Issues of compliance with drug regimens are universal across all medical disciplines. The impact of taking none or less than the appropriate amount of an antiepileptic drug can have consequences to the patient and to the health care system. This chapter reviews typical problems and suggests potential ways to enhance compliance to achieve the desired outcome—good seizure control with minimal adverse effects or impact on quality of life.

The high prevalence of inadequate compliance is a major contributor to the cost of medical care in every therapeutic area. The National Council for Patient Information and Education estimates that half of the 1.6 billion prescriptions written in the United States annually are not taken properly. No consequence is so severe that all patients comply. The leading cause of organ rejection in transplant patients is noncompliance with immunosuppressant drugs.¹² Despite the best intentions and understanding of the importance of taking drugs, many epilepsy patients do not take their drugs as prescribed. A postal survey of community-based patients revealed not only that many patients acknowledge having missed doses, but also that patients are aware they had seizures because of missed doses.⁴

Lacking a cure for epilepsy, researchers are developing new drugs to provide better control of seizures. Unfortunately, the availability of a plethora of new and highly effective antiepileptic drugs will not alter a pervasive aspect of human behavior—partial compliance with the prescribed regimen. Few patients are willfully noncompliant, but many are negligent—partial compliers who take fewer (rarely more) doses than prescribed. To improve outcome for patients with few or many seizures, it is necessary to understand when and why patients do not take drugs as prescribed.

The Health Belief Model was developed as a predictor of preventive health behavior.¹ It is based on patient perceptions, similar to the approach in quality-of-life measures. In this model, the patient must be ready to address the issue of compliance, have some motivation (e.g., seizure control), learn how to take drugs, and receive support from family and health care providers. Paradoxically, good seizure control leads to complacency about taking drugs and may ultimately result in a relapse. Although education is an important feature in the model, knowledge does not ensure compliance, as demonstrated by declines in compliance after counseling is discontinued.¹¹ The number of medical professionals who do not complete their own treatment programs (e.g., antibiotics), leading to a superinfection, or who lapse in complying with their birth control system (e.g., daily oral contraceptive), resulting in an unplanned pregnancy, demonstrates this point. Urquhart¹³ noted that “technical knowledge does not compete effectively for priority in a busy schedule.”

A novel approach to understanding patient behavior in taking drugs and providing feedback on compliance is incorporated in the new microelectronic monitoring technology (MEMS’²⁵⁰; AARDEX Ltd., Zug, Switzerland). The system combines monitoring of drug dosing using MEMS bottles and immediate reading of the electronically stored information on a personal computer in the office. Information is provided directly to the patient and medical staff about dosing activities since the last visit.⁵

MEMS units are special caps for medication bottles that have a microprocessor chip embedded in the cap to record the date and time when the bottle cap is opened for dosing. Months of dosing data can be stored in the cap until retrieval during a follow-up visit. Patients are asked to use the electronic caps, with the explanation that the physician would like to understand how the patient takes drugs as part of the treatment plan. The cap mechanism is demonstrated to the patient, with instructions not to open the bottle except when the drug is removed for dosing. When the patient returns for a follow-up appointment, the bottle is placed on a communicator apparatus that reads the electronic information and transmits it to the computer. A base rate of compliance can be estimated using the first month as a control period because the patient does not yet know how the data will be used.

Data are displayed on the screen in the format of a monthly calendar showing the number of times the bottle was opened for dosing each day. A second type of display shows the exact date and time of every bottle opening. Both displays show the actual dosing pattern and any unusual patterns of missed doses on weekends or during morning or evening dosing. Provided with this information and a report of seizure frequency or dose-related adverse effects, the clinical staff can quickly determine whether seizures have occurred after periods of missed doses or toxic effects after periods of extra doses. The issue is whether the drug has failed to control seizures or whether the patient has failed to take adequate amounts of the drug. The immediate electronic report helps the physician to determine whether the dosing regimen needs adjustment or whether the patient needs assistance to remember to take doses. The electronic monitoring system prevents either the patient or the physician from having a misconception about lack of drug efficacy when inadequate doses have been consumed. Display of data is objective and nonjudgmental, providing immediate feedback to the patient about behavior. This is an optimal time for the physician or nurse to ask what strategies the patient is using to remember the doses, focusing on the more commonly forgotten days and times. For example, if a patient tends to skip pills during the weekend or misses more doses in the morning than in the evening, those time periods can be discussed in detail.

In a survey of 55 patients observed for an average of 14 weeks, the overall rate of compliance with dosing regimens was 75% (range: 3% to 100%). Mean compliance rates
declined as the number of doses increased (each day, 86%; twice a day, 80%; three times a day, 76%), with a significant decrease to 53% compliance for four-times-a-day dosing.^5,6 In numerous instances, documentation of dosing demonstrates breakthrough seizures occurring only after missed doses. As stated by former Surgeon General Koop, “Drugs don’t work in patients who don’t take them.”