Are the minutes of the last meeting agreed? Agreed. We received an e-mail from Nuria O'Mahony enclosing The Future of Drug Safety: Action Steps for Congress, which we will note. I welcome Mr. Jim Dorgan of Curtin Dorgan Associates, who has been commissioned to assist the sub-committee in preparing a draft report on this issue and who will attend all future meetings of the sub-committee.
Adverse Side Effects of Pharmaceuticals: Presentation.
I also welcome Mr. Dorgan.
From the Pharmaceutical Society of Ireland, I welcome Mr. Ronan Quirke, president; Dr. Ambrose McLoughlin, registrar; and Mr. Matthew Lynch, assistant registrar. Before I ask them to commence their presentation, I draw their attention to the fact that members of the sub-committee have absolute privilege but this same privilege does not apply to witnesses appearing before the sub-committee. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official by name or in such a way as to make him or her identifiable.
Mr. Ronan Quirke
The Pharmaceutical Society of Ireland is the statutory body that regulates the profession and practice of pharmacy here in the public interest. As the society's president, I thank the sub-committee for affording me and my colleagues the opportunity to address it on the important matter of the adverse side effects of pharmaceuticals. The adverse side effects of pharmaceuticals are an issue of considerable importance to patient welfare and safety. The society answered this sub-committee's call for submissions because of the important and significant contribution that pharmacists can make to preventing and dealing with adverse effects of pharmaceuticals and critical incidences relating to medication errors.
Pharmacists are highly trained in medicines, therapeutics and technologies and are a unique health resource. Pharmacists have a comprehensive knowledge and understanding of drugs, their uses and actions, why they act in the way they do and how best to deliver them into the body for optimal effect. Medicines can harm patients as well as help them, particularly when not used appropriately. Adverse effects can arise in a number of ways such as: overdose; adverse interaction with another drug; being taken by someone for whom it is not appropriate; and so on.
The professional practice of pharmacists has developed significantly to add value and safety to the supply of medicines. Whether working in a community pharmacy, in a hospital pharmacy, in a nursing home or prison, whether dispensing a medicine on foot of a prescription or making an over-the-counter recommendation, pharmacists ensure that the medicine supplied is appropriate and safe for the particular person in light of his or her health status, age, current medication history and previous pharmaceutical history. By doing so, pharmacists provide important protection for patients against adverse side effects. Not a day passes in my pharmacy that I or one of my staff does not make an intervention in regard to the supply of medicines, either on prescription or over-the-counter, which, if it did not occur, would very likely result in that person experiencing an adverse effect. For example, diabetics require specialist advice at this time of year when choosing simple, over-the-counter cough and cold remedies, as a number of them are not suitable for use by them.
Adverse effects can arise with the use of over-the-counter medicines, particularly where they are misused or abused or are supplied without the benefit of professional advice. For example, ibuprofen, the anti-inflammatory painkiller found in Nurofen, if not appropriately used, can cause gastric ulceration and haemorrhaging and increased incidences of heart attack. It is for this reason that the society is concerned about the application currently being considered by the Irish Medicines Board to have this product supplied through non-pharmacies without any professional advice available and the likely increase in adverse effects that will arise as a result.
In our submission, we refer to the modern philosophy of pharmacy practice as one of pharmaceutical care and treatment. Pharmaceutical care is the responsible provision of pharmaceuticals for the purpose of achieving definite outcomes that improve or maintain a patient's quality of life. It embodies a continuous quality improvement process for the use of medicinal products. The scope of pharmacy practice is ever expanding in several ways, all of which have a direct impact on reducing and preventing the adverse effects of pharmaceuticals. These include formal medicines management and review, where the pharmacist collaborates with the patient, medical practitioners and other health care professionals in identifying changes to improve a patient's drug therapy, formulary development and health promotion campaigns such as how to safely dispose of unwanted medicines.
Modern pharmacy practice requires that the current legislative framework governing the profession and practice of pharmacy in Ireland be reformed and updated. It currently operates under Pharmacy Acts dating back to 1875 and is in need of reform. The new pharmacy Bill should not just regulate pharmacists but also include parallel and complementary provision to regulate pharmacies and the provision of pharmacy services in all locations, be it a pharmacy on the main street, in a hospital, in a privately owned clinic, in a prison, in a nursing home or a residential home for those with mental disability.
The Minister has committed herself to introducing two new pharmacy Bills and the society welcomes these initiatives. However, it believes that a single comprehensive Bill should be introduced to address the totality of issues involved. To attempt to regulate pharmacists in one Bill, with the promise of a second Bill in the future to regulate pharmacies and pharmacy services, will not protect the welfare of patients or maximise the value of such legislation to the public.
The society will host a pharmacy summit on 16 October next which will be addressed by the Minister and a number of speakers whose experience will support the call to regulate all aspects of pharmacy service delivery. The society's submission highlights other areas where action could contribute to reducing and preventing the incidence of adverse effects with pharmaceuticals.
Effective communication can play a very important role at several levels. Effective communication of professional advice and support by the pharmacist with the person using the medicines or his or her representative with respect to need, dosage, other medicines being taken, other conditions, expected or common side effects etc. play an important role in reducing the incidence of adverse effects while taking the medicinal product in question. A total of 400,000 people visit pharmacies every day here. This, together with open access to a highly trained pharmacist, demonstrates the resource this is in reducing and preventing adverse effects.
Where a pharmacist in his or her professional opinion considers that a prescribed drug regimen is likely to give rise to adverse effects in the patient, he or she needs to be able to communicate his or her concerns to the person prescribing the therapy with a view to ensuring that adverse effects are avoided where possible. Prompt notification to the Irish Medicines Board, IMB, of suspected incidences of adverse drug reactions is very important in alerting the IMB in order to minimise their recurrence in the future.
The Internet supply of medicines is an area of grave concern. The public has no assurance as to the safety and appropriateness of medicines supplied via the Internet. With Internet supply, there is an absence of direct contact with a pharmacist to give advice and guidance. As a result, Internet supply of medicines has the potential to contribute greatly to patients experiencing adverse effects with pharmaceuticals. Effective action to enhance and enforce controls on the Internet supply of medicines must be prioritised.
The global increase in the production and supply of counterfeit medicines is alarming. It is no longer a problem confined to developing countries. Already in 2006, there have been 130 incidents in Europe involving the supply of counterfeit medicines. Counterfeit medicines have entered the legitimate supply chain in the UK and elsewhere in Europe. This is a major threat to human health and welfare and requires action at both national and EU level to combat it.
I thank the members of the sub-committee for their attention. My colleagues and I will be pleased to answer any questions they may have.
I thank Mr. Quirke for his presentation. I invite Senator Glynn, Deputy Devins and Senator Henry to ask their questions.
I thank Mr. Quirke for his presentation. Without being patronising, I must state that I have a very high regard for local pharmacists because they provide a most important service. Local pharmacists often play an important advisory role which cannot be overstated.
Mr. Quirke stated:
Where a pharmacist in his or her professional opinion considers that a prescribed drug regimen is likely to give rise to adverse effects in the patient, he or she needs to be able to communicate his or her concerns to the person prescribing the therapy with a view to ensuring that adverse effects are avoided where possible.
