PROBLEMS OF PHARMACEUTICAL CONTAMINATION IN THE ENVIRONMENT: COMPARATIVE STUDY ON LEGAL MEASURES FOR ENVIRONMENTAL RISK ASSESSMENT OF MODERN MEDICINE FOR HUMAN USE IN THE UNITED STATES AND CANADA

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กัญญาภัทร เหมรา

Abstract

This article examines the problems of Pharmaceutical Contamination in the Environment emerging worldwide. For Thailand, research reports and academic articles show that active pharmaceutical ingredients of modern medicine for human use have been detected in the wastewater treatment systems and receiving water bodies, representing that the current technologies used in wastewater treatment plants may be inefficient to accomplish their complete removal. Moreover, the exposure to human drugs in the environment not only causes damage to environmental quality but also causes adverse effects on animals as well as living organisms in food chains and humans. Therefore, this article surveys the provisions concerning environmental risk assessment (ERA) of modern medicine for human use before marketing authorization in the United States (USA) and the Dominion of Canada (Canada) to find a recommendation for Thailand.


From the comparative study, the USA requires the ERA of human pharmaceuticals at the stage of registration, while Canada assesses the environmental risk of substances or the active pharmaceutical ingredients before the substance is manufactured or imported into the country. This article agrees with the USA’s approach because Thailand’s mechanism of supervising modern medicine for human use is more consistent with the legal measures of the USA. Consequently, Thailand should impose legal requirements for applicants filing for approval of modern pharmacopeias for human use to submit documents of environmental risk assessment (ERA). In addition to drug labeling, legal measures should be enacted for displaying environmental information together with methods for disposing of pharmaceutical wastes and current ministerial EIA notification should be amended by listing pharmaceutical plants manufacturing active pharmaceutical ingredients in Thailand.

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References

อัญชลี จิตรักนที และคณะ, 'บทที่ 3 การคัดเลือกยา' ใน วิชัย โชควิวัฒนและคณะ (บรรณาธิการ) ระบบยาของประเทศไทย 2563 (พิมพ์ครั้งที่ 1, สถาบันวิจัยระบบสาธารณสุข 2564).

อำนาจ วงศ์บัณฑิต, กฎหมายสิ่งแวดล้อม (พิมพ์ครั้งที่ 4, สํานักพิมพ์วิญญูชน 2562) 98.

-- Environmental risk assessment (ERA) : an approach for assessing and reporting environmental conditions. (Victoria, B.C: Habitat Branch, 2000).

OECD, Pharmaceutical Residues in Freshwater: Hazards and Policy Responses (OECD Publishing, 2019).

Timothy O'Riordan and James Cameron, Interpreting the Precautionary Principle, (Cameron May 1994).

TIM aus der BEEK and others, ‘Pharmaceuticals in the environment-Global occurrences and perspectives’ (2016) 35 Environmental Toxicology and Chemistry 823.

Ying Li and others, ‘Pharmaceutical Residues in Wastewater Treatment Plants and Surface Waters in Bangkok’ (2012) 16 Journal of Hazardous, Toxic, and Radioactive Waste 88.

วาลิกา เศวตโยธิน และคณะ, 'การปนเปื้อนของสารกลุ่มผลิตภัณฑ์ยาและผลิตภัณฑ์ดูแลสุขภาพในแม่น้ำบางปะกง’ (รายงานฉบับสมบูรณ์เสนอต่อศูนย์วิจัยและฝึกอบรมด้านสิ่งแวดล้อม กรมส่งเสริมคุณภาพสิ่งแวดล้อม 2559).-- ‘Environmentally Persistent Pharmaceutical Pollutants (EPPPs)’ (UN environment programme) <https://www.unep.org/explore-topics/chemicals-waste/what-we-do/emerging-issues/environmentally-persistent-pharmaceutical> สืบค้นเมื่อ 30 สิงหาคม 2564.

-- ‘Environmental Risk Assessment for Pharmaceutical Drugs’ (Labcorp) <https://drugdevelopment.labcorp.com/content/dam/covance/assetLibrary/whitepapers/Environmental-Risk-Assessment-WPCPC003.pdf> สืบค้นเมื่อ 5 กุมภาพันธ์ 2565.

John L Wilkinson and others, ‘Pharmaceutical pollution of the world’s rivers’ (2021) 119 Proceedings of the National Academy of Sciences 2 <https://www.pnas.org/doi/10.1073/pnas.2113947119> สืบค้นเมื่อ 21 มีนาคม 2565.

-- ‘Risk assessment of chemical substances’ (Government of Canada) < https://www.canada.ca/en/health-canada/services/chemical-substances/canada-approach-chemicals/risk-assessment.html#s2> สืบค้นเมื่อ 30 กันยายน 2564.