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 a 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 exposed.
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 environment.
“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 and Eco-management.
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 assessments.
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 system.
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.