Put a lid on it

NICE's new guidance – Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence – published earlier this year, sets out why patient non-adherence is a headline-grabbing issue of considerable interest to both healthcare professionals and the taxpayer. The guidance says: "It is thought that between a third and a half of all medicines prescribed for long-term conditions are not taken as recommended. If the prescription is appropriate, then this may represent a loss to patients, the healthcare system and society. The costs are both personal and economic."

The costs are not limited to wasted medicines (NICE estimates that around £4bn of medicines are not used correctly), but include the knock-on costs arising from the increased demand for healthcare, ie unnecessary hospital admissions when a patient's health deteriorates because of non-adherence. These costs, of course, extend to pharma.

With product profitability being squeezed from all sides and pharma companies needing to invest substantial funds to drive new prescriptions, tackling non-adherence rates presents a significant opportunity to repair a financial leak, achieve excellent returns on investment (value/patient increases), and improve the treatment outcomes of existing patients. Improving adherence rates can mean that everyone's a winner – patients, NHS and the healthcare industry.

Research into adherence has grown exponentially over recent years, but the key question remains: why have such high rates of non-adherence persisted? 

Long-term solution
Pharma's general approach to patient adherence has been tactical and short-term, and solutions to non-adherence have not been pursued with the same energy and professional exactitude routinely applied to the generation of new sales. Some interventions have, of course, worked, but they arise 'in the mix' and have not always been clearly identified. The industry unquestionably has the talent to improve adherence by drawing on evidence from outcomes-based research. The focus must now be on identifying a long-term strategy to improve adherence rates, and weaving it into the lifecycle of each product. Industry may even be challenged by NICE to do just this.

In 2003, a study by Sabaté et al on behalf of the World Health Organisation entitled Adherence to long-term therapies: evidence for action cited the multiple factors influencing non-adherence. These ranged from economic and social factors to the nature of the condition, and type of therapy, along with the individual's physical and psychological capabilities.

Improving adherence
Non-adherence is an avoidable problem that should not be assumed to persist simply because some patients always 'forget to take their medication'. The problem is more complex than this. While patients might report forgetfulness to researchers as the main reason (56 per cent) for not adhering, there is typically an underlying conviction or confidence problem. The challenge for all adherence programmes is to reach out to these people – the sceptical, the unaware and the frustrated – and provide a combination of information and motivation. The unaware and frustrated want to get better, but don't know how to do it, while the sceptical need the motivation. Successfully targeting these patients will move the adherence curve in a positive direction.

Non-adherence is not simply a 'patient problem' either. As the guidance points out, it starts with an exploration of patients' perspectives of medicines and the reasons why they may not want to, or are unable to, use them. The main contention and broad thrust of the guidance is, therefore, that adherence rates will improve when healthcare professionals really understand the needs of their patients, what motivates them and how involving  them in the decision-making process can have a positive influence.

Involving the patient
Non-adherence often occurs as a result of a failure to agree the prescription with the patient in the first place, or to support them adequately after the medication has been dispensed. The guidelines, therefore, offer recommendations about how healthcare professionals can help patients make informed decisions by facilitating their involvement in the decision to prescribe, and on how they can support patients to adhere to the prescribed medicine.

This may involve a 'motivational style' of consultation, ie one that is more patient-centric and supportive of adherence. Merely providing patients with instructions to follow is not sufficient and is a long way away from being best practice. Where patients wish to be consulted, they should be given the opportunity to be involved in prescription decisions, especially if the end result is a reduction in wasted medicines. The National Audit Office estimates that £100m worth of medicines are returned to pharmacies alone every year and that the total wastage bill is likely to be significantly higher.

Better communication
The guidelines also make clear that communication between healthcare professionals needs to be improved. However, they stop short of advising what best practice looks like and how it might be implemented. Communication can break down at various points, for instance, between GPs and pharmacists, or when patients are transferred from hospitals back into the care of their families and communities. While there are pockets of good practice, communication is not universally excellent between healthcare agencies in the UK. On average, around 20 per cent of patients don't turn up at the pharmacist to collect the prescription written by the GP, but the pharmacist won't know that the prescription has been issued and the GP won't know that the patient hasn't picked it up, or indeed returned for the repeat prescription. (E-prescriptions may help in this regard.) By the same token, the GP doesn't know if the patient has had a discussion with the pharmacist and revealed intolerance to a particular medication and has, therefore, decided to use an alternative. The intervention Medicines Use Review (MUR) seeks to address this problem, but little data are available to measure how often this takes place.

