Patient adherence: time to fix the leaking bucket?

Klynn Alibocus

IMS Health

The National Institute for Health and Clinical Excellence (NICE) published new guidance ‘Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence’ (CG76) earlier this year. I would like to pick over the salient points and challenge pharmaceutical companies to respond.

At the outset the guidance sets out why medicines adherence is a headline grabbing issue of considerable interest both to healthcare professionals and taxpayers.

“It is thought that between a third and a half of all medicines(Ref 1) 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 economic costs are not limited to wasted medicines (NICE estimates(Ref 2) that around £4bn of medicines are not used correctly) and include the knock-on costs arising from increased demands for healthcare, including unnecessary hospital admissions, when patient health deteriorates because of non-adherence. The economic costs of course also extend to the pharmaceutical industry.

With product profitability being squeezed from many angles and pharma companies needing to invest substantial funds to drive new prescriptions, tackling non-adherence rates presents a significant opportunity for pharmacos to repair a financial leak, achieve excellent returns on investment (value/patient increases), and improve the treatment outcomes of existing patients. In fact, improving adherence rates can mean that ‘everyone’s a winner’: patients, NHS, and the healthcare industry.

IMS analysis of the Medline database (Ref 3) indicates that since 1996 almost 25,000 articles have been published in English alone by researchers on the subject of patient compliance or adherence – research in this area has grown exponentially over recent years. The key question is why have such high rates of non-adherence persisted?

Some interventions have of course worked, but they arise ‘in the mix’ and have not always been clearly identified. Pharmacos general approach to patient adherence is tactical and short term, solutions to non-adherence have not been pursued with the same energy and professional exactitude routinely applied to the generation of new sales. Adherence may be a multi-faceted problem on a global scale, but the industry unquestionably has the talent to improve it by drawing on the evidence from outcomes based research. The industry, having previously focused on short term tactics may need to commit to a long term strategy to improve adherence rates and weave the solutions into the life-cycle of each product, and could now be challenged by NICE to address this issue.

In 2003 the World Health Organisation (Sabaté et al. Adherence to Long-Term Therapies: Evidence for Action, World Health Organisation, 2003) cited multiple factors as to why patients don’t adhere. These ranged from reasons linked to economic and social factors to those related to the nature of the condition, the type of therapy, as well as to an individual’s physical and psychological capabilities.

Non-adherence is not therefore an unavoidable problem that should be assumed to persist simply because some patients always ‘forget to take their medication’. The problem is more complex, whilst patients might report forgetfulness to researchers as the main reason (56%) for not adhering (see Cheng JW, et al. Pharmacotherapy. 2001, 21:828-841) 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 (to the unaware and frustrated, who want to get better but don’t know what to do) and motivation (to the sceptical). Successfully targeting these patients will move the adherence curve positively outwards.

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 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 and motivations of their patients and involve them in the decision-making process accepting that there is a balance of risks and benefits from the side-effects of the medication and setting patients’ expectations around that.

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 guideline therefore offers ‘recommendations about how healthcare professionals can help patients to make informed decisions by facilitating the involvement of patients in the decision to prescribe, and how they can support patients to adhere to the prescribed medicine.’

This may involve a ‘motivational style’ of consultation: one that is more patient-centric and supportive of adherence. Merely providing patients with instructions to follow is not sufficient and is a distance away from being best practice. Where patients wish to be consulted then they should be given the opportunity to be involved with the prescription decisions if medicines wastage is to be reduced. The National Audit Office estimates (Ref 4) that £100m worth of medicines are returned to pharmacies alone every year and that the total wastage bill is likely to be significantly higher.

The guideline also makes clear that communication between healthcare professionals needs to be improved. Communication can break down at various points: between GPs and pharmacists, and when patients are transferred from hospital back into the care of their family/community. Whilst there are pockets of good practice, communication is not universally excellent between healthcare agencies in the UK – the guidance however stops short of advising what best practice looks like and how it might be implemented.

For example, whilst on average around 20% (Ref 5) of patients don’t turn up at the pharmacist to collect the prescription written by the GP, 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.) Neither does the GP know if the patient has had a discussion with the pharmacist and revealed intolerance with 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 is 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 pharmacos to inform patients appropriately about that medication. There is more than a whiff of a suggestion here that more can and should be done in this regard and, although the guidance again doesn’t specifically indicate what this ought to be, pharmacos will be taking notes.

