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1. Ensuring Vaccine Safety U.S. Centers for Disease Control and Prevention. Vaccine Safety Monitoring. Accessed October 27. 2021 from https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/index.html. U.S. Department of Health and Human Services. Vaccine Safety. Accessed October 27. 2021 from https://www.hhs.gov/immunization/basics/safety/index.html.
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1. J. Vespa, L. Medina, and David M. Armstrong, “Demographic Turning Points for the United States: Population Projections for 2020 to 2060.” Current Population Reports, U.S. Census, February 2020,   https://www.census.gov/content/dam/Census/library/publications/2020/demo/p25-1144.pdf.
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1. Zelaya, C., Dahlhammer, J., Lucas, J., and Connor E. “Chronic Pain and High-Impact Chronic Pain Among U.S. Adults, 2019.” National Center for Health Statistics Data Brief No. 390, November 2020, https://www.cdc.gov/nchs/products/databriefs/db390.htm; and Awsare, S., Havens, C., and Lippi, J. “Facing the Opioid Crisis: Practical, Effective Actions We Can Take.” Gastroenterology, May 2019; 156(6) https://pubmed.ncbi.nlm.nih.gov/30682346/.
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8. Cho, J., Spence, M., Niu, F., Hui, R., Gray, P., and Steinberg, S. “Risk of Overdose with Exposure to Prescription Opioids, Benzodiazepines, and Non-Benzodiadepine Sedative-Hypnotics in Adults: a Retrospective Cohort Study.” Journal of General Internal Medicine. March 2020; 35(3), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7080944/.

This document summarizes the key findings of research conducted by the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, in collaboration with Kaiser Permanente. Original articles: 

• Moneer O, Brown B, Avorn, J et al. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence. Drug Safety. 2022. 45(4):305-318. https://pubmed.ncbi.nlm.nih.gov/35182362/ 
• Mitra-Majumdar M, Gunter SJ, Kesselheim AS, et al. Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020. JAMA Network Open. 2022. 5(5):e2212454. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2792372  
• Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ 2015;351:h4633
• Naci H, Smalley KR, Kesselheim AS. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration. JAMA 2017;318(7):626-636
• Darrow JJ, Avorn J, Kesselheim AS. FDA approval and regulation of pharmaceuticals, 1983-2018. JAMA 2020;323(2):164-176

1. Centers for Disease Control and Prevention, “Climate and Health,” https://www.cdc.gov/climateandhealth/effects/default.htm, April 25, 2022.

2. Kristie L. Ebi and Jeremy J. Hess, “Health Risks Due to Climate Change: Inequity in Causes And Consequences,” Health Affairs, 2020 39:12, 2056-2062; https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01125.

3.  Kristie L. Ebi and Jeremy J. Hess, “Health Risks Due to Climate Change: Inequity in Causes And Consequences,” Health Affairs, 2020 39:12, 2056-2062; https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01125.

4.  Kristie L. Ebi and Jeremy J. Hess, “Health Risks Due to Climate Change: Inequity in Causes And Consequences,” Health Affairs, 2020 39:12, 2056-2062; https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01125.

5.  The Commonwealth Fund, “How the U.S. Health Care System Contributes to Climate Change, https://www.commonwealthfund.org/publications/explainer/2022/apr/how-us-health-care-system-contributes-climate-change#:~:text=While%20health%20care%20systems%20shoulder,%2C%20and%20ozone%2C%20among%20others, April 19, 2022.

6.  Sarah Gibbens, “Can Medical Care Exist Without Plastic?,” National Geographic,      https://www.nationalgeographic.com/science/article/can-medical-care-exist-without-plastic, October 4, 2019.

7.  Kaiser Permanente, “Our Earth Day Pledge to Keep Fighting Climate Change,”   https://about.kaiserpermanente.org/commitments-and-impact/healthy-communities/news/our-earth-day-pledge-to-keep-fighting-climate-change, April 18, 2022.

8.  Health Care Without Harm and Kaiser Permanente, “The Path to Carbon Neutral: A Guide to Building a Climate-Smart Health Care System,” https://practicegreenhealth.org/sites/default/files/2020-10/kaiser-permanente-path-to-carbon-neutral-guide_20200923.pdf, September 2020.

9.  National Academy of Medicine, “Action Collaborative on Decarbonizing the U.S. Health Sector,” https://nam.edu/programs/climate-change-and-human-health/action-collaborative-on-decarbonizing-the-u-s-health-sector/, accessed March 15, 2023.

10.  Kaiser Permanente, “Total Health for All: 2021 Environmental, Social, and Governance Report,”  https://about.kaiserpermanente.org/content/dam/kp/mykp/documents/reports/Kaiser-Permanente-ESG-Report_2021_ADA.pdf, 2021.

11. Kaiser Permanente, “Environmentally Preferable Purchasing Standard,”   https://supplier.kp.org/impactspending/wp-content/uploads/sites/2/2020/12/KPEPPStandards.pdf, revised April 2022.

12. U.S. Green Building Council, “Benefits of LEED,” https://www.usgbc.org/leed/why-leed, accessed March 15, 2023.

13. Jeff Lagasse, “Healthcare Gas Emissions Responsible for 10% of National Emissions, 98,000 Deaths Annually,” Healthcare Finance, https://www.healthcarefinancenews.com/news/healthcare-gas-emissions-responsible-10-national-emissions-98000-deaths-annually, September 20, 2022.

14. Kathy Gerwig, “Greening Health Care: How Hospitals Can Heal the Planet,” Stanford Social Innovation Review,  https://ssir.org/books/excerpts/entry/greening_health_care_how_hospitals_can_heal_the_planet, September 15, 2014.

15. Health Care Without Harm and Kaiser Permanente, “The Path to Carbon Neutral: A Guide to Building a Climate-Smart Health Care System,” https://practicegreenhealth.org/sites/default/files/2020-10/kaiser-permanente-path-to-carbon-neutral-guide_20200923.pdf, September 2020.

1 https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
2 https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027
3 https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
4  https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged#:~:text=%E2%80%9CEMA%20has%20approved%2086%20biosimilar%20medicines%20since%202006
5 https://www.cardinalhealth.com/content/dam/corp/web/documents/Report/cardinal-health-biosimilars-report-2023.pdf
6  https://jamanetwork.com/journals/jama/fullarticle/2698912
7  https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm.
8  https://www.fda.gov/news-events/press-announcements/fda-approves-inflectra-biosimilar-remicade.
9 https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-neulasta-help-reduce-risk-infection-during-cancer-treatment
10 https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-cancer.
11 https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
12 https://www.fda.gov/drugs/fda-approves-truxima-biosimilar-rituxan-non-hodgkins-lymphoma
13 https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira
14 https://newsroom.viatris.com/2021-11-16-Viatris-and-Biocon-Biologics-Announce-Launch-of-Interchangeable-SEMGLEE-R-insulin-glargine-yfgn-Injection-and-Insulin-Glargine-insulin-glargine-yfgn-Injection
15 https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
16 https://www.fda.gov/drugs/biosimilars/biosimilar-product-information