The Australian Rheumatology Association has expressed concerns about risks to patient safety it says could follow from measures on biosimilars going through the Senate today as part of the wider Pharmaceutical Benefits Bill.

“The proposed new powers will allow pharmacists to switch particular drugs at the pharmacy counter with the potential for patients to get a different drug every time they go to the chemist,” says Dr Mona Marabani, President of the ARA.

Biologics and biosimilars are used in the treatment of a number of forms of arthritis, inflammatory bowel disease and psoriasis.

The substituted biosimilar drug sold by the pharmacist could have the following potential effects, she says:

The patient’s prescribing doctor and the patient him/herself may not know which drug is being given which could cause problems in working out which drug is at fault if there is a serious side effect later.

A person’s immune system may recognise the drugs as being different and can mount a defence against them. This has the potential to cause a loss of effect to both the original drug and its biosimilar.

Risk of side-effects and immune reactions: “we don’t know what may happen as there is no clinical evidence as to the safety of multiple switching of biosimilar/biologics”.

“Scant evidence exists regarding switching to a biosimilar in people with autoimmune arthritis who are stable or in remission on the original biologic. Switching to a biosimilar could undo years of clinical stabilisation.”

Dr Marabani says most Australians are very proud of our world class health system and probably would be very surprised to learn that an Australian regulator will empower pharmacists to substitute biologic and biosimilar drugs “where there no data to prove multiple switching of these drugs is safe”.

“First world countries have banned pharmacy-level substitution of biosimilars including the UK, Germany, Ireland, Spain, Sweden, Norway, and Finland,” she says.

Only Venezuela permits the practice.

“This proposed possibility of random, multiple drug substitutions is charting new territory. Australians might not want to be part of a World first experiment without their knowledge which may put them at risk.”

The ARA says it supports the availability of cheaper medicines, but cannot support putting the safety of patients at risk in the absence of information that the drugs are interchangeable.

“Advisory bodies within Australia (eg Council of Australian Therapeutic Advisory groups) and leading regulators around the world do not advise switching these drugs, as we do not know if it is safe,” Dr Marabani says.

“We have no problem with patients who are new to this type of therapy starting on a biosimilar where there is clinical trial evidence that such a drug is appropriate for the disease, but we do not support a system permitting multiple substitutions of drugs, because the consequences are unknown.”

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