Pharmaceutical Commerce - July/August 2011 - (Page 25)

Manufacturing & Packaging New Labeling Laws Encouraging Innovative Ways to Update Rx Drug Info < continued from page 1 is prescribed. Among the most significant changes was requiring drug makers, for the first time, to submit prescribing and product information to FDA in an electronic Structured Product Labeling (SPL) format and update package inserts (PIs) annually. SPL is designed to provide accurate, updated information using standardized medical terminology in a readable, accessible format while PIs provide important information for the safe and effective use of the Rx drug. “Before the implementation of SPL, labeling updates were literally at the mercy of the supply chain,” notes a senior labeling specialist at a major pharma company who declined to be identified for this story. “Even a safety update acted upon immediately, and getting pushed through artwork creation, printing, and manufacturing in as little as two to four months, may sit six months to a year in distribution centers and on retail shelves before reaching a customer.” With SPL, new labeling information— such as updated warnings and precautions— can be published literally overnight. The Nosco’s Lit-A-Sure package inserts can be attached to the secondary (carton) packaging. SPL system works through an electronic gateway that feeds directly into the U.S. National Laboratory of Medicine’s (NLM; Bethesda, MD) DailyMed Web site. Earlier this year, FDA launched the FDA Online Label Repository, which also contains SPL data, providing another source for updated information. “This additional SPL repository ensures that the public has yet another resource to be utilized to access the up-todate safety information available in SPL format,” says Karen Mahoney, an FDA spokesperson. According to Mahoney, NLM recently informed FDA that the DailyMed website receives 10 million visits per month. “This number of visits is indicative that the public not only has access to, but is view- ing the up-to-date safety information included in many of the tens of thousands of unique SPL files posted on DailyMed,” she says. “In addition, NLM has added a feature which will allow consumers/patients to more easily print the medication guide as a separate document.” Pharma companies have reportedly invested a significant amount of time managing product labeling documents such as PIs, Summaries of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). FDA recommends SPL document authors select specific codes (Logical Observation Identifiers Names and Codes, or LOINCs) to identify the medication guides and patient package inserts (PPIs) in SPL files. “Inclusion of the LOINC codes specific to medication guides and PPIs presents the opportunity for consumers/patients to rapidly navigate the SPL file to locate the medication guide or PPI, if present in an SPL file posted in one of the publicly available SPL repositories,” Mahoney says. continued on page 26 > Combined Solutions Offer Promise for Combating Rx Drug Counterfeiting L NOSCO abels not only bear the responsibility of communicating essential product information; because of how dosages are manufactured, they are also a key component in product authentication or anti-counterfeiting. The traditional method of categorizing anticounterfeiting measures as overt, covert, and forensic still applies. What is changing is an acknowledgment in industry circles that any one technology may not be enough to deter the various types of Rx drug fraud. “We see clients often deploying multiple technologies depending on how they define the problem,” observes Nosco’s Albrecht. “Authentication, track and trace, and tamper indicating are uniquely different fraud deterrents. But the goal is universal; authentic product in its intended market void of any tampering.” Nosco claims to be the only certified printer of SignaKey encrypted symbology to track, trace and authenticate product and packages. SignaKey (Clawson, MI) has a technology to print a unique encrypted code on many types of surfaces, which can be read easily provided that the securitycode software is available for a scanner or camera. 3S Simons Security Systems (Nottuln, Germany) reports developing a solution product or of the data matrix code,” Simons says. “As soon as a code has been checked in the corresponding database, the next code with the same specifications will be identified as fake.” This raises a sort of “chicken-andegg” type question: was the first product original or false? What if the second or third item checked is the 3S Simons’ SecuTag, original and the first one was a councombined with a serialization terfeit? To ensure these problems do code (carried, in this case, not hinder the supply chain of origiby an RFID tag) provides double authentication. nal medicines, another code needs to be applied to the traceability label, which combines counterfeit protection Simons says. “The information sent to the databases and track and trace in one single system. “A micro color code (Secutag) and a track- needs to be double-checked,” he points out. and-trace device (Secudata) are conjointly “This can be done by applying a micro color applied onto a label and attached to the code to the traceability device. This code is primary or secondary packaging of the deposited in the databases and can be verimedicines,” explains Rolf Simons, general fied by use of a simple microscope.” Each manager. “The label can, of course, also be producer receives its individual color code equipped with additional identification fea- so products can unambiguously be attributed to the manufacturer of a certain phartures on demand.” The data matrix code is scanned and its maceutical. Indeed, R&D is focused on designcontent is checked in international databases. This shows where, when and by ing products to meet growing tamper and whom the product has been handled up to counterfeit protection demands for pharthis point in the supply chain. “Yet this is no ma products and packaging, observers guarantee for the authenticity of the medical say. Earlier this year, Schreiner ProSecure (Oberschleissheim, Germany), a sister division of Schreiner Medi-Pharm, introduced a new covert security feature for proof of authenticity which integrates its invisible FluxSecure authentication technology into self-adhesive products. The FluxSecure feature can be quickly checked even through product enclosures and packaging, is easy to integrate and ensures reliable authentication, according to the company. The FluxSecure technology consists of a magnetically encoded, extremely thin thread which is inserted between the adhesive and the masking paper. The magnetic properties of the security feature are read out without line of sight, using a handheld reader or a sensor that generates a magnetic field. This allows products to be verified even through heavy and metallic packaging. While legislative bodies worldwide are aware of the drug counterfeiting problem, they are still far apart from agreeing on a uniform solution and implementation. Further mudding the waters is the wide spread belief that traceability equals anti-counterfeiting. “So some legal proposals advise pharmaceutical companies to ‘secure’ their products with RFID or data matrix codes,” Simons says. “This is basically a good idea. But it cannot be the sole answer to the counterfeiting problem.” —F.J. Quinn July | August 2011 25 www.PharmaceuticalCommerce.com 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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