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December 14, 2020

All I want for Christmas is… Not more Alerts! Coping with EU alerts.

In many parts of Europe, Saint Nicholas brings gifts on 6th December to those children who have been good. Those who have not been so good, however, don’t get any gifts and may get a severe telling off instead.

This year, Sunday 6th December brought a similar experience to all the pharmaceutical companies supplying the European Market: EMVO’s new EU-Hub release 1.8 that was successfully deployed; it fixed a number of long-standing issues and brought other welcome improvements. However, a change to the way some alerts are being propagated back to the pharma companies meant that all OBPs are now facing a surge in alerts coming back to them that has caught many off-guard.

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We have been talking about the immediate impact and how to deal with this new challenge to two Excellis experts, Brandon, who heads up the European Service Bureau Team that operates the EU Alert Management Service on behalf of more than a dozen pharma companies, from one of the top 3 global pharma companies to small biotech companies supplying orphan drugs, and Brian, who is Excellis’ Alert Management lead.

Q: Brandon, what is suddenly going on with EU Alerts?
Brandon:
“Since the new EU-Hub release, the number of alerts has significantly increased. In the best case we see simply doubling of the number of daily alerts, for other companies the Alerts have skyrocketed with some companies reporting the alerts up by 500%.”

Q: How come?
Brandon:
“It’s a combination of factors that have come together to create a perfect storm: There is the increase of activity, particularly more pharmacies in France now connected, and the persisting issues with end-user processes and scanner issues in some markets, for example Spain. But the main reason is, of course, that the new alert statuses A7, A24 and A68 are now being reported back to OBPs that need to deal with them within the strict timeline prescribed by the markets.”

Brian: “The main challenge is that there are no shortcuts: If manufacturers don’t take this seriously, they are not fulfilling their legal duty: Manufacturer must analyse every alert to make sure that ‘genuine’ counterfeits can be ruled out. This means they need to carry out a formal root cause analysis which is often not straightforward and can be very time consuming. Even if the alert is caused by end-users and are most likely double scanning or process errors, the MAH remains responsible.”

Q: So how are manufacturers coping with this sudden surge?
Brandon:
“To put it bluntly: Not well. We know that many pharma companies have still tried to ignore EU Alerts…”

Brian:“Which is really risky: Look at the EU GMP Inspection Aide-Memoire that calls out the presence of a robust process to deal with these alerts…”

Brandon: “… yes, exactly. So there are small companies that have had only few alerts, sometimes weeks without any, who are now receiving alerts on a daily basis and have not been prepared to deal with this obligation.”

Q: Right. And I can imagine that the impact on the Service Bureau as an organisation that is responsible for a service that customers can rely on, has also been massive?
Brian:
“Well, actually: Not really. Because we have established our Alert Management Service as a robust, flexible and scalable offer, we have all the pieces in places: A comprehensive set of processes, a fully validated system that has been engineered (and tested) to scale up and down to the numbers we are now processing and a team of well-trained Alert Engineers. So when the routine reports last Monday suddenly showed thousands rather than hundreds of alerts, we activated our contingency plans and made sure we had the right resources in place to deliver the service to the agreed SLAs.”

Brandon: “It was gratifying to see that our plans and designs have been able to cope with this real-life stress test without fail, every day, for every customer. And for the customers who subscribe to the full Service Bureau, we have been able to use our cross-functional Service Bureau team to go to the next level and resolve the underlying in-house issues.”

Brian: “In fact, because we are providing the service to multiple customers, our team were ready for the new alert messages when they started coming through for some of our orphan drug customers who would otherwise have been totally surprised and would have scrambled to respond properly and on time.”

Q: Sounds good, so what have you learned and what are your recommendations to any pharma company supplying Europe?
Brian:
“The key message is that this must be taken seriously, it is not something that can be ignored. Or if you ignore it, you can only get away for so long: Eventually things catch up with you, and then you can be in deep trouble.”

Brandon: “It’s been great to have been able to help our customers deal with this challenge. They have been grateful to have been reassured by the solid service provided by our Excellis Service Bureau team and I’m very pleased with how smooth it has all worked out. This gives us reassurance that our Alert Management Service is the right service, supported by the right tool and operated by best team there is.”

Check out the Excellis Service Bureau Alert Management Service: The facility provides a robust and reliable managed service that scales and configures to your needs and helps you discharge your duty, in conjunction with your internal teams and pre-existing processes or contact us directly at getsecured@excellishealth.eu.

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