Good Example Of Off-Label Drug Use In Pediatrics Essay
Throughout history, the lifespan of a person has somehow been increasing due to the advancement in technology. Medicines have provided a cure for a majority of illnesses that were deemed incurable in the past decades.
As all experiments are conducted, each proposed medicine for a certain illness must first be tested in order to prove that the medicine is indeed effective. These clinical trials are conducted by physicians to volunteers who possess the illness that the physicians are trying to cure. These volunteers come from different age brackets. But through the years, some of these trials were seen as unethical specifically clinical trials on children. This dilemma made medical prescriptions to children incomplete or vague. Indeed there are available medications, but the most important details such as safety and dosage, if applied to children, are not defined (Kimland, 2012). When these medications are prescribed by physicians to be used other than the approved use, the prescription is called an off-label prescription (Bazzano, 2012).
Furthermore, there are different ways to classify a drug as an off-label prescription. One way, as described previously, is the definition used in most recent studies. Off-label prescription happens that when a drug has no indication for pediatric use as well as when the drug is used at an unapproved dosage in relation to the patient’s weight or age. Another classification, as described in some earlier studies is that if the frequency of the dosage or the patient’s age and weight do not match those indicated on the label of the drug (Kimland, 2012).
The case study of Bazzano (2012) involves off-label prescriptions. In the study, a 5-year old girl was given an off-label prescription including the dosage so as to help the girl relax about a pending medical examination. Right before the examination, the child was not given anything else because of the medicine prescribed by her physician. Hours of the examination, the girl felt very sleepy and somnolent that she had to stay in the hospital for close monitoring. The parents of the girl were confused as to why the physician would prescribe a medicine that would pose a danger to their daughter.
According to the Food and Drug Administration, as stated by Bazzano, a physician can prescribe a certain drug at a different dosage and frequency to patients in different age bracket other than those approved. But it is the responsibility of the physician to have full understanding of the effects of the drug as well as full information about how the drug should be administered as proven by studies conducted using the drug.
Administering off-label prescription drugs to children comes with danger and uncertainty. The drug might not have any effect or the drug can be dangerous (Bazzano, 2012). The danger even becomes more critical when the involved patients are infants or even those in the womb. This age bracket involves bodies that are vulnerable. In addition to that, when a drug is administered to them, they won’t be able to describe or directly assess the effects of the drug. Off-label prescription drugs for infants and neonates are in need of immediate attention for they are the recipients of a large proportion of these kinds of drugs. Analgesics, as well as nonsteroidal anti-inflammatory drugs, need immediate trials for dosage, efficiency and safety data for pediatric patients (Kimland, 2012).
Aside from further studies, off-label prescription drugs available in the market should have an easily distinguishable label which indicates that the drug is in need for a better set of safety information and efficiency (Burckart, nd). Also, if the drug is not of immediate need, the dosage can be increased gradually until the right dosage for a specific person or pediatric patient is reached.
Bazzano, Alicia Theresa Francesca. (2012). Putting Pediatric Off Label Prescribing on the Map: A Study to Understand which Children, Medications and Physicians are Involved in Prescribing Drugs for Unapproved Uses. UCLA: Health Services 0427. Retrieved from: <https://escholarship.org/uc/item/39c8k38n>
Burckart, G. J. (n.d.). Off-Label Drug Use in Pediatrics Patients: How can we change the system?. PPAG. Retrived from:
Kimland, E. and Odlind, V. (2012). Off-Label Drug Use in Pediatric Patients. Clinical Pharmacology & Therapeutics 91(5), 796–801.