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The Wrong Way to Do a Drug Recall

Posted Oct 29 2010 5:05pm

Having never been affected by a prescription drug recall before, this is my only data point. But I’m still damn sure this isn’t the way it’s supposed to go.

Earlier this week recalled a drug called methotrexate; which at my house, we use to manage the rheumatoid arthritis my daughter was diagnosed with as a toddler. I learned of the recall on the morning of October 26 from our Pharmacist, who said not to use the medicine anymore and to call Sandoz to find out how to return it and to report adverse events. That’s all the information he had. He gave me an 800 number to call. Sounds scary right? I mean, as if it’s not bad enough that your child has to live with a chronic illness, now you also have to worry that the medicine she’s taking could hurt more than it helps.

I called the number and it was answered brusquely by a woman who said (don’t quote me on my quotes, I didn’t record the call): “Genco, please hold” (click). While I was on hold, I googled since I had no idea where I’d just called. Turns out they’re a supply chain management company, with a service line focused on managing pharma product recalls. I guess that makes sense.

When the woman came back on the line, she asked me what I wanted. I relayed what the pharmacist told me “my daughter’s medication was recalled and I was told to call this number about returning the medicine and about adverse events”. She pauses, “hold on.” I wait. She says she’s going to transfer me to the Medical Adverse Events department. She takes my name and number since she has to “announce” me when I get there. I was waiting some more, so I googled some more and noticed there was nothing on the FDA website and nothing on the news sites about it. Maybe that explains why the people in rheumatology at didn’t know anything either.

Eventually I got clicked off hold and found myself listening to a recorded message listing the options I could select. None of the options said anything about a recall, so I selected option #8 for questions about Sandoz products. A woman answers and does say I’ve reached Sandoz. Thank goodness, since that’s where I thought I was calling in the first place. Before I can say anything, the first woman bursts onto the line and says who I am and asks if she can put the call through. The woman agrees. Then the woman at Sandoz asks me why I’m calling. I repeat what the pharmacist told me. Unfortunately, this woman seems to be unaware of a recall or why I’d be calling her, and transfers me to someone in the Medical Quality Group.

The person in the Medical Quality Group also asks me why I’m calling, and again I repeat what the pharmacist told me. She says “Genco’s supposed to handle that”. But then she does help a little bit. She explains that she’s just getting information about the recall now, she tells me the lot # and expiration date of the recalled product; she says it’s a voluntary recall because small glass flakes were found in the medicine as a result of delamination of the glass vials (guess I’ll be looking up delamination later). She asks if I got the patient letter, I told her I didn’t get anything except a phone call from the pharmacist and a phone number to call. She provides a phone number that I should call to arrange to return the medicine. Guess what, it’s the number for Genco. I stop her by saying, “you know, I’m far less concerned about finding out how to return your product than I am about finding out the risks to my child.” She pauses.

Her: We don’t have any health issues associated with the recall.

Me: Is there anything I should look out for?

Her: No. But of course if you “notice anything”, you should call us.

Yeah lady. I really feel like helping you out. (well, I didn’t actually say that)

The next day, with help from my sister who happens to be in pharma research herself, I did find out what the potential adverse reactions are for an injectable medication that had been contaminated with glass flakes as a result of delamination of a glass vial. But it didn’t come from Sandoz. It came from the information provided by another company who had a similar recall in the somewhat recent past.

I can’t help but wonder if this recall was for a more widely used medicine, like PLAVIX® or VIAGRA®, if information would have been shared more quickly or more freely, or even if the people who answered the phone at the hotline would have a clue as to what’s going on. A drug recall is a big deal for the people on that drug, it would be nice if it seemed like someone cared or could explain what the risks are for the patients. Maybe they really don’t care that much when the drug isn’t used by that many people. I don’t know.

Two things I do know are these:

Thank goodness for the friends and family network of people (this includes those online networks too) who can help you figure things out when the people who are supposed to provide information don’t.

And

Our pharmacist is someone we’re darn lucky to have in the “friends and family” bucket. He called me immediately with the news. He called the “hotline” number when I told him I had trouble getting information. He has since left messages (unanswered) for people at Sandoz, including the person who issued the notice to pharmacists. He got my daughter’s medication from another manufacturer so that she won’t have to miss this week’s dose.

That pharmacist will have my business for life.

Sandoz? Not if I can help it.

- Christine

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