Obligations of the Saxenda® Network Pharmacy for reporting safety information

A Saxenda® Network Pharmacy has the following obligations for the reporting of ‘safety information’ (SI), as defined below:

Safety Information
All reports of adverse events (AEs) occurring during the use of a NOVO NORDISK (NN) medicine or medical device.

In addition, SI includes any of the following information relevant to the safety of the NN medicine or device:
  • Serious outcomes e.g. hospitalisation, death
  • All reports relating to pregnancies, including outcome of a pregnancy, where the fetus may have been exposed to a medicine through parental exposure
  • Any AE occurring in infants following exposure to an NN medicine from breastfeeding
  • Reports of lack of efficacy
  • Any suspected transmission of an infectious agent via an NN medicine
  • All reports of overdose, drug abuse, drug misuse and occupational exposure
  • All reports of medication errors
  • All device failures with NN devices or the device part of marketed drug-device combination products, which could have led to death or serious deterioration in the state of health, even if in the actual situation nothing happened
  • All reports of off-label use
  • Technical complaints

Collection and reporting of safety information
As a Saxenda® Network Pharmacy and pharmacovigilance safety partner, immediately (where possible in the presence of the reporter) report SI relating to NN medicines using the “Partners safety report” webform here. To avoid the need for archiving and reconciliation of SI source data, ONLY the webform is to be used for collection and reporting of SI to NN.

Informing the reporter about, and obtaining reporter consent for, processing of personal data related to SI
‘Personal data’ is any information relating to an identifiable natural person e.g. name, phone number, address, email. If the data cannot be linked to an identifiable person (e.g. initials, age, gender), it is not considered personal data.

Inform the reporter that with their consent:
  • Any personal data related to SI will be reported to NN
  • SI will be entered in NN’s global safety database
  • In accordance with applicable law, Novo Nordisk may share personal data related to SI with health authorities, other NN entities, partner companies that assist NN, other pharma companies if the SI is considered related to their product(s).
  • In accordance with applicable law, personal data related to SI will be kept permanently by NN. Technical complaints without related adverse events will be kept by NN for 12 years, or longer if required by applicable law.

By following the prompts in the Partners Safety Report webform, record the reporter’s consent, or denial of consent, for how Novo Nordisk will handle their personal data.