Drug Compliance

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Non-compliance is one of the commonest

causes of therapeutic failure in both

medicine and psychiatry. With psychiatric

patients the factors contributing to

non-compliance are related to: illness

variables (schizophrenia, mania, paranoia, chronicity), patient variables (inappropriate

health beliefs, need to rebel against

authority, a wish to remain sick, defective

memory), medication variables (inefficient

and ineffective regimens, side effects) and

patient-therapist variables (degree of

supervision, trust and information).

Treatment must consist of constant

vigilance, health teaching-both verbal and

written-enlisting the help of family and

community to provide supervision, simplification of drug regimens, frequent


examination and vigorous treatment of side

effects, and improving the patient-therapist

interaction. (Can Fam Physician 26:725-727,

1980).

Dr. Seltzer is a senior resident at

the Clarke Institute of Psychiatry in

Toronto, and Dr. Hoffman is

assistant professor of psychiatry at

the University of Toronto and a

staff psychiatrist at the Clarke

Institute. Reprint requests to: Dr.

B. Hoffman, Clarke Institute of

Psychiatry, 250 College St.,

Toronto, ON. M5T 1R8.

OMPLIANCE AMONG medical

h_ patients is poor despite serious


life-threatening and chronic physical

illnesses. 1-3 Non-compliance rates with

longterm treatments for conditions

such as rheumatic fever and glaucoma

have varied from 15-80%. It is not surprising that non-compliance is even

higher among psychiatric patients4' 5 especially on an outpatient

basis where the non-compliance rate

has been shown to average 50%.

Although patient non-compliance

with medication can be defined as an

error of omission, it has 'not been easy

to find an objective measure of comCAN. FAM. PHYSICIAN Vol. 26: MAY 1980

pliance or non-compliance. Both patient reports and doctor opinions tend

to overestimate patient compliance,6' 7

while blood and urine levels are not

entirely accurate and do not take into


account the possibility of poor absorbtion from the bowel or rapid degradation and excretion.

Despite the difficulty in measuring

compliance, both the literature and

clinical experience tell us that noncompliance is exceedingly common,

and is a major cause of rehospitalization of those who suffer from the

schizophrenias or the affective disorders.8 For many psychiatric patients,

medication will mean the difference

between control of illness, and active

illness and hospitalization. For instance, discharged schizophrenics who

take their medications have a readmission rate in the first year of approximately 30%. If they do not take
active

medication, the readmission rate is approximately 67%.Y If they take medication for two years, the
readmission

rate is 48%-but if they take placebo

the rate is 80%. 10 Lithium is also

known to decrease the average number

of hospitalizations in patients with unipolar and bipolar affective disorders.


Baastrup1 studied 28 patients with

manic depressive psychosis who were

kept on lithium and found that no patient relapsed, whereas 12 of 22 patients who were switched to
placebo

under double-blind conditions relapsed

in a five month period. Similarly, none

of 17 patients with recurrent depressive disorder relapsed on lithium,

whereas nine of 17 patients who were

switched to placebo relapsed.

The rate of non-compliance varies

between inpatients and outpatients and

according to the degree of supervision.

A study of psychiatric inpatients using

a urine color test for phenothiazines revealed 32% of inpatients were not taking their medications, and
once they

left hospital this noncompliance increased to 63%.12 In 1974, Klein13

demonstrated an overall incidence of


drug defaulting of 24% among 40 psychiatric inpatients on a self-medication

schedule. However, the incidence of

drug defaulting among patients who

received their medications from nurses

was 7.5%. Blackwell" also concluded


that non-compliance increases in outpatients who lack supervision.

In 1965, Willcox15 studied 125 outpatients who were taking either chlorpromazine or imipramine. They

showed 56% non-compliance rate for

chlorpromazine and 27% non-compliance rate for imipramine as determined

by quantitative urinalysis. Their failure rates were not influenced significantly by side effects, age,
intelligence, or neuroticism. Willcox also

showed that when psychiatric patients

lived alone, the non-compliance rate

was 52.%, but when they lived with

someone who could supervise them

this rate dropped to 35%. Masona16

showed that on rehospitalization, following various outpatient maintenance


periods, 33% of psychiatric patients

were not adequately medicated as determined by urine testing.

