti-ageing formulations are also booming.

As they are not classified as manufacturers, compounding pharmacists do
not have to comply with safety standards set by the TGA or the
professional pharmaceutical body, Medicines Australia. And as they
operate within professional standards, state and territory pharmacy
boards cannot intervene.

Last year the Australian Health Ministers Advisory Council and the TGA
agreed tighter regulation was necessary. However, a TGA spokeswoman said
a decision on future regulation would be postponed until after the
administration merged with the New Zealand authority, expected late next
year.

Associate Professor John Gullotta, chairman of the Australian Medical
Association’s therapeutics committee, said the TGA must act urgently.
“They can’t put it off any longer because it’s been going on far too
long,” he said.

Patients can pay thousands of dollars for diagnostic tests and hundreds
more for expensive medications made by compounding pharmacists.

The sector is led by the Professional Compounding Chemists of Australia,
a commercial subsidiary of the powerful US lobby, Professional
Compounding Centers of America, and a supplier of drug ingredients.

To attract customers, compounding pharmacists use websites, newspaper
advertisements and customer loyalty programs, and some lobby GPs
directly. At least one pharmacist has offered GPs up to $11,000 a year
in extra income and company shares if they wrote just three
prescriptions for compounded products a day.

Mr Marty, from the Pharmacy Board of Victoria, said most pharmacists
practised in good faith and further regulation must allow for legitimate
compounding. “I don’t want to see pharmacists prohibited from dispensing
unique, one-off products. It’s fine for them to do so provided they have
got the evidence-base (to prove its) safety and efficacy,” he said.

Vital difference in therapies

Natural hormone replacement therapy (NHRT or bio-identicals) is a
hormone preparation made by select pharmacists with inadequate
regulation, scientific research or quality control, and is not approved
for use.

Conventional hormone replacement therapy (HRT) is a hormone preparation
made by pharmaceutical companies. It is strictly regulated, based on
extensive research and approved for use.
SOURCE: PROFESSOR HELENA TEEDE