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Risk management plans: A chain of compliance responsibility

Calvin London ( is the Founder and Principal Consultant of The Compliance Concierge.

Risk management plans (RMPs) for pharmaceutical products originated as regulatory responses to public concerns that pharmaceutical medications were being approved too early. As a result, known problems from using the medication did not become apparent until after introduction into the marketplace.

RMPs are not designed to mitigate adverse events or their reporting. Rather, they are required by some regulatory agencies to specifically manage known risks associated with the use of a drug. Although these go by different names and require differences in design, approval, and operation, they all have a common core element—compliance.

In all medication regimes, there is an unspoken requirement for compliance. While this is often assumed to only be relevant to the manufacturer (also known as the sponsor), RMPs provide an opportunity to look at the broader requirements for compliance at all steps of the process, from drug registration through to patient use. The operation of an RMP is a shared responsibility among the regulatory body, the manufacturer, prescriber, pharmacist, and the patient. This can be viewed as a chain of responsibility, as shown in Figure 1.

Figure 1: Management of known risks through a compliance chain of responsibility

Prescribers and pharmacists both uphold the principles of the RMP. However, as described later, the overall success of the RMP is just as dependent on the individual patient’s sense of responsibility to be compliant. A breakdown in compliance in any of the links—manufacturer, prescriber, pharmacist, or patient—can have significant effects on the effectiveness of the RMP.

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