I welcome Dr. Orla O'Donovan who will make a presentation on the adverse side effects of pharmaceuticals. Before she commences, I draw her attention to the fact that members of the sub-committee have absolute privilege but that this same privilege does not apply to witnesses appearing before the sub-committee. The presentation appears to be substantial. We will read it in its entirety and take it on board. However, I encourage Dr. O'Donovan to synopsise it in ten minutes so as to allow time for members to ask questions.
Dr. Orla O’Donovan and Dr. Martin Henman: Presentations:
Dr. Orla O’Donovan
I thank the members of the sub-committee for inviting me to participate in these public discussions about the adverse side effects of pharmaceuticals. As a citizen and someone who teaches and undertakes research on the politics of health policy, I welcome the establishment of the sub-committee and hope it will contribute to the opening up of drug regulation policy in Ireland to greater public scrutiny and debate. The establishment of the sub-committee is significant, as it gives public recognition to the concerns of many individuals and groups, especially mental health movement activists who have lobbied for greater acknowledgement of the potential harmful effects of pharmaceuticals and changes in how the pharmaceutical industry is regulated.
Dramatic increases in recent years in the consumption of pharmaceutical industry products in Ireland, both drugs and marketing messages, give added urgency to the deliberations of the sub-committee. A further reason its deliberations are important is the extent of the reliance of the economy on the pharmaceutical industry. Currently, 83 foreign-owned pharmaceutical companies have bases in Ireland, including 14 of the world's largest 15 pharmaceutical corporations. In 2005, 44% of the country's annual exports were pharmaceutical industry products. Despite the growing centrality of pharmaceuticals to the health care system and this economic dependency on the industry, there has been remarkably little public debate about this increasingly important aspect of health and regulatory policy. Public scrutiny, including the kind of social research I undertake, is hampered by the secrecy that pervades drug regulation agencies and freedom of information law that privileges commercial interests over citizens' rights to know. I hope the work of the sub-committee will contribute to an opening up of this obscure realm of policy-making.
I wish to focus on five issues concerning the adverse side effects of pharmaceuticals. First, there is a need for a fundamental reorientation in the drug regulation system to redress the current imbalance between post-marketing pharmacovigilance and the speedy licensing of medicines. Even though pharmacovigilance generates superior drug safety information, it is very much the poor relation of product authorisation in the current drug regulation system. The limitations of pre-marketing clinical trials are clearly evident in the fact that in the case of 50% of new drugs serious adverse drug reactions are detected following market approval. The imbalance between pre-marketing and post-marketing drug surveillance is a feature of many regulatory agencies. A recent report commissioned by the European Commission on member state regulatory agencies found that the median proportion of pharmacovigilance staff was only 5% of total agency staff.
If we examine the history of drug regulation in Ireland, two shifts in the definition of the role of the State in protecting the public from unsafe medicines can be discerned. First, the State shifted from a Pontius Pilate, "it has nothing to do with us", official attitude at the time of the thalidomide drug disaster to the establishment in 1966 of the National Drugs Advisory Board, NDAB, and a severely under-resourced and, consequently, largely ineffective regulatory system. Despite its shortcomings, the NDAB's primary function was pharmacovigilance, that is, monitoring reports of suspected negative side effects of medicines.
The pharmacovigilance aspect of the work of the NDAB was, however, seriously hindered by the lack of reporting of adverse drug reactions, ADRs, by health professionals. In 1981, the NDAB estimated that only approximately 5% of ADRs occurring in general hospitals were reported and almost none from maternity and psychiatric hospitals. In 1995, during a debate in the Seanad on the Irish Medicines Board Act, Senator Henry, a member of the sub-committee, addressed what she referred to as the "gross under-reporting" of ADRs and expressed the hope the establishment of the Irish Medicines Board would contribute to rectifying it. There is little evidence to suggest this happened.
The second major shift in medicine regulatory policy involved the establishment of the Irish Medicines Board in 1995, which constituted a move to an industry-funded drug regulation system principally concerned with the industry priority of speedy drug licensing which enables the marketing of pharmaceuticals as quickly as possible. This second development involved a new mode of regulation, a shift from hands-off regulation to regulation for competition.
While pharmacovigilance never rose to the top of the drug regulation policy agenda, the industry priority of accelerating the product authorisation process did. By January 2002, the backlog of product authorisation applications had been reduced to 325, from 2,097 in 1986. In 1999, the median time for new product authorisations was 73 weeks. By 2004, it was down to 34 weeks. As a result of this increased efficiency, 7,887 products are listed on the IMB's list of authorised medicines on the market for human use.
What is remarkable about the prioritisation of the backlog issue is the virtual absence of evidence that policymakers critically questioned its causes and consequences for public health. Apart from a few exceptions, the explosion in the number of drugs queuing up to go on the Irish market and the dramatic escalation of public spending on health have not been questioned. By and large, the equating of more drugs with better health is accepted.
An examination of the parliamentary debates around the time of the establishment of the IMB reveals the backlog was almost invariably discussed with reference to the importance of the pharmaceutical industry to the economy and the industry's disquiet about delays in getting its products onto the market. Commentators such as the former editor of the New England Journal of Medicine, Dr. Marcia Angell, contend many of the plethora of medicines now available are only “me too” drugs, copies of existing drugs on the market, and that many others, particularly so-called “lifestyle drugs” used in the treatment of recently medicalised conditions, are of dubious benefit.
In recent years drug regulation policy witnessed measures serving the commercial interests of the pharmaceutical industry rising to the top of the policy agenda in a way measures protecting public health did not. This imbalance, whereby the imperatives of what has come to be known as "economic competitiveness" are prioritised over public health, must be redressed. A rigorous publicly-funded system of post-marketing pharmacovigilance must be put in place. Strong arguments can be made for having a separate agency with responsibility for pharmacovigilance activities, as there are obvious tensions when the same agency approves drugs for marketing and takes responsibility for monitoring their safety in practice. In redressing the current imbalance in the regulatory system the conflicts of interests between health and trade imperatives must be recognised. Pharmacovigilance must be framed first and foremost as a health policy concern, unlike, for example, in the European Commission where responsibility for European drug regulation is assumed by DG Enterprise.
