No better time…

by Kazeem Olalekan MRPharmS on January 27, 2012 · 0 comments

in Opinion

by Kazeem Olalekan MRPharmS

fotolia_17530626_XSThere is no better time than the present to start putting forward the list of the changes we will like to see at the MHRA. MHRA is making valuable contribution to the safety of medicines and devices in the UK although its work has sometimes been constrained by the regulatory framework in Europe. I am not saying this because of any euro-sceptic tendencies but because of the example I eluded to in September last year where I expressed by my concern and disappointment at GSK’s response on Avandia (1). When the UK regulators are unanimous on a particular issue, why are they constrained to act because of timing of decision making elsewhere? Harmonisation of decision making is clearly needed.

My long standing gripe about Packaging is still there (2). Why is the MHRA focusing too much attention on this? It seems trivial and well…not green!

Whilst I disagreed with the criticism of the MHRA by Mr Mel Braham (3), the editorial in the Lancet about lesson from the USA (4) may offer a way forward with regards to how the regulation of medical devices should change in the future. Professor Toft of Coventry University also identified that the ‘EU regulatory framework is not fit for purpose’ (5). The MHRA according to professor Toft, ‘does not have the power to do the things they have to do pro-actively’. The comments by the good professor is worth listening to.

There are other suggestion on the configuration of the MHRA that is definitely worth listening to: They are joint comments by my professional body and other pharmacy organisations (6). They revolve around the following:

  1. Cost of implementing a single set of regulation
  2. Future guidance
  3. Removing ‘prepared medicines’
  4. Abolishing fluted bottles
  5. Statutory warning for medicines
  6. Obsolete exemptions
  7. Universities and research institutions
  8. Patient group directions
  9. Optimisation of Medicines

The statement is comprehensive and include a number of other changes which Royal Pharmaceutical Society will like to see.

So there is no better time than the present for the MHRA to intensify its effort to address all of these issues. I am sure the organisation is doing just that.

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Who mackem, who tackem and who usem?

by Kazeem Olalekan MRPharmS on January 25, 2012 · 0 comments

in Opinion

by Kazeem Olalekan

fotolia_23943391_XSIf you have ever lived in the North East of England you will understand the rivalry between Sunderland and Newcastle. I spent about 6 years in the North East of England studying at the prestigious, to me in any case, School of Pharmacy in Sunderland and the equally prestigious Northumbria Business School in Newcastle. And in between the two, we have Gateshead, which hosts the ‘Angel of the North’. It takes the intersession of the angels to prevent what is sometimes acrimonious rivalry to turn into something more sinister. As an outside observer then (because I consider myself an unofficial Mackem and Geordie now), I used to wonder what the point was. To me at the time, they spoke with the same ascent which I could hardly understand anyway. So when the Geordies use the supposedly derogatory term Mackem to describe the people from Sunderland you wonder who’s got the last laugh now (1). I am of course referring to the ship making days when the people of Sunderland ‘make’ the ships and the people from Newcastle ‘take’ those ships for fitting (hence ‘Mackem’ and ‘tackem’). Fitting ships was considered to be more skilled compared to the more physical role of assembling the hull. As we are now in a time when the emphasis is on re-balancing the economy to a position where we make things again, being a Mackem – the people that makes things – has never been cooler. I hope the people of Sunderland (in particular) and people of the North East (in general) will dig deep into that heritage (with the help of government) to re-balance their economy to a position where they make things again.
I raise the above issue to illuminate the concept of rivalry (and competition) and co-operation as it relates to the current PIP breast implant saga which I eluded to in my previous post (2).

