The Use Of Off-Label Drug Use In Pediatrics - 829 Words

Off-Label Drug Use in Pediatrics Off-label means the medication is being used in a manner not specified in the FDAs approved packaging label, or insert. Off-label prescribing occurs when a child receives a medication that has not received FDA approval for the child’s age or diagnosis, it occurs when the patients have exhausted all other approved options, as may be the case with rare diseases or cancer. (WebMD, n.d) Off-label prescription lack information on the medication safety, efficacy, and proper use in children such as dosing and interactions and this has been associated with adverse drug events (Bazzano, Mangione-Smith, Schonlau, Suttorp, Brook, 2009) The best clinical practice is still to use drugs with FDA indications when†¦show more content†¦Prescribing a drug off-label may be necessary when no FDA-approved drug is available due to lack of research. (Mayhew, 2009) A lack of suitable formulations exacerbates these problems. Many medicines have a bitter taste, which children may then refuse to take. Parents can worry about the health consequences of adding a spoonful of sugar or including other additives to improve palatability. In other cases, prescribers might need to measure a small fraction of an adult formulation and few package inserts offer adequate information to guide dosing, which further increase the risk of error (Tomlin Morris, 2009) Strategies Use in Off-Label Medication Strategies to improve the off-label use and dosage of drugs for infants to adolescences are to make providers aware of how dangerous prescribing these medications can be. Ideally, children should receive drugs licensed for that age group. However, relatively few medications have undergone clinical trials in children and prescribing unlicensed medications is inevitable in many indications. Labeling medications properly with correct dosages as well as labeling them for whom they should be used or may help as well. When an unlicensed medicine is appropriate, health professionals should identify whether specials or imports are available. Off-label medicines may be appropriate if the patient requires urgent treatment, but are usually subjected to limited quality assurance.Show MoreRelatedThe Issues Associated With The Demand For A Pediatric Randomized Controlled Trials1290 Words   |  6 Pagesan Increase in Pediatric Randomized Controlled Trials The Literature Review Submitted to Kennesaw Mountain High School by Andrea Jais Kennesaw, Georgia May 2015 â€Æ' Brief Review of Literature Introduction The importance of drug trials is to properly inform pharmacologists and physicians of proper dosage amounts. Most trials conducted today are performed on the average adult. From these trials, the dosage amount is decided then sent to pharmacy companies to print on labels. 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