CASE STUDY: Long Term Risk Evaluation & Mitigation Strategy (REMS) Pharmacy Audits

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  • The reality of REMSThe reality of REMS: From 2009 to 2010 the number of drugs requiring REMS components increased by 160%
    One third of these medications require more than the minimum REMS requirement (medication guide).1 If REMS is not conducted according to FDA regulations, penalties can be imposed ranging from $250,000 to $1 million per violation.2 Furthermore, the FDA may red flag the drug, which prohibits it from interstate retail commerce.3

  • The SituationA large pharmaceutical company required annual audits at over 100 US based specialty pharmacies as part of its REMS compliance program
    These drugs were associated with known and potentially dangerous risks. To ensure that the pharmacy requirements of their REMS program were being met, ClinAudits was hired to conduct annual specialty pharmacy audits.
  • The ResponseClinAudits assembled and provided a dedicated auditing team, including a project manager and six highly qualified GCP and REMS experienced auditors to conduct the annual audits
    The team delivered over one hundred audits per year for this eight – year project. Project specific metrics included timelines of deliverables and auditor responsiveness to sponsor feedback. ClinAudits utilized internal peer-reviewed audit reports to ensure appropriate classification of findings and quality control of deliverables. The team ensured accurate CAPA compliance and follow-up with effectiveness checks to provide a full service auditing solution.
  • The Results ClinAudits’ seamless coordination, commitment to deadlines, and highly competent auditors fostered a long-term relationship with this firm, resulting in over 800 successful audits performed to date
    The client was able to leverage consistent best practices and benefit from ClinAudits processes to ensure successful completion of all audits.
    • ClinAudits, an independent niche provider of auditing services, offers an objective approach to REMS auditing which prevents conflicts of interest that can arise from full service CROs or internal sponsor audits.
    • Long-term utilization of ClinAudits auditing services fosters a unique relationship between auditors and clients, enabling auditors to better understand clients’ processes and evolving goals, which results in conducting high quality audits.
    • ClinAudits also offers flexibility based on its client’s needs. For example, due to the nature of a REMS based audit, ClinAudits utilized the client’s SOPs and processes for these pharmacy audits rather than its own.
    • ClinAudits has significant experience auditing many different types of REMS programs and vendors.

    “Having a third-party auditing program helps to reduce non-conformances, regulatory actions, poor product quality, loss of certification and registration, and product liability risk.”
    – NSF, The Public Health and Safety Organization4

    1 Soller, W. R, Vogt, E. “The REMS Primer: Understanding the Strategies for Risk Management” Medscape, 12 Dec. 2011. Web. 3 Mar 2015.
    2 FDCA § 303(f)(4)(A)
    3 Food and Drug Administration, “Guidance for Industry: Format and Content of Proposed Risk Evaluation Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modification”. September 2009. Web. 3 Mar. 2016.
    4 NSF, “Compliance/Third Party Audits”. NSF, The Public Health and Safety Organization. n.d. Web. 3 Mar 2016.

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