To ensure that every Roche product is not only effective but also well-tolerated, Roche has established a systematic process designed to optimise patient safety throughout the lifecycle of a medicine.
We collaborate with regulatory agencies, monitor reports of adverse events experienced by patients, and communicate on our product safety activities, as appropriate to the audience.
Information about the safety and efficacy of a medicine is available from clinical trials. However, clinical trials may not detect all possible adverse events due to the limited patient population who receive a medicine. After a medicine is registered, adverse event reports received from health care professionals and the public are an important source of information, and help Roche to monitor the benefit-risk profile of our products throughout their lifecycles.
Continuously monitoring patient safety
We continuously collect, analyse and monitor information about any adverse events associated with our products.
Some information on adverse events and related risks may be known only after a drug is used in large numbers of patients in the wider population. For that reason, our safety risk management process begins in the early stages of the medicine's development and continues for the entire time the medicine is on the market. This helps us to identify potential adverse events before they occur, enabling appropriate preventative strategies to be designed and implemented.
Who is responsible for Drug Safety at Roche Products New Zealand?
We have a dedicated Drug Safety team who are responsible for processing all incoming safety information and reporting this to Medsafe or the Centre for Adverse Reactions Monitoring (CARM), based on local regulations. All adverse event reports are reviewed and analysed as soon as possible and classified in terms of their seriousness and the possible causal association to the Roche product.
What information do we need for an adverse event report?
All reports received by Roche of any untoward medical occurrence experienced by a patient administered a Roche medicine, whether or not this is considered related to the Roche medicine, are recorded as adverse events.
Roche wants to receive reports of any suspected adverse event experienced by a patient who has been administered a Roche medicine, including reports of both known (expected) and unexpected adverse events or side effects.
The following minimum information is required:
- A patient identifier (such as initials, gender or age)
- Name and contact details of the reporter
- A description of the event
- Name of the Roche medicine the patient was taking
If available, reporters are also asked to provide:
- Details of treatment with the Roche medicine (indication, dosage, start and stop dates)
- Any other medicines the patient was taking
- Date of onset of the adverse event
- Details of how the adverse event was treated
- The outcome of the event, and the date of the outcome
- In cases where the outcome is death, the date and cause of death
- Any relevant patient medical history
What do we do with adverse event reports?
Each report that is received is entered onto the Global Roche Safety Database. The Safety Database is regularly reviewed by our global Drug Safety team to assess reports received in relation to the known safety profiles of our products and to identify any potential new safety signals.
In some cases, Roche may need to request further information about the adverse event from the reporter.
Adverse event reports which meet the reporting requirements of the Centre for Adverse Reactions Monitoring (CARM) are submitted to them, usually within 15 days of receipt by Roche.
How to report an adverse event to Roche?
Adverse events can be reported to Roche in the following ways:
Contact Roche Medical Information on 0800 276 243
Email us at email@example.com