I welcome the delegation from the Irish Pharmaceutical Union, Ms Liz Hoctor, vice president, Mr. Darragh O'Loughlin, treasurer, Mr. Seamus Feely, secretary general, and Pamela Logan, professional and business manager. Before asking the representatives to commence their presentation on the adverse side effects of pharmaceuticals, I draw their attention to the fact that members of the committee have absolute privilege but this same privilege does not apply to witnesses appearing before the committee. Members are reminded of the long-standing parliamentary practice to the effect that members 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.
Irish Pharmaceutical Union and Irish Medicines Board: Presentations.
Thank you, Chairman. The Irish Pharmaceutical Union, IPU, is the representative body for community pharmacists. Members of the union aim to provide the best possible professional pharmaceutical service for all members of the public. They are committed to delivering a quality, accessible, personal and professional service that puts the patient first and has, as its primary goal, the optimisation of the health and well-being of society.
As vice-president of the IPU, I thank the sub-committee for affording me and my colleagues the opportunity to address it on the issues surrounding the adverse side effects of pharmaceuticals and to highlight the way pharmacists can assist in addressing this issue.
Drawing on existing resources always makes sense. Currently, pharmacists play a vital role in health care delivery but they are still one of the most under-utilised resources in the health services. They are highly qualified health care practitioners who are easily accessible to the public in city and town centres, residential and rural areas. People do not need an appointment to see a pharmacist and they have ready access, in a familiar, informal environment, to expert knowledge about medicines in particular and health care generally. Pharmacists are medicine experts and are best placed to identify, report and offer advice on adverse side effects.
Spontaneous reporting of suspected adverse reactions to medicines by pharmacists is an important element of effective pharmaco-vigilance. However, the European Medicines Agency recognises that under-reporting continues to be a problem. Therefore, there needs to be a better mechanism for feedback, through professional journals and bulletins, from professional competent authorities on observations submitted and action taken. This will encourage all health care professionals to be active in this area.
The primary role of the pharmacist is to improve health outcomes by safely dispensing medicines and advising patients on how to get the optimum benefit from them. Pharmacists are able to intervene when a patient requests advice or visits the pharmacy for any reason. However, there is considerable scope to develop the current level of professional services delivered by community pharmacies into a more comprehensive structured and organised service to the community.
Community pharmacists tend to be the link between all health care professionals and 75% of patients use the same pharmacy on a regular basis. Clause 9 of the community pharmacy contract requires pharmacists to review each prescription, prior to supply, for potential drug therapy problems, interactions, side effects and incorrect dosage or duration of action. However, once supplied there is no further follow up to check compliance. For this and other reasons, the union has been advocating the introduction of structured medication reviews for a number of years. These reviews are now a normal part of the work of pharmacists in other jurisdictions.
Medication reviews have many benefits. In the UK preventable drug reactions are implicated in up to 17% of hospital admissions in older patients. Many of these admissions would have been prevented if patients had a better understanding and knowledge of the medication they were taking. The union commissioned some independent research in August and this found that one in five patients is on two or more medicines in Ireland and of these 23% are concerned they are not taking their medicines correctly.
A study in the USA has shown that structured medication reviews can reduce the number of adverse drug events by the order of 60%. That is due to reduction in GP costs, drug costs, accident and emergency department visits and hospital admissions. Similarly, research in Sweden and Denmark has shown the medication reviews result in savings of €129 million and 174 lives every year.
The following figures were reported in a study about adverse drug reactions in the UK. A total of 392,000 acute admissions were due to adverse drug reactions during 2003 and 2004 and this accounted for 0.7% of the Ministry of Health budget. Approximately 60% of adverse drug reactions were potentially preventable, equivalent to a potential saving of almost €370 million.
A formal structure of medicine management would have many and significant benefits for individual patients, health care professionals who deal with them and the health system as a whole. In the opinion of the IPU there would be significant reductions in the harm caused to patients by incorrect or inappropriate medicines used; patients' overall health status and satisfaction would be improved; significant cost savings would accrue to the health systems; and key elements of the Government's overall health strategy would not only be met but also exceeded.
Further detail and medication reviews can be found in our original submission. The union calls upon the sub-committee to support the implementation of such structured medication reviews in Ireland.
An important part of the pharmacist's role is to check the prescription for accuracy. Frequently, prescriptions are incorrect and need to be altered. This involves the pharmacist telephoning the doctor or hospital to clarify the information on the prescription and to alter the prescription where appropriate. This is a vital check in safeguarding patient health and well-being. For this reason, traditionally there has been a clear divide between the role of the pharmacist and the role of the prescriber. However, this divide has become blurred in recent times here with the development of health centres by doctors which incorporate a pharmacy. It is interesting in this context to note that the sixth Shipman report stated:
...it is obvious that where both prescribing and dispensing functions are carried out by the same person or within the same commercial or professional entity, there is a potential for the loss of professional objectivity or even abuse.
The Minister for Health and Children, speaking in the Dáil on 27 September 2006, said:
The Government accepted the pharmacy review group recommendation that there should be no beneficial ownership or business interest of any kind between dispensing and prescribing.
However, the Minister has indicated she does not intend to address this patient safety issue in the first pharmacy Bill, which is due to be published later this year. The location of pharmacies within health centres enables one pharmacy to corner the market, leading to the closure of other pharmacies, which will reduce patient choice and ready access to pharmacy services. I appeal to the sub-committee to urge the Minister for Health and Children to address this issue in the first pharmacy Bill, to prevent business relationships from developing between doctors and pharmacists.
Pharmacists play an important role in health promotion, both as a source of knowledge to patients and also as a means to improving lifestyle. The union has run many health promotion campaigns through pharmacies over the years. In March 2005, we ran a joint campaign with the IPHA, called Ask About Your Medicines. This was designed to encourage patients to ask their pharmacists for more information about their medicines. A copy of the leaflet is in the information pack we have provided for members of the committee.
A survey was carried out at the time of that health promotion campaign which showed that almost 50% of Irish people do not read the information leaflet contained in non-prescription medicine packs before they take the medicines. Furthermore, only 30% of those who take other medicines at the same time as non-prescription medicines check the label on the box or the product insert with the pharmacist to see if it is appropriate to do so. When the union ran a similar campaign in 2003, it followed it with a survey which showed there was an increase of 20% in the number of patients asking questions about their medicines following the launch of the campaign.
In 2006 the union has focused more on the management of chronic diseases in its health promotions, specifically heart disease and diabetes. The main aim of these campaigns is to make people aware of the risk factors associated with these diseases and also to encourage them to adopt a healthier lifestyle, with a view to preventing heart disease and diabetes rather than waiting for it to happen and then treating it.
The union is also strongly involved in the forthcoming national launch of the personal information pack, PIP. The PIP is aimed at improving emergency care for people in the community. It is a pack containing an insert with relevant medical and personal information about the owner and it is designed for people at risk, who will keep the PIP at home in case of an out-of-hours general practitioner visit or an emergency visit to hospital. The union will also be involved in other joint health promotion campaigns with other health care professionals towards the end of this year, particularly on the safe use of analgesia.
Earlier this year the union called for a public awareness campaign to inform patients of the dangers of buying medicines over the Internet. When patients buy medicines over the Internet, they have no way of knowing whether the medicines are counterfeit or genuine. They have no idea what these medicines contain, if they are putting their lives at risk by taking them or whether they might interact with other medicines they might be taking. Sometimes people believe that buying medicines over the Internet is cheaper than buying them in the local pharmacy. This is not the case and that was clearly shown in an article in the Irish Examiner. The majority of medicines are actually more expensive when bought from websites.
It is vital that patients have face to face contact with a community pharmacist when they are receiving their medication. A pharmacist is trained to provide health care advice and is responsible for the safety, health and well-being of patients. Critically, when dispensing medication to patients, the pharmacist checks for the possibility of drug interactions, side effects, incorrect drug dosage and clinical abuse. Last year the IPU endorsed a patient safety campaign which warned patients about the dangers of counterfeit medicines. The union requests the support of the sub-committee for a public awareness campaign on this issue.
