EVALUATION OF ADVERSE DRUG REACTIONS OF SECOND GENERATION

ANTIPSYCHOTICS IN PSYCHIATRY OUT-PATIENT DEPARTMENT,OF BISHOFTU

GENERAL HOSPITAL, OROMIA REGION,ETHIOPIA.

BY: BEYENE KUMA

MERARTU GETACHEW

FETRA HUSEIN

HANA BELAY

IYERUS SHIMELIS

A RESEARCH PROPOSAL SUBMITTED TO RIFT VALLEY UNIVERSITY,

FACULTY OF HEALTH SCIENCE, DEPARTMENT OF PHARMACY, IN PARTIAL
FULFILLMENT OF THE REQUIREMENT FOR BACHELOR OF DEGREE IN
PHARMACY (B. Pharm)

MARCH, 2021

ADAMA, ETHIOPIA
EVALUATION OF ADVERSE DRUG REACTIONS OF SECOND GENERATION
ANTIPSYCHOTICS IN PSYCHIATRY OUT-PATIENT DEPARTMENT, OF
BISHOFTU GENERAL HOSPITAL,OROMIA REGION, ETHIOPIA

BY: BEYENE KUMA

MERARTU GETACHEW

FETRA HUSEIN

HANA BELAY

IYERUS SHIMELIS

ADVISOR: TESHOMA

A RESEARCH PAPER SUBMITTED TO RIFT VALLEY UNIVERSITY, FACULTY OF

HEALTH SCIENCE, DEPARTMENT OF PHARMACY, IN PARTIAL FULFILLMENT
OF THE REQUIREMENT FOR BACHELOR OF DEGREE IN PHARMACY (B. Pharm)

MARCH, 2021

ADAMA, ETHIOPIA

2
ACKNOWLEDGMENT

I would like to express my deepest gratitude to my research advisor Teshoma for his unreserved
encouragements and provision of constructive comments and guidance while preparing this
proposal.

Furthermore, Rift Valley University Faculty of Health Sciences Department of pharmacy is

appropriately acknowledged for giving me this golden and educative opportunity.

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ABBREVIATION AND ACRONYMS
AAA- Atypical Antipsychotic Agents
ADRs -adverse drug reactions
CMC- Calcutta Medical College
CNS –central nervous system
CSE -cardio metabolic side effects
DKA-diabetic ketoacidosis
EPS- extra pyramidal symptoms
HDL-C - High-density lipoprotein cholesterol
LDL-C – Low-density lipoprotein cholesterol
OPD- outpatient department
SGA- second-generation antipsychotics

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 TABLE OF CONTENTS

Contents Page
Acknowledgment..............................................................................................................................I

Abbreviation And Acronyms..........................................................................................................Ii

Table Of Contents..........................................................................................................................Iii

List Of Tables.................................................................................................................................V

Abstract...........................................................................................................................................V

1. Introduction..................................................................................................................................1

1.1 Background................................................................................................................................1

1.2 Statement Of The Problem........................................................................................................2

1.3 Significance Of The Study.........................................................................................................3

2. Literature Review........................................................................................................................4

3. Objective......................................................................................................................................6

3.1 General Objective:.....................................................................................................................6

3.2 Specific Objectives:...................................................................................................................6

4. Materials And Methods...............................................................................................................7

4.1 Study Area & Period:.................................................................................................................7

4.2 Study Design:.............................................................................................................................7

4.3. Population.................................................................................................................................7

4.3.1. Source Population:.................................................................................................................7

4.3.2. Study Population:...................................................................................................................7

4.4. Inclusion And Exclusion Criteria.............................................................................................8

4.4.1 Inclusion Criteria....................................................................................................................8

4.4.2. Exclusion Criteria..................................................................................................................8

4.5 Sample Size& Sampling Technique..........................................................................................8

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4.5.1 Sample Size............................................................................................................................8

4.5.2 Sampling Technique...............................................................................................................9

4.6. Variables...................................................................................................................................9

4.6.1. Independent Variables...........................................................................................................9

4.6.2 Dependent Variables...............................................................................................................9

4.7. Data Collection Instrument & Technique.................................................................................9

4.7.1. Data Collection Instruments..................................................................................................9

4.7.2 Data Collection Technique.....................................................................................................9

4.8 Data Processing And Analysis...................................................................................................9

4.9. Ethical Consideration..............................................................................................................10

4.10. Definitions Terms.................................................................................................................10

5. Work Plan..................................................................................................................................11

6. Budget Breakdown....................................................................................................................12

Reference.......................................................................................................................................13

Annex: Data Collection Format.....................................................................................................15

Annex 2 : Data Collection Format ( In Oromic )...........................................................................18

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LIST OF TABLES
Table 1:-WORK SCHEDULE FOR THE EVALUATION OF ADVERSE DRUG REACTIONS
OF SECOND GENERATION ANTIPSYCHOTICS IN PSYCHIATRY OUT-PATIENT
DEPARTMENT,OF BISHOFTU GENERAL HOSPITAL FROM MARCH 2021 TO MAY
2021………………………………………………………………………………………………12

Table 2: -REQUIRED OPERATIONAL BUDGET FOR EVALUATION OF ADVERSE DRUG

REACTIONS OF SECOND GENERATION ANTIPSYCHOTICS IN PSYCHIATRY OUT-
PATIENT DEPARTMENT,OF BISHOFTU GENERAL HOSPITAL, OROMIA REGION,
ETHIOPIA. MARCH 1 , 2021-MAY 30, 2021………………………………………….13

v
ABSTRACT
BACKGROUND: Antipsychotic medications, including clozapine, aripiprazole, olanzapine,
quetiapine, zotepine, risperidone, ziprasidone, are an important component in the medical
management of many psychiatric conditions. Although the SGAs have many notable benefits
compared with their earlier counterparts, their use has been associated with reports of dramatic
weight gain, diabetes and an atherogenic lipid profile.

OBJECTIVE: To assess the adverse drug reactions of second generation antipsychotics in

Bishoftu General Hospital in outpatient psychiatric clinic.

METHODS: A retrospective cross sectional study will be conducted using psychotic patient
profile form.

WORK PLAN AND BUDGET : work plan of the study contain topic selection, reviewing
different literature , proposal writing , data collection , data analysis and finally writing and
reporting the result of the study. A total of 725 birr is required for the study .

Key words: Adverse effect, SGAs, Respire done, Weight gain

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1. INTRODUCTION

1.1 BACKGROUND

Psychotic disorders are a diverse group of illnesses that have their origins in abnormal brain
function and are characterized by fundamental distortions of thinking, perception and emotional
response. These disorders include, among others, schizophrenia, schizoaffective disorder, bipolar
disorder and delusional disorder (1).Schizophrenia is one of the most common and severe
psychotic disorders .In fact it is a cluster of disorders characterized by fundamental disturbances
of thinking, perception and emotions. The onset of schizophrenia is often in young adulthood,
and for those affected the disorder often causes many years of severe suffering. The course and
symptoms in individual patients are highly variable, but for a smaller group the disorder causes
lifelong disabilities with deterioration in functional capacity. A recent meta-analysis found a
median proportion 13.5% of recovery in schizophrenia (2).Antipsychotic medications are an
important component in the medical management of many psychotic conditions. With the
introduction of the second-generation antipsychotics (SGAs) over the last decade, the use of
these medications has soared. Although the SGAs have many notable benefits compared with
their earlier counterparts, their use has been associated with reports of dramatic weight gain,
diabetes (even acute metabolic decompensating, e.g., diabetic ketoacidosis [DKA]), and an
atherogenic lipid profile (increased LDL cholesterol/and triglyceride levels and decreased HDL-
C (high density lipoprotein cholesterol)(3).

Adverse drug reaction is an expression that describes harm related with the use of given
medicines at a recommended dosage. ADRs may occur due to single dose, prolonged
administration of a drug or result from the combination therapy of two or more drugs. Atypical
antipsychotics differ from typical antipsychotics in that they cause less extrapyramidal motor
control disabilities in patients, which include unsteady Parkinson's disease-type movements,
body rigidity and involuntary tremors. The currently available SGAs (clozapine, aripiprazole,
olanzapine, quetiapine, zotepine, risperidone, ziprasidone) vary in their efficacy, formulation,
biochemistry, receptor binding, and side effect profiles. There fore, the present work was

1
planned to study to develop a protocol for ADR monitoring for second generation antipsychotics
(SGAs) like olanzapine, clozapine, quetiapine and risperidone(4).

The first generation of antipsychotic medication is known as the ‘typical antipsychotics ‘and
these were first discovered in the 1950s Soon following their clinical use it was recognized that
hey caused extrapyramidal symptoms (EPS) in patients including parkinsonism, tardive
dyskinesia, akathisia and dystonia . The severe side effects created a need for a new generation
of these medications that would be more tolerable to the patient. Subsequently a second
generation antipsychotics were developed known as the ‘atypical antipsychotics’, the first of
which was clozapine which was clinically introduced in the 1970s. While some success has been
observed with a reduction in EPS, a new list of concerning side effects have been associated with
both generations of the drugs – namely weight gain and associated metabolic effects; prolactin
elevation; associated sexual side effects; and QT-c prolongation. Further, when the atypical anti-
psychotic group was introduced it had been hoped that compliance to antipsychotics would be
improved, but a 2008 review found that the data has not supported the original expectation that
there would be increased compliance and better clinical results (5).

1.2 STATEMENT OF THE PROBLEM

Second-generation antipsychotics (SGAs) are associated with significant cardio-metabolic side

effects (CSE), such as age-inappropriate weight gain, obesity, hypertension, and lipid and
glucose abnormalities. Although the relationship between antipsychotics, especially SGAs, and
weight gain is well documented in adults. Young people are especially vulnerable to SGA-
induced CSE and childhood CSE adversely affect adult cardiovascular outcome through a series
of persistent risk factors or accelerated mechanisms (6). Antipsychotics are commonly used
drugs for mental disorders, so early detection of ADRs in patients treated with antipsychotics
becomes necessary to minimize morbidity and economic burden to the patients as well as to the
country. These drugs are used for months, years or lifelong so monitoring of ADRs is very
important. The novel or second generation antipsychotic medications-clozapine, olanzapine,
Risperidone, ziprasidone, quetiapine and aripiprazole have been gaining wide usage throughout
the United States since 1980, and also worldwide. Despite their efficacy and the lack of extra
pyramidal side effects, these medications have their own unique side effects profiles. The most

2
important side effects that are emerging are weight gain and metabolic disturbances.
Cardiovascular effects and hyper-prolactinemia are troublesome issues for some of the members
of this class of agents. Weight gain and sexual dysfunction can lead to non adherence to
treatment and ultimately contribute to relapse (7).ADRs are considered among the leading causes
of morbidity and mortality causing hospital visits and admissions.There is a need to continuously
monitor the safety profile of all medications after they enter the drug market (post marketing
surveillance)(8).

1.3 SIGNIFICANCE OF THE STUDY

Atypical antipsychotics differ from typical antipsychotics in that they cause less extrapyramidal
motor control disabilities in patients, which include unsteady Parkinson's disease-type
movements, body rigidity and involuntary tremors. The currently available SGAs (clozapine,
aripiprazole, olanzapine, quetiapine, zotepine, risperidone, ziprasidone) vary in their efficacy,
formulation, biochemistry, receptor binding, and side effect profiles. Therefore, the aim of this
study is to identify the most ADR due to SGAs (4).Adults with serious mental illness, commonly
treated with second generation antipsychotic (SGA) drugs, have up to two-times-greater
prevalenceof type 2 diabetes, dyslipidemia, hypertension, and obesity .This study will help health
professional to monitor ADR due to SGAs and benefit patient from treatment regimen available
for psychosis and other mental disorders (9).

3
2. LITERATURE REVIEW

A long term observational study conducted in the psychiatry out-patient department (OPD) of
Calcutta Medical College (CMC), Kolkata, for 5 months show that among 91 patients in total
171 adverse events was noted. Most common ADRs were weight gain 47(51.64%), sedation
11(12.08%), insomnia 09(9.89%), G. I.upset 08(8.79%), aggressive behavior 06(6.59%), dry
mouth 05(5.49%), alopecia 05(5.49%), anxiety 04(4.39%), sexual dysfunction 04(4.39%),
fatigue 04(4.39%), dizziness 04(4.39%), tremor 03(3.29%), asthenia 03(3.29%), anorexia
03(3.29%), cough 03(3.29%), headache 03(3.29%), concentration difficulty 02(2.19%), itching
02(2.19%), nervousness02(2.19%), these patients during the 5 months observation period, were
treated mostly with four different second generation antipsychotics (SGAs) such as clozapine,
olanzapine, quetiapine, and risperidone. It was also noted that atypical antipsychotic drugs were
used in the following dosages i.e. olanzapine (5mg, 10mg), risperidone(2mg, 1mg),
clozapine(0.5mg) and quetiapine (100mg, 50 mg & 25 mg) (4).

A longitudinal prospective observational study of ADRs of Atypical Antipsychotics drugs

(AAPS) in patients of psychiatric illness done in Indian show that 2540 patients were treated
with atypical antipsychotics, out of these 87.61% treated with olanzapine, 11.02%treated with
risperidone and 2.37% treated with clozapine.104 ADRs due to atypical antipsychotics - 3.55%

4
with olanzapine, 6.42% with risperidone and 13.33% due to clozapine. Majority of patients in
this study belonged to 21-30 years age group which was 24% of the total. According to the
severity of ADRs, majority of cases were reported of having weight gain 38.46% followed by
sedation 19.23%, dry mouth 13.46% and orthostatic hypotension 5.76%. According to the
severity of ADRs by individual drugs 13.46% had severe ADRs. Out of these 9.61% patients had
severe ADRs due to Olanzapine and 3.84% by Clozapine. 53.84% patients were reported to have
moderate ADRs. Out of these 11.53.84% had moderate ADRs due to Olanzapine and 7.69% due
to Risperidone. Onset of ADRs after starting atypical antipsychotics was maximum in 0-1 weeks
42.30% and in 6-1weeks 42.30% followed by 11.5% in 3-6 week and 3.84% in 1-2 weeks(7).

The Clinical Antipsychotic Trials of Intervention Effectiveness study was initiated in

ENGLAND to compare the effectiveness of antipsychotic drugs. The study was conducted
between January 2001 and December 2004 at 57 clinical sites in the United States (16 university
clinics, 10 state mental health agencies, 7 Veterans Affairs medical centers, 6 private nonprofit
agencies, 4 private-practice sites, and 14 mixed-system sites).

Patients were initially randomly assigned to receive olanzapine, perphenazine, quetiapine, or

risperidone under double-blind conditions and followed for up to 18 months or until treatment
was discontinued for any reason. Overall, 74 percent of patients discontinued the study
medication before 18 months (1061 of the 1432 patients who received at least one dose): 64
percent of those assigned to olanzapine, 75 percent of those assigned to perphenazine,82percent
of those assigned to quetiapine, and 74 percent of those assigned to risperidone, and 79 percent
ofthose assigned to ziprasidone. The time to the discontinuation of treatment for any cause was
significantly longer in the olanzapine group than in the quetiapine (P<0.001) or risperidone
(P=0.002) group, but not in the perphenazine (P=0.021) or ziprasidone (P=0.028) group. The
times to discontinuation because of intolerable side effects were similar among the groups, but
the rates differed (P=0.04); olanzapine was associated with more discontinuation for weight gain
or metabolic effects, and perphenazine was associated with more discontinuation for
extrapyramidal effects (9).

A longitudinal observational study was undertaken in the psychiatry out-patient department

(OPD) of Bishoftu general Hospital, , between March 2021 and May 2021.Patients were
screened for suspected ADRs irrespective of their psychiatric diagnosis for over a period of 12

5
months. The screening was carried out by psychiatry and pharmacology residents. A total of 100
patients were screened for the study, of which 45 were suspected of having at least one ADR. Of
45 patients 34(75.55%) were males and 11(24.44%) were females. The median age of the
subjects was 34.4 years. Type of ADR Weight gain 15(33.33 % ), Constipation 12(26.66 %),
Tremor 7(15.55 %), Sedation 3(6.66%), Increased appetite 1(2.22% ),Headache 2(4.44% ), Dry
mouth 1(2.22% ) , Fatigue 1(2.22%), Swelling of lips 1(2.22%) ,Mouth ulcer 1(2.22%),
Palpitation 1(2.22%).weight gain with quetiapine, Olanzapine and risperidone, which accounted
for 33.33% of total ADRs. Regarding the drugs responsible for the 45 ADRs olanzapine
(33.33%) showed maximum followed by quetiapine and risperidone (10).

Another prospective interventional study was conducted in mental health department of a tertiary
care hospital in South India over a period of 2 years (March 2021-May 2021)Of the 950 patients
reviewed, 517 (54.42%) patients (220 outpatients and 297 inpatients) received at least one
antipsychotic medication. A total of 289 ADRs were identified from 217 patients with an overall
incidence rate of 41.97%. Average number of ADR per patient in this study was 1.6. The median
age of patients with and without ADRs was 34.5 years (range: 13-90 years). Females were
slightly more in ADR group (57.21% vs. 42. 25%).Number of medications prescribed was same
in both groups (average: 4.6; range: 1-13).Of the 298 suspected ADRs identified, nine ADRs
could not be evaluated due to the non-availability of the data. Of the 289 ADRs, 66.43% (n =
192) were detected by intensive monitoring, while 33.56% (n = 97) were spontaneously reported
(11).

3. OBJECTIVE

3.1 GENERAL OBJECTIVE:

 To assess the adverse drug reactions of second generation antipsychotics in Bishoftu

General Hospital in outpatient psychiatric clinic.

3.2 SPECIFIC OBJECTIVES:

 To identify the most common ADRs of second generation antipsychotic drugs

 To determine the prevalence of ADRs of second generation antipsychotic drugs

6
  To identify measures taken to manage ADRs of second generation antipsychotic drugs

4. MATERIALS AND METHODS

4.1 STUDY AREA & PERIOD:

The study will be conducted in Bishoftu General Hospital., psychiatry OPD clinic from April 21-
May-21/, 2021 G.C Bishoftu is located 46 km from Addis Ababa on the way to Adama and it is
found in east shewa zone of Oromia region of Ethiopia. The district is bordered by the Somali
Region to the east; the Amhara Region, the Afar Region and the Benishangul -Gumuz Region to
the north; Dire Dawa to the northeast. The 2007 national census reported a total population for
Bishoftu of 99,928, of whom 47,860 were men and 52,068 were women. The majority of the
inhabitants said they practised Ethiopian Orthodox Christianity, with 79.75% of the population
reporting they observed this belief, while 13.82% of the population were Protestant , and 4.98%
of the population were Muslim . The hospital has given many services to respected customers.
These are Outpatient Services,  Inpatient services, Emergency care services,  Delivery
services, Minor and major surgery,  MDR , psychiatry OPD ,Laboratory services, X-Ray &
ultrasound services, Pharmacy, Private clinic, Library, and  Special treatment  services

7
4.2 STUDY DESIGN:

This study will be conducted using a retrospective chart review of ADR of second generation
antipsychotic drugs which was carried out at psychiatry outpatient clinic of Bishoftu General
hospital.

4.3. POPULATION

4.3.1. SOURCE POPULATION:

All patients with psychotic disorder on follow up at psychiatry department of Bishoftu General
hospital.

4.3.2. STUDY POPULATION:

All psychotic disorder patients who attended psychiatry outpatient department from March 2021
to May 2021, who were prescribed second generation antipsychotics drugs and on follow up at
psychiatry outpatient clinic of Bishoftu General hospital.

4.4. INCLUSION AND EXCLUSION CRITERIA

4.4.1 INCLUSION CRITERIA

All patient cards with at least one second generation antipsychotic will be included.

4.4.2. EXCLUSION CRITERIA

All Psychiatric patients cards with no antipsychotic medication.

All Psychiatric patients cards of pregnant women.

8
4.5 SAMPLE SIZE& SAMPLING TECHNIQUE

4.5.1 SAMPLE SIZE

The sample size was determined by using the following formula

ni = (zα/2)2pq
d2
ni = (1.96)2(0.5) (0.5) =384
(0.05)2
Where, z=confidence interval
ni = sample size
P= proportion of relatives,
q=1-p,
d=margin of error

Since the total number of Psychiatric patients is less than 10,000 the following correction
formula was used.

nf = ni × N=384 /1 + 384/ 950 = 274

Where ni= initial sample size,

N=sample population

nf =exact sample size

4.5.2 SAMPLING TECHNIQUE

The study will be conducted using a systematic random sampling the first patient information
card is selected randomly and then gone through by every 1 interval.

4.6. VARIABLES

4.6.1. INDEPENDENT VARIABLES

9
  Sex  Marital status
 Age  Educational status
 Religion  Residence.
 Ethnicity  Occupation

 Dose of anti-psychotics

4.6.2 DEPENDENT VARIABLEs

 Number of adverse effects
 Type of adverse effects

4.7. DATA COLLECTION INSTRUMENT & TECHNIQUE

4.7.1. DATA COLLECTION INSTRUMENTS

Data collection questionnaire is used.

4.7.2 DATA COLLECTION TECHNIQUE

Drugs received and ADRs experienced by the patients will be collected by reviewing patient
information card through questionnaires.

4.8 DATA PROCESSING AND ANALYSIS

All the data will be collected and analyzed manually and, entered into a computer,present in
table, frequency table and pie chart. The participants are categorized in to ADR and non-ADR
groups.

4.9. ETHICAL CONSIDERATION

A formal letter was obtained from Rift Valley University, the department of pharmacy and
permission was obtained from Bishoftu General Hospital, to collect data. The concerned hospital
administrative assured that to collect data and kept confidentiality of the patient information.

10
 4.10. DEFINITIONS TERMS
Adverse drug reaction: An appreciably harmful or unpleasant reaction, resulting from an
intervention related to the use of a medicinal product, which predicts hazard from future
administration and warrants prevention or specific treatment, or alteration of the dosage regimen,
or withdrawal of the product.

Bipolar disorder: A brain disorder that causes unusual shifts in mood, energy, activity levels,
and the ability to carry out day-to-day tasks.

Extra pyramidal symptoms: Physical symptoms, including tremor, slurred speech, akathesia,
dystonia, anxiety, distress, paranoia, and bradyphrenia, that are primarily associated with
improper dosing of or unusual reactions to neuroleptic (antipsychotic) medications

Insomnia: A sleep disorder that is characterized by difficulty falling and/or staying asleep

Paradoxical effect: An effect of medical treatment, usually a drug, opposite to the effect which
would normally be expected.

Psychosis: Psychosis is a serious mental disorder characterized by thinking and emotions that
are so impaired, that they indicate that the person experiencing them has lost contact with reality.

Seizure: The physical findings or changes in behavior that occur after an episode of abnormal
electrical activity in the brain.