1.0: Competition (Rivalry):

fotolia_37222905_XSIf the Mackems and the Geordies can compete fairly on the basis of who can make the better ships or who can performs better on the football pitch, then that is the rivalry that the angels will approve of. In the UK there is a myriad of cosmetic surgery providers each competing for your business. We all want them to compete on the basis of who will gives you the best quality of care that is grounded in evidence. We do not want them to compete on the basis of some fancy advertisement campaign. In fact the British Association of Aesthetic Plastic Surgeons (BAAPS), is now calling for an outright ban on advertising of all cosmetic surgery (3). We also want those that can deliver a high standard of care to the patient even when things go wrong and not those who attempt to shy away from that responsibility. The angel: The NHS, has set out a standard of care to these organisations. Some will match it, some will better it and some will fall short of it. You have a choice to make. Choose your private provider wisely next time. The following is a collection of the response of the private providers to the PIP scandal:

NHS service standard (4):

  1. The patients will be contacted to inform them and give them all relevant information and advise.
  2. Women who wish to will be able to speak to their GP or the surgical team which carried out the original implant to get advise on the best way forward for them.
  3. If the woman chooses, this will include examination by imaging.
  4. If when informed by the assessment of clinical need of the risks involved and the impact of unresolved concerns, a woman with her doctor, decides that it is right to do so, the NHS will remove and replace the implants if the original operation was done by the NHS.

    “I believe that that those who receive their implants privately should also receive a similar level of service and reassurance from their care provider” – Rt Hon Andrew Lansley MP for Cambridgeshire (5).

How does the providers fair?

Best in class

BMI Healthcare (link)

Since the first MHRA alert regarding PIP implants in March 2010, BMI Healthcare has prioritised patient care by providing clinically indicated diagnostic imaging and removal of ruptured PIP implants at no cost to individual BMI patients. We have already sympathetically treated a number of patients in this way.

BMI Healthcare’s commitment to patient care remains its core priority and, whilst at some stage there will need to be a financial reckoning with those responsible for putting these implants into the UK market, we do not believe patients should be kept waiting whilst this is resolved.

We have therefore decided that any patient who paid BMI Healthcare for their PIP implant surgery and who wishes now to have their PIP implant removed and replaced will be able to do so, at no cost…(6)

Spire Healthcare (link)

Spire Healthcare’s foremost priority is always the safety and wellbeing of our patients.

Current MHRA guidance is that there is no evidence of toxicity or adverse health effects arising from the filler in the PIP implants. However, we take our responsibility to our patients extremely seriously and have become increasingly concerned by the level of anxiety they will be facing.

We are therefore offering every patient treated at a Spire hospital a free consultation with a specialist consultant surgeon and a screening scan. If, following clinical advice from the consultant, the patient chooses to have their implants removed and replaced, Spire will arrange this free of charge.

Additionally, women who choose not to have their implants removed will also be offered a follow-up scan in two years’ time, or earlier should they have any concerns.(7)

Nuffield Health (link)

We know that the recent media coverage may have worried patients who have had breast implants…

Nuffield Health only used a small number of these implants in only a few of our hospitals, however we would like to reassure any of our patients who might be concerned that, if there is a clinical need to do so, we will cover the cost of investigating or removing your implants.

However, our key ambition is always to do the best for you, our patients, and should any procedure carried out at one of our hospitals give cause for concern, we have always, and will continue to, take responsibility to resolve outstanding issues. This includes PIP breast implants…(8)

…and the rest

[click to continue…]

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Everyone is talking about it–It’s Despondex!

by Kazeem Olalekan MRPharmS on January 18, 2012 · 0 comments

in vid

By Pfizerr

Are you insufferably cheery (even in these chastened times)? Get Despondex. That should sort it. Remember to read the information leaflet for cautions, contra-indication, side effects and interactions. Remember, this is FDAA approved!!

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Product Recall–Sterimar (Batches: FE1248b; FE1249)

by Kazeem Olalekan MRPharmS on January 17, 2012 · 0 comments

in Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) has received warning of possible bacterial contamination in batches of the saline nasal spray Sterimar Isotonic 100ml. The spray is sold online and at high street retailers and is commonly used to cleanse the nasal passage.

As part of its regulatory requirement the manufacturer has informed the MHRA of a bacterial infection in two batches of the spray. The two bacteria identified are commonly found in soil, water and hospital environments and human infections are rare. The bacteria shouldn’t affect healthy people. However, those who suffer from existing sinus or nasal problems, have recently undergone surgery or have a weakened immune system may be at risk. The possible symptoms exhibited can be nasal or facial tenderness, discoloured mucus or a fever.

Consumers are asked that if they have any of the affected batches, to stop using the product immediately and return it to the retailer. If they exhibit any of the symptoms listed above then they should consult a healthcare professional.

The affected batches are FE1248b and FE1249. The batch number can be located on the product packaging and on the base of the can.

Links 1 ; Link 2

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Timely pips…

by Kazeem Olalekan MRPharmS on January 16, 2012 · 2 comments

in Opinion

Kazeem Olalekan MRPharmS

Female Doctor Offer Breast ImplantAn avid listener to the BBC Radio stations will not fail to notice a series of six short tones broadcast at one-second intervals (1) to mark the precise start of each hour. When in May last year the pips went missing (2), a typical radio 4 listener (moi included), lost a sense of orientation. I didn’t write in but I understand Eddie Mair received a number of letters from confused listeners. In other words, the presence of the pips is a timely reminder of the time.

It is the unfolding PIP breast implants scandal that is a timely reminder of an issue which needs to be nailed down as we reconfigure our healthcare system. I want to use this piece to lay out explicitly what I think is happening and what I feel should be done about it.

NHS: as it was:

As I stated before in my previous commentary on this: ‘The NHS today is an admixture of public and private providers.’ (3). It is well acknowledged that when something goes wrong in the private sector (like complication from operations etc), the NHS always pick up the tab because the healthcare requirement of the patient has become acute. That was accepted. I also said in my previous commentary that: “You see, I love the NHS a lot and will like to deliver my services within the NHS framework but if I encounter inertia, then I have to say there is something else I love even more than the NHS: my patients. I will quite happily be a private provider with the NHS social constraints if I have to.” (4). As private providers attempt to increase provision within (and outside) the NHS, the PIP scandal is a timely reminder of the need to understand the ground rules. It also presents an opportunity to develop a framework for dealing with a glaring loophole in the system.

The story so far…

The government set out its leadership position by forming an expert group led by the Chief Medical Officer to look at the evidence. The interim report (5) has been endorsed by the British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) (6). It reviewed the available evidence and concluded that there is no clear evidence at present that patients with a PIP implant are at greater risk of harm. Mr Lansley set out in a statement to the Commons what that gold standard service of care should look like (7). He expects all the private operators to follow that standard of service to their patients.

Harley Medical Group (HMG), one of the largest provider of these implants in the UK has come out, through its Chairman: Mr Mel Braham, to say it will not be providing replacement breast implants (8). That is a shame because no one will want to see HMG go out of business but the MHRA argument advanced by Mr Braham is a red herring. If the significant majority of these implants are provided by the private sector and the current evidence is insufficient, then you have to ask if the rupture rate for these implants were fully disclosed to the relevant authorities in order to make an informed decision. I am not suggesting that anyone is withholding information but it is also conceivable that the data on this is still evolving. In medicines, when a drug is launched, there is still a system of monitoring (post-market) which might result in the withdrawal of the product in light of new adverse effect or event. I have commented in the past about parts of the MHRA that require improvement (9) but the statement by Mr Braham is unfair, in my view. It might well be that HMG and other private providers (those still in business) are trying to mitigate their liabilities but nonetheless, my concern is for the patients and all concerned must do everything to make sure that the patients receive the highest standard of care as laid out by the NHS.

A timely case…

This case is timely and offers an opportunity for the NHS to consider a range of options to address this loophole. The NHS will support the patients but should recover the cost from the private providers (Mr Lansley has been explicit on this point). It should do so systematically without necessarily forcing the private provider out of business.

