March 20
IN THIS ISSUE / March 20, 2019
- Sodium bicarbonate injection recalled due to presence of glass
- DW Insights and Inquiries: Dermatologists will increasingly meet mammalian meat allergy
- Diversifying the specialty can result in high-quality access to dermatologic care
- Trouble getting off-label meds? Flawed compendia causing coverage denials for dermatologic conditions
- Miami Beach commissioners vote ‘no’ on sunscreen ingredient prohibition
Sodium bicarbonate injection recalled due to presence of glass
Hospira, Inc. has issued a voluntary nationwide recall of 8.4% sodium bicarbonate injection USP, 50 mEq/50 mL (1 mEq/mL), due to the presence of particulate matter, confirmed as glass. The recall applies to lot numbers 79-238-EV, 79-240-EV, and 80-088-EV (NDC# 0409-6625-02). The product was distributed nationwide to wholesalers, distributors, and hospitals in the United States and Puerto Rico from August 2017 to September 2017.
Administration of a glass particulate through an intravenous drug may result in local irritation or swelling. More serious outcomes would include blockage and clotting in blood vessels. To date, Hospira, Inc. has not received reports of adverse events associated with this issue. The company has notified its direct customers via recall letter to arrange for return of any recalled product. Anyone with existing inventory of the recalled lots should stop use and quarantine immediately.
For additional assistance, call Stericycle at 1-800-805-3093 from 8 a.m. to 5 p.m. (ET) Monday through Friday. To report adverse events or product complaints, contact Pfizer Safety at 1-800-438-1985, option 3, 8 a.m. to 7 p.m. (ET) Monday through Friday.
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DW Insights and Inquiries: Dermatologists will increasingly meet mammalian meat allergy
It has been a decade since Van Nunen et al detailed 25 patients living in a tick-endemic region of Sydney, Australia, who developed a red meat allergy following large, local reactions to tick bites. Tick-induced mammalian meat allergy (MMA) has become an emergent allergy on six continents where humans are bitten by ticks. In each country, a major specific tick species has been implicated. In Australia, it is Ixodes holocyclus (the Australian paralysis tick); in the United States it is Amblymomma americanum (the Lone Star tick). Keep reading!
Diversifying the specialty can result in high-quality access to dermatologic care
“The real reward comes when we provide access to care and use our rare skills and expertise — as dermatologists — to make an impact on the most vulnerable communities,” said Valerie D. Callender, MD, AAD Board of Directors member and champion of the AAD 2019 Strategic Plan. She reflects on the strategic goal — access to dermatologic care — and how members and the specialty-at-large can increase access to care for patients who need it most. Keep reading!
Trouble getting off-label meds? Flaws found in compendia for dermatology conditions
A group of researchers reviewed two compendia used to make Medicare Part D coverage determinations for off-label prescribing, and found the compendia “incomplete, outdated, idiosyncratic, and unpredictable” for some chronic dermatologic conditions, according to recent findings published in JAMA Dermatology.
When the Centers for Medicare and Medicaid Services (CMS) developed the Medicare Part D program, coverage was a serious concern. At the same time, prescribing had to be limited so a prior authorization process was developed, said Joerg Albrecht, MD, a Chicago-based dermatologist who took part in the study. “In order to standardize the approach between carriers it was felt that all accepted treatment had to be covered. To solve the problem without much burden on the administration, CMS suggested a number of compendia that could serve as a standardized database to assure uniform coverage between carriers.”
The CMS regulation may need to be changed more broadly, said lead researcher John S. Barbieri, MD, MBA, because patients are being denied coverage because of these flaws. The patient that sparked interest in this study for Dr. Albrecht had been denied acitretin, which had worked in the past to treat his hidradenitis suppurativa (HS) patients. “It turned out that HS is practically unknown in the compendia. Only one of the two compendia even listed adalimumab, which has an FDA indication. The other compendium did not even list the drug. All other treatments — from rifampin to doxycycline, acitretin to spironolactone and finasteride — would be denied because they are not in either compendium,” Dr. Albrecht said. Keep reading!
Miami Beach commissioners vote ‘no’ on sunscreen ingredient prohibition
Last week, Miami Beach commissioners voted not to prohibit the sale of sunscreens containing oxybenzone and octinoxate — two ingredients found in many over-the-counter sunscreens approved by the FDA, reported CBS Miami.
Read coverage from when the Hawaii governor signed legislation banning sunscreen with oxybenzone and octinoxate in Dermatology World Weekly.
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