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American Pain Society
4700 W Lake Ave
Glenview, IL 60025
C. Richard Chapman, PhD
This is my 25th year in the field of pain medicine. I have seen enormous progress over the past quarter century, not only in the accumulation of knowledge but also in our ability to work together as a multidisciplinary community in the pursuit of common scientific and humanitarian goals. New questions and interventions continue to emerge, and much to my surprise, we still stumble upon overlooked areas of obvious importance for patient care. Patient compliance with medication regimens is one such area.
Compliance is important because prescription medication is our first line of intervention for most pain problems. We generally assume that patients with pain will take their medications in the prescribed amount at the prescribed frequency, and little or no evidence exists to indicate that they do not. Unfortunately, extensive literature from other fields strongly suggests that compliance is a problem in pain management. Noncompliance for all types of drugs ranges from 13% to 93% among adult patients (Sclar, Tartaglione, & Fine, 1994), and poor compliance is less the exception than the rule. Moreover, it is not restricted to asymptomatic problems such as hypertension. High-risk asthma patients—those who are often awakened by severe symptoms and frequently visit emergency rooms for asthma problems—demonstrate poor compliance (D'Souza et al., 1996). Aware of our collective oversight, Turk and Rudy (1991) highlighted noncompliance as a neglected issue in the treatment of chronic pain patients, but I can find no subsequent pain medication compliance studies.
Investigations focused on other issues indicate indirectly that a problem exists, however. Heavner, Shi, Diede, and Racz (1996) investigated acetaminophen concentrations in 57 chronic pain patients who used various medications containing this drug. Only 7% of these patients had plasma concentrations in the therapeutic range for acetaminophen.
Compliance is important for scientific as well as clinical reasons. Evaluation of a new drug cannot be accurate if study patients fail to comply with study regimens. Burney, Krishnan, Ruffi, Zhan, and Brenner (1996) studied adherence to explicit written and verbal instructions in 57 healthy, paid subjects who agreed to take a single daily dose of aspirin in a chemoprevention trial. They observed a compliance rate of only 35%. Because poor compliance can confound simple studies with paid volunteers, it merits rigorous measurement and inclusion as a variable in clinical drug trials (Melnikow & Kiefe, 1994).
Measurement of compliance behavior has come a long way in recent years, and objective measurement options exist. New, noninvasive measurement methods employ unobtrusive microelectronic monitoring devices in the caps of medication containers (Cramer, 1995). For examples of this type of technology and a valuable bibliography of compliance studies, see APREX: The Patient Compliance Experts, available on the World Wide Web (http://www.aprex.com/).
Compliance is a compelling research area still awaiting our attention. Because physicians, psychologists, pharmacists, and nurses are concerned with compliance issues, it is an ideal topic for multidisciplinary cooperation. If you would like to share your thoughts on this topic, please write to the editor with comments, case histories, or research experience that will help us better understand compliance as a factor in patient care and pain research.
Burney, K.D., Krishnan, K., Ruffi, M.T., Zhan, D., & Brenner, D.E. (1996). Adherence to single daily dose of aspirin in a chemoprevention trial: An evaluation of self-report and microelectronic monitoring. Archives of Family Medicine, 5, 297-300.
Cramer, J.A. (1995). Microelectronic systems for monitoring and enhancing patient compliance with medication regimens. Drugs, 49, 321-327.
D'Souza, W., Burgess, C., Ayson, M., Crane, J., Pearce, N., & Beasley, R. (1996). Trial of a "credit card" asthma self-management plan in a high-risk group of patients with asthma. Journal of Allergy and Clinical Immunology, 97, 1085-1092.
Heavner, J.E., Shi, B., Diede, J., & Racz, G. (1996). Acetaminophen (paracetamol) use and blood concentration in pain patients. Pain Digest, 6, 215-218.
Melnikow, J., & Kiefe, C. (1994). Patient compliance and medical research: Issues in methodology. Journal of General Internal Medicine, 9(2), 96-105.
Sclar, D.A., Tartaglione, T.A., & Fine, M.J. (1994). Overview of issues related to medical compliance with implications for the outpatient management of infectious diseases. Infectious Agents and Disease, 3, 266-273.
Turk, D.C., & Rudy, T.E. (1991). Neglected topics in the treatment of chronic pain patients-relapse, noncompliance, and adherence enhancement. Pain, 44, 5-28.
