ASSESSMENT OF DRUG THERAPY PROBLEMAMONG

CARDIOVASCULAR DISEASE IN THE MEDICAL WARDS OF DEMBI

DOLLO HOSPITAL WEST WOLLEGA, OROMIA, ETHIOPIA.

BY AMANUEL TESHOME

A RESEARCH PROPOSAL SUBMITTED TO JIMMA UNIVERSITY,

COLLEGE OF HEALTH SCIENCES, DEPARTEMENT OF PHARMACY
FOR PARTIAL FULFILLMENT OF THE REQUEREMENTS FOR THE
BACHLER OF SCIENCE DEGREE IN PHARMACY

JANUARY 2019

JIMMA,ETHIOPIA
 JIMMA UNIVERSITY

COLLEGE OF HEALTH SCIENCES, DEPARTEMENT OF PHARMACY

ASSESSMENT OF DRUG THERAPY PROBLEMS AMONG

CARDIOVASCULAR DISEASE IN THE MEDICAL WARDS OF DEMBI
DOLLO HOSPITAL WEST WOLLEGA, OROMIA, ETHIOPIA.

BY AMANUEL TESHOME

ADVISOR:MR. FEKEDE BEKELE(B. PHARM,MSC,MPH)

JANUARY 2019

JIMMA,ETHIOPIA
i
ABSTRACT

Background:
Although pharmacotherapy in cardiovascular diseases can improve the well-being, its benefit can
be compromised by drug- therapy problems. A study conducted in Coimbatore showed that Drug
interactions (46.19%), drug over dosage (17.26%) and drug duplication (11.17%) were the most
frequently occurring drug therapy problems.
Study conducted in Felege hiwot referral hospital among cardiovascular patients a total of 105
numbers of DTPs were identified with the mean number of DTP was 1.38 + 0.8. Most of the
patients had drug therapy problem, of which indication related problems constituted the highest
part. The aim of this study will be characterize the prevalence of drug therapy problems among
hospitalized patients with cardiovascular diseases in Dembi Dollo Hospital.

Objective: The objective of the research will be to characterize the prevalence of drug therapy
problems among hospitalized patients with cardiovascular diseases in Dembi Dollo, West
Oromia, Ethiopia.

Methods and materials: Hospital based prospective cross sectional study design will be
used. A convenient sampling will be used. All admitted patients with cardiovascular disease/s,
in Dembi Dollo hospital fulfilling the inclusion criteria will be included. Four Pharmacy
interns will be involved in collecting the data. Interview guided semi-structured questionnaire,
data extraction formats for card review and drug therapy problem evaluating questionnaires will
be used for data collection. Finally data will be coded, edited and processed to meet the objective
of the study.

Work plan and Budget: The data will be collected from April 20 to may 05 2019 G.C and
the budget required will be 2000 Ethiopian birr.

Key words: Drug therapy problem, Dembi Dollo hospital, Drug related problems

i
 Acknowledgment

I would like to express my deepest gratitude to my adviser Mr. Fekede Bekele for his
constructive advice in the preparation of this proposal. My sincere gratitude also goes to my
lovely family and colleagues for their tireless support and encouragement throughout the years
of my study. Last but not least, I would like to acknowledge Jimma University, Institute of
Health Science, and Department of Pharmacy for providing me this golden chance to conduct
this study.

