This step is performed by the pharmacovigilance physician:
Based on the level of safety risk or patient impact, recommend action and review recommendations with the product safety board. The recommendations may include any or a combination of the following conclusions:
- A post-authorisation study to be conducted according to an agreed protocol and submit the final results of that study.
- Initiation of a Health Hazard Assessment (HHA) for potential field action (field alert reporting evaluation)
- Request quality complaint investigation for further product evaluation
- Expedited reporting to regulatory agencies
- Direct healthcare professional communication / Dear Doctor Letters
- Updating safety related labeling or prescribing information
- Clinical expert statements
- Reporting to investigators, Institutional Review Boards (IRB), Ethics Committees, updating study documents, or holding or stopping ongoing studies early
- Continued assessment of the product benefit-risk balance
- Further investigation of the safety risk through additional studies
- Development of a pharmacovigilance plan focused on evaluating the identified risk
- Reporting via periodic report submission
- Risk management document updates
- Additional educational materials or training
For all validated signals, and in accordance with final recommendations from the committee:
- Modification of the ongoing monitoring strategy of the product
- Initiation of label change and/or other external communication activities
- Initiation of recall/correction procedure
- Information to concerned health authorities
- Issuing or updating a Risk Management Plan
- Introduction of enhanced pharmacovigilance activities
- Introduction of additional risk minimization activities
- Conducting a post-authorization safety study
- Periodic review of the signal
The product safety review committee will determine appropriate timelines for initiation and completion of suitable actions for all validated signals, which will be documented in the meeting minutes and in the individual product safety signal investigation report.
Exchange of Information
The following steps will be performed by the PV physician:
- Communicate immediately to regulatory affairs (to generate prompt regulatory action as communication to applicable regulatory authorities and interested business partners) as an Emerging Safety Issue all validated signals pointing towards an implication for public health or the benefit-risk profile of the specific product.
- Depending on the severity of the signal, communicate validated signals representing a new potential signal or a new aspect of a known risk and not having implications for the benefit-risk profile to applicable regulatory authorities.
- Communicate the outcome of signal assessment involving new or changed risks to the public including health care professionals and patients as well as to the concerned marketing authorization holders.
