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Global experts seek to standardize best practices

A conference of medication safety organizations and advocates from over 20 countries convened at the FDA's White Oak Campus in Silver Spring, Md., to discuss the use of technologies to reduce medication errors and the need for an international bar code standard. The goal was to identify an internationally accepted set of best practices for drug labeling and packaging. They agreed upon nine specific recommendations and best practices for improving labeling and packaging, which include the following.


* Include both the per mL and the per container quantity (not the per mL quantity alone) when presenting the concentration for injectables.


* Use metric units for products and eliminate ratio expressions.


* Eliminate error-prone abbreviations and dose designations, such as U for units, IU for international units, and trailing zeros (such as 1.0) for dosages.


* Prominently display precautions on carton and immediate container labels of neuromuscular blockers, potassium chloride concentrate injection, methotrexate, and other selected high-risk medications.



"We are trying to harmonize safe labeling and packaging practices," said co-chair Michael R. Cohen, SCD, MS, RPh, president of the Institute for Safe Medication Practices, in an interview. "We shared safety issues with one another and there was a great deal of learning by all." A follow-up meeting in Portugal is planned.


Source: Vecchione A. International group pushes for 9 new drug labeling, packaging guidelines. Drug Topics. July 2, 2018.



Antidiabetic drugs linked to Fournier gangrene

The FDA has issued a warning that necrotizing fasciitis of the perineum has been linked to use of sodium-glucose cotransporter-2 (SGLT2) inhibitors indicated to treat type 2 diabetes. This rare but serious bacterial infection of the genital area is also known as Fournier gangrene. A new warning about this risk will be added to the prescribing information for all SGLT2 inhibitors, such as canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin, and to Medication Guides for patients.


Instruct patients taking SGLT2 inhibitors to watch for tenderness, redness, or swelling in their genital or rectal area; a temperature above 100.4[degrees] F (38[degrees] C); and/or an unwell feeling. Because symptoms can worsen quickly, they should seek treatment immediately. Healthcare professionals suspecting Fournier gangrene should immediately initiate treatment with a broad-spectrum antibiotic and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide alternative therapy for glycemic control.


Source: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. U.S. Food & Drug Administration. Safety announcement. August 28, 2018.



FDA takes action to meet demand

To mitigate the potential shortage of EpiPen (epinephrine) autoinjectors, the FDA is extending the expiration date of specific lots of 0.3 mg products marketed by Mylan by 4 months beyond the labeled expiration date. This change is based on stability data provided by Mylan and reviewed by the FDA. The FDA also has been in contact with the other manufacturers of epinephrine autoinjectors regarding their supply, as the beginning of the school year is historically accompanied by increased demand for the product.


In addition, the FDA recently approved the first generic version of EpiPen and EpiPen Jr autoinjectors for emergency treatment of allergic reactions, including anaphylaxis, in adults and children weighing more than 33 lb (15 kg). Marketed by Teva Pharmaceuticals USA, the generic product will be available in 0.3 mg and 0.15 mg strengths.


Sources: FDA in brief: FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication. U.S. Food & Drug Administration. News release. August 21, 2018. FDA approves first generic version of EpiPen. U.S. Food & Drug Administration. News release. August 16, 2018.



Inappropriate antibiotic use provokes adverse events

Although antibiotics are among the most prescribed drugs for children, about one-third of these prescriptions are estimated to be unnecessary. Data on short- and long-term antibiotic harms could inform efforts to reduce antibiotic overprescribing in children. Using adverse event data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project and retail pharmacy dispensing data, researchers investigated the frequencies and rates of ED visits for antibiotic adverse drug events (ADEs) in children. Based on 6,542 surveillance cases, an estimated 69,464 ED visits were made annually for antibiotic ADEs among children age 19 years or younger from 2011 to 2015. This accounts for over 46% of ED visits for ADEs related to systemic medication. Among children age 9 and younger, amoxicillin was the most commonly implicated antibiotic. Amoxicillin also was associated with the highest rate of ED visits for antibiotic ADEs among children age 2 years and younger, whereas sulfamethoxazole-trimethoprim had the highest rate among children ages 10 to 19 years.


To reduce inappropriate antibiotic prescribing and ADEs in children, the authors endorse educational programs such as the CDC's "Be Antibiotics Aware: Smart Use, Best Care" and the American Board of Internal Medicine Foundation's "Choosing Wisely" series of recommendations. They also recommend communicating information on the risk of antibiotic ADEs to parents and caregivers as a way to lessen the demand for or expectation of antibiotics.


Source: Lovegrove MC, Geller AI, Fleming-Dutra KE, Shehab N, Sapiano MRP, Budnitz DS. US emergency department visits for adverse drug events from antibiotics in children, 2011-2015. J Pediatric Infect Dis Soc. [e-pub Aug. 23, 2018]



More harm than benefit for healthy older adults

To investigate whether 5 years of low-dose aspirin therapy extends disability-free life in healthy older adults, researchers enrolled 19,114 community-dwelling older adults with no history of cardiovascular disease, dementia, or physical disability. The study was conducted from 2010 through 2014 in the US and Australia. The participants (median age, 74) were randomly assigned to receive 100 mg/day of enteric-coated aspirin or placebo orally. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points included the individual components of the primary end point and major hemorrhage.


The study showed that low-dose aspirin therapy did not extend disability-free survival over 5 years, but it did lead to a higher rate of major hemorrhage than placebo. The authors note several limitations to the study; for example, because participants were predominantly White, whether the results apply equally to non-White persons is unclear. In addition, the study did not address whether healthy older adults who have been using aspirin for primary prevention should continue or discontinue its use.


Source: McNeil JJ, Woods RL, Nelson MR, et al. Effect of aspirin on disability-free survival in the healthy elderly. N Engl J Med. [e-pub Sep. 16, 2018]