Reactions 1322 - 9 Oct 2010 ADR reporting forms need to be harmonised There exists "a need to harmonize the ADR reporting forms" of all countries, as discrepancies in these forms lead to incomplete data capture by WHO, resulting in "inappropriate causality assessment of ADRs and possible signal detection", declare researchers from India. They suggest that the development of guidelines for creating an effective spontaneous ADR reporting form "is the need of the hour". The researchers compared ADR reporting forms for ten different countries obtained via the Internet, and scored them on 18 different elements (for a total possible score of 18), such as patient information, and adequacy of space and columns to capture information required for causality assessment. All of the forms analysed asked for detailed patient information, such as sex, age, weight, list of suspected drugs, outcome of the reaction, and start and stop date of the suspected drugs and reaction. However, information about patients’ allergic status was not requested in the ADR forms of Kenya, Pakistan and the UK, and pregnancy status was required only in the forms from Kenya and Pakistan. Information about dechallenge, which the researchers say is "most important" for causality assessment was not asked for in the ADR forms of Australia, Pakistan, South Africa and the UK. In addition, information about rechallenge was not requested on the forms for Australia, Kenya or Pakistan. The ADR form of Malaysia scored the highest on the points system, with 16 out of a possible 18 points....