Patient Compliance

Sweetening the Pill

Faiz Kermani, Madhu Davies

• Publisher: Routledge
• Year: 2016
• ISBN:
  9781317083252
• Edition: 1
• Topic: Medicine
• Subtopic: Public Health, Administration & Care

Vast global resources are ploughed into the delivery of treatment interventions ranging from diet and lifestyle advice to complex surgery. In all cases, whatever the intervention, unless the recipient is engaged with the process and understands why the intervention has been offered and the part they play in its success, compliance is an issue. Even where the individual does engage and understand, he or she may choose not to comply. Non-compliance is estimated to cost the pharma industry US$70 billion per year. No figures exist for the cost to healthcare insurers and public health but non-compliance is undoubtedly one of the top five issues facing both drug developers and healthcare providers. During clinical trials, non-compliance undermines the accuracy of the data generated from the whole trial as well as particular aspects such as the efficacy of different dosages. This book explores the key factors which drive compliance and the part that healthcare professionals can play in improving this, with the key underlying goal of improving public health in its broadest sense.

Part 1
What is Compliance?

The opening chapters set the scene: they illustrate the scope of the issue, defining compliance, persistence, adherence and concordance together with the health economic impact of non-compliance and its consequent impact on public health.

CHAPTER 1
Patient Compliance: Setting the Scene

Dr Faiz Kermani and Dr Madhu Davies

Medical non-compliance is the failure of patients to comply with their medical care regimens. There is a host of health care professional– patient interactions which may be affected by non-compliance, ranging from medico-social issues such as patients refusing to accept ‘Meals on Wheels’¹ when they are too frail to shop and/or cook for themselves, through to a conscious or unconscious decision, after going through all the trauma of an organ transplant, not to comply with anti-transplant rejection therapy.

In order to produce a manageable text for the reader, we have chosen to focus on the factors influencing compliance with medicines. We tried to obtain insights on compliance from the areas of complementary and alternative medicine and also consumer health but failed. We wanted to include these areas because patients often instigate the decision to access them without conventional healthcare professional intervention. By definition, they have engaged with the process, at least at the outset: what factors drive them to remain engaged and what factors turn them away from these options? We felt that there could be valuable lessons to learn and apply to conventional, mainstream medicine with its heavy reliance on pharmacology. We failed in our attempt because potential authors cited a lack of published data on which to base their chapters. We hope to address this problem in the next edition of this book.

So, from the perspective of this book, and very broadly, non-compliance refers to the failure of patients to take medicines in their prescribed manner. Where relevant, the authors set the scene for their topics and provide their working definitions of non-compliance; this in itself begins to illuminate the multi-faceted aspects of compliance.

The problem of non-compliance is not a new one and it has been investigated for several decades worldwide. Regardless of the science and medical technology behind a particular drug, it will only be therapeutically effective if patients take it according to their doctors’ recommendations.

Patient non-compliance with their medication lessens the quality of healthcare and, in some cases, can lead to dangerous consequences for patients. It is taken so seriously that the New York Times described the scale of its occurrence in the USA as the nation’s ‘other’ drug problem (Zuger, 1998). It also has an important, and often underestimated, economic impact on healthcare. Now that the allocation of healthcare resources has become such an important issue for governments, healthcare providers can no longer ignore patient compliance issues. Some believe that advances in improving compliance may be as important as improving the actual treatments on offer.

The importance of patient compliance is also well recognized by those running clinical trials, as it has an important bearing on the evaluation of new drugs. Even though compliance in trials is often better than that seen in general clinical practice for many conditions, patient compliance is an important issue that must not be overlooked. For example, a Canadian study focusing on migraine concluded that better adherence to treatment could improve health outcomes, but that the compliance strategies available were mostly ineffective and were poorly assessed (Aubé, 2002). The therapeutic gain in many studies was, at best, in the order of 30–40 per cent, but the author suggested that the frequency of migraine attacks could be reduced by 50 per cent through effective compliance strategies (ibid.).

Paying attention to compliance issues is therefore essential to ensuring that the data collected during trials are as accurate as possible. When planning trials, clinical teams aim to ensure maximum patient compliance. Compliance will be affected by factors such as the duration of the treatment, the number of times a drug has to be taken per day and potential side-effects.

