FMD: A hospital pharmacy perspective
The Oxford University Hospitals NHS Foundation Trust wanted to run a pilot, in line with the requirements of the Falsified Medicines Directive (FMD), to understand what they needed to do to authenticate their medicines and the clinical value behind this.
What was the problem?
There are a number of stats that illustrate the size of the problem and the reasons behind the Falsified Medicines Directive. A few examples include:
- The World Health Organisation estimates that 1% of all medicines in the developed world are counterfeit, and that number goes up to 10% globally
- Involving nearly 2,500 cases, EU Customs seized 27.4m doses of falsified medicines at EU borders in 2011 – an almost seven-fold increase from 2007
How was the problem solved?
In 2011, the European Parliament adopted the Falsified Medicines Directive and in February 2016, the Delegated Regulation supplementing Directive 2001/83/EC and 4 Annexes was published in the Official Journal of the European Union. Pan-European implementation of the directive is expected by February 2019.
The legislation requires the serialisation of every pack of prescribed drugs with a 2D barcode matrix using GS1 or IFA/PPN standards.
The process behind the legislation means that products can be checked and verified at all stages of the supply chain – by the manufacturer, the wholesaler or the pharmacist. This way, nobody else can reuse or falsify the product.
The aim of the pilot in Oxford University Hospitals NHS Foundation Trust (OUHNFT) was to:
- Look at their existing workflows and drug distribution cycle
- Identify potential stages of authentication
- Develop the protocols to go with the authentication
From their early experience as a UK hospital implementing FMD as a pilot project, some of the key things OUHNFT learned were:
- In terms of the actual integration it was very quick to integrate (5 days). However it took 5 months to arrange meetings and to get all the required permissions
- Physical authentication rate was approximately 70%
- Staff adapted well and requested some additional changes to the system. 70% said it was easy to use
- All departments need to get in touch with their robot and pharmacy system supplier as soon as they can
- Educational requirement is key to overcome resistance to change
- A key decision will be where to do the verification
- Implementing your solution could make you more productive
- Don’t buy pharmacy robots that do not scan 2D data matrices
- Don’t do the ‘dreaded calculation’. The number of packs x time for scan = number of man hours leading to a lot of full time equivalents!