The second issue I wish to address is the need for a transparent system of pharmacovigilance, whereby members of the public can access details of ADR reporting and follow-up, as well as the decision-making process on drug safety issues. In principle, information available within regulatory agencies should be freely available to the public. In this regard, members of the sub-committee may be interested in pursuing full implementation of the 2004 EU directive on the Community code relating to medicinal products for human use, which stipulates that member states shall ensure: the competent authority makes publicly accessible its rules of procedure and those of its committees; agendas for and records of its meetings; decisions taken; and details and explanations of votes, including minority opinions.
The next point I wish to make is that under-reporting of adverse drug reactions poses a serious problem to ensuring the safety of medicines. Such reporting is also crucial to our understanding of the level and cost of iatrogenic illness caused by the consumption of pharmaceuticals.
There is little evidence that the gross under-reporting of ADRs has been redressed by the IMB. The number of ADRs reported to it decreased between 2001 and 2002 and again between 2002 and 2003. In 2004 it received 1,727 ADR reports, a very small number considering that somewhere between 1% and 10% of administrations of medicines are thought to result in an ADR, that over 2,500 general practitioners are prescribing to at least 100 patients per week and that many of these are receiving more than one medicine. Only 277 reports were submitted by general practitioners in 2004, indicating that one in ten on average submits one ADR report per annum. Hospital doctors, of whom there are approximately 4,000, made even fewer reports. Therefore, assuming every report comes from a different doctor, it appears that fewer than 4% of doctors make one report per year. These figures suggest the rate of reporting ADRs may now be even worse than in the days of the National Drugs Advisory Board. The moral obligation on health professionals to report adverse drug reactions needs to be emphasised, not financial incentives. Ways of stimulating adverse drug reaction reporting that have been found to be effective include educating health professionals on the importance of reports, familiarising them with the reporting system and providing them with a follow-up on the reports they submit.
It is not possible for members of the public to submit an adverse drug reaction report to the IMB but there are growing demands internationally for reporting systems that allow for direct reporting by members of the public. As noted in a report from Health Action International Europe, a copy of which I submitted to the sub-committee, the motivations behind a system of direct reporting are, first, that pharmacovigilance systems will be more effective if reports by members of the public are included and, second, that allowing members of the public to report demonstrates a necessary attitudinal change towards members of the public who are marginalised in the pharmacovigilance system. There are a number of systems of direct reporting in operation in Europe which could perhaps provide models to inform the establishment of such a system in Ireland.
The fourth issue is the need to stem the blurring of the boundaries between drug promotion and health information and to resist moves to lift the ban on direct to consumer advertising. Members of the public are increasingly exposed to marketing messages from the pharmaceutical industry. This has been shown to lead to over-medicalisation and inappropriate consumption of medicines. In Ireland, as elsewhere, the boundaries between health information and marketing have been blurred. A clear distinction needs to be drawn between health information and advertising that masquerades as health information. The role of the pharmaceutical industry in the provision of health information needs to be restricted because of conflicts of interest. Companies cannot provide unbiased comparative information on medicines or non-drug treatment alternatives.
The blurring of boundaries is evident in the continuing education of health professionals which relies heavily on drug company sponsorship and in the activities of many patients' organisations. A recent study in which I was involved found that almost half of 112 Irish patients' organisations surveyed had received sponsorship from drug companies and that this was frequently provided for educational activities. A recent and highly inappropriate way in which the industry is promoting brand recognition and casting a role for itself as an educator is through its involvement in schools' health education activities. An example of such a venture is the Way2Go programme, sponsored by Pfizer, that operates in all secondary schools. Surely school health education should not have to rely on sponsorship from pharmaceutical companies which are eager to promote an image of themselves as philanthropic entities, while at the same time accumulating vast profits and engaging in trade and pricing practices in so-called Third World countries that deny millions of people access to essential medicines. The chairperson of the Irish College of General Practitioners has indicated that he regards the rise of industry-funded health education campaigns as the thin end of the wedge in the introduction of direct to consumer advertising.
Despite the failure of efforts to remove the EU ban on direct to consumer advertising in 2002, the establishment this year of the European Commission's Pharmaceutical Forum signals a renewal of efforts to allow the pharmaceutical industry play a greater role in the provision for the public of what it refers to as "medicines information". I will circulate a joint declaration from a number of health consumer organisations which oppose this move. It calls for an end to the confusion of roles in the provision of information on medicines. Drug companies' roles in this respect should be confined to the provision of clear labelling and informative patient information leaflets with their products.
I call for an extension of the important work of the sub-committee in a way that will instigate a more wide-ranging and extensive public debate about regulation of pharmaceutical companies and the pharmaceutical industry. The sub-committee only received 16 submissions, while its public hearings will be completed over four afternoons. This is a modest affair when compared, for example, with the public consultations undertaken by the Canadian standing committee on health which reported in 2004 and the British House of Commons committee on the influence of the pharmaceutical industry which reported in 2005.
I would like to read a salutary quotation from the final report of the House of Commons committee in which its conclusions in respect of the British equivalent of the IMB are outlined:
During this long inquiry we became aware of serious weaknesses in the MHRA [Medicines and Healthcare Products Regulatory Agency]. Worryingly, in both its written and oral evidence the agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The agency's attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs.
When such a damning assessment is made in respect of such a well resourced agency as the MHRA, is it not appropriate that provision be made to inquire if the same is true of the IMB?
I thank Dr. O'Donovan for her extensive report. We have dealt with and have copies of the House of Commons report, The Influence of the Pharmaceutical Industry, which we intend to examine. We have looked at the possibility of extending the time available to us for investigating the side effects of pharmaceuticals. We will take questions from each member in turn.
It is worrying reading the submission and listening to the witness, as there is no doubt sales considerations have taken precedence over public health. It is reported on page 3 of the submission that "In 1981 the NDAB estimated that only about 5% of ADRs occurring in general hospitals were being reported and almost none from maternity and psychiatric hospitals". That is outrageous and I have reason for saying so. It is stated on page 4, "While pharmacovigilance never rose to the top of the drug regulation policy agenda, the industry priority of accelerating the product authorisation process did". In other words, the sale of pharmaceutical products has won over the health of those who take them. In most, if not all, cases the drugs were prescribed.
Apart from what the witness said in her well presented submission, what does she think can be done? The reporting method must come into focus. I strongly support the concept of input from members of the public. Why should consumers not be allowed to have an input? Those taking the drugs should be entitled to give a first-hand account of how they impact on them. Something is seriously wrong.
