Compliance Corner: ‘Pharmacist-In-Charge’ Reminders
Montana Administrative Rule 24.174.301(28) states in definition,
“‘Pharmacist-in-charge’ [PIC] means a pharmacist licensed in Montana who
accepts the responsibility for the operation of a pharmacy in conformance
with all laws and rules [state and federal] pertinent to the practice of pharmacy,
who assures that the pharmacy and all pharmacy personnel working
in the pharmacy have current and appropriate licensure and certification,
and who is personally in full and actual charge of such pharmacy. . .” In
other words, as the PIC of a facility, you become responsible for all actions
and activities in your facility.
Maybe you are the owner PIC or you have been asked to be the nonowner
PIC. What does this mean to the Board, to Bob and Bill as inspectors
for the Board, and more importantly, to you, the PIC? By now, most of
you have been inspected multiple times in your facility and hopefully you
are on the same page as the Board and its inspectors. However, the Board
continues to see certain issues that you are responsible for that have somehow
been missed in some locations. With this in mind, the Board felt that
it was time for a PIC reminder related to what the Board will continue to
review and look for on each site visit/inspection. Some things to consider:
♦♦ Is your facility license, all of its endorsements, and its Drug Enforcement
Administration (DEA) license current and posted?
♦♦ Is the license and certification of each employee current and posted
in your facility (this includes pharmacists, interns, technicians, and
technicians-in-training)?
♦♦ Does each technician you employ have his or her certificate for being
a certified pharmacy technician and his or her CE file up-to-date
and on site?
♦♦ Is the DEA initial controlled substance inventory or biennial inventory
current and on site?
♦♦ Is the technician utilization plan (if you use technicians) up-to-date,
on site, and accessible?
♦♦ Are your policies and procedures for the facility and its employees
current and in line with the practice standards of pharmacy?
♦♦ Are your collaborative practice agreements current, signed, and on
site?
♦♦ Are all of your record keeping requirements current and available for
inspection (prescriptions, profiles, invoices, inventories, etc)?
♦♦ Are you and your facility Health Insurance Portability and Accountability
Act-compliant?
♦♦ Is your drug inventory properly stored and secured?
♦♦ Is access to the facility properly defined?
♦♦ Is patient consultation taking place in an appropriate area in the
facility?
♦♦ Are you using any ancillary personnel to aid your facility and are they
properly identified?
♦♦ Do you have Internet access to use the Board’s web page (www.pharmacy
.mt.gov) and the Montana Prescription Drug Registry (MPDR) program
(www.mpdr.mt.gov)?
The Board recognizes this is a long list, but know that it is just the
beginning of the inspection process you are responsible for in your facility
In addition to all of the record keeping requirements, as the PIC you
also are responsible for all the actions of personnel working in the pharmacy.
So, how does a PIC stay on top of all of this, especially in a busy
facility? Some recommendations include that you need to be properly
trained as a PIC so that you can proactively train your staff, and then take
time to revisit any problem areas.
As all of you know, things are changing rapidly in the practice
of pharmacy and the facilities you work in. Communication is a key
component in getting all the staff on the same page to meet all of these
expectations. Whether you use policies and procedures, bring up files,
automatic reminders, read-and-signs, e-mails, staff meetings, or some
other avenue to get the information out to all your staff, it needs to happen.
Issues need to be addressed sooner rather than later, as they will not go
away on their own. The Board also suggests you actively use the Board
website at www.pharmacy.mt.gov to stay up-to-date on issues, rules and
regulations, Newsletters, and other important information from the Board.
No one said it would be easy, but it is expected!
quoted from here
The Canadian Pari-Mutuel Agency has issued a notice to the racing industry regarding compounded medication.