A final area in which the union believes that pharmacists can make a significant contribution to the well-being of society is in the disposal of unused medicines properly — DUMP campaigns. It might not appear to come under the remit of this committee but death is the ultimate side effect of medicines. The issue of self-harm due to overdose is well documented and the fourth annual report on the national parasuicide registry, launched by the Minister of State, Deputy Tim O'Malley, in December 2005 indicated that drug overdosing was the most common method of self-harm. It represented 77% of all parasuicide cases registered in 2004. While it was common for several drugs to be taken in the same act, minor tranquilisers, paracetamol and anti-depressants were the most commonly used medicines. In addition, 68% of all queries to the national poisons centre at Beaumont Hospital are directly related to conventional medicines.
The south-western area health campaign has been running a DUMP campaign since January 2004. To date, it has collected 13.5 tonnes of medicines, which otherwise might have been stored in people's homes and available to people who might inadvertently consume them, or to people wishing to harm themselves.
The HSE's Dublin, mid-Leinster and midlands areas have recently undertaken to fund DUMP campaigns through community pharmacies to return out of date or unused medicines. The union has called on the HSE to roll out the campaign nationally. The HSE has replied that it will consider this for its 2007 budget submissions. The union asks the sub-committee to support it in this request. The union would like to reassert its commitment to developing the role of pharmacists in delivering a quality, accessible, personal and professional community pharmacy service that puts the patient first and has as its primary goal the optimisation of the health and well-being of society.
The Irish Pharmaceutical Union recommends the introduction of a structured medicine management programme, the development of a more structured health promotion role for community pharmacists, a public awareness campaign on the dangers of buying medicines on the Internet, the initiation of a national initiative to dispose of unused medicines safely and the maintenance of current checks and balances in the prescribing and dispensing relationship. We believe these will contribute greatly to patient safety and to reducing the adverse side effects of medicines among patients and in the community at large.
I thank the sub-committee for its attention. My colleagues and I will be happy to discuss the issues raised in this presentation or other relevant issues.
I thank Ms Hoctor for a comprehensive presentation. We will have some questions and I propose we take them in sequence.
I am interested in what Ms Hoctor has said about the process operating from the top downward. She is saying the hospital consultant gives a prescription to the patient, who goes to the GP, who in turn goes to the pharmacist. She said patients are often unaware of what drug treatment they are receiving, even from hospitals. The fact that 50% of people still do not read the labels that come in the boxes in order to know exactly what they are taking shows either the unbelievable confidence of patients in their doctors or an unbelievable failure in the system.
The DUMP campaign raises another concern about compliance — in other words, patients are not taking their medication. Figures are available for the percentage of people who do not take their medication and I believe they are quite high. Anything up to one in ten prescriptions is not taken. Ms Hoctor is talking about medication that is being dispensed but not used. Another campaign examined cases where doctors wrote prescriptions but the number of people who do not even get the prescription from a pharmacist is unbelievable
Ms Hoctor has shown that we have failed completely to persuade a sizeable proportion of patients that what we are doing for them is good for their health. Either they do not get the prescription or, if they do get it, they often do not finish the course of treatment.
This sub-committee is specifically examining adverse reactions to medication. I suppose that is why we are more interested in what Ms Hoctor said about the review of medication. One would think it should be standard practice, not just by pharmacists but also by general practitioners, to review every six months a person who is on four or more drugs. It is not unusual to see patients on anything up to eight medications. With the complex interreactions between those medications, one must be extremely careful in how one adds in a new drug for patients if required. One would think it would be part of the day to day job to review patients' prescriptions if they are on such medication. I am surprised that is not going ahead.
Ms Hoctor referred to the pharmacy review group and its recommendations on separating, dispensing and prescribing. I heard the Minister for Health and Children — again, the innocent bystander in the health care service — state she was shocked and horrified to see this happening. However, this has almost become part and parcel of the Irish health care service. Most primary care centres being constructed have a pharmacy on the ground floor. In some respects the recommendations of the pharmacy review group might now be unimplementable, and I would like to hear Ms Hoctor's opinion on that if she is prepared to give it. For commercial reasons, it would be impossible to start to close primary care centres.
There are major plans for the future. A number of private companies intend to build primary care centres which will have pharmacies as anchor tenants. They could easily take the State to court if it tries to implement the pharmacy review group's recommendations. The recommendations were drawn up in 1998 but the situation has changed quite dramatically since then.
Ms Hoctor's remit is not pharmaceutical companies but to try to prevent adverse drug reactions among patients and to ensure they are reported properly where they occur. Does Ms Hoctor believe the regulations under which she works are adequate? She pointed out the problems with the pharmacy Bill and the fact it is being split into two, which will create huge problems. As it stands, does Ms Hoctor believe the patient is properly protected? Can she do something about this? Does she have the same problem as general practitioners, namely, filling out the yellow form and sending it back to the Irish Medicines Board
What would be the advantage if we brought the two pharmacy Bills together? How would that affect patient care in terms of preventing adverse effects for the patient?
I welcome Ms Hoctor and thank her for her very comprehensive presentation. I agree wholeheartedly with a number of points, the first being the dangers of taking drugs bought on the Internet. I do not know how that can be stopped. As Ms Hoctor suggested, perhaps a publicity campaign might be the first step in that direction. I would be interested in teasing out Ms Hoctor's ideas because it is, in many ways, a minefield.
Ms Hoctor also referred to the relationship between the pharmacist and the prescribing doctor. In this case, it is mainly the general practitioner. As a general practitioner, I valued the close relationship I had with the local pharmacists and I am delighted one of those pharmacists is the current president of the Irish Pharmaceutical Union, Michael Guckian. I had many occasions to telephone his father's pharmacy to talk about drugs and individual patients.
I wish to take up a point raised by Deputy Twomey, namely, the situation of pharmacies within health care centres or commercial premises. I am well aware of the stance of the IPU in this regard but as Deputy Twomey said it is, in many cases, a fact of life. I see the dangers but I also see the ease with which patients can get their prescribed medicines. I would be interested to hear how we can deal with this issue as it stands rather than as it stood some years ago when the ideas were first mooted.
I would be especially interested in Ms Hoctor's comments on the adverse effects on a patient. We discussed this with some of the other pharmacists who appeared before the committee. Currently, the patient has the prescription filled out and, obviously, he or she, if in regular attendance at a particular pharmacy, may well return to the pharmacy if he or she has problems. In most cases where a patient has problems, however, he or she probably will return to the doctor rather than the pharmacist.
Would Ms Hoctor be open to suggestions whereby there might be closer liaison between the prescribing doctor and the pharmacist so that if a patient has had an adverse effect from a pharmaceutical product, when he or she returns, perhaps having been prescribed by a different doctor, the pharmacist would play a central role in this rather than, as is the case at present, being very much dependent on hearing it by word of mouth because the business is between the doctor and the patient rather than directly involving the pharmacist?
I am rather shocked and alarmed by the unused medicines issue. I would certainly agree with the disposing of unused medicines properly campaign. I recall that on visiting many patients' houses and asking what drugs they were on, they would state X or Y but when they opened the cupboard, one would find seven, eight or nine medicines which people had stored, possibly unused, for maybe six months to a year. It is a considerable problem and I would welcome that campaign at national level.
I thank Ms Hoctor for the clear presentation. Like Deputy Devins and Deputy Twomey, I share Ms Hoctor's anxiety about the blurring of the divide in the roles of prescriber and pharmacist because in the past that was always considered terribly important. Ms Hoctor is quite correct to point out the dangers of business relationships between doctors and pharmacists. Although it may not be quite what the sub-committee is supposed to be doing, we need to examine that carefully.