Psychiatric outpatients with a diagnosis of schizophrenia have the highest

non-compliance rates. Results of a

non-compliance study of 50

schizophrenic outpatients at a community mental health clinic"7 revealed

that 56% of patients missed at least

one medication dose as determined by

a pill count study. Van Putten'8 conducted a study which focused on the

drug-taking behavior of 85 chronic

schizophrenic patients during a two

year period: 46% took less antipsychotic medication than the amount

prescribed. The reluctance to take antipsychotic medication was shown to be

-significantly associated with extrapyramidal symptoms, most notably a

subtle akathisia.

Patients suffering from the affective


disorders appear to have a somewhat

lower non-compliance rate. Schou19

found that 28% of patients successfully maintained on lithium stopped

taking it against medical advice. Apparently these patients 'missed' their

manic states or did not understand the

concept of prophylaxis.

The non-compliance rate increases

in patients with a psychiatric diagnosis, increases with outpatients as opposed to inpatients, and
increases with

patients who live alone as opposed to

those who have someone to supervise

their medication.

Characteristics of the Non-compliant Patient

It is difficult to know who will and

who will not comply with the drug regimen; compliance can never be assumed. Richards20 found no
differences with respect to age, drug, or

dose. However, a typical refuser was a


person who resisted coersion, had had

long hospitalizations, was not convinced that medication was helpful,

and had a poor attitude toward authoritative figures. It must be noted that the

most unmotivated, uncooperative patients are not necessarily the most noncompliant. Porter21 and
Clinite22 report that it was not possible to identify

the "6uncooperative patient"; every

patient is a potential defaulter. Wooley" stresses that non-compliance may be related to the "sick role""

and the need to be cared for. Other authors such as Stimson24 stress that the

non-compliant patient does not understand the role of prophylaxis and believes that medicine should
only be

used when one is acutely ill. There

seem to be many reasons why patients

stop taking prescribed medication. Parkes2" questioned his schizophrenic

outpatients who were not taking their

prescribed medication and found that

they stopped because of side effects,

suspicion around pill taking, failure to


understand the need, and because they

followed the advice of friends. Ren- ton2" also found correlation between

side effects, particularly sedation, and

decreased compliance. Nelson27 found

that non-compliance by his

schizophrenic patients increased with

decreased physician interest, the patient living alone, the presence of severe side effects, and the
patient not

noticing any beneficial effect. Surprisingly, one study12 revealed better

compliance with chlorpromazine than

with thioridazine since the latter had

fewer side effects and the patients concluded that the drug was not working.

It is clear that compliance among

psychiatric patients is extremely poor

and that the wide range of non-compliance rates depends upon a number of

variables. Although there is no single


or simple explanation for noncompliant behavior, it is correlated with a

number of factors. Sackett and

Haynes6 described the factors associated with non-compliance:

1. Psychiatric diagnosis

2. Complicated, longterm, or complex drug regimens

3. Inadequate and inconvenient

clinics

4. Patient dissatisfaction with therapist and inadequate supervision

5. Patient characteristics such as pre-

726

vious non-compliant behavior, difficulty with authority figures, lack of

understanding of prophylaxis, and a

wish to remain sick.

Baretz28 also reported factors he has

noted to be associated with non-compliance: chronicity, boredom, forgetfulness, increased time of


feeling well,
poor insight, and poor memory with

geriatric patients. Compliance increased with being white, middle

class, educated, and being on minor

tranquillizers. Compliance decreased

with a disrespect of authority figures,

hostility, obessional patients who

feared losing control, immaturity and

irresponsibility, paranoia, too many

medications, increased dosing times

and side effects. Baretz stressed the

importance of patients receiving an explanation about medications through a

therapeutic relationship.

