Microchips and Medication
Substantially improve therapy compliance and quality of care, reduce medicine waste and counterfeiting and enhance medication distribution by means of microelectronics.
Over de innovatie
Place a microchip in medication packages and patient's therapy can be accurately and objectively monitored in a simple way. For example, the microchip sits in the neck of the medication bottle and the chip measures exactly when (day and time) a pill is taken. The chip detects the pills that are taken out but also detects if they are returned to the bottle. If two or more pills are taken out and one is returned this is exactly recorded. If there is temperature-sensitive medication inside, the chip also registers whether the bottle has been stored at the correct temperature. Reading the information from the chip is also extremely simple and can be done with any smartphone that is held near to the medication. The same goes for a medication blister or syringe which includes the chip. In this way it can be recorded when the blister or syringe is used and when the syringe has been emptied. With many medicines, the storage temperature is also extremely important to guarantee that the drug remains effective. Is it well preserved from production to the use of the drug, it is easy to check with this microchip. When using the syringe, it must be checked whether the drug is already the correct temperature for injecting and this is also indicated by the chip. Wastage can also be counteracted if the packaging is still intact and the chip indicates that the storage conditions were excellent. Above all, the chip improves the logistics involved in medication distribution and reduces counterfeiting opportunities, so that the right medicine comes to the right patient.
Therapy non-compliance is a concern in healthcare. Taking the medication on time and taking the right dosage is not an easy task if you need to do this day in and day out. In complex therapies, proper coaching is indispensable in order to take the often expensive medicines in the right way. High costs are incurred in the care sector and more importantly, mal-compliance may adversely affect the outcomes for patients. It results in unnecessarily extra hospitalisations and a lot of additional doctor consultations. There may also be miscommunication involved in the follow-up of the prescribed therapy and in some cases the language may be a handicap, in particular for the leaflet. The wrong medicine being given to the wrong patient is still a problem in the distribution. And what about the authenticity?
Technology can be a great help to solve this problem. The use of Smartphones as a means of communication has now been accepted by all layers of society. Therapy adherence begins with measuring the drug usage and the chip on the medication monitors exactly when the medication is taken. Communicating with the chip is also extremely simple and the information can be stored securely in the patient's dossier. Patient monitoring can happen real-time on-line and when the therapy is not properly followed, the system puts a message on the patient's Smartphone screen and if necessary it can be repeated a few times. Caregivers can check on their own laptop, Smartphone or tablet to see if the patient is following his therapy properly. A healthcare provider can follow so many patients without visiting them and the system automatically notifies when a patient does not follow his therapy properly. This greatly reduces the workload of healthcare providers and self-care of the patient is the new standard with this technology. The system can also make the hard-to-read leaflet more readable on the smartphone and when the smartphone is set to a different language, then the leaflet is also shown in that language, or the Smartphone can read the leaflet aloud. Other valuable information such as the availability of the refill at the pharmacy or instructions with audio and video messages on how to follow the therapy, can be easily and clearly made readable/visible on the smartphone or tablet, so that the patient can check at all times how the therapy was prescribed by the doctor. If the prescription is 2 pills per day, the system will immediately cause an alert when a different amount of medication is taken. Whether the patient has the right medicines, in this system it can hardly go wrong.
The solution is unique, no company has such an advanced solution in the market. There are many "smart bottles" (clever caps, smart caps and glow caps) and also "smart blister devices" but these are all devices that need interventions from the patients. This solution is integrated, the chip is factory-mounted on existing production lines and we are the first and only in the high-tech world that have realised this. The system measures objectively, the patient does not have to fill in an App (subjective measurement), and it is not yet another device for the patient but part of the product he picks up from the pharmacist.
The technology consists in addition to the software infrastructure, of putting a microchip in medication packages. This microchip contains a pill sensor, a clock/calendar, a temperature sensor, memory and a wireless interface to read the data in a simple way from the chip. The technology also consists of an App on smartphones and Tablets and an Internet accessible Database where all therapy measurements of patients can be stored. The Database can be consulted by any authorised person and it analyses and communicates with the patient by sending back and forth information on the therapy adherence, including an eDiary and eNotifications plus eReminders and eInstructions. The patient submits information about his or her therapy compliance measurements and the system monitors whether it meets the prescribed therapy. If not, then the system communicates with the patient with reminder messages, instructions and notifications and if it does not go well, then the system can warn the healthcare provider or "buddies".
