Our medicines must not only be effective and reliable, they have to be safe. Consumers of our medicines must be confident that every effort is being made to ensure their safety through rigorous testing, ongoing monitoring and risk management.
All medicines can cause side effects although not everyone gets them. In order to ensure that we provide highly effective medicines that improve quality of life, while minimising potential risk, we continually collect information on all possible adverse effects of our medicines.
Our product information clearly describes potential side effects, and, if necessary, we also provide advice to reduce these risks. This information is available from many sources, but the most important information is contained in the Summary of Product Characteristics (SPC), which is available to all healthcare professionals (and can be viewed on www.medicines.ie). We also provide patient information leaflets (PILs) in all medicine packaging, which are also accessible on www.medicines.ie. These documents are approved by either the Health Products Regulatory Authority (HPRA) or the European Commission as appropriate before they are published.
Monitoring drug safety
Roche employ a vast number of people in drug safety globally, as well as a team in Ireland. Roche’s drug safety departments systematically monitor all Roche drugs worldwide, both before and after they are launched. Whenever a new adverse event is identified in connection with a Roche drug, we work with the health authorities—in our case, the Irish Medicines Board—to update the product labelling appropriately.
We have a policy and set of standard operating procedures requiring all of our employees to immediately report any issues relating to the safety or quality of our medicines.
Furthermore, to optimise medication safety, the benefits of taking a particular medicine must outweigh the risks of side effects. Each new Roche medicine is subject to a detailed benefit-risk analysis using Roche’s safety risk management processes.
Finally, we respond promptly to customer complaints. An effective and well documented issue management procedure is immediately initiated should a product defect be reported anywhere in the world.
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