Liam Twomey (Wexford, Fine Gael)

I extend a happy Christmas to the Acting Chairman, the Ministers of State present and all the staff and Members of the Houses of the Oireachtas.

This is interesting legislation and much debate will surround it as it proceeds on Committee and Remaining Stages. Many important points in the debate will not be raised by us in the House but they may crop up when people read about this legislation in the media. People will then make comments on it and express their concerns. There are many good points in the legislation and it functions well in tidying up. It covers new ideas coming into the health services, such as nurses prescribing medication and the current and future role of pharmacists in the community. Although there is much to commend in the legislation, there are many factors in it that we have not considered fully. We will probably consider them fully during the course of debating the Bill over the next few months.

The central point of any health service legislation in this House is patient safety. It is a core point in this Bill. In drawing up legislation such as this we must look at how it affects the professionals who provide patient care. The legislation will bring some new practices with regard to how some professionals will work within our health services. If the legislation is not properly enacted, it could have detrimental consequences for some professionals and their patients. In particular, the nursing profession should pay much attention to what this legislation will bring about. Section 16 is a clear indicator of this.

Hundreds of nurses could see their careers destroyed if the regulations in the legislation are not put into practice properly or if proper safeguards are not put in place when the Bill is going through. For example, palliative care nurses in the community work regularly with controlled drugs and in conjunction with local general practitioners. Both, in some respects, are a quality check on each other. The palliative care nurse is a quality check on the GP and vice versa. These people play a significant role in the community, which must be protected. We must be careful going forward, particularly in considering the use of controlled drugs. It is a major point that cannot be emphasised enough.

The Minister of State wishes to extend the prescription of all medications to nurses, but we must be careful about the issue of controlled drugs. This will become the vital issue in this legislation, both for patients and nurses involved. I am surprised there is not more detail around this matter when we are discussing the legislation. To state that regulations will follow on such a significant topic is wrong. It demonstrates an inherent weakness in the beginning of discussions on the legislation.

It is a failure on the part of the Minister of State that more has not been put forward on how the issues of prescribing medication outside the medical profession are being thought of. There is some prescription of medication outside the medical profession, as pharmacists do it and nurses have an increased role in how they dispense medication. However, this legislation changes the issue, and it allows pharmacists and nurses to be the primary prescribers. There should be much more in the primary legislation to point this out, and I am surprised the Minister of State has not done so.

I will list issues that have cropped up in the media recently that will alert the Minister of State that we are not talking about giving out Smarties and that the issues are important. A recent Irish Medical Council report from the fitness to practice committee examined doctors who fail in the duty to protect patients and prescribe properly. The report showed that doctors were struck off for taking controlled drugs themselves, selling controlled drugs to addicts and providing controlled drugs for sexual favours. The numbers of these offences are extremely small, as the legislation covering the Irish Medical Council and how doctors operate is reasonably robust. The council takes these concerns quite seriously and acts strongly on any complaint made about doctors abusing their privileged position in handling controlled drugs.

We are broadening this issue. The matter of controlled drugs in our society is discussed on a regular basis. The prescription rate for benzodiazepines, such as Xanax or Valium, is very large. The potential for abuse is also very large. These prescribed drugs are sold as illegal products in this country. For example, Valium is regularly sold to heroin addicts and people who take ecstasy as a means of helping them control the highs and lows of the drugs. There is a huge potential for abuse with these types of drugs in our community. If we are to open up the prescribing of these types of drugs to nurses and pharmacists and to open up their use in nursing homes, hospitals and the community, we need extremely robust legislation to prevent abuse and protect patients from misadventure.

The events surrounding Dr. Harold Shipman exposed this as an issue in society some years ago. Shipman used controlled medication, Cyclomorph, to murder a huge number of his own patients. It is possible that no amount of legislation would have protected those patients from the psychopathic behaviour of the individual, but it shows that we must be extremely diligent about the auditing and control of this type of medication. Shipman was ordering vast amounts of Cyclomorph from pharmacists and wholesalers. It was noted that he was taking into his possession a large amount of these drugs, and people wondered what happened to them. Nothing was done, however, until he was exposed as having murdered hundreds of people.

