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Why Are Correct Screening Procedures So Important?
GVP Module VI makes it clear that regulators expect consistent screening to be an integral part of your day-to-day drug safety operations. For each marketing authorisation you hold, you are expected to:
- Understand which publication databases are most relevant to each medicinal product
- Systematically monitor these for publications worldwide at least once a week
- Systemically monitor all “active substances” for which you hold Marketing Authorisations within the EU (where not listed by the EMA)
- Monitor articles published locally in each territory where your product is marketed
- Route the results of this activity to the appropriate departments within your company
- Understand and comply with the time deadlines that apply to Individual Case Safety Reports Literature Screening – even if a third party is completing your screening
- Avoid reporting duplicate ICSRs within literature
- Describe and analyse any “new and significant safety findings” in the medicinal product’s PSUR
- Understand and comply with the requirement to immediately notify regulators of new safety information from screening
Primevigilance operate a comprehensive Worldwide Pharmacovigilance Literature Screening Service as part of the suite of drug safety services offered by the company. Features include:
- Conduct of searches via validated databases e.g. Medline and, Embase – Screening of Abstracts for identification of potential ICSRs
- Screening of Abstracts for identification of potential new and significant safety findings for inclusion in PSURs
- Pregnancy outcomes (including termination) with no adverse outcomes;
- Use in paediatric populations;
- Compassionate supply, named patient use;
- Lack of efficacy;
- Asymptomatic overdose, abuse or misuse;
- Medication error where no adverse events occurred;
- Important non-clinical safety results. Ordering selected full publications for evaluation of ICSRs or safety issues
Targeted Literature Screening For Safety Assessments And Benefit Risk Analysis
PrimeVigilance’s system for monitoring literature currently screens approx. 800 different INNs and is constantly increasing. Significant cost savings are incurred when multiple clients share the same INN. You can choose to receive search results via a dedicated secure client specific directory on the Primevigilance Portal. Or results may be sent directly to you if you prefer.
Your service may be extended to full or part service including:
- Entry of identified cases onto a validated safety database
- Full medical review of ICSRs
- Regulatory reporting of ICSRs
- Signal Detection and Benefit risk analysis
- Medical Assessment of safety issues
Why Choose PrimeVigilance For Your Pharmacovigilance Literature Screening Service?
The requirement to proactively screen the published medical and scientific literature as part of a pharmacovigilance system can lead to difficulties: the screening can be time-consuming and resource intensive; inadequate searches are a common finding during regulatory authority inspections; and the identified cases can be complex and difficult to evaluate and to enter onto the safety database.
One benefit of contracting PrimeVigilance to carry out your Literature Screening for you is that we have been offering it as part of our range of drug safety services for a number of years. Our staff have extensive experience in this arena and can comprehensively manage your literature screening requirements in a cost-effective manner. Involving medical review of cases rather than adopting a mechanistic approach can also help to identify important signals in the literature. We can also utilise our existing international network to establish screening of the local, non-indexed medical and scientific literature.
We can also carry out literature searches for purposes of signal evaluation or for identifying safety concerns for inclusion in PSURs.
Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products
Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report
21CFR314.80 Postmarketing reporting of adverse drug experiences