An observational study to compare the contents and quality of information furnished in CDSCO ADR reporting form, yellow card, medwatch and blue form by the healthcare professionals
Affiliations: Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India | Department of Pharmacology, HIMSR, Jamia Hamdard, New Delhi, India
Note: [] Address for correspondence: Dr. Harmeet S. Rehan (MD), Professor and Head, Department of Pharmacology (Co-ordinator pharmacovigilance programme of india), Lady Hardinge Medical College, New Delhi 110001, India. Tel.: +09811694040; Fax: +91 11 23347561; E-mail: harmeetrehan@hotmail.com
Abstract: BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting form is a vital tool for collecting information about ADRs, which helps in establishing the causal assessment and generating a signal. This is feasible if quality information is translated into the reporting form by health care professional (HCPs). Hence, present study was carried out to compare efficiency of HCPs in translating suspected ADR information in the spontaneous reporting forms and to compare the ADR reporting forms of different countries and their duration of training in pharmacovigilance. METHODS: In a cross-sectional study, 50 doctors, 50 Nurses and 50 Pharmacists were asked to fill different reporting forms (CDSCO form, Medwatch, Yellow card and the Blue form) using different simulated ADR case reports. Filled forms were analysed for their contents, information captured and time taken to fill these forms. They were also asked about their training and exposure to pharmacovigilance related activities. RESULTS: All the spontaneous ADR reporting forms had 24–26 data elements to furnish information. Information regarding dechallenge was lacking in the Yellow card and Blue form. Blue form also lacked the information on rechallenge. Overall nurses took longer time to fill all the ADR reporting forms as compared to the doctors and pharmacists. Majority of HCPs missed to fill reporter's information in all the forms. CONCLUSION: Study suggested that the quality of information translated by the HCPs needs improvement for which they should be sensitized periodically on the basic elements of pharmacovigilance.
