DRUG SAFETY & PHARMACOVIGILANCE
Pharmacovigilance encompasses the surveillance, detection, assessment, understanding, and prevention of adverse effects. Surveillance is an ongoing activity designed to detect potential safety signals and minimize the risks of drug exposure.
PATIENT- AND EVENT-LEVEL NARRATIVES
- Rapid processing of small and large and/or rescue batches
- Prepared using your format, our format, or a customized format that we develop together with your team
- Use data from draft or final data listings or programmed patient profiles
- Errors and missing information identified during thorough QC processes at each stage
- Minimize inconsistencies when addressing comments from your inhouse clinical reviewers and/or study safety physician(s)
RISK EVALUATION AND MITIGATION STRATEGY (REMS)/ RISK MANAGEMENT PLAN (RMP)
- Medication Guide or Patient Package Insert
- Communications Plan
- Elements to Assure Safe Use (ETASU), including healthcare provider certification, pharmacy certification, restrictions of dispensing to certain healthcare settings, restriction of dispensing only to patients with documentation of a safe-use condition, such as laboratory tests results)
- Implementation System
- Timetable for Submission of REMS Assessments
Ensure Consistency Across All PV Documents
"The medical writer's role is crucial to ensure that the presentation of patient safety, the drug's benefit/risk profile, and the MAH's risk management assessment are clear to RAs, are consistent across the whole suite of PV documents, and that PV documents are produced in accordance with their strict deadlines."
"The DSUR, PBRER, and RMP are designed to be modular documents, meaning that sections should be common to all 3 documents. Therefore, PV medical writers also have to ensure that the content of the PBRER is consistent with the information provided int he parallel DSUR and the potential RMP update."
AGGREGATE SAFETY REPORTS
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DEVELOPMENT SAFETY UPDATE REPORT (DSUR)
"The aim of the DSUR is to provide a periodic analysis of the safety of an investigational drug in clinical trials, to ensure patient safety during clinical dev elopment. There are several other requirements for reporting individual adverse events during trials, and so the DSUR is not the primary tool for reporting new important safety information to RAS. Instead, is summarizes all relevant safety informationt hat was collected during the reporting period. As for all PV documents, time can be a critical issue, and this is especially the case when working on DSURs for drugs well advanced in clinical development. The PV medical writer guides the team through the specific requirements of the DSUR and ensures that the document is conise and focuses on enw and relevant safety information."
POST-AUTHORIZATION SAFETY STUDY (PASS)/NONINTERVENTIONAL PASS (NI-PASS)
"Often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in CTD format. Comparability of observational studies to clinical trials is limited by a number of factors related to the differences in design and conduct of these studies. These include selection bias, which is harder to control in the observational setting, and typically a relatively higher extent and quality of data collection in the clinical setting. The PASS also places a strong focus on risk without collecting new formal benefit information."
"Offsetting the challenges, the PASS creates opportunities to assess the "real world" prescribing of a drug, to compare the real target population with the label population, and , because of the large scale of such trials, to assess safety across multiple subgroups with greater certainty than possible in a clinical trial."
POSTMARKETING PERIODIC SAFETY REPORTS
- Periodic Adverse Drug Experience Report (PADER): US
- Periodic Benefit-Risk Evaluation Report (PBRER): European Union and most Eastern European countries
- Annual Safety Report (ASR): Canada
"The aim of the PBRER is to present a comprehensive and critical analysis of the benefit-risk profile of the drug, taking into account new or emerging information, in teh context of cumulative information. This is to assure RAs that the evolving risk profile of the drug is adequately monitored. The PBRER focuses on summarizing improtant relevant safety information from the reporting period, putting it into context with the cumulative experience. It is neither a tool to preovide relevant information for the first time nor a "data dump" of extensive data from individual case reports."
"The PBRER is assessed by the RA and feedback is provided to the MAH in the form of assessment reports. In these reports, an authority may request more detail on exisitng issues or for new safety topics to be addressed in the next PBRER. PV medical writers have to guide teams through teh relevant topics, advise on the level of detail, and manage the report timeline. Especially when writing for drugs on a 6-month periodicity, good time and project management skills are essential, considering that the assessment report for the last PBRER can be expected when the team is already writing the next report."
Select Your Important Identified/ Important Potential Risks Carefully
"DSURs are produced during clinical development, and so the most critical point is the introduction of "important identified and important potential risks. These are well defined subsets of the risks known to be, or are potentially, associated with the investigational drug, as described in the Investigator's Brochure. An important risk is any risk that could have an impact on the benefit-risk profile of the drug or have implications for public health. Once defined in the DSUR, important identified and potential risks are carried forward beyond marketing approval and significantly drive the content of other PV documents (eg, the RMP and PBRER), and may require specific PV activities to prevent or minimize them. They must therefore be selected carefully and the PV medical writer's role and experience is crucial to guide the team and alert them to the implications for future documents."
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