Affiliations: Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India
Note: [] Corresponding author: Dr. Deepti Chopra, Resident, Department of Pharmacology, Lady Hardinge Medical College, New Delhi 110001, India. Tel.: +91 9818710237; E-mail: [email protected].
Abstract: Adverse drug reaction reporting is an important means of establishing new knowledge and generating early signals of possible drug complications. Several reporting systems exist for adverse events however these reporting systems are associated with relatively low levels of reporting. The quality of the reporting is also important which ultimately depends upon the information furnished by the clinician in the available form. In order to improve the quality of information provided in the form, healthcare professional should know the importance of any information that he/she is providing. In this study hundred filled ADR reporting forms were selected and analyzed with respect to the quality of information provided. It was observed that the columns which were required to be filled completely, but were not filled correctly were diagnosis, description of the event, outcome attributed to adverse event, relevant test/lab data, concomitant medications. These are important details that must be reported, for evaluation of cause–effect relationship. Thus health care professionals should be aware of the importance of the information they are providing in the form and they should get proper instructions for filling the form, so as to improve the quality of information provided in the form. More CMEs and workshops should be conducted to improve awareness. In this article an attempt is made to provide information on how to fill the form completely.
Keywords: ADR, reporting form, adverse events, reporting systems
