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VOLUME 2 , ISSUE 1 ( January-June, 2018 ) > List of Articles

MEDICAL ETHICS, LAW AND SOCIETY

Big Data Analytics and Pharmacovigilance—An Ethical and Legal Consideration

Jaswinder Singh, Rahat Kumar, Pratyush Sharma, MaheshInder Singha

Keywords : Adverse drug reactions (ADRs), Big data analytics, Ethical considerations, Pharmacovigilance.

Citation Information : Singh J, Kumar R, Sharma P, Singha M. Big Data Analytics and Pharmacovigilance—An Ethical and Legal Consideration. Curr Trends Diagn Treat 2018; 2 (1):58-65.

DOI: 10.5005/jp-journals-10055-0040

License: CC BY-NC 4.0

Published Online: 01-06-2018

Copyright Statement:  Copyright © 2018; The Author(s).


Abstract

Drug side effects become once the drugs enter the market. Such type of side effects also called adverse drug reactions (ADRs). ADRs are a major cause of morbidity and mortality among people and present a major health problem worldwide. Thus, what we need is effective post-marketing safety surveillance (or called as pharmacovigilance). In pharmacovigilance, adverse events are obtained from various sources such as drug manufacturers, healthcare professionals, and patients/people consuming these drugs but this presents a problem of lesser reporting as reporting is voluntary amongst these groups. The solution to this problem is the use of big data analytics. Big data” has become a more and more cited term in health care, for the potential use of the huge amount of data collected from digital medical records or administrative data (e.g., drug prescriptions, hospital dismissal forms, healthcare services, etc. and also as a support for regulatory decisions, pharmacovigilance included. Big data also references artificial intelligence, infrastructure, and services, as well as automated processing operations that facilitate the collection, storage, and analysis of data gathered and being produced in ever-increasing quantities. Big data obtained via social media is analyzed using statistics might have considerable errors and biases for individuals not conforming to group characteristics. Utilization of big data in Pharmacovigilance will bring in the potential to complement traditional spontaneous reporting systems, by allowing an epidemiological approach to determine the incidence of adverse events in the population.