I am delighted to hear how well the DUMP campaign is going, even though I am horrified at the tonnes of medicines which are being collected. It is a most worthwhile campaign. I am sure we can promote that because another area where adverse drug reactions occur is where a person takes somebody else's medicine because it seemed to do the other person good and because it was left over. That seems to be a regular practice in this country and there is some surprise when the medicine does not do the person much good at all.
It is alarming that so many people are admitted to hospital with adverse side effects from prescribed drugs. I noted a survey which stated that only 35% of people are told of potential side effects by doctors, which is really very bad. I read the article, The Impact on Antithrombotic Therapy On Neurosurgical Emergency Referral Load, in the most recent edition of the Irish Medical Journal. I do not know whether any member of the delegation read it, but this was a paper by Dr. John Caird of the neurosurgical unit in Beaumont Hospital. Dr. Caird and his colleagues found, when questioning over a three-month period, that of 713 emergency referrals, 174 presented with intracranial or spinal haemorrhage and 75 — 43% — of these were on antithrombotic therapy. This, I suppose, was fair enough except that of those 75 on antithrombotic therapy, 17 — 22% — who all were on aspirin presented with a haemorrhagic complex but had no obvious indication for such therapy.
When a patient presents with a prescription would Ms Hoctor find it awkward to feel the need to question the doctor on why the patient was being put on a medicine when there was no relevant reason to do so? She is obviously anxious to make the health care position of pharmacists clearer. What sort of reception does Ms Hoctor think she would get?
There is quite a problem with people taking natural health care remedies because they believe they cannot be bad for one if they are natural. There seems to be a serious lack of knowledge about the potency of some of these products. Does the IPU have a relationship with health care shops in respect of this matter?
I thank Ms Hoctor for her presentation. I will commence with one of my pet aversions, namely, the prescription of drugs over the Internet. My views on this matter are well known. Is it correct that some preparations ordered on the Internet are infused with standard properties that would be pertinent to regular drugs to ensure that they have an effect? The obvious reason for making such infusions is for the companies involved to be able to claim that their drugs work when conventional alternatives do not. That is bare-faced fraud.
The Irish Pharmaceutical Union's proposal regarding a public awareness campaign on the dangers of buying medicines on the Internet is an absolute must. Each of us has an obligation to tackle this matter because it has major implications for the well-being of society in the context of health care. A vigorous approach must be taken in respect of it.
On over-the-counter drugs, when I was a member of a certain profession some years ago, there were people who regularly went into pharmacies and ordered whatever drugs they wanted on an ongoing basis. Is it common for members of the Irish Pharmaceutical Union to question people as to why they want to buy certain drugs? If it is common for such questions to be asked, is it done on an ad hoc basis or is it a policy of the IPU? If the IPU does not have such a policy, it should adopt one because the abuse of over-the-counter drugs can be just as harmful to people’s health as that relating to prescribed drugs
As regards the DUMP campaign, I am not surprised that 13.5 tonnes of medicines have been recovered to date in the old South Western Health Board area. I recall when I worked as an acting CPN, visiting houses in which there were to be found cupboards full of medicines, many of which were out of date. Does the IPU believe that greater awareness should be created, first, on the part of patients and, second, on that of their next of kin, who have a pivotal role to play? Public health nurses and CPNs should be vigilant to the point of being nosy in respect of discovering if there are unused medicines lying around people's homes.
Ms Hoctor made a good point that the national parasuicide registry indicates that drug overdosing is the most common method of self-harm and represented 77% of all parasuicide cases registered in 2004.
My final point relates to a matter raised by Senator Henry. Regardless of whether drugs are manufactured or natural, people should be made aware of their ingredients. If a person is taking a natural drug or preparation, he or she should be able to discover what it contains. If such drugs or preparations can cause adverse effects, people should be so advised.
I also compliment Ms Hoctor on her excellent presentation. I am delighted that 75% of patients use the same pharmacy regularly. That is the safest way to proceed. When my parents were still alive but in their latter years, they got great comfort from using the same pharmacy in their town and they received excellent advice from those who worked there. They were very familiar with the pharmacy to which I refer and felt safe using it.
On clause 9, Ms Hoctor stated that pharmacists are to review each prescription prior to supply for potential drug therapy problems, interactions, side effects, incorrect dosage or duration of action. If the union members were concerned about something, do they feel they could pick up the telephone and speak to the prescribing general practitioner about it? I was surprised by the following statement: "However, once supplied, there was no further follow up to check compliance". I meet many people who are concerned about family members being addicted to prescription and non-prescription painkillers. What are the representatives' views on this? Are there many people with addictions who may not have realised they were becoming addicted to a substance? If the union or its members have a concern about the prescribing pattern of a general practitioner, what avenues are open to voice concerns?
The DUMP campaign was great. I did not realise it had concluded, although it is a while since I saw a box in my local pharmacy. It would be better if people returned unused drugs to their pharmacy rather than pour them down the plughole. Perhaps the campaign should be rolled out on a similar basis to the campaign on the recycling of domestic waste. People connect much more quickly to such campaigns when there is a purpose to their involvement.
I would like to make a number of comments and ask some questions. Many of our questions are similar but we share similar concerns. I am concerned about the DUMP project and I cannot understand why it has not been rolled out nationally. How much would it cost to expand the pilot scheme?
With regard to Internet prescriptions, is self-diagnosis a factor? Are patients going on the Internet to diagnose themselves, thereby taking the doctor out of the loop to save €40 or €50 and taking the pharmacist out by trying to buy the medication cheaper? Is that a problem?
We all must be concerned about the business relationship between doctors and pharmacies. However, there are times when a good working relationship is needed. Will Ms Hoctor comment on that? Why was no reference made to drug companies and medication suppliers in the presentation? Should the methods used by them to push their products in pharmacies be taken into account?
I am also concerned that preventable drug reactions are implicated in 17% of hospital admissions. That is a major reason to try to do something about that because it is a major drain on limited resources. How much does it cost to implement medication reviews? Significant savings both in lives and money can be achieved, as has been proved in Sweden and Norway. What are the potential savings?
Ms Hoctor referred to the union's recommendations when concluding her presentation. How much would it cost to implement them? Would they be cost effective? Who would pay the bill?
A number of interesting points have been raised, which I and my colleagues will attempt to answer and provide clarification on. A number of questions were posed about the medication review. As Senator Feeney pointed out, clause 9 pharmacists review the prescriptions for potential drug therapy interactions. However, there is no follow up and, therefore, once the patient leaves the pharmacy following the dispensing of the medicine required, there is no structured medication review. They do not return to the pharmacy to have the medication reviewed. That can then lead to the concerns raised by a number of members about unused medicines.
If the structured medication review does not happen, it is more likely that if medications cause side effects patients may not take them and the unused medications will remain in the house. These unused medications are dangerous substances to leave around the house. Therefore, the review links in with the disposing of unused medicines properly, DUMP, campaign. The union recommends structured medication reviews that will lead to more rational safe and effective use of medicines and by linking that with the DUMP campaign we will remove the unsafe substances from patients' homes
With reference to structured medicine reviews, does Ms Hoctor mean pharmacists will contact patients every month to ascertain how they are taking their medicines or that patients should come to the pharmacist? How will it work in practice?
The Chairman referred to the costs of running a structured medication campaign. Our colleagues in the North already run one and for every £1 spent on structured medication reviews there is a saving of between £5 to £8. To operate the system we would first look at the higher risk groups, patients on polypharmacy, namely patients taking five or more medicines a month. These are the higher risk patients and pharmacists would target these for a structured medication review. This would make the best use of pharmacists' time and would lead to the greatest cost savings, efficiencies, rationalisation and safer use of medicines for patients
My question concerned the practicalities. Does a structured review mean that every month a patient on five plus drugs must come into the pharmacy and sit down with the pharmacist for a review or will the pharmacist visit the patient? I understand the principle, but how will it work in practice?
