Advertisement

Drug Safety

pp 1–4 | Cite as

Real World Evidence: Time for a Switch?

  • Rachel E. Sobel
  • Andrew Bate
  • Robert F. Reynolds
Commentary
  • 34 Downloads

Real World Evidence (RWE) provides critical information about the performance of medicines in routine clinical practice, as actually prescribed by physicians and taken by patients. For decades, observational designs and electronic healthcare databases have been used to characterize patient populations, describe the natural history of diseases, assess postapproval safety and conduct risk management programs as part of the drug development lifecycle. These approaches have evolved in recent years due to advances in electronic data collection, data linkage, computing power, the greater availability of analytic tools and methodologies, and established best practices. The US FDA Sentinel Initiative illustrates these advances well by rapidly generating evidence (in days, not months) in large populations (more than half of the US population in some analyses) and with increased transparency [1]. These advances have made possible the potential use of these systems for outcomes other than...

Notes

Compliance with Ethical Standards

Conflicts of interest

Rachel E. Sobel, Andrew Bate, and Robert F. Reynolds are employees and shareholders of Pfizer, which manufactures both generic and branded medicines. The views expressed in this paper are those of the authors and may not necessarily reflect the views or opinions of Pfizer.

Funding

No sources of funding were used to assist in the preparation of this commentary.

References

  1. 1.
    Ball R, et al. The FDA’s sentinel initiative: a comprehensive approach to medical product surveillance. Clin Pharmacol Ther. 2016;99(3):265–8.CrossRefGoogle Scholar
  2. 2.
    US FDA. Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II). 2017. https://www.fda.gov/NewsEvents/Testimony/ucm547898.htm. Accessed 25 Sep 2018.
  3. 3.
    Gagne JJ, et al. Evaluation of switching patterns in FDA’s Sentinel system: a new tool to assess generic drugs. Drug Saf. 2018.  https://doi.org/10.1007/s40264-018-0709-4 (epub 17 Aug 2018).CrossRefPubMedGoogle Scholar
  4. 4.
    Bohn J, et al. Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs. Clin Pharmacol Ther. 2015;97(5):508–17.CrossRefGoogle Scholar
  5. 5.
    Barlas S. Frustration over generic drug shortages and prices prompts federal and private actions: health systems take matters into their own hands. Pharmacy Ther. 2018;43(4):211.Google Scholar
  6. 6.
    Hansen RA, et al. Comparison of outcomes following a switch from a brand to an authorized versus independent generic drug. Clin Pharmacol Ther. 2018;103(2):310–7.CrossRefGoogle Scholar
  7. 7.
    Desai RJ, et al. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018;361:k1180.CrossRefGoogle Scholar
  8. 8.
    DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200–9.CrossRefGoogle Scholar
  9. 9.
    Ruppar TM, et al. Medication adherence interventions improve heart failure mortality and readmission rates: systematic review and meta-analysis of controlled trials. J Am Heart Assoc. 2016;5(6):e002606.CrossRefGoogle Scholar
  10. 10.
    Iuga AO, McGuire MJ. Adherence and health care costs. Risk Manag Healthc Policy. 2014;7:35–44.PubMedPubMedCentralGoogle Scholar
  11. 11.
    Bate A, et al. Oral contraceptives and VTE across the Sentinel data network: an IMEDS evaluation pilot assessment. Pharmacoepidemiol Drug Saf. 2016;25(Suppl 3):S531.Google Scholar
  12. 12.
    Sobel RE, et al. Risk minimization evaluation in a distributed data network: an IMEDS evaluation pilot assessment of the 2010 class label change for proton pump inhibitors. Pharmacoepidemiol Drug Saf. 2016;25(Suppl 3):S6.Google Scholar
  13. 13.
    Fife D, et al. Medication changes after switching from CONCERTA(R) brand methylphenidate HCl to a generic long-acting formulation: a retrospective database study. PLoS One. 2018;13(2):e0193453.CrossRefGoogle Scholar
  14. 14.
    Gagne JJ, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400–7.CrossRefGoogle Scholar
  15. 15.
    Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 375: brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 Pt 1):447–8.Google Scholar
  16. 16.
    US FDA. FDA updates on valsartan recalls. 2018. https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm. Accessed 15 Sep 2018.
  17. 17.
    European Medicines Agency. Workshop: measuring the impact of pharmacovigilance activities. 2016. https://www.ema.europa.eu/events/workshop-measuring-impact-pharmacovigilance-activities. Accessed 25 Aug 2018.
  18. 18.
    European Medicines Agency. PRAC strategy on measuring the impact of pharmacovigilance activities (rev 1). 2017. https://www.ema.europa.eu/documents/other/prac-strategy-measuring-impact-pharmacovigilance-activities_en.pdf. Accessed 4 Oct 2018.
  19. 19.
    Lester J, et al. Evaluation of FDA safety-related drug label changes in 2010. Pharmacoepidemiol Drug Saf. 2013;22(3):302–5.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Pfizer Inc, Worldwide Safety and RegulatoryNew YorkUSA
  2. 2.Pfizer Ltd, Worldwide Safety and RegulatoryWalton OaksUK

Personalised recommendations