As REMS (Risk Evaluation and Mitigation Strategy) programs grow and encompass additional pharmaceutical product manufacturers and wholesaler/distributors, pharmacies are faced with the challenge of compliance. With potential penalties of up to $250,000 per violation, lackadaisical compliance is not an option. Pharmacies must not only register and report, but are also faced with a supply chain that is slow and/or inefficient in monitoring. Before we dive into specifics, a bit of history.
The FDA (Food and Drug Administration authorization to require REMS programs for specific products is part of the 2007 Food and Drug Administration Amendments Act (FDAAA). The act was created when a number of drugs postapproval were found to cause various adverse effects. The most recognized of these incidents involved the drug Vioxx. Approved in 1999, it was later found to cause serious adverse effects in a significant population. Over the course of five years prior to the drug’s removal from the market, it is thought to have caused as many as 60,000 deaths.
This FDAAA empowers the FDA to require of all market participants the additional REMS monitoring requirements. Drugs can be required to have REMS monitoring either postapproval or preapproval as a condition of approval. Simply put, this is a mechanism whereby tracking begins with the manufacturer, through the wholesale/distributor, to the pharmacy, and then down to the end user patient level. In one common program, iPledge for isotretinoin products, the patients can only receive a 30-day supply that can only be refilled once documentation of appropriate use and absence of adverse effects have been logged.
Manufacturers can set up and manage a REMS program in a number of ways. For some drugs, such as Zolgensma and Tracleer, limited distribution networks are used. This allows the manufacturer a tighter level of control and compliance. Specialty pharmacies purchase product either directly or via drop ship so that the manufacturer is directly verifying eligibility. While this may work for some drugs, others with much wider use, such as clozapine or isotretinoin, require broader distribution. Here, the manufacturer is dependent on the distributor to verify eligibility before shipping product.
In a typical REMS program like iPledge, pharmacies must preregister to participate. Wholesalers can only ship product once registration and eligibility are ascertained. This can present a challenge to pharmacies from both inventory and cost-of-goods perspectives. While the primary wholesalers all have automated systems to verify eligibility, McKesson, through a technology division, is actually the current manager for iPledge: this is not the case with many smaller wholesalers/distributors. Many smaller distributors have a manual process to check eligibility or make a business decision not to distribute these REMS-required products.
The Impact on Independents
It goes without saying that in today’s reimbursement-driven market, managing costs and inventory are primary concerns. A pharmacy’s ability to quickly find competitive costs that assure positive reimbursement is critical. Anything that negatively impacts this normal course of trade can be devastating. In a recent price comparison, the price variance for clozapine products between wholesalers and distributors was 50% or more. However, finding the lower cost of goods is meaningless if the distributor hangs your order up an extra day or longer while going through a manual verification process. In such a case you not only risk the loss of margin but potentially the customer. Pharmacies need to not only identify the best opportunities but to also have the confidence that the trading partner is able to verify and deliver their needs in the normal course of business.
New to Market
New to the market, opioid medications have only been approved of late with a REMS component. Looking at the growth in number of medications requiring REMS (initially, 16 products required REMS at initiation; currently, there are 76 drugs requiring REMS), the potential for many existing therapies (potentially the entire opioid class), and products new to market, REMS monitoring looks to become more of a dynamic in the marketplace. The need for pharmacy technology providers to build and include seamless programs that address and solve these REMS-driven pitfalls is critical. PharmSaver downloads registration data on a daily basis from iPledge, verifying the pharmacy’s eligibility status at the time of ordering. The certification status is passed to the wholesaler in the purchase order and displayed with the order on the PharmSaver website. CT
Mike Sosnowik, R.Ph., is president of PharmSaver. Learn more about the
company at www.pharmsaver.net.