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  1. Harpaz R, DuMochel W, Shah N. Big Data and Adverse Drug Reaction Detection. Clinical Pharmacology & Therapeutics. 2016:99(3):268-269.
  2. Cedric B, Badisse D, Sylvie G L, Stefan J D, Carole F, Charles H, Sandrine K, Vincent L, Suzanne P, Christophe R, Stéphane S. The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process. JMIR Res Protoc 2017;6(9):e179.
  3. Jeetu G, Anusha G. Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring. J Young Pharm. 2010 Jul- Sep;2(3):315-320.
  4. Waller PC, Wood SM, Langman MJ, Breckenridge AM, Rawlins MD. Review of company postmarketing surveillance studies. BMJ. 1992 Jun 6;304(6840):1470-1472.
  5. Butler D. Google Flu Trends. Nature 2013; 494:155.
  6. Butler D. When Google got flu wrong. US outbreak foxes a leading webbased method for tracking seasonal flu. Source: https://www.nature.com/news/whengoogle- got-fluwrong- 1.12413. (Last accessed on 27-02-2018.)
  7. U.S Food and Drug Administration. Transcript: FDA's Adverse Event Reporting System (FAERS). Source: https://www.fda. gov/Drugs/NewsEvents/uc m577118.htm. (Last accessed on 27-02-2018.)
  8. The Sentinel Initiative National Strategy for Monitoring Medical Product Safety. May 2008. U.S. Food and Drug Administration Office of Critical Path Programs. Source: https://www.fda.gov/downloads/safety/fdassentinelinitiative/ ucm124701.pdf (last accessed on 22-03-2018.)
  9. Xindong Wu, Xingquan Zhu, Gong-Qing Wu, Wei Ding. Data mining with big data. IEEE Transactions on Knowledge and Data Engineering [Internet]. Institute of Electrical and Electronics Engineers (IEEE); 2014 Jan;26(1):97-107.
  10. Shibata, Atsuko, and Manfred Hauben. “Pharmacovigilance, Signal Detection and Signal Intelligence Overview.” Chicago, Illinois, USA, 2011.
  11. Arlett P, Portier G, de Lisa R, Blake K, Wathion N, Dogne J-M, et al. Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee. Nature Reviews Drug Discovery [Internet]. Springer Nature; 2014 Apr 22;13(5):395–397.
  12. Upshur RE. Principles for the justification of public health intervention. Can J Public Health. 2002 Mar-Apr;93(2):101-103.
  13. Hilbert M, López P. The world's technological capacity to store, communicate, and compute information. Science. 2011 Apr 1;332(6025):60-65.
  14. IBM What is big data? – Bringing big data to the enterprise. [Last accessed on 28 May 2018]. Available from: www.ibm.com.
  15. Vcloudnews.com. (2017). Every Day Big Data Statistics – 2.5 Quintillion Bytes of Data Created Daily. [online] [Last accessed on 27 Mar 2017]. Available at: http://www.vcloudnews.com/everyday- big-data-statistics-2-5-quintillionbytes-of-data-created-daily/
  16. Wigan MR, Clarke R. Big data's big unintended consequences. Computer. 2013 Jun;46(6):46-53.
  17. Ekbia H, Mattioli M, Kouper I, Arave G, Ghazinejad A, Bowman T, et al. Big data, bigger dilemmas: A critical review. Journal of the Association for Information Science and Technology [Internet]. Wiley; 2014 Dec 31;66(8):1523-1545.
  18. McKee R. Ethical issues in using social media for health and health care research. Health Policy [Internet]. Elsevier BV; 2013 May;110(2-3):298-301.
  19. Newell S, Marabelli M. Strategic opportunities (and challenges) of algorithmic decision-making: A call for action on the long-term societal effects of ‘datification’. The Journal of Strategic Information Systems. 2015 Mar 1;24(1):3-14.
  20. Benton A, Ungar L, Hill S, Hennessy S, Mao J, Chung A, Leonard CE, Holmes JH. Identifying potential adverse effects using the web: a new approach to medical hypothesis generation. J Biomed Inform. 2011 Dec;44(6):989-996.
  21. Zimmer M. But the data is already public? On the ethics of research in Facebook. Ethics Inf Technol. 2010;12:25.
  22. Julie Brill. Federal Trade Commission. Protecting Consumer Privacy in an Era of Rapid Change: A Discussion of the FTC's Privacy Report.https://www.ftc.gov/public-statements/ 2012/03/protecting-consumer-privacy-era-rapid-changediscussion- ftcs-privacy (last accessed on 27-08-2018).
  23. European Parliament. Council of the European Union E. U. Directive, 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Off. J. EC. 1995;23(6):348/74–348/99.
  24. Opinion 7/2015. Meeting the challenges of big data. European Data Protection Supervisor. Source: https://edps.europa. eu/sites/edp/files/publication/15-11-19_big_data_en.pdf accessed on 26-06-2018.
  25. Hermanussen M, M de Los Angeles Roi de Lama, Romero AP, Ruiz CA, Burmeister J, Tresguerres JAF. “Differential catch-up in body weight and bone growth after short-term starvation in rats,” Growth Regulation 1996;6(4):230-237.
  26. Banu MJ, Orhii PB, Mejia W et al.“Analysis of the effects of growth hormone, voluntary exercise, and food restriction on diaphyseal bone in female F344 rats,”Bone. 1999; 25(4):469-480.
  27. Banu J, Orhii PB, Okafor MC, Wang L, Kalu DN. “Analysis of the effects of growth hormone, exercise and food on diaphyseal bone in female F344 rats,” Bone 1999; 25(4): 469-480.
  28. Janiszewski P. Obesity Panacea – [News nutrition, peer reviewed research]:[Janiszewski]; [may 13, 2011] - The Science of Starvation: How long can humans survive without food or water?Available from http://blogs.plos.org/obesitypanacea/ about this blog.
  29. Beresford D. Ten Men Dead. New York: Atlantic Press. 1997. ISBN 0-87113-702-X.
  30. Srimat Bhagvatam. SB 4.8.71 - SB 4.8.79
  31. Attia E. “Anorexia nervosa: current status and future directions,”Annual Review of Medicine 2010;61(1) 425-435.
