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Archive for October, 2009

Item-Level Serialization Could Assist EHR during Vaccine Rationing

Wednesday, October 28th, 2009

I knew it would happen. People are panicking about the H1N1 flu. Yesterday The New York Times reported that people lining up at flu shot clinics are lying about underlying medical conditions so they can qualify for the rationed doses. "Some reduce themselves to lying about a pregnancy, or an underlying ...

As Mom-and-Pop Pharmacies Head toward eHealth, Auto-ID Needed on Unit-of-Use Packs

Monday, October 26th, 2009

Could the wiring of neighborhood pharmacies encourage the use of automatic identification in drug packaging? A proposed lending program is intended to ease funding of information technology upgrades that could bring state-of-the-art connectivity to these small businesses. The U.S. House of Representatives' Small Business Committee has reportedly passed H.R.3854, the Small ...

Change Still Needed to Improve Pharmacy Dispensing

Thursday, October 22nd, 2009

Here's a letter just in from a reader this week in response to my October issue editorial: "Daphne, I read your editorial and I think one solution is to package all drugs in compliance packaging such as blister packs. As you know, 80% of the drugs in Europe are packaged this way ...

Could Electronic PIs Be Coming?

Thursday, October 22nd, 2009

Years ago, the Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC) encouraged FDA to allow drug manufacturers to provide prescribing information (PI), also known as professional or pharmacist inserts, solely in electronic formats. In 1999, we reported that PhRMA formed a Paperless Labeling Task Force to evaluate the technologies ...

Don’t Stick that in My Mouth

Wednesday, October 21st, 2009

I've read this before, but judging from today's ISMP Medication Safety Alert! it obviously bears repeating: clinicians should "never use parenteral syringes to prepare or administer small volumes of oral/enteral products." ISMP shares several heartbreaking accounts of how nurses or pharmacists who prepared fluids meant to be fed to patients accidentally ...

Do Educational Materials Need to Follow an FDA-Approved Script?

Monday, October 19th, 2009

FDA and the Federal Trade Commission wrote to Weil Lifestyle Inc. last week about marketing claims made for the firm's Immune Support Formula. "The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. ยงยง 331, 351, 352. We request that you immediately cease ...

HCPC Urges FDA to Reconsider Ban on Calendarized Generics that Differ from Branded Drugs

Thursday, October 15th, 2009

The Healthcare Compliance Packaging Council sent the following letter to FDA, HHS, and the White House today. Executive director Peter Mayberry wrote to protest an FDA decision that "prohibits generic drug manufacturers from calendarizing unit dose blister cards, strips, and other packaging formats" if the branded drug was not packaged ...

Any Drug Subject to Supply-Chain Pain

Wednesday, October 14th, 2009

The latest theft of pharmaceutical products in the supply chain reminds me of my days as a bank officer and coming across a counterfeit $5 bill. Why didn't the counterfeiters just stick with $20s and $100s? Why dupe the low denominations? FDA reported last week that cases of Tylenol Arthritis and ...

Whither MTM?

Monday, October 12th, 2009

As healthcare reform legislation plays out in Congress, various bills are addressing medication therapy management services (MTM). MTM belongs in any healthcare program that includes a focus on improving healthcare quality while also reducing healthcare spending and waste. The Affordable Health Choices Act (AHCA) put forth by the Senate's Health, Education, Labor, ...

FDA-Approved Labeling Critical to Proper Care

Friday, October 9th, 2009

This week GSK wrote to healthcare providers warning them that Relenza (zanamivir) inhalation powder must not be nebulized. The formulation contains lactose sugar that can obstruct mechanical ventilator equipment. Sadly, a pregnant woman outside the United States on mechanical ventilation received zanamivir solution made from dry powder via nebulizer for ...