The time might be fast approaching for the government to mandate all private providers of healthcare to contribute to an insurance fund to mitigate against this sort of problems in the future. The size of such contribution being proportionate to the size of the private provider, the complexity of procedure provided and the claims against a provider. A model can be worked out, I trust.

The government bailed out the private banks which resulted in a huge bill on the taxpayer. The NHS is the backstop for people’s healthcare and as private provision increases, it will be a surprise if the government allow the taxpayer to accept unlimited liability for problems which has its origin elsewhere. A robust insurance model should limit the taxpayer’s liability.

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Stop; take a deep breath, then count to 72 hours

by Kazeem Olalekan MRPharmS on November 18, 2011 · 0 comments

in Opinion

by Kazeem Olalekan MRPharmS

My advise to patients requesting antibiotics for common cold will be: Stop; take a deep breath and count to 72 hours. There is now a well recognised problem of increasing antimicrobial resistance due to overuse (1).

We all have a duty to do our best to moderate that cycle of expectation and belief which Professor Little described in an interview he gave to the Today program in 2008. I have no doubt that Dr Kieran Hand (who we interviewed recently as part of our case studies) shares the same sentiments.

Key Quotes:

"It comes down to education of pharmacy staff — getting the message across to patients that antibiotics are not always the answer for self-limiting conditions and that self-care is probably the best option,"

Jonathan Mason, the Department of Health’s national clinical director of primary care and community pharmacy.

“…the evidence from our research is that actually, most people if you talk to them and provide a decent advice about natural history; what they can do for themselves actually will be happy either if you don’t prescribe or if you offer what we call a delayed prescription: collect a prescription in a few days, if things are not settling.”

Professor Little, Professor of primary care research at University of
Southampton

antibiotics

Relevant Link on bookapharmacist.com

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Done it again: Got the interview!

by Kazeem Olalekan MRPharmS on November 16, 2011 · 0 comments

in Case Studies

by Kazeem Olalekan

kieran2In August of this year, bookapharmacist.com reported on the antimicrobial iphone app developed by the team at Southampton University Hospital NHS Trust (now: University Hospital Southampton NHS Foundation Trust). At the end of that piece, Kazeem promised to try and get an interview with Dr Kieran Hand, the pharmacist involved in the App development. Well we did!

Dr Hand gave a great interview. Some great quotes from the interview are:

“Multidisciplinary teams are challenging but worth the effort…The fundamental thing for me is that you should really be sincere about your desire to work in a multidisciplinary team and not just pay lip service to the concept of multidisciplinary team and that means showing respect to colleagues who work in different areas and different specialties and genuinely listening to what they have to say and acting upon it”

 

“The objective of the app is to make information available to the doctors at the bedside that would support their clinical decision making”

 

Listen to the full interview here.

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by Kazeem Olalekan

closeup of a pencil eraser correcting an errorMy last post:  “Loose your tariff and your ethics” has one too many ‘o’ in it and was pointed out to me by my former student: Rahul Gogna on Facebook. That is the kind of attention to detail I expect from pharmacists especially some starting out in their professional career. That is one of the key attributes of pharmacists: attention to details. Clinical safety depends on it.

It is also important that as we focus on the details, we don’t lose sight of the big picture. So I agree with Rahul, I will lose the ‘o’ but I will not worry too much about it;  in so far as the meaning is not lost.

Confusing lose with loose is a common writing mix up.

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Loose your tariff and your ethics

November 2, 2011

The news item yesterday on PJOnline which announced that preregistration trainees will not be requiring the Drug Tariff or Medicines, Ethics and Practice guide from next summer is encouraging. This is not to say that students should pay scant notice of issues relating to drug tariff and ethics for that matter. All are still important [...]

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New Medicine Service

October 10, 2011

by Kazeem Olalekan I attended the Annual General Meeting of Hampshire and Isle of Wight LPC on the 14th of September 2011. The LPC has launched a new website (pictured) and after the paraphernalia of the AGM, it was time to introduce the key presenters: Professor John Weinman: Psychology Professor at Kings College, London and [...]

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