Follow-up methods should include the use of targeted specific forms in the local language to avoid requesting the reporter (or primary source) to repeat information already provided in their initial report.
- Require validation and collection of the four minimum criteria to enable reporting.
- Require supplementary detailed information significant for scientific evaluation of cases, if the initial report is incomplete.
- Patient age is important to try and obtain in order to be able to identify safety issues occurring in paediatric or elderly populations.
- Particularly important for monitored events of special interest, prospective reports of pregnancy and subsequent foetal outcome, death, new risks or changes in known risks.
- Encourage Primary Source to submit follow-up by tailoring methods towards optimising collection of missing information.
- Incomplete consumer reports – request consent to contact their HCP (e.g. GP or pharmacist) to obtain medical validation and further information. If it is not possible to get follow up information from an HCP, the consumer should be asked for follow up information.
- For biological medicinal products – product specific information should be requested, e.g. product brand name and batch number, since biosimilars have different safety profiles from the originators.
Adding specific additional questions related to each case will assist the reporter to identify areas of particular importance or special interest.
To smooth the follow up process for the reporter, consider pre-populating some data fields in follow up forms to make completion easier by the primary source.