BRIEF OBSERVATION Effect of Community Pharmacist Intervention on Cholesterol Levels in Patients at High Risk of Cardiovascular Events: The Second Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP-plus) Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc, Kari L. Olson, BSc(Pharm), PharmD, Alexander M. Dubyk, BSc(Pharm), PharmD, Terri J. Schindel, BSP, MCE, Jeffrey A. Johnson, BSP, PhD D espite strong evidence and wide dissemination of practice guidelines, a large proportion of pa- tients with dyslipidemia are not diagnosed or started on appropriate therapy to lower cholesterol levels (1–10). Multidisciplinary care may help to improve the management of dyslipidemia (11). The purpose of this study was to assess the effect of a community pharmacist- initiated management program on cholesterol levels in patients at high risk of cardiovascular events. METHODS Study Design The study, which utilized a before-after design, involved the participation of 42 Pharmasave community pharma- cies in six provinces in Canada (Appendix). Approval was obtained from the Research Ethics Board of the Univer- sity of Alberta. Trial management, data quality assurance, and analysis were conducted by the Epidemiology Coor- dinating and Research (EPICORE) Centre, University of Alberta. We enrolled patients who were at “very high” risk of cardiovascular events, defined as a history of coronary artery disease, coronary revascularization procedures, peripheral vascular disease, or cerebrovascular disease; presence of diabetes (30 years of age); or a 10-year Fra- mingham risk score 30% (12). Exclusion criteria in- cluded a low-density lipoprotein (LDL) cholesterol level 2.5 mmol/L (97 mg/dL), which is the recommended target level for very high-risk patients; enrollment in an- other lipid-lowering study; being followed in a specialty risk reduction clinic; dosage changes or use of a new lipid- lowering medication within the previous 6 weeks; or myocardial infarction within the previous 3 months. The pharmacist training program consisted of a Web- based educational module and a workshop (13). Pharma- cists approached potential subjects based on known his- tory of cardiovascular disease or use of marker medications (e.g., nitroglycerin products, oral hypogly- cemic agents/insulin) (14,15). Subjects were then invited to attend a baseline (screening) visit held at the phar- macy, during which the pharmacist performed two fast- ing cholesterol measurements 5 to 10 minutes apart using the point-of-care device, Cholestech LDX (Cholestech Corporation, Hayward, California). Patients had been in- structed to fast for 8 to 12 hours before the test. Only patients with an LDL cholesterol level 2.5 mmol/L (97 mg/dL) were enrolled in the study and followed for 6 months. Pharmacists completed interven- tion forms detailing the results of the lipid measure- ments, risk factors assessed, and recommendations for therapeutic interventions (including lifestyle changes), and faxed these forms to the patients’ physician. The pharmacist contacted the patients by telephone at weeks 2 and 4 after enrollment, and at the 3- and 6-month (in-person) follow-up visits. Follow-up visits assessed progress with the intervention(s) recommended at the baseline visit, medication adherence, adverse effects or drug interactions, and patient education. Outcome Measures The primary endpoint of the study was the change in LDL cholesterol level between baseline and 6 months of fol- low-up. Secondary outcomes were the proportion of pa- tients reaching target LDL cholesterol levels as defined by the Canadian Dyslipidemia (12) and National Choles- terol Education Program (NCEP) III (16) guidelines, or the proportion of patients with dosage changes to their lipid-lowering medication, who began lipid-lowering treatment, or who adhered to lipid-lowering medication. Adherence was calculated with the following formula: number of units dispensed between first and last pre- scription/number of days between first and last prescrip- tion  number of units taken per day. Sample Size Based on an estimated average LDL cholesterol level of 3.2 mmol/L (124 mg/dL) for very high-risk patients, a detectable change of 10%, and a two-sided  of 0.01, a sample size of 235 patients was required for 99% power. In order to have power to evaluate secondary endpoints, a sample size of 400 was chosen. 130 © 2004 by Excerpta Medica Inc. 0002-9343/04/$–see front matter All rights reserved. doi:10.1016/j.amjmed.2003.09.024