Pharmaceutical Commerce - January/February 2013 - (Page 1)

jAnUARy/FEBRUARy 2013 Legal & Regulatory Brand Marketing & Communications In an EHR era, adverse event reporting takes on a new look As the number of adverse events (AEs) grows year by year, regulators and industry managers are looking at automated systems to handle the burden By Lena Anthony, contributing editor How to prevent ‘agg spend’ sunburn Implementation of the Physicians Sunshine Act may require you to begin data gathering by Feb. 25, but questions remain over the law’s details, from data to dollars By Bob Sperber, contributing editor In Oct. 2012, the Health IT Policy Committee, which advises the Office of the National Coordinator for Health IT, released preliminary recommendations for Stage 3 meaningful use requirements for electronic health records (EHRs). Included in those recommendations are a requirement that certified EHRs (those that are eligible for federal incentive payments) be capable of reporting adverse drug events to FDA and/ or the Centers for Disease Control and Prevention. If the recommendations receive final approval, which is expected this April, drug companies could see a surge in AE reporting start in 2016, when Stage 3 requirements begin to take effect. Meanwhile, FDA continues to work toward an active drug safety surveillance system through its Sentinel Initiative, which was mandated by the FDA Amendments Act of 2007, and its Mini-Sentinel pilot project that has secure access to records of more than 126 million patients nationwide from 17 data sources. Further adding to the volume of AE data is an increasing focus on social media as a source for finding out about adverse events. “We’re going to see an evolution of change in pharmacovigilance over the next five to 10 years,” says Elizabeth Garrard of Garrard Safety Solutions (Chapel Hill, NC). “Individual case study reports and the pressures we have today will be different, largely alleviated by tremendous automation and other technological advances” that will allow us to extract better quality data out of a greater volume of adverse event reports and, ultimately, detect safety signals earlier. EHRs notwithstanding, the number of adverse events reported to FDA has grown steadily since 2002, approaching 800,000 in 2011, and projected to top that for 2012 (see Fig. 1). Outsourcing AER FDA requires pharmaceutical companies to report AEs that meet four basic criteria: an identifiable patient; an identifiable reporter; a specific drug; and a symptom or effect. Per FDA rules, pharmaceutical companies also are required to provide the agency with a complete dataset about the event, a process that often involves following up with the patient and healthcare provider. Trained investigators categorize the symptoms and possible causes, and sometimes involve the prescribing physician as well. What FDA and pharmaceutical companies are most concerned about are AEs that are categorized as both serious and unexpected. These are the ones that most often lead to label changes and product withdrawals. Traditionally pharma companies had their own staffs to handle the initial reports and followup interviews. As with other pharma industry duties, many companies now outsource that function, or employ a hybrid model of both internal and external resources. According to Greg Fiore, chief medical officer for The Medicines Company (Parsippany, NJ), most pharmaceutical companies, including his, employ a hybrid model. “We focus in-house resources on the most strategic and highly scientific jobs, while outsourcing technical operations,” he says. “I think continued on page 18 The reelection of Pres. Barack Obama assured that the Patient Protection and Affordable Care Act (PPACA or ACA), signed into law on March 23, 2010, will move forward, and with it, the Physician Payment Sunshine Act provisions. It goes by lots of names. Officially named the Transparency Reports and Reporting of Physician Ownership or Investment Interests section, it also goes by the “Sunshine Act,” aggregate spend law or simply “agg spend.” By any name, it will require pharma, device and medical supply manufacturers to submit reports of spending on physicians and teaching hospitals to a database maintained by the Centers for Medicare and Medicaid Services (CMS). Reports must include “payment or other transfers of value” (POTVs) exceeding $10 for everything from small meals to consulting fees, to speaking and research fees, to stock ownership. Manufacturers can’t begin collecting data for strict compliance until the final rule is published. The latest news at presstime is that CMS completed the final rule, and on Nov. 27, sent it to the White House Office of Management and Budget for review. Expectations are that within 90 days of OMB’s receipt, CMS rule will be issued as final. If so, manufacturers could be required to begin data gathering on Monday, Feb. 25, 2013, for their 2014 agg spend report submissions. Will you be ready when(ever) the law comes? Penalties as proposed continued on page 14 Manufacturing & Packaging When serializing packages for e-pedigree, go random The looming California e-pedigree standards do not specify how to generate product codes, but random codes are easy to produce and essential for supply chain security By Scott Pugh, Verify Brand The US pharmaceutical industry is approaching a significant milestone in the upcoming months: 24 months until the first phase of California e-pedigree regulations go into effect. For many global pharmaceutical companies, serialization initiatives have been underway for a number of years. Counterfeit intrusions continue to occur both domestically and internationally, and various serialization schemes are becoming the standard around the world. Whatever the driver may be, the need for supply chain security and visibility remain at the forefront. The debate over whether to serialize within the pharmaceutical industry is effectively being answered for companies—but that shouldn’t stop the industry and regulators from performing the due diligence required to ensure that serialization and traceability are implemented in ways that maximize supply chain security. One of these key decisions is whether or not to utilize random codes versus sequential serial numbers. Pharmaceutical companies have a number of factors to consider when determining serial continued on page 21 January | February 2013 Visit our website at www.PharmaceuticalCommerce.com 1 PRSRT STD US POSTAGE PONTIAC, IL PERMIT 268 PAID http://www.pharmaceuticalcommerce.com http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - January/February 2013

Pharmaceutical Commerce - January/February 2013
Editorial
Contents
Op-Ed
Top News
Business/Finance
Brand Marketing & Communications
Supply Chain/Logistics
Legal & Regulatory
Information Technology
Manufacturing & Packaging
Meetings and Editorial Index

Pharmaceutical Commerce - January/February 2013

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