Jerry Fahrni

Tag: fda

  • Don’t confuse Durezol and Durasal (S.A.L.A.D.)

    PharmQD: “FDA is alerting pharmacists and other health care professionals of potential injury due to confusion between the FDA-approved eye medicine Durezol (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover Durasal (salicylic acid) 26%.

    There has been one report of serious injury when a pharmacist mistakenly gave an eye surgery patient Durasal, the salicylic acid–containing wart remover, instead of the prescribed Durezol eye drops. Durezol is approved for treatment of inflammation and pain association with ocular surgery.”

    Seems like I’ve read about this mistake before. Being their typical efficient self, the FDA alert was issued on December 28, 2011, more than three months after ISMP alerted everyone.

    Some things you can do to prevent stuff like this from happening include (taken from a Pharmacy Times article):

    • Include both brand and generic names, along with indication, when prescribing look- or sound-alike drug names.
    • Spell out drug names that have been confused when accepting telephone orders. Require staff to write down the prescription and then perform a read back (and spell back for drugs that are known to cause confusion) of the complete prescription for verification.
    • Assign time to provide counseling to patients and/or caregivers, especially for new prescriptions.

     

  • Wanna’ tell the FDA about drug shortages? Here’s how

    Here’s the contents of a email I received today from ASHP in regards to drug shortages and the FDA:

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    The Food and Drug Administration Wants to Hear How Drug Shortages Impact Patients

    The Food and Drug Administration has opened a comment period to gain insight about the causes and impact of drug shortages. The agency is seeking feedback as a follow up to a public workshop on the impact of shortages.

    You know first-hand the devastating effect that drug shortages are having on patient care.  Today, ASHP’s Drug Shortages Resource Center lists 208 shortages. That’s nearly the same number of shortages that were reported in all of 2010.

    This is your chance to speak up.

    Write a letter to the FDA that describes your experiences and challenges managing drug shortages.  Here’s what you should include:

    • Impact on patient care.  Share examples from your practice site, such as patients who’ve had to delay care or who’ve experienced adverse affects from second-line therapies.

    • Impact on pharmacy department operations: Discuss how the time spent researching availability of drug products and the redeployment of pharmacists from patient care roles affects the pharmacy department.

    Be sure to ask your colleagues in the pharmacy department as well as your nursing and physician colleagues to join you. Enlist your patients as well. Every voice counts!

    The deadline to submit comments is December 23, 2011. You can post comments on www.regulations.gov or send comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.  See the Federal Register notice for more details.

    Your input and expertise are not only welcome, they are essential to achieving a solution to this critical issue.

    Use the resources below to familiarize yourself with ASHP’s messages on drug shortages.

  • “What’d I miss?” – Week of August 9th

    As usual there were a lot of things that happened during the week, and not all of it was pharmacy or technology related. Here’s a quick look at some of the stuff I found interesting.
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  • FDA revises ceftriaxone-calcium warning

    The FDA has issued an update to the previous alert on the interaction between calcium and ceftriaxone (Rocephin). The original warning was based on reported fatalities involving neonates. The update occurred after Roche (manufacturer of ceftriaxone) conducted two studies using neonatal and adult plasma with varying concentrations of ceftriaxone and calcium. Based on the results, ceftriaxone and calcium-containing products may now be used concomitantly in patients greater than 28 days old.