The Impact of Generic Labels on Compliance

The Impact of Generic Labels on Consumption Dosage and Medication Compliance

Although generic drugs are pharmacologically equivalent to their brand-name counterparts, prejudices against the former remain strong among patients and doctors. In a randomized controlled field experiment, this research assesses the extent to which generic (versus brand-name) labels affect patients' consumption dosage, medication compliance and reported pain.

Study Overview

• Status: Completed
• Conditions: Generic Label; Brand-name Label
• Intervention / Treatment: Other: Label

Detailed Description

One hundred one patients scheduled to undergo invasive dental surgeries (i.e., dental implants) participated in the experiment. After dental surgery, patients were prescribed a once-daily analgesic regimen for up to 7 days. The intervention consisted of label manipulation. Patients were randomly assigned to either the brand-name analgesic or to its (purportedly) cheaper generic version. In reality, all participants obtained the same brand-name medication. The medication was provided at no cost, and patients were instructed to take the first pill while at the clinic. They were informed that they could (a) increase the dosage of the prescribed analgesic to twice daily if necessary and (b) stop taking the medication when no longer needed. Any other changes to the regimen were discouraged, and patients were instructed to consult with the dentist before any such changes. Telephone follow-ups were conducted at 24 hours, 4 days, and 7 days after surgery. Two main dependent variables were obtained: the number of prescribed analgesics consumed and the number of non-prescribed analgesics consumed. The patients also reported the pain felt during the period.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic

Exclusion Criteria:

• Patients not scheduled to undergo these treatments

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Generic Label; Purportedly generic version of the analgesic presented	Other: Label; Participants were presented with either a generic label or a brand-name label
Active Comparator: Brand-name Label; actual brand-name analgesic presented	Other: Label; Participants were presented with either a generic label or a brand-name label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Compliance	Number of patients who consumed at least one non-prescribed analgesic pill during the first 24 hours	1 day after the intervention
Non-Compliance	Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 2 to day 4)	4 days after the intervention
Non-compliance	Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 5 to day 7)	7 days after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption Dosage	Average number of pills consumed during the study period (first 24 hours)	1 day after the intervention
Consumption Dosage	Average number of pills consumed during the study period (from day 2 to day 4)	4 days after the intervention
Consumption dosage	Average number of pills consumed during the study period (from day 5 to 7)	7 days after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain levels	Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)	1 day after the intervention
Pain levels	Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)	4 days after the intervention
Pain levels	Average retrospective and current level of pain; eleven-point scale (0=not at all, 10=extreme)	7 days after the intervention
Perceived Efficacy	perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)	1 day after the intervention
Perceived Efficacy	perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)	4 days after the intervention
Perceived Efficacy	perceived efficacy of prescribed painkiller (0=It does not reduce pain at all; 10=it eliminates pain completely)	7 days after the intervention
Referral	the likelihood of indicating it a friend (0=Never; 10=Certainly).	1 day after the intervention
referral	the likelihood of indicating it a friend (0=Never; 10=Certainly).	4 days after the intervention
referral	the likelihood of indicating it a friend (0=Never; 10=Certainly).	7 days after the intervention

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: UFSC-CEPSH-649-322600