That sounds marvellous and is laudable but in cases where people are not able to attend for reasons of mental or physical infirmity, what means are employed to communicate concerns to them?
The supply of medicines on the Internet is an area of grave concern. I put my neck on the line in stating that this should be outlawed. I am completely opposed to this practice. Under no circumstances should it be allowed. It is a dangerous practice. We are getting examples every day of just how dangerous it is.
Mr. Quirke
I will respond to the questions the Senator posed about the means pharmacists employ when they are not dealing directly with the patients concerned. He is quite right to identify that there are many housebound patients who cannot, for a variety of reasons, attend their local pharmacy. In such cases their representatives normally attend on their behalf, be they carers, family members, spouses or siblings. Communication with individuals to optimise drug therapy does not always have to be directly with the patient; it can be with the prescriber. It is important to bear in mind that very often there is more than one prescriber per patient. People get prescriptions generated in primary and secondary care. The vast majority of patients with chronic diseases tend to attend one pharmacy and therefore their drug record and medication profile tends to be complete. While they may not be able to attend the local pharmacy, patients can be assured that if there is a prescription that gives rise to a concern, as a rule pharmacists almost always explore whatever avenue is necessary to make sure that those issues are addressed and overcome where necessary.
Does Mr. Quirke have anything to say about the supply of drugs on the Internet?
Mr. Quirke
I echo the Senator's comments in terms of the difficulties.
I propose that this issue form an integral part of our report. I ask all members of the sub-committee to support me on this.
I would have thought there would be great practical difficulties attached to banning anything on the Internet.
Let us make the effort.
I join Senator Glynn in thanking Mr. Quirke. Can he outline for the sub-committee the sequence of events that occurs when a pharmacist detects an adverse side effect? Can he also tell us roughly how many adverse side effects are reported per annum and to whom they are reported? What record is kept of those side effects? Is there a database that we, as a sub-committee, can utilise to ascertain the types of side effects and their frequency?
I echo what Senator Glynn said in regard to the supply of drugs over the Internet. I am interested to hear if Mr. Quirke has any proposals as to how their supply might be regulated or stopped. We would all subscribe to the idea that there should not be unregulated availability of drugs over the Internet.
As the Chairman stated, it is easy for us to say that, but we would like to get help in finding how to stop it.
Mr. Quirke
I will answer the Deputy's third question first. The IMB is the competent authority from the point of view of keeping data on the adverse effects of medicines. The reporting of adverse effects of pharmaceuticals is reported to the IMB. The incidence of reporting of adverse events by all practitioners — medical, pharmaceutical, dental and nursing in the Republic — is low by European and international standards. I am unclear as to what the barriers are to a more rigorous reporting of the adverse effects of pharmaceuticals by professionals. Information technology resources can be utilised better to have more on-line reporting of the adverse effects of pharmaceuticals by health care professionals. The Irish Medicines Board would take a view on some of the reasons for the low incidence of reporting of adverse effects.
Deputy Devins asked about the sequence of events in a pharmacy when a pharmacist identifies an adverse effect. The first communication would be with the patient or the patient's representative, who often reports adverse effects to the patient. In a number of instances, the primary information that patients require from pharmacists at the time of prescribing new medication concerns the side effects. The pharmacist can explore some of them with the patient at the point of dispensing when the patient first gets the medication. The patient may or may not experience some of the side effects, but reassurance is often sought from the pharmacist about the safety profile of the medication and how it will interact with other prescriptions, medications dispensed over the counter, or herbal medicines, which are not exempt from drug interactions.
When adverse effects are identified, communication takes place with the prescriber to identify whether the side effect warrants the cessation of the therapy or whether alternatives could be utilised to deliver the same therapeutic goals without the adverse effects.
Regarding the Deputy's final question, I——
That is the kernel of the problem. While I accept that a pharmacist will discuss the matter if Joe or Mary Bloggs tells the pharmacist that he or she has experienced a side effect, is there a legal obligation on the pharmacist to report it to the medicines board, the drug company or whoever? Is there a pool of data that the committee can access to discover the true incidence of side effects?
Mr. Quirke
Patients report many potential adverse effects on a daily basis. The onus is sometimes on a pharmacist to decipher whether the effect is related to a pharmaceutical. It may be a complication of the disease and be portrayed as an adverse side effect to a pharmaceutical when that dialogue takes place. Pharmacists have a duty of care to patients, but they do not currently have a legal obligation to report adverse effects.
That is fine. I thank Mr. Quirke.
I welcome Mr. Quirke and his colleagues. If one examines any of the Irish Medicines Board's surveys, the situation in terms of doctors and pharmacists reporting is woeful. There is a low level of reporting.
Modern drug trials have shortened considerably in time and the number of patients involved. While we have no legal responsibility — I am also a doctor — do we need to understand that we have a significant ethical responsibility to try to report these issues? In many cases, such as the Vioxx trial and others, it is only after drugs are put on general release that the importance of their adverse side effects is established, as some effects are not picked up during the initial trials.
There is a shortage of pharmacists in this country and pharmacies appear to have many assistants reporting to pharmacists. Does Mr. Quirke believe that people are interfacing with their customers so that pharmacists are in a position to do their best to assess whether something is an adverse reaction to a drug? As Mr. Quirke said, the problem could easily be a deterioration of the disease or the development of another condition. I spoke to the Irish Medicines Board about this matter years ago when I heard about the low level of reporting by doctors. Can anything be done to encourage people to report? If the board does not get the information, the situation slows significantly.
I have always gone to the same pharmacy, but a number of people believe it is a good idea to shop around. That is not good practice. Could people be encouraged to subscribe to the same outfit or, if they do not like it, move to another instead of buying one lot of subscriptions in one pharmacy and another lot in a second pharmacy? It is impossible for pharmacists to keep up with what is going on because they do not have a proper picture of what drugs patients are on.
The Internet has been mentioned. We cannot ban it, but we can do as much as we can——
We could take a stab at it.
It has been found impossible internationally, but we could publicise how dangerous it is to buy medicines over the Internet. Not only does one have no idea of the safety or appropriateness of the medicines supplied, but one has no idea of their efficacy or quality, or whether they are counterfeit drugs. This is a serious problem. Another problem that has not been mentioned is that of people believing something cannot harm them if it is a natural cure or alternative medicine. While we know that there have been ghastly episodes in respect of items that have been bought from health stores or via the Internet, patients have notions about natural drugs. A drug is meant to drug something, but people cannot believe that those drugs can have adverse side effects or can interact with prescribed drugs.
The delay in respect of the pharmacy Bills is appalling and I have spoken on this matter in the Seanad. If Mr. Quirke can think of something to hurry them through the Department of Health and Children, I would be delighted to table a motion. Given my spontaneous remarks, they are always good when prepared ahead of time.
Mr. Quirke
I will address the Senator's last point first. The Pharmacy Acts are out of date and overdue for an update. We work primarily from the 1875 Act, which obviously predates the Houses. For many years, successive Ministers have promised updated legislation, but we continue to labour under the 1875 Act. It is important to state clearly that there is no doubt that the public is not being protected under the current legislative framework. We come to this matter as a regulator, the remit and terms of reference of which are purely to protect the public. However, the public is not protected by legislation that is 130 years old.
