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- Anthony N. DeMaria, MD, Editor-in-Chief, Journal of the American College of Cardiology⁎ ()
- ↵⁎Address for correspondence to:
Dr. Anthony N. DeMaria, Editor-in-Chief, Journal of the American College of Cardiology, 3655 Nobel Drive, Suite 630, San Diego, California 92112
As I have written before, the health care community in San Diego has universally come together for the rather audacious aim of reducing the number of heart attacks and strokes in our county by 50% in 5 years. The basis of this effort is to have all citizens reach guideline-recommended goals for blood pressure, lipids, and blood sugar as well as live a healthy lifestyle. In the course of this effort, we have recognized that sustained adherence to medications and lifestyle modification would be required to achieve our goal. Therefore, as part of our preparations we had a presentation on patient adherence from a local expert. Although the issue of noncompliance is certainly not new, I was a bit surprised by the magnitude of the problem, and decided to look into it further.
As you may have expected, I found that there is an extensive literature regarding adherence, or the lack thereof. As evidence, there have been a number of Cochrane Systematic Reviews on the subject over the years (1), and the World Health Organization issued a report dealing with it in 2003 (2). Despite the extensive bibliography on the subject (3), the issue of adherence is shrouded in uncertainty. To begin with there are differences in definition; noncompliance may be total or partial, the degree of which can vary between articles, and can even include extra medications. In fact, in an effort to emphasize the need for physician–patient collaboration in achieving compliance, the terms adherence and compliance have been replaced by concordance by a number of authorities. Methods to identify adherence are also multiple, and often involve imperfect strategies, such as testimony from the patient. Although several specific issues are frequently cited as being responsible, the causes of nonadherence are multiple, and one review indicated that as many as 200 potential reasons have been evaluated over the years (4). One classification that appealed to me was intentional versus unintentional. Data exist to suggest that noncompliance results in a suboptimal clinical benefit, a lesser quality of life, and, of course, a significant waste of resources to the healthcare system. Nevertheless, I was surprised to find that the most recent systematic review of the subject by Haynes et al. (1) concluded that a clear causal relationship between adherence to therapy and clinical outcome had yet to be unequivocally established.
Depending upon the definition and the setting, the frequency of noncompliance with medications varies from 25% to 80%, with a prevalence of 50% being generally accepted as typical (2). I must admit, I find it hard to believe that one-half of my patients do not take their medications as prescribed, but this is likely to be the case. Predictably, a number of factors predispose to a high incidence of nonadherence, including age, underlying medical condition, psychosocial setting, and the nature of the medication. Cardiologists are especially likely to encounter noncompliance, since it is particularly prevalent with therapies that are prophylactic in nature, such as antihypertensive and lipid-lowering agents (4). There is evidence that even patients who have experienced acute coronary syndromes and coronary revascularization often fail to follow their recommended treatments. In addition, adherence rates almost invariably fall over time, so that the rate is markedly reduced after 2 years for chronic therapies such as those often applied for cardiovascular conditions. Obviously, this is a serious problem that all of us have to deal with.
As with other aspects of nonadherence, considerable uncertainty exists regarding remedies. Since there are a large number of potential causes and conditions that may influence the problem, it is not surprising that no single solution has been identified. Several issues are readily addressed by specific measures. The remedy for the inability to afford drugs is straightforward, if not easily achieved, and a variety of devices and strategies are being developed to deal with the problem of forgetting doses. Simplifying the number and frequency of pills to be taken is another obvious tactic to achieve compliance. However, the most effective approach to the problem involves the interaction between the patient and the physician. Patients are most likely to follow a therapeutic regimen when the rationale behind it, the benefits expected, the potential side effects, and the importance of adherence have been discussed in detail. Unfortunately, in the present economic climate the necessary time and compensation for such discussions is often lacking.
The issue of nonadherence to therapies has clear significance for journal editors. JACC, like other journals, receives many manuscripts that use administrative databases. It is, of course, impossible to know how many patients have complied with the medical regimen in these studies. In fact, even in well-organized prospective trials, documentation of the percent of enrollees that have followed the prescribed pharmaceutical intervention for the duration of the protocol may not be reported. While the cross-over rate is nearly always scrutinized in trials of procedural interventions, the same degree of attention is not always given to the potential equivalent of noncompliance in studies of medications. It can be argued that, despite the rate of adherence in any study, recommending the superior regimen is the strategy that will yield the best outcome. However, poor compliance may result in the inability to demonstrate benefit from an effective drug compared to placebo, and variable adherence to 2 agents in a comparative trial can result in misleading findings. It is obvious, therefore, that adherence is an important variable to be taken into account by investigators, editors, and readers.
As have most physicians, I have always been aware of the issue of nonadherence, and the role it plays in clinical practice. It has been the cause of hospitalization for many of the patients admitted to my service, and I have always taught house officers that patients given 3 or more multiple dose medications daily are likely to fail to follow the regimen. I must admit, however, that I have probably underestimated the full dimension of the problem, and not addressed the issue as seriously as I should. The implications of noncompliance for prophylactic interventions, such as for hypertension or hyperlipidemia, are enormous and surely will affect the potential to accomplish a large reduction in heart attacks and stroke. A greater appreciation of the role of nonadherence in clinical research is clearly warranted. However, of greatest importance is the effect of noncompliance on the patients under my care. I still find it hard to accept that 50% of my patients may not be taking their medications as prescribed. I owe it to them to strive to achieve the highest adherence possible by whatever means are necessary. Determining the best therapy for patients is and will always be critically important, and has been the primary focus of my clinical care. Insuring that patients actually take that therapy is equally important, and will receive equal attention in my practice from now on.
- American College of Cardiology Foundation
- Haynes R.B.,
- Ackloo E.,
- Sahota N.,
- McDonald H.P.,
- Yao X.
- World Health Organization (WHO)
- Carter S.,
- Taylor D.,
- Levenson R.,
- Medicines Partnership