Pharmacists must be able to carry out the 2 step Authentication processes by February 2019 or they may not be able to trade. If they trade without carrying out the required FMD checks they may face an unlimited fine or a custodial sentence. Standing still is not an option.y the beginning of February next year pharmacies must be able to carry out the following:
1.Scan the new 2D data matrix which will be printed on Prescription Only Medicine(POM) packs, they must be able to do this to allow then to check the pack is authentic and not falsified and also to be able to decommission the pack from the national database.
2.To carry a visual check of a tamper evident seal which will be on POM packs.
To carry our step 1 above the scanner used must be able to access the national database(NMVS) and verify that the data matches the data uploaded to the database by the manufacturer.
When dispensing this product, the pack must be scanned and decommissioned or removed from the database
Pharmacists and pharmacy owners must decide if they want a standalone scanning system or one which is linked in with their PMR system.
They should issue a change control and create a change plan to look at all the options, actions required including writing new SOPs and training all the staff on them, risks and costs involved and log them. Once the plan of actions has been agreed then no time should be lost to deliver the plan on time.
To carry out step 2 above the pharmacy must have a procedure in place to cover this check which may include a signature or initial of the person who completed the check. In addition, a procedure for what to do if the seal is broken or missing.