Pediatricians in the absence of amoxicillin: "We have prescribed other pharmaceutical forms, such as sachets instead of syrups"

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This Friday we celebrate the European Day for the Prudent Use of Antibiotics with the confirmation of

which has been affecting doctors, pharmacists and patients throughout Spain for about two weeks.

, by preferably using presentations in syrup and in sachets.

The Spanish Agency for Medicines and Health Products (Aemps) has admitted to this newspaper the existence of

to 15 of the 124 commercialized presentations

.

The cause?

Verbatim, Aemps explains that

.

The coincidence of production problems in the two laboratories with the greatest presence in the market has a domino effect in the rest".

What do some of the laboratories involved think?

Sandoz, with problems in six presentations, acknowledges its difficulties to this medium:

, located in Europe,

due to an unprecedented combination of challenges: sharp swings in demand, manufacturing capacity constraints, raw material shortages and the energy crisis."

In this sense, they add that

, and our goal is to maximize production, not reduce it, to meet growing patient demand and optimize our unit production costs.

We continue to work to resolve these supply difficulties in some of the presentations of these antibiotics, in close collaboration with the health authorities."

And how do pediatricians act in the face of shortages?

pediatricians like

, member of the Medicines Committee of the Spanish Association of Pediatrics (

AEP

), trust that the problem will be solved in the next few days.

"In the meantime, we have prescribed other pharmaceutical forms, such as sachets instead of syrups. But,

Although this is not ideal,

.

In fact, he points out that two weeks ago it was very common for patients to return for a new prescription, "but now it is not so frequent and it should not generate any social alarm."

Piñeiro Pérez gives some examples:

, because it is a bacterial fanringitis". And he points out that, in the case of amoxicillin, the supply of 120-millilitre syrup is being prioritized.

Even with everything, shortages of amoxicillin are not common, as pediatricians confirm:

because viruses are not treated with antibiotics." However,

: "For example, as there are more viral infections, there may be more bacterial superinfections, such as otitis, but antibiotics

.

From my point of view, it has been more of a punctual shortage not linked to an increase in prescriptions."

Likewise, the pediatrician

Vice President of the Spanish Association of Primary Care Pediatrics (

aepap

), who practices in the Basque Country, is also experiencing the problem on the front line.

and refers to a

with "unknown date" of completion of problems in amoxicillin.

Gorrotzategui explains that he has been changing the prescription to amoxicillin clavulonica, "but he is also having supply problems. We give the prescription to the patient and we tell him that if they cannot find it in the pharmacy, tell us and we will change it.

It is the most widely used drug for otitis media and tonsillitis.

.

Regarding the impact on pharmacies, Gorrotzategui admits that he knows parents who have had to visit up to five pharmacies.

What do you think of the General Council of Pharmacists?

Antonio Blanes Jimenez

, director of Technical Services, clarifies that

, because that would mean a change in prescription.

.

But,

.

Blanes explains that the fundamental problem is that

: "We have spoken at the distribution level.

, but the situation is beginning to become tense, with more incidents and in some pharmacies it is difficult to find it.

But the channel is prepared to withstand these tensions, although not to infinity". In fact, distribution sources explain to this medium that these are specific problems.

Ask to be

: "Sure, the alternatives are less selective, but

For example, to treat tonsillitis in allergy sufferers we can prescribe azithromycin, which is what we can sometimes prescribe as secondary intention.

According to each process, we are seeing what second-choice antibiotic we can give."

In these situations,

, of the Council, to which more than 5,000 pharmacies are attached and which helps to find the medicine: "It exists for situations like this.

".

He does comment that there are still stocks of amoxicillin combined with clavulonic acid, and

.

"We also have Cismed, and we are in contact with Aemps, with whom we have already discussed this issue."

Yes, he believes that, in these cases,

, as it finally did this afternoon, and "as it did recently with antidiabetics, which also began with supply problems. In the end, it is about regularizing this situation for prescribers, dispensers, and patients."

Recommendations of the Spanish Medicines Agency

So much so that this Friday afternoon

, in which

, as an extraordinary measure while the supply problem with amoxicillin oral suspensions persists,

the dispensing of an oral suspension of amoxicillin 250 mg in vial by amoxicillin Normon 250 mg powder for oral suspension in EFG sachets, 30 sachets (registration no.: 62786, national code: 700273)".

all this,

.

For this reason, the Aemps has enabled a procedure with the General Directorate of Common Portfolio of Services of the National Health and Pharmacy System of the Ministry of Health so that, if necessary, due to the absence of the prescribed medicine, the pharmacist can carry out these actions.

Not only that, but it also allows you to divide 500 mg scored tablets,

, which can be dissolved or disintegrated in water.

And it clarifies that "the suspension should be reserved for those patients in whom the dose adjustment requires doses that cannot be obtained with the fractionation of 500mg tablets, such as patients under 6 months of age."

Although it specifies that the technical sheet does not contemplate using this administration modality, since it indicates that

but it does not ensure the division into equal doses", he considers that "it is the most accessible option considering the existing supply problem".

A) Yes,

, It allows

:

-Amoxicillin Normon 500 mg tablets EFG

, 20 tablets (registration number: 64388, national code: 694726).

-Amoxicillin Almus 500 mg dispersible tablets EFG

, (Registration number: 81389, national code: 713505)

-Amoxicillin Ardine 500 mg tablets EFG

, (Registration number: 53623, national code: 694743).

Faced with this situation, the

amemps

just posted some

although he expects the situation to be normalized by the end of the week of November 21.

Thus, he explains that "in order to cover a greater demand,

.

In this way, units of amoxicillin Normon 250 mg/5 ml powder for oral suspension EFG 1 vial of 120 ml are being released continuously and the supply is expected to return to normal by the end of next week.

By prioritizing this presentation, the reinstatement of the 40 ml presentation (estimated for January 2023) will be delayed."

In turn, Aemps reports that "Sandoz Farmacéutica, SA has reported that it has also resolved its problems with amoxicillin Sandoz 250 mg/5 ml powder for oral suspension EFG 1 bottle 120 ml and its supply will be restored at the end of November" .

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