We have the House of Commons report. I have remarked that three quarters of Nottingham Forest must have been employed in providing it. I received my copy in the post only yesterday and will read it.
Another point I want to make concerns the input of the drug companies to the distribution of workbooks and videos to all secondary schools. I believe that is unethical. I do not think drug companies should be doing this, or that it is their business to do so. This should be done by the Department of Education and Science in tandem with the Department of Health and Children. How can this practice, which I do not believe to be right or ethical, be discontinued? How can we involve health professionals? I have underlined Dr. O'Donovan's statement to the effect that health professionals should be able to make an input into reporting. She states: "The limitations of pre-marketing clinical trials are clearly evident in the fact that in 50% of new drugs, serious adverse drug reactions are detected following market approval."
Everything becomes evident when drugs are on the market for a period of time. Is Dr. O'Donovan saying, in effect, that the pre-trials that take place are grossly inadequate, because that is certainly what is coming across to me? If that is the case, it is extremely worrying.
I thank Dr. O'Donovan for her excellent presentation. I shall start where Senator Glynn has left off, concerning drug trials. Has there a reduction in the length of drug trials and in the numbers of people involved? Most drug trials now seem to be multi-centred. Unfortunately, the results are sent into the drug companies, where they are written up in-house. I wonder whether, if this practice is as widespread as I believe it is, it has repercussions for pharmacovigilance, since part of the trial is conducted among the general public after the drug has been approved. The length of time for the production of a drug from the bench to when it is on sale to the general public has come down from 20 years to 12 years. Something must be happening because people must be on drugs for a certain length of time for adverse side effects to be seen.
Dr. Marcia Angell has always been a heroine of mine. Dr. O'Donovan may recall when Dr. Angell was editor of the New England Journal of Medicine she said at one stage she would not publish any more articles on new drugs if those involved in the drug trials had more than a certain financial interest in their manufacture. After about two years she had to back down on that policy because she could find no trials that did not have a problem with this stipulation.
I have told the committee about this already. Has Dr. O'Donovan seen the report in the Irish Medical News by Mr. John Caird et al. of Beaumont Hospital about intercranial and spinal bleeding in people who were on aspirin? Some 75 mg. of aspirin has to be prescribed, but a very large number of the people on anticoagulants who presented over a three-month period were listed because they thought that, internationally, this was becoming a problem. While all those people were on warfarin, for very good reasons, a large proportion, some 43% of those on aspirin, without much of a medical indication as to why they were taking it, experienced this very serious side effect. Obviously the people taking it thought it was of little consequence.
The situation as regards selling direct to the public is becoming very dodgy. Again this involves Pfizer, which is a very good company, a fine employer and so forth. I have written about this issue in the Irish Medical News. Was it suitable for Pfizer to run the health survey at the ploughing championships, where 45% of those screened were diagnosed as having raised cholesterol levels? These could not have been fasting cholesterol levels. At the same time, they give advice on radio on what cholesterol levels should be. They are the largest makers of statins and were advising that cholesterol levels should be under 5. It is not until the end of the advertisement that they announce the advertisement is sponsored by Pfizer. Like Senator Glynn who expressed concern about health education in schools, we must express concerns about biodrug companies. It is a potent drug and a big seller but it has serious adverse side effects. The EU cardiovascular strategy states doctors should advise a change in lifestyle before prescribing anti-cholesterol drugs.
We take this presentation seriously. It is most worrying. Dr. O'Donovan can be sure we will address the situation.
I thank Dr. O'Donovan for her thought provoking presentation. She states, "Public scrutiny, including the kind of social research I undertake, is hampered by the secrecy that pervades drug regulation agencies". I presume she refers to the Irish Medicines Board. Perhaps she can explain this comment.
Dr. O'Donovan states, "The limitations of pre-marketing clinical trials are clearly evident in the fact that in the case of 50% of new drugs serious adverse drug reactions are detected following market approval". She cites an article in The Medical Journal of Australia by Elizabeth Roughead and Joel Lexchin in support of this. Could she supply the sub-committee with a copy of that report and any others that back up such claims? I find the claim alarming and very surprising.
Dr. O'Donovan refers to major differences between the IMB and its precursor, the NDAB. Representatives of the IMB appeared before the sub-committee last week. Perhaps Dr. O'Donovan was confused — she states it is not possible for members of the public to submit an adverse drug reaction report to the IMB. From our conversation with representatives of the IMB, I believe it is.
I agree that greater reporting by members of the public and health professionals should be encouraged. Dr. O'Donovan refers to a journal report from Canada on how this might be achieved. In reality, it may be difficult to achieve.
I thank Dr. O'Donovan. It would have been better if we had heard her presentation before last week's meeting to enable us to put further questions to the IMB. It is hard to believe the number reporting decreased between 2001 and 2003 as now more than ever people are more vigilant about their health. They are aware of Internet prescribing and sometimes look up the components of drugs they are taking. I found it difficult to understand this, although I do not say I disbelieve it.
Dr. O'Donovan says the Irish Medicines Board received 1,727 adverse drug reaction reports, which is a small number. Does she think people are simply not bothering to report, through inaction or other reasons, or does she believe the general public is not familiar with the role of the Irish Medicines Board? Does the IMB need more advertising to educate the public as to its needs? As a former member of the Medical Council, there was a time when the general public did not know what the council was about or that it could complain about a consultant or other doctor directly to it.
Like Deputy Devins, I understood from the Irish Medicines Board's presentation to the sub-committee last week that people could report directly to it. I was surprised to hear today that this course was not open to members of the public. I support the growing international demand for a reporting system for the general public. When the sub-committee is compiling a report, we should look at this matter. From my experience on the Medical Council, I know that when members of the public go to the trouble of writing to make a complaint, they have serious concerns which are playing on their minds and they are compelled to commit to paper. People will not complain willy nilly. Therefore, whatever is reported must be taken seriously.
The figures suggest the rate of reporting of ADRs is even worse than in the days of the National Drugs Advisory Board. Why is this and what can the sub-committee do about it?
Reference has been made to Mental Health Movement activists. We received two presentations from the Mental Health Movement. They were concerned about the prescribing of medicines. It is important to say people who worked in the mental health services in the 1950s say medicines made a great difference to the quality of life of patients at the time. Nevertheless, there may now be a tendency to over-prescribe, while other therapies such as counselling are not sufficiently resourced.
Deputy Devins raised the matter of public scrutiny. I share his concerns and would like to hear Dr. O'Donovan's comments on that matter.
