Top Tips for Acing a Board of Pharmacy Inspection
There’s nothing that can muck up a busy day like a Board of Pharmacy inspector walking through the door, unannounced, to poke around your pharmacy. Even for a pharmacy in good order, an inspector can take up to an hour of work time or more, all while prescriptions and vaccinations are backing up or you are forced to balance both the inspector’s queries and the needs of your patients.
Having everything organized and at hand will help you, who wants the inspector’s visit to wrap up as quickly as possible, as well as the inspector, who also wants to get your location checked off the list and move on to the next pharmacy.
Here are my best suggestions to get you passing with flying colors, while also making the process as painless as possible.
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Create and keep a compliance binder
A compliance binder is a collection of documents containing everything an inspector could ever ask for, or in the case that such records won’t fit into an actual binder (like invoices and prescriptions), it’s the location of all those records.
The compliance binder serves several purposes:
Helping the pharmacy manager ensure that all documentation is up to date and complete
Ensuring that any pharmacist, even floater pharmacists, can quickly find records for an inspector
Helping get the inspector in and out of your pharmacy fast, while leaving a good impression
Here’s what to include in your compliance binder:
Table of contents (so the inspector can easily navigate the binder)
Locations of all records that aren’t in the compliance binder
Pharmacy policies and procedures
State-specific record requirements
General and professional liability insurance
Training documentation
Pharmacist key log
Most recent controlled substance inventory
DEA Power of Attorney and controlled substance ordering system (CSOS) documentation
When putting together the binder, I like to use sheet protectors for each type of document, and then stick a label (I use blank address labels, which work really well) on the bottom right corner to identify the type of document. This method makes it easy to remove an old document and replace it with the new one, while keeping your binder neat and complete.
Ensure records are labeled and easy to find
In addition to listing the location of all your records in the compliance binder (including materials that will not fit or are not appropriate to put in the binder), it is best to clearly label the folders and the filing cabinets where records are kept.
I like to label each filing cabinet and each drawer by assigning them letters or numbers. Then I use those letters or numbers to describe the exact location of those records in the compliance binder.
For example, if I keep my C3-5 controlled substance invoices in the second drawer from the top in one of my filing cabinets, I might put a large “#2” at the top of the filing cabinet and label each drawer A-D, starting from top to bottom. Then, in the records location document in the compliance binder, I would have an entry that says “C3-5 Controlled Substance Records: Filing cabinet #2, drawer B.”
Clean up and maintain your archived records
Too many pharmacies “send and forget” their archived records, whether the records are sent off-site to a warehouse via third party or are stored on-site in a storage room.
Unfortunately, this can cause problems when an inspector asks for records that have been stowed away (and maybe can’t be found), or when records are kept longer than they should be, which exposes the pharmacy to liability. If the minimum number of years to keep records has been reached, discard those records; otherwise, they will become a liability.
Many off-site storage vendors have an online portal for you to track boxes, which is the absolute best way to maintain those records. If you don’t have a portal accessible or are storing those records in a separate area on-site, it’s a good idea to keep a log of what you have. Check that log once or twice every year for any records that can be destroyed, then mark them as destroyed. If you keep a paper log, keep that log in the compliance binder.
Review the Board of Pharmacy inspection checklist
Many states publicly post their inspection checklists on their websites. This is not only for the inspector, but also as a tool for managers to audit themselves. After all, the primary role of the Board of Pharmacy is to protect the public’s health; by preventing compliance mistakes, the board can further that mission. (I live in Florida, so as an example, Florida’s checklist can be found here.)
What’s the best way to use this form to maintain compliance? Here is what I do:
Print the form out at least once or twice per year for a full review. These forms are updated regularly as laws change, so in addition to helping you maintain compliance with existing laws, this will also help you keep up with changing laws.
Go through each item as if you were the inspector. Be hard on yourself so the inspector doesn’t have to be. Are all your licenses actually posted in a conspicuous place? Are your daily logs signed and readily accessible? Are your controlled substance records in order?
Bonus: Write a response for each item. In my compliance binder, I have a document where I’ve copied and pasted every item on the inspection checklist in one column and jotted down a response, if I think a response or clarification may be helpful, in the other column. For example, for “Controlled substance inventory taken on a biennial basis and available for inspection,” I wrote something like “Most recent controlled substance inventory is in the compliance binder. Previous inventories are available in the filing cabinet, drawer C.”
Pharmacy inspectors have the same goal in wanting to protect the public. Preparation and staying on top of record-keeping are key to having a smooth inspection.
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