Download Risk management of substances used in Pharmaceuticals

Lecture No.5 : Risk Assessment of
Pharmaceutical Waste
Production
Distribution
Disposal
Content of Presentation
- Life Cycle Review of Environmental and Health Impacts
- Risk management in Life Cycle Stages
- Risk management of substances used in Pharmaceuticals
- Package description should advice on disposal
“ Unused drugs : Dispose properly”
- Effective “ collection and disposal” systems needed
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
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
.
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.
Production Phase ( cont.)
Issues List :• VOC emissions from :o Reactors
o Separation and purification processes
• Particulate emissions from grinding and polishing operations
• Solvent residues in wastewater from
o Two phase separations
o Wet scrubbers
• Solid wastes (often containing solvent residues) from extractive operations
Quantitative impact data – USA , National Emmission Trends , 1996
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
tons/ year:
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
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
Conclusions Reported ----------------------------------------------Pharmaceuticals
selected :
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
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
How to manage substances in different use
areas ?
Same substances under different regulations
Different use areas of active substances examples
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
Seminar : Safe Disposal of Dangerous
Pharmaceutical Waste
Conclusion
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