The practice of pharmacy, as the Senator has outlined, has changed significantly in the past five to ten years. The range of medicines patients are asked to take, pharmacogenetics, pharmacogenomics and the advent of high-tech medicines will change the role of the pharmacist further. In terms of polypharmacy, patients live longer and diseases do not exist in isolation. Diabetics can experience complications associated with diseases other than diabetes, as they tend to have cardiovascular disease, peripheral vascular disease, etc. Therefore, the range of medicines used to treat an individual can expand.
A patient of my pharmacy in south County Tipperary gets 25 items per month. An individual living alone cannot be expected to manage a medication regime of 25 items in a calendar month.
The role of the pharmacist comes into play in managing the medicines for that patient to ensure, first, therapeutic goals are met — there is no point in initiating a pharmaceutical in a patient unless there is a therapeutic goal and that goal is attained — and, second, the interaction profile between those different agents and the adverse effect profile that can occur when using so many different agents.
In terms of patients shopping around, the experience in Ireland and internationally is that patients with chronic conditions tend to stay with one pharmacy and continue to go back to the same pharmacy, which has benefits from the point of view of medication records, particularly when one has more than one prescriber and primary and secondary care prescribers.
I am unsure whether I answered the question on what the members of the committee can do to speed up the updating of the Pharmacy Acts. Anything that any Member of either House can do to assist with the updating of the pharmacy legislation would be most welcome. The Minister for Health and Children has given a firm commitment to update the pharmacy legislation and we are hopeful that the new and updated legislation will be before the Houses before Christmas or certainly before the Dáil rises. Perhaps I am showing my naivety in this regard.
I doubt that, by which I mean naivety.
Mr. Quirke
A number of questions were raised about medicines being procured over the Internet. With the Chairman's permission, I will defer to the assistant registrar, who may be better qualified than I am to state the legal position on prescription laws in Ireland.
The current legal position is that supply of prescription-only medicines by mail order is prohibited in this country, in that one cannot supply a medicine by mail order and by default, that eliminates medicines being supplied via the Internet from this jurisdiction. There was previously a ban on all medicines but a judgment in the European Court of Justice reviewed this issue. The court took the view that if it was not confined to prescription-only medicines, it was fine to supply medicines over the Internet. This would cause the Pharmaceutical Society of Ireland and pharmacists much concern. Just because something is available OTC does not mean it is without dangers and, as the president has indicated, adverse reactions often arise where one takes OTC medicines with other medicines. We would be concerned about this situation.
The 2005 amendment to the Medical Products (Prescription and Control of Supply) Regulations changed the position so that the prohibition applies only to the supply of POMs by mail order. The difficulty, to which the Chairman alluded, is that these medicines can be supplied from an island in south-east Asia. The Customs and Excise and the Irish Medicines Board find it difficult to monitor every package that comes into the country, whether the contents are for personal use or for someone attempting to procure large amounts for supply to others. There is a useful legal provision in respect of prescription-only items but, unfortunately, an issue arises around enforcement. The Internet and counterfeit medicines are somewhat closely linked. There are instances of counterfeit medicines being supplied via the Internet.
Have there been any seizures of medicines coming into the country?
Yes. There have been a number of such instances. The Irish Medicines Board is the authority which would be to the fore in that regard and the board and its enforcement unit work closely with the postal service to isolate and identify suspicious packages and then seize them.
It is difficult. The authorities must be lucky all the time, whereas the person importing must be lucky only once. It is much more difficult to police an activity at that end than to prohibit it up-front. There is a requirement to take a global perspective on counterfeit medicines and the WHO has an initiative which is engaging with the European Union as a single entity, the United States and large central agencies to counteract these practices, particular in the case of counterfeit medicines, but there are also some analogies with the Internet supply.
Does Mr. Quirke have any views on natural products which are freely available? Some of them interact with medicines, which some patients do not seem to understand.
Mr. Quirke
I agree entirely with Senator Henry. As a medical doctor, she will be aware that opium and digitalis are natural products, both of which have serious consequences associated with them. There is a job of work to be done to educate the public that just because something is a natural product, which perhaps may be bought in a health food shop, does not confer safety benefits. A medicine is just that. A medicine free from side effects has yet to be invented. Even conventional simple medicines that can be purchased in non-pharmacy outlets are not free from side effects. I often found, when taking drug histories from patients as a hospital pharmacist, that they would not identify natural products to prescribers or pharmacists because they deemed them to be safe. I can only reiterate that there is no safe medicine.
I was at another meeting and I apologise to the Chairman and the delegation for my absence. I will take away the briefing notes to read.
Returning to a question asked by Deputy Devins, Mr. Quirke stated there is no legal obligation on the society to report side effects on hearing of them. Will that matter be included in the upcoming Bill?
Let us hope the Bill will come before the Houses. Any member of the Joint Committee on Health and Children or anybody who has an interest in wider health issues would like to see the pharmacy Bills and the Medical Practitioners Bill brought before us, either before Christmas or before the end of the current Dáil.
I was delighted to see Ms Claire O'Connell, writing in today's health supplement in The Irish Times, state that legislation that controls the sale of paracetamol in Ireland appears to have reduced the severity of paracetamol overdose, a matter I raised in the Seanad from time to time. I am glad to see smaller packets and persons only being allowed to buy one pack of 12 instead of several packs of 24. One must bear in mind that supermarkets are still selling paracetamol and it is available OTC in chemists. Every reasonably sized town could have upwards of six or seven pharmacies as well as three or four supermarkets, not to mention convenience shops.
This issue was brought home to me by a telephone call I received last year from the distraught family of a very young girl who engaged in self-harm using paracetamol and whiskey. She did not intend killing herself; it was a cry for help. She did this on two occasions. This young professional girl ended up with severe liver damage, which killed her in the end. What was so sad about this case was she wanted a liver transplant but the fact she had self-harmed on two occasions deemed her an unsuitable candidate for a transplant. I can understand that decision. There are people in need of transplants who are very sick, livers do not come ten a penny and there must be criteria for who will get them. The girl died. It was difficult for her; she did not want to die. It was difficult for her family and for the clinicians involved in her case.
When I read a report like this it is good to see that the incidence of paracetamol overdoses is down. However, people who do not intend to kill themselves but just wish for some attention are still dying from paracetamol overdose. Some of them are getting more than attention; it is taking their lives.
Are there plans for further advertising campaigns? Instead of using a phrase on cigarette boxes, the Office of Tobacco Control now displays pictures of the chronic lung, chest or heart damage caused by cigarettes on billboards throughout the State. Although this may be further down the road, are there any similar plans in this area?
