Not for publication before 11.

00 hours Thursday January 17th 2013

A UCL School of Pharmacy Pharmaceutical and Health Policy Briefing

Reducing NHS medicines wastage and the global challenge of preventing drug counterfeiting
Significant problems which demand serious attention, but should not be exaggerated relative to improving health care access and outcomes Medicines wastage in the NHS and pharmaceutical falsification (counterfeiting and allied crimes) across the world are controversial topics which receive frequent media coverage. There have been allegations that poor prescribing, unnecessary dispensing and inappropriate patient use of medicines (in part, some suggest, related to the fact that most NHS prescription drugs are throughout the UK supplied free of charge) are leading to levels of wastage that are undermining health service finances. Some sources also claim that up to 100,000 people a year are being killed by illegal and sub-standard medicines1. However, research undertaken at the UCL School of Pharmacy indicates that although both medicines wastage and medicines counterfeiting represent significant problems, there are dangers in exaggerating their scale and impacts. This could distort priorities and lead to counter-productive public policies. There is in fact no evidence that NHS medicine users behave less responsibly than those who pay for treatments, or that levels of drug wastage are higher in Britain than in other relatively rich countries. At the same time it has been observed that charges can lead vulnerable people (and others) to stop taking therapies. Similarly, progress is across the world being made in the field of preventing medicines falsification, in part because of the work of agencies such as the WHO and, for example, Chinas State Food and Drugs Administration (SFDA). Against this background this UCL School of Pharmacy Pharmaceutical and Health Policy Briefing provides updates relating to these two areas, and seeks to identify positive ways forward with regard to protecting public interests and promoting better public health. Research on medicines waste and the importance of taking medicines to optimum effect Medicine wastage is normally measured in terms of the physical volume and (pack price defined) cost of drugs which have been dispensed but not taken, and are ultimately either incinerated after being returned to pharmacies or discarded via rubbish bins or the drains. Nonadherence in medicine taking is much a broader concept, which includes the incorrect use of medicines as well as simply not taking them. (Some studies include not having prescriptions dispensed as a form of non-adherence.) Even in the context of life threatening conditions such as cancers and AIDS drugs may be fully consumed, but not in the ways that lead to the greatest possible health gains.

See, for example, PHAKE by Dr Roger Bate, published by the American Enterprise Institute

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In 2007 the National Audit Office suggested that in the order of 10 per cent of all the NHS medicines dispensed in the community (including care homes) in England are wasted, implying in todays terms a cost of almost 1 billion. But research undertaken by the School of Pharmacy and the York Health Economics Consortium, published at the end of 20102, found that the true (physical) wastage total is about 4 per cent (1 in every 25). The represents a total of between 300 and 350 million. Of this 50 per cent was regarded as unavoidable, because it stemmed from factors such as patients conditions changing. Hence the savings to be made from further improving the NHS record in reducing medicines wastage in England are in reality (allowing for the costs of new measures, such as providing better health and linked social support for vulnerable people living alone in the community and who are experiencing problems with medicines taking) unlikely to be greater than 100 million. This is an appreciable amount, but it is small (less than 0.1 per cent) as compared to the 110 billion annual cost of the health service in England. It is also of note that despite recent advances in areas such as cancer and HIV care, overall hospital and community prescription drug costs have fallen as a proportion of NHS spending during the past decade. They stand at about 10 per cent of total health service costs. This is about the same proportion as that recorded half a century ago, in the mid 1960s. Falling pharmaceutical costs have been due to the genericisation of medicines, which has raised the relative cost of health service labour as compared to that of the average medicine dispensed in the community. By contrast, the School of Pharmacy/York analysis found that in just five therapeutic areas (including asthma and diabetes treatment, and the prevention of heart disease and strokes) the health gains and cost savings to be derived from better use of supplied medicines amount to 500 million in England alone. Such observations underline the importance of investing in better pharmaceutical/health care delivery by pharmacists and/or other professionals and taking medicines to optimal effect, rather than concentrating narrowly on reducing dug wastage. This finding is in line with more recently published research presented to a meeting of Health Ministers held in The Hague in October 2012, which suggested that better use of medicines world-wide could generate global health care efficiency gains of up to $US 500 billion3. Following the publication of the School of Pharmacy/York Health Economics Consortium report the Department of Health organised a roundtable meeting, held at the Kings Fund at the start of 20114. This in turn led to the establishment of a Steering Group to Improve the Use of Medicines. Its report, Improving the Use of Medicines for Better Outcomes and Reduced Waste5, was published at the end of December 2012. As its title implies, this analysis argues that cutting material medicines waste (that is, the cost of discarded medicines) is a secondary goal as compared to improving health outcomes. It
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Webreferencehttp://php.york.ac.uk/inst/yhec/web/news/documents/Evaluation_of_NHS_Medicines_Waste_Nov_2010.pdf Seehttp://www.responsibleuseofmedicines.org/2012/10/advancingresponsiblemedicineuseisahalftrilliondollarglobalimperative/ 4 Makingbestuseofmedicines:ReportofaDepartmentofHealthroundtableeventhostedbytheKingsFund http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_128283 5 http://www.dh.gov.uk/health/2012/12/medicinesreducedwaste/ Mezzanine Floor, BMA House, Tavistock Square, London WC1H 9LP T: 020 7874 1270 F: 020 7378 5693 www.pharmacy.ac.uk