Dr. O'Donovan says the National Drugs Advisory Board was severely under-resourced. Is that still the situation? She tells us that only 5% of ADRs occurring in general hospitals were reported in 1981, and none from the maternity and psychiatric services. I do not know what the sub-committee can do about this, other than to appeal to doctors to inform the proper authorities about adverse side effects.
A presentation to the sub-committee referred to a pilot programme carried out in a Dublin hospital when a financial incentive was given to doctors to report. The number of reported adverse reactions increased greatly. Should we incentivise people to make such reports? Is reporting too cumbersome and inconvenient? We must examine these issues.
Dr. O'Donovan says there is "little evidence that gross under-reporting of ADRs has been redressed by the IMB". I would like to hear a comment on that claim.
Dr. O'Donovan talks about members of the public and their opportunity to report and deal with side effects. The sub-committee conducted a substantial public advertising campaign inviting submissions from all interested parties, including members of the public, but I was disappointed with the public reaction. We received only six or seven replies from the public. I had expected to be inundated with submissions. One often hears of adverse reactions to drugs and I had expected people to put pen to paper when they were provided with a channel for their complaints.
I share the concerns of the members who mentioned the Pfizer programme. At what age should children be exposed to such programmes? Will they soon be offered in playschools? I share this concern.
Dr. O’Donovan
We would be here for a long time if I were to address all the questions raised but I will try to give a brief response to each of them. The Pfizer schools programme is only one of a number of such ventures. The delegation from the Irish Pharmaceutical Health Care Association, for example, spoke about a number of programmes in which it has been involved. The Pfizer programme, part of the social and personal health education programme, is general in nature and addresses issues such as healthy lifestyles. The Irish Pharmaceutical Health Care Association has also been involved specifically in programmes dealing with patient compliance and medicines. While the Way2Go programme is one of several such programmes, it is also a clear example of how the boundaries between marketing and health information are being blurred. The Department of Education and Science does not need to rely on such ventures.
On the question of how health professionals and members of the public can be encouraged to engage in adverse drug reaction reporting, a number of approaches have been considered. While a debate has taken place on whether to make it mandatory for health professionals to report adverse drug reactions, this approach was found to be virtually impossible to implement. How would one police it? Introducing financial incentives is not appropriate. As health professionals have a moral obligation to report, this may be an educational issue best addressed in the training of health professionals who prescribe. With nurse prescribing on the increase, the number of professionals prescribing is being extended. Educational institutions have a role in schooling people on the importance of this type of reporting.
I circulated a document from Health Action International, an organisation which hosted a seminar last year on its investigation of systems of direct reporting by patients. It found that the level of uptake of formal reporting systems for members of the public, for example, in Britain and the Netherlands, was low. Again, there is a public education deficit in this regard and such programmes need to be actively promoted.
I will assume the role of devil's advocate. Perhaps the reason the level of reporting is so low is that the incidence of adverse side effects is not as high as people believe.
Dr. O’Donovan
The experience in countries which have introduced direct adverse drug reaction reporting by patients has been that different kinds of reports are made and the new information is added to the body of pharmacovigilance data. Patients not only report in a different manner but also report different things. There is evidence that such patient reporting complements reporting by health professionals.
Deputy Devins's question was answered when financial incentives were introduced. Regrettably, it was only when doctors were offered such an incentive that the incidence of reporting increased to a high level.
I disagree. Even when there was a financial incentive, the incidence of reporting was low.
The pilot project showed that the rate increased when financial incentives were offered.
Dr. O’Donovan
To return to the question of whether it is possible for a member of the public to make a direct report, I was intrigued by statements made by a delegation from the Irish Medicines Board at a meeting of the sub-committee last week because I had been under the impression that patients could make direct reports. Since then, I visited the IMB website and found that it has a number of adverse drug reaction report forms available. That is one example of a measure that can encourage greater reporting by health professionals. However, none of these forms is directed at members of the public. They are for people organising drug trials or health professionals, and it says so on the forms. The data presented every year in the IMB's annual reports give a breakdown of the sources of the ADR reports; members of the public are not included there. I phoned the pharmacovigilance section of the Irish Medicines Board and asked whether it was possible for a member of the public to report. I do not want to name the individual to whom I spoke but she said that such reports have to be validated by health professionals. There is nothing to stop a person from writing and members of the public can send in an e-mail or letter to the IMB, but there is not a formal system for doing that. It is not recorded and members of the IMB's delegation were not able to give us figures on the number of reports. It may be possible for members of the public to do it informally but there certainly is not a formal system of patient reporting in place.
As there is no such facility, there is an established need for members of the general public.
Dr. O’Donovan
There is no formal facility. Introducing a system of patient reporting of adverse drug reactions is not straightforward. If we look at the experience of the four or five European countries that have introduced systems whereby patients or members of the public can report directly, there are all sorts of complexities about whether it is all on-line data, how should the form be designed, or whether the system should be designed around drug reactions within particular conditions. The existing systems of patient reporting, which are all relatively new, show that different models are being adopted. In Denmark, they have gone so far as to enshrine in law the right of members of the public to make reports, so it is no longer an informal system there. That is a positive measure. Work needs to be done on how patients can submit adverse drug reaction information in a way that can inform our drug regulation system.
What other European countries are involved along with Denmark? Dr. O'Donovan said there were three or four. For our own benefit we might have a look at them.
Dr. O’Donovan
I sent that information with my original submission.
Do we have the data somewhere?
Dr. O’Donovan
Yes. With my original submission I sent a copy of details on a seminar that was hosted by Health Action International Europe. People involved in these systems were invited. They are in the Netherlands, Sweden and Britain. It was one of the outcomes of the House of Commons report that a system was introduced in Britain. In some cases the system is managed by a public body while others are run by consumer organisations.
I am sorry to labour this point with Dr. O'Donovan but I am a bit confused. As things currently stand, is it her understanding that members of the public cannot report on adverse effects to the Irish Medicines Board?
Dr. O’Donovan
My understanding is that there is nothing to stop an individual sending in details but there is not a formal system in place. There is no form. If one goes on to the Irish Medicines Board website there is a form for health professionals whereby one can give details. If somebody is running a clinical trial, there is a form for giving details. There is no form that is directed at members of the public but people can do it informally. Certainly, when the IMB's annual reports provide data on the sources of ADR reports, reports from members of the public are not included. When I made an inquiry yesterday I was told that such reports have to be validated by a health professional. Such a system may operate informally, therefore, but there is not a formal system for patient reporting.
