Heather Morel, BS, MBA

Why are REMS not standardized today? Our columnist offers insight into the problem and how to lead specialty pharmacy forward. 

It’s a key Six Sigma tenet and it makes sense: “Standardization of processes that are performed thousands of times can eliminate costs, reduce errors, and improve quality.” Then why are we operating with so many distinct processes and methods in REMS? This is a chief complaint of every stakeholder I discuss REMS implementation challenges with today. “We need easier, less time consuming, more standardized processes to comply with REMS, particularly those with ETASU” (Elements To Assure Safe Use, which include training certification, enrollment, and other strategies).

There are several reasons why REMS are not standardized today. In my opinion, it is too simplistic to blame the FDA or pharmaceutical and biotech companies. Certainly, the FDA and pharma can work to help remedy the challenge, but I believe it is our fragmented, disconnected health care delivery system itself that contributes to the lack of standardization.

The FDA must abide by the FDAAA legislation that grants the authority to implement REMS with ETASU. It gives the FDA the ability to require a REMS and encourage both brand and generic pharmaceutical companies with competitive products to work together to centralize 1 REMS in a shared system for a class of their competitive products. One REMS—with a shared system and, thus, a single process for compliance for an entire class of products&mdash;is certainly preferred over a different process for each product. Sounds simple, but it’s not.

Developing a shared class REMS for existing products on the market that meets the FDA’s approval takes time, and the FDA must at the same time provide a pathway for new products that meet the regulatory criteria to enter the market in this same class. During this interim, separate REMS programs must be developed by the individual pharma companies in the class and approved by the FDA. So, until a shared class REMS is approved, individual REMS must be used, which prevents standardization and consolidation goals from being met.

Another way to standardize is to ensure that the processes for managing REMS are aligned with industry standards. One major improvement in the standardization of REMS was the development of guidelines to ensure a consistent implementation of the NCPDP Telecommunication Standard for REMS. “These standards allow us to run REMS transactions on our network in sub seconds to ensure safe use criteria are met for enrolled pharmacies,” stated Scott Genone, vice president of RelayHealth Pharmacy.

Before the use of these standards, REMS required pharmacists to constantly step out of their normal work flow to perform REMS safety activities. I believe that the future of all retail pharmacy—based REMS with ETASU will be to use the NCPDP standard. This is a terrific advance and will be a large leap forward for retail REMS. But what about REMS for products dispensed or administered in other points of care such as physicians’ offices?

Many REMS with ETASU are for products that are infused or injected in a community physician’s office. To help ensure compliance with REMS, the FDA often requires that biopharma companies implement restrictive distribution, limiting access to only enrolled and compliant distributors and prescribers.

This can create significant challenges in standardization since most prescribers have multiple identifiers associated with them, including DEA numbers and NPI numbers. To complicate this further, when a distributor sets up a “ship to” location for a drug purchase, the distributor does not track and manage changes in all of the prescriber’s associated “ship to” locations. The distributor will track 1 site DEA and the NPI typically, but it may be used for multiple sites for many practicing physicians. Now, imagine the challenge of trying to ensure that only REMS-enrolled prescribers have access to the product. Our health care system is composed of disparate IT systems and simply cannot link to these levels of details across stakeholders at this time.

I believe McKesson and other organizations like ours that serve the many stakeholders in health care have a unique opportunity to help lead the industry forward toward greater standardization and greater use of IT in REMS. Our commitment is to drive this to reality through strategies, investments, and engagement with industry.

Heather Morel is vice president and general manager of reimbursement & access services for McKesson Reimbursement, Access and Safety Services in Scottsdale, Arizona. Morel leads the development and execution of reimbursement strategies and support services, patient assistance programs, risk evaluation and mitigation strategies programs, and other patient- and physician-focused initiatives. She is a nationally recognized expert in health care reimbursement and marketing and is a member of the 

Heather Morel, BS, MBA

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