Public and private agencies share a role in protecting and promoting public health through the control and supervision of health-related products, technologies and services. These may include international, national and government entities with legal powers or best practice, recommendations that ensure public safety in the healthcare community. Examples include but are not limited to FDA, EMA, NATA, Health Canada, WHO, UNDP, CLIA, IATDMCT, MHRA, WADA.

In order to better support their mission and deliver the recognised benefits of patient centric sampling technologies, such agencies need to set forth best practice and standardisation for these devices. Further, some of these agencies are actively supporting the use of patient centric devices for population studies and improve standards of public health.
The creation of new regulatory standards for these technologies relies upon the continuous feedback and engagement with stakeholders (e.g. healthcare providers, patients, manufacturers) to understand their risk and benefit profile.

With the constant evolution of technologies, standards regulating their implementation also need to evolve rapidly in order to provide better access to healthcare monitoring and diagnostic capabilities by healthcare professionals and consumers.

References

 

Case Studies

Drug Testing in Sport

Determination of oxycodone and its major metabolites in haematic and urinary matrices: Comparison of traditional and miniaturised sampling approaches. Protti, M. et al. J Pharm Biomed Anal 152, 204-214, doi:10.1016/j.jpba.2018.01.043 (2018).

Sports drug testing using complementary matrices: Advantages and limitations. Thevis, M., Geyer, H., Tretzel, L. & Schanzer, W.. J Pharm Biomed Anal 130, 220-230, doi:10.1016/j.jpba.2016.03.055 (2016).

 

Exposure Science

Novel volumetric adsorptive microsampling technique for determination of perfluorinated compounds in blood. Koponen, J., Rudge, J., Kushon, S. & Kiviranta, H. Anal Biochem 545, 49-53, doi:10.1016/j.ab.2018.01.015 (2018).

 

Forensics

Liquid Chromatography –High Resolution MS-based assay for broad-spectrum drug screening of dried blood spot as microsampling procedure. Joye, T. et al. Analytica Chimica Acta, doi:10.1016/j.aca.2019.02.011 (2019).

 

Therapeutic Drug Monitoring

Official International Association for Therapeutic Drug Monitoring and Clinical Toxicology Guideline: Development and Validation of Dried Blood Spot-Based Methods for Therapeutic Drug Monitoring.Capiau, S. et al. Ther Drug Monit 41, 409-430, doi:10.1097/FTD.0000000000000643 (2019).