PEDIATRIC DOSAGE FORMS

To support research on and development of pediatric-specific drug formulations; further,

To encourage manufacturers to develop formulations suitable for pediatric administration during research that includes pediatric patients; further,

To encourage manufacturers of off-patent medications that are used in pediatric patients to develop formulations suitable for pediatric administration; further,

To advocate that manufacturers comparably price a newly developed pediatric-specific commercial product to that of its extemporaneously prepared formulation; further,

To educate prescribers and caregivers regarding the nuances of pediatric drug administration to ensure the availability of an appropriate dosage form is considered when selecting and administering safe and effective therapies for a pediatric patient. 

Rationale

Pediatric patients are at high risk for medication errors because so few formulations are created for them. Challenges to pediatric dosage development include insufficient background information on the drug molecule in the target population, issues with safety and tolerability of excipients, taste-masking issues, technology requirements, the risks involved in clinical trials, small market size and low profitability, and lack of regulatory clarity.

To ensure that the proper dose is administered, different routes of administration, dosage forms, and strengths may be required. Because many existing formulations are not suitable for children, many hospitals and health systems will use components to extemporaneously prepare a formulation that provides a measurable, stable, and consistent delivery of a needed medication. The concentration and availability of these formulations, most often in the form of suspensions and solutions, may also vary in storage requirements, bioavailability, and palatability, all which can affect patient tolerability and adherence.

Furthermore, since many medications are needed for a relatively small patient population, often only a few commercial products are manufactured, resulting in the need for compounding. As a result, research is often stymied in the pediatric patient population as well, since compounding a medication may introduce variables that may affect results in unpredictable ways.

Boards of pharmacy have also recognized the safety issues surrounding variability in stability and concentrations of the same drug, and many have laws in place that prohibit the extemporaneous compounding of drugs in concentrations that are commercially available.

As pediatric patients have different tolerability to excipients, organ development, taste preferences, and swallowing abilities as they age, it is essential that pharmacists are a part of the team that determines a medication regimen. It is also important that caregivers are taught to properly measure, store, and administer pediatric formulations as a part of patient care.