Pharmacovigilance in the hands of patients

By Angharad Baldwin 4-Sep-2018

Angharad Baldwin caught up with Dr Andrew Rut, founder of MyMeds&Me, at FutureLink 2018 to talk about what software as a service means to the pharmaceutical industry and the patient ... and whether there’s such a thing as too much data

Working for 18 years in the pharmaceutical sector, including 11 years with GSK as the VP of Clinical Safety and Pharmacovigilance, with a doctorate in molecular genetics and a background as a physician, Dr Andrew Rut has a wealth of industry experience, making him aptly placed to cofound MyMeds&Me in 2011.

Having worked in the pharma industry for almost two decades, Dr Rut noticed huge gaps in the way things could be done regarding how companies interacted with patients and the issues they faced with medication. He was particularly concerned by the lack of a system to obtain data directly from the patient at the time an issue occurred. However, he realised it was impossible to change things from within the slow moving pharma environment, so decided to launch MyMeds&Me.

Dr Rut established the software as a service (SaaS) provider to simplify and automate adverse event reporting and capture product quality data from the patient. The team developed Reportum, a solution designed to transform the end-to-end pharmacovigilance process. Digitalising the information at source, the multiplatform software solution enables the standardised capture of data from patients, healthcare professionals and pharmaceutical company employees alike.

“The concept of personalised medicine emerged in the 1990s, but has not yet come to fruition; this is only the beginning,” believes Dr Rut. “Now, patients are more central to pharma and are demanding a better service than they’ve had in the past. I believe the current number of hand-offs between the patient and the medical evaluation teams in pharma has inevitably resulted in undesirable ‘improvements’ to the data, meaning data quality and data consistency has suffered.”

He continues: “The patient knows how medicines are affecting them, they want to convey that information quickly and simply and, in return, they want trusted, relevant information. Therefore, the pharma industry and healthcare professionals need to interact with patients in a more meaningful way and more directly with them.”

We can see that ‘individualised’ medicine is making a come back with the commoditisation of genomics and a recognition of tremendous variation in benefit-risk across a population. The closer we can get to the patient and their experiences, understanding the issues they face or desires they have, the better.

Dr Rut adds: “However, communicating directly with the patient does present challenges and the sector must ensure patients can understand the information provided and the actions they should take. Communication is driven by what the recipient understands, not what the sender thinks they understand!”

“Currently, in many instances, you need a PhD to comprehend what pharma and healthcare companies can provide to patients. The patient needs to know whether the integrity of their product is right or wrong, does it fulfil their specifications and is the data they can access meaningful and relevant? If I have a problem or an adverse reaction, can I communicate this problem quickly and easily? This is what our system provides. Then, if necessary, it’s possible to drill down further if more information is required. There is also the potential to deliver ‘self-service’ information through the website or app and operator contact should the patient wish for direct communication,” he says.

Dr Rut continues: “In recent decades, technology has transferred the way in which the pharmaceutical industry interacts with patients. The Falsified Medicines Directive and mandate for the serialisation of medicines has provided further opportunity to improve patient trust. Patients should know whether the medicines they take are of the required quality and drug manufacturers need to be aware of adverse events caused by issues in the supply chain. Accurate data from patients means manufacturers can quickly determine the cause and, through new report management technology, access key information at source for the first time.”

“Although the quality of the system should deter counterfeiting, unless manufacturers remain ahead of the digital game, it won’t be a perfect system. However, using traceability and data encryption, they can; this is a question for manufacturers to address. Reportum can help to address the issues of serialisation and link directly to traceability solutions such as Tracelink,” Dr Rut concludes.

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FutureLink Chicago will take place 5-7 November 2018