I apologise if it is clear to the other readers, but case reporting to whom/what? (Journal, national scheme, registry, pharmaceutical companies...)

I dont understand al all the question but i think you ask about the bibliographic / scientific evidence to reinforce the case report???to be interesting, a case report should be very rare and sometimes there´s not evidence but appliyng correctly the causality scores can give strong evidence.

in my opinion, for regulatory agencies, every case matters. but for meetings and scientific congress not a lot. because we know that every drug can generate almost every adverse event.

Yes, case reporting is part of pharmacovigilance. Apart from describing an adverse drug reaction observed, you can go further to investigate the effect on other organs or corresponding markers in the blood or urine. Case reports will also give details on how the reaction was managed i.e withdrawal of the suspected drug and prompt normalization of blood and urine parameters.

the most intersting is for regulatory agency because if there are some ¨case reports¨ in differents places at the same time, you can asses this with a disproportionality test (ROR or PRR, etc) and send a warning.

Thank you dear researchers for taking time to respond to my query...

Mrs. Celia, my question is regarding reporting the case to the journal as well to the national scheme, I would be more thankful if you can help me in finding the appropriate answer.

Mr. Marcelo, thank you for responding to the query I'm just looking for the scientific evidence and generalized idea regarding the causality scores that needed to be applied in case reports. Can you please elaborate on the dis proportionality tests.

A case report in a paper of a suspected adverse drug reaction will be picked up by the pharmaceutical industry and (re-)reported into national (and international) pharmacovigilance databases such as the AERS, the WHO and the EV databases. These will then be included in the assessment of the drugs reported. the disproportionality measures used differ in different databases but the general idea is to see if the drug-reaction combination occurs more often than expected by using the whole database to estimate the expected proportion of reports that should have the reaction and compare it to the proportion observed in each specific drug. Together with measures such as a minimum number of cases this creates a list of potential signals that will then be further assessed and potentially validated.

For the EMA way of managing signals see here: http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2009/09/WC500002962.pdf and also see the list of more specific work instructions in the beginning of the document (they are all available online).

Dear researchers,

A case report is very important in pharmacovigilance or any in the sequence of scientific evidence. A case report is the basic step to find negative consequences of the treatment or any uneven. A case report can produce an observation for case series and the collection of case series can make a research study and the number of research studies can change the policy. Everything in the science will be important in bridging. 

Case reporting is indeed a crucial part of pharmacovigilance and helps in generating signals about the adverse effects of marketed drugs. However, case reporting to a national scheme and case reporting to a scientific journal may require different formats. You should therefore check the specifications for each. Generally an established national pharmacovigilance system will have a ADRE reporting form. The important thing is to provide as much information as you can about the case in relation to patient drug and medical history, time frames, challenge/dechallenge etc..because very often what weakens the validity and contribution of cases to scientific evidence in causality assessment is absence of information recorded and transmitted. Hope this helps.