Cost benefits a big attraction in generic route to prescriptions

It’s no secret that Irish consumers are paying over the odds for prescription drugs. Just consider the number of people who pick up their prescriptions while on holiday abroad.

Now people are increasingly turning to generics to try to reduce their monthly bill for medication. But what are they and do they suit everyone?

What are generics?
When a new drug is produced, it is protected by its patent for a certain number of years.

Once this ceases, any drug manufacturer can produce their own equivalent, which is typically sold at a significantly lower price, given that this manufacturer hasn’t incurred all the costs associated with developing and creating the drug. These are known as generics.

According to the US pharmaceutical oversight authority, the Food and Drug Administration (FDA), a generic is “comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use”.

Akin, perhaps, to swapping Kellogg’s cornflakes for Dunnes Stores’ own brand version, opting for a generic drug can give you the same benefits – but at a lower cost.

So, instead of getting Lipitor to bring down your cholesterol, you will be sold Atorvastatin.

All generic medicines in Ireland are approved by the Irish Medicines Board before being made available for use.

The State's move
to generics
Following the introduction of legislation last year, the Health (Pricing and Supply of Medical Goods) Act, pharmacists are now obliged to substitute a brand name drug for its generic equivalent, provided that it is included on a list published by the Irish Medicines Board.

The new legislation applies to certain types of medicines first, such as those for high cholesterol, high blood pressure, acid reflux and stomach ulcers, but is being expanded upon all the time.

For example, the Irish Medical Board will examine a further 20 substances this year, including drugs such as Bisoprolol, Zopiclone and Sertraline.

Once the board approves a drug for mandatory substitution, pharmacists are then obliged to swap this drug for both medical card patients, and private patients availing of the drugs payment scheme.

So, for example, if you take a branded medication that has been approved for generic substitution, your pharmacist will automatically make the switch.

Monthly ceiling
Doing so will reduce the cost to the Exchequer – and to your pocket perhaps if you regularly meet the monthly ceiling of €144 under the drugs payment scheme.

According to Daragh O'Loughlin, secretary general of the Irish Pharmacists Union, the only time a pharmacist can offer you a branded drug under either the drugs payment or medical card schemes is if the doctor prescribing the medication writes "do not substitute" on the prescription.

“The legislation is very clear that the prescribing doctor must write it in their own handwriting where it is deemed there is a clinical exemption,” he says.

This means that in certain circumstances – such as those outlined below – a patient can continue to use the branded medication under the existing schemes.

If, however, they opt to stick with the branded drug simply because they are familiar with it and fear change, they will have to pay the difference themselves and will no longer enjoy the monthly ceiling of €144.

“There is no ceiling on the extra that you will pay,” says O’Loughlin.

But are generics always equivalent?
Typically, there is no risk to a patient in switching from a brand name drug to its generic equivalent. However, there may be exceptions.

While Dr Angie Brown, medical director with the Irish Heart Foundation, acknowledges that the use of generic drugs is "appropriate and vital to containing costs", she adds that it's important to remember that although generic drugs have the same active ingredient as branded drugs, they are composed differently.

This means that they may have different bioavailability from either the branded drug or, indeed, other generic drugs of the same class.

Typically, this won’t affect the patient in terms of efficacy and safety, she says, but warns that “in drugs with a narrow therapeutic index, this could potentially lead to adverse effects”.

“It is therefore important to use generic drugs as substitutes only if they have been shown to have similar bioavailability to the branded drug and have been approved for use in Ireland.”

Therapeutic efficacy
"Prescribers need to be cognisant of theoretical changes in therapeutic efficacy and monitor for any changes," she advises, adding that numerous changes in a patient's generic medication mean the name and colour of the tablet changes which can lead to confusion and may lead to poor compliance.

Prescribers should again ensure patients are aware and understand the changes being made to their medication.

Last year, Prof Norman Delanty of Brainwave, the Irish Epilepsy Association, warned that the bioequivalence of generic drugs may vary and may, therefore, put epilepsy patients at a risk of a seizure.

He was drawing on research in The Lancet medical journal, which highlighted the drawbacks of generic substitution for epilepsy patients.

As a result, Epilepsy Ireland is calling on those receiving such medication to ask their doctor to write the brand name medication on their prescription, along with “do not substitute”.

It has prepared a card that people can cut out and keep in their wallet to help them remember (see epilepsy.ie).

In any case, if you’re in doubt about the suitability of generic medication, check with your GP or whoever prescribes your medication for reassurance, or call into your local pharmacist.

“You’re entitled to freely available advice from your pharmacist so just go in and ask,” says O’Loughlin.

Looking for low-cost generics
Generic alternatives to many drugs should be available in your local pharmacy, so whether they are part of the new generic substitution scheme or not, you can always ask for the generic substitution for any medication you may be taking.

If the drug is still under patent it won’t be available, or it may turn out to be unsuitable for your needs, but it’s still worth asking about.

Another option is to consider joining a new type of pharmacy, Healthwave, which promises to offer the same drug prices available in Northern Ireland to Irish consumers.

Under Healthwave’s model, you pay €25 a year in membership fees, or €60 family fee for two adults and children under 18, and it promises that if you don’t save this amount on your prescriptions, it will refund you this charge.

The savings can be significant, as Healthwave imposes a lower mark-up on its supply of generic drugs.

Take Lipitor. According to a survey from the National Consumer Agency last year, a month's supply of this drug (10mg) could set you back between €20.13 to €27.65.

Healthwave, however, is offering its generic equivalent for just €4.95.