Login Register Cart 0
Generic placeholder image

Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Review Article

Artificial Intelligence in Pharmacovigilance and COVID-19

Author(s): Kamini Bhardwaj*, Rabnoor Alam, Ajay Pandeya and Pankaj Kumar Sharma

Volume 18, Issue 1, 2023

Published on: 23 May, 2022

Page: [5 - 14] Pages: 10

DOI: 10.2174/1574886317666220405115548

Price: $65

Abstract

The history of pharmacovigilance started back 169 years ago with the death of a 15- year-old girl, Hannah greener. However, the Thalidomide incident of 1961 brought a sharp change in the pharmacovigilance process, with adverse drug reaction reporting being systematic, spontaneous, and regulated timely. Therefore, continuous monitoring of marketed drugs was essential to ensure the safety of public health. Any observed adverse drug reaction detected by signals was to be reported by the health profession. Moreover, signal detection became the primary goal of pharmacovigilance based on reported cases. Among various methods used for signal detection, the Spontaneous Reporting System was most widely preferred; although, it had the limitation of "under- reporting”. Gradually, the World Health Organization collaborating centre and “Uppsala Monitoring Centre” were established in 1978 for international monitoring of drugs. The centre was responsible for operating various databases like vigiflow, vigibase, vigilyze, and vigiaccess. Recently, huge data could be generated through spontaneous reporting linked with computational methods, such as Bayesian Framework, E-Synthesis.

Furthermore, drug safety surveillance at an early stage prior to the official alerts or regulatory changes was made possible through social media. In addition, India created a National Pharmacovigilance Program, and Schedule Y of the Drug and Cosmetic Act 1945 was reviewed and amended in 2005. The collaboration of Information Technology and Pharmaceutical Company can further enhance the awareness regarding artificial intelligence in pharmacovigilance, which was in its infancy until 2017. Artificial intelligence helps improve the quality and accuracy of information much quickly.

Keywords: Adverse drug reaction (ADR), artificial intelligence (AI), National Pharmacovigilance Program (NPP), pharmacovigilance (PV), Spontaneous Reporting System (SRS), Uppsala Monitoring Centre (UMC), World health organization (WHO).