In mainstream medicine, prescribers, healthcare providers and manufacturers have struggled to determine the myriad factors that contribute to the non-compliance problem in order to counteract its effects. The field of compliance-related issues is growing, and there is considerable debate on the appropriate terminology to be used (Mullen, 1997). Much of the confusion has arisen from where the different terms to describe the usage of medicines have originated. Some terms and phrases are used exclusively in the clinical domain, some in the educational/social science arena and others in the pharmacoepidemiology/drug utilization research domain. Patient compliance remains a multi-faceted problem, and the difficulties in defining what is relevant to the field mean that there are no easy solutions.

Furthermore, as medical practice and social issues can vary widely around the world, approaches to improving patient compliance in one country cannot automatically be assumed to be appropriate for solving the problem in another. Internationally there will be variations in the preferences and dislikes of the patients in each individual nation or particular region. This means that all parties involved in healthcare must learn more about the societies from which these patients are drawn. It is sadly all too easy to make assumptions and generalizations about patients. Yet as we are only beginning to learn, patients’ attitudes to their medicines can be influenced by many aspects of their daily life.

Understanding the patient’s perspective on the disease in question can lead to considerable improvements in compliance. For example, a study on type I diabetes patients in England focused on the dietary constraints that the disease imposed (‘Diabetics’, 2002). The majority of these patients had to follow strict diets to ensure that their blood sugar levels remained stable. In the study, patients were divided into two groups. The first group were trained on how to adjust their insulin intake to take account of their changing diet, whereas the second group received their usual treatment. After six months, the researchers found that those in the first group had more stable blood sugar levels despite the fact that they were actually requiring more frequent insulin injections. The authors of the study concluded that that this approach would help patients ‘to fit diabetes into their lives rather than their lives into diabetes’.

From a technical point of view, the nature of a medicine can affect patient compliance with a therapy. When developing a new drug, pharmaceutical companies often spend considerable time on assessing how the dosage form appropriate for their candidate will affect patient compliance. Consequently, novel drug delivery technologies are being applied to new drugs in the hope that they might encourage patients to comply with their treatment. Yet a form that proves popular in one country may not necessarily be as popular in another. However, unless those companies developing medicines communicate effectively with those who prescribe medicines and use them, few advances will be made in improving patient compliance.

These aspects of patient compliance are well known in the treatment of HIV infection with antiretroviral drugs. The antiretroviral therapies that are now available have the potential to achieve and sustain suppression of viral replication in many individuals, thereby transforming the outlook for patients. In many cases, HIV has been transformed into a manageable chronic disease (Altice and Fridland, 1998) provided that patients maintain a near-perfect adherence to therapy. However, studies have found that compliance rates vary substantially (ibid., Singh et al., 1996), and it is well known that differing levels of adherence to therapy explain much of the magnitude and durability of the therapeutic response (Altice and Friedland, 1998).

Early on in the attempt to resolve this problem it was recognized that improving adherence was not the sole responsibility of the patient. As drug manufacturers and prescribers began to better understand patient attitudes to antiretrovirals, dramatic improvements were made in terms of compliance. Patients wished to take as few pills as possible and found the frequent dosing to be problematic (Dixon, 2002). Once-daily and twice-daily treatments have proved more acceptable to patients than those that had to be taken three times a day. Similarly, the use of fixed-dose combination antiretrovirals, which contain two or three antiretroviral drugs in a single formulation, can improve compliance. Reducing the number of pills and thereby reducing the frequency of dosage have enabled patients to fit the treatment in more easily with their lifestyles.

In this introductory chapter we have hopefully illustrated the range of factors that can affect patient compliance, all of which will be expanded upon and supplemented in the following chapters. As suggested above, in the modern context it is also important to appreciate that many patients are using complementary medicines based on their own assessment of their health. Compliance issues relating to these remedies have not been explored, but they could well have a bearing on how patients use the medicines prescribed by their physician.

As the field expands, it is hoped that there will be scope to widen the discussion concerning patient compliance further in the future.

REFERENCES

Altice, F.L. and Friedland, G.H. (1998), ‘The Era of Adherence to HIV Therapy’, Annals of Internal Medicine, 129(6), pp. 503–505. Also available at: http://www.annals.org/cgi/content/full/129/6/503#R9-15.

Aubé, M. (2002), ‘Improving Patient Compliance to Prophylactic Migraine Therapy’, Canadian Journal of Neurological Science, 29, Supplement 2, S40–S43.

‘Diabetics “Freed from Strict Diets”’ (2002), BBC News, 4 October at: http://news.bbc.co.uk/1/hi/health/2295325.stm.

