MEDICATION ERRORS

Serious out-of-hospital mistakes have doubled

In a recently published study, researchers analyzed medication errors with serious medical consequences occurring outside a healthcare facility. They found that from 2000 through 2012, the rate of these serious errors rose by 100%, with an overall average rate of 1.73 per 100,000 population.

The retrospective study was based on National Poison Database System (NPDS) data on 67,603 exposures related to unintentional medication errors that occurred outside of healthcare facilities and resulted in "serious medical outcomes;" these are defined by the NPDS as moderate effect; major effect; death; or death, indirect report. Most errors occurred in a home; other locations included workplaces, schools, restaurants, and public areas.

Over the 13-year study period, the rate and frequency of serious medication errors increased for all age groups except for children under age 6. The most common error types were incorrect dose, taking or administering the wrong medication, and inadvertently taking the medication twice. The medications most commonly associated with serious errors were cardiovascular drugs (20.6%), primarily beta-blockers, calcium antagonists, and clonidine; analgesics (12%), such as acetaminophen and opioids; and hormones/hormone antagonists (11%), particularly insulin and sulfonylureas.

"These errors represent an important burden on the health care system, with one-third of the 67,603 exposures included in this study resulting in hospital admission," the researchers write. "Most non-health care facility medication errors are preventable, and our findings can help inform prevention efforts." Recommended strategies for reducing errors include improving product packaging, labeling, and dosing instructions; prescription drug monitoring; and more education for healthcare providers, patients, and parents/caregivers.

Source: Hodges NL, Spiller HA, Casavant MJ, Chounthirath T, Smith GA. Non-health care facility medication errors resulting in serious medical outcomes. Clin Toxicol (Phila). [e-pub July 10, 2017]

SICKLE CELL DISEASE

First drug approved for SCD in decades

The FDA has approved Endari (l-glutamine oral powder), an amino acid indicated to reduce the acute complications of sickle cell disease (SCD) in patients age 5 and older. The first drug approved for SCD in nearly 20 years, it's administered orally twice a day at a dosage based on the patient's weight. Each dose should be mixed in 8 oz (240 mL) of a cold or room temperature beverage or 4 oz to 6 oz of food such as applesauce or yogurt.

Endari's safety and effectiveness were studied in a large randomized trial of patients ages 5 to 58 with SCD who'd had two or more painful sickle cell crises within the 12 months prior to enrollment in the trial. Patients were assigned randomly to treatment with Endari or placebo and evaluated over 48 weeks. Compared with patients treated with placebo, those in the Endari group experienced fewer hospital visits for SCD-related pain treated with a parenterally administered opioid or ketorolac, fewer hospitalizations for sickle cell pain, fewer days in the hospital (median 6.5 days versus median 11 days), and fewer occurrences of acute chest syndrome, a life-threatening complication of SCD. The most common adverse reactions included constipation, nausea, headache, abdominal pain, and cough.

Teach patients to take a missed dose as soon as they remember, but warn them not to double a dose. Inform them that the powder needn't completely dissolve to be effective.

Sources: Food and Drug Administration. FDA approves new treatment for sickle cell disease. News release. July 7, 2017. Endari prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208587s000lbl.pdf.

ANAPHYLAXIS

Many serious reactions aren't treated promptly

A large retrospective review of electronic medical records suggests that administration of epinephrine, the first-line treatment for anaphylaxis under current practice guidelines, is underused by both patients and healthcare personnel. The researchers examined data on 408 patients (mean age, 7.25 years) treated for anaphylaxis in the ED or urgent care center (UCC) at a pediatric academic referral center during 2009 to 2013. Of these patients, only 148 had received epinephrine before arriving at the ED or UCC. Patients were more likely to have been treated with epinephrine prior to arrival if the reaction occurred at school rather than at home. Those who hadn't been treated prior to arrival were significantly less likely to be discharged home from the ED or UCC. The most common anaphylaxis trigger was food, particularly peanuts or tree nuts.

For unknown reasons, patients with signs and symptoms affecting more than one organ system were less likely to receive epinephrine than those whose reactions involved one organ system. The researchers characterize this as "a very ominous and illogical finding, considering a marked campaign in recent years specifically identifying multiorgan system reactions and reactions beyond 'just hives' as prime indications for epinephrine administration." They recommend more education for patients, parents, and healthcare professionals to promote prompt recognition of signs and symptoms of anaphylaxis and adherence to current treatment guidelines. Because patients treated for anaphylaxis should be considered at high risk for serious reactions in the future, they should also be educated about epinephrine autoinjector use and referred to an allergist for follow-up.

Source: Robinson M, Greenhawt M, Stukus DR. Factors associated with epinephrine administration for anaphylaxis in children before arrival to the emergency department. Ann Allergy Asthma Immunol. [e-pub June 30, 2017]

OPANA ER

Extended-release opioid removed from the market

Citing concerns about the risk of drug abuse, the FDA asked Endo Pharmaceuticals to remove the opioid analgesic Opana ER (oxymorphone hydrochloride) from the market in June. While expressing confidence in the drug's safety and effectiveness when taken as prescribed, the company voluntarily complied in July.

Opana ER was approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period. In 2012, the original formulation was replaced with a new formulation intended to make the drug resistant to manipulation for abuse by snorting or injecting.

The FDA action was based on a review of postmarketing data demonstrating a "significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation." Use of reformulated Opana ER by injection has been associated with outbreaks of HIV and hepatitis C, and cases of thrombotic microangiopathy. In March, an FDA advisory committee concluded that the benefits of reformulated Opana ER no longer outweigh its risks.

Sources: Food and Drug Administration. FDA requests removal of Opana ER for risks related to abuse. News release. June 8, 2017. Endo provides update on Opana ER. Endo Pharmaceuticals. News release. July 6, 2017.