Indo American Journal of Pharmaceutical Research, 2014

ISSN NO: 2231-6876

IMPACT OF PATIENT EDUCATION ON INCIDENCE OF ADVERSE DRUG REACTIONS

IN POST MECHANICAL REPLACEMENT PATIENTS.
Pragathi reddy gunnam , Divya satyanarayana , Meghana tummalapalli.
Malla reddy college of pharmacy, Dhulapally, secundrabad.
ARTICLE INFO
Article history
Received 08/11/2014
Available online
25/12/2014

Keywords
Warfarin ,
Adverse Drug Reactions ,
INR,
Patient Education.

ABSTRACT
Patients with mechanical valve replacement surgery require lifelong therapy with warfarin .
Warfarin is a drug with narrow therapeutic index, its monitoring parameter INR below 2
results in clotting ,while above 3 results in bleeding and other ADRs like dark urine, limb
pain, headache,etc. Hence an effective patient education is essential for achieving better
outcomes of warfarin therapy and also reduction in the incidence of ADRs. The objective of
this study was to determine the impact of patient education on warfarin therapy and also
reduction in the incidence of ADRs by comparing counseled to that of non-counselled group.
For the study patients were divided into 2 groups, counseled and non-counselled groups.
ADRs observed in both patient groups were noted during their follow-up. SPSS version 20
and INSTAT software were used for data analysis. Unpaired t test was performed .The
results showed that there was reduction in the incidence of ADRs in the group counseled.
Further non counseled group were twice as much as risk of ADRs to that of counseled group.
Unpaired t test showed a significant difference between the two groups. It can be concluded
from the study that patient education plays an effective role in the reduction of incidence of
ADRs and also in the achievement of better outcomes of warfarin therapy.

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Please cite this article in press as Pragathi reddy gunnam et al. Impact of Patient Education on Incidence of Adverse Drug
Reactions In Post Mechanical Replacement Patients. Indo American Journal of Pharm Research.2014:4(12).

5797

Corresponding author
Pragathi reddy gunnam
Fl no.303,prem estates block b,
Behind BSNL office, chandanagar,
Hyderabad-500050, Telangana, India.
gpragathi.reddy29@gmail.com
9000455445

Vol 4, Issue 12, 2014.

Pragathi reddy gunnam et al.

ISSN NO: 2231-6876

INTRODUCTION
The introduction of valve replacement surgery has dramatically improved the outcome of patients with valvular heart disease.
Patients with prosthetic valves especially mechanical valves are at risk of thromboembolic complications causing valve obstruction or
regurgitation[1]. Hence such patients require lifelong anticoagulation with warfarin .Warfarin produces its anticoagulation effect by
interfering with cyclic interconversion of vitamin k and its epoxide. It is the common vitamin k antagonist[2] but as warfarin has a
narrow therapeutic index, close monitoring is essential which is done using INR[3].INR (international normalized ratio) is a ratio of
prothrombin time of the patient to the mean normal prothrombin time[4]. Optimal INR range for post valve replacement patients is
2.5-3.5 .INR above the range leads to complications like bleeding, bruising, etc. while INR below 2 leads to clotting and embolism[3]
From the observations during our posting at the hospital and close monitoring of patients who have undergone mechanical
valve replacement surgeries, during their hospital stay and even after discharge, it was observed that 90% of the patients lacked
adequate knowledge about the importance of lifelong warfarin therapy post surgery and its indications and most of the patients
complained with adverse effects ranging from minor to major, according to deviation of INR from their normal ranges. Hence an
adequate knowledge about the uses, importance of monitoring and incidence of adverse events among the patients with therapy
seemed to achieve the better outcomes of therapy. The main aim of this study is to determine the impact of counseling in reducing the
incidence of adverse drug reactions in patients. This study was conducted with the objective of reducing adverse effects of patients
and reduce the need for re-surgery in patients with warfarin therapy, further by effective patient education better outcomes of therapy
can be achieved that helps in improving the quality of life of patients on long term basis.
MATERIALS AND METHODS:
A cohort, interventional study which was carried out for a period of 8 months at a multispeciality hospital,hyderbad. The
required permission was obtained from institutional ethics committee and medical superintendent of the hospital. Patients who have
undergone mechanical valve replacement surgeries and were on warfarin therapy for at least a period of 3 months and also patients
who discontinued the therapy due to development of ADRs were included under this study. Patients with a history of risk of
haemorrhage, pregnant women and lactating mothers were not included in this study. A total of 70 patients were selected and divided
into two groups. One group of patients were selected before the establishment of patient education services in the hospital, hence they
were not counseled. Another group of 35 patients were selected and educated regarding the uses , importance of monitoring therapy
and adverse events. Patient counseling was done even during their further follow-up and information was provided with the help of
patient information leaflets. Patients who were not counseled were considered as exposed to the adverse drug events. During follow up
of the patients the various ADRs observed as well as assessed using questionnaire were noted. The incidence , severity of ADRs was
noted in both the counseled as well as non counseled groups, and compared with the help of contingency table and unpaired t test.
ADRs were assessed in counseled and non counseled groups respectively and also the risk among non counseled group was found.
SPSS version 20 and INSTAT software were used for the processing of data. Unpaired t test was used for data analysis. A p
value less than 0.01 is considered significant.
RESULTS:
A total of 70 patients were under various age groups between 14 to 70(table 1)
Table 1: Demographic details of patients.
Age
13-18
19-39
459
60-74
Gender
Male
Female

Non counseled group

2.8%
20%
45.7%
31.4%

Counseled group
8.5%
37.1%
28.5%
25.7%

51.4%
48.6%

45.7%
54.3%

Various ADRs were found in two different groups. The incidence and percentages of various ADRs found in patients. They
were bruising, bleeding, dark colored urine, limb pain, bloating & headache.(table 2)

Non counseled group

34.2%
20%
22.58%
22.85%
14.28%
25.71%

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Counseled group
17.1%
5.71%
2.8%
2.85%
2.85%
0%

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Adverse drug reactions

Bruising
Bleeding
Dark colored urine
Limb pain
Bloating
Headache

5798

Table 2: Adverse drug reactions observed in non-counseled and counseled group.

