A National Survey on the Prevalence and Impact of Multiple Pharmacy Use in Specialty Pharmacy

Specialty medications often have dispensing restrictions which can be dictated by manufacturer limited distribution strategies, narrow insurance networks, or a combination of both. Unfortunately, this may result in patients being required to use 2 or more pharmacies to fill their prescription medications; this is referred to as multiple pharmacy use (MPU). The investigators' plan is to administer a survey to patients who have been prescribed one or more specialty medications to evaluate the prevalence of MPU in this population as well as to investigate patients' attitudes about MPU and potential factors increasing the likelihood of MPU

Study Overview

• Status: Enrolling by invitation
• Conditions: Health Services Accessibility
• Intervention / Treatment: Other: Survey

Detailed Description

The investigators will identify patients from participating member sites via a review of prescribing records for specific specialty medications. Patients will be contacted via telephone to explain the purpose and risk of the study. Consented patients will then be asked a series of 11 questions about their attitudes and experience with taking and obtaining their specialty medication(s). Additional demographic and clinical information about patients will be collected via chart review.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects 18 years of age or older
• English-speakers
• An active patient of a performance institution and ability to provide informed consent to participate with the survey
• Electronically prescribed at least one specialty medication by a performance site provider, which can be either a new or renewed order, within the last 3 months

Exclusion Criteria:

• Subjects less than 18 years of age
• Non-English speakers
• Patients that cannot or are unwilling to provide consent
• Patients who have not had a new or renewed specialty medication prescription order placed electronically within the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specialty Pharmacy Patient; Patients who have been prescribed at least one selected specialty medication	Other: Survey; Multiple Pharmacy Use Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients using Multiple Pharmacies	Of all patients consented, the percentage of patients using more than one pharmacy to obtain their medications	Within one year of study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported adherence and barriers	Patient response to questions about having missed doses in the past month	Within one year of study initiation
Method of obtaining medications	Patient response to questions about distance from pharmacy and how prescriptions are primarily obtained	Within one year of study initiation
Experience with obtaining and administering medications	Patient response to questions about how easy it is for patients to obtain and administer medication	Within one year of study initiation

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: University of California, Los Angeles; The Cleveland Clinic; University of Illinois at Chicago; University of Washington
• Investigators: Principal Investigator: Whisler, PharmD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB00277792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data from individual study sites will be collected and stored together either via a password-protected Excel file or Qualtrics.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No