Pharmaceuticals and Environment: a web-based decision support for considering environmental aspects of medicines in use

Helena Ramström, Siv Martini, Johanna Borgendahl, Marlene Ågerstrand, Gerd Lärfars, Marie-Louise Ovesjö, Helena Ramström, Siv Martini, Johanna Borgendahl, Marlene Ågerstrand, Gerd Lärfars, Marie-Louise Ovesjö

Abstract

Purpose: The database Pharmaceuticals and Environment is a non-commercial, freely available web-based decision support presenting compiled environmental information for pharmaceutical substances. It was developed by Region Stockholm and launched in 2016 at janusinfo.se. The purpose of this paper is to present the database, report on its current use, and reflect on lessons learned from developing and managing the database.

Methods: A standard operating procedure describes the work and content of the database, e.g., how information is retrieved, processed, and presented. Google Analytics was used for metrics. Issues related to the database have been discussed and handled by a reference group. The experiences from this work are presented.

Results: The database contains environmental hazard and risk information, primarily gathered from regulatory authorities and pharmaceutical companies. There are also assessments comparing substances within some groups of pharmaceuticals. The database is used by the Swedish Drug and Therapeutics Committees to include environmental aspects when recommending pharmaceuticals for health care providers. Page views show that users primarily look for information on commonly used substances, e.g., diclofenac and paracetamol/acetaminophen. Major problems for the development of the database are lack of data, lack of transparency, and discrepancies in the available environmental information.

Conclusion: In the absence of an adequate decision support produced by the regulatory authorities, we find the database Pharmaceuticals and Environment to be useful for Swedish Drug and Therapeutics Committees and health care providers, and it is our belief that the information can be valuable also in other settings.

Keywords: Decision support; Environmental classification; Environmental hazard assessments; Environmental risk assessment; Pharmaceuticals.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Information about paracetamol/acetaminophen from the database Pharmaceuticals and Environment at janusinfo.se [14]. P = persistence, B = bioaccumulation, and T = toxicity

