Health Bill |
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Jane Kennedy: The hon. Gentleman asked many detailed questions. If I miss some of them, I may need to write to him and to the Committee. I shall begin with a couple of quick responses. On the hon. Gentleman’s fears about extensions to independent prescribing—that is, the role of nurse prescribers and, to a degree, of pharmacy technicians—controlled drugs would not be prescribed. Even in the case of palliative care, a nurse prescriber would prescribe such drugs only if directed by the clinical management plan agreed by a doctor. With regard to vets, there are observers from the Department for Environment, Food and Rural Affairs and the field of veterinary science on the controlled drugs advisory group, and we are working with them to develop policy in that area. The hon. Gentleman has caused us to pause for a moment to consider the serious circumstances under which we are doing this work. As he said, the role of the accountable officer is part of a package of provisions intended to strengthen the governance and accountability arrangements for the safe management of controlled drugs in health care. The clause provides the legislative framework for the programme of action in the Government’s response to the fourth report of the Shipman inquiry, which I mentioned earlier. Controlled drugs are medicines that are used to treat a variety of clinical conditions, such as severe chronic pain in palliative care. They are subject to special legislative controls because of the potential for abuse. As the hon. Gentleman correctly pointed out, that potential was illustrated by the Harold Shipman case, which led us to introduce these additional measures. A key finding of the Shipman inquiry was that a variety of people had concerns about Dr. Shipman’s practice, but no single person had ever drawn together those concerns or the information held by individuals. The accountable officer will be responsible for all aspects of the safe and effective use and management of controlled drugs. The accountable officer will have information on the requisitioning, storage and destruction of controlled drugs in their organisation and information on the quality and quantity of prescribing and dispensing such drugs. That list may have answered some of the points that the hon. Gentleman raised. The disposal of controlled drugs is specified in clause 23, which we have not yet reached. It defines the accountable officer’s responsibility to include disposal. The witnessing of destruction is covered in regulations to the Misuse of Drugs Act 1971. Some of the proposed changes to those regulations will provide accountable officers with a great deal of information about the prescribing habits of professionals in private and NHS practices. The data will be collated nationally and any discrepancies will be highlighted to
Many of the measures required to enhance the audit trail will be covered by the Misuse of Drugs Act 1971, which is managed by the Home Office. I reassure the hon. Gentleman that officials from the Department of Health are working closely with the Home Office to put in place the measures that are necessary. It is our intention that all private prescriptions will be collected and analysed, all prescriptions for controlled drugs will require prescriber identification and all orders from manufacturers and wholesalers will be collated and analysed. We are discussing restrictions to the prescribing of controlled drugs with the GMC, the General Dental Council, the Royal Pharmaceutical Society and the Nursing and Midwifery Council. We are currently working on that issue and, in some cases, those organisations are consulting their members on restrictions on prescribing. They are considering whether, for example, a practitioner should be able to prescribe controlled drugs for themselves or for their family. They have all been key stakeholders in developing the approach we adopted and I am grateful for the co-operation we have received from the professions in doing that. In NHS primary care, the accountable officer of the primary care trust will be responsible for all its independent contractors, such as GPs, dentists and out-of-hours services. All NHS secondary care providers will be required to appoint an accountable officer. We accept the need for better oversight of the use of controlled drugs in the NHS. No one studying the Shipman case who then saw the outcomes of Dame Janet’s inquiry could argue with that. However, I have been persuaded that it is better done at local level as an integral part of the local clinical governance machinery. The Healthcare Commission will give additional assurance that local arrangements are fit for purpose. The hon. Gentleman will be pleased to hear that we will make regulations to provide detail on which organisations must appoint an accountable officer and the criteria for that appointment. We have probably already covered that subject. The regulations will set out the responsibilities of the officer in relation to the management of controlled drugs including storage, carriage and safe custody, prescribing, administration, recovery and disposal of these drugs and the requirement to follow best practice. The regulations also allow for the creation of offences punishable by a fine, as we discussed briefly, and for other procedures for enforcing the provisions. Although we cannot guarantee that the provisions would prevent another Harold Shipman, we are confident that poor practice would be detected much earlier if such measures were in place. That is why I am happy to commend the clause to the Committee. Question put and agreed to. Clause 16 ordered to stand part of the Bill. Column Number: 366 Clause 17 Co-operation between health bodies and other organisations Dr. Murrison: I beg to move amendment No. 15, in page 16, line 47, at end insert—
