News & Views
Institutional Profile
Cleveland Clinic’s Center for Personalized Healthcare: setting the stage for value-based care Cleveland Clinic (OH, USA) launched the Center for Personalized Healthcare in 2011 to establish an evidencebased system for individualizing care by incorporating unique patient characteristics, including but not limited to genetic and family health history information, into the standard medical decision-making process. Using MyFamily, a web-based tool integrated into our electronic health record, a patient’s family health history is used as a surrogate for genetic, environmental and behavioral risks to identify those with an elevated probability of developing disease. Complementing MyFamily, the Personalized Medication Program was created for the purpose of identifying gene–drug pairs for integration into clinical practice and developing the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. We have successfully implemented the gene–drug pairs HLA-B*57:01–abacavir and TPMT–thiopurines into patient care. Our efforts to establish personalized medical care at Cleveland Clinic may serve as a model for large-scale integration of personalized healthcare. The USA spends more per capita on healthcare than any other high-income country, yet scores lower in measures of quality, access and outcomes [1,2]. High, and possibly unsustainable, healthcare spending combined with the need for improved outcomes is propelling the restructuring of healthcare delivery into a system that is focused on high-value care. A value-based care-delivery system will have to account for both clinical outcomes and cost [1]. To achieve value-based care, there will need to be a fundamental change from a one-sizefits-all approach that is reactive to disease to a delivery system that embraces disease prevention and individualization of healthcare. Personalizing healthcare based on an individual’s risk for disease development and likelihood of treatment response has the potential to decrease healthcare costs and improve clinical outcomes [3]. Incorporating disease prediction tools into patient care can help identify patients at an elevated risk for disease, allowing for early interventions that may delay or prevent more expensive medical treatments. Integrating pharmacogenomics into the clinical workflow may help clinicians identify those predicted to be at increased risk of an adverse drug event or nonresponse to a medication, thereby preventing hospital admissions or extended stays due to poor treatment outcomes. 10.2217/PGS.14.31 © 2014 Future Medicine Ltd
Cleveland Clinic (OH, USA), renowned for innovative healthcare, launched the Center for Personalized Healthcare in 2011 to establish a standardized evidencebased system for personalizing care by incorporating unique patient characteristics, including but not limited to genetic information and family health history, into the medical decision-making process. The Center for Personalized Healthcare is implementing individualized patient care at all Cleveland Clinic practice sites which consist of 12 hospitals, 16 full-service family health centers, and numerous outpatient facilities throughout Ohio, Florida, Nevada, and Canada. Cleveland Clinic is a physician-run integrated healthcare system with all practice locations, which see over 5 million patient visits per year, having a unified electronic health record. Our unified electronic health record allows us to create a standardized platform with which to integrate health information technology, including point-of-care clinical decision support for pharmacogenomics and disease risk assessment, at all practice sites. Our model of physician leadership enhances our ability to deliver clinically useful solutions that work for clinicians. Because there is a limited number of large comprehensive healthcare systems with practice sites in multiple states and countries that are integrating clinical pharmacogenomics
Kathryn Teng*,1,2, Jennifer DiPiero1,2, Thad Meese2,3, Megan Doerr2,3, Mandy Leonard4, Thomas Daly5, Felicitas Lacbawan5, Jeff Chalmers4, David Stowe4, Scott Knoer4 & J Kevin Hicks1,3,4 Center for Personalized Healthcare, Internal Medicine, Cleveland Clinic, 9500 Euclid Ave, NE50, Cleveland, OH 44195, USA 2 Medicine Institute, Cleveland Clinic, Cleveland, OH, USA 3 Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA 4 Department of Pharmacy, Cleveland Clinic, Cleveland, OH, USA 5 Robert J Tomsich Pathology & Laboratory Medicine Institute, Cleveland Clinic, Cleveland, OH, USA *Author for correspondence: Tel.: +1 216 444 8801 Fax: +1 216 636 0009 [email protected] 1
Pharmacogenomics (2014) 15(5), 587–591
part of
ISSN 1462-2416
587
News & Views – Institutional Profile and disease risk assessment into clinical practice, our implementation process may serve as a model of large-scale integration of personalized healthcare.
