“It is necessary to delve deeper into the scope of the provision, certainly innovative, which allows the provision of this type of analysis on medical prescription and reimbursed to the pharmacy by the NHS rather than decided and paid out of pocket by the citizen. The issue of accreditation of the service pharmacy as a structure affiliated with the NHS, like an affiliated private laboratory, implying specific requirements”.
22 APR – In relation to the Simplifications Bill, recently approved by the Council of Ministers and not yet formalized in Parliament, the Fno Tsrm and Pstrp express with a “propositive spirit” some considerations regarding the announced contents of the article aimed at promoting the provision of services at pharmacies.
“In the introduction, it should be underlined that the objectives that the legislator intends to pursue are entirely acceptable. Especially in small inhabited centers, the possibility for citizens to be able to use a whole series of services, from telemedicine to the possibility of choosing the doctor family or to carry out diagnostic tests to combat antibiotic resistance, are some of the certainly positive aspects of the rule.
On the other hand, some possible critical issues must be highlighted in the implementation of analyzes in pharmacies, compared to clinical laboratories. In particular, in the pre-analytical phase of carrying out the sampling, which turns out to be fundamental to guarantee the reliability and safety of the results, compliance with universally recognized standards is necessary, as is the case in the subsequent analytical phase only with knowledge of the processes and the correct management of quality controls by laboratory professionals can guarantee the reliability and precision of the data acquired. The reporting phase of the results should not be underestimated either, where it is necessary to guarantee clear and correct communication to the citizen, especially in cases where critical values have emerged”, explains the Federation.
“The article of the Simplifications bill circulated in the press, however, seems to want to transform pharmacies into multifunctional spaces of the ‘basic diagnostics in a community home’ type and authorizes the pharmacy, unlike an analysis laboratory. The delivery of tests through a receipt without the clinician’s signature, skipping the technical validation phase which is the synthesis of analytical skills, biochemical and biological knowledge and communication skills (ISO 15189:2023) typical of the medical laboratory healthcare technician (Tslb) professional who is also responsible for the verification of the reliability of the results as well as the assumption of responsibility towards the person who receives the results and/or report.
At present, the tests performed in pharmacies are comparable to tests performed in self-tests. For each exam it will be necessary to use specific instrumentation in compliance with the standards and methods capable of guaranteeing the quality of the parameter analyzed. The use of Point of care testing (PoCt) systems is in fact adequate in the self-control and monitoring phase of the disease, while it is inadequate in the diagnosis phase. For this reason, the correct management of these devices is necessary also to avoid the potential consequences resulting from the use of unreliable test results”, continues the note.
“Finally, it is necessary to delve deeper into the scope of the provision, which is certainly innovative, which allows the provision of this type of analysis on medical prescription and reimbursed to the pharmacy by the NHS rather than decided and paid out of pocket by the citizen. The issue of accreditation should not be overlooked of the service pharmacy as a structure affiliated with the NHS, like an affiliated private laboratory, implying specific requirements regarding institutional accreditation, i.e. from the point of view of the premises and equipment, both from the point of view of certified skills which must be possessed by the staff carrying out the analytical tests. The hope is that during the parliamentary process of the Bill the aforementioned critical issues can be the basis for careful reflection and will contribute to improving the contents of the law in the exclusive interest of the population. and to protect their health”, concludes the Fno Tsrm and Pstrp.
April 22, 2024
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