Patient Education and Counseling 54 (2004) 5560

Assessment of impact of medication counseling on patients medication

knowledge and compliance in an outpatient clinic in South India
Sivasankaran Ponnusankar a, , Mallayasamy Surulivelrajan b ,
Nunjundiah Anandamoorthy c , Bhojraj Suresh d
a

Center for Patient Counseling and Education, Department of Pharmacy Practice, JSS College of Pharmacy, Ooty, The Nilgiris, Tamilnadu, India
b SRMC & RI, Porur, Chennai, India
c Priyanka Clinic, Ooty, India
d JSS College of Pharmacy, Ooty, The Nilgiris, Tamilnadu, India
Received 15 November 2002; received in revised form 15 March 2003; accepted 9 June 2003

Abstract
The primary aim of this study was to assess the impact of patient medication counseling by comparing the levels of patients medication
knowledge and adherence achieved by medication counseling in an outpatient clinic. Ninety patients were randomized in the ratio of 1:2 into
either counseled or usual care group. Their medication knowledge was assessed by a questionnaire and adherence was assessed by pill count
method and self-assessment by the patients. Their medication knowledge was assessed at baseline and during their subsequent appointments.
The average medication knowledge score of the counseled group versus usual care group was 13.821.8064 and 11.783.5037. Compliance
score of the patients during their follow-up period was 92.29 4.5 and 84.71 11.80 for the counseled and control group, respectively.
Statistical analysis of medication knowledge was carried out and all the demographic characters and number of medication were individually
correlated with medication knowledge score and the difference observed was statistically significant. Compliance score of the patients was
92.29 4.5 and 84.71 11.8% for the counseled and usual care group, respectively.
2003 Published by Elsevier Ireland Ltd.
Keywords: Compliance; Medication counseling; Medication knowledge; India

1. Introduction
Poor adherence to the prescribed medication regimen is
a critical health care concern for the health care providers
all over the world [1]. The National Pharmaceutical Council of US estimated the medical costs related to prescription
medicine misuse and adverse reactions total more than US$
20 billion a year. When consequences such as lost productivity are included, annual are as high as US$ 100 billion
[2]. This is particularly true for chronic diseases [3].
Numerous studies have been performed to identify therapeutically non-adherent patients, to measure the degree of
non-adherence, to characterize the reasons and to develop
strategies for improving compliance [418]. Educating the
patients about their disease state and medications will result
in the improvement of their knowledge regarding medications and can increase their active participation in therapy

Corresponding author.
E-mail address: ponnusankarsivas@hotmail.com (S. Ponnusankar).

0738-3991/$ see front matter 2003 Published by Elsevier Ireland Ltd.

doi:10.1016/S0738-3991(03)00193-9

and improve medication adherence, this may ultimately improve the outcomes.
Pharmacists with their professional knowledge irrespective of their working place either in hospital or in community can play a vital role in educating the patients and can
improve medication adherence and clinical outcome. Numerous studies have established this fact [1922].
1.1. Pharmaceutical care
Pharmaceutical care is defined as the direct, responsible provision of medication related care for the purpose of
achieving definite outcomes that improves patient quality of
life [23].
Pharmaceutical care services is almost nil in all Indian
hospitals and pharmacists are underutilized in the Indian
health care system. A recent initiation of clinical pharmacy
education and service in India [24], changes the industry focus education to patient focused. Clinical pharmacy service
includes ward round participation, provision of drug information service and patient counseling, etc.

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S. Ponnusankar et al. / Patient Education and Counseling 54 (2004) 5560

So, it is our interest to study the impact of patient counseling services on patient outcomes. Such evaluation should
lead to improved quality of service, and help justify and
even further expand the pharmacists role in patient care.

Table 1
Patient medication knowledge assessment form
Questions

Visit

1.2. Aim of the study

What is the name of this medication?/

Can you identify this medications?

I
II
III

What is the timings of this medications

and directions (if applicable)?

I
II
III

What these medications are for?

I
II
III

What is the dose of these medications?

I
II
III

Do you know how long you have to

take this medication?

I
II
III

Do you know what other food/medication

you have to avoid while taking this
medication?

I
II
III

The primary aim of this study was to assess the impact

of medication counseling on patient medication knowledge
and change in compliance behavior in an outpatient clinic
attached to the private hospital. We chose medication knowledge and adherence as our pilot end points before proceeding to study the effects on clinical outcome.

