Eye opener

The amount of scrutiny and downward pressure on drug prices is overwhelming. Yet, while the government, the Office of Fair Trading and activists hammer on about the rising costs of medicines, little attention is given to patient compliance. It's a bit like complaining that your grocery bill is too big and then throwing out spoiled food from the refrigerator.

While studies regularly address the importance of compliance and its potential to create significant cost-savings, very little is being done. Patient compliance is complicated; it is a multi-factoral problem with no clear solutions. However, there is a role in improving compliance for a number of public health stake- holders, including pharmaceutical companies.

The World Health Organisation (WHO) defines patient compliance as: The extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes - corresponds with agreed recommendations from a healthcare provider. Non-adherence, where patients fail to complete drug treatments, not only wastes pharmaceutical expenditures but also results in a continuing, if not worsening, state of health, both of which increase costs to healthcare systems. Non-adherence is such a problem that the ability to reduce it may have a far greater impact on society's health than most advances in specific therapy areas.

Not only detrimental to a patient's health, the costs of non-compliance are considerable. According to a 2003 study by Elliot, some 6.5 per cent of adult hospital admissions in the UK are likely to be drug-related, 30 per cent of which are due to non-adherence. Taking severe asthma as just one example, the Global Initiative for Asthma estimates that improving patient compliance could save about 45 per cent of the total medical costs.

Getting attention
When patient compliance does generate debate, it is in the periphery. The Mental Health Bill has sparked huge controversy in large part due to the inclusion of community treatment orders, which would allow for compulsory treatment. Parliamentary and media questions are not about the problem, cause or solution to improved compliance but rather the ethics of detaining patients and making them take their pills.

Hopefully, discussion of the Mental Health Bill will draw attention to the broader problem of patient drug compliance. The mentally ill raise unique challenges in treatment, especially in terms of drug therapy. However, it is not just those suffering from mental disorders who skip their medications. According to the WHO, roughly 50 per cent of patients in developed countries fail to comply with their drug regime. While it is particularly common in chronic diseases such as asthma, diabetes and hypertension, it also plagues acute care. Public health notices are regularly issued about the weakening effectiveness of antibiotics because of over-prescribing and poor compliance, which in turn builds resistance - leaving few options for future treatment of infections.

Why not?
There is an almost endless list of reasons why patients fail to comply with their medicines, but the key factors are associated with patients themselves and their doctors. Reasons for non-adherence include patients feeling embarrassed or shy about sharing their concerns with their doctor, or reluctance to tell their doctor they have experimented with dose of their medicines or over-the-counter drugs.

While some patients want an active role in their treatment decisions, others may wish to defer that responsibility solely to their doctor. Additional factors include individual health beliefs and behaviours. Patients are strongly ruled by their belief of whether medicines are 'good' or 'bad' for their bodies. If a patient believes that a drug is intrinsically 'unnatural' and thus 'harmful', they are likely to modify their treatment by either not taking it at all or reducing the dose. Cultural and sociological aspects also play important roles in the identification of medicine being 'good' or 'bad'. Other variables also include the physical capabilities of patients including age and mental state. A patient will not be successful at adhering to his or her prescription if he or she is physically or mentally unable to take it. For example, those who suffer from mental illness may miss a dose and then not understand the importance of, or reason for, their medication.

Meanwhile, drug dosages and their delivery methods may be too complicated or difficult for individuals to follow. This is especially the case for the elderly who lose motor skills and may have difficulty managing small and multi-coloured pills. Perhaps unsurprisingly, young people are less likely to follow their treatment regimen than older adults for such reasons as a lack of immediate concerns of poor health.

Additional factors include the ability to obtain medications, language barriers and the ability to pay for a full regime of treatment. Many patients may find getting to the pharmacist a challenge due to physical ability or the lack of transport. For those who do make it to the pharmacy, they may not be able to afford their drugs. Affordability is of particular concern because of NHS co-payments. It is estimated that nearly 750 million people in England and Wales are not filling out their prescriptions because of cost. Meanwhile, immigrants face language barriers that are further complicated by complex treatments that include multiple drugs and changes in drug regimens due to varying symptoms. All these factors are underscored by the need for the support and supervision required to successfully complete prescription treatments. There are an overwhelming number of patient factors, but doctors are also integral to improving patient compliance. Most studies suggest that improved doctor-patient communication and increasing the role of patients in treatment decision-making increases compliance rates.

While these are well-intended 'solutions', they have practical limitations. GPs are charged with an ever-increasing list of responsibility. They fairly state that their top hindrance to improving communication is time. On average, GP consultation time has shrunk to less than 10 minutes per patient. In an attempt to trim waiting lists and increase efficiency, doctors are left with less time for building a communicative doctor-patient relationship. Many doctors may also perceive their role in diagnosis and treatment as superior to the patient's, a perception well-founded on the doctor-patient relationship because of the information asymmetry inherent in healthcare. This type of relationship can lead to a paternalistic perception of doctors where patients feel less comfortable asking questions and doctors are less willing to ask for patient input. In this situation, unvoiced patient concerns can lead to poor health outcomes. The delicacy of this relationship between doctor and patient vis-a-vis adherence to drug regimes is mirrored in the changing terminology employed by the Department of Health: compliance in the 1980s, concordance in the 1990s, and increasingly concurrence under the new Labour ideology in which the patient rules.

