Draft Pharmacy Order 2010


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Mark Simmonds: I thank the right hon. Gentleman for his intervention. He makes a sensible point. I am not trying to demean the role of industrial pharmacists, who clearly play a fundamental role in the research and development of pharmaceutical products. Down the chain, they have a direct link with and importance for patients. My point is about ensuring that the regulatory role undertaken by the MHRA with respect to industrial pharmacies is not duplicated and replicated by the order.
May I also probe the Minister a little further about the retired pharmacists? Again, I take her point about the non-practising register. However, in times of emergency —for example, if the UK had suffered greater prevalence rates of swine flu that were more serious—there might be an active role for retired pharmacists with such expertise in providing the relevant drugs to the patients who need them.
I am concerned that we might not have either a register under which retired pharmacists can keep up with pharmaceutical advances—a point made by my hon. Friend the Member for East Devon—or an ability for the pharmaceutical bodies to know who they can call back in to assist.
Those issues need to be thought about. It would be helpful if the Minister explained with even more clarity and detail why she and her civil servants have concluded that it is not appropriate to have a non-practising register.
The Minister rightly mentioned the fact that Northern Ireland has for the moment opted out of the regulation. It would be helpful for those in Northern Ireland if she set out—if she knows or has the information to hand—why Northern Ireland has decided not to participate in this change of regulatory structure. Does she know the time scales within which they might feel it appropriate in Northern Ireland to do so? If they do not do this, other issues will be thrown up that involve the future of pharmacy in Northern Ireland, which I think would be easier to develop under this structure than the previous one. However, the Northern Irish people and the pharmaceutical society there are to maintain it for the present.
Paragraph 36(5)(b) of the order will allow different fees for different geographical locations. Is that merely to allow the Welsh and Scottish to have different fees from the English, or is it to have different fees in every primary care trust area in England? That matter causes some concern.
Another issue that has been drawn to my attention, in the context of pharmacies taking on additional service provision, is the importance of cleanliness in relation to many pharmacies. The GPhC has produced draft guidelines, which quite rightly refer to the need for good hygiene. However, they do not directly refer to the responsibility for preventing health care-associated infections.
Some pharmacies operate in hospitals, some of which have a big problem with hospital-acquired infections. The Minister will be aware that the issue was raised in the Council for Healthcare Regulatory Excellence consultation document. It will be interesting to know why she and her officials have decided not to ensure that that important point about preventing health care-associated infections is included in the guidance.
My seventh point regards premises inspections. The Minister rightly referred to a point that has been put to her, to me and, I am sure, to the hon. Member for Romsey, which is potential duplication. Clearly, there is a role at the moment for primary care trusts in ensuring that pharmacy premises are suitable or fit for purpose. That seems to duplicate the role.
The Minister mentioned sharing information, but that is not the same as ensuring that there is no duplication of responsibility and role. Is the Minister proposing to remove that responsibility from PCTs? Where pharmacies are co-located in GP surgeries, as with dispensing practices or in hospitals, will the whole premises have to undergo inspection by the GPhC? We must be careful to not overburden pharmacies with administrative and regulatory duplication, particularly when we are keen for them to take on a larger role in providing services and to spend more time with their patients.
The Minister also referred to the core issue of the ability of pharmacists who qualify abroad to practise in the UK. We must be absolutely sure that we do not have the same situation that we had in that terrible and tragic case of a GP providing out-of-hours services in Cambridge, when he could not communicate with the patient, nor did he seem to have a detailed understanding of the drugs he was dispensing.
Mr. Swire: My hon. Friend makes his customary excellent points, not least on the ability for pharmacists to be able to communicate properly and understand what they are prescribing, and, as importantly, for the patient to understand what they are being told. However, is he slightly concerned about whether there are sufficient checks inherent in the order to ensure that the qualifications provided by pharmacists coming from overseas are genuine? Is he convinced that enough is being done to put in place a mechanism so that those credits and qualifications are subject to regular checks?
Mark Simmonds: I thank my hon. Friend for his pertinent intervention. He is absolutely right. The simple answer is yes, I am concerned—not about some of the more developed countries in the EU, but about some of those countries that have joined the EU more recently. I am also concerned about the situation whereby pharmacists can qualify outside the EU, get a certificate to practise in another EU country and come to the UK off the back of that historical qualification.
It is critical that the Minister clarifies what safeguards are in place to ensure the safety of patients in the UK and tells us what rigorous checks must be undergone before a pharmacist who has qualified elsewhere, either in the EU or in the rest of the world, can get on to the UK register and be allowed to practise. The wording on the ability of a pharmacist to get on to the register seems to be confused, just as it is in relation to “visiting” pharmacists who move from one part of the register to another. The combination of issues relating to “visiting” pharmacists who might come from outside the UK is causing concern.
My next point relates to paragraphs 34(2) and 35(1) on groups of pharmacists. If I have read the order correctly, it appears to allow groups of persons to be entered on the register in the event of an emergency without first identifying who those individuals are. That could be dangerous. Who will check and ensure that they are fit to practise? That would be particularly important in an emergency.
Under paragraph 35(1), people and groups are given the ability to
“order drugs, medicines and appliances”,
seemingly without being suitably qualified to do so. I would like the Minister’s reassurance on that. I accept that I may have misinterpreted the clause, but it would be helpful for the Minister to explain what criteria and safeguards are in place and tell us that she has received assurances that such provisions will be safe and in the best interests of patients.
My final point is not specifically related to the order, but while the Minister and senior pharmacy civil servants are here, it would be helpful if she confirmed what progress the Department has made towards decriminalising dispensing errors. The initial guidance was expected before now, in relation to the 1968 Act.
