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Pharmaceuticals in the Environment: The Problem in Perspective

Pharmaceuticals in the Environment: The Problem in Perspective



Presentation given at the PHARMAS Conference: Pharmaceutical Products in the Environment: Is there a Problem held in Nimes (France) June 3-4 2013

Presentation given at the PHARMAS Conference: Pharmaceutical Products in the Environment: Is there a Problem held in Nimes (France) June 3-4 2013



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    Pharmaceuticals in the Environment: The Problem in Perspective Pharmaceuticals in the Environment: The Problem in Perspective Presentation Transcript

    • 1Pharmaceutical Products in the Environment: Is there a problem?The “Problem” in PerspectiveDavid Taylor - wca environment& Thomas Senac - Sanofi
    • Slide 2PHARMAS Conference – Nimes June 2013 Advances in analytical science enable us to see residues ofpharmaceuticals in the environment that used to be invisible. These residues are widespread in the environment (mainly in water) Most are <1 µg l-1, many are <0.1 µg l-1, Drinking Water <0.01 µg l-1 The principle source of most pharmaceuticals to the environmentis from the excretion products of patients. 90% of medicines are estimated to be used by patients as prescribed At the levels currently present in the environment: Risks to human health are considered to be very unlikely Acute effects on aquatic life are considered to be insignificant Data on the potential long term impacts is increasing,and varied, however some significant impacts onsome aquatic life forms cannot be ruled out.What do we know about PIE?
    • Slide 3PHARMAS Conference – Nimes June 2013PharmaceuticalsPlasticisersPesticides BiocidesFlame RetardantsFragrancesPersonal Care ProductsDetergentsPharmaceuticalsBut do we have tunnel vision?
    • Slide 4PHARMAS Conference – Nimes June 2013What defines a pharmaceutical?Pharmaceuticals cannotbe defined by any oftheir chemical, physical,structural or biologicalproperties
    • Slide 5PHARMAS Conference – Nimes June 2013Pharmaceuticals cannot be defined by structurePropofol InsulinAtorvastatinNitroglycerine
    • Slide 6PHARMAS Conference – Nimes June 2013It is only the use to which it is put thatdefines a chemical as a pharmaceutical.WarfarinAny substance has the potential to be used as a pharmaceuticalAll substances will exert harmful effects at some concentrationDimethyl FumarateTecfidera
    • Slide 7PHARMAS Conference – Nimes June 2013So what is it thatmakes pharmaceuticals‘different’?
    • Slide 8PHARMAS Conference – Nimes June 2013“They are designed tobe biologically active” Which also implies that more ‘environmentally friendly’alternatives could be developed. However, few if any drugs are really ‘designed’. Our knowledge is simply insufficient to do this If design was possible, drug pipelines would be more robust. Drugs are ‘discovered’ & then optimised for efficacy & safety. This is the fundamental reason why the ‘green by design’concept cannot currently be well defined for pharmaceuticals Even if drugs were 90% degradable they would still bedetectable in the environment (1.0 µg l-1 becomes 0.1 µg l-1)
    • Slide 9PHARMAS Conference – Nimes June 2013“They are designed tobe biologically active” The implication being that they are therefore of muchmore concern than other substances. Biological activity shouldn’t be confused with toxicity. Only antibiotics and antineoplastics are deliberately toxic Mammalian toxicity and bioaccumulation are very, veryunhelpful properties of any potential pharmaceutical. Compounds that are toxic to mammals or bioaccumulate willusually be screened out during preclinical developmentAny substance has the potential to be used as a pharmaceuticalAll substances will exert harmful effects at some concentration
    • Slide 10PHARMAS Conference – Nimes June 2013Pharmaceuticalsare “down the drain”chemicalsTherefore entry to the environment iscontinuous from multiple point sourcesBUT This is a common attribute that theyshare with many other substances
    • Slide 11PHARMAS Conference – Nimes June 2013“Pharmaceuticals couldbe a problem becausethey might:” be metabolised by the body before release. breakdown into potentially more toxic substances not be fully removed in waste water treatment form transformation products during water disinfection. disrupt the endocrine system interact with each other to increase potency interact with other substances to increase potencyBUT These concerns apply to micropollutants in general
    • Slide 12PHARMAS Conference – Nimes June 2013“There are only a few Pharmacompanies so control is easy”Research CompaniesGeneric Companies
    • Slide 13PHARMAS Conference – Nimes June 2013Pharmaceuticals are data richsubstances and are getting richerMore information is available on the toxicology ofpharmaceuticals than all other substances put togetherData on toxicology (including mutagenicity, carcinogenicity,cytotoxicity, histopathology, teratogenicity …), kinetics,metabolism, mode of action… for humans AND animals.
    • Slide 14PHARMAS Conference – Nimes June 2013The risk benefit balance is differentfor pharmaceuticals Society will usually tolerate a higher level of risk to gain significantpatient benefit. Risk benefit assessment of pharmaceuticals is complex. Not all side effects are known when the product is approved. Trade offs will need to be made between + ve and – ve aspects. A balance will be needed between benefit and uncertainties. A single regulator is needed to simultaneously weigh ALL the evidence. Pharmacovigilance is used to update the assessment Pharmaceuticals receive a comprehensive in depth risk benefitevaluation before they receive a marketing authorisation. It is inappropriate to introduce new regulations that override thiscarefully balanced holistic judgement.
