A review of the literature on the economics of noncompliance. Room for methodological improvement
Introduction
Therapeutic compliance is often defined as ‘the degree to which patient behaviour (in terms of taking medication, following diets, executing lifestyle changes, …) is congruent with the recommendations of health-care providers’ [1]. For medication intake, compliance includes both regularity in dosing and timing of intake [2] and for some specific patient populations (e.g. HIV/AIDS patients) also food recommendations.
For the assessment of the economic consequences of noncompliance, costs and outcomes should be considered in a cost–benefit, cost–effectiveness or cost–utility analysis. Cost–benefit, cost–effectiveness and cost–utility analyses evaluate the ‘value for money’ of health interventions and compare these across interventions to assist decision makers in health-care in setting priorities between health interventions [3].
Therapeutic noncompliance entails costs due to the occurrence and consequent treatment of new or more morbid conditions and, in case of medication noncompliance, sometimes due to increased side-effects of medication. Under-dosing or extended time intervals between two medication intakes may increase morbidity, whereas over-dosing or shorter intervals between two medication intakes may increase unpleasant side-effects or toxicity of the medication. Moreover, buying medication without actually taking it implies a pure economic production cost. The same applies for appointment noncompliance. If the patient does not show up, there might be a slot in the doctor's consultation schedule. In contrast, if the untaken medication is not purchased or if the doctor can see another patient without appointment instead, costs are decreased, if no complications occur. The severity of the disease and the cost of the medication or the opportunity cost of the doctor will determine whether these savings offset the treatment costs of increased morbidity.
As for the outcomes, noncompliance has often been associated with increased clinical risk in chronic patient populations, in terms of increased morbidity and mortality [4], [5], [6], [7], [8], [9], [10]. Less is known about the quality of life associated with noncompliance. If noncompliance would have an obvious negative impact on quality of life, and a positive impact on costs, there is no doubt that noncompliance is undesirable from the economic point of view. Unfortunately, the picture is not that clear, especially with regard to quality of life issues. There is conceptual obscurity in the precise relationship between quality of life and noncompliance. Noncompliance may improve patients' quality of life, for instance when they deliberately adapt their medication schedule to their own lifestyle, or it may decrease their quality of life due to increased moribidity and/or side-effects. From the societal point of view, there might be a problem of negative externalities related to noncompliance, especially if it concerns noncompliance with treatments for infectious diseases. For instance, noncompliance with anti-retroviral therapy in HIV/AIDS may result in viral mutations and resistance, causing a major public health problem if other patients are infected. However, poor or good quality of life may also be a trigger for noncompliance [11], [12]. There might, moreover, be a recursive relation between quality of life and noncompliance, meaning, for instance, that noncompliance impairs quality of life, which in turn decreases compliance. Whether the relationship is recursive or non-recursive is unclear. The effect of noncompliance on the cost–effectiveness of the treatment, if effects are expressed in terms of quality of life, then becomes very ambiguous.
In practice, very few cost–effectiveness analyses correct for the factor of noncompliance [13], [14]. The correction usually occurs in a sensitivity analysis in which the impact of varying compliance rates on the cost–effectiveness ratio of an intervention is tested [14], [13], [15]. For example, Scharfstein et al. [14] found that the cost per Quality Adjusted Life Years (QALYs) gained, of a specific prophylaxis regimen for Mycobacterium avium complex in patients with AIDS, was $25 000/QALY, using efficacy results from a clinical trial. The cost amounted to $34 000/QALY with an assumed noncompliance rate of 20%. In this particular case, the increase in the cost per QALY had no impact on the cost–effectiveness of the regimen relative to other prophylaxis regimens, but it could impact upon its cost–effectiveness relative to interventions in other patient groups. An example of a prophylactic regimen in which the relative efficiency was influenced by the assumed noncompliance rate, was provided by Jönsson et al. [15]. With a compliance rate of 70%, the use of prophylactic misoprostol in patients with osteoarthritis and nonsteroidal anti-inflammatory drug-associated abdominal pain was less costly than no prophylaxis. Because the regimen was also more effective in preventing gastric ulcers, it was obvious that misoprostol administration was a preferable option. However, with an assumed compliance rate of 60%, the regimen became more costly relative to doing nothing.
The assessment of the economic consequences of medication noncompliance is hampered by a number of methodological problems. These problems relate to the definition and measurement of noncompliance, the study design for the economic evaluation of noncompliance, the identification, measurement and valuation of noncompliance-related costs and outcomes and the consideration of compliance-enhancing interventions.
Section snippets
Objective
The main objective of this study is to review the literature on the economics of therapeutic noncompliance in patients and explore the methodological problems in studying the economic consequences of non-compliance. Recommendations for future economic research in this area will be formulated.
