HRR - Gap - Med02: We do not have the capability to provide a safe and effective pharmacy for exploration missions.

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Med02: We do not have the capability to provide a safe and effective pharmacy for exploration missions.

Content in this Gap was merged from 1 other Gap

Last Published: 07/30/21 01:05:31 PM (Central)

Responsible Element: Exploration Medical Capability (ExMC)

Status: Closed

Closure Rationale

This gap has been consolidated with the PK/PD concern and elevated to an inclusive Pharm Risk. As such, it will no longer be kept as a gap within the Medical Risk.

Please see new Pharm risk and associated gaps.

Closure Documentation:

No Closure Documentation Available

Description

Initial State:
A major concern of exploration missions is that the duration may exceed the expiration date of a medication. The purpose of this gap is to identify a strategy to ensure that medications needed during an exploration mission are available, safe, and effective.

Approach:
Projects will be conducted to explore avenues that will:
    1. Improve understanding of current drug usage and stability during spaceflight and what medications to manifest during an exploration mission.
    2. Understand any changes in bioavailability (pharmacokinetics and pharmacodynamics) that will impact the clinical effectiveness of medications selected.
    3. Optimize the usable lifespan of a medication by providing storage recommendations within the vehicle environment.
    4. Ensure the availability of medications by exploring the possibility of drug pre-position and/or resupply (based on the DRM) and the technology behind in-vehicle production.

Target for Closure

A recommendation of an exploration pharmacy and policies that support the operational concept for each DRM.

Mappings

Risk of Adverse Health Outcomes and Decrements in Performance Due to Medical Conditions that occur in Mission, as well as Long Term Health Outcomes Due to Mission Exposures

Med02: We do not have the capability to provide a safe and effective pharmacy for exploration missions.

Completed

Medication Stability Analysis: Device

Task Book: Entry Unavailable
Principal Investigator: Farquharson, Stuart

Short Title: Medication Stability Analysis: Device

Responsible HRP Element: Exploration Medical Capability

Collaborating Org(s):

Funding Status: Completed - Task completed and produced a deliverable

Procurement Mechanism(s):

Solicited

Aims:

Numerous physical and environmental factors unique to the space flight environment have been shown to affect the stability and shelf-life of medications flown on the Space Shuttle and the International Space Station (ISS). It is imperative that a device to test the stability of these medications is developed to avoid untoward medical risks.

A). Step 1: Will use analytical instrumentation to provide a platform for development of medication safety during flight.

Integration/Unique Aspects: Collaboration with ExMC's Phase I SBIR

Resources (Other)

Deliverables (1)

Retrospective Analysis of Medication Usage During Long Duration Spaceflight

Task Book: Entry Unavailable
Principal Investigator: Wotring, Virginia

Short Title: Retro Med Use

Responsible HRP Element: Exploration Medical Capability

Collaborating Org(s):

Funding Status: Completed - Task completed and produced a deliverable

Procurement Mechanism(s):

Directed

Aims:
All medication-related information will be collected from LSDA, including as many details as possible regarding medication use during missions: medication name, dose, dosage form used, frequency of administration, indication for use, perceived efficacy and side effects. The data will be non-attributable but will include basic demographics like weight and gender. This information will permit researchers to retrospectively search for correlations that could result in therapeutic changes like correlations of certain medical complaints with medication use, or gender with certain side effects.

Integration/Unique Aspects: This study will enable identification of medication related issues across all aspects of physiology.

Resources (Other)

Deliverables (1)

Dose Tracker Application for Monitoring Crew Medication Usage, Symptoms and Adverse Effects During Missions

Task Book: Entry
Principal Investigator: Wotring, Virginia

Short Title: Dose Tracker

Responsible HRP Element: Exploration Medical Capability

Collaborating Org(s):

Funding Status: Completed - Task completed and produced a deliverable

Procurement Mechanism(s):

Directed

Aims:
Aim 1: To develop an iOS application (app) for collection of medication usage data from crewmember participants during their missions.

Aim 2: To employ the application to collect in-flight medication usage data to elucidate if 1) data suggest in-flight pharmacokinetic changes; 2)data suggest in-flight pharmacodynamic changes; 3) there are unusual side effects in-flight.

Integration/Unique Aspects: This study will enable Identification of medication related issues across all aspects of physiology. Currently planning to integrate SHFH's app development with the Dose Tracker app to give a consistant look and feel to both applications.

Resources (Flight)

Deliverables (1)

Multi-Disciplinary Research Plans

Documentation:

No Documentation Available

Related Gaps (24)

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Risk Approach Plans (1)

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Common Item(s)
	Dose Tracker Application for Monitoring Crew Medication Usage, Symptoms and Adverse Effects During Missions