Furthermore, the guidance acknowledges that healthcare professionals should not rely on the patient information literature supplied by the companies to inform patients appropriately about their medication. There is a suggestion here that more can, and should, be done in this regard, but again the guidance does not specifically indicate what this ought to be. Pharma, however, will be taking notes.

The pharmacist's role
The guidelines recognise that it is more than just the GP consultation that impacts on patient adherence. Families, patient support groups and pharmacists are seen as having important roles to play too. The White Paper, Pharmacy in England: building on strengths - delivering the future, published in April 2008, pointed towards the enhanced role for pharmacists, and the new guidance is in-line with this thinking.
In their capacity as dispensers and reviewers of the use of medicines, pharmacists have a particularly important role to play in helping patients adhere and make best use of what may be a cocktail of medicines, some of which the GP may not even know the patient is still taking (including OTCs).

Pharmacies each have an annual quota of 400 funded MURs that they can perform each year. The recorded information is only shared with the GP if significant clinical issues are identified. The average annual number of MURs completed per participating pharmacy as of March 2008 in England and Wales was only 125, but this number is expected to have grown by around 50 per cent for the year ending March 2009.  If MURs are recognised as a cost-effective way to reduce non-adherence rates, more funding may be required for more pharmacies to complete their 400, or to allow an extension of the quota. This funding does not appear to be forthcoming.

Pharma executives need to consider seriously the role of the pharmacy channel and how they can help the profession. With patients walking off the High Street and into their shops on a regular basis, pharmacists are well positioned to effect change. Pharmacists see their patients, on average, four times more often than GPs do.

The NICE Guideline Development Group (GDG), chaired by Dr Henry Smithson (a GP), highlighted a number of research recommendations to improve NICE guidance and patient care in the future, based on its review of what's happening in the industry. First among these was "developing effective, equitable interventions to support adherence to appropriate prescriptions." The development group says this research is important because: "Systematic reviews of adherence interventions show that although adherence can be improved, the effects were generally modest and there is considerable room for improvement. Few previous interventions have been developed systematically using appropriate theoretical models, and they have not been modelled and piloted with assessment of process variables as well as outcomes."

Put another way, the GDG suggests the collective approach to improving adherence needs to be based on robust evidence of what works and what doesn't. A one-size-fits-all, concept-based solution is unlikely to work with all patients, and across all conditions and treatments. NICE is, therefore, throwing down a challenge – both to the industry and academia – and awaits a positive response. Although again, NICE stops short of telling the industry how to do it.

A workable solution
In line with the NICE guidance, IMS Health has developed a five-fingered model that is to help clients develop robust, workable, strategic adherence solutions across many therapy areas grounded in the evidence. The adherence strategy developed can be built into both mature and launch brands. While diagnosis of the underlying problems, of course, requires detailed and sophisticated analysis of the evidence around the multiple reasons why patients don't adhere, the solutions need to be easy to implement.

The process begins with analysing the segmentation using patient longitudinal data to understand the size of the problem and the profile of patients it effects. The next step is to determine what to say to patients based on their observed and recorded behaviours around non-adherence. How best to communicate the messages is then considered, ie via which 'platform'. Is it more appropriate for the information to come from GPs or nurses in a practice setting, or from pharmacists who may have more frequent patient contact? Alternatively, the problem may lend itself to a self-managed approach (with patients using an online resource, for example).

We also need to consider how the messages should be delivered; is face-to-face with a pharmacist using a MUR best, or will technology be more effective with the patient enrolled into, say, a website chat-room where he or she can talk things through with other patients? Should the patient receive a regular SMS message, a newsletter or some other direct mailing?

Solutions will vary according to the perceived past behaviours, stated preferences and circumstances of the patient group.

Finally, it is the step that is usually overlooked – evaluation. Did it work? Did the message resonate and change behaviour? Did you get the RoI you expected? If yes, then shouldn't this programme be given long-term continual investment to realise these benefits?

The performance of medicines during clinical trials may be sufficient to satisfy NICE of their efficacy in 2009, but will this still be the only appropriate test by, say, 2011 or 2012? My hypothesis is that in the future NICE will pay much more attention to adherence rates and could commission further health technology assessment (HTA) audits of patented drugs. If the evidence proves patients fail to persist with certain brands and that, in practise, they deliver poorer outcomes than predicted in the clinical trials, they could potentially have the price that NHS is willing to pay reduced in line with these outcomes.

So will pharma consider patient adherence as a long-term profitable strategy? We will have to wait and see.

The Author
Klynn Alibocus is senior manager, patient adherence solutions at IMS Health
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