I will ask Mr. O'Loughlin to clarify that.
Mr. Darragh O’Loughlin
The Deputy has picked up on the two ways it will work. However, we do not see this being done every month, but every six months or annually. It will not be practicable for some patients to come to the pharmacy because they are bed or house bound and do not have the necessary mobility. Therefore, it will be necessary to visit these patients in their homes. What the review involves is sitting down with patients once or twice a year for 20 to 30 minutes to go through their medications and ensure they understand what they are for and how to identify any potential side effect or adverse reaction. The review would ideally occur before they suffer from an adverse reaction so that they could identify such reactions as soon as they occur and inform the GP or hospital or whoever prescribed the drug so that the medication therapy can be altered.
A patient may, for example, be on four drugs prescribed by a GP and then go to hospital for an unrelated complaint. For example, a heart patient might go in for a hip replacement and come out with a prescription for anti-inflammatories and painkillers from the surgeon without reference to the drugs he or she is already taking for his or her heart disease. In such cases the pharmacist can sit down with the patient and look at the range of drugs prescribed and pick up on potential interactions and help the patient identify side effects he or she might suffer. If patients then suffer an interaction or side effect, it will be picked up before they end up as some of the 17% of patients in hospital who are there because of their medicine.
That figure is very high.
What is the source of that figure?
Mr. O’Loughlin
The figure is a consistent figure in research from the UK and the United States. The figure tends to be relatively consistent.
Deputy Devins and I were just discussing that as we were both full-time GPs. The figure implies that one in five of our patients ended up in hospital because of the medication prescribed for them. I understand patients can get gastrointestinal, GI, bleeds from anti-inflammatories, that patients on warfarin can get strokes and that significant side effects can occur with our patients. However, if one in five of our patients ended up in hospital as a result of our prescriptions, we would not consider ourselves successful in our job, the aim of which is to keep people out of hospital. I question that high figure.
Can Mr. O'Loughlin provide the sub-committee with references for those figures?
We need to look at that figure; it sounds very high.
Committee members raised concerns about the blurring of the prescribing and dispensing relationship and the links between pharmacists and GPs. I will ask Mr. Feely to address those issues.
Mr. Seamus Feely
With regard to the pharmacy Bill, the reason we are anxious to see one comprehensive piece of legislation is that we want all aspects of pharmacy to be dealt with in one Bill. We are concerned that basic issues such as defining a pharmacy, a pharmacy service, and what constitutes dispensing should be covered in comprehensive legislation.
We have also asked the Minister to address the issue of the responsibility of the pharmacy owner. Currently under the proposed legislation, if the owner is a pharmacist, that pharmacist is accountable for how they run their pharmacy. However, in the case where the pharmacy is owned by a person who is not a pharmacist, he or she also has to be held accountable for how the business of the pharmacy is conducted and how patients are being served in that pharmacy. We want to avoid a situation where it is a pharmacist in a non-pharmacist owned outlet who takes the rap while the company continues to trade in the normal way. There is a dual responsibility of accountability, both on the part of the owner and equally on the pharmacist working in that pharmacy.
The issue of health centres is one we would like to see addressed in the pharmacy Bill. It could equally be addressed under current legislation if the desire was there to do so. We do not accept it is too late to deal with it. Under the current pharmacy contract, a doctor cannot have an interest in a pharmacy in the area in which he or she is practising. We would like to see the contract extended to cover an interest in the property in which the pharmacy is located. These centres are currently being developed and pharmacies are paying very high rents in those centres. Given the conclusions of the Shipman report, we have concerns about a blurring of the lines. There is a risk to patient safety. Once there is a risk, we should do all we can to ensure it is not allowed to develop.
There has by tradition and internationally been a divide between the two roles and we see no reason this should not continue in this country. This could be dealt with under the contract but it can also be dealt with in the context of the pharmacy Bill. If it is not addressed within the next 12 months, it will be too late — the horse will have bolted and only time will tell the outcome. This is a key issue for the union and for pharmacists. We firmly believe it must be addressed. We are asking Government to implement its own policy. The Government says it accepts this recommendation of the pharmacy review group report. We ask the Minister to act on it and to implement it.
Is Mr. Feely saying the Government could have enforced the legislation on this issue? Is it the case the Minister for Health and Children is not pushing this issue?
Mr. Feely
There are a number of issues. The Health Act 1970 was amended in 2000 and this allowed the Minister for Health and Children to address the issue of pharmacies in health centres under current legislation. It could also be addressed under the contract as it currently stands; it does not have to wait the enactment of legislation.
The centres are being developed. Under the health strategy the original idea was that the pharmacy would be part of the health care network and not part of the health care team nor of the health care centre. This strategy has been taken over by private developers, as the Deputy pointed out. These centres are being developed and the whole success and economic viability of these centres is heavily dependent on having a pharmacy which in a sense has the opportunity to corner the market for medicines in that locality. We also have concerns about what this means for patient choice in the longer term.
The Chairman asked about marketing of medicines. Most of the marketing strategies of the major companies are addressed to doctors rather than pharmacists because they are the ones who ultimately determine what will be prescribed and dispensed in that they write the prescriptions. There is therefore not a significant marketing campaign for prescription medicines geared towards pharmacies because they gear the campaigns more towards general practitioners because they are the people who make the decision to prescribe.
Senator Feeney asked whether pharmacists had concerns either about patients who may be developing a dependency on painkillers or about the prescribing pattern of GPs. Mr. Feely has alluded to the development of a relationship between the prescriber and dispenser and Mr. O'Loughlin wishes to make some points on that matter.
Mr. O’Loughlin
There are two issues to be considered. One issue is what happens when a pharmacist is concerned about patients being dependent either on over-the-counter painkillers or any prescription drug or anti-depressants or any medication which has a dependency potential. A pharmacist would always be very alert for the signs of dependency. In the case of an over-the-counter medicine which is purchased without a prescription, it is incumbent on the pharmacist to discuss this with the patient and to make a patient aware of his or her concerns. This is not done in a prohibitive manner or by saying the patient cannot have the medicine, but rather by explaining to a patient the downstream dangers of continuing to take this medication. Pharmacists do that day in, day out. Pharmacy is the only sector of the retail industry in which managers tell customers why they cannot buy a product. Pharmacists more often intervene to avoid making it than to make it. I was also asked about prescribing patterns.
Do pharmacists talk to general practitioners, as well as the patients themselves, when patients come in all the time with repeated prescriptions?
We will try to focus on the side effects of medication. We should not start to discuss systems of prescription. We have gone 15 minutes over schedule. The representatives of the Irish Medicines Board are waiting to come in. We should try to conclude this part of the meeting within the next five or ten minutes.
Mr. O’Loughlin
Addiction is a major side effect of some medications. If there are concerns about certain patients, we explain the various issues to those patients. If it is a prescription medicine, we also give a call to the doctor in question. We mention that the patient is trying to refill a prescription that should not be refilled, or is coming in too often to refill it. As the doctors prescribe the medicines, it is up to them to take the matter in hand.
I also asked about what happens when pharmacists have concerns about the actions of doctors.
Mr. O’Loughlin
It is extremely rare for a pharmacist to be concerned that a doctor is acting entirely unethically or unprofessionally in prescribing something that should not be prescribed, but when it happens we report it to the Medical Council.
Okay.
Mr. Feely
Senator Feeney also asked what we mean by there being no follow-up. It is obvious that patients go back to pharmacies and general practitioners. There is no follow-up in the sense that patients are not asked to take out their medication, to sit down with the pharmacist and to go through that medication. The real effect of such an approach would be to reduce prescribing that is not required and to ensure that patients correctly take the medication they should be taking. It would also be of assistance in the cases of patients who should be on medication but are not getting it, which is an important factor.
