SAMPLE QUESTIONS


REGULATORY Audit question:

1.  Automated counting devices [291.33 (i)][291.32(a)(1)(i-v)]

a.  SOP for device(s)? Y/N

b.  Documentation of calibration on routine basis? Y/N

c.  Does RPh perform final check after tech loads device? Y/N

d.  Does pharmacy keep record of loading bulk or unlabeled drugs into the automated counting device? Y/N

1.  Record should include: drug name, strength, dosage form, manuf, lot number, exp date, date of loading, initials of person and sig of responsible RPh


BILLING PRACTICES Audit question:

1.  REMS Medications-

a.  Does computer system automatically print MedGuides? Y/ N

b.  Medguide Required: Check Will call to see if the following meds contain med guides, tally results below.

                                 i.  Butrans, Belbuca, Dolophine, Duragesic, Embeda, Exalgo, Hyslinga, MS Contin, Nucynta ER, Opana ER, Oxycontin, Zohydro
                                                             1.  Yes:                                            No:
                                 ii.  Testosterone products: Fortesta, Testim, Androderm, Androgel
                                                             1.  Yes:                                            No:


PATIENT SAFETY PRACTICES AUdit question:

1.  Products with look-alike drug names and packaging that are known by the staff to be problematic are segregated and not stored next to one another, and a system clearly redirects staff to where the products have been relocated.  Y/N

a.  Review ISMP look-alike, Sound-alike list and identify medications on shelf within this list and write drugs below:

 

b. SCAN SHELF and identify bottles that look like, list below:

 

c. Have any medications already been segregated? Y/N