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Why Do These Pharmacy Laws Exist?

While every industry has its unnecessary regulation, various government agencies (both Federal and state), standards agencies, payers, and middlemen have created a web of regulation in pharmacy so complex it's enough material for an entire website just to help pharmacies sort it out (ahem.....yours truly).


All of us would agree that some or even most of it is necessary, but others are the bane of my existence (yes I do still comply though). They are a waste of time, produce no meaningful information that cannot be obtained elsewhere, and they pull us all away from doing what we were trained to do.


To celebrate their faithful contributions to wasting our time, I'm presenting each of them with the PharmCompliance Medal of Stupidity!


GOLD MEDAL

CSOS Archiving

The enforcing agency: The DEA


It was a fierce competition for gold, with so much stupidity in the running, but at the last minute CSOS Archiving pulled through!


I was afraid with the DEA eliminating triplicate forms he might not make it, but he worked hard to prove just how idiotic he is.


Yes, Federal law requires that, in addition to:

  • The wholesaler reporting to ARCOS (the wholesaler's version of the PDMP);

  • The pharmacy electronically receiving the medications in the wholesaler's website;

  • The pharmacy printing a copy of their CSOS order, then signing and stapling it to their paper invoices and filing it for at least two years (or longer in many states . See our honorable mentions!);

  • 99%+ of pharmacies also logging the order into both a paper log and a computerized perpetual inventory,

Pharmacies must also save a .pdf copy of their CSOS order and upload it into their own electronic drive (again, for at least two years).


Who knows? Maybe one day the entire ARCOS system will go down, the wholesaler's site will crash, and the pharmacy will burn down (along with all that tinder called 'invoices') and the only thing left will be your hard drive that somehow survived the burn. And, after all that, the biggest thing we'll need to know is how many bottles of oxycodone you ordered a year and half ago.


PLEASE.....make it stop.


SILVER MEDAL

The "Daily Signature Log"

The enforcing agency: The DEA, and most state Boards.


"Mrs. DSL," as we'll lovingly refer to her in this post, put up a tough fight for the gold. Ultimately, though, she is easier to make a part of our opening and closing procedures than Mr. Archiving is (I think he got he got an honorable PhD, so maybe he's 'Dr. Archiving'?).


Still, though, she presents a completely worthless additional step in our day that also provides pointless fodder for inspectors. I personally really like our state inspector, who has just asked me to be sure going forward that everyone is signing it (we were missing a few signatures once out of 3-4 inspections we've had), but I can definitely see an inspector with a power trip going to town with this.


I guess the supposed point, though, is that you are 'attesting that everything is accurate,' whatever that means. I haven't personally met a pharmacist who would purposely make an error, and regardless attesting accuracy is completely meaningless and, in a court case, our liability would be judged through professional duty, not Mrs. DSL.


That leads me to think - maybe Mrs. DSL is there to keep track of who is working that day?


But how, might you ask, without our chicken scratch in a notebook could we ever know who was working that day?


In case someone is reading who can make Mrs. DSL go away, here are a few ideas:

  • Our electronic time cards

  • The security cameras

  • The workflow history in the pharmacy dispensing system

  • The other staff working that day

  • Patients

  • Our initials on the quantity part of the label on a C2 (99+% of pharmacies double-count and initial, and many only allow pharmacists to count C2's).

  • The printed initials on the back-tag of the prescription

  • The initials on the perpetual inventory log

  • The initials on the temperature log

  • The initials on the Vaccine Consent Forms

As with Dr. Archiving, though, you can never be too sure. We better keep signing that notebook in case all else fails!


Until this law can change, if you want Mrs. DSL to be as little of a hassle as possible, check out this one available for download. Print that sucker off and you're set for a year of fun.


BRONZE MEDAL

Printing and filing non-controlled electronic prescriptions

The enforcing agency: State Boards of Pharmacy


Notice the word 'electronic.' I should stop here, because that should be enough to know where I'm going with this, but I'm having too much fun, and plus it's my site anyway!


To all you BOP's out there - I know you all have pharmacists on them, don't you? Aren't many of you even still working in a pharmacy? Why are you making us all do this?


While it's true that, without printing an electronic prescription you wouldn't know if you have a complete book (i.e. are missing a paper prescription), let me propose to both you and the pharmacy IT industry how to fix this:


Step 1: Make the law go away. Pharmacies will then want a way for their software to filter electronic from paper prescriptions so they can quickly know that they have a complete book.


Step 2: The IT industry steps in and creates a computer system with a new filing method; I'll let you use your imagination, but here's an idea:

  • All non-controlled electronic prescriptions start with a "7" - "7516000"

  • All non-controlled paper prescriptions start with a "6" - "6516000"

  • All C3-5 and C2 start with a 4 and 2, like they usually do. We still pointlessly print those out for now (and initial!) just so you don't have to change too much at once.

Voila! Problem solved. Now, if it's electronic, it won't interfere with keeping the books straight.


HONORABLE MENTION

Keeping paper invoices

The enforcing agency: State Boards and the DEA


I've been a pharmacist for ten years, and I've never needed paper invoices for anything other than showing the inspector. The inspector has never needed the invoices for anything other than making sure I have them.


Aren't we having fun yet? I love this game. Make up as many rules as possible to distract me from doing my job, then come in once every 1-2 years just to make sure I'm doing them!


Inconsistency in record retention laws

The enforcing agency: Who knows?


So I recently worked to create a draft of our national record retention policy (which included Federal and each of about 15-20 states) and quickly gained an appreciation for how much of a pain in the butt it is just to figure out how long, in each state, you even have to keep something.


The Controlled Substance Act says 2 years, your state says 5 years, and CMS says 10 years! And this is for something simple, like a prescription. But what about your last on-site PBM audit? How long should you keep that? What about a subpoena? How about those records you have from firing your last employee for showing up drunk?


You can't, and don't, want to keep any of these records past when they can be destroyed (and thus not be brought up in a court later). But no one will just tell you straight how long to keep them.


DMEPOS Accreditation and Set Up

The enforcing agency: CMS


In two words: You suck. I can bill Medicare Part D, which the government ultimately pays for, for medications worth thousands, but to bill a walker or a $5 box of lancets I need to go through DMEPOS accreditation, fill out the beloved CMS-855s, get set up with a "CEDI," and more? It sounds like a sadistic theme park, but in fact it's just called Medicare.


In case you're stabbing your eyeballs out right now trying to deal with this form so you too can get $5 from Uncle Sam for those lancets, check out my post on DMEPOS accreditation.


Requirements for 19th Century Supplies

The enforcing agency: State Boards of Pharmacy


"Mr. Technician, where are our weights for my Torbal scale so I can compound cocaine toothache drops for that fussy child!"


Ahh... fond words I hear all the time in our 19th century, snake-oil slinging establishment. Thankfully, I keep my weights handy so I'm always ready for the next "recipe."


Unless you're in a compounding pharmacy, your scale, glass stirring rod, beakers, and extremely outdated copy of the USP compendium sits in the back as a $2000+ museum of pharmacies past.


[So this doesn't get misread - I have enormous respect for the USP. We don't need 100 chapters on manufacturing and food standards laying around, though. If we're that bored at work we'll look at cat videos or maybe even PharmCompliance].


This goes back again to professional judgement - we'll mix magic mouthwash, we'll reconstitute antibiotic suspensions, but we're not going to weigh out tiny amounts of powder and then mix it with gelatin and other magic for that dog's salmon-flavored heart worm medicine in-between vaccines and the drive through.


With the majority of medications needed being commercially prepared, the safest thing is for pharmacies to either get into compounding (which is a specialty in and of itself), or not. If they are, they should actually do it and get PCAB accreditation. Pharmacists should go through significant additional training, too.


There you have it folks. Which laws would you like to give an award? Let me know!


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