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W-32: A U.S. REMS Quality Strategy: A Comprehensive Approach

Poster Presenter

      Jorge Hechavarria

      • Senior Director, Diversity in Clinical Trials, Operations Administration
      • Janssen Pharmaceutical Companies of Johnson & Johnson
        United States


To review the REMS program quality strategy used by a REMS Sponsor with their certified pharmacy network, and determine types of compliance outcomes to be evaluated and measured in order to improve REMS program operations and REMS stakeholder compliance.


The methodology of a REMS quality strategy for REMS pharmacy network auditing is presented here. It includes; 1) establishing consistent audit standards, 2) incorporating post audit effectiveness checks, and 3) maximizing the use of metrics to monitor operational improvements.


Due to the safety risks of embryo-fetal toxicity associated with thalidomide, lenalidomide, and pomalidomide, they are available in the U.S. only through a Risk Evaluation and Mitigation Strategy (REMS) program. One of the REMS sponsor’s requirements is to monitor and analyze the implementation of REMS tasks by the certified REMS pharmacies. The audit approach originally applied against the Celgene REMS-certified pharmacy network was based on risk-based site ranking, which considered past performance factors (e.g. number of REMS process deviations, audit observations, prescription volume, number of female patients of reproductive potential, and number of REMS products handled). Recently, in order to ensure maximum program compliance and increase pharmacy engagement, every REMS certified pharmacy is audited annually. The REMS auditors use a consistent approach, for example; (1) the principles of ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) are used to clearly explain REMS document handling practices to the pharmacies, (2) audit standards are aligned with organizational quality ontology, (3) during and after the audit, the auditor clearly communicates the REMS requirements, acceptable sources, and types of verification of REMS compliance, (4) an audit report is communicated back to the pharmacy with the final findings, (5) the auditor examines any proposed CAPA (Corrective and Preventative Actions) from the pharmacy if necessary to address any audit observations, (6) the auditor performs an Effectiveness Check to monitor success of any required pharmacy CAPA, (7) metrics are analyzed by observation type, and compliance rates are compared year over year to determine site performance, and (8) metrics can also be applied against a pharmacy group to provide overall insight into their REMS program compliance.


There are several published articles in the scientific literature regarding the quality plans and auditing approaches within the pharmaceutical industry including areas in GMP, GCP, and GLP, Pharmacovigilance, and Finance. However, even though the audit function is a mandatory part of many REMS programs, there is little to no published discussion on REMS program audit approaches and outcomes. The proposed REMS quality strategy uses a consistent set of compliance measures that has enhanced our audit process and approach. Furthermore, the introduction of the Effectiveness Check has also made a positive impact to strengthen communications between the REMS sponsor and REMS pharmacy, and enhance their engagement. A REMS quality strategy could be further enhanced by combining data obtained from the REMS pharmacy audit function with data obtained from other REMS operational areas to identify potential program improvements as well as serve as an indicator of stakeholder REMS compliance to further ensure that REMS programs are meeting their goals.

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