I think the IMB explained that. Dr. Gilvarry said the patient is advised to go to his or her general practitioner.
Dr. O’Donovan
Which is not a system of direct reporting.
No.
My understanding is that she also said that if a member of the public has a complaint and rings them, they will redirect the complaint back to the prescribing person. It is a very important message that members of the public should have access to reporting.
Dr. O’Donovan
What was referred to by the delegation from the Irish Medicines Board is very different from the systems of direct reporting introduced in a number of European countries where there are campaigns and leaflets in doctors' surgeries and pharmacies encouraging members of the public to report adverse drug reactions.
Many more people will make reports it they do not have to go through a third party such as a health professional. It is sometimes the case that members of the public would consider that if they go back to the doctor, he or she might think they were making a complaint about him or her, when this is not the case. The health professional may not regard it as a complaint against themselves but it is nevertheless an inbuilt belief in Irish people that if we have to go through a third party, they will think they are part of the complaint.
Dr. O’Donovan
It is also associated with a broader attitudinal shift where rather than seeing patients as the passive recipients of medicines and of health care, patients have a role to play in the whole system of pharmacovigilance and patients' expertise is recognised and incorporated into the system.
It might be an issue that patients do not recognise the side effects.
Dr. O’Donovan
Yes.
This could be a major issue. A professional would recognise the side effects more readily.
Dr. O’Donovan
One of the problems with the system of pharmacovigilance that relies on health professionals being the mediator — this has been shown to be the case especially in Britain with regard to the adverse effects of SSRIs — is health professionals translate patient accounts in a way where valuable information is often lost. This is one of the benefits where one gains a new kind of pharmacovigilance data where patients can report directly and where health professionals are not commenting on the relevance of the information and reinterpreting patients' accounts. I refer to the work ofAndrew Herxheimer and Charles Medawar in Britain. They examined patients’ accounts of their experiences of SSRIs and were able to demonstrate the qualitative difference between the way in which health professionals reported those accounts and the way patients reported them themselves.
I will respond to the questions asked by members of the committee about my statements relating to the secrecy that pervades this realm of policy making. I have been involved in a number of studies of health services research. It was not until I started doing work in this area that I encountered situations where people would not agree to be interviewed by me.
I approached members of the board of the IMB and I was told it would be wholly inappropriate for them to meet me owing to the confidentiality rules. At the time, a person who was referred to as a consumer representative was on the board of the IMB. I presumed the consumer representative on the board would speak to me but she declined, saying that she did not have permission to be interviewed by me, even though it is a public body and these are publicly appointed board members. I have experienced difficulties with gaining access to people in the IMB and I have not experienced this difficulty in any other health body.
However, this difficulty is not confined to the IMB. A few years ago saw the first example of an advertisement on television for a prescription medicine, Twinrix, which is a vaccine for hepatitis. It was reported in the newspapers that the manufacturers of this medicine had succeeded in persuading the Department of Health and Children that the direct consumer advertising of this prescription drug was in the public interest. As I was interested in getting insights into the process of persuasion, I made a freedom of information request for documentation relating to the exchange between the manufacturers of the drug and the Department of Health and Children. As I was given access to some, but not all, the documentation because some was deemed commercially sensitive.
Speaking as a researcher, I have encountered difficulties in gaining access to data and interviewees in this realm of policy making that I have not encountered elsewhere. I am not unique in this. Social scientists internationally have found research in the field of medicines regulation consistently hampered by secrecy rules.
We will talk to the Irish Medicines Board.
As Senator Feeney remarked, we might have gained more had the meetings come in reverse order.
May I ask about the multi-centred trials being written centrally by people employed by the drugs company? Is this practice widespread?
Dr. O’Donovan
In recent years the industry has assumed a greater role in shaping regulatory science internationally and this has had widespread consequences.
I was astonished by the Vioxx case. A considerable number of the members of the Food and Drug Administration, FDA, committee that approved it had financial or commercial involvement in the firm.
Dr. O’Donovan
The recent Vioxx disaster is comparable to the thalidomide disaster and it illustrates the limitations of pre-marketing clinical trial research. The signals of harmful effects were noticed in the pre-marketing trials but they were not acted upon. This is a recent example that shows the limitations of the existing research that informs our regulatory policy.
Given the research that was available, a considerable number of the members of the FDA committee voted against making it available to the public.
Dr. O’Donovan
I think there is a connection with our earlier discussion on the blurring of boundaries between marketing and advertising. Vioxx was a heavily promoted medicine. In the US the manufacturers of Vioxx, Merck, spent more promoting it than Pepsi Cola did promoting its products.
I thank Dr. O'Donovan for her comprehensive presentation and the forthright way she answered questions put to her by the committee.
Dr. O’Donovan
I refer the committee to a document in my presentation, a joint declaration by a number of European organisations called Relevant Health Information for Empowered Citizens.
We will be happy to have it.
Sitting suspended at 3.44 p.m. and resumed at 3.45 p.m.
I welcome Dr. Martin Henman to the meeting. Before I ask him to make his presentation, I draw witnesses' 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. Dr. Henman may now begin his presentation and there will be questions afterwards.
I thank the Chairman and members of the sub-committee for inviting me to appear before it and give a presentation. This is a very important area and pharmaceutical policy as a whole is somewhat undervalued within our present system. It is especially regrettable that in a sense, both in the Department of Health and Children and the Health Service Executive, HSE, there are very few experts associated with pharmaceutical policy, which includes this area and the area of regulation. For example, the Department of Health and Children does not have a chief pharmacist, although it has some fairly expert senior people within the organisation. There is a very strong need for the Department to devise policy once again and look to other bodies to enact that policy by way of implementation.
On the central issue for the sub-committee, the adverse side effects of pharmaceuticals, there are two main reasons adverse effects are generated. One relates to the properties of the drug or product concerned, and the other relates to how the drug or product is used. Most of our systems for trying to detect adverse effects are focused on the first rather than the second of those two causative factors.
As the sub-committee has heard from members and other witnesses, the Irish Medicines Board has the job of protecting and enhancing public and animal health through the regulation of veterinary and human medicinal products. It is important in considering what the Irish Medicines Board does to note this is a focus on product regulation rather than process regulation or other aspects.