References

    1. European Environment Agency (2016) Population trends 1950–2100: globally and within Europe. . Accessed 2 July 2019
    1. Lindgren B, National Institute of Economic Research (2016) Working paper no 142. The rise in life expectancy, health trends among the elderly, and the demand for health and social care. . Accessed 27 August 2019
    1. Kingston A, Comas-Herrera A, Jagger C, MODEM project Forecasting the care needs of the older population in England over the next 20 years: estimates from the Population Ageing and Care Simulation (PACSim) modelling study. Lancet Public Health. 2018;3(9):e447–e455. doi: 10.1016/S2468-2667(18)30118-X.
    1. Kidd KA, Blanchfield PJ, Mills KH, Palace VP, Evans RE, Lazorchak JM, Flick RW. Collapse of a fish population after exposure to a synthetic estrogen. PNAS. 2007;104:8897–8901. doi: 10.1073/pnas.0609568104.
    1. Fick J, Lindberg RH, Parkkonen J, Arvidsson B, Tysklind M, Larsson JDG. Therapeutic levels of levonorgestrel detected in blood plasma of fish: results from screening rainbow trout exposed to treated sewage effluents. Environ Sci Technol. 2010;44(7):2661–2666. doi: 10.1021/es903440m.
    1. Säfholm M, Norder A, Fick J, Berg C. Disrupted oogenesis in the frog Xenopus tropicalis after exposure to environmental progestin concentrations. Biol Reprod. 2012;86(4):1–7. doi: 10.1095/biolreprod.111.097378.
    1. Shultz S, Baral HS, Charman S, Cunningham AA, Das D, Ghalsasi GR, Goudar MS, Green RE, Jones A, Nighot P, Pain DJ, Prakash V. Diclofenac poisoning is widespread in declining vulture populations across the Indian subcontinent. Proc Biol Sci. 2004;271:S458–S460. doi: 10.1098/rsbl.2004.0223.
    1. Brodin T, Fick J, Jonsson M, Klaminder J. Dilute concentrations of a psychiatric drug alter behavior of fish from natural populations. Science. 2013;339(6121):814–815. doi: 10.1126/science.1226850.
    1. Kellner M, Porseryd T, Porsch-Hällström I, Borg B, Roufidou C, Olsen KH. Developmental exposure to the SSRI citalopram causes long-lasting behavioural effects in the three-spined stickleback (Gasterosteus aculeatus) Ecotoxicology. 2018;27(1):12–22. doi: 10.1007/s10646-017-1866-4.
    1. World Health Organization (2018) Antibiotic resistance. . Accessed 2 July 2019
    1. Larsson DG. Antibiotics in the environment. Ups J Med Sci. 2014;119(2):108–112. doi: 10.3109/03009734.2014.896438.
    1. Larsson DG, de Pedro C, Paxeus N. Effluent from drug manufactures contains extremely high levels of pharmaceuticals. J Hazard Mater. 2007;148(3):751–755. doi: 10.1016/j.jhazmat.2007.07.008.
    1. Gunnarsson B, Wennmalm Å. Mitigation of the pharmaceutical outlet into the environment – experiences from Sweden. In: Kümmerer K, editor. Pharmaceuticals in the environment: sources, fate, effects and risks. 3. Berlin Heidelberg: Springer-Verlag; 2008. pp. 475–487.
    1. Health and Medical Care Administration, Region Stockholm, Sweden (n.d.) Pharmaceuticals and Environment [database].
    1. Ågerstrand M, Brenig M, Führ M, Schenten J. Refining tools to bridge the gap between academia and chemical regulation: perspectives for WikiREACH. Environ Sci Process Impacts. 2017;19(12):1466–1473. doi: 10.1039/c7em00422b.
    1. LIF (The Trade Association for the Research-Based Pharmaceutical Industry in Sweden) Fass Vårdpersonal. . Accessed 11 December 2019
    1. European Medicines Agency, Search for medicines. . Accessed 11 December 2019
    1. Norman (n.d.) NORMAN Ecotoxicology Database [database]. . Accessed 11 December 2019
    1. MistraPharma (2015) Identification and reduction of environmental risks caused by human pharmaceuticals. MistraPharma research 2008–2015. Final Report. . Accessed 14 April 2020
    1. Schudoma D, Michel B, Lippke A (2008) ETOX. Information system ecotoxicology and environmental quality targets. Handbook for queries and data recording/entry. . Accessed 11 December 2019
    1. iPiE (n.d.) iPiE Summary Database Search (iPiE*Sum). . Accessed 2 July 2019
    1. United States Environmental Protection Agency (n.d.) ECOTOX Knowledgebase. . Accessed 11 December 2019
    1. Wennmalm Å, Gunnarsson B. Public health care management of water pollution with pharmaceuticals: environmental classification and analysis of pharmaceutical residues in sewage water. Drug Inf J. 2005;39(3):291–297. doi: 10.1177/009286150503900307.
    1. Committee for Medicinal Products for Human Use (CHMP) EMA (2006) Guideline on the environmental risk assessment of medicinal products for human use. Doc. Ref. EMEA/CHMP/SWP/4447/00 corr 2. . Accessed 2 July 2019
    1. Mattson B. A voluntary environmental classification system for pharmaceutical substances. Drug Inf J. 2007;41(2):187–191. doi: 10.1177/009286150704100209.
