Blue Sphere Health

Posts Tagged ‘polypharmacy’

What’s in a Deceased Person’s Medicine Cabinet?

This may seem like a gratuitously macabre subject for a blog post, but bear with me. The links between adverse events and bad medicines discussed in my last post are hard to find. Especially if we don’t look for them. If a patient suffers an unexpected “side effect” it could be due to any number of things: their unusual reaction to the normal pharmacology of the drug; a dosing error; interaction with another drug; fake or substandard drugs .  In most cases mild, drug-related adverse events will go unrecognised and unreported and no-one will ever find out.  Unfortunately, the same is probably also true if their drugs happen to kill them, because often we don’t check for evidence. If the patient dies unexpectedly, medication issues could be a contributory cause of death and in my view we should always examine the possibility.  This may seem a disproportionate response compared to the apparent prevalence of the problem – the vast majority deaths are not due to fake or sub-standard drugs – but I think it is both necessary and feasible.  Most of the proximal causes of death are pretty straightforward – heart attack, stroke etc – and the death certificate is completed accordingly unless there is clear evidence of other contributing factors (eg deliberate overdose). However, if society required coroners and medical examiners to record and investigate the patient’s drug regimen after all unexpected deaths, and to send samples of the medicines for routine analysis, I think it would throw up some very useful data and benefits in several areas. Firstly, the problem of polypharmacy (patients taking many different medicines, prescribed and self-medicated, which may interact in unpredictable ways)  is poorly understood and almost certainly under reported. Secondly, dosing errors and prescribing of  inappropriate drug combinations are shockingly common but we don’t know the full effects of these mistakes: the errors that occur in hospitals are more easily identified but in primary care the situation is very fuzzy. Thirdly, hard numbers on the problem of poor adherence to prescribed therapy would be welcome: a cabinet full of untaken hypertension pills might explain a sudden stroke. The World Health Organisation estimates up to 50% non-compliance with long term medication but there is little widescale evidence. Finally, analysis of a large number of medicine samples from a broad spectrum of the population would provide data for evidence-based strategies on counterfeit medicines, rather than basing our approach on minimal information and guesswork. So far, so facile.  Identify a problem, make general observations, end of blog post.  Well maybe, but Blue Sphere is about trying to tackle big health issues differently and this time I’ll try to go further. I think there is a way for everyone to gain by implementing a better framework along the following lines:
  • A “return-to-sender” system where samples of medication are taken after all unexpected deaths, regardless of the cause of death noted on the death certificate, and returned to the original drug manufacturer. In cases of doubt as to the authenticity of the drug, the samples are sent to the apparent manufacturer, so the system is actually “return-to-brand-owner”.
  • The samples are initially analysed by low-cost means only – hand-held spectroscopic techniques are cheap and simple and can quickly confirm authenticity by comparison with manufacturers’ reference scans.
  • Suspect samples are analysed further and held as possible evidence if the coroner wishes to pursue the case.
  • Genuine drug samples are destroyed (as a side benefit this helps to reduce inappropriate re-use by friends and relatives, re-sale, environmental pollution due to disposal in household trash etc)
  • Anonymised statistics are compiled and shared amongst stakeholders in the system.
The key problems will be complexity and cost.  Both of these can be addressed by using a collaborative, industry-wide approach and outsourcing the service to a central laboratory.  Coroners and medical examiners can be provided with standard envelopes for postage-paid return. Issues such as patient anonymity can be dealt with using techniques we already know: e.g. envelopes can be coded so that only a number links the sample with the patient and personal details are not transmitted.  Central labs already have the logistics and infrastructure needed to undertake this task. The system will probably need to be financed by brand-owners, who could pay a levy based on number of units analysed, but given an efficient system this should not be too onerous.  As well as being an element of brand protection strategy, it should  form part of corporate social responsibility activities.  In this regard it could be politically attractive and may even attract tax breaks from governments or at least some slack on pricing controls. Furthermore, as an element of risk analysis and liability management it could also be sympathetically received by corporate insurers in the form of lower premiums. None of the above is easy, but it is feasible and provides good return-on-investment.  It also has the attraction of being testable on a pilot basis and scalable.  Feel free to comment below or privately, especially if you know of places where routine medication analysis after death is already in place in a non-hospital setting.  If a central lab, venture capitalist or government regulator wants  to develop the proposition further, feel free to get in touch. (c) Blue Sphere Health Ltd, 2011 Photo: Steve Isaacs from flickr
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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.


Pharmaceutical Anti-Counterfeiting book