West Pharmaceutical Services Inc.’s Carol Mooney, Global Market Segment Director, Pharma/Biotech, offers guidance on complying with the new standards.
Q. How does the new standard impact pharmaceutical packaging?
Procedure packs are typically swathed in common blue surgical wrap, making it difficult for nurses or other practitioners to identify specific packs quickly. And such homogeneity has led to error. According to a recent survey conducted by Medline of more than 400 operating room staff, 67% of respondents said that the incidence of picking the incorrect pack occurs at least several times a year.
ISPE (www.ispe.org) has developed industry guidance to help companies conducting global clinical trials standardize booklet labels. Available for purchase on the group’s Web site (http://www.ispe.org/ispe-good-practice-guides/booklet-labels), the ISPE Good Practice Guide: Booklet Labels was developed to help train clinical trial personnel on proper booklet label use.
Packaging for Zicam Cold Remedy has been redesigned by Beardwood&Co. The over-the-counter product family marketed and sold by Matrixx Initiatives Inc. includes 15 SKUs, including Rapidmelt tablets, chewables, liquid lozenges, crystals packets, and oral mist.
“We helped define this different segment,” says Julia Beardwood, founder, Beardwood&Co, in a press release. “But, to be successful, we had to help consumers quickly sort through this myriad of products in the cold aisle and understand what Zicam is and when to take it.”
The Food and Drug Administration is warning doctors and patients that a widely used antibiotic from Pfizer can cause rare but deadly heart rhythms in some patients.
The agency is adding new warnings to the label of Zithromax, which is commonly used to treat bronchitis, pneumonia and other infections.
Doctors should consider prescribing other antibiotics to patients at risk of heart problems, including those with irregular heartbeats or low levels of potassium or magnesium in their blood.
In the medical device industry, labeling errors can lead to costly consequences. Both the industry and federal regulators require specific information about each medical device and its packaging to travel with each item in order to provide full traceability up and down the supply chain.
Pharmaceutical and medical device manufacturers alike are gearing up to include more product information in labeling. Many of these products will need to carry item-level serialization or other variable information, and some products must bear detailed warnings to convey product risks. And for manufacturers serving a global market, they must accommodate the 20-plus languages spoken within the European Union (EU), along with new outer packaging requirements under the Falsified Medicines Directive.
AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, welcomed the news today the boxed warning label (also called the ‘black box warning’) on Gilead Sciences’ blockbuster AIDS treatment Truvada for use as a form of an HIV prevention pill appears much stronger than proposed versions of the label earlier this year.
Datalogic S.p.A. (Borsa Italiana S.p.A.: DAL), a global leader in Automatic Identification and total solutions provider of bar code readers, data collection mobile computers, RFID and vision systems, is enhancing processes in the healthcare sector by meeting high demands in patient safety and inventory tracking solutions.