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Ironing out confusing product labeling for iron supplements

Error Alert

Institute for Safe Medication Practices, Horsham, PA

Fer-In-Sol's Supplemental Facts label lists only the amount in elemental iron form. (Image provided courtesy of ISMP.)

Longstanding lack of standardization for iron product labeling has led to frequent dispensing and administration errors. More than 60 reports concerning iron have been submitted to the National Medication Errors Reporting Program of the Institute for Safe Medication Practices (ISMP). Roughly 40% of these reports were related to confusing product labeling on both the outer package of multidose containers and on individual unit dose packages.

OTC iron products are regulated as food supplements by FDA’s Center for Food Safety and Applied Nutrition (CFSAN). So, a Supplement Facts panel appears on the label instead of a Drug Facts panel.

Unfortunately, there is tremendous variability in the labeling of OTC iron products, many of which do not match with how providers often order these products based on their salt form (e.g., ferrous sulfate 325 mg daily).

Ambiguous labels cause confusion that leads to errors

ISMP has seen container labels of some iron products that express only the amount of elemental iron in each tablet. Other iron products express the amount of iron in salt form on the primary display panel and a differing amount of iron, the elemental form, in the Supplement Facts panel (Figure 1).

Still others use ambiguous labeling that makes it difficult to interpret whether the salt form or elemental iron strength is indicated (Figure 2).

Some iron supplements, such as the liquid formulations, do not include the amount of iron on the primary display panel and instead list the dose of elemental iron only on the Supplement Facts panel (Figure 3).

In the latter example, one must search under the ingredients section to find that the iron is from ferrous sulfate.

Finally, some products may list the apothecary strength (5 gr), which can also lead to confusion.

Error reports

ISMP has received reports involving both patients and health care practitioners. For example, ISMP heard from a mother whose daughter received an overdose of an oral iron product because of her difficulty understanding OTC iron supplement labels.

The mother was confused about the relationship between ferrous sulfate and elemental iron, each of which appeared on the label. She also remarked about differences in the way iron concentrations are listed for available liquid formulations.

She explained that she spent over an hour trying to figure out how much her daughter was receiving before she realized it was more than prescribed.

In another case, a practitioner reviewing an older adult’s home medication list learned that the patient’s daughter had been giving him five tablets of ferrous sulfate daily to equal the 325-mg dose recommended by her father’s physician.

The ferrous sulfate she had purchased at a pharmacy was only labeled with the amount of elemental iron in each tablet, 65 mg. The label provided no indication that each tablet was equivalent to ferrous sulfate 325 mg.

The patient’s daughter thought she was supposed to give her father five 65-mg tablets for each 325-mg dose. The patient experienced severe constipation and stopped taking the iron after 2 days but was soon hospitalized for other reasons, where the error was discovered.

Nobody is immune to label confusion

ISMP has even heard from practitioners who have similarly misinterpreted iron supplement labels.

For example, after receiving a product labeled “Iron (as ferrous sulfate) 65 mg,” a nurse in a skilled nursing facility calculated that five tablets were needed for a single dose of ferrous sulfate 325 mg.

Fortunately, she realized that five tablets per dose seemed unusual, and a call to the facility’s pharmacist helped prevent a serious medication error.

These are a small fraction of the errors that may go undetected and lead to patients receiving unintended amounts of elemental iron.

For tips on how to minimize errors with iron supplements, see "Safe practice recommendations" below.

Have you experienced a medication error or close call? Report such incidents in confidence to ISMP’s National Medication Errors Reporting Program (MERP) at www.ismp.org, ismpinfo@ismp.org, or 800-324-5723 to activate an alert system that reaches manufacturers, the medical community, and FDA. Your information may also be published anonymously to alert your professional colleagues.

Safe practice recommendations

Because most iron supplements are available OTC, patients may purchase products in any type of store or online, including a pharmacy, without a pharmacist’s assistance. To minimize the likelihood of errors with iron supplements, consider the following recommendations:

Do not refer to the supplement as “iron” but instead, as “elemental iron” or the appropriate ferrous salt, especially when communicating dosage information.
Despite iron’s OTC status, prescribers should provide patients a prescription for iron supplements to facilitate patient counseling by a pharmacist. Prescribers should also encourage patients to seek assistance from a pharmacist when selecting iron supplements, especially liquid formulations.
Ideally, all dosages should be expressed in milligrams of elemental iron. However, because prescribers often express doses in the ferrous salt form, while some package labeling indicates strength in the elemental iron form, both should appear in all forms of communication, including patient charts, prescriptions, pharmacy labels, medication administration records (MAR), manufacturer labels, and drug references. For example, use “ferrous sulfate 325 mg (elemental iron 65 mg).”
Ensure that staff understands that iron-containing products are available in salt forms such as ferrous gluconate, ferrous sulfate, and ferrous fumarate. It is also important for them to know that, respectively, only 12%, 20%, and 33% of each dose is elemental iron. Educate patients about the difference between elemental iron and its salt forms.
Store iron supplements behind the pharmacy counter, and require a pharmacist to provide counseling on dosing instructions. If this is not possible, place products near the pharmacy checkout in plain view of the pharmacist to capture an important counseling opportunity. At minimum, use “shelf-talkers” near these products that instruct patients to ask for a pharmacist’s help when selecting iron supplements.
Pharmacists should verify that the prescribed dosage falls within the guidelines for iron-replacement therapy for the patient’s age and weight.
Pharmacists and nurses should clarify prescriptions that contain only the volume to be administered for liquid iron products. Use the teach-back method to ensure that patients understand how to measure the proper dose.
All practitioners should stress the importance of keeping these products up, away, and out of the reach of children. If an accidental ingestion occurs, recommend calling the Poison Help number (800-222-1222) immediately (encourage patients and caregivers to store this number in all their phones, including cell phones). It may take only a few tablets to cause serious toxicity in children.
Manufacturer package labels should clearly express dosage strengths in both elemental iron and the ferrous salt form. Pharmacists should affix a pharmacy label that clarifies dosing instructions. In addition, pharmacies should not purchase products found to have ambiguous labeling.