Patient safety

Every day, millions of people rely on the quality and safety of Novo Nordisk products. 

All medicines have potential side effects as well as benefits. We routinely monitor the safety and quality of all our products. This includes review of safety data from clinical studies and review of side effects and technical complaints received on marketed products. By monitoring quality and safety information on Novo Nordisk products we can take due and appropriate actions to safeguard patient safety if needed. 

 

Policies and governance 

Our Quality Mission is to safeguard patient safety, product quality and compliance with external and internal requirements. 

Our Quality Management System ensures that we adhere to international and local legislation and that safety information is handled in the same way no matter in which country the patient lives.

Global Safety in Novo Nordisk has a Qualified Person for Pharmacovigilance overseeing that the necessary means for collection and notification of any safety data are in place.

Internally, a safety committee with members from all relevant functional areas is established prior to any clinical investigation of a new pharmaceutical product or medical device. This committee will exist throughout the product or device’s life-cycle. It is a multi-disciplinary team providing assessments of safety data, for a pharmaceutical product or medical device in development or on the market.

 

Assessing risks and taking action

Our Quality Management System includes the following to ensure we continuously assess risks and act upon findings in a timely manner:  

  • Information about side effects, technical complaints and counterfeits are received from multiple sources, for example clinical trial participants, patients, healthcare professionals, partner companies, health authorities and literature
  • This information is entered into our complaint database, and side effects are transferred to the Novo Nordisk safety database
  • Safety Surveillance advisers search the safety database continuously to find any new information, such as new types or higher frequency of side effects.
  • Safety Surveillance advisers present all relevant safety data from clinical trials, as well as safety data on marketed products, to the safety committee on a regular basis. 
  • The safety committee decides on any necessary actions which Novo Nordisk will agree with the health authorities. Actions could include advice on how the medicine should be used, inclusion of new warnings in the package leaflet, or ultimately stopping the use of the product. In parallel, the health authorities independently review the information. This dual system ensures optimal patient safety.
  • Further procedures ensure we are able to react promptly and adequately if a Novo Nordisk product on the market, or used in clinical trials, is suspected of being affected by a significant product defect. 

 

In 2017, the number of reported side effects from developing countries with weak or no pharmacovigilance legislation continued to be low. Initiatives to increase side effect reporting from countries or areas with a low reporting rate have begun. Preliminary results from these initiatives show that reporting rates can go up in connection with awareness campaigns, but the effect is temporary and declines again outside of campaign periods. This shows that it takes time to change the culture of side effect reporting and a number of players (industry, authorities and advocacy groups) must collaborate to see a real change.

 

Performance

Global Safety in Novo Nordisk continuously monitors reported safety information for safety signals. In 2017 Novo Nordisk had six product recalls from the market, which is the same level as in 2016. None of these recalls were critical. Local health authorities were informed in all instances to ensure that distributors, pharmacies, doctors and patients received appropriate information.

On a monthly basis, Global Safety Compliance Management meetings and Global Safety Management Board meetings take place to monitor the effectiveness of our Quality Management System. KPIs include:

  • Timeliness of reported side effects, technical complaints, Periodic Safety Update Reports and safety variations submissions
  • Identified safety signals
  • Number of potential and actual recalls which are included in our annual report.
  • Audit and inspection findings

 

Stakeholder engagement

We engage and collaborate with external stakeholders to influence upcoming legislation and exchange knowledge of pharmacovigilance. Experience with external partner organisations is exchanged for example via the European Medicines Agency Stakeholder Meetings, EFPIA Pharmacovigilance Expert Group, EFPIA Anti-Counterfeit Working Group and Local trade associations. 

When engaging with stakeholders, we observe Business Ethics regulations.

 

Reporting concerns

We carry liability for our products in clinical trials as assumed under the special laws, acts and/or guidelines for conducting clinical trials in any country. However we assume no liability in the event of negligence, or any other liability of the sites or investigators conducting the trial, or by persons for whom the site or investigator are responsible.

For marketed products, we have a responsibility to prevent or mitigate the risk of an impact continuing or recurring. This is done by continuously monitoring the safety profile of our products and ensuring appropriate actions are taken in case of a safety signal.