One of the main drivers for the adoption of closed-loop medicine (CLM) administration in the acute sector is the adoption of the HIMSS EMRAM capability maturity model and achievement of the higher levels. At level 6, healthcare institutions must implement CLM administration integrated with electronic medication administration record (eMAR) and computerized physician order entry (CPOE) systems, and they must deliver the ‘five rights’ of medication administration (the right medicine administered to the right patient at the right time in the right dose via the right route) at the bedside, based on patient and medicine identifiers.
The most trust-worthy identifier is the one provided by the manufacturer themselves. But in clinical settings, this identifier is missing-in-action.
There is little support for unit-dose dispensing across the UK. Pharmacists generally dispense drugs in the original packaging with a patient information leaflet. They may, in some cases, ‘split’ those packs, for example by placing an inner blister pack containing several doses in a blank carton to which they affix a label. They do this to match the amount of doses supplied to the patient to the requirements of the prescription. Pharmacists do not, as a general rule, dispense individual doses to patients. For this reason, there is no requirement in the UK to print individual barcodes on the inner packaging for each dose.
Bit by bit, things are changing. There have been a number of pilot schemes in the UK in recent years, and unit-dose dispensing is used at a few sites. However, for the most part, pharmacists do not implement this approach. The necessary investment is significant. In a busy hospital pharmacy, for example, it would be inconceivable to handle unit-dose dispensing manually. Pharmacies need to invest in automated machines that will, for example, divide blister packages into individual doses, package those doses for individual patients, apply a barcode and place each package or pouch into a secure dispensing cabinet for delivery to the bedside. Closing the loop requires integration into existing EPR and ancillary systems, changes to processes across the healthcare institute, investment in new hardware, training programmes for staff and much more. These changes will not happen quickly.
The problem has been discussed at the national level, with some effect. The HIMSS EMRAM requirements for level 6 assume the use of unit dose dispensing. We hear that HIMSS accreditors, in some circumstances, have been willing to relax this requirement in the UK. However, the situation is far from clear.
The UK faces the real prospect of falling behind the rest of Europe. We must not allow this to happen.
The immediate need in the UK is to provide better ways of closing the medicine administration loop based on existing identifiers. Today, that means the pack identifier printed on the outer packaging of each pack of medicine. Prescription medicines must, by law, have a two-dimensional Data Matrix barcode containing a unique identifier for the pack. Non-prescription medicines typically have a linear barcode containing the manufacturer’s product code. Product codes are almost always GS1-issued GTINs (Global Trade Item Numbers).
Here is the problem. The need for reliable identification of medicinal products lies at the core of CLM. The fundamental and most trust-worthy identifier for a manufactured, traded medicinal product is the one provided by the manufacturer themselves, rather than any ancillary identifier provided by a third party. However, the manufacturer’s identifier is largely missing-in-action in clinical settings. Data sets often don’t contain them, and if they do, the data is incomplete and difficult to maintain. In any case, the manufacturer's identifier is rarely recognised by existing software or used widely in medicine catalogues or formularies. There is no formal requirement for the manufacturers to disclose their product codes to healthcare institutions.
We should close the loop over the core representation of a medicinal product as a manufactured trade item. This reflects reality.
Let’s consider dm+d. This foundational data set is mandated for use across the NHS and provides a crucial bridge between medicine supply and administration. It supports two distinct perspectives. ‘Virtual’ records provide a clinical view of medicines in terms of their ingredients, strength and other pharmacological characteristics. ‘Actual’ records identify manufactured products. At the level of Actual Medicinal Product Packs (AMPP), dm+d is directly aligned with the manufacturers’ perspective.
The dm+d data set has long shipped with a companion data set containing the manufacturer GTIN product codes, mapped directly to AMPP codes. This is great…until you realise that less than half of the medicines in dm+d have a mapped GTIN. That means that in a CLM scenario based on the use of dm+d data, many scans will be ‘misses’. The product will not be found. How can care workers be asked to trust and use a CLM administration process that only works half the time?
Effective and reliable CLM administration has the potential to save hundreds of lives a year in the UK, alone, with better outcomes for many thousands of patients. However, much more effort is required to realise this benefit, and core pieces of the puzzle are still missing.
We need urgency, clarity and leadership to solve the CLM puzzle.
In short, the loop should be closed all the way back to the core representation of a medicinal product as a manufactured trade item. This reflects reality.
The European Medicines Verification System, which we have been involved in since 2012, provides answers to some of the challenges above. Manufacturers are required by law to upload product data, including both GTINs and other identifiers for prescription medicines. 90% of the missing GTINs in dm+d are for prescription medicines. Unfortunately, some national systems don’t yet allow pharmacists to access the full catalogue data, making it difficult or even impossible to map to national catalogues and dictionaries. We can expect that this will improve in time.
In the UK, there is uncertainty about the long-term support for medicine verification after the current transition period ends in a few months, but this is no excuse. The UK now faces the real prospect of falling behind the rest of Europe in medicine management and patient safety, and this must not be allowed to happen. In reality, lives depend on this. There are plans to leverage the UK National Medicines Verification System to provide a comprehensive and direct mapping to dm+d, although these plans are not yet in force. We need urgency, clarity and leadership to solve this crucial piece of the CLM puzzle.