Francesca Spera -

The Italian Medicines Agency (AIFA), in line with what is reported in the Guideline on good pharmacovigilance practices (GVP) Module VI and in the Ministerial Decree April 30th, 2015, has published an update concerning the management within the National Pharmacovigilance Network (RNF) of the reports of suspected adverse drug reactions related to lack of efficacy.

In general, the reports of suspected adverse drug reactions included in the RNF are those considered valid., i.e. the ones that have the four minimum requirements:

  • an identifiable reporter
  • an identifiable patient
  • one or more adverse reactions
  • one or more suspected medicines

The reports of lack of therapeutic efficacy must be collected and if they do not meet the minimum requirements follow-up attempt(s) must be performed.

It is important to determine whether it is a lack of therapeutic efficacy of the medicine or a disease progression. All cases in which it is believed that the aggravation or the progression of the disease are not to be attributed to the drug itself but to a natural evolution of the pathology should not be recorded in the RNF.

Normally, if those reports are not associated with suspected adverse drug reactions, they do not have to be recorded in the RNF, but they will be discussed in periodic safety update reports (PSUR) prepared by the marketing authorization holders, when applicable. However, in certain circumstances, those reports of therapeutic failure without suspected adverse reactions may require to be registered. Medicines used in critical conditions or to treat diseases that can be life-threatening to the patient, vaccines and contraceptives are examples of such circumstances.

In the event that the report of lack of therapeutic efficacy is to be recorded in the RNF the most appropriate MedDRA terms should be used to describe the clinical condition of the patient, according to what is reported in the most updated version of the guide MedDRA Term Selection: Points to Consider.

Biological drugs deserve special mention, for which a partial or complete loss of the efficacy of the product can occur.

For the reports of suspected adverse reaction resulting from biological medicines it is important to report the number of the organic batch indicated as suspect.

For more details you can find the full notice at the following link

RPN constantly monitors the AIFA website in order to stay up to date on pharmacovigilance and it is available to provide full support for any query and for the management of ICSRs.

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