Kathy Hare, Falcon resident, didn’t know her prescription for Levoxyl, a drug that helps regulate the thyroid gland, had been recalled until after she had taken the prescription for three months and then went to the pharmacy to get a refill. Hare said her pharmacist wouldn’t refill the prescription; she needed to contact her prescribing physician.
“I asked when it was recalled and they had no idea,” Hare said. “Here, I was taking a medication for over 80 days, a medication that didn’t have enough potency in it. If it doesn’t have enough medication in it, it can be extremely dangerous.”
Hare said when she asked her pharmacist why they didn’t attempt to notify her about the recall, she was told pharmacies don’t have to notify anyone with an outstanding prescription like she had. They just have to notify the person when they ask for a medication refill, she said.
Chris Gassen, program director for the Colorado State Board of Pharmacy, said Hare’s pharmacist was right. Unless the drug is one created in that particular pharmacy, as opposed to being distributed in large quantities and in multiple lots by a drug company, the pharmacy is not required to inform their patients of the recall, Gassen said.
“More often than not, drug manufacturers’ customers, like prescription drug wholesalers and pharmacies, will get the recall information,” Gassen said. “Pharmacies don’t record a specific lot number on the stock bottle that identifies the lot of drug that is being recalled. Sometimes the lots are mixed.
“If we’re dealing with a common drug, we’re talking potentially thousands of patients who could have gotten that particular lot. It’s quite a different matter if you’re making the drug yourself. The expectation is clear and it’s a reasonable expectation that the pharmacist picks up the phone and calls the patient.”
Gassen said the drug companies are required to send the U. S. Food and Drug Administration the recall information for an evaluation, and the FDA makes the determination regarding the “class” of the drug recall. “The FDA cannot mandate the recall; only the drug manufacturer can,” he said. The FDA also helps determine a plan for dispersing the recall information, Gassen said.
“For a Class I recall, the (FDA) compliance guide is quite clear,” he said. “For Class II and III recalls, it gets a little muddy. “
Class I recalls are the most serious – there is a reasonable possibility that the particular drug could cause serious illness or death, Gassen said. Class II recalls are less serious and Class III recalls indicate the drug is not likely to cause adverse health issues, he said. The voluntary recall of Levoxyl was labeled a Class II recall, according to the FDA’s website, http://fda.gov.
According to Title 21 of the Code of Federal Regulations found on the website http://accessdata.fda.gov, “A recalling firm is responsible for promptly notifying each of its affected direct accounts (pharmacies) about the recall.” Usually, a press release is sufficient to get the recall information dispersed, Gassen said.
“These news releases are a really big deal, and that alerts everybody and tells everybody to check their medicine cabinets,” Gassen said. “This particular system in place, this is what they’ve done for years. Could it be improved on? It quite possibly could be.”
Apparently it does need improving because Hare said her physician hadn’t been notified about the recall either. Customer beware.
Editor’s note: After numerous attempts; neither the FDA nor Pfizer Inc., manufacturer of Levoxyl, returned phone calls to The New Falcon Herald.