Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.


Don't use plagiarized sources. Get Your Custom Essay on
Get an essay WRITTEN FOR YOU, Plagiarism free, and by an EXPERT!
Order Essay







Week 11 Discussion

Off-label Use of Drugs

Off-label use refers to the unapproved use of an approved drug. This implies that a drug is either used for a medical condition or disease that it is not approved to treat, such as when a drug that is approved for the treatment of one cancer being used to treat another cancer, used in a different way, such as when a capsule drug is used as an oral solution or used in a different dose, such as when a drug that is approved at a two-tablet dose is given to a patient as a single tablet every day (Mayhew, 2009). Off-label drug use might be used because there is no approved drug for treating a medical condition or disease. It may also be used when all approved treatments and drugs have been tried and there are no benefits observable. Off-label drug use can be safe since the fact that a disease or patient category is not included on a drug label does not mean that a drug is not appropriate for that use. It only means that the authority (FDA) has not approved a particular use of the drug, but it may be appropriate.

Off-label use is an important part of contemporary medicine as many patients benefit when they are given prescriptions under circumstances that are not specified on the label approved by the FDA. For children, off-label use has the capability of providing the best medical intervention. For the children population, off-label use may even be the standard of care for specific health problems. Most of the drugs that are prescribed to children are used off-label since drugs are rarely tested in that age group. The practice is an accepted medical practice that is reasonable when there exists scientific or medical evidence that a certain drug is effective for a certain medical application.

Improving Safety

In a state of perfection, all drug use should be supported by research. In reality, however, the medical community finds itself with the duty to determine when the use of off-label prescriptions is appropriate to help patients (Mayhew, 2009). To ensure safety when giving off-label prescriptions, the use of research methods is an important strategy for medical practitioners. Pharmaceutical companies should fund research and publish journals to improve best practices in off-label prescriptions. As Bazzano et al. (2009) state, “Research and policy interventions may benefit from understanding which children receive which medications off-label”. This is only through medical research on children to determine which off-label drugs are appropriate. National consortium and pediatric drug studies should be conducted rationally to improve drug use safety.

All children have the right to receive effective and safe medicine in the correct dosage, indication, and route of administration. While off-label use of drugs can be beneficial, it is sometimes associated with negative drug reactions in children (Horen et al., 2002). Respiratory and psychiatric drugs are the most common drugs that are prescribed off-label in children. An example of a commonly used drug is Sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) antidepressant (Arcangelo et al., 2017). It is usually given to children with OCD. Loratidine (Claritin) is also a commonly used drug, an antihistamine that minimizes the effects of histamine in the body. It is commonly used in children for allergic rhinitis and urticaria (Arcangelo et al., 2017). While using these drugs to treat children, it is important to weigh the potential risk versus the clinical need.


Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins.

Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81-88.

Horen, B., Montastruc, J. L., & Lapeyre-Mestre, M. (2002). Adverse drug reactions and off-label drug use in paediatric outpatients. British journal of clinical pharmacology, 54(6), 665.

Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122-123.

Homework Sharks
Order NOW For A 10% Discount!
Pages (550 words)
Approximate price: -

Our Advantages

Plagiarism Free Papers

All our papers are original and written from scratch. We will email you a plagiarism report alongside your completed paper once done.

Free Revisions

All papers are submitted ahead of time. We do this to allow you time to point out any area you would need revision on, and help you for free.


A title page preceeds all your paper content. Here, you put all your personal information and this we give out for free.


Without a reference/bibliography page, any academic paper is incomplete and doesnt qualify for grading. We also offer this for free.

Originality & Security

At Homework Sharks, we take confidentiality seriously and all your personal information is stored safely and do not share it with third parties for any reasons whatsoever. Our work is original and we send plagiarism reports alongside every paper.

24/7 Customer Support

Our agents are online 24/7. Feel free to contact us through email or talk to our live agents.

Try it now!

Calculate the price of your order

We'll send you the first draft for approval by at
Total price:

How it works?

Follow these simple steps to get your paper done

Place your order

Fill in the order form and provide all details of your assignment.

Proceed with the payment

Choose the payment system that suits you most.

Receive the final file

Once your paper is ready, we will email it to you.

Our Services

We work around the clock to see best customer experience.


Flexible Pricing

Our prces are pocket friendly and you can do partial payments. When that is not enough, we have a free enquiry service.


Admission help & Client-Writer Contact

When you need to elaborate something further to your writer, we provide that button.


Paper Submission

We take deadlines seriously and our papers are submitted ahead of time. We are happy to assist you in case of any adjustments needed.


Customer Feedback

Your feedback, good or bad is of great concern to us and we take it very seriously. We are, therefore, constantly adjusting our policies to ensure best customer/writer experience.

× Contact Live Agents
Verified by MonsterInsights