Although there are exceptions, patient education results in compliance

among outpatients.29 With education,

surgical patients required fewer narcotics for pain, asthmatic patients had

fewer emergency room visits, and congestive heart failure patients had fewer
readmissions.6 Hypertensive patients30 and diabetics31 improved with

education. It is not known whether patient education will increase compliance with the psychiatric
population,

and in fact, one study has shown that

patient instruction by nurses had a negative influence on patient compliance. 13

What Can be Done to

Increase Compliance?

The physician should always be

alert to the possibility of non-compliance. However, the schizophrenic, the

previous non-compliant patient, and

the patient who lives alone, have the

highest rates of non-compliance. Compliance will increase if a trusting relationship is formed between a
physician

and his patient, if the physician is able

to ask about the patient's attitude

toward medication, prophylaxis, side

effects, his fears about being "controlled by drugs", addiction, and social stigma. If the patient is or has
been
non-compliant, the physician should

consider enlisting the help of the family, or community agencies (such as

community occupational therapists),

to encourage the patient to follow up

the treatment regimen. The physician

can also consider the use of injec

that non-compliance increases in outpatients who lack supervision.

In 1965, Willcox15 studied 125 outpatients who were taking either chlorpromazine or imipramine. They

showed 56% non-compliance rate for

chlorpromazine and 27% non-compliance rate for imipramine as determined

by quantitative urinalysis. Their failure rates were not influenced significantly by side effects, age,
intelligence, or neuroticism. Willcox also

showed that when psychiatric patients

lived alone, the non-compliance rate

was 52.%, but when they lived with

someone who could supervise them

this rate dropped to 35%. Masona16


showed that on rehospitalization, following various outpatient maintenance

periods, 33% of psychiatric patients

were not adequately medicated as determined by urine testing.

Psychiatric outpatients with a diagnosis of schizophrenia have the highest

non-compliance rates. Results of a

non-compliance study of 50

schizophrenic outpatients at a community mental health clinic"7 revealed

that 56% of patients missed at least

one medication dose as determined by

a pill count study. Van Putten'8 conducted a study which focused on the

drug-taking behavior of 85 chronic

schizophrenic patients during a two

year period: 46% took less antipsychotic medication than the amount

prescribed. The reluctance to take antipsychotic medication was shown to be

-significantly associated with extrapyramidal symptoms, most notably a

subtle akathisia.
Patients suffering from the affective

disorders appear to have a somewhat

lower non-compliance rate. Schou19

found that 28% of patients successfully maintained on lithium stopped

taking it against medical advice. Apparently these patients 'missed' their

manic states or did not understand the

concept of prophylaxis.

The non-compliance rate increases

in patients with a psychiatric diagnosis, increases with outpatients as opposed to inpatients, and
increases with

patients who live alone as opposed to

those who have someone to supervise

their medication.

Characteristics of the Non-compliant Patient

It is difficult to know who will and

who will not comply with the drug regimen; compliance can never be assumed. Richards20 found no
differences with respect to age, drug, or
dose. However, a typical refuser was a

person who resisted coersion, had had

long hospitalizations, was not convinced that medication was helpful,

and had a poor attitude toward authoritative figures. It must be noted that the

most unmotivated, uncooperative patients are not necessarily the most noncompliant. Porter21 and
Clinite22 report that it was not possible to identify

the "6uncooperative patient"; every

patient is a potential defaulter. Wooley" stresses that non-compliance may be related to the "sick role""

and the need to be cared for. Other authors such as Stimson24 stress that the

non-compliant patient does not understand the role of prophylaxis and believes that medicine should
only be

used when one is acutely ill. There

seem to be many reasons why patients

stop taking prescribed medication. Parkes2" questioned his schizophrenic

outpatients who were not taking their

prescribed medication and found that

they stopped because of side effects,


suspicion around pill taking, failure to

understand the need, and because they

followed the advice of friends. Ren- ton2" also found correlation between

side effects, particularly sedation, and

decreased compliance. Nelson27 found

that non-compliance by his

schizophrenic patients increased with

decreased physician interest, the patient living alone, the presence of severe side effects, and the
patient not

noticing any beneficial effect. Surprisingly, one study12 revealed better

compliance with chlorpromazine than

with thioridazine since the latter had

fewer side effects and the patients concluded that the drug was not working.

