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Managing Medication Safety

Patient Safety

Roche products not only have to be effective, they have to be safe. Roche employs a vast number of people in drug safety whose job is to protect patients from adverse drug reactions. They do this by identifying reactions to Roche drugs as early as possible and classifying them in terms of their severity. 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 to update the product labelling appropriately.

Roche responds 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.

Ensuring Patient Safety: Network of global professionals

Roche’s Global Drug Safety Department is responsible for monitoring, analysing and reporting on the safety of our medicines at all stages of the product lifecycle – from volunteers and patients participating in clinical trials of a new compound to patients taking a medicine once it is available by prescription.
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Drug Safety Governance Framework: Process and Responsibilities for safety assessment

Roche has global systems in place throughout the Roche Group to monitor and collect adverse events associated with its products, follow-up with the reporter where necessary, transmit the adverse event data to the central safety departments, forward relevant reports to the regulatory authorities and evaluate any new and emerging safety information. Roche also has a policy and set of standard operating procedures requiring all staff members to immediately report any issues relating to the safety or quality of Roche’s medicines.
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Monitoring Safety: Process for reporting, collecting and analysing safety data

Roche’s risk management procedure ensures the compliance with applicable regulations for informing regulatory authorities, healthcare professionals and patients about the safety profile of its medicines. Roche follows strict regulatory requirements and guidelines. For example, Roche reports all serious or unexpected safety events to regulatory authorities and also sends in periodic reports examining all adverse events reported over a set time period.
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Managing Risks: Risk assessment and risk minimisation

Almost all medicines have some side effects which occur in some patients. 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.
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