Off Label Drug Use in Pediatrics with Mood Disorders (Essay Sample)
The task was to show that there are many prescription drugs currently marketed in the U.S. that lack pediatric use information. These medication are not FDA-approved for use in minors but are still used "off-label," meaning that they are used in children younger than the approved age or for other conditions that they are not approved for yet. However, this does not mean that it is not safe to use these medications. When deciding to use a medication 'off-label', a healthcare provider should be making that decision based on sound scientific evidence, expert medical judgment, or published literature.
Off Label Drug Use in Pediatrics with Mood Disorders
Off Label Drug Use in Pediatrics with Mood Disorders
Off-label drug usage involves giving or administering medicines that have not been licensed for the patient's condition, age, or weight. This practice is legitimate and prevalent, more so among the pediatric group, representing about 10 to 20% of all written prescriptions. The pediatric medical practice remains greatly off-label. Throughout history, minors have been exempted from clinical trials because of scientific and ethical concerns, which has left a vast gap in medical knowledge. Off-label medicine usage among the minors is mainly centered on extrapolation of efficiency, dosage, and adverse reactions profiles from adult research. Antihistamines, antibiotics and antidepressants are the predominant off-label treatment methods used among neonates, infants, and other minors. Antidepressants are mainly recommended to minors with mood disorders like dysthymia, major depression, and bipolar disorders to manage the depression signs. Off-label medications are used to treat pediatrics with mood disorders when no alternative treatment methods exist, and if the patient fails to react to existing drugs, however, continuous well-designed and rational scientific trials on children as well as clinically-informed assessments can make the drugs safer for minors.
Circumstances under Which Children Should Be Prescribed Drugs for Off- label Use
Various circumstances justify off-label drug usage among minors. A physician may administer off-label treatment methods for pediatrics with mood disorders when no effective alternatives exist. As earlier mentioned, the few scientific trials performed on the pediatric group limit health experts from establishing a broad range of treatment options to guarantee efficiency and protection for this group. As a result, physicians can advocate for off-label treatments to save the patient's life if they perceive that the advantages exceed the health risks. For example, pain management is predominant among minors experiencing mild to acute pain due to various health complications, including bipolar disorder. In such a scenario, a doctor may administer off-label analgesics such as morphine, codeine, oxycodone, and tramadol to relieve the minor’s pain. Also, off-label treatment among minors may be administered if the patient fails to react to existing treatments practices (O'Brien et al., 2017). Just like adults, children may react differently to various treatment methods. This implies that a certain treatment may be effective in one child but fail on another. Therefore, under such conditions, the doctors can administer an off-label treatment based on the diagnosis. For instance, if antidepressants like fluoxetine, clomipramine, fluvoxamine, and sertraline prove ineffective on a 4- year-old with major depressive disorder, a physician can administer Lexapro even though it is unauthorized for children under 12 years. Similarly, off-label treatments can be given to pediatrics with mood disorders if their physiologic or pathologic characteristics match those approved for on-label use (O'Brien et al., 2017). For example, lithium has been licensed to treat the signs of bipolar disorder among teenagers aged 12 to 17 and adults. However, if a 5-year-old minor with bipolar disorder presents episodes of mania, the physician can prescribe lithium to the patient.
Strategies to Make the Off-label Use and Dosage of Drugs Safer for Children from Infancy to Adolescence
Clinical decision-making should always be guided by clear and effective evidence-based practices. The pediatric group, particularly those with mood disorders, is entitled to receive safe and quality treatment. Several strategies can be implemented to make off-label usage and dosage safer for minors. In this context, physician-researchers require government support to actively participate in continuous rational and critical pediatric scientific trials. Further studies and well-designed scientific trials on minors may assist in developing effective and suitable treatments. This may be realized through the enforcement of policies that promote drug testing among minors. For instance, the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act have enabled the labeling of over 600 pediatric drugs (Allen et al., 2018). This suggests that enacting additional laws in the pediatric field may increase labeling of medications for minors, hence minimizing off-label usage. Likewise, in scenarios where off-label treatments are the only available alternatives, their use should be based on expert clinical judgment and clearly outlined scientific proof to prevent any health threats or fatal adverse reactions. A well-thought and clinically-guided decision may guarantee the minor’s safety. Several off-label treatments like using opioids as analgesia require extra care when used among pediatrics. In this context, codeine has been connected to acute respiratory depression and fatalities among this group (Matson et al., 2019). Codeine, among other opioids helps relieve pain after surgery or severe pediatric health complications. Also, fentanyl which is used in neonatal ICUs needs to be administered carefully. Resear
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