Pharmaceutical serialisation provides new opportunities such as theft prevention
Six years ago while I was working on eHealth for developing countries, I had a meeting with an executive from a company providing security services (access control) for hospitals in a 3rd world country. The main problem he discussed on was hospital staff stealing pharmaceuticals to sell them in the black market – under-the-table in local pharmacies. The same problem may appear at pharmaceutical warehouses and even pharmacies as well.
Thefts of high-value prescription medications continue to occur. In March, thieves broke into an Eli Lilly warehouse in Enfield, Connecticut, and stole $75 million worth of prescription drugs. Theoretically, those stolen drugs would not be able to re-enter the legal distribution chain if they had SNIs printed on 2D barcodes or RFID tags on each package label. (Barlas, 2010)
Think about the situation where the serialized medicine packages would have been stolen from a hospital or a supplier warehouse. The status of a medicine package would immediately become clear at the counter of the pharmacy as the pharmacist would not be able to decommission the package. In future, the customer could even check the package him/herself with a mobile phone. Thus, purchasing stolen or counterfeit medicine becomes a conscious choice.
The serialization of medicine packages could enable anonymous follow-up studies done with a mobile phone app
New uses for serialization can also be found in medication compliance and protecting the patients from taking wrong, expired or recalled medicine. According to Cleary et al. (2012), self-infusion of coagulation factor concentrate (CFC) to manage hemophilia becomes safer, when the patient can scan the medication package with a smartphone app. The app checks if the CFC is correct for his/her prescribed treatment, that the expiry date has not yet been reached, and that the product has not been recalled. Failing any of these three checks results in an audible and visible alert to the patient. These applications do not rely on pharmaceutical serialization only, but serialization is just one base supporting these new services. Thus, the technology already exists to improve patient safety, increase medication compliance, and provide high-quality data to the medical personnel real-time. There just need to be medical institutions with the ability to provide these services.
Self-treatment in hemophilia with coagulation factor concentrate (CFC) is central to the management of the condition. However, there have been ongoing issues with this form of treatment, including reconciliation and traceability. These issues arise because completing and returning a manual treatment sheet (diary) is cumbersome, time-consuming, and retrospective, which has led to poor compliance. St James’s Hospital, Dublin, Ireland has implemented an electronic diary, based on medication bar-coding and a Smartphone app. Patients on home treatment are offered a free smartphone with a specially designed app that is used to capture their usage data and the reason for treatment, by simply scanning a 2D (data matrix) barcode on the CFC box. The app was designed in conjunction with a patient focus group and after being piloted by 18 patients initially; 75 patients now use the app to record their CFC usage in the home. Results show that the app is user-friendly, and compliance for patients using the app is almost 100%. (Cleary et al., 2012)
Pharmaceutical companies also need to study the effects of the medication they already have in the market. Local reimbursement authorities require facts for cost-benefit analysis. Today, much of the research is done at the pharmacy counter, but serialization of medicine packages could enable anonymous follow-up studies done with a mobile phone app. Privacy laws put strong protection on the privacy of the patient, but the medicine package does not need such protection. This type of research would not even need to use the official serialization databases but just make an own database with serialization code as the identifier. The serialized package could be tied to patient information on sufficiently loose terms, such as “40 years old female living in Helsinki, Finland”.
I would also assume there will emerge scientific applications using the serialization of medical packages. Pharmaceutical research on drugs already on the market would benefit from identification codes not compromising patient privacy and smartphone-app-based data gathering.
CTO, Chief Technology Officer
Servicepoint Kuopio Oy