Goodbye to paper drug leaflets

The Spanish Agency for Medicines and Health Products (Aemps) has promoted a

on access to electronic information on medicines in the hospital setting

and suppression of the paper leaflet.

, and its objective is to evaluate the impact on a small group of drugs in the hospital setting. Specifically,

-among which are

, from more than 20 laboratories,

.

In fact, the project also involves the Spanish Society of Hospital Pharmacy (SEFH), in coordination with the Hospital committee of the General Council of Official Associations of Pharmacists, and a series of pharmaceutical companies, mostly integrated in the Pharmaindustry and the Spanish Association of Generic Drugs (Aeseg).

In view of the results, the duration or number of drugs involved in the

pilot

The planned duration of the

project

, with an assessment carried out each year through a satisfaction questionnaire completed by the pharmacy services of the hospitals.

In view of the results,

project may be extended

, if so agreed by the parties involved;

these results will be published for general knowledge.

The aim is to

, in order to guide

, especially taking into account the advancement of new technologies and their implementation in the pharmaceutical sector.

The information, by Datamatrix code

To consult the information on the medicines that are part of this

project

,

Information Center for

Authorized Medicines (CIMA), through a

that will appear in the primary packaging of containers.

Ana López de la Rica, associate director of the Technical Department of Farmaindustria

, advanced this project in the seventeenth seminar organized by the employers of the innovative industry with the media on November 10.

"

. Another is that we will always have in real time the information on the prospectus and the authorized and updated technical sheet," he explained.

All this will be possible, as he commented, thanks to

: "In addition, the supply chain will be more flexible and regulators will reduce the bureaucratic burden they have when updating documents (Word, PDF ...) of technical sheets and prospectuses" .

Avoid relabels

Ana Herranz, national member of hospital pharmacy in the General Council of COF

and head of the hospital pharmacy section at the Gregorio Marañón General University Hospital, maintains to this media that this project has a double objective: "On the one hand, to eliminate the leaflet, which the industry is delighted for its processes, as well as being more sustainable, and we,

, especially those of high risk that we use in traceability systems ", he points out.

In addition, in line with what Aemps commented in its statement, Herranz explains that "in hospitals, when we need to search for information on a drug, we connect to the CIMA. Then,

and, in addition,

.

How have the drugs that are part of the

been selected

Herranz clarifies that it has been "at the proposal of the industry, and the hospital pharmacy has required the inclusion of drugs that we consider to be a priority, in order to have their traceability".

E

includes over 40 presentations (

575 mg hard capsules are confirmed), "but hospitals have 4,000 references.

It is much better code bars in each vial. "

Situation in Europe

What is happening in the rest of Europe?

"

The EMA and the heads of the national drug agencies are working on the

. 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, "said De La Rica.

"80% of CIMA's prospectus and technical sheets documents are in a semi-structured format"

This tool in which Europe works will be able, according to De La Rica, to

which is interoperable between the systems. prescription with product information, both for healthcare professionals and patients.

Spain is not in a bad position

, since "thanks to the good work of the Spanish pharmaceutical industry,

Of course, he points out that "there is a need for an adjustment to be compatible with the European format in which we are working. But it is important and we are ahead.

, thanks to that possibility of exploiting data. "

What patients think

The

project

focuses on hospital drugs, as other countries such as Belgium and Luxembourg have already started, according to De la Rica. But, if it were extended to more drugs,

Faced with this question, De La Rica considers the

. However, it is still necessary to reach the general population: "It will imply a cultural change. We are still very far from that reflection," says Herranz.

For her part,

), points out to this medium that the presentations that

are included in the

are medicines used in the hospital when the patient is admitted or administered in a hospital during the day: "Normally we do not see these prospects.

. When I go to the day hospital to take a medication, I would like to have a file of what they are putting me, with a report on possible interactions and medications with which I should be careful ".

"and we patients can understand it, especially when we are sick, that it costs us more."

In this regard, Herranz comments that

; for example, so that intravenous chemotherapy is supplemented with oral drugs in day hospitals. In our hospital in day there are two pharmacists working

and we try to make a much more understandable information. But of course,

. But there is many initiatives to improve the information that patients receive. "

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