2. Materials and methods

The managing director of the private hospital and the
consultant physician of the outpatient clinic approved this
study. Patients meeting the inclusion criteria were randomized into the counseled and usual care group. Inclusion
criteria were: (i) patients with chronic conditions like hypertension, diabetes mellitus, cardiovascular conditions and
bronchial asthma, (ii) patients who had an established prescription and were diagnosed atleast 6 months before the
inclusion into the study. Exclusion criteria were: (i) patients
with cognitive or perceptual problems, (ii) patients who cannot be followed up.
Demographic data were obtained from all the patients. A
total of 90 patients were enrolled into the study in chronological order of their visits to the clinic and the study was
conducted for 9 months.
2.1. Randomization
A total of 90 data sheets were given to the consultant. Each
data sheet was coded as either (+), () or (0). The symbols
(+) and () was considered for the counseled group and (0)
was considered for the usual care group. After the consultation, the physician randomly picked one sheet and gives
it to the patient and sent the patient to the pharmacist. Depending upon the symbol of the data sheet, the patients were
enrolled into the counseled group or usual care group. A total of 30 patients were placed in the counseled group and
60 patients were placed in the usual care group. The ratio of
1:2 was chosen between the usual care and counseled group
as this was having the modest increase in power to detect
the differences more statistically significant.

Scores
B

Iinitial visit, II1st follow-up, III2nd follow-up; A, B, C, D

represents scoring (A: 3 marks, B: 2 marks, C: 1 mark, D: 0 mark).

in the medication knowledge assessment form, there was a

four-tiered grading scale that graded the patient as 0, 1, 2
and 3 according to their response. Four responses were expected for each question. Each response was assigned a particular score and then finally scores were added to get the
total score for the patient. The question asked to the patients
were: (a) what is the name of the medication you are taking during pregnancy/can you identify the medications? (b)
What are the timings of the medication? (c) What are the
medications for? (d) What are the doses of the medications?
(e) Do you know how long you have to take this medication?
(f) Do you know what other food/medication you have to
avoid while taking this? The expected response and scores
were: 3answering the questions correctly; 2answering
the questions partially; 1answering when prompted; 0
not answering the questions correctly.
Patient randomized to the counseled group received medication counseling from the pharmacist. This counseling session lasted 1520 min. Patient randomized into the usual care
group did not receive any counseling during the assessment
period.
2.3. Medication counseling

2.2. Counseling sessions and medication knowledge

assessment
Upon enrollment, patients were given a pretest to evaluate their knowledge regarding their disease and medications. For this purpose, medication knowledge assessment
form was designed and used (Table 1). For each question

At the out patient clinic, counseling sessions were performed at a separate corner of the clinic to ensure privacy.
One patient was counseled at a time. Counseling sessions
were designed so that all patients were counseled according to their individual understanding and attitude of their
medication. Pharmacist explained about their disease, the

S. Ponnusankar et al. / Patient Education and Counseling 54 (2004) 5560

name of the medications, identification of the medications,

dose, time of administration, purpose, duration of therapy of
their medication, food and other medications that have to be
avoided during their therapy, etc. Sufficient time was provided for the interaction of the patients with the pharmacist.
2.4. Follow-up visits
All patients were followed-up during their two subsequent
appointments, which was usually after 1 month, to assess
their medication knowledge and compliance.
2.5. Medication adherence
Medication adherence was assessed by the following two
methods:
(i) pill count method;
(ii) self-assessment method.
This was carried out during second appointment after the
enrollment. Patients were asked to bring back all the remaining medications and empty foils along with their medication
receipts. From this, medication adherence was calculated by
pill count method using the formula:
Percentage compliance
total number of doses the patient has
consumed since last appointment
=
100
total number of doses to be consumed
since last appointment
After this, patients were given a self-assessment form,
which was a bilingual one in both English and Tamil (local language). In this assessment patients who were rating
themselves less than always compliant were asked to state
the reason for their non-compliance.
2.6. Statistical analysis
Statistical analysis was carried out to study the difference
between the groups in medication knowledge by student
t-test. Influence of each demographic factor like age, sex,
education, number of drugs, duration of disease on medication knowledge was individually analyzed.