The Chairman: With this it will be convenient to discuss amendment No. 16, in clause 20, page 19, line 14, at end insert—
Dr. Murrison: I was so taken with the Minister’s speech that I felt I ought to reflect on it and I could not find my place, but I have now. We are largely content with the clause, but it deals with issues of confidentiality that trouble us a little. In my rather discursive remarks on clause 16, I said what I needed to say but I shall reiterate it in the context of clause 17. We need to be clear about the transfer of patient-identifiable material between various health bodies. That worries me considerably. I cite the example of a methadone clinic, where we are dealing with people who are quite vulnerable. We are not only dealing with the generality of medical practice, which is important in itself, but on top of that we are talking about people who have a range of conditions that are sensitive in many respects. Controlled drugs can be used for a variety of things. They can be used for palliative care, but they can also be related to drug abuse and other sensitive areas of practice. Therefore, it is particularly important that we pay close attention to issues of medical confidentiality. We need to be clear that in transferring material from one body to another for the purposes of the clause, we are doing so in a way that is highly sensitive and preserves, as far as possible, the confidentiality of those individuals. During this brief debate, I want to press the Minister on that matter and seek her assurance that she recognises the extent of the potential abuse that could take place and the possibility that people will be dissuaded from seeking medical advice for particular conditions if they are not absolutely confident that the organisation that they are seeking attention from will deal carefully and sensitively with information given to it in confidence. The way in which the provisions are drafted means that there is the potential for the whole thing to look far more diffuse to somebody who is seeking help in that way. That is my chief concern. We have talked about how Dame Janet’s initial recommendation might be of assistance in that respect, but clearly the Minister has chosen a different pathway. I hope that she can give me some assurances about the use of the information, particularly in respect of confidentiality. Jane Kennedy: We do not feel that the amendments are necessary. I hope to reassure the hon. Gentleman that the necessary safeguards already exist. We already plan to provide advice to organisations to ensure that patient confidentiality is upheld. We have already
I appreciate the spirit in which the hon. Gentleman has moved his amendment. He is right to reinforce the need to protect patient confidentiality. We believe that the clause does that and that the protocols and procedures are already in place to ensure that. However, I take his point. I hope that he will withdraw his amendment and accept the reassurances that I have offered. Dr. Murrison: The Minister has sort of given me some reassurance. Obviously, she understands that this is a difficult area. I suppose that there is no obvious way forward. At the end of the day, if we are going to safeguards patients, clearly there will have to be some sort of transfer of information. The purpose of amendments Nos. 15 and 16, which apply to clauses 17 and 20 respectively, but which are closely related, was to make the Minister aware of our concerns about confidentiality. We have expressed those concerns elsewhere in connection with NHS Connecting for Health and NPfIT and no doubt we will return to the matter at greater length at some point in the future. Some people might be discouraged from seeking treatment, which is a pity. However, at the end of the day, I guess that a judgment has to be made. I accept the Minister’s assurances and recognise that if we are to enhance the safety of patients, we will have to allow the transfer of information. I hope that it will not be patient-specific unless absolutely necessary and that it will be generic wherever possible. With that in mind, I beg to ask leave to withdraw the amendment. Amendment, by leave, withdrawn. Clause 17 ordered to stand part of the Bill. Clause 18 Controlled drugs: power to enter and inspect Question proposed, That the clause stand part of the Bill. 3 pmSir George Young: The Committee should pause for 90 seconds—the length of time for which I propose to speak—before it confers on somebody other than a police officer the right to enter a citizen’s home against their wishes, which is what the clause does. From the definition of “any relevant premises” in subsection (7)