5. WORK PLAN

Every human activity is carried out through time it is also inevitably requires resources. Research
as a human activity accordingly is necessarily in need of both time and resources. Since it’s a
procedural task, it has to be undertaken in a systematically bounded time and resources are to be
allocated reasonably. The time period and cost budget required to complete the entire study is
carefully estimated and presented as follows.
Table 3:-WORK SCHEDULE FOR THE evaluation of adverse drug reactions of second generation
antipsychotics in psychiatry out-patient department, of bishoftu general hospital FROM MARCH
2021 TO MAY 2021
NO Activates Responsible Time table
body
March April May
1 Topic selection

11
2 Summary writing
3 Writing statement of problem
4 Review of literature
5 Setting &writing of objective
6 Setting and writing
methodology
7 Preparing work plan
8 Budget setting
9 Reference writing
10 Review task
11 Presentation and defense

6. BUDGET BREAKDOWN
The researcher allocated fund from his own source and all stationary materials, printing cost ,
photo copy cost, internet cost and other miscellaneous expense related to the research work is
expected to cost around birr,725.00 as it is shown in the table below. Since estimated cost is
subject to inflation over the research period, contingency for escalation of some cost is taken in
to consideration while preparing the budget.
Table 4: -REQUIRED OPERATIONAL BUDGET FOR evaluation of adverse drug reactions of second
generation antipsychotics in psychiatry out-patient department, of bishoftu general hospital,
oromia region, ethiopia. MARCH 1 , 2021-MAY 30, 2021

Activity Description Unit of Measurement Quantity Unit Total

Cost Cost/Birr/
/Birr/

1 Paper Ream 1 200 200.00

2 Pen Pieces 4 15 60.00

3 Printing Page Number 200 2 400.00

6 Copy Page Number 160 1 160.00

7 Binding Pieces 4 15 60.00

12
9 Internet Minute 900 0.50 450.00
10 Transport Pieces 5 30 300
11 Miscellaneous 50.00
Sub Total 1680.00
Contingency10% 168.00
Grand Total 1680.00

REFERENCE

1. Morgan A, WaterreusA, Jablensky A, MacKinnon A, John J. McGrath, CarrV, et al: People

living with psychotic illness 2015 ISBN: 978-1-74241-613-7.

2. McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence,

prevalence, and mortality. Epidemiologic reviews. 2008 Nov 1; 30(1):67-76.

3. American association of clinical endocrinologist, north American association for the study of
obesity: Consensus Development Conference on Antipsychotic Drugs and Obesity and
Diabetes,diabetes care, volume 27, number 2, February 2016

4. PahariN , Tripathisk, MaityT, GuptaBK, BagchiCH, MondalDK: Evaluation and analysis of

adverse drug reactions of second generation antipsychotics in a psychiatry out-patient
department , International Journal of Pharmacy and Pharmaceutical Sciences .Vol 4,
Supply 5, 2017

5. The University of Western Australia School of Psychiatry and Clinical

Neurosciences:neuropsychiatric epidemiology research unit (neru) annual report 2015

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6. ArangoC, AldezMG,MerchJ,NaranjoA,BaezaC, FornielesJC, et al. Second-Generation
Antipsychotic Use in Children and Adolescents. A Six-Month Prospective Cohort Study in
Drug-Naïve Patients. journal of the american academy of child &adolescent psychiatry
volume 53 number 11 November 2017

7. HemlataV, VermaVk and RaoSS, study of adverse drug reactions to atypical antipsychotic
drugs in psychiatric illness, Int J Pharm Bio Sci 2014 April ; 5 (2) : (P) 370 - 376

8. LahonK, ShettyHM, ParamelA and SharmaGSH; Adverse drug reaction monitoring of

antipsychotics, antidepressants and mood stabilizers in the psychiatric outpatient unit of a
teaching hospital ;international journal of pharma and bio sciences; vol 3/issue 1/jan – Mar
2015

9. MorratoEH,NewcomerJW,KamatS,BaserO,HarnettJ,CuffelB:MetabolicScreening After the

American Diabetes Association’s Consensus Statement on Antipsychotic Drugs and
Diabetes;diabetes care, volume 32, number 6, p (1037-1042) June 2016

10. SandiyaR, SankaranarayananB and KumarA. Adverse Drug Reaction Monitoring in

PsychiatryOut-Patient Department of a Tertiary Care Hospital;Global Journal of
Pharmacology 8 (2): 176-180, 2015

11. LuccaJM,MadhanR, ParthasarathiG,MyalilJ ,and RamD;Identification and management of

Adverse effects of antipsychotics in a tertiary care teaching hospital 2014 Apr-Jun; 3(2): 46–
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12. Pahari N, Tripathi SK, Maity T, Gupta BK, Bagchi C, Mondal DK.Evaluation and analysis of
adverse drug reactions of second generation antipsychotics in a psychiatry out- patient
department; International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-
1491 Vol 4, Supply 5, 2015

13. Lahon KS, Shetty HM, Paramel A and Sharma G. adverse drug reaction Monitoring of
antipsychotics, antidepressants and mood stabilizers in the psychiatricOutpatient unit of a

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 teaching hospital – a retrospective study; International Journal of Parma and Bio Sciences
ISSN 0975-6299 Vol 3/Issue 1/Jan – Mar 2015

14. Jain T, Bhandari1 A, RamV, Parakh M, Wal P, and Nagappa AN. Drug Interactions
andAdverse Drug Reactions in Hospitalized Psychiatric Patients ;A Critical Element in
Providing SafeMedication Use; Faculty of Pharmaceutical Sciences, Jodhpur National
University, Rajasthan, India, ISSN 1433-1055: 1/7/2016.

15. Juno J.Joel1, Shastry C. S and Satheesh Rao. Evaluation of adverse drug reactions associated
with the psychotropic drugs in the management of patients with schizophrenia; ISSN 0975-
5071 2015, 6 (6):129-134.

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antipsychotic drugs in psychiatry OPD. Indian J Psychol Med 2011; 33:153-7

ANNEX: DATA COLLECTION FORMAT

A) Social demographic characteristics of the study participants
1. Age: _______
2. Sex: Male _____Female ______
3. Ethnicity:
A) Oromo________
B) Amara _______
C) Walayita ______
D) Gurage _______
E) Somali _______
F) Other (specify) ______________
4. Religion:
A) Muslim ______
B) Orthodox _____
C) Protestant ______
D) Others(specify) _______

15
5. Marital status
A) Single _____
B) Married _____
C) Widowed ____
D) Divorced_____
6. Educational level
A) Literate_____
B) Illiterate_____
7. Occupation
A) Employed _____
B) Merchant _____
C) Farmer ____
D) Others (specify) ___

8. Residence
A) Urban____
B) Rural _____
B Patient condition
9. Type of psychiatric disorder of patients
A) Psychosis
B) Bipolar affective disorder
C) Schizophrenia
D) Depression________
E) Others____________
C) Medication information
10. What medication is prescribed for the patient?
A) Respiredone dose and duration_______
B) Clozapine dose and duration ________
C) Olanzepine dose and duration________
D) Quetipine dose and duration __________

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 E) Aeripiprazol dose and duration________
11. How many atypical antipsychotic medications have been given?
A) one antipsychotics
B) two antipsychotics
C) three antipsychotics
D) more than three
12 Is there any adverse effect due to medication?
A) Yes
B) No

13.If yes for Q. No 12 list of adverse effect recorded and the most probable drugs cause ADR.

S.N A D R Respiredone Clozapine Olanzapine Quetiapine Aeripiprazol

14.
1.
2.
3.
4.
5.
6.
7.
8.
9.
What was done in response to development of ADR?
A) Treatmentfor ADR and continue current medication
B)Dosage and regimen change
C) Discontinuationof medication
D) No management for ADR OR others___________________

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