The board derives its income primarily from user fees, and the principal clients are therefore, in a sense, those holders of product authorisations and people within health care professional groups who make reports and work for it. It has a very particular focus. As has been alluded to elsewhere, pharmacovigilance is therefore merely one of a number of roles the Irish Medicines Board must complete. As a result, it has tended in the past to be a comparatively low priority in its overall mandate.
Much has been made about the low reporting rates of adverse drug reactions. It is fair to say these are similar from one country to another. In so far as it is possible to determine from published figures, approximately only one in ten is reported in most countries. That is a fairly consistent estimate by groups of independent researchers in many different countries around the world.
It is possible to use a number of initiatives to try to improve reporting. As pharmacovigilance is under-resourced within the Irish Medicines Board, not all these have necessarily been given the required priority. There is certainly a need for postgraduate education and continuing education of health care professionals once they are in practice. This would bring to their attention the importance of the process of reporting. Although this has occurred, it has been relatively sporadic. Given the staff numbers in the Irish Medicines Board, it is easy to see that a really intensive programme could not be sustained. There needs to be more collaboration between the IMB and the different health care professional bodies in the provision of suitable programmes for members of each group. I would also like to see the importance of this area recognised in undergraduate education in general health sciences. In addition to doctors and pharmacists, nurses will have prescribing rights and abilities and we therefore need all the groups within health science to have received a suitable undergraduate education before they qualify. Although we run such a course in the pharmacy degree in Trinity College, where I work, I am not sure that is replicated universally in this country.
Another factor that makes a difference when health care professionals report adverse events is whether the regulatory body follows up on reports. If the IMB had the resources to follow up on adverse events reported by prescribers, it would increase reporting rates to some extent and create confidence in the quality and the process with which the regulatory body handles reports. This has recently been shown in the UK.
Another positive influence, which has been demonstrated to some extent in the UK and in France, is the use of regional centres. The idea is that a more local drive to report adverse reactions will increase rates through local leadership from significant individuals in the medical, pharmaceutical and nursing community. It can also be used as a means of educating those health care professionals about the important issues with specific drugs for which they should be actively looking rather than merely passively collecting. In a number of countries drugs that are new to the market, are novel or have a narrow risk-benefit ratio are usually indicated to prescribers, so they are fully aware that the regulatory authority is particularly interested in those products and considers that issues may be detected once they are in general use. I am not sure the present system communicates that message.
Some members have already discussed access to information. There is a need for increased access to information. In a number of countries one can access additional information about adverse drug reactions from the regulatory bodies by direct interrogation of their databases which have been prepared, so they can be easily perused by individuals going on-line, or can be the subject of freedom of information requests. Another possibility is that all drugs marketed in this country and throughout the EU would have to complete periodic safety update reports at certain intervals. These reports could be summarised in lay language and I would like them to be made available on a request basis to those who are interested in using them. This would be useful for health care professionals and the public.
I have mentioned resources and whether the IMB is properly resourced to do all these activities. I am not sure it is. I do not believe the National Drugs Advisory Board, NDAB, was fully resourced to do this either. I have had dealings with both organisations at different times.
Another issue that emerged in the United States, and to some extent in the House of Commons report, is the power to interrogate and seek information, to require compliance from marketing authorisation holders and others. It is not apparent once again, looking at the role of the Irish Medicines Board and its authority, whether it has the necessary powers to look for information in these circumstances. Therefore, if it has a concern, how does it address that? It would appear to do it, primarily, by negotiation.
The committee should be aware that the European Medicines Evaluation Agency, EMEA, has begun to address this issue. In its Roadmap 2010 document it makes a particular point to the effect that it is looking for additional powers. It will look, in particular, at this process with regard to getting information once drugs have been marketed. Once a drug is in the post-authorisation phase, and being marketed, this is the time in which it is most difficult to get the additional information and the EMEA is looking for a way to do this. That might essentially become a Europe-wide approach to this issue.
One point that has not been mentioned so far is that quite some time ago when the National Drugs Advisory Board was the agency, there was concern among its board members and to some extent, its staff, that they were not suitably indemnified by the State if they were discussing or making decisions as regards adverse drug reactions that were reported to them. Therefore, this might in part explain some of the reluctance to go further into this issue. I do not know where the issue is now, but if that is still the case, it would certainly limit their capacity for follow-up. For example, at one stage, although adverse reports were submitted and certain details would have been taken down, the data as regards who had submitted the report might not necessarily have been recorded, simply whether it was a general practitioner, a hospital consultant, dentist or a pharmacist. That was the only record made at that time. That meant, therefore, that one could not go back and follow up a case. One might not necessarily want to follow it up immediately, but at a later stage, perhaps, if a number of reports started to appear, one might want to go back to look at the earlier data, to see whether there was any additional information that could corroborate what was now emerging. If this indemnification issue is a problem, then it is one that needs to be looked at.
Even if we do all of these things, however, the system is inherently limited. What we have in this country as in most others is a spontaneous reporting system. These systems tend to identify unusual serious drug reactions. They do not tend to identify those which are comparatively frequent and which only occur a little more frequently than the background, in other words, two to three times more above the average. They also tend not to collect much information about comparatively obvious symptomatic problems, which doctors, patients and other prescribers can recognise. There is often an issue as to whether a symptom is associated with a drug or with some change in the condition. Both the health care professional and the patient can be confused on this, and this limits the extent to which those types of symptomatic reports are made.
There is another issue which limits reporting, and there has been some discussion about it this afternoon. It relates in part to who is responsible and whether there are lines of demarcation between the different members of the health care professions as they work together in providing care for patients. Very often there is an issue that relates to who should do what. Who should report? If the prescriber has prescribed, is it principally and purely his or her responsibility to report, or can others in the team report? In the past and even to some extent, now, anecdotal evidence and certainly comments from colleagues of mine in both community and hospital practice suggest that some individuals take a particularly paternalistic view and consider that theirs is the responsibility for doing this rather than anybody else. There might be some who discourage reporting because of that.
Another issue that limits reporting and the usefulness of these systems is that we refer to ADRs when we mean events. At the time of the report there is no determination of whether the drug or some other factor is the causative factor. The distinction between a reaction and an event is poorly understood. I have examined the understanding of pharmacists in this regard and it was not great. Information in published literature suggests that other prescribers do not draw this distinction well. They consider they may be unfairly attributing something to a drug when they are simply putting forward a supposition about an event.
