Do you remember the book, Catch-22, by Joseph Heller? Airmen in World War II were faced with a no-win situation. To be exempted from a suicidal bombing mission you had to plead insanity. But if you asked to be grounded, there was “catch-22.” The doctor (Doc Daneeka) explained that, “Anyone who wants to get out of combat duty isn’t really crazy.” In other words, you were crazy to fly a suicidal mission but the moment you asked to be relieved you would be judged sane and have to fly. This sort of trap is what a patient is faced with when trying to file a report with the FDA based on the prescription drug label.
How Would You Know If Your Pills Were Recalled?
Have your blood pressure pills been recalled? Over the last several months, more than 600 lots of valsartan, irbesartan and losartan have been recalled due to contamination with a probable carcinogen. Each lot contains numerous bottles, some of which may contain as many as 1000 pills. We suspect that hundreds of thousands, if not millions, of pills have been recalled.
If you are concerned about whether your medicine is included in the recall, you may be surprised to learn that you probably can’t determine the lot number of your specific batch of pills. That’s because most pharmacies do not keep track of the specific lot of pills they dispense to any given patient.
The lot number is rarely, if ever, on the prescription bottle unless it is dispensed in the manufacturer’s original container. If the pharmacist took pills out of a big bottle and put them in a little bottle for you, the lot number is not even recorded in the pharmacy computer.
You read right! The pharmacist doesn’t have a clue what lot number she dispensed to you last week, last month or ever!
The Prescription Drug Label Is Inadequate!
When a can of tomatoes is recalled, the supermarket can alert you as long as you have your loyalty code on file. Computers are very good about keeping such records when the data are in the system. We have received a call from our supermarket when a specific lot of peanut butter was recalled. It was efficient. We were told to return the jar to the market for a refund.
You might think that pharmacists would have the lot numbers of the medicines they dispense in their computerized systems. You would be wrong.
When a company like Aurobindo, Mylan or Teva recalls valsartan because of a contamination problem, the FDA lists the recalled products with their lot numbers at this link. The implication is that a patient, pharmacist or physician could check a prescription drug label to see whether the pills inside were suspect.
Do Your Own Pharmacy Test of the Prescription Drug Label!
Good luck! If the pills were repackaged into a typical drugstore bottle, there will be no record of your precise lot number at the pharmacy. Don’t believe us? Do your own test!
Grab a typical pharmacy-dispensed bottle (one of those semi-transparent orange bottles with a hard-to-remove push-and-turn cap). Look for a lot number. If you can’t find one, call the pharmacist and ask her what lot number she has in her computer for that precise batch of pills. See what she says.
Catch-22 and the FDA’s 3500 Form!
The lot number becomes extremely important when a physician, pharmacist, nurse or patient wants to report an adverse drug reaction to the FDA. The agency encourages health professionals and patients to tell it about problems, “including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures.”
MedWatch is purportedly interested in trouble that people may experience with over-the-counter as well as prescription drugs. Medical devices, cosmetics and foods or beverages are also included.
The 3500 Form the FDA makes available requires some very specific information. This allows the agency to follow up on an investigation. In addition to data about the problem you experienced, the form requests an expiration date, the NDC identifying number and the lot number.
Here is a link to the FDA’s main 3500 Form the “Adverse Event Reporting Program” for health professionals.
The MedWatch Consumer Voluntary Reporting (Form FDA 3500B) can be found at this link.
If you go to either of those links you will see that part of the key information the FDA seeks is:
- Expiration date (dd-mmm-yyyy)
- Lot number
- NDC number
The FDA states:
“Please complete all sections that apply to your report.”
“Dates should be entered as DD-MMM-YYYY (for example, October 12, 2016 = 16 OCT 2016).
If exact dates are unknown, please provide the best estimate.”
The Missing Information on the Prescription Drug Label:
You won’t have any trouble finding a lot number and expiration date on your canned beans. Good luck getting a lot number for your lisinopril or levothyroxine.
As we just explained, the pharmacy doesn’t keep track of lot numbers. Unless you had some reason to ask for it when you picked up your prescription and kept track of it independently, you would have no way of knowing the lot number. Very few people go to this trouble.
The NDC number represents the National Drug Code. It is a unique 10-digit number that serves as a universal product identifier for drugs. It is required on every bottle of medication, but your pharmacy may use a bar code. That means you might not be able to translate it readily. The pharmacy can provide it, but you do have to make an effort to get that required information to fill out the 3500 Form.
The Missing Expiration Date on the Prescription Drug Label:
The expiration date is another hoop you have to jump through. There is a “discard after date” on your prescription bottle. In most states that will correspond to one year after the date the prescription was filled. It has nothing to do with the actual expiration date of your medicine.
If your pills were dispensed in the original manufacturer’s packaging, they will carry a true expiration date. But if your pharmacist took your pills from a big bottle to put them in a smaller container, the discard date is usually unrelated to the actual expiration date.
Filling out the 3500 Form is Challenging!
As a result of these serious flaws in current pharmacy dispensing practices, you cannot fill out a MedWatch 3500 Form accurately and completely. Some people are likely to feel as if they are caught in a catch-22 situation.
The FDA states unequivocally “Please complete all sections that apply to your report.” Many people might interpret that as check the prescription drug label, find the lot number, expiration date and NDC number. Since that information is not available on a repackaged pill bottle, some people may give up in disgust.
An FDA official tells us that they do accept reports that do not contain that information. Great. But that may not be obvious to everyone. A lot of wasted time could go into seeking information that is hard, if not impossible, to obtain. (For the record, the minimum information that has to go on a report is an identifiable patient, an identifiable reporter [these may or may not be the same person], a suspected product and an adverse event.)
Lack of lot numbers on prescription drug labels means that no one (not physicians, pharmacists, nurses or patients) can determine if a particular bottle of pills has been recalled. We find that unacceptable! Pharmacies need to demand that their software vendors change the software so this can be readily tracked.
Passing the Buck!
People at the FDA shrug their collective shoulders over these deficits. The agency says that the practice of pharmacy is not its problem. It claims no jurisdiction over what the pharmacist puts on the prescription drug label, even though the FDA issues drug recalls and asks for things like the lot number and expiration date.
Drug companies say that they comply with the legal requirement to put lot numbers, expiration dates and the NDC numbers on their original containers. They do not, however, have any responsibility if the pharmacist takes pills out of their big bottle and puts them in a little orange bottle.
The pharmacist shrugs his shoulders and says that it’s not his problem. The computer program he uses does not offer the opportunity for including lot numbers or expiration dates in the record or on the prescription drug label. Those sorts of things are controlled by the state board of pharmacy and the chain drugstore that buys the computers and software that maintains labeling. It’s about time for these entities to seek out automated software that can track this information. There is nothing inherent about these data that would resist computerization.
What Do You Think?
Does this “system” make any sense? Do you feel caught in a catch-22 situation? Please share your thoughts in the comment section below.