ii
Table of Contents
Acknowledgment.........................................................................................................................................4
CHAPTER ONE:.............................................................................................................................................1
Background..............................................................................................................................................1
Statement of the problem.......................................................................................................................2
CHAPTER TWO: LITERATURE REVIEW.........................................................................................................3
Literature Review....................................................................................................................................3
Significance of the study..........................................................................................................................4
CHAPTER THREE..........................................................................................................................................5
3.1 General objective...............................................................................................................................5
3.2 Specific Objectives.............................................................................................................................5
CHAPTER FOUR: METHODS AND MATERIALS..............................................................................................6
4.1 STUDY AREA.......................................................................................................................................6
4.2 Study period......................................................................................................................................6
4.3 Study Design......................................................................................................................................6
4.4 POPULATION......................................................................................................................................6
4.4. 1 Source population......................................................................................................................6
4.4.2 The study Population :................................................................................................................6
4.5 Sample size and sampling technique.................................................................................................7
4.6 Sample size and Sampling technique.................................................................................................8
Variables..............................................................................................................................................8
Independent variable..........................................................................................................................8
Dependent variables............................................................................................................................8
4.7 Operational definition of terms.........................................................................................................8
4.8 Data collection procedure and Instrument........................................................................................9
4.9 Data processing & analysis................................................................................................................9
4.10 Data quality assurance.....................................................................................................................9
4.11 Ethical considerations......................................................................................................................9
4.12 Result dissemination plan..............................................................................................................10
4.13 Possible limitation of the study.....................................................................................................10
CHAPTER FIVE: WORK PLAN.....................................................................................................................11
iii
CHAPTER SIX: BUDGET...............................................................................................................................12
REFERENCES..............................................................................................................................................13
ANNEX:......................................................................................................................................................14
TABLE 1. Socio demographic characteristics of the study population..................................................14
ANNEX II:QUESTIONARIES.........................................................................................................................17

iv
List of tables
Table 1.Socio demographic characteristics of the study population

Table 2. Type and number of DTPs among patients with CVD admitted in DDH

Table 3.

v
List of acronyms and abbreviations
DTP….drug therapy problem
DDH….Dembi Dollo hospital
ADR…Adverse drug reaction
CVD…Cardiovascular disease
DRP….Drug related problems
ME……Medication error
NGO…. Non governmental organization

vi
vii
CHAPTER ONE:
1. INTRODUCTION

1.1 Background
The identification of drug therapy problems (DTP) is the focus of the assessment and the last
decision made in that step of the patient care process. Although drug therapy problem
identification is technically part of the assessment process, it represents the truly unique
contribution made by pharmaceutical care practitioners [5].

Drug therapy problem is an undesired patient experience that involves drug therapy and that
actually or potentially interferes with the desired Patient outcome. It is an event or
Circumstance involving drug therapy that actually or potentially interferes with desired health
outcomes. They are known to be the a major problem associated with pharmacotherapy[11,8].

According to Robert J. Cipolle text book of pharmaceutical care practice (third edition), there
are seven basic categories of DTPs. These are: Need for additional therapy, Unnecessary drug
therapy, Wrong drug, Dosage too low, Adverse drug reaction(ADR), Dosage too high and Non-
compliance[10]

Drug-related problems (DRP) include medication errors (ME) (involving an error in the process
of prescribing, dispensing, or administering a drug, whether there are adverse consequences or
not) and adverse drug reactions (any response to a drug which is noxious and unintended, and
which occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease,
or for the modification of physiological function). Medication error rates found in observational
studies are reported to vary between 1.7 and 59%, in which prescribing errors are reported to be
0.3-2.6%. Medication errors also frequent cause for adverse drug reaction. Incidences of ADR
reported in studies published since 1991 vary between 1.9 and 37.3% 2. Studies estimated that
adverse drug events (ADEs) account for approximately 5% of all hospital admissions, occur
during 10–20% of hospitalizations and are responsible for 7–9% of hospitalization days. Incident
ADEs cause by medication errors were observed in 1 out of 250 patients and accounted for
approximately 6% of ADEs and accounted for 30% of ADE-related hospital admissions[15]

Many studies have shown DRPs to be very common in primary care and in hospital settings.
Problems associated with drug use are many and includes inappropriate medication prescribing,
discrepancies between prescribed and actual regimens, poor adherence, drug interactions,
inappropriate use, patients monitoring and inadequate surveillance for adverse effects etc. Drug
related problems may leads to reduced quality of life, increase hospital stay, overall increase
health cost and even increase risk of morbidity and mortality 4-6. However, studies shows that
majority of Drug-related problems (50-80%) are often preventable, and pharmaceutical services
can reduce the number of ADRs, the length of hospital stays, and the cost of care (8,15).