Methods and materials
A literature search was performed using Medline 1974-2000, CINAHL 1982-2000, PsychINFO 1966-2000 and reference lists of retained articles. A combination of the following key-words was used: (non-)compliance, (non-)adherence, cost*, economic*, financial. Eighteen studies on the economics of patient noncompliance with therapeutic regimens were found. Five studied the costs of noncompliance in general, seven the costs of medication noncompliance in specific diseases and six the cost–effectiveness,
Results
In the literature on the economics of noncompliance, a number of problems were identified. These problems relate to the definition and measurement of medication noncompliance, study design, cost calculation, outcome measurement and consideration of determinants of noncompliance and compliance-enhancing interventions.
Recommendations
It is clear from the above review that the existing studies on the economics of medication noncompliance lack methodological rigour. Table 4 lists a number of criteria according to which economic evaluations of noncompliance can be assessed.
Conclusion
Therapeutic noncompliance is a behaviour that leads to increased health-care costs and decreased cost–effectiveness of interventions. For both clinicians, policy-makers in health-care and patients, it is important to take the impact of noncompliance on the cost–effectiveness of interventions into account. Studies about the economic consequences of noncompliance are generally performed in a very elementary way. Costs are not valued according to the standard principles of cost calculation, and
References (73)
- et al.
Concomitant factors of decompensation in chronic heart failure
American Journal of Cardiology
(1996) - et al.
Factors associated with medication noncompliance in rural elderly hypertensive patients
American Journal of Hypertension
(1995) - et al.
Physician compliance with advanced cardiac life support guidelines
Annals of Emergency Medicine
(1995) - et al.
Variations in compliance among hypertensive patients by drug class: implications for health care costs
Clinical Therapeutics
(1997) - et al.
Malaria chemoprophylaxis compliance in pregnant women: a cost–effectiveness analysis of alternative interventions
Social Science and Medicine
(1993) - et al.
Adherence to combination therapy in persons living with HIV: balancing the hardships and the blessings
Journal of the Association of Nurses in AIDS Care
(1999) - et al.
Making cost assessments based on RCTs more useful to decision-makers
Health Policy
(1996) - et al.
Adherence to combination therapy in persons living with HIV: balancing the hardships and the blessings
Journal of the Association of Nurses in AIDS Care
(1999) - et al.
Patients with psoriasis and their compliance with medication
Journal of American Academic Dermatology
(1999) Determinants of compliance: the disease and the mechanics of treatment
Patient noncompliance with drug regimens: measurement, clinical correlates, economic impact
European Heart Journal
Methods for the Economic Evaluation of Health Care Programmes
Variations in patient compliance with common long-term drugs
Medical Care
Compliance with anti-tuberculous therapy: a field trial of a pill-box with a concealed electronic recording device
European Journal of Clinical Pharmacology
How often is medication taken as prescribed? A novel assessment technique
Journal of the American Medical Association
Incidence, determinants and consequences of subclinical noncompliance with immunosuppressive therpy in renal transplant recipients
Transplantation
Measuring transplant patients' compliance with immunosuppressive therapy
Western Journal of Nursing Research
Noncompliance in organ transplant recipients
Transplantation Proceedings
Facilitating acceptance of a patient's decision to stop treatment
Clinical Nurse Specialist
Drug-related morbidity and mortality
Archives of Internal Medicine
The cost–effectiveness of prophylaxis for Mycobacterium avium complex in AIDS
International Journal of Technology Assessment in Health Care
Cost–effectiveness of misoprostol in Sweden
International Journal of Technology Assessment in Health Care
Physician noncompliance with the 1993 National Cholestorol Education Program (NCEP-ATPII) Guidelines
Circulation
Physicians' reasons for failing to comply with computerized preventive care guidelines
Journal of General Internal Medicine
An economic view of high compliance as a screening objective
British Medical Journal
Hospitalisation for adverse events related to drug therapy: incidence, avoidability and costs
MJA
Cost of relapse in schizophrenia
Schizophrenia Bulletin
The relationship between drug therapy noncompliance and patient characteristics, health-related quality of life, and health care costs
Pharmacotherapy
The costs of interrupting antihypertensive drug therapy in a Medicaid population
Medical Care
Estimating the cost of hospital admissions due to patient nonadherence in Ontario, Canada
Pharmacoepidemiology and Drug Safety
Labour productivity effects of prescribed medicines for chronically ill workers
Health Economics
Evaluation of the efficacy and cost–effectiveness of health education methods to increase medication adherence among adults with asthma
American Journal of Public Health
Cost–effectiveness evaluation of compliance therapy for people with psychosis
British Journal of Psychiatry
Improving compliance among hypertensives: a triage criterion with cost–benefit implications
Medical Care
Cost–effectiveness of outpatient geriatric assessment with an intervention to increase adherence
Medical Care
Economic impact of noncompliance in kidney transplant recipients
Transplantation Proceedings
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