The Impact of Generic Labels on Compliance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of Generic Labels on Consumption Dosage and Medication Compliance

Conditions
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Generic Label, Brand-name Label

Intervention / Treatment
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* Other: Label


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |