Module 6

04/10/2024

Most Issues never escalate to a CRISIS, because they have limited impact upon Patients

Product Recall/Defective Medicine Categories in UK

• Class 1 : The defect present a life threatening or serious risk to health.

• Class 2 : The defect may cause mistreatment or harm to the patient, but it is not life threatening or serious .

• Class 3 : The defect is unlikely to cause harm to the patient , and the recall is carried out for other reasons, such as non compliance with the marketing authorisation or specification. • Class 4 : The MHRA also issues “ Caution in Use ” Notices which are called Drug Alerts where there is no threat to patients and no serious defect likely to impair product use of efficacy. These are generally used for minor defects in packaging or other printed materials.

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

5

The life cycle of risks are influenced by media attention… causing a crisis

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

6

3