Are generic drugs safe?

Have you ever been offered a generic version of a branded medicine that your doctor  prescribed and been unsure if it will work in the same way?

Generic medicines contain the same active ingredient as a brand-name equivalent.

Pharmaceutical companies whose drugs have come off patent must allow them to be manufactured by a competing, generic company.

The philosophy behind this is that the generic version ought to be considerably cheaper, because the second manufacturer has not had to invest in expensive trials and testing of the drug to ensure it is safe and at what dose it is effective.

This is good for customers and ultimately for the lower subsidies the Government’s Pharmaceutical Benefits Scheme pays towards the cost of medicine.

“When companies develop a new medication they have a period of exclusivity – normally around 10 years – where only they can produce that drug,” Aine Heaney, a pharmacist and spokesperson at NPS Medicinewise, said in an article published by HCF (the Hospitals Contribution Fund of Australia).

“When that exclusive period ends, other companies can copy the drug and bring out their own version,” she said.

Under Australian law, the generic medicine must work in exactly the same way as its brand-name equivalent. That is, the active ingredient must have the same bioequivalence.

However, other ingredients, such as binders, fillers, colours and preservatives, can be different between generics and branded medicines.

In some case, this may affect how efficiently the medicine works in some people, especially if they have allergies or intolerances to substances such as lactose or gluten.

“The patient information leaflet in the pack lists every ingredient in the drug so you can compare this and see if there’s a difference in what the drug contains that might account for any new side effects,” Ms Heaney said.

“Because the drugs are cheaper, people often think they must be lower quality which can trigger a nocebo effect where they think the drugs don’t work as well.”

This is the opposite to a placebo effect, where a person’s symptoms improve because they have convinced themselves that the medicine they took was effective.

Not all branded drugs that are out of patent have a cheaper, generic version.

“These are drugs with what’s known as a narrow therapeutic index – that means the dose window at which the drug works is very small – too little won’t give effects and too much can be toxic. For this reason, it’s hard to create bioequivalence,” Ms Heaney said.

Such drugs are the blood thinner warfarin, the heart drug digoxin and some anti-seizure drugs, according to Pharmacy Practice Journal and Epilepsy Australia.

Before swapping from a branded to a generic medicine, discuss it with your doctor.

Do you prefer branded or generic drugs? Does it even matter?

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Health disclaimer: This article contains general information about health issues and is not advice. For health advice, consult your medical practitioner

Written by Olga Galacho

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