There are many devices in the market and they all contribute something to improve therapy adherence but the use of a microchip which is integrated during the manufacturing process of the drug is completely unique, and is not employed by any other company. This integration makes a dozen of new, very important other features possible which can’t be realised by add-ons and devices which are applied by patients.
The target group, apart from the patients, is anyone who uses medicines, and anyone who is professionally engaged in medications such as the doctor and pharmacist, the distribution chain and the caregivers. And, in addition health insurers and governments benefit from this technology.
ECCT does not manufacture, but sells licenses on the technology for the medication packaging manufacturing industry and/or pharmaceutical companies. Knowledge and skills are transferred to allow the integration of the programmed microchip including ECCT's firmware. Many billions of medication packs are produced per year and the license is based on the volume units. The software infrastructure and application software programs are sold or licensed directly to the industries concerned (healthcare providers, medication distribution companies, pharmacies, pharmaceutical companies, drug industry).
The system has been developed to be able to do clinical trials more accurately and faster, and has the big advantage of measuring objectively. The use in other environments still needs to be done so that the system can also be adjusted accordingly. This will primarily involve the adaptation of the functionality of the software programs to suit specific environments. For example, the Smartphone App must be extremely user-friendly so that everyone can work with it and benefit from it. The chip can also be used for many other purposes such as Tracking & Tracing. The right medicine is given to the right patient and the chip lends itself perfectly to checking the authenticity of the medication. This can only be made clear in test phases where this is enabled.
The system has been tested by big pharmaceutical companies and universities in various (clinical) studies and in many places in the world. The system has been adapted to this, but there are many more use cases where technology can and should be tested. Testing the system in hospitals and nursing homes or used by home care. Testing in all kinds of situations and adjusting the technology to these "other" use cases is the goal of the new test phase.
The test results are positive and big pharma companies have embarked on the implementation of this technology to provide all clinical studies with this technology. The use of the Smartphone, also among the older population, is clearly accepted and after giving the correct instruction, problems on usage of the Smartblisters are gone. Unanimously the tests are received very positively, and the feeling of Big Brother is watching you is not experienced. On the contrary, patients want to get better and they experienced such a tool in general as a fantastic aid because it allows them to have control over their own therapy.
The challenges are to provide all commercial medications with the microchip, so that all patients and professionals benefit from this technology in medication usage and in distribution. The first steps have been taken, but more investments are needed to replace the manual processes for putting the microchip on the drug package by automation and robotization to reduce the costs.
There have been several pilots in recent years and they are still going on at this moment. Clinical trials are planned for 2018 and 2019 whose data may not yet be published. A large-scale pilot study is also planned in the US and Switzerland, which also involves many pharmacies.
The project is realised together with a few multinational companies. West Rock (US) for the part where cardboard medication packs are used, Amcor Rigid plastics (US) for the medication bottles/syringes and a close co-operation has been set up already many years ago with Schreiner-Medipharm GmbH (Munich), for special Plastic and/or cardboard blisters and other special medication packages.
The use of the microchip in clinical trials has led the pharmaceutical industry to set up large-scale projects in which many millions of euros are invested to add the microchip in the near future to various medications. E.g. the pharmacology divisions of the Universities of Mainz and Basel have published very positive research results with this technology and will do their future research investigations with this technology too.
The implementation and integration of the microchip into the medication packages must be done at the pharmaceutical company production facilities. For some pharmaceutical companies, this is currently being implemented and research is done by other pharmaceutical companies within their organisation, when and how to implement this technology.
ECCT is an engineering bureau that has developed and is further developing this technology with software and electronic hardware engineers. ECCT supports the pharmaceutical companies in the implementation and realisation and adapts internal logistic systems accordingly. The Dutch NXP semiconductors plays a major role in the manufacture of the chip and the improvements and releases of new powerful microchips.
This technology with microchip and with the necessary software infrastructure, is developed together with a pharmaceutical company that puts high priority on innovation. Regulation is an important stumbling block that could hinder innovations in health care. For this we have opted for a pharmaceutical company which operates globally and therefore knows the regulations in most countries.