« Previous Next »
Graphical Abstract

[1]
Routledge P. 150 years of pharmacovigilance. Lancet 1998; 351(9110): 1200-1.
[http://dx.doi.org/10.1016/S0140-6736(98)03148-1] [PMID: 9643710]
[2]
Commission on Anaesthetics. Lancet 1893; i: 629-38.
[3]
Woolf AD. The Haitian diethylene glycol poisoning tragedy: A dark wood revisited. JAMA 1998; 279(15): 1215-6.
[http://dx.doi.org/10.1001/jama.279.15.1215] [PMID: 9555763]
[4]
FDA Consumer Magazine. 1981. Available from: https://www.fda.gov/about-fda/histories-product-regulation/sulfanilamide-disaster Accessed on 5th Jan, 2021.
[5]
Food and Drug Administration (FDA). History. Available from: https://www.fda.gov/about-fda/what-we-do Accessed on 5th Jan, 2021.
[6]
Rich ML, Ritterhoff RJ, Hoffmann RJ. A fatal case of aplastic anemia following chloramphenicol (chloromycetin) therapy. Ann Intern Med 1950; 33(6): 1459-67.
[http://dx.doi.org/10.7326/0003-4819-33-6-1459] [PMID: 14790529]
[7]
Randall T. Thalidomide’s back in the news, but in more favorable circumstances. JAMA 1990; 263(11): 1467-8.
[http://dx.doi.org/10.1001/jama.1990.03440110019002] [PMID: 2308171]
[8]
Levy M. The epidemiological evaluation of major upper gastrointestinal bleeding in relation to aspirin use. In: Kewitz H, Roots I, Voigt K, Eds. Epidemiological Concepts in Clinical Pharmacology. Berlin, Heidelberg: Springer 1987; 100-4.
[http://dx.doi.org/10.1007/978-3-642-71043-8_11]
[9]
ICH. Available from: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf Accessed on 5th Jan, 2021.
[10]
Van Grootheest K. The dawn of pharmacovigilance. Int J Pharm Med 2003; 17(5-6): 195-200.
[http://dx.doi.org/10.2165/00124363-200317050-00006]
[11]
World Health Organization. Pharmacovigilance: Ensuring the safe use of medicines. World Health Organization Geneva. 2004. Available from: https://apps.who.int/iris/bitstream/handle/10665/68782/WHO_EDM_2004.8.pdf
[12]
Mann RD, Andrews EB. Pharmacovigilance. Chichester: John Wiley & Sons Ltd 2002.
[13]
EudraVigilance. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000633.jsp Accessed on 5th Jan, 2021.
[14]
Kesharwani V, Farooqui MA, Kushwaha N, Singh RK, Jaiswal PK. An overview on pharmacovigilance: A key for drug safety and monitoring. J Drug Deliv Ther 2018; 8(5): 130-5.
[http://dx.doi.org/10.22270/jddt.v8i5.1970]
[15]
EMA. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000628.jsp Accessed on 5th Jan, 2021.
[16]
World Health Organization. The importance of pharmacovigilance Geneva. 2002. Available from: https://apps.who.int/iris/bitstream/handle/10665/42493/a75646.pdf Accessed on 5th Jan, 2021.
[17]
Mazzaglia G, Straus SMJ, Arlett P, et al. Study design and evaluation of risk minimization measures: A review of studies submitted to the European medicines agency for cardiovascular, endocrinology, and metabolic drugs. Drug Saf 2018; 41(2): 191-202.
[http://dx.doi.org/10.1007/s40264-017-0604-4] [PMID: 29124666]
[18]
Deye N, Vincent F, Michel P, et al. Changes in cardiac arrest patients’ temperature management after the 2013 “TTM” trial: Results from an international survey. Ann Intensive Care 2016; 6(1): 4.
[http://dx.doi.org/10.1186/s13613-015-0104-6] [PMID: 26753837]
[19]
World Health Organization. Safety monitoring of medicinal products: Guidelines for setting up and running a pharmacovigilancecentre. 2000. Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/EMP_ConsumerReporting_web_v2.pdf Accessed on 5th Jan, 2021.
[20]
Lawson DH. Pharmacovigilance in the 1990s. Br J Clin Pharmacol 1997; 44(2): 109-10.
[http://dx.doi.org/10.1046/j.1365-2125.1997.00641.x] [PMID: 9278192]
[21]
Netdoctor. Available from:
[22]
http://www. netdoctor.co.uk/medicines/100004446.html Accessed on 5th Jan, 2021.
[23]
World Health Organization. Safety of medicines: A guide to detecting and reporting adverse drug reactions. Geneva: World Health Organization 2002.
[24]
EMA. Better vigilance for public health protection. Overview of the New European UnionPharmacovigilance Legislation 2021. Available from: https://www.ema.europa.eu/en/documents/leaflet/better-vigilance-health-protection-innovation_en.pdfaccessed Accessed 5th Jan, 2021.
[25]
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998; 279(15): 1200-5.
[http://dx.doi.org/10.1001/jama.279.15.1200] [PMID: 9555760]
[26]
