Pharmaceutical Commerce - May/June 2013 - (Page 24)

Information Technology Better interoperability is the goal of an EHR vendor consortium CommonWell Health Alliance, led by McKesson and Cerner, wants to create a private-industry-focused, neutral forum for resolving technical issues At last week’s HIMSS (Health Information Management Systems Society) annual meeting in New Orleans, something of a stir was generated among the 35,000 attendees by the unexpected announcement of an industry alliance organized by two leading vendors in the electronic health records (EHR) market: McKesson and Cerner Corp. McKesson, besides being the biggest drug wholesaler in the world and an EHR vendor in its own right, is also the owner of RelayHealth, a widely used claims-processing service (handling, for example, adjudication of pharmacy benefits). Cerner (Kansas City, KS) is one of the leading EHR vendors, managing clinical data and claims processing for 10,000 facilities worldwide. Three other EHR vendors have joined the consortium: Allscripts (Chicago); Greenway Medical Technologies (Carrollton, GA) and athenahealth (Marlborough, MA). The members were very emphatic that, while they themselves compete with each other, they want more EHR vendors to join the effort (there are several hundred EHR vendors, in a very fragmented market—a problem for advancing healthcare IT in itself). Noticeably absent from the group was Epic Systems (Verona, WI), said to manage nearly half of the EHRs in the US currently. Carl Dvorak, COO of Epic, told Forbes magazine that the announcement caught the company “by surprise,” and that it is unlikely to join the group. During the HIMSS press conference, the companies said that two initial goals were to develop a reliable patientidentification system (so that EHRs from different providers can be matched up for individual patients), and a method to ensure that permissions to disclose information from one provider to another are in place. “Our government is not going to deal with this problem,” asserted Neal Patterson, CEO of Cerner, saying that it was up to private industry to lead the effort. Such interoperability issues are recognized as one of the major hurdles to overcome, both in getting healthcare systems to adopt EHRs, and to obtain value from the stored data. There are a bewildering array of HIT organizations, ad hoc work groups and public and public-private efforts at work; interoperability itself is one of the “meaningful use” measurements by which CMS scores EHR implementations, in order to justify financial incentives it is providing to healthcare systems. One of the more prominent interoperability groups formed last fall: the Care Connectivity Consortium (Washington, DC), which has allied itself in turn with Healtheway, a group that combines several federal agencies with private health information organizations. In fact, what CCC calls “patient identity management services” and “enhanced consent management” are two of the five valueadded services that the consortium is working on. Notably, however, CCC’s members are exclusively health systems such as Kaiser Permanente and Mayo Clinic (some of whom are customers of the CommonWell members, ironically). Pharma: a place on the EHR screen HIT is a massive, ongoing undertaking in healthcare delivery, and to a certain extent the pharma industry is on the sidelines, watching it play out with interest. But as physicians employed by health systems increasingly become excluded from direct interaction with sales reps, the need is growing to Enabling item level serialization: Ten key steps to ensure success By Gary Lerner, BrandSure, LLC Fig. 1. Assembling the right leadership team for a serialization project. Item level serialization (ILS) and traceability fosters supply chain integrity. Whether to expose counterfeits, identify sources of product diversion, improve integrity in the reconciliation of returns or comply with increasing regulation, the ability to establish uniqueness at the item level provides unparalleled supply chain accountability and visibility benefits. ILS illuminates transaction activity and enables the manufacturer, distributor, pharmacist and/or regulator a greater insight into the who, what, when and how of network activity after initial shipment. Attaining a common, yet integrated, approach requires participation and consensus of diverse stakeholders. Often the route to ILS and traceability requires the traversing of organizational boundaries and teams with cross-functional competencies in areas such as product packaging, distribution, warehousing, process automation and information systems. Consensus building across divisions, geographic regions and corporate structures, while necessary to assure a common approach to serialization, is difficult to manage and control. Adherence to a comprehensive, disciplined approach is necessary to clarify objectives, align priorities and facilitate a successful project outcome. Consider the following ten steps when establishing your ILS and traceability program. 1. Recruit leadership; mobilize troops ILS requires cooperation and coordination from internal departments and external trading partners, many of 24 Visit our website at May | June 2013 which do not typically work together. Establishing a serialization enablement leadership team is complicated by the typical decentralized organization structure found in pharmaceutical manufacturing; management is often diffused into various operational units with differing objectives and little understanding of each other. Selecting a leadership team which is passionate, motivated and empowered to unite diverse interests into a common effort will be critical for the success of the project. Who is responsible for ensuring the customer experience meets the promise of the brand? Can they commit sufficient time to leading or actively participating in a project of this scope and scale? Will they be given sufficient authority, time and resources to effect change? What groups need representation on the leadership team? Select representatives from areas impacted by ILS changes. These include product labeling, package design, packaging, logistics and order fulfillment, as well as the information systems needed to support each of these functions. Other departments will need to modify or implement new processes to facilitate serialized supply networks; impacted departments include: quality, regulatory, legal, security, finance and training. 2. Establish vision of success With the disruptive nature and complexity of enabling uniqueness into a batch-oriented process, a concrete, credible vision can save the initiative from losing its way. Gaining alignment of business operations with diverse and potentially competing interests will be essential to keeping the program on track. Being able to refer to a concrete description of desired outcomes is often necessary to avoid being trapped in the weeds. Is your serialization enablement effort driven by the need for visibility, accountability and transparency, or simply by regulatory compliance? With hard-to-quantify business benefits many pharmaceutical manufacturers discount the potential market advantage gained from supply integrity and focus exclusively on attaining compliance. If the focus is purely compliance, avoid building a rigid solution to address current laws. Understand current and emerging regulatory requirements from a global perspective and how they impact serialization efforts. Many track-and-trace regulations are continuing to evolve; expect that. Set a vision that establishes a platform for compliance and incorporates flexibility to adapt to changing legislation. 3. Formulate an attack plan Establishing ILS is a process, not an event and as such, getting there is neither quick nor easy. New, more-disciplined processes will be created and these will impact internal operations and external supply and trading partners. As a result, adherence to a comprehensive, disciplined approach is necessary to clarify objectives, align priorities and coordinate deployments. It is important to understand the end deliverables first and establish a plan and timeline that sets the organization up for success. Consider structuring the ILS program around transforming the following three areas: information systems, packaging and logistics. Define the desired outcomes for each of these areas and detail all the activities

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2013

Pharmaceutical Commerce - May/June 2013
Table of Contents
Top News
Brand Marketing & Communications
Supply Chain/ Logistics
Information Technology
Manufacturing & Packaging
Legal & Regulatory
Meetings and Editorial Index

Pharmaceutical Commerce - May/June 2013