Pharmaceutical Commerce - May/June 2011 - (Page 26)

Legal Regulatory How REMS Affect Pharmaceutical Distribution Processes and Partners First-ever study of the impact of REMS on supply chains finds that collaboration is a critical requirement By Karen Ribler, Center for Healthcare Supply Chain Research The report Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain is available for purchase. For more information, contact Tonya Martin of the Center for Healthcare Supply Chain Research at tmartin@hdmanet.org. N ew research from the Center for Healthcare Supply Chain Research (the Center), the nonprofit research foundation of the Healthcare Distribution Management Association (HDMA), indicates that cross-industry collaboration and uniformity are essential ingredients to successfully implement the federally mandated risk evaluation and mitigation strategies (REMS) initiative. recommendations for process improvement and, for the first time, offers insights into the economic impact of REMS. Background REMS originates with the 2007 FDA Amendments Act, which authorized FDA to require REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. These strategies reflect FDA-approved manufacturer mitigation objectives and can be described as simple or complex programs that are broken down into four components. “Simple” REMS employ one or more of the first two components: medication guides for patients and communications plans to educate healthcare professionals. “Complex” REMS add elements to assure safe use (ETASU)—such as training, certification and registries documenting compliance; and systems to implement the ETASU. All strategies require assessment tactics and timetables to measure the strategies’ mitigation effectiveness (Fig. 1). More than 175 drugs currently have REMS; the most recent requirement being a class-wide mandate for long-acting and extended-release opioid products. Working with the Campbell Alliance Group, Inc., the Center’s newly published report, Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain, documents the impact of the REMS mandate on manufacturers (brand, generic, biologic and small-molecule drugs); distributors (traditional wholesale, specialty and self-distributing specialty pharmacy); and providers (physicians, nurses, patient advocates and retail and specialty pharmacists). Using interviews and secondary data, this timely research presents opportunities, challenges and Figure 1. Industry guideposts Assessing the Impact reviews the four stages of a REMS program (planning, implementation, monitoring and assessment) to illustrate how key supply chain stakeholders are affected. Even simple REMS were noted to present supply chain issues that are time-consuming and carry the potential to adversely affect patients. For example, it was noted that the manner in which a medication guide is formatted, distributed and understood can help or hinder its use and therefore its viability as a mitigation tool. The study offers lessons learned noting that distributors, dispensers and providers all wish to be involved in the design and implementation of REMS programs. This appeal underscores their desire to provide input into the program, obtain sufficient time to develop internal training to ensure smooth program execution and time to test each system prior to product launch. Interviews with manufacturers revealed a growing willingness to work with downstream partners while advancing with the design of new REMS programs. Stakeholder perspectives To understand the issues associated with as well as the costs and benefits of REMS from a supply chain perspective, each interview participant was asked to prioritize their concerns. Sample groups of manufacturers, distributors and healthcare providers provided comments on concerns or priorities in administering REMS programs. All study participants expressed reservations about delays that ultimately may hinder patient access to drugs. Distributors, who have a concern for meeting manufacturer expectations, would prefer to be more involved in program planning. Providers have a concern for unreimbursed costs, and express a desire for standardization of processes, especially in cases where dozens of different programs—all with different requirements—impact the prescribing and dispensing processes. The study’s economic analysis indicates REMS requirements are costly to the supply chain and underscore the need for additional research into REMS program costs, including those that are hidden, unforeseen and not reimbursable through current business practices and government benefit programs. Assessing the Impact includes separate sections reviewing tasks and associated of REMS for manufacturers, distributors and healthcare providers. These data were based on interviews and documentation from: Manufacturer: ■ Medical Affairs ■ Brand management ■ Trade relations ■ Safety ■ Regulatory continued on page 28 > REMS Elements That the FDA May Require Element Medication Guide Description • Paper handouts and/or package inserts that contain FDA-approved instructions and warnings • Distributed to patients when drug is dispensed. • May be through letters to HCP or through professional societies about drug risks and safety protocols. Communication Plan to Healthcare Professionals Elements to Assure Safe Use (ETASU) • ETASU need to be commensurate with risk. • Must be posted publicly within 30 days of being imposed with an explanation of how elements will mitigate risk. • Should not be unduly burdensome on patient access (due to life-threatening diseases or difficulty accessing healthcare). • To the extent practicable, should minimize the burden on the healthcare system and should be compatible with current distribution system. • ETASU elements include: – Prescribers training or certification. – Certification for pharmacies, practitioners or healthcare settings – Drug must be dispensed only in certain healthcare settings. – Drug is dispensed to patients only with documentation of safe-use conditions such as laboratory test results. – Patients must be subjected to monitoring. – Patients, physicians, pharmacies and distributors must enroll in a registry. • May be required to monitor and evaluate implementation of ETASU elements by those responsible, and to work to improve implementation. • Assess by 18 months, by three years and in seventh year after REMS approval. • The FDA may increase frequency of assessments or eliminate requirements after three years. • Assessment within 15 days for cause. Implementation System Timetable for Submission of REMS Assessments From the Center for Healthcare Supply Chain Research, Healthcare Distribution Management Association, Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain, March 2011. Sources: FDA. Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. (www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf). FDA. SEC. 505-1. [21 USC §355-1] Risk Evaluation and Mitigation Strategies. (www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109090.htm). 26 May | June 2011 www.PharmaceuticalCommerce.com http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109090.htm http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2011

Pharmaceutical Commerce - May/June 2011
Table of Contents
Editorial
Op-Ed
Top News
Business / Finance
Brand Communications
Supply Chain / Logistics
Information Technology
Legal/ Regulatory
Executive Development
Meetings and Editorial Index

Pharmaceutical Commerce - May/June 2011

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