Pillans PI. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev Clin Pharmacol 2008; 1(5): 695-705.
[http://dx.doi.org/10.1586/17512433.1.5.695] [PMID: 24422739]
[27]
Aspinall MB, Whittle J, Aspinall SL, Maher RL Jr, Good CB. Improving adverse-drug-reaction reporting in ambulatory care clinics at a Veterans Affairs hospital. Am J Health Syst Pharm 2002; 59(9): 841-5.
[http://dx.doi.org/10.1093/ajhp/59.9.841] [PMID: 12004462]
[28]
Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: Updating the cost-of-illness model. J Am Pharm Assoc 2001; 41(2): 192-9.
[http://dx.doi.org/10.1016/S1086-5802(16)31229-3] [PMID: 11297331]
[29]
White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. PharmacoEconomics 1999; 15(5): 445-58.
[http://dx.doi.org/10.2165/00019053-199915050-00003] [PMID: 10537962]
[30]
Amran MS. Adverse drug reactions and pharmacovigilance. In: Herdeiro MT, Roque F, Figueiras A, Silva TM, Eds. New Insights into the Future of Pharmacoepidemiology and Drug Safety. London: IntechOpen 2021.
[31]
Bond CA, Raehl CL. Adverse drug reactions in United States hospitals. Pharmacotherapy 2006; 26(5): 601-8.
[http://dx.doi.org/10.1592/phco.26.5.601] [PMID: 16637789]
[32]
Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ 1998; 316(7140): 1295-8.
[http://dx.doi.org/10.1136/bmj.316.7140.1295] [PMID: 9554902]
[33]
Najafi S. Importance of pharmacovigilance and the role of healthcare professionals. J Pharmacovigil 2018; 6(252): 1-2.
[34]
Robertson D. Side effects and adverse drug reactions. Nurse Prescribing 2017; 15(10): 512-4.
[http://dx.doi.org/10.12968/npre.2017.15.10.512]
[35]
Egberts TC. Signal detection: Historical background. Drug Saf 2007; 30(7): 607-9.
[http://dx.doi.org/10.2165/00002018-200730070-00006] [PMID: 17604412]
[36]
Hauben M, Reich L. Communication of findings in pharmacovigilance: Use of the term “signal” and the need for precision in its use. Eur J Clin Pharmacol 2005; 61(5-6): 479-80.
[http://dx.doi.org/10.1007/s00228-005-0951-4] [PMID: 15991039]
[37]
Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Saf 1994; 10(2): 93-102.
[http://dx.doi.org/10.2165/00002018-199410020-00001] [PMID: 8011183]
[38]
Ståhl M, Edwards IR, Bowring G, Kiuru A, Lindquist M. Assessing the impact of drug safety signals from the WHO database presented in ‘SIGNAL’: Results from a questionnaire of National Pharmacovigilance Centres. Drug Saf 2003; 26(10): 721-7.
[PMID: 12862506]
[39]
Hochberg AM, Reisinger SJ, Pearson RK, O’Hara DJ, Hall K. Using data mining to predict safety actions from FDA adverse event reporting system data. Drug Inf J 2007; 41(5): 633-43.
[http://dx.doi.org/10.1177/009286150704100510]
[40]
International Society of Pharmacovigilance. Drug safety. New Zealand 2005.
[41]
Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Arias LM. Under-reporting of adverse drug reactions estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 54(6): 483-8.
[42]
Biriell C, Edwards IR. Reasons for reporting adverse drug reactions--some thoughts based on an international review. Pharmacoepidemiol Drug Saf 1997; 6(1): 21-6.
[http://dx.doi.org/10.1002/(SICI)1099-1557(199701)6:1<21:AID-PDS259>3.0.CO;2-I] [PMID: 15073801]
[43]
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: A systematic review. Drug Saf 2006; 29(5): 385-96.
[http://dx.doi.org/10.2165/00002018-200629050-00003] [PMID: 16689555]
[44]
Watson S, Chandler RE, Taavola H, et al. Safety concerns reported by patients identified in a collaborative signal detection workshop using VigiBase: Results and reflections from Lareb and Uppsala monitoring centre. Drug Saf 2018; 41(2): 203-12.
[http://dx.doi.org/10.1007/s40264-017-0594-2] [PMID: 28933055]
[45]
Shanks N, Greek R, Greek J. Are animal models predictive for humans? Philos Ethics Humanit Med 2009; 4(1): 2.
[http://dx.doi.org/10.1186/1747-5341-4-2] [PMID: 19146696]
[46]
Price KL, Xia HA, Lakshminarayanan M, et al. Bayesian methods for design and analysis of safety trials. Pharm Stat 2014; 13(1): 13-24.
[http://dx.doi.org/10.1002/pst.1586] [PMID: 23897858]
[47]
Poluzzi E, Raschi E, Piccinni C, De Ponti F. Data mining techniques in pharmacovigilance: Analysis of the publicly accessible FDA Adverse Event Reporting System (AERS). In: Karahoca E, Ed. Data Mining Applications in Engineering and Medicine. London: Intech Open 2012; pp. 201-13.
[48]
