Home » medicines
Category Archives: medicines
I am not sure what made me think about and look for this report: ‘N=1: Why people matter in medicines.’
Perhaps it was all the talk last week about the Department of Health’s 11th report to parliament on the Pharmaceutical Price Regulation Scheme (PPRS) - in essence the way in which drug prices are set – and the steps being taken to introduce a new system called ‘value-based pricing.’ Or the paper also published last week suggesting that the design of clinical trials is often inherently flawed and ultimately unhelpful to clinicians because studies look to answer the wrong question. That is, rather than looking at the benefits of one treatment compared to another, they compare the treatment against placebo. Or the fact that the Royal College of Physicians will be much in the news today for other reasons.
It certainly wasn’t this post on ‘Scrubbing Up’ on the BBC site and which I only heard about today. Although the article made me feel very angry indeed, after taking a step back I realised that it only served to prove my point in this blog that we are not thinking through the issues around medicines development and use. As follows.
‘N=1: Why people matter in medicines’ is the report of the sub-group of the Royal College of Physicians Medicines Forum. This working party was brought together to look at the medicines pipelines from a patient perspective.
Chaired by Harry Cayton, its members included patients, regulators, health professionals, academics. We took evidence from people such as Ben Goldacre, Fiona Fox from the Science Media Centre, Boots the chemist, charities and others. We also went out in the field visiting a GP surgery and a hospital pharmacy.
The report was completed last June and press released in September but it is quite hard to find on the College’s website unless you are looking for it. Nor did it get much coverage anywhere else as far as I can tell. So, I thought I would post its recommendations here for good measure (see below).
The overall conclusion will not be a surprising one for many people: that the way in which medicines are developed and prescribed could be more effective and efficient if designed around the needs of patients. That it is not, can be pointed to as a key reason for the current inefficiencies in prescribing practice; why many patients do not keep to their medicines regime Reform of the system has to be approached in a radically different way that focuses on making the system work holistically from a patient point of view as opposed to being preoccupied with making ‘disobedient’ patients more compliant. Instead of ‘concordance,’ think coherence.
And the report did propose some radical new approaches: every GP practice should have access to a local pharmacy adviser to whom patients could be referred for help and support; the better use of IT for prescribing; development of a patient formulary for the public to help them find better information about medicines and their impact; and the need to listen more closely to the way in which patients talk about their experiences of medicines and find ways of translating this into clinical practice so that patients and doctors are speaking the same language.
This might not be the right day for this blog, but there is no time like the present as they say.
Before I go, a quick mention of the fact that Harry Cayton will be chairing the new Public Engagement and Involvement Committee at the MHRA which should be up and running some time this year. Good news.
Recommendations for more effective engagement
The pharmaceutical industry, medicines regulators, commissioners and prescribers need to capture and appreciate what patients say about medicines more thoroughly and comprehensively, and to understand the stories that people tell about medicines: how they use them; the benefits they experience; and the adverse reactions that can arise, so that we can make the most of this area of healthcare.
Start the process with a collection of patient terms and descriptors, collected throughout the medicines system: in clinical trials; regulatory decisions; technical appraisals; the consulting room; the pharmacy, in order to help health professionals work with patients to get the most from a medicine they have decided to take.
Create new opportunities to capture and react to patients’ views and experiences about medicines. The current opportunity to report suspected adverse drug reactions through the Yellow Card Scheme needs greater use and a higher profile. We need to explore other options to report – for example developing a patient formulary and using initiatives like healthtalkonline.
The Expert Patients Programme should explore how it could further develop expert medicine users to provide support and advice to people about their medicines.
To build further on existing achievements, more sustained effort needs to go into the quality and design of medicine information leaflets, addressing a range of needs, and using a range of formats and approaches – including exploiting opportunities offered by new communication tools.
Recommendations for service improvement
GP consortia in collaboration with local networks of pharmacists, nurses and other healthcare professionals should introduce a proactive system of aftercare to allow patients to be contacted in the first few weeks after starting a new medicine. Some people may need longer-term support. We welcome the planned introduction of the Department of Health’s ‘new medicines service’ which may be an opportunity to improve the management of medicines use.
Every GP practice in the country should have access to a local pharmacist adviser, to whom they can refer patients with medication problems, and who can be used as a source of advice for both patients and GPs on medication related issues.
Patients should control access to their care record and, if they wish, allow pharmacists and other healthcare professionals to access and input into their electronic NHS patient record.
There should be a better use of information technology in general practices to assist the public in requesting and obtaining prescriptions.
Recommendations for improving research for the benefit of the public
Reporting guidelines on patient and public involvement in medicines research should be developed to: improve standards of reporting of patient and public involvement (PPI); strengthen the evidence base for PPI in medicines research; and encourage its inclusion in research design and conduct. These guidelines should be primarily aimed at scientists writing up their research for publication or involved in peer review, and at academic journals.
Health departments across the UK should collaborate and fund initiatives to improve public awareness and understanding of the importance and role of research in delivering quality care. We would like to see public involvement in health research extended to include their involvement in the development of new medicines.
