The use of off-label drugs in children has gained substantial group over the past few years. While the use of these drugs does not necessarily occur as an illegal or unapproved method, there are issues in regard to the utilization of these drugs in this pediatric group since most of these off-label drugs have not undergone clinical trials to investigate the specific reactions within the pediatric group (Bazzano et al., 2009). These drugs are available within many outlets and this includes pharmaceutical outlets, privately-owned clinics and even within non-governmental healthcare facilities (Mayhew, 2009). The use of these drugs comes as a result of the avoidance of the normal healthcare procedures such as full diagnosis, testing and screening for the mild cases of illnesses in children. Systemic drugs such as antibiotics, analgesics and respiratory ailments have all been associated with the mild illnesses and with their assured healing effect and minimal contraindications they have over time gained popularity for this group (Morales-Carpi et al., 2010).
In response to the increasing use of off-label drugs in pediatric populations and the knowledge that most of these drugs have not undergone any specific clinical trials targeting children, the regulatory agencies in the pharmaceutical instructions have to come up with measures that call for the labeling of such drugs and the description in regard to their use in children (Bazzano et al., 2009). These measures include the provision of economic incentives for pharmaceutical bodies that agree to the labeling of drugs in regard to patent protection. Further, these regulatory bodies have to call out on research bodies to facilitate clinical trials in pediatric groups for those drugs in a safe and ethically appropriate manner. This will help determine the effects and indications of those drugs on children rather than basing their prescription on the idea that children are small adults with aspects such dosage minimization based on weight. For all those drugs that do not adhere to the pediatric clinical trials, the regulatory agencies have to gradually eliminate them in the market and reduce their usage across this group (Mukattash, Hawwa, Trew & McElnay, 2011).
Some of the drugs available in the market and that have significantly been used in the pediatric population include paracetamol whose prescription in children is based on weight/age estimates. These are mostly used in premature infants. Secondly, the use of diclofenac as a cure for abdominal pains is based on the monitoring and prediction of indications without any clinical or research evidence to support the same (Kimland & Odlind, 2012). Similarly, the administration of morphine in the absence of pediatric specialists is a sure case of the disregard for the safety and ethical guidelines. Further, the intravenous administration of adrenaline still has found its way and to an almost conventional status despite the lacking evidence to assure that this method of administration is safe in children (Mukattash, Hawwa, Trew & McElnay, 2011).
References
Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81–88.
Kimland, E., & Odlind, V. (2012). Off‐Label Drug Use in Pediatric Patients.Clinical Pharmacology & Therapeutics, 91(5), 796-801.
Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123.
Morales-Carpi, C., Estañ, L., Rubio, E., Lurbe, E., & Morales-Olivas, F. J. (2010). Drug utilization and off-label drug use among Spanish emergency room paediatric patients. European journal of clinical pharmacology, 66(3), 315-320.
Mukattash, T., Hawwa, A. F., Trew, K., & McElnay, J. C. (2011). Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials. European journal of clinical pharmacology, 67(5), 449-461.
