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Critical dose medicines and brand substitution: issues with anti-epileptic drugsCritical dose medicines and brand substitution: issues with anti-epileptic drugs

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The National Prescribing Service has removed this media release due to misinterpretations of its intent and incorrect reports.

Please note the following:

Generic medicines available in Australia adhere to stringent regulatory requirements and criteria for bioequivalence. Bioequivalence between the original brand and the generic version of a medicine is the fundamental basis of generic substitution.

Generic products for epilepsy are bioequivalent with their innovator brand equivalents. NPS has no concerns about the ability of these products to effectively and safely control seizures when prescribed appropriately.

However when switching brands — whether it is from the innovator to a generic or from one generic to another — there is always a small risk that the patient may not fully understand the change and become unintentionally non-compliant.

For this reason and because loss of seizure control is a catastrophic event for some people with epilepsy, the advice of the treating doctor is essential in deciding to switch brands. This helps ensure the patient receives specific information about the switch of medication from their doctor and understands its importance for their ongoing well-being.

Many other medicines can also affect a patient’s seizure control and so it is good practice for a person with epilepsy to always check with their doctor and pharmacist before taking a new medicine — even an OTC or complementary medicine.

For further information please refer to NPS News 55, Australian Prescriber and Australian Pharmacist 28:2 Feb 2009, p88.

National Prescribing Service Limited (NPS) is an independent, non-profit organisation for Quality Use of Medicines funded by the Australian Government Department of Health and Ageing.


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Date published: 2009-10-12 15:00:00

Reasonable care is taken to provide accurate information at the date of creation. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment. Where permitted by law, NPS disclaims all liability (including for negligence) for any loss, damage or injury resulting from reliance on or use of this information. Read our full disclaimer.

References to brands should not be taken as an endorsement by NPS.