Labeling

ISPE Surveying Patients on Clinical Trial Materials

ISPE, the International Society for Pharmaceutical Engineering, reports that it is surveying patients globally on their experiences with clinical trial materials. The goal is to gather feedback on the suitability of clinical trial packaging, label information and design, interacting with clinical trial technologies, and transportation and storage, ISPE reports in a press release. With a target of 2000 or more patients from around the world, this study is the first known of its kind in size and scope, it reports.

Preparing for Printing Changes: USP Ch <1> Labeling Revisions

Taking effect on December 1, 2013, is the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard regarding labeling for cap overseals and ferrules on injectable drug vials. The revised chapter covers all injectable drug products, human and veterinary, intended for sale in the United States.

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?

Color Coding to Hasten Identification, Reduce Errors

Medline Industries Inc. (www.medline.com) has launched a new system of color coding and labeling in order to ease surgical procedure pack identification. Medline’s EMPOWER Packaging System features color-coded outer packing labels and matching color-coded insert forms.

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.

Standardizing Labeling

ISPE seeks to improve clinical trial personnel understanding and practitioner patient compliance through standardized booklet labels.

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.

New OTC Cold Product Packaging Anything but Common

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.”

FDA Adds Heart Risk Warning to Pfizer Antibiotic

The agency is adding new warnings to the label of Zithromax, an antibiotic used to treat infections such as bronchitis and pneumonia.

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.

The Right Rx for Label Accuracy

Mangar Medical Packaging eliminates labeling errors with on-demand printing solution.

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.

USP Announces Change in Labeling Requirement for Total Strength of Heparin

To address safety concerns about the expression of drug strength on labels for heparin sodium injections and heparin lock flush solutions, the U.S. Pharmacopeial Convention (USP) has revised its current standards for these products.

Packing in More Labeling Solutions at PACK EXPO

It is no surprise that pharmaceutical and medical device packaging professionals are looking for efficient ways to add printing, labeling, and verification technologies to their packaging lines.

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.

HIV Treatment Receives Stronger Label Warnings After Call From Advocates

Advocacy groups moved the FDA to call for packaging of Truvada to bear a “black box warning” after its earlier approval as an HIV prevention pill.

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.

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