suggests building further on developments such as the introduction of Medicines Use Reviews by pharmacists and the more recent launch of the New Medicines Service in England. This last is largely based on School of Pharmacy research that showed that when pharmacists pay special attention to resolving the medicines taking related problems people may experience in the first few weeks after they start taking treatments intended for long term use adherence rates improve, opening the way to better outcomes and reduced waste. The recommendations made in Improving the Use of Medicines for Better Outcomes and Reduced Waste included: improving repeat prescribing and dispensing processes, in part via the greater use of arrangements already available for enabling pharmacists to take greater clinical responsibility in instances where patients are on stable long term therapeutic regimens. This can reduce GP practice workloads and enhance pharmaceutical care; providing incentives for encouraging pharmacists not to dispense PRN (take when required) prescription items when patients already have adequate stocks at home. In Sheffield, for example, there is a local not dispensed scheme which pays pharmacies 4 per item judged not to be required, plus 10 per cent of the cost of each specific medicine not supplied; targeting additional medicines taking support on individuals identified as being at special risk of having particular problems, including individuals with complex and multiple conditions known to be living alone and/or with disabilities that restrict their opportunities for accessing resources such as community pharmacies; and building further on successes in areas such as encouraging more patients to bring the medicines they are taking with them when admitted to hospital and to go on taking them normally unless their treatment is changed (PODs schemes). This can be done by, for instance, improving discharge procedures and pursuing opportunities for re-using medicines that have been supplied to wards but not given to patients. Provided the latter are in date, have been stored properly and have not been out of the hospitals supervision there is no reason to discard such stock. It is possible that annual savings of in the order of 10-20 million could be achieved by changes of practice in this context.

However, no change in policy in relation to resupplying NHS medicines returned to community pharmacies, either to other NHS patients or to poor communities abroad, has been recommended. There is evidence that many members of the public would like to see returned medicines re-issued in this way, but the costs involved in achieving this safely would normally be greater than the supply cost of the medicines involved. That is, outside hospitals it is usually more cost effective to incinerate returned medicines and to purchase new supplies for use domestically or abroad.

