– In Spain the compassionate use and off-label prescription, are both regulated in the same law: ... more – In Spain the compassionate use and off-label prescription, are both regulated in the same law: the Royal Decree 1015/2009. This norm facilitates the access to drugs in specific clinical situations, similar to US regulation and in a different way to the UE regulation.– It is a legal practice to prescribe in an off-label manner if the following requirements are followed: there are no authorized therapeutic alternatives, prescribed in health centers, when access to these drugs is provided through a protocol of use after justifying (written) and properly informing (verbal) and obtaining the patient's consent.– When prescribing off-label the doctor's decision is based on contrasted scientific evidence (not merely on personal intuition nor personal experience). In fact, this anticipates an eventual update of the data sheet for new indications or populations, unlike the French situation where they have the ATU (Temporary Utilization Authorization).– In Spain the holder of the Marketing Authorization is obliged not to promote or advertise the use of the drug in different conditions to those approved (unlike the USA regulation).– The jurisprudential analysis from the Spanish Courts states that the doctor's responsibility is equal than that concerning on-label prescription, that is, only in the case of bad medical praxis (as in the USA). The most important cause of sentencing were: the lack of informed consent, lack of control of the medication and lack of correct follow-up of the illness, whereas this does not include the drug, dose, duration or even the patient's age.– In European Union the general rule dictated by the Courts is to permit off-label use if this is according to the best medical practice (lex artis ad hoc). Even more, there are some specific cases (in Germany, like in the USA) where it is possible to generate doctor's responsibility for no prescribing in a off-label manner.
Bilirubin, biliverdin and their serum albumin complexes were tested as oxyradical scavengers (sup... more Bilirubin, biliverdin and their serum albumin complexes were tested as oxyradical scavengers (superoxide generated by the xanthine/xanthine oxidase system and peroxyl radical-trapping antioxidant ability). As superoxide scavengers the free bile pigments showed activities near to that of serum albumin, higher than the water soluble vitamin E analog Trolox and lower than ascorbic acid. The peroxyl radical-trapping antioxidant abilities of the tested bile pigments were much higher than those of the serum albumin and of the same order as their serum albumin complexes. This interaction with peroxyl radicals showed different stoichiometric factors for bilirubin (approximately 2) and biliverdin (approximately 4).
Childhood is characterized by continuous growth and development during which the organs and syste... more Childhood is characterized by continuous growth and development during which the organs and systems gradually mature. Because drug pharmacokinetics and pharmacodynamics in children differ from those in adults, pediatric patients are highly susceptible to adverse drug reactions. Surprisingly, very few studies have been designed to study the efficacy and safety of drugs in this population and consequently dosage regimens are based on the assumption that children are small adults. We present a detailed review of these controversial aspects and propose the establishment of a multicenter, multidisciplinary network to monitor drug-induced liver disease in children. This project represents the integration of an epidemiological approach into routine clinical care. A protocol agreed by consensus for the collection of data on cases of hepatotoxicity with uniform and internationally accepted criteria for causality assessment and the classification of drug-induced liver injuries is proposed.
– In Spain the compassionate use and off-label prescription, are both regulated in the same law: ... more – In Spain the compassionate use and off-label prescription, are both regulated in the same law: the Royal Decree 1015/2009. This norm facilitates the access to drugs in specific clinical situations, similar to US regulation and in a different way to the UE regulation.– It is a legal practice to prescribe in an off-label manner if the following requirements are followed: there are no authorized therapeutic alternatives, prescribed in health centers, when access to these drugs is provided through a protocol of use after justifying (written) and properly informing (verbal) and obtaining the patient's consent.– When prescribing off-label the doctor's decision is based on contrasted scientific evidence (not merely on personal intuition nor personal experience). In fact, this anticipates an eventual update of the data sheet for new indications or populations, unlike the French situation where they have the ATU (Temporary Utilization Authorization).– In Spain the holder of the Marketing Authorization is obliged not to promote or advertise the use of the drug in different conditions to those approved (unlike the USA regulation).– The jurisprudential analysis from the Spanish Courts states that the doctor's responsibility is equal than that concerning on-label prescription, that is, only in the case of bad medical praxis (as in the USA). The most important cause of sentencing were: the lack of informed consent, lack of control of the medication and lack of correct follow-up of the illness, whereas this does not include the drug, dose, duration or even the patient's age.– In European Union the general rule dictated by the Courts is to permit off-label use if this is according to the best medical practice (lex artis ad hoc). Even more, there are some specific cases (in Germany, like in the USA) where it is possible to generate doctor's responsibility for no prescribing in a off-label manner.
Bilirubin, biliverdin and their serum albumin complexes were tested as oxyradical scavengers (sup... more Bilirubin, biliverdin and their serum albumin complexes were tested as oxyradical scavengers (superoxide generated by the xanthine/xanthine oxidase system and peroxyl radical-trapping antioxidant ability). As superoxide scavengers the free bile pigments showed activities near to that of serum albumin, higher than the water soluble vitamin E analog Trolox and lower than ascorbic acid. The peroxyl radical-trapping antioxidant abilities of the tested bile pigments were much higher than those of the serum albumin and of the same order as their serum albumin complexes. This interaction with peroxyl radicals showed different stoichiometric factors for bilirubin (approximately 2) and biliverdin (approximately 4).
Childhood is characterized by continuous growth and development during which the organs and syste... more Childhood is characterized by continuous growth and development during which the organs and systems gradually mature. Because drug pharmacokinetics and pharmacodynamics in children differ from those in adults, pediatric patients are highly susceptible to adverse drug reactions. Surprisingly, very few studies have been designed to study the efficacy and safety of drugs in this population and consequently dosage regimens are based on the assumption that children are small adults. We present a detailed review of these controversial aspects and propose the establishment of a multicenter, multidisciplinary network to monitor drug-induced liver disease in children. This project represents the integration of an epidemiological approach into routine clinical care. A protocol agreed by consensus for the collection of data on cases of hepatotoxicity with uniform and internationally accepted criteria for causality assessment and the classification of drug-induced liver injuries is proposed.
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Papers by Maria Peire