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P101: Optimizing the i-access Pregnancy Prevention Program to Improve how Immunomodulatory Drugs (IMiDs) are Dispensed

Poster Presenter

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences
Bristol-Myers Squibb Company
United States

Objectives

Our objective was to improve pharmacist autonomy when dispensing the immunomodulatory drugs (IMiDs) thalidomide, lenalidomide, and pomalidomide by optimising the i access Pregnancy Prevention Program (PPP) and healthcare professional education.

Method

Pharmacists at selected Australian hospitals were given specific i-access training to help them self-manage IMiD verifications that are not automatically approved. This training, and upgrades to the i-access program, were designed to reduce the need for i-access program administrator intervention.

Results

A 6-month pilot project using the new educational materials was well received, with a total of 190 verifications (confirmations that the patients meet specific health authority-mandated criteria to minimise pregnancy) completed across all hospital sites. During that pilot project, 93% of verifications were correctly processed by the pharmacists without intervention by i-access PPP administrators—an improvement from the national average of 69%. The remaining 7% of verifications required intervention from i-access PPP administrators, mostly due to clerical errors. Pharmacists were able to utilise the educational materials and were able to dispense IMiDs in a well-regulated and safe manner. Verification processing time on i access was reduced from a mean of 50 minutes to 4 minutes. The i-access platform, with additional capabilities, was launched as a result of the successful pilot project. After training, 174 pharmacists (at 9 institutions) were provided the upgraded platform. Processing of verifications by pharmacists was monitored during the first month of deployment. An analysis of a sample of 77 of these verifications determined that 79% were correctly processed without intervention by i-access PPP administrators. In the future, verifications will be quality checked using a sampling size algorithm on a monthly basis.

Conclusion

For more than a decade the i-access PPP has provided patients with safe access to the IMiDs thalidomide, lenalidomide, and pomalidomide, while successfully preventing pregnancies in patients who take these drugs. Co-authors: Alanna Kontaxis, Gillian Polglase, and Tuyen Ha Over the period of time that the i-access PPP has existed, however, the landscape of clinical practice and the management of IMiDs has progressed. Therefore, the program was upgraded to increase efficiency without compromising patient safety, as defined by correctly processed verifications that patients meet specific criteria to minimise pregnancy. Our aim was to optimise i-access and healthcare professional education to improve pharmacists’ ability to independently approve—or correct, if required—verifications that otherwise would have required review by program administrators. The improved i-access system enables pharmacists to more effectively implement and manage a robust pregnancy prevention program, achieving greater than 93% compliance in the pilot project and 79% compliance for the system capability upgrade over a 4-week period, thus reducing the resources required to dispense IMiDs and ensuring prompt patient access to treatment. This study has successfully demonstrated that Australian hospital pharmacists are able to execute the risk minimisation program for IMiDs with minimal intervention by i-access PPP administrators when provided with targeted education, training, and system capabilities to facilitate compliant verification processing. Through continued close monitoring of the i-access system and ongoing education, the program continues to be implemented in accordance with our health authority requirements and upholds our commitments to healthcare professionals and patients.