It is clear that compliance among

psychiatric patients is extremely poor

and that the wide range of non-compliance rates depends upon a number of
variables. Although there is no single

or simple explanation for noncompliant behavior, it is correlated with a

number of factors. Sackett and

Haynes6 described the factors associated with non-compliance:

1. Psychiatric diagnosis

2. Complicated, longterm, or complex drug regimens

3. Inadequate and inconvenient

clinics

4. Patient dissatisfaction with therapist and inadequate supervision

5. Patient characteristics such as pre-

726

vious non-compliant behavior, difficulty with authority figures, lack of

understanding of prophylaxis, and a

wish to remain sick.

Baretz28 also reported factors he has


noted to be associated with non-compliance: chronicity, boredom, forgetfulness, increased time of
feeling well,

poor insight, and poor memory with

geriatric patients. Compliance increased with being white, middle

class, educated, and being on minor

tranquillizers. Compliance decreased

with a disrespect of authority figures,

hostility, obessional patients who

feared losing control, immaturity and

irresponsibility, paranoia, too many

medications, increased dosing times

and side effects. Baretz stressed the

importance of patients receiving an explanation about medications through a

therapeutic relationship.

Although there are exceptions, patient education results in compliance

among outpatients.29 With education,


surgical patients required fewer narcotics for pain, asthmatic patients had

fewer emergency room visits, and congestive heart failure patients had fewer

readmissions.6 Hypertensive patients30 and diabetics31 improved with

education. It is not known whether patient education will increase compliance with the psychiatric
population,

and in fact, one study has shown that

patient instruction by nurses had a negative influence on patient compliance. 13

What Can be Done to

Increase Compliance?

The physician should always be

alert to the possibility of non-compliance. However, the schizophrenic, the

previous non-compliant patient, and

the patient who lives alone, have the

highest rates of non-compliance. Compliance will increase if a trusting relationship is formed between a
physician

and his patient, if the physician is able

to ask about the patient's attitude


toward medication, prophylaxis, side

effects, his fears about being "controlled by drugs", addiction, and social stigma. If the patient is or has
been

non-compliant, the physician should

consider enlisting the help of the family, or community agencies (such as

community occupational therapists),

to encourage the patient to follow up

the treatment regimen. The physician

can also consider the use of injecthat non-compliance increases in outpatients who lack supervision.

In 1965, Willcox15 studied 125 outpatients who were taking either chlorpromazine or imipramine. They

showed 56% non-compliance rate for

chlorpromazine and 27% non-compliance rate for imipramine as determined

by quantitative urinalysis. Their failure rates were not influenced significantly by side effects, age,
intelligence, or neuroticism. Willcox also

showed that when psychiatric patients

lived alone, the non-compliance rate

was 52.%, but when they lived with


someone who could supervise them

this rate dropped to 35%. Masona16

showed that on rehospitalization, following various outpatient maintenance

periods, 33% of psychiatric patients

were not adequately medicated as determined by urine testing.

Psychiatric outpatients with a diagnosis of schizophrenia have the highest

non-compliance rates. Results of a

non-compliance study of 50

schizophrenic outpatients at a community mental health clinic"7 revealed

that 56% of patients missed at least

one medication dose as determined by

a pill count study. Van Putten'8 conducted a study which focused on the

drug-taking behavior of 85 chronic

schizophrenic patients during a two

year period: 46% took less antipsychotic medication than the amount

prescribed. The reluctance to take antipsychotic medication was shown to be


-significantly associated with extrapyramidal symptoms, most notably a

subtle akathisia.

Patients suffering from the affective

disorders appear to have a somewhat

lower non-compliance rate. Schou19

found that 28% of patients successfully maintained on lithium stopped

taking it against medical advice. Apparently these patients 'missed' their

manic states or did not understand the

concept of prophylaxis.

