Product and Container Label Changes May Cause Confusion

Statins reduce the risk of vascular events in people of all ages, although there is less evidence of this in people aged over 75 years than in younger patients, researchers have found.

A meta-analysis published in The Lancet (online, 2 February 2019) found that, irrespective of age, statins reduced the risk of major vascular events by 21% per 1mmol/L reduction in low-density lipoprotein (LDL) cholesterol. For major coronary events the overall reduction was 24% per 1 mmol/L reduction, but ranged from about 30% in people aged under 55 years to around 20% in people aged over 75 years.

The study looked at evidence from 28 randomised controlled trials, which included 186,854 patients — 14,483 of whom were aged over 75 years. It also found no adverse effects of statin therapy on nonvascular mortality or cancer.

Jordan Fulcher, a researcher at the Cholesterol Treatment Trialists’ Collaboration at the University of Sydney, which carried out the research, said his team had wanted to consider the evidence gap on the efficacy and safety of statins in older people.

“Our analysis indicates that major cardiovascular events were reduced by about a fifth, per mmol/L lower LDL cholesterol, by statin therapy across all age groups. Despite previous concerns, we found no adverse effect on cancer or nonvascular mortality in any age group,” he said.

Martin Marshall, vice chair of the Royal College of GPs, said it was “particularly reassuring to see evidence of benefit in patients over the age of 75 [years] — the age group most likely to need cholesterol medication, and who are at risk of heart attacks and strokes”.

Changes in product concentration and design, as well as units of measure, can introduce the risk of errors. Significant changes were recently made to rabies immune globulin (human) (HyperRAB) and vitamin A, D, and E products that may contribute to confusion for patients and practitioners.


Recently, Grifols, the manufacturer of HyperRAB, changed the concentration of the product. Because a higher concentration allows for more efficient wound infiltration (ie, more of the immune globulin can be delivered to the affected area in less volume), the concentration was increased from 150 to 300 units/mL. When dispensing, stocking, and storing HyperRAB, it is important to recognize that the product is available in both 1- and 5-mL vials and cartons that are hard to tell apart (image 1). The only visual differences are the volume noted in the lower left corner of the carton and different National Drug Code numbers. The vials both have a 5-mL capacity, athough one contains 5 mL while the other contains just 1 mL.

The 1-mL vial is sufficient for a child weighing up to 15 kg, while the 5-mL vial is sufficient for an adult weighing up to 75 kg, according to the package insert. Both are single-use vials. Confusing the sizes may lead to costly waste if a 5-mL vial is dispensed and used for a child. The situation could also result in inventory issues. For example, an individual may visually scan his or her inventory, not notice the volume differences, and think that enough product is in stock when there may be less than needed. To prevent this, one hospital is storing the 2 sizes separately. Auxiliary labels to better differentiate the products and the use of barcode scanning during inventory and product selection are also options.

The units of measure on the labels of OTC fat-soluble vitamins (A, D, and E) have changed from international units (IUs) to metric units (eg, micrograms or milligrams). For example, aqueous vitamin D oral drops previously labeled as 400 IU/mL are now labeled as 10 mcg/mL (image 2). This change also involves OTC solid forms, but it does not include prescription products such as Aquasol A (water-miscible vitamin A palmitate). These changes are based on an FDA final rule, Food Labeling: Revision of the Nutrition and Supplement Facts Labels. The rule also requires listing the absolute amounts of vitamins and minerals in milligrams or micrograms, in addition to the percent daily value on the label.

Unfortunately, most consumers and health care practitioners are unaware of the change, and the labeling may not be helpful in communicating the change. Only the metric measure may appear on container labels, including the supplement facts label (online figure), making it difficult to identify the equivalency between the previous measure in IUs and the new metric measure. However, the notice in the Federal Register mentions that although the amount of vitamin D expressed in IUs is not allowed to appear on the label alone, it may appear in parentheses after the amount of vitamin D in micrograms.

Incidentally, the labeling changes do not reflect changes in strength. One microgram of vitamin D is equal to 40 IUs, so 10 mcg is the same as 400 IUs on the new label. To help prevent confusion, manufacturers should express the units in parentheses after the metric strength to allow for safe transition to metric-only labeling.

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