Mr. Quirke
The Senator is correct that the report in today's edition of The Irish Times is welcome, in that the number of paracetemol tablets being taken by suicide and parasuicide victims is declining. However, the number of successful or attempted suicides with paracetemol has not declined and 14% of all deliberate self-harm cases reported to the national poisons bureau in Beaumont Hospital involve paracetemol. The onus is on all bodies, and not only the pharmaceutical sector, to identity why paracetemol continues to cause such a problem for toxicologists. Paracetemol can often be a hidden ingredient in many cough and cold remedies and, therefore, not all paracetemol poisoning is deliberate. Some might well be accidental. One can buy paracetemol in shops, petrol forecourts and other non-pharmacy outlets identified by the Senator and that may be responsible for complacency among the public as to the potential hazards of a drug that is widely available. A drug free of side effects has yet to be invented. Paracetemol causes significant complications when taken in an overdose. It remains the number one cause of poisoning within the State and it is still a problem for the health care sector. While we welcome the impact made by the reduction in pack sizes on the number of deaths, it has not had an impact on the incidence of paracetemol poisoning and that is the next step. All stakeholders need to identify what can be done to remedy this.
Hospitals have different criteria and I do not have a difficulty with them. Livers are not ten a penny and they must be given to people who will appreciate them. I did not know that hospitals have criteria regarding the recipient of organs, including livers, but perhaps the sub-committee should highlight this in its report. The family to which I referred is devastated on the basis that if the girl had known what was coming down the road and that she would be faced with this perhaps she would have looked at this in a different light. At the end of the day it was a matter of life and death because she had tried self-harm on two occasions.
Perhaps the joint committee should address that.
I recently read about somebody who had a serious difficulty regarding the use of Nurofen and Solpadeine, which also contain paracetemol. Will Solpadeine be withdrawn from the market? Is that being flagged?
Mr. Quirke
The Senator's question relates to over-the-counter codeine abuse. Nurofen contains ibuprofen, not paracetemol. Ibuprofen is being reviewed by the Irish Medicines Board from the point of view of deregulating it further to permit its sale in non-pharmacy outlets. Ibuprofen is the number four cause of poisoning within the State. The consequences of misuse of this drug are more serious than the misuse of paracetemol, which already causes a significant problem for the State, in that it causes gastric haemorrhaging, precipitates asthmatic attacks and increases the incidence of heart attacks. The society takes a strong position on the declassification of ibuprofen on patient safety grounds.
With regard to Solpadeine and Nurofen Plus, codeine addiction is a problem in Irish pharmacies but I can only provide anecdotal evidence in this regard. I cannot provide scientific data to support my contribution but I have no doubt, from my own clinical practice, that codeine addiction is a real problem in this State. We must identify what is causing this and in what ways this can be addressed. The Solpadeine issue has received media attention in recent weeks and that is probably why it is on the sub-committee's radar but it will need to be addressed sooner rather than later. I am not aware of plans to reclassify it.
With regard to self-medication, I recently read an article by Mr. John Caird, Beaumont Hospital, about intracranial bleeding. A substantial number of cases involved people on warfarin or aspirin. The patients in the warfarin cases had been prescribed the tablet but 25% of the aspirin cases involved self-medication for no particularly good reason. Is the public in receipt of sufficient information about these issues? When one takes a tablet, one is taking a drug, even if it is available over the counter. Senator Feeney referred to paracetemol, while Senator Glynn mentioned Nurofen. Is enough of an effort being made to inform the public? I am astonished that 25% of the aspirin cases involved taking the tablets for no particularly good reason. If one is taking drugs, one is taking something important. Is enough effort being made to get this message through to the public? Irish people take only one third of the pharmaceuticals taken by US citizens.
Mr. Quirke
The Senator is correct that aspirin is initiated by patients rather than prescribers. Perhaps the positive publicity about aspirin regarding primary prevention of cardiovascular disease may contribute to that but risk factors for such disease must be taken in their totality rather than the patient initiating aspirin on an ad hoc basis. The antiplate dose of aspirin for cardiovascular purposes tends to be 75 milligrammes, which is a prescription-only medication, and, therefore, is not subject to over-the-counter sale.
But what happens if doctors do not know what people who self-medicate are taking?
Mr. Quirke
The Senator is absolutely correct. I am surprised the figure is 25% and I am slightly alarmed it is that high.
I am almost certain the article was published within the past six months by Mr. John Caird of Beaumont Hospital.
Mr. Quirke
To answer the Senator's question, if that is the statistic, we are not doing enough. The pharmacy profession is as involved as any other health profession in health promotion and if the incidence of intracranial haemorrhage is of that proportion, another body of work needs to be undertaken.
A total of 25% of people who took aspirin admitted it was self-mediction but they had not suffered a brain haemorrhage.
Mr. Quirke
I understand that.
Perhaps the warfarin figure was included but I was surprised at how high the figure was.
Do many people suffer in silence without knowing what a side effect is? We presume everybody knows the side effects. For example, people might not consider a dry mouth or blurred vision to be a side effect. What action is being taken to suss out people who take medication with known side effects? Does any body seek out people and ask about side effects? Patients sometimes do not know whether they are suffering a side effect or whether that is part of their illness. As a pharmacist, does Mr. Quirke believe there is a correlation between doctors prescribing medication that is a fad and their closeness to the sales agents of particular drugs?
We also referred to the Internet. Part of the reason the Internet is so attractive is that medications accessed over it are much cheaper. They are more than 30% cheaper in some European countries than in Ireland. They are also cheaper in Northern Ireland. On the Continent one can get statins, antibiotics and a number of other medications over the counter. Will the delegates comment on these points? I thank them for their comprehensive responses to previous questions.
Mr. Quirke
I agree with the Chairman with regard to patients who are suffering in silence. There are often instances where the side effects of medicines can be non-specific — I am thinking of the range of medicines called ACE inhibitors which are used to treat hypertension and heart disease. The most common side effect is a dry cough, which occurs in upwards of 15% of cases. However, many of the patients who develop a dry cough might not make an association between a respiratory complaint and a medication used to treat a heart complaint. The only way such patients can be identified is if formal medication reviews become part of practice for physicians and pharmacists in the State. If one has a patient on polytherapies, periodic medication reviews must become part of the care afforded to the patient from both the pharmacy and the physician. This will ensure that what is being prescribed is appropriate and free from side effects, be it an over-the-counter or natural remedy. Senator Henry alluded to this issue.
The Chairman asked whether I had experience of doctors prescribing medications in a certain way — I cannot remember his exact words but I understand what he meant. In my experience, most physicians and pharmacists follow evidence-based practice in their recommendations and prescriptions rather than any marketing strategy that might be in vogue at the time. Physicians who become aware of breakthroughs in medication are not reluctant to prescribe them, provided they are satisfied with the safety profile associated with the medication. I do not know of any evidence to support prescribing on the basis of marketing as opposed to evidence. Most physicians and pharmacists follow evidence-based practice.
The question of why medicines are cheaper in continental Europe is one with which I deal almost every day I meet patients. I remain to be convinced that the only reason patients try to procure medicines over the Internet is cost. The fact one does not need a prescription for certain medicines can also be a driver for people to use the Internet. The medications most frequently sought over it are for conditions such as erectile dysfunction, where there are barriers for patients to obtaining prescriptions for those agents from their physicians. The barriers might be evident but there are reasons people choose to use the Internet; cost is one but I am not convinced it is the only reason patients look to the Internet to procure medicines.
