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Banu et al. World Journal of Pharmacy and Pharmaceutical Sciences
DRUG UTILIZATION REVIEW OF ANTIEPILEPTIC DRUGS: A
RETROPROSPECTIVE STUDY
Zeenath Banu* and Syeda Juveria Fatima
Assistant Professors, Shadan Women’s College of Pharmacy, Khiartabad, Hyderabad.
ABSTRACT
Drug utilization review can be defined as review of drugs used in a
population to determine effectiveness, potential dangers, problems
with drug interaction and other issues. It aims at providing guidelines
to doctors with respect to the rational use of drugs, minimizing side
effects, poly pharmacy and exposure to potent drugs. Our aim of
choosing this topic is to give a brief idea about the disease and
highlight the rational and cost effective use of the anti-epileptic drugs
which is not rational may ultimately lead to poor patient outcome and
significant wastage of money and resources Method: A retrospective
observational study was conducted at Princess Durre Shehvar
Children’s and General Hospital, Hyderabad. It was conducted over a
period of one month. A total 100 patient’s data were collected, Percentage of men 47(61%)
suffering from epilepsy was higher than female 30 (40%).Our data shows that most of the
patients 77 were from age group (0-10) years; followed by 8 of patient in the age group of
(11-20)years. Conclusion, the use of anti-epileptic drugs was almost found to be rational.
Pharmacist is the key person for better management of therapy based on stage and condition
of patient.
KEYWORDS: Drug Utilization, Prescription Pattern, Seizures, Antiepileptic drugs.
INTRODUCTION
The word “Epilepsy” is derived from a Greek word meaning “a condition of being
overcome, seized, or attacked”. The word “Epilepsy” means nothing more than the tendency
to have seizures. It is defined as a chronic disorder which causes disturbances in the electrical
signalling and its transmission in the brain and is characterized by recurrent and sudden
occurrence of seizures which stop spontaneously. [1]
WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
SJIF Impact Factor 6.041
Volume 5, Issue 3, 684-702. Research Article ISSN 2278 – 4357
Article Received on
14 Jan 2016,
Revised on 05 Feb 2016,
Accepted on 26 Feb 2016
*Correspondence for
Author
Zeenath Banu
Assistant Professors,
Shadan Women’s College
of Pharmacy, Khiartabad,
Hyderabad.
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ETIOLOGY
The causes of epilepsy are as follows
Figure 1: Causes of Epilepsy
PATHOPHYSIOLOGY
Neurons are interconnected in a complex network in which each individual neuron is linked
through synapses with hundreds of others. A small electrical current is discharged by neurons
to release neurotransmitters at synapses levels to permit communication with each other.
Epilepsy occurs when there is an imbalance between excitatory and inhibitory influences in
brain.
(a) Na+
or Ca2+
ion conductance of the neuronal membrane.
(b) Inhibitatory GABA neuronal circuits, i.e. defects in GABA transmission.
(c) Excitatory mechanisms involving NMDA receptor channels to produce depolarization
and
(d) Other functions related to pre- or postsynaptic activity.[2]
Excitatory Imbalance: When there is excessive discharge of impulses i.e. seizure Mg+2
induced shock, NMDA receptors are released which causes Ca+2
influx which leads to the
activation of calmodulin and other kinases as a result of increased AMP receptor sensitivity
and release of Glutamate which further leads to the opening of Na+
channels which results in
the generation of impulses.
Inhibitory Imbalances: GABA (Gamma amino butyric acid) is an inhibitatory
neurotransmitter in brain. The levels of GABA are maintained in the brain by GABA
transaminase enzyme which is responsible for its degradation. In epileptic conditions, GABA
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Banu et al. World Journal of Pharmacy and Pharmaceutical Sciences
transaminase activity is imbalanced as a result its inhibitory effect is suppressed which leads
to increased excitatory activity which results in seizures. [3]
A neuron discharging can either
excite or inhibit neurons connected to it. An excited neuron will activate the next neuron
whereas an inhibited neuron will not. In this manner information is conveyed, transmitted and
processed throughout the central nervous system. If neurons are damaged, injured or suffer a
chemical or metabolic insult, a change in the discharge pattern may develop.
