Permission for widespread use of a drug is issued on the basis of reliable data on the efficacy and safety of the drug obtained in the course of preclinical and clinical studies, the result of which is the registration of the drug. Today, the laws of all countries oblige pharmaceutical companies to conduct multi-stage clinical trials of their drugs before these drugs become widely available. Below, the case of off-label medicines that can be prescribed for children will be discussed.
The scientific and practical significance of clinical trials is beyond doubt in the medical community. Methodological and ethical aspects of planning and conducting clinical trials are developed, available, and followed by conscientious researchers. However, adherence to evidence-based medical practice is, in most cases, beyond the reach of the pediatrician. The frequency of prescribing off-label drugs to children varies in different countries in a wide range. Pediatricians are still often forced to use drugs efficacy and safety of which have been assessed in adult studies, while the course of many diseases in an adult and a child can be strikingly different (Gordon, 2019). The main problems related to the lack of appropriate information on the pediatric population are the insufficient number of clinical trials involving children, which limits data on the efficiency of treatment.
Here, it seems reasonable to empathize that there are specific conditions under which children should be prescribed drugs for off-label use. The crucial circumstance can be shown through a particular example of asthma – a disease that is treated with the help of albuterol (an off-label drug for children). This is supported by the following statement, “Although commonly used in infants and toddlers, albuterol is only FDA-approved for use in children over 2 years old” (Iannelli, 2020, para. 5). Then, Iannelli (2020) continues, “In the case of these asthma medications, … these medicines have been used so much, they are thought to be safe and studies have shown that they work” (para. 6). Alternatives that cannot deal with asthma symptoms of a child should not be accepted and applied in practice.
Attainments within the scope of the treatment of children today cannot be achieved without large controlled clinical trials, in which it is crucial to evaluate the effectiveness of medications. The expansion of indications and age ranges, the study of new dosage regimens, and routes of drug administration in children from infancy to adolescence should be considered as one of the priority areas of activity of pharmaceutical companies. For pharmaceutical associations, an important condition for conducting clinical trials with pediatric patients is their ability to ensure that these trials are carried out in strict accordance with internationally accepted requirements (Gordon, 2019).
It is also necessary to improve the system of national pharmacovigilance in the field of control of off-label prescriptions. Healthcare practitioners can make a significant contribution to solving this problem by informing health officials in a timely manner about the issues associated with prescribing off-label drugs in childhood.
Moreover, off-label drugs that are used to treat psychological disorders require extra care and attention. In particular, Lexapro is an antidepressant selective serotonin reuptake inhibitor with a high affinity for the primary active center that is used to cure depression (“Lexapro,” n.d.). Then, Luvox is used to deal with OCD; its mechanisms may be considered as the specific inhibition of the reuptakes of serotonin by neurons (“Luvox,” n.d.).
To conclude, the essentials of off-label drugs were discussed, appealing to evidence-based sources. Particular circumstances under which children can be prescribed these drugs were identified, as well as the related examples given. Finally, strategies of how to make the off-label use and dosage of drugs safer for children were provided.
References
Gordon, S. (2019). Kids often prescribed drugs ‘Off-Label,’ raising concerns. WebMD. Web.
Iannelli, V. (2020). Off-label prescribing in pediatrics. Very Well Health. Web.
Lexapro. (n.d.). WebMD. Web.
Luvox. (n.d.). RxList. Web.