We must bear in mind that legislation on its own is not good enough to protect patients. It is important before this Bill is cleared to clarify what the Minister of State is intending with checks and balances being put into legislation to protect patients. The enforcement of legislation is important, and the point has been made repeatedly that it is much better to have primary legislation as the way to protect patients. Amendments to a Bill and ensuing regulations should not have to follow primary legislation, which should be the gold standard for the Members in this House. We should not begin with catch-all primary legislation to cover the Minister of State, only to issue regulations and amendments afterwards.

This has in some ways facilitated the major problem we have today. It is the type of action that will cost the Government €1 billion over the nursing home charges issue. In that case, amendments after the primary legislation created ambiguity with regard to legal issues. Although it was strenuously denied by the Ministers involved, there may have been reaction when primary legislation was going through relating to old age patients. We will never know for sure. This shows that primary legislation should be the main way for this House to act and not through amendments. We are told that much of this Bill will be followed by amendments and regulations later on.

It looks as if this legislation will go through next February. The Government does not talk about continual medical education and competence assurance for the people involved. This applies, for example, to general practitioners. I take part in continual medical education but competence assurance does not apply to general practice.

The continual medical education in which I participate happens at night and weekends. There is no time off to do it. It is voluntary. Since I qualified as a general practitioner I have been under no obligation to read a book, attend a lecture or pursue any form of continual medical education whatsoever, yet I am one of the primary prescribers in this country.

In respect of competence assurance I can be registered on the specialist register of the Medical Council as a specialist general practitioner. That too is voluntary. I do not have to be included on the register but can remain as a general doctor in the Medical Council.

The structure of continual education must be crystal clear, otherwise, nurses, pharmacists and other health professionals will run into problems, not deliberately but because they have not kept up to date with the training and issues surrounding prescription of drugs. That is extremely important.

The Minister of State said he will talk to the stakeholders about section 16. What consultation has there been to date with the stakeholders, of whom there are many? These include the Department of Health and Children, the Health Service Executive, administrators at community level, pharmacists, general practitioners, hospital consultants, nurses, the regulatory bodies and unions, the Irish Nurses Organisation and the Irish Medical Organisation, An Bord Altranais and the Medical Council. The Minister of State should tell us what discussion has taken place with those stakeholders who will in turn discuss with us aspects of this Bill which they fear or distrust, over the next eight weeks.

Has the Minister of State drawn up protocols for nurses prescribing and under what circumstances they may do this? If there is to be limited prescribing there must be protocols. In Monaghan hospital that unfortunate man, Mr. Walsh, died because people did not follow the protocols. There was much discussion about what the consultants in Monaghan hospital should have done but the protocols were not followed. There will be another inquiry into that episode.

The protocols stated that if surgery could not take place in Monaghan hospital the patient was to be transferred to Cavan hospital, regardless of whether there was a bed there or whether someone would take him in. The protocol was flawed because the consultants in Cavan hospital could not accept patients with serious illnesses. The protocol failed Mr. Walsh.

We must be careful about how we draw up the protocols that are necessary. We should issue them now to the stakeholders to show them what we are discussing. The legislation might be fine but the thinking behind it and the work that needs to be done to make it stand up does not seem to be coming through.

Are there any plans to set up an organisation similar to the National Institute in Clinical Excellence, NICE, in the United Kingdom? Officials in the Department of Health and Children will be familiar with NICE. It is a controversial organisation because in some respects it limits the medication patients can take. If we extend the roles of different people and the scope for prescribing, it will no longer suffice to use the regulations covering members of the Royal College of Surgeons, the Royal College of Physicians or the Irish College of General Practitioners. If nurses and pharmacists are to have a broader role in prescribing we need a national organisation of clinical excellence to guide people in this area.

The Irish Medicines Board cannot do this because its role is specific. We need to go further than that. Has the Minister of State studied the situation in the United Kingdom, following the Harold Shipman case? The authorities there were concerned about how regulations for drugs and prescription were applied. I believe that nurse prescribing in the United Kingdom does not cover controlled drugs because of the limitations and controls on how this might work. I look forward to hearing the Minister of State's comments on that when he has the opportunity to reply.

