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Patient safety

Ensuring patient safety is extremely important and we take the safety of all our medicines and medical devices very seriously.

Safety of medicines
Medicines are a part of modern life. In an ideal world, a medicine would target only the disease or disorder it's meant to and never do anything else; the so called 'magic bullet'. Unfortunately, despite the best efforts of scientists, such a medicine does not yet exist.

Most if not all medicines can cause side effects. However, not everyone who takes a medicine will experience side effects. Nevertheless, patients must discuss with their doctors the risks of experiencing side effects from medicines and that the benefit they receive from a medication should outweigh the risk.

Role of the pharmaceutical industry
The pharmaceutical industry has two major roles in managing the safety of medicines:

1. To collect, investigate and proactively evaluate information relating to side effects of medicines for the purpose of protecting patients and advising on drug safety.
   
2. To fulfil its legal obligations to the regulatory authorities by reporting individual adverse events (AEs) on an expedited basis and/or periodically, according to the drug safety regulations of each country.

We strive to ensure patient interest is served through the prompt detection of a potential safety issue with one of our drugs so that appropriate communication with regulators occurs, and then, following evaluation, decisions can be made and action taken.

How do we monitor safety?
We have policies which demand that an efficient, fully operational, worldwide system for pharmacovigilance be maintained within our company. Pharmacovigilance is the science and activities relating to the detection, assessment and understanding of adverse effects or any other drug-related issue.

We have dedicated teams of scientists and healthcare professionals across the world who monitor, review, evaluate and communicate safety issues with our medicines.

The safety of our products is assessed in clinical trials before a product can be approved for marketing. Sometimes adverse events occur after approval when a product is being used by large numbers of patients. We have policies and a governance framework in place to help us detect and act on any adverse events reasonably associated with our products. See also Drug safety governance framework.

Adverse events are recorded on our global safety database and clinical trial database and investigated by our clinical and pharmacovigilance teams. This helps us to monitor the balance between benefits and risks, see Benefit-risk management.

When appropriate, we respond to safety issues by changing product labelling and communicating with doctors. In most cases these courses of action are sufficient, but in a small number of cases we conduct additional risk minimisation activities. See collecting and reporting safety data.

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