Safety, quality, efficacy: regulating medicines in the UK (HC 255) Public Accounts Committee 5 Mar 2003

Mr. Gerry Steinberg (City of Durham): A very interesting and topical issue at the moment is the Office of Fair Trading's report into retail pharmacy services. One of the suggestions is that one of the results would be is that doctors would be not only allowed but probably encouraged to dispense themselves. If you look at page 35 in the report at paragraph 3.38 it says, "The Department of Health's September 2000 report, Pharmacy in the future, set out the Government's aims to integrate pharmacy services better with other healthcare professions and ensure that pharmacists have a greater role in increasing the benefits patients get out of medicines." That appears to me to be contradictory to what the Office of Fair Trading is perhaps suggesting and one chemist has actually described to me how, if this were allowed to happen, it would virtually be signing death warrants because doctors would prescribe and dispense and they often make mistakes and, as it is often the chemists who discover the mistakes made, this sort of guard would be taken away. What is your view on that?

Mr McKeon: The report of the Office of Fair Trading to Government is still under consideration within the department and therefore by ministers and they have certainly not reached a conclusion about the recommendations nor indeed reached a view on what the consequences of that might be. So, it is a little difficult, in those circumstances, to comment. This is a point of fact perhaps for the Committee. I am sure some of you will know that doctors do indeed dispense and prescribe in rural areas and that there are very strict rules about that and how that should be done. It is actually a popular service amongst the patients who do have dispensing doctors in those rural areas.

Mr. Gerry Steinberg (City of Durham): Only because they cannot get to the chemist shop.

Mr McKeon: Actually, they quite like having the one-stop shop facility.

Mr. Gerry Steinberg (City of Durham): I can assure you that the village I originate from did not have a chemist shop but the doctor dispensed and there was a huge campaign to get a chemist shop, a huge campaign. So, you are wrong.

Mr McKeon: Views differ because we have had different views from people about the value of doctor dispensing. Of course, the OFT report recommended that the rules governing doctor dispensing should also be changed, which would perhaps offer a further opportunity to pharmacists. So, there are swings and balances on this, but the Government have not made any view on that.

Mr. Gerry Steinberg (City of Durham): Dr Munro, what do you think? Presumably, as someone who is licensing medicines, your whole job is to ensure that nothing happens to people on the basis of the medicines that you have licensed. How do you feel about this? Do you think that pharmacists should still have this crucial role which was clearly laid out in the report Pharmacy in the future which could be undermined?

Dr Munro: I have to say that this is not an area for which the Agency is responsible.

Mr. Gerry Steinberg (City of Durham): I am aware of that, but you are an expert.

Dr Munro: I can give you my personal view as an expert. I think - and this is going to sound like I am prevaricating - it is a finely balanced decision and I think that is why the Government are taking time to review it and are trying to come to a well-balanced conclusion.

Mr. Gerry Steinberg (City of Durham): So you are sitting on the fence?

Dr Munro: Yes.

Mr. Gerry Steinberg (City of Durham): Turn to page 14. I have one or two questions on alternative medicines. I understand and I am told that manufacturers of homeopathic medicines have been complaining for a long time now about the time it is taking for you to respond to licence requests for a new product. I understand that once you have acknowledged that you have received a licence request, it should take you 120 days to issue the licence. My understanding is that, at the present time, it is taking a year before you even actually reply to the applicants and then 120 days on top of that. Is that accurate? Why has that happened? What are you going to do about it?

Dr Munro: I am not aware of any such incidences. If you have some specifics or you have a contact about specifics, please make sure that they send them to me because that should not be happening.

Mr. Gerry Steinberg (City of Durham): So, what you are saying is that you are not aware that is happening but that, if there are cases, you are prepared to look at them?

Dr Munro: Yes, I will.

Mr. Gerry Steinberg (City of Durham): Half-way down paragraph 1.18 it says, "The Agency has found no evidence of significant safety risks from the approximately 3,000 older homeopathic products ... However, some have been withdrawn from the market because of problems complying with the evolving EU quality standards." Can you tell me how many products have actually been withdrawn?

Dr Munro: I cannot tell you the exact figure here and now. If you want the precise figure, I will tell you in the same note.

Mr. Gerry Steinberg (City of Durham): I am told also that there are no specific safety risks with some of these products and, if that is the case, I want to know why they have been withdrawn.

Dr Munro: The once instance that I can think of is to do with compliance with the TSE regulations where there is a requirement that licensed products all comply with the guidelines introduced right across Europe and there have been products withdrawn under that context.

Mr. Gerry Steinberg (City of Durham): Perhaps you could give us a note on that. In paragraph 1.19 it says, "The Agency plans to introduce in 2002-03 a new 'national rules' scheme for products that did not meet the eligibility criteria of the original registration scheme." Do you know how many products did not actually meet the criteria of the original registration scheme?

Dr Munro: I would not like to quote a number. This goes back many years and pre-dates me in the MCA. I would need to get that information.

Mr. Gerry Steinberg (City of Durham): Would you give me that in writing as well, please.

Dr Munro: If indeed we have it because this is dealing with products that we have not regulated and I will clarify that for you.

