Unfortunately it is all-too common in the community pharmacy for the pharmacy manager to have all the pharmacy records filed away nice and neatly, all by themselves, with their own system of filing, in a place where no one else can find it. I get it - as manager you are legally responsible for ensuring the pharmacy maintains the records required by law and you want to ensure that no one messes up the filing, that you can find it quickly in the case of an inspection, and that all records are there.
Have you thought, though, about what would happen if an inspector came in while you were out? Maybe your regular staff pharmacist is there and will call you.
But what if:
1) It is a float pharmacist you've never met and has never worked at your store (if you work for a chain pharmacy or an independent with multiple locations this is very possible) or
2) You are out of the country or otherwise cannot be gotten ahold of?
Now your staff is there, in your pharmacy, with the inspector present, trying to find the records that are required by law to have and that are being requested. They know you have them because you keep everything in great order but just can't find them. Unfortunately the inspector will probably not give you a pass and come back when you are there. Make sure your staff knows where to find important records!
How can you do that? Here are my top tips:
1. Make a compliance binder: I will be elaborating on this in a future article, but this binder is essentially something that could be given to an inspector, even with no explanation, and the inspector could use it to find all the information they would need. It should also have your contact information in it.
2. Make a list of records required and their location: A best practice would be to put this list inside the compliance binder. The list of required records can be very long and it is easy to overlook something, which is why I recommend you check out my free template to get you started. When making your list, think of everything possible they could ask for. When describing location, make sure it is associated with the drawer number (or letter) of the filing cabinet it is in (see Tip #3). Also, don't forget to add any state-specific or service-specific records you might need in addition to these.
3. Label the filing cabinet: It doesn't have to be fancy. I have always used a Word document, scissors, and some clear tape but if you're really into making things pretty you can go for a label maker. The labels for the filing cabinet can consist of two parts:
Labels identifying each drawer and/or cabinet ("Drawer 1" "Cabinet A", etc): This should correspond to the location specified in the records list in your compliance binder.
Labels identifying each drawer's contents: This is basically a backup to the list of records in the compliance binder. It will make it even more obvious where everything is and will reduce the time the pharmacy staff and/or inspector have to search to find what they need.
Before you get started creating your filing cabinet labels, be sure to download this one in the Free Products section.
4. Communicate this information to your one-up: If you are working for a chain or larger organization with multiple layers of management it is imperative to ensure that your direct supervisor (District Pharmacy Manager, etc.) knows about your compliance binder and your records location list. In addition to them being very impressed (and possibly rolling it out to the other locations) they can serve as your backup in the case that you cannot be reached when there is an inspection. After all, it is very unlikely that your staff would not be able to reach you or your supervisor.
5. Separate the controlled substance records: As in the example above, it is best practice to have drawers of the filing cabinet dedicated to controlled substances. While this is not the law (the law only requires that specific records be separated, like invoices or prescriptions), doing so will ensure that the records can be found quickly, that if the DEA (for example) comes they can get everything they need in just one (or two) drawer(s), and that you can quickly ensure all the records are there and identify when records need to be destroyed.
6. For archived records, be sure everyone knows where they are: Some of our records are boxed up in a closet that is in a completely different part of the building. Other records are off-site. This is the best way to manage archived records:
Specify archived records on the cabinet and the required records list: For my archived records I have the room number (or location) AND key number to unlock that room printed on my filing cabinet label. Even if they don't know where our key (or the room) is they can easily call and find out with that information. The entire organization only uses one vendor to store records off-site, but if there is any possibility of confusion about where those records might be then it is best to specify that as well.
Don't send control records off-site: It is best not to ship control records out; keep them in-house, clearly labeled, and in chronological order.
Keywords: Pharmacy record keeping, filing, controlled substance records