FDA Cautions on Misuse of Pen Needles
An FDA communication (http://www.ismp.org/ext/105) cautioned pen (e.g., insulin and EPINEPHrine) users and clinicians about the misuse of pen needles by patients. Standard pen needles have an outer cover and a removable inner needle cover, which both need to be manually removed before an injection. Safety pen needles have an outer cover that is removed, and an inner needle shield that is not removed before an injection. Most hospitals use safety pen needles to protect staff from needlesticks. So, hospital staff may teach patients to self-inject a medication using a safety needle. Patients who later purchase standard pen needles may not know to remove both the outer and inner covers. If the inner cover is left on, the needle will not enter the skin at the time of administration. Although some medication may leak out from the inner cover, the problem may not be realized. In such cases, the patient will not receive any of the medication.
The FDA communication lists recommendations to patients using pens and their healthcare providers. FDA also asked needle manufacturers to review educational materials to assess the need for updates to clearly explain how to use the pen needle safely. In addition, FDA requested that standard pen needle manufacturers consider adding a warning in the labeling regarding the need to remove both the outer cover and the inner needle cover before use.
Health Alert! EpiPen and EpiPen Jr Autoinjectors
Earlier this month, the U.S. Food and Drug Administration released an alert about a problem with the EPIPEN (EPINEPHrine) 0.3 mg and EPIPEN JR (EPINEPHrine) 0.15 mg autoinjectors (including their authorized generic versions). Some of the autoinjectors may not easily slide out of their carrier tube, which could delay or prevent use in an emergency.
In a letter to healthcare professionals (http://www.ismp.org/ext/469), Pfizer, the manufacturer of the Mylan EpiPen, warns that the label sticker on the autoinjector unit may have been improperly applied, causing resistance when removing the autoinjector from the carrier tube. In some cases, the patient or caregiver may not be able to quickly remove the EPINEPHrine autoinjector from the carrier tube.
Patients and caregivers should follow the steps outlined in the letter and inspect their EPINEPHrine autoinjector. To facilitate this process, pharmacists should inspect the products with the patient at the point-of-sale. If an autoinjector does not slide out easily from the carrier tube OR the label is not fully adhered to the autoinjector, the patient should contact Mylan Customer Relations at 800-796-9526.
Container Label Changes for Vitamin A, D, and E
You may have noticed changes in the units of measure on the labels of over-the-counter (OTC) fat-soluble vitamins (A, D, and E) from international units (IU) to metric units of measure-micrograms (mcg) or milligrams (mg). For example, aqueous vitamin D oral drops previously labeled as 400 IU per mL are now labeled as 10 mcg per mL (Figure 1). This change also involves OTC solid dosage forms, but it does not include prescription products such as AQUASOL A (water-miscible vitamin A palmitate). These changes are based on a U.S. Food and Drug Administration (FDA) final rule, "Food Labeling: Revision of the Nutrition and Supplement Facts Labels," published in the Federal Register on May 27, 2016 (http://www.ismp.org/ext/112, page 33748). The rule also requires listing the absolute amounts of vitamins and minerals in mg or mcg in addition to the percent daily value (% DV) on the label.
Unfortunately, most healthcare practitioners and consumers 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 remaking it difficult to identify the equivalency between the previous measure in IU and the new metric measure. Still, the notice in the Federal Register mentions that, "The amount of vitamin D may, but is not required to, be expressed in IUs [sic], in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IUs [sic] must appear in parentheses after the declaration of the amount of vitamin D in mcg." Note that IU is used here within the quotations as it appears in the notice. However, ISMP discourages the use of IU because of multiple cases in which IU was mistaken as IV. Given that some vitamins (e.g., vitamin E) are available only as liquids, a wrong route error is possible in certain settings. Such a mistake could prove harmful, even fatal.
ISMP fully supports including the strength on container labels and Supplement Facts panels in both mcg or mg as well as IU in parentheses to allow for the safe transition to metric-only labeling. Incidentally, the labeling changes do not reflect changes in strength. One mcg of vitamin D (cholecalciferol) is equal to 40 IU, so 10 mcg is the same as 400 IU. We have been in touch with the FDA Center for Food Safety and Applied Nutrition (CFSAN) about this situation and asked the agency to consider a public announcement about the change. Practitioners will most likely still recommend doses in units, and this will be confusing to patients. Thus, we also hope that manufacturers will express the units in parentheses after the metric strength.
Marker of Autoimmunity Increases in U.S.
A healthy immune system protects the body against infection by attacking bacteria, viruses, and other foreign invaders. In people with autoimmune diseases, the immune system malfunctions and turns against the body's own organs and tissues. Common autoimmune diseases include rheumatoid arthritis, lupus, type 1 diabetes, and inflammatory bowel disease. Genes, in combination with infections and other environmental exposures, are believed to play a role.
The presence of antinuclear antibodies (ANA) in the blood is the most common biomarker of autoimmunity. Researchers led by Dr. Frederick Miller at NIH's National Institute of Environmental Health Sciences (NIEHS) investigated whether the prevalence of ANA had changed over a 25-year span. The team measured ANA in blood serum samples from more than 14,000 participants, 12 years and older, in the U.S. National Health and Nutrition Examination Survey. The prevalence of ANA was measured over three time periods.
The researchers found ANA in 11.0% of subjects in 1988-1991, 11.5% in 1999-2004, and 15.9% in 2011-2012. These percentages corresponded to 22, 27, and 41 million ANA-positive individuals, respectively. These findings suggest that the prevalence of ANA has increased considerably in recent years, particularly among males, adults 50 years and older, and non-Hispanic whites. Among adolescents, ANA prevalence rose steeply. For those 12-19 years of age, positive ANA tests doubled and then nearly tripled over the three time periods (from 5% to 9% to 13%).