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To put this (for some people surprising) conclusion into perspective, a typical medicine costs a little less than 10 for a months supply in this country. Employing a health professional in the NHS often costs 10 for 10 minutes working time. Such figures highlight the relative importance of using labour prudently in the pursuit of better public health, and wherever possible recognising the abilities of NHS service users to take more independent control over the use of their medicines, as well as adopting healthy life styles in order to protect their health. For example, although 28 day prescription durations are normally considered good practice, it can be argued that in instances where medicines are stable when stored in home conditions and health service users want longer intervals between needing to collect their treatments there is good reason for respecting such individual preferences. The tangible dispensing related savings generated by such flexibility are likely to be limited. But any resources released might be channelled into providing better, more individualised, medicines taking support and care for people at the highest risk of isolation and neglect in the community.

Medicines falsification and world health Some estimates suggest that 100,000 deaths a year are caused by illegally supplied counterfeit or otherwise falsified/sub-standard medicines. It is in addition sometimes (incorrectly) said that the WHO has stated that 10 per cent of all the worlds medicines are counterfeit. It is also frequently claimed that over a half of all medicines supplied via unregulated internet sites are counterfeit. Studies by experts such as Dr Paul Newton of Oxford University have drawn particular attention to the hazards caused by counterfeit malaria medicines, up to a half of which have in some localities been reported to be in some way falsified and lacking the correct amounts of (or any) active ingredient6. In some cases this has caused people given such treatments to die, and it may in addition increase the risk of drug resistance developing. There is good reason to be concerned about the harm that medicines counterfeiting and allied crimes cause, and to take robust preventive measures wherever possible. However, a new report entitled Falsified Medicines and the Global Publics Health7 from the UCL School of Pharmacy and the independent research agency Matrix Insight (which has undertaken studies on behalf of bodies such as NICE and the European Commission) urges caution with regard to aspects of the public debate on medicines falsification. For instance, any claim that 10 per cent by value of the worlds medicines are counterfeits (as defined in terms of being deliberate made fakes, produced in unregulated environments) is likely to be a marked exaggeration. The UCL School of Pharmacy/Matrix Insight report emphasises the uncertainties involved, but suggests the true figure is likely to be closer to 1 per cent. It also stresses that many more people across the world die or are disabled because they lack affordable access to modern health care, as opposed to being harmed by falsified or substandard medicines.
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See http://www.ox.ac.uk/media/news_stories/2012/120116.html Copies of this document are in the press pack containing this Policy Briefing

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The Schools analysis highlights the ongoing need for more reliable data on the scale of medicines falsification and sub-standard treatment provision. It also indicates that countries such as China, Nigeria, India, Brazil, Russia and Turkey have made significant efforts to improve the quality of medicines supply over the past decade. The preliminary findings of large scale empirical surveys by leading researchers like Dr Harpakash Kaur of the London School of Hygiene and Tropical Medicine in addition suggest that the quality of anti-malaria medicines available across a number of sub-Saharan countries is better than in the past. There are unquestionably continuing problems with counterfeiting (and pharmaceutical quality more broadly), especially in the poorer parts of the world. Even in countries such as the UK there are significant risks associated with unregulated internet medicines supply. But the work by the UCL School of Pharmacy and Matrix Insight team emphasise the importance of building and maintaining trust in low cost generic medicines supplied by reputable manufacturers. Following the effective closure of the WHO linked IMPACT (International Medical Products AntiCounterfeiting Taskforce), a meeting involving delegates from 76 Member WHO Member States held in Buenos Aires was held at the end of 2012 to discuss the establishment of a new mechanism for addressing the problems caused by substandard and falsified medicines. In this context the UCL School of Pharmacy and Matrix Insight report offers a blueprint for a multi-tier, globally coordinated, approach to protecting the world public. It calls on governments across the world to collaborate constructively, and to involve informed stakeholders such as patient groups and other voluntary sector organisations as well as pharmaceutical companies whenever they have knowledge and expertise to contribute.

For further information and contacts relating to the topics covered in this UCL School of Pharmacy Pharmaceutical and Health Policy Briefing please contact Professor David Taylor on 07970 139892 or at David.G.Taylor@ucl.ac.uk

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