1
1.2 Statement of the problem
Drug related problems are of a major concern in health care because of increased cost, morbidity
and mortality. DTP is associated with prolonged length of stay, increased economic burden, and
an almost 2-fold increased risk of death. Drug therapy problems are the dominant reasons for
admission. Cardiovascular diseases are the number one cause of death globally, more people die
annually from cardio vascular diseases (CVDs) than any other causes. Most developing countries
will experience the double burden of pre-transitional and post-transitional disease. The potential
costs of CVDs epidemic for African countries are staggering. It is estimated to cost (direct and
indirect) $300 billion annually in USA, equal to the entire gross domestic product of the African
continent. Of death in the sub Saharan region, CVD is the second leading killer over the age of
30 year. This shows appropriate management should be used to decreases such problem. On the
hand other researcher found, even single-disease management does not appear promising as a
strategy to care for patients [5]

2
CHAPTER TWO: LITERATURE REVIEW
2.1 Literature Review

According to a study conducted in general midicine and cardiology department of 640 beded
multi disciplinary tertiary care hospital at coimbatore on 80 patients. The major diagnoses
included systemic hypertension (SHT) 47.5%, ischemic heart disease (IHD) 16.25%, congestive
cardiac failure (CCF) 10%, and cerebro vascular accident (CVA) 7.5%. A total of 1051 drugs
were prescribed during the study period. Patients with SHT were prescribed with 494 drugs.A
total of 112 DRPs (28.43%) were identified in these patients (4.77 ± 0.683). Among the IHD
patients who received a total of 217 drugs (9.86 ± 2.45), 71 DRPs (18.02%) were recognized
with a mean of 4.64 ± 0.71. About 129 drugs were prescribed in patients with CCF with a mean
of 9.21 ± 2.359 and a sum of 47 (11.93%) DRPs (4.21 ± 0.745) were observed. In patients with
CVA, 70 drugs (10 ± 3.16) were prescribed and 33 (8.38%) DRPs (4.69 ± 0.49) were identified.
In patients with SHT and IHD, the most frequently identified DRPs were drug interactions
(54.46% & 57.75%), drug over dosage (12.5% & 11.27%) and drug duplication (8.93% &
8.45%)[15].

According to an observational study involving 340 patients aged over 60 years using at least five
prescription drugs and discharged from hospital In total, 992 potential DRP were observed in the
340 patients (mean 2.9 ± 1.7). No drug prescribed but clear indication, an unnecessarily long
duration of treatment, dose too low, and incorrect drug selection were the DRP most commonly
observed. Ten percent of DRP occurring in 71 patients were drug–drug interactions. The number
of DRP was related to the number of drugs prescribed. Frequently occurring DRP found using
the patient interview were fear of side effects and inadequate knowledge of drug use.

Medication of patients discharged from the pulmonary department and of those with type 2
diabetes was particularly associated with occurrence of DRP [14]

According to a cross-sectional study conducted in Adama Hospital Medical College, East

Ethiopiaon Assessment of Drug Related Problems among Hypertensive Patients Follow up on
192 hypertensive patients total of 452 DTPs were identified in 155 patients.
In 93 (57.4%) patients there was only one type DTP, while it was two types in 57(36.1%) and
three types in 5 (6.5%) patients. In this study most of the drugs prescribed to the patients
contains appropriately adjusted dosage. Only nifedipin under dose was prescribed for 4 (0.9%)
persons, but there was no prescription which contain anti-hypertensive drug over dose. In 10
(2.2%) cases there was no indication (heart failure and edema) for such therapeutic scheme: a
combination of three drugs including Calcium channel blocker, Angiotensin converting enzyme
(ACEI) and Thiazide diuretics (6 patients), a combination of three drugs including Calcium
channel blocker, Beta blocker and Thiazide diuretics (1 person) and a combination of four drugs
3
including beta-blocker, ACE-inhibitor, calcium channel blocker, and Thiazide diuretics (3
patients)[16].

According to a study conduted in india teriary care teaching hospital a total of 112 patient case
sheets were reviewed during the study period, out of which 53 drug related problems were
identified from 44 patients. The most common drug related problem was found to be drug
Interactions (49.05%) followed by Adverse Drug Reaction (18.86%), and failure to receive drugs
(9.43%). The most frequent suggestions provided by the intervening pharmacist were cessation
of drug (24.52%), followed by Change in frequency of administration (22.64%), change in drug
dose (20.75%). The majority of level of significance of drug related problems was seen to have
moderate significance in grade. The acceptance rate of recommendations and change in drug
therapy was found to be high (96.21%)[3].

