Management of Pharmaceuticals in the Environment: Views of Expert Stakeholders

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Management of Pharmaceuticals in the Environment
Views of Expert Stakeholders

• EnviroPharm 2007, Toronto
• Nora Doerr-MacEwen
• (B.Sc., M.Sc., Ph.D. Candidate)

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My Research

• Ph.D. student in environmental planning at U.
  Waterloo
• Background in environmental chemistry
• Became interested in pharmaceuticals in the
  environment because of complex, challenging
  nature of the issue
• Studying the management of pharmaceuticals in the
  environment

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Presentation Outline

• View of expert stakeholders on issue of PhACs in
  the environment
• Expert stakeholders views on management
  strategies
• Existing management strategies internationally
• Possible future developments in management

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My Research on Stakeholder Opinions

• Stakeholder consultation is an essential
  component of risk management
• Wanted to gain an in-depth understanding of views
  of stakeholders
• Focused on stakeholders with thorough knowledge
  of the issue
• Interviewed 27 expert stakeholders from academia
  (n9), government (n12) and industry (n5 pharm.
  1 cons.)

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My Research on Stakeholder Opinions

• Interviewees were from Canada (n12), U.S. (n5),
  and Europe (n10)
• Purpose Discover views on issue of, and
  management strategies for, PhACs in the
  environment

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Stakeholder Views

• 81 believed pharmaceuticals were a concern for
  ecosystem health
• 62 thought pharmaceuticals were a concern for
  both ecosystem and human health
• Some who were concerned about human health
  effects believed they were unlikely from a
  scientific viewpoint, but said they should be
  considered from a public policy and public
  perception perspective

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Pharmaceuticals Perception of Drinking Water
Risks
Globe Mail, 2003
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Damage to Aquatic Ecosystems

• 61 of interviewees believed PhACs were likely to
  cause serious or irreversible damage to aquatic
  ecosystems
• They saw ecosystems as sensitive, vulnerable,
  unpredictable
• Interviewees who did not think serious or
  irreversible damage was likely, focused on
  ecosystem resilience

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Comparison With Other Water Contaminants

• Overall ranking of contaminants according to need
  for management action
• Pathogens
• Nutrients
• Pesticides
• Metals
• Pharmaceuticals
• Organic Solvents
• Road Salt

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Comparison With Other Water Contaminants

• European interviewees, however, saw PhACs as a
  greater concern, ranking it 4th (above pathogens)
• May reflect concern with contaminants that impact
  the environment at large, rather than those which
  are most likely to impact human health

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Uncertainty of Effects on Aquatic Organisms

• Uncertainty in effects of PhACs on aquatic
  organisms seen as fairly high 3.6 on a scale of
  1-5
• Main sources of uncertainty in determining
  effects
• Low level effects
• Chronic effects
• Lack of appropriate risk assessment methodology

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Potential PhAC Management Strategies

• PhAC management strategies from literature,
  conferences, interviewee suggestions
• Optimization of wastewater treatment plants
  without technological upgrades
• Education of medical practitioners to a) reduce
  pharmaceutical over-use, b) prescribe
  environmentally-friendly drugs
• Returns programs for unused expired medications
• Separate treatment of hospital wastewater

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Potential PhAC Management Strategies

• Incentives for the manufacturing of green
  (environmentally friendly) drugs
• Advanced wastewater treatment (ex. Ozonation,
  membrane filtration)
• Environmental risk assessment regulations
• Requirements for all municipal wastewater
  treatment plants to have secondary treatment as a
  minimum

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Interviewees Assessment of Management Strategies

• Scores out of 10 in terms of effectiveness

• Advanced wastewater treatment 8.0
• Educating medical practitioners 7.1
• Pharmaceutical returns programs requirements
  for secondary
• wastewater treatment 6.8

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Interviewees Assessment of Management Strategies

• Scores out of 10 in terms of feasibility

1) Requirements for secondary wastewater
treatment 7.9 2) Pharmaceutical returns
programs 7.8 3) Environmental risk assessment
regulations 7.4
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Interviewees Assessment of Management Strategies

• Management strategies seen as least effective
• Environmental risk assessment regulations
• Incentives for green drug manufacturing
• Optimization of existing wastewater treatment
  plants

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Interviewee Opinions on Management Strategies

• Very divided on risk assessment regulations and
  incentives for green drug manufacturing
• Risk assessment regulations
• Recommended by many interviewees, yet seen as
  ineffective in mitigating environmental impacts
• May reflect a dichotomy between the ideal and the
  real
• We need to ask the right questions, answer the
  right questions with the right tools, come up
  with the right answers. We dont do that very
  effectively right now. University Interviewee

