Dean Erhardt, D2 Consulting

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. 

 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: 

Do I have an infrastructure that can support high touch requirements at the physician and patient level? 

Do I have a system that can track and report the data required by an FDA mandated program? 

Do I have the infrastructure to support all potential stakeholders with which I may be required to interact on behalf of the program requirements including: patients; physicians (RNs, office staff, billing staff); and payers (case management)? 

Have you qualified your services to ensure you are within the boundaries of Fair Market Value? 

Do I have clinical personnel that can support unique clinical requirements? 

	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: 

Corporate culture- Will the manufacturer feel comfortable working with your organization? 

Financial stability- Do you have the ability to invest in or support additional requirements in the future? 

Customer service- Do you have the right customer service skills to support the needs of specific product requirements? 

Reimbursement support- Does your organization have the ability to provide reimbursement support across both the pharmacy and medical benefit? 

Training- Do you have a formalized training process in place with the applicable Standard Operating Procedures across all functional areas? 

Facility- Does this licensure support the distribution model required for this product? 

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: 

Understand the manufacturer’s perspective and potential risk associated with non-compliance. 

Demonstrate a commitment to the success of the program and the product. 

Have the ability to interact with stakeholders across a variety of touch points. 

Have the infrastructure available to scale up (or down) as the product is launched to the market. 

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.

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. 

Articles

Specialty pharmacies are competing to position themselves as the best partners for manufacturers dealing with high-touch, high-risk products