The EU Falsified Medicines Directive (FMD) will introduce major changes for community pharmacists in the UK when the requirements for medicines verification are introduced on 9^th February 2019.

Pharmacy contractors will be required to include two additional steps in the dispensing process in order to comply with the requirements of FMD.

These additional steps include:

• Checking the anti-tamper device on the product pack is intact before dispensing, this will be a simple visual check
• Decommissioning the product by scanning the medicine to confirm the data held on the Unique Identifier correlates with that on the NMVS, this process will change the medicines status on NMVS from “active” to “inactive-supplied”.

Scanning medicines within the pharmacy can also have other functions which will be discussed later in this article, including:

• Re-commissioning (see 10 day rule)
• Verification

The delegated regulation does not stipulate exactly when during the dispensing process that these additional processes should be completed; the regulation simply specifies they should happen “at the time of supplying to the public”. This means that these processes can happen at any point between selecting the pack to dispense and the time when the medicine is supplied to the patient or their representative.

The exact process adopted within the pharmacy can be determined by the contractor and should be incorporated into the pharmacy SOPs.

Suggested workflow processes

The UK FMD Working Group has suggested two potential workflow processes:

• Decommissioning during the dispensing process
• Decommissioning at the point of supply using an aggregated code

These options are both supported by the use of aggregated codes.

Aggregated codes- Each pack will have its own Unique Identifier (UI) that is specific to the individual pack, the data within the UI is used for verification and decommissioning. However where a prescription requests multiple packs of medicines it is possible to incorporate the data from multiple UI into a single aggregated code generated by the dispensing system. This code can be printed as a linear or 2D data matrix onto a dispensing or address label that is applied to the dispensing bag containing the patient’s medicines. Scanning the aggregated code at the point of supply to the patient would decommission all of the products simultaneously.

Visual representations of how decommissioning using an aggregated code can be incorporated into the dispensary workflow have been produced by the UK FMD Working Group; these representations can be accessed here:

• Producing the label first
• Dispensing first 

Contractors may adopt a different process and decide to scan and decommission each product at the point of supply i.e. during hand out to the patient. Key concerns regarding adopting this approach are discussed later in this article.

10 day rule

When deciding the process for decommissioning to be adopted within their pharmacy it is important that contractors consider the 10 day time window (10 day rule) imposed by the legislation.

The 10 day rule means that once a pack has been scanned and decommissioned and its status changed to “inactive-decommissioned/supplied” there is only a relatively short period of time that this can be reversed.

Reversal of decommissioning can only happen within 10 days of the decommissioning and is only permitted where the following requirements are satisfied:

• Same location: reversal must be undertaken by the same organisation as the original decommissioning and at the same premises
• 10-day rule: reversal occurs not longer than 10 days (240 hours) after the decommissioning
• Not expired- product is still within its expiry date
• Not recalled: not subject to a recall during the intervening period
• Not supplied: the product has not been supplied to a patient or otherwise left the premises

Contractors should consider that if a product is decommissioned it should not be issued to a patient after the 10 day period has elapsed. Consequently it is important to consider when decommissioning takes place to avoid significant stock loss.

Decommissioning at the point of supply without using aggregated codes- contractors who opt to decommission at the time of issuing medicines to the patient without the use of an aggregated code should consider that emptying a bag of dispensed medicines to scan the products in front of the customer could:

• compromise patient confidentiality,
• result in increased queues at dispensary reception
• increase the time taken to issue medicines
• raise problems should a pack fail to “authenticate” in front of the patient

Verification- verification is an optional process that contractors can adopt to confirm a pack is still “active” and that there are no recalls or alerts assigned to the product. Verification will not alter the status of the product.

A visual representation of how verification could be completed within the pharmacy can be accessed here.

Response to negative scans

The process for responding to negative or failed scans has yet to be determined. Guidance is expected from MHRA later in 2018. Some of the issues that still need to be clarified include:

• who is responsible for investigating negative scans- the pharmacy contractor, wholesaler, manufacturer, SecurMed or the MHRA
• information that must be provided to the investigating body, along with how this information will be transferred
• timescales for the provision of information and the investigation

Negative or failed scans could indicate that the medicine has been stolen or already dispensed which would require the pharmacy to contact the National Competent Authority (MHRA). A failed scan as a result of the product being out of date would not require the pharmacy to contact the NCA.

Standard Operating Procedures

Once contractors have determined the best process for complying with FMD for their pharmacy it is essential that all Standard Operating Procedures are updated to reflect the revised processes that have been adopted.

Staff training

Pharmacy contractors will need to ensure that all staff involved in the assembly and delivery of prescriptions are fully trained on FMD and the processes adopted within their pharmacy. It is important to remember that this training must include details included in the revised SOPs.

Training materials, including online help pages, should be provided by the IT systems supplier. This will ensure that all pharmacy staff are able to safely and efficiently operate the FMD compliant IT system.

Patient Information- It is highly likely that the launch of FMD in community pharmacies will generate significant patient interest. It is important that consistent information is available that pharmacy contractors can give to patients, customers and carers. This information will need to be produced by the Department of Health and Social Care (DHSC), Medicines and Healthcare products Regulatory Association (MHRA) and SecurMed in conjunction with the UK FMD Working Group.

Enforcement of the directive

Within the UK the National Competent Authorities, the DHSC and MHRA, are jointly responsible for the implementation and enforcement of FMD. It is likely that the GPhC and PSNI, along with the Department of Health (Northern Ireland) will be involved in enforcing the FMD regulations in community pharmacy. At present there are no details regarding potential sanctions for none compliance with the FMD regulations.