Implementing a Personalized Medicine Program in a Community Health System

Abstract

The implementation of a de novo personalized medicine program in a rural community health system serving an underserved population is described. Focusing on the safe use of drugs impacted by genetic variations in the non-oncology setting, we first addressed drug–gene pairs designated by the US FDA in black-box warnings (codeine, clopidogrel, abacavir, carbamazepine). The program's first success was a policy change to remove codeine from the pediatric formulary, rather than a testing recommendation. Pilot studies were then conducted with primary care providers to get them familiar with pharmacogenetic testing, and a consultative outpatient clinic for patients was developed. The assessment, planning, implementation, challenges, successes and lessons learned are described.

Keywords::

• community health system
• dissemination science
• implementation science
• personalized medicine
• pharmacogenetics
• pharmacogenomics

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at:

https://www.tandfonline.com/doi/suppl/10.2217/pgs-2018-0130

Acknowledgements

The authors would like to acknowledge the help and support of our research nurse, Pearl Abernathy, and the many leaders, clinicians, staff, patients and philanthropists, including: William Hathaway, MD, Chief Medical Officer; Christopher DiRienzo, MD, Chief Quality and Safety; Susan Mims, MD, VP, Children’s Hospital and Genetics; Jonathan Bailey, Chief Clinical Programs; Jonathan Brown, Chief Informatics Officer; Charles Sawyer, MD, Chief, Medical Informatics Officer; Dale Fell, MD, former Systems CMO; Ryan Tilson, PharmD; and the numerous informatics, pharmacy and Department of Philanthropy staff who helped support these efforts.

Financial & competing interests disclosure

The authors recieved support from the North Carolina Biotechnology Center (state funding agency of North Carolina, NC, USA). The authors have no other relevant affiliations or financialinvolvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Notes

‘Black box’ drugs: drugs that the FDA has place a boxed warning.

CQI: Continuous quality improvement.

Pharmacy and Therapeutics Committee: the hospital committee approving medication related issues.

EMR: Electronic medical record.

The clinic physician is a medical geneticist. The referring physician is the patient's treating physician.

GC: Genetic counselor; PGX: Pharmacogenetic.

CDS: Clinical decision support; EMR: Electronic medical record.

Service line leader = physician leading a healthcare area (e.g., neurology).

PCP: Primary care physician; PGx: Pharmacogenetics; PM: Personalized medicine.

Additional information

Funding

The authors recieved support from the North Carolina Biotechnology Center (state funding agency of North Carolina, NC, USA). The authors have no other relevant affiliations or financialinvolvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript