Pharmaceutical Commerce - July/August 2011 - (Page 26)

Manufacturing & Packaging < continued from page 25 Greater Access to Updated Reporting Data The SPL initiative has reportedly led pharma companies to leverage modern information technology to provide better reporting data to consumers and healthcare providers while enhancing patient safety. For example, a smartphone can be used to access the DailyMed Web site, even while at the doctor’s office or waiting in line at the pharmacy. “A patient is given the increased ability to be aware of side effects, contraindications, and drug-drug interactions,” the pharma company source says. Smartphone applications have demonstrated new ways to improve effectiveness and efficiency of established approaches to managing chronic diseases by helping patients record and manage their medication in real time. A case in point is the National Centre for Hereditary Coagulation Disorders (NCHCD), based at St. James Hospital (Dublin, Ireland), where more than 2,000 patients have bleeding disorders. There hemophlia patients are utilizing a user-friendly application from Crimson Tide which is fully compliant with the GS1 bar code track-and-trace system and extends the management of bar-coded medication into the patient’s home, according to a published report. Alternative placements of barcodes, some produced with Nosco’s digital printing capabilities. mation is included on PIs for healthcare professionals and patients while pharma companies are being more careful in providing details on Rx drug benefits/risks so they are better protected against potential liability. “There is a tendency to include more information with the help of extended content labels that contain all crucial information to help improve patient safety,” Schreiner MediPharm’s Dul says. To that end, FDA, NLM, the National Institutes of Health, drugmakers, and drug Schreiner MediPharm’s peel-off label options integrate well with hospital tracking procedures. example, to ensure that computer screen readers utilized by visually impaired persons are able to ‘read’ the information about images, FDA requires that SPL document authors include descriptive text which will permit the computer screen reader to provide a description of the content of the image file to visually impaired persons.” There are solutions providers who specialize in enabling pharma companies to create and manage their labeling and drug listing information, NDC Labeler Code Requests, and Establishment Registrations in an SPL format. For instance, Glemser Technologies (Bethlehem, PA), a designer, developer and implementer of content management solutions for life sciences companies, offers xmLabeling for SPL which enables clients to do just. Glemser reports that its OnDemand Conversion Services allow companies to author MS Word-based product information documents and utilize Glemser products and services to convert these documents for submission to health authorities. Nosco (Waukegan, IL) offers a system which allows pharma manufacturers to provide prescribing and product information directly to the company. “Nosco works directly with them to design the copy to fit their and the FDA’s needs,” explains Kregg Albrecht, VP, solutions engineering. “Since Nosco is providing all of the printing and converting of the packaging and labeling materials, coming directly to Nosco reduces cost and complexity for the pharmaceutical manufacturers.” Studies show patient outcomes improve when they actively participate in their own care. Many tend to think of SPL solely as a means of communicating the prescribing information, or product use information. While a valuable communication tool, SPL impacts the safe use of drugs in many more ways. “SPL includes all of the active and inactive ingredients, places of manufacture or processing for each major step, including API manufacturing, importer information, and several other data elements,” the pharma company source says. “All this information is set up in a standardized process which enables automatic and robust processing into databases for further use.” FDA wants to ensure meaningful infor26 July | August 2011 www.PharmaceuticalCommerce.com information companies are collaborating to improve the safe use of drugs by increasing access to updated data. Drug product information is now required to be uploaded as SPL files for use on Web sites, computer systems and other processes to make it accessible to healthcare providers, patients and the public. Prescribing and product information in the SPL format can be electronically managed, allowing users to search for specific data, such as indications, dosage and administration, and warnings. “Since 2005, FDA has responded as soon as possible to requests related to the improvement of the content of labeling in SPL format to ensure that the labeling is clearer and more user friendly,” Mahoney says. “For “LIT-A-SURE CAN BE DESIGNED IN SUCH A WAY THAT IT WILL PRESENT ITSELF TO THE CUSTOMER WHEN THE PACKAGE IS OPENED, MAKING IT ACCESSIBLE, AND COMPLIANCE FRIENDLY.” — Kregg Allbrecht, Nosco Life-saving innovations The latest products from carton and label providers have enough space to accommodate more useful information while removing any obstacles additional components would have on packaging line efficiencies. Methods of artwork layout, including color schema and visual structure, are being targeted to help reduce medication errors, observers say Problems with medication errors are well documented and estimated to cause 100,000 deaths annually in the United States, according to the Institute of Medicine of the National Academies (IOM; Washington). Mistakes occur at different points of transition in care, ranging from admission to a hospital, transfer from one department to the next (such as from critical to general care), and at discharge from home to another facility. Further compounding matters are patient challenges in self-administration, which are numerous and include complex regiments, poor patient education and literacy. Rx drug labels are now clearer, more user friendly and designed to improve patient safety. For example, Nosco’s Lit-a-Sure is a product that allows for the combination of customer’s FDA required literature to be attached to the pharmaceutical manufacturer’s cartons by Nosco. ”Lit-a-Sure can be designed in such a way that it will present itself to the customer when the package is opened, making it accessible, and compliance friendly,” Albrecht says. “The literature can be designed with a combination of PI and/or PPI and include other compliance prompting features such as calendarization or patient recording features.” Up to 130 panels in a single style format can be designed, or Nosco can attach multiple folded pieces into one compact literature pack. Fix-a-Form (FaF) multi-panel labels are another form of labeling from Nosco that addresses the needs of the consumer for improved clarity and ease of information access. The labels provide multiple pages of copy, which are attached directly to the product or carton in an easy-to-read format. “Fix-a-Form labels keep the information at the fingertips of the consumer,” Albrecht says. “Multiple languages can also be printed on the same FaF, making access to many cultures using one label a reality.” A technology which holds the promise of driving life-saving innovation to drug labeling is barcode-enabled medication administration (BCMA). BCMA is used to verify all medications electronically before they are administered to patients. Healthcare providers who implemented barcoding solutions found improved patient safety through the reduction of preventable medication errors, according to published reports. “Barcoding is getting more and more important and there is an increasing use of 2-D barcodes which contain much more information,” Schreiner MediPharm’s Dul says. “However, there still seems to be some reluctance in implementing this widely within healthcare practice.” Industry members attribute part of the slow market acceptance SCHREINER NOSCO http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011
Contents
Op-Ed
Top News
Business/Finance
Brand Communications
Supply Chain/Logistics
Manufacturing & Packaging
Legal/Regulatory
Information Technology
PDMA Exhibitors
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover1)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover2)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page 3)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 4)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 5)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 6)
Pharmaceutical Commerce - July/August 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 8)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 9)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 10)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 11)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 12)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 13)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 14)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 15)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 16)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 17)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 18)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 19)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 20)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 21)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 22)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 23)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 24)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 25)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 26)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 27)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 28)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 29)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 30)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 31)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 32)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 33)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 34)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page 35)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page Cover4)
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