2.5. PharmEcoVigilance (Ruhoy)

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By Ilene Ruhoy. …

By Ilene Ruhoy.

This slidecast is part of the GreenPharmEdu.org program.

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  • 1. PharmEcovigilance
    GreenPharmEdu.org
  • 2. PharmEcovigilance
    Conventional pharmacovigilance expanded beyond conventional focus on ADRs to encompass environmental concerns
    Unify the parallel but interconnected needs for protecting both human and ecological health
    Daughton CG and Ruhoy IS "The Afterlife of Drugs and the Role of PharmEcovigilance," Drug Safety, 2008, 31(12):1069-1082; doi: 10.2165/0002018-200831120-00004.
  • 3. Actions to reduce APIs in the environment and protect human health & safety
    Unit dosing and trial scripts
    Low-quantity packaging of OTC medications
    Increased monitoring of patient
    Samples and donations
    Reduce incentives for excessive purchasing
    Personalized medicine (e.g., lower doses)
    Reduce polypharmacy
    Lower doses via non-racemic APIs
    Environmental assessments of newly designed drugs
    Prescribers to account for possible environmental impact
    Widespread implementation of sustainable take-back programs
    Improved record keeping of disposed pharmaceuticals by institutions
  • 4. Stewardship
    Stewardship involves much more than prudent disposal of leftover drugs
    Actions taken to reduce PPCPs in the environment will have collateral benefits in also capturing chemicals we are currently not aware of and may lessen human morbidity and mortality
  • 5. Actions to reduce APIs in the environment and protect human health & safety
    Unit dosing and trial scripts
    Low-quantity packaging of OTC medications
    Increased monitoring of patient
    Samples and donations
    Reduce incentives for excessive purchasing
    Personalized medicine (e.g., lower doses)
    Reduce polypharmacy
    Lower doses via non-racemic APIs
    Environmental assessments of newly designed drugs
    Prescribers to account for possible environmental impact
    Widespread implementation of sustainable take-back programs
    Improved record keeping of disposed pharmaceuticals by institutions
  • 6. Variables in calculating relative environmental footprint of a disposed drug
    Total consumption
    Fraction disposed
    Fraction excreted unchanged
    urine & feces
    bathing:
    residues in sweat
    residues from dermally applied drugs
    Fraction excreted as conjugates
  • 7. Unintended Consequences
    By avoiding the flushing of unwanted drugs into sewers could human morbidity and mortality perhaps be exacerbated?
    The ultimate objective might not be to determine the relative contributory role of disposal in the occurrence of PPCPs in the environment, but rather to design systems that result in eliminating the need for disposal in the first place
  • 8. Mining the Literature
    Compiled data are needed not just for geographically based occurrence in waters, contaminant treatability, and toxicity, but also for other environmental compartments
    Landfills, biosolids, and sediments
    And for various aspects of the larges issue
    Aquatic and vegetative bioconcentration, drug disposal
  • 9. Data Gaps
    Comparatively slight coverage of extent and scope of PPCPs occurrence in finished or point-of-use drinking water and landfills
    The majority of APIs have never been targeted for environmental monitoring
    Monitoring tens to focus on a core set of roughly a hundred or so of the thousands of APIs (or the degrades) from commercial use
    Scant coverage also on:
    Occurrence of environmentally derived residues of PPCPs in tissues of aquatic organisms and plants
    Inventories of disposed medications and of the usage frequency of the methods of disposal
    Potential for human effects and immune responses
  • 10. Models of Change
    European Union
    “Green” drugs – requires pharmaceutical companies to analyze environmental risks of new drugs (database available to physicians)
    KNAPPE
    Knowledge and Need Assessment on Pharmaceutical Products in Environmental Waters
    In Sweden, systems for classification of drug environmental risk and hazard have been used for 5 years
    START: Management strategies for pharmaceutical residues in drinking water - Pharmaceuticals for Human Use: Options of Action for Reducing the Contamination of Water Bodies
  • 11. Significance of Disposal vs. Excretion and Bathing
    APIs enter the environment by three primary routes:
    Excretion (primarily via urine and secondarily via feces) comprises continual low-level contributions from multitudes of people
    Bathing releases APIs from medications applied directly to the skin and excreted via sweat *
    Disposalof leftover, unwanted medications represents acute but transient and episodic contributions from fewer people
    Disposalis the best route for pollution prevention / source control measures
    • Indirect entry can occur via disposal of unwanted drugs and used delivery devices to trash (e.g., in leachates from landfills)
    • 12. Proper disposal is greatly complicated by the conflict between the need to protect public safety (e.g., from drug diversion) and the need to minimize environmental exposure
    * DaughtonCG and Ruhoy IS. "Environmental Footprint of Pharmaceuticals: The Significance of Factors Beyond Direct Excretion to Sewers," Environmental Toxicology & Chemistry 2009, 28(12):2495-2521; doi:10.1897/08-382.1; available: http://www3.interscience.wiley.com/cgi-bin/fulltext/123234136/PDFSTART
  • 13. 12
    Major Unknown
    What fractions of drug residues occurring in the ambient environment result from discarding leftover drugs?
    No studies provided objective data from well-defined populations to support any type of conclusion
    Data are needed on the the types, quantities, and frequencies with which drugs accumulate and are disposed of as household waste
  • 14. Drug Disposal: Major Unknowns
    ?
    Unknown: types, quantities, or frequencies by which APIs enter the environment via disposal.
    What percentage of any given API’s environmental loading is contributed by disposal: Disposal could be significant for certain APIs and insignificant for others.
    This means that conscientious control of disposal may not lead to any detectable change in the environmental occurrence of many (or most) APIs.
    ?
    !
  • 15. Drug Disposal: Major Unknowns
    ?
    Significance of antibiotic residues in environment with respect to evolution of pathogen resistance
    Portion of human poisonings resulting from accidental ingestion and abuse of diverted drugs that are stored or disposed imprudently
    Prevention of diversion and human poisonings may be the more important driver for prudent disposal.
    ?
    !
  • 16. Drug Disposal: Major Objectives
    An emphasis regarding disposal needs to be on protecting humans, pets, and wildlife from unintended acute exposures as a result of imprudent storage, stockpiling, or disposal of unwanted medications.
    • It is critical that guidance for disposal of drugs does not jeopardize the protection of human (or ecological) health.
    • 17. The ultimate objective, however, needs to be on reducing or eliminating the incidence of unwanted medications to begin with.
  • Ultimate Objective:No Leftover Drugs
    The long-term focus should not be how to properly dispose of drugs
    but rather
    how to minimize, and ultimately eliminate the creation of drug waste