The Spanish Agency for Medicines and Health Products (AEMPS) has boosted a pilot project on access to electronic information on hospital medicines and suppression of paper prospectus. It will start in January 2022, and its goal is to evaluate the impact on a small group of hospital medicines. Specifically, it is 46 presentations - among those found by Adiro, of more than 20 laboratories, both of the generic and innovative industry.
In fact, the project also participate in the Spanish Society of Hospital Pharmacy (SEFH), in coordination with the vocality of hospitals of the General Council of official colleges of pharmacists, and a number of pharmaceutical companies, mostly integrated in Farmaindustry and the Spanish Association of Generic medications (AEEG).
In view of the results, the duration or number of medications involved in the pilot may be extended
The expected duration of the pilot project will be at least two years, taking place an assessment through a satisfaction questionnaire completed by the pharmacy services of hospitals. In view of the results, the duration or number of medications involved in the pilot project may be extended, if so agreed by the parties involved; These results will be published for general knowledge.
It is intended to assess at the national level the impact of the suppression of paper prospectus, in order to guide future revisions of pharmaceutical regulation, especially taking into consideration the progress of new technologies and their start-up in the pharmaceutical sector.
To consult the information of the drugs that are part of this pilot project, the pharmacy services of the hospitals will be able to access the prospectus available at the Online Information Center for Authorized Medicines (CIMA), through a non-serialized DataMatrix code that will appear In the primary packaging conditioning.
Ana Lopez de la Rica, Associate Director of the Technical Department of Farmaindustry, progressed this project at XVII Seminar organized by the employer of the innovative industry with the media on November 10. "What are the advantages? One of them, and very important, is that we are protecting the environment. Another is that we will always have in real time the information of the prospect and the authorized and updated technical sheet," she explained.
All this will be possible, as said, thanks to the DataMatrix code: "In addition, the supply chain will be more flexible and the regulators will decrease the bureaucratic load that they have when they update documents (Word, PDF ...) of technical and prospects" .
Ana Herranz, National Vocal of Hospital Pharmacy in the General Council of COF and Head of Hospital Pharmacy Section at the Gregorio Marañón General University Hospital, it holds this project that this project has a double objective: "On the one hand, eliminate the prospect, which The industry is delighted for its processes besides that it is more sustainable, and we, at the hospital pharmacy, we have always had the demand not to have to reall medications, especially those of high risk we use in traceability systems, "he says.
In addition, online with Review by the AEMPS in his statement, Herranz explains that "in hospitals, when we need to look for information about a medication, we connect to the top. So, this datamatrix code will take you direct to the top and, in addition, We can use it to guarantee the traceability and safety of use of medications within the hospital ".
How have the medications that are part of the pilot have been selected? Herranz clarifies that it has been "at the proposal of the industry, and from the hospital pharmacy it has been required to include medications that we consider priorities, to have their traceability."
The pilot includes more than 40 presentations (Nolotil 575 mg hard capsules is pending confirmation), "but in hospitals there are 4,000 references. Yes it is true that we use the prospect and do not make any sense. We are very better the barcode In each vial. "
What is happening in the rest of Europe? "EMA and heads of national medicine agencies are working on the development of an electronic information standard of semi-structured products. This will allow easier access through electronic resources to the prospectus and the technical sheet, and will allow the data to be exploited Included in both, "he said of the rich.
"80% of the documents of prospects and top technical chips are in semi-structured format"
This tool in which Europe works will be able, according to the rich, of transforming all prospects that are currently authorized, regardless of their format (PDF, HTML, XML), in a common electronic language, which is interoperable between systems of prescription with product information, both for health professionals and patients.
Spain is not bad stop, since "thanks to the good practice of the Spanish pharmaceutical industry, 80% of the documents of prospects and technical chips currently published at the top are in that semi-structured format". Yes, it points out that "there is a lack of an adjustment to be compatible with the European format in which it is being worked. But it is important and we go ahead. This will make it easier for the AEMP to develop projects that are related to artificial intelligence, thanks to That possibility of exploiting data ".
The pilot project focuses on hospital drugs, they have already started other countries such as Belgium and Luxembourg, as indicated by rich. But, to be extended to more medications, what would happen to elderly patients not accustomed to the use of new technologies? Given this question, the possibility that in the pharmacy offices could be printed on paper prospects in the pharmacy offices. However, there is still a need to reach the general population: "It will involve a cultural change. We are still far from that reflection," says Herranz.
For its part, Carina Escobar, president of the Patient Organizations (POP) platform, points out that the presentations that A priori are included in the pilot are medications used in the hospital when the patient is admitted or managed in a hospital by day: "Normally we do not see these prospects. What is good, and we always ask, is that they give us information. To me, when I go to the day hospital to get a medication, I would like to have a chip of what They are putting me, with a report on possible interactions and medications with which I should be careful. " Escobar points out that we must advance that the information is more accessible "and the patients can understand, especially when we are sick, which costs us more."
In this regard, Herranz comments that "there are more and more pharmaceuticals in day hospitals and try to alleviate and cover this need; for example, so that intravenous chemotherapy with oral medicines is complementinated in our hospital. day there are two pharmacists for them working full time and we try to make a much more understandable information. But of course, normally medication to day hospitals is ready for use, in doses individualized by patient, and that does not have prospect. But there is Many initiatives to improve the information received by patients. "
Date Of Update: 08 December 2021, 07:58
