The resurgence of drug-making
Tuesday 26, July 2011
The resurgence of drug-making in pharmacies has sparked calls for tighter regulation of the industry to prevent chemists from becoming large-scale medicine producers.
Compounding, an intrinsic role of chemists before the birth of the pharmaceutical industry, is experiencing a boom because of an increase in allergies and consumer demand for tailored medicines.
Australasian Compounders Association secretary Jenny Giam said increased regulations would stop pharmacies becoming "Pseudo-manufacturers". "If a pharmacist is supposed to be compounding and moves to a large manufacturing operation and does not have that stringent oversights in place then there is more potential for error."
Ms Giam said problems arose from a small number of pharmacists abusing the Therapeutic Goods Act, which includes exemptions for compounding when no commercial product is available.
A Therapeutic Goods Administration spokeswoman said pharmacists had a legitimate role in creating medicines. But more quality controls were needed. "In more recent years there has been significant examples of high volume compounding and preparation of injectable medicines, which require more stringent quality controls to make sure that patients are no being put at unnecessary risk."
A national consultative committee chaired by the TGA had approved the development of a regulatory impact statement to limit the quantity of medicines produced through compounding. Compounding pharmacists operate within standards set by the Pharmacy board of Australia and are not subject to evaluation by the TGA.
Faruq Amin is one of three Canberra pharmacists who offer specialised compounding service and welcomes increased regulation. In the four years he has run Capital Chemist Woden, he has seen a 10 to 15 per cent increase in customers requiring compounded medicines.
The majority required hormone replacement therapy. Others were pet owners who required medications for their animals in non-tablet form, as well as dermatology clients, and people with allergies who were unable to consume lactose or gluten. "The other area is masking tastes and flavouring for children.
Published in The Canberra Times 26th July 2011
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