Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
Appendix 8
Defective Drug Alert system
Report received by the Defective Medicines Report Centre
The report is evaluated and confirmed if appropriate
Risk Assessment
If a report is confirmed, the Defective Medicines Report Centre carries out an
investigation and risk assessment. Further action may not be required. If a recall is
necessary, the defect is categorised according to the potential risk to public health
Class 1 alert
! Defects which are potentially life-threatening or could cause serious risk to health
! Action now, including out of office hours
Class 2 alert
! Defects which could cause illness or mistreatment
! Action within 48 hours
Class 3 alert
! Defects which may not pose a significant hazard but where a recall has been
initiated for other reasons
! Action within 5 days
Class 4 alert: Caution in use
! Defect is of a minor nature that is of no threat to patient safety or is unlikely to
impair product use or efficacy
! Correction may be carried out at point of issue or use
Quarantine
! A temporary embargo on further use of an implicated batch while further
investigation is carried out
Alert issued
Within the UK
'Drug Alert'
Alerts sent to relevant
organisations through a
cascade system
European Union/European
Economic Area
'Rapid Alert'
World-wide
Pharmaceutical Inspection
Co-operation Scheme
hospital
pharmacies
community
pharmacies
special
hospitals
private
and
voluntary
care
! Class 1 alerts sent to all countries
! Class 2 alerts sent to countries
where it is known that the medicine
batch is distributed
Countries with mutual recognition
agreements with the European Union
! Class 1 alerts sent to all countries
! Class 2 alerts sent to countries
where it is known that the medicine
batch is distributed
An informal network of medicines inspectors
from 26 national regulators
! Class 1 and class 2 alerts sent to
countries where it is known that the
medicine batch is distributed
World Health Organisation
! Notified where defect is life threatening
or a long term hazard and distribution
is widespread
appendix eight
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