State of Knowledge: Medications have been shown to change in the space environment. The exact mechanisms have not been delineated but contributing factors may include radiation exposure and ambient environmental conditions.  Many medications on the International Space Station are repackaged from initial manufacturers’ packaging for operational reasons (mass/volume reductions, convenience of use) and it is unclear if this approach exacerbates the changes seen in the space environment.

Approach: We will consider a variety of packaging and storage solutions, including but not limited to: keeping all medications in manufacturers’ packaging; re-packaging medications using current operational parameters; novel packaging/storage options; and environmental control chambers and/or shielding.  For each of these solutions, analysis shall consider the following components: benefits with respect to preserving effectiveness and minimizing toxicity; resource “costs” associated with solution (mass, volume, power, etc.); and operational impacts including pre-flight packaging implications (timing, location, storage, etc.) and techniques/technologies necessary for novel packaging solution.

Recommendation of packaging/storage strategies to be incorporated into future exploration spaceflight operations

State of Knowledge: The current spaceflight formulary is based upon operational spaceflight experience and subject matter expert consultation.  These are the medications that are available to be used by astronauts on the International Space Station to treat the most common clinical conditions and those with significant consequences. As new evidence arises and novel risk assessment techniques are developed, future versions of an exploration formulary need to be developed using all of the best available evidence at any given time.

Approach: The optimal exploration formulary will treat those conditions that are expected to arise during deep space missions and will complement all the capabilities included in an exploration medical system. This exploration formulary will be developed using an iterative process based upon the best available evidence at the time. Currently, the evidence available is linked to exploration conditions lists which are subsequently mapped to medical capabilities and resources required (this includes pharmaceuticals. Future efforts will focus on using traceable and repeatable probabilistic risk assessment and trade space analysis processes that will utilize modeling to create more refined estimates for spaceflight conditions treated, capabilities and resources needed (including medications), and associated “costs” (mass, volume, etc.). This work is interconnected with other human system risks, primarily the Medical risk but also any other human system risk that is considering using pharmaceuticals as a mitigation strategy.

Delivery of final exploration candidate formulary based upon trade space analysis that considers all human system risks

State of Knowledge: Insufficient information has previously been gathered on the extent to which medications change in the spaceflight environment. Furthermore, there are a number of potential factors that may contribute to the overall safety and effectiveness profile of any given medication considered for exploration spaceflight and the relative contribution of each of these factors is unclear. It is believed that there is additional existing evidence available that must be gathered and collated for each medication being considered for the Exploration Candidate Formulary.

Approach: The initial effort will be to synthesize all known ground, analog, and spaceflight data from all available sources (including NASA, academia, pharmaceutical companies, and other governmental organizations) for each medication on the iterative Exploration Candidate Formulary with respect to safety and effectiveness. This data will be used to feed a systematic process whereby each medication on the Exploration Candidate Formulary will then be categorized in terms of the level of confidence that sufficient information is currently available to accurately predict each medication’s safety and effectiveness profile for exploration missions.

State of Knowledge: For a number of medications that are being considered for inclusion in the Exploration Candidate Formulary, there is insufficient data and evidence to demonstrate that they will have acceptable safety and effectiveness profiles throughout an exploration mission.

Approach: Ground, analog, and/or flight studies will need to be performed that will expose indeterminate Exploration Candidate Formulary medications (see Pharm-301) to conditions that mimic the spaceflight environment. These research samples will then need to be analyzed for selected stability and toxicity characteristics when compared to control samples.

An Exploration Candidate Formulary which includes only medications with demonstrated acceptable safety and effectiveness profiles.

State of Knowledge: There is insufficient information available about how medications are used during spaceflight, especially for long-duration missions. Previous data regarding medication use on Space Shuttle and International Space Station missions were collected as part of medical records or post-flight medical debriefs; however, studies have shown that this data collection method is incomplete. Currently, there is no mechanism in place to improve the data collection process in a way that will ensure full and complete capture of medication usage information.

Approach: Consistently obtain astronaut medication usage data through an onboard software application to which crewmembers will have easy access and sufficient crew time is protected for its use.