An observational study to evaluate drug utilization pattern and adverse drug reaction profile in radiotherapy and oncology section.
- Conditions
- Adverse drug reaction profile and drug utilization pattern in radiotherapy and oncology section.
- Registration Number
- CTRI/2016/11/007421
- Lead Sponsor
- Department of Pharmacology Government Medical College Bhavnagar
- Brief Summary
The study is meant to determine ADRs due to anticancer regimens and to evaluate its causality , severity, preventability, and to study drug utilization pattern in patients attending day care oncology section.
Ø **Study Design**- Prospective,observational study.
Ø **Duration**- 24 months.
Ø **Methodology**- A prospective analysis of ADR ,drug utilization pattern of medicines prescribed in the Oncology section will be done for 24 months after approval from Institutional Review Board.
a. For drug utilization pattern all patients will get enrolled.
b. The participant will be screened during the OPD hours and inwards for suspected ADRs thrice a week.
c. Consent will be taken if any interventional investigation is done and in a case of children or illiterate people consent will be taken from a guardian.
d. All newly diagnosed patients or known cases of cancer, any type and of any age group and either gender (including pregnant women) attending oncology section who will be prescribed anti-cancer medications having ADR will be included in the study.
e. ADRs noticed by the principal investigator or assigned doctors , spontaneously reported by patients or their guardian based on clinical examination and laboratory findings will be noted.
Ø **ADR’S** will be assessed according to
· Causality assessment by Naranjo scale and WHO Scale.
· Severity assessment will be done by (Modified Hartwig and Siegel-1992)
· Preventability will be assessed by Modified Schumock and
Thornton scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 200
- 1.All the participants undergoing chemotherapy in day care centre during the study time period will be enrolled.
- 2.All participants receiving anti-cancer regimens, will be included in the study .
- 3.Participants of any age group.
Patients not receiving any kind of cancer chemotherapy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To analyze drug utilization pattern. In morning OPD hours and in evening round ( 3days per week)for 2 year duration. •To identify the ADR’s caused by anti-cancer drugs In morning OPD hours and in evening round ( 3days per week)for 2 year duration.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Government Medical College and Sir Takhtsinhji General Hospital Bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
Government Medical College and Sir Takhtsinhji General Hospital Bhavnagar🇮🇳Bhavnagar, GUJARAT, IndiaDr Ruchika KalraPrincipal investigator09772616565drruchika@gmail.com