1. Lecture No.5 : Risk Assessment of Pharmaceutical Waste
Production
Distribution
Disposal

2. Content of Presentation
- Life Cycle Review of Environmental and Health Impacts
- Risk management in Life Cycle Stages
- Risk management of substances used in Pharmaceuticals

4. - Package description should advice on disposal
“ Unused drugs : Dispose properly”
- Effective “ collection and disposal” systems needed

5. Pharmaceuticals in the environment : Causes
- Thousand of tons of pharmacologically active substances are used yearly to treat human and animal illnesses, in farming and aquaculture
- These substances can be excreted unmetaboloised or as active metabolites, escape sewage treatment plants, enter the environment
- Improper disposal of expired medications contribute to this contamination
Issue : Contamination of sewage, surface, ground and drinking water

6. Pharmaceuticals in the environment : Consequences
- Pharmaceuticals are designed to stimulate a response in humans and animals at low doses with a very specific target.
- Pollution from pharmaceuticals is a complex phenomenon
Thousand of different molecules,with different structures, characteristics and properties
Differences amongst countries
Frequent changes, new molecules .

8. Risk Management : Production Phase
Audits - Waste Minimisation- BATNEEC , BPEO Issues
** The major environmental impacts from processes carried out by the pharmaceutical industry stem from the use of solvents as reaction media and as aids for separation and purification processes.  The solvents may be emitted directly into the atmosphere as VOCs (often as HAPs), or may appear in wastewater.  Sources of the latter include solvent residues from separative operations involving both a water and a solvent phase, as well as solvents captured in wet scrubbers.
** 
A Secondary impact from pharmaceutical operations is dusts generated by grinding and polishing operations.

9. Production Phase ( cont.)
Issues List :-
VOC emissions from :-
Reactors
Separation and purification processes
Particulate emissions from grinding and polishing operations
Solvent residues in wastewater from
Two phase separations
Wet scrubbers
Solid wastes (often containing solvent residues) from extractive operations
Quantitative impact data – USA , National Emmission Trends , tons/ year:
Subsector
VOC
NOx
HAP
Medicinals And Botanicals
5,410
8,118
630
Pharmaceutical Preparations
7,997
6,558
4,287
Diagnostic Substances 20 17 18
Biological Products, Except Diagnostic 57 46 10
Total, pharmaceutical subsectors
13,484
14,739
4,945

10. Risk Management : Use Phase Major source of environmental impact !
Environmental risk reduction by reducing emissions into the environment
Risk mitigation measures in the context of authorisation
Instructions for safe handling and use
Disposal of “ unused” pharmaceuticals
Note – Specific Case of Cytotoxic Drugs

11. Effects on environment and human health needs to be investigated
Example -
Reported in Lancet, 2000 : “Italian Case Study for the Monitoring of Pharamceuticals in the Environment” by the Institute for Pharmacological Research,Milan

12. Conclusions Reported -----------------------------------------------
Pharmaceuticals selected :

13. Early this year the European Parliament proposed:
“risk to the environment ” to be included in the risk / benefit assessment of new pharmaceutical drugs.
- develop an environmental classification system for new pharmaceutical drugs
eco-toxicological data on all new drugs
“return-to-pharmacy” – label on all drugs

14. Public Purchasing
Issue of eco-toxicological data in all purchasing of pharmaceuticals
Results: environmental questioning should yield:
- increased awareness among producers that the
environmental problem of pharmaceutical drugs
cannot be neglected
- eco-toxicological data may in future be used for
environmental classification of pharmaceuticals

15. How to manage substances in different use areas ?
Same substances under different regulations

16. Different use areas of active substances - examples

17. Example : Environmental Relevance of NPEO
NPEO leaves non ( very poorly ) degradable metabolite Nonylphenol in the environment
NP is bioacumulative, high aquatic toxicity, inc. endocrine effects
Within the EU Legislation ( 2001/838/EC ) :
- Veterinary drugs : specific limits for PE containing teats
- Pesticides & Biocides: Subtitution /phase-out of NPEO as active ingredient and co-formulant

18. Conclusion Seminar : Safe Disposal of Dangerous Pharmaceutical Waste
Risk management should and can take place at all stages of life cycle
Objectives of risk management is to reduce the environmental release and potential risks.
Awareness raising for environmental problems linked with use of pharmaceuticals
Conclusion