Falsified Medicines Directive implementation toolkits

NHS Digital and stakeholders from across the medicines supply chain are working together to implement a national system to ensure compliance with the FMD. We are led by the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA), and collectively known as the National Competent Authority (NCA). 

We have been commissioned to develop guidance toolkits for healthcare providers to help them prepare for the implementation of FMD.

It is the responsibility of healthcare institutions to ensure that they have a suitable system in place for FMD decommissioning. Queries relating to the implementation of FMD policy should be directed to the MHRA.  Healthcare providers can also contact IT system suppliers directly for information.

The United Kingdom is committed to meeting the 9 Feb 2019 deadline for the launch of EU FMD safety features delegated regulation, and we expect all stakeholders in the UK supply chain to be aiming to comply with these new requirements, indeed we know much of the UK supply chain is already prepared.

Despite the significant work undertaken to date in the UK and given the complexities associated with setting up the medicines verification system across the EU it is anticipated issues will arise especially during the initial operational/implementation phase. It is important that these issues do not compromise confidence in the medicines supply chain. The government’s priority is the continued supply of safe medicines to patients.

For example, several member states have formally advised those who may receive ‘unknown’ error messages to dispense anyway. Therefore, the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified. This position will be kept under review.

We are also aware of issues around non-FMD compliant packs released to market before 9 February 2019, and wholesalers’ designated status, We will continue to work with UK stakeholders to help bring them into full compliance with the safety features regulation as soon as possible.

Medicinal products manufactured and released before 9 February 2019 containing safety features may not necessarily be fully uploaded to the repositories system. There are also packs of medicines already on the UK market which contain 2D barcodes that do not relate to the FMD safety features due to other international initiatives. Attempts to verify or verify and decommission these products will trigger system alerts. This situation may continue for a period of time due to the shelf life of medicinal products, in some cases up to five years. Where Alert IDs are triggered please refer to the guidance published by the Royal Pharmaceutical Society and the UK FMD working group.  

Any instances of suspected falsification (including physical signs of tampering) are to be reported in the usual way via the yellow card scheme using the ‘fake’ button.

Where the Marketing Authorisation Holder is notified by the alerting system that a data error has occurred, they are to notify the MHRA if upon further investigation, falsification is suspected.

Further background explaining the alert management process on the EMVO website

Toolkits are available for the following care settings:

• Secondary care toolkit, including organisations that hold a Wholesale Dealers Licence (WDL) or Wholesale Distribution Authorisation (WDA)
• Community pharmacy toolkit (v0.1)
• Dispensing doctors Toolkit (v0.1)
• GP surgery toolkit (v0.1)
• Out-of-hours services (v0.1)
• Additional guidance on ‘Article 23 providers’, ‘Healthcare institutions’ and ‘Article 26 exemption

Each toolkit will highlight a number for supply chain scenarios that are common across that care setting and identify all possible points at which verification and decommissioning could happen.

The purpose of these toolkits is to inform and prepare staff in various care settings for the implementation of FMD. The majority of care settings that receive and supply medicines will need to implement FMD for verification and decommission purposes.

The toolkits can be used to assist each individual healthcare setting identify the most suitable place to verify/decommission based on their needs and inform staff of what they need to do to successfully implement FMD and be compliant. In addition the toolkits can also provide useful links to other sources of relevant FMD information.

The Directive on the Falsified Medicines was legislation passed by the European Union Parliament, which aimed to increase the security of the manufacturing and delivery of medicines in Europe and provide protection to patients from falsified medicines in the legal supply chain of pharmaceuticals.

Under the FMD, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features:

The unique identifier must be carried in a 2D data matrix code. The information contained within this is specified in the Delegated Regulation. The information in the 2D code must also appear on the package in human readable format. Often this will appear where the batch number and expiry date are currently located on the packaging. Sometimes due to the size of the carton it will not be possible to accommodate this information as currently and other solutions will be needed. Exceptionally the information may be split over different faces of the carton.

The human readable information with the 2D data matrix code can appear in any order. Any descriptive terms may be used provided it is clear what is being referred to. Where necessary the prefix descriptive terms may be located above or adjacent to the information

Verification:  can take place at any time during the movement of the medicine through the supply chain. It is a check within the repository (IT database) of the data held which ensures that the product is authentic and originates from a legitimate manufacturer.

Decommissioning: takes places at the end of the supply chain when the product is being supplied to the patient and changes the status of the unique identifier in the repository to indicate that the pack has been supplied– so that any other pack bearing the same unique identifier cannot successfully be verified/or decommissioned.

The Falsified Medicines Directive (FMD) delegated regulation requires those who supply medicinal products to verify their authenticity via a decommissioning process. Decommissioning involves reading (scanning) a unique 2D bar code printed on every manufactured medicinal product pack.

When you are looking for a scanner, look for these decode capabilities. 

Prescription Only Medicines 

These drugs need to be verified and decommissioned, with the exception of those excluded, see below. 

General Sale List Medicines (GSL) pharmacy medicines

Non prescriptions medicine are not included under FMD. They do not need to be decommissioned or verified. The exception to this is the OTC Omeprazole. 

Article 23 of the delegated regulation provides member states with legal flexibility regarding their respective supply chains about where the decommissioning process should take place for
persons or institutions captured under Article 23 (‘Article 23 providers’). This list is made up of the following Article 23 providers:

(a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy
(b) veterinarians and retailers of veterinary medicinal products;
(c) dental practitioners
(d) optometrists and opticians
(e) paramedics and emergency medical practitioners
(f) armed forces, police and other governmental institutions maintaining stocks of
medicinal products for the purposes of civil protection and disaster control
(g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions
(h) prisons
(i) schools
(j) hospices 
(k) nursing homes. 

At a local level it is not anticipated that the additional network load generated by FMD traffic will cause any significant impact to existing HSCN/N3 connections. The amount of network traffic generated by FMD transactions is very small so there should be no noticeable degradation of performance of other applications,or a requirement to increase the capacity of the existing connection. Current applications should, where required, by protected during times of network congestion, through Quality of Service (QoS) which guarantees a minimum amount of bandwidth to an application or group of applications. Clearly, where a network link is currently experiencing congestion regularly and consistently, the addition of any additional load may have a negative impact on overall performance. The management and maintenance of traffic level on existing connections to HSCN/N3 is the responsibility of the local organisation.

Rough guide to data transfer times

The table is a very rough guide in order to further illustrate to amount of network traffic that FMD transactions are likely to generate, and the impact on network connections of varying sizes. It is important to note that the data below is for guidance purposes only and does not represent a ‘real-world’ scenario given that FMD transactions will be spread out across a day rather than transmitted altogether in a single data file.

This table gives an idea of the speed at which a network link of 1, 5, 10, 20, 50, or 100 Mbps could transfer the total amount of data generated in one day FMD transactions, based on the number of transactions per day.The calculations above take into  consideration network overhead (TCP/IP header size and Ethernet framing) but assume no other application traffic on the network.

It is fair to estimate that for a network link that is not continuously congested,the additional traffic load generated by FMD transactions should not require an immediate increase in capacity. However, the local organisation should have in place processes to highlight any increases in demand for network bandwidth,and activities to monitor and plan for future growth. It is difficult to estimate the additional bandwidth required to support the extra network traffic generated by the FMD transactions without knowledge of historic and recent traffic patterns and utilisation of the current network connection, as well as future capacity requirements.