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Falsified Medicines Directive (FMD) Implementation Toolkits

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

NHS Digital has 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: FMD.safetyfeatures@mhra.gov.uk. Healthcare providers can also contact IT system suppliers directly for information.

Purpose

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.

Toolkits

Toolkits are available for the following care settings;

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.

FMD Overview

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:

Credit: The Pharmaceutical Journal, FMD How It Will Work

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.

The Process

Verification: 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: 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.

Minimal Technology Specifications – Scanner

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:

What drugs need to be scanned

Prescription Only Medicines (POM)

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

General Sale List Medicines (GSL)

Pharmacy Medicines (P)

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

Article 23 Exemptions

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; and
(k) nursing homes

Bandwidth and HSCN/N3/WAN link sizing

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 below is included as a very rough guide in order to further illustrate to amount of network traffic that FMD transaction 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.

click to enlarge

The table above 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.