Some patients leave hospital with prescriptions which are incorrect, which is a significant issue. Many members of the union have to spend a great deal of time trying to sort out prescriptions for patients who leave hospital late in the evening with prescriptions which are incorrect or do not take any account of the medication such patients are taking.
I think most issues have been covered at this point.
Senator Henry and I did not receive a response to the question we asked about the components of natural medications. When one buys a preparation from a chemist, over-the-counter or by prescription, one can see what are its components. The composition of natural preparations is an important issue.
I will ask my colleague, Ms Pamela Logan, who is the union's professional and business development manager, to answer that question.
Ms Pamela Logan
Senator Glynn is right. Herbal medicines are as important as normal medicines. Patients believe there is nothing wrong with such medicines — they cannot cause any harm and do not have any side effects — because they are herbal and natural. The union has organised an Ask About Your Medicines campaign on two occasions over the last three years. The campaign encourages patients to ask their pharmacists about medicines they get on prescription and over the counter, as well as vitamin and mineral supplements and other herbal products which can interact in a certain way and have side effects.
Patients may treat themselves for self-diagnosed illnesses by using homeopathic or herbal products which are not particularly appropriate. The union has tried to address such matters in the campaigns I have mentioned. As many patients have a low level of awareness of what medicines are for, they tend to stop taking them and to fail to recognise their side effects. The union has had some success with its campaign. It intends to run it every couple of years.
Mr. O’Loughlin
Senator Glynn rightly said that many products which are sold as traditional medicines from various parts of the world contain scheduled medicines. When the Irish Medicines Board tested traditional remedies for eczema or psoriasis, for example, it found they contained prescription steroids. It found that supposedly traditional remedies for male erectile dysfunction contained ground-up Viagra tablets — there was nothing traditional about the remedies at all. The importation of untested produce using the Internet — nobody knows what is in it or is not in it — is a significant ongoing problem. People are self-diagnosing, rightly or wrongly, and taking medicines without knowing what is in them. Senators Glynn and Henry are right to raise concerns about that. Every pharmacist and general practitioner in Ireland has concerns about that.
I will conclude by speaking about one of my pet aversions, to which I have already referred. What further measures can be taken by the Irish Pharmaceutical Union, which dispenses medication, to outlaw the practice of on-line medication?
Mr. O’Loughlin
All the union can do is spend as much time and energy as possible on trying to ensure that the public and patients are aware of the dangers of purchasing medicines on the Internet. We take every opportunity to speak on local radio or to journalists and we talk to patients in the shop. Purchasing medicines on the Internet is a deadly and dangerous practice and those who engage in it do not know with what they are poisoning themselves.
I thank the delegation for its comprehensive presentation and responses to members' questions. Unfortunately, as a delegation from the Irish Medicines Board is scheduled to appear before the sub-committee, I am unable to extend this meeting.
I welcome the delegation from the Irish Medicines Board, Mr. Pat O'Mahony, chief executive, Dr. Joan Gilvarry, director of human medicines, and Dr. Brendan Buckley, member and chairman of its advisory committee for human medicines. I draw witnesses' attention to the fact that while members of the sub-committee have absolute privilege, this same privilege does not apply to witnesses appearing before the sub-committee. I ask the delegation to commence its presentation on the adverse side effects of pharmaceuticals.
Mr. Pat O’Mahony
I thank the Chairman for the invitation to address the sub-committee. I am the chief executive of the Irish Medicines Board. I am accompanied by Dr. Joan Gilvarry who is director of human medicines at the board. Dr. Brendan Buckley is a consultant endocrinologist in Cork, lecturer in pharmacology at the medical school in University College Cork and director of the European Centre for Clinical Trials in Rare Diseases. Dr. Buckley is a member of the board of the Irish Medicines Board and chairman of our advisory committee for human medicines. With the Chairman's permission, Dr. Gilvarry will make a short presentation, after which we will take any questions members may have.
Dr. Joan Gilvarry
I thank the Chairman and members of the sub-committee for affording my colleagues and me an opportunity to address them on this most important issue, the side effects of pharmaceuticals. I promise I will not take up much of the committee's time so as to allow scope for discussion. I believe it is important to introduce what the Irish Medicines Board does and how we do it. This may be of assistance in terms of the questions committee members may have.
The mission statement of the Irish Medicines Board as the regulatory authority, is to protect and enhance public health through the regulation of medicines in Ireland. We see ourselves as one link in the chain of the many institutions that protect public health. Consistent with the current medicinal and scientific knowledge, we ensure that the medicinal products licensed for use in Ireland are of an acceptable safety, quality and effectiveness standard under normal conditions of use, by which, I mean the indication they are licensed for, the duration of use for which they are recommended, the recommended dosage and strict adherence to the contra-indications, warning and side effect profile that is written on the summary of product characteristics. We see it as very important to play an active role in the European systems for the regulation of medicinal products.
The next slide is very detailed and I will go through it briefly. We have a board of nine members which is appointed by the Minister for Health and Children. There are three sub-committees under the board. The principal one for discussion here is the advisory committee for human medicines. Dr. Buckley has already been introduced as the chair of this committee. He is also a member of the board. Each of the advisory committees can appoint sub-comittees. A number of the sub-committees of the advisory committee for human medicines are listed, for example, the clinical expert sub-committee and the pre-clinical expert sub-committee.
Clinical trials were referred to in the last presentation. We have now undertaken to set up a sub-committee of herbal medicinal products as we have been asked to be the competent authority. We await from the Department of Health and Children the transposition of the European directive on traditional herbal medicinal products into Irish law. We expect that legislation before the end of this year or early next year. We have taken the pre-emptive step of having an expert committee at the board ready and willing to start the regulation of herbal medicines as soon as we have a legislative basis.
The other clinical committees and clinical trials committees are made up of consultants in clinical practice here in Ireland. All of them are international experts in their areas of therapeutic medicine, including oncologists, haematologists and respiratory experts, in addition to positions in the other areas of medicine that are required.
Our chief executive, Mr. Pat O'Mahony, who has already been introduced, is involved in the day to day running of the business. He is assisted by the management committee which is composed of the heads of all departments. I have the privilege of heading up the human medicines department, to which the next slide refers. This department may be of most interest to the committee.
Some members will remember the late Dr. Aileen Scott, one of the founder members of the National Drugs Advisory Board which was set up in 1996. Dr. Scott ran this board with the minimum of staff and had the foresight to see the need for pharmaco-vigilant structures and a comprehensive assessment procedure which we have tried to build upon. It is a changed system today. In the past Dr. Scott had only a handful of staff, whereas we have 100 staff in the human medicines department. In the medical assessment team we have 14 medical doctors, all with specialist expertise and on the specialist register of haematology, oncology, respiratory medicine, in addition to clinical pharmacologists. We have a significant amount of expertise. The same is true of our pharmaco-vigilance unit, led by Niamh Arthur who is present.
Our pharmaceutical assessment team is made up of scientists and approximately 25 pharmacists, all of whom have worked in hospital or retail pharmacies before coming to work with us at the board. We have toxicologists, nurses, immunologists, scientific and biotechnology expertise. Of the 100 staff, probably about 60 of them are highly qualified scientific personnel who are involved in making decisions at the board. This structure covers the life cycle of the product from the day we first see it at the clinical trial until it goes on the market. We regard it as important because the risk-benefit analysis can change throughout the life cycle of a product. Perhaps some members have read this week's New England Journal of Medicine which outlines that the Institute of Medicine in the United States was asked to review the structure of the USFDA. This was done in recent years and the institute issued its recommendation on 26 October — it is hot off the press. The institute is encouraging the USFDA to amend the structure to represent the life cycle of the product. I like to believe Ireland is well ahead of the United States in this regard.
When I refer to the life cycle of the product, I refer to the licensing of clinical trials. We approve approximately 120 clinical trials per year, and do so in a very controlled setting. The age recommendation is included in the protocol, as are the inclusion and exclusion criteria.
