Leo Pharma’s inaccurate Innohep app has prompted a slap-down from the PMCPA. The U.K. marketing watchdog ruled Leo brought discredit on the pharma industry by leaving the app live for three months after the errors were discovered.
Two healthcare professionals complained to the PMCPA about an app for patients prescribed Innohep, Leo’s tinzaparin sodium product. The app presented information from the patient information leaflet, and users were prompted to select their prescribed dosage and shown information on injection technique.
Both complainants flagged inaccuracies in the dosing information presented in the app. A Leo employee identified the errors in August 2024, and Leo’s medical affairs team learned of the inaccuracies the next day, according to the PMCPA report, yet the app was still available when the PMCPA contacted Leo in November. Leo deactivated the app and made an updated version available within two weeks of being contacted by the PMCPA.
Responding to the marketing authority, Leo said two senior medical affairs employees concluded that the full volume of the syringe would always be administered, despite any conflicting information in the app, and, as such, the inaccuracies didn’t affect patient safety.
The PMCPA panel took a dim view of Leo’s conclusion, stating that inaccurate dosing information is a serious matter regardless of the likelihood of a safety issue.
The panel said it “was extremely concerned about Leo Pharma’s lack of urgency” and the company’s “conscious decision to keep the app live with the inaccuracies for approximately three months.” The dosage volume inaccuracies and failure to withdraw the app immediately could “reduce confidence in the industry being able to produce patient material to the required quality standards,” the panel said.
Leo accepted that “appropriate actions were not taken to rectify the issue immediately.” The company listed mitigating factors that may have played a role in the failings, including a disruption that affected the company from July, when the app was certified, to October, when Leo was still working through its response to the inaccuracies.
“At the time of this issue occurring there was a reorganization of the thrombosis business impacting resource and headcount; many colleagues’ roles were placed at risk of redundancy. There was no dedicated medical support for the U.K. thrombosis business at this time,” Leo said. “Whilst this does not negate the seriousness of the issue and decisions made, we believe this to be a contributing factor.”
The PMCPA appeal board opted against imposing additional sanctions on Leo. The board reached the decision after assessing Leo’s work to enhance its governance, train staff and update its processes to add checks and scrutiny. Leo said “it was not experienced with creating and managing apps and had relied on external expertise,” according to the PMCPA, and would act differently if in the same situation today.