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Label Uses of Medication

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Date Created: September 14, 2024

Last Modified: September 14, 2024

Label Uses of Medication

Off-label prescribing is defined as prescribing a medication for an indication not approved by the Food and Drug Administration (FDA) (Mayhem, 2008). Off-labeling is most frequent with the special population of pediatrics. Off- label medications should be prescribed to children responsibly when there is sufficient evidence to support, when additional research is necessary, and when patients and their families are aware of possible side effects (Dresser and Frader, 2009).

Safer Strategies

Safer strategies that should be used each and every time a medication is prescribed to a pediatric is utilizing the weight of the child for dosage purposes along with the age of the child (Arcangelo and Peterson, 2013). Another strategy is reviewing the patient’s current medications to determine what other medications may interact with the new medication that is being prescribed.

Specific Medications

There are multiple medications that are used as off-label which consist of antibiotics, antidepressants, and respiratory medications. Antimicrobials such as amoxicillin, cephalexin, and zithromycin are most frequent off-label uses (Bazzano et al., 2009). Respiratory medications to assist with breathing such as albuterol and steroids used intranasally susch as flonase are frequently used off label (Bazzano et al., 2009). As practitioners it is important to make sure that when prescribing off label medications the patient and family are educated on the expected results as well as the side effects.

discussion no.2

Prescribing off-label drugs

Off- labeling consists of prescribing drugs for purposes other than what it is approved for by the FDA or a particular patient population (Mayhew, 2009). Off- label prescribed drugs in pediatrics should be used when practitioners have weighed the risks and benefits and establish patient safety as well as the beneficial results. The practitioner must be able to justify prescribing off- label medication and should review all risks and benefits with the caregiver or child (if age appropriate) when prescribing medication. Off- labeling consists of prescribing drugs for purposes other than what it is approved for by the FDA or a particular patient population (Mayhew, 2009). Providers must use their best knowledge and judgement to provide successful care to patients. Physicians are known to utilize off-label drugs in children for the majority of their office visits in the US (Bazzano, A.T., Mangione-Smith, R., Schonlau, M., Suttorp, M., Brook, R.H., 2009).

Safe strategies

Strategies and dose usage for safe medication delivery for children consists of knowing the patients type; for example an infant, pediatric or adolescent (Arcangelo, V.P. & Peterson, A.M., 2013). It is important to establish the recommended body weight dose per patient type since this is commonly the method used for pediatric dosing (Arcangelo, V.P. & Peterson, A.M., 2013). Therefore, utilizing off-label medication requires the prescriber to determine the dose based on patient age and weight.

Off-label drugs that require extra care

Off label medications that require extra care are respiratory medications, anti-infectives, central nervous system drugs and antihistamines (Bazzano, A.T., Mangione-Smith, R., Schonlau, M., Suttorp, M., Brook, R.H., 2009). Off label prescribing is not regulated by the FDA and can be utilized as the prescriber sees fit (Mayhew, 2009). However, it the responsibility of the prescriber to ensure the medication being prescribed is appropriate and used for the greater good of the patient. Education about drug purpose and adverse effects is also important to teach families. The goal is to ensure the welfare and safety of the child.

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