Who monitors pharmacies’ systems to curb pseudoephedrine sales?

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CVS Pharmacy has been in the news recently after it agreed to pay $75 million in penalties and forfeit $2.6 million in profits made from illegally selling pseudoephedrine. Scott Hensley did a nice job of explaining why the retailer got in trouble, which boils down to a defect in the electronic system the chain used.

As most allergy sufferers know, federal laws (and some state laws) limit how much pseudoephedrine consumers can buy. Retailers are left with the chore of monitoring who buys how much of the drug, which also can be used to make methamphetamine.

As the CVS case seems to show, and my personal experience backs up, retailers apparently can set up their own systems for tracking the sale of pseudoephedrine as long as they meet some basic requirements:

Regulated sellers are required to maintain a logbook, written or electronic, to record sales of products containing ephedrine, pseudoephedrine, or phenylpropanolamine. The seller must enter into the logbook the name of the product, and quantity sold. The customer must write or enter into the logbook their name, address, date, and time of sale. The customer must also sign the logbook. You may not sell the product unless these requirements are met.

What isn’t clear is who is regulating those systems.

If a retailer’s system doesn’t prevent someone from making multiple pseudoephedrine buys and exceeding the federal limit – as happened at CVS – or if a retailer’s computer program mistakenly calculates the wrong amount of pseudoephedrine contained in a medication, then the system is failing. In the case of CVS, the problem happened for more than a year at multiple locations.

Now, for that personal experience I mentioned earlier …

After recently being told I had met my limit of pseudoephedrine at a neighborhood pharmacy, despite the fact that I take less than the maximum dosage to control my allergies, I asked to look at the store’s records.

A sympathetic pharmacist showed me the log of my purchases and I discovered that when I bought a package of 18 pills, the store’s computer recorded it as a package of 18 pills, but it calculated the amount of pseudoephedrine in that package to be the same as what would be in a 36-count package. That amount of pseudoephedrine was what triggered the computer to tell the pharmacy not to sell any more to me.

Once I pointed out the error, the pharmacist got out a calculator and eventually concluded I was right. He was rather incredulous that the error could happen. He tells me that he’s put in a request with the company’s help desk to fix the problem.

However, I’m left wondering whether my name is flagged in a computer database somewhere because of the store’s error and how many other innocent people are also flagged. Not to mention how many allergy sufferers have been left unable to breathe properly because computer systems show they’ve bought more pseudoephedrine than they actually have.

Perhaps more importantly, what about the methamphetamine criminal cases that have been brought as a result of authorities examining these records? There was recently a large raid on meth labs in my area based on pharmacy records and the pharmacist I talked to said he’d been in court testifying recently in meth cases. Could errors in pharmacy records be a defense attorney’s dream?