[Pharmwaste] EU "benign by design" drugs
Laurie.Tenace at dep.state.fl.us
Wed Feb 4 08:19:26 EST 2009
Europe leads effort to push for design of "green" drugs
European Union requires environmental review of new drugs. Sweden leads the
way, creating database so doctors can check whether medications are "green"
before prescribing them.
By Jessica A. Knoblauch
Environmental Health News
February 4, 2009
Before Dr. Lars Lööf writes a prescription for his patients, he checks a
new database--but it's not just to search for the typical warnings about a
drug. He wants to know whether the medication might harm the environment. In
some cases, he even can find a more environmentally friendly drug, all with
the click of his mouse.
The new database, available to physicians in Sweden, is the first of its
kind in the world, prompted by a broader law in Europe that transforms the
way pharmaceuticals are evaluated before going to market.
The European Union requires pharmaceutical companies to analyze the
environmental risks of new drugs, adopting guidelines in 2006 that grew out
of concern about traces of drugs discovered in waterways and drinking water.
Medications such as antidepressants, painkillers, antibiotics and estrogen
are excreted by humans, and they wind up in treated sewage that is released
into the environment, where fish and aquatic animals, even humans, can be
While the United States focuses on figuring out how to keep drugs and
other chemicals out of the nation's waterways, the European Union's approach
could be called "benign by design." It goes right to the source, evaluating
the dangers of medications when they are created, before they enter the
"Without this information, doctors and patients cannot take environmental
aspects into account when choosing between products," said Lisa Anfält, a
technical expert at Sweden's Environmental Ministry Division for Chemicals
Evidence that a chemical may harm the environment doesn't necessary mean a
product will be banned. But the new legislation does mean that all
pharmaceuticals are now evaluated by the European Medicine Agency under the
same standards. Products already on the market are exempt, unless their use
or form has changed.
Most EU countries are simply performing the minimum required risk
But some have gone further. Germany, in a program called START, has
brought together pharmaceutical industry officials and others to explore ways
to reduce contamination of waterways.
Sweden, a long-standing architect of pioneering environmental legislation,
has taken the biggest steps.
The Stockholm County Council, which provides public health care to
Stockholm's residents, set up a regional environmental classification system
for pharmaceuticals in 2003.
The European Commission thought it was too soon to act "so we took the idea
back home and started it there," said Åke Wennmalm, Environmental Director of
the Stockholm County Council and the driving force behind the classification
Called JanusInfo, the database rates pharmaceutical substances in terms of
their toxicity, persistence, and bioaccumulation potential based on data
given by pharmaceutical manufacturers. It is part of Stockholm's larger
effort to reduce levels of the most environmentally hazardous medicines in
wastewater effluent and in surface water by 2011.
The database was so well received that it was soon extended to all of
Sweden. Then-prime minister of the environment, Lena Sommestad, expressed
interest in obtaining more knowledge about the environmental risks of
pharmaceuticals. As a result, an industry trade group, the Swedish
Association of the Pharmaceutical Industry worked with government to create a
standardized model for environmental classification of pharmaceuticals.
Like Stockholm's JanusInfo, the national database includes environmental
hazard assessments. It also contains risk assessments, which rate substances
based on the probability that they will cause adverse effects.
The hope is that doctors will use the data to pick the greener option
among two drug equivalents.
Some studies have shown that drugs such as the antidepressant Prozac and
birth control pills that contaminate wastewater can harm fish, amphibians and
other aquatic life. Traces of drugs also have been found in some drinking
water supplies, too, although the potential effects on people are unknown.
The database is located online in the Swedish Medicines Information
portal, or FASS, a commonly used resource for both doctors and the general
public for up-to-date pharmaceutical information.
"FASS is very well known among doctors in Sweden as a source for
everything you want to know about a particular pharmaceutical, so it just
felt natural to add an environmental component onto it," says Matilda
Persson, a spokesperson for the Swedish pharmaceutical industry group.
So far, the database lists about 1,100 substances, although only 60 percent
have been environmentally reviewed. One-fourth of those have detailed data.
By 2010, all pharmaceuticals marketed in Sweden are supposed to be assessed,
excluding those unlikely to have an environmental impact, such as vitamins.
Although there are no statistics available on how many doctors have used
the database, Persson says that it registers about 5 million visits per month
and is regarded as the most important pharmaceuticals website in Sweden.
Lööf, a physician at Central Hospital in Västerås who specializes in
internal medicine and gastroenterology, said he and many of his colleagues
feel the database is useful but that it needs more hard data on drugs,
especially older ones that don't fall under EU legislation.
"Physicians do use the database, but it's not yet common for them to use it
for every prescription because it's still lacking a lot of information on
pharmaceuticals," said Lööf, chairman of the Drug Therapeutic Committee at
the Centre for Clinical Research in Västerås, which works with local
physicians to provide drug therapy strategies.
He adds that drugs without environmental data are often classified first
as high risk, but then changed to low risk once more information is obtained,
which can be confusing to physicians and patients.
"The list changes from year to year and this is a problem," Lööf said.
Still, he believes that the database is a good start in managing
There are no plans to extend the database to the rest of Europe. That
could change as the European Environmental Agency, under the European
Commission, recently recommended that all EU countries introduce a drug
"We don't know whether the European Commission will accept this
recommendation, but it is a very strong push on the Commission to adopt this
system in all of the EU," said Wennmalm. He believes that in a few years, a
drug classification system might be introduced to all 27 EU countries,
especially Germany, which has already expressed interest.
Christina Rudén, program manager of MistraPharma, a Swedish national
research initiative that studies pharmaceuticals' environmental effects, said
because the European Union's pharmaceutical legislation is fairly new, it may
be easy to change. She said Swedish reviewers are likely to suggest an
amendment that includes a classification system similar to JanusInfo.
"It's quite impressive of Sweden to put this voluntary classification
system in place since these pharmaceutical industries are so multi-national,"
Ruden said. "There are some serious concerns internationally and particularly
in the U.S. about why the industries should do this voluntary classification
system, but at the end of the day the pharmaceutical industry agreed to do
it, and I think that's a very positive sign."
Not all drugs can be green. Some might seep into waterways yet save
people's lives. And since the environmental threats of pharmaceuticals are
not yet fully understood, some experts worry about passing laws without
properly assessing the risk that they pose.
"It's far worse if people in need of a treatment lose the treatment
because of a poor risk assessment that overestimates something that's a small
risk to the environment," said Frederick Bouder, a research associate at the
King's Centre for Risk Management at King's College London who studied
regulation of pharmaceuticals in the environment in the United States and
"At the same time," he said, "it would be a pity if people are
contaminated by something quite bad because we haven't understood the
interactions of several chemicals in the water."
The United States does not assess or classify drugs based on their
environmental impacts, but legislation from Brussels-often originating in
Sweden-sometimes influences U.S. policy. The EU has the world's most
stringent chemical program.
Åke Bergman, head of Stockholm University's Department for Environmental
Chemistry, said if some companies are persuaded by these government programs
to implement green chemistry policies, it may force others to do so as well.
Some pharmaceutical companies are indeed gaining interest in green
chemistry. Industry, policymakers and scientists convened at the first
International Conference on Sustainable Pharmacy in Germany last April to
discuss how to make drugs more environmentally friendly. In the United
States, major corporations have joined the American Chemical Society's green
chemistry pharmaceutical roundtable.
According to an article published by the American Chemical Society, a new,
birth control pill from drug maker Schering-Plough is scheduled for animal
and human drugs trials. A company representative was unwilling to comment on
the product. But the article claims that the new drug uses biodegradable
Without green chemistry, "the industry will find it more and more difficult
to manufacture and sell their chemicals," Bergman said.
Waste Reduction Section
Florida Department of Environmental Protection
2600 Blair Stone Rd., MS 4555
Tallahassee FL 32399-2400
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