Innovations-Magazine-August-2022 - 6

INTERVIEW WITH A BOARD INSPECTOR
Gillian Staikos, RPh, CISCI
Senior Pharmacist, Florida Department of Health
How long have you been serving as
an inspector for the Board? What
was your prior role?
I have served as an inspector for five years.
Prior to this position, I was a pharmacy
director at a rural disproportionate share
hospital and worked in home infusion.
I have spent most of my 33 years as a
pharmacist in hospital pharmacy. I qualified
as a pharmacist in South Africa and took the
Foreign Pharmacy Graduate Equivalency
Examination®
in 1998. I now also have
Florida
Board of Pharmacy
Number of Board
Members
7 pharmacist members
and 2 public members
Number of
Compliance
Officers/Inspectors
29
Rules & Regulations
Established by
Board of Pharmacy
What tools or skills are a musthave
in a pharmacy inspector's
toolkit?
Senior pharmacists in Florida are responsible
for inspection of sterile compounding permits,
so knowledge of United States Pharmacopeia
(USP) Chapter <797> is important. We also
complete inspections under Section 503B of
the Federal Food, Drug, and Cosmetic Act
and must be knowledgeable about current
Good Manufacturing Practices.
Patience and listening skills are also
important. I believe that you get a better
response from people when you are not
intimidating. The goal of my inspections
is to find areas of noncompliance, so that
changes can be made that ultimately
improve patient safety.
Number of
Pharmacist Licensees
35,824
Number of
Pharmacies
10,109 (in-state)
Number of Wholesale
Distributors
Regulated by another
state agency
What are some common issues
that you have witnessed and
addressed as a board inspector?
It is very frustrating when you reinspect a
facility and find that it has not fixed the
problems you noted. A very common
response is, " Nobody told me that. " It is
hard to explain to people that they are
responsible for educating themselves.
In Florida, do inspectors also
conduct investigations for other
health regulatory boards?
No.
4 | AUGUST 2022
Foreign Pharmacy Graduate Examination
Committee™ Certification.
Is there an inspection experience
that you found particularly
interesting, egregious, or unusual?
The Florida Board of Pharmacy adopted
USP Chapter <797> in its entirety, and
pharmacies in Florida are required to have a
sterile compounding permit for compounding
of sterile preparations. During the inspection
of a community pharmacy with no sterile
compounding permit, we noticed instructions
on the wall for making vancomycin and
tobramycin eye drops that had been requested
by physicians. The drops were compounded
in a powder hood with expired vials of
vancomycin and tobramycin and given 14
days beyond-use dating. The pharmacist was
totally unaware of requirements for sterile
compounding of eye drops and felt that he
was not doing anything wrong. Unfortunately,
he had a lot of dirt on his shelves and the
equipment he used for compounding. In
2020, he had items in his stock that had
expired in 2005, kept food in the refrigerator
with medications, could not find his biennial
inventory for controlled substances, and had
not completed any of his Drug Enforcement
Administration Form 222s. As a pharmacist, I
was disappointed that a professional serving the
public as a pharmacist would put the health of
people at risk by not remaining in compliance
and following simple pharmacy requirements.
What advice would you give to a
new board inspector?
Knowledge is key; make sure you know
the subject. It is important to understand
the statutes and rules. The power is in the
pen - document what you see. I try to
explain to pharmacists that inspections can
be used as a learning tool for improvement.
It is important to understand that
pharmacists are very busy, normally
multitasking on a daily basis. When
completing an inspection for sterile
compounding, you will be at the pharmacy
for four to six hours. While completing an
inspection, you have to assure the pharmacist
that patient care comes first.
Innovations-Magazine-August-2022

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