ICOP-Pharm: could the new paradigm bridge a gap in evidence raised by 2022 ESC guidelines on cardio-oncology?

Cardio-oncology is an emerging subspecialty in the field of cardiology that is based on a multidisciplinary approach.1 Although pharmacists play an essential role in monitoring and reducing cancer therapy-related cardiovascular toxicity (CTR-CVT), as well as optimizing the management of baseline cardiovascular risk factors (CVRFs) and/or cardiovascular disease (CVD) in cardio-oncology, published evidence and a service model for pharmacists in this domain are absent. To highlight the importance of this issue, 2022 European Society of Cardiology (ESC) Guidelines on Cardio-Oncology included a ‘Gaps in Evidence’ section that emphasized on the need for future research to specify the role of pharmacists in cardio-oncology teams.1 Overall, pharmacists have a known role in the management of different types of CVD, primarily in the setting of patient education and medication management.2 Evidence supports that patient medical history-taking by a pharmacist reduces the time needed for physician consultation.3 Consequently, this approach can increase the number of patients that can be managed by the medical team. Pharmacists are expected to undergo specialized training and certification to be qualified for delivering advanced and unique healthcare services in the field of cardiology.2 In Canada, a model cardio-oncology clinic is staffed by cardiologists, whereas the first cardio-oncology clinic in the United Kingdom is staffed by consultant cardiologists, a senior clinical fellow in cardio-oncology, and a senior clinical nurse specialist.4,5 Of importance, the role of a cardiology pharmacist is missing in both of these models. The emerging role of a qualified cardiology pharmacist in the cardio-oncology clinic was initiated with the establishment of the first cardio-oncology clinic in Iraq. The current evidence-based article may initially bridge one of the evidence gaps raised by the 2022 ESC guidelines on cardio-oncology regarding the role of the pharmacist. In 2019, the Iraqi Cardio-Oncology Program (ICOP) was founded by a senior consultant cardiologist and a cardiology clinical pharmacist as a mentee. The mission of ICOP is to reduce the burden of CVRF/CVD and CTR-CVT among patients with cancer by establishing a recognized cardio-oncology clinic based on teamwork—with a team that includes a qualified pharmacist. As an initial step, an online survey was conducted to evaluate the readiness of cardiologists and oncologists to start the new organized subspecialty service in Iraq. One of the survey questions was directed to identify the perception of the specialists regarding the suggested cardio-oncology team members.6 More than 60% of cardiologists chose a pharmacist to be part of the multidisciplinary team; in contrast, only 11.3% of oncologists selected a pharmacist.6 Beginning 15 December 2020, and onward during the coronavirus disease 2019 pandemic, the first cardio-oncology clinic in Iraq was established in the Medical City. The clinic is open 1 day weekly, excluding national holidays. A new ICOP-Pharm paradigm was designed to guide multidisciplinary teamwork. Initially, the number of the attending patients was 3–5 patients per clinic, which subsequently increased over time to up to 22 patients per clinic. Oncologists refer all patients for echocardiography for a baseline measurement, for baseline cardiovascular risk stratification and multidisciplinary team decision, for suspected cardiotoxicity, or for follow-up among those who are receiving high-risk cardiotoxic cancer therapy or those who are cancer survivors. Heart Failure Association/International Cardio-Oncology Society proformas are used for the baseline assessment of cardiovascular risk.7 A new cardio-oncology clinic paradigm for a multidisciplinary heart team was designed with the enrolment of a cardiology clinical pharmacist qualified in the management of patients with cancer and CVRF/CVD, including CTR-CVT. The clinic heart team includes a senior consultant cardiologist who is board-certified by the International Cardio-Oncology Society; a cardiology clinical pharmacist who is board-certified with 8 years of practice in the field of cardiology, including 6 years as the data collection officer and clinical researcher in six registries of the international EURObservational Research Programme, in addition, the team includes a cardiology fellow-in-training (FIT).8 The new model is based on a ‘complementary’ or ‘sequential’ approach that permits the cardiology pharmacist to initially suggest cardiovascular drug interventions, followed by discussion with the cardiologist/FIT for their opinion and for additional drug interventions.8 A registry for the ICOP-Pharm