Generic Substitution & antiepileptic drugs

Generic Substitution - Common Questions & Answers

03 December 2012
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What is the Generic Substitution system about?
Generic substitution is a system that will allow pharmacists to dispense a different version of a particular medicine, even when a specific brand has been prescribed. As the law currently stands, a pharmacist may only supply the particular brand that is prescribed.

What is a branded medicine?
A branded drug (also called an originator or innovator drug) is a drug that has a trade name and is or has been protected by a patent in the recent past. It can be produced and sold only by the company holding the patent.

What is a generic medicine?
A generic medicine is one that is similar to the original, brand-name medicine, and contains the same active substances but it will have a different (but often similar) name. Generic versions of branded drugs can be made by any other drug company once the patent on the branded drug expires. The price of generics are usually less than the branded drug as the company making the generic version does not have to cover the costs of research and marketing. Generic versions of a medicine may have different colours, flavours or non-active substances. They may also be a different shape or size and come in different packaging.

What is the Health (Pricing & Supply of Medical Goods) Bill?
The Bill provides for the introduction of a system of generic substitution between 'interchangeable' medicines. The Irish Medicines Board (IMB) will be responsible for developing lists of medicines that are interchangeable. To be deemed interchangeable, drugs must have the same qualitative and quantitative composition of each of their active substances, must be in the same pharmaceutical form, and must have the same route of administration. Only drugs that the IMB deem interchangeable can be substituted and substitution of a particular drug cannot take place until the IMB permit it. Once a drug is deemed interchangeable, pharmacists will be obliged to dispense the cheapest generic version of that drug which they have in stock that day. This could mean that a different generic is received every month by a patient. If a patient refuses a generic version and insists on the branded drug, they must pay the difference between the cost of the generic and the cost of a set reference price for the branded drug.

Is Generic Substitution safe?
For most classes of drugs (not including AEDs), there are no safety issues associated with substituting a branded drug for a generic equivalent. A generic medicine must meet exactly the same standards of quality and safety, within certain limits, and have the same effect as the branded medicine. Pharmacists will only be able to substitute medicines that have been designated as 'interchangeable' by the Irish Medicines Board (IMB). If a doctor believes that there may be a safety concern, the Bill allows him/her to indicate on a prescription when substitution should not take place for clinical reasons.

Why was Epilepsy Ireland objecting to the Bill?
Unlike in most other treatment areas, there are serious concerns regarding the safety of substituting a branded AED with a generic version of that drug and even greater concerns around switching from one generic to another from time to time. These safety concerns have been highlighted in a number of studies of generic AED substitution and also in a HSE/ Department of Health report (the Moran Report) from 2010. In addition, many European counties do not allow substitution of AEDs. Despite this evidence, the Government has refused to exempt AEDs from the new legislation introducing the new system. By not including a specific exclusion for AEDs, the Government missed an opportunity to protect the wellbeing of people with epilepsy, instead exposing them to real risk.

Why are AEDs different to most other classes of medications?
There are several AEDs available, all of which work in different ways. When doctors prescribe an AED, many factors are taken into account including your age, gender, seizure type and medical history. For the medication to work most effectively, it must be taken according to the doctor's directions. AEDs usually take time to become effective as the epilepsy specialist will increase the dosage slowly over time until an optimum level is attained, something which will vary with each person. In medical terms, AEDs are regarded as having a "narrow therapeutic range". In other words, 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 or breakthrough seizure. Switching between different generic versions is particularly problematic in this regard. Two different generic drugs could in theory, have bioequivalence values at the two extremes of the permitted 80%--125% range from the branded drug, causing large fluctuations in how the drug would perform in the individual.

What are the risks for people with epilepsy?
If your epilepsy is controlled, switching from one version of a drug to another may lead to breakthrough seizures. Just one seizure can have a huge impact in terms of driving, employment, education and social life. Seizures also expose risks to the person such as injury from falls, burns and accidents. Maintaining seizure control is also vital in preventing SUDEP. If your seizures are not controlled, switching may make it more difficult to achieve seizure freedom.

What can I do to stay safe?
Currently, AEDs are not considered interchangeable and therefore cannot legally be substituted. However, Epilepsy Ireland is concerned that there may not be full awareness among GPs and Pharmacists that AED substitution differs from other drugs. Unfortunately, we have received several reports of substitution actually taking place, in some cases with negative outcomes for the people concerned. For this reason, we urge you to follow our 3-step guide to make sure that you remain on your usual brands of epilepsy drug.

Is Epilepsy Ireland entirely against the concept of generic substitution?
No. We recognise that generic substitution will reduce the State's annual drug bill and we have no difficulty with the system provided that it does not endanger the health and wellbeing of PWE. Equally, we are not against the use of generic AEDs when prescribed for new patients and on the condition that there will be an adequate supply of that specific generic available in the longer term (so that switching does not need to take place).

What is Epilepsy Ireland doing to ensure the safety of people with epilepsy?
EI is doing everything possible to protect the health and welfare of people with epilepsy. In recent months, our work has focused on informing politicians about the dangers of AED switching and raising the issue in the media. We have been meeting with TDs and Senators as well with HSE, Department of Health and IMB officials. In March, we addressed the Joint Oireachtas Committee on Health with our concerns. We will also work to educate PWE and their families on the issues involved while also working with the IMB, and with doctors and pharmacists to ensure they understand the special case of AEDs.

When will the Bill become law?
The Bill is currently going through the Oireachtas. It is expected to be passed into law shortly (May/ June 2013).

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