Complexity in the Pharmacy Preparation of Lyophilized Levothyroxine Formulations

BC Childress, PharmD, MBA, MOL, BCACP, FASCP, Director of Pharmacy, Owensboro Health System in Owensboro, Kentucky, discusses the potential for errors with the preparation of the lyophilized levothyroxine.

BC Childress, PharmD, MBA, MOL, BCACP, FASCP: The preparation of the lyophilized levothyroxine is complicated, one, because it is about an 18-step process to get it prepared all the way from the time it's ordered up until it's administered at the bedside. That leaves a lot of room for errors throughout all the various steps in that process. That's also complicated because it doesn't just involve pharmacy, but involves a coordination with the care team, including the nurses that are at the bedside that will eventually be administering the medication to the patient. With a process that's approximately 18 steps long to get the lyophilized formulation to the patient for injection, you’ve got potential to introduce errors in a lot of places.

First, it begins with pharmacy verification of that order. There's obviously the opportunity to make an error there at the right dose, the right concentration, is it scheduled for the right time. As it moves through that process usually you have a technician that's going to be the one putting in the diluent to mixing the product and then getting it ready for intravenous administration. There, once the diluent reaches a lyophilized product, that's when your 4-hour window for used begins and so the clock starts ticking—even before you have a pharmacist check on it and before you've got a product labeled and ready to go out the door [and sent to the patient floor]. That introduces potential for error. You could always have labeling issues. You sometimes may have a different pharmacist check a product that’s been prepared then the pharmacist was that verified the order. You've got multiple personnel involved in that and then you’ve got care coordination, you've got to get that prepared product to the floor, to the right team, and ready for the right patient. It [has to be] protected from light throughout that [process]. If you fail to protect the final product from light, it could be degraded and it could not be as safe and effective as we wanted it to be. And then you want to make sure that it's to the right care team they know how to administer it and it's for the right patient at the right time.

As you can see from all those steps in the process, there is so much opportunity for error and having a ready-to-use formulation can really cut out a lot of those steps and promote a safer process. With the preparation of the lyophilized levothyroxine, having so many required steps, it introduces the potential for errors in various ways. Those orders usually come through and have to be verified by a pharmacist, and they're going to be looking for: the right dose; the right concentration; and, the right time for the patient. There’s potential for errors there all the way through the admixture process where a lot of times a pharmacist may verify that order but then you have a technician that's going to gather the product, that's going to begin the compounding of it or the dilution of the lyophilized product, and then preparing it for injection. Then another pharmacist will have to then check off on that process, make sure it's labeled correctly, and then make sure it gets to the floor in the appropriate time span. There are also issues with storage. Once you compound the lyophilized product, you have 4 hours to administer it or it goes bad and it has to be protected from light. Even in bigger health systems you have the risk for error, but especially in smaller rural community hospitals, where you may not have overnight services or 24/7 pharmacy coverage. That introduces potential for all new care coordination problems and getting those drugs in the right format to the patient at the right time.

With myxedema coma being such a critical illness, it is very time-sensitive that we get the appropriate therapies in place as soon as we can. A lot of times when you don't have a full 24/7 staffing of a pharmacy, or in some cases where it's just urgent that we get that first dose administered, there's always going to be cases where providers and care teams can override those and pull a product from the medication cabinet somewhere and go ahead and administer that and it goes around the approval process and the safety steps that are in place for pharmacist to coordinate that and help assure safety. Having a ready-to-use product in those cabinets will even go further in helping us assure safety because now we know that we've got standardized colors and concentrations but we also have taken out a lot of those steps in the compounding process so that will make even those cases safer.

*Transcript was edited for clarity.