According to Hospital based general cohort study conducted in Felegehiwot referal hospital
north east ethiopia on total of 76 cardiac patients The most common diseases encountered
during the data collection period were hypertensive heart diseases (26, 32.9%), rheumatic heart
diseases (24, 31.6%) and functional heart failure and corpulmonale (pulmonary heart disease)
(14, 18.4%). Heart failure (70, 78.9%) was the common syndrome that accompanied the
admission of greater number of patients. A total of 230 numbers of drugs were used. The mean
number of drug was 3 + 1.4 per patient. A maximum of seven numbers of drugs were
prescribed. Diuretics (58, 76.3%) and antibiotics (40, 52.6%) were the commonly used drug. A
total of 73 (96.1%) patients had one or more DTP/s. There was a total of 105 DTPs identified.
The mean number of DTP was 1.38 + 0.8 per patient. The maximum number of DTPs was four.
Most of the patients (35, 46.1%) had two DTPs[5].

2.2 Significance of the study

The study aimed to close the gap by providing recent information on drug therapy problems in
patients with cardiovascular disease in Dembi Dollo hospital.
The findings generated from this study will be made available to Dembi Dollo hospital
pharmacists and other Health care providers, top management staffs and researchers, and we
hope that this will lead to better provision of pharmaceutical care in the hospital so that patients
will be benefited from this study. In addition findings will assist the Hospital to communicate
with other Hospitals and also ministry of Health in efforts to establish pharmaceutical care
services for better patient care. The result of this study will be more beneficial for Planners,
health personnel’s, regional and federal Health bureaus, nongovernmental organizations (NGOs),
and researchers, who are engaged in the health care system.

4
 CHAPTER THREE
3. OBJECTIVE OF THE STUDY

3.1 General objective

To assess drug therapy problems among patients with cardio vascular disease in Dembi dollo hospital
(DDH).

3.2 Specific Objectives

a. To know drug therapy problems among hospitalized patients with cardiovascular diseases in
DDH.
b. To measure the percentage of each types of drug therapy problems on cardiovascular diseases

C. To identify the class of drugs involved in the drug therapy problems

5
CHAPTER FOUR: METHODS AND MATERIALS
4.1 Study area
This study will be conducted in Dembi dollo hospital, kellem wollega,,west oromia and Ethiopia.
Geographically, DD is located 639km away from Addis Abeba.

4.2 Study period

The study will be conducted from Jan 15-Feb 1, 2019.

4.3 Study Design

A prospective cross sectional study will be used.

4.4 POPULATION

4.4. 1 Source population

The source population will be all patients who are admitted to the medical ward of DDH with
cardiac problems .

4.4.2 The study Population :

Target population for this study are patients who are admitted to DDH with CVD during the data
collection period.

Inclusion criteria
 Patients who are admitted with CVD.

 Patients who are on drug therapy or who needs drug therapy.

Exclusion Criteria
 Incomplete information on the patient card.
 If patients discharched before cross checking the collected data
 Unconscious and patients who have no care giver that facilitates communication with the
interviewer (Intensive care patients)

6
  Those not willing to participate(interviewed)

4.5 Sample size and sampling technique

Sample size
The following sample size determination formula will used
n= (Z∂/2)2 x P (1-p)
d2 where, n=required sample size
Z = the standard normal variables at 95% level of confidence
P-73.5% = (taken from the previous data research) [18]
d= margin of sampling error tolerated= 0.05

n= (1.96)2 x(0.735)x (1-0.735)

(0.05)2
n=299
 Since the total number of Cardiovascular patients is less than 10,000, the sample
correction formula is applied.
N f =n/1+n/N
=299/1+299/240

= 134

 By adding 10% non-respondent rate , the final sample size will be

=144 Where N-source of population,

N f- Final sample size.

7
4.6 Sample size and Sampling technique
The sample size will be depending on the number of patients admitted during data collection
time. Convenient sampling technique was used as per the data collection period and inclusion
criteria. If the sample size is too small during the data collection period the data will be extended
for one week.