Research has demonstrated that terms related to frequency, such as "uncommon", "rare", "common" and "frequent", are not fully appreciated or understood. The interpretation of "rare" by health care professionals is very different from that of the IMB.
Another inherent limitation of this country is the size of the population. The population of Ireland is small, relatively speaking, and rare events will not be found easily. Some events are so rare that a large population is required to discern them. In finding these types of reports we are heavily dependent on other countries and on participation in European and WHO programmes and co-operation with the United States, Japan and Europe in respect of harmonisation of pharmaceuticals. Although our small population is a disadvantage, we desperately need the signals. We must put as much effort as everyone else into increasing our report rate so that if we find a rare event it acts as a signal to us that something is going on.
The next limitation, typified by the Vioxx case, is that this is a global industry. Drugs are prepared and marketed in other countries and clinical trials are carried out in other countries. Those who hold product authorisation in this country may not have access to relevant data about the product. It may be retained in another country. Recently, a company failed — either deliberately or inadvertently — to recognise that it had useful information on adverse events. The information was held 3,000 miles away and if half of the company's staff in the United States were not aware of it, it is unreasonable to expect staff in Dublin to know about it. We need assistance from the Food and Drug Administration in the United States to access this data so that we can incorporate it into our risk management ideas.
Our focus on products marketed in this country via product authorisation means that we do not have a method of collecting information on products that do not require authorisation, such as certain health and herbal supplements and medicine purchased over the Internet, by mail order or abroad. Although the IMB issues warnings and seeks information on some of these products, that is outside its remit because it is supposed to look after medicines for which product authorisation has been granted. That is a limitation of the present system. I have already suggested what might be done to improve reporting, particularly education. It is necessary to consider this issue, not merely in the context of adverse reactions to drugs but also in the reporting of errors within the health system in general.
Colleagues of mine in the Adelaide, Meath and National Children's Hospitals have done a great deal to develop medical error reporting systems there. We need to increase the effort we put into that work. The reporting of adverse events associated with pharmaceuticals will become part of that process. These events arise for two reasons, the properties of the drug or product and how the product or delivery system is used. Sometimes we fail to capture those events caused by inappropriate use or prescription or other failure, as errors in the system.
Many years ago there were drugs and therapeutics committees in hospitals which played a role in devising appropriate prescribing guidelines in particular specialties in hospitals and in encouraging adverse drug reaction reporting. According to the Department of Health and Children, this appears to have fallen by the wayside. I would like to see a renewed interest in that practice and an effort to generate such committees. This applies not only to acute hospitals and primary care, both of which need urgent attention, but also to residential and long-stay institutions. A colleague of mine is researching prescription and drug use in nursing homes, the quality of which is extremely patchy in some areas. We need to consider this too.
The drugs and therapeutics committees remind people that the team associated with drug use comprises three principal health care professionals, the doctor, the nurse and the pharmacist. Wherever medicines are used, all three must collaborate in detecting and reporting adverse events and errors. Only when health policy recognises and involves all three will pharmaceuticals be better managed.
The sub-committee has discussed consumer reporting of adverse drug reactions, which occurs in the United Kingdom, the Netherlands, Denmark and North America where it has been done for many years. If we are to have a patient-oriented health service, this is one of the voices the patient must receive. I would prefer this to be achieved through a patient safety authority or organisation than through the Irish Medicines Board which runs the spontaneous adverse drug reaction reporting system which is a relationship between it and health care professionals. For it to look after reporting by patients would require a different approach because patients have a different set of concerns. Patients will definitely want a degree of follow-up and advice. The Irish Medicines Board is not resourced and would not necessarily feel able to do this.
Patients want to report problems. It is up to the health care professionals to work out what problem is involved; who best should deal with it; how to classify and collate it; and produce statistics in order that we can see what is happening in the population in general.
I met colleagues at a conference during the summer who stated that patients, not surprisingly, tend to report symptomatic adverse reactions and they also tend to report the more frequent and better known ones as far as health care professionals are concerned. This is good as it complements the spontaneous reporting system which does not tend to find those types of adverse reactions. We may also get reports of adverse events associated with health supplements, herbal or other non-registered products and Internet medicines which we do not get under the current system. This is valuable to us because it gives patients the opportunity to provide that information to an authority whose principle concern is patient safety.
Some mechanism would need to be put in place for a patient safety authority and the Irish Medicines Board to work together on and share data. This is feasible. To the best of my knowledge, it has never been formally possible to report as a patient to the National Drugs Advisory Board or the Irish Medicines Board. One can send in a report informally but no formal mechanism is in place.
I would like to think a patient safety authority would follow the example of several countries to raise the issue of the safety of medicines and increase its visibility with health care professionals and the public. In the UK, the authorities have examined confusing labelling, where the strength of a medicine cannot be easily ascertained, which led to overdoses. Such a practice would be useful in improving the quality of drug use. A patient safety authority would act as a patient advocate, helping to reinforce the point that it is the responsibility of health care professionals to report adverse events. Whether they prescribe, dispense or monitor a patient's condition, if something appears to be amiss, the health care professional involved should report the event and its possible associations.
I thank Dr. Henman for a comprehensive presentation. He raised the issue of how one can forward a complaint. Often it is not always the product that is at fault but the method in which it is administered. I would be interested to hear more on the indemnified bodies and their investigative capacities being curtailed. What are Dr. Henman's views on who should report the side effects of medication? I would have thought it would be the health care professional who sees the side effects at first hand. The sub-committee has had several discussions about herbal and Internet medicines and shares the same concerns as Dr. Henman. What are his views on the Food and Drug Administration model in the United States?
I thank Dr. Henman for a useful account. I examined his seven deadly sins regarding fear of litigation which may lead to prescribers not reporting side effects. In the case of Tallaght Hospital, it was the hospital pharmacist who produced the initiative on increasing reporting. It made a significant difference. Should we consider obliging hospital staff to report cases of patients who display side effects to drugs to the hospital pharmacist who in turn can report to the Irish Medicines Board? While I am not stating a patient safety authority is not needed, its establishment is a big step. If the sub-committee recommends it, the first question will be whether we considered the cost of a setting up a separate body, especially if the patients will want follow-up advice. It will require much organisation. I may not be here when Dr. Henman replies and I hope he will forgive me. It is a most useful report. I am very concerned about the global industry. There may be useful information about adverse drug reactions 2,000 miles away which we are not getting.
