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Adverse Effects and Pharmacovigilance

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Abstract

No drug can be testified to be entirely free of undesired effects. These undesired or unintended effects of drug administration are broadly called adverse effects. When the concept of causality is factored in, the term adverse drug reaction is used. This causality assessment can be done in several ways, Naranjo scale and WHO-UMC scale being the most common ones. Pharmacovigilance is a growing domain that concerns the detection, assessment, understanding and prevention of drug-related adverse effects. On a similar line, hemovigilance is the set of activities that govern adverse effects related to transfusion chains. When the medical materials and devices are involved, it is called materiovigilance, and when cosmetic products are concerned, the cosmetovigilance comes in to play. Addictovigilance is an ill-defined category of events that cover drugs of addictive or recreational misuse. This chapter covers the broad types of vigilance (medicovigilance) and their relevance in the Indian scenario.

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Bibliography

  • Boparai JK, Singh S (2015) Hemovigilance: a new beginning in India. Int J App Basic Med Res 5:200–202

    Article  Google Scholar 

  • Faber JC (2004) Haemovigilance procedure in transfusion medicine. Hematol J 5:S74–S82

    Article  Google Scholar 

  • Flesland O, Wiersum-Osselton JC (2016) Donor vigilance and hemovigilance. In: Tl S, McCullough J, Snyder EI, Solheim B, Strauss RJ (eds) Rossi’s principles of transfusion medicine. Wiley Blackwell, Chichester, pp 58–68

    Chapter  Google Scholar 

  • Gentile G, Jego M, Spadari M, Griffiths K, Jouanjus E, Micallef J (2018) Identification and tracking of Addictovigilance signals in general practice: which interactions between the general practitioners and the French Addictovigilance Network? Fund Clin Pharmacol 32:643–651

    Article  CAS  Google Scholar 

  • Gupta P, Janodia MD, Jagadish PC, Udupa N (2010) Medical device vigilance systems: India, US, UK, and Australia. Med Devices (Auckl) 3:67–79

    Google Scholar 

  • Jain A, Kaur R (2012) Hemovigilance and blood safety. Asian J Transfus Sci 6(2):137–138

    Article  Google Scholar 

  • Jouanjus E, Gibaja V, Kahn J-P, Haramburu F, Daveluy A (2015) Signal identification in addictovigilance: the functioning of the French system. Therapie 70:113–131

    Article  Google Scholar 

  • Kalaiselvan V, Thota P, Singh GN (2016) Pharmacovigilance programme of India: recent developments and future perspectives. Indian J Pharmacol 48:624–628

    Article  Google Scholar 

  • Kalaiselvan V, Srivastava S, Singh A, Gupta SK (2018) Pharmacovigilance in India: present scenario and future challenges. Drug Saf 42:339–346

    Article  Google Scholar 

  • Medical device adverse event reporting form. [Online] [cited 2018 Sep 20]; Available from: URL http://ipc.nic.in/writereaddata/mainlinkFile/File528.pdf

  • Moretti U, Velo G (2008) Cosmetovigilance: the “beautiful” risk. Drug Saf 31:437–439

    Article  Google Scholar 

  • Mukherjee S, Maiti R (2016) Haemovigilance: a current update in Indian perspective. J Clin Diagn Res 10:5–9

    Google Scholar 

  • Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA et al (1981) A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 30(2):239–245

    Article  CAS  Google Scholar 

  • Pharmacovigilance Programme of India (PvPI). [Internet] 2017 [cited 2018 Oct 13]. Available from: http://www.ipc.gov.in/PvPI/about.html

  • Rani S, Singh K (2018) Materiovigilance: an emerging discipline. Int J Sci Res 7:15–16

    CAS  Google Scholar 

  • Sarma P, Kumar H, Medhi B (2017) Cosmetovigilance in India: need of the day. Indian J Pharmacol 49(5):341–343

    PubMed  PubMed Central  Google Scholar 

  • Tripathi KD (2013) Adverse drug effects. In: Essentials of medical pharmacology, 7th edn. Jaypee Publishers, New Delhi, pp 82–91

    Google Scholar 

  • Tseng ZH, Hayward RM, Clark NM, Mulvanny CG, Colburn BJ, Ursell PC et al (2015) Sudden death in patients with cardiac implantable electronic devices. JAMA Intern Med 175:1342–1350

    Article  Google Scholar 

  • Udupa N, Ligade V (2016) Need of cosmetovigilance in India. Value Health 19(7):A836

    Article  Google Scholar 

  • Vigan M, Castelain F (2014) Cosmetovigilance: definition, regulation and use “in practice”. Eur J Dermatol 24(6):643–649

    PubMed  Google Scholar 

  • Zaki SA (2011) Adverse drug reaction and causality assessment scales. Lung India 28(2):152–153

    Article  Google Scholar 

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Arivazhahan, A., Kunder, S.K. (2019). Adverse Effects and Pharmacovigilance. In: Raj, G., Raveendran, R. (eds) Introduction to Basics of Pharmacology and Toxicology. Springer, Singapore. https://doi.org/10.1007/978-981-32-9779-1_11

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