The future of in-home healthcare is arriving with smart sensor networks, opening doors to monitor sensitive drugs at the point of consumption. This new era of drug monitoring promises to transform patient care but demands careful navigation. Because as technology advances, questions arise: Who is responsible for this new frontier? How do we ensure quality and equality for all patient groups?
Whilst past and current GxP regulations have all focused on controls for the development, production, and distribution of pharmaceuticals with powerful impact on the quality of drugs and inherently quality of life for patients the vital last step in the drug supply chain has gotten little attention.
The challenges of in-home drug control
For critical patient groups that are administered highly sensitive drugs, correct storage conditions of their drugs become an integral part of ensuring that the drugs are effective and yield the intended results.
When patients are administered sensitive drugs to be delivered in-home, there is often very little control over storage conditions, mostly due to a lack of appropriate technology and the inability to enforce control and regulations in the patient’s own home with temperature often being the most critical factor.
The future of sensitive drug monitoring at the point of consumption
However, with the emergence of new technologies within wireless sensors (often identified as Internet of Things (IoT) sensors), we are now at a point where monitoring of sensitive drugs at the time of consumption – that being at home or in a healthcare facility – is feasible.
Due to years of intensive research and development within the field of smart sensors, a mirage of options are available that all offer seamless deployment of sensors with minimal effort from the patient, ensuring that deployment and use of sensors is possible for all patient groups, independent of technology preparedness.
Even though the technology is ready, there are a lot of unanswered questions that still need to be addressed before a complete adoption will yield true value to the patient:
Responsibility of action
The responsibility to act on findings and data from a smart sensor solution has yet to be placed. Who is responsible for drugs that are administered and delivered to patients, and how do we ensure that all patient groups receive quality care independent of technology maturity and socioeconomic status?
Much like other interactions between the healthcare system and the patient, patients with the ability to maintain a high level of diligence and involvement in the treatment process would be likely to act themselves on non-ideal conditions, but care must be given to patient groups where that is not possible. This introduces the potential to inadvertently heighten inequality in a healthcare system that is, in numerous aspects, already characterized by significant inequalities.
The burden of any screening process is finding resources to act on findings, and the same will surely be true for point-of-consumption monitoring.
As with all other efforts to improve the quality of care, resources are required to deploy and implement a system for monitoring sensitive drugs.
Currently little control is in place in most healthcare systems, and as such the problem has yet to be quantified which means the extent of any efforts is hard to gauge causing a lack of understanding of the true size of the problem. This in turn means that prioritization of resources can be hard to justify.
Level of requirements
The backside of the emergence of IoT on the scale that we are currently facing is that the variety in quality of sensors is very large and requirements that were traditionally very harmonized for traditional sensor technologies are becoming blurred and misinterpreted.
Setting harmonized minimum standards for the level of quality to be expected from sensor networks is crucial for the success of any future efforts to incorporate monitoring at the last step of drug delivery.
Furthermore, effective monitoring of drug conditions at any point in the journey relies on a constant stream of high-level data that can be effectively utilized to give insight into the storage conditions of sensitive drugs. For that to be available at a level of quality that is acceptable, global standards need to be defined for this new place in a drug’s journey, something that is yet to be defined.
The need for governmental involvement
There is a huge potential for improving the quality of life for patients who rely on the storage of drugs in their homes if effective monitoring can be applied at this last point of the journey.
However, this requires the involvement of governmental agencies to ensure baseline
expectations are present, as well as harmonization of standards for levels of quality by harmonization organizations.
With technology progressing even further, driven by a strong commitment to smarter sensor technologies, it is also foreseeable that even more intelligent solutions will be available to broader patient groups.
Jakob Konradsen has a background in electrical engineering and has worked with quality, compliance, and validation for his entire work life. Jakob is the Head of Quality and one of five co-founders of the Danish-founded company Eupry working to ensure optimal storage for medicine worldwide through technology to automate temperature monitoring and compliance processes. Jakob has broad experience with finding solutions that balance regulatory requirements with a cost-effective, pragmatic, and risk-based approach within the field of thermal validation, calibration, and temperature monitoring and compliance.