2.5. PharmEcoVigilance (Ruhoy)

483 views

Published on

By Ilene Ruhoy.

This slidecast is part of the GreenPharmEdu.org program.

Published in: Technology, Business
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
483
On SlideShare
0
From Embeds
0
Number of Embeds
18
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

2.5. PharmEcoVigilance (Ruhoy)

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

×