These are the highest risk medicines, by a country mile. Recently we had a major snafu in the drug supply chain that was potentially catastrophic. The supply of a skin cream, by a mainstream wholesaler, as an eye treatment, was a huge blunder. It illustrated all that is wrong in the medicines authentication/verification system. It cannot protect the public when it needs to.

Ironically, last month we passed a milestone. That few of us noticed is a testament to the importance that we attach to it. It was a mailshot from the IIOP, about one year on from FMD going fully live, that drew the focus. The statistics presented from the previous few weeks illustrated the inanity of the system. All the alerts appeared to be due to procedural issues. Not a single false medicine detected. While this is touted as an example of success, in the form of prevention, statistically this doesn’t stack up. If there was any percentage of fraudulent packs on the market, then we would surely see at least a meaningful data point that would assure us that the system is working. What has this technological achievement done for the public? Without delving into Monty Pythonesque ramblings, it has been an utter waste of resources. Hailed as a public safety initiative, that we have to pay for, it has failed, and will continue to fail in its primary objective. It doesn’t take a genius to figure out that the supply chain of licensed medicines is rock solid. With protocols, procedures, validation and verification, it would take an extraordinary effort to get illicit medicines into the normal supply chain. While none of us are privy to the commercial procurement secrets of the unlicensed medicines suppliers, there is at least one obvious weakness — items originating within the EU, in unfamiliar language and characters, are ultra high-risk.

The issues surrounding unlicensed/unauthorised medicines are becoming starker and starker. What was once a quaint irregularity has become a millstone around our collective necks. While we all appreciate the reasons for supply chain failures, it is very clear that Ireland has a serious handicap in relation to older, inexpensive drugs. While global issues there are aplenty, we can quite clearly see what is happening in our own pharmacies. Let me take a very small example. Sotalol is an essential heart medicine. The single licensed brand marketed in Ireland is gone until at least October. There is a wholesaler waiting list for any unlicensed brand, currently at least three weeks. There is a low strength unlicensed version, that costs, per milligram, about eight times the reimbursement price. Needless to say, the PCRS aren’t paying for the alternative. And we cannot even check if this pack, which could potentially look as dodgy as Dell boy’s antiques, is actually genuine. While, undoubtedly, there are legitimate API unavailability reasons why the licensed drug is unobtainable, the root cause of this particular shortage is, in my view, quite clearly a result of HSE/PCRS intransigence. The reimbursable price of 28 sotalol is now €1.68. The German reimbursement price is €12.68 (source www.bfarm.de, the German statutory body). It doesn’t take a genius to figure out where at least some of the European supplies of sotalol are being sold. Despite all the hype over many years, the cost of many reference priced Irish medicines are now so low, that there is little incentive to import them to Ireland. While this is but one example, it gets to the core of a particular malaise that has crept into the medicines supply chain. Pharmacists are scrambling, routinely, to source alternatives to common medicines. Last week there was no lactulose available from the two main wholesalers. Once upon a time we had four different brands, now we have one. As choice disappears, we become hostages to the slightest delay.

Today I look at my dispensary shorts list, of well over 100 medicines, that I cannot get. If the patient is lucky, there is a licensed alternative. If they are not, then I have to start scrambling. So, getting back to FMD, can it become more useful than a chocolate teapot? Can it help protect the public from getting unsafe, or hazardous, treatments. There actually might be a saving grace. What if, upon scanning a product, that its SNOMED CT or ATC code was downloaded? Suddenly we could see relevant pharmaceutical information in front of us. No longer a best guess, but relevant particulars and, even better, a route of administration. This is not some advanced AI functionality, it is available now. The fact that we cannot access it is down to a singular lack of vision at regulatory level. The medicines supply chain is currently seriously fractured, only being held together by the herculean efforts of pharmacists. The least we could expect is some help.