Bill Overview
Title: Right Drug Dose Now Act
Description: This bill sets out requirements and activities to address adverse drug events, including using pharmacogenomic testing to prevent them. (Pharmacogenomic testing uses a patient's genetic information to help determine the safety, efficacy, and dosage of medications for treatments.) Specifically, the Department of Health and Human Services (HHS) must report to Congress about the implementation of a national plan to prevent adverse drug events. Additionally, HHS must coordinate with relevant federal agencies on the report and convene a steering committee to update the plan. HHS must also (1) require, as a condition of certification, that health information technologies automatically indicate when pharmacogenomic testing is appropriate before a medication order is completed; and (2) assess electronic health records to identify improvements necessary for developing the capacity for collecting real-world evidence in pharmacogenomics. Furthermore, HHS must consult with the Food and Drug Administration (FDA) to carry out a program to improve reporting of adverse drug events and their association with a patient's genetic status. In addition, the FDA must issue regulations and make other administrative changes to update adverse drug event reporting processes, including to facilitate the acceptance of information directly from electronic health records. The bill also requires the National Human Genomics Research Institute, which is part of the National Institutes of Health, to (1) carry out a public awareness campaign on adverse drug events, and (2) establish a program to educate health care providers and related professionals about pharmacogenomic testing and associated issues.
Sponsors: Rep. Swalwell, Eric [D-CA-15]
Target Audience
Population: Individuals on prescription medications globally
Estimated Size: 231000000
- Pharmacogenomics focuses on how genes affect a person's response to drugs. Therefore, individuals who are on prescription medications or are potential candidates for new medication regimens are the primary group impacted by this legislation.
- The implementation of pharmacogenomic testing can significantly alter drug prescription guidelines, aiming to minimize adverse drug events. This will impact patients who would otherwise experience adverse effects or suboptimal effectiveness from standard dosages.
- The bill includes directives that are relevant to the entire population because healthcare practices (including prescription drug processes) affect everyone who uses healthcare services.
- Global health trends show that there are approximately 7.9 billion people as of 2021, many of whom require some form of pharmaceutical intervention. Therefore, a large portion of the global population could potentially benefit from improved prescription accuracy.
- Although not all individuals will have immediate access to pharmacogenomic testing, the legislation’s focus is likely to influence worldwide health systems over time.
Reasoning
- Given the policy's focus on pharmacogenomic testing, individuals who are prescribed multiple medications or who have experienced adverse drug events in the past are more likely to see direct benefits from this policy.
- The implementation of the policy will largely affect urban populations with better access to healthcare technologies and services initially, due to the infrastructural requirements associated with implementing pharmacogenomic testing.
- Younger populations might have more exposure and adaptation to new health technologies, whereas older populations, being on more medications, could benefit more clinically from accurate dosing and reduced adverse effects.
- The budget constraints suggest that while initial implementation may target specific groups (e.g., high-risk patients, major healthcare providers), broader impacts may be seen as technology dissemination increases over time.
- Since the American healthcare system utilizes comprehensive health records, this integration will provide the infrastructure needed for supporting such policy developments effectively.
- Among various demographics, individuals with chronic conditions who are subject to complex drug regimens (such as the elderly or those with genetic predispositions) will experience the most significant impact.
- Rural and underinsured populations, despite being large in number, might initially face challenges accessing pharmacogenomic testing due to geographical and financial constraints.
Simulated Interviews
Clinical Pharmacist (New York, NY)
Age: 52 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- As a clinical pharmacist, I believe the policy will streamline processes and reduce medication errors significantly.
- The emphasis on pharmacogenomics aligns with the future of personalized medicine, which is a positive step forward.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Software Developer (Los Angeles, CA)
Age: 40 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- The idea of getting my medications tailored to my genetics sounds promising.
- I hope this reduces the side effects I've experienced from my blood pressure meds.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 5 |
Retired Nurse (Houston, TX)
Age: 67 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 2/20
Statement of Opinion:
- I have seen medication errors first hand, and anything that reduces them is welcomed.
- I worry about accessing these tests being expensive or complicated.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 8 | 5 |
Genetic Counselor (Chicago, IL)
Age: 29 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Pharmacogenomics is crucial to improving patient outcomes, and the policy supports that direction.
- There might be a learning curve for some healthcare providers which could delay benefits initially.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
CEO of Health Tech Startup (Seattle, WA)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- Interoperability improvements required by the policy could significantly benefit health tech innovations.
- There might be considerable initial costs for developing required technology solutions across the board.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 7 | 6 |
Healthcare Administration (Miami, FL)
Age: 55 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Reducing adverse drug events has been a long-standing goal, and this policy provides a good framework.
- Administrative and training costs could be a hurdle.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 7 | 5 |
Research Scientist in Genomics (Boston, MA)
Age: 33 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This policy is exciting as it accelerates the application of genomics in everyday medicine.
- Integration with current healthcare systems will be the key challenge.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 7 |
Patient Advocate (Phoenix, AZ)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Policy changes like this are essential to protect patients from harmful drug reactions.
- Ensuring the patient's voice is heard during these changes is critical.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 6 |
College Student (Austin, TX)
Age: 22 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 9/20
Statement of Opinion:
- As a student, it will be interesting to see how genetics can tailor mental health medications.
- I hope this could help manage my medication side effects better.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Primary Care Physician (Honolulu, HI)
Age: 60 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This policy could enhance medication management in geriatric care, where it's most needed.
- Implementing new technology in practice takes time and training.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 6 |
Cost Estimates
Year 1: $500000000 (Low: $400000000, High: $600000000)
Year 2: $450000000 (Low: $350000000, High: $550000000)
Year 3: $450000000 (Low: $350000000, High: $550000000)
Year 5: $400000000 (Low: $300000000, High: $500000000)
Year 10: $300000000 (Low: $200000000, High: $400000000)
Year 100: $50000000 (Low: $30000000, High: $70000000)
Key Considerations
- The costs and benefits of pharmacogenomic testing are dependent on the speed of technological adoption and integration within existing healthcare systems.
- Variability in healthcare providers' technology capabilities might initially limit the realization of intended benefits.
- Consumer awareness and acceptance of pharmacogenomic testing will be crucial to achieving cost savings and other benefits.