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At least 73 records · Page 4

JSC Pharmacy Services for Remote Operations

The Johnson Space Center Pharmacy began operating in March of 2003. The pharmacy serves in two main capacities: to directly provide medications and services in support of the medical clinics at the Johnson Space Center, physician travel kits for NASA flight surgeon staff, and remote operations, such as the clinics in Devon Island, Star City and Moscow; and indirectly provide medications and services for the International Space Station and Space Shuttle medical kits. Process changes that occurred and continued to evolve in the advent of the installation of the new JSC Pharmacy, and the process of stocking medications for each of these aforementioned areas will be discussed. Methods: The incorporation of pharmacy involvement to provide services for remote operations and supplying medical kits was evaluated. The first step was to review the current processes and work the JSC Pharmacy into the existing system. The second step was to provide medications to these areas. Considerations for the timeline of expiring medications for shipment are reviewed with each request. The third step was the development of a process to provide accountability for the medications. Results: The JSC Pharmacy utilizes a pharmacy management system to document all medications leaving the pharmacy. Challenges inherent to providing medications to remote areas were encountered. A process has been designed to incorporate usage into the electronic medical record upon return of the information from these remote areas. This is an evolving program and several areas have been identified for further improvement.

Stoner, Paul S.↗

Stability of Dosage Forms in the Pharmaceutical Payload Aboard Space Missions

Efficacious pharmaceuticals with adequate shelf lives are essential for successful space medical operations. Stability of pharmaceuticals, therefore, is of paramount importance for assuring the health and wellness of astronauts on future space exploration missions. Unique physical and environmental factors of space missions may contribute to the instability of pharmaceuticals, e.g., radiation, humidity and temperature variations. Degradation of pharmaceutical formulations can result in inadequate efficacy and/or untoward toxic effects, which could compromise astronaut safety and health. Methods: Four identical pharmaceutical payload kits containing 31 medications in different dosage forms (liquid, tablet, capsule, ointment and suppository) were transported to the International Space Station aboard the Space Shuttle (STS-121). One of the 4 kits was stored on the Shuttle and the other 3 were stored on the International Space Station (ISS) for return to Earth at 6-month interval aboard a pre-designated Shuttle flight for each kit. The kit stored on the Shuttle was returned to Earth aboard STS-121 and 2 kits from ISS were returned on STS 117 and STS-122. Results: Analysis of standard physical and chemical parameters of degradation was completed for pharmaceuticals returned by STS-121 after14 days, STS - 117