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ISSN (Print): 1872-2083
ISSN (Online): 2212-4012

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Review Article

The Role of Advanced Technologies Supplemented with Traditional Methods in Pharmacovigilance Sciences

Author(s): Mandali V. Satwika, Dudala S. Sushma, Varun Jaiswal, Syed Asha and Tarun Pal*

Volume 15, Issue 1, 2021

Published on: 21 October, 2020

Page: [34 - 50] Pages: 17

DOI: 10.2174/1872208314666201021162704

Price: $65

Abstract

Background: The immediate automatic systemic monitoring and reporting of adverse drug reactions, improving the efficacy is the utmost need of the medical informatics community. The venturing of advanced digital technologies into the health sector has opened new avenues for rapid monitoring. In recent years, data shared through social media, mobile apps, and other social websites has increased manifolds requiring data mining techniques.

Objective: The objective of this report is to highlight the role of advanced technologies together with the traditional methods to proactively aid in the early detection of adverse drug reactions concerned with drug safety and pharmacovigilance.

Methods: A thorough search was conducted on papers and patents regarding pharmacovigilance. All articles with respect to the relevant subject were explored and mined from public repositories such as Pubmed, Google Scholar, Springer, ScienceDirect (Elsevier), Web of Science, etc.

Results: The European Union’s Innovative Medicines Initiative WEB-RADR project has emphasized the development of mobile applications and social media data for reporting adverse effects. Only relevant data has to be captured through the data mining algorithms (DMAs) as it plays an important role in timely prediction of risk with high accuracy using two popular approaches; the frequentist and Bayesian approach. Pharmacovigilance at the pre-marketing stage is useful for the prediction of adverse drug reactions in the early developmental stage of a drug. Later, post-marketing safety reports and clinical data reports are important to be monitored through electronic health records, prescription-event monitoring, spontaneous reporting databases, etc.

Conclusion: The advanced technologies supplemented with traditional technologies are the need of the hour for evaluating a product’s risk profile and reducing risk in population especially with comorbid conditions and on concomitant medications.

Keywords: Adverse drug reaction, pharmacovigilance, drug safety, social media, data mining, signal detection, COVID-19.

