Legal Regulation and Critical Analysis for an Effectively Treatment of Pharmaceutical Waste
The extermination and proper disposal of
pharmaceutical wastes from expired and unused medications remains
a disputable issue due to their specific nature and characteristics.
Even though the hazards from these wastes are already well known in
terms of environment and human health, people still treat them as
usual wastes. At a national level, in many countries the management
of pharmaceutical and medical wastes has been one of the main
objectives in order to protect people’s health and the environment.
Even though many legal regulations exist in this respect, there has not
been a single law that would clearly explain the procedures of
returning medicines, ways of selection, treatment and extermination
of pharmaceutical wastes. This paper aims at analyzing the practices
of pharmaceutical waste management and treatment in some
European countries as well as a review of the legislation and official
guidelines in managing these kinds of wastes and protecting the
environment and human health. A suitable treatment and
management of expired medications and other similar wastes would
be in the interest of public health in the first place, as well as in the
interest of healthcare institutions and other bodies engaged in
environment protection.
[1] Eurostat. Waste Generation, 2010 (kg per inhabitant). Available:
http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Waste_st
atistics
[2] EU Waste Statistics Regulation (EC 2150/2002) 2004-06. Available:
http://publicdata.eu/dataset/eu-waste-statistics-regulation-ec-2150-2002-
2004-06
[3] WHO, 2011. Waste from health-care activities. Fact sheet n°253. World
HealthOrganization.Available:<http://www.who.int/mediacentre/factshe
ets/fs253/en/index.html>
[4] WHO, 2009 How to Dispose Unused Medicines Available:
http://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyin
gusingmedicinesafely/understandingover-thecountermedicines/
ucm107163.pdf
[5] US EPA (US Environmental Protection Agency), 2011. Pharmaceuticals
and personal care products, relevant literature. Available:
<http://www.epa.gov/ppcp/lit.html>
[6] Basel Convention Regional Centre, Bratislava. Strategy on Biomedical
(Healthcare) Waste Management. Former Yugoslav Republic of
Macedonia. Skopje, January 2008,14-18
[7] 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. Official journal L- 311,28/11/2001, pp.66-128, article
127b
[8] Directive 2004/27/EC of the European Parliament and of the Council of
31 March 2004 amending 2001/83/EC on the community code relating
to medicinal products for human use. Official journal L- 136 30/4/2004,
pp. 57, article 127b
[9] Protocol on Liability and Compensation for Damage Resulting from
Tran’s boundary Movements of Hazardous Wastes and Their Disposal.
Annex VIII; 72-79. Available: http://www.basel.int/Portals/4/
Basel%20Convention/docs/text/BaselConvention Text-e.pdf
[10] US FDA, 2012. How to dispose of unused medicines. Food and Drug
Administration. Available: <http://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm101653.htm>
[11] European Environmental Agency. Pharmaceuticals in the environment.
EEA Technical report/No 1/2010, Copenhagen,2010
[12] WHO Fact sheet n° 231, April 2002 (http://www.who.int/mediacentre/
factsheets/fs231/en/)
[13] Preparation of National Health-Care Waste Management Plans in Sub-
Saharan Countries- Guidance Manual Secretariat of the Basel
Convention and World Health Organization (http://www.basel.int/
Portals/4/Basel%20Convention/docs/pub/techguid/gm_hc_sussahara_e.p
df)
[14] Campagnolo, E. R; Jonson, K. R.; Karpati, A.; Rubin, C. S.; Kolpin,
D.W.; Meyer, M.T.; Esteban, J.E.; Currier, R.W.; Smith, K; Thu, K.M.,
2002 “Antimicrobial residues in animal waste and water resources
proximal to large-scale swine and poultry feeding operations”. The
science of the total environment, 299:89-95
[15] German Advisory Council on the Environment, 2007. Pharmaceuticals
in Environment. Statement April 2007. No. 12. Available at:
http://www.unweltrat.de/english/edownloa/statemen/Stellung_Pharmace
uticals_in _the_Environment_2007_eng.pdf
[16] Holm JV, Rügge K, Bjerg PL, Christensen TH. Occurrence and
distribution of pharmaceutical organique compounds in the groundwater
down gradient of a landfill (Grinsted, Denmark).Environ Sci. Technol.
