Statement by the Joint Diagnostics Commission of the DVV and GfV on the planned Pharmacy Reform Act (ApoRG)

Statement by the Joint Diagnostics Commission of the German Association for the Control of Viral Diseases (DVV) and Society of Virology (GfV) on the planned Pharmacy Reform Act (ApoRG)

-Application of patient-oriented in-vitro diagnostic rapid tests

Background: On June 25, 2024, the Federal Ministry of Health (BMG) invited to an oral hearing on the draft bill of the Pharmacy Reform Act (ApoRG). Associations involved have until June 28 to submit a statement.

An important point of the draft concerns the use of in vitro diagnostic (IVD) rapid tests close to the patient for the detection of reportable pathogens such as adenovirus, influenza virus, norovirus, respiratory syncytial virus (RSV) and rotavirus in pharmacies. It remains unclear in the draft whether these are rapid antigen tests or molecular point-of-care detection methods.

Pharmacies are also allowed to administer vaccinations (with inactivated vaccines) to people over the age of 18.

The Joint Diagnostics Commission of the German Association for the Control of Viral Diseases (DVV) and Society of Virology (GfV) comments on the draft bill. From the point of view of the virological societies, the following reasons for the planned expansion of patient-oriented IVD rapid tests must be critically assessed and clearly rejected in this form:

Quality management and guidelines of the German Medical Association: Medical laboratories must maintain an established quality management system and observe the guidelines of the German Medical Association (RiliBÄK 2023). Key components include internal and external quality assurance (proficiency testing). Currently, the RiliBÄK stipulates a mandatory EQA scheme for the detection of influenza and RSV antigens, but not for adenovirus, norovirus and rotavirus antigens. However, an expansion of the pathogen detection methods subject to RiliBÄK seems necessary in view of the increasing use of these methods. Documentation, including the prescribed retention period and the transmission of findings between laboratories and the sending medical practices, is also established and is mainly carried out electronically. Among other things, there is a considerable interface problem here with unforeseeable risks with regard to the documentation and transmission of findings from pharmacies to medical care. Also affected is the selection of the tests used (who selects and verifies the tests) and the continuous monitoring of their performance (batch testing). It must also be taken into account that the requirements of the "In Vitro Diagnostic Regulation 2017/746" (IVDR) must be met. The currently available rapid tests are still approved under the previous "In Vitro Diagnostic Directive" on a transitional basis (transition period) and a switch to the IVDR has not been communicated in many cases.

Infection/occupational safety, Biological Agents Ordinance: The use of pathogen-specific detection methods is subject to various legal requirements such as the Biological Agents Ordinance (BioStoffV), which regulates the disposal and handling of infectious residual waste, the Technical Rules for Biological Agents (TRBA) 100 ("Protective measures for activities involving biological agents in laboratories") and, if applicable, TRBA 250 (biological agents in healthcare and welfare) as well as occupational health and safety (ArbStättV). In terms of infrastructure, pharmacies are not equipped to handle infectious pathogens and staff will generally not have a permit to work with pathogens in accordance with Section 44 of the Infection Protection Act (IfSG). Some of the above-mentioned pathogens have structural characteristics that require special protection, decontamination and disinfection procedures (adenovirus, norovirus). For reasons of infection prevention, it is difficult to imagine acutely ill patients with diarrhea or respiratory diseases visiting pharmacies and staying there until they receive the results.

Obligation to report: According to §7 IfSG, these are reportable pathogens, which are reported via the German Electronic Reporting and Information System for Infection Protection (DEMIS). This raises questions about the transmission of rapid test results by pharmacies and users, which can lead to increased bureaucracy and costs as well as reporting losses.

Scientific evidence: During the COVID-19 pandemic, pharmacies throughout Germany were given the opportunity to offer low-threshold testing as part of the fight against the pandemic. The national testing strategy provided a clear indication that linked symptomatic patients to medical care. After the end of the pandemic, there is no longer any reason to maintain an IVD rapid test service for highly infectious pathogens. Even during the pandemic, numerous scientific publications demonstrated the limited diagnostic sensitivity of SARS-CoV-2 rapid tests [1]. The poor sensitivity and specificity of rapid antigen tests for pathogens such as adenoviruses, influenza viruses and rotaviruses has been well documented for a long time [2]. As the pathogens mentioned circulate seasonally, careful medical indication is essential. The positive predictive value (PPV) is very low at times of low pathogen circulation and, if ignored, can lead to frequent false-positive findings and the resulting non-indicated therapeutic-clinical consequences.

Physician's discretion: The detection methods for adenovirus, influenza virus, norovirus, RSV and rotavirus must continue to be subject to a physician's discretion. For the above-mentioned reasons, a medical indication for testing is also necessary for reasons of cost-effectiveness and the resulting medical-therapeutic consequences. The implementation of vaccinations must also remain under medical supervision. Medical vaccination services include not only the vaccination itself, but also the vaccination anamnesis including possible contraindications, the exclusion of acute illnesses and information on the vaccination and possible side effects as well as the notification of any damage to health that goes beyond the usual extent of a vaccination reaction (Section 6 IfSG). Although provided for in the draft ApoRG, there are currently no structures in place to enable the acquisition of the relevant expertise or to verify this expertise.

The cost-effectiveness of this measure is largely unclear, as retesting may be required in the event of unclear rapid test results and to exclude false-positive (in the case of low PPV) or false-negative (due to low sensitivity) results and the measure has never been evaluated in pilot trials. Therefore, unforeseeable follow-up costs (additional visits to the doctor, further differential diagnostic clarifications, isolation measures, sick leave certificates) are to be feared for the solidarity community.

For the Joint Diagnostics Commission of DVV/GfV and in consultation with INSTAND e.V. (Society for Quality Assurance in Medical Laboratories Funding )

PD Dr. Nadine Lübke and Prof. Dr. Marcus Panning, Düsseldorf and Freiburg on 27.06.2024

(Chairwoman of the DVV/GfV Joint Diagnostics Commission)

Literature
1 Dinnes J, Sharma P, Berhane S, et al. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2022;7(7):CD013705.
2 Gentilotti E, De Nardo P, Cremonini E, et al. Diagnostic accuracy of point-of-care tests in acute community-acquired lower respiratory tract infections. A systematic review and meta-analysis. Clin Microbiol Infect. 2022;28(1):13-22.