In case of epilepsy, regular low frequency discharge is replaced by bursts of high frequency
discharges usually followed by period of inactivity. This occur due to influx of extracellular
Ca+2
ions in very high amounts followed by opening of voltage gated sodium channels
(depolarization phase).
Figure 2: Pathophysiology
A single neuron discharging in abnormal manners usually has no clinical significance. It is
only when a whole population of neurons discharges synchronously in an abnormal way that
an epileptic seizure may be trigged. This abnormal discharge may remain localized or it may
spread to adjacent areas, recruiting more neurons as it expands [2]
. The area from which the
abnormal discharge originates is known as the epileptic focus. An EEG recording carried out
during one of these abnormal discharges may show a variety of atypical signs, depending on
which area of the brain involved its progression and how the discharging area projects to the
superficial cortex. [2]
CLASSIFICATIONS OF EPILEPSY
Epileptic seizures can be classified into two types
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Figure 3: Classification of Epilepsy
1. Partial seizures / Focal seizures: These are the most common type of seizures which are
always due to a focal brain lesion.
(a) Simple partial seizures: Simple partial seizures are localized seizures that occur in only
one part of the brain. A wide range of clinical phenomena may occur depending on the
site of the brain lesion.
Motor: This begins as recurrent contractions of a part of the body and may spread to
involve contiguous areas.
Sensory with numbness or parasthesia limited to one part of the body.
Olfactory, Gustatory, Auditory and vertiginous symptoms.
Autonomic symptoms
Psychic Symptoms such as déjà-vu and dreamy states or unwarranted sense of fear or
anger. [4]
Figure 4(a): Simple partial seizure
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A simple partial seizure with motor symptoms.
(a) First the fingers then the hand and arm are jerking.
(b) It has spread to the upper shoulder.
(c) The woman’s head is drawn towards her shoulder.
(d) The leg is drawn up.
Figure 4(b): Simple partial seizure
(b) Complex partial seizures or Psychomotor Epilepsy
This seizures originate in temporal lobes (frontal lobe & accompanied with partial loss of
consciousness) of brain. The patient may present with altered or automatic behaviour:
plucking his or her clothes fiddling with various object and acting in confused manner. Lips
smacking/Chewing movements, undressing performing aimless activities and wandering
around in a drunken fashion may occur on their own or in different combinations during
complex partial seizures. [2]
Figure 5: Complex partial seizure
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(c) Secondary Generalized seizures
When partial seizures progresses to generalized seizures in which the discharge spread to the
entire brain. The patient may have warnings but not every time.
Figure 6: Secondary Generalized Seizure
EEG shows localized onset but involvement of entire brain leads to same convulsive attacks
as that in generalized tonic – clonic seizures.
2.Generalized seizures: This type of seizures involves initial activation of both hemisphere
of brain simultaneously. It results in impairment of consciousness from the onset.
a) Absence Seizure (petit-mal): The rarely occurring seizures are seen only in children&
young adults. It consists of sudden cessation of ongoing conscious activity without
convulsive movement & without loss of postural control. The point appears to go blank for
one second to one minute, & there may be accompanying fluttering of eyelids or small
chewing movements of the mouth.
Figure 7: Absence Seizure
The EEG shows Symmetric spikes at 3 Hz & wave pattern of discharge /sec hat begins &
ends suddenly.
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b) Myoclonic Seizures
These are abrupt, very brief involuntary shock like jerks, which may involve the whole body
or the arms or the head .EEG shows 2 Hz spikes & wave pattern/sec.[13]
Figure 8: Myoclonic seizure
c) Tonic –Clonic Seizures or Grandmal epilepsy: These are the commonest of all epileptic
seizures without warning, the patient suddenly goes stiff, fall and convulses with laboured
breathing and salvation.
Figure 9: Tonic – Clonic Seizure
The attack may be accompanied by tongue biting, frothing at the mouth and incontinence.
The convulsion ceases after a few minutes and may often be followed by a period of
drowsiness, Confusion Headache and Sleep.
