da few months some drugs have become unobtainable: L’AIFA (the Italian Medicines Agency) reports that they are 3,200 those lacking in Italy. Almost half are missing because they are no longer on the market and another 400 will be withdrawn in the coming months. “Obviously, the shortage of medicines is not only due to commercial reasons. The Aifa dataset identifies 750 medicines that are difficult to find due to production problems, 168 due to the high demand for them from doctors and patients and 77 for a combination of these two reasons”, declares Aifa.
But what effect does this situation have on the people who use it on a daily basis and who perhaps have an absolute need for it, as in the case of chronic respiratory problems? We talked about it with Simon Barbagliapresident of theNational Association of Patients Let’s Breathe Togetherfounded in 2014 with the faith in the possibility of collaboration between public and private institutions and organizations, as well as the many regional realities
and national voluntary organizations that deal with patients with respiratory diseases.
Missing drugs and respiratory pathologies
«It is a pity that one does not take into account that for respiratory pathologies, the drug is dispensed by a device and the patient has been educated to use that type of device to manage and control the typical symptoms of the disease. For example, two of the most used drugs, Fluimicil 500 and Foster, represent the most significant shortage, and there are thousands of children and adults who suffer from asthma and cannot find their drug. The health minister Schillaci in January 2023 it announced a table to check the deficiencies, but as far as we know there have not yet been any significant results perceived by the patient», explains Simona Barbaglia of Respiriamo Insieme.
“By changing the drug and therefore the device, there is a high risk that the patient does not perform the therapy correctly because he does not know or does not know how to use the device that delivers it”, adds Barbaglia.
What are the consequences for patients with respiratory disorders?
«Adherence to inhalation therapy, a therapeutic cornerstone in respiratory diseases, is among the lowest in chronic diseases and is further lowered in these situations of inadequately managed changes, with dramatic relapses negative in terms of therapeutic efficacy same and in economic terms for non-use or misuse of medications.
Unlike all other pharmacological therapeutic aids, the effectiveness of inhalation therapy may be null if the inhalation maneuver performed to assume the therapy is not correct. Furthermore, the inhalation technique is different according to the type of formulation (powder or spray) and according to the type of inhaler (there are different types and technologies and they are not equivalent)», explains Simona Barbaglia.
How many requests for help have you received?
On the internal chat of the members of Respiriamo Insieme we read several requests for help to find the medicines that are in shortage. And so the chain of solidarity among the members starts, that you make willing to ship an essential drug to other members to avoid relapses. «Since the end of November 2022 and ever more severely, we have been experiencing difficulties from our members in finding the drugs used to manage diseases such as asthma and COPD. We have received over 34 requests from members in relation above all to four drugs distributed across several regions, including virtuous regions such as Lombardy and Tuscany.
What happens if you change a drug
Even when drugs are replaceable, the impact that the modification of the therapy of the individual treatment plan can have is underestimated on therapeutic adherence of the individual or of an entire category of patients. Adherence to inhalation therapy, a therapeutic cornerstone in respiratory diseases, is among the lowest in chronic diseases and is further reduced in these situations of inadequately managed modifications with dramatically negative repercussions in terms of the effectiveness of the therapies themselves and in economic terms due to failure use or misuse of drugs. In fact, by modifying the drug and therefore the device there is a high risk the patient does not adequately perform the therapy because he doesn’t know, he doesn’t know how to use the device that delivers the drug.
In fact, it is necessary to point out that, unlike all other pharmacological therapeutic aids, theefficacy of the inhalation therapy may be null if the inhalation maneuver performed to assume the therapy is not correct and that the inhalation technique is different according to the type of formulation (powder or spray) and according to the type of inhaler (there are different types and technologies and they are not equivalent).
Drug Shortages: What Can Be Done?
«Already on 22.10.2022 and then again on 11.11.2022 our Association wrote to the CTS of AIFA signaling the criticality of inhaled drugs for patients with chronic respiratory disease with a view to collaborative participation, highlighting our serious concern for these many patients.
Already at the end of 2022 we had highlighted the data of one our internal survey, to which around 400 subscribers respondedwhich beyond the 40% of patients had taken over in the last year a increase in the difficulty of managing their pathology and the 21% said they had not accessed/withdrawn from therapy due to these difficulties.
Close-up of girl using asthma inhaler at home. Little girl is suffering from health issues. She is looking away while taking dose.
In order to be adherent to the treatments, the patient must necessarily, correctly and promptly be informed and educated about the change that will await him and guided and accompanied in the necessary familiarity to acquire with different solutions and devices that may be offered to him by the doctor or pharmacist.
This fundamental activity to improve the management of the therapy of chronic respiratory patients is still not sufficiently exercised with chronic respiratory patients, for many reasons, neither by the GP nor by the hospital or territorial specialist and therefore the modification of the drug due to difficulty in obtaining the itself, only strongly exposes to the loss of compliance in the therapy», explains Barbaglia.
As an association, what can you do to help patients find alternatives?
«Given the reports of drug shortages received, as an association we necessarily had to act as one “finding and sorting operations center” of medicines to try to guarantee the therapeutic continuity of all our members. If one or more patients reported or report a shortage of a specific drug in a Region, through our members whatsapp groups we try to find the drug through partners in other regions who put us in contact with the pharmacies that have it, we buy it and then we have it delivered to patients in cities where it is not available. Obviously this is one buffer solution but it cannot be the answer to the problem», explains Simona Barbaglia.
The appeal of the Association Breathe Together
“In light of this critical situation, we ask AIFA and the table set up at the ministry on the proposal of the Minister of Health Orazio Schillaci, want to include i representatives of patient associations who every day deal side by side with the difficulties they encounter in managing the disease, considering them a resource for hypothesizing and co-constructing solutions, strategies and services capable of identifying and responding adequately, in individual regions or at a national level, to the needs of care for people with chronic respiratory disease or rare lung disease”, concludes the President Simona Barbaglia.
Breathe Together Association, to protect those with asthma (and others)
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