  32. Rosen JC, Reiter J, and Orosan P, “Assessment of body image in eating disorders with the body dysmorphic disorder examination,” Behaviour Research and Therapy 1995; 33(1):77–84.
  33. Grinspoon S, Miller K, Coyle C et al., “Severity of osteopenia in estrogen-deficient women with anorexia nervosa and hypothalamic amenorrhea,” Journal of Clinical Endocrinology and Metabolism 1999;84(6):2049-2055.
  34. Biller BMK, Saxe V, Herzog D.B., Rosenthal DI, Holzman S, Klibanski A. “Mechanisms of osteoporosis in adult and adolescent women with anorexia nervosa,” Journal of Clinical Endocrinology and Metabolism 1989; 68(3): 548-554.
  35. Grinspoon S, Thomas E, Pitts S et al., “Prevalence and predictive factors for regional osteopenia in women with anorexia nervosa,” Annals of Internal Medicine 2000;133(10): 790-I42.
  36. Rigotti NA, Neer RM, Skates SJ, Herzog DB, Nussbaum SR, “The clinical course of osteoporosis in anorexia nervosa. A longitudinal study of cortical bone mass,” The Journal of the American Medical Association 1991;265(9): 1133-1138.
  37. Baker D, Roberts R, Towell T, “Factors predictive of bone mineral density in eating-disordered women: a longitudinal study,” International Journal of Eating Disorders 2000;27(1): 29-35.
  38. Khosla S, Lufkin EG, Hodgson SF, Fitzpatrick LA, Melton LJ III, “Epidemiology and clinical features of osteoporosis in younindividuals,” Bone 1994;15(5):551-555.
  39. Zipfel S, Seibel MJ, Löwe B, Beumont PJ, Kasperk C, Herzog W. “Osteoporosis in eating disorders: a follow-up study of patients with anorexia and bulimia nervosa,” Journal of Clinical Endocrinology and Metabolism 2001;86(11):5227–5233.
  40. Soyka LA, Grinspoon S, Levitsky LL, Herzog DB, Klibanski A. “The effects of anorexia nervosa on bone metabolism in female adolescents,” Journal of Clinical Endocrinology and Metabolism 1999;84(12):4489-4496.
  41. LA Soyka, M. Misra, A. Frenchman et al., “Abnormal bone mineral accrual in adolescent girls with anorexia nervosa,”Journal of Clinical Endocrinology and Metabolism 2002; 87(9):4177-4185.
  42. MM LaBan, JC Wilkins, AH Sackeyfio, and RS Taylor, “Osteoporotic stress fractures in anorexia nervosa: etiology, diagnosis, and review of four cases,” Archives of Physical Medicine and Rehabilitation 1995;76(9):884-887.
  43. Y Maugars, J.-M. Berthelot, S. Lalande, C. Charlier, and A. Prost, “Osteoporotic fractures revealing anorexia nervosa in five females,” Revue du Rhumatisme (English Edition) 1996; 63(3):201–206.
  44. Golden NH et al. Resumption of Menses in Anorexia Nervosa. Arch Pediatr Adolesc med 1997;151:16-21.
  45. Audi L et al. Leptin in Relation to Resumption of Menses in Women with Anorexia Nervosa. Mol Psychiatry 1998;4:544-547.
  46. Mehanna HM, Moledina J, Travis J. “Refeeding syndrome: what it is, and how to prevent and treat it”. BMJ 2008; 336: 1495 8. doi:10.1136/bmj.a301.PMC 2440847. PMID 18583681.
  47. “The Physiology and Treatment of Starvation”. US national library of medicine. Retrieved 17 August 2012. chromeextension://mhjfbmdgcfjbbpaeojofohoefgiehjai/index.html
  48. Kreipe R et al. Eating Disorders in Adolescents and Older Children. Pediatrics in Review 1999; 20:12.
  49. Pike KM et al. Cognitive Behavior Therapy in the Posthospitalization. Treatment of Anorexia Nervosa. Am J Pyschiatry 2004; 11:2046-2049.
  50. Bender DA. Carbohydrates of Physiologic Significance. Murray RK, Bender DA, Botham KM, Kenelly PJ, Rodwell VW, Weil PA.. Harpers Illustrated Biochemistry 28th ed. New York:Mc Graw Hill publications; 2009. p 113-120.
  51. Koffler M, Kisch ES. Starvation diet and very-low-calorie diets may Induce insulin resistance and overt diabetes mellitus. J Diabetes Complications.1996;10(2):109-12.
  52. Hales CN, Barker DJ The thrifty phenotype hypothesis. Br Med Bull. 2001;60:5-20.
  53. Hales CN, Barker DJ (July 1992). “Type 2 (non-insulindependent) diabetes mellitus: the thrifty phenotype hypothesis”. Diabetologia. 35 (7): 595-601.
  54. Barker, D.J.P. (1997). “Maternal Nutrition, Fetal Nutrition, and Disease in Later Life”. Nutrition, ‘13’, pp. 807.
  55. Martin, Paul; Bateson, Patrick (1999). Design for a life: How behaviour develops. London: Jonathan Cape. ISBN 0-224- 05064-8 pp. 110-111.
  56. Barker, DJP. ed. (1992). Fetal and infant origins of adult disease. London: British Medical Journal. ISBN 0-7279-0743-3.
  57. Robinson R (February 2001). “The fetal origins of adult disease: No longer just a hypothesis and may be critically important in south Asia”. Editorial
  58. Mazur A. Why were “starvation diets” promoted for diabetes in the pre-insulin period? Nutrition Journal 2011;10:23.
  59. Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical complications of osseointegrated implants. J Prosthet Dent 1999 May;81(5):537-552.
  60. Kois JC. Predictable single-tooth peri-implant esthetics: five diagnostic keys. Compend Contin Educ Dent 2004 Nov;25(11):895-900.
  61. Evans CD, Chen ST. Esthetic outcomes of immediate implant placements. Clin Oral Implants Res 2008 Jan;19(1):73-80.
  62. Romeo E, Lops D, Rossi A, Storelli S, Rozza R, Chiapasco M. Surgical and prosthetic management of interproximal region with single-implant restorations: 1-year prospective study. J Periodontol 2008 Jun;79(6):1048-1055.
  63. Nagaraj KR, Savadi CR, Savadi AR, Prashanth Reddy GT, Srilakshmi J, Dayalan M, John J. Gingival biotype— prosthodontic perspective. J Indian Prosthodont Soc 2010 Mar;10(1):27-30.
  64. Jung RE, Sailer I, Hämmerle CH, Attin T, Schmidlin P. In vitro color changes of soft tissues caused by restorative materials. Int J Periodontics Restorative Dent 2007 Jun;27(3): 251-257.
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