Community pharmacist—and parent—voices needed in push for pediatric formulations

A centre that advocates for pediatric formulations to be commercially available is asking Canadian parents and guardians to share their stories about giving medicines to their children that has to be compounded specially for a child. “We think now it is the time to add the parent voice, because it is the parent that has to administer these medications to their children,” said Andrea Gilpin, general manager of the Goodman Pediatric Formulations Centre of the CHU Sainte-Justine. The Goodman Pediatric Formulations Centre of the CHU Sainte-Justine opened in 2016 with the goal to improve access to child-friendly medicines. The non-profit centre works with industry, Health Canada and reimbursement bodies to break down barriers to get pediatric formulations on the Canadian market. The Centre is holding a workshop on February 17, 2022 “to better understand the impact of adapting adult medications for children.” The workshop will be presented with the Institute for Safe Medication Practices Canada. Gilpin shared the story of a family who has to compound 6-mercaptopurine, a cytotoxic medication for their child who has leukemia. This means that twice a day the parents must don gloves and gowns to prepare the medication, which is available in a pediatric formulation elsewhere. “We would like to hear some more of the stories about parents who have children who take medications chronically and who are stuck with compounding them, modifying the adult form and making it suitable for use in children,” Gilpin said. Gilpin said she would also like to hear from community pharmacists about their experiences providing specially compounded pediatric formulations to families. Read: Finding your niche: Pediatric care Drawbacks to not having pediatric formulations includes pharmacists having to scramble to get the correct ingredients and families who must travel long distances to get the medication from a compounding pharmacy. There’s also the yuck factor: cutting up or crushing adult medication that was meant to be swallowed whole means the medicine often tastes bad or has a gritty texture. “I makes it very difficult for parents to administer these adapted forms to kids,” Gilpin said. Often the pediatric formulations are available in the United States or Europe, but not in Canada. There are a number of reasons why manufacturers might not introduce pediatric formulations into the Canadian market. Size of market Canada has a small population of children who need these medications. While this is good news for child health, it means that the costs to develop, market and maintain the supply of commercially-available pediatric formulations are high, so drug companies don’t release pediatric formulations to the Canadian market. Even if a drug manufacturer gets a pediatric formulation approved by Health Canada, it still has to go get the formulation listed on the provincial and territorial formularies. “The path to commercialization is pretty complex and for a small market, a lot of the companies choose not to commercialize,” Gilpin said. Regulatory issues In the United States and Europe, drug manufacturers must submit data from pediatric clinical trials if they anticipate that the drug will be used in children. This has been in place for more than a decade. “It has been very successful in ensuring pediatric data is submitted in those jurisdictions,” Gilpin said. “The most frustrating thing is that the big pharmaceutical companies have to do those trials, they have the data, but they chose not to submit it here in Canada.” Health Canada announced a Pediatric Drug Action Plan (PDAP) in early 2021. While pediatric health organizations were pleased with the move, they suggested actions that should be added to the plan, including getting Health Canada to require pediatric clinical trial data. “There is unanimous agreement that the mandatory submission of pediatric data to Health Canada, when pediatric use can reasonably be expected or anticipated, is an urgent priority,” nine pediatric health organizations wrote in an April 2021 letter to Health Canada about the PDAP. While drug companies get a six-month extension on their patent if they provide pediatric data, many of the medicines where pediatric formulations would be useful are off-patent. Read: CPhA checklist highlights best possible setting for pediatric vaccinations in pharmacy Patient safety Not having readily-available pediatric formulations introduces a number of patient safety issues. Since many medications are used off-label in children, it means that there is no formal adverse event reporting. “By not having it on-label, we’re missing an awful lot of data that’s out there about how these medications actually work in kids,” Gilpin said. There is also a lack of communication at the dispensing level. Parents and physicians often don’t know that the child is getting compounded medication, Gilpin said. Often a physician will write a prescription, and it is only at the pharmacist level where they realize it has to be compounded. But the physician is often not informed that the medication had to be compounded. This means if the medicine is not working, the physician may not consider a possible compounding error. In a November 2021 safety bulletin, the Institute for Safe Medication Practices Canada recommended that pharmacy staff inform the prescriber that the medication needs to be compounded into a pediatric-friendly formula. While rare, compounding errors do happen. In their safety bulletin, the Institute for Safe Medication Practices Canada outlined an incident where a compounding error meant a child was given 25 mg of clonidine instead of 25 mcg, causing hypotension and bradycardia. The child had to be hospitalized. The Goodman Pediatric Formulations Centre of the CHU Sainte-Justine has had some successes over the years. For example, in 2019, Health Canada approved pediatric formulations for amlodipine and levetiracetam. Progress is slow, but it is happening, Gilpin said. The next step is to hear from parents and community pharmacists. Anyone interested in participating in the workshop or who would like to share experiences can contact Andrea Gilpin Andrea.gilpin.hsj@ssss.gouv.qc.ca Read: Yeah, but, should there be an app for that? Examining AI's benefits and pitfalls in dermatology

Community pharmacist—and parent—voices needed in push for pediatric formulations

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