Information for Patients and Clients
"Successful medical care is only possible when the right patient receives the right treatment.
This requires every patient to be reliably identified at every stage of care." [1]
In the treatment of substance use disorders, testing bodily fluids for substances of abuse is an established tool for assessing the course of treatment. The primary therapeutic objective is to achieve and maintain abstinence [2]. At the same time, relapse is recognised as part of the chronic course of substance use disorders [ibid.]. The tension between the requirement for abstinence and the recognition that relapse may occur makes it necessary to examine specimens for authenticity and quality in order to detect specimen manipulation or substitution. This applies particularly to urine, a frequently used specimen matrix which, despite its high analytical value, is susceptible to manipulation and requires particular care in establishing the link between the person providing the specimen and the specimen itself.
Alongside directly observed urine collection, urine marking using inert polyethylene glycols (PEGs) has become an established method for reliably identifying the person providing the specimen [3]. The reliability of this method is supported by scientific evidence [4]. However, conventional urine marking also requires patients to attend the administering facility, as the marker substance must be taken under supervision for identification purposes.
The requirements defined in agreements governing addiction treatment [5] concerning patients' awareness of their illness, willingness to engage in treatment, motivation and reliable adherence to the agreed treatment plan are collectively referred to as adherence.
The RUMA Digital-System (Pro) is a verified digital security system that makes patients' independent participation in defined therapeutic processes secure, traceable and retrospectively verifiable. Adherence is therefore not merely assumed or documented, but can be objectively demonstrated through a verifiable process.
To achieve this, the system combines unique attribution, digital identity verification, secure process execution and independent verification within an integrated security architecture. Each verification procedure is individually assigned, single-use and protected against reuse or unauthorised multiple use.
Security-relevant information is stored securely and used within the RUMA Digital-System (Pro) to verify the respective attribution and the integrity of the process. Unauthorised verification procedures, procedures not registered in the system or those already completed cannot be reused as valid evidence.
RUMA thus creates a digital layer of trust and verification between patients, healthcare providers and other authorised parties. The result is traceable, verifiable and documented evidence of adherence within a verified security system.
1 Handlungsempfehlung - Sichere Patientenidentifikation in der ambulanten ärztlichen Versorgung, Aktionsbündnis Patientensicherheit (APS), Stand 18.07.2013
2 Vereinbarungen im Suchtbereich, Gemeinsames Rahmenkonzept der deutschen Rentenversicherung und der Gesetzlichen Krankenversicherung, 2. Auflage 8/2013
3 Leitfaden für Ärzte zur substitutionsgestützen Behandlung Opiatabhängiger, Bayerische Akademie für Sucht- und Gesundheitsfragen (BAS), 4. vollständig überarbeitete Auflage, 19.12.2018
4 Baum K, Schüler-Springorum M, Huppertz B; Process Reliability and Psychological Stress in Urine Sample Collection for Drug Testing: A Pilot Study; J Appl Life Sci Int. 2018; 19(1): 1-12
5 Vereinbarungen im Suchtbereich, Kriterien der Spitzenverbände der Krankenkassen und Rentenversicherungsträger für die Entscheidung zwischen ambulanter und stationärer Rehabilitation (Entwöhnung) bei Abhängigkeitserkrankungen, 2. Auflage 8/2013.
