Prescription medications are dangerous. Yes, they can cure certain infections or control chronic conditions, but there is a reason some pharmaceuticals cannot be bought over the counter. Regulation is key and processes exist to protect patients from adverse events. It is an ever-evolving landscape and continuous improvement and vigilance is crucial. That said, no system is perfect, and we have much to fix.
It is by no means an exaggeration to say there is an opioid crisis in the U.S. More than 42,000 deaths in 2016 were as a direct result of overdose of these drugs – 40% of those involving a prescription. A 2017 survey on drug use and health estimated 11.4 million people misused prescription opioids. The Centers for Disease Control and Prevention estimates that the total "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. And the problem is not confined to North America. Globally, it is estimated that 27 million people suffered from opioid use disorders in 2016.
Analgesics aside, there are many other groups of medications that can cause serious harm – both to individuals and at a global level. The European Antimicrobial Resistance Surveillance Network (EARS-Net) published a study in 2015 which estimates that about 33000 people die each year as a direct consequence of an infection due to bacteria resistant to antibiotics in the EU/EEA. Whilst we would love to give bacteria all of the credit, there is good evidence that antibiotic stewardship and prescribing practices are somewhat to blame. Antibiotic use has risen by 6.5% in the past four years in the UK and estimates suggest that as many as half of all patients who visit their family doctor with a cough or cold leave with a prescription for antibiotics. Viruses cause many of these infections, meaning antibiotics are of no use.
It’s not just inappropriate prescribing that is encouraging resistance to the drugs. The way people use antibiotics is also a big problem. Skipping doses, sharing medication with others and stopping courses early also contribute significantly. Education alone is insufficient to meet the challenges of medication mishaps. We may not be able to control patient behaviour, but all should be done to ensure the systems are designed with safety in mind.
For decades, prescriptions have been written on paper. While this method is certainly easier for doctors, it presents many risks which need to be mitigated. The use of e-prescribing is up 500% in the U.S. since 2015. Though the UK and Europe are lagging in adoption, there is a significant drive to make Electronic Prescribing Systems (EPS) the norm.
International evidence shows that EPS may improve the safety of inpatient medicines management processes, reduce medication errors and, to a lesser extent, reduce adverse drug events. However, unintended consequences, including new errors, may occur. Evidence on the effects of EPS on workflow is limited and in my experience, e-prescribing can add significant time and administrative burden for busy doctors.
Of course, as with many hospital IT systems, the issue of data silos and interoperability remains. In-hospital prescribing systems are generally isolated from local pharmacies and family physician practices. The medicines data landscape is fragmented, and programs are underway to improve the understanding of use, spend, safety and effectiveness of drugs in the NHS. An estimated 237m medication errors occur in the NHS in England every year and the estimated NHS cost of definitely avoidable adverse drug reactions is £98.5m per year, consuming 181,626 bed days, causing 712 deaths, and contributing to 1,708 deaths. There is certainly good reason to make improvements.
There are clearly potentially great advantages to electronic prescriptions.
Incorrect spelling, dosing or inappropriate medications can be filtered out. Patients can’t add a zero onto the Morphine dose or photocopy the prescription for their friend. An electronic record allows for inventory management, audit trails, research possibilities and cost analysis. Digital signatures enable accountability, enhanced security and when checked against the database of licensed prescribers can help reduce fraudulent activity.
But like all things digital, there are several hurdles to overcome. Centralised systems are single points of failure, suffer down-time and can be hacked and altered. The user interface may not be intuitive, and the system may not link to the myriad of other related patient information systems in the practice or hospital.
My own family doctor surgery does input prescriptions on a computer – only to print out a paper copy for me to take to the pharmacy. They do also have an electronic system where prescriptions can be sent to a nominated pharmacy, but knowing when this has been authorised, has arrived, been reviewed and is ready for collection often remains a mystery. It is not uncommon to need to make several phone calls to both organisations to track down the status of repeat medications. Also, the nominated pharmacy may have received the prescription but not have stock of the medication in store. A fact to be discovered after a wasteful journey in the car.
In an ideal world, all participants along the value chain would have access to a real-time, unalterable record of the status of prescriptions, medication inventory and use. To achieve this, we would need data from pharmaceutical company production facilities, pharmacies, hospitals, doctors, patients and ultimately a view of the way drugs are disposed.
It would be fanciful to imagine a system like this to develop overnight. Notwithstanding resistance from incumbents, costing and building a centralised system for something like this is unlikely to occur without top down mandates from governments. Trust between participants and willingness to share data are equally obstacles to progress with this model.
It should not come as a surprise to the astute reader that this article might suggest distributed ledger technology (DLT) or blockchain as a possible part of the solution. Consider the value proposition:
- The ability to collaborate with stakeholders in a trust-less manner by sharing a real-time state-of-now database which remains in sync through consensus.
- A practically unalterable audit trail of events
- A decentralised and distributed system that is always available.
Pharmaceutical firms have begun dipping their toe in this water with pilot studies in the drug supply chain. The ability to track and trace medication from materials in the ground to pills being dispensed promises to add significant value to the reduction in counterfeits as well as bring innumerable efficiencies to the relevant parties. Digital asset provenance, however, is certainly not infallible. It remains possible to track a rock in a box labelled as penicillin from source to destination. That said, DLT does enable a log of transactions that helps pinpoint the accountable culprit along the chain. The immutability and decentralised nature of the record makes it virtually impossible for nefarious actors to alter the general consensus.
The solutions that are currently being developed could equally link into the prescribing systems for useful inventory feedback. Near real-time views of the state of the chain could have a significant impact on how supply and demand are managed, with rich data sets that may bring enormous insights over time.
Of course, the data collection doesn’t need to end when the medications have been dispensed. The consumption chain (a phrase coined by a respected Catena colleague, Bedie Moran) is equally important in the circular economy. Part of that cycle is where unused or near-expiry drugs can be repurposed.
Bedie’s work with Remedichain as Chief Strategy Officer and Director of International Relations, highlights an incredibly valuable program where unused meds are re-distributed to areas of need with economic benefits for all stakeholders. Unbelievably, an estimated $100 billion of medication is destroyed each year in the U.S. (up to 20% of manufactured medications!).
On the consumer side of this equation, there are other advantages for using DLT. Prescriptions are valuable items, and what better way to exchange value electronically than as digital assets on a blockchain? Smart contracts can facilitate repeats and consensus mechanisms keeps the system in check. And with patient-centric care becoming more of a focus, control and choice become incredibly important.
Once added to a record, a prescription’s ownership can be transferred from physician to patient for use at a pharmacy of their choice. Then, after the digital asset has been exchanged for a physical one, the token can be sent to a blockchain address where it can no longer be spent. There are many technical options for how this can be achieved, but the end result should be peer-to-peer transfer of ownership of a digital asset with no possibility of double spending or fraud.
Reconciliation in this system is again virtually instantaneous and a full audit trail with all the granular data sharing features become feasible. It goes without saying that there are efficiencies, cost savings and potential new revenue models that emerge with this method.
Pharmeum, with Zain Rana as CEO (disclosure, I am advising them on medical strategy) has built such a system and incorporates AI to improve safety and to generate clinical insights. Scalamed and Blockmedx are claiming to provide similar solutions and all are in their very early stages.
The final dream state involves coordination across the supply chain, and this will probably take a decade to be realised, if at all. In spite of this, I believe DLT is a good place to start.
Blockchain/distributed ledgers are not a panacea for these serious challenges. As standalone products they are unlikely to replace the legacy systems and cure all ills. As with many emerging technologies, we will have technical and cultural hurdles to overcome before any significant adoption can occur. The solutions will probably incorporate many elements in a technology stack which include AI, IoT, DLT and systems already in use.
The push for digitised health is important. There is much to be gained from machine learning, big data sets and coordinated care. As a doctor, occasionally on the front-line, all I ask is that companies make it easier than using paper.