EEG shows a bilateral diffuse pattern of high voltage poly spikes of 10 - 30Hz/ sec.
d) Tonic Seizures
Tonic seizures are characterized by the muscles stiffening and the person falling to the
ground. These seizures frequently occur in clusters during sleep. People who suffer from
tonic seizures are at risk of head injury from falls.
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Figure 10: Tonic Seizure
(e) Atonic (Akinetic) Seizure: These comprise a sudden loss of muscle tone, causing the
person to collapse to the ground suddenly. These kinds of seizures generally occur in
children, are turns drop attacks whose recovering is almost instantaneous.
EEG shows brief spikes and wave discharge is slow. [2]
Figure 11: Atonic Seizure
DIAGNOSIS
Diagnosis is based on detailed history of seizures, clinical examination, electro
encephalogram (EEG) and appropriate neuron-imaging.
A diagnosis of epilepsy is made after the patient has had more than one event recognizable as
a seizure not related to fever. Diagnosis of epilepsy in people aged over 60 years is more
difficult than in younger adults and children. Diagnosis of epilepsy can be compounded by an
inadequate medical history or documentation, particularly if there is a substantial period of
time between witnessed seizures.[2]
1.ELECTROENCEPHALOGRAM
Electroencephalography (EEG) is the recording of electrical activity along the scalp. EEG
measures voltage fluctuations resulting from ionic current flows within the neurons of
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the brain. It is aim to record abnormal neuronal discharges. However, EEGs have limitation
that should be clearly understood up to 5% of people without Epilepsy may have not specific
abnormalities in their EEG recording, while up to 40%of people with Epilepsy may have a
normal EEG recording between seizures. [2]
Figure 12: EEG
Therefore the diagnoses of Epilepsy should be strongly supported by a history of epileptic
attacks otherwise EEG will be invaluable. The change of recording the discharges of an
actual seizure during a routine EEG, which usually takes 20-30 minutes.
(a) Ambulatory EEG
It allows recording in day to day circumstances using a small cassette recorder.
(b) EEG video –Telemetry
In this, patient is hospitalized and kept under continuous monitoring. It is useful in the
assessment of difficult cases, particularly if surgeries are considered. This is only helpful in a
few cases, and it is best suited for patients who have frequent seizures. [3]
CLASSIFICATION OF ANTI-EPILEPTIC DRUGS
1.Hydantoin derivatives: Phenytoin, Fosphenytoin
2.Barbiturates: Phenobarbitone and Primidone
3.Iminostilbenes: Carbamazepine , Oxcarbazepine
4.Succinimide: Ethosuximide, Methsuximide
5.GABA-transaminase inhibitors: Sodium valproate, vigabatrin
6.GABA reuptake inhibitors: Tiagabin
7.GABA agonists: Gabapentin
8.Benzodiazepines: Clonazepam, Diazepam, Clobazepam, Lorazepam
9.Miscellaneous: Lamotrigine, Sulthiame, Phenacemide and amphetamine.[4]
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METHODOLOGY: PHASES AND STEPS INVOLVED IN CONDUCTING A DRUG
UTILIZATION REVIEW
STEP 1: IDENTIFY DRUGS OR AREAS OF PRACTICE FOR POSSIBLE STUDY
Identify drugs or therapeutic areas of practice for possible inclusion in the program .It is not
possible and also unnecessary to examine every drug that is used in the hospital .Hence ,the
DUR committee must identify priority drugs or areas of practice where improvement in use
will result in the greatest clinical impart .These areas can be identified through various source
of information , such as medication error , adverse drug reaction reports , feedback from
prescribes or clinical pharmacists , local microbiology that and the medical and
pharmaceutical literature.[5]
STEP 2: DESIGN OF STUDY
Observational research methods are most commonly used than experimental methods such as
randomized controlled trials .Cross sectional studies, where drug use is examined at a single
point in time, are useful for proper identification .The pre post design where drug use is
examined before and after interventions to improve prescribing is another commonly used
observational method. During a retrospective DUR, drug therapy is reviewed after a patient
has completed a course therapy.
STEP 3: DEFINE CRITERIA AND STANDARDS
After the DUR target has been selected, it is important to conduct a comprehensive literature
review. Standard are professionally developed expressions of the range of acceptable
variation from a criterion .Criteria should be scientifically based and be supported by clinical
or research literature .They must be valid, unambiguous, realistic, easily measured and
outcome oriented. [6]
STEP 4: DESIGN THE DATA COLLECTION FORM
Just as it is impossible to monitor and evaluate all drugs used in the hospital, it is also
impossible to address all aspect of use for each individual drug.
STEP 5: DATA COLLECTION
Data collectors should be choosing carefully and should be familiar with new information is
arranged in the patients care notes .Knowledge of drug names, strength and the way orders
are written is also important .Depending upon their availability, physicians, pharmacist and
nurses make ideal data collectors. [7]
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STEP 6: EVALUATE RESULTS
Data evaluation is one of the most critical steps in DUR. The data obtained should be
collected using available resources such as spread sheets, data bases, and word processing.
The next step is to summarize the major categories of results and to identify where exactly
the data shows deviation from guidelines and usage criteria that are previously identified.
STEP 7: PROVIDE FEEDBACK OF RESULTS
The success of any DUR strategy depends on feedback of the results to prescribers, other
hospital staff involve in the study and in the administrative heads. The result can also be
circulated to hospital staff via newsletters, DUR meetings or hospital academy meetings. [8]
This study was conducted in the Princess Durru Shevar Children’s & General Hospital,
Hyderabad, Andhra Pradesh, which is a reputed hospital. It has also a pharmacy in it. Many
patients from in and around AP visit here. It was conducted over a period of 1 month Princess
Durru Shevar Children’s & General Hospital. About 100 patients was surveyed, their case
sheets were studied in detail. The study includes retrospective treatment chart reviews. We
focused on different parameters like various class of drugs given to the patients, gender, age,
route of administration.
SOURCE OF INFORMATION
Documented information was collected from the case sheet of respective wards, only in the
presence of deputed neurologist and his assistants though the identity of the patient was
confidential, an ID number was given for each patient. [9]
DATA COLLECTION
A total of 100 cases were reviewed and the analysis of forms was done according to the
neurologist guidelines .The data collection for included the information:
Patient ID no.
Date of admission and date of discharge
Age
Sex
History of illness
Provisional diagnosis
Names of drugs prescribed
Dose
Route of administration
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Data collection chosen must be familiar with how information is arranged in the patient’s
case sheet .Knowledge of drugs names, strengths, and the way the order is written is also
important. Retrospective review was performed during the course of treatment and it involves
the review of drug therapy after the patient has completed a course. [10]
RESULTS AND DISCUSSION
PATEINT DEMOGRAPHIC DATA
A total of 80 patients were treated with anti-epileptic drugs for various types of epilepsy
disorders. The number of patients were maximum from children (first) aged group (0-10
years) which account for 75% of the total patients. Of the 80 patients, 50 (62.5%) and 30
(37.5%) were male and female, respectively. The disorder like simple febrile seizure and
generalized seizure were prominent. The most common route of administration in the
treatment of epilepsy was found to be parenteral (83.7%) than oral (81.2%).
