Question

• Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
• 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.

Answer 1

To control the symptoms and to alleviate the pain or something like that in a paediatric patient in a disease condition where treatment failure occur by guideline- based treatment,we use off line drug.Here the particular drug is not meant for that particular disease or age group and meant for any other disease or different age group

E.g , Suppose in a case of terminal illness,where we can not cure the patient we can only alleviate the symptom of severe pain by using Ketorolac. Ketorolac is not approved for children below 16 years, by mouth or I.M use. It starts from 16 yrs as the drug safety is not established in children below 16 years.Hence if we use this drug for the above reason then we call it a offline drug and usually used in paediatric palliative care.

Not only the terminal illness, post surgical trauma pain etc are also the condition where off label drugs are used to give the patient a quality life for the time being. Actually these drugs did not meet the strict quality criteria of safety, and efficacy which when done , normally approved by FDA.

Strategies Actually there are not many randomized control tests study of several drugs in infants or children and hence many drugs are having a label---- off label. So a strategy to be built to enhance the research of the safety and efficacy of these drugs in this age group, for which a well knit balanced action between the pharmaceutical industry ,FDA and Governmental research funding for young researcher to be there

Anti infectives

Gentamicin....In NICU where aminoglycosides are used hearing loss is a side effect which should be taken care of

Ciprofloxacin.....Cause arthropathy in lower animals and not recommended in children.

Analgesics

ketorolac tromethamine....as told above

Opioids......