Streit R, Silver J. Data fusion aspects of pharmacovigilance. In Proceedings of the 14th International conference on information fusion. 2011 Jul 5-8; Chicago, IL, USA. 2011; pp. 1522-28.
[49]
Shibata A, Hauben M. Pharmacovigilance, signal detection and signal intelligence overview. In 14th International conference on information fusion. 2011 Jul 5-8; Chicago, IL, USA. 2011; 1515-21.
[50]
Haghighat M, Abdel-Mottaleb M, Alhalabi W. Discriminant correlation analysis: Real-time feature level fusion for multimodal biometric recognition. IEEE Trans Inf Forensics Security 2016; 11(9): 1984-96.
[http://dx.doi.org/10.1109/TIFS.2016.2569061]
[51]
Koutkias VG, Jaulent MC. Computational approaches for pharmacovigilance signal detection: Toward integrated and semantically-enriched frameworks. Drug Saf 2015; 38(3): 219-32.
[http://dx.doi.org/10.1007/s40264-015-0278-8] [PMID: 25749722]
[52]
Tricco AC, Zarin W, Lillie E, et al. Utility of social media and crowd-intelligence data for pharmacovigilance: A scoping review. BMC Med Inform Decis Mak 2018; 18(1): 38-53.
[http://dx.doi.org/10.1186/s12911-018-0621-y] [PMID: 29898743]
[53]
Surendra E, Garlapati R. Development of pharmacovigilance culture. Int J Pharm Res Tech 2020; 10(1): 1-4.
[54]
Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapie 1978; 33(3): 373-81.
[PMID: 684688]
[55]
Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA 1979; 242(7): 623-32.
[http://dx.doi.org/10.1001/jama.1979.03300070019017] [PMID: 449002]
[56]
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-45.
[http://dx.doi.org/10.1038/clpt.1981.154] [PMID: 7249508]
[57]
Lagier G, Vincens M, Castot A. Imputability in drug monitoring. Principles of the balanced drug reaction assessment method and principal errors to avoid. Therapie 1983; 38(3): 303-18.
[PMID: 6612667]
[58]
Venulet J, Ciucci A, Berneker GC. Standardized assessment of drug-adverse reaction associations--rationale and experience. Int J Clin Pharmacol Ther Toxicol 1980; 18(9): 381-8.
[PMID: 7450930]
[59]
Loupi E, Ponchon AC, Ventre JJ, Evreux JC. Imputability of a teratogenic effect. Therapie 1986; 41(3): 207-10.
[PMID: 3750260]
[60]
Danan G, Benichou C. Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuries. J Clin Epidemiol 1993; 46(11): 1323-30.
[http://dx.doi.org/10.1016/0895-4356(93)90101-6] [PMID: 8229110]
[61]
Mashford ML. The Australian method of drug-event assessment. Special workshop--regulatory. Drug Inf J 1984; 18(3-4): 271-3.
[http://dx.doi.org/10.1177/009286158401800313] [PMID: 10268555]
[62]
Ahmed I, Thiessard F, Miremont-Salamé G, et al. Early detection of pharmacovigilance signals with automated methods based on false discovery rates: A comparative study. Drug Saf 2012; 35(6): 495-506.
[http://dx.doi.org/10.2165/11597180-000000000-00000] [PMID: 22612853]
[63]
Matsushita Y, Kuroda Y, Niwa S, Sonehara S, Hamada C, Yoshimura I. Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer. Drug Saf 2007; 30(8): 715-26.
[http://dx.doi.org/10.2165/00002018-200730080-00008] [PMID: 17696584]
[64]
UMC WHO. Available from: https://www.who-umc.org/vigibase/vigilyze/vigimethods/ Accessed on 5th Jan, 2021.
[65]
Caster O, Sandberg L, Bergvall T, Watson S, Norén GN. vigiRank for statistical signal detection in pharmacovigilance: First results from prospective real-world use. Pharmacoepidemiol Drug Saf 2017; 26(8): 1006-10.
[http://dx.doi.org/10.1002/pds.4247] [PMID: 28653790]
[66]
Tregunno PM, Fink DB, Fernandez-Fernandez C, Lázaro-Bengoa E, Norén GN. Performance of probabilistic method to detect duplicate individual case safety reports. Drug Saf 2014; 37(4): 249-58.
[http://dx.doi.org/10.1007/s40264-014-0146-y] [PMID: 24627310]
[67]
Bergvall T, Norén GN, Lindquist M. vigiGrade: A tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf 2014; 37(1): 65-77.
[http://dx.doi.org/10.1007/s40264-013-0131-x] [PMID: 24343765]
[68]
Barr A, Feigenbaum E, Roads C. The Handbook of Artificial Intelligence. 1st ed.. Oxford, UK: Butterworth-Heinemann 1981; 1: 3- 14.
[69]
Mockute R, Desai S, Perera S, et al. Artificial intelligence within pharmacovigilance: A means to identify cognitive services and the framework for their validation. Pharmaceut Med 2019; 33(2): 109-20.
[http://dx.doi.org/10.1007/s40290-019-00269-0] [PMID: 31933254]
[70]
