Mahatme M S Et. Al., 2018
Mahatme M S Et. Al., 2018
Mahatme M S Et. Al., 2018
1
Department of Pharmacology,
ABSTRACT
Indira Gandhi Government
Medical College, Nagpur, Background: Epilepsy is a common disorder of brain function which affects
Maharashtra, India
2 around 1% of world population. Due to nature of chronicity of this disease, long
Department of Medicine, Indira
term medical treatment with Anti-Epileptic Drugs (AEDs) is required to achieve
Gandhi Government Medical
control of the seizures. Antiepileptic drugs are responsible for 5% of ADRs
College, Nagpur, Maharashtra,
among all of the prescribed drugs. Due to the significant number of adverse drug
India reactions spontaneous reporting and knowledge about ADRs have gained the
importance. Knowledge(K), attitude (A) and practices (P) studies are preferred
Received: 11 October 2018
nowadays so as to have the better understanding and implication of the studies
Accepted: 01 November 2018
for the benefit of the patients. Therefore, this study was planned to evaluate
Knowledge, Attitude and Practices (KAP) regarding Anti-Epileptic Drug (AEDs)
*Correspondence to: therapy in epileptic patients and their relatives and to create awareness regarding
Dr. Vartika Gupta, the same.
Email: [email protected]
Methods: A questionnaire based study for assessment of KAP during a period of
2 months in patients of epilepsy and their relatives.
Copyright: © the author(s),
Results: The maximum side effects were seen in central nervous system and
publisher and licensee Medip
functions (80%) followed by dermatological problems (6.57%), visual defects
Academy. This is an open- (5.19%), GIT complaints (4.84%) and lastly sexual function impairment (3.34%).
access article distributed under Carbamazepine was most commonly prescribed drug followed by phenytoin.
the terms of the Creative
Certain gender and age specific adverse events were found. 95% patients were
Commons Attribution Non-
found to be compliant with medicines’ dose and schedule.
Commercial License, which
Conclusions: The chronicity of epilepsy calls for long duration of treatment so
permits unrestricted non-
consideration and addressing ADRs are essential to maintain compliance among
commercial use, distribution, patients.
and reproduction in any
medium, provided the original
Keywords: Adverse Drug Reactions, Antiepileptic drugs, Attitude, Knowledge,
work is properly cited.
Practice
www.ijbcp.com International Journal of Basic & Clinical Pharmacology | December 2018 | Vol 7 | Issue 12 Page 2336
Mahatme MS et al. Int J Basic Clin Pharmacol. 2018 Dec;7(12):2336-2341
Epilepsy has various aetiologies, which can be categorized above, guardians of epileptic patients who had cognitive
according to age or causes irrespective of age or of impairment and those who signed the informed consent
idiopathic origin. The different causes among different age form. Patients with uncertain diagnosis of epilepsy, those
groups can be: in newborns (perinatal hypoxia, intracranial who refused to sign the informed consent form and
hemorrhage, metabolic disturbances etc), infants and relatives of cognitively impaired patients who refused to
children (febrile seizures, trauma or developmental sign were excluded from the study.
disorders etc), adolescent and young adults (trauma, illicit
drug use etc) and older adults (head injuries, brain tumors, After approval from the Institutional Ethics Committee,
alcohol withdrawal, cerebrovascular disease).6 Due to patients and relatives of cognitively impaired patients who
nature of chronicity of this disease, most patients with signed informed consent form were explained about the
epilepsy depend on long term medical treatment with Anti- study. A set of 42 different pre-validated questions were
Epileptic Drugs (AEDs) to achieve control of their asked in questionnaire. The questionnaire covered the
seizures.7 Commonly used AEDs are carbamazepine, basic history of patient's condition, various adverse effects
sodium valproate, phenytoin and phenobarbitone. 8 involving different systems suffered by them and their
practice towards those ADRs.16 Post data collection,
AEDs have multifaceted pharmacological properties and information leaflets translated into vernacular language
narrow therapeutic index, leading to adverse drug were given to patients about the basic knowledge of ADRs
reactions (ADRs) which often complicate proper choice of caused by the AEDs to create awareness. The leaflet
medication, requiring subsequent adjustment of therapy. 9 contained list of common side effects which were to be
The target of therapy should be full control of seizures with reported and various dos and don’ts while taking the
minimal or no adverse reactions attributed to medications medications like following proper drug schedule, avoiding
to lead an optimal quality of life.10 ADRs deteriorates self-medication etc. were handed to patients.17 Being the
usual life style which can range from mild appetite and tertiary care hospital, different AED like carbamazepine,
behavioural change to serious related problems like losing phenytoin, phenobarbitone, clobazem, sodium valproate
control over own actions and tremors, ineffective response and clonazepam were provided free of cost to every patient
when required. This contributes to a high number of for a period of 7 days. Folic acid was given along with
morbidity and mortality.6 Antiepileptic drugs are these medications. Patients were again called for
responsible for 5% of ADRs among all of the prescribed evaluation by the physician and for refill of the drugs. The
drugs. Carbamazepine and phenytoin are the commonest patients were encouraged to meet the investigator in the
among the group.11 Studies from USA and UK have follow-up visits.
reported that AEDs are associated with a significant
number of ADRs and fatality.12,13 The extensive data RESULTS
regarding ADRs in Indian setup is still lacking. The newer
reliable AEDs are also available in the Indian market and There were 130 patients primarily approached for the KAP
used at par with the older one like carbamazepine and study, out of which 102 epileptic patients gave consent to
phenytoin. Even the newer AEDs are also associated with participate in the survey. This included 58 male and 44
numerous ADRs.14 female patients.