Cleveland Clinic’s Center for Personalized Healthcare mission & goals Cleveland Clinic’s Center for Personalized Healthcare houses an initiative to provide individualized patient care by incorporating genetic information, environmental exposures and family health history into a tailored medical management plan for the purpose of improving clinical outcomes in a cost-effective manner. The Center for Personalized Healthcare promotes and oversees a multidisciplinary team approach with physicians, clinical pathologists, pharmacists, geneticists and genetic counselors, and informaticists collaborating together to integrate personalized healthcare into clinical workflows. The mission and goals of the Center for Personalized Healthcare are focused on four areas: Clinical implementation: Integrate disease risk assessment tools and clinical pharmacogenomics into the standard practice of medicine at Cleveland Clinic. Research: Develop new and innovative technologies to advance the integration of personalized healthcare into routine patient care and evaluate the impact on patient outcomes and healthcare costs. Education: Provide educational programs focusing on clinical pharmaco genomics and disease risk assessment to students, healthcare providers and patients. Advocacy: Promote and advocate for government policies that will enhance our ability to provide personalized healthcare. The Center for Personalized Healthcare has developed two programs to help address these goals. The MyFamily initiative assesses disease risk based on family health history, and the Personalized Medication Program focuses on clinical pharmacogenomics. Novel health information technology has been developed to integrate both programs into our unified electronic health record. 588
Pharmacogenomics (2014) 15(5)
Personalizing healthcare: disease risk prediction Although there is increasing evidence that genomics has medical benefit, the practice of medicine has not yet reached the point where every patient is genotyped or sequenced. There are still barriers that need to be overcome before whole-exome or whole-genome sequencing is accepted as routine patient care. These barriers include financial capabilities of health systems to sequence all patients, the integration of large volumes of genomic information into an electronic health record and logically presenting pertinent information to clinicians, and the state of evidence to interpret such tests. An individual’s family health history can be used as a surrogate for genetic, environmental and behavioral risks that may be used for disease risk stratification and identifying those that may benefit from genetic testing or prophylactic treatment [4]. For example, individuals with a family history of breast cancer, especially a health history that includes many affected relatives diagnosed at a young age, would be at a much higher risk of breast cancer than the general population, and possibly more likely to carry detrimental BRCA variants than those with no family history of breast cancer [4]. Early identification of such individuals can have a significant impact on preventive care recommendations and can facilitate higher quality care and appropriate utilization of resources. MyFamily was created in partnership with Cleveland Clinic’s Genomic Medicine Institute to enhance the ability of primary care clinicians to obtain and utilize family health history for prevention and disease risk prediction. MyFamily has several key features: web-based, patient-entered electronic collection of family health history; generation of a pedigree based on disease context and patient-entered family history; a scoring system to identify and stratify disease-risks; clinical decision support offering evidence and consensus-based standard-of-care recommendations; and integration into the clinical workflow by leveraging the electronic health record. MyFamily facilitates more robust and complete ascertainment of family health history than can be done in a typical office future science group
Institutional Profile – visit, and compiles the information in an efficient manner for clinicians, enabling them to more accurately and efficiently identify disease risk. The goal of MyFamily is to allow clinicians to spend their time with patients counseling about individualized risk for disease and developing personalized preventive care plans, rather than collecting family history. Our experience thus far is that MyFamily has facilitated greater efficiency in the primary care workflow and has assisted in the identification of those at potentially increased risk of disease. In addition, it has enabled appropriate utilization of resources by recommending the right tests and consultations based on individual risk. MyFamily is an important first step towards personalizing patient care and providing value-based care.