Mr. Gerry Steinberg (City of Durham): There are a number of questions that follow on from that but I can probably see you at the end of this meeting. I would like to move on now to paragraph 3.34 on page 29. I have tremendous faith in my doctor and I suspect that everybody else has as well. So, the number of people who take no notice of the patient information leaflets in the statistics came as no surprise to me. It says that only 30% read all the information and that 8-12% do not read it at all and I would certainly be included in those statistics. In fact, when I saw that, I had some tablets in the cupboard and I went to look for a leaflet and, sure enough, there was a leaflet in the box of Ibuprofen, which I had never opened and had never looked at. When I looked at it and thought to myself that I should have read it, I was quite horrified at why you should not take the medicine if you suffer from certain things. Frankly, I would not read that and I am surprised that it is as low as 12% who do not read it. How can you make the patient information leaflet more attractive? My other question is, why on earth do doctors prescribe medicines to people that could have an effect? Surely they should know what their records are. For example, it says here, "Have you a bleeding disorder?" and "Have you a history of an active peptic ulcer?" If they have, surely the doctor should never have prescribed these tablets in the first place.

Dr Munro: There is a whole range of questions in there. The first point I would make is that it is only since 1999 that there have been patient information leaflets approved for all the 15,000-or-so medicines in the market. We have recognised for some time the need to improve and clarify them. The CSM has had a working group on this and has produced guidelines and best practice for these documents, some of which have now won awards from the Campaign for Good English, but clearly not all of them. In terms of the information that is provided, much of that is currently undertaken by European law and manufacturers are obliged to put on to that patient information leaflet the same information which is on their standard particulars and is in the licence.

Mr. Gerry Steinberg (City of Durham): It says in paragraph 3.5 that the United States have simplified their drug fact sheets for over-the-counter medicines. Do you have plans to do that?

Dr Munro: The difference with the States is that they had a gap to plug with their over-the-counter medicines. Regrettably at the moment, we are tied to following the European rules even for those. We are actively campaigning to get more flexibility into those rules during the current review of the European regulations and, at the same time, are striving to influence industry in best practice and commonsense in making the information clearer and putting the important information to patients or doctors very clearly into these leaflets in a prominent position.

Mr. Gerry Steinberg (City of Durham): What about the question regarding doctors themselves? It seems to me damn carelessness if you have a family doctor such as the same one I have been going to since I was a babe ... Well, not the same doctor because he is probably dead and gone now but the same practice and surgery. It seems ludicrous to me that he could prescribe a medicine for me that might be dangerous to me when, frankly, he should know my records. It is all well and good to say that you cannot look at everybody's record, but presumably they have computers these days and they just press a button. Indeed, I often look over my doctor's shoulder to look at what is on the screen and it details every medicine that you have been given and your whole record. It seems quite lax of a doctor to prescribe you medicine which could be harmful to you.

Dr Munro: I would not expect a doctor to prescribe a medicine that is harmful to me, but it would not stop me wanting to know what the potential side-effects of the medicine were and I think the patient has a right to see all that information but in a clear and precise form.

Mr. Gerry Steinberg (City of Durham): So you would not expect a doctor to do that?

Mr. Gerry Steinberg (City of Durham): I read this report and was frankly quite alarmed at the apparent - and I do not want to say "incompetence" - attitude of doctors. There are two issues in the report that I think are a grave cause for concern. The Chairman touched on one of the points when he first opened the meeting on the adverse effects of drugs and he actually mentioned some of the issues. I would like to read them out again. "The most common reasons given by GPs and hospital doctors for not reporting adverse effects of medicines" and the Chairman skipped over them in what I thought was a very friendly manner but I want to be more aggressive. "Not my responsibility to report". If it is not a damned doctor's responsibility to report, whose responsibility is it? "Too busy" - big deal. Too busy to report and too busy to fill in the yellow card. "It is not easy to find a Yellow Card when necessary." He might have to move two or three yards to pick one up. These are outrageous excuses and people could actually die because of this. It is just a lax attitude and I think that you have a responsibility to do something about this. I think it is outrageous.

Mr McKeon: I agree entirely that some of the statements in the report there are very surprising, to say the least. There is a point about actually focusing the attention of doctors, not just about medication and medication errors but about safety in general, and that is one of the big campaigns of the Chief Medical Officer and the work that he has been doing in a series of reports in establishing the National Safety Patient Agency in order to address those kinds of issues. I have to say that it is not just about doctors, it is about health professionals in general and that has been, as I say, one of the big personal campaigns, and indeed the Government's, in actually seeking to address that kind of approach. Safety is an absolutely prime subject.

Mr. Gerry Steinberg (City of Durham): That was one case but if you look at the report, you will see in figure 18 that there were 13 deaths in 15 years because the doctors or the surgeons did not read the instructions correctly and they injected into a patient's spine rather than into a vein, or that is the way I read it. That is just damned incompetence. Thirteen people have died because of pure incompetence and, in my view, because of the laziness of some doctors or the lack of concern of some doctors. Then you have another example in the report where, for four years in a row, they were warned about a certain indigestion tablet yet they took no notice and, in the end, you had to withdraw the tablet. There seems to be a total disregard of the safety of patients by some doctors. Presumably, Dr Munro and Mr McKeon, you have a responsibility and you have to be giving us guarantees this afternoon that this is going to stop and that doctors are going to be made aware of what the situation is because it seems that you can apparently just throw people's lives away.

Mr McKeon: We can certainly say that we are making every effort to make sure that doctors are fully aware of their responsibilities and of the importance of safety and are introducing systems that would help with that. There has been a particular inquiry into what happened with vincristine, which is set out in the report, and what emerges is that there were a number of things that needed to be put right. It was not just one individual junior doctor in this case but a number of things about the system which had to be put right as well as the training of the individual.

Mr. Gerry Steinberg (City of Durham): He was the thirteenth person to die.

Mr McKeon: Yes, indeed, and I agree that it should not have taken that long to put the system right.