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Medicines for children: half have no indication

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More than half of pediatric drug prescriptions are off-label, i.e. more than once in two, exactly in 54% of cases, in the world, drugs are prescribed to children outside of the indications recognized by the agencies: this is molecules used either at different ages, or for different pathologies, or even with other doses and routes of administration than those for which they are registered. In Italy the percentages of off-label prescriptions vary: in pediatricians’ clinics they range from 11 to 37%, from 16 to 62% in general pediatric wards, in pediatric and neonatological intensive care units they exceed 80%.

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The numbers tell us that we are talking about an extended phenomenon, therefore. And transversal: the off label concerns every branch of pediatrics and many pharmacological types. They range from everyday medications prescribed by the family pediatrician, for example broncodilatatori per aerosol, which we all know and use without harm for our children for years, are there antinausea for gastroenteritis, medicines for the headache prophylaxis of teenagers. And then there are cardiological and biological drugs such as monoclonal antibodies. Oncohematological, and treatments for palliative care, ie medicines necessary for those who cannot recover but need specific care to keep the quality of life as high as possible.

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Off-label employment in paediatrics is one of the issues addressed at the recent congress of the SIP, the Italian Society of Pediatrics. “The use of the drug outside the indications of use recognized by the agencies is transversal to all areas of pediatrics and widespread everywhere”, confirms Francesca Rusalen, medical director of the Veneto Regional Center for Pediatric Palliative Care, Padua University Hospital and member of the pediatric pharmacology study group of the Sip. “And – he explains – it is linked to the fact that clinical studies dedicated to drugs are absolutely insufficient in the pediatric field. And this for several reasons “.

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The reasons for a few trials

Here are the reasons: why is there little pharmacological research done in children? “Children tend to be a healthy population, and large numbers of patients are needed to set up clinical trials. And children are also a heterogeneous population with highly variable pathologies, let us remember that infants, adolescents and young adults are included in the pediatric range. These two factors in themselves complicate setting up targeted trials, ”says Rusalen.

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Another reason is ethical in nature: there is probably a kind of ethical reluctance to expose children to clinical trials and we tend to do it only in the most extreme situations, is that so? “Yes, there is also the ethical question, of course. But this is a prejudice – continues the pediatrician – clinical trials can be built in absolute safety not only without harming the child but rather protecting him, and at the same time obtaining information. Finally, there is the economic aspect, which is the strongest: the experimentation in pediatric pharmacology in the face of high costs guarantees limited economic returns, because children and young people are few, especially in Italy with an increasing denatality, and in general, as they also said healthy “.

A hot and little perceived topic

The use of off-label drugs in pediatrics and the lack of trials is therefore a hot topic, but also little perceived, probably precisely because it is daily and very widespread “And little perceived – confirms Rusalen – is the need to invest at both the universities and pharmaceutical companies in studies dedicated to the pediatric population. But implementing trials ensures better quality and safety of care. Every medicine has both desired and unwanted effects: we don’t know what the short and long term effects might be, for example. After a drug has been approved for the adult population it should be tested in the pediatric population. The knowledge that comes from targeted drug trials is a health and safety investment for future generations “.

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Security is guaranteed

Speaking of health and safety, what is the effect of off-label use of so many prescriptions? “It must be clear that everything that is implemented off-label is always implemented with the greatest possible protection of the little patient. Speaking of serious pathologies, and therefore of important drugs, the off-label prescription is intended for selected cases, when we do not have therapeutic alternatives available and in any case we always make use as much as possible of already available literature data: everyone, doctors and families, they are aware of the space in which one moves, and of the relationship between risk and benefit ”.

Law 648 of 1996

Law 648 1996 of 1996 allows the dispensing of a drug in an off-label manner at the expense of the National Health System after obtaining the favorable opinion of a technical-scientific commission. “The off labels being outside of a recognized use, in theory they would be borne by the family, unless solutions are found, as happens for the therapeutic plans of rare diseases for example and not only. But thanks to this law, the NHS can supply drugs with off-label use when there is no valid therapeutic alternative, or in the case of innovative drugs already used in other countries, or not yet authorized but undergoing clinical trials, or if it is a matter of of medicines already authorized for other diseases – explains Rusalen -. To include a drug in this path, it is necessary to activate practices: a request must be made by a prescribing center and documentation must be attached, also in terms of expenditure data. When a drug is included in this path it could be recognized for the indication to which the request and documentation referred. We are therefore talking about a channel to which more reference should be made ”. However? “But it is not an automatic channel, which is a positive thing, because the fact that it is not automatic guarantees a quality and a selection of the drugs that enter the process. However – concludes Rusalen – it is a demanding path, and it would be advisable to create working groups dedicated to favoring it, and perhaps even simplifying it could be useful ”.

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