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[1]
Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008; 64(8): 743-52.
[http://dx.doi.org/10.1007/s00228-008-0475-9] [PMID: 18523760]
[2]
McBride WG. Thalidomide and congenital abnormalities. Lancet 1961; 2(1358): 90927-8.
[3]
Dave VS. Current trends in pharmacovigilance. J Pharmacovigil 2013; 1(2): e104.
[http://dx.doi.org/10.4172/2329-6887.1000e104]
[4]
Talbot JC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol 1998; 45(5): 427-31.
[http://dx.doi.org/10.1046/j.1365-2125.1998.00713.x] [PMID: 9643613]
[5]
Onakpoya IJ, Heneghan CJ, Aronson JK. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC Med 2015; 13(1): 26.
[http://dx.doi.org/10.1186/s12916-014-0262-7] [PMID: 25651859]
[6]
Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: an overview. Online J Public Health Inform 2015; 7(2): e223.
[http://dx.doi.org/10.5210/ojphi.v7i2.5595] [PMID: 26392851]
[7]
Pierce CE, de Vries ST, Bodin-Parssinen S, Härmark L, Tregunno P, Lewis DJ, et al. Recommendations on the use of mobile applications for the collection and communication of pharmaceutical product safety information: lessons from IMI WEB-RADR. Drug Saf 2019; 42(4): 477-89.
[http://dx.doi.org/10.1007/s40264-019-00813-6] [PMID: 30911975]
[8]
Rohilla A, Singh N, Kumar V, Kumar M, Sharma AD, Kushnoor A. Pharmacovigilance: needs and objectives. J Adv Pharm Educ Res 2012; 2(4): 1-5.
[9]
Coronavirus WH. Coronavirus disease (COVID-19) pandemic. 2020. Available at: https://www. who. int/emergencies/diseases/novel-coronavirus-2019www. who. int2020.
[10]
Rukmangathen R, Devi BV, Bhoopathi D. The roles and responsibilities of pharmacovigilante’s in adverse drug reaction monitoring centre. Ind J Pharm Prac 2017; 10(2): 137.
[11]
Dal Pan GJ. Ongoing challenges in pharmacovigilance. Drug Saf 2014; 37(1): 1-8.
[PMID: 24264884]
[12]
Lu Z. Information technology in pharmacovigilance: benefits, challenges, and future directions from industry perspectives. Drug Healthc Patient Saf 2009; 1: 35-45.
[PMID: 21701609]
[13]
Sarker A, Ginn R, Nikfarjam A, O’Connor K, Smith K, Jayaraman S, et al. Utilizing social media data for pharmacovigilance: a review. J Biomed Inform 2015; 54: 202-12.
[http://dx.doi.org/10.1016/j.jbi.2015.02.004] [PMID: 25720841]
[14]
Yang M, Kiang M, Shang W. Filtering big data from social media-building an early warning system for adverse drug reactions. J Biomed Inform 2015; 54: 230-40.
[http://dx.doi.org/10.1016/j.jbi.2015.01.011] [PMID: 25688695]
[15]
Korkontzelos I, Nikfarjam A, Shardlow M, Sarker A, Ananiadou S, Gonzalez GH. Analysis of the effect of sentiment analysis on extracting adverse drug reactions from tweets and forum posts. J Biomed Inform 2016; 62: 148-58.
[http://dx.doi.org/10.1016/j.jbi.2016.06.007] [PMID: 27363901]
[16]
Lewis JD, Schinnar R, Bilker WB, Wang X, Strom BL. Validation studies of the health improvement network (THIN) database for pharmacoepidemiology research. Pharmacoepidemiol Drug Saf 2007; 16(4): 393-401.
[http://dx.doi.org/10.1002/pds.1335] [PMID: 17066486]
[17]
Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10(6): 483-6.
[http://dx.doi.org/10.1002/pds.677] [PMID: 11828828]
[18]
Sarker A, Gonzalez G. Portable automatic text classification for adverse drug reaction detection via multi-corpus training. J Biomed Inform 2015; 53: 196-207.
[http://dx.doi.org/10.1016/j.jbi.2014.11.002] [PMID: 25451103]
[19]
Ithnin M, Mohd Rani MD, Abd Latif Z, Kani P, Syaiful A, Aripin KN, et al. Mobile app design, development, and publication for adverse drug reaction assessments of causality, severity, and preventability. JMIR Mhealth Uhealth 2017; 5(5): e78.
[http://dx.doi.org/10.2196/mhealth.6261] [PMID: 28559222]
[20]
Hauben M, Madigan D, Gerrits CM, Walsh L, Van Puijenbroek EP. The role of data mining in pharmacovigilance. Expert Opin Drug Saf 2005; 4(5): 929-48.
[http://dx.doi.org/10.1517/14740338.4.5.929] [PMID: 16111454]
[21]
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: Poluzzi E, Raschi E, Piccinni C, De Ponti F, Eds. Data mining applications in engineering and medicine London IntechOpen. 2012.
