20 March 2007
Dr. Henry: I welcome the Minister and the Bill. One can see how badly needed it is when one sees the dates of some of the Acts being repealed, such as 1790 and 1870. It is astonishing that we still must use these Acts, so it is good to see them repealed.
The Pharmaceutical Society of Ireland, for whom I have great regard, is both a regulatory and a representative body. The Minister continues this in the Bill. It is the situation in the United Kingdom but I gather it is thinking of trying to separate the two parts of the society. Has the Minister read its thoughts on that? The situation with the Medical Practitioners Bill is different because the regulatory and representative aspects of the medical profession are represented differently, as I am sure the Minister knows only too well. The Veterinary Practice Act, brought in by the Minister for Agriculture and Food, separates the regulatory and representative aspects of that profession.
I am glad the Minister will deal with the conflict of interest between prescribing and dispensing. This has worried many people recently with the changes in the health care centres being set up. I read that the Taoiseach said it had not been envisaged that there would be pharmacies in the health care centres when set up, which I had also thought. In the past - apart from a very small number of dispensing practices in parts of rural Ireland - it was essential that there was clear blue water between those who prescribed and those who dispensed. The pharmacy review group also made that very clear when it reported in 2003.
When one looks at the sixth Shipman report, one can see why, in practice, it is so important that there are vigilant pharmacists keeping an eye of what prescribers - members of my profession - are doing. It stated that it is now generally accepted that the involvement of a pharmacist in the process of providing medication to a patient acts as a safety check against error. It further stated that where prescribing and dispensing functions are carried out by the same person, or within the same commercial or professional entity, there is a potential for loss of professional objectivity or even abuse. In the case of Dr. Harold Shipman, it was reckoned that there had been far too cosy a relationship between the pharmacist supplying the injectable opiates and Dr. Shipman. This led to a great deal of trouble.
The situation in regard to health care centres is very worrying. In centres being set up by four or five doctors, tenders are being invited for a pharmacy in the centre. I heard that key money of €1 million or more is being asked in some cases and that rents of €150,000 to €300,000 are being asked. If this is the case, the doctors will rely on rent from the pharmacist, which is not a good relationship. I do not know whether the Minister thought this would happen.
It has been brought to my attention that in one area, the Health Service Executive is involved in selling the land for the new health care centre. I had envisaged, as I am sure many others did too, that there would be social workers and occupational health workers - probably people employed by the State - in these centres rather than giving someone a huge commercial advantage over others in the area. As I said, this could lead to a really serious conflict of interest between the dispenser and the prescriber. I hope the Minister addresses that very carefully.
Apparently, the Minister will clarify the definition of a "retail pharmacy". I gather it will cover hospitals but will it cover all hospitals? There is no definition in the Bill of a "hospital". Will it cover private hospitals or day hospitals? We really need to know what hospitals will be covered. Will it cover fertility clinics? Some of these places supply pharmaceutical products directly to the public. I am not saying there is anything the matter with what they are doing but they supply pharmaceutical products directly to the public and we need to know who will be allowed to prescribe. Will methadone clinics be covered? It is very important that major hospitals have the right to so do because they are trying to do things like increase the incidence of having chemotherapy administered at home in order that patients with cancer, whose immune systems are compromised, are not obliged to run the risk of going to hospital and contracting infections. Important matters must be addressed in this regard and HIV and AIDS patients are also generally encouraged to take the treatment at home. Moreover, pharmaceutical companies will only supply some drugs for schizophrenics and so forth through hospitals because of their side-effects such as changes in blood counts. The companies want to ensure that pharmacists can induce patients to report to the phlebotomist immediately to reduce, in so far as possible, any side-effects that may arise.
I am unsure whether pharmacists working in industry are covered by this Bill. Moreover, trainee pharmacists also should be included. As the registered pharmacist cannot have eyes in the back of his or her head all the time, the latter group should be included. What is the issue regarding pharmacists who are involved in industry? In addition, from the perspective of the three-year registration period that will be needed before one can set up a pharmacy, it is very important to include hospital pharmacists. Otherwise, no one will work in hospital pharmacies which are vital because, frequently, such people perform postgraduate research work of enormous value. Moreover, medical teams would be sorely compromised if they did not have such people involved in their clinical trials and so forth.