When trials are completed, we license the human medicines. There are approximately 6,000 licensed medicines on the marketplace at present. We see licensing as a critical juncture in the life cycle of the product. When the drug hits the market for the first time, the public will be widely exposed to it. Another life cycle thus begins, whereby pharmaco-vigilance and the compliance of the pharmaceutical companies are paramount. Thereafter, we actively pursue and manage any emerging knowledge on the risk versus the benefits and we communicate this, where relevant, to health care professionals and patients. Everything we do is underpinned by European and Irish legislation.
When we assess a medicinal product before it goes on the market, we think in terms of there being three legs to the stool. The first leg involves the assessment by the pharmaceutical department of the quality of the product, the formulation, its stability and the end product, be it a capsule, tablet or injection formulation. The other two legs involve determining the safety and effectiveness of the product. These are assessed in conjunction with our experts by our toxicologists and the medical assessment department of the IMB.
At this point we reach the critical juncture whereby we weigh the benefits against the risks. One may talk about adverse reactions to pharmaceuticals, the determination of which is extremely important, but we must remember that there is no medicine available in the marketplace that does not have a side effect. Patients, carers, doctors, pharmacists, nurses and others must be aware of this and try to decrease the risk for patients.
We license the medical product if the benefits outweigh the risks. In the post-marketing surveillance activities we undertake at the board, we acquire, integrate and communicate relevant information to patients and users of the medicines to ensure their appropriate use.
I circulated to the members a summary of product characteristics. One in particular may be of interest to Senator Henry because she asked questions some weeks ago on statins and their overuse and abuse in regular medical practice. In the SBC, as we call it for short, I highlight the indication of statins. Dr. Buckley might elaborate on this after my presentation because he is a world authority on statins and represented the IMB in a recent review thereof. These agents are licensed as an adjunct to diet. When the response to diet and other non-pharmacological means of treatment — for example, exercise and weight reduction — have proved inadequate, they are then used to reduce one's cholesterol. They are not the primary treatment of choice. All the non-pharmacological means should be instituted initially.
The summary of product characteristics outlines for the health care professional the recommended use of the product, the contraindications to use — for example, certain products should not be used on patients with cardiac failure — the known side effects, the interactions for use, the precautions for use, etc. All of these are made available on the IMB's website for easy access by health care professionals. I also brought along a sample of the package leaflet which reflects all the information available in summary form of the product characteristics but in patient-friendly language. Patients, their carers and next of kin can read information on their drugs. It all lends to the correct and safe use of medicines.
There is a perception that reporting rates are very low in Ireland and across Europe. However, Ireland is one of the seven leading countries in the world for the reporting of adverse reactions to pharmaceuticals. We know this from the WHO reporting programmes. Approximately 90 countries contribute to the WHO reporting system. Since 1968 Ireland, through Dr. Scott, was one of the first countries to report to the programme. Last year, the WHO considered Ireland to be one of the top seven countries for reporting. Over the past 30 years, we have entered over 30,000 adverse drug reaction reports to the database. In 2005, over 1,800 reactions were reported to the board. Approximately 40% were from pharmaceutical companies while the remaining 60% were from our doctors, health care professionals, hospitals, community doctors and general practitioners.
We like to think this reporting rate is good because we actively encourage health care professionals to report to us. We assess and follow-up each adverse reaction with health care professionals. We monitor and assess the reaction reports and implement any safety related regulatory action that we deem necessary. This may include changing the summary of product characteristics to include the new side effect, to make a new counter indication, to add a new precaution or warning or to restrict it from being a first-line treatment. One should use the safer medicinal products first before using the stronger ones. We communicate with the EU, the WHO, the pharmaceutical companies and, most importantly, the health care providers and professionals.
Communication is an important part of the board's job. Most members of the sub-committee will have seen our drug safety newsletter. We issue it three to four times a year to update health care professionals on hot topics and latest safety issues. We produce monthly articles in MIMS. We met recently with the Irish Medical Times to arrange for these articles from MIMS to be transposed to its publications. Most health care professionals will browse the Irish Medical Times every week. We publish articles on our website. In the past two years, we have issued up to 100 press statements on different issues.
The sale of medicines over the Internet is a subject close to our hearts. Apart from it being illegal to both sell and buy medicines over the Internet, we see it as a highly dangerous practice. In 2005 we issued 31 press articles and radio broadcasts and 20 so far in 2006. This is the tip of the iceberg. We have discussed with the Department of Health and Children how an education programme delivered through the health promotion unit might provide a way forward. Apart from its being illegal, I stress on my radio broadcasts that one has no idea of the quality, safety or effectiveness of the product. One may be buying it cheaper, but one has no idea what one is buying, meaning that it is ultimately a very dangerous practice.
There are also the "Dear health care professional" letters that one receives on safety issues. Approximately one every week or fortnight is sent by the various companies on safety issues. They all come through the Irish Medicines Board, since we instruct the companies to issue them to highlight important safety information to emerge regarding the product in question. The details of such letters are agreed by the IMB, and companies are not allowed to send them until we have done so. We advise the pharmaceutical companies on distribution. For example, if it is a rheumatology product, the letter will probably go to GPs and rheumatologists — whatever the right place is.
We make as many presentations as possible to health care professionals at an undergraduate level in medical and pharmaceutical schools, and at postgraduate level, to urge increased knowledge and reporting of adverse reactions to drugs. We see ourselves as one link in a chain forming a strong public health system.
We work very closely with the Department of Health and Children. I will not go through the list, except to say that I am a member of the national immunisation advisory committee, the board of the National Medicines Information Centre, the anti-doping committee of the Sports Council and the flu pandemic experts group. I bring expertise from the Irish Medicines Board regarding medicines in the area to those specific committees, just as I depend on people in various areas to assist our day-to-day work.
We liaise very closely at an international level. Hardly a day passes without one of our staff being at a meeting of the European Medicines Agency representing the Irish Medicines Board. We participate very closely in the WHO programme. We have an agreement with the Food and Drug Administration on the rapid exchange of information. If something hits the press in the United States, and the FDA is to release a statement, we know about it. From an international perspective, we collaborate very closely through the international conference on harmonisation to forge agreement on scientific and regulatory issues.
I will not delay the committee any longer. The Irish Medicines Board and its predecessor, the National Drugs Advisory Board, have a long history of licensing medicinal products. We have a structure that actively monitors medicinal products throughout their life cycle. The clock never stays still; we simply await the next telephone call regarding an adverse drug reaction. We will continue to develop systems and procedures to meet new and evolving needs. I thank the Chairman.
I thank Dr. Gilvarry for that comprehensive presentation. She said that Dr. Buckley would comment briefly on statins.
Dr. Brendan Buckley
The summary of product characteristics and sample package leaflet clarify the indications to the prescribing doctor and the patient being prescribed the drugs. There are debates and popular discussions in medicine regarding cholesterol, but regulation of the drugs and how they are to be prescribed is very clear from the licence as expressed in the summary of product characteristics. The second check is that the patient can see from the product leaflet in the box containing the tablets whether he or she should be on them. Statins are an example of a medicine in very wide use but clearly constrained in its licence through what is described in the product characteristics.
Several members have questions. We will bank several questions before the witnesses answer, the same pattern that we used previously.
I welcome the IMB delegates and I have a number of short questions. Does the IMB feel there is a need to regulate everything sold in the country that is not described as a food product? Should every form of medicinal product be regulated by the Irish Medicines Board? An enormous number of products are not regulated. From the sub-committee's viewpoint this cropped up recently in that mushrooms were being sold which had the same properties as "magic mushrooms".
We have also heard of a drug on the market being sold as a stimulant which has the same properties as ecstasy. Should there be a regulation for everything that is being sold which may in any way be described as either medicinal or potentially medicinal? Have the IMB representatives read the House of Commons report, The Influence of the Pharmaceutical Industry, published by its health committee two years ago, which dealt with adverse drug reactions? Was the union asked to make any official response to that report?
