In general reports of suspect adverse drug reactions must fulfil 4 key criteria (contactable reporter, identifiable patient, adverse effect – reaction, suspect MP). It consequently applies – according to GVP Module VI, paragraph VI.B.2 - that reports are invalid in case that an unspecified adverse reaction is reported, i.e. by written description such as “he felt ill” or simply “an adverse reaction occurred”. In both cases no adverse reaction is given.
Reports are similarly invalid in case that only the consequences are known (i.e. death or life threatening condition is recorded) without any other description of the occurring situation, on the basis of which it would be possible to evaluate the connection to the administered MP.
Reports are also invalid in case that they are formulated as: “I have also heard of this reaction after administering MP X”, which needs an identifiable patient to make the report fully valid.
In relation to PSP reports, it applies that reports are considered patient reports even if information is obtained and compiled by physicians or healthcare professionals within the terms of questionnaires or telephone conversations. The healthcare professional, who obtained the information in this manner, is not the patient’s attending physician and is not capable of providing additional information about the circumstances of the reported adverse reaction in the case of necessary follow-up (FU) to the report.
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