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Pharmaceuticals in the Environment

Background

Medicines, as any other chemical substances, can be discharged into the environment as a result of human activities. They have become a focus of attention due to their biological activity and because their presence, even in small amounts, represents a concern for the environment.

In certain countries, public debate has recently focused on reducing the size of packaging for medicines and changing the criteria for establishing products’ expiration dates. These issues reflect the public’s concern about household waste and pharmaceuticals in the environment.

Finding pharmaceuticals in the environment

After pharmaceuticals are absorbed or administered, they are partly excreted by patients into the environment either in the same form or as substances called metabolites.

There are also other sources of discharge – effluent from drug production plants and discharge resulting from the inappropriate disposal, of unused medicines (e.g., by an end-user directly discharging unused medicine into a sewage system).

The improvement in analytical methods since the mid-1970s has made it possible to detect an increasing number of pharmaceuticals in the environment. Depending on the substances and the environment in which they are found, they may be present in very low concentrations, measured in nanograms or micrograms per liter.

While the risk to human health appears low in light of such small concentrations based on current information, environmental risks are a genuine concern, particularly for certain classes of pharmaceutical products such as hormonal substances, cytotoxic drugs and antibiotics. Further research on this topic has contributed to public awareness and regulatory changes.

Additional research is needed to increase our understanding of:

• The fate of pharmaceuticals in the environment
• Possible long term effects of low level exposure to pharmaceuticals on human health and the environment
• Possible combined effects of mixtures of pharmaceuticals and other micropollutants found in the environment

Packaging units and expiration periods

In the debate over the impact of pharmaceuticals in the environment, stakeholders such as environmental groups have raised questions about drug companies’ role in determining expiration dates and drug packaging units. They ask whether laboratories contribute to an increase in the consumption of medicines and waste by manufacturing boxes with as many units as possible or by shortening expiration periods. In actual fact, the health authorities in each country establish the rules for the size of drug packaging, taking into account the proper use of medicines, length of treatments, etc. Drug companies then work with the authorities and many other stakeholders to establish expiration dates and to determine the packaging units for their products.

Expiration dates

The stability of medicines is influenced by intrinsic factors (e.g., raw materials, pharmaceutical formulations and packaging) and extrinsic factors (e.g., temperature, humidity and light). The deterioration of a drug can reduce its therapeutic efficacy and lead to products that create adverse or toxic effects.

Stability testing provides data on how the quality of a drug varies based on different factors. These tests are a key part of obtaining drug-marketing approval, helping ensure the quality of a drug and its safety for use. Based on the results of stability testing, pharmaceutical companies propose expiration dates. Healthcare authorities then evaluate and establish expiration dates.

Drug packaging

The number of units packaged in each box of medicine also depends on many factors (i.e., whether a drug will be dispensed unit by unit, sold at the local pharmacy, etc.). Health authorities in each region are responsible for establishing the conditions for dispensing drugs, product packaging and the number of units for boxes sold. Pharmaceutical laboratories work with stakeholders (health authorities, healthcare professionals, NGOs, etc.) to define the methods for establishing the packaging units for drugs based on dosages, length of treatment, public health, environmental and other concerns.

Policy

Sanofi is aware of the growing concern about the issue of pharmaceuticals in the environment (PIE) and has developed a policy encompassing the following key areas:

• Improving the Group’s knowledge about the environmental impact of our products – conducting mandatory and voluntary environmental risk assessments on new and marketed products
• Developing general knowledge about the issue of PIE, working in close collaboration with stakeholders
• Analyzing discharge from the Group’s production sites, assessing impacts on the environment, if any, and exploring new technologies to remove micropollutants
• Supporting take-back programs for unused medicines where applicable and available

The Group is also committed to complying with expiration dates and local regulations on product packaging, working with all involved players (e.g., health authorities, healthcare professionals, patient organizations and NGOs) in order to define the methods for establishing packaging sizes and expiration periods for medicines that take into both public health and environmental issues.

The topic of micropollutants in water supply today is an emerging environmental and health issue. Beyond micropollutants, there are increasing concerns over the occurrence of pharmaceutical traces in water, from the scientific community, NGO s , and public authorities, which would probably lead to new regulations. In this context, Sanofi has been engaged in developing scientific and technological knowledge about the environmental impacts of its products.

Alain Lamaud,
Vice President, Health Safety Environment