Much of this prescribing will happen in the controlled environment of either a nursing home or a district or acute or psychiatric hospital. Have formulae been drawn up within those hospitals on how nurses prescribe? Have discussions taken place with the Medical Council and An Bord Altranais to cover the professional level of this activity? The Minister of State will need to talk to the INO especially and to the IMO about this. Nurses must be protected.

These regulations can be introduced but in a few years people will be a bit casual, the legislation will be forgotten, the training gets slack, then young nurses who are overworked and under pressure will find themselves in the courts for the reasons that doctors sometimes end up there, for misadventure, negligence or whatever. We must be robust about the regulations and highlight them to ensure no young nurse gets into trouble because we think this practice will make life a bit easier in hospitals. It is important to discuss these matters with patient advocacy groups. I presume the Attorney General will also have his say on this development.

A recent report from the Irish Society for Quality and Safety in Health Care should jolt the Minister for Health and Children and the Department out of complacency on these issues. According to that report half of all patients received their medication with no explanation of its side effects. Several patients probably got medication before anyone checked whether it was the correct patient. There may even be cases where the wrong medication is given.

The question often arises in respect of private nursing homes and other similar institutions whether the person distributing the medication in the evening is the appropriate person to do so. Several reports show that the working of the drug trolley on which medication is stored can be haphazard, a problem the former health boards have exposed. I would not like to see a situation develop in which prescription of serious medication becomes casual.

Hospitals are extremely pressurised environments. Recently I sat beside the bed of a family member and watched the nurses and other staff working around me. Ten years ago I worked in hospitals but the environment is more pressurised now than the one in which I worked. Student nurses now spend most of their time in university and do not have the same on-the-ground training that many of the older staff nurses experienced. One learns a great deal from experience rather than books. If we are not careful about how people dispense medication we could run into problems.

There are many reports in medical literature of patients dying from being prescribed the wrong medication. It is difficult to prove but it happens. In the United States the numbers run into thousands. In extending the range of people who can dispense medication, especially controlled drugs, we will encounter serious problems if we are not careful. This must be taken on board and it will be watched closely on Committee Stage.

Many organisations such as the INO, the IMO, the Pharmaceutical Society of Ireland and patients groups will study the legislation and will be getting in touch with Members in the new year. It is imperative the Tánaiste and Minister for Health and Children publishes her proposals on the Bill well before Committee Stage is taken. It is too dangerous to be given these the night before Committee Stage sometime in February. Members will only be fumbling in the dark, trying to work out what the Tánaiste means and its implications.

More changes will be proposed to the Bill because a large number of issues surround it. There are, however, issues outside the legislation which the Department of Health and Children must address. An examination is needed of continual medical education, protocols and the establishment of a national institute of clinical excellence. How can we ensure nurses maintain their training, particularly if it is not being done now? Once a person qualifies as a general practitioner, there are no further checks on his or her prescribing habits. In the ten years since I qualified as a GP, treatment of basic conditions such as diabetes and blood pressure has changed dramatically. It is important to understand how reviews of people's training and competence are managed.

These will be the questions I will ask the Tánaiste and Minister for Health and Children on Committee Stage. I will also ask what plans are in place to ensure standards in prescribing do not drop so that doctors do not contribute to the deaths of their patients.

I am unsure of the Tánaiste's intentions regarding the EU directive on human organ tissues. The report of the inquiry into organ retention has not yet been published. When this issue broke in 1999, the Royal College of Pathologists drew up regulations on how to deal with the issues arising from organ retention. A similar set-up of protocols is needed in Ireland. If there is anything unusual or different in the Irish situation, it must be discussed on Committee Stage.

In vitro fertilisation treatment is not provided for in the Bill. Has any aspect of the report of the commission on assisted human reproduction being included in the Bill? There were issues around stem cell research and in vitro fertilisation, as well as the protocols for handling embryos and gametes. Has the Department of Health and Children examined the recommendations of the commission? Do any of these impinge on the legislation? The commission needs serious legislation as a follow-up on its recommendations. If any issues exist, we need to address them to avoid any problems in the future.

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