If one considers subsection (2), which puts parameters around those powers, all one needs to do to exercise those powers is to turn up at a reasonable hour and produce the written authority of the person exercising them. The constraints seem rather flimsy on what could be a draconian power, particularly if one considers subsection (3)(b), when the person who has the power can take away relevant records kept on the premises. The least I should expect under subsection (2) is reasonable grounds for suspecting that an offence might have been committed, or, under the clause, guidelines about when the Government envisage the appropriate exercise of those powers. There is very little about that. This is a potentially draconian power. It will be given to an authorised person, as defined in subsection (4), who can turn up any time before 9 o’clock at the home of a GP or a pharmacist and, with a letter, which is the written authority of the person exercising the power, demand to come in. We should pause for 90 seconds and press the Minister about exactly how those powers will be used. The House has been sensitive about giving tax and VAT inspectors and Revenue and Customs employees the powers to enter peoples’ homes against their wishes. However, clause 18 extends that privilege with, as far as I can see, very little explanation about when the powers might be used. Jane Kennedy: I have thought long and hard about the matter, and I share some of the right hon. Gentleman’s concerns that we should not take those powers lightly, and nor have we. Physical inspections, the power to enter the premises and to inspect, and the general powers in the clause are only one aspect of the new monitoring and inspection arrangements. Persons exercising those powers would not be able to enter the home of a GP or a pharmacist unless that home was used for the provision of health care or for the supply or administration of a controlled drug. That is the proviso. When an inspector turns up to carry out a routine inspection, there will be no problem and the inspection will be complied with. A number of people, including in the case of pharmacists, the Royal Pharmaceutical Society, can do that. We anticipate that there may be occasions when objections will be made, but it is necessary to allow the inspectors the right to insist on being granted entry. The intention is that routine inspections should normally be carried out by the accountable officers appointed under the clause that we have just debated. Inspections will be carried out also by regulated bodies that already have powers of entry. As the right hon. Gentleman rightly said, the powers may be used only at reasonable hours and with the production of written authority. The regulated bodies are not explicitly mentioned in the clause, as many already have powers
I appreciate the concerns that the right hon. Gentleman has raised. The provision is not as draconian as he fears it may be; it will be used only on rare occasions and probably when there are already concerns about the premises to be inspected. I hope that he will reflect on my comments as I shall reflect on his. We have not taken the powers lightly; we have thought about them carefully. In the context of the other package of measures that we are putting forward, the provision is an important part of the Bill. Question put and agreed to. Clause 18 ordered to stand part of the Bill. Clause 19 Offences in connection with power to enter and inspect Question proposed, That the clause stand part of the Bill. Dr. Murrison: There is very little with which we could take issue in the clause, as it is reasonably technical. However, I seek the Minister’s clarification. As I understand it, the clause would give penalties similar to those outlined in section 23 of the Misuse of Drugs Act 1971 in respect of a failure to allow access to the relevant person to commercial premises that have to do with controlled drugs. If the Minister were able to confirm that the penalties and the offences that are set out in the clause are similar to, and comparable with, section 23 of the 1971 Act, we would be content. Jane Kennedy: I can give the hon. Gentleman that assurance. Those things are comparable. I hope that, in that brief way, I have been able to reassure him. Question put and agreed to. Clause 19 ordered to stand part of the Bill. Clauses 20 to 23 ordered to stand part of the Bill. Clause 24 Requirements about supervision Jane Kennedy: I beg to move amendment No. 90, in clause 24, page 21, leave out lines 10 to 14 and insert—
