Abuse of antibiotics, use of useless drugs: in children the risk of side effects and adverse reactions is around the corner. “This is what pediatric pharmacovigilance deals with, which from birth to 16 years has a rather delicate area of intervention because clinical trials often do not involve children – or in any case are not represented in adequate numbers – and this can lead to the administration of small drugs used in adults, with the empirical method of reducing the dose “. Thus the pediatrician Michele Gangemi, editor of the ‘Drugs and children’ column on the pharmacovigilanza.eu portal of the Regional Pharmacovigilance Center of the Veneto Region, in an interview with ‘Allies for Health’, a portal dedicated to medical-scientific information created by Novartis. “The dosage of drugs – explains Gangemi – should be at least linked to weight, compared to the age group alone, because in children the pharmacokinetics”, that is the speed of absorption and distribution of the drug to give the therapeutic effect, “is different compared to the adult and adverse reactions may have different frequency and characteristics, based on age “. Antibiotics, for example, “which are the most used drugs in healthy children with relapsing respiratory infections – underlines the pediatrician – are often administered in oral suspension and the drug must be diluted according to prescription. Here the pediatrician, in dialogue with the parents, should do not assume that the dilution of the powder takes place in the correct way and also provide indications for its conservation, especially in the summer season, when the temperature rises. It is therefore important that you pay attention not only to the dosage and storage of the drug, but also remember that some antibiotics can give photosensitivity “, ie dermatitis triggered by exposure to sunlight,” so make sure that the child avoids being in the sun when taking certain drugs. Another example is aerosol therapy which “is often used badly and with a cosmetic effect – he continues – For asthma it is important that it is done with adequate drugs, at the right dosage and with the collaboration of the child: if it does not cooperate, the feasibility of therapy suffers. It is necessary to understand if the child aerosols, knows how to inhale and, if not, evaluate alternative therapies. We cannot assume that the child knows how to aerosol or accept that he does it while he sleeps, as they sometimes report the parents, because the active part of the child is missing and consequently the effectiveness of the treatment is reduced “. In addition to the concentration, storage and method of administration, the schedules of therapy are also important. “In the case of the antibiotic to be taken every 8 hours – recommends Gangemi – it is advisable for the pediatrician to check with the parent if times such as 7, 15 and 22 are compatible with those of the child, that he is awake. In case it is necessary to adapt the therapy at the times, an adequate compromise must be considered and the 8 hours must not become 5-6, and ensure that the pharmacokinetics of the drug that must reach the target organs are not altered effectively and with the lowest possible risk of adverse reactions “. All this information – the article reads – is present in the package leaflets, which should be read by parents, although the way they are written can make it difficult to consult and interpret. “Attempts have been made to make them simpler, they can be improved – reflects the pediatrician – In general, collaboration between pediatric scientific societies, regulatory authorities and pharmaceutical companies is needed, because adults too often struggle to read all the information that is very detailed for legal issues, while they are particularly complex to interpret, especially if you think of an upset parent who has to start therapy for his baby “. In the absence of leaflets of simpler interpretation, “the relational communicative aspect between pediatrician and parent is particularly important”, highlights Gangemi. As the pediatrician recalls, in fact, “drugs, after authorization for use in adults, undergo ad hoc trials for age groups. This is difficult to do in children, because it is normal for a parent to be perplexed at the request to enroll the infant and healthy child in a clinical trial. On the one hand, the scientific community requires ad hoc experiments, but on the other hand, being complex to carry out them in some pediatric age groups, we risk not having drugs tested for some clinical conditions. In the absence of a therapeutic alternative “, therefore,” if there is reasonable evidence, it is possible to resort to off-label use, ie off-label use or indications given by the pharmaceutical company, approved for the use of the drug. very delicate use not only for medical legal aspects, but also for the question of information for parents, who must know why this choice is made “. A good relationship between pediatrician and parent also helps in the best therapeutic choice and avoids exposure of the child to unnecessary adverse effects. “The first rule of pharmacovigilance is not to give unnecessary drugs – concludes Gangemi – With very few drugs the pediatrician can cure most of the children. Sometimes the parent thinks that by giving the antibiotic the child can heal sooner, but in reality two thirds of the infections respiratory diseases are given by viruses, not by bacteria. Therefore, the antibiotic is often improperly administered, without any therapeutic advantage, but with the risk of adverse reactions and drug resistance “. The complete article is available on: https://www.alleatiperlasalute.it/alla-scoperta-di/la-farmacovigilanza-pediatria.
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