Innovations-Magazine-April-2023 - 11

ASSOCIATION NEWS
NABP Inspections by the Numbers, 2018-2022
STERILE COMPOUNDING
OUT OF 1,198 VPP INSPECTIONS
Pharmacist does not provide (proactive) counseling for all new prescriptions
picked up at the pharmacy
Pharmacist does not provide (proactive) counseling for all refilled prescriptions
picked up at the pharmacy
Pharmacist does not provide (proactive) counseling for refilled prescriptions
picked up at the pharmacy when there is a change in therapy or other issue
Patient/caregiver training programs/materials do not contain information
on handling and disposing of nonsterile compounded products like fentanyl,
hormones, and chemotherapy medications*
*Out of 676 inspected
COUNT %
271
23%
547 46%
OUT OF 598 VPP INSPECTIONS
Pharmacy performs medium-risk sterile compounding
Pharmacy performs sterile compounding with hazardous drugs
263
22%
Pharmacy sends sterile samples to an outside lab for testing
106
16%
Sterile compounded products are noncompliant in visually checking for
particulates or other foreign matter against a light- and dark-colored
background as a condition of release
COUNT %
391
65%
274 46%
COUNSELING
333 56%
153
26%
STERILE ENVIRONMENT, ENVIRONMENTAL
MONITORING, AND GARBING
OUT OF 598 VPP INSPECTIONS
Clean/buffer rooms are noncompliant by having dust collecting overhangs
Pharmacy is noncompliant by not having a working sink located on the clean
side of the line of demarcation that enables pharmacy personnel to wash hands
and enter the sterile compounding area without contaminating hands
Noncompliant hand cleaning is performed in the anteroom and includes
removing debris from under the nails with a nail cleaner followed by a vigorous
washing of the hands and forearms with soap for at least 30 seconds
Air pattern analysis using smoke testing was not performed under dynamic
conditions
COUNT %
70
52
12%
9%
NONSTERILE QUALITY ASSURANCE
OUT OF 676 VPP INSPECTIONS
Nonsterile recall system is noncompliant in including both patient and
physician/prescriber regarding the affected nonsterile compounded
preparations
Nonsterile quality assurance programs do not identify action limits or
thresholds and the appropriate follow-up mechanisms when action limits
or thresholds are exceeded
119 20%
Nonsterile patient profiles are not complete and drug utilization review is
not performed for each prescription
107
18%
Facility does not have a continuous quality improvement program that
includes end-product testing for nonsterile compounded medications
COUNT %
48
7%
98
14%
187
179
28%
26%
PRODUCT TRACING
TEMPERATURE MONITORING
OUT OF 179 SUPPLY CHAIN INSPECTIONS
Facility has a process for identifying returned items and moving to quarantine
in a timely manner
Facility has a process for ensuring that product tracing information is received
prior to placing items into stock
Facility distinguishes if the prescription drugs it has sold or distributed are subject
to Drug Supply Chain Security Act product tracing requirements
Facility has a process for when receipt does not match the purchase order
and packing slip
COUNT %
173 97%
OUT OF 179 SUPPLY CHAIN INSPECTIONS
Facility has a process for identifying temperature-sensitive items and
ensuring that required temperatures are maintained during transit
161 90%
Facility has both heating and cooling for all product storage areas
154 86%
175 98%
Temperature/humidity data are reviewed periodically
Facility has humidity alarm settings
COUNT %
165
92%
167
93%
153
105
85%
59%
APRIL 2023 | 9
Innovations-Magazine-April-2023

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