HDA Media And Political Bulletin – 31 August 2016

Falsified medicines directive: the clock is ticking

30 August 2016, Chemist & Druggist, Jeremy Main


The implementation of the falsified medicines directive (FMD) is quickly approaching, despite some beliefs that Brexit may halt it or prevent FMD from happening, it is already entrenched into UK legislation and is certain to go ahead. This means that the countdown is on for the pharmaceutical industry to comply with the enhanced security requirements. There is a collective responsibility in the industry and it is important that all the manufacturers, wholesalers and distributers have an aligned approach for the FMD’s implementation. Jeremy Main the Chair of the HDA wants to encourage the pharmaceutical industry to begin the preparations now rather than leave it too late.


Shortages force GPs to prescribe second choice drug and causes harm

30 August 2016, Pharmacy Business, Neil Trainis


A survey of 441 GPs run by GPOnline found that 82% of them have been forced to prescribe a second choice drug to patients due to shortages. A further 18% of these GPs said that their patients experienced negative effects of these second choice drugs, including harm or slower recovery. Dr Andrew Green, Chairman of the GPC Clinical and Prescribing Subcommittee believes that informing GPs about drug shortages is a very key issue and he feels they would be open to some form of central system to alert them about shortages.


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Falsified medicines directive: the clock is ticking

30 August 2016, Chemist & Druggist, Jeremy Main


Whilst proposals for a hub-and-spoke prescription fulfillment model appear to have been pushed onto the back burner, the implementation of the falsified medicines directive (FMD) is really starting to cook on gas.

This affects everyone within the pharmaceutical supply chain and is a transformational change to current systems and processes.

You may be tempted to believe FMD will disappear following the EU referendum, but no one should bury their head in the sand; FMD is already incorporated into UK legislation and is certain to happen.

With the legislation becoming effective from February 9, 2019, the countdown is on for the pharmaceutical industry to comply with the enhanced security requirements. With increasing fears, concerns and instances of counterfeit medicines entering the pharmaceutical supply chain, these changes should be welcomed even if they don’t come cheaply.

Collective Responsibility

Previously, I’ve encouraged all parties to take a holistic view of the industry. FMD is a prime example of an issue affecting all stakeholders and needs to be considered by manufacturers, wholesalers and dispensers with an aligned approach.

The legislation requires prescription medicines for sale to carry a unique and randomised serial number encoded in a 2D-barcode and a visible anti-tampering device.

Manufacturers will be responsible for uploading the serial numbers to a system of national databases linked by a European hub, and country-based national data repositories will allow verification at different times and final decommissioning when each pack is dispensed to a patient.

At each stage of the supply chain, the product will be inspected to ensure it hasn’t been tampered with, has not previously been dispensed and that the packaging is intact. Additionally, goods distribution practice (GDP) guidelines will require the individual product to be scanned to record the batch number and expiry date. This check will indicate whether the product is authentic and bring up information such as whether the product has been subject to a recall.

These actions, to be carried out across the pharmaceutical supply chain, are vital to its integrity and minimise the opportunity for the original product to be replaced with a counterfeit.

FMD to increase patient safety

I wholeheartedly support the objective of FMD to implement end-to-end verification of the medicines supply chain for all prescription medicines, to not only enhance patient safety, but also provide greater confidence in the integrity and quality of medicines prescribed.

To ensure its successful implementation, FMD will require significant investment both in financial terms and a commitment of time and resource.

As one of the UK’s leading pharmaceutical wholesalers, we’ll continue to work with regulators, stakeholder bodies, our manufacturer partners and pharmacy customers to ensure all participants in the medicines supply chain are ready to safely implement the processes for medicines authentication in time.

Transformational change

February 2019 may seem a long way off, but don’t underestimate the scale of change required and, in reality, we have less than two years to be ready and to develop, test and input new systems and working practices. I’d encourage everyone to familiarise themselves with the requirements and start collective discussions with stakeholders now!

I have no doubt the change will be difficult and will come at a price, but I believe the long-term benefits far outweigh the short-term challenges. Given that all of us either take some form of medicine or have family or friends who are dependent on medication, it may be in our best interests to deliver this solution for the benefit of all.


Shortages force GPs to prescribe second choice drug and causes harm

30 August 2016, Pharmacy Business, Neil Trainis


An online survey of GPs has reignited concerns that drug shortages continue to blight patient care across the UK.

The survey, run by GPonline, found that 82% of 441 GPs who took part were forced to prescribe a second choice drug in the last year because of a shortage.

Of great concern was 18% of those GPs who said patients went on to experience “negative effects…including harm or slower recovery.” That conflicted sharply with Earl Howe’s infamous insistence to an All-Party Pharmacy Group inquiry in 2012 that there was no firm evidence that drugs shortages caused patient harm.

“The issue of secure drug supply is an on-going problem that no one has been able to adequately address. Sometimes problems can be very localised, so you can have difficulties in one part of the country and not in others. That makes informing GPs really quite a difficult task to do,” Dr Andrew Green, chairman of the GPC clinical and prescribing subcommittee, told GPonline.

“That’s an absolutely key issue. The first thing a GP knows about a drug shortage is when a patient returns disgruntled from the community pharmacy saying that the chemist can’t get hold of a particular medicine.

“And even when that happens, you can’t be sure if it’s a problem that’s widespread or limited instead to that particular pharmacy chain. I think that GPs would welcome some sort of central system of alerting, but it doesn’t help patients who are on a regular medication.

“There’s no doubt patients find changes in medication inconvenient, and whenever you change a patient from a medication on which they are settled there’s always a chance of introducing new adverse drug reactions.”

HDA Media And Political Bulletin – 31 August 2016

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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