[22]
Whitebread S, Hamon J, Bojanic D, Urban L. Keynote review: in vitro safety pharmacology profiling: an essential tool for successful drug development. Drug Discov Today 2005; 10(21): 1421-33.
[http://dx.doi.org/10.1016/S1359-6446(05)03632-9] [PMID: 16243262]
[23]
Sharrar RG, Dieck GS. Monitoring product safety in the post marketing environment. Ther Adv Drug Saf 2013; 4(5): 211-9.
[http://dx.doi.org/10.1177/2042098613490780] [PMID: 25114782]
[24]
Selker HP, Eichler HG, Stockbridge NL, McElwee NE, Dere WH, Cohen T, et al. Efficacy and effectiveness too trials: clinical trial designs to generate evidence on efficacy and on effectiveness in wide practice. Clin Pharmacol Ther 2019; 105(4): 857-66.
[http://dx.doi.org/10.1002/cpt.1347] [PMID: 30610746]
[25]
Barnes J. The international society of pharmacovigilance (ISoP) special interest group on herbal and traditional medicines: towards progress in pharmacovigilance for herbal and traditional medicines and other “natural health” products. Drug Saf 2020; 43(7): 619-22.
[http://dx.doi.org/10.1007/s40264-020-00937-0] [PMID: 32328906]
[26]
Gagnon S, Schueler P, Fan JD. Pharmacovigilance and risk management. In: Bairu M, Chin R, Eds. Global clinical trials playbook. 1st ed Academic Press. 2012; pp. 141-59.
[http://dx.doi.org/10.1016/B978-0-12-415787-3.00013-8]
[27]
Sun J, Deng X, Chen X, Huang J, Huang S, Li Y, et al. incidence of adverse drug reactions in covid-19 patients in china: an active monitoring study by hospital pharmacovigilance system. Clin Pharmacol Ther 2020; 108(4): 791-7.
[http://dx.doi.org/10.1002/cpt.1866] [PMID: 32324898]
[28]
Guan WJ, Liang WH, Zhao Y, Liang HR, Chen ZS, Li YM, et al. China medical treatment expert group for COVID-19. Comorbidity and its impact on 1590 patients with COVID-19 in China: a nationwide analysis. Eur Respir J 2020; 55(5): 2000547.
[http://dx.doi.org/10.1183/13993003.00547-2020] [PMID: 32217650]
[29]
Hughes R, Pedotti R, Koendgen H. COVID-19 in persons with multiple sclerosis treated with ocrelizumab - A pharmacovigilance case series. Mult Scler Relat Disord 2020; 42: 102192.
[http://dx.doi.org/10.1016/j.msard.2020.102192] [PMID: 32570202]
[30]
Maitra A, Mohamedrasheed AK, Jain TG, Shivaram M, Sengupta S, Ramnani RR, et al. Accenture Global Services Ltd, assignee. System for automated analysis of clinical text for pharmacovigilance. US Patent 2020; 10,614,196
[31]
Gogolak V. Pharmacovigilance database. US Patent 778:994US6, 2004.
[32]
Mehta RR, Wei HG, Steinberg GB. System and method for pharmacovigilance. US Patent 744:872.US8, 2014.
[33]
Viklund S, Snowdall C, Kaehler A, Spix A. Pharmacovigilance systems and methods. US Patent 418:69.US16, 2019.
[34]
Garrow AG, Leidner JL, Plachouras V, Nugent TC. Pharmacovigilance systems and methods utilizing cascading filters and machine learning models to classify and discern pharmaceutical trends from social media posts. US Patent 861:714US14, 2016.
[35]
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]
[36]
Brahmachari B, Fernandes M, Bhatt A. Pharmacovigilance for clinical trials in India: current practice and areas for reform. Perspect Clin Res 2011; 2(2): 49-53.
[http://dx.doi.org/10.4103/2229-3485.80366] [PMID: 21731854]
[37]
Kim M, Kim M. Effect of A Pharmacovigilance practice training course for future doctors of korean medicine on knowledge. Attitudes Self Efficacy J Korean Med 2020; 41(1): 21-44.
[38]
van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, et al. What future healthcare professionals need to know about pharmacovigilance: introduction of the WHO PV core curriculum for university teaching with focus on clinical aspects. Drug Saf 2018; 41(11): 1003-11.
[http://dx.doi.org/10.1007/s40264-018-0681-z] [PMID: 29949100]
[39]
Bahri P, Dodoo AN, Edwards BD, Edwards IR, Fermont I, Hagemann U, et al. The ISoP CommSIG for improving medicinal product risk communication: a new special interest group of the international society of pharmacovigilance. Drug Saf 2015; 38(7): 621-7.