The guideline recognises 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. The White Paper, ‘Pharmacy in England: Building on strengths – delivering the future’, published in April 2008, pointed towards the enhanced role for pharmacists. The new guidance is in-line with this thinking.

In their role as dispensers and reviewers of the use of medicines pharmacists have a particularly important role helping patients adhere and make best use of what for some patients may be a cocktail of medicines – some of which the GP may not know the patient is still taking (including OTC’s).

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 at March 2008 in England and Wales was only 125 (General Pharmaceutical Services in England and Wales 1998-99 to 2007-08), but is expected to have grown by around 50% for year ending March 2009. If MURs are recognised as a cost-effective way to reduce non-adherence rates then more funding may be required in order for more pharmacies to complete their 400, or to allow extension of the quota. This funding does not appear to be forthcoming.

Pharmaco 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.

The NICE Guideline Development Group (GDG), chaired by Dr Henry Smithson (a GP), highlighted a number of recommendations for research, based on its review of what’s happening in the industry, to improve NICE guidance and patient care in the future. First amongst these was ‘developing effective, equitable interventions to support adherence to appropriate prescriptions.’ For the development group 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/ treatments. NICE is therefore throwing down a challenge both to the industry and academia and awaits a positive response, although NICE again stops short of telling the industry how to do it.

In line with the NICE guidance IMS has developed a five-fingered/step model (fig 1) that is already being used with clients to help develop robust, workable, strategic adherence solutions across many therapy areas grounded in the evidence. The process can be applied and an adherence strategy built into both mature and launch brands. Whilst diagnosis of the underlying problems of course requires detailed and quite sophisticated analysis of the evidence around the multiple reasons why patients don’t adhere, the solutions need to be easy to implement.

Leaking Bucket Figure 1 600x284

Fig 1. IMS Patient Adherence Solutions: A strategic and evidence based approach

The process begins with analysing the segmentation using patient longitudinal data to understand the size of the problem and the profile of patients within. The next step is around determining what to say to patients based on their observed/recorded behaviours around non-adherence. Next we consider how the messages should best be communicated – via what ‘platform’. Is it more appropriate for this 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.)

Then we need to consider how the messages should be delivered. Is it face-to-face with a pharmacist using a MUR, 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, and/or should the patient receive a regular SMS message, for some a newsletter or some other direct mailing may be the best solution. Solutions will vary according to the perceived past behaviours, stated preferences and circumstances of the patient group.

Finally, the step that’s usually overlooked – evaluation. Did it work? Did the message resonate and change behaviours? Did you get the ROI you expected? If it did then shouldn’t this programme have long term continual investment to realise these benefits? IMS is uniquely positioned to measure these benefits, for all the stakeholders, the patient, the pharmacos and the NHS.

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

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

References:

1. ‘Medicines’ is used as a general term to refer to prescribed medicines that are self-administered and includes tablets, syrups, ointments, eye-drops and suppositories.

2. Costing statement: Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence, NICE, January 2009.

3. IMS Analysis of Medline Database, April 2008.

4. NAO report – Prescribing Costs in Primary Care, HC454 Session 2006-2007, 18 May 2007.

5. Patient Compliance, Disease Management and Consumer Outreach: Cutting Edge Information report, 2006.

POWERED BY THE IMS LIFELINK PROGRAM

IMS LifeLink™ is a unique global program of patient-centered information, analytics and consulting. Through LifeLink’s longitudinal disease and treatment dynamics, healthcare stakeholders gain critical knowledge about drug utilization, prescribing and cost-of-care trends. LifeLink offerings range from syndicated products and services infused with new patient-level metrics to proprietary custom analytics and consulting engagements, all incorporating a patient perspective. Building on significant IMS investments in technology and anonymized patient-level data around the world, the underlying LifeLink database is sourced from longitudinal prescriptions, health insurance claims and electronic medical records.

About the author:

Klynn Alibocus is Senior Manager of Patient Adherence Solutions at IMS Health, based in the UK.

For enquiries please email KAlibocus@uk.imshealth.com