Managing Medication Safety
Roche products not only have to be effective, they have to be safe. Any medicine may cause side effects in some patients. Our priority is to make sure the benefits outweigh the risks. We have robust processes in all countries to monitor how patients react to our medicines. We regularly analyse medicines against various reference databases and continually collect information from the field to help us spot potential safety risks. All products in clinical development have a safety management plan, and all marketed medicines have a risk management plan reviewed and approved by major health authorities.
We investigate all reported side effects to find out whether our product caused them. If there is a link, we re-evaluate whether the benefits of the medicine still outweigh the risks. We also have procedures in place to promptly inform patients, physicians, healthcare providers and regulators of any new product safety information. We update product labelling and information with new safety information as required and, when necessary, write to healthcare providers with updated advice on the use of our products.
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. We have a strict product recall process to ensure we can withdraw products rapidly on the rare occasions that quality problems do arise.
Improving the benefit-risk profile
In an ideal world, every patient should be prescribed the medication that is best suited to his or her specific condition. Therapies should show precisely the effect that is intended, and have few, if any, effects on the patient’s quality of life. With this in mind, Roche is leading in the drive towards Personalised Healthcare. Our aim is to enable healthcare to be tailored more closely to patients’ individual needs, thereby enabling better outcomes and more safe and efficient use of healthcare budgets.
Optimising the safe use of Roche products
All medicines are subject to rigorous testing before they are approved by regulatory authorities (such as the US Food and Drug Administration). Before a medicine is prescribed to patients, findings from early laboratory studies are carefully analysed by Roche scientists and discussed with regulatory authorities. The medicine then undergoes a long process of investigation using well-designed and controlled clinical trials. Controlled trials are those which compare the new medicine to a placebo or existing medicines. They are usually “double blind” so that neither the patient nor the doctor knows which medicine the patient is receiving. This ensures the results are not biased. These studies or trials gather information about the efficacy and safety (e.g. side effects) of new medicines compared to existing treatments. In addition, information is gathered by studying different patient groups (e.g. young, elderly), different dosages and the use of a drug in combination with other medicines to see which patients benefit the most or have side effects.
Our product information clearly describes potential risks but, if necessary, we also provide advice to reduce these risks. This information is available from many sources. The most important information is contained in the Summary of Product Characteristics (SmPC) which is available to all prescribers. In addition, patient information is included in all medicine packaging. SmPC and patient information must be approved by regulatory authorities. This helps doctors and patients to decide whether the benefits of taking a particular medicine outweigh the risks in each individual case and if specific actions are required to reduce any risk.
Network of global professionals
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.
During each phase of the clinical trials for a medicine, Roche’s Global Drug Safety Department evaluates the safety and effectiveness to determine the benefit–risk profile of the medicine. If the risk exceeds the patient benefit, then Roche will change the study or halt development of that medicine.
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.
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.
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.