If Dr. Henman's contribution does not raise many queries, it is because it was clear and comprehensive. What he said makes absolute sense. I have a few comments which relate to what Senator Henry and the Chairman said.
In the hospital setting, there is the prescribing entity, the consultant or the non-consultant hospital doctor; the dispensing entity, the hospital pharmacists; and the administering entity, the nurse. If, for example, we say the consultant or whoever prescribes the drug should be responsible for reporting, we contribute to the old saying "There is many a slip between the cup and the lip", and the matter winds up not being reported at all. In that situation, everybody has a responsibility for appropriate reporting of side effects, although the nurse would have the most contact with the patient.
Dr. Henman made a valuable point in regard to confusion between reaction, whether to the drug, and a change in the condition for which the drug is prescribed. That is very important. A spontaneous reporting system is extremely important.
How much has the "pop" or policy procrastination approach contributed to lack of reporting, that is, putting something off until tomorrow? Like everything else subject to procrastination, it does not get done at all.
Dr. Henman
I thank members for those questions. I will do my best to answer all of them. I cannot give a clear cut answer on the indemnification because I do not know the situation. The original discussions were held by the board of what was the National Drugs Advisory Board. It was the board's decision, therefore, to adopt a particular policy. I do not know the extent to which that is still the policy or whether the environment has changed sufficiently, so the issues have changed as well. I am afraid that is one area I cannot consider.
On the issue of who should report particular instances, I agree it is everybody's responsibility. However, we are essentially trying to reorientate our health service from a comparatively paternalistic, or authoritarian, one in which there is a hierarchy, to one in which responsibility for the patient's care is shared between several individuals. Everybody should be entitled and morally required to report. I pointed out that it is an issue and one which the individual health care professional bodies must approach with their members. They need to educate their members and remind them that if they believe there is a problem, they should report it irrespective of whether they work on a team and whether they believe they have the sanction of other members of the team to do so. It is up to somebody else in this instance to determine the importance of the causation or whether there is any causation.
One reason for underreporting in hospitals is that in a sense, such adverse events are dealt with and treated. As the patients are cared for, the issue is seen as a normal complication of patient management rather than something out of the ordinary that might continue to cause a problem in some way. I suspect this partly relates to Senator Glynn's final point regarding procrastination, that is, if people feel they have addressed the issue, they may not necessarily then go ahead and report it. While in so far as I am aware there is no evidence to this effect in the literature, I imagine this would cover that issue.
I reiterate, as did Senator Glynn, that we must put at the centre of our policy the idea that there are teams of people who care for patients. Moreover, we must be quite careful how we set out who is in the team. While doctors, pharmacists and nurses are invariably in the team whether one is in hospital or primary care, this should also be the case in residential long-stay care. This must be the goal and we must ensure that all such people are involved and can express themselves.
I have a background in nursing and nursing professionals invariably include in their reports observations that pertain to adverse drug reactions. I refer to the nurses' notes or, in the case of the psychiatric services, the Roy model.
Dr. Henman
While I understand, accept and agree with that——
It is important to take such observations on board and refer them to the appropriate authority.
Dr. Henman
The willingness is there and in terms of patient care, undoubtedly this is what they do appropriately. However, the difficulty lies with reporting this back to the Irish Medicines Board or whoever. This is where the seven deadly sins come in because this poses a barrier. As I noted, if it is felt that the problem has been dealt with, the patient is not suffering or the issue has been contained, it seems to be a less urgent matter for reporting. This constitutes a barrier.
The possibility of how to increase the extent of reporting has also been discussed. I understand that a move towards obligatory reaccreditation or reregistration of all health care professionals with their professional bodies through some form of assessment on a periodic basis throughout their professional lives is under consideration. As part of that process, we should require them to have a clear and obvious understanding of the adverse drug reaction reporting system. Moreover, if such people must prepare a professional portfolio, as is very often the case for such assessments, it should provide evidence that they are both aware of and may have used the system during their period of practice. This seems to be a way to follow on in this regard.
Issues were raised regarding the cost of a patient safety authority. The State cannot continually state that this would cost a great deal while simultaneously contemplating a large and powerful industry that quite justifiably spends its money to ensure it makes a profit and to market its products. The State cannot pit a David against a Goliath in this regard. While a patient safety authority may require considerable resources, we must examine how our resources are spent and determine whether we should direct our resources into that area.
A question has been raised about the cost. The point is whether we can afford not to have a patient safety authority. I believe we must have such an authority.
There is no argument in this regard. Dr. Henman mentioned his concern regarding patterns of prescription in nursing homes and long-stay units. Will he expand on this point?
Dr. Henman
Nursing homes and residential care facilities fall into a number of different patterns. Some are privately owned and run, while others are under the umbrella of the public service. Most recently, those within the public service have essentially become attached to or at least partially supervised by substantial hospitals within their region. I believe this development is very positive because it means there is expertise available from the hospital to help deal with problems in these nursing homes. Usually, the expertise that has been provided is at the senior professional level within the ranks of doctors and the nursing professions.
There needs to be slightly more emphasis on the pharmaceutical profession because some of the prescribing that is done for the patients of these institutions is done by prescribers who are not in the hospital and are not permanently attached to the home. The situation in private nursing homes is even looser and more open. Not only may private nursing homes have prescribers from a variety of places contributing, they may also essentially contract out their drugs supply and treat it as merely as drugs supply. I would not see it in this way. There is a need to establish a pharmaceutical service within each of these institutions which complements the medical and nursing services and works with these services to care for patients who are at high risk. Such patients are the ones who are readmitted to hospital at intervals.
One of the reasons my colleagues in Naas General Hospital are examining this is because they can see the extent to which there is loose, rather than poor, prescribing because there may be more than one prescriber, all the prescribers are not in touch with each other and there is no obvious supervision of the pharmaceutical process. In that instance, when the pharmacist in question began work, the first people to welcome the process were the nurses who were delighted to have someone who was interested in the problem and with whom they could sit down and work. Fortunately, the matter is moving ahead fairly well. However, this initiative needs to take place elsewhere within residential and long-stay care institutions. A national programme recently commenced but it does not appear to include a pharmaceutical service that would operate in this highly practical and efficient way.
I thank Dr. Henman for his very comprehensive presentation. We found it most interesting.
The sub-committee adjourned at 4.25 p.m. sine die.