    1. Wennmalm Å, Gunnarsson B. Pharmaceutical management through environmental product labeling in Sweden. Environ Int. 2009;35(5):775–777. doi: 10.1016/j.envint.2008.12.008.
    1. LIF (The Trade Association for the Research-Based Pharmaceutical Industry in Sweden) (2012) Environmental classification of pharmaceuticals at . Guidance for pharmaceutical companies. . Accessed 2 July 2019
    1. Caneva L, Bonelli M, Papaluca-Amati M, Vidal JM. Critical review on the environmental risk assessment of medicinal products for human use in the centralised procedure. Regul Toxicol Pharmacol. 2014;68(3):312–316. doi: 10.1016/j.yrtph.2014.01.002.
    1. Ågerstrand M, Ruden C. Evaluation of the accuracy and consistency of the Swedish environmental classification and information system for pharmaceuticals. Sci Total Environ. 2010;408(11):2327–2339. doi: 10.1016/j.scitotenv.2010.02.020.
    1. Bengtsson-Palme J, Larsson DG. Concentrations of antibiotics predicted to select for resistant bacteria: proposed limits for environmental regulation. Environ Int. 2016;86:140–149. doi: 10.1016/j.envint.2015.10.015.
    1. Stockholm County Council (2017) Environmental Programme 2017–2021. . Accessed 2 July 2019
    1. OECD . Pharmaceutical residues in freshwater: hazards and policy responses, OECD studies on water. Paris: OECD Publishing; 2019.
    1. European Chemicals Agency (ECHA) (2008) Guidance on information requirements and chemical safety assessment. Chapter R.10: characterisation of dose [concentration]-response for environment. . Accessed 2 July 2019
    1. Sustainability, Region Stockholm (n.d.) Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm (Samples of pharmaceutical residues in water, sediment and fish for Region Stockholm). . Accessed 2 July 2019
    1. Fick J, Lindberg RH, Fång J, Magnér J, Kaj L, Brorström-Lundén E, IVL Swedish Environmental Research Institute (2015) Screening 2014: analysis of pharmaceuticals and hormones in samples from WWTPs and receiving waters. . Accessed 2 July 2019
    1. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E, IVL Swedish Environmental Research Institute (2011) Results from the Swedish National Screening Programme 2010: Subreport 3. Pharmaceuticals. . Accessed 2 July 2019
    1. Wahlberg C, Björlenius B, Paxéus N, Stockholm Water Company (n.d.) Läkemedelsrester i Stockholms vattenmiljö: Förekomst, förebyggande åtgärder och rening av avloppsvatten. (Pharmaceutical residues in Stockholm’s aquatic environment: occurrence, preventive actions and purification of wastewater.). . Accessed 2 July 2019
    1. Ågerstrand M, Berg C, Björlenius B, Breitholtz M, Brunström B, Fick J, Gunnarsson L, Larsson DG, Sumpter JP, Tysklind M, Ruden C. Improving environmental risk assessment of human pharmaceuticals. Environ Sci Technol. 2015;49(9):5336–5345. doi: 10.1021/acs.est.5b00302.
    1. European Commission (2019) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee. European Union Strategic Approach to Pharmaceuticals in the Environment. . Accessed 2 July 2019
    1. Nörby U, Källen K, Eiermann B, Korkmaz S, Winbladh B, Gustafsson LL. Drugs and Birth Defects: a knowledge database providing risk assessments based on national health registers. Eur J Clin Pharmacol. 2013;69(4):889–899. doi: 10.1007/s00228-012-1399-y.
    1. Böttiger Y, Laine K, Andersson ML, Korhonen T, Molin B, Ovesjö M-L, Tirkkonen T, Rane A, Gustafsson LL, Eiermann B. SFINX-a drug-drug interaction database designed for clinical decision support systems. Eur J Clin Pharmacol. 2009;65(6):627–633. doi: 10.1007/s00228-008-0612-5.
    1. Eriksen J, Gustafsson LL, Ateva K, Bastholm-Rahmner P, Ovesjö M-L, Jirlow M, Juhasz-Haverinen M, Lärfars G, Malmström RE, Wettermark B, Andersen-Karlsson E, Stockholm DTC. High adherence to the ‘Wise List’ treatment recommendations in Stockholm: a 15-year retrospective review of a multifaceted approach promoting rational use of medicines. BMJ Open. 2017;7(4):e014345. doi: 10.1136/bmjopen-2016-014345.
    1. Gunnarsson L, Snape JR, Verbruggen B, Owen SF, Kristiansson E, Margiotta-Casaluci L, Österlund T, Hutchinson K, Leverett D, Marks B, Tyler CR. Pharmacology beyond the patient – the environmental risks of human drugs. Environ Int. 2019;129:320–332. doi: 10.1016/j.envint.2019.04.075.
    1. Burns EE, Carter LJ, Snape J, Thomas-Oates J, Boxall ABA. Application of prioritization approaches to optimize environmental monitoring and testing of pharmaceuticals. J Toxicol Environ Health B Crit Rev. 2018;21(3):115–141. doi: 10.1080/10937404.2018.1465873.
    1. Committee for Medicinal Products for Human Use (CHMP) EMA (2018) Guideline on the environmental risk assessment of medicinal products for human use: Draft. .

Source: PubMed

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