Europe is stepping up the fight against counterfeiters – so how will you and your business be affected?
"One of the most significant European directives for community pharmacy that we have ever seen." This is the NPA's verdict on the falsified medicines directive – EU plans to strengthen protection against counterfeits across members states.
As a result of the directive, the European Commission (EC) has consulted on plans to introduce a system of unique barcodes on medicines packaging that could be scanned for verification throughout the supply chain, including at the point of dispensing. And European chiefs are clear about the need for this step-up in the fight against counterfeiting. "We still very much have a problem with falsified medicines," says Hugh Pullen, associate director for European government affairs at Eli Lilly.
"Pharmacists must put forward their concerns so that we can make sure the ultimate technical framework reflects these considerations" John Chave, PGEU general secretary
More on counterfeiting
"An example in the past three months is counterfeit Avastin appearing in the legitimate supply chain in the US, which had passed through EU member states before it got there," he told the annual conference of the European association of full-line wholesalers (GIRP) in Lisbon earlier this month (June 4).
"It shows we have certainly not solved this problem and this is why we take our responsibility to proactively implement the falsified medicines directive so seriously."
Pharmacists on the frontline
But just how the directive will be implemented – and therefore the ultimate impact on community pharmacists – across the member states is less clear.
Many agree pharmacists are already on the frontline of the anti-counterfeiting war. UK medicines regulator the MHRA points out that incidents of falsified medicines reaching community pharmacies in the country are "mercifully rare" (just 10 occasions in the past eight years) – but it advises patients suspicious of a medicine to "first consult with your pharmacist" for a legitimate explanation. And the NPA agrees: "Pharmacists have a duty of care towards their patients and that includes making sure that the medicines they dispense are safe and legitimate."
It also agrees that "community pharmacy can strengthen and entrench its role in patient safety" and that "the directive could be a platform for this if the final requirements are workable".
Devil in the detail
But it's the ‘if' that's key. UK community pharmacist representatives are supportive of the directive's "laudable aim", as Numark calls it, to improve patient safety – how could they not be? But they are cautious about the detail, namely how verification at the point of dispensing would affect pharmacy processes.
"Any legislation that adds to the efforts of pharmacists to supply medicines will affect patient care," Numark head of information services Gary Choo tells C+D. "In a busy dispensary this extra step in the SOP could potentially impact waiting times."
"The verification process should be a collaborative approach involving parties higher up the supply chain," Mr Choo adds. "It is imperative that drug manufacturers, distributors and suppliers take the main responsibility in this."
He asks: "Why should the ordinary local independent pharmacist shoulder more bureaucracy from Brussels?"
European pharmacy chief John Chave thinks he has the answer. It would be a "strategic mistake" for pharmacists to leave verification to agencies outside of the sector, the general secretary of community pharmacy lobby group PGEU told the GIRP conference. "It's important that pharmacists maintain their position on the frontline, face to face with patients, providing value service and guaranteeing security and quality."
But Mr Chave agrees with the likes of Numark and the NPA that critical questions remain around the practical implementation of verification at the point of dispensing: the cost implications, the technological upgrades required, the training needed, the workload and workflow issues. "We know that... we're going to have to adapt our pharmacy software," Mr Chave says. "There may also be additional costs with staff training; we haven't been able to adequately quantify this." And he adds "the possibility of the system breaking down, causing unnecessary delays" to the list of concerns with the process.
While all these questions remain, the falsified medicines directive means pharmacists look set to face medicines verification in one form or another in the not-too-distant future. So Mr Chave encourages pharmacists to "get involved" now. "It would be a pity if... we ended up with a system that didn't really fit the way that we do things in pharmacy," he tells C+D, "and the only way to avoid that is for pharmacists to get involved, put forward their concerns, explore what the issues are and let us know so that we can make sure the ultimate technical framework reflects those considerations."
And, whatever that technical framework ultimately entails, the NPA advises pharmacists to get ahead of the game. "Although the directive will not take effect for a number of years," head of external relations Stephen Fishwick says, "pharmacy owners would be wise to think now about the implications on day-to-day workflow because preparations cannot be left until the last minute."