PharmaLedger

We all want 100% certainty that the medical products that we are using are safe, that the instructions that come with our medicines are clear and up-to-date and that during the journey from the factory to our pharmacies our medical products have not been tampered with. Participants in clinical trials also have concerns about the safety of their data, which is often of a sensitive nature, and which needs to be shared with many individuals throughout the course of clinical trials. By harnessing the power of blockchain, the PharmaLedger project proposed new technological solutions that will improve the security of our medicines and boost trust in the pharmaceutical pipeline.

Secure, up-to-date product information in your pocket

With each package of medicine comes a hefty stack of instructions. But if you are a French person and you get sick on holidays in Crete, those instructions will be provided to you in Greek. That makes it much less likely that you will take the medicine correctly, which could have adverse consequences for you. Also, the information provided in the package is only up-to-date from the date that it was packed, so any more recent information cannot be included. That is especially relevant in the case of drugs that are being developed quickly in response to a threat, as happened during the COVID-19 pandemic. What’s more, eliminating the thick stacks of paper that are provided with medicines could significantly reduce waste. If all of the information leaflets that are produced in one year globally were laid out flat and placed on top of each other, the pile of paper would be well over 500km high.

The PharmaLedger consortium built an electronic product information app which addresses these concerns, currently being piloted in Singapore and Ecuador and due to be launched soon in several other markets. Co-designed using patient feedback, the app allows you to scan a type of barcode on the package of any medication, which brings you to a digital version of the corresponding information leaflet that can be constantly updated in real time, in any language. The use of blockchain ensures that you always have the correct and up-to-date information that can be trusted, and this solution will dramatically reduce the amount of product information leaflets that have to be printed. And in a future version of the app, the scanned barcode will also be able to alert you if the medical product has been tampered with along the supply chain.

Privacy, security and more accurate information for clinical trials

Clinical trials require the storage, sharing and analysis of large amounts of data, some of which is sensitive and of a personal nature. At present, ensuring that data storage and use is in compliance with privacy regulations is time-consuming and difficult for all actors involved. It is difficult for patients to successfully extract all their data if they wish to leave a trial, and there is a heavy administrative burden on those carrying out the trials, who must review large amounts of documentation.

PharmaLedger’s goal was to decentralise the entire clinical trial process so that data will be owned by the trial participant alone, real-time changes in data can be instantly realised, withdrawn consent can be translated directly to removal of relevant samples, and researchers can be sure that data is completely traceable and that they have up-to-date permission to use it.

Decentralising the clinical trial process paves the way for better remote patient monitoring which in turn opens the door to more at-home clinical trials of higher quality. PharmaLedger also worked on secure and safe blockchain-based systems for integrating real-world data and real-world evidence collected via Internet of Things (IoT) technologies – such as wearable devices – into clinical trials.

The first step to a completely decentralised system is the development of blockchain-based eConsent forms. Signed securely by the patients, these consent forms were developed by PharmaLedger and can be updated in real time enabling rapid re-consent for additional procedures as part of the trial, or near-immediate removal of samples or data from datasets if the patient decides to pull out of the trial. It also cuts down on the risk of fraudulent data being used in the project, as well as ensuring that data is being dealt with in accordance with regulatory requirements. The idea was that eConsent could be used in countries which have different regulations so this was also taken into account. Beyond the project’s end, eConsent will continue to be optimised by the non-profit which has been set up to further the work of PharmaLedger, the PharmaLedger Association.

Managing supply chains and preventing counterfeiting

From manufacture to patient, there are many points along the supply chain where blockchain could be leveraged to improve security, reduce errors and increase trust in the final product. For instance, the majority of delivery dockets are currently paper-based and can easily be forged. Utilising blockchain would allow that entire process to be digitised, making it more accurate and more secure while enabling the tracking of a package of medicine and reducing counterfeiting. Blockchain-based solutions would also increase transparency within the supply chain – meaning that suppliers would have to undergo less audits and manufacturers would have more visibility on the process from raw materials to finished product. PharmaLedger envisioned a trustworthy depository of information that all the actors along the supply chain could access simultaneously, tracking medicine development in real time. The project investigated solutions to improve the supply chain using blockchain and that work will continue to be carried out by the PharmaLedger Association.

Currently, a 2D matrix code including a barcode and a serial number is the standard for identifying medical products. But a barcode and serial number can easily be faked, with a patient none the wiser. The black market trade in counterfeit medicines creates serious health risks. Estimates show that between 72 000 and 169 000 children may die from pneumonia every year after receiving counterfeit drugs, and that fake anti-malarial medication might be responsible for an additional 116000 deaths. The costs to EU governments of counterfeit medicines is around EUR 1.7 billion. In the future, patients will be able to scan the matrix code on the back of a medicine package using the PharmaLedger app and will receive an alert if the medicine packaging is fake.

Ensuring that the legacy of PharmaLedger lives on

The potential that blockchain presents for the healthcare system was proven by the PharmaLedger project, and the consortium developed a non-profit, membership-based association to ensure that the work led by the project will continue. The association currently involves 32 members who work together within various working groups to advance the research on the different use cases explored by PharmaLedger. Some of the projects that the Association will investigate is the further improvement of the electronic product information app, the integration of anti-counterfeit features into the app, furthering the eConsent form for digitising clinical trials and boosting digital traceability for finished products in the supply chain. If you have an idea for a blockchain-related project that could help improve the digital health ecosystem, you can submit a proposal to the PharmaLedger Association’s Innovation X Lab, and if it is in line with PharmaLedger’s values, a project may be initiated.