Personalizing healthcare: clinical pharmacogenomics The Personalized Medication Program was launched in 2012 for the purpose of identifying gene–drug pairs for integration into clinical practice and developing the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. Criteria for identifying gene–drug pairs for implementation are as follows: Evaluation of the literature for strong evidence supporting clinical utility, such as Clinical Pharmacogenetic Implementation Consortium Guidelines [5]; Identifying the most commonly prescribed drugs at Cleveland Clinic that are influenced by variants in pharmacogenes; Gene–drug pairs that physicians deem important to their clinical practice. For each new gene–drug pair implemented, clinical pathologists review the genetic variants and alleles that are interrogated to ensure appropriate coverage of clinically significant polymorphisms. A pharmacogenomic translation table that encompasses all possible reported allele combinations is created to guide phenotype interpretation and link clinical interpretations and clinical decision support to actionable pharmacogenetic test results a priori [6]. Additionally, Best Practice Alerts are deployed to the electronic health record to guide pharmacogenomic test ordering future science group
News & Views
and pharmacotherapy recommendations at the point of care. For those clinicians who desire additional information, each Best Practice Alert contains a link to detailed algorithms for pharmacogenetic testing and pharmacotherapy modifications. Although not viewable to the end user, but of extreme importance for value-based care, the Personalized Medication Program consists of a collaborative workflow that occurs behind-the-scenes to avoid duplication of genetic testing. Pharmacogenomic test results are placed into the electronic health record in a discrete data field that is automatically mined by decision support tools. If a genotype of interest already exists within a patient’s electronic health record, the Best Practice Alert that recommends genotyping is suppressed, and instead the results of the test are presented to the clinician within the prescription field. As such, clinicians are made aware that the result is available and the genotyping test does not need to be re-ordered, thus avoiding costly duplicate testing. Because the genotyping results are presented to clinicians in the prescription field, they do not have to search for laboratory results in the electronic health record, which may foster increased efficiency. There are two oversight committees for the Personalized Medication Program. The Pharmacogenomics Advisory Board, a multidisciplinary group including physicians, pharmacists, bioethicists and attorneys, approves the policies and clinical usage of pharmacogenomics. When deemed necessary, pharmacogenomic policies are presented to the Pharmacy and Therapeutics Committee for approval. For each gene–drug pair targeted for clinical implementation, a pharmacogenomic workgroup is formed to guide the implementation process and approve the clinical decision support language, along with the accompanying algorithms for pharmacogenomic testing and pharmacotherapy modifications. The physicians or provider groups identified as the most frequent prescribers of the drug of interest are invited to be a part of the workgroup. This selection process has helped to ensure that our clinicians are engaged in the development, implementation and communication of Best Practice Alerts, and that they can serve as resources for their peers throughout the www.futuremedicine.com
589
News & Views – Institutional Profile integration process. Most importantly, it also ensures that clinical decision support tools are of clinical utility to the physicians who will be using them. The Personalized Medication Program, with oversight from the Pharmacogenomics Advisory Board and pharmacogenomic workgroups, has implemented HLA-B*57:01–abacavir and TPMT–thiopurines into the clinical workflow. We are currently in the process of implementing HLA-B*15:02-anticonvulsant drugs, with the goal of implementing at least two gene-drug pairs a year. As a part of the Personalized Medication Program, we are establishing a clinical pharmacogenomics service. The initial phase of this service includes a Pharmacogenomics Clinical Specialist reviewing all pharmacogenomic test results, and for those with an actionable result providing support for the medical team when needed. In cooperation with our clinical pathologists, we are also creating a pharmacogenomics consultation service that clinicians may access through the electronic health record. The purpose of this consultation service is to assist with any questions pertaining to pharmacogenomics, including the evaluation of patients who are experiencing an adverse drug event or are not responding to therapy to determine if they may be candidates for pharmacogenomic testing.
Education A Cleveland Clinic internal medicine resident education assessment found that 100% of our medical residents wanted additional genetic education, and 97% of our residents agreed that understanding genetic risk factors and applying that knowledge to clinical practice could potentially improve their patients’ outcomes.
