In­for­ma­tio­n for pa­ti­en­ts

„On­ly if the right pa­ti­ent receives the right treat­ment,

me­di­cal care can be suc­cess­ful.

This requires that every patient can be reliably identified at any point in time during their treatment.“ [1]

In the treatment of addictive disorders the testing of body fluids for the consume of abuse substances is an accepted tool for the evaluation of therapeutic process. Here, the therapeutic aim, the achievement and preservation of abstinence[2], is a central point. It is accepted that the relaps is part of the chronic disease incidence of addicted persons. The conflict between the claim for abstinence and the assumption of relapses causes the necessity to examine samples regarding origin and quality to identify manipulation and replacement of samples. This can be applied especially to the matrix urine which is, despite the high analytical value, vulnerable to manipulation and needs special accuracy regarding assignment of test persons and samples.


Besides the supervised sample collection the method of urine labeling with inert polyethylene glycoles for the certain identification of the test person could be established [3]. The reliability of this method is confirmed by scientific studies [4]. However, the method of urine labeling also requires the presence of the test person in the respective practice or institution, since the labeling substance needs to be taken under supervison.


The requirements listed in the agreements for patients in the field of addiction[5] with regard to insight into the disease, willingness of therapy and motivation to follow the therapy plan and to achieve the therapy goals are summarized according to McDonald et al. 2002 [6] under the term adherence. In this sense, the patient demonstrates on one hand willingness for therapy and motivation (evidence of adherence) by carrying out a self-responsible urine labeling that can be verified at a later point in time. 


Urine labeling substances are according to the directive 2011/62/EU and the legal requirements of the european organization for the authentication of pharmaceuticals securPharm individually identified by the manufacturer and provided with dedicated security features. This information is stored in a blockchain and is used by the Ruma Digital-System (Pro) application to verify the assignment of patient and urine marker substance. It is not possible to use a urine marker that has not been assigned to the patient or that has already been used. All urine labeling substances are suitable with individual security features that can be processed by Ruma Digital-System (Pro).

[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

[6] Haynes RB, McDonald HP, Garg AX. Helping patients follow prescribed treatment: clinical applications. Jama. 2002 Dec 11;288(22):2880-3.