Description of RxFMEA™
RxFMEA™ is a proprietary modification and extension of the basic FMEA methodology and that of Healthcare FMEA (HFMEA™), an adaptation of FMEA that was developed by the U.S. Veteran’s Administration. My review of the process suggests that the objective of RxFMEA™ is the comprehensive management of risks in the pharmaceutical industry. Because of the active involvement of trained personnel and untrained consumers in the distribution and use of pharmaceuticals, RxFMEA™ extends the basic FMEA and HFMEA™ processes in the following ways:
• The scope of the analysis is defined to include the entire process of medication administration and use, including the diagnosis, prescribing, dispensing, consumption, and monitoring of the pharmaceutical product in actual field use. In this scope, the residual risks from the product design and manufacturing processes are considered to be “intrinsic” risks. These are incorporated in the analysis for mitigation along with the risks generated during the medication administration and use processes.
• The hazard scoring (assessment of the combined severity and likelihood of each adverse outcome) has been modified to be consistent with an industry standard, from the Council of International Organizations of Medical Science. Under the matrix of severity and likelihood adopted by RxFMEA™, death or permanent disability resulting from a patient’s adverse reaction to a pharmaceutical product is classified as a risk that always requires control or mitigation regardless of its probability of occurrence. Consequences of less severe, but still serious, severity (for example, requiring blood transfusion or hospitalization, or resulting in temporary disability) require mitigation until they occur with a frequency no greater than 1 in 10,000.
• The actions proposed to control or mitigate risks are designed in systems of multiple interventions to provide redundancy in the event of the failure of one or more of the interventions.
• To maximize the effectiveness of the interventions in controlling risk, those that rely upon human action or monitoring (usually involving aspects of communication, training, and procedures) are designed to be consistent with known characteristics of adult learning, including the development of tools and materials to assist with learning and performance. Interventions involving medical professionals (for example, physicians) use peer-involvement to motivate adoption and adherence to the protocols of the intervention.
• The program includes pre-implementation field-testing and post-implementation data collection and analysis to assess the effectiveness of interventions.
RxFMEA™ in Application – Preliminary Findings
In its initial application to an actual pharmaceutical product, RxFMEA™ used an interdisciplinary team of physicians, pharmacists, safety professionals, epidemiologists, biostatisticians, marketing personnel, and regulatory affairs specialists to cooperatively define the scope of the analysis, identify the product distribution/use processes and their subcomponents, identify the failures that each subcomponent can experience, identify the consequences of these failures, evaluate the risks of these consequences, and propose multiple interventions to mitigate the risks. The team met together more than 10 times to accomplish the analysis. The first iteration of the analysis is apparently complete, with interventions proposed for mitigating all of the identified risks to acceptable levels.
As of the time of writing this paper, these interventions have not yet been implemented in field use. Once implementation has occurred, RxFMEA™ is designed to obtain feedback on the effectiveness of the interventions by monitoring data on adverse outcomes as well as direct measures of compliance by physicians, pharmacists, and patients with the individual interventions. These feedback programs will be supplemented with additional market research about the performance and acceptability of the specific interventions. It is anticipated that feedback may suggest changes in the interventions, and as specific failure rate and intervention reliability data replace the original estimates, these data will have to be explicitly incorporated into the RxFMEA™ worksheets and analysis. [Read the White Paper]