Control your controls
Important question of the day:
How proactive are you with accountability of your controls?
not sure?
Keep reading
Reality:
The DEA Pharmacist Manual and state board rules are the MINIMUM standards you need to follow… I know, it’s a bummer. The rules are already stringent and it can be a lot of work.
Your mindset should be to impress them. They like that stuff, kinda like being the teacher’s pet. Except this one will help you avoid return inspections, spiking cortisol levels and thousands of dollars in fines.
Physicians write for them, yes, but YOU are in possession of them. So you’ve got a whole other set of rules to follow.
Lets take a quick trip down the rabbit hole and make sure you’ve got your basics (and a few tangents) covered. Link to printable version of this here.
But honestly, what else is new?
SOPs and documentation-
This is where they will start. They want to see what you’re doing in writing first then verify you are actually performing according to your manual.
Professional Responsibility- This SOP would include your policies on verifying a legitimate medical purpose, what to do in the case of suspected and confirmed forgeries, and identifying pill mill practices.
Prescription Monitoring Programs- Its voluntary right now but starting in September of 2019, all Texas Pharmacies will be REQUIRED to check PMP for the for ALL schedule II-V medications. Start incorporating into your workflow now.
So get all your pharmacists signed up and all your techs delegated under the pharmacists. Not sure how? Heres a link.
It is not going to be required that you document on the prescription itself that PMP was verified- but I would strongly recommend getting your staff in this habit. It proves an action was performed and can reduce redundancy.
Internal and External Diversion- This describes the measures you are taking with staff and external theft prevention. This is also a required SOP for many PBM/CMS contracts and a great training opportunity.
I also recommend looking at the burglary post I recently did and incorporating those items as well.
Ordering/Receiving Controlled Substances (CS)- Speaks for itself, but this section will include a description of how you properly use CSOS and file all paperwork.
REMEMBER! CSOS can only be used by the person it is assigned to. Think of it as if you were forging someone’s signature of a paper 222.
Print all your CSOS paperwork after you save the pdf’s. It IS more work and more paper BUT if you can’t retrieve the document, its a $10,000 fine PER LINE for anything you can’t retrieve.
Dispensing of CS- This overlaps with the professional responsibility but it can also include how to properly document for certain medications. For example:
Buprenorphine
For opioid withdrawal: The pharmacist MUST verify a Physician has a waiver under the DATA 2000 program that allows them to prescribe Buprenorphine for opioid withdrawal.
For Pain management: Obtain a diagnosis code for pain management from the practitioner’s office.
Fentanyl
The pharmacy should attempt to obtain a diagnosis code and document on the hardcopy. If Dx code is not for Oncologic purposes, Insurance may recoup reimbursement. I’ve seen a pharmacy lose $25,000 for 1 year’s worth of refills.
Testosterone
The pharmacy should attempt to obtain a diagnosis code and document on the hardcopy. TSBP does not allow prescribing of testosterone for muscle building. Check with your board
The FDA is constantly updating the REMS website. It is your responsibility to be aware of changes and implement. I recommend subscribing for REMS updates here.
Inventory Control
Perpetual Inventory Monitoring- This section describes your perpetual monitoring system of CIIs.
Annual Inventory- Make sure you have all your documentation in order.
Quarterly Audits- Required by the TSBP. Here’s an example of documentation.
What to do with expired meds in each class and how to document it
Internal investigation into discrepancies, determining what is significant and actions to take it is it.
PSE sales- explain how you will train staff, track and document sales.
Facility and Inventory-
Review your current pharmacy lay out and security measures.
Are your CIIs in a locked cabinet? Is it out of site? Is it secure or bolted to a wall, floor or the ceiling?
Are your expireds logged and secured in a way thats shows if they have been tampered with?
Is your key log up to date?
Have you changed the alarm codes recently?
Does every person able to disarm the alarm have their own code? Are the security alarm codes checked regularly?
Compounding Pharmacies-
Don’t worry, I didn’t forget about ya.
Are your production logs organized? How often is a pharmacist or the PIC checking them?
Where are you storing your controlled substance APIs?
How are you accounting for waste?
Are these controlled compounds coded correctly in your data processing system so that they are being reported accurately to your state board?
Have you performed a risk assessment to comply with USP 800?
Organization-
Make sure all invoices from receiving and distributing are separate by schedules, and signed and dated. Have a tech go back for the last two years and verify.
Keep a binder for your perpetual inventory documents.
See my post with a free Audit Binder.
Extra Credit-
you are the teacher’s peT after all….
Make sure you a reporting your dispensing correctly, especially when you get new software
Perform in-service trainings and document!
Become familiar with your state board’s policies on pain management clinics and any other controlled substance regulations they post on their site. Here’s one for the TSBP.
I’m sure you’ve all seen the CDC infographics for pain medicine and PDMP. But never hurts to have them incorporated into your SOPs, especially now that PMP gives you that information.
Get educated about Naloxone dispensing.
Perform the self-evaluation checklist. Document and file it.
Take a serious look.
Grade yourself.
Fix it.
My References for this post..
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