The National Safety Features Oversight Group comprising the Irish Medicines Verification Organisation (IMVO), the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) continues to meet regularly to monitor implementation of FMD in Ireland. Excellent progress has been made in all sectors over the last few months:
All alerts generated in pharmacies, wholesalers and hospitals, upon scanning a pack during the use and learn period, are forwarded by the system to the IMVO, the HPRA and the manufacturers/MAHs so that they can be investigated, monitored and resolved.
The use and learn period will end on a phased basis starting from 31st January 2020.
Planning for the end of ‘use and learn’ will continue over the coming weeks. The Safety Features Oversight Group, taking into account all relevant factors, will determine the different phases and communicate details to affected parties.
What am I expected to do now?
Advice issued in previous communications about ‘use and learn’ still applies:
Wholesalers, pharmacies and hospitals:
After the use and learn period ends, every single alert will have to be investigated and the risk of the pack being falsified must be ruled out before it can be supplied. It is therefore critical to ensure that all avoidable alerts are eliminated early before the use and learn period ends to minimise disruption for everyone, especially patients. To achieve this objective, all parties are requested to intensify efforts now to address issues that are causing alerts and errors, such as:
IMVO will work with all groups over the coming weeks to further raise awareness of how to identify and fix these problems. Furthermore, a national procedure will be finalised for managing alerts after use and learn, including detailed guidance on what each party needs to do to investigate and close out an alert. These guidelines will set out the roles and responsibilities of pharmacies, hospitals, wholesalers, MAHs, IMVO and the HPRA, so there is clarity for everyone after the use and learn period ends.
For further information
Queries re alerts: email@example.com
Queries re end-user registration/connection to national system: firstname.lastname@example.org
Tel: +353 1 5715320
HPRA website – General FMD information
HPRA website – Report an issue
Tel: +353 1 6764971
PSI website – General FMD information
Tel: +353 1 2184000
(for manufacturer queries relating to EU Hub & uploading of data)
Support queries: email@example.com
Tel: +32 2 657 00 08