What are my FMD obligations as a community pharmacy?
Community pharmacies are obliged to verify the authenticity of medicines with safety features and decommission them at the point of dispensing. This is done by checking that the anti-tamper device on the pack is intact and by scanning the 2D barcode on the pack and ‘decommissioning’ the pack via an Internet connection to the Irish Medicines Verification System. There are a number of steps to be completed in order to be able to scan barcodes and check them against the data held in the IMVS:
- Identify where exactly scanning will take place, including how many scanners you will need, and what computers/devices need to be connected;
- Identify what software solution you will use to connect to the IMVS. A list of the IT software providers whose FMD solutions have been certified by IMVO is available on the FMD Software Providers section of our website. The IPU has prepared a report for its members on systems that were tested in community pharmacies during the IMVO pilot and this is available from the IPU;
- Source scanner(s) to read barcodes. Your IT software provider will be able to advise you on models that will work correctly with their solution;
- Consider how you will incorporate scanning into your work practices in the pharmacy;
- Inform your team about what’s happening and training relevant staff;
- Consider how anti-tamper device checks will be managed;
- Get connected to the IMVS – click here for more details.
Getting connected to the IMVS
You can find more information about getting connected to the IMVS here.
When you scan the 2D barcode, an alert will be generated if the data in the barcode or the pack status (‘active’/’decommissioned’) doesn’t match what’s in the IMVS. During the use and learn period, you may continue to supply the pack if an alert has been generated unless you have an overriding concern that the pack may be falsified or has been tampered with.
IMVO may contact you from time to time for additional information on alerts generated in your pharmacy. If you have any queries about alerts for IMVO, please email email@example.com or phone us on +353-1-5715320.
Use and learn
The Safety Features Oversight Group comprising the 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) has been closely monitoring progress with the implementation of the IMVS since it went live on 9th February 2019. In order to allow time for it to stabilise, the system has been in a use and learn phase since then and this will be ended on a phased basis over the coming months.
During the use and learn period:
- All medicinal products released for the Irish market since 9th February 2019 must bear the safety features as required i.e. a tamper proof seal (anti-tamper device) and 2D barcode.
- During the use and learn period, pharmacies, hospitals and wholesalers must scan packs where obliged to do so and if an alert or any other unexpected message is flagged, should continue to supply packs to patients in accordance with their existing procedures, unless they have overriding concerns that a falsified medicine is involved.
- All alerts generated in pharmacies, wholesalers and hospitals, upon scanning a pack during the use and learn phase, are forwarded by the system to IMVO, the HPRA and the manufacturers/MAHs so that they can be investigated and monitored.
- Notwithstanding the above, if a pharmacist or wholesaler has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA (as a suspected quality defect via the usual reporting mechanisms) and not supply the pack.
National legislation to support the implementation of the Delegated Regulation was introduced in February 2019. However, offences for breaches of the legislation will not be commenced until a later date, after use and learn ends.
For more information on Use and Learn visit the News and Events page.
How to scan correctly – This short video demonstrates how to scan FMD packs and provides useful tips for scanning.
Check your scanner – Use the ‘IMVO Check your scanner’ guidance to test if your scanner is set up correctly. As part of checking your scanner you will need to determine which mode your scanner is in. The ‘Check your scanner’ guidance will tell you how to do this.
If you identify problems with your scanner after carrying out those tests, then proceed to the relevant ‘IMVO Fix your scanner’ guidance for your scanner make and mode. These documents should help you fix any problems with your scanner and set it up correctly.
Fix your scanner – If you identify problems with your scanner after checking it, then you need to ‘fix’ them. This is done by scanning a series of barcodes that will set your scanner to the correct configuration:
- The instructions for fixing the scanner depend on what make it is and the mode it is set up in (keyboard wedge or serial mode. Look at the scanner to see what make it is. See IMVO ‘Check Your Scanner’ for details of how to find out what mode it is in.
- IMVO has drawn up guidance on how to fix Datalogic and Honeywell scanners as these are the most commonly used FMD scanners in Ireland.
- If you have a Datalogic or Honeywell scanner, follow the instructions in the relevant ‘Fix Your Scanner’ guidance below. There are 4 different versions so use the one that corresponds to your scanner’s make and mode.
- If you are using any other make of scanner, your FMD software provider may be able to advise you on how to reconfigure it. Please also inform IMVO (Contact us) so that we can update our scanner guidance.
- If you’re unsure what to do next, please contact us at firstname.lastname@example.org, including the make of your scanner in your email.
Guide to IMVS alerts and next steps
Information to follow
IMVO webinars for pharmacies & hospitals
For information on any upcoming webinars visit the News and Events page
The PSI has a section on falsified medicines on its website with information for pharmacists.
Pharmacy with wholesaler’s authorisation
Some pharmacies have been granted wholesaler’s authorisations by the HPRA as they carry out distribution activities. If you are one of these pharmacies, please note that you will have to register with IMVO as a pharmacy and as a wholesaler (i.e. two registrations and two separate accounts in the IMVS). Scanning transactions as a wholesaler must be carried out using your wholesaler account in the IMVS, not the pharmacy account (and vice versa).