    • Slide 15PHARMAS Conference – Nimes June 2013So why are pharmaceuticalsbeing treated differently toother micropollutants? Pharmaceuticals can only be differentiated from other substancesas a consequence of their use. Compared to other micropollutants pharmaceuticals are: Neither more widely distributed nor found at higher concentrations Not necessarily more biologically active. Likely to be less toxic and accumulative in mammals Data rich & likely to have a much higher value to society There is thus no reason to treat the pharmaceutical groupdifferently to other groups of micropollutants However individual pharmaceuticals, like any other micropollutant,might be of environmental significance
    • Slide 16PHARMAS Conference – Nimes June 2013DICLOFENAC
    • Slide 17PHARMAS Conference – Nimes June 2013Consequences & ActionsBeware the Policy Syllogism“Something must be done!,This is something,Therefore we must do this”Actions need to address actualproblems and be proportionate
    • Slide 18PHARMAS Conference – Nimes June 2013Wrong diagnosis can lead to wrong action
    • Slide 19PHARMAS Conference – Nimes June 2013TREATED SEWAGE DISCOVEREDIN OUR DRINKING WATERLorem Ipsum In librisgraecis appetere mea. Atvim odio lorem omnes, pri idiuvaret partiendo. Vivendomenandri et sed. Loremvolumus blandit cu has.Sitcu alia porro fuisset.Ea pro natum inviduntrepudiandae, his et facilisisvituperatoribus. Mei euubique altera senserit,consul eripuit accusata hasne.In libris graecis appeteremea. At vim odio loremomnes, pri id iuvaretpartiendo. Vivendo menandriet sed. Lorem volumusblandit cu has.Sit cu aliaporro fuisset.Ea pro natum inviduntrepudiandae, his et facilisisvituperatoribus. Mei euubique altera senserit,consul eripuit accusata hasne.THE DAILY NEWSwww.dailynews.com THE WORLD’S FAVOURITE NEWSPAPER - Since 1879
    • Slide 20PHARMAS Conference – Nimes June 2013Monitoring PharmaceuticalsHow to expend large resources to learn nothing of significance. The literature is overflowing with data on measurements of thesame few pharmaceuticals in various water bodies. This uses very substantial and sophisticated laboratory resources We already know that all waters will contain pharmaceuticals But academics, regulators & industrialists are already using validatedprecautionary risk assessment methods to predict exposures and assessthe environmental and human impact of pharmaceuticals in both theirmanufacturing and use Meanwhile little or no data exists either for theconcentration of, or the human or environmental impactof, thousands of other micropollutants.
    • Slide 21PHARMAS Conference – Nimes June 2013Any additional treatment technology should beaimed at the global reduction of ALL thosemicropollutants which indicate significantenvironmental risk, not just pharmaceuticalsRemoval of pharmaceuticals from wastewaterAn expensive way to solve the wrong problem
    • Slide 22PHARMAS Conference – Nimes June 2013Going beyond compliance Working proactively via Trade Associations, ResearchGroups & individual companies industry is co-operatingwith Authorities, Academics and other stakeholders. Continually improving product risk assessments Developing intelligent testing strategies Improving fate modelling and testing (e.g. PhATE) Addressing effluents from manufacturing Improving risk assessments, process design & treatment technologies Sharing expertise with contract manufacturers Promoting unused medicine take back programmes
    • Slide 23PHARMAS Conference – Nimes June 2013Conclusions Pharmaceuticals as a group are no more of a problem thanany other micropollutant ‘group’. Individual pharmaceuticals may pose specific problems butthese should be dealt with on a case by case basis. Antibiotics may be a special case A satisfactory ERA is needed for all micropollutantsincluding existing pharmaceuticals. A proportionate ‘no-regrets’ approach should apply toreducing inputs of all micropollutants includingpharmaceuticals to the environment . Faulty diagnosis can lead to inappropriate solutions andwasted resources yet provide no improvement to moresignificant problems
    • Slide 24PHARMAS Conference – Nimes June 2013Contacts for further informationwww.wca-environment.comsolutions@wca-environment.comQuestions?
    • Slide 25PHARMAS Conference – Nimes June 2013Supplementary Slides
    • Slide 26PHARMAS Conference – Nimes June 2013With a big enough sample analysts cannow find anything, anywhere if they lookhard enoughDecade Detection Limit Ratio Description1900s 0.1% 1 in 103Parts per thousand1930s 1 milligramme / litre 1 in 106Parts per million1960s 1 microgramme / litre 1 in 109Parts per billion1980s 1 nanogramme / litre 1 in 1012Parts per trillion1990s 1 picogramme / litre 1 in 1015Parts per quadrillion2010s 1 femtogramme / litre 1 in 1018Parts per quintillion???? 100 molecules / litre 1 in 1021???? 1 molecule / litre 1 in 1023
    • Slide 27PHARMAS Conference – Nimes June 2013Pharmaceuticals in Drinking WaterRisk to HumanConsumers in Perspective
    • Slide 28PHARMAS Conference – Nimes June 2013 Slide 28University of York - June 2011Pharmaceuticals in Water – Environmental ImpactRatio of MECs to lowest reported effect concentrations (Boxall et.al. 2008)