1. DEMOGRAPHIC DATA OF PATIENT
S.No. Age Group No. of patients Percentage
1 0 - 10 62 77.5%
2 11 – 20 6 7.5%
3 21 – 30 5 6.2%
4 31 – 40 - -
5 41 – 50 - -
6 51 – 60 4 5.1%
7 61 – 70 3 3.7%
Based on Demographic Data of Patients
77.5
6 50 0
4 3
0
10
20
30
40
50
60
70
80
90
Age Group
% o
f P
ati
en
ts
0-10
11-20
21-30
31-40
41-50
51-60
61-70
2. BASED ON GENDER
S.No. Gender No. of Patients Percentage
1 Male 50 62.5%
2 Female 30 37.5%
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Based On Gender
62.5
37.5
0
10
20
30
40
50
60
70
Gender
% o
f P
atie
nts
Male
Female
3. BASED ON ROUTE OF ADMINISTRATION
S.No. Route of Admin. No. of Drugs Percentage
1 Oral 65 49.2%
2 Parenteral 67 50.7%
Based on Route of Administration
49.2 50.7
0
10
20
30
40
50
Route
% o
f Pat
ient
s
Oral
Parenteral
4. PRESCRIBING FREQUENCIES OF SELECTED DRUG CATEGORIES
S.No. Class of Drugs Total no. of
Patients
Males Drugs
%
Females Drugs %
1 Benzodiazepines 77 50 64.9% 27 35%
2 Hydantoin 39 27 69.2% 12 30.7%
3 GABA Transominase
Inhibitor
15 11 73.3% 4 26.6%
4 Barbiturate 2 2 100% 0 0
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Based on Prescribing Frequencies of
Selected Drugs in Males
64.969.2
73.3
100
0
20
40
60
80
100
Classes of Drug
% o
f P
ati
en
ts Benzodiazepine
Hydantoin
GABA
Barbiturate
Based on Prescribing Frequencies of
Selected Drugs in Females
35
30.7
26.6
00
5
10
15
20
25
30
35
40
Classes of Drug
% o
f P
ati
en
ts Benzodiazepine
Hydantoin
GABA
Barbiturate
5. PRESCRIBING FREQUENCIES OF OTHER DRUGS
S.No. Classes of Drugs Total No. of
Patients Males Drugs % Females Drugs %
1 Antibiotics 94 61 64.8% 33 35.1%
2 Anti-pyretic 51 37 72.5% 14 27.4%
3 Analgesics 51 35 68.6% 16 31.3%
4 Anti-emetics 29 14 48.2% 15 51.7%
5 Anti-ulcer 26 10 38.4% 16 61.5%
6 Anti-amoebic 6 2 33.3% 4 66.6%
7 Anti-diarrheal 6 3 50% 3 50%
8 Anti-depressant 1 0 1 100%
9 Diuretics 6 2 33.8% 4 66.6%
10 Anti-anxiety 1 1 100% 0
11 Anti-diabetic 1 1 100% 0
12 Anti-allergic 2 2 100% 0
13 Anti-septic 1 1 100% 0
14 Laxatives 2 1 50% 1 50%
15 Autacoids 5 2 40% 3 60%
16 Multivitamins & Mineral
Combination 12 1 8.3% 11 91.6%
17 Anti-malarial 4 1 25% 3 75%
18 Haematinics 2 0 2 100%
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Based on Prescribing Frequencies of Other Drugs in Males
61
37 35
1410
2 3 2 1 1 2 2 1 2 1 1
0
10
20
30
40
50
60
70
Classes of Drug
No
. o
f D
rug
s
Antibiotics
Anti-pyretics
Analgesics
Anti-emetics
Anti-ulcer
Anti-amoebic
Anti-diarroheal
Diuretic
Anti-anxiety
Anti-diabetic
Anti-allergic
Anti-septic
Laxative
Autocoid
Multivitamin
Anti-malarial
Based on Prescribing Frequencies of Other Drugs in Females
33
1416 15 16
4 31
4
13
11
3 2
0
5
10
15
20
25
30
35
Classes of Drugs
No
. o
f D
rug
s
Antibiotics
Anti-pyretic
Analgesic
Anti-emetic
Anti-ulcer
Anti-amoebic
Anti-diarrhoeal
Anti-depressant
Diuretic
Laxative
Autacoid
Multiviatmin
Anti-malarial
Haematinic
6. BASED ON ETIOLOGY
S.No. Causes Total No. of
Patients
Male
No. %
Female
No. %
1 Genetic / Hereditary 31 15 48.3% 16 51.6%
2 Infection 38 26 68.4% 12 31.5%
3 Metabolic Disorder 5 3 60% 2 40%
4 High Fever 15 12 80% 3 20%
5 Tumor 1 1 100% 0
6 Sudden Withdrawal of Drug 7 1 14.2% 6 85.7%
7 Developmental Delay 6 6 100% 0
Based on Etiology in Males
15
26
3
12
1 1
6
0
5
10
15
20
25
30
Causes
No
. o
f M
ale
s
Genetic
Infection
Metabolic Disorder
High Fever
Tumor
Drug Withdrawal
Developmental Delay
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Based on Etiology in Females
16
12
23
6
0
2
4
6
8
10
12
14
16
18
Causes
No
. o
f F
emal
es Genetic
Infection
Metabolic Disorder
High Fever
Drug Withdrawal
7. BASED ON SIGNS AND SYMPTOMS
S.No. Signs and Symptoms Total no. of
Patients
Male No.