If there is a programme on television that covers these types of topics, such as "Panorama" which dealt with SSRIs, does the IMB examine such findings to see whether any issues are raised with which it should deal? Harmonisation across the world was mentioned and sometimes the Food and Drug Administration, the US equivalent of the IMB, is accused of not having sufficient resources or links with other organisations to do its job properly. Too often it is forced to fall back on data given to it by pharmaceutical companies in making its decisions. I wonder whether the IMB believes harmonisation with the rest of Europe, let alone with the rest of the world, needs to be moved on at a faster pace in order that patients may have confidence that the regulator market is working in their favour.
The risk-benefits referred to and how they compare over time is a very interesting concept. Most adverse reactions to drugs occur in the post-licensing phase when patients are taking them in significant numbers. An issue was raised before as regards clinical trials and we see this cropping up again. It is even happening in the movies, where clinical trials are being organised and structured in Third World countries. Some of these trials can be manipulated in order to get the results the pharmaceutical companies want. Is there any way pharmaceutical companies across the world can register their drug trials before they begin? In other words, unless registration is in place for a drug trial before it starts it should not be recognised at all. That would probably prevent trials from being manipulated. It would mean a bad trial could be dropped and forgotten about while a good one would be heavily promoted. Trials should be licensed before they start so that we may look for the results after a certain period of time to see precisely what has happened.
The post-market surveillance, as referred to, is where most adverse drug reactions arise. One of the interesting features of the presentation was the fact that around 1,800 adverse drug reactions were reported in 2005. Millions of prescriptions are written every year for drugs, some of which produce adverse reactions. Could the IMB give us a breakdown of these reactions? There are a number of doctors on this committee as well as people who have been involved with the health services. We are aware of warfarin and strokes, as I have already pointed out, gastrointestinal bleeding from non-steroidal drugs and so on. However, could we have a breakdown of the 1,800 cases reported to the union? How many of them are different? How many are major and how many would be considered minor? It is not minor for a patient to get certain unpleasant side effects such as nausea and dizziness, but that is not the same as a case where someone experiences a significant adverse medical outcome from a drug reaction.
I thank the delegates for their detailed explanation of the structure and functions of the Irish Medicines Board. They are well aware of the purpose of this sub-committee. We are looking to the future in hoping to make recommendations on how best to identify and limit the potential side effects of pharmaceuticals. Even with the best will in the world side effects are inevitable at some stage. Our job is to identify those side effects.
Dr. Gilvarry showed us a table giving a breakdown of reports of adverse side effects by source in 2005. It struck me that there was no report from a member of the general public, that is, from a person who may have suffered such side effects. Does the Irish Medicines Board have any suggestion as to how the public could be encouraged to make reports? I do not envisage a situation where the board would be inundated with every perceived side effect. However, it is members of the public who will first experience any such side effects. One assumes patients will report those effects to a medical professional but we cannot be sure the latter will always pass that information to the board. Is there a need for some type of campaign to encourage the public to make such reports?
I thank Dr. Gilvarry for her lucid presentation. I read the board's drug safety leaflets, as well as its articles in MIMS, and find them extremely well presented. I hope everybody reads them. I was pleased to hear Dr. Buckley speaking about the importance of first trying non-pharmacological methods. The example he gave in regard to statins is topical. The Irish Medicines Board makes the point in its drug safety leaflets, in the EU cardiovascular recommendations and in its MIMS articles that medical practitioners should begin by advising a change of lifestyle and, where the patient does not comply, to repeat that advice. I find it extraordinary that patients who have been prescribed statins, for example, including those patients who are not diabetics or have not suffered a coronary attack, rarely seem to have been given this initial advice. I hope the 45% of farmers tested at the national ploughing championship and found to have high cholesterol are not now gobbling up statins.
Does the Irish Medicines Board ever seek to discover whether notice is taken of its drug safety leaflets? A positive aspect of these leaflets is that they do not contain too much information. One is not tortured by reading after reaching the end. I have read that only 50% of the medical profession has a history of reporting adverse drug reactions. Does the Irish Medicines Board ever contact the 50% who have never made any such reports? It would be extremely unusual for a doctor never to have encountered a patient who suffered an adverse reaction to a drug.
I understand fewer clinical trials are being undertaken in Ireland. Is this of any consequence? Does it mean the medical profession in general will be at a disadvantage through having less experience of dealing with such trials?
I am pleased Dr. Gilvarry mentioned Dr. Aileen Scott. I knew Dr. Scott well and she did admirable work in encouraging pharmacological vigilance in this country many years ago.
How does the Irish Medicines Board legislate for the performance of clinical trials on children? How does it deal with the issue of informed consent in regard to persons younger than 18 years of age? Is there a financial inducement for parents to put their child forward for a clinical trial? We recently heard news about a vaccine for cervical cancer, which would be administered to young girls. I have read many worrying stories about deaths related to this vaccine in the US. Could Dr. Gilvarry comment on this issue?
Is there any licensing in respect of herbal products? This was a point made by Deputy Twomey. If a herbal medicine is on sale and on the shelves, does any licensing authority exist that would examine claims on the label? Dr. Gilvarry stated earlier that every drug has a potential side effect and that there is a balance of risks. Does this same risk apply or do all herbal remedies have potential side effects? Are any good and genuine medications for sale on the Internet? This is a major problem.
I strongly support Deputy Devins's comments about reporting by members of the general public. His comments pretty much stole my thunder but I will repeat them if only to underline and support them. Somebody very close to home who took a preparation for cholesterol experienced certain side effects which I am not so sure are in the general run of things. I will probably report these side effects to the Irish Pharmaceutical Union.
Touching again on non-established or herbal medicines and what is available on the Internet — an area about which I feel strongly — is there any random testing of these preparations? As I said to the previous delegation, I am reliably informed that additives are added to these preparations to give them greater effect in order to con the people who are buying them into believing that they are superior to established prescribed medications.
Dr. Gilvarry
I once again have the floor and have many questions to answer. I will go down through them and try to answer them as best I can. Every medicine should be regulated. However, we must have a legislative basis if we are to regulate a medicine. If we pursue a course of action for which we have no remit or legislative backing, we will get our fingers burnt very quickly and be informed of this by whoever we go after. We have a remit in respect of licensed medicinal products and clinical trials in Ireland so that is as far as it goes. Products such as magic mushrooms should be regulated.
I read the UK report on adverse drug reactions with interest. A number of other issues concerning mandatory reporting by health care professionals of adverse drug reactions arose in some of Deputy Twomey's other questions. We do not need mandatory reporting given the system in Ireland and the fact that it is one of the seven top countries in the world. Our health care professionals are very good and astute at reporting these adverse reactions to us. Enforcing such reporting will not necessarily lead to better results. France and Sweden have introduced mandatory reporting but the incidence of adverse reaction reports has not increased. If we wanted to introduce mandatory reporting, we would find it next to impossible to enforce. I cannot visit a GP's surgery and ask him or her whether he or she has encountered an adverse reaction to a particular drug and the reason he or she did not report to us because it is down to the GP's clinical expertise and his or her decision as to whether an adverse drug reaction took place.
Questions were asked regarding reporting by members of the public. Reporting by members of the public is very important and we welcome it. However, it is also very important to follow up that adverse reaction report with the health care professional mainly in the interests of the patient so that we can get further information on the medical history, the other concommitant medications that patient was on and any other factors that may have contributed to that adverse drug reaction. The Irish Medicines Board must also let the doctor, nurse or pharmacist of the patient who reported to us, know that the patient had an adverse reaction. While health care professionals and not the Irish Medicines Board should deal with the health care of members of the public, we accept reports from the public.
Does the Irish Medicines Board communicate with the patients involved in all of the reported adverse drug reactions? If a general practitioner sends in the form, does the board communicate with the person involved?
