PROSPECTIVE OBSERVATIONAL, NON-RANDOMIZED, PARALLEL SEQUENCE STUDY FOR ASSESSMENT OF ADVERSE DRUG REACTIONS DUE TO CHEMOTHERAPEUTIC TREATMENT IN DIFFERENT TYPES OF CANCER PATIENTSABSTRACTAbstract
Objective: To assess incidence, causality, severity, predictability and preventability of adverse drug reactions (ADRs) in hospitalised oncology patients.
Materials and Methods: A prospective observational, non-randomized, parallel sequence study was conducted at Dr B. Borooah Cancer Institute (BBCI) after getting an approval from human ethical committee. Patients hospitalised at BBCI from Aug 2010 to June 2011 were interviewed about symptoms related to their drug therapy. Patient medical records were also reviewed for data collection.
Results: Total 663 patients associated with hospitalizations were interviewed. 899 ADRs were identified in total 410 (61.84%) patients detected with ADRs. Most of all ADRs were moderate, predictable and not preventable. The most common ADRs were leucopenia, weakness, anorexia, alopecia, vomiting, diarrhoea, nausea, abdominal pain, fatigue, and anaemia in this study.
Conclusions: For definite conclusion study should be repeated. Strict drug analyzing and in vivo study is also required if feasible.
Key message: The process of defining and concluding about ADRs should be continuous and ongoing to keep a record of newly marketed drugs and medicinal products.
Mrugank B.P. *and Hareesha R.P.
Clinical Research Scientist, Division of Research and Development, Alembic Pharmaceuticals Limited, Vadodara, Gujarat, India
19 September, 2012
12 October, 2012
27 December, 2012
01 January, 2013