NON GOV. REGULATIONS & AUDITS AND NDA Flashcards
What does ISMP stand for?
Institute for Safe Medication Practices.
Name 4 causes of medication errors identified by ISMP.
Look-alike or sound alike drug names.
Drug labeling.
Packaging similarities for different drug doses.
Misinterpreted abbreviations.
According to the ISMP, ______________ between doctors, pharmacists, and other healthcare team members contribute to medication errors.
Miscommunication.
True or False
According to the ISMP, when prescribing and administering drugs, incomplete patient information does not contribute to medication errors.
False.
Incomplete information contributes to medication errors.
What documentation must be provided when an auditor requests the hard copy of a prescription?
The original written rx, or telephone/faxed prescription drug order.
What documentation must be provided when an auditor asks if the patient picked up the prescription?
A copy of the patient’s signature or signature of the person designated to pick up the script. (Insurance log book)
What documentation must be provided when an auditor questions if we stock the merchandise we say we do?
The same size bottle billed to the insurance.
Summarize what the Joint Commission is.
A non-governmental agency that conducts voluntary certification inspections.
True or False
A Joint Commission inspection is not a “high stress” time for the pharmacy.
False.
A Joint Commission inspection process is lengthy and detailed.
Name the committees involved in the NDA process.
Medical, Biopharmaceutical, Pharmacology, Chemistry, Microbiology, and Statistical.
True or False
The development stage of the New Drug Application Process consists of being approved by committees.
False.
The development stage includes study results compiled for presentation to the FDA for consideration.
Once the NDA has been approved by the committees, there are two more hurdles to pass. They are:
Verify accurate and detailed labeling.
Inspect the manufacturing facility.
Describe Phase I of the NDA Process.
Determine tolerated dose, not efficacy.
Small # of healthy volunteers.
ETOC: 1-2 yrs
Describe Phase II of the NDA Process.
Determine drug effectiveness for intended disease group.
Many volunteers.
0 degree of effectiveness = no pass to Phase III
ETOC: 2-3 yrs
Describe Phase III of the NDA Process.
Final trials before FDA submission.
Double blind for thousands of individuals.
Compares effectiveness to a known drug.
ETOC: 3-4 yrs