The Chairman: With this it will be convenient to discuss Government amendment No. 91. Column Number: 370 Jane Kennedy: My habit in Committee is usually to move relatively quickly in order to make progress and to answer briefly at the end of a debate any concerns raised. The clause seeks to make clear our intention to set out in regulations the requirements as to the conditions that must be complied with before a pharmacist may discharge his duty to supervise from another location, which is what we are introducing as part of the clause. As originally drafted, the measure provided simply that regulations could be made to specify what would constitute adequate supervision. If no regulations were made, the measure as originally drafted did not clarify whether or not the use of remote technology was otherwise acceptable. The provision is fairly straightforward, so I will sit down and see whether there is further debate on it. Dr. Murrison: We have some concerns about the clause, which I hope that you will allow us to express in a clause stand part debate, Mr. Illsley. We seek clarification of the Minister’s expectations of pharmacists in respect of telemedicine and remote supervision of the sort that she mentioned. It is important that she understands the limitations of those media, and it is not clear from what she briefly said that she does. I would be grateful for further clarification about exactly what she is getting at by tabling the amendments. Jane Kennedy: The amendment will clarify the pharmacist’s obligation and will make provision for the appropriate use of new technologies that enable pharmacists to supervise dispensing activity safely when away from pharmacy premises. The hon. Gentleman is right that we must consider what those technologies are. We intend to set out in regulations where the pharmacist is required to be personally involved in the preparation, sale and supply of medicines, or the supervision of those activities, and the conditions for use of new technologies. For example, the conditions might include the use of technologies such as robotics or a video link, which can help the pharmacist meet their supervision obligations from another location. That is what we mean by remote supervision. With the aid of appropriate technologies, the pharmacist may continue to meet his or her responsibilities, through the ability to remain in contact, to provide professional advice to staff and patients. In most circumstances, use of a telephone alone would be insufficient to meet the pharmacist’s supervision requirements. It would not allow the pharmacist to check the prescription being dispensed, and he would be reliant on information from pharmacy staff. Effectively, we are tightening the provisions. However, there are technologies that allow the pharmacist to see a prescription electronically. Also, video links can support face-to-face contact with both staff and patients. We want new technologies to be used in a way that maintains patient safety. We intend to consult key stakeholders on the regulations, including conditions that could support remote
Amendment agreed to. Amendment made: No. 91, in clause 24, page 21, leave out lines 23 to 27 and insert—
Question proposed, That the clause, as amended, stand part of the Bill. Steve Webb (Northavon) (LD): I am grateful for the opportunity for a brief stand part debate, because we are now on a new chapter of the Bill. It would be helpful if the Government could put on record a bit more of their thinking, because the clause gives them power to make various regulations. The pharmacists of Britain want to know a bit more about what is intended, so that they can plan ahead. I hope that the Minister will take our questioning in that spirit. We just want to understand a bit more about what is planned. It is my understanding of the clause and this chapter of the Bill that the Medicines Act 1968 contained the concept of personal control by a pharmacist, to the extent that if the pharmacist pops over the road to a shop, or something like that, certain things cannot be sold. We are moving from that situation to one in which the pharmacist has to ensure that things are done under the supervision of a “responsible” pharmacist, not necessarily one on the premises. We have just heard the beginnings of a discussion about whether that would mean having a pharmacist on the other end of a video link, or that the pharmacist had put in place some other alternative arrangement. I admit that I have an open mind on the subject. Certainly, it seems a reasonable assumption that there may be people working in pharmacies other than fully qualified pharmacists who have skills that have not so far been tapped. I am all in favour of using the talents of those who have already had some training and could do some things. The problem is the all-or-nothing nature of the provision. In one way, I am more relaxed about a pharmacist being on the other end of a video link in another pharmacy than about a pharmacist simply being off the premises and therefore uncontactable in some sense. The Minister may say that the Government are asking pharmacists to put in place structures—that is, to train people, to have procedures and protocols, and to have feedback at the end of the day on what was prescribed and to whom, and so on. It seems an all-or-nothing issue, because currently we say that a person cannot be sold medication that is not on the general sale list unless the pharmacist is physically there, but clause 24 and succeeding clauses take away that
