|Pharmacy Facing New Compliance Challenges||| Print ||
Joe Ross, director of business services at McKesson Pharmacy Systems, talks in this interview with ComputerTalk senior editor Will Lockwood about existing and anticipated regulations that are changing what drug sales pharmacists are required to log. State and Federal regulations that require tracking the sale of non-prescription methamphetamine precursors have contributed to a demonstrable reduction in the illegal use of these drugs. More regulation may be in store, since the FDA is currently considering a behind-the-counter class of drugs.
CT: There's an increasing need for pharmacists to track and report products that fall outside the regular pharmacy dispensing flow. Tracking Methamphetamine precursors, such as pseudoephedrine, is a great example. What are the current pharmacy compliance needs McKesson is seeing?
Ross: For many pharmacies, the passing of the combat methamphetamine epidemic act [CMEA] introduced the burden of having to manually track and log the sale of what used to be over-the-counter products. Our pharmacy customers quickly realized that traditional paper logbooks would no longer suffice for meeting their regulatory requirements. The workflow and data retention issues combined with complex and ever-changing local, state, and Federal sales and reporting requirements necessitated an automated solution. Beyond PSE [pseudoephedrine] products, this necessity will only grow stronger with the movement of other products, such as Dextromethorphan, into this regulated category.
CT: There are other challenges on the horizon as well, aren't there? For example, Melissa Sherer wrote in the January/February 2008 issue of ComputerTalk about the possibility of a new class of behind-the-counter [BTC] drugs. What are some of the strategic and compliance issues you see developing for such a class of drugs?
Ross: I agree with the position expressed in Melissa's article that the de facto creation of this third class of drugs began with the movement of PSE products from over-the-counter to behind-the-counter. Whether it's a drug transitioning from OTC to BTC, or Rx to BTC, the expansion of this category is inevitable and will include an abundance of product-specific sales requirements. These requirements will likely fall outside the traditional dispensing flow, create gaps between processes and systems, and inevitably create more work for already time constrained pharmacists. At the same time that this category is expanding, pharmacists are increasing their role as healthcare providers through medication therapy management programs. The strategic challenge for pharmacies will be how to efficiently capitalize on these new categories of products and services. Our focus is to provide technology solutions that will limit this burden and help our customers better serve their patients.
CT: So how are you applying this focus currently?
Ross: As a customer-centric company, McKesson Pharmacy Systems is committed to delivering solutions based on feedback from our customers. What we've learned from our pharmacies is that there is a strong desire for an automated solution to enable them to easily sell this new class of drugs. In response to this need, we have formed a long-term strategic partnership with Pharmitas, a compliance-technology company based in Bellevue, Wash., to deliver a fully automated solution called ComplyScan. This solution provides end-to-end compliance with all local, state, and Federal regulations for the sale of BTC drugs, including pseudoephedrine products as mandated by the CMEA. ComplyScan replaces onerous and time-consuming paper-based logbooks with an electronic data capture and management system that instantly reads consumers' identification and product purchases.
CT: Tell us a little more about how this product and the partnership developed.
Ross: As I mentioned earlier, ComplyScan began as a customer-driven initiative to streamline pseudoephedrine (PSE) product purchases and ensure 100% compliance with the Combat Methamphetamine Epidemic Act. Using a wired or wireless connection to the Internet, the ComplyScan solution utilizes a scanning device along with proprietary data collection and management software to instantaneously capture a customer's identification information, recognize the PSE product being purchased, automatically check to ensure that the customer has not exceeded their PSE product purchase limit, and securely store the purchase transaction record.
One of the compelling aspects in partnering with Pharmitas is the ease with which additional products and services can be rolled onto the ComplyScan platform. As this market continues to evolve, we see ComplyScan and our partnership with Pharmitas as a key component in providing innovative and timely solutions to meet the changing needs of our pharmacy customers.
CT: How are HIPAA and data security issues handled with this kind of solution?
Ross: McKesson Pharmacy Systems has long recognized the importance of protecting the personal information entrusted to us by our customers. While HIPAA requirements for these emerging products and services may vary, McKesson and Pharmitas have adopted and adhere to strict standards of security and confidentiality to protect customer information. In our view, HIPAA compliance is a strategic priority, both in terms of achieving compliance, as well as monitoring and managing internal processes to ensure continued compliance.
CT: What resources are available for pharmacists who want to learn more about OTC compliance, how the possible BTC class is developing, and technological solutions in this new regulatory environment?
Ross: We're dedicated to educating our customers on changes in the marketplace and we've scheduled several upcoming educational sessions pharmacists can attend to learn more about this topic. McKesson Pharmacy Systems will be hosting an online Webinar on Thursday, June 26th for customers wanting to learn more about OTC compliance and the impacts to their business. Customers can go to the MPS homepage or click here to register. In addition, McKesson customers can register for one of our continuing education courses at the annual McKesson Pharmacy Strategies conference in Las Vegas this July where Melissa Sherer will be a guest speaker on this subject. Key discussion points will include understanding the direction of the OTC/BTC product class, compliance requirements, and solutions. Pharmacists may also want to read the transcript of the pubic meeting FDA held on behind the counter availability of certain drugs. A PDF is available by searching for "behind the counter drugs" on regulations.gov or by clicking here: FDA BTC Public Meeting Transcript 374.14 Kb.
CT: This sounds like an important issue for pharmacists to pay attention to. Thanks for your perspective, Joe.