The price of medicines across the European Union differs. Their price in Ireland is subject to an agreement with the industry which was recently negotiated between the Department of Health and Children and the Irish Pharmaceutical Healthcare Association, which I understand will attend the committee later today and may be able to provide further clarification in this regard.
The Chairman's final point concerned over-the-counter medicines, including agents such as statins which are used to treat raised cholesterol and dyslipidaemia. As far as I am aware, we have not reclassified medications from prescription-only to pharmacy medications since 2003, yet during the corresponding period the United Kingdom reclassified 30 products, not only statins but a variety of other medications which are more widely available without the need for a prescription. We need to consider what triggers a reclassification of medication in the State because, as I understand it, the Irish Medicines Board responds to applications for reclassification as opposed to identifying a public need. If medicines are to be reclassified, it should be done on the basis of public need rather than submissions from the pharmaceutical industry.
What should be done with regard to members of the public thinking they need medication? Families who were concerned about MRSA attended the committee recently but the issue of the abuse and overuse of antibiotics was not mentioned.
Mr. Quirke
The Senator is absolutely correct that MRSA——
I should join the society.
Mr. Quirke
I seem to be agreeing with the Senator.
What can we do about this issue?
Mr. Quirke
There is a body of work to be done in this regard. The Chairman referred to medication purchased in other European countries.
That is correct. One can get a good supply of Augmentin.
Mr. Quirke
That is correct. One can buy antibiotics from countries such as Spain, for example. This contributes to issues such as multi-drug resistance, MRSA, clostridium difficile and so on. There are data from microbiologists to suggest we overuse antibiotics. There is no doubt that what should be done in this regard is an issue for general practice and pharmacy.
It is a matter of educating the general public, with regard to which there must be a combined effort.
Mr. Quirke
I agree.
That draws the discussion to a conclusion. I thank the delegation for attending and its comprehensive presentation and responses to questions.
Sitting suspended at 3.26 p.m. and resumed at 3.29 p.m.
From the Irish Pharmaceutical Healthcare Association I welcome Mr. John McLaughlin, president; Ms Anne Nolan, chief executive; Mr. John Stinson, medical director; and Ms Leonie Clarke, consultant. Before I ask the association to commence its presentation, I advise it that while members of the committee have absolute privilege, the same does not apply to a witness appearing before the committee. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official by name or in such a way as to make him or her identifiable.
The Irish Pharmaceutical Healthcare Association represents the international research-based pharmaceutical industry in Ireland. We represent both prescription medicines manufacturers and those which manufacture OTC or consumer health care medicines available without a prescription. Over 90% of the medicines available in Ireland are manufactured by IPHA member companies.
We very much appreciate the opportunity to address the sub-committee. In summarising our submission, we are conscious of its composition and expertise. I might repeat some of the issues that arose at the previous session, although I will try not to do so because I know Senator Henry was hoping it would be even shorter. We might also be able to add to some of the issues that arose, if the sub-committee so wishes.
The first point we would like to make, one with which I am sure members are familiar, is that medicines make a big difference to the lives of a great number of people and play a crucial role in the fight against disease and ill health. I would wish members to retain that thought throughout this summary. Having said that, the industry recognises that all medicines, including OTCs, are associated with a risk of possible adverse effects. However, the safety profile of a medicine must be considered in terms of the balance between the risks and benefits associated with taking it. What is considered an acceptable level of risk forms the basis of decisions by regulatory authorities which approve medicines for use, by doctors who prescribe them, by pharmacists who dispense them and by patients who take them. Taking medicines requires a trade-off between the benefits and risks. Not everyone who takes a medicine will experience adverse effects. In general, many patients taking a medicine will not suffer any adverse effects or will suffer only mild reactions. Exceptionally, some may suffer severe adverse effects but these are rare in comparison with the number taking medicines.
The safety of a medicine can also depend on the ability of an individual to tolerate one medicine versus another similar one. Because no two individuals are alike, it is important that, when deciding whether to use a medicine, the benefit-risk balance be assessed for each individual. In this context, doctors, pharmacists and other health care professionals have an important role to play.
No matter how good a medicine is or how great the demand for treatment in a particular therapy area, no medicine will make it out of the development phase unless it is shown to be sufficiently safe. Pharmaceutical companies continually assess the balance between benefit and risk throughout a medicine's lifecycle, from its earliest development in the laboratory, during the numerous clinical trial phases it undergoes, after it is placed on the market, and for as long as it continues to be available. It is in the industry's interest to minimise the risk profile of any product. No company wants to produce a medicine that unduly harms a patient.
The testing phase is lengthy, rigorous and complex. It takes on average ten to 12 years to conduct and, even then, only one in every 10,000 molecules that shows promise in the laboratory will actually end up being available as an approved medicine for patients. However, before a medicine is placed on the market, its safety, efficacy and quality profile are also independently verified by the regulatory authorities. As members of the sub-committee know, the regulatory authority here is the Irish Medicines Board. In accordance with regulations laid down in EU law, it determines if the benefits of a medicine outweigh its risks, in which case it will be approved for placing on the market. No subsequent changes to the authorisation can be made without the prior approval of the IMB.
Pharmaceutical companies and regulatory authorities continually assess the balance between benefit and risk throughout a medicine's lifecycle, for as long as it continues to be available. After a medicine is authorised, the industry is legally obliged to collect and evaluate all available information on possible previously unknown risks to patients and communicate any such information to regulatory authorities, health professionals and ultimately, through changes to the labelling and patient information, the end user of the product. This is commonly referred to as pharmacovigilance. The IMB will then assess whether the benefit-risk balance has been altered by data that come to light about new adverse effects and whether the conditions of use of the medicine need to be amended further to minimise any risk. At that stage, for example, a company may be asked to carry out additional clinical trials or to establish a formal risk management programme for the medicine. In some cases, it may be asked to withdraw it from the market entirely.
In the past the pharmaceutical industry, regulators and health care professionals did not provide transparent, objective and easily understood safety information for patients. As recently as 20 years ago, when I was a young pharmacist, patients were being handed medicines labelled "The tablets — take one three times a day", and that was it. Patients had no information on what the medicines were for, what adverse effects to expect and so on. Nowadays, keeping patients in the dark is no longer acceptable and the industry collaborates with doctors, pharmacists, regulatory authorities and consumers to develop better communication tools to promote the safe use of medicines. For example, we now produce easily understandable patient leaflets on all aspects of a patient's medicine. There are discussions of the benefit-risk profiles of medicines on many company websites and we consult increasingly with consumer groups to improve their understanding of the benefits and risks of medicines. More recently, a number of companies have taken the initiative to publish the results of their clinical trials — both positive and negative information — on their corporate websites and international industry portals.
Here the industry collaborates through our association to make available the summary of product characteristics, a detailed technical dossier of a medicine — "warts and all", as Ms Clarke calls it. We have most medicines on our website at www.medicines.ie. This means that members of the public now have unrestricted access to independently verified, Irish-specific information on medicines that traditionally was restricted to health professionals. We are lucky in Ireland because we are allowed to promote the website and we do so directly to the public. This may go some way towards answering the question of what we can or should be doing to help patients to access this information. We also produce a CD-ROM, a copy of which we sent to the sub-committee in our original information pack. I have the brand-new one today for anybody who is interested. It was dropped into our office yesterday. We produce this compendium in CD format for all health care professionals and distribute it free of charge to everybody.