These findings are similar to other peerreviewed publications demonstrating that healthcare professionals understand the importance of personalized healthcare, but are not adequately informed to apply it to their own practice [7]. In response to this medical education assessment, we developed a Personalized Healthcare Series that educates our internal medicine residents about clinical pharmacogenomics and disease risk prediction based on family health history. We are actively engaged in curriculum development for the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (OH, USA), and there are initial plans to collaborate with pharmacy schools located in northeast Ohio to participate in the teaching of clinical pharmacogenomics. The Center for Personalized Healthcare organizes continuing medical education opportunities for Cleveland Clinic clinicians. We invite a Visiting Professor for Medical Grand Rounds yearly, and we host an annual Personalized Healthcare Summit that has been attended by clinicians and nonclinicians from around the USA and the world. Patient and clinician education is also offered through unique avenues such as web blogs, a quarterly newsletter and various lay press publications and live events. In addition, the Center for Personalized Healthcare has actively participated in advocacy efforts to educate our elected officials about personalized healthcare and its role in the future of healthcare delivery.
Future perspective At Cleveland Clinic, we have successfully integrated personalized healthcare into the clinical setting through MyFamily and the Personalized Medication Program. The
Highlights Cleveland Clinic launched the Center for Personalized Healthcare to incorporate patients’ genetic information, environmental exposures and family health history into a tailored medical management plan for the purpose of improving clinical outcomes in a cost-effective manner. MyFamily, a web-based family health history tool, was created to help identify genetic, environmental and behavioral risks that may be used for disease risk stratification, and identifying those that may benefit from early medical interventions. The Personalized Medication Program identifies gene–drug pairs for integration into clinical practice and develops the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. Our efforts to establish personalized medical care at Cleveland Clinic may serve as a model of large-scale integration of personalized healthcare. The Center for Personalized Healthcare is actively engaged in educating students, residents, clinicians and other stakeholders about clinical pharmacogenomics and personalized healthcare.
590
Pharmacogenomics (2014) 15(5)
future science group
Institutional Profile – keys to our success include the use of multidisciplinary collaborative workgroups, methodology-based implementation and measurement of outcomes, and the engagement of clinicians early in the process of development. Future plans include the development of an algorithm for identifying patients most likely to be prescribed a pharmacogenomic high-risk drug and targeting those patients for prospective genotyping. Integrating personalized healthcare into a large comprehensive healthcare system gives us a unique opportunity to evaluate the impact individualized patient care has on clinical outcomes and healthcare costs. We will continue our efforts to create new and innovative technologies to advance and promote the use of personalized healthcare as a part of routine medical care. Financial & competing interests disclosure Cleveland Clinic provided support. All authors are employees of Cleveland Clinic. The authors have no other relevant affiliations or financial involvement 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.
future science group
News & Views
References 1
Curfman GD, Morrissey S, Drazen JM. High-value health care – a sustainable proposition. N. Engl. J. Med. doi:10.1056/ NEJMe1310884 (2013) (Epub ahead of print).
2
Murray CJ, Frenk J. Ranking 37th – measuring the performance of the U.S. health care system. N. Engl. J. Med. 362(2), 98–99 (2010).
3
Crawford JM, Aspinall MG. The business value and cost–effectiveness of genomic medicine. Pers. Med. 9(3), 265–286 (2012).
4
Doerr M, Teng K. Family history: still relevant in the genomics era. Cleveland Clin. J. Med. 79(5), 331–336 (2012).
5
Relling MV, Klein TE. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network. Clin Pharmacol Ther. 89(3), 464–467 (2011).
6
Hicks JK, Crews KR, Hoffman JM et al. A clinician-driven automated system for integration of pharmacogenetic interpretations into an electronic medical record. Clin. Pharmacol. Ther. 92(5), 563–566 (2012).
