Off-Label Drug Use in Pediatrics

Review the Bazzano et al. and Mayhew articles in the Learning Resources. Reflect on situations in which children should be prescribed drugs for off-label use.

Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence.

Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.

Write an explanation of circumstances under which children should be prescribed drugs for off-label use. Then, describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.

Articles to review:

Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122123.

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), 8188.

Off-Label Drug Use in Pediatrics

 In many instances, patients are prescribed off-label drugs. These are drugs used in a manner that is  not specified by the Food and Drug Administration  act . These drugs therefore do not have an approved FDA label (Bazzano, Mangione-Smith, Schonlau, Suttorp & Brook, 2009). The label provides a report or detailed instructions on the approved uses and doses based on the clinical research studies. There is however various issues that pertain to use of these drugs that this paper delineates on.

Various situations exist where children requires to be given prescribed drugs for off-label use. One of the situations is when the prescription lacks pediatric dosing information as part of the dosage (Bazzano, et al., 2009). In this situation, the medical practitioner can use his/her own expert to prescribe these drugs. Some of these drugs may be effective in treatment and therefore, in such situations the medical practitioner is at liberty to use his or her own expert opinions. The other situation is where the drugs or the therapy has been approved as to be satisfying the controlled clinical trials. Some of these drugs may have been approved as meeting the threshold but may not be having a label. Medical practitioners have the right to use such drugs or therapies to treat children. Another situation is whereby the decision is made based on the rational scientific theory.

Strategies to make off label use and dosage of drugs safer for children from infancy to adolescence include, ensuring that the drugs are scientifically proven and approved by the approved bodies such as FDA. Ensure that experts such as pediatrician prescribe the drugs and ensure that the drugs and dosage is the right recommended by the authorization market (Mayhew, 2009).

Various sources of information exist from where these doctors can use to verify the effectiveness of these drugs. These sources include the AMA Drug Evaluations Annual, clinical pharmacology   services in the hospital, and  from the pharmaceutical companies themselves as information specific therapeutic agents dosage (Bazzano,  et al., 2009).These information is very important as it allows the practitioners to understand the components of the drugs and  its appropriate use in the treatment of various diseases.

 Various off label drugs exists which require extra care and attention when used in pediatrics. These drugs include albuterol, quinine, and elixir. In elixir, the label clearly identified the formulation but failed to indicate that the alcohol was used in its compounding. Others include, metoclopramide, Maalox and Bethanechol which their safety and effectiveness in children has not yet been established. Furthermore, some of these drugs require to be administered in the right dosage through titration. They also require that the doctor or medical practitioners have a good understanding of the ontogeny of the pharmacokinetic processes that children and infants go through (Mayhew, 2009).

 In conclusion,  off- label use of drugs in children is appropriate  and as well  necessary.  One reason is that most of these drugs lack labels on the dosage but are effective. The doctors however should use these drugs if they have knowledge and information that they are effective. They also need to ensure that the drugs meets the standard set by various institutions, have been approved and gone through controlled clinical trial to establish their effectiveness. Sound medical judgment remains one of the important attribute when using off-label drugs.

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.

Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123.

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