Pharmaceuticals, Health and Environment

ISDE, Geneva 18.5.2009Ingrid Eckerman

Swedish Doctors for the Environment www.dnsy.se/lfm

ingrid@eckerman.nu

Pharmaceuticals are chemicals …

• Biologically active• Non-degradable• Long life• Often toxic

Pharmaceuticals …

• Used in increasing amounts, increasing sorts of substances

• Sewage plants not made for them • Continuous release• Restrictions on use not plausible• Not possible to prohibit

Joakim Larsson 2008

Examples: effectsFish, frogs, mussels:• Reproductive disturbances• Sex disturbances• Development disturbances• Behavior disturbancesBirds:• Behavior disturbances• Kidneys affectedButterflies:• Blocking of the cholesterol synthesis

in the larvae

Examples: tested products

• Etinyloestradiol• SSRI• Simvastatin• Diclofenac• Klotrimazol

Sewage plants in India• Several broad spectrum antibiotics

found in concentrations toxic to bacteriae and plants

• Ciprofloxacin 30 milligram per liter • Enterococcae in the sewage plants

resistant to all known antibiotics

Larsson J, de Pedro C, Paxby N. Journal for Hazardous Materials 2007;Vol 148 (3):751-755

Oseltamivir does not break down in sewage plants

The active substance is still in water where birds with influesa viruses are living.

Läkemedelsvärlden 3.10.2007

Medicines in the water plants of Stockholm, 2 april, 2007 (ng/l)

Generic name

Norsborg incoming

Lovön incoming

Görväln incoming

Norsborg outgoing

Lovön outgoing

Görväln outgoing

Atenolol 1.0 0.5 1.5 <0.3 0.3 <0.3

Citalopram <0.3 1.4 0.5 <0.3 <0.3 0.3

Diklofenak 0.6 0.8 1.1 <0.1 <0.1 0.7

Ibuprofen <0.2 0.4 1.2 0.5 0.3 1.3

Metoprolol 1.1 1.5 2.5 0.3 0.5 0.4

Naproxen 1.4 1.4 2.0 0.7 0.2 1.3

Trimetoprim 0.4 <0.3 0.4 <0.3 <0.3 <0.3

Medicines in liver of perche caught in central Stockholm

Inner station Intermediate station

Outer station

Citalopram 0.1 µg/kg <0.1 µg/kg <0.1 µg/kg

Propoxyfen 0.25 µg/kg 0.16 µg/kg <0.1 µg/kg

Number of medicines found in drinking water

Place of sample Number of detected pharmaceuticals

Perth 14Singapore 8Paris 7Peking 6Edinburgh 4Hamburg, Johannesburg 3Bryssel, Helsingborg, HongKong, Copenhagen, Lyon, Sofia

2

Dubai, Düsseldorf, Hoorn (NL) 1Manchester, New York, Shipol 0

Miljö och hållbarhet

Examples on low degradable pharmaceuticals (t1/2 , days)

> 365 days amitriptylin ifosfamidbarbitursyrederivat kodeinbezafibrat metyldopacyklofosfamid metronidazoldextropropoxifen naproxenerytromycin sulfametoxazolfluorokinoloner tetracyklin

Medicines reach the human being

• Via consumption of fish, crustaceous animals or other aquatic organisms (bio-ackumulation, medicine residuals)

• Via drinking water (medicine residuals, metabolites)

Potential effects

• Sub-therapeutical exposure to mixtures under long periods, in all phases of life

• Synergy effects in mixtures (1+1=3)

• Changes in genes• Resistance to antibiotics• Hormone effects• Allergic reactions

Potential effects• The effects of life long exposure to very low

doses of pharmaceuticals on human receptor mechanisms are not known.

• There are no scientifical methods to evaluate a possible ocurrence of such effects.

Swedish sewage plants

Less than half of the pharmaceuticals are degraded more than 50%.

Exemple easily purificated: IbuprofenExemple difficult to purificate: Diclofenac,

Tramadol

Läkemedelsprojektet – Stockholm Vatten AB

We will be more humans on the earth We will eat more medicinesBut ...we will not have more water on the earth!

2005 = 2030 =

1997- 1998

• ”Medicines and the Environment. What Do We Know Today? A Brief State of the Art Analysis”

• Sent the report to all pharmaceutical companies that sold medicines in Sweden, to authorities and to our professional organisations

• Prepared presentation at ISDE GA in Arezzo • Tried in vain to interest LIF,

the pharmaceutical industry’s organisation

1999

• Demanded environmental classification in Fass (the directory on medicines)

• Presented the report to the environment director of SLL (Stockholm county council), dr Åke Wennmalm

2002 - 2004

• Lobbying to get environmental effects of pharmaceuticals included in the EU laws about medicines.

• The government ordered the Medical Products Agency (LMV) to make a report.

• The LMV said “compulsory classification is not possible”.

2003 Environmental classification

of pharmaceuticalsA Swedish initiative

2004

• Worked in EU to reduce the environmental effects by pharmaceuticals

• Environmental classification of medicines• Analyses of residuals in water from

medicines

2004-2006

• Two big full day seminars on ”Pharmaceuticals, environment and health”

• Writh concerning the LMV report

• Brought up the question at HCWH

2007

• Pharmaceuticals NOT included in REACH

• HCWH published a fact sheet

http://www.lif.se/cs/default.asp?id=5362

2008

• Two seminars for the parliament, together with the Green party

• Swedish Medical Association decided to work with environment and health. Pharmaceuticals and climate changes were chosen.

EU 2008

Pharma package:1. Access to reliable information 2. Safety monitoring of medicines

(pharmacovigilance). Environment NOT included

3. Fake medicines

Sweden 2007 -• Spreading of the classification system• Support by the Swedish government• Germany and Netherlands have joined • The commission is attended• Working groups• Pharmaceutical Forum (includes the Standing

Committee of European Doctors CPME)• EMEA (European Medicines Agency)• EEA (European Environment Agency)• DG Environment (Directorate General)

What needs to be done?

• Pharmaceuticals included in REACH?

• Environmental monitoring included in pharmacovigilance

• Environmental classification compulsory

• Professional organizations' working for good choices

Life habits and the inheritance are the base

Non-pharmaceutical treatments is the next step

Medicines must sometimes be used as a complement

TO PREVENT ILLNESS AND TREAT DISEASES

Folkhälsoenheten i Nacka 2005

WHAT CAN DOCTORS DO?Not prescribe medicines that are not needed• Concider other alternatives• Not slide on indications• Reconcider regularlyNot prescribe medicines that will not be taken• Concordance with the patient• Start packagesChoose the best preparation• Janusinfo, Kloka listan, Fass …• Ask the company consultant!Lobby for more environment friendly medicines• Ask the company consultant!

Folkhälsoenheten i Nacka 2005

Environmental demands• Do you buy active substances from other

producers?• Do you make environmental demands upon the

contractors?- which demands?- how do you control?

• Do you make environmental demands upon the subcontractors?- which demands?- how do you control?