Title: Ecopharmacovigilance
Authors: Dr Deepak Bhosale, Dr Sameer Khan, Dr Abhijeet Bhagat, Faheem Ashraf, Dr Huzaif
DOI: https://dx.doi.org/10.18535/jmscr/v6i3.140
Abstract
In this article we have presented some ideas on what Ecopharmacovigilance (EPV) might mean in practice, together with what challenges and opportunities it poses in today’s scenario implementing EPV procedures.
References
- Ankley GT, Black MC, Garric J, Hutchinson TH, Iguchi T. A framework for assessing the hazard of pharmaceutical materials to aquatic species. In: William RT, editor. Human pharmaceuticals: assessing the impacts on aquatic ecosystems. Florida: SETAC Press; 2005.
- Gunnarsson L, Jauhiainen A, Kristiansson E, Nerman O, Larsson DGJ. Evolutionary conservation of human drug targets in organisms used for environmental risk assessments. Environ Sci Technol. 2008;42(15):5807–13.
- Oaks JL, Gilbert M, Virani MZ, Watson RT, Meteyer CU, Rideout BA, et al. Diclofenac residues as the cause of vulture population decline in Pakistan. Nature. 2004;427(6975):630–3.
- La¨nge R, Hutchinson TH, Croudace CP, Siegmund F, Schweinfurth H, Hampe P, et al. Effects of the synthetic estrogen 17beta-ethinylestradiol on the life-cycle of the fathead minnow (Pimephales promelas). Environ Toxicol Chem. 2001;20(6): 1216–27.
- Nash JP, Kime DE, Van der Ven LT, Wester PW, Brion F, Maack G, et al. Long-term exposure to environmental concentrations of the pharmaceutical ethynylestradiol causes reproductive failure in fish. Environ Health Perspect. 2004;112(17): 1725–33.
- Caldwell DJ, Mastrocco F, Anderson PD, La¨nge R, Sumpter JP. Predicted-no-effect concentrations for the steroid estrogens estrone, 17beta-estradiol, estriol, and 17beta-ethinylestradiol. Environ Toxicol Chem. 2012;31(6):1396–406.
- Jobling S, Nolan M, Tyler CR, Brighty G, Sumpter JP. Widespread sexual disruption in wild fish. Environ Sci Technol. 1998;32(17):2498–506.
- Jobling S, Tyler CR. Introduction: the ecological relevance of chemically induced endocrine disruption in wildlife. Environ Health Perspect. 2006;114(Suppl. 1):7–8.
- World Health Organisation. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organisation; 2002.
- Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov. 2009;8:779–82.
- Alder AC. Consumption and occurrence. In: Ternes TA, Joss A, editors. Human pharmaceuticals, hormones and fragr-ances: the challenge of micropollutants in urban water management. London: IWA Publishing; 2006.
- Daughton CG, Ternes TA. Pharmaceuticals and personal care products in the environment: agents of subtle change? Environ Health Perspect. 1999;107(Suppl.6):907–38.
- Kt‹mmerer K. Drugs in the environment: emission of drugs, diagnostic aids and disinfectants into wastewater by hospitals in relation to other sources: a review. Chemosphere. 2001;45(6–7): 957–69.
- Vanderford BJ, Snyder SA. Analysis of pharmaceuticals in water by isotope dilution liquid chromatography/tandem mass spectrometry. Environ Sci Technol. 2006;40(23):7312–20.
- Batt AL, Kostich MS, Lazorchak JM. Analysis of ecologically relevant pharmaceuticals in wastewater and surface water using selective solid-phase extraction and UPLC-MS/MS. Anal Chem. 2008;80(13):5021–30.
- Kasprzyk-Hordern B, Baker DR. Estimation of community-wide drugs use via stereoselective profiling of sewage. Sci Total Environ. 2012;423:142–50.
- Kt‹mmerer K. The presence of pharmaceuticals in the environment due to human use—present knowledge and future challenges. J Environ Manage. 2009;90(8):2354–66.
- Cunningham VL, Binks SP, Olson MJ. Human health risk assessment from the presence of human pharmaceuticals in the aquatic environment. Regul Toxicol Pharmacol. 2009;53(1):39–45.
- Heberer T. Occurrence, fate, and removal of pharmaceutical residues in the aquatic environment: a review of recent research data. Toxicol Lett. 2002;131(1–2):5–17.
- Fent K, Weston AA, Caminada D. Ecotoxicology of human pharmaceuticals. Aquat Toxicol. 2006;76(2):122–59.
- Kim SD, Cho J, Kim IS, Vanderford BJ, Snyder SA. Occurrence and removal of pharmaceuticals and endocrine disruptors in South Korean surface, drinking, and waste waters. Water Res. 2007;41 (5):1013–21.
- Daughton CG, Ruhoy IS. Environmental footprint of pharmaceuticals: the significance of factors beyond direct excretion to sewers. Environ Toxicol Chem. 2009;28(12):2495–521.
- Snyder SA. Pharmaceuticals, personal care products and endcrine disruptors in water: implications for the water industry. Environ Eng Sci. 2003;20:449.
- Koplin DW. Pharmaceuticals, hormones and other organic wastewater contaminants in US streams, 199–2000: a national reconnaissance. Environ Science Technol. 2002;36:1202–11.
- Kt‹mmerer K. Pharmaceuticals in the environment: a brief summary. In: Kt‹mmerer K, editor. Pharmaceuticals in the environment. London: Springer; 2008. p. 3–21.
- Monteiro SC, Boxall AB. Occurrence and fate of human pharmaceuticals in the environment. Rev Environ Contam Toxicol. 2010;202:53–154.
- Bound JP, Voulvoulis N. Predicted and measured concentrations for selected pharmaceuticals in UK rivers: implications for risk assessment. Water Res. 2006;40(15):2885–92.
- Barnes KK, Christenson SC, Kolpin DW, Focazio MJ, Furlong ET, Zaugg SD, et al. Pharmaceuticals and other organic waste water contaminants within a leachate plume downgradient of a municipal landfill. Ground Water Monit Remediat. 2004;24(2): 119–26.
- US FDA. Guidance for industry: environmental assessment of human drug and biologics application. Silver Spring; US FDA, 1998.
- Commission European. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Off J Eur Commun. 2004;311:67.
- Holm G Implementing ecopharma-covigilance in practice: challenges and potential opportunities.Drug Saf.2013 Jul;36(7):533-46
- Winter MJ, Owen SF, Murray-Smith R, Panter GH, Hetheridge MJ, Kinter LB. Using data from drug discovery and development to aid the aquatic environmental risk assessment of human pharmaceuticals: concepts, considerations, and challenges. Integr Environ Assess Manag. 2010;6(1):38–51.
- Boxall ABA, Rudd MA, Brooks BW, Caldwell DJ, Choi K, Hickmann S, et al. Pharmaceuticals and personal care products in the environment: what are the big questions? Environ Health Perspect. 2012;120(9):1221–9.
- Roos V, Gunnarsson L, Fick J, Larsson DGJ, Rude´n C. Prioritising pharmaceuticals for environmental risk assessment: towards adequate and feasible first-tier selection. Sci Total Environ. 2012;421–422:102–10.