When teenage sons and daughters go off to college, some of their mothers call Daniel Blakeley, BSPharm, to thank him for reminding their children to take their medicine.
Blakeley, joint owner of Foundation Care Pharmacy in Earth City, MO, specializes in compounding sterile preparations for inhalation. Many of his patients are living with cystic fibrosis and must be on inhaled antibiotic therapy every other 28 days as prophylaxis against Pseudomonas in their lungs.
About 10 days before a patient is due to start the next course of antibiotics, Blakeley or a member of the patient care team calls the patient.
“We work hard at making sure that we contact them, see how they’re doing, talk to them about any issues that they’re having with their device or the prescribed therapy, and then talk to them about the need to start their therapy again in 10 days,” Blakeley said. “We get a lot of accolades from the moms of the teenage cystic fibrosis patients who go away to college. They say that we have replaced them in making sure that they take their medications when they’re supposed to.”
TOBI (tobramycin inhalation solution, USP) and Cayston (aztreonam for inhalation solution) are the only antibiotics available commercially in an inhalable formulation. Patients who require different antibiotics for inhalation—or strengths tailored to different types of inhalation devices—rely on compounding pharmacists for their therapy. As inhalation devices improve and become more efficient, the need for additional volumes and strengths of inhalable drugs grows.
The Pari Trio, a new inhalation device that many of Blakeley’s patients use, is too efficient for commercially available inhalable antibiotics.
For example, “If you use a commercially available dose—about 300 milligrams of TOBI twice a day—you could potentially start seeing side effects from the drug because the nebulizer is so efficient the patient would actually be getting twice the effective dose as compared to a traditional nebulizer,” he said.
Foundation Care’s expertise in sterile inhalable and intranasal preparations led Blakeley and his partner Mike Schultz to be selected to provide compounded drugs for two current clinical trials. One trial is testing the efficacy of an inhalable antibiotic to treat methicillin-resistant Staphylococcus aureus. The other is testing the use of an intranasal delivered drug to restore the sense of taste and smell in people who have lost their ability to taste and smell.
Foundation Care earned their Pharmacy Compounding Accreditation Board accreditation in 2009, and while the process wasn’t easy, Blakeley says that Missouri’s high compounding standards prepared his store for the challenge.
“Missouri’s standards are some of the toughest in the country. I think the state boards of pharmacy can take a lesson from the Missouri Board of Pharmacy, and other states that are doing it right, to see that there are right ways to regulate compounding pharmacy and wrong ways, and that if you hold your pharmacies to a high standard, they will deliver to them.”