Report from the 2018 Consensus Conference on Immunomodulating Agents in Thoracic Transplantation

Published 9 July 2020

Adam B. Cochrane, PharmD, MPH; Haifa Lyster, MSc, MPharm; JoAnn Lindenfeld, MD; Christina Doligalski, PharmD; David Baran, MD; Colleen Yost, RN; Michael Shullo, PharmD; Martin Schweiger, MD; David Weill, MD; Linda Stuckey, PharmD; Steven Ivulich, BPharm; Janet Scheel, MD; Lisa Peters, PharmD; Monica Colvin, MD; Kyle Dawson, PharmD, MBA; Reda Girgis, MD; Phillip Weeks, PharmD; Tracy Tse, PharmD; Stuart Russell, MD; Maureen Flattery, MS, NP; Doug Jennings, PharmD; Michelle Kittleson, MD; Tara Miller, RN; Tam Khuu, PharmD; Tamara Claridge, PharmD; Patricia Uber, PharmD; Katrina Ford, PharmD; Christopher R. Ensor, PharmD; Kathleen Simpson, MD; Anne Dipchand, MD; Robert L. Page II, PharmD, MSPH

J Heart Lung Transplant. Jul 2020;39(7):1050–1069

• Cardiothoracic Surgery
• Consensus Document
• Pharmacy
• Publications & Journals
• Standards & Guidelines

In 2009, the International Society for Heart and Lung Transplantation recognized the importance and challenges surrounding generic drug immunosuppression. As experience with generics has expanded and comfort has increased, substantial issues have arisen since that time with other aspects of immunomodulation that have not been addressed, such as access to medicines, alternative immunosuppression formulations, additional generics, implications on therapeutic drug monitoring, and implications for special populations such as pediatrics and older adults. The aim of this consensus document is to address critically each of these concerns, expand on the challenges and barriers, and provide therapeutic considerations for practitioners who manage patients who need to undergo or have undergone cardiothoracic transplantation.

This consensus statement briefly reviews the generic approval process but moves beyond to examine what barriers exist for patients and providers for accessing immunosuppressants and whether the interference is due to the healthcare delivery system, insurance or payer, pharmaceutical industry and drug availability, or a combination of factors. This consensus statement will also address available formulations and important considerations with non-oral administration of immunosuppressants; data regarding generic products and outcomes associated with their use; recommendations for appropriate therapeutic drug monitoring of immunosuppression; and finally special populations such as infants and children, aging transplant recipients, and pregnant and nursing patients, especially those who are not commonly covered in most clinical trials or consensus documents.

Read at JHLT