study was designed to record cardiovascular drug interventions that are performed by the heart team among patients with cancer and CVRF/CVD. In the ICOP-Pharm model, the cardiology pharmacist completes the initial face-to-face patient interview before performing echocardiography. During the patient interview, the past medical history, cardiovascular drug therapy, electrocardiographic data, and the available laboratory investigations are obtained. Suggested drug interventions are documented. Next, the cardiologist/FIT discusses with the cardiology pharmacist the suggested drug interventions and reviews the summary of the patient medical history to identify if any additional drug intervention must be performed that the pharmacist may have missed. Interventions by the cardiology pharmacist are agreed on by the cardiologist/FIT based on the recommendations of the updated European or American guidelines for the management of CVD or on updated published evidence in cardio-oncology. The final patient-centred decision is made collaboratively.8 During the face-to-face interview, and in the case of unknown cardiovascular medications used by the patient at home, telemedicine is used for communication and management. While each patient is being interviewed by the cardiology pharmacist, the cardiologist/FIT uses this time to perform echocardiography for another patient who has already completed the interview. This approach allows the team to gain time by completing the imaging procedure for the largest number of cancer patients. Based on the ICOP-Pharm paradigm (Figure 1 and Table 1), the cardiology pharmacist is responsible for the following work: Management of CVRF/CVD and CTR-CVT using a complementary approach and collaborating with the cardiologist to make patient-centered decisions Face-to-face patient interview Data collection and registration Telemedicine for patient follow-up, optimization of cardiovascular treatment, and confirmation or exclusion of hypertension diagnosis by asking the patient to record and share home blood pressure measurements as a part of preventive cardiology Ordering baseline and follow-up laboratory tests related to cardiovascular drug therapy Diagnosis of CVRF/CVD (note: 3 of 4 newly diagnosed patients with atrial fibrillation during the clinic’s first year were identified by the cardiology pharmacist based on symptoms and electrocardiogram, which was confirmed by the cardiologist) Patient education about cardiovascular risk factors, particularly hypertension, and their impact on the increased risk of CTR-CVT Initiating ‘bad news’ discussions for patients with newly diagnosed CTR-CVT or baseline newly diagnosed heart failure ICOP-Pharm paradigm for teamwork at the cardio-oncology clinic. The new ICOP-Pharm paradigm is based on the involvement of a cardiology clinical pharmacy specialist among the heart team in the cardio-oncology clinic to be responsible for initial patient interview and suggests cardiovascular drug interventions to be discussed later on with the cardiologist/FIT. Final decision for drug intervention is based on patient-centered decision. Multidisciplinary team decision involves cardiologist, oncologist, and cardiology clinical pharmacist. * Perform by cardiology clinical pharmacist. ** Shared decision making by the cardiologist and cardiology clinical pharmacist. CT, cancer therapy; hx, history; CTR-CVT, cancer therapy-related cardiovascular toxicity; CTRCD, cancer therapy-related cardiac dysfunction; CV, cardiovascular; CVD, cardiovascular disease; CVRF, cardiovascular risk factor; dx, diagnosed; ECG, electrocardiogram; Echo, echocardiography; HBP, home blood pressure; HF, heart failure; HTN, hypertension; PCD, patient-centred decision. Examples for the role of cardiology pharmacist in cardio-oncology clinic from the real daily practice8 For patients who are newly diagnosed with CTRCD, initiate cardioprotective agents e.g. beta blockers and ACEI or reinitiate these medications if patients discontinued them after improved LVEF. Up-titrate the dose of cardioprotective agents for patients with CTRCD during follow-up, or down titrate e.g. reduce beta blocker dose due to symptomatic bradycardia. Based on the guidelines recommendation, e.g. a patient with HTN (with no comorbid disease) treated by atenolol only and he/she suffered from uncontrolled HTN induced by cancer therapy, therefore, switch atenolol to ACEI. Either due to development of adverse drug reactions (e.g. stop NSAID which exacerbates CTRCD) or due to drug-drug interaction [e.g. patient who is using two drugs from the same class (e.g. two ARBs) because he/she has two brands of the same drug. This happened because some patients visit two physicians at the same time (private and public clinics)]. Lab tests: Serum potassium and serum creatinine for ACEI/ARB/ARNI and MRA monitoring. ECG: Patient with palpitation and dyspnea to exclude or confirm atrial fibrillation related to cancer therapy. Echo: Follow-up LVEF to identify the response to cardioprotective agents in case of CTRCD. Educate patients about CTR-CVT e.g. CTRCD and the importance to continue cardioprotective agents even after improvement of LVEF as long as they are treating with cancer therapy. Advise to keep follow-up and educate patients when to seek advice. Educate patient to adhere to the medical therapy of baseline CVD and CV risk factors e.g. HTN. Share in patient-centred and multidisciplinary team decision with the cardiologist and oncologist regarding baseline risk of cardiotoxicity or after diagnosis of CTR-CVT. Data collection, registration, and clinical researches are essential additional roles to improve patients care and outcomes. For patients who are newly diagnosed with CTRCD, initiate cardioprotective agents e.g. beta blockers and ACEI or reinitiate these medications if patients discontinued them after improved LVEF. Up-titrate the dose of cardioprotective agents for patients with CTRCD during follow-up, or down titrate e.g. reduce beta blocker dose due to symptomatic bradycardia. Based on the guidelines recommendation, e.g. a patient with HTN (with no comorbid disease) treated by atenolol only and he/she suffered from uncontrolled HTN induced by cancer therapy, therefore, switch atenolol to ACEI. Either due to development of adverse drug reactions (e.g. stop NSAID which exacerbates CTRCD) or due to drug-drug interaction [e.g. patient who is using two drugs from the same class (e.g. two ARBs) because he/she has two brands of the same drug. This happened because some patients visit two physicians at the same time (private and public clinics)]. Lab tests: Serum potassium and serum creatinine for ACEI/ARB/ARNI and MRA monitoring. ECG: Patient with palpitation and dyspnea to exclude or confirm atrial fibrillation related to cancer therapy. Echo: Follow-up LVEF to identify the response to cardioprotective agents in case of CTRCD. Educate patients about CTR-CVT e.g. CTRCD and the importance to continue cardioprotective agents even after improvement of LVEF as long as they are treating with cancer therapy. Advise to keep follow-up and educate patients when to seek advice. Educate patient to adhere to the medical therapy of baseline CVD and CV risk factors e.g. HTN. Share in patient-centred and multidisciplinary team decision with the cardiologist and oncologist regarding baseline risk of cardiotoxicity or after diagnosis of CTR-CVT. Data collection, registration, and clinical researches are essential additional roles to improve patients care and outcomes. ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI = angiotensin-neprilysin receptor inhibitors; CTRCD = cancer therapy-related cardiac dysfunction; CV = cardiovascular; CVD = cardiovascular disease; CTR-CVT = cancer therapy-related cardiovascular toxicity; ECG = electrocardiogram; Echo = echocardiography; HTN, hypertension; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; NSAID, non-steroidal anti-inflammatory drug. Examples for the role of cardiology pharmacist in cardio-oncology clinic from the real daily practice8 For patients who are newly diagnosed with CTRCD, initiate cardioprotective agents e.g. beta blockers and ACEI or reinitiate these medications if patients discontinued them after improved LVEF. Up-titrate the dose of cardioprotective agents for patients with CTRCD during follow-up, or down titrate e.g. reduce beta blocker dose due to symptomatic bradycardia. Based on the guidelines recommendation, e.g. a patient with HTN (with no comorbid disease) treated by atenolol only and he/she suffered from uncontrolled HTN induced by cancer therapy, therefore, switch atenolol to ACEI. Either due to development of adverse drug reactions (e.g. stop NSAID which exacerbates CTRCD) or due to drug-drug interaction [e.g. patient who is using two drugs from the same class (e.g. two ARBs) because he/she has two brands of the same drug. This happened because some patients visit two physicians at the same time (private and public clinics)]. Lab tests: Serum potassium and serum creatinine for ACEI/ARB/ARNI and MRA monitoring. ECG: Patient with palpitation and dyspnea to exclude or confirm atrial fibrillation related to cancer therapy. Echo: Follow-up LVEF to identify the response to cardioprotective agents in case of CTRCD. Educate patients about CTR-CVT e.g. CTRCD and the importance to continue cardioprotective agents even after improvement of LVEF as long as they are treating with cancer therapy. Advise to keep follow-up and educate patients when to seek advice. Educate patient to adhere to the medical therapy of baseline CVD and CV risk factors e.g. HTN. Share in patient-centred and multidisciplinary team decision with the cardiologist and oncologist regarding baseline risk of cardiotoxicity or after diagnosis of CTR-CVT. Data collection, registration, and clinical researches are essential additional roles to improve patients care and outcomes. For patients who are newly diagnosed with CTRCD, initiate cardioprotective agents e.g. beta blockers and ACEI or reinitiate these medications if patients discontinued them after improved LVEF. Up-titrate the dose of cardioprotective agents for patients with CTRCD during follow-up, or down titrate e.g. reduce beta blocker dose due to symptomatic bradycardia. Based on the guidelines recommendation, e.g. a patient with HTN (with no comorbid disease) treated by atenolol only and he/she suffered from uncontrolled HTN induced by cancer therapy, therefore, switch atenolol to ACEI. Either due to development of adverse drug reactions (e.g. stop NSAID which exacerbates CTRCD) or due to drug-drug interaction [e.g. patient who is using two drugs from the same class (e.g. two ARBs) because he/she has two brands of the same drug. This happened because some patients visit two physicians at the same time (private and public clinics)]. Lab tests: Serum potassium and serum creatinine for ACEI/ARB/ARNI and MRA monitoring. ECG: Patient with palpitation and dyspnea to exclude or confirm atrial fibrillation related to cancer therapy. Echo: Follow-up LVEF to identify the response to cardioprotective agents in case of CTRCD. Educate patients about CTR-CVT e.g. CTRCD and the importance to continue cardioprotective agents even after improvement of LVEF as long as they are treating with cancer therapy. Advise to keep follow-up and educate patients when to seek advice. Educate patient to adhere to the medical therapy of baseline CVD and CV risk factors e.g. HTN. Share in patient-centred and multidisciplinary team decision with the cardiologist and oncologist regarding baseline risk of cardiotoxicity or after diagnosis of CTR-CVT. Data collection, registration, and clinical researches are essential additional roles to improve patients care and outcomes. ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI = angiotensin-neprilysin receptor inhibitors; CTRCD = cancer therapy-related cardiac dysfunction; CV = cardiovascular; CVD = cardiovascular disease; CTR-CVT = cancer therapy-related cardiovascular toxicity; ECG = electrocardiogram; Echo = echocardiography; HTN, hypertension; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; NSAID, non-steroidal anti-inflammatory drug. The initial data from the ICOP-Pharm study was presented in-person as a moderated poster during the American College of Cardiology 2022 Conference in Washington, DC, and published in Journal of the American College of Cardiology.9 Study results showed that the cardiology pharmacist initially performed 63% of drug optimizations and more than 81% of the cessations of drugs that exacerbated CVRF/CVD/CTR-CVT or cessations of nonindicated cardiovascular drugs.9 ICOP-Pharm was a prospective pragmatic study that identified the role of the cardiology clinical pharmacist in the cardio-oncology clinic.8 The 1-year results were recently published and showed that 75% of cardiovascular drug interventions were accomplished by the cardiology clinical pharmacist collaboratively with the cardiologist. The involvement of a qualified pharmacist in a cardio-oncology clinic may be the explanation for the ICOP multidisciplinary team’s ability to successfully manage an annual patient volume that was three-fold larger than that in other cardio-oncology clinic service models in the United Kingdom and Canada.8 The ICOP-Pharm study highlights the vital role of the cardiology clinical pharmacy specialist within the emerging cardio-oncology paradigm, which is based on a complementary approach with the cardiologist for optimization of cardiovascular drug therapy among patients with cancer and CVRF/CVD or CTR-CVT. This model is a transformation of the current cardiovascular care approach and can be considered a roadmap to be implemented in other cardio-oncology services to improve patient outcomes and save time for the team to manage a larger number of patients. Future studies are required to identify the cardiovascular outcomes in patients with cancer and CVRF/CVD or CTR-CVT using the ICOP-Pharm paradigm. In addition, research is needed to study the impact of this model on increasing the number of patients to be managed at different cardio-oncology clinics as a benchmark study against their previous documented patient volume and quality of care. Finally, a study is needed on the cost-effectiveness of using ICOP-Pharm paradigm in cardio-oncology service. None declared.