Medication noncompliance: Systematic approaches to evaluation and intervention

Medication Noncompliance: Systematic Approaches to Evaluation and Intervention Alan Stoudemire, Assistant

Professor

M.D.

of Psychiatry,

Troy L. Thompson, Associate

Professor

Emory

University

School

of Medicine

II., M.D.

of Psychiatry

and Medicine,

University

Abstract: Medication noncompliance

is a significant problem in medical practice, but many intervention strategies developed for noncompliant patients (such as tangible rewards, contingency contracting) are not practical for the large numbers ofpatients seen by private practitioners on an ongoing basis. Based upon a review of the literature concerning the key determinants affecting compliance, the authors have developed a practical, rational, and systematic approach to assessing medication compliance that may serve as a guide for psychiatrists in formulating consultation recommendations, in liaison teachingactivities, and in clinical psychiatric practice. Special emphasis is placed upon the identification of psychiatric syndromes that may negatively affect compliance. Implications for compliance-related research in consultation-liaison psychiatry are also discussed.

Medication noncompliance is a significant problem in medical practice, but the implementation of many of the intervention strategies devised to facilitate compliance (tangible rewards, contingency contracting, home visits, recall programs, and even many educational techniques) [l] are usually not practical for general medical physicians with large numbers of patients. This paper presents a simplified approach for fostering compliance and intervening in noncompliance, based upon a literature review of the key determinants that affect medication adherence [2,3]. The model presented here may be used when evaluating noncompliant patients on a consultation basis and in formulating intervention recommendations for general medical physicians. The approach may also be used as a teaching model for use in liaison education activities. Special emphasis is placed on identifying General Hospital Psychiatry 5, 233-239, 1983 0 Elsevier Science Publishing Co., Inc. 1983 52 Vanderbilt Avenue, New York, NY 10017

of Colorado,

School

of Medicine

psychiatric factors that may negatively influence compliance. While the strategies presented here are primarily formulated with primary care physicians in mind, most of the basic principles are applicable for use in psychiatric practice as well.

Determinants of Compliance and Noncompliance Compliance with any given medical regimen, for any given disease, in any given patient, is a complex phenomenon that may vary over time. Due to the number and complexity of the variables determining compliance, the authors have divided the factors for examination into ten different areas for the purpose of delineating those factors that are important and thus potentially amenable to direct physician intervention.

The

Illness

Neither the actual severity of the illness (based upon the physician’s evaluation), nor prior hospitalizations related to the illness, nor the diagnosis of previous problems caused by the illness correlate consistently with the degree of compliance [2,4]. No consistent evidence indicates that sicker patients comply any better with their medications than healthier ones. On the contrary, the disability or limitations associated with some illnesses (e.g., sensory impairments, dementia, or depression) may make compliance even more difficult or unlikely. 233

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A. Stoudemire and T. L. Thompson

Sociological

Factors

Studies reporting no consistent correlation between compliance and socio-economic status, age, sex, education, occupation, income, or marital status outnumbered by threefold those studies that do report positive correlations between these factors and compliance [2,4,5]. For example, middle-class patients apparently comply no better than poorer patients [6]. Likewise, intelligence is not a reliable predictor of good compliance [2]. While elderly patients have been cited as frequent noncompliers [7], this probably has more to do with memory or sensory impairments than age alone. Demographic data, therefore, do not consistently correlate with compliance and have little predictive value.

Patients’ Knowledge

of Their Disease

Detailed knowledge of their illness does not necessarily cause patients to comply better with recommended treatments. Patient knowledge of rheumatic fever and its complications does not predict compliance with penicillin prophylaxis [8]. Glaucoma patients who know that glaucoma can cause blindness do not comply better then those who do not [9]. In one study, intense patient education regarding hypertension failed to enhance compliance among those receiving the intense instruction compared to a control group who did not [lo]. In general, individua2 educational attempts aZone have failed to show any consistent effect on compliance in chronic illnesses [3]. These observations do not mean that educational strategies are not worthwhile, but only that when used as the sole interuention, they may have minimal effect on actual compliance behavior. For educational interventions to have optimal effect, they must be used in context with other practical considerations that foster compliance, such as simplified dosage regimens, involvement of the family, continuity of care, and good doctor-patient communication. These other factors determining compliance are specifically examined later. Unempathic fear techniques (e.g., morbid predictions of disability and death) are not successful in improving compliance and may have a negative effect on the doctor-patient relationship [11,12].

Patients’ Knowledge

of Their Medications

When patients do not know the basic function of the drugs that have been prescribed for them, er234

rors in compliance increase [5]. Compliance errors also increase when patients do not know the nume of the drug that have been prescribed [5].

The Medical Regimen Errors in compliance rise as the number of drugs being prescribed increases and with the complexity of the regimen [5,13,14]. That is, the fewest drugs taken in the fewest possible daily dosages leads to better compliance, especially if medication administration is organized around rituals of daily life (e.g., with meals, at bedtime).

Medication

Side Effects

Unpleasant or bothersome side effects have been cited as a cause of noncompliance [15]. Medications that cause excessive sedation (e.g., clonidine, chlorpromazine, amitriptyline), gastrointestinal distress (e.g., lithium, aspirin), anticholinergic symptoms (e.g., tricyclic antidepressants, phenothiazines), sexual dysfunction (e.g., guanethidine), and changes in physical appearance (e.g., steroids) are also more likely to be discontinued or taken unreliably.

Patients’ Attitude Toward Health and Illness The patient’s attitude toward health and illness is an abstract concept but is important in determining compliance. Compliance is better when the patient has the following beliefs or attitudes 116,171: a. The patient feels susceptible to the illness or its complications. b. The patient believes that the illness or its complications could pose severe consequences for his life. C. The patient believes that the medication will probably be effective in decreasing the likelihood of factors (a) and (b). d. The patient sees or has no major obstacle (e.g., side effects, cost of medication, transportation to follow-up visits) to fully engage in the recommended treatment. Several components of this “Health Belief” model have been confirmed to influence compliance. For example, in a study of children with otitis media, attendance at follow-up appointments correlated positively with the mother’s perception of the risk of relapse and perceived severity of the illness [18]. Success in taking antibiotics for pro-

Systematic Approaches to Noncompliance

phylaxis against a recurrent rheumatic fever was found to correlate positively with the patient’s estimation of the risk of recurrence [19].

Involvement

of the Spouse and Family Support

The attitude of the spouse or other major supportive figure towards the illness or the recommended treatment is a crucial variable influencing compliance. In pediatric populations, the mother’s attitude toward the illness [18] and the physician [20-221 are major determinants of compliance. The spouse’s attitude was found to be critical in the compliance of a group of men at high risk for coronary artery disease for whom a program of physical activity was recommended. When the wife’s attitude was positive, there was an 80% chance that the husband’s compliance with the program would be good. When the wife was negative or neutral, the likelihood of program compliance fell by one-half to 40% [23]. Strife, emotional turmoil, and family disorganization increases the risk for nonadherence [24-261. Conversely, a close and stable family or other social support system (e.g., friends, neighbors) facilitates compliance [27].

The Doctor-Patient

Relationship

Several aspects of the doctor-patient relationship are important in determining compliance. The importance of an ongoing relationship and confinuify of care was demonstrated by finding that a child was much more likely to receive a full course of penicillin if the medication was prescribed by his or her personal physician rather than a randomly assigned physician [6]. Good communication between doctor and patient, especially pertaining to instructions regarding the medical regimen and agreement as to what is expected of the patient, significantly improves compliance [5,28]. Patient satisfaction with the quality of the doctor-patient interaction may also be a critical factor. A patient is more likely to be compliant if (a) the patient’s expectations of the physician or the treatment of his condition are being met, (b) the patient perceives warmth and empathy in the doctor-patient interaction, and (c) the doctor explains the diagnosis, the cause of illness, and addresses the patient’s individual questions and concerns [20-221. Interestingly, physician-patient interactions “friendly” are not correlated that are excessively with better compliance, implying that some degree

of formality and directiveness may faciltiate taking medical advice seriously [29]. The same study found that doctors who were passive, permissive, and nondirective achieved poor rates of compliance in their patients who had more active and “authoritarian” personalities. In summary, compliance is better when the doctor and patient agree on the treatment approach and when good communication exists. Physicians with a positive and optimistic attitude, who are active rather than passive, and who have a more personalized and warm interview have lower patient dropout rates [30]. In addition, optimism regarding the likelihood of benefit of an antidepressant medication leads to better patient response

1311. Psychiatric

Factors

Psychiatric patients are generally held to be particularly prone to noncompliance, although there is little firm data to support this contention. A review of published reports on noncompliance in psychiatric populations revealed that psychiatric patients are similar to other patients populations requiring chronic medication 132,331. Under certain extreme circumstances, however, psychiatric factors may partially influence successful adherence to a medical regimen. There are three general types of psychiatric factors that may increase the likelihood of noncompliance:

1. Major psychiatric disorders a. Major Depression-Severely depressed patients may be noncompliant due to apathy, pessimism, decreased energy levels, and even passive suicidal tendencies. Anticholinergic side effects of antidepressant drugs also diminish compliance [33]. he is invincible, the b. Bipolar Disorder-Believing manic patient may become grandiose and thus reject the need for both psychiatric or medical treatment. to disruptions in judgment C. Schizophrenia-Due and reality testing, paranoid schizophrenics may view the physician as a foe or persecutor and the medication as poison. with cognitive d. Dementia/Delirium-Patients and memory deficits may find it difficult to keep track of different medications and the appropriate times to take each. Such deficits may lead to 235

A. Stoudemire and T. L. Thompson

duplication of dosages, confusion of drugs, and errors of omission. Moreover, some medications that cause sedation (e.g., antidepressants, phenothiazines, some antihypertensives) may exacerbate preexisting cognitive impairments. Patients with chronic metabolic disorders (e.g., chronic obstructive pulmonary disease, chronic renal failure) may also have secondary cognitive deficits that lead to medication errors. e. Alcoholism (and other types of drug dependence)-Impulsitivity, impairments in judgment and cognition, excessive denial, and the problematic lifestyles associated with alcoholism put these patients at an unusually high risk for noncompliance. 2. Personality disorders a. Borderline personality-These patients often have difficulty in developing enough trust and confidence in the doctor to be compliant. Borderline personalities tend to be impulsive, often suicidal, have a propensity for alcoholism and drug abuse and by their often angry and suspicious personality traits can be exceedingly difficult to manage in the medical setting 1341. b. Paranoid-Some individuals, (e.g., paranoid and schizoid personalities) may be mildly suspicious of all people, especially authority figures such as physicians, and equally suspicious of medications. C. Other problematic personality features-l’aCents with masochistic personality traits, alternatively known as “self-destructive deniers” [35], may have not only an irrational need to suffer and impair their health by direct acts of self-destruction, but may do so passively through compliance. Some of these patients also have a chronic psychologic need to struggle with, defy, and “defeat” anyone in authority (such as physicians) by frustrating every attempt that is made to help them. Noncompliance (with oral contraceptives) has also been found to be higher in women who are more immature, impulsive, irresponsible, and more prone to risktaking [36]. Some diabetic adolescents are notorious for acting out their angry feelings about their illness through noncompliance with insulin and diet. While the personality traits noted above are occasionally associated with noncompliance, no specific “noncompliant” personality profile has been determined. Psychodynamic factors that may potentially 236

influence compliance individually.

must

be

assessed

Maladaptive psychologic defense mechanisms: denial. The ways in which patients characteristically deal with stress or illness may partially determine their degree of compliance. Many behavioral patterns used in dealing with stress, fear, or threats to bodily integrity are adaptive and strengthen the individual’s ability to cope with stress. At times, however, these psychologic defense mechanisms may become so amplified that they become maladaptive or pathologic. The most common defense mechanism that interferes with compliance is denial, either of the presence of the illness, its potential complications, or the necessity for treatment. Denial, used to an appropriate degree, is a “healthy” defense, but denying the presence of a potentially dangerous illness and its complications is excessive and may be self-destructive. Such pathologic denial may result from the patient’s need to avoid unconscious fears of illness, disability, and dependency.

Evaluating and Facilitating A Systematic Approach

Compliance:

The authors approach to the evaluation of compliance and to intervention in the event of noncompliance is given in Tables 1-3 [1,4,5,37-511. Table 1 may be used as an initial clinical guide to improve patient compliance or to assess specific factors associated with noncompliance. Positive (i.e., “yes”) responses to the items in this table increase the likelihood of compliance. Negative responses indicate potential problem areas and the need for further evaluation or intervention to facilitate compliance. For example, a patient is found to be unconcerned about his illness and to lack motivation for treatment. This may indicate general misinformation and a disregard for health, or it could represent “pathologic” denial or depression in need of further evaluation. When the perceived lack of concern is due to simple ignorance about the illness, educational efforts may help to resolve the problem. Basic measures to enhance compliance consist of simplifying the regimen as much as possible and organizing pill taking around daily rituals. Eliciting the support of the patient’s spouse and anticipating the management of side effects also enhances compliance. The importance of continuity of care and a personal relationship with the physician charac-

Systematic Approaches to Noncompliance

Table 1. Fostering Compliance 1. Patient Factors A. Has the basic nature of the illness, rationale for treatment, benefits of compliance, and hazards of noncompliance been explained to and understood by the patient? B. Does the patient appear appropriately concerned about the illness and motivated for treatment? (If not, why?) C. Have major psychiatric syndromes been ruled out? D. Can the patient recite the.name of the medication and when and how to take it? 2. The Medical Regimen A. Is the regim& as simple as possible in terms of number of pills and the number of daily doses? B. Are doses arranged around daily self-care rituals (at meals, at bedtime)? C. Have frequent side effects been anticipated and explained in terms that will not frighten the patient? 3. The Spouse and Family A. Does the spouse or other support figure understand the illness, the need for medication, and will they support compliance? 4. The Doctor-Patient Relationship A. Has continuity of care been established? B. Has good rapport been established with the