Dr. Gilvarry
Not necessarily. If a patient reports to us, we always ask his or her permission to approach the GP to get follow-up information. By the nature of the process, we are normally in contact with patients because they want to find out more about their adverse reactions, namely, how many other people experienced them, what will the board do about the matter and so on. Rarely do patients report to us and forget about it.
A way around the issue would be for the board to send a letter of acknowledgement to the person affected if an adverse drug reaction is reported. The person will then know that the adverse reaction has been reported and the extra detail referred to by Dr. Gilvarry would also have been achieved because the patient will have gone to the health care professional.
Dr. Gilvarry
I take the Deputy's point, but much of the information sent to us is confidential. For example, the patient's initials might be given to us, but we might not have his or her full details. We do not necessarily want those details. We are not interested in Joe Soap who has experienced a reaction. Rather, we are interested in Mr. X who has experienced it and whether we can do something about the case. We are not interested in Mrs. O'Grady from a specific street in a specific town. No health care professional would want us to go back to his or her patients saying his or her doctor had reported the reaction to us, but the matter is worth examining.
How many adverse reaction reports has the board received from members of the public directly?
Dr. Gilvarry
I cannot give the Deputy an answer off the top of my head, but approximately 100.
We will take supplementary questions afterwards.
I apologise.
Dr. Gilvarry
On the FDA and collaboration, we collaborate well with other EU member states under the co-ordination of the European Medicines Agency, which has scientific committees in which our experts participate. We not only get the expertise of 100 Irish experts, but we also get the expertise of 3,000 to 4,000 European experts. We have our fingers on the button where European expertise and harmonisation are concerned. If anything, we are overharmonised.
Members asked a number of questions about whether the numbers in respect of clinical trials are decreasing. Thankfully, that is not the case. We license approximately 120 clinical trials per year. I take Deputy Twomey's point regarding clinical trials moving to southern European countries and perhaps India. While this may be owing to a lack of regulation therein, it could burn the pharmaceutical companies because they need clinical trials when they apply to us for licences for medicinal products. The trials must be conducted in accordance with international standards of good clinical practice and monitored by us. If the trials have not been conducted in that way, they will not be accepted as part of the companies' drug licence applications.
A database of all clinical trials undertaken in European has been set up in the European Medicines Agency. Health care professionals can access it and see what research has been conducted. That is an additional database.
A member asked about post-marketing surveillance and the adverse drug reactions over the past number of years. I cannot say that we have seen every reaction but we do not necessarily need to do so. The majority of reactions we have seen are to newer drugs and we have asked to be notified of these reactions. Any adverse reactions to a new drug that has come to market in the past two years should be reported to us, as should cases where there is infrequency in minor adverse reactions with established agents, adverse reactions to the use of vaccines and suspected teratogenic effects. By and large, these are the cases of which we are notified.
The member refers to bleeding from non-steroidals. We know about this but we are interested in hearing about further details. It may add to the database on a particular non-steroidal rather than non-steroidals as a class. By and large, there are reactions to newer agents and, in increasing frequency, to established agents.
I referred to the general public and the reporting of adverse drug reactions, ADRs. The committee may be aware of a recent EU directive and legislation concerning drugs and children. It provides extra exclusivity to the pharmaceutical industry in return for clinical research on children. Much research is being carried out on children, which is a positive step. It is always under the control of a consultant paediatrician. In children of the five to eight and eight to 11 age groups, a child-specific patient information leaflet is available with each clinical trial. In this way, the child can give consent to the clinical trial. In the case of a neonate, we depend on the parents or guardians. Our guidelines recommend that the child be asked for permission if possible. In the interests of the children of the country I hope to see an increase in clinical trials using children, which is more likely after the passing of the legislation at European level.
The vaccine for cervical cancer has only recently been licensed, on 5 October in the EU. The centralised procedure was used, in that the Commission licensed it for the 25 member states. The HSE will decide if it is to be introduced into the national immunisation campaign, on the recommendation of the national immunisation advisory committee, of which I am a member. That matter will be discussed in the next few weeks. From the evidence I have seen to date, the cause of deaths during the trial cannot be directly related to the vaccine. A second application has been made for a cervical cancer vaccine. We expect it to be processed by the end of 2007.
There has been much discussion of herbal medicinal products. There is no one checking the contents of these bottles. The Irish Medicines Board will become the competent authority for herbal and medicinal products but we await the legislative basis for that. We have set up an expert committee. As soon as we make progress, we will be able to guarantee that claims made on product packaging are accurate. Any known side effects will be made available. This area needs to be regulated.
Regarding Internet sales, the Irish Medicines Board analysed many of the seizures made by our enforcement officers. It is difficult to do so because while we can verify whether a package marked "testosterone" contains that, if it does not it is more difficult to establish what it is. We must consider some 150 products that it might be. In the top ten, based on cost, one might find the answer rather than having to check 30 without success. God only knows what is contained in products sold over the Internet, which is an illegal practice. Enforcement officers have closed down ten sites, informed patients on numerous occasions and worked closely with Customs and Excise and the Garda Síochána. It is the tip of the iceberg. One can buy anything on the Internet, including medicines. However, it is extremely unsafe to buy medicines on the Internet. We would welcome anything the committee can do to help us in this campaign.
I believe I handled most of the questions.
I believe Dr. Gilvarry has given extremely comprehensive responses. Do members have any further queries?
People buy certain drugs over the Internet which come in the same packaging as is used in Ireland. One must assume they come from the same drug company and according to rumour they are far cheaper. Is it Dr. Gilvarry's experience that a particular drug bought over the Internet from another country is the same as the drug on sale in Ireland, or is it a counterfeit?
We will take one question each from other members.
Dr. Gilvarry said it all when she answered my question on random testing. She stated in a number of cases the product does not match what the packaging states it contains. If the general public does not get that message from our friends in the media we are all wasting our time.
I wish to return to concerns about the FDA being adequately resourced to conduct a proper audit on clinical trials in pharmaceutical companies. Is that concern genuine? We receive many items of correspondence, some of which indicate that if clinical trials were examined before licences were awarded, some of the difficulties found in post-marketing surveillance would be discovered as they are apparent already at that stage. As most of this relates to the United States, it indicates the FDA does not have sufficient resources. I feel the FDA has far superior resources than most national bodies, such as the Irish Medicines Board. Will Dr. Gilvarry comment on the existence of a need for more resources and staff? Dr. Gilvarry previously stated the Irish Medicines Board is already well staffed and doing a good job and that we do not have a serious problem in Ireland.
Dr. Gilvarry
To return to the first question, companies receive a great deal of bad publicity about Internet sales. However, I do not believe they are behind the Internet sales of their products. It is in their interest to ensure their medicines are sold correctly to patients.
I did not think the companies were behind it. I meant a situation whereby a product is advertised in another jurisdiction and initially appears to be considerably cheaper than it is here. People tell me they bought a drug with the same packaging and company name as one which is available here. Is it the same drug or a counterfeit? Does Dr. Gilvarry have any experience of this issue?
Dr. Gilvarry
More than likely it is not the same drug. It is probably cheaper which is great when one buys a bag of sugar. However, if one buys a product which will cause a severe adverse reaction it is not cheaper as it may pose a risk to one's life. Most of the products we tested are not what they are stated to be and it is a problem.
I would be loth to discuss the staffing levels of a sister agency, particularly the FDA. All I will state is that I thank our board which has been extremely generous to us over the past number of years. I agree completely with Deputy Twomey that the job cannot be done without resources being made available because staff are too stretched. I took over as medical director in 2000, when the board had three medical officers and approximately ten pharmaceutical assessors. We now have a staff of approximately 100 and I would like more. When we have to deal with herbal medicinal problems and products I will ask the board for many more staff.
We have had a very useful afternoon. I thank the delegation for its responses and presentation, which were very comprehensive.