Variables

Independent variable
 Socio demographic characteristics such as;

 Age,
 sex,
 marital status
 Educational level
 religion
 Length of hospital stay
 number of drugs and co morbidities social drug use
 medication history
 organ function test

Dependent variables
 Presence of DTP

4.7 Operational definition of terms

Adverse drug event: Any injury related to the use of a drug, even if the causality of this
relationship is not proven [7].
Adverse drug reaction: Any response to a drug which is noxious and unintended and
Which occurs at doses normally used in humans for prophylaxis,
diagnosis or therapy of diseases, or for the modification of
8
physiological functions [7].
Medication error: Any error in the medication process (prescribing, dispensing,
administering of drugs), whether there are adverse consequences
or not [7]
Adherence: is drug taking behavior of a patient measured with Morisky scale in which when a
patient says no at least for one of the question, he/she is non-compliant [5].

4.8 Data collection procedure and Instrument

Data will be collected by the investigators by using pretested check lists.
Which are prepared in English and four data collectors will be involved during data collection.
Supervision of data collectors will be made by the principal investigator and the collected data
will be carefully checked for completeness as well as consistency.

4.9 Data processing & analysis

The collected data will be edited, coded, and analyzed manually. Descriptive statistical
techniques will be employed. And also the result of the study will be presented using different
graphs, tables, charts and texts.

4.10 Data quality assurance

In order to assure the quality of data the following measures will be undertaken:-
 Data will be collected by investigators.

 An advisor will supervise the data collection process.

 The data collectors and the advisor will review all filled checklists.
 Documented DTPs will be validated by the advisor

4.11 Ethical considerations

All the process will be started after getting permission from DDH. A letter will be submitted to
concerned bodies of DDH.

9
Privacy and confidentiality will be ensured during the pharmaceutical care services. Thus, name
and address of the patient will not be recorded in the DTP data collection checklist.

4.12 Result dissemination plan

The results of the study will be disseminated to relevant bodies such as woreda health office, JU,
other concerning body etc.
This will be done through submission of reports and presenting findings at appropriate seminars,
workshops and conferences. Besides publication of the study findings on the reputable peer-
reviewed local/international journal will be considered.

4.13 Possible limitation of the study

 The study did not show the overall prevalence of DRPs for a patient in his or her hospital
stay (admission to discharge) rather it shows DRPs up to some cross sectional of time
after his or her admission.
 The results of the study may not be generalized to all hospitals because it was single
centered study conducted in a hospital serving reffered patients who have severe illness
and more co morbidities

10
CHAPTER FIVE: WORK PLAN

S.no Activities Responsibl Duration of month 2019

e body
Dec Jan Feb Mar Apr May Jun

1. Title Pi $ advisor
selection

2. Proposal PI
Development

3. Finalize PI
proposal

4. Proposal PI
presentation

5. Pre test
Key: PI =
6. Data PI $DC Principal
collection
Investigator
7. Data PI or DC =
Data collector
analysis

8. Report PI
writing

9. Submission PI
of first,
second&
final draft

10. Report PI
presentation
and
submission

11
 CHAPTER SIX: BUDGET

S.NO Number of persons needed and their wage

Personal cost No of person No of working Cost per day Total cost

1
day for each
Coffee/tea during data 4 2 40.00 180.00

collectors training
Coffee/tea during data 4 4 40.00 640.00
collection for data collectors
Sub total _ _ _ 820.00
Contingency _ _ 10% 80.00
Quantity Unit cost(ET, Total cost
2 Stationary cost
birr)
Pen 4 5.00 20

Pencil 4 3.00 12
Eraser 4 2.00 8
Sharper 4 2.00 8
Proposal printing and laminating 2 40.00 80
Research report printing and laminating 2 50.00 100
Subtotal _ 228
Contingency 10% 23
Grand total _ _ 1299

