Absolute safety is something we may be aiming at continually, but which can never be fully and completely attained. This particularly applies to pharmaceuticals and medicines. Doing everything in our power to safeguard patient safety, along the entire lifecycle of a medicine, is of paramount importance to us. To this end, we have a highly professional pharmacovigilance (PV) system in place which closely monitors all the suspected side effects, or adverse events, which have been reported in conjunction with our medicines, initiating all the necessary steps to address and remediate situations which may pose a health risk to the people taking our medicines.
Last year, around 150 million people all over the world received one of Roche’s more than 40 approved medicines. All in all, there were close to 400’000 instances of suspected adverse events reported in association with Roche medicines. To be able to handle all of this, a total of more than 2,000 Roche employees professionally deal with patient safety issues, at the global, regional and local level.
Felix Arellano, Global Head of Drug Safety Risk Management at Roche, points out: "On top of these 2,000 safety experts, it is all of our 90,000-plus staff around the world who, strictly speaking, have a shared responsibility for safety. This is why our employees are kept in the loop by taking compulsory annual trainings in adverse event reporting. Also, our contractors and partners have to be fully aware of the company requirements for drug safety processes."
Kristof Vanfraechem, Head of International Pharmacovigilance in the Drug Safety Risk Management unit, echoes: "We obviously study our medicines in clinical trials, but much of the learning on the safety of our medicines happens post-launch during real life use. For instance, patients have other diseases or take other medicines that confuse adverse event diagnosis. Roche has a great network of Local Safety Responsibles across our affiliates. They are there to help employees link into the PV system, regardless of which country they work in."
How does the mechanism of collecting, processing, analyzing and reporting adverse events work? And who eventually decides on the necessity of a label change on the package insert of a Roche medicine, based on a real, hitherto unknown adverse event? Kristof explains: "First of all, adverse events are collected in the country where the patient resides. After they have reached the local Roche company, the affiliate safety teams ensure these events make their way into the global safety database. This is where the global teams monitor the events and analyze potential "signals" which may be indicative of an adverse event. For example, we have to find out and decide whether an adverse event report contains known or new information, and whether it requires a fuller investigation. Of course, we always have to make sure that we are in compliance with all the regulatory requirements. It is our Drug Safety Committee, consisting of a number of senior physicians and other experts, that ultimately has to decide on what to do: once it has identified a new side effect, we then issue a new label which goes back to the affiliates so that the medical communities outside Roche and the patients can be told about it. Sometimes we add specific risk management activities for serious adverse events where we are convinced there is a need for more than just a label update."
Felix adds: "Having worked in this field for 30 years, I can say that one of the most fascinating and also challenging aspects of my job is that there is always an element of uncertainty around safety. This comes with the territory: Is an adverse event totally due to a drug, or is it a symptom of the underlying disease? The other aspect is that there are things you can expect drugs to do based on their pharmacological profile, while other things are complete surprises which nobody can foresee - for example, that an anti-hypertensive drug could induce cough. This means you always have to stay alert, keeping an open mind for such unexpected things to happen. You have to be willing to cope with incertitude. Like any medical decision, it’s a judgement call. Being responsible for safety, we are always trying hard to err on the side of safety. Drug safety is of fundamental importance in a business where being a trusted partner in a patient-centric environment is all-important."
There are mainly three types of sources regarding adverse event information, as Felix notes. First, there are the spontaneous reports from Health Care Professionals who suspect there is a link between a given drug and an adverse event. Secondly, there are reports from clinical trials and, finally, there is information from market access and patient support programmes. Felix adds: "Of course we also closely monitor all of the publicly available literature out there. Every piece of information has to be taken seriously, there is no room for compromises in this space."
Kristof emphasizes that while the safety people have to collect and process all of the information they can get hold of, it is the responsibility of the Roche professionals interacting with the external space to relay the information to the safety people. "We have an entire organization available at Roche that makes sure we analyze what is reported to us. The importance of getting this shared responsibility effectively executed across the organization is obvious."
Felix underlines this by saying: "There is not the one perfect Pharmacovigilance System to be adopted by everyone. But I am convinced that we have evolved and implemented the best possible system that works in the context of our culture and that fulfills all applicable requirements. For the safety function, it is imperative that people around the world work in consistent ways throughout the 95 plus countries in which we operate."
Pharmacovigilance, or PV, refers to a drug safety reporting system that systematically appraises, collects and reports suspected adverse events or safety "signals" as they relate to medicines post-launch, that is, in "real life use", after they have received marketing authorisation. It is aimed at enabling optimal use of Roche’s medicines in terms of safety on a sustainable basis. Per year, around 150 million people all over the world receive one of Roche’s more than 40 approved medicines, and there are approximately 400’00 cases of suspected adverse events reported in association with Roche products.
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