Medication errors associated with levothyroxine products

Posted by philpharmass on September 3, 2009 at 8:36 AM


FDA Advise-ERR: Medication errors associated with levothyroxine products


From the September 6, 2000 issue, ISMP Medication Safety Alert


PROBLEM: Over the years, numerous medication errors associated with levothyroxine products have been reported to FDA or published in the literature. Some have resulted in serious patient harm, including death. To better understand the causes of these errors, FDA's Office of Post-marketing Drug Risk Assessment (OPDRA) recently reviewed reported and published incidents. Most errors involved confusion between LANOXIN (digoxin) and levothyroxine, especially before the brand name, LEVOXINE, was changed to LEVOXYL to reduce the likelihood of confusing these two drugs. Nevertheless, the generic name, levothyroxine, can resemble Lanoxin, especially when orders are poorly handwritten. The risk of an error is also heightened because both drugs are prescribed for chronic use, have a similar daily dosing regimen, and have overlapping dosage strengths of 0.125 mg. Some of the errors involved dispensing and administering an incorrect dose of levothyroxine, most often a 10-fold overdose after a decimal point had been misinterpreted. Abbreviations used during the prescribing process have also played a role. In one case, a prescription for SYNTHROID (levothyroxine) "QD" was misinterpreted as "QID." In another case, the abbreviations "mcg" and "mg" were confused with each other and a patient who had been taking Synthroid 25 mcg orally each day received a fatal IV dose of Synthroid 25 mg prior to surgery. In another reported error, unclear product labeling led to a two-fold overdose of IV Synthroid. Manufacturer labeling states that the product, a lyophilized powder of 200 or 500 mcg, is supplied in a 10 mL vial. This refers to the size of the glass vial but the product is supposed to be reconstituted with 5 mL of diluent, resulting in a final concentration of approximately 40 or 100 mcg per mL. Although only 5 mL of diluent was used, the pharmacist miscalculated using 10 mL as the final volume, yielding an incorrect concentration of 50 mcg per mL. The patient received 1 mL (100 mcg), not the correct dose of 0.5 mL (50 mcg).


SAFE PRACTICE RECOMMENDATION: To reduce the risk of an error, prescribers should print all orders for Lanoxin and levothyroxine and include the purpose for each drug on all prescriptions. Both the mg dose and the mcg conversion should be listed in all levothyroxine orders and on product labels, such as "levothyroxine 100 mcg (0.1 mg)" or "Synthroid 0.1 mg (100 mcg)." Always write a leading zero for doses less than 1 mg to avoid misinterpreting a dose of "Synthroid .025 mg" as "Synthroid 0.25 mg." Never include trailing zeros (e.g., Synthroid 25.0 mcg), as the order may be misread (e.g., Synthroid 250 mcg). Pharmacists should consider storing one of the products in a separate section of the pharmacy to break the usual pattern when filling prescriptions. It's also important to carefully restock unit-dose bins when either Lanoxin or levothyroxine doses are returned to the pharmacy. Patients can also help prevent errors. Make sure they understand the risk of an error if prescribed either Lanoxin or levothyroxine and encourage them to verify the drug and dose with the pharmacist when dispensing prescriptions.

Categories: Medication Safety

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Reply Yollie Robles
10:35 AM on September 19, 2009 
Practicing pharmacists in both hospital and community settings should allot time checking the details of the prescription to be sure that no medication error was committed during prescription. After that, careful checking of medicines taken from the shelf against the prescription has to be done. In this way, we fulfill our mandate of protecting every patient or consumer who visits the pharmacy. Our recognition would come only after we have done our best to serve whole-heartedly (",)
Reply jingle
4:20 AM on May 4, 2010 
Yollie Robles says...
Practicing pharmacists in both hospital and community settings should allot time checking the details of the prescription to be sure that no medication error was committed during prescription. After that, careful checking of medicines taken from the shelf against the prescription has to be done. In this way, we fulfill our mandate of protecting every patient or consumer who visits the pharmacy. Our recognition would come only after we have done our best to serve whole-heartedly (",)

I agree ma'am.
Reply Angelo
7:40 PM on September 20, 2010 
While it may be true that "the generic name, levothyroxine, can resemble Lanoxin, especially when orders are poorly handwritten" and because both starts with the letter "L", the likelihood of committing an error in dispensing is less if certain provision of A.O. 63 s. of 1989 is to be applied.

In the context of not filling prescriptions that are written in brand name only, why would a pharmacist fill a prescription if he reads it as "Lanoxin" (a brand name which resembles "Levothyroxine")? I have seen thousands of prescriptions for "Digoxin" and in these instances the "D" there does not resemble the "L" in "Levothyroxine".

Also, in my 18 years of practice, I have not heard of anyone in our hospital committing this kind of error because we try our best to apply what's in that administrative order (i.e., not filling prescriptions that are written in brand name only)

Those who committed similar errors like in the case of "Thiamine" and "Thorazine" which happened in one of the branches of a leading chain of drugstores here in the Philippines, reflect only the inattention to rules and regulations in the practice of pharmacy that might have saved some of us from landing in courtrooms.

The same principle applies to those who committed error in dispensing "Melleril" for a prescription that required "Methergin" or that prescription for "Diamicron" in which "Dormicum" was given, instead, to Mr. Sebastian Baking which caused him to fall asleep while driving his car and eventually figured in a vehicular accident.

These are violative prescriptions which I believe that dispensing errors might have been avoided if only these prescriptions were not filled by applying the provision of the above administrative order.

Relative to this, when certain policies are in place, pharmacists might just as well follow these to avoid similar errors. Take for example a dispensing error that happened recently in our hospital which involved morphine sulfate and magnesium sulfate in their abbreviated forms (MoSO4 and MgSO4, respectively).

The guidelines in our formulary system state that names of drugs may not be abbreviated. A memorandum was already issued that no prescriptions with abbreviated names of drugs shall be filled. Also, an article that listed these abbreviations as dangerous was already published. Monthly monitoring of filled prescriptions is also conducted to check compliance and everyone was made aware about these things.

But since this policy was violated, an order for "MoSO4" was interpreted as magnesium sulfate and erroneously dispensed.

By reflecting on these, it may be said that "look-alike/sound-alike" dispensing errors happen again and again because pharmacists do not follow policies, rules and regulations that are already in place to prevent such errors from happening again.
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Reply grace
5:41 AM on October 9, 2011 
We as a pharmacists need to double check the prescribed medication, but we need to call the attention of some practitioner,some of them always wrote a wrong dosage so the pharmacists will suffer to that incident, we just followed what is written in the ordered prescription....
Practicing pharmacists in both hospital and community settings should allot time checking the details of the prescription to be sure that no medication error was committed during prescription. After that, careful checking of medicines taken from the shelf against the prescription has to be done. In this way, we fulfill our mandate of protecting every patient or consumer who visits the pharmacy. Our recognition would come only after we have done our best to serve whole-heartedly (",)
[/Yollie Robles]
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Reply Dr. Easwaran Vigneshwaran
3:32 AM on December 29, 2016 
It is an international issue, need to be sorted out. Even the package of levothyroxin makes a confusion for dispensing pharmacist or pharmacy technicians could lead to potential errors. This was posted long time ago in the year 2009, but still it is an existing problem where we need to concentrate more whole serving patient.
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