%
Female No.
%
1 Up rolling of eye balls 49 26 53.06% 23 46.9%
2 Tonic pasturing of UL & LL 50 37 74% 13 26%
3 Cough & cold 19 14 73.6% 5 26.3%
4 Involuntary movements 14 7 50% 7 50%
5 Frothing from mouth 12 10 83.3% 2 16.6%
6 Fever 53 33 62.26% 20 37.7%
Based on Signs & Symptoms in Males
26
37
14
710
33
0
5
10
15
20
25
30
35
40
Signs & Symptoms
No
. o
f M
ale
s
Up rolling of eyes
Tonic pasturing of LL & UL
Cough & cold
Involuntary movements
Frothing from mouth
Fever
Based on Signs & Symptoms in Females
23
13
57
2
20
0
5
10
15
20
25
Signs & Symptoms
No
. o
f F
em
ale
s
Up rolling of eyes
Tonic pasturing of LL & UL
Cough & cold
Involuntary movemnets
Frothing from mouth
Fever
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8.BASED ON CLASSIFICATION OF EPILEPTIC DISORDER
S.No. Disorder Total No. of Patients Percentage
1 Simple Febrile 26 32.5%
2 Complex Febrile 4 5%
3 Generalized 16 20%
4 Atypical Febrile 4 5%
5 Status 2 2.5%
6 Acute Febrile 6 7.5%
7 Seizure Under Evaluation 18 22.5%
8 Seizure Disorder 16 20%
Based on Classification of Epileptic Disorders
32.5
5
20
52.5
7.5
22.520
0
5
10
15
20
25
30
35
Disorder
% o
f P
ati
en
ts
Simple Febrile
Complex Febrile
Generalized
Aypical
Status
Acute Febrile
Seizure Under
EvaluationSeizure Disorder
7.Based on Generic Incidence of Epileptic Disorder
S.No. Disorder Total no. of
Patients
Male
No. %
Females
No. %
1 Simple Febrile 26 20 76.9% 6 23.07%
2 Complex Febrile 4 2 50% 2 50%
3 Generalized 16 11 68% 4 25%
4 Atypical Febrile 4 1 25% 3 75%
5 Status 2 2 100% 0
6 Acute Febrile 6 1 16% 5 83%
7 Seizure under Evaluation 18 13 72% 5 27.7%
8 Seizure Disorder 16 6 37.5% 10 62.5%
Based on Generic Incidence of Epileptic Disorder in Males
20
2
11
12
1
13
6
0
5
10
15
20
25
Disorder
No
. o
f M
ale
s
Simple Febrile
Complex Febrile
Generalized
Aypical
Status
Acute Febrile
Seizure Under
EvaluationSeizure Disorder
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Based on Generic Incidence of Epileptic Disorder in Females
6
2
43
5 5
10
0
2
4
6
8
10
12
Disorder
No
. o
f F
em
ale
s
Simple Febrile
Complex Febrile
Generalized
Aypical
Acute Febrile
Seizure Under
Evaluation
Seizure Disorder
CONCLUSION
The use of antiepileptic drugs was almost found to be rational. In this hospital 3 different
drugs were prescribed which are from National list of essential drugs. Rational use of drugs
minimizes poly pharmacy drug interaction. In turn it minimizes the hospital stay. Though it
may take a long way, but gradually it is possible to achieve the objectives. The prescribing
habits are appropriate and are in accordance with WHO guidelines. Pharmacists are the key
persons for better management of therapy based on stage and condition of patient.Thus, the
pharmacist is a “DRUG EXPERT who carries out valuable, knowledge based duties and
serves the community in a very dutiful manner”.
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