Antibiotic prophylaxis: challenges for Italian patients

[Emanuela]
In Italy, penicillin injections represent the majority of prescription choices for rheumatic fever and oral penicillin is prescribed to a very less extent, and I think the main reason is that on one side, the adherence problem. And on the other side also that the intramuscular penicillin – we are in the country where incidence of rheumatic fever is high – the parenteral prophylaxis is better for this case.

In our country also, both the approved antibiotics, parenteral and oral, are not more available because production ceased many years ago for oral penicillin and some years ago for benzyl penicillins. So now we have import procedures to ensure therapeutic continuity.

Since 2020, “endocardite reumatica, corea e/o Pandas” Facebook group represent a permanent support for families facing major and minor difficulties related to the periodic injections. Now we have 150 Members in this group and 1/3 of them has had Sydenham’s Chorea condition.

The difficulties we face with the problem of antibiotic injections were collected last year in June in a survey we performed among the group for which we have 49 responders. And the main difficulties we saw were injection pain (98% at first injection) and pain management was not addressed at first injection, it was not managed for 43% of children.

And also there is the problem that families leave a clinical setting and choose a more expensive setting: private nurse at home, or the less safe home setting where they do injections on their own (73%).

These are the main problems.

After the survey, we make a request to our Italian health authority.  In our request we ask for access to formulation with anaesthetic because the importation procedures does not follow patient needs. Hospitals always buy a certain kind of formulation and if a patient has special needs he cannot access maybe an antibiotic with anaesthetic inside.

We ask also for a more sensible approach to this procedure, because we saw that sometimes nurses or the health professional who performs injections do not communicate or are not sensible [sensitive] enough towards the children.

We ask for distribution of the antibiotics through the district pharmacies and also for better communication and information for patients.

This request was made to the health medicine authorities, through the Scientific Paediatric Society, which is named SICUP.

In September, our request reached the authorities and we are awaiting an answer now.

We also specified in our request the right to avoid pain, fear, and stress, making reference to many papers from international health Organizations, here I report an abstract from the European Association for Children in Hospital (EACH).

We also go through literature to see how injection pain was analyzed, but we found only a few papers and so we cannot derive a firm conclusion from examination of these papers.

One of these papers was this Australian study [“Aboriginal Children and penicillin injections for rheumatic fever: how much of a problem is injection pain?”], which was interesting because it considers not only pain from the point of view of children, but also from the point of view of health professionals and which is a unique paper comprehensive of all the parts involved in the problem.

It is free, you can read freely.

Also, we look at the new papers about penicillin injection in rheumatic fever prophylaxis and we also found a recent paper from the American Heart Association who warn about a precaution for children who also had severe heart diseases and are malnourished or dehydrated or perform a long journey by foot to reach the ambulatory or clinical setting to perform these injections, because there was sign that in these cases there can be a risk of sudden death of the child and so oral prophylaxis in these cases should be considered.

We also looked at this for patients and parents, when they perform injections, and we saw these fact sheets from the Department of Health and Wellbeing the of the Government of South Australia, which I think is very useful because it gives information on what we can do to reduce pain and what we can ask, in the first part.

[“Don’t have the penicillin injection cold… take it out of the fridge 15 minutes before…  hold it in your hands to warm it up”]

[“Ask for the injection to be given very slowly, over 2-3 minutes”]

[“You can ask for an ice pack (wrapped in cloth) on the injection site” “EMLA cream” “cold spray” etc]

Then it gives advice for adherence in the second part.

It also gives advice on actions to do in the in the third part.

And also advice for parents and care givers at the end. So maybe we can also for our needs adapt this paper or perform a new one.

OK, another issue is side effects reporting, and only a few people know that also for this reason and procedural pain or reasons like that, adverse reporting can be performed.  As a patient there is the right to report on unwanted side effect of medicine directly to the authorities. So not only pharmacist and physician can do this kind of reporting but also citizens and patients, and also side effects can be reported on behalf of someone we care for and so maybe a parent or relative can report a side effects for a child.

And this is important if we see spontaneous reports for pain of intramuscular benzylpenicillin we find that they are only scarcely reported in Italy, but reporting is an instrument which contributes to make medicine use safer and highlights issues which should stimulate therapy improvements.

So it is to be considered to report side effects also for these issues. And I leave you also some videos to learn to learn more which are suitable for patients and families. One is of the European Medicine Agency and one is a patient association (Alliance for Patient Access).