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Interviewee Opinions on Management Strategies

• Incentives for green drug manufacturing
• Naïve University Interviewee
• Structure and function are inextricably linked.
  The attrition rate for drug candidates is already
  very high based on safety, efficacy, stability,
  and manufacturing requirements. Adding yet
  another requirement with respect to
  biodegradability for the structure of these
  molecules will probably result in a massive
  increase in the attrition rate of drug
  candidates. Industry Interviewee

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Interviewee Opinions on Management Strategies

• Incentives for green drug manufacturing contd
• We are already developing and marketing several
  such active substances. Industry Interviewee
• Some pharmaceutical companies may try to develop
  a niche market by manufacturing green drugs

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Ongoing Management ActivityNational Governments

• National governments mainly focusing on risk
  assessment regulations
• US already requires risk assessment for human
  veterinary pharmaceuticals
• EU has recently finalized risk assessment
  guidelines for human pharmaceuticals and has had
  guidelines for veterinary PhACs since 1996
• Canada still in the process of developing risk
  assessment regulations

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Risk Assessment Regulations for Human
Pharmaceuticals Key Points

• Cutoff environmental concentration below which no
  risk assessment is required is 100x higher in US
  than EU
• US risk assessments based more on acute tests
  than EU guidelines, which use chronic tests
• EU risk assessment guidelines specify that
  results will not prevent registration of a human
  pharmaceutical
• Management outcomes resulting from findings of
  risk assessments are often not clear

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Ongoing Management ActivityPharmaceutical
Returns Programs

• Pharmaceutical sector various levels of
  government engaged in running pharmaceuticals
  returns programs
• Allow consumers to return unused expired
  medication, rather than throwing in toilet or
  garbage

SIGRE pharmaceutical returns program, Spain
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Ongoing Management ActivityPharmaceutical
Returns Programs

• Example Medications Returns Program, B.C.
  (organized by PCPSA)
• B.C. Recycling Regulation requires pharmaceutical
  industry to organize and fund returns programs
• Consumers can return unused and expired
  medications to pharmacies, which contract out for
  incineration
• Has high rate of participation among pharmacies
  (90)
• But low rate of waste diversion (10), likely
  due to lack of consumer awareness (Marr, 2007)
• Similar programs involving returning drugs to
  pharmacies exist in NS and PEI

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Ongoing Management ActivityPharmaceutical
Returns Programs

• Example Cyclamed (France)
• Pharmaceutical manufacturers fund run drug
  returns programs
• Consumers return unused drugs packaging to
  pharmacy
• Returned drugs used for either
• medical charities, if intact and unexpired
• incineration with energy recovery

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Other Ongoing Management

• Stockholm County Councils Kloka Listan (Wise
  List)
• Pharmaceuticals receive score for environmental
  friendliness based on toxicity, bioaccumulation,
  persistence
• Pamphlet publishing scores sent to doctors to
  help them choose environmentally friendly drugs
• County Council hopes to use list for drug
  labelling as well

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Future Management of PhACs in the Environment
Gazing into the Crystal Ball
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Likely Steps in Canadian PhAC Management

• Risk assessment regulations will be developed in
  Canada
• Other provinces will follow the lead of BC, NS,
  and PEI in developing drug returns programs
• ON considering addressing pharmaceutical
  disposal as part of municipal household hazardous
  waste

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Other Management Possibilities

• Government working on requirements for minimum of
  secondary treatment for municipal WWTPs but not
  just because of PhACs
• Possible labelling of pharmaceuticals for
• Proper disposal
• Environmental hazard
• Public demand for green drugs???
• Pressure to produce cleaner water public
  perception of tap water

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Future Issues Related to PhACs in the Environment

• Increasing public awareness and concern about
  environmental contamination
• Demand for cleaner drinking water
• Possible demand for advanced wastewater
  drinking water treatment?
• But
• Limited financial resources for management
• Need to avoid negative environmental side effects
  (ex advanced wastewater treatment consumes more
  energy, so more CO2 produced)

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PhACs in the Environment and the Pharmaceutical
Industry

• Pharmaceutical industry has made great efforts to
  green manufacturing process
• Advisable to also be proactive on issue of PhACs
  contaminating environment
• Efforts such as CYCLAMED and Canadian returns
  programs Good stewardship
• Green drugs Possible niche market?

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Questions?