3. Results
Totally 90 patients were included in the study. Out of this
only 85 could be followed till the end of the study period.
Table 2 summarizes the baseline demographic data. Males
outnumbered females in the study population. In the total
selected patient population, majority of the patients had their
high/higher secondary education, their age between 41 and
60, consumed more than four drugs, duration of disease

57

Table 2
Baseline demographic data of patients
Factors

Number of patients
in counseled group

Number of patients
in usual care group

19 (63.33%)
11 (36.66%)

31 (51.66%)
29 (48.33%)

8 (26.6%)
6 (20%)
14 (46.66%)

9 (15%)
11 (18.33%)
30 (50%)

2 (6.66%)

10 (16.66%)

Age (in years)

40
4160
61

2 (6.66%)
20 (66.6%)
8 (26.6%)

5 (8.33%)
38 (63.33%)
17 (28.33%)

Number of drugs
3
4

9 (30%)
21 (70%)

30 (50%)
30 (50%)

Gender
Male
Female
Education
Illiterate
Middle school
High/higher secondary
school
Above school

Duration of disease (in years)

0.54
19 (63.33%)
59
7 (23.22%)
10
4 (13.33%)

36 (60%)
17 (28.33%)
7 (11.66%)

Diagnosis
Hypertension (HT)
HT & co-morbidities
Diabetes mellitus (DM)
DM & co-morbidities

7
45
3
5

1
19
1
9

(3.33%)
(63.33%)
(3.33%)
(30%)

(11.66%)
(75%)
(5%)
(8.33%)

0.54 years and established hypertension and co morbidities

patients were documented.
3.1. Medication knowledge score
Assessment of medication knowledge score was done using correlation between the score and demographic characters like age, education, diagnosis, duration of disease and
number of drugs. Table 3 summarizes the results of the correlations.
Baseline score of the males were higher than female
patient population. In the counseled group both the sex
showed statistically significant improvement from the baseline. Where as patients in the usual care group did not show
any statistically significant difference.
Baseline medication score showed a trend of gradual increase with the increase in the level of education. In the
counseled group, except graduates all other groups showed
a significant difference of score. In the usual care group, no
significant difference was observed.
Baseline medication score of the patients who were more
than 60 years of age are less, when compared with other
groups. In the counseled group, all the age group showed a
significant difference, where as in the usual care group did
not show any significant difference.
Baseline score of the patients who were taking 3 or less
number of medications was higher than the patients who are

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S. Ponnusankar et al. / Patient Education and Counseling 54 (2004) 5560

Table 3
Effect of medication knowledge score and counseling
Factors
Gender
Male
Female

Baseline medication score

11.3 0.5293
10.4 0.4841

Medication score counseling group

Medication score usual care group

14.07 0.4742
13.57 0.4884

12.57 0.8155
11.3 0.5136

Education
Illiterate
Middle school
High/higher secondary school
Graduate

7.94
9.53
11.7
13.83

Age (in years)

40
4160
61

12.14 1.4869
10.98 0.4482
10.36 0.6997

16 0.00
13.8 0.4142
13.57 0.6116

14 1.3874
11.8 0.6126
11.5 0.9219

Number of drugs
3
4

11.87 0.5027
10.12 0.4978

14.3 0.3333
13.5 0.3847

12.51 0.6070
11.68 0.996

Duration of disease (in years)

0.54
59
10

11.17 0.4497
11.15 0.7247
9 1.0702

13.8 0.4917
13.57 0.5281
14 0.8164

12.31 0.5509
12.51 1.0257
8.85 1.4045

0.5908
0.8185
0.4491
0.8423

12.14
13.33
14.62
16

0.3400
0.6146
0.4317
1

9.25
10.09
12.43
14.72

0.9401
1.2318
0.6266
0.7310

P < 0.05.
P < 0.001.

consuming 4 and more number of medications. With counseled group, both the groups showed a significant difference. Usual care group did not show significant difference
in medication score.
Baseline medication score of the patients who had longer
duration of disease was less when compared with the patients
who had shorter duration of disease. Medication knowledge
score was significantly improved in the counseled group
when compared with usual care group.
3.2. Compliance assessment
3.2.1. Pill count method
Patients were asked to bring all the remaining medications and empty foils and medication receipts along with
their last prescription to assess the compliance. With the
help of remaining medications, the compliance was assessed (pill count). Due to the non-availability of previous
data regarding compliance baseline medication compliance could not be assessed for the first time. Medication
compliance could be assessed only during follow-up. Compliance score of the patients in the counseled group was
92.24 4.5 where as score of the patients in the usual
care group was 84.71 11.8. Counseling might have produced a positive effect on the compliance behavior of the
patients.
3.2.2. Compliance by self-assessment method
In this method of assessment of compliance, 75% of the
patients in the counseled group rated themselves as always
compliant against 66.6% in the usual care group. 25% in

