A succinct medical safety: periodic safety update reports

Authors

  • Arun Chander Yadav Krishnamurthy Department of Pharmacology, JIPMER, Pondicherry, India
  • Jayasudha Dhanasekaran Department of Medicine, Madras Medical College, Chennai, Tamil Nadu, India
  • Anusha Natarajan Department of Pharmacology, JIPMER, Pondicherry, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20172714

Keywords:

Periodic safety update report, Periodic benefit-risk evaluation report, Pharmacovigilance

Abstract

In the rapidly developing era of advanced of medical sciences, pharmacovigilance plays an important role to put necessary brakes and help the medical fraternity to prescribe in a safe manner. Unanimously PSUR contributes in an essential way to regulate the drug marketing agencies to make sure that biological products which are marketed do not harm the general population by its adverse drug reactions. As we all know that the regulatory agencies like EMA, US FDA, CDSCO etc. are very stringent in approving the drugs, they have framed several rules and imposed strict timelines for reporting the necessary documents pertaining to drugs. Inevitably several new drugs like immunomodulators, anticancer drugs are on the raise which further adds a huge responsibility on the regulatory agencies regarding the risk and benefits of such biological products. Thus, the regulatory agencies have added several new implementation and amendments in the existing rules for the marketing of new drugs as well as already prevailing drugs. Hence, it is of paramount importance for the drug companies to follow the guidelines and abide by the rules of regulatory agencies for the benefit of mankind. However, several factors can impede the process of PSUR like improper data retrieval, inadequate training of resource personnel concerned with the development of PSUR. To overcome such difficulties, the field of advanced technology extended its arms for the regulatory authorities to implement electronic documentation and databases for the development of PSURs. In spite of all these efforts several challenges are to be met in the future in the field of pharmacovigilance. In this review several aspects of PSUR in different countries, necessary processes and format in which it needs to be submitted, pitfalls and ways to overcome such situations have been discussed in brief. Therefore, it is the collective responsibility of both Regulatory agencies and the drug companies to ensure a good quality PSUR is produced with its benefits outweighing the risk of the drug for the suffering human population. 

References

Verpilat P, Toumi M. Periodic Safety Update Reports. In: Mann RD, Andrews EB, editors. Pharmacovigilance. 2nd Ed. West Sussex: John Wiley and Sons; 2009.

Guidance for Industry Providing Post Market Periodic Safety Reports in the ICH E2C (R2) Format (Periodic Benefit-Risk Evaluation Report). 2013 [accessed on 2016 Feb 9]. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346564.pdf

Module VII - Periodic safety update report. 2013 [accessed on 2016 Feb 2]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf

Submission of Periodic Safety Update Reports. 2012 [accessed on 2016 Feb 2]. Available at: http://www. www.cdsco.nic.in/writereaddata/Submission%20of%20PSUR.pdf

E2C (R2) Implementation Working Group ICH E2C. 2014 [accessed 2016 Feb 2]. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_QAs_Step4.pdf

PBRER Draft Guideline - ICH. 2012 [accessed on 2016 Feb 1]. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_Step4.pdf

Periodic benefit risk evaluation reports for medicinal products - Detailed guidance - GOV.UK. 2014 [accessed 2016 Feb 2]. Available at: https://www.gov.uk/guidance/periodic-benefit-risk-evaluation-reports-for-medicinal-products

Ebbers HC, Mantel-Teeuwisse AK, Sayed-Tabatabaei FA, Moors EHM, Schellekens H, Leufkens HGM. The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals. Eur J Clin Pharmacol. 2013;69:217-26.

López MDC. Pharmacovigilance and risk management in the EU. Pharm Policy Law 2013;15:71-84.

Bouvy JC, Ebbers HC, Schellekens H, Koopmanschap MA. The cost-effectiveness of periodic safety update reports for biologicals in Europe. Clin Pharmacol Ther. 2013;93:433-42.

Jullian S, Jaskiewicz L, Pfannkuche HJ, Parker J, Lalande-Luesink I, Lewis DJ, et al. Aggregate analysis of regulatory authority assessors’ comments to improve the quality of periodic safety update reports. Pharmacoepidemiol Drug Saf. 2015;24:971-82.

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Published

2017-06-23

How to Cite

Krishnamurthy, A. C. Y., Dhanasekaran, J., & Natarajan, A. (2017). A succinct medical safety: periodic safety update reports. International Journal of Basic & Clinical Pharmacology, 6(7), 1545–1551. https://doi.org/10.18203/2319-2003.ijbcp20172714

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Section

Review Articles