What are Czech requirements for reporting serious adverse reactions and non-serious adverse reactions to MP?
On 22nd November 2017 new extended EudraVigilance database was put into operation. As of this date, reports by all EV stakeholders have to be submitted to the EV database directly (centralized reporting system) within time limits stipulated by the law:
|From the date the expanded EudraVigilance database is put into operation|
|All EU serious reports||Report to the EV database within 15 days|
|All EU non-serious reports||Report to the EV database within 90 days|
|Non EU serious reports||
Report to the EV database within 15 days
Should suspicions on drug abuse , misuse or medication error of MP or generally off-label use of MP be reported in the case that these do not lead to adverse effects?
Reports (ICSRs) of drug overdose, drug interaction, abuse of MP, medication error or off-label use of MP – if these are not linked to a simultaneous adverse drug reaction– should not be reported to the EV database. However, they should be monitored by the MAH and recorded for the purpose of potential evaluation of the specific product risk/benefit ratio.
Reporting from post-authorisation studies – which information compiled during these studies should be reported to the SUKL or to the EV database within the terms of pharmacovigilance?
The term post-authorisation studies may include various systems of organised data collection, which do not fall under the definition of clinical trials – this includes PASS, patient programmes and registers, patient support programmes for patients with a specific disease and patient and physician questionnaires. If information is sought actively (by the study sponsor, register operator, etc.) within the terms of these systems, potential resulting reports are considered solicited reports. These are always classified as reports “From the study” (not spontaneous). In such cases reports of suspect adverse drug reactions are reported to the EudraVigilance database only if it is probable that the adverse reaction is related to the suspect MP within the terms of the study.
This causality is identified in the section titled Drug Reaction Relatedness (B.4.k.18) in the electronic report format E2B R2 or in the section Assessment of Relatedness of Drug to Reation (G.k.i.2.r.) in the format E2B R3, and this field should be completed for all reports “From the study”.
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.
GVP Module VI part VI.B.3 places special emphasis on reporting ADRs related to suspect MP of biological origin. In the case of these reports MAH and SUKL shall make efforts to obtain the precise brand name of the suspect MP, including the batch number. Information about the effort to obtain this information (or FU) must be recorded in the “Case narrative” part of the report, and this includes cases that this information could not be obtained.