Senator Glynn raised the issue of the risks associated with the Internet, and he is correct. However, Members must also consider the risks regarding counterfeit drugs. The description of the premises that the Minister's inspectors will be permitted to inspect should be very wide. For example, the legislation should allow for the inspection of boats and aircraft as counterfeit drugs are getting into Ireland and there is a huge market for them. This must be addressed and it is most important that these matters are properly covered.
The three year rule is very important as people should have experience before starting a pharmacy. In addition, this must also apply to EU graduates because many Irish people have been obliged to qualify abroad owing to the high points needed for pharmacy, which is caused by the serious limitation in places. However, Senator Browne was correct to state that while someone from Newry will be able to practice in Dundalk and to start a shop, the reverse is not true. The rest of the EU should follow Ireland's current actions.
In addition, although the Bill states a person must have linguistic ability, it says nothing about an examination. Members encountered trouble when this issue was discussed in respect of nurses coming to Ireland. I have been informed that were nurses who come from other EU countries obliged to take an examination to ensure their English is good enough, Irish people would also be so obliged. If this is what is required, so be it. One hopes they would all pass.
At present, the Bill describes the pharmacy schools as pharmacy faculties. I presume this is a mistake because we have schools of pharmacy and there are no such faculties at present. In addition, the Pharmaceutical Society of Ireland should be allowed to continue to do things it did in the past, such as awarding honorary fellowships. The Minister and I might be able to get one from it one day and it would be a pity if it were unable to award them. People who have received such awards have regarded them highly. They are usually given to those who have been involved in research work, teaching or something similar.
Ms O'Rourke: That would be nice.
Mr. Minihan: It would.
Ms Harney: The Senator and I should propose each other.
Ms O'Rourke: The other Members would go along to applaud.
Dr. Henry: The Competition Authority has been mentioned. While I can understand why the Minister would want to refer matters to the Competition Authority, the society should have sent its code of conduct to the Minister first. Thereafter, if the Minister believed it was necessary, she could have referred it to the Competition Authority.
The Bill does not mention recertification, on which the Minister was very keen in respect of the Medical Council. Drugs change almost hourly and I seem to have MIMS Ireland to hand continually, trying to look up drugs that are mentioned to me. While this may be a matter for the future, it will be an important issue for the Minister to address.
I am also concerned about the establishment of registers on the Internet. While openness and transparency are desirable, I am unsure whether the names of pharmacists and pharmaceutical assistants should be listed. I presume their addresses will not be included. Has the Minister discussed this proposal with the Garda Commissioner, Noel Conroy? He spoke the other day about draft rules for pharmacies to try to improve safety. The lives of pharmacists and their assistants could be in danger because drug addicts do not merely want to get hold of illegal drugs. They also want perfectly legal ones, such as opiates, steroids, anxiolytics, any sort of analgesics and even codeine cough bottles. I am really concerned about including people's names like this because it would be all too easy to establish, for example, that a particular person would be the keyholder every third night. Moreover, apart from putting that person at risk, the risk of theft of drugs would be much higher. The Minister should reconsider this measure.
The Bill also makes some very good points that may be difficult for existing pharmacies to adhere to at present. I hope this will not mean they will be obliged to go out of business. For example, I refer to the requirement for a private area to which one could take a person to discuss his or her medication. While this is an excellent idea, I was in a pharmacy this afternoon in which it was obvious that the pharmacist wanted to talk privately to another person who was waiting for a prescription. While she did her best to take him to one side to talk, it would be very difficult for the pharmacy in question to acquire immediately a private area. One cannot bring people behind the counter to where the drugs are kept as that would be open to abuse all too easily. I hope existing pharmacies will not be closed down simply because they are unable to fulfil this requirement. They should be required to so do when they are being reconfigured or being built. However, such an obligation would be very onerous on them.
I welcome the Bill. I have prepared many amendments that I intend to table next Thursday and I hope the Minister will receive some of them very well.
It is important to emphasise the existence of those who are known as shadow directors. They have been problematic in the past in other businesses. When dealing with directors, managers and so forth, the Minister must ensure that shadow directors, that is, those who act as directors without being listed as such, are also dealt with. There is much money in the pharmaceutical business and a great deal of it could be at stake if one had people who were in any way involved with any sort of laissez-faire attitude towards what was going on there. The Minister should ensure that such people are also covered by these necessary regulations. I am sure they will be welcomed by the medical profession as well as the pharmaceutical profession. However, I am especially anxious that the Minister would provide clarity on the position in respect of prescribers and dispensers. This is a road we have never gone down before and I would like to see it made into a cul-de-sac.
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