the counseled group and 32.76% in the control group rated

themselves as compliant most of the time.
Patient who rated himself or herself less than always compliant were asked to state reasons for their non-compliance.
Most patients have rated forgetfulness (57.14% in the
counseled and 36.84% in the usual care group), and cost
of medications (28.57% in the counseled and 15.78% in
the usual care group). 11.1% of patients in the counseled
group and 47.36% in the usual care group stated side effects and lack of accessibility as reasons for their noncompliance.

4. Discussion and conclusion

There was a significant increase in the medication knowledge score of the patients in the counseled group compared to that in non-counseled group. Generally in Indian
hospitals, patients are not receiving counseling regarding their medications and therefore preliminary initiative
study was taken up and the study results shows counseling sessions was able to produce a statistically significant
improvements.
Determination of compliance by the pill count method and
self-assessment are the tools available for assessing compliance in the third world countries like ours, so these methods
were chosen for assessing compliance.
Compliance of the patients in the counseled group was
higher than the usual care group; counseling might have
produced a positive effect on the compliance behavior. Although this was a positive aspect, it cannot fully attributed to

S. Ponnusankar et al. / Patient Education and Counseling 54 (2004) 5560

counseling since the baseline compliance was not assessed

and this was the limitation of our study.
Since this study is the first of its kind in our country, we did
not have similar studies in our population to compare with.
Woronieki et al. [20] studied the effect of pharmacist counseling on long-term recall of drug information in 28 clinic
and hospital patients. By random assignment, patients were
placed into counseled and control group. All patients were
given pre-test before counseling and an identical post-test
after a period of 8 weeks. The counseled group scored better than the control group during the post test (88.10% versus 62.33%, P < 0.05). Similarly, in our study medication
knowledge of the patients in the counseled group was increased after the counseling.
By pill count method, it was found that compliance of
both the groups was well below 100%, however, in the
self-assessment large proportion of the patients rated themselves as always compliant. This showed either the patients
inflated their compliance or they were reluctant to admit
their non-compliance.
Other limitations of our study that are to be addressed are,
incomplete follow-up, in which five patients could not be
followed till the end of our study. The same investigator carried out medication knowledge assessment and counseling
and this might introduce bias to an extent into the study.
Assessing the medication adherence of the patients may
be good; it may not necessarily result in better clinical outcome. Clinical outcome measurement can only be carried
out during long-term follow-up of the patients. Since this
was a preliminary study from our department, we did not
measure the clinical outcome. Future studies will incorporate the use of clinical outcome to assess the role of pharmacist in quality health care.
4.1. Conclusion
Medication knowledge improvement was found to be statistically significant in the counseled group than the usual
care group. Compliance behavior of the patients showed a
positive trend. Since the baseline assessment of the compliance was not carried out, statistical analysis was not done.
Compliance of the patients in both the groups was found to
be good by pill count method and self-assessment method,
and these methods are liable to go unreliable since it depends
fully on the patient reports. Use of advanced systems like
medication event monitoring system might produce a clearer
picture of compliance scenario among the patient population
studied. Apart from the counseling other modalities such as
providing medication reminders, medication calendars and
emotional support and encouragement may improve compliance.
We are planning our future studies, which will incorporate the use of objective clinical outcome assessment (such
as change in blood pressure, blood sugar levels) to better establish the impact of pharmacists providing pharmaceutical
care in ambulatory settings.

59

4.2. Practice implications

Under developed countries may not have the facilities to
assess the adherence of the patients. However, pill count
method and self-assessment method moderately help the
pharmacists to assess the patient adherence. The concept of
pharmaceutical care provision in an outpatient clinic is well
established in developed countries, but yet to be initiated
in developing countries. This preliminary experiment in our
set-up, provision of pharmaceutical care by the pharmacists
in an outpatient clinic, was well received and encouraged by
the patients and medical fraternity.

Acknowledgements
Authors wish to thank FIP Foundation for Education and
Research, The Netherlands for providing FIPInternational
Travel Grant to present the summary of this paper at 61st
International Congress of FIP2001, Singapore.

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