Admera Health Director of Medical Affairs, Rubén Bonilla Guerrero featured in the latest edition of Clinical Omics magazine- Proper Prescribing: Pharmacogenetics Testing Gains Traction but Requires a Delicate Balancing Act
By Frieda Wiley, PharmD on Clinicalomics.com.
Since the completion of the Human Genome Project in 2003, the pharmacogenomics industry has experienced waxes and wanes in reaction to healthcare dynamics and technological advancements.[i] With the continued push towards personalized medicine, pharmacogenetics offers organizations a potential solution to fine-tune therapy by helping predict the patient’s response to a medication. However, incorporating pharmacogenetics into clinical practice with high fidelity is a delicate balancing act: The lack of standardized testing methods and data analytics, poorly informed payer perceptions, and misconceptions held by both the public and healthcare industry professionals give rise to many questions and ambiguities.
“Pharmacogenomics is not the general standard of care yet,” said Ruben Bonilla Guerrero, M.D., director of medical affairs at Admera Health. “However, it’s become the standard of care for institutions and practices where they’ve seen the practical application and its health and economic benefits and have the personnel who understand how it works and how to implement it into patient care.
Patient settings and health status also affect the ability to perform tests and implement regular testing. For example, pharmacogenetics testing can be performed in outpatient settings such as community pharmacies and ambulatory care clinics. However, testing eligibility becomes a more arduous task in the hospital setting—especially for patients who lack cognition such as incapacitated patients in intensive care or comatose patients.
“Genetic testing requires consent forms, so a patient in the ICU will have to be in an alert and communicative status to understand and consent to testing,” Admera’s Bonilla Guerrero said. “Comatose patients need a Power of Attorney or Advanced Directive.”
Bonilla Guerrero said a recurring question pharmacogenetics companies get from physicians is “Why is my gene or medication of interest not listed in your report?”
“Pharmacogenetics is about the genes’ ‘pharmacogenes’ function and medications interaction as predicted by the molecular findings, and the impact that complex has on the potential medication response in a particular patient,” Bonilla Guerrero noted.
For that reason, the specific gene-variant and drug combination must have a sufficient level of clinical evidence to produce an actionable clinical statement. Gene-drug pairs failing to meet such criteria are omitted from reports. Regardless, testing companies could include these findings in an informative but not clinically actionable fashion.
Genes deemed as important could change with continued discovery of new genes and technological advancements.
“Pharmacogenomics is not about the molecular findings of the so-called pharmacogenes alone but rather the combined effect of the interactions between a drug and pharmacogenes’ function,” said Bonilla Guerrero. “As time passes, there’ll be new genes and variants associated with the same medications we use right now, and there will be new genes and variants associated with medication that we cannot foresee.”
[i] Drozda K, Paconowski M, Grimstein Z, Zineh I. JACC Basic Transl Sci. 2018 Aug; 3(4): 545–549. Published online 2018 Aug 28. doi: 10.1016/j.jacbts.2018.06.001.
Originally published on Clinicalomics.com.