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Ensuring medication safety: a shocking incident that exposed a dangerous flaw

Richard Plotzker, MD
Meds
June 28, 2023
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At six-week intervals, I replenish my supply of omeprazole. Initially, I took it for symptomatic relief of GERD, becoming symptomatic again within a week or two during periodic self-directed suspensions. An esophagogastroduodenoscopy, done for another reason, disclosed Barrett’s esophagus, shifting that daily pill of personal comfort to a more essential intervention. It falls within several Gastroenterology Society recommendations as a component of later malignancy prevention. My weekly pill case, set up every Sunday morning, ran out of omeprazole the following Wednesday, so a refill was needed.

Normally, I make a dedicated trip to a nearby big box department store which has a pharmacy section. It sells for $14.99, so I ordinarily opt for three small white plastic bottles with safety caps further sealed in a light cardboard sleeve. On occasion, I will purchase it somewhere else such as a pharmacy or a supermarket if I have some other reason to shop there and the price is within $2 of what I usually pay, or sometimes even BOGO, which gets me a three-month supply for a little savings. In addition to the white plastic bottles, the manufacturer offers this medicine in three small boxes of 14 that the consumer opens one at a time, taking out a card with each pill in a metallic blister, then pressing out how many are needed. It has less spillage but is less convenient than just taking seven pills out of the white plastic bottle each week for distribution to a daily pill case. But sometimes the retailer’s shelf has only one option.

On a major grocery expedition, needing another $25 purchase to qualify for some mega-discounts with coupons clipped from their weekly circular, it paid to get my omeprazole there. The $2 increment above my customary price would more than be offset by savings from the qualifying food coupons. They only had the three small boxes inside the one big box, so I tossed one into my cart.

A few days later, it came time to fill the weekly white plastic container with each day’s prescriptions. My last small white plastic bottle had enough omeprazole tablets to get me through Tuesday, so I took out the big box to remove the first little inner box. The outer cardboard seemed unremarkable. I opened it, removing the uppermost of the three interior boxes. Normally, these slide right out, factory sealed, to be opened by peeling the end flap from its glue. This box didn’t have glue. It had a strip of Scotch tape keeping it closed. When I removed the metallic blister pack, the only pill it contained was the one next to the Scotch tape; the other thirteen blisters were empty. I thought about returning it to the store as defective but extracted the middle small box, also sealed with a strip of Scotch tape. On removing that sleeve, it also had a single tablet within its foil blister; the other thirteen had either been removed after packing or never filled by the manufacturer’s automated packing process. The one pill still present was in the same position it had been in the top box. I did not open the third small box, also sealed by a strip of Scotch tape rather than factory-applied adhesive.

The side of the box contained some information. Manufactured in Israel, some code numbers, and an 800# consumer contact line. Despite this being the weekend, I called it and an agent answered after a short time on automated hold. A very pleasant person, same native language as me. I provided a brief description of opening their packaging, leaving the final inner box undisturbed should it need to be returned for their internal investigation. She recorded the code numbers on the box and my own contact information. Rather than return the box to the supermarket, she advised me to hold on to the product in case their complaint investigator would need it. My expense would be reimbursed. So, it remained on my living room table, where I had placed it when I made the call to their consumer center.

Several days into the week, an investigator called my home, leaving a message with my wife, who neglected to tell me about the call. Instead, I found an email from the investigator with a telephone number to contact her, which I did upon its receipt. Another very cordial and informative conversation. Again, I described my encounter, how I found the number to make the initial report, and how the packaging was still in the condition I left it when I made the first call. She definitely wanted it returned to the factory or the investigating unit for inspection. I assumed “Made in Israel” meant just that. Images popped into my mind of subversives or malcontents with an agenda tweaking their Innovation Nation’s economy to create mayhem. Harm a few consumers, or maybe harm the company to make a statement or leverage some type of concession. The daily news from the Middle East must have poisoned my perception. It turns out that while the manufacturer is indeed an Israeli company, the factories that produce their sponsored medications are scattered all over the world. My omeprazole was apparently made and packaged in Michigan. She sent me an email with a prepaid mailing label to take to the post office for priority mail.

The next day, I gingerly wrapped the box in a sheet of plastic, then placed it in one of those flimsy grocery bags that my state no longer allows retailers to offer, then put that in a manila envelope. I sealed it with packing tape, then placed the mailing label on the outside, skirting the perimeter with packing tape, followed by a short drive to the post office.

A few days later, my reimbursement came in the form of coupons: three scannable $5 coupons and two scannable $1 coupons for any of their OTC products. While I’m not at all eager to shop at that supermarket’s pharmacy again, I’ll do my best to redeem them.

While my TV addiction abated in junior high, I still tune into How It’s Made, Modern Marvels, and Food Factory episodes. The wonders of manufacturing leave me awed, as in my physician career, I’ve depended upon the creativity of developing innovative products, particularly medicines, along with their common availability. Yet, I’ve never created anything unique myself, nor have I ever scaled up a product or process to enable widespread use. I’ve had a few snafus in my professional time. Synthroid sample tablets given to me by the company got recalled due to packaging misjudgment that threatened the potency of the individual pills in their blister packs. Any number of popular medicines prescribed by endocrinologists: Vioxx, Rezulin, Propulsid, Redux all looked acceptable to the FDA expert committees until people started using them in substantial numbers. The reps confiscated my remaining samples. And then there were the Tylenol tampering deaths which made us all more attentive to how packages are properly sealed for safety at the factory. This lapse caught my attention.

I will likely never know what becomes of this incident. Yet, I have no reservations about reporting it and cooperating as best I can to make the transition from manufacturer, distributor, patient as safe as it can be.

Richard Plotzker is an endocrinologist who blogs at Consult Maven.

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