Challenges and Solutions to Pharmacovigilance Literature Screening

1. CHALLENGESAND SOLUTIONSTO PHARMACOVIGILANCE LITERATURESCREENING TAGS:  PharmacovigilanceDefinition | GoodPharmacovigilancePractice | Pharmacovigilance certification | PharmacovigilanceConsultant| Drugsafetyandpharmacovigilance | Signal detectioninpharmacovigilance | Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

2. Background Adverse drug reactions assume much significance in terms of risk associated with safety of patients and could make a major impact on costs related to health systems. Owing to its significant implications for public health and safety of patients, regulatory authorities around the world have enforced and put into practice novel legislations related to pharmacovigilance in recent times. Activities related to pharmacovigilance largely hinges on undertakings for signal detection, which is executed on data assimilated from impulsive reporting systems. Health professionals tend to under-report any adverse drug reactions, the focus of new legislations are largely on pertinence of other safety information sources. Scientific and medical literature could prove to be a substantial source for valid information in order to monitor the risk-benefit balance and safety profile of medicinal products . Copyright © 2019 pepgra. All rights reserved Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance

3. Pharmocovigilance Regulations Regulations related to Pharmacovigilance have concentrated largely on Medical Literature Monitoring(MLM), which is a complex procedure, the scope of which continues to deepen and widen. Current regulations offer in-depth guidance on medical literature searches and review in order to facilitate reporting of individual Case Safety Reports (ICSRs) those that have not been directly reported to the sponsor, while helping signal detection . Copyright © 2019 pepgra. All rights reserved Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance

4. Literature screening is a key element of pharmacovigilance. Medical and scientific literature emerges as a vital information source on cases of suspected adverse drug reactions. Pharmacovigilance and Literature Screening: The Link Main objective of the screening is to recognize ICSR and / or any substantially new information from studies pertaining to safety and efficacy. Such studies might not be covered through current product labeling and / or any deviation from the existing safety information pertaining to the product label. Copyright © 2019 pepgra. All rights reserved Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance

5. Challenges The continuous growth in the number of sources for data or information, combined with the regulatory requirements could render the procedure to be a rather formidable proposition. Teams functioning in the domain of pharmacovigilance are under duress to come up with strategies that are not only flexible but extensive too as . Pharmaceutical organizations are confronted by several challenges in terms of scientific literature screening. Contd. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance Copyright © 2019 pepgra. All rights reserved

6. Pharmaceutical organizations are faced with the issue of amalgamating the continuously growing data on safety from literature, within their efforts towards pharmacovigilance . This is done with the objective of being compliant with regulations that are applicable. Literature screening for product citations emerges to be a humongous task. This requires significant time (in excess) to be invested, cost and effort of sifting through large volumes of cross-disciplinary and heterogeneous reports. Copyright © 2019 pepgra. All rights reserved Copyright © 2019 pepgra. All rights reserved Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance

7. The European Medicine Agency’s (EMA) latest initiative (September, 2015) is focused on lowering the number of duplicates in terms of monitoring medical literature and efforts at review by the Marketing Authorization Holders (MAHs). Solution This initiative has the potential to enhance monitoring of drugs for safety by improving the consistency and quality of information(EudraVigilance). Monitoring medical literature and entering pertinent data within EudraVigilance would be executed by the EMA in order to improve adverse drug reaction reporting efficiency. ICSRs found within the literature would be rendered available to MAHs, enabling them to incorporate it within their safety databases while meeting their obligations in terms of reporting . Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance

8. Conclusion There is a gnawing need for the industry to adopt novel, extensive, cost-effective and efficient solutions for medical literature screening and review with a view to match the continuously evolving marketing, regulatory and strategic requirements. In order to ensure regulatory compliance, Pharmaceutical organizations should adopt enhanced tools and procedures that allow triage, monitor and review pertinent articles from every literature source available. This has to be rather rapid as well as accurate and at the same time should also have the capability to interrogate and incorporate new streams of data. Such solutions need to facilitate incorporation of safety data from diverse sources within a single unified repository throughout the whole lifecycle of the product. Clinical Research monitoring | Global Regulatory Writing | Patient Recruitment | Data Management | Post Market Surveillance

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