Blistering criticism about packaging
Several complaints about the way levOCARNitine tablets are packaged in blisters have been received by the Institute for Safe Medication Practices (ISMP). As shown below, the bar codes on the levOCARNitine blister pack from the manufacturer, Hi-Tech Pharmacal, do not line up with the individual tablets, so each tablet does not have its own corresponding bar code. LevOCARNitine is used to prevent and treat carnitine deficiency in patients with kidney disease who are on dialysis. In a recent event, a patient received a single levOCARNitine dose of 3 tablets (990 mg) instead of 1 tablet (330 mg) three times daily as intended, causing an overdose. Adverse reactions associated with an overdose include nausea, vomiting, abdominal cramps, diarrhea, and seizures.
Although the pharmacy dispensed 3 tablets that had been cut from the blister pack, the tablets had not been separated individually. Thus, the nurse administering the levOCARNitine thought that the 3 tablets comprised a single dose. The fact that only one bar code was visible on the part of the blister pack containing the 3 tablets reinforced the nurse's misperception. An additional problem was that the lot and expiration date are embossed, difficult to read, and located at the very top edge of the blister-pack sheet.
Unable to locate the patient's next dose, another nurse realized that all 3 doses had been administered as a single dose. Thankfully, the patient was unharmed.
Leadiant Biosciences, which manufactures Carnitor, a brand of levOCARNitine, is the new drug application (NDA) holder. This company revised the Carnitor packaging last year. Authorized generic manufacturers must package their products in the same way as the NDA holder. However, the problem continues because the packaging change did not address all problems and the drug name, dose, and bar code still do not properly align over the individual tablets. ISMP has been informed that no further packaging changes are planned.
For facilities that stock the Leadiant or Hi-Tech product shown in the photo, ISMP recommends relabeling each tablet blister individually and adding a bar code. However, the product should not be repackaged as this can compromise the integrity of the tablets.
Pharmacy relabeling increases the risk of errors and decreases efficiency. ISMP urges clinicians to contact companies that package medications like this about the potential for errors, and to report errors and near-misses via www.ismp.org, 1-800-FAIL Safe, or firstname.lastname@example.org.
Fuzzy logic may lead to a wrong choice
The 2018 Epic upgrade has incorporated “fuzzy matching” (also called “fuzzy logic”) into its electronic medication order platform. Simply put, if a practitioner misspells a word (for example, a medication name or lab test) when entering orders, or misspells a patient's name when searching, Epic's “fuzzy matching” feature presents a list of what the system “thinks” the practitioner is searching for, which may not be an exact match. The practitioner must then select the correct medication, lab test, patient, or other intended word or name from on-screen listings of “near-hits.”
Seemingly, this feature would be helpful given that misspellings and missing letters are common reasons why a requested drug or patient does not appear on the screen. However, for medications, near-hits for drug names are not safe and can be downright dangerous if they lead a practitioner to select the wrong drug. Medication selection errors are frequent when similar drug names are presented in drop-down lists and computer screens, as occurs when the list of near-hits is generated.
Epic has adjusted algorithms used for fuzzy matching to eliminate some problem names and proposed various strategies facilities can initiate to mitigate risks. However, ISMP still does not believe that fuzzy matching is currently safe for medication ordering. Although fuzzy matching can be disabled for all search options, it cannot be disabled for medications only; the entire feature is either on or off. As soon as possible, Epic should prevent automatic enabling of fuzzy matching and allow the disabling of fuzzy matching for medications only. For now, the use of fuzzy matching is a risk not worth taking.