The Latest Pharma Theft: Generic Epilepsy Pills
12 CommentsBy Ed Silverman // June 1st, 2010 // 8:16 am
Three months ago, some enterprising thieves staged a daring theft by cutting a hole in the roof of an Eli Lilly warehouse and making off with all sorts of medicines (background). The made-for-TV moment focused attention on supply chain security and so here is another episode: 10 days ago, a trailer containing 15 pallets of Lupin Pharmaceuticals generic drugs was stolen in Memphis, Tenn.
Lupin never bothered to put an announcement on its website, but we have a copy of the letter sent to its wholesalers (see this). The heist yielded a slew of generic cholesterol-lowering pills, namely generic Zocor and Mevacor, as well as generic Depakote, which is taken by epileptics and is sensitive to temperature, and the Cefadroxil antibiotic.
There is nothing sensational about a stolen trailer, of course, particiularly from Memphis, which is a big hub for Federal Express shipments. But the theft underscores a growing problem for drugmakers. Last year, there were 46 such thefts worth $184 million, up from $41 million in 2007, according to FreightWatch International, a logistics security provider that tracks commodity thefts (see this).
Of course, drugmakers fear the bad publicity over such heists, because they undermine confidence in the supply chain - stolen meds, particularly, low-cost generics, are likely to wind up on the Internet or used for counterfeiting. This may explain why Lupin notified its distributors, but not the public. Meanwhile, though, someone may be swallowing one of those generic Depakote pills right now, unaware that the meds were stolen off the back of a truck.
pharmavet
Don’t expect that temperature-sensitive drugs or biological samples will get special handling with overnight deliveries. Two examples come to mind. During one summer in Pharma we were importing a shipment of transdermal patches from ex-US, and when they arrived all of the medication had leached out of the patches. We had put temperature monitors in the shipping containers, which revealed that the interior temperature had risen to over 100 degrees F due to prolonged exposure on a loading dock in the south.
I also worked at a Central Laboratory in the midwest that serviced the pharma industry. Blood collection tubes were shipped to investigators and the blood samples were Fedexed back to us. Despite proper insulation, approximately 2/3 of the blood tubes were frozen solid one unforgettable day in Decdember, 1989 because they had sat for a prolonged period on a Fedex loading dock in subfreezing temperatures.
Most drugs are supposed to be stored between 59 and 86 degrees F. This doesn’t guarantee that the shipping conditions will be the same.
Anne PME
Hi Ed,
Would it make sense to get this info to FDA MedWatch? This way, pharmacists and prescribers would be alert to the potential safety issues associated with these stolen Lupin medicines.
Unfortunately, here in my state, there are no regulations that require pharmacies to document the batch lot number or manufacturer’s drug expiration date. I am not sure how this works with mail order pharmacies. Even if we had a regulation like this, state agency budget cuts and ongoing deficits would likely not allow any enforcement of it. The manufacturer’s packaging is usually destroyed because medicines like pills and tablets are usually dispensed in pharmacy packaging/bottles, and the labels on the pharmacy bottles do not have lot numbers. The discard date is usually a year from the date of dispense or earlier per our state pharmacy board regulations.
Also, is this one of the situations where the FDA might recall the entire batch lots of all of the stolen Lupin medicines if they had recall authority?
Josh
Anne,
They wouldn’t necessarily “recall” the batch, but instead the agency may ask for a “withdrawal” of the lot from the marketplace. More than likely the distributors were sent the email so they wouldn’t buy the stolen product. This same instance had happened to an OTC product that our parent company owns. The people who stole it turned right around the next week and tried to sell it to Walmart way cheap.
We use a company that helps track shipments and trailers if we are shipping by truck. Serialization should also help in the future but the industry is still a few years out.
JaT
When Pfizer changed it’s product page for 30mg Dilantin Kapseals (apparently to match the page for it’s new 100mg product) storage temperature was one of the things changed. It went from what pharmavet stated above (between 59 and 86 degrees F) to 68-77 degrees F.
One of the other people investigating the change to the 100mg product said that the 30mg product continued to be produced as it was, for the purposes of pediatric dosing, under some obligation agreement.