The new National Institute for Health Research (NIHR) School for Public Health Research and NIHR Policy Research Unit on Behaviour and Health to be established as part of the government’s white paper proposals on public health should investigate public health-orientated approaches to the use of medicines, alongside conventional applications of pharmaceutical technologies.
Regulatory approaches should also support consideration of the population benefits of medicines use. The outcomes of regulatory decisions should be evaluated in terms of population health benefit, together with an evaluation of the acceptability of such an approach to the public.
Announcements are like buses. There are none for what seem like days and then several come all at once. My job is to make sure you get on the right one…
NIHR has several announcements out today which AMRC and its members have had some involvement or interest in. The first is the launch of the new model Industry Collaborative Research Agreement (mICRA). It will enable research studies to start much more quickly by enabling people to work through the contractual issues more efficiently, particularly issues around Intellectual Property (IP). AMRC was on the working group that developed it.
I see no reason why the document should not be as reliable, solid, or user-friendly as its automobile namesake, the Nissan Micra, but a lot faster! And if you can tell me what the link is between that car and a well-known UK charity that is an AMRC member charity you can have a free invite to our Science Communication Award ceremony in March.
The second announcement of note is the launch of PROSPERO. Developed by the NIHR’s Centre for Reviews and Dissemination, PROSPERO is the first online facility to register systematic reviewes for research about health and social care from all around the world. And access is free and open to the public. An excellent tool in the drive towards greater transparency and the curtailment of duplication.
And if you’re up for a good debate in this half-term week then my favourite blog of the moment is Alice Bell’s on the recent remarks by the Chief Scientist, John Beddington, calling for science and scientists to be more intolerant of those that spin pseudo-science etc. It has prompted a rather good discussion in my view.
So the UKCMRI partners were in front of the House of Commons Science and Technology Committee yesterday as were representatives of the local community. Meanwhile the Science Minister, David Willetts, announced that the Government had agreed the business plan for the new centre as put forward by the Medical Research Council (MRC). A good day all in all for the Centre and its supporters.
Interestingly UKCMRI is mentioned in two diagnostic articles looking back at last week’s announcement by Pfizer. The first is by Andrew Jack in the Financial Times. The second is by Colin Macilwein in NatureNews. Each piece has a different accent with the latter taking a slightly more critical stance as regards the relationship between Government and pharma. But there are also themes common to both around the need to reduce regulation and for better data sharing by companies.
I suppose Pfizer’s Sandwich plant and UKCMRI are both of their time and I thought David Cooksey’s (Chair, UKCMRI) take on how UKCMRI will differ from what has gone before in the way it will cluster capabilities and knowledge was quite helpful to understanding why UKCMRI is so important to UK science.
There was a lot of talk about the science ‘ecosystem’ at the time of the Spending Review and the need for the Government to avoid breaking it by not thinking through the consequences of its actions. That’s the real issue about Pfizer and Sandwich, that together with other pharma cuts over the last few years, the UK has lost a significant amount of its pharma R&D capacity and capability with major knock-on effects for all including medical research charities.
Against that background, initiatives such as UKCMRI take on even greater importance but the Government needs to think more strategically if we are to better manage the ecosystem going forward. A TaskForce in Sandwich is important to managing the impact on the local community but we could do with a national Task Force as well. One can only load so much onto UKCMRI.
And..finally from the sector…my congratulations to Alzheimer’s Research Trust who changed their name to Alzheimer’s Research UK yesterday and have a new website to boot.
Over the weekend Professor Colin Blakemore said he hoped the Academy of Medical Sciences would come up with radical proposals to end the regulatory mess that holds up UK health research such as clinical trials.
I am not sure whether he will feel today’s report by the Academy lives up to that aspiration, but I do believe it is a good and important document and I suspect so will my members. Why?
For a number of reasons. It prefers careful surgery to the slapdash ‘slash and burn’ approach beloved of short-sighted politicians when talking about regulation or quangos. Its prescription for the future is measured and precise – there are no sledgehammers to crack nuts here. It takes a wide-lens view of the issues, not least the extent to which the NHS has largely been allowed to brush-aside its role in research. And lastly, for an Academy report, there is a refreshing recognition of the importance of public and patient involvement. A glint it may only be, but I will take it for starters.
For AMRC member charities who pulled no punches in their commentary on the current system of research regulation and governance, there will be much support for the recommendations to establish a Health Research Agency (HRA) and to house a National Research Governance Service (NRGS) within it which will focus on speeding up NHS R&D permissions. The fact is that current delays mean it takes far longer than it should to get donor money working for research. Also, some relief that the review panel resisted calls to collapse the myriad functions of many others regulators into the HRA. The more one looked at this idea the more it promised a whole lotta pain with little gain.
Its many proposals for improving the culture around health research are not necessarily new – indeed a number of them have long been muted. But to see them packaged as part of a report which is essentially about better and more efficient delivery of research is extremely important. It moves us away from considering them as soft components of reform. They are just as important as cutting red tape and always have been; ministers must now galvanise this culture change with their own backing.
