The Ministry of Health rejects for the moment the use of antigen tests in pharmacies, something that Catalonia and Madrid have requested –the Government of the latter has raised the request to the European Union-. Minister Salvador Illa does not close the door to having this type of test done in pharmacies, but he conditions it for the communities to present a plan “with all the details” and reports to local, regional, national and European authorities on “what and how “they want to do it. The proposals submitted by the communities in this regard have been assessed by the Ministry of Health “through the Secretary of State for Health, the Spanish Agency for Medicines and Health Products (AEMPS), and the Carlos III Health Institute”. The Ministry is also analyzing the recommendations issued by the European Commission on this type of test, and in a first assessment Illa concludes that “these tests are useful if they are used properly for specific purposes”, limited to being administered by “trained health personnel and in accordance with the manufacturer’s instructions. ”
The measure has been debated in the Interterritorial Council, the meeting that the regional councilors and the minister Salvador Illa hold weekly and that was held this Wednesday – also with the Minister of Territorial Policy, Carolina Darias, and this time the presence of the minister of Health of Portugal, Marta Temido–. Catalonia and Madrid have already warned that they would bring the issue to the Council this Wednesday. At this meeting it was also agreed to create a working group to present, next Wednesday, a document with recommendations and directions for December, especially for the Constitution bridge and for the celebration of the Christmas holidays: guidelines “for those elderly who want to enjoy those days with their families and can do so with safety criteria “, for” students who want to return to their homes “, safety in general in family and religious celebrations, and also” how we will welcome their majesties the Kings Wizards “.
The process for antigen testing to be carried out in pharmacies does not imply the authorization of the AEMPS, the entity explained, but rather that what would have to be carried out to allow it as pharmacies are right now is a change in the protocols and requirements. “The instructions for use prepared by the manufacturer establish the conditions of use and sampling provided by the manufacturer, currently only for professional use, which guarantee a correct result,” specifies the AEMPS. These instructions for use establish conditions that a priori “cannot be given in pharmacies” as described at the moment, Agency sources point out. The minister has therefore conditioned it to detail how this type of establishment can carry it out.
According to the AEMPS, the Community of Madrid and Catalonia therefore do not need an authorization to use the tests in pharmacies, but they would have to demonstrate those conditions. In the letter that the president of Madrid, Isabel Díaz Ayuso, sent to the European Union yesterday, she did affirm that. “Currently, the Spanish Agency for Medicines and Health Products does not allow us to use these centers. That is why I would consider it useful for a European authority to validate this new form of testing, not only in Spain but also for the rest of the European regions “, Ayuso requested.” The authorization and activities carried out by the analysis laboratories, both public and private, It is the competence of the autonomous communities. The Agency’s competences are those related to the product and to guarantee that the products that are marketed are safe and work properly, through its surveillance and market control tasks “; they write in the AEMPS. That is, the Agency is competent authority on the conditions of the product itself, but not on where it is used.
“We are aware that the management of the disease and the changes in the epidemiological situation make a continuous analysis of new tests and the recommendations of the reference institutions necessary, in order to adapt the diagnostic strategies to each situation,” they add in the AEMPS. The Health spokesman, Fernando Simón, already clarified that they were reluctant to the idea because “we cannot think that a person with symptoms goes to a pharmacy and gets tested.” According to the General Council of Nursing, Minister Salvador Illa had told them in a letter “That absolutely, these tests cannot be done in pharmacies, except in those that may have clinical analysis departments.”
There is a divergence of opinions between professionals and experts. On the one hand, a pharmacy procedure can be very complicated if it is not accompanied by an elaborate strategic plan because, indeed, many pharmacies do not meet the requirements. “It would mean creating a center of infection without need,” declared María José García, general secretary of the Madrid Nursing Union, SATSE, to this newspaper. Ildefonso Hernández, spokesperson for the Spanish Society of Public Health and Health Administration (SESPAS), believed that “it can be chaos. It is very complicated if they do not have the resources to face everything that the diagnostic task means, such as the interview and the study of contacts “.
The main argument of the Catalan and Madrid administrations is that this system will help clear the Primary Care plug, which continues to worry health authorities in this second wave. The drugstores defend their work as agents of Public Health in crisis, as has already happened with HIV, and they believe that actions could be established that have the network of Spanish pharmacies. Hernández only contemplates tackling such a strategy “with a good evaluation of the risks and benefits, of the tests, of what it means for the system, and of how it is going to be done.” For the College of Pharmacists of Madrid, the main value of having its establishments “is the accessibility” they have for the general public and, especially, that it would facilitate the work of diagnosis in rural areas.