Diplomat to distribute Otezla for psoriatic arthritis
FLINT, Mich. — Diplomat on Monday announced that it is one of a select group of specialty pharmacies contracted by Celgene to distribute Otezla (apremilast), a new medication for the treatment of psoriatic arthritis. Otezla is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP).
Otezla was approved by the FDA on March 21, 2014, and is available in 10 mg, 20 mg and 30 mg tablets.
Per manufacturer’s instructions, patients taking Otezla should have their weight monitored regularly by a healthcare professional. If clinically significant or unexplained weight loss occurs while taking Otezla, the patient should be evaluated and discontinuation of therapy should be considered. The most common side effects experienced by patients taking Otezla were diarrhea, nausea and headache. In clinical trials, patients taking Otezla were also associated with more reports of depression compared to those patients on placebo.
Military retailer Exchange conducts in-house product quality testing
DALLAS – In the Army and Air Force Exchange Service’s Quality Assurance testing facility, it is not uncommon to see a flicker of light through the blinds or to experience the faint smell of burning plastic seeping up from under the closed doors.
Military shoppers expect the products they purchase to meet high standards for safety and quality, and the Exchange takes steps beyond federal regulations to ensure customers can be confident that the diamond engagement ring is genuine, the baby’s crib is secure and kids’ toys are safe.
The Exchange employs 19 associates in making up the QA team including two Gemology Institute of America alums who ensure the value, authenticity and quality of the Exchange’s jewelry selection. While QA inspections are primarily visual, many products are also checked for functionality to examine if products are fit for sale and use.
The Exchange also conducts product testing or evaluations based on customer complaints and concerns. Select samples are also tested from outside labs to ensure the consistency and integrity of vendor or manufacturer’s test results.
“There is nothing more important than ensuring all of the products we carry are safe for our soldiers, airmen and families,” stated the Exchange’s deputy director Maj. Gen. Joseph Ward. “Whether it’s a car seat for children, pieces of tactical gear or a household cleaning product, Exchange inspectors carefully test merchandise before it goes on our store shelves.”
HDMA in testimony to Congress: Government, industry should partner on combating Rx drug abuse
ARLINGTON, Va. — Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.” HDMA is in support of the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, H.R. 4069, sponsored by Reps. Marino, R-Pa., and Blackburn, R-Tenn.
“The Marino-Blackburn legislation will further define key terminology in the Controlled Substances Act, so companies registered with the Drug Enforcement Administration have clearer direction of their responsibilities under the law," he testified.
"A key provision allows DEA-registered companies to establish corrective action plans to address and mitigate any agency concerns — similar to the way FDA interacts and regulates pharmaceutical manufacturers — so industry and regulators can partner to address drug abuse and diversion. HDMA and our primary healthcare distributor members are working to identify collaborative and transparent solutions, in partnership with our supply chain trading partners and government officials, to slow the prescription drug abuse epidemic in our country, and the Marino-Blackburn bill is one step in our efforts to achieve that goal.”