Pharmacist-Managed Collaborative Practice for Chronic Stable Angina

Coronary artery disease (CAD) continues to have a significant impact on society. The latest update by the American Heart Association estimates that 83.6 million American adults have some form of cardiovascular disease (CVD) with an anticipated 15.4 million attributed to CAD.¹ A portion of patients with CAD experience predictable chest pain, which occurs as a result of physical, emotional, or mental stress, more commonly referred to as chronic stable angina (CSA). Based on the most recent estimates, the incidence of patients who experience CSA is about 565,000 and increases in the male population through the eighth decade of life.¹

Although it may be common, treatment options for patients with CSA are limited, as these patients may not be ideal candidates for coronary artery bypass graft or percutaneous coronary intervention (PCI) and may often prefer less invasive treatments. It has also been demonstrated that optimal medical management results in similar cardiovascular outcomes when compared with optimal medical management combined with PCI.^2,3 Therefore, optimizing medical management is a reasonable alternative for these individuals.

Pharmacists have been successful in implementing collaborative practices for the management of various conditions, including anticoagulation, diabetes, hypertension, and hyperlipidemia.^4-7 Pharmacists are heavily involved with cardiovascular risk reduction and management, so it seems opportune that they also treat CSA.⁸ The latest estimated direct and indirect costs for CVD and stroke were well over $315 billion for 2010, and it is anticipated that the costs will continue to rise.¹ Because CSA is typically a medically managed disease and due to its huge medical expense, the development of a pharmacist-managed collaborative practice for treating CSA may prove to be beneficial for both clinical and pharmacoeconomic outcomes.

Clinic Development and Practices

In June 2007, following the approval of ranolazine by the FDA, the VA adopted nonformulary criteria for ranolazine use (Appendix).^9,10 In order for patients to receive ranolazine, health care providers (HCPs) within the North Florida/South Georgia Veterans Health System (NFSGVHS) network were required to submit an electronic nonformulary consult using the computerized patient record system (CPRS). Select clinical pharmacists who had knowledge of the health system’s nonformulary criteria and who were granted access to the electronic consults responded to the requests.

The consults primarily consisted of an automated template that required providers to fill out their contact information and the name of the requested nonformulary medication, dose, and clinical rationale for requesting the specified medication, including any previous treatments that the patient could not tolerate or on which the patient failed to achieve an adequate response. It was highly recommended but not required that the HCPs include other supporting information regarding the patient’s cardiovascular status, such as results from diagnostic cardiac catheterization, stress tests, electrocardiograms (ECGs), or echocardiograms if not readily available from the CPRS. If procedures or tests were conducted at outside facilities, then this information was supplied in the request or obtained with the patient’s consent. However, this information was not necessarily required in order to complete the nonformulary consult. Nonformulary requests for ranolazine were typically forwarded to the clinical pharmacists who specialized in cardiology.

A pharmacist-oriented collaborative practice was established to increase cost-effective use, improve monitoring by a HCP because of the drug’s ability to prolong the corrected QT (QTc) interval, and to more firmly establish its safety and efficacy in a veteran population. This practice operated in a clinic, which was staffed by a nurse, postdoctoral pharmacy fellow, clinical pharmacy specialist in cardiology, and a cardiologist. The nurse was responsible for obtaining the patient’s vitals and ECG and documenting them in the CPRS. The pharmacy fellow interviewed the patient and obtained pertinent medical and historical information before discussing any clinical recommendations with the clinical pharmacy specialist.

The recommendations consisted of drug initiation/discontinuation, dose adjustments, and assessing and ordering of pertinent laboratory values and ECGs, which took place under the scope of the clinical pharmacy specialist. The focus of the ECG was to assess for any evidence of excessive QTc prolongation. Due to the variable and subjective nature of CAD, a cardiologist was available at any time and was used to review any relevant information and further discuss any treatment recommendations.

Based in the NFSGVHS Malcom Randall Veterans Affairs Medical Center (VAMC) in Gainesville, Florida, clinic services were primarily offered to patients of that facility due to the limited number of cardiology providers and services offered at other NFSGVHS locations. Despite being driven by requests for ranolazine, especially after cardiac catheterization when further cardiac intervention may not have been feasible, all patients were allowed to enroll in the clinic at the discretion of their primary care provider (PCP) for optimization of their CSA regimen with the intent of adding ranolazine when appropriate.