Basile AO, Yahi A, Tatonetti NP. Artificial intelligence for drug toxicity and safety. Trends Pharmacol Sci 2019; 40(9): 624-35.
[http://dx.doi.org/10.1016/j.tips.2019.07.005] [PMID: 31383376]
[71]
USFDA individual case safety reports. Available from: https://www.fda.gov/industry/fda-resources-data-standards/individual-case-safety-reports Accessed on 5th Jan, 2021.
[72]
IPC. Available from: https://ipc.gov.in/mandates/pvpi/pvpi-updates/8-category-en/646-annual-performance-report.html Accessed on 5th Jan, 2021.
[73]
White RW, Wang S, Pant A, et al. Early identification of adverse drug reactions from search log data. J Biomed Inform 2016; 59: 42-8.
[http://dx.doi.org/10.1016/j.jbi.2015.11.005] [PMID: 26610385]
[74]
Shankar PR. VigiAccess: Promoting public access to VigiBase. Indian J Pharmacol 2016; 48(5): 606-7.
[http://dx.doi.org/10.4103/0253-7613.190766] [PMID: 27721554]
[75]
Bhushan S, Ray RS, Prakash J, Singh GN. Global versus Indian perspective of pioglitazone-induced adverse drug reactions including bladder cancer: A comparative retrospective pharmacovigilance analysis. Clin Ther 2019; 41(11): 2252-62.
[http://dx.doi.org/10.1016/j.clinthera.2019.08.018] [PMID: 31543285]
[76]
Plöen M, Wallberg M, Olsson S. User-driven development of a web-based tool for patient reporting of drug-related harm. Drug Saf 2015; 38(4): 359-64.
[http://dx.doi.org/10.1007/s40264-015-0276-x] [PMID: 25711669]
[77]
Abo Loha C, Livio F. Pharmacovigilance update. Rev Med Suisse 2019; 15(632-633): 92-5.
[PMID: 30629378]
[78]
Chiappini S, Schifano F, Corkery JM, Guirguis A. Focus on clozapine withdrawal-and misuse-related cases as reported to the European Medicines Agency (EMA) pharmacovigilance database. Brain Sci 2020; 10(2): 105-22.
[http://dx.doi.org/10.3390/brainsci10020105] [PMID: 32079135]
[79]
Vickers-Smith R, Sun J, Charnigo RJ, Lofwall MR, Walsh SL, Havens JR. Gabapentin drug misuse signals: A pharmacovigilance assessment using the FDA adverse event reporting system. Drug Alcohol Depend 2020; 206107709
[http://dx.doi.org/10.1016/j.drugalcdep.2019.107709] [PMID: 31732295]
[80]
Anand K, Burns EA, Ensor J, Rice L, Pingali SR. Mycobacterial infections with ruxolitinib: A retrospective pharmacovigilance review. Clin Lymphoma Myeloma Leuk 2020; 20(1): 18-23.
[http://dx.doi.org/10.1016/j.clml.2019.08.008] [PMID: 31699655]
[81]
Matsuo J, Yamaori S, Murai K, Mimura A, Ohmori S. Detecting Co-administered drugs that affect the incidence of long QT syndrome associated with fluoroquinolone antibiotics using a spontaneous reporting system. J Pharmacovigil 2020; 8(1): 278-84.
[82]
Al-Worafi YM. Drug Safety in Developing Countries: Achievements and Challenges. (1st ed.), Cambridge, Massachusetts: Academic Press 2020.
[83]
Arora D. Pharmacovigilance obligations of the pharmaceutical companies in India. Indian J Pharmacol 2008; 40 (Suppl. 1): S13-6.
[PMID: 21369406]
[84]
Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systematic review. Drug Saf 2009; 32(1): 19-31.
[http://dx.doi.org/10.2165/00002018-200932010-00002] [PMID: 19132802]
[85]
Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48(4): 623-7.
[http://dx.doi.org/10.1046/j.1365-2125.1999.00060.x] [PMID: 10583035]
[86]
Ekman E, Bäckström M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 2009; 65(1): 43-6.
[http://dx.doi.org/10.1007/s00228-008-0564-9] [PMID: 18825377]
[87]
Williams D, Feely J. Underreporting of adverse drug reactions: Attitudes of Irish doctors. Ir J Med Sci 1999; 168(4): 257-61.
[http://dx.doi.org/10.1007/BF02944353] [PMID: 10624366]
[88]
Hasford J, Goettler M, Munter KH, Müller-Oerlinghausen B. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55(9): 945-50.
[http://dx.doi.org/10.1016/S0895-4356(02)00450-X] [PMID: 12393084]
[89]
Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: Predictors of under-reporting in Malaysia. Pharmacoepidemiol Drug Saf 2007; 16(2): 223-8.
[http://dx.doi.org/10.1002/pds.1313] [PMID: 16947117]
[90]
Madhan R, Gurumurthy P. Adverse drugreaction reporting: Attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res 2009; 2(2): 10-4.
[91]
Aseffa A, Lulseged S, Makonnen E. Mitigating the impact of COVID-19 on Pharmacovigilance. Ethiop Med J 2020; 58(4): 303-4.

Rights & Permissions Print Cite
Article Metrics
8
© 2024 Bentham Science Publishers | Privacy Policy