I cannot point you to the statement without sifting through endless pages of documents to find the source material.
When we questioned the new product information in our communications- we were led to believe it was a new FDA standard which applied to all drugs previously labeled with the wider temperature range. I still have a manufacturers bottle for 30s which are labeled the old way- kept to show that the 30mg information page had been altered with the introduction of the new 100mg product.
Josh
JaT, usually product would be labeled at USP room temperature (25 C). The USP permits excursions from 15-30 (59-86) for a limited amount of time. Anything tighter than that may have been requested by the agency or the company itself.
JaT
Thank you for explaining, Josh. I just looked and the page continues to list the temp range at 68-77 degrees F.
Does this seem a little unreasonable to anyone else? In the extreme weather of summer and winter- who the heck maintains such temperature control?
Adam J. Fein
Why would anyone steal low-price generics that sell for pennies a pill? I doubt the thieves knew what they were taking.
Adam
Anne PME
Josh..thanks for the follow up. Would some of the stolen medicines be in-stock items that are direct ship? Also, it seems reasonable that state pharmacy boards would also have recieved the Lupin letter. Unfortunately, here in my state, the pharmacy board has been budget cut and probably does not have the necessary manpower to do anything to help ensure that these medicines do not wind up in patient hands.
JaT..I used a specialty compounding pharmacy for a number of years. These medicines needed to be Fed Ex’d express on icepacks to me every two weeks. The pharmacy and Fed Ex did an excellent job of working with me (I worked for a custom packaging company a number of years ago) to keep my medicine within a tight temperature control range. Unfortunately, the one thing that none of us could never fully control was the weather, so I switched to a new local compounding pharmacy and now have a different set of challenges. I was very fortunate because PBMs do not typically cover these S&H compliance costs but the pharmacy did not charge me.
Adam, drugs that are sold illegally over the internet typically cost more.
Do you think that maybe the theives targeted generics because they are easier to sell and not as easily tracked as some of the more expensive brand name drugs?
Josh
Almost no companies direct ship to individual pharmacies, so I doubt that it would have gone direct. The first thing that the company would have done is to send a letter to the companies that may have product in inventory to make sure they aren’t buying anything additional.
The thieves probably didn’t know what they were stealing. One of the newest trends is to try to sell it to a distributor in China, as pharmaceuticals that come from the US are highly prized based on the amount of counterfeits that China has seen in recent years. Though, the trailers are usually found not long after the highjacking as trying to move pharmaceuticals without a plan is usually tough to do.
A good distributor will make sure they are buying from the manufacturer and not from some schmo on the street. Selling it abroad makes the most sense.
Recall companies have a feature called faxblast, that lets them send out letters to all of the pharmacies that they have fax numbers for…which covers most of the pharmacies in the US. The right thing for Lupin to do would be send out such a message.
Josh
JaT, if the temp ranges are that tight, more than likely it is flying air and they will send it in reefers (refrigerated trucks). That will control the temp. The problem is that patients are not always the best at storing it in the correct temp and humidity, as people like to store it in areas where it may get warmer and more humid (kitchen and bathrooms).
JaT
Maybe Josh.
When we were sent packaging materials to send product to Puerto Rico for evaluation, there was no special pick up, or request for info on how we stored it, or anything relating to the temperature. Seems it would be difficult to evaluate the product having no idea.
Of course, humidity could be an issue, though it isn’t temperature specific. Coastal regions have high humidity rain or shine.
Maybe when they reformulated, as it was due to a change in the manufacturing process, they changed something making the product less stable. Or started using cheaper excipients that break down differently. Who knows.
Still, as the 30mg product was supposedly not changed, it seems odd that they would change the labeling for it.
If the 30mg product was changed- as the 100mg product was, they should have been yelling it from the roof tops because of it’s use in small children.
It’s a mystery.
Josh
Without seeing the process validation or change controls, it would be tough to say. Could be that the agency wanted tighter cotnrols relating to degradation. Could be they got a new supplier for API or excipient that changed how sensitive the product is or even switched granulation to a more modern approach…