Understanding the effects of our medicines on the natural world is a long-standing commitment for AstraZeneca.

Thursday, 3 June 2010

We want to identify any potential adverse effects on the environment that our medicines might have so that we can responsibly balance these against the benefits that these medicines bring for patients.

In recent years, advances in analytical techniques have resulted in the detection of trace amounts of pharmaceutical residues in the environment. We understand, and take seriously, the concerns that this has raised.

The presence of extremely low levels of pharmaceuticals in the environment (PiE) is mainly the result of patient excretion and is an inevitable result of the way most medicines work today. To be effective, medicines have to be stable enough to get to the part of the body where they need to be active, without deteriorating along the way. This means that sometimes there are residues, which leave the body in the usual way and enter the environment via the sewage system.

The trace levels found in the environment as a result of patient use and excretion are generally extremely low and unlikely to pose a risk to human health in the short term. However, whilst improving all the time, the understanding of potential long-term effects, for example to aquatic life and higher predators, needs further research.

We work both within AstraZeneca and in partnership with others to improve understanding of the way in which pharmaceuticals interact with the environment.

We actively engage and partner with other pharmaceutical companies, non-governmental organisations, scientists, regulators, patients and prescribers to share scientific knowledge and experience to strengthen the global research effort and manage issues on this topic responsibly.

Our scientists are at the forefront of the global research effort.

Our dedicated environmental laboratory at Brixham UK is home to over 45 scientists with a broad range of skills and experience in environmental sciences. They work together, and with leading external experts to better understand the potential long-term effects of pharmaceuticals in the environment.

We further boosted our capabilities with the opening of an additional, $26 million state-of-the art laboratory at Brixham in 2007.

AstraZeneca’s business is focused on making a difference in healthcare, but we also have a responsibility to the environment. I am privileged to lead a team including the team at Brixham that is dedicated to helping the company meet that responsibility by pushing the boundaries of environmental science for the benefit and protection of the environment for future generations. In particular, we are developing new and improved ways of predicting likely levels of pharmaceutical residues and better understanding the potential effects on the environment.

Steve Rumford

AstraZeneca’s Director of SHE Product Support

We are also looking at how we can build environmental considerations into a medicine’s complete lifecycle – from discovery and development, through marketing, use and ultimately disposal.

We have introduced Environmental Risk Management Plans that will accompany all new medicines throughout their lifecycle. These Plans will enable all available environmental data to be taken into account at key decision points during drug discovery and development, and provide early warning of medicines that could pose a potential risk to the environment.

Some of the medicines in our development portfolio are anyway likely to result in fewer residues because the enhancements that we seek in drug design to improve effectiveness against disease could also reduce the amount of medicine excreted by the patient.

Also, we continue to expand our biopharmaceuticals research and biopharmaceuticals tend to be metabolised by the body or are rapidly and extensively degraded in the environment.

Excretion from patients is recognised as the major source of pharmaceuticals in the environment, but inappropriate disposal of unused medicines is also a factor.

We work with national and local authorities to make appropriate disposal options and guidance available and to discourage disposal to the drain or directly to sewage systems.

We also support the use of approved, voluntary take-back programmes where these are available.

Our medicines are manufactured in accordance with strict regulatory requirements and our processes are designed to avoid or otherwise reduce to a minimum the loss of product to the environment.

We have internal discharge standards for active pharmaceutical ingredients that underpin our commitment to making sure that our manufacturing activities do not present an unacceptable risk to the environment.

And, as we continue to increase our use of external manufacturing suppliers in line with our business strategy, we remain committed to using only those that embrace environmental standards consistent with our own. Read more about our responsible procurement.

In line with AstraZeneca’s overall commitment to transparency and open communication, we make environmental risk data for our existing products publicly available.

We publish information on the Swedish Doctors Prescribing Guide website, using the voluntary disclosure system introduced by the Swedish Association of the Pharmaceutical Industry (LIF). AstraZeneca has a leading role in developing the guidance for this activity.

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