FMD – an introduction to ezFMD

ezFMD is a software tool to quickly and easily perform the required steps to comply with the Falsified Medicines Directive 2011/62/EU (abbreviated to FMD). There are separate modes for wholesalers and pharmacies. The available functions depend on the type of your organisation.

It has been designed to be fast, simple and stand-alone software. This avoids the complications of integration and validation needed with any existing systems you may have in your organisation. ezFMD can be used in single-user or multi-user modes and is highly configurable – Read More.

For ease of reporting and to ensure data integrity and reliable retention, ezFMD is built on Microsoft SQL Server. Hardware recommendations are very straightforward.

ezFMD was used for what has been desrcibed as likely the “… the first pack decommissioned in a community pharmacy anywhere in Europe …” – congratulations to Moore’s Pharmacy. Read the IMVO’s full report here.

About FMD
The FMD (Falsified Medicines Directive 2011/62/EU) requires each manufacturer to add elements to a pack of prescription medicine to make it harder to falsify. Examples of falsification would include counterfeiting a medicine, changing the expiry date or even supplying a medicine through an unapproved  route. The objective is to ensure that as best as one can each and every patient receives the medicine in good condition as their doctor prescribed and no less. Overall management of verification is organised at a European level (by the EMVO). FMD systems are located in each EU country – examples include the IMVO, E-Vis and the DMVO.

Elements to protect patients
One of these elements is each pack of medicine will receive a unique serial number at the manufacturing site. This unique serial number will allow the medicine to later be verified or marked as used (dispensed). Once marked as used, that individual pack cannot be supplied again. Every pack sold in a pharmacy will have to be scanned at the time of supply to a patient. Medicines supplied through other means, such as hospital or clinic use will also have FMD related means of validation.

ezFMD allows the medicines wholesaler or pharmacist to validate any pack or mark it as supplied in an easy manner, ensuring compliance with the law. All that is required is a basic PC and a scanner, along with ezFMD software installed. Initial registration with the NMVO in the country is very straightforward.System Landscape 2

Source: EMVO

ezFMD addresses the needs of the System Owner Pharmacist or Wholesaler in the above diagram.

Time is limited
The time to achieve legal compliance is limited as the clock below shows. This includes the time taken to incorporate ezFMD into your systems, register and configure your systems, revise any impacted SOPs and complete staff training. Don’t leave it too late.