What the FDA Needs to Do


There are a lot of factors that go into medication errors-pharmacists are stepping up, but the FDA must also act.

FDA building

I tell my technicians that I am the only one in the pharmacy who can make a mistake. It’s my responsibility to catch any discrepancy between the provider’s order and what the patient receives. If a patient receives a prescription that is in error, it is my fault.

Back in August 2016 I wrote a column describing my “red pen” technique. In that essay I described how I physically check prescriptions using a red pen, so I know I verified that prescription. I make every effort I can to ensure the accuracy of every order.

Related article: How to Prevent the Top 4 Medication Errors

A sad event occurred in our area. A patient had a prescription filled for amitriptyline 10 mg at her local pharmacy.

When she got the prescription refilled at the same store, the pills looked different. She called the pharmacy and the tech reassured her that “these generics change all the time.”

A few days later, before she started the new batch of pills, she again called the pharmacy and the same tech reassured her that the generics are always changing.

The patient started the new bottle, and after a couple of days, had slurred speech and was disoriented and blamed the pills. Finally, her daughter took her to the hospital, where everyone assumed the pills were correct.

It took a young family member to look up the medication on a database to learn that it was amitriptyline 100 mg pills in the bottle. The outcome was not good. The patient had a mild stroke attributed to the tenfold increase dispensed in error.

The pharmacy had two opportunities to verify the prescription, as did two healthcare professionals in the hospital. No one did.

Because of situations like this, my rule is that when a patient inquires because of a different appearance in their medication, I am the only one who will make such a verification. We use a barcoded pill counter, I use my red pen, but ultimately, I get on the phone after physically verifying the medication. I’ll get the meds off the shelf or pull up images on a database; and only I will talk to the patient.

Since I never elucidate a problem without a proposed solution, and given the fact that I do everything I can in my pharmacy to minimize errors, I’d like to enlist the help of the FDA in the name of patient safety.

Here is my proposal: We need standardization.

When I need a bolt and nut for a home project, it doesn’t matter which hardware store I go to. If I need a #3 bolt with a coarse thread I can be assured there will be 48 threads per inch due to standardization.

I’d like to see the FDA adopt the standardization our hardware manufacturers use.

When any abbreviated new drug application is approved, there should be in that approval letter exactly what the tablet or capsule looks like. I feel all generics of a drug should be the same size, color, and shape. One side should have three or four letters for the generic name, plus the strength; for example, Omep 40 for generic omeprazole (Prilosec) 40 mg. The other side should have the manufacturer’s identifying marks.

For a drug like levothyroxine, where there is a question of bioequivalence between generics and brands, different generics could keep different shapes or colors to alert patients that a switch has been made. But this would be the exception to the rule.

When a patient gets a prescription for lisinopril 20 mg, will they receive a round white tablet, a pink round tablet, an oblong pink tablet, or a white pentagonal tablet? It depends on the manufacturer. Even us experienced pharmacists must check a database to verify whether it is lisinopril.

More from the author: Explaining the Flawed DIR System to Student Pharmacists

Standardized markings would enable anyone to verify the name, strength, and manufacturer of a tablet. Patients would not be so confused as to what color and shape their meds are, as the pills would be the same.

I’m asking no more from the FDA than I am from the suppliers of my hardware store. 

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