12
REFERENCES
1. Rania Reedman Abraham. drug related problems and reactive pharmacist intervention for
patients receiving cardiovascular drugs. international journal of basic medical science and
pharmacy 2013December; 3(2):42-48
2. Palomar G, Shalom I, Jose E, Laura T, M.AntoniaM, Antoni B. Negative clinical outcomes
associated with DRPs in heart failure outpatients, impacts of pharmacist in a multi-
disciplinary heart failure clinic. journal of cardiac failure, 2011;17(32011): 217-233
3. Marten H, Vander W, Tiny J,Dirk JV.Noncompliance in patients with heart failure, how we
can manage it?.European journal of heart failure, 2005;7: 5-7
4. Salish, Assessment of clinical pharmacist intervention in tertiary care hospital of southern
India. Asian Journal of Pharmaceutical and Clinical Research ,2013; 6(2):0974-2441
5. Syed F.et al ,reasons for noncompliance in heart failure patients , Pakistan heart journal
july-december 2011, 43: 3-4
6. Gobezie T, Belay Y, Elias A, Belayed K, Masala D .Drug Therapy Problem among Patients
with Cardiovascular Diseases in felege hiwot Referral Hospital, North East, Ethiopia.
international journal of pharmacy teaching and practice2014;5(3):989-996
7. Mohammednur H, Jimi L, Minyahil A, Obese T, Guru T,Hun duma D, Belayed K. Clinical
Assessment of Drug Related Problems among Hypertensive Patients on follow up in Adam
Hospital Medical College, East Ethiopia. Bio pharm 2014; 3(2)
8. CjEng T, Bruce J, Debra J G, Alison R M, Emily J T. barriers to medication adherence in
chronic heart failure patients during home visit, journal of pharmacy practice and
research ,2010; 40(1 ):27-28
9. Saied FM Tariq M, Denial Khalid.personal and social factors regarding medical
noncompliance in cardiac failure patents. journal of the college of physicians and surgeons
Pakistan 2011;21(11):659-661
10. Richard S, Vicky C, Roger W.Adverse drug events and associated factors in heart failure
patients, among very elderly. Guadiana geriatrics journal, 2011December; 14( 4):79
13
11. Bereket MT, Daniel D, Belete H. Drug-related problems among medical ward patients in
Jimmia university specialized hospital, Southwest Ethiopia, journal of research in pharmacy
practice,2014 january-march;3(1):1-5
12. Jived S. teal, Assessment of DTP in patients with cardiovascular diseases in a tertiary care
hospital in India, journal of pharmaceutical care,2014; 2(2):70-76
13. Salish, Assessment of clinical pharmacist intervention in tertiary care hospital of southern
India. Asian Journal of Pharmaceutical and Clinical Research ,2013; 6(2):0974-2441
14. pro, Dr. Beer hard parlor D. pharmaceutical care practice, DRP and opportunities for new
services , April 2010.

ANNEX: LIST OF DUMMY TABLES

TABLE 1. Socio demographic characteristics of the study population

Characteristics Number Percent(%)

Sex Male

female Pregnant breast feeding

Pregnant non breast feeding

Non pregnant breast feeding

Non pregnant non breast

feeding

Total

Age 15-35

36-65

≥65

Social support Relies on care

giver

Lives alone

Marital status Single

14
 Married

Widowed

Divorced

Education Illiterate

Primary school

Secondary school

College and above

Social drug use No

Tobacco

Alcohol

Caffeine

More than one

social drug use

Family history No

CVD

Diabetes

Morethan one
family history

Occupation House wife

Employed

Private

Post employed

TABLE 2. Type and number of DTPs among patients with CVD admitted in DDH
15
Table 2 showing the type and percentage of DTs

DTP Sub category Number Percent

(%)

1. Unnecessary drug No medical

therapy indication

Duplicate therapy

Treating avoidable
ADR

Total

Untreated medical
2.Needs additional condition
drug therapy
Preventive or
prophylaxis

Synergistic or
potentiating

Total

3.Ineffective drug More effective

therapy alternative available

4.Dosage too low Wrong dose

5.ADR Frequency
inappropriate

Undesired effect

Drug interaction

Total

6.Dosage too high Frequency

inappropriate

Duration too long

16
 Total

Direction not
understood
7.compliance
Patient preferred not
to take

Patient forget to take

Patient not aware of

medication change

Drug product too

expensive

Total

ANNEX II:QUESTIONARIES
Data collection tool to identify drug therapy problems and associated factors among hospitalized
cardiovascular patients ……cont.d

17