Importance of Pediatric Studies in SARS-CoV-2 Vaccine Development.

Vaccination efforts against COVID-19 must include the pediatric population, not only to protect children and their families from the virus, but also to support a safe return to in-person schooling. Given the novel methodologies and targets used in the COVID-19 vaccines and the potential for multisystem inflammatory syndrome-children, it is insufficient to extrapolate safety and efficacy data between different vaccine candidates or from adult studies. Adequate enrollment in pediatric studies for COVID-19 vaccines is crucial. The Pediatric Pharmacy Association supports continued research, surveillance, and transparency for COVID-19 vaccines in the pediatric population, including those younger than 12 years of age.

Stability of extemporaneously compounded temozolomide 10 mg/mL suspensions in Oral Mix SF® in glass and plastic bottles and plastic syringes.

BACKGROUND: Temozolomide oral suspension is not commercially available. OBJECTIVE: To evaluate the stability of three temozolomide 10 mg/mL suspensions prepared in Oral Mix SF® in three container types stored at 4°C and 23°C. METHODS: Using commercial capsules, three separate batches of three different temozolomide 10 mg/mL formulations (Oral Mix SF® with PK-30; PK-30 and citric acid; and neither PK-30 nor citric acid) were made and stored in three container types (amber glass bottles, amber polyethylene terephthalate bottles, and polypropylene oral syringes). The aliquots in each container type were stored protected from light, half at 25°C and half at 4°C. On study days 0, 5, 8, 14, 21, 28, 35, 42, and 56, physical properties of samples from each container type at each temperature were assessed, and the temozolomide concentration was determined using a stability-indicating method. The beyond-use-date (time to achieve 90% of initial concentration calculated using the lower limit of the 95% confidence interval of the observed degradation rate) was calculated. RESULTS: Samples stored at 25°C turned from white to orange within seven days. Temozolomide crystals were observed in all samples. Concentration changes due to study day and temperature (p < 0.001) were observed but not due to container (p = 0.991) or formulation (p = 0.987). The beyond-use-date of all formulations in all container types was 56 days at 4°C and 6 days at 23°C. CONCLUSIONS: We recommend that these temozolomide 10 mg/mL formulations be stored at 4°C and be assigned a beyond-use-date of 30 days.

Standardization of Concentrations for Extemporaneously Compounded Oral Liquid Medications.

Many children require medications in oral liquid dosage forms when their dose does not conform to a manufactured tablet or capsule size. Liquid medications are also needed for children who are unable to swallow solid dosage forms. This statement from the PPAG is in support of standardizing the concentrations of extemporaneous formulations of liquid medications for the benefits of safety, accuracy, and overall communication between providers.

Improving Uptake of Hydroxyurea in Patients with Sickle Cell Disease: A Retrospective Study of a Clinic-based Change in Consenting Practices.

INTRODUCTION: Sickle cell disease (SCD) can shorten lives and may result in severe clinical complications. Hydroxyurea (HU) is inexpensive, widely available, and National Institutes of Health (NIH) recommends HU for SCD. Despite these benefits, utilization of HU is low. Barriers to taking HU include inaccurate perceptions of serious side effects such as hair loss, a significant barrier in the African American community. However, at doses for treating SCD, the incidence of side effects is extremely low. Using a retrospective medical record review, the impact of a revised consent procedure for HU that addressed these barriers was evaluated. METHODS: SCD patients 2-20yo eligible for HU were examined. Patients prescribed HU versus those not prescribed HU were compared one year before and one year after revising consent procedures. RESULTS: Change in clinic practice (including revised consent procedures) resulted in 158% more patients agreeing to HU therapy (p<.001). DISCUSSION: The revised consent procedures are not resource intensive and easy to implement. Future research should address treatment acceptability, intimidation, and cultural sensitivity.

Position Paper: Pharmacists and Childhood Vaccines.

Vaccination rates of children in the United States remain below the target coverage levels identified in the Healthy People 2020 objectives. Given the success of pharmacists in providing adult vaccinations and the accessibility of pharmacists to the public, expanding pharmacists' authority to vaccinate children may improve vaccination rates of children, particularly in key disease states. This article serves as a Position Statement of the Pediatric Pharmacy Advocacy Group (PPAG), who supports the expansion of pharmacists' authority to vaccinate children. PPAG also believes that increased use of state vaccination registries by pharmacists will help improve communication and documentation of vaccines between providers. PPAG also recommends that continued education and maintaining current knowledge of vaccines and vaccine schedules are vital for pharmacist immunizers. Finally, PPAG believes that pharmacists should be advocates for childhood vaccinations.