We have medicines on sale in over 100 countries worldwide. We use global and local systems to monitor the safety of all our marketed medicines and respond to any potential new side effects as quickly as possible.
Our key principles for patient safety are outlined in our Bioethics Policy and include:
- Safety data must be regularly analysed so that potential new side effects are identified as early as possible.
- All safety reports must be scrutinised by medically qualified individuals.
- We provide investigators, prescribers, consumers and research subjects with updated safety information in a timely manner.
- All relevant patient safety information must be incorporated in product labelling.
- Our employees are required to report any potential safety issues they become
- aware of.
Who is responsible for patient safety within AstraZeneca?
Our Chief Medical Officer has overall accountability for the benefit/risk profiles of the products we have in development and those on the market. He works with our Head of Patient Safety and the European Qualified Person responsible for Pharmacovigilance to oversee patient safety across AstraZeneca. This group is supported by a dedicated patient safety organisation that monitors the safety of our investigational products and marketed medicines, and maintains our patient safety systems.
At a global level, every medicine in development and on the market is allocated a Global Safety Physician and a team of patient safety scientists. In each of our markets, we also have dedicated safety managers with responsibility for product safety at a local level.
Our sales representatives also play an important role. They are trained to ask about possible side effects during visits to doctors and to update doctors on new safety information for our products as it becomes available.
Everyone who works at AstraZeneca is expected to report safety issues that come to their attention. We run awareness campaigns for staff about adverse events (possible side effects) and how to report them.
Do you adopt the same standards in all countries?
Yes. Our standards are global and apply in all countries where we operate.
We audit our patient safety systems regularly to make sure our policies and standards are being implemented. Audits of the pharmacovigilance systems within our marketing companies are done on a risk management basis and include areas such as audit/inspection history, compliance reporting, number of medicines, number of studies and number of local contracts/agreements.
In some countries, particularly emerging markets, national systems for safety reporting are not yet well-established and doctors, regulators and others are less likely to report potential safety issues. As our business expands in these markets, we are working with regulators to improve safety reporting.
Do you use contractors for any of this work and how do you make sure they apply your standards?
Yes, we use an external provider, Tata Consultancy Services (TCS), to manage the data entry process for individual case safety reports relating to AstraZeneca therapies, including our H1N1 vaccine. As experts in their field, TCS are driving improvements in the efficiency and consistency of data entry across AstraZeneca and using TCS for this work means our patient safety teams can focus primarily on case prioritisation, the medical aspects of patient safety and continuing to improve our safety science. MedImmune Patient Safety manages the processing of individual case safety reports for all biological products.
Before becoming an AstraZeneca supplier, TCS completed a thorough evaluation process including an assessment of their case handling expertise, and their approach to quality and risk management. The review included site visits and discussions with other TCS customers. TCS are contractually required to comply with our patient safety standards, and are closely monitored through audits against detailed quality and compliance performance indicators.