In pediatric healthcare, every decision is a crucial one. Prescription medications play a vital role in the fight against illness for adults, yet pediatric formulation research of the same drugs is scarce. Over 75% of pediatric prescriptions in North America and Europe were labeled “off-label” (Rieder, 2019). This implies that children are often prescribed medications never specifically studied for their age group. To avoid treatment failures and side effects, precise dosing for children should be a necessity. It is mandatory to test new drugs on children – something that should have been perfected a long time ago if it wasn’t for a reluctance to “experiment” with children. The complexities of a child’s physiology and biological processing of drugs come into play, demanding a more tailored approach to pediatric medication dosing. Children are not just miniature versions of adults; the “one-dose-fits-all” mentality is long gone. What are the dosing criteria for children, and how should doses be calculated? This blog will explore all the above and unveil the latest developments in precision dosing for pediatric medication, including the world of 3D-printed medications.
Pediatric medication dosing criteria:
When calculating pediatric doses, healthcare professionals consider various factors before ensuring the safe and effective administration of medications. Beyond the commonly known factors of age, weight and underlying health conditions, a combination of more elements leads to a more comprehensive approach:
Age is usually one of the first factors taken into account. It is necessary to consider whether you’re dealing with infants, toddlers, preschoolers, school-age children, or adolescents. Variations in metabolism and growth rates mean that dosages may differ across these developmental stages.
Next comes weight, which is also critical in pediatric dosing, with medications often prescribed based on the child’s weight to ensure suitability for their size. However, certain medications consider Body Surface Area (BSA) as the best approach as it incorporates both weight and height. This parameter is particularly relevant for drugs like chemotherapy medications, where BSA is a crucial factor. Thus, underlying health conditions and organ function need consideration alongside specific medication guidelines.
The pediatric dosing criteria are numerous and vary. It is necessary to realize that the right combination of factors is the key to accurate medication dosage. Precision dosing for pediatric medication is necessary to ensure safe and effective administration tailored to each child’s needs.
How do you calculate pediatric doses?
The above criteria prove the importance of a meticulous approach when it comes to pediatric dosing. What are the methods used in calculating pediatric doses? The complexity of a child’s physiology demands precision. Thus, healthcare professionals rely on various approaches to calculate pediatric doses effectively.
1. Body weight
One of the most straightforward and widely used methods in pediatric dosing is based on body weight. This approach acknowledges that a child’s weight is a reliable indicator of physiological development. Clark’s rule is a commonly used formula to determine a specific dosage for pediatric medication based on the child’s weight and a specified adult dose of the wanted medication. This method is often the go-to for quick and practical dosing decisions.
The calculation for weight in pounds is represented below:
(Weight divided by 150 lbs.) x Adult Dose = Pediatric Dosage
The same calculation can be adapted for weight in kilograms:
(Weight divided by 68 kg) x Adult Dose = Pediatric Dosage
2. BSA
Calculating BSA takes into account both weight and height, providing a more precise measure of the child’s physical development. This method is particularly favored when dealing with medications that act on the entire body rather than specific organs or systems. It adds an extra layer of accuracy, ensuring doses are adapted to individual variations.
3. Age-based method
The age-based method considers a child’s age as the primary factor in determining dosage. It simplifies the dosing process by aligning with the general developmental stages of childhood. While this method may lack the precision of weight or BSA calculations, it is often used as a starting point, especially when the child’s weight or height measurements are unavailable or challenging to obtain.
4. Young’s method
Named after pediatrician Robert J. Young, this method takes a holistic approach, considering age and body weight. By combining these two factors, Young’s method aims to balance simplicity and precision. It is handy when clinicians aim for a middle ground, factoring in age-related developmental changes and the influence of body weight on medication metabolism.
Table1. Medication dosage chart for ibuprofen use based on child’s weight and age.
It’s important to understand that this method has its advantages. Healthcare professionals often blend these methods as dosing depends on various factors. The trustworthiness of a dosing method depends on the context, the available information about the child, and the specific medication administered.
New developments in pediatric dosing: 3D printed medication
Addressing the unique medication needs of pediatric patients has been a challenge in drug mass production. As mentioned earlier, children often require different dosages and combinations of medicines as they grow. Compared to the infinite variety of medications for adults, there is only a limited amount of drugs being formulated specifically for children. Some common examples include:
- Amoxicillin
- Ibuprofen
- Azithromycin
- Cephalexin
The doses are usually calculated by age, method of administration, and the type of disease they are prescribed for. It is interesting to notice how variations and unique combinations of these factors shape pediatric doses. To meet these specific requirements, healthcare professionals often resort to compounding, where adult tablets are crushed and dissolved in liquid. However, this practice raises concerns about drug quality and precision in dosage.
Co-principal investigator Dr. Mansoor Khan, a professor of pharmaceutical sciences at Texas A&M, highlights the issue of manipulating dosages when only larger tablets are available. During a local news interview, he raised a critical question: “If a child needs 3.4 milligrams and only a 10-milligram tablet is available, how can we ensure that the manipulated liquid dosage retains the same amount of the drug?”
In the pursuit of advancing “personalized medicine,” which not only tailors treatments to individual patient needs but also makes the dosing procedure safer for children, 3D printing emerges as a promising solution. Khan emphasizes the difficulty of fixing doses based on body weight in developing children, leading to the prevalent testing and development of drugs primarily for adults, who tend to have more stable weights.
Figure 1. 3D printed tablets using the DoseRx1 (by Doser).
Currently, 3D printing technology in drug delivery has been applied across various administration routes, including oral, transdermal, pulmonary, and intrauterine. 3D-printed drugs could overcome conventional drug limitations and enable the production of specialized pediatric medication with specific release characteristics. Specifically for oral drug delivery, 3D printing will allow the development of different sizes, colors, flavors, and more precise dosage forms, including immediate-release systems, delayed-release systems, and polypills.
Although these applications have been mostly tested on adults, the application of 3D printing technology holds significant potential in shaping the future of pediatric drug production. As it addresses challenges like dosing precision, weight-based formulations, and compounding issues, this technology aligns with the vision of personalized medicine by offering treatments for the unique needs of pediatric patients.
Outlook on precision dosing for pediatric medication
In pediatric healthcare, the critical nature of decisions in oral dosage control requires careful consideration and expertise in pediatric pharmacy. However, the lack of research in pediatric drug formulation leads to the majority of prescriptions labeled as “off-label”. This highlights the necessity for precise dosing strategies to avoid treatment failures and side effects. Dosing criteria extend beyond age and weight, considering factors like Body Surface Area (BSA) and organ function.
Various methods, including body weight, BSA, age-based, and Young’s approach, are employed for pediatric dosing, each offering unique advantages. The challenges of compounding adult medications for pediatric use highlight the need for innovative solutions. 3D printing is a promising advancement that aligns with the vision of personalized medicine for safer and more effective pediatric treatments.
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References:
https://www.sciencedirect.com/science/article/pii/S2666964121000321#sec0006