On patient data issues the Academy nudges rather than propels us towards reform. It focuses on specific levers and measures such as ‘safe havens’ that might get us out of the current fix, while supporting ongoing initiatives such as the Research Capability Programme (RCP) pilots and the North West Exemplar. Its proposal to make researchers part of the clinical care team would likely have benefits beyond just improving recruitment to clinical trials; it would complement the Academy’s overall call to get the front-end of this debate right by improving NHS staff and public awareness of the importance of patient data to research. And it almost goes without saying that I am delighted the Academy strongly endorses AMRC’s public awareness work in this field on behalf of, and with, other UKCRC partners.
The fact that the report cites a considerable number of voices from the patient workshop that AMRC and INVOLVE held in November 2010 is helpful to its overall tone and style and it includes the headlines from our independent report of this event without amendment. It also makes a number of references to the importance of patient and public involvement to the conduct of health research. But it doesn’t quite give the weight or billing to the need to facilitate greater involvement in the way that I and many others see as integral to improving the UK’s performance in clinical research.
And if there is one further criticism I would make, it is that the Academy keeps a respectable distance from prescribing the leadership make-up and governance systems for the new regulator HRA. It would have been good to have seen it float a few ideas and proposals that further demonstrated that it had taken on board the importance of regulation in ensuring public trust and confidence.
I see that Andrew Lansley has been quick off the mark in welcoming the report. Watch this space as they say.
Of the coverage I have seen so far I rather liked this one most.
Ahead of next week’s Academy of Medical Sciences (AMS) much anticipated report on medical research regulation I see The Times and Sunday Times (both paywall) have published pieces this weekend by scientist Professor Colin Blakemore and journalist Brian Deer respectively, offering different perspectives on the issue of regulation.
If you are looking for further background on this issue, a reminder that you can read more about patient views on research regulation in the independent report published by AMRC/INVOLVE on 20th December 2010. And AMRC’s two written submissions to the Academy’s review can be found on our website.
The Academy’s pages on the review are available here.
A piece of good news with which to begin the New Year. PharmaTimes is reporting that the number of patients participating in clinical trials jumped by 67% last year to over half a million (compared to over 300,000 in 2009).
The new CEO of the National Institute for Health Research Clinical Research Network Co-ordinating Centre (NIHR CRN CC) – which provides the machinery for how clinical trials are delivered in the UK, Jonathan Sheffield is quoted as pointing to the involvement of the wider NHS (not just teaching hospitals) and increased public awareness as key factors behing the increase.
A rather interesting piece of news I thought given a) today’s news about the ‘polypill’ trial going ahead, b) the impending Academy of Medical Sciences report on medical research regulation and, on a more personal note, c) that these first few months of the year shall see me busy working with patients and colleagues in NIHR CRN CC to ensure an even better plan for the implementation of patient and public involvement across the UK’s clinical research networks.
Jonathan alludes to this work in his interview and it is an area where medical research charities have had, and will continue to play, an important role – assisting in patient recruitment to trials, raising awareness among patient constituencies of the importance of research, as well as funding such trials themselves of course. As NIHR figures showed last year, 37% of all clinical studies on their portfolio are funded by charities.
Hopefully the Academy’s forthcoming report will show the way to how we might build on this success.
So it’s 10pm and I’m busy here putting the final touches to the AMRC/INVOLVE report of the workshop we held in November which drew together patient views on health research regulation.
This was at the invitation of the Academy of Medical Sciences as part of their review of regulation and governance but – and all credit to them – we agreed that AMRC/INVOLVE will produce its own independent report of the event and I hope this will be out before Christmas.
Anyway, that’s just a bit of context for you. While writing, I listened to an excellent edition of ‘In Business’ entitled ‘Bitter Pills’ looking at changes in the pharmaceutical industry with a focus on GSK. Its worth a listen if you are interested in how the business model for pharma is changing fast.
‘Medics’ will be gathering in Scotland this week for a 5-day meeting at the Royal College of Physicians of Edinburgh to discuss the medical breakthroughs that have done most to shape and indeed saved lives over the past fifty years.
Scotland on Sunday have a report today previewing the meeting. The article includes a list of the top 20 advances as voted by over 600 ‘docs.’ Antibiotics came top and Scotland has a link to 8 of the top 20; interesting also to see things appear in the list such as randmized clinical trials.
But Office for National Statistics data published earlier in the weekend shows that Scotland still has mountains to climb in combatting the biggest killers in society – cancer, heart disease and stroke. (Note the very important health warning on the stats though given by the British Health Foundation).
The challenge is that it will require not just new medical breakthroughs such as stem cell treatments or stratified medicine but also changes in people’s behaviour as well if we are to truly win the battle against them, And that is what will probably mark the next 50 years out from the previous 50 in many respects.
So, I have been following with interest the House of Lords Science and Technology Sub-Committee Inquiry into behaviour change that is underway. The committe have already taken evidence from members of No 10’s so-called ‘nudge unit’ and Government departments and I think witnesses from MRC and other science organisations are up before the committee on 30th November.
This committee may be going quietlyand efficently about its business outside of the glare of media attention but sometimes a ‘nudge nudge, wink wink’ can speak volumes.