The non-compliance rate increases

in patients with a psychiatric diagnosis, increases with outpatients as opposed to inpatients, and
increases with

patients who live alone as opposed to

those who have someone to supervise

their medication.

Characteristics of the Non-compliant Patient


It is difficult to know who will and

who will not comply with the drug regimen; compliance can never be assumed. Richards20 found no
differences with respect to age, drug, or

dose. However, a typical refuser was a

person who resisted coersion, had had

long hospitalizations, was not convinced that medication was helpful,

and had a poor attitude toward authoritative figures. It must be noted that the

most unmotivated, uncooperative patients are not necessarily the most noncompliant. Porter21 and
Clinite22 report that it was not possible to identify

the "6uncooperative patient"; every

patient is a potential defaulter. Wooley" stresses that non-compliance may be related to the "sick role""

and the need to be cared for. Other authors such as Stimson24 stress that the

non-compliant patient does not understand the role of prophylaxis and believes that medicine should
only be

used when one is acutely ill. There

seem to be many reasons why patients

stop taking prescribed medication. Parkes2" questioned his schizophrenic

outpatients who were not taking their


prescribed medication and found that

they stopped because of side effects,

suspicion around pill taking, failure to

understand the need, and because they

followed the advice of friends. Ren- ton2" also found correlation between

side effects, particularly sedation, and

decreased compliance. Nelson27 found

that non-compliance by his

schizophrenic patients increased with

decreased physician interest, the patient living alone, the presence of severe side effects, and the
patient not

noticing any beneficial effect. Surprisingly, one study12 revealed better

compliance with chlorpromazine than

with thioridazine since the latter had

fewer side effects and the patients concluded that the drug was not working.

It is clear that compliance among


psychiatric patients is extremely poor

and that the wide range of non-compliance rates depends upon a number of

variables. Although there is no single

or simple explanation for noncompliant behavior, it is correlated with a

number of factors. Sackett and

Haynes6 described the factors associated with non-compliance:

1. Psychiatric diagnosis

2. Complicated, longterm, or complex drug regimens

3. Inadequate and inconvenient

clinics

4. Patient dissatisfaction with therapist and inadequate supervision

5. Patient characteristics such as pre-

726

vious non-compliant behavior, difficulty with authority figures, lack of

understanding of prophylaxis, and a

wish to remain sick.


Baretz28 also reported factors he has

noted to be associated with non-compliance: chronicity, boredom, forgetfulness, increased time of


feeling well,

poor insight, and poor memory with

geriatric patients. Compliance increased with being white, middle

class, educated, and being on minor

tranquillizers. Compliance decreased

with a disrespect of authority figures,

hostility, obessional patients who

feared losing control, immaturity and

irresponsibility, paranoia, too many

medications, increased dosing times

and side effects. Baretz stressed the

importance of patients receiving an explanation about medications through a

therapeutic relationship.

Although there are exceptions, patient education results in compliance


among outpatients.29 With education,

surgical patients required fewer narcotics for pain, asthmatic patients had

fewer emergency room visits, and congestive heart failure patients had fewer

readmissions.6 Hypertensive patients30 and diabetics31 improved with

education. It is not known whether patient education will increase compliance with the psychiatric
population,

and in fact, one study has shown that

patient instruction by nurses had a negative influence on patient compliance. 13

What Can be Done to

Increase Compliance?

The physician should always be

alert to the possibility of non-compliance. However, the schizophrenic, the

previous non-compliant patient, and

the patient who lives alone, have the

highest rates of non-compliance. Compliance will increase if a trusting relationship is formed between a
physician

and his patient, if the physician is able


to ask about the patient's attitude

toward medication, prophylaxis, side

effects, his fears about being "controlled by drugs", addiction, and social stigma. If the patient is or has
been

non-compliant, the physician should

consider enlisting the help of the family, or community agencies (such as

community occupational therapists),

to encourage the patient to follow up

the treatment regimen. The physician

can also consider the use of injec

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