When people think of a power outage, they usually picture a dark room, no internet, and a silent fridge. But not many realize that a power outage far away in Europe can also affect the daily operations of a Nordic pharmaceutical company which has pharmacovigilance obligations.
Many companies depend on multiple countries and IT systems, such as cloud services and international partners. This makes preparation even more important, as issues can have wide-reaching effects. For example, a power outage in Spain in April affected the daily routines at Medimo as well.
– The outage happened during the day. When pharmaceutical companies noticed it, Medimo’s clients started to ask whether the power outage had any impact on the Nordic countries, and if so, how, Anu Gummerus, the founder of Medimo, explains.
Especially in pharmacovigilance, it is important to report adverse events within specific time limits, either to the clients’ own systems or directly to the authorities for the client companies.
– All received messages were acknowledged and responded to, and we told the clients that the power outage did not affect pharmacovigilance reporting in the Nordic countries. We also informed them that connections were working normally, Anu Gummerus tells.
What the law says
One of the most important tasks for a pharmaceutical company with pharmacovigilance obligations is to make sure that medicines are safe for patients. This work relies on regular data collection, analysis, and reporting to authorities.
Both national and EU laws require pharmacovigilance teams to stay operational during emergency situations and to continue adverse event reporting. If operations stop, critical processes are at risk.
A power outage abroad may slow down or interrupt the flow of information from international partners and subcontractors. This can make time-critical adverse event reporting more difficult. That’s why it’s essential to be prepared for international issues to keep pharmacovigilance work running in all situations.
Good preparation helps
When a power outage happens, many offices may have backup power supplies or generators. Companies often have a documented action plan, called a business continuity plan, which explains what to do during different types of disruptions.
A business continuity plan usually includes a clear division of responsibilities. It also lists alternative communication channels. For example, it explains what to do if the company’s email system stops working. Staff are also regularly trained for crisis situations.
More and more often, companies use cloud-based systems that automatically back up data. These systems can be accessed from other devices or through remote connections if needed.
How Medimo stays ready
At Medimo, emergency preparedness is taken seriously. The team regularly runs drill tests to practice what to do in unexpected situations. A solid business continuity plan is in place, aligned with GVP (Good Vigilance Practice) modules, the EU’s pharmacovigilance guidelines. The plan is updated regularly and shared with the staff to ensure everyone is informed.
In addition, clear standard operating procedures (SOPs) are established to guide daily work and crisis actions.
Good preparation in pharmacovigilance also includes structured information management. At Medimo, contact details and an up-to-date contact list are stored securely to allow quick action in case of a crisis.
Also regular data backups are made, and if needed, any necessary paper documents are archived properly according to regulatory requirements and internal guidelines. This ensures that important information is available at all times.
Learning from simulations
A power outage does not check the clock or location. But when a pharmaceutical company is well-prepared, the impact of a power outage or emergency situation can be minimized.
Even if a power outage doesn’t happen in your own country, it can still have surprising effects across Europe. Anu Gummerus knows that testing emergency situations brings added confidence.
– Testing emergency situations is really important, even if it’s a simulated event. Through these exercises, we learn who makes contact and what the contact details are, Anu Gummerus explains.
By testing critical situations beforehand and clarifying procedures, a company can better focus on communication and information sharing during a real emergency. These exercises build a solid foundation for effective crisis management.
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