7
Stanek EJ, Sanders CL, Taber KA et al. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin. Pharmacol. Ther. 91(3), 450–458 (2012).
www.futuremedicine.com
591
Institutional Profile
Cleveland Clinic’s Center for Personalized Healthcare: setting the stage for value-based care Cleveland Clinic (OH, USA) launched the Center for Personalized Healthcare in 2011 to establish an evidencebased system for individualizing care by incorporating unique patient characteristics, including but not limited to genetic and family health history information, into the standard medical decision-making process. Using MyFamily, a web-based tool integrated into our electronic health record, a patient’s family health history is used as a surrogate for genetic, environmental and behavioral risks to identify those with an elevated probability of developing disease. Complementing MyFamily, the Personalized Medication Program was created for the purpose of identifying gene–drug pairs for integration into clinical practice and developing the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. We have successfully implemented the gene–drug pairs HLA-B*57:01–abacavir and TPMT–thiopurines into patient care. Our efforts to establish personalized medical care at Cleveland Clinic may serve as a model for large-scale integration of personalized healthcare. The USA spends more per capita on healthcare than any other high-income country, yet scores lower in measures of quality, access and outcomes [1,2]. High, and possibly unsustainable, healthcare spending combined with the need for improved outcomes is propelling the restructuring of healthcare delivery into a system that is focused on high-value care. A value-based care-delivery system will have to account for both clinical outcomes and cost [1]. To achieve value-based care, there will need to be a fundamental change from a one-sizefits-all approach that is reactive to disease to a delivery system that embraces disease prevention and individualization of healthcare. Personalizing healthcare based on an individual’s risk for disease development and likelihood of treatment response has the potential to decrease healthcare costs and improve clinical outcomes [3]. Incorporating disease prediction tools into patient care can help identify patients at an elevated risk for disease, allowing for early interventions that may delay or prevent more expensive medical treatments. Integrating pharmacogenomics into the clinical workflow may help clinicians identify those predicted to be at increased risk of an adverse drug event or nonresponse to a medication, thereby preventing hospital admissions or extended stays due to poor treatment outcomes. 10.2217/PGS.14.31 © 2014 Future Medicine Ltd
Cleveland Clinic (OH, USA), renowned for innovative healthcare, launched the Center for Personalized Healthcare in 2011 to establish a standardized evidencebased system for personalizing care by incorporating unique patient characteristics, including but not limited to genetic information and family health history, into the medical decision-making process. The Center for Personalized Healthcare is implementing individualized patient care at all Cleveland Clinic practice sites which consist of 12 hospitals, 16 full-service family health centers, and numerous outpatient facilities throughout Ohio, Florida, Nevada, and Canada. Cleveland Clinic is a physician-run integrated healthcare system with all practice locations, which see over 5 million patient visits per year, having a unified electronic health record. Our unified electronic health record allows us to create a standardized platform with which to integrate health information technology, including point-of-care clinical decision support for pharmacogenomics and disease risk assessment, at all practice sites. Our model of physician leadership enhances our ability to deliver clinically useful solutions that work for clinicians. Because there is a limited number of large comprehensive healthcare systems with practice sites in multiple states and countries that are integrating clinical pharmacogenomics
Kathryn Teng*,1,2, Jennifer DiPiero1,2, Thad Meese2,3, Megan Doerr2,3, Mandy Leonard4, Thomas Daly5, Felicitas Lacbawan5, Jeff Chalmers4, David Stowe4, Scott Knoer4 & J Kevin Hicks1,3,4 Center for Personalized Healthcare, Internal Medicine, Cleveland Clinic, 9500 Euclid Ave, NE50, Cleveland, OH 44195, USA 2 Medicine Institute, Cleveland Clinic, Cleveland, OH, USA 3 Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA 4 Department of Pharmacy, Cleveland Clinic, Cleveland, OH, USA 5 Robert J Tomsich Pathology & Laboratory Medicine Institute, Cleveland Clinic, Cleveland, OH, USA *Author for correspondence: Tel.: +1 216 444 8801 Fax: +1 216 636 0009 [email protected] 1
Pharmacogenomics (2014) 15(5), 587–591
part of
ISSN 1462-2416
587
News & Views – Institutional Profile and disease risk assessment into clinical practice, our implementation process may serve as a model of large-scale integration of personalized healthcare.
