Unused pharmaceuticals: where do they end up?

Unused Pharmaceuticals - Where Do They End Up?

Adela MaghearPharmaceuticals Policy Officer

Health Care Without Harm Europewww.noharm-europe.org

Minsk, 27 April 2016

Slide Title


HCWH Vision & Mission

Vision

Healthcare mobilizes its

ethical, economic and

political influence to

create an ecologically sustainable,

equitable and healthy world.

Mission

Transform healthcare

worldwide so that it reduces

its environmental

footprint, becomes a community anchor for

sustainability and a leader in

the global movement for environmental

health and justice.


HCWH Goal on Pharmaceuticals


Support the safe production, management and disposal of pharmaceuticals, reducing their environmental and health

impact throughout the entire life cycle and fostering innovations for green products.

How Do Pharmaceuticals Get in the Environment?


• Production Consumption(human

excretion)

Disposal

2nd m

ajor pathway in the environm

ent!!!


Residues can reenter the water supply and spread to other environmental compartments (e.g., surface waters, agricultural lands)

Wastewater treatment plants unable to completely filter the improperly disposed pharmaceuticals




(1) BIO Intelligence Service. 2013.

(2) Kummerer K. 2009.

(3) York Health Economics Consort. 2010.

Therapeutic Classes That Can Have Harmful Effects on Unintended Organisms

Cytostatics => cytotoxic by design

Antibiotics => risk of promoting antimicrobial resistance

Synthetic hormones => endocrine disruptors

Anti-inflammatory drugs and sedatives => consumed in large quantities


There Is a Large Number of Pharmaceuticals on the Market

and Consumption Is Increasing


(1) BIO Intelligence Service. 2013.

How Are Humans Exposed to Pharmaceuticals in the Environment?


Pharmaceutical residues that re-enter the water supply and spread to surface waters and agricultural lands

can end up in drinking water and accumulate in vegetables and fish.

Low concentrations of pharmaceuticals in the environment can have adverse effects on animals

and other organisms.

? How humans can be affected by continuous, long term exposure to

low concentrations of pharmaceuticals ?

How Are Humans Exposed To Pharmaceuticals in the Environment?


(4) WHO. 2012.

(5) Heberer T et al. 1997.

(6) Huerta-Fontela et al. 2011.

(7) Mons M et al. 2003.


But Isn’t Water Filtered?

80%• Sewage treatment plants generally remove only

80% of pharmaceuticals and their metabolites (8).

10%• Even using the most advanced treatment

methods, 10% of pharmaceuticals remain after water has been treated (8).

600+

• More than 600 pharmaceuticals have been detected in sewage treatment effluents, sludge, groundwater, surface waters and biota across the globe(9).

(8) EurEau. 2014.

(9) Kuester A, Adler N. 2014.

How Can Pharmaceuticals in the Environment Affect Wildlife?


(14) Larsson DGJ. 2007.

Antibiotics in the environment can promote the development of antibiotic-resistant pathogens.

Though traces of pharmaceuticals in the environment are well below therapeutic doses, they can still have effects on unintended targets.

“Resistant pathogenic microorganisms need

to develop only once at a single site. Then,

heavy drug use, insufficient hygiene and extensive travel

habits often take care of their spread.”

PROF JOAKIM LARSSON (14)



(14) Larsson DGJ. 2007.

(16) Arnold KE et al. 2014.

(17) Cuthbert R et al. 2007.

(18) Kidd KA et al. 2007.



(15) Jobling S et al. 1998.

(19) Lazarus RS et al. 2014.

(20) Oaks JL et al. 2004.

What Is Currently Being Done at the EU Level to Address Pharmaceutical Pollution?

Collection systems for

unused medicinal products

• Directive 2004/27/EC (relating to medicinal products for human use) introduces an obligation for Member States to implement appropriate collection schemes for unused pharmaceutical products.



• It does not provide any guidelines on implementation of schemes and a number of studies have pointed to significant differences between Member States.



• Detailed information regarding the implementation and efficiency of collection schemes for unused pharmaceuticals throughout Europe is highly scattered and deficient, preventing comparisons between countries and type of scheme implemented.

• It is not clear that all EU countries have implemented their obligations.


Environmental Risks of Medicinesin European Legislation


In practice, this means that environmental risks are not part of the risk-benefit analysis for human medicines.

“In any event this impact should not constitute a criterion for refusal of a marketing authorisation” (Directive 2004/27/EC ).

The application must contain “an indication of any potential risks presented by the medicinal product for the environment”, and “specific arrangements to limit it [the

environmental impact] shall be envisaged” (Directives 2001/83/EC and 2004/27/EC).

Before being placed on the European market, pharmaceuticals have to undergo an authorization process.

Collection Schemes for Unused Pharmaceuticals

The Waste Framework Directive (Directive 2008/98/EC) establishes the basic principles and provisions on re-use,

recycling, recovery and disposal of waste to avoid dangers to human health and harm to the environment.

Collection schemes for medicines from household waste are not to be subject to registration, as the schemes present a

low risk and contribute to the separate collection of waste.

Diclofenac and two synthetic oestrogens are included on the Watch List of substances subject to EU-wide monitoring

under the Water Framework Directive (Directive 2013/39/EU).


Strategic Approach


The European Commission will develop a strategic approach to

the pollution of water by pharmaceuticals.

In autumn 2016, the Commission will propose

a Roadmap on PiEs.

Challenges

HCWH is advocating for upstream, preventative solutions to address pharmaceutical pollution:

• raising public awareness

• improving the implementation and enforcement of pharmaceutical collection systems

• optimising use of the environmental risk assessment for pharmaceuticals

• promoting the development of green and sustainable pharmaceuticals


Copenhagen19-21 October 2016

Thank You !