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Pragathi reddy gunnam et al.

ISSN NO: 2231-6876

STATISTICAL ANALYSIS:
SPSS version 20 and INSTAT software were used for data analysis. Unpaired t test was performed with a value less than
0.01 considered significant. There was reduction in the incidence of ADRs in the group counseled.
Unpaired t test showed a significant difference between the two groups. A contingency table was drawn between number of
patients counseled and non-counseled to determine the incidence of adverse drug reactions from the table, the incidence in the group
not counseled was found to be 57.1 per 100 individuals, while the incidence in the group counseled was found to be 25.7%(table 3 &
3.1)
Table 3: Contingency table of ADRs.

Non counseled
Counseled
total

ADR
20
9
29

No ADR
15
26
41

TOTAL
35
35
70

Table 3.1: Incidence of ADRs.

Non counseled group

Counseled group

Total cases with ADRs/

Percentage of incidence

total patients=incidence
20/35=0.571
9/35=0.257

57.1%
25.7%

From the above table, it can be further determined that those who were not counseled were twice (2.22 times approximately)
as much as risk of ADRs as those who were counseled.

Figure 3: Comparision between ADRs of counseled and non-counselled group.

The above graph shows a comparison between ADRs of counseled (in blue)to that of non-counseled group(in brown).
Among the total sample size of 35 in both groups, incidence of ADRs has been found to decrease considerably in the counseled group.
Unpaired t test between ADRs of non-counseled and counseled group was done with (p=0.01) and it was found that ADRs
have significantly got reduced from 1.37 to 0.57 in the counseled group.( table 4)

Total ADRs in counseled

group(n=35)
1.371.45
1
5

group(n=35)
0.571.03
0
5

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Mean
Median(50th percentile)
maximum

Total ADRs in non-counseled

5799

Table 4: Unpaired t test between ADRs of non-counselled and counseled groups.

Vol 4, Issue 12, 2014.

Pragathi reddy gunnam et al.

ISSN NO: 2231-6876

DISCUSSION
Post mechanical valve replacement patients require lifelong anticoagulation management with warfarin . Use of warfarin in
the post operative setting is quite challenging task as warfarin has narrow therapeutic index and results in adverse drug events if
therapeutic INR levels were not maintained. Comparing our initial observations before the establishment of patient education services
to that of after counseling, and the results of this study, it was can be found that patient counseling has helped greatly in achieving
better outcomes and also decreased incidence of ADRs . In a study on the effect of centralized clinical pharmacy anticoagulation
service, the incidence of ADRs was reduced by 39% [5]. The post thrombotic complications were reduced from 24% to 18%. in
another study on the impact of an inpatient anticoagulation management service on clinical outcomes[6],the reduction of post
thrombotic complications was from 3.1% to 1.3%. The impact of clinical pharmacist interventions reduced the repeat surgeries from
12.48% to 0%. In another study on anticoagulation therapy after prosthetic valve replacement, the need for repeat surgeries was
reduced from 1.2% to 0%.
CONCLUSION
The results of this study indicate further scope of patient counseling on improvement of outcomes of warfarin therapy and
also reduction in the incidence of ADRs. Further the results indicate that effective patient counseling services are required for patients
post mechanical valve replacement surgeries for better outcomes of warfarin therapy. this study leads to an emphasis on establishment
of patient education services in the hospital settings where such surgeries are performed so as close monitoring of therapy can be done.
ACKNOWLEDGEMENT
1. Richa srivastava, asst.professor, malla reddy college of pharmacy, dhulapally,secundrabad.
2. Dr.Anand agarwal , senior CT surgeon, Narayana Hrudayalaya-malla reddy hospital, suraram x roads,secundrabad.
CONFLICT OF INTEREST
none
REFERENCES
1. Phillippe pibarot,DVM, PhD; Jean G. Dumesnil, MD,FRCP. Prosthetic heart valves. Selection of the optimal prosthesis and long
term management.
2. Whilton DS, Sadowski JA .Mechanisms of coumarin action; significance of vitamin k epoxide reductase inhibition
3. Joseph t dipiro, pharmacotherapy- a pathophysiologic approach,seventh edition.
4. Denson KWE, Reed SV ,Haddon ME, validity of the INR system for patients with liver impairment . Thromb
Haemost,1995;73:162166
5. Daniel M witt, pharmD ,et al . the effect of an anticoagulation management service on the outcomes of anticoagulation therapy.
Pubmed;117(5);1515-1522..2011.
6. Paula j biscup-horn pharmD et al. Impact of an anticoagulation management service on clinical outcomes, Pubmed 2012;128(9)
1301-1309,2012.
7. Takanobu mori,MD., et al .anticoagulation therapy after prosthetic valve replacement, pub,ed 128(2):83-87.,2010.

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