Cleveland Clinic’s Center for Personalized Healthcare mission & goals Cleveland Clinic’s Center for Personalized Healthcare houses an initiative to provide individualized patient care by incorporating genetic information, environmental exposures and family health history into a tailored medical management plan for the purpose of improving clinical outcomes in a cost-effective manner. The Center for Personalized Healthcare promotes and oversees a multidisciplinary team approach with physicians, clinical pathologists, pharmacists, geneticists and genetic counselors, and informaticists collaborating together to integrate personalized healthcare into clinical workflows. The mission and goals of the Center for Personalized Healthcare are focused on four areas: Clinical implementation: Integrate disease risk assessment tools and clinical pharmacogenomics into the standard practice of medicine at Cleveland Clinic. Research: Develop new and innovative technologies to advance the integration of personalized healthcare into routine patient care and evaluate the impact on patient outcomes and healthcare costs. Education: Provide educational programs focusing on clinical pharmaco genomics and disease risk assessment to students, healthcare providers and patients. Advocacy: Promote and advocate for government policies that will enhance our ability to provide personalized healthcare. The Center for Personalized Healthcare has developed two programs to help address these goals. The MyFamily initiative assesses disease risk based on family health history, and the Personalized Medication Program focuses on clinical pharmacogenomics. Novel health information technology has been developed to integrate both programs into our unified electronic health record. 588
Pharmacogenomics (2014) 15(5)
Personalizing healthcare: disease risk prediction Although there is increasing evidence that genomics has medical benefit, the practice of medicine has not yet reached the point where every patient is genotyped or sequenced. There are still barriers that need to be overcome before whole-exome or whole-genome sequencing is accepted as routine patient care. These barriers include financial capabilities of health systems to sequence all patients, the integration of large volumes of genomic information into an electronic health record and logically presenting pertinent information to clinicians, and the state of evidence to interpret such tests. An individual’s family health history can be used as a surrogate for genetic, environmental and behavioral risks that may be used for disease risk stratification and identifying those that may benefit from genetic testing or prophylactic treatment [4]. For example, individuals with a family history of breast cancer, especially a health history that includes many affected relatives diagnosed at a young age, would be at a much higher risk of breast cancer than the general population, and possibly more likely to carry detrimental BRCA variants than those with no family history of breast cancer [4]. Early identification of such individuals can have a significant impact on preventive care recommendations and can facilitate higher quality care and appropriate utilization of resources. MyFamily was created in partnership with Cleveland Clinic’s Genomic Medicine Institute to enhance the ability of primary care clinicians to obtain and utilize family health history for prevention and disease risk prediction. MyFamily has several key features: web-based, patient-entered electronic collection of family health history; generation of a pedigree based on disease context and patient-entered family history; a scoring system to identify and stratify disease-risks; clinical decision support offering evidence and consensus-based standard-of-care recommendations; and integration into the clinical workflow by leveraging the electronic health record. MyFamily facilitates more robust and complete ascertainment of family health history than can be done in a typical office future science group
Institutional Profile – visit, and compiles the information in an efficient manner for clinicians, enabling them to more accurately and efficiently identify disease risk. The goal of MyFamily is to allow clinicians to spend their time with patients counseling about individualized risk for disease and developing personalized preventive care plans, rather than collecting family history. Our experience thus far is that MyFamily has facilitated greater efficiency in the primary care workflow and has assisted in the identification of those at potentially increased risk of disease. In addition, it has enabled appropriate utilization of resources by recommending the right tests and consultations based on individual risk. MyFamily is an important first step towards personalizing patient care and providing value-based care.