them for positive reinforcement of compliance (praising the patient’s dedication, control, perseverance, and so forth). Pill counts may also be useful in reinforcing compliance. It is important not to establish an atmosphere of trying to “catch” the patient being noncompliant, but to offer such “counts” as an aid in helping the patient keep track of pills taken. Similarly, serum levels of drugs may be offered as a means of guiding therapy. As a final resort, hospitalization may provide the only controlled way to document that failure to respond is due to noncompliance. Brief hospitalization may also instill and reinforce compliance habits. Social service intervention may help with problems (e.g., transportation, housing, welfare, or disability payments) that interfere with compliance. Social agencies may also facilitate involvement of family members. Such interventions may be necessary for patients with cognitive deficits, physical handicaps, or sensory losses that impair the ability to comply. Referral for intensive psychiatric evaluation and treatment should be recommended in the presence of major affective disorders, severe anxiety disorders, psychosis, severe personality disorders, and dementia, or when the presence of pathologic de-

patient? (If not, why?)

Table 2. Reevaluating Compliance terized by warmth and good communication been noted earlier.

Reevaluating

have

Compliance

Table 2 represents a reevaluation of the factors in Table 1 for use in cases of failure to respond due to noncompliance rather than disease progression. Special attention is given to the patient’s attitude toward the illness and the treatment, side effects of medication, and the possibility of simplifying the regimen.

Intervention

Strategies

Table 3 represents strategies for persistent noncompliance. These tactics involve the use of structured records or logs in an attempt to document the actual taking of medication and to establish learning “habits” for long-term maintenance regimens. Treatment logs can be brought to follow-up appointments for review by the clinician, who can use

1. The Patient A. Has a major psychiatric syndrome emerged or been overlooked? B. Has the patient become apathetic or frustrated regarding the treatment and hopes of symptom relief? (If so, why? Would further educational efforts help?) 2. The Regimen A. Have unpleasant side effects emerged? (e.g., sexual dysfunction, depression, oversedation, anticholinergic effects). B. Can the regimen be further simplified? 3. Spouse/Family A. Can the spouse or other supportive figure be more actively involved in supporting compliance? 4. The Doctor-Patient Relationship A. Has the patient become dissatisfied with some aspect of his or her treatment? B. Is there a personality conflict between doctor and patient? C. Has the physician become frustrated or “given up on” the patient because of suspected noncompliance?

237

A. Stoudemire

and T. L. Thompson

Table 3. Interventions to improve Compliance A. Medication Charting Use of daily medication logs (e.g., charts, calendars, diaries) in which the patient records having taken the medication. The record is subsequently brought for review at follow-up appointments. Handwritten reminders and instructions that may be posted in the patient’s home can also be used. B. Pill Packs Some pharmaceutical companies have prepackaged “pill packs” (e.g., birth control pills, short-term steroid administration) which may be useful in

facilitating compliance. Compartmentalized “pill

C.

D. E. F.

G. H.

boxes” where multiple medications can be arranged according to days in a grid fashion are also available. Medication Monitoring (pill counts) The patient is instructed to bring medication bottles to return visits where the amount of medication taken during a given time interval can be estimated. Serum Drug Levels Increase the Frequency and Length of Appointments Social Service Interventions (Visiting nurse, Public Health Nurse, periodic checks by a community social worker) Brief Hospitalization (Stabilization, evaluation, and education). Psychiatric Referral (Severe depression or anxiety, pathologic denial, psychosis, suicidal tendencies, and personality disorders)

nial frustrates reasonable efforts to educate and motivate the patient. This model for the systematic evaluation of this problem provides a general approach that is adaptable to both medical and psychiatric settings and may serve as a guide in liaison teaching and in formulating treatment recommendations for general medical physicians.

Implications for Compliance-Related Consultation-Liaison Research The cost efficacy of psychiatric treatment has been a topic of recent interest and the problem of noncompliance as it is related to psychiatric factors is a potential area for research. For example, clinical experience suggests that certain psychiatric disorders, such as major depression, may predispose to noncompliance. The extent that severe depression affects outcome in medical disorders is not fully 238

known, but appropriate screening for depression coupled with specific interventions in medical patients might improve compliance with prescribed regimens and thus decrease overall morbidity and mortality. One paradigm for research in this area would be to screen for depression in patients undergoing treatment for a specific disorder (such as diabetes), and to compare the compliance rates for depressed vs. nondepressed patients. If the hypothesis that compliance rates are lower in depressed patients is confirmed, the effects of psychiatric interventions on compliance could then be examined by randomizing depressed patients to “intervention” vs. “nonintervention” groups. Empirically derived strategies for improving compliance, such as the one presented here, could also be experimentally tested with intervention and nonintervention matched control groups. Studies of this nature could further establish the importance of recognition and treatment of psychiatric disorders in medical practice and confirm the practical value of psychiatric treatment for the general health care of medical patients. The authors thank Dr. Francis Neelon for valuable editorial assistance.

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to Noncompliance

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