Due to the significant number of adverse drug reactions of CBZ PHT PHB VAL CLO CLP
all the antiepileptic drugs spontaneous reporting and
knowledge about ADRs have gained the importance.15 20
More and more preference is given to knowledge (K),
attitude (A) and practices (P) studies nowadays so as to 15
No of patients
International Journal of Basic & Clinical Pharmacology | December 2018 | Vol 7 | Issue 12 Page 2337
Mahatme MS et al. Int J Basic Clin Pharmacol. 2018 Dec;7(12):2336-2341
in male and female is shown in (Figure 1 and 2). 60% and sexual function impairment (3.34%). In CNS, motor
participants reported spontaneous origin of first attack of function and coordination were commonest affected
seizure associated with loss of consciousness along with function system (Figure 4). Table 1 shows detailed
forgetfulness of the rest of the events that took place analysis of CNS ADRs. Headache was the most common
afterwards. 30% patients had epilepsy since birth and the ADR i.e. 82.35% of total ADRs. Age and gender related
rest 10% patients acquired this condition while being variations were seen in this study. Younger patients
under stress or due to some other causes like severe complained more of irritability. Behavioural changes like
headache and head injuries. increased irritation and aggressiveness were more
prevalent in females whereas depressive symptoms i.e.
staying worried for all day long and feeling miserable were
CBZ PHT PHB VAL CLO
more common in males.
14
Table 1: Central nervous system ADRs.
Number of patients (%)
12
10 Patient %
Drowsiness and sleepiness 76.47%
8
Tiredness and lethargy 70.59%
6 Inability to concentrate on same thing
66.67%
4 for longer times
2 Incapability in performing daily
1.96%
activities
0 Increased irritability
14- 18 19-25 26-40 41-55
Increased aggressiveness 52.94%
Age in years Increased feeling of agitation and
60.78%
Carbamazepine = CBZ, Phenytoin = PHT, Phenobarbitone = restlessness
PHB, Valproate =VAL, Clobazem = CLO Constant feeling of pressure or over-
21.57%
excitedness
Figure 2: Age specific AEDS used in females. Increased irritation 64.71%
Depressive symptoms
Staying worried all days 52.94%
Polytherapy 39.22 Feeling of depression and misery 27.45%
Clonazepam 1.23 Decreased activeness 52.94%
Difficulty in sleeping 21.45%
Sodium Valproate 2.47
Cognitive function
AEDs
International Journal of Basic & Clinical Pharmacology | December 2018 | Vol 7 | Issue 12 Page 2338
Mahatme MS et al. Int J Basic Clin Pharmacol. 2018 Dec;7(12):2336-2341
Cognitive functions such as difficulty in remembering effects and side effects. 90% of subjects contacted their
names and events and in finding right words were observed doctors for the same.
more in males. In females, there was prevalence of severe
headache which rendered them unable to work sometimes. DISCUSSION
Table 2 shows detailed analysis of other system ARDs.
Epilepsy is a neurologically disturbed state of brain cells
which doesn’t have any age preference. There is no
35 30.98
observed pattern for the occurrences of epileptic attacks or
No of patients (%)
27.09
30 seizures, which may be spontaneous or unwarned. So,
25 timely action by starting prompt treatment or management
20 15.85 14.7 11.38 is essential.18
15
10
Monotherapy is preferred as standard management
5
keeping in view less ADRs, cost, convenience, better
0
compliance, adherence to standard treatment guidelines
and lesser drug interactions.19 In this study, 62 patients
were kept on single drug therapy and desired results were
achieved.
International Journal of Basic & Clinical Pharmacology | December 2018 | Vol 7 | Issue 12 Page 2339
Mahatme MS et al. Int J Basic Clin Pharmacol. 2018 Dec;7(12):2336-2341
International Journal of Basic & Clinical Pharmacology | December 2018 | Vol 7 | Issue 12 Page 2340
Mahatme MS et al. Int J Basic Clin Pharmacol. 2018 Dec;7(12):2336-2341
India towards adverse drug reaction (ADR) reporting. 21. Varun T, Sebastian J, Ramesh A, Narahari MG, Bs K,
Perspectives in clinical research. 2012 Jul;3(3):90. Harsha S. Prospective Monitoring and Reporting of
18. Narayan SS, Sharma GK, Rodrigues RJ, Kulkarni C. Adverse Drug Reactions associated with Antiplatelet
Pattern of adverse drug reactions to anti‐epileptic and Antiepileptic Drugs in a South Indian Tertiary
drugs: a cross‐sectional one‐year survey at a tertiary Care Teaching Hospital. Ind J Pha Practi. 2012;5(3).
care hospital. Pharmacoepidemiology and Drug
safety. 2008 Aug 1;17(8):807-12.
19. Shorvon SD, Chadwick D, Galbraith AW, Reynolds
EH. One drug for epilepsy. Br Med J. 1978 Feb Cite this article as: Mahatme MS, Gupta V, Hiware
25;1(6111):474-6. SK, Hardas MM. A questionnaire based study of
20. Anderson M, Egunsola O, Cherrill J, Millward C, adverse drug effects of antiepileptic drugs in a
Fakis A, Choonara I. A prospective study of adverse tertiary care hospital in Central India. Int J Basic Clin
drug reactions to antiepileptic drugs in children. BMJ Pharmacol 2018;7:2336-41.
open. 2015 May 1;5(6):e008298.
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