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Sandra Gidley (Romsey) (LD): I would like to add to the comments made by the Minister and the hon. Member for Boston and Skegness—I hope my voice lasts. I will start by declaring an interest. I am a fellow of the Royal Pharmaceutical Society of Great Britain and I am also on the practising register, which provides a few challenges from time to time. The vast majority of pharmacists recognise the need to split the society, as it has perhaps not performed either part of its dual role as well as it should have. There is recognition that the public increasingly expect a body to concentrate just on regulation.
I must start with a little bit of a rant. I was quite offended by some of the comments in the explanatory notes. The notes claim that one of the benefits of a new regulator will be that changes in regulation resulting in “fewer dispensing errors”. I would love to know the evidence base for that, because I do not believe that any pharmacist goes to work in the morning expecting to make a mistake. The concern of any professional is to get it right for the patient, not for the regulator. I found that a rather strange statement.
I agree that dispensing error rates are possibly too high, but over the years many firms and individuals have made strenuous efforts to identify causes of errors and take steps to reduce them. The only advantage of changing the regulator or the regulatory powers would be if the regulator had powers over the employers. In my view, one of the biggest causes of dispensing errors is tiredness. Some companies expect pharmacists to work for eight, nine or 10 hours without a break, and nobody seems to have any power to address the problem or put a stop to that practice.
At a time when we have measures such as the working time directive, with which not everyone always agrees, it is important that the regulator has the power to look at working conditions. I might have overlooked such a provision, but I could not see one in the documents. I could make the same comments about the avoidance of serious misconduct incidents. None the less, I support the proposed separation.
I want to mention the race equality impact assessment, because 20 per cent. of the profession are Asian. Some ethnic minority groups have expressed concern that a disproportionate number of the cases being taken to the stat comm involve ethnic minorities. It would be helpful to have some means of monitoring whether there is a fault in the process or whether something is fundamentally wrong with how cases are brought to the attention of the council.
The shadow body, which the Conservative spokesman mentioned, has been set up under the chairmanship of Bob Nicholls, but I understand that no member can be officially appointed until the order is approved. I gather that the new council has held a few informal meetings. Surprisingly, the draft council appears to be consulting on a new set of standards. The RPSGB already has a good code of ethics that was reviewed as recently as late 2007. It was a lengthy and open process involving the profession and members of the public and it was independently chaired by Professor Sheila McLean, a medical ethicist of international repute.
The RPSGB produced a code with seven clear principles that put patients at the heart of the agenda, of which we would all approve. As far as I am aware, the code has not led to any problems, so, on the basis of “if it ain’t broke don’t fix it”, will the Minister explain what the problem is with the current code of ethics and why there has been such an unseemly rush to consult on a new code, which the new body will not own. The Department of Health appears to have taken rearguard action, to no apparent benefit. If the Minister clarifies why that action has been taken, it might put some pharmacists’ minds at rest.
Paragraph 5 of the order states:
“Before setting any standards or requirements under this Order, the council must consult”.
How can a council that does not officially exist consult on something into which it has had no input? Will the Minister explain why the existing standards were not adopted as an interim measure, enabling the new body to work with the existing standards and adopt them in the light of experience? That would seem to be a much more sensible and pragmatic way forward. I suspect that the Minister is unaware of what is going on.
It is not only me who is expressing concern. The consultation period had to be completed by 12 January, which coincides with the busiest time of the year for community pharmacists, many of whom will not have had time to study the proposed changes in depth. The English board of the pharmaceutical society has raised concerns, and the issue has become the election platform for the next round of board elections.
I am not sure whether I am allowed to use the word “cack-handed”, but the way the issue has been handled risks alienating a profession that supports most of the aims of the GPhC.
I welcome the standards for retail pharmacies, but I would have liked the opportunity to be taken to tackle hours at work. Also, the council has to establish an inspectorate. The start date is supposed to be April 2010—is that still realistic and will existing pharmaceutical society staff automatically transfer over? If not, is there still sufficient time to get an inspectorate in place?
Paragraph 13(3) deals with improvement notices. I note that a notice is deemed as served
“if it is sent by first class post”.
The Department obviously has more faith in the postal service than I do. Should not the legal minimum be recorded delivery, especially as non-compliance could eventually lead to removal from the register. I would have liked that provision to be beefed up.
Part 4 deals with the register, which will be much more extensive than that which currently exists. Paragraph 19(3)(g) refers to
“the recording of continuing professional development matters”.
Does that mean that a complete CPD record must be present or will that part of the register be used just to note problems of which the registrar is aware? I am not sure that that is entirely clear. At the moment, not all recorded information is published. Will the Minister clarify which parts of the register will be matters of public record and which will not?
Finally, I want to pick up on something the Minister mentioned. She talked about the fitness to practise cases that are already in train and may be finished. My understanding is that there was, at one stage, a significant backlog of fitness to practise cases at the RPSGB. Will cases that have already been referred to the society have to go through that body or will cases that have not reached a certain stage be transferred to the new body? Again, that would impact on how much work the new regulator could deal with from day one.
I want to mention titles. It is a shame that the non-practising register is being dropped as it was very useful. Many people who have objected regard themselves very much as pharmacists. They have been years on the register and do not see why that should be taken away. They will not misrepresent to the public; they have pride in what they are and in the profession. Calling themselves a retired pharmacist does not quite satisfy them.
I ask the Minister, if that is such an important principle to apply to pharmacists, do the Government plant to introduce the same regulation for doctors? Far more people who have the title “Doctor” are sloshing around the system than there are retired pharmacists. It seems that society would be better served by better transparency over who is a proper registered medical practitioner, rather than penalising people who have served a profession well all their lives only to be told that, no, they cannot use that title any more.
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