1995; 29(5):1415-1420
[17] Choi CO. Pollution in solution, drug-resistance DNA as the latest fresh
water threat. Scientific American. Januari 2007:22-23.
[18] Daughton CG, Ternes TA. Pharmaceuticals and personal care products
in the environment: agents of subtle change ?Environ Health Perspect.
1999; 107 Suppl. 6: 907-938.
[19] Daughton CG. Cradle-to-Cradle Stewardship of Drugs for Minimizing
Their Evironmental Disposition While Promoting Human Health
Environ Health Perspect. 2003; Vol.111,No. 5
[20] Taylor D. Poulimare M. An initial survey of unused and expired
medicine take back schemes in the Europian Union. Conference:
pharmaceutical products in the environment : trends towards lowering
occurrence and impact. KNAPPE International Conference, Nimes,
France ;2008
[21] Glassmeyer S.T et al. Disposal practices for unwanted residential
medications in the United States. Environment International. 35 (2009)
566-572.
[22] “Miljöpåverkanfrånläkemedelsamtkosmetiskaochhygieniskaprodukter”.
(“Environmental effects of pharmaceuticals as well as cosmetics and
hygiene products”, report by the Swedish MPA, 2004, contains a
summary in English, www.lakemedelsverket.se)
[23] Generated waste by section of economic activity. State Statistical Office
of the Republic of Macedonia 2012, No : 5.1.12.17 (www.stat.gov.mk)
[24] National Plan for Waste Management (2009-2015) of Republic of
Macedonia (2009-2015), based on the National Strategy for Waste
Management. Finaldraft document, October 2008
[25] Feasibility study for landfill "Drisla", 2011282292/EVT/EES/1/C 5th
August 2011
[1] Eurostat. Waste Generation, 2010 (kg per inhabitant). Available:
http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Waste_st
atistics
[2] EU Waste Statistics Regulation (EC 2150/2002) 2004-06. Available:
http://publicdata.eu/dataset/eu-waste-statistics-regulation-ec-2150-2002-
2004-06
[3] WHO, 2011. Waste from health-care activities. Fact sheet n°253. World
HealthOrganization.Available:<http://www.who.int/mediacentre/factshe
ets/fs253/en/index.html>
[4] WHO, 2009 How to Dispose Unused Medicines Available:
http://www.fda.gov/downloads/drugs/resourcesforyou/consumers/buyin
gusingmedicinesafely/understandingover-thecountermedicines/
ucm107163.pdf
[5] US EPA (US Environmental Protection Agency), 2011. Pharmaceuticals
and personal care products, relevant literature. Available:
<http://www.epa.gov/ppcp/lit.html>
[6] Basel Convention Regional Centre, Bratislava. Strategy on Biomedical
(Healthcare) Waste Management. Former Yugoslav Republic of
Macedonia. Skopje, January 2008,14-18
[7] 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. Official journal L- 311,28/11/2001, pp.66-128, article
127b
[8] Directive 2004/27/EC of the European Parliament and of the Council of
31 March 2004 amending 2001/83/EC on the community code relating
to medicinal products for human use. Official journal L- 136 30/4/2004,
pp. 57, article 127b
[9] Protocol on Liability and Compensation for Damage Resulting from
Tran’s boundary Movements of Hazardous Wastes and Their Disposal.
Annex VIII; 72-79. Available: http://www.basel.int/Portals/4/
Basel%20Convention/docs/text/BaselConvention Text-e.pdf
[10] US FDA, 2012. How to dispose of unused medicines. Food and Drug
Administration. Available: <http://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm101653.htm>
[11] European Environmental Agency. Pharmaceuticals in the environment.