[http://dx.doi.org/10.1007/s40264-015-0301-0] [PMID: 26032946]
[40]
Danysz K, Cicirello S, Mingle E, Assuncao B, Tetarenko N, Mockute R, et al. Artificial intelligence and the future of the drug safety professional. Drug Saf 2019; 42(4): 491-7.
[http://dx.doi.org/10.1007/s40264-018-0746-z] [PMID: 30343417]
[41]
Coghlan ML, Maker G, Crighton E, et al. Combined DNA, toxicological and heavy metal analyses provides an auditing toolkit to improve pharmacovigilance of traditional Chinese medicine (TCM). Sci Rep 2015; 5: 17475.
[http://dx.doi.org/10.1038/srep17475] [PMID: 26658160]
[42]
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; 206: 107709.
[http://dx.doi.org/10.1016/j.drugalcdep.2019.107709] [PMID: 31732295]
[43]
Every-Palmer S, Ellis PM. Clozapine-induced gastrointestinal hypomotility: a 22-year bi-national pharmacovigilance study of serious or fatal ‘slow gut’ reactions, and comparison with international drug safety advice. CNS Drugs 2017; 31(8): 699-709.
[http://dx.doi.org/10.1007/s40263-017-0448-6] [PMID: 28623627]
[44]
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.
[http://dx.doi.org/10.3390/brainsci10020105] [PMID: 32079135]
[45]
Gérard A, Romani S, Fresse A, Viard D, Parassol N, Granvuillemin A, et al. “Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers. Therapie 2020; 75(4): 371-9.
[http://dx.doi.org/10.1016/j.therap.2020.05.002] [PMID: 32418730]
[46]
Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, et al. Identification of anticancer drugs associated with atrial fibrillation - analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother 2020, pvaa037: Epub ahead of print.
[http://dx.doi.org/10.1093/ehjcvp/pvaa037] [PMID: 32353110]
[47]
Scavone C, Mascolo A, Ruggiero R, Sportiello L, Rafaniello C, Berrino L, et al. Quinolones-induced musculoskeletal, neurological, and psychiatric ADRS: a pharmacovigilance study based on data from the Italian spontaneous reporting system. Front Pharmacol 2020; 11: 428.
[http://dx.doi.org/10.3389/fphar.2020.00428] [PMID: 32351386]
[48]
Molina-Guarneros JA, Sainz-Gil M, Sanz-Fadrique R, García P, Rodríguez-Jiménez P, Navarro-García E, et al. Bullous pemphigoid associated with the use of dipeptidil peptidase-4 inhibitors: analysis from studies based on pharmacovigilance databases. Int J Clin Pharm 2020; 42(2): 713-20.
[http://dx.doi.org/10.1007/s11096-020-01003-6] [PMID: 32140915]
[49]
Ali TB, Schleret TR, Reilly BM, Chen WY, Abagyan R. Adverse effects of cholinesterase inhibitors in dementia, according to the pharmacovigilance databases of the United-States and Canada. PLoS One 2015; 10(12): e0144337.
[http://dx.doi.org/10.1371/journal.pone.0144337] [PMID: 26642212]
[50]
Stämpfli D, Weiler S, Burden AM. Movement disorders and use of risperidone and methylphenidate: a review of case reports and an analysis of the WHO database in pharmacovigilance. Eur Child Adolesc Psychiatry 2020; 1-2. Epub ahead of print
[PMID: 32621088]
[51]
Eiden C, Peyrière H, Cociglio M, Djezzar S, Hansel S, Blayac JP, et al. Network of the French Pharmacovigilance Centers. Adverse effects of voriconazole: analysis of the French Pharmacovigilance Database. Ann Pharmacother 2007; 41(5): 755-63.
[http://dx.doi.org/10.1345/aph.1H671] [PMID: 17456542]
[52]
Cottin J, Pierre S, Pizzoglio V, Simon C, Durrieu G, Bleyzac N, et al. Methylprednisolone-related liver injury: a descriptive study using the French pharmacovigilance database. Clin Res Hepatol Gastroenterol 2020; 44(5): 662-73.
[http://dx.doi.org/10.1016/j.clinre.2019.12.008] [PMID: 31948782]
[53]
Bretagne M, Lebrun-Vignes B, Pariente A, Shaffer CM, Malouf GG, Dureau P, et al. Heart failure and atrial tachyarrhythmia on abiraterone: a pharmacovigilance study. Arch Cardiovasc Dis 2020; 113(1): 9-21.
[http://dx.doi.org/10.1016/j.acvd.2019.09.006] [PMID: 31685432]
[54]
Singh AP, Tousif S, Umbarkar P, Lal H. A Pharmacovigilance study of hydroxychloroquine cardiac safety profile: potential implication in COVID-19 mitigation. J Clin Med 2020; 9(6): 1867.
[http://dx.doi.org/10.3390/jcm9061867] [PMID: 32549293]
