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Specialty pharmacies are competing to position themselves as the best partners for manufacturers dealing with high-touch, high-risk products
In the process by which FDA has set up compliance requirements for Risk Evaluation and Mitigation Strategies (REMS), there can be a close interplay between the manufacturer who supplies the drug, the distributors who deliver it, and clinical or retail pharmacies that dispense it. [ed. note: see related story]. This is particularly true of specialty pharmacies (SPs) who are often handling the very “high touch” products that REMS address.
In the most restrictive case, a REMS with ETASU (Elements to Assure Safe Use), both the distributor and the pharmacy can be involved with certifications, training and special procedures, all of which have to be documented and reported. But with or without ETASU, SPs that can handle REMS as part of an overall case-management process have an advantage.
As with many mandated activities there are often unintended consequences. In the event of REMS the unintended consequence for the SP is the need to deal with manufacturers who must now engage in a rigorous SP selection process. If an SP provider would like to be included for consideration in a REMS program, it must be able to address key issues including:
The right fit
Manufacturers should plan on a formalized RFP and site selection process in evaluating SPs. The RFP and site visit will focus on both the capabilities as well as the right “fit” with the personality of the manufacturer. Generally speaking the Specialty Pharmacy Provider should look to meet the manufacturer requirements across several key areas including but not limited to:
In the end, the Specialty Pharmacy Provider must demonstrate the flexibility to support REMS requirements that come in all shapes and sizes. The key to providing this support is to:
The more an SP can understand the needs of a specific manufacturer program, the greater that SP’s opportunity to be included in a distribution model that requires a REMS with ETASU.
About the Author
Dean Erhardt is principal at D2 Consulting (St. Charles, MO; d2rx.com), which provides advisory services to manufacturers and pharmacies on distribution practices, business processes and regulatory compliance.