EMA does not state what they mean under local literature, so we choose the easiest way: we subscribe to and review all medical journals. Our definition of the word ‘medical’: journals that can publish advertisements of prescribed drugs.
Adverse reactions do not respect the branches of medicine: ADRs can turn up anywhere and may not be bound by the borders of medical specialisations. Such cases may be published in journals targeted at experts of the prescriber’s therapeutic branch, or doctors specialised in treating the given ADR. This implies that with the approach of selecting journals by medical fields, MAHs may risk missing safety data. One of the more commonly known examples is jawbone necrosis caused by bisphosphonate taken by patients suffering from osteoporosis. Patients go and see their dentists with their problem caused by the agent prescribed by rheumatologists. Thus, we do not cherry pick professional fields when reviewing journals.
Most cases appear in non-indexed journals. Where doctors share their research data and their experiences, adverse reactions are mentioned. Depending on the country, 15-70% of the local medical journals are NOT available in reference databases, thus 50-80% of adverse reactions cannot be accessed if only reference databases are searched.