Jane Kennedy indicated assent. Steve Webb: The Minister nods, which is interesting. So, have we been over-regulating, or are we reacting to a shortage by lowering standards? If we are saying, “Actually, we never really needed the pharmacists to be there, and 37 years on, we have just realised it,” then that is a strange argument. The regulatory impact assessment says that the provisions in the 1968 Act were unclear in that respect, which is interesting. We have got by with them for 37 years, and only now do we seem to need to clarify them. That is surprising. What sorts of requirements are we talking about? The Royal Pharmaceutical Society has suggested that the regulations should include provisions for the responsible pharmacist to be contactable when absent and in a position to return without undue delay. It would be helpful if the Minister could clarify whether that is the sort of thing that the Government have in mind. For example, if simply being on the other end of a video link is good enough, why should not a qualified pharmacist be in charge of not one or two but 10 or 15 pharmacies? He or she could sit in front of their video link all day, dispensing—if that is the right word—wisdom. In respect of clause 24 and later clauses, once we have agreed that someone does not physically have to be present, there is no obvious reason why the number should be restricted to two or three. There is the potential to go a long way from where we are now. The Minister may say, “No, we don’t mean that, we just mean they can pop out to meetings with local GPs for half an hour,” but either pharmacists need to be there or they do not. If they do not need to be there, but just to be accessible, the powers given by the clause could be far-reaching. 3.15 pmHowever, unless the Government intend to specify in regulations that pharmacists can be responsible for, say, only two premises simultaneously, or if no limit is specified in regulations, the change could be far more radical than we have been led to believe. I have misgivings about the view that we have been wrong for 37 years and now we need to change, that the regulations so far have been unduly restrictive and that it is safe to relax the restrictions. The Committee must therefore know far more about what the Government plan to put in the regulations that the clause gives them the power to introduce. I have a number of reservations and anxieties and I look forward to hearing what the Minister has to say. Dr. Murrison: What has changed in the past 37 years are the expectations we put on pharmacists. The hon. Member for Northavon (Steve Webb) made an interesting point: he asked why limits were being imposed and why there could not simply be a central pharmacists’ bureau—“Pharmacy Direct” or something like that—from which someone sitting
What seems to have changed in the past few years is what we expect of pharmacists. What Ministers expect, and what Conservative Members would support, is the extended role of the pharmacists, which means face-to-face contact. I do not know the intention of the limits that the Minister wishes to set on the absence of pharmacists from their premises, or what drives it. It is said to be safety, but I suspect, and hope, that it might be more than that. I hope that it is a desire to increase the extended role of the pharmacist in respect of the services that they offer, not just in the community, which is stated in the guidance note, but also in their premises. That means face-to-face contact; giving authoritative, credible advice to patients who visit those highly accessible premises. We have probably all visited pharmacists in our constituencies who are expanding their role—they measure blood pressure, do tests for diabetes and a range of other things—and pushing the boat out in terms of the responsibility that they are prepared to accept, the sort of advice they give to people and the autonomy with which they practise. For that to work, there must be an accessible pharmacist in the practice. If they are not accessible, they are nothing at all. In recasting their image of pharmacists, people are looking for someone who is there, and accessible. The advantage that pharmacists have over GPs is that they are in the high street and behind fewer barriers than is traditionally the case with general medical practitioners. I hope that such thinking lies behind the Minister’s intention that there should be a limit on the number of practices that pharmacists are able to supervise. If that is not the case, I am inclined to agree with the hon. Member for Northavon that all that would be needed was some superintendent pharmacist, remotely located, sitting behind a computer screen and fielding calls from the periphery put in by people with a basic level of training perhaps not that much greater than that of anybody who is engaged in selling a product. If that is the case, the safety case for restricting the number of premises pharmacists can supervise has not yet been made to my satisfaction. I know that it has been cited by representative bodies of the pharmaceutical profession, and they may be right. However, to date, I have been less than convinced that they are. I am wholly signed up to the idea that if the role of pharmacists is to be extended and people are to have confidence in pharmacists in their new role, which is what we all want to see, then it has to be conducted one to one and face to face rather than one conducted at arm’s length from some remotely located office. Column Number: 374 |
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