[55]
Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, et al. A pilot study of hydroxychloroquine in treatment of patients with moderate COVID-19. J Zhejiang University 2020; 49(2): 215-9.
[56]
Dubert M, Visseaux B, Isernia V, Bouadma L, Deconinck L, Patrier J, et al. Case report study of the first five COVID-19 patients treated with remdesivir in France. Int J Infect Dis 2020; 98: 290-3.
[http://dx.doi.org/10.1016/j.ijid.2020.06.093] [PMID: 32619764]
[57]
Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 2020; 30(3): 269-71.
[http://dx.doi.org/10.1038/s41422-020-0282-0] [PMID: 32020029]
[58]
Li Y, Xie Z, Lin W, Cai W, Wen C, Guan Y, et al. Efficacy and safety of lopinavir/ritonavir or arbidol in adult patients with mild/moderate COVID-19: an exploratory randomized controlled trial. Med 2020; 1(1): 105-13.
[59]
Cain DW, Cidlowski JA. After 62 years of regulating immunity, dexamethasone meets COVID-19. Nat Rev Immunol 2020; 20(10): 587-8.
[http://dx.doi.org/10.1038/s41577-020-00421-x] [PMID: 32778829]
[60]
Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, et al. Dexamethasone in hospitalized patients with Covid-19 - preliminary report. N Engl J Med 2020; 384(8): 693-704.
[PMID: 32678530]
[61]
Chandler RE. Serious neurological adverse events after ivermectin-do they occur beyond the indication of onchocerciasis? Am J Trop Med Hyg 2018; 98(2): 382-8.
[http://dx.doi.org/10.4269/ajtmh.17-0042] [PMID: 29210346]
[62]
Choi MH, Ahn H, Ryu HS, Kim BJ, Jang J, Jung M, et al. Clinical characteristics and disease progression in early-stage COVID-19 patients in South Korea. J Clin Med 2020; 9(6): 1959.
[http://dx.doi.org/10.3390/jcm9061959] [PMID: 32585855]
[63]
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res 2020; 178: 104787.
[http://dx.doi.org/10.1016/j.antiviral.2020.104787] [PMID: 32251768]
[64]
Cai Q, Yang M, Liu D, Chen J, Shu D, Xia J, et al. Experimental treatment with favipiravir for COVID-19: an open-label control study. Engineering (Beijing) 2020; 6(10): 1192-8.
[http://dx.doi.org/10.1016/j.eng.2020.03.007] [PMID: 32346491]
[65]
Lian N, Xie H, Lin S, Huang J, Zhao J, Lin Q. Umifenovir treatment is not associated with improved outcomes in patients with coronavirus disease 2019: a retrospective study. Clin Microbiol Infect 2020; 26(7): 917-21.
[http://dx.doi.org/10.1016/j.cmi.2020.04.026] [PMID: 32344167]
[66]
Drożdżal S, Rosik J, Lechowicz K, Machaj F, Kotfis K, Ghavami S, et al. FDA approved drugs with pharmacotherapeutic potential for SARS-CoV-2 (COVID-19) therapy. Drug Resist Updat 2020; 53: 100719.
[http://dx.doi.org/10.1016/j.drup.2020.100719] [PMID: 32717568]
[67]
Wakefield D, McCluskey P, Penny R. Intravenous pulse methylprednisolone therapy in severe inflammatory eye disease. Arch Ophthalmol 1986; 104(6): 847-51.
[http://dx.doi.org/10.1001/archopht.1986.01050180081035] [PMID: 3521558]
[68]
Cantini F, Niccoli L, Matarrese D, Nicastri E, Stobbione P, Goletti D. Baricitinib therapy in COVID-19: A pilot study on safety and clinical impact. J Infect 2020; 81(2): 318-56.
[http://dx.doi.org/10.1016/j.jinf.2020.04.017] [PMID: 32333918]
[69]
Zhang X, Zhang Y, Qiao W, Zhang J, Qi Z. Baricitinib, a drug with potential effect to prevent SARS- COV-2 from entering target cells and control cytokine storm induced by COVID-19. Int Immunopharmacol 2020; 86: 106749.
[http://dx.doi.org/10.1016/j.intimp.2020.106749] [PMID: 32645632]
[70]
El Kantar S, Nehmeh B, Saad P, Mitri G, Estephan C, Mroueh M, et al. Derivatization and combination therapy of current COVID-19 therapeutic agents: a review of mechanistic pathways, adverse effects, and binding sites. Drug Discov Today 2020. S1359-6446(20): 30307-X.
[PMID: 32801052]
[71]
Gatti M, Fusaroli M, Caraceni P, Poluzzi E, De Ponti F, Raschi E. Serious adverse events with tocilizumab: Pharmacovigilance as an aid to prioritize monitoring in COVID-19. Br J Clin Pharmacol 2020; epub ahead of print.
[http://dx.doi.org/10.1111/bcp.14459] [PMID: 32639062]

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