EEA Technical report/No 1/2010, Copenhagen,2010
[12] WHO Fact sheet n° 231, April 2002 (http://www.who.int/mediacentre/
factsheets/fs231/en/)
[13] Preparation of National Health-Care Waste Management Plans in Sub-
Saharan Countries- Guidance Manual Secretariat of the Basel
Convention and World Health Organization (http://www.basel.int/
Portals/4/Basel%20Convention/docs/pub/techguid/gm_hc_sussahara_e.p
df)
[14] Campagnolo, E. R; Jonson, K. R.; Karpati, A.; Rubin, C. S.; Kolpin,
D.W.; Meyer, M.T.; Esteban, J.E.; Currier, R.W.; Smith, K; Thu, K.M.,
2002 “Antimicrobial residues in animal waste and water resources
proximal to large-scale swine and poultry feeding operations”. The
science of the total environment, 299:89-95
[15] German Advisory Council on the Environment, 2007. Pharmaceuticals
in Environment. Statement April 2007. No. 12. Available at:
http://www.unweltrat.de/english/edownloa/statemen/Stellung_Pharmace
uticals_in _the_Environment_2007_eng.pdf
[16] Holm JV, Rügge K, Bjerg PL, Christensen TH. Occurrence and
distribution of pharmaceutical organique compounds in the groundwater
down gradient of a landfill (Grinsted, Denmark).Environ Sci. Technol.
1995; 29(5):1415-1420
[17] Choi CO. Pollution in solution, drug-resistance DNA as the latest fresh
water threat. Scientific American. Januari 2007:22-23.
[18] Daughton CG, Ternes TA. Pharmaceuticals and personal care products
in the environment: agents of subtle change ?Environ Health Perspect.
1999; 107 Suppl. 6: 907-938.
[19] Daughton CG. Cradle-to-Cradle Stewardship of Drugs for Minimizing
Their Evironmental Disposition While Promoting Human Health
Environ Health Perspect. 2003; Vol.111,No. 5
[20] Taylor D. Poulimare M. An initial survey of unused and expired
medicine take back schemes in the Europian Union. Conference:
pharmaceutical products in the environment : trends towards lowering
occurrence and impact. KNAPPE International Conference, Nimes,
France ;2008
[21] Glassmeyer S.T et al. Disposal practices for unwanted residential
medications in the United States. Environment International. 35 (2009)
566-572.
[22] “Miljöpåverkanfrånläkemedelsamtkosmetiskaochhygieniskaprodukter”.
(“Environmental effects of pharmaceuticals as well as cosmetics and
hygiene products”, report by the Swedish MPA, 2004, contains a
summary in English, www.lakemedelsverket.se)
[23] Generated waste by section of economic activity. State Statistical Office
of the Republic of Macedonia 2012, No : 5.1.12.17 (www.stat.gov.mk)
[24] National Plan for Waste Management (2009-2015) of Republic of
Macedonia (2009-2015), based on the National Strategy for Waste
Management. Finaldraft document, October 2008
[25] Feasibility study for landfill "Drisla", 2011282292/EVT/EES/1/C 5th
August 2011
@article{"International Journal of Business, Human and Social Sciences:68667", author = "Merita Dauti and Edita Alili-Idrizi and Sihana Ahmeti–Lika and Ledjan Malaj", title = "Legal Regulation and Critical Analysis for an Effectively Treatment of Pharmaceutical Waste", abstract = "The extermination and proper disposal of
pharmaceutical wastes from expired and unused medications remains
a disputable issue due to their specific nature and characteristics.
Even though the hazards from these wastes are already well known in
terms of environment and human health, people still treat them as
usual wastes. At a national level, in many countries the management
of pharmaceutical and medical wastes has been one of the main
objectives in order to protect people’s health and the environment.
Even though many legal regulations exist in this respect, there has not
been a single law that would clearly explain the procedures of
returning medicines, ways of selection, treatment and extermination
of pharmaceutical wastes. This paper aims at analyzing the practices
of pharmaceutical waste management and treatment in some
European countries as well as a review of the legislation and official
guidelines in managing these kinds of wastes and protecting the
environment and human health. A suitable treatment and
management of expired medications and other similar wastes would
be in the interest of public health in the first place, as well as in the
interest of healthcare institutions and other bodies engaged in
environment protection.
", keywords = "Pharmaceutical waste, legal regulation, proper
disposal, environment pollution.", volume = "8", number = "11", pages = "3679-8", }
