Bill Overview
Title: Patients’ Right to Know Their Medication Act of 2022
Description: This bill requires the Food and Drug Administration (FDA) to issue regulations concerning the patient medication information that is included in the labeling for prescription medications. The regulations must impose various requirements, such as requiring the information to (1) be scientifically accurate and approved by the FDA; (2) include general directions for proper use and warnings that are written in understandable plain language; (3) contain information about known clinically important interactions with drugs, food, and other substances; (4) include a statement of whether there is sufficient data about the drug's use by specified subpopulations, such as children or pregnant women; and (5) be provided in a printed format with each prescription dispensed. The bill prohibits prescription medications that fail to meet this bill's requirements.
Sponsors: Rep. Golden, Jared F. [D-ME-2]
Target Audience
Population: Individuals Using Prescription Medications
Estimated Size: 200000000
- The bill mandates regulations for patient medication information, affecting all users of prescription medications.
- Prescription medications are widely used across various demographics including children, adults, and the elderly, meaning the bill impacts a broad population.
- The bill's requirement for accessible medication information impacts individuals' ability to safely use medications.
- The bill affects healthcare providers and pharmacists who distribute prescription medications.
Reasoning
- The policy affects a large segment of the population who use prescription medications, impacting various demographic groups, including older adults who use more medications.
- Improved medication information can lead to better medication adherence and reduced health complications, thereby improving wellbeing over time.
- Pharmacists and healthcare providers need to adapt to new information requirements, potentially leading to initial increased workloads.
- Over time, as clearer communication reduces errors, pharmacists may face reduced patient inquiries about prescriptions.
- The policy budget restricts the degree of outreach and education, possibly limiting immediate impacts in rural or underserved areas.
Simulated Interviews
Retired (Florida, USA)
Age: 67 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 15/20
Statement of Opinion:
- This policy is long overdue. I've struggled with understanding the complex medical jargon on my medications.
- I appreciate having clear instructions and warnings that prevent harmful side effects.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Pharmacist (New York, USA)
Age: 29 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- This will initially increase the workload for pharmacists like me due to new labeling requirements.
- However, I believe that in the long run it will alleviate confusion and reduce the number of queries regarding medication instructions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Healthcare Administrator (Texas, USA)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This regulation will require substantial administrative adjustments in hospitals, but it will ultimately benefit patient understanding.
- Clear communication is crucial in avoiding readmissions for preventable medication errors.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Pharmaceutical Sales Representative (California, USA)
Age: 52 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 2/20
Statement of Opinion:
- While detailed medication information is necessary, it might complicate our sales processes initially.
- Clear and precise information ensures our drugs are used correctly, ultimately reflecting positively on the pharmaceutical companies.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Software Developer (Illinois, USA)
Age: 37 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 2.0 years
Commonness: 8/20
Statement of Opinion:
- I don't use prescriptions often, but it's comforting to know the information I receive will be clear and concise under this policy.
- Maybe it sets a precedent for how we should handle all complex consumer information.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Retired Nurse (Pennsylvania, USA)
Age: 65 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 5/20
Statement of Opinion:
- For years I've seen how poor communication can lead to medication misuse.
- This policy will reduce errors and anxiety among patients concerning their prescribed medications.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 6 |
Small Business Owner (Ohio, USA)
Age: 50 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 7/20
Statement of Opinion:
- I support policies that empower consumers through better information.
- Though I don't use medications frequently, I recognize the benefit of this approach.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
College Student (Washington, USA)
Age: 23 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- As a student, the streamlined info helps when allergic reactions strike.
- Standardizing this information seems like a common-sense move that should be extended to over-the-counter medications too.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Retired (Nebraska, USA)
Age: 80 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 9/20
Statement of Opinion:
- I'm glad this policy requires plain language. Often, I'm confused about my prescriptions.
- Clearer instructions lower the need to depend on potentially inaccurate online resources.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 7 | 4 |
Operations Manager (Minnesota, USA)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- Having clear medication guidelines boosts my confidence in managing my health.
- For people like me, who manage their health proactively, this policy provides peace of mind.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $50000000 (Low: $30000000, High: $70000000)
Year 2: $45000000 (Low: $25000000, High: $65000000)
Year 3: $40000000 (Low: $20000000, High: $60000000)
Year 5: $35000000 (Low: $15000000, High: $55000000)
Year 10: $30000000 (Low: $10000000, High: $50000000)
Year 100: $1000000 (Low: $500000, High: $2000000)
Key Considerations
- The initial implementation cost may be significant due to changes required in prescription labeling and distribution processes.
- The act affects a large population, given that a significant portion of the US population uses prescription medications.
- Long-term healthcare savings are speculative and depend on the effectiveness of the information in reducing medication errors and improving adherence.