At EU level, the public has access to a range of databases on medicines held by the European Medicines Agency. For example, details of marketing authorisations for medicines authorised by the European Union are available on-line. Eventually, it is planned that pharmacovigilance data and clinical trials information held by regulatory authorities throughout the European Union will be available on-line also.
One of the complicating factors in the utilisation of medicines is the fact that up to 50% of patients do not take their medicines correctly. This results not only in poor outcomes from treatment but also a higher risk of adverse effects. There are a number of ways in which this problem can be tackled. In the first instance, doctors and pharmacists have a key role to play in ensuring that patients know to take their medicines and that they are a repository of information for patients to ask about their medicines. The provision of comprehensive, easily understood information on the packaging and leafleting of medicines is also an important factor. We have been providing patient leaflets since approximately 1994. Recent changes to EU legislation have made user testing of these leaflets mandatory before we produce them to ensure they are comprehensible. We thought that certain leaflets were comprehensible but when we asked patients, we found they were not. Companies now have to user-test their leaflets beforehand.
IPHA member companies are proactively working to improve compliance through patient-focused educational initiatives to help users of their products get the best possible health outcomes. Examples range from the development of patient information booklets to support for various patient associations — on a hands-off basis, I hasten to add — and the provision of specialist nurses in areas such as asthma and diabetes who train patients to use inhalers correctly or manage their diabetes programmes properly. The IPHA runs several educational initiatives in collaboration with the health promotion unit of the Department of Health and Children. These are to tackle the problem of non-compliance and foster as best we can a responsible approach among the general public to the consumption of medicines.
Another important legislative plank contributing to the correct use of medicines relates to the advertising and promotion of medicines by the industry. Companies can only promote their products in accordance with the conditions of use set out in the SPC, summary of product characteristics. They cannot make exaggerated, misleading or inaccurate claims. We also publish codes of practice for the industry with a view to providing practical guidance on the implementation of these items of legislation. The codes are sent to the Minister for Health and Children for approval.
Restrictions on the way medicines are distributed offer an additional mechanism for minimising and managing risks associated with medicines, a matter about which the Chairman talked a little at the previous session. These include the requirement for a doctor's prescription for the majority of medicines on the market. Products that have the potential to be misused are subject to even more restrictive controls under the Misuse of Drugs Acts. At the other end of the scale, a limited range of medicines are deemed appropriate to be made available to the public to purchase without prescription for mild conditions such as coughs, colds, etc. Special attention is given by the regulatory authorities and the industry to the wording on the labels and leaflets for these medicines to ensure the public has the information necessary to decide when and how to take them correctly. Some non-prescription medicines can only be sold under the supervision of a pharmacist to ensure professional advice is always available to the public.
We in the industry submit that the availability of safe, effective medicines is important for patients, health professionals and pharmaceutical companies alike. The IPHA and its member companies have long understood the special responsibility we have towards those who use our medicines and the importance of operating to the highest possible ethical standards and regulatory requirements. We thank the sub-committee for giving us the opportunity to express our views and would be happy to respond to any questions members may wish to ask us.
I thank Ms Nolan. Her presentation was comprehensible and useful. It contains much detail that sub-committee members will find very useful. It is very well put together.
I, too, thank the deputation for coming before the sub-committee and making such a concise presentation. I wish to pose a number of questions. As we are dealing with the adverse side effects of pharmaceuticals, I wish to ask about the mechanism by which adverse side effects are reported in the public domain. I note from page 3 of the presentation that the association is legally obliged to pass on to the Irish Medicines Board information on all adverse side effects reported to a company. Is that correct?
Yes.
I take it that includes all adverse side effects, irrespective of the level of seriousness.
Yes.
How are such adverse side-effects brought to the notice of a company? Does a medicine user or health care professional report it directly to the company? I am interested to know how the association is made aware of such adverse side effects.
Mr. John Stinson
Perhaps I should answer that question. The doctor, pharmacist or dentist involved reports the event directly to the company and depending on the seriousness or the expectedness of the adverse event, strict legislation covering the matter is laid down. For example, a serious adverse event reported by a doctor such as the Deputy to a pharmaceutical company must be reported to the Irish Medicines Board within 15 calendar days, as opposed to 15 working days. If the event occurs on Christmas Eve, it must still be reported within 15 calendar days. Usually notification of the occurrence of the event is forwarded to the pharmaceutical company's headquarters for that information to be included in its worldwide database. Notification is then submitted to the Irish Medicines Board. Of all the adverse events reported to the board, well over half are reported by pharmaceutical companies. Doctors or other health care professionals can also report directly to the Irish Medicines Board, and some do. In that event, the board will write to the pharmaceutical company in question informing it that it has received notice of an adverse event reported about its product. The company then includes the information in its worldwide database and collates more data on it. I stand to be corrected but to my knowledge approximately 2,500 adverse events are reported to the Irish Medicines Board per annum, of which more than 60% are reported by pharmaceutical companies.
That is the total number from all sources.
Mr. Stinson
Yes, in the Republic of Ireland.
Approximately 2,500 adverse effects are reported.
Mr. Stinson
Yes. I am a medical doctor and I did some research on this issue 14 or 15 years ago when I was working in St. James's Hospital. The junior hospital doctors or, to be politically correct, non-consultant hospital doctors were given a small financial incentive to report adverse events when they occurred. Within a three-month period doctors in St. James's Hospital reported more adverse events than had been reported in the previous eight years. That was a different era and there were many education programmes at the time. Doctors, pharmacists and dentists are very busy. Such a health professional may spot something at the end of a consultation with a patient and think an adverse event might have occurred, but he or she has to take a telephone call, the next patient is coming in, the clinic is running late and when he or she is dictating letters the question is whether the top priority is to fill in a form, ring the Irish Medicines Board or submit a report. That is how there is slippage in the reporting of such events.
Pharmaceutical companies are inspected by the Irish Medicines Board on their pharmacovigilance responsibilities. They take these responsibilities extremely seriously and train their sales force and receptionists in this area. The clock starts ticking the minute a member of staff, be it a secretary, managing director, representative or doctor, hears about an adverse event.
Is Mr. Stinson aware of the number who report a side effect directly to a company and thus bypass the health professional?
Mr. Stinson
The number is very small. We record such reports but also encourage the patient to go back to his or her doctor. We get the name of the doctor from the patient and inform him or her that the patient has reported a side effect to us, as it is the health care professional who can make a proper judgment as to whether the side effect was related to the medicine prescribed, a different medicine or a combination of medicines. We always encourage patients to go back to their health care professionals.
