When Senator Catherine Ardagh described something last week as the cruellest cut of all, she was referring to the decision of the HSE, endorsed by the Minister, to arbitrarily cut the use by thousands of people of Versatis patches by severely restricting reimbursement under the drugs payment and medical card schemes. It was estimated that up to 25,000 people were on Versatis patches and the Government has, by reducing the number of patches available by 90%, also reduced the cost by 90%. It has taken a vital medicine away from 90% of its users, for whom it was essential in their daily lives. These people are in chronic pain and it is the equivalent of shutting down the emergency department of each sufferer across the country.

The individual testimonies are heart-rending. For example, Catherine Carroll said every day is like a living hell and that the pain is unbearable. She cannot use other pain medicines because of complications. Ann Nolan Walsh tells the story of her 100 year old father, who was taken off the patches and is now in extreme pain, even from just trying to get out of bed. Barbara Donehy, a founding member of Patch Us Back Up, says sufferers do not live anymore but are existing day by day, and Jennifer O'Meara cannot even do things with the children. Her engagement with family life has been severely restricted by being taken off the patches as a result of this decision.

The "Liveline" programme, and its presenter Joe Duffy, has been the real patient advocate on this issue and hundreds of people have been in touch with the programme about it. There has been no bigger case for "Liveline" than this issue in terms of sufferers contacting the programme and that tells us something about the reaction to this decision across the country. These people, who are all in acute pain, contacted the programme to tell their own personal stories and to reveal their anger and disbelief. This patient evidence has been ignored.

John Lindsay, of Chronic Pain Ireland, says people in Ireland are in chronic pain and are suffering. He makes the point that there was no research and no thinking through of the decision. The suddenness was incredible and has caused enormous difficulty and pain for many people. This was about cutting costs but, overnight, it has visited great trauma on many families and thousands of people across the country. I ask the Taoiseach and the Minister for Health to intervene to suspend this decision of the HSE and to put the patient at the centre of the issue, rather than on the periphery as has been the case to date. I ask them to do due diligence to enable people to get their lives back together again, to live meaningful lives and to live again as they had lived while on the patches.

I have heard the harrowing stories on the radio and many people have contacted me personally about this issue. As a result of the concerns expressed, and the personal stories of people in terrible pain, I endeavoured to look into it and discussed it in detail with the Minister for Health last week. It is important that we fully understand and are honest about the background to this issue.

This is a medicine and these are patches that are licensed for one purpose only, which is post-shingles pain in adults. It is to be given to adult patients who have localised pain after having had shingles. Unfortunately, over the course of the past number of years, many doctors have been prescribing it for an off-licence use, for other uses for which it is not licensed. That is a legitimate medical practice in certain circumstances but there need to be some controls around this practice because people can become dependent on such medicines. It is an anaesthetic and not something one should prescribe lightly. Long-term use of anaesthetics can have consequences for people. They can become dependent on them and there are other long-term side effects. There is no problem when GPs prescribe this medicine for the thing it is licensed for in Ireland, which is post-shingles pain in adults, but if they are going to prescribe it for a purpose that is unlicensed, they have to go through some sort of procedure to ensure it is done safely and I do not think anybody should be against that. It is not simply a matter of money. It is also a matter of patient safety.

This patch was being prescribed ten times as much, per capita, in Ireland as it was in the UK and there is something seriously wrong when a medicine is being used ten times as much here as in a very similar country such as the one over the water. That is because it was being prescribed for a use for which it was not licensed and without any sort of controls. From the point of view of patient safety, it was the right thing to do to make sure that, if GPs and other doctors are prescribing this medicine for a purpose for which it is not licensed, there should be some controls around it. That is what the HSE has done.

I do not accept that. I think it was a cost-cutting measure by any yardstick, and the briefing note of the HSE to the committee also goes through the costs of the significant increase in patients using this medicine. The sudden, overnight nature of this decision was appalling and visited untold trauma on people. Dr. John Goddard, a researcher in Sheffield, published an article in the Pain Medicine journal, identifying a 70% effective rate for juveniles who used Versatis patches. He points out the difficulty with researching pain and identifying the optimal treatments for people.

I did not just speak to GPs but spoke to a woman this morning whose consultant, having done all the epidurals and beta-blockers etc., recommended Versatis patches. The casual, arbitrary, sudden and overnight nature of this decision was appalling and was not about patient safety. As John Lindsay said, in any other jurisdiction they know that taking people off a medication so suddenly can be injurious to them and damaging to patients.

The time for explanations is over. This has caused enormous trauma to too many people and the decision needs to be urgently revisited so that people can be given back their lives. Whether the Taoiseach likes it or not, their lives have been taken from them.

There is now a process in place for doctors who are prescribing this medicine off licence. The HSE has advised me that the turnaround time for initial applications is three working days and it is five days for appeals. As of last Friday 1,500 post-shingle patients have been approved for it and the patch is being provided for them in the normal manner. Another 4,784 patients were registered by their GPs for uses other than post-shingles pain and 14% of these patients - 670 - have been approved. This means there are now more than 2,300 patients who are approved for the patch in the drug schemes, with more than one third approved for uses other than post-shingles pain.

We know this. We have had all of this already from the HSE.

The background to this decision is that the lidocaine patches are licensed for localised post-shingle pain in adults. As I said earlier, this is the only licensed use in Ireland. When the plasters were first introduced the budget impact was low because it was prescribed only where appropriate and in line with specific indications for which it is licensed. It is, however, a cause of clinical concern and a real patient safety concern, that usage spiralled so much that we reached the point where there were ten times as many patches in use in Ireland per head of population. Details of the changes were circulated to prescribers and pharmacies in August 2017 to give clinicians time to inform their patients about the changes and where appropriate to change the treatment or to seek continued treatment. Under these new arrangements all patients who are receiving lidocaine plasters for a licensed indiction were automatically approved. All of these patients continue to receive the treatment under the community drug schemes. Patients who had been prescribed lidocaine plasters for other indications were given a three month grace period. Doctors were informed in August and the changes came in during November and December.