Concern on new generic drug law

New generic drug substitution legislation passed yesterday in the Dail could lead to epilepsy sufferers getting unsuitable drugs that could worsen their condition, it has been claimed.

The support group Epilepsy Ireland said the new law, which allows pharmacists to switch drugs prescribed by GPs for cheaper alternatives, could lead to some people with epilepsy getting tablets that are not completely suitable for them, which could lead to them suffering breakthrough seizures.

The group said the new law has not been amended to specifically exempt epilepsy drugs from generic substitution, despite considerable pressure being put on the Government to do so.

The Health (Pricing and Supply of Medical Goods) Bill has introduced a system of generic substitution, where pharmacists will for the first time be allowed to substitute a cheaper generic equivalent of a drug on a GP's prescription in cases where a more expensive product has been prescribed.

Until now, pharmacies have not been allowed to substitute a generic equivalent where a doctor prescribes a specific brand of drug.

Epilepsy Ireland said it campaigned for an amendment to recognise the special case of epilepsy drugs.

"Unlike most medications which are readily interchangeable, anti-epilepsy drugs (AEDs) are concentrated carefully for each individual to ensure good seizure control, and any variation in the manufacture and composition of a tablet or capsule introduces a factor that may disturb the balance and result in an otherwise avoidable breakthrough seizure."

Under the new law, the Irish Medicines Board (IMB) will draw up a list of interchangeable medical products which can be substituted for cheaper versions.

Epilepsy Ireland said it will now campaign to ensure that the IMB does not include epilepsy drugs on the list of interchangeable products.

Health Minister James Reilly told the Dail this week that in drawing up the list of products, the IMB cannot add a product to the list where there may be a clinically significant difference in efficacy in a drug that could potentially be used as a cheaper substitute for treating a particular condition.

He added that the legislation also allows a doctor to indicate on a prescription that a branded interchangeable drug should, for clinical reasons, not be substituted.

The Minister said these provisions should address concerns on epilepsy drugs.

Epilepsy Ireland said it will launch an education campaign to advise people with epilepsy to insist that their doctor writes their AED prescription using the regular brand name and not the generic name on a prescription.

It says it will also be telling patients to insist that the prescriber hand-writes 'do not substitut'e beside the name of each AED each time he or she writes the prescription.

Epilepsy Ireland says it will also be asking people to check their medication at the pharmacy after it has been dispensed to ensure it is exactly the same as they received when it was last dispensed.

The new legislation, in addition to introducing generic substitution, also provides for a system of reference pricing for drugs.

Reference pricing involves the HSE introducing a set price for a selected group of drugs beyond which the State  will not fund or reimburse under its drug schemes. These schemes include the medical card, Long-Term Illness and Drug Payment Scheme.

Only this reference price will be reimbursed by the State, and where the drug prescribed is in excess of the reference price, the patient will have to pay the difference. To avoid out-of pocket payments, patients can opt for a generic medicine at or below the reference price.

The new law also provides for greater transparency and sets out criteria which the HSE must take into account when making decisions to reimburse drug costs.

The legislation also allows the HSE to attach conditions and restrictions to the supply of certain medical products, provided such restrictions 'are evidence-based and in the interests of patients, and ensuring value for money.'

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[Posted: Fri 10/05/2013]

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