Pharmaceutical Commerce - July/August 2011 - (Page 30)

Information Technology IT Solution Offered for Suspicious-Order Monitoring DEA suspends the license of another wholesaler over unmonitored shipments of controlled substances, including oxycodone B y means of a federal regulation (21 CFR 1301.74b) the US Drug Enforcement Administration is authorized to investigate wholesalers who do not sufficiently monitor their shipments of controlled substances. The latest company caught up in this regulation is Keystone Medical (Cincinnati), whose license was temporarily suspended, pending an administrative review, in early June. Keystone—an otherwise well-established legitimate wholesaler (the company has the Verified Authorized Wholesale Distributor, or VAWD, accreditation from the National Assn. of Boards of Pharmacy, and is a member of HDMA)—joins a string of other wholesalers, including all of the Big Three, who have been subject to DEA enforcement actions. The CFR regulation requires wholesalers to “make a good faith inquiry” either with DEA or state agencies to ensure that customers are permitted to obtain the drug, and even to report directly to DEA “suspicious” levels of ordering. Wholesalers have complained that they’re being turned into de facto DEA agents; DEA’s response is that it’s more efficient for them to go after sources of drug shipments over the many dispensers (although enforcement occurs there as well). The Big Three wholesalers and others caught up in DEA investigations have responded by developing “suspicious order monitoring” (SOM) systems, and now an IT vendor, eSupplyLink (Traverse City, MI; www.esupplylink.com) is seeking to fill that gap with SOMLink, a tailored IT solution. According to Ron McCreery, sales manager, SOMLink sits next to the order-entry system of the wholesaler, and performs ongoing statistical analysis of order receipts. Actions like sudden, unusually large orders, or orders from new customers, are flagged for further review. Version 2.2 of SOMLink was introduced in July. McCreery says that it has been upgraded with user-controlled “threshold management,” which defines the parameters around which an order gets flagged. Up to 16 separate statistical analyses are performed. By purchasing a packaged solution, rather than customizing the functionality on an enterprise order-management system, McCreery says that costs can be cut by nearly an order of magnitude. SOMLink is complementary to the online Controlled Substances Order System (CSOS) that DEA instituted to allow e-commerce to replace its Form 222, a paper-based system for recording controlled-substances orders (Pharmaceutical Commerce, Nov/Dec, 2010, p. 18). McCreery says that eSupplyLink has business relationships with Axway (Phoenix, AZ; www.axway.com) and Legisym (Temple, TX; www.legisym.com), two of the companies with validated CSOS systems available for retailers and wholesalers. PC Tracelink Sharpens Focus on Brand-Owner/CMO Collaboration With Quality Review Tool Cloud-based collaboration system provides for production, status and now quality interactions between business partners TraceLink (Woburn, MA), which has supplied online networking tools for, among others, contract packager Sharp Corp. (Allentown, PA) and contract manufacturers Catalent Pharma Solutions (Somerset, NJ) and Patheon (Research Triangle Park, NC), has expanded its service offerings into the quality-management sphere with Quality Review (QR). The expansion builds on the messaging and collaboration tools TraceLink has already built for managing relationships, specific to biopharma manufacturing, between CMOs and brand owners to initiate, schedule and monitor the many steps between a production run beginning and filing the necessary documentation for releasing production lots from one step to the next. By enabling this coordination, while cutting the expense of linking disparate enterprise systems among many brand owners and many CMOs, the goal of responsive, high-visibility supply chains can be achieved, says the company. TraceLink has roots in the early days of drug pedigree programs, which enable similar coordination between trading partners to document shipment and transfer of commercial quantities of product. The founders, led by Shabbir Dahod, were also the founders of SupplyScape (which TraceLink later acquired, and still maintains the pedigree-documentation technology from then.) The new QR package has these capabilities: • Exchange, analysis and tracking of batch record, change control, event / incident and general quality reviews in a collaborative team workspace • Integrated KPI dashboard providing real-time information on current and historical quality review performance • Integrated communication and feedback trail, including comments and documents, for each iteration of the review cycle • Alerts and status indicators that highlight when information has been submitted, viewed, modified or needs attention • Quality review and production order linkage to increase insight into potential impacts of schedule or project changes. Express Scripts Tackles Medication Adherence With SAS Analytics SAS’ new Center for Health Analytics will expand statistical applications SAS Analytics is well known in the clinical space for its tools to manage clinical trials data; less well-known are applications in commercial or healthcare-provider applications. But one of its clients, Express Scripts, is touting the Cary, NC, company’s technology for addressing an ongoing problem in life sciences: getting, and keeping, patients on therapy. Express Scripts uses the predictive models created with SAS Analytics to continually improve its services and become a proactive partner in patients’ health. “We’re talking about treating patients proactively. We can predict who will comply with their medication or not,” says David Tomala, Express Scripts Director of Advanced Analytics. “Even if medication costs increase marginally, overall medical costs are minimized through better health outcomes.” Tomala’s team worked with 400 variables that are accessible in the Express Scripts’ patient databases, building a predictive tool that helps them analyze patients’ care and adherence. Depending on what results surface from the statistical analysis, the company can tailor an adherence program to the patient’s needs. “Our outreach programs address an individual’s risk factors. People too busy to order a refill can be moved into an automated refill program before a lapse occurs. Patients concerned about side effects might benefit from talking to a pharmacist. We analyze each patient to offer the most effective programs to keep them healthy.” Medication adherence is but one application that SAS hopes to address with a newly opened Center for Health Analytics, which brings a team of experienced life sciences and healthcare project managers together to identify new application areas for SAS tools. There are three broad buckets where we see potential for SAS services,” says Jason Burke, managing director at the Center, “improving patient outcomes; providing financial analytics; and providing customer intelligence.” Besides having powerful analytical capabilities built into the SAS platform, Burke says that the company has invested heavily in visualization tools that help users grapple with large datasets. “The adherence type of problem is a good example,” he says. “Large datasets must be brought together from disparate sources; and many variables are present to be factored into the analysis.” At the same time, while Tomala notes that he was able to tap into a pool of experienced SAS analysts to build up his analytics team, Burke emphasizes that “you don’t need to be a PhD mathematician” to use the visually-oriented SAS tools. PC “As outsourced production of pharmaceuticals increases, virtual quality teams struggle to efficiently monitor, measure and control quality review processes typically based on phone, FAX and email communications,” said Dahod, CEO at TraceLink, “Quality Review is a quality information management service that connects quality teams across external supply relationships and ensures that all team members have access to the precise and timely information they need to reduce risk, ensure quality and meet production schedules.” PC 30 July | August 2011 www.PharmaceuticalCommerce.com http://www.esupplylink.com http://www.axway.com http://www.legisym.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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