Making the medicine go down
The WHO recognises that improving patient compliance will require a multifaceted approach. Relying on improved doctor-patient communication and shared decision-making is not enough, especially given the demands on doctors' time and resources. Rather, solutions should be sought from healthcare workers, pharmaceutical manufacturers and patient groups, as each has a part to play in improving patient compliance.

The traditional role of pharmacists is changing. WHO recognises pharmaceutical care as part of the role of pharmacists. Pharmacists are also becoming more active in helping patients manage long-term illnesses: some even have the authority to prescribe. Using pharmacists to impart knowledge to patients and to address their concerns regarding medication is an efficient use of their expertise. Nurses too are becoming more independent from doctors and can readily address patients' pharmaceutical needs and concerns. In some cases, they can also prescribe.

Support groups may also play a key role in improving adherence, especially for those who will need long-term treatment, such as the mentally ill and HIV/AIDS patients. Active listening, home visits and counselling can all help improve adherence. In addition to emotional support, such groups can provide practical assistance by sending dosage and appointment reminders to members.

Technology is a promising tool for improving adherence and health outcomes. Mobile text messaging can be used to remind patients to take their medications. A pilot study in the UK showed quantifiable improvements in health outcomes with a mobile text campaign for children with diabetes. Meanwhile, the use of microelectronic devices to provide feedback on patients' adherence is already being used to monitor of many long-term illnesses. The internet also provides a valuable forum for patients to not only share their frustrations, but also learn how to better manage their disease from their peers. Patients also gather information which may influence their drug use from health information websites and blogs.

Action to improve compliance does not end at the door of patients and doctors. The pharmaceutical industry has a key responsibility to the adherence problem through the reduction of drug regimen complexity. Pharma companies regularly invest resources to improve the ease and use of their products. Ask About Medicines Week is a pharmaceutical industry-led forum to reach out to and engage patients - helping make patients more knowledgeable and comfortable with their drug treatments.

Considerable resources are also put into making drugs easier to take. For example, patches and more convenient doses, such as sustained release drugs have been brought to market. While regulatory approval may consider changes in drug dosage or delivery method as different from the originally approved drug, it is in the interest of good corporate governance for pharma companies to make their products as beneficial to patient health as possible and for regulatory bodies to reward such efforts. Compliance can only be improved through a dynamic approach, where healthcare providers are sensitive to patient needs, patients are empowered by emotional support and information, and every effort is made to make treatment as simple as possible. Compliance is more than an individual patient problem; it is a significant and costly concern to society and deserves practical action.

Tactics to overcome compliance issues
Non-compliance is moving to the forefront of pharma marketers' concerns. However, it still has a long way to go before it progesses from vague awareness to a point of widespread and decisive action.Many marketers don't realise that lack of compliance can be dealt with effectively and with good return on investment (RoI). There are many communications channels available: some are more effective in addressing particular causes of non-compliance than others and the correlation between efficacy and regulatory pressures should be considered when selecting the channels.

• Nurse-led call centres, possibly equipped with voice-automation technology: Effective, instant support through phone calls either to or from patients - no other communication is as reassuring and interactive. Where compliance is being adversely affected by patient understanding, call centres can be a critical element of a compliance programme. They also provide a useful gauge of distance between the patient and the pharma company. But, with the wrong supplier, these can be expensive to set up and maintain, so it's important to find suppliers who understand pharma marketing and appreciate the need for RoI.
• Email: This is cheap and can be effective in reminding patients to take their medication as prescribed. However, forgetfulness may not always be an issue. There are many reasons for poor compliance, and forgetfulness is just one of them. Also, not all patients have email.
• Direct mail: Useful, especially in support of call centres, direct mail can deliver information, always provided that the patient has explicitly agreed to receive it. But, the written word is not always the best medium to communicate complex issues; its best use is in support of a telephone-based discussion.
• CD-ROM: Can deliver information quickly and, once the cost of generation has been amortised, inexpensively. Yet it suffers from has the same objection as email  not all patients have computers. More importantly, this medium is not sufficiently interactive to act on its own as a compliance programme.
• SMS texting: Like email, useful to remind patients to take their medication, ask for repeat prescriptions etc. But it is limited to 160 characters, so not suitable for complex messages. It is also less effective with a senior audience who may not own a mobile. Though there are challenges in talking to patients, it's both possible and desirable. You are unlikely to run into patient resistance - most patients want drug information to be supplied directly by pharma companies and providing such information improves both patient outcomes and sales. GPs alone cannot be solely responsible for a constant flow of compliance information to patients, especially with the growing health consciousness of patients across Europe, where 60 per cent rate their medical knowledge as above average. Research shows that talking directly to patients has other benefits:
• GPs are more likely to prescribe a drug with a support line
• 85 per cent of patients surveyed would welcome a telephone helpline manned by a healthcare professional
• 73 per cent of patients would prefer a drug supported by such a helpline
• 57 per cent of patients said they would stop taking their medication if unable to receive answers to questions.

Nurse programmes have been shown to improve compliance by an average of 30 per cent in a year. One reason is that nurses, being more keenly attuned to patient, rather than disease issues, know how to gain patients' confidence and provide valuable understanding and support. In the patients' eyes a nurse can also seem less threatening than a GP, and they are often more prepared to open up to a nurse about their concerns. For many patients, this reassurance makes the difference between complying and not complying. In fact, a professional nurse used to managing compliance often seeks concordance almost subconsciously.

Sunita Apte is pharmaceutical business manager and Sarah Hefford is pharmaceutical marketing manager at AXA Assistance.