Dixon, B. (2002), ‘Reasons for Low Compliance with HAART Regimens Pinpointed’, AIDSmeds.com at: http://www.aidsmeds.com/news/20021028publ005.html.

Mullen, P.D. (1997), ‘Compliance Becomes Concordance’, British Medical Journal, 314, p. 691.

Singh, N., Squier, C., Sivek, C., Wagener, M., Nguyen, M.H. and Yu, V.L. (1996), ‘Determinants of Compliance with Antiretroviral Therapy in Patients with Human Immunodeficiency Virus: Prospective Assessment with Implications for Enhancing Compliance’, AIDS Care, 8, pp. 261–69.

Zuger, A. (1998), ‘The “Other” Drug Problem: Forgetting to Take Them’, New York Times, 2 June.

1. Meals on Wheels: A United Kingdom intervention aimed at getting hot meals to those who need them in the community, typically the frail and elderly. A small charge is levied.

CHAPTER 2
View from the Real World

Dr John Parkinson, Dr Li Wei and Professor TM MacDonald

THE EXTENT AND EFFECT OF NON-COMPLIANCE

Poor adherence to treatment of chronic diseases is a worldwide problem of striking magnitude and adherence to long-term therapy for chronic illnesses in developed countries averages 50 per cent. In developing countries, the rates are even lower. It is undeniable that many patients experience difficulty following treatment recommendations.
(WHO, 2003)

Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments.
(Haynes et al., 2001)

The literature contains different terms that describe the phenomenon of ‘compliance’. Already we have used two, compliance and adherence. We should therefore commence any discussion with a series of definitions of the various terms.

Definitions

Over the years, a whole series of words and phrases has been applied to the act of taking, or not taking, medicines ‘as directed’. Some of these are used exclusively in the clinical domain, some in the educational/ social science area and others in the pharmacoepidemiology/drug utilization research domain. Care should be exercised as the use of these terms is not always consistent.

The variation in terms used can be partly explained by the different sources of drug use information, the precise type of data available or, sometimes, the tone of the message to be conveyed – particularly if work on behavioural science is being reviewed. The main words/phrases in current use, together with an explanation, follow.
Our intention here is not to dictate which definition is correct or should be used but to point out that anyone interested in the area should take care, when comparing results in different publications, to ensure that comparisons have meaning. Our own personal preferences for definitions will become clear later when we present research results.

Compliance

Compliance is the degree to which a patient is compliant with the instructions that are given by a healthcare professional and written on the medication label (for example, prescribed dose and time schedule). Accepting that compliance can involve both a time and dose dimension, it can be measured in a number of ways. These range from the absolute whereby there is some method of monitoring, using a biological marker, that the patient has actually swallowed or inhaled the medication, to pill counts that are often used in clinical trials, to a medication event monitoring system (MEMS) that records the date and time when a container was opened or activated, to electronic databases that record the redemption of a second or subsequent prescription of pills as a marker that the previous pills have been taken. In the latter case, the difference between the redemption dates should equal the number of days of medication available for 100 per cent compliance.

Some studies also report compliance rates as expressed by patients, but it has been noted that good compliers express this accurately whereas poor compliers tend to overstate their compliance (Cramer and Mattson, 1991; Spector et al., 1986). There are also studies that report providers’ recommendations, although these also tend to overestimate (Norell, 1981). The term ‘compliance’ is a value-laden and hierarchical term and, because of this, has been much criticized.

Adherence

Most authorities agree that adherence and compliance have the same meaning. However, a recent WHO report states that adherence requires the patient’s agreement, thereby suggesting that compliance does not require this. The term ‘adherence’ is thus still authoritarian and has its critics (WHO, 2003). Others, including ourselves, have used adherence as a composite term to ‘lump together’ compliance and persistence.

For example, over a 100-day period a subject takes 56 tablets spread out evenly over these 100 days. The compliance is 56 per cent. Another subject takes 56 tablets on successive days and then stops. His persistence is 56 days. Another subject takes 56 tablets over 70 days and then none for 30 days. Over the first 70 days he is 80 per cent compliant but his persistence is only 70 days. However, over 100 days he is 56 per cent adherent. Thus adherence is a convenient term when examining the ‘intention to treat’ type o...

Table of contents

• Cover Page
• Title Page
• Copyright Page
• Contents
• List of Figures and Tables
• List of Abbreviations
• List of Contributors
• Preface
• Part 1 What is Compliance?
• Part 2 The Challenge of Compliance
• Part 3 Building For Success
• Part 4 Achieving Compliance: Looking to the Future
• Index