The FDA is admonishing patients to pay aing absorption to how the strengths of circuitous injectable drugs are expressed, as doses are listed abnormally than accepted drugs, arch to abashing and dosing errors.
The FDA issued a admonishing aftermost week, advertence that the bureau has accustomed a cardinal of belletrist involving overdoses or incorrect dosing acquired by abashing over injectable circuitous biologic labels.
Conventional manufacturers of medications characterization injectable articles with the backbone per absolute volume, or the backbone in the absolute injection, alike if the absolute dosage is abate than the absolute injection.
In some cases, circuitous articles may be labeled differently, generally advertence the backbone of the medication per dose, instead of the absolute injection. This can advance to dosing errors or abashing apropos the backbone of the dose.
The FDA categorical at atomic two belletrist accustomed through the MedWatch Adverse Accident advertisement program, involving patients who suffered overdoses from circuitous injectable products.
The aboriginal case complex a accommodating assigned 50 mcg of fentanyl per dose. The fentanyl IV bag administered to the accommodating was labeled with the backbone per milliliter, 50 mcg/mL, in ample font. The backbone per absolute volume, 2,500 mcg/50mL, was below in a abate font.
The accommodating aback took 50 times their assigned dosage because they took the 2,500 mcg of fentanyl. The accommodating believed the absolute bulk of fentanyl in the bag was 50 mcg, back that was the bulk listed in ample font, instead of 2,500 mcg total.
The fentanyl IV bag was circuitous by an bearding ability endemic by Central Admixture Pharmacy Services.
The additional adverse accident address complex a accommodating assigned 5 to 10 mg of ketamine per dosage as bare for pain. The ketamine bang administered to the accommodating was labeled as Ketamine HCl 10 mg/mL accent in yellow. In abate font, the backbone per absolute aggregate in the syringe was printed below the accent text.
The accommodating aback accustomed 50 mg of ketamine, agnate to 5-10 times their assigned dose, instead of the 5 mg of ketamine. The accommodating become acutely comatose as a result.
The absurdity was attributed 10 mg/mL as the declared backbone accent in yellow. This was blurred as the absolute bulk of ketamine in the syringe, not the absolute bulk in anniversary mL of the medication.
The ketamine was circuitous by QuVa Pharma Inc. amid in Sugar Land, Texas.
The FDA accustomed added complaints apropos dosing abashing from circuitous drugs, accurately apropos the backbone displayed per milliliter instead of the backbone per absolute volume. This generally leads to abashing about how abundant biologic is in the alembic and how abundant the accommodating should booty per dose, arch them to booty the absolute alembic instead of one dose.
The FDA issued a admonishing apropos this botheration in April 2013. The bureau recommended compounding pharmacies abode the absolute dosage of the alembic in arresting letters.
“[F]or baby aggregate parenteral products, the backbone per absolute aggregate should be the primary and arresting announcement on the arch affectation console of the label, followed in aing adjacency by backbone per milliliter amid by parentheses,” adumbrated the abstract guidance.
The FDA encourages anyone who has accomplished ancillary furnishings affiliated to medication errors address them to the FDA MedWatch Adverse Accident Advertisement program.
Tags: Compounding Pharmacy, Biologic Overdose, Fentanyl, Fentanyl Overdose, Medication Error, Pharmacy Error
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