Format for project proposal

Section A
1. Title of Research: Assessment of Drug Reaction Profile in Patient on Antibiotic Therapy

2. Name & signature of the Principal Investigators: Suhail. M. Sidhick

Mufeeda S

Shifana K. N

3. Designation of Principal Investigators: 8th Semester B. pharm Students

Al Azhar College of Pharmacy

4. Address for communication

(including telephone and email id) : Al Azhar College of Pharmacy Perupillichira, Thodupuzha

Ph: 9645901563

Email id : suhailmsidhick@gmail.com

5. Name of Guide (for students) : Vijayalakshmi . S

6. Department of Institution where

the research will be carried out : General Medicine Department of Al Azhar

Medical College & Super Speciality Hospital.

7. Names and addresses of the

institutions where research will be

carried out : Al Azhar Medical College & Super Speciality

Hospital Ezhalloor, Thodupuzha

8. Duration of the Scheme : 2-3 months

9. Sources of Monetary

or Materials support : Patient files from medical record department

 Section B
1. Title of the project : Assessment of Drug Reaction Profile in Patient on

Antibiotic Therapy

2. Objective

• To study the adverse drug reaction(ADRs) related to antibiotics in all patients from general
medicine department on antibiotic therapy.
• To access the causality of reported ADR using Naranjo scale.

3. Summary of research proposal

Drugs are the most common medical interventions, primarily used to relieve sufferings. But it has been
recognized long ago that drug themselves can prove fatal; as the saying rightly goes “Drugs are Double Edged
Weapons”. According to WHO, ADR is “any response to a drug which is noxious and unintended, and which
occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease, or for the modification
of physiologic function. Antibiotics are one of the major drug classes responsible for adverse reaction. The
irrational prescribing of antibiotics leading to increase in the medical costs as well as patients do not get
professionally appropriate prevention services of treatments. Due to the enormous use of antibiotics after
covid pandemic, we have chosen Antibiotics for studying the incidence of ADRs associated with them. We
planned to conduct a retrospective study in the general medicine department of Al -Azhar medical college and
super speciality hospital, Thodupuzha. All patients from general medicine department on antibiotic therapy
will be include in the study. Relevant demographic data, including age, gender, complaints on admission,
relevant past medical and medication history, drug therapy details, previous allergies, during of antibiotic
therapy (parenteral and oral), will be collected from MRD files. Causality of ADR will assessed by using
Naranjo’s scale.

4. Present knowledge and relevant bibliography

Aifa Faneeza et al conducted a prospective observational study on Assessment of Adverse Drug Reactions
of Antibiotics in General Surgical Patients of a Charitable Hospital for six months. The Naranjo and WHO
scales were used to determine ADRs’ causality, whereas severity and preventability were measured using
Modified Hartwig and Siegel scale, Modified Schumock and Thornton scale, respectively. 32 ADRs identified
among 300 study subjects receiving antibiotic therapy. Causality assessment based on the WHO-UMC criteria
showed that 56.25% of ADRs were probable, whereas, by Naranjo’s scale, 71.87% of ADRs were possible.
Penicillins, Fluoroquinolones, and Cephalosporins were the most common antibiotics prescribed to induce
ADRs (21.875%). The most frequently experienced ADRs were gastrointestinal reactions (65.625%) followed
by skin reactions (28.125%). The occurrence of antibiotic-induced ADRs in the study is 10.66%. The study
concluded that ADRs are indeed a major drug related problem affecting health outcomes and an issue that
needs to be addressed vastly.
A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital was conducted by M.
Shamna et al . It was a prospective spontaneous reporting study carried out for a period of six months. A
total of 49 ADRs were reported during the study period with more number of ADRs was from General
Medicine and Pediatric departments in which the most affected organ systems were the GIT (38.77%) and the
skin (30.61%). The antibiotic classes mostly accounted were cephalosporins (34.69%) followed by
fluoroquinolones and others in which type A reactions were more compared to type B and 59.18% of them
were predictable. The severity assessment revealed that most of them were moderate (63.26%) followed by
mild and severe reactions. Of the reported reactions, 55.10% were definitely preventable and causality
assessment was done which showed that 71.42% of the reactions were probable, possible (18.36%), definite
(10.20%) and no reactions were unlikely.

Bismi S et al was done A Prospective Interventional Study on Prescription Auditing, Adverse Drug Reaction
Monitoring and Health Related Quality of Life of Patients in a Tertiary Care Teaching Hospital in South
Kerala. Out of 235 prescriptions, 1742 drugs were analyzed using prescription auditing checklist. The average
no.of drugs were prescribed about 7.41. The incidence of ADRs is 0.025 and 6 were identified and analyzed
using Naranjo scale and Hartwig severity assessment scale.

5. Detailed Research plan

• Design of study: Retrospective observational study.

• Inclusion criteria

All patients from general medicine department on antibiotic therapy.

• Exclusion criteria

All patients from general medicine department other than antibiotic therapy.

Patient with no recorded information.

• Method of statistical analysis

By using SPSS

• Method of data collection

By standard data collection form

6. Study Tools

• Standard data collection form.

• Naranjo’s Scale