Pediatric Pharmacy Technology Program

While the Pediatric Pharmaceutical Reformulation Program (link to that page) will increase availability of drug products optimized for children, there may also be a need for better pharmacy technology enabling hospitals to provide individualized liquid oral dosages for children.

Most drugs are available only in pills intended for adults or older children, but most children under 6 years old are unable to swallow pills. So pharmacies in hospitals that care for children reformulate, re-compound, and repackage a substantial portion of the prescriptions written for children. Pharmacy staff crush the pills and suspend the resulting powder in a liquid delivery solution using recipes obtained from diverse sources. Because children of different sizes and ages require different dosages, the liquids are individually dispensed for each child, usually in an oral syringe or small cup.

This on-site, extemporaneous, individualized drug reformulation poses significant risks of medication error. Concerns include precision of dispensed concentrations; undefined shelf life and bioavailability of resulting products; and inconsistent identification and tracking of drugs and dosages by the hospital’s information technology system. The process lacks the manufacturing quality control and precision of information tracking required by the FDA and GMP standards. In addition, this process demands a significant commitment of specialized labor by resource-strapped hospital pharmacy departments 24 hours a day.