Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)

Statin Therapeutic Interchange by Pharmacist Collaborative Practice Process

A group of ~ 225 patients were switched from atorvastatin to an equivalent statin either by their physicians usual management or by an collaborative pharmacist coordinated process. We will compare the results of pharmacist process to the standard medical practice to find potentially which process is more effective, safer and efficient. We are surveying a total of 35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their satisfaction of the 2 processes.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: atorvastatin

Detailed Description

This study is a retrospective analysis of patients converted from atorvastatin to another equivalent statin. It is observational because the patients were all on atorvastatin, had been informed by their prescription drug plan that it would not be covered, and that if agreed they would be changed to an equivalent that is covered by their plan. The patients were either converted with the help of pharmacist by collaborative practice agreement (CPA)or upon contacting their physician requesting a different medication. We are comparing the percentage first converted to the equivalent dose in each group and whether patients continued to be at hyperlipidemia treatment goal after the interchange.

• Study Type: Observational
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

225 insured eligible subjects, 35 Primary Care Internal Medicine (PCIM) physicians

Description

225 insured eligible subjects, 35 PCIM physicians

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eligible plan beneficiaries on atorvastatin; A group of 225 eligible patients would no longer have atorvastatin covered by their prescription plan and would need to be changed to another equivalent anti-hyperlipidemic agent.	Drug: atorvastatin; All patients desired to change atorvastatin 10, 20mg to an equivalent that is covered by their prescription plan. This is accomplished by either pharmacists by MD/Pharmacist practice agreement or physicians in usual practice; Other Names: atorvastatin, (Lipitor®),; interchanged to simvastatin, pravastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if a process of pharmacist practice agreement is effective in changing from atorvastatin 10, 20mg to a therapeutic equivalent dose.	We compared doses selected for therapeutic equivalency for the new statin Did the process result in selecting a safe and effective statin alternative?	3 to 9 months after conversion from atorvastatin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Was the process regarded as efficient and satisfying to physician compared to usual practice.	A satisfaction survey of physicians who utilized the pharmacist collaborative practice agreement(CPA) will be compared to satisfaction of phycians who were not able to use the CPA. Was the process regarded as efficient and satisfying to physician compared to usual practice.	5 months post conversion
Did the patients' low density lipoprotein(LDL) cholesterol require further statin dose intervention?	Of patients who had a follow up LDL cholesterol, how many required another intervention after failing to stay within treatment goal. Physicians usually measure each of these patients within 3 months of a change of treatment and annually thereafter. We will look at follow up LDL cholesterol and liver function test (LFT) as recommended.	6-12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Laura Odell, PharmD, RPh, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: September 24, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): May 28, 2012
• Last Update Submitted That Met QC Criteria: May 25, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: statin; low density lipoprotein (LDL) cholesterol; dose equivalent; Hypercholesterolemia (defined by LDL guidelines)
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Pravastatin; Simvastatin
• Other Study ID Numbers: 10-000986