Drugs for off-label use - Essay Example

Off-Label Drug Use in Pediatrics [Type the document sub Auhtor [Pick the “Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration” (Stafford, 2008). Off-label ways to use drugs are prescription drugs and over-the counter drugs (OTCs). Off-label use of drugs is legal, when ethical guidelines and safety regulation are observed in true letter and spirit. However, it has certain risks and requires utmost care and attention.

There are many reasons for the lack of drug testing mechanism for children and major amongst them is lack of interest by the pharmaceutical companies as they consider it less profitable. Circumstances under which children should be prescribed for off-label use:The use of off-label drugs is most common among oncology and pediatric patients due to the lack of appropriate medicines and therapies. In certain circumstances, the use of off-label medicines proved beneficial for children, especially when all the approved medicines fail to bring the desired results as in the case of cancer.

American Cancer Society reveals that some of the chemotherapy medicines are approved for one type of cancer but it has the potential to cure the other types of tumors.Other example of beneficial use of off-label medicine is Beta-blockers. FDA approved it for the patients of high blood pressure but it proved in curing heart diseases also. But before prescribing the off-label drugs, it is the duty of medical practitioners to inform the parents or guardians of children about this very fact; and reveal the side effects that may occur.

They should also inform the alternative remedies available with them. Besides, medical practitioners should inform the company or relevant medical authority about the adverse effects, if they occur. In the case of United States vs. Evers, the court even authorizes a medical practitioner to use off-label drugs if they were not contraindicated (Fauber, 2012). Strategies to make the off-label use and dosage of drug safer for children:A prescriber should adhere with the following strategies to make the off-label use and dosage of safer for children: (Henney, 2006)1.

After observing adequate evidences that licensed medicine is not producing the desired results,2. Have sufficient experience to ensure the efficacy of the medicine,3. Properly observe and take care of child after dosage,4. Record the reason of choosing the medicine in history sheet. Descriptions and names of off-label drugs that require extra care and attention when used in pediatrics:Some off-label drugs require extra care and attention when use in Pediatrics. Example includes diazepam rectal solution in children under 1 year (not licensed for age group), amiloride tablets in any children (formulation), or rectal injection of lorazepam for a child with an acute seizure (route).

An example of unlicensed use is the preparation of a suspension from a tablet by the hospital pharmacy.Work citedFauber, J. (2012). “Off-Label Drug Marketing is ‘Free Speech, ‘Court Rules”. ABC News, Retrieved 14.05.14Henney, J E (15 August 2006). Editorial: Safeguarding Patient Welfare: Who’s in Charge?”. Annals of internal Medicine 145 (4): 305-307Stafford, R. S. (2008). Regulating off-label drug use—rethinking the role of the FDA. New England Journal of Medicine, 358(14), 1427-1429.