Study setting and period
This research was conducted from April to June 2018 at pediatric ward of Jimma university medical center (JUMC), which is located in Jimma town; 352 km Southwest of Addis Ababa, Ethiopia. JUMC is the only teaching and referral hospital in the south western part of the country with bed capacity of 600. It provides services for approximately 9000 inpatient and 80,000 outpatient clients per year with a catchment population of about 15 million people. It has different wards. Pediatric ward is among the ward which has different unit such as: level I, Level II, neonatal unit, Intensive care unit and Oncology unit. Annually about one thousand six hundred twenty three patients with infectious disease admitted to pediatric ward of Jimma university medical center (41).
Study Design
A prospective observational study design was conducted over all pediatrics patients with infectious disease admitted to JUMC from April 01 to June 30 2018.
Source Population
All pediatric patients with infectious disease admitted to JUMC during study period.
Study Population
All pediatric patients with infectious disease admitted to JUMC during study period and who fulfill inclusion criteria.
Sample size and sampling technique
The sample size was calculated by using single population proportion formula based on the following assumption: Z= (1.96)2 , P =the prevalence of DTP in Zewditu hospital (31.57%) (35) with 95% confidence interval (CI) and marginal error (d) of 5%
Due to technical limitations, Equation 1 has been placed in the Supplementary Files section.
n= 332
Whereas:
n – Sample size=332
Z – Confidence interval at 95% = 1.96
P – The prevalence of DRP in pediatrics ward in Zewditu referral hospital in 2014 = 31.57%.
d – Margin of error = 5%
The size of the population is less than 10,000. Therefore; the sample size was corrected using the following correction formula.
Due to technical limitations, Equation 2 has been placed in the Supplementary Files section.
Where: n – Sample size=332
N – Number of pediatric patients with infectious disease admitted to JUMC in 2017=1623
NF=adjusted sample size
So, the total sample size after 10% of non-response added = 303.6~304 patients
All patients diagnosed with infectious disease admitted to pediatric ward during data collection period and who fulfilled the inclusion criteria were consecutively included in the study.
Inclusion and Exclusion criteria
Inclusion criteria
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Patients admitted to pediatric ward of JUMC with in the study period.
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Age less than 18 years old
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Patient diagnosed with at least one infectious disease during the study period
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Patients whose parents gave and signed the informed consent.
Exclusion criteria
Study variables
Dependent variable
Independent variables
Disease and drug related variables
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Professional related & other variables
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· Number of drugs used
· Comorbidity
· Number of infectious disease
· Number of disease condition
· Class of drug prescribed
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· Type of admission
· Duration of hospital stay
· Culture
· Medication error
· Pharmacist intervention
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Patient related variables
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· Sex
· Age
· Weight
· Place of residence
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Data collection process and data quality assurance
Data were collected through medical record reviews and patient interview using a prepared structured questionnaire which was translated to Afan Oromo and Amharic language for patient interview to collect information on adherence, socio-demographic, medication and disease related issues. The data collection format (Annex III) was prepared by reviewing different literatures for important variables that used to assess drug therapy problems and its contributing factors. Its content includes: patient details, diagnosis, comorbidities, duration of hospital stay, review of system and patient’s investigations, intervention taken, current and past medications. The data collection involved four pharmacists (bachelor degree) and one supervisor to organize the whole activities daily. The principal investigator reviewed all filled format so that any suggestion and corrections was given soon. Data collectors reviewed the medical chart by using prepared standard questionnaires’ for all patients who fulfills inclusion criteria daily for their drug related need. Recommendations was done by a panel of experts of clinical pharmacist and forwarded to physicians and/or other health care provider during rounds.
DTPs Identification and Classification
In this study drug therapy problems were classified according to Cipolle, Morley and Strand DTPs identification and classification method. The method was refined based on literature review and different treatment guidelines with further revision, and endorsement by panel of experts (Clinical Pharmacists).
The case (DTP) was identified by reviewing of patient’s chart (pediatricians’ note, Residents notes, medical interns’ notes) and interviewing the parents/caregiver. The prescribed drugs were evaluated against different international (WHO 2016, CDC, Micromedex, Medscape, Nelson textbook of pediatrics 20th edition, Naranjo scale and different therapeutic guidelines) and national guideline (Ethiopian pediatric hospital care 2016) for their appropriateness in the order of indication, effectiveness, safety and drug interaction. The identified DTPs were classified as unnecessary drug therapy, needs additional drug therapy, ineffective drug therapy, dosage too low, adverse drug reaction, dosage too high and noncompliance.
Data Quality Assurance
The Questionnaires were translated from English to Afan Oromo and Amharic, and back translated into English by independent person to assure its consistency. Data was compiled, cleared, coded and checked for completeness and accuracy before entering into Epidata manager version 4.0.2. Double entry verification was made and data was analyzed using statistical software package, SPSS version 21.0. Training was given for four data collectors. The data collectors were also strictly supervised daily and the principal investigator reviewed all filled format so that any suggestion and corrections was given soon. A panel of experts (clinical pharmacists) assessed whether the data collection format would measure what it was intended to measure, and if it was comprehensive enough to collect all the information needed to address the purpose and goals of the study. Then a pretest was done on 16 (5%) patients and an appropriate change was made based on expert opinion.
Data processing and statistical analysis
All statistical tests were performed using statistical software package, SPSS version 21.0. Descriptive analysis was computed as frequency, mean and standard deviation (SD) for continuous variables and for categorical data. Binary logistic regression analysis was performed to examine the association between independent variables and drug therapy problem. In binary logistic regression analysis, variables with p values < 0.25 was selected for further multiple logistic regression analysis. Multiple logistic regression analyses were used to determine the independent predictors of occurrence of DTP. The Odds ratio with 95% confidence interval (CI) was calculated to measure the strength of association between predictor and outcome variables. Probability values less than 0.05 will be accepted as statistically significant. The out puts of processed data was presented using tables, graphs and figures accordingly.
Ethical consideration
Ethical clearance was obtained from ethical review committee of jimma university,institute of health. This committee wrote aletter of permission dated the 30th February 2018; with reference number “IHRPGD/205/18“ to Jimma university medical center to seek it cooperation and access the data. Pateint’s infprmed consent was obtained after explaining about the purpose and procedure of the study. When the child was too young to provide informed consent,it was obtained from parents/caregivers. All the responses were kept confidential.
Operational definition and Definition of terms
Infectious disease: is a disease caused by pathogenic microorganism such as bacteria, fungi, Virus, protozoa, worms and parasites.
Adverse drug reaction: is a noxious and unintended response to a drug which occurs at doses normally used for the prophylaxis, diagnosis, or treatment of disease that occurred during the study period (42).
Comorbidity disease: is a medical condition diagnosed other than infectious diseases and which its cause is not by microorganism .
Drug therapy problem: is any undesirable event experienced by a patient which involves, or is suspected to involve, drug therapy, and that interferes with achieving the desired goals of therapy, which can be identified using Nelson 20th ,Ethiopian pocket of hospital care for pediatric 2016, WHO 2016, and different pediatrics books.
Medication error: any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer (43).
Poly-pharmacy: defined as concomitant use of five or more prescription medications (44).
Pediatric Patient: is a patient whose age range from birth up to the age of 18 during the study period.
Neonate: pediatric age ranging from birth to 28 days
Infant: pediatric age ranging from 29 days to ≤1 years
Toddler: pediatric age ranging > 1year to ≤3 years
Preschool: pediatric age > 3years to ≤ 5 years
School age: pediatric age > 5years to ≤ 10 years
Adolescent: pediatric age > 10years to ≤15 years