Personalizing healthcare: clinical pharmacogenomics The Personalized Medication Program was launched in 2012 for the purpose of identifying gene–drug pairs for integration into clinical practice and developing the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. Criteria for identifying gene–drug pairs for implementation are as follows: Evaluation of the literature for strong evidence supporting clinical utility, such as Clinical Pharmacogenetic Implementation Consortium Guidelines [5]; Identifying the most commonly prescribed drugs at Cleveland Clinic that are influenced by variants in pharmacogenes; Gene–drug pairs that physicians deem important to their clinical practice. For each new gene–drug pair implemented, clinical pathologists review the genetic variants and alleles that are interrogated to ensure appropriate coverage of clinically significant polymorphisms. A pharmacogenomic translation table that encompasses all possible reported allele combinations is created to guide phenotype interpretation and link clinical interpretations and clinical decision support to actionable pharmacogenetic test results a priori [6]. Additionally, Best Practice Alerts are deployed to the electronic health record to guide pharmacogenomic test ordering future science group
News & Views
and pharmacotherapy recommendations at the point of care. For those clinicians who desire additional information, each Best Practice Alert contains a link to detailed algorithms for pharmacogenetic testing and pharmacotherapy modifications. Although not viewable to the end user, but of extreme importance for value-based care, the Personalized Medication Program consists of a collaborative workflow that occurs behind-the-scenes to avoid duplication of genetic testing. Pharmacogenomic test results are placed into the electronic health record in a discrete data field that is automatically mined by decision support tools. If a genotype of interest already exists within a patient’s electronic health record, the Best Practice Alert that recommends genotyping is suppressed, and instead the results of the test are presented to the clinician within the prescription field. As such, clinicians are made aware that the result is available and the genotyping test does not need to be re-ordered, thus avoiding costly duplicate testing. Because the genotyping results are presented to clinicians in the prescription field, they do not have to search for laboratory results in the electronic health record, which may foster increased efficiency. There are two oversight committees for the Personalized Medication Program. The Pharmacogenomics Advisory Board, a multidisciplinary group including physicians, pharmacists, bioethicists and attorneys, approves the policies and clinical usage of pharmacogenomics. When deemed necessary, pharmacogenomic policies are presented to the Pharmacy and Therapeutics Committee for approval. For each gene–drug pair targeted for clinical implementation, a pharmacogenomic workgroup is formed to guide the implementation process and approve the clinical decision support language, along with the accompanying algorithms for pharmacogenomic testing and pharmacotherapy modifications. The physicians or provider groups identified as the most frequent prescribers of the drug of interest are invited to be a part of the workgroup. This selection process has helped to ensure that our clinicians are engaged in the development, implementation and communication of Best Practice Alerts, and that they can serve as resources for their peers throughout the www.futuremedicine.com
589
News & Views – Institutional Profile integration process. Most importantly, it also ensures that clinical decision support tools are of clinical utility to the physicians who will be using them. The Personalized Medication Program, with oversight from the Pharmacogenomics Advisory Board and pharmacogenomic workgroups, has implemented HLA-B*57:01–abacavir and TPMT–thiopurines into the clinical workflow. We are currently in the process of implementing HLA-B*15:02-anticonvulsant drugs, with the goal of implementing at least two gene-drug pairs a year. As a part of the Personalized Medication Program, we are establishing a clinical pharmacogenomics service. The initial phase of this service includes a Pharmacogenomics Clinical Specialist reviewing all pharmacogenomic test results, and for those with an actionable result providing support for the medical team when needed. In cooperation with our clinical pathologists, we are also creating a pharmacogenomics consultation service that clinicians may access through the electronic health record. The purpose of this consultation service is to assist with any questions pertaining to pharmacogenomics, including the evaluation of patients who are experiencing an adverse drug event or are not responding to therapy to determine if they may be candidates for pharmacogenomic testing.
Education A Cleveland Clinic internal medicine resident education assessment found that 100% of our medical residents wanted additional genetic education, and 97% of our residents agreed that understanding genetic risk factors and applying that knowledge to clinical practice could potentially improve their patients’ outcomes.
