Dispensing of Biologics Flashcards
What should Pharmacists know about biological drugs?
-knowledge of biotechnical production
-therapeutic aspects
-Able to educate patients: Usage, precaution, side effects
-storage conditions!! (biologics are sensitive to aggregation and cause ADA harming the patient)
-knowledge about reimbursement issues
How should Biologics be stored?
-Avoid temperature extremes (heating, freezing) - store at 2-8°C: weak interactions in the structure can easily be disrupted by temperature
-some products are at RT (f.e. G-CSF (filgrastim, Neupogen); Etanercept for 30 d at RT)
-follow individual product insert!
What can help to monitor the cold chain of a drug?
-Apps connected with a temperature sensor, that monitors the temperature
Why are biologics so prone to adsorb to the device?
Because of the hydrophobic regions that are looking for a way to reduce the surface tension -> they stick the wall of the device rather than being in contact with water
What are the challenges with Dosing devices?
-Adsorption to dosing devices (about 75% loss)
-Adsorption is greater in dilute solutions causing more loss (the dose is low in dilutes so the loss is more severe, compared to a concentrated high-dosed drug)
-Human serum albumin (HSA) added during reconstitution can reduce adsorption
-the requirement of prefilling of syringes and storage + type of syringe
What is an example of a light-sensitive Biological drug
and how can the patient protect it from light?
-Dornase-alpha (Pulmozyme) is a DNAase
-stored in light-protected pouches or special travel pouches
Why is shaking or agitation critical for Biological drugs?
How to handle Biological drugs instead?
-Shearing triggers tertial structure change -> hydrophobic start aggregating
-Gently swirling during reconstiution
What are the signs of instability within the biological drug?
-Frothing, cloudiness, or physical separation
Why is the dose different for the same Biological drug?
-Depending on the indication (or disease to treat) the dose may vary
-Adalimumab (Humira) is given at 40 mg sc every other
week for Rheumatoid Arthritis
-For Crohn’s, 160 mg sc twice a day for 2 days, followed
by 80 mg/week followed by 40 mg/week
Why should biologicals NOT be filtered?
-filtration is often performed for IV administration
-Because the proteins may adhere to the filter material
-Biologicals need to be injected below line filters
-if required a special low protein-binding filter must be used
What are the solutions that are used for flushing?
5% dextrose or 0.9% saline
Why should Biological drugs NOT be mixed and co-administered with other drugs?
Because there could be incompatibilities between the drugs
Why may Biological drugs cause Hypersensitivity?
f.e. from a mouse
Because biological drugs may have a non-homologous origin (not from humans, f.e. from mice)
-Example: Infliximab (mouse-origin) causing IgE-mediated skin irritation
What are strategies to encounter hypersensitivity?
-prophylaxis for infusion reactions
-acetaminophen and diphenhydramine pretreatment -> mouse-originated drug
-Lowering infusion rate
Which type of antibody in the human body mediates hypersensitivity?
IgE (on mast cells)
-drugs bind to IgE on mast cells, and cause Granulation