Ms Leonie Clarke
I would like to add to the point on companies' responsibilities. As well as logging reports from doctors made by telephone or by the submitting of a form to the company, all company employees must be trained to be vigilant in the reporting of ADRs. If a company employee is out socially and hears somebody talking about one of the company's products and a side effect is mentioned, that employee is obliged under company policy to report the occurrence. This applies to every member of staff in the company from the receptionist to the medical director. General management must be trained to be actively on the look out for such reports. If a manger is at a meeting at which a company product is discussed, he or she should monitor the discussion and identify any issues that need to be examined. Similarly, if a query is raised with a manager that he or she suspects may have been prompted by an adverse effect, he or she is required to probe more deeply to ascertain if there has been an ADR or adverse effect and, if so, it must be reported.
I welcome the delegation. I remember the work Mr. Stinson did in St. James's Hospital in this area. I was going to be so venal as to suggest to the Pharmaceutical Society of Ireland that we should do something like that again. That incentive, which did not involve much money, greatly improved the reporting rate of side effects. When Ms Aileen Scott operated a system whereby one filled in a yellow card, I recall one received about five shillings in the good old days.
When we produced the compendium in book form, we used to put the yellow cards into it. We did not include them with this information. Perhaps we should revert to doing this because we share the Senator's concerns on the collecting of such reports.
I am sure the association does, because the buck stops with it. When the heavy money comes into play, it is the association, not anyone else, which will have to pay up. Naturally, it would be most alarmed if side effects were not reported. Should we obtain a copy of Mr.Stinson's report in writing our report? He might forward it to us. I recall that he wrote it.
Mr. Stinson
I was not its author. I believe it was published in the Irish Journal of Medical Science.
Yes, it was included in some such journal.
It is a matter we should follow up.
It would be worthwhile receiving it.
It would illustrate that many side effects are not reported. Nobody is actively seeking to monitor the side effects of medication. At one time it was part of the job of health care professionals in the psychiatric service to observe to monitor the potential side effects of medication but, for the most part, that does not seem to be the practice in general hospitals. If a small incentive resulted in the presentation of such evidence, why was the scheme discontinued?
Mr. Stinson
It was operated in a different era when money was scarce, but education also played a role. The department of pharmacology in the hospital concerned was constantly educating people in this area. The failure to continue this is part of the problem. When the educational component is tailed off, namely, the production of posters and reminders, matters revert to their old format.
It says a lot about the profession if a practitioner must have a financial incentive to report a side effect. There should be a moral obligation on him or her to report it without having to be paid.
Mr. Stinson
That is absolutely right. The incentive was the payment of a very small amount of money. I do not believe the offering of such an incentive would make a huge difference today. The world has become increasingly busy and the reporting of the occurrence of a side effect is often placed at the bottom of a to-do list and, unfortunately, can be forgotten if it is not particularly handy for a health care professional or patient to report the occurrence.
As Senator Henry said, we will have to address that issue.
With regard to money, several authors of very reputable medical journals, such as The New England Journal of Medicine and the British Medical Journal, have complained about the financial involvement of medical practitioners in clinical trials through the large pharmaceutical companies and that frequently these are spread over a wide number of doctors and consolidated by members of the medical profession employed by the company. This needs to be addressed very urgently. In the good old days those of us who did clinical trials had to stand over what we did. That does not seem to happen nowadays, as it seems to be spread widely. That is one of the problems in major side effects emerging without anyone appearing to have to take responsibility for it. Adverse clinical effects — trials where it was shown that the stuff did nothing or did harm — always had to be published and that is very important. We have to recognise there is a real deficit in clinical trials not being done on children. Please do not ask me how to solve it. That is the delegation’s problem, not mine. I am old enough to remember aspirin and Reye’s syndrome. Deputy Devins is not old enough to remember it. We have a serious issue when perhaps not all the side effects on children are being recognised. That was a remarkable one.
The pharmaceutical society states that another important legislative plank contributing to the correct use of medicines relates to advertising and promotion of medicines by the pharmaceutical industry. I am really concerned about the way in which statins are being pushed. According to what was going on at the Irish ploughing championships 2006, if one's cholesterol level, whether of the good, bad or indifferent type, is not under five, the position is really serious. If one looks at any of the studies on cholesterol levels, those that suggest that over five is dangerous always relate to diabetics or to one or two other serious factors. It appears as if the pharmaceutical society has not heard about this.
No.
I will not name the company, even though I have protection here. That company was at the ploughing championships telling the men of the soil, whose cholesterol levels are probably lower than ours——
——and the women of the soil.
——and the women of the soil how much they had to look out to have their cholesterol level under five. That is very low. I would like to think one had to take other things into account, particularly when statins have major side effects. I did not hear that pointed out in anything. If one looks at NIMS and reads about statins, one sees that the first thing it advises if cholesterol is five, six or even over seven is to change lifestyle. If the person returns after a month or six weeks and the level is the same, it advises an even greater change in lifestyle. I do not think it is right to go out to the general public with such an easily measured thing as this on such a topical issue and run such a campaign. I suggest the pharmaceutical society look at some of its members. I am sure Anna-May McHugh could supply the details on this incident at the ploughing championship. Certainly the matter was covered in the Irish Farmers Journal.
Mr. John McLaughlin
Perhaps I can give some of the background about the company. We have a problem in Ireland. I was at a meeting recently at which Professor John Nolan said we treat disease in Ireland but we do not treat health. It is probable that company, like other companies, is trying to drive the patient to the doctor to make a decision on that element of cholesterol. The position plays a pivotal role in that decision but often the problem is in primary care, where we treat the disease but not the health and, therefore, the complications materialise later. Today we spend €18 million on the drug bill for diabetes and €416 million in hospitals treating the complications of diabetes. It depends on how one wants to look at that initiative. Whether it is right or wrong is not for me to say because it is not my company but it drives patients to doctors and they are the people who are qualified to make a decision on whether that person requires treatment. Perhaps it is a good thing because the patient goes in before it is too late or before something happens later on in life. I do not defend it and I do not condone it but if we look at it with an open mind, perhaps we will see that these things are not as bad as they appear.
Patient pressure can be enormous regarding the prescription of drugs and this has to be taken into account. Once one decides to go over the head of the medical profession, pharmacists and so on and start publicising such a drug, one has taken on a huge responsibility.Senator Devins is in general practice, which I never was. In general practice it is more difficult than in hospital medicine but there is huge pressure.
Mr. McLaughlin
My point is that the physician has the ultimate choice and no other decision should be taken without the physician.
I thank the delegation for its presentation. To take up Mr. McLaughlin's point, I have been saying for a long time and as late as today in the Royal College of Physicians, where there was a seminar on cervical cancer, that if we spent more time being proactive and less time being reactive we would do a far better job. By the time we have people in hospital, in whatever discipline, we have lost the battle.
The first two paragraphs on page five of the submission are a very important part of the delegation's presentation. The brief of the sub-committee is to consider the adverse effect from using pharmaceuticals, and this relates to the adverse effect of not using pharmaceuticals. I have spent some time, like the Chairman, in a certain discipline where many were on anti-depressants. When Johnny or Mary has a problem with hypertension, he or she suffers a stroke. In some cases where the person has been discharged it comes to light that he or she had not been taking the medication. When one asks why they did not take the medication, they say they felt good. The only reason they felt good was that they were on the correct regime and the appropriate dosage was being administered. When they attained a good feeling about themselves because of the medication regime they were on, they stopped taking it. This has been the case, as the Chairman will confirm in the case of psychiatric patients who have been discharged on anti-hypertension drugs and other drugs. When they feel well they stop taking them. They then return to the hospital with jars of tablets and say they did not take them because they were feeling well.
This brings me to the subheading proposing the correct use of medicines. The most important aspect of proposing the correct use of medicines relates to the basic measures that can be taken to ensure proper use, for example, the reading of the explanatory leaflet. Advice must also be given to patients more forcefully because in many cases the message is not getting through. If patients were getting the message, there would be no need for the inclusion of the two paragraphs in the submission. The importance of knowing the side effects and of taking medication must be explained clearly to patients and next of kin. Public health nurses should be informed with regard to patients in their community and community psychiatric nurses with regard to psychiatric patients so they can explain the importance of taking the medication and inform patients of what to report. For example, a dry mouth is a common side effect when taking amitriptyline. If a patient taking antipsychotic medication develops extrapyramidal side effects, it may be because he or she is not taking his or her cogenten or whatever.
The adverse impact of not taking medication is hospitalisation. A person not taking his or her anti-hypertensive drug may suffer a stroke and then hold down an acute bed and require physiotherapy and other follow-up treatment. It is important people be made aware of the side effects of their medication and of the importance of taking it correctly.
Members of the previous delegation referred to over-the-counter medication and the "pill for every ill" syndrome. There is no doubt some people have a pill in their house for almost everything. Name it and they have it, or if not, they will get it by hook or by crook. I am not surprised to see the medical supplement of The Irish Times point out the dangers and reactions to a certain medical preparation. It is important that we make the public aware of the importance of taking the right medication and of its possible side effects. We must also ensure the public is aware that over-the-counter medication can be just as dangerous as prescribed medication.
What proposals could be brought forward to inform and educate the public further on the proper use and side effects of medication, of the dangers of over-the-counter remedies and of the need to follow instructions when taking medication?
Ms Clarke
This is an issue close to our hearts because we have done significant work in recent years towards promoting the correct use of medicines. We have taken it as far as the level of school-going children because we believe that we should start early to educate people about medicines. School is the time to get them. We developed a campaign for the transition year programme, which is also suitable for the leaving certificate applied programme, on the topics of over-the-counter medicine safety, understanding medication leaflets, reading labels, who to go to for advice, how medicines work, etc. The programme is similar to the one currently in schools on eating correctly and the food pyramid.
We have been supported in our efforts in this regard by the health promotion unit which, over the years, has supported a number of our campaigns. In our schools programme we have had a campaign specifically on over-the-counter medicines and the need to discuss the medication with a pharmacist when unsure. With the Irish Pharmaceutical Union we have produced leaflets on paracetamol because while it is a safe drug, we recognise that if not used properly, it can cause significant difficulties such as those already mentioned. We went to the public and pharmacies with this information, which advises patients not to take too much or use it for too long and that if symptoms persist, the patient should return to his or her doctor. We advise that such medicines are intended for self-limiting conditions for a short period of time. The message needs to be reinforced through labels, leaflets and the interaction of both pharmacists and doctors who should keep an eye on what over-the-counter medicines people take.
We are keen to continue this type of campaign. The leaflet and publicity campaigns have been well received. We have also done much work on regional and local radio stations on the issue. A collective effort can be made to continue the work. The HSE has taken on the health promotion function. The Pharmaceutical Society of Ireland, the Irish Pharmaceutical Union and medical organisations should also be involved. We spend significant amounts on effective medicines here that have been through a significant research process and do our best to ensure they are safe. However, we need to ensure that people do not suffer any undue harm from these medicines because of not using them properly. A multifactorial effort will be required to achieve this.
Mr. McLaughlin
I will add one comment. In the past seven years the number of retail pharmacies in Ireland has increased from just under 1,000 to over 1,400, a 40% increase. In Norway, which has a similar-sized population, there are 300 pharmacies. The opportunity we have here is the number of pharmacies per capita and therefore any initiative for which we can use the pharmacies will be welcomed by everybody in the industry.
I have a few brief questions. How many medicines were withdrawn from the system during the year? It was well known in the United States that a medicine used in the psychiatric service caused suicide, but that medicine remained available on prescription here. Will the delegation comment on that? Senator Henry referred to the issue of trials on children. How is it proposed to get through this conundrum and conduct trials? A child cannot give consent to a trial, and therefore children's drugs can only be tested on adults.
Mr. Stinson
To answer the last question first, it is very difficult to conduct trials. Everyone would agree that a child cannot consent, but parents asked to put a child forward for a clinical trial unanimously say "No". Where children do participate in clinical trials, we get the written informed consent of both parents. Also, where possible we get the informed consent of the child. Obviously, if a child is only 18 months old, that is impossible, but if a child is six or seven years old, the doctor will try to explain it and if the child is not interested, no matter what the parent wants, the child does not participate in the clinical trial. It is a very difficult area.
The same is true with regard to getting data on medicines for women with child-bearing potential where there could be adverse effects for the foetus. This is a difficult area, yet the FDA requires that women with child-bearing potential are part of the control group in early trials because there may be gender differences. It is a difficult hurdle. The only way to get over the hurdle with regard to child trials is to approach as many children and their parents as possible to see if they want to participate. The amount of clinical trial work in Ireland is probably decreasing and I am not aware of many trials here that involve children. This is partly because it is so difficult to get participants for such trials.
New legislation on paediatric trials has just been adopted and in future companies will be obliged to conduct trials on children. How this operates will continue to be a difficult issue.
Ms Clarke
In the US for a number of years a regulation gave a company some incentive in terms of patent life or data protection when it conducted trials on children. Now Europe has had a similar regulation introduced at EU level which will give an additional six months' protection or market exclusivity in recognition of the fact that doing trials on children is more difficult. Trials are costly to run because of the logistics of trying to get an adequate number of patients, obtaining additional consents, etc. It will be mandatory to do these trials unless it can be proved that the medicine definitely will not be used in paediatric patients.
For example, paediatric studies will clearly not be required on a drug for Alzheimer's disease. This is one initiative at European level which has been identified. There is a general realisation across the board by health professionals and the industry alike that one is giving mini-doses of adult medicines to children and we do not know if the mini-dose is the correct way to proceed.
Will the delegation respond on the issue of the suicide medication?
Mr. Stinson
With regard to the role of antidepressants, the Irish Medicines Board is the regulatory authority which decides which medicines are safe to be used and prescribed in this country. As members will be aware, it is often the case that profoundly depressed people have very little energy and are very lethargic. It is a paradox that sometimes when they are on the road to recovery, when they have good days and bad days, they get enough energy to do something as traumatic and tragic as committing suicide. This is a very difficult area. My sister is a psychiatrist and I have seen her traumatised by some of her patients who, when on the road to recovery, have committed suicide. That decision is not made by the pharmaceutical company. These data would all be shared with the Irish Medicines Board, which is the regulator and the authority.
I thank the delegation for attending the meeting and for its very comprehensive presentation, which has been very useful.
The sub-committee adjourned at 4.15 p.m. until 2.30 p.m. on Tuesday, 17 October 2006.