These findings are similar to other peerreviewed publications demonstrating that healthcare professionals understand the importance of personalized healthcare, but are not adequately informed to apply it to their own practice [7]. In response to this medical education assessment, we developed a Personalized Healthcare Series that educates our internal medicine residents about clinical pharmacogenomics and disease risk prediction based on family health history. We are actively engaged in curriculum development for the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (OH, USA), and there are initial plans to collaborate with pharmacy schools located in northeast Ohio to participate in the teaching of clinical pharmacogenomics. The Center for Personalized Healthcare organizes continuing medical education opportunities for Cleveland Clinic clinicians. We invite a Visiting Professor for Medical Grand Rounds yearly, and we host an annual Personalized Healthcare Summit that has been attended by clinicians and nonclinicians from around the USA and the world. Patient and clinician education is also offered through unique avenues such as web blogs, a quarterly newsletter and various lay press publications and live events. In addition, the Center for Personalized Healthcare has actively participated in advocacy efforts to educate our elected officials about personalized healthcare and its role in the future of healthcare delivery.
Future perspective At Cleveland Clinic, we have successfully integrated personalized healthcare into the clinical setting through MyFamily and the Personalized Medication Program. The
Highlights Cleveland Clinic launched the Center for Personalized Healthcare to incorporate patients’ genetic information, environmental exposures and family health history into a tailored medical management plan for the purpose of improving clinical outcomes in a cost-effective manner. MyFamily, a web-based family health history tool, was created to help identify genetic, environmental and behavioral risks that may be used for disease risk stratification, and identifying those that may benefit from early medical interventions. The Personalized Medication Program identifies gene–drug pairs for integration into clinical practice and develops the implementation tools needed to incorporate pharmacogenomics into the clinical workflow. Our efforts to establish personalized medical care at Cleveland Clinic may serve as a model of large-scale integration of personalized healthcare. The Center for Personalized Healthcare is actively engaged in educating students, residents, clinicians and other stakeholders about clinical pharmacogenomics and personalized healthcare.
590
Pharmacogenomics (2014) 15(5)
future science group
Institutional Profile – keys to our success include the use of multidisciplinary collaborative workgroups, methodology-based implementation and measurement of outcomes, and the engagement of clinicians early in the process of development. Future plans include the development of an algorithm for identifying patients most likely to be prescribed a pharmacogenomic high-risk drug and targeting those patients for prospective genotyping. Integrating personalized healthcare into a large comprehensive healthcare system gives us a unique opportunity to evaluate the impact individualized patient care has on clinical outcomes and healthcare costs. We will continue our efforts to create new and innovative technologies to advance and promote the use of personalized healthcare as a part of routine medical care. Financial & competing interests disclosure Cleveland Clinic provided support. All authors are employees of Cleveland Clinic. The authors have no other relevant affiliations or financial involvement 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.
future science group
News & Views
References 1
Curfman GD, Morrissey S, Drazen JM. High-value health care – a sustainable proposition. N. Engl. J. Med. doi:10.1056/ NEJMe1310884 (2013) (Epub ahead of print).
2
Murray CJ, Frenk J. Ranking 37th – measuring the performance of the U.S. health care system. N. Engl. J. Med. 362(2), 98–99 (2010).
3
Crawford JM, Aspinall MG. The business value and cost–effectiveness of genomic medicine. Pers. Med. 9(3), 265–286 (2012).
4
Doerr M, Teng K. Family history: still relevant in the genomics era. Cleveland Clin. J. Med. 79(5), 331–336 (2012).
5
Relling MV, Klein TE. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network. Clin Pharmacol Ther. 89(3), 464–467 (2011).
6
Hicks JK, Crews KR, Hoffman JM et al. A clinician-driven automated system for integration of pharmacogenetic interpretations into an electronic medical record. Clin. Pharmacol. Ther. 92(5), 563–566 (2012).
7
Stanek EJ, Sanders CL, Taber KA et al. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin. Pharmacol. Ther. 91(3), 450–458 (2012).
www.futuremedicine.com
591
