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Risk Risk of Ineffective or Toxic Medications During Long-Duration Exploration Spaceflight
Content in this Risk was merged from 2 other Risks show content
Short Title: Pharm Last Published:  04/20/22 11:43:17 AM (Central)
Element: Exploration Medical Capability (ExMC)
Evidence:  Report
Risk Master Logic Diagram:  Not Available
Point of Contact:  Kris Lehnhardt
HRP Risk Status: Active [current research ongoing]
Risk Ratings and Dispositions per Design Reference Mission (DRM) Category
DRM CategoriesMission Type and
Duration		OperationsLong-Term Health
LxCRisk Disposition *LxCRisk Disposition *
Low Earth OrbitShort
(<30 days)		1x1Accepted1x1Accepted
Long
(30 days-1 year)		1x1Accepted1x1Accepted
Lunar OrbitalShort
(<30 days)		2x1Accepted1x1Accepted
Long
(30 days-1 year)		3x2Accepted with Optimization2x2Accepted with Monitoring
Lunar Orbital
+ Surface		Short
(<30 days)		3x1Accepted with Optimization2x1Accepted with Monitoring
Long
(30 days-1 year)		4x2Accepted with Optimization2x2Accepted with Monitoring
MarsPreparatory
(<1 year)		4x3Requires Characterization3x2Accepted with Monitoring
Mars Planetary
(730-1224 days)		5x3Requires Mitigation5x3Requires Mitigation
Note: LxC is the likelihood and consequence rating. The information above was last approved by the Human System Risk Board in 12/2021.
Risk Statement
Given that there is no current method to sufficiently characterize medication use, drug quality and performance, clinical outcomes, and the impact of a hostile space environment on pharmaceutical stability and potency during long-duration exploration missions, there is a possibility that provision of a safe and effective drug treatment will be significantly limited, impacting crew health and performance.
Gaps (6)
Gap Pharm-101: We need to determine the optimal packaging/storage strategy for medications in space that balances the needs of mitigating toxicity, preserving effectiveness, and minimizing resource “costs” (mass, volume, power, etc.).
Gap Pharm-201: We need to establish an exploration formulary that identifies medications with maximal clinical benefit and minimal resource “costs” (mass, volume, etc.).
Gap Pharm-301: We need to categorize all medications that are included in the iterative Exploration Candidate Formulary based upon the current state of knowledge of their effectiveness and safety in the spaceflight environment.
Gap Pharm-401: We need to perform further research to understand and characterize the active pharmaceutical ingredient and degradation profiles of medications for which we have low to moderate confidence in their safety and effectiveness for exploration missions.
Gap Pharm-501: We need to accurately characterize when astronauts use medications in space, why they use them, how they use them, whether they work, and if they cause any problems.
Gap Pharm-601: We need to characterize the extent to which spaceflight alters pharmacokinetics and pharmacodynamics.
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