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Special Report: Is Your Medicine Safe?

By: Lindsay Merwin
Updated: November 19, 2012
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Ever since the deadly meningitis outbreak began, we've witnessed a terrible twist of irony.

It's that medicine, the very thing that should ease our pain, has been the cause of so much pain both here and across the nation.

As we reported Monday, the Indiana Board of Pharmacy is taking formal steps to yank the Indiana license of the company responsible for the meningitis outbreak.

But for those already put at risk by this bad batch of medication, it may be too little...too late.

***
A peaceful afternoon...in Patsy Bivins' backyard.

But the steady rhythm of the swing...and the comfort of a close friend...cannot keep her mind off the words written in a letter she recently received from St. Mary's Surgicare.

"Even if you had previously visited the emergency room and were evaluated and released...these symptoms could still develop during that three month period," Bivins reads. "It drives you nuts," she says. "Because it's just like, like I said, with the headaches, you wonder. If you get dizzy, you wonder if it's from the sinuses or if it's from the meningitis."

We first spoke to Bivins more than a month ago, right after she and hundreds of other St. Mary's Surgicare patients got word they'd received a potentially contaminated steroid injection. 

And even though her test came back clear, the future...is anything but.

"I'm not the happy person that I was, because I've always got it on my mind."

Plus, she's in a lot of pain.

There isn't one pill she's found that can do what that steroid injection could...and she doubts there ever will be.

"So I hurt. I feel like crying. Honest to God, I feel like crying. Even if I could go back, i'm scared to."

The national outbreak injected fear in us...and so did the fallout.

We now know the New England Compounding Company's "clean rooms" weren't clean at all...and the FDA noticed it months before.

Now those grave violations...have cost dozens of lives.

To understand why it happened...and who is responsible, you need to know what makes an entire industry tick.

And for that, we go to the lab of Hook's Apothecary, Indiana's first compounding-only pharmacy.

"We are filling orders for patients with specific needs. Either the drug is no longer available...There's a lot of drug shortages right now," says manager Catherine Arwood.

Specialty pharmacies like Hook's are licensed by each individual state, not the FDA...but pharmacists here say that means even stricter regulations.

When inspectors visit about once every two years, they check everything from the room temperature to staff training procedures...and the place better be clean.

"I think they're pretty thorough as it is. I think it's tightened up since I've been out of school," Arwood says.

Then how did a company like the NECC slip through the cracks?

All Arwood knows is...Indiana's rules for nonresident pharmacies work...when companies actually follow them.

"You're trusting everyone else to do their job," says Barry's Pharmacy owner Terrye Gower. "And I think that's why you put us through school, doctors through school, and that's why we have testing in the laboratories."

Gower says that's why we shouldn't worry when a drug already in our medicine cabinets gets pulled from the shelves.

"It's become a lot more frequent since the FDA has been a lot more like big brother in the sky and actually watching over the consumer," he says.

But the system isn't foolproof...even more incentive for patients to ask the right questions.

Gower would know; he gets those steroid injections himself.

"When I go to the doctor and I'm taking a steroid injection, I ask, 'where did this come from?' I think the consumer should always be the one to be aware because you're the last watchdog on the list," Gower says.

All compounding facilities are required by national regulations to put their products through tests for sterility. If you want proof of that when you pick up your sterile compound prescription, just ask.

Chances are they keep a record of whether or not it passed the test.

Gower trusts his profession too much to forgo treatment out of fear.

But for someone like Patsy Bivins, fear is something even the best medicine cannot cure.

"I've learned you can't trust anybody. And I hate that, I really do. But I'll always be scared and wonder."

***

Patsy's three-month incubation period ends November 27th.

She's cautiously optimistic her risk will continue to go down after that.

 

Some Helpful Tips:

If you're picking up a prescription:

-Hold your pharmacist accountable. He or she has been professionally trained to check the safety of your medication. If you're concerned, don't be shy about asking for more information about the company that made it, especially if it's a new prescription for you. "The best thing we can do is provide information that we have tested, checked and called about the reliability of the product we're dispensing," Gower says.

If you're buying over-the-counter medication:

-Keep an eye out for company or FDA recalls. Gower says if companies detect a manufacturing error, they'll usually pull those products off the shelves right away. He says they do it to escape liability, but that's a good thing for consumers. The FDA tests all of those medications for safety and efficacy, so Gower says it's less likely contaminated OTC drugs will find their way to your medicine cabinet.
-Google it. If a drug manufacturing company has a checkered history, you should be able to find out with the click of a mouse.

If you're picking up a sterile injection from a compounding pharmacy:

-Ask if your medication has been tested for sterility...and ask for a written record of it. Compounding pharmacist Catherine Arwood says compounding pharmacies nationwide are required to follow USP 797 guidelines, which include testing for sterility and a separate fungal test that takes 14 days to process.
-Ask for more information about the company's chemical supplier. What's their reputation? Do they have the resources to ensure the safety of those chemicals? Arwood says their provider does. "They're providing formulas, they have chemists. They have all kinds of people on hand to back all of that up."

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