Pharmacovigilance

Pharmacovigilance department at Ipsen plays an important role by continuously evaluating information received from patients and healthcare professionals in balancing the benefits against the risk of our medicines.

 

What is pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects and any other medicine-related problem.

Its aim is to improve patient care and safety, to ensure public health and safety in relation to the use of medicines and to promote understanding, training and effective communication to health care professionals and the public.

Countries have regulations and laws that require manufacturers of medicines to notify appropriate health authorities of adverse effect reports. The authorities inspect manufacturers periodically to ensure obligations are met.

 

What types of information are collected by pharmacovigilance?

When medicines come onto the market, there is relatively limited information about their safety from clinical trials as they are performed in relatively small numbers of people and some populations are not included, for example, pregnant women. All medicines have risks as well as benefits and the Pharmacovigilance department plays an important role by continuously evaluating information received from patients and healthcare professionals in balancing the benefits against the risk.

Some of the information we collect include:

  • Side effects to medicines
  • Use of medicines during pregnancy and breastfeeding
  • Abnormal laboratory findings
  • Occupational exposure to medicines
  • Overdose, misuse of medicine
  • Product complaints
  • Counterfeit products
  • Unexpected benefit from a medicine
  • Lack of effectiveness etc.
  • Death while using a medicine
  • Interactions between medicines and between medicines and food
  • Using a medicine outside of its intended use
  • Medication errors

 

Reporting adverse effect information

IMPORTANT NOTE:
If you are worried about your health while taking a medicine, always talk to your doctor, pharmacist or nurse first.

Always read the Patient Information Leaflet, or instruction supplied with your medicine. It lists the known side effects or problems and advises you on what to do.

You can report adverse effects to your doctor, nurse or pharmacist. The details on how to do this will be described in the Patient Information Leaflet or instructions supplied with your medicine.

You may also want to report your adverse effect to the manufacturer of your medicine. If you would like to report any side effects you have experienced with an Ipsen medicine, please contact Ipsen Medical Information team on +44 (0)1753 627777 or by email medical.information.uk@ipsen.com.

 

Adverse events should be reported. Reporting forms and information can be found at wwww.mhra.gov.uk/yellowcard

Adverse events should also be reported to the Ipsen Medical Information Department on 01753627777 or medical.information.uk@ipsen.com

Date of preparation January 2018 / ALL-UK-000455