So in conclusion, there is a need to detect, monitor and manage Italian young patient and families difficulties related to intramuscular penicillin.

The National Health institution should elaborate suitable therapeutic path including information involving patient and families.

Family paediatrician should be more involved in managing intramuscular related difficulties and patient and family should collaborate reporting side effects.

So I thank you for your attention and I especially I thank you, Marcella, Lucia and Davide and all the Italian cardite Chorea pandas, Facebook group and all the Sydenham’s chorea association trustees.

Thank you.

[Mike]

I mean, maybe it’s another question, but it seems to me the big question. Should we be giving intramuscular penicillin? Why don’t we use oral penicillin more for patients with Sydenham’s Chorea? What is your view?

[Emanuela]
I think the there is a problem with adherence, and for a physician it is quite hard to know if the child takes at home oral penicillin because it should be taken twice a day, and it’s not simple to verify that this is done. And then there is a maybe also a doubt, that oral penicillin works less well than parenteral penicillin. There are not many studies on this, but what we know is probably that it works better than oral and also we [Italy] are a country of “not at low incidence” of the disease. So also this matter can play a role in convincing a physician to prescribe the intramuscular.

We tried both with my daughter, it was not so easy, we have done three and half years with oral therapy, which was not so easy to be each time adherent but we did it.

And then we changed to parenteral because we had to travel [to get the medicine]- there was no availability of oral medicine – but we faced the problem with intermuscular. We first performed it with a nurse who was not trained and it was quite traumatic for our daughter. Then we changed, we switched to a trained nurse because we have a service where we live for palliative care, and we reached a nurse of this service and it could be better.

OK, but I think we need to work on it, on this pain from injection. And also what I see is that in Italy, family paediatricians are not enough involved because the injection is performed in hospital or in a care setting, not by the paediatrician.

And yes, there are many points which can be improved from involving family paediatricians more, to write advice for patients, to improve communication and also to have the possibility to try everything to avoid or at least limit pain. Maybe sometimes a child need also injection with anaesthetic, but if you have no possibility to receive it…

There are many families who go abroad and buy it themselves from international pharmacies. Also in England or in Switzerland they do so now. So there is some ways to escape from national system practice and join others.

And sometimes I I think, in my opinion, it is also dangerous when you do the injection yourself. I don’t know ,if something happens, then… What we should do?

[Nadine]
I think it’s a very interesting topic Emanuela and I know when we’ve discussed it in the past in the UK I think in children’s services we try to avoid injections at all costs, and I know when we spoke about blood tests for the Sydenhams Chorea study, that there’s a lot of controversy around that kind of invasive treatment. But actually what you explained was actually you were traveling a significant number of miles, to go over the border to get the tablets. So it wasn’t a case where we would write a prescription and you would go and get that tablet or that injection – you were having to actually go quite far to be able to source the tablets. So there was an element of the treatment being hindered if it wasn’t in injection form. Am I right in thinking that?

[Emanuela]
Yes, we would buy from abroad.

And with oral penicillin, we have a procedure to import the medicine from abroad. But when you start this procedure it is not straight away, it can go on [for some time]. So if you want to start the penicillin right away you have to go abroad to buy it for two or three months.

And then you can join the regular procedure and you get it every three months, the health institution gives you the tablets or the syrups but at the beginning you start by buying it abroad.

[Nadine]
OK, yeah, which is very different to here in the UK.

[Michael]
I think this question about treatment difference is really important and it seems very sad that children should have injections because people think they won’t take tablets. So there is the separate issue about efficacy and there may be different recommendations for different situations. But I hope that when [the Delphi process] comes to looking at this issue, there will be some way of wording recommendations to consider the best conditions for adherence.

I personally feel that the children we saw in Glasgow (and Callum’s described how he learned about it), the children understood, and the cardiologists were extremely robust, but also sympathetic, in explaining to the children why this was important – explaining to the children as well as the parents. And I don’t think we, certainly I didn’t, come across from the patients we followed up worries about adherence.

I think it was much more about how you set up the start of a long term prescription, so that it’s understood and continued, so it is perhaps important to separate out efficacy and adherence in this.

[Nadine]
And I think I would add to that, Michael, my experience within the Sick Kids Hospital working alongside paediatric psychology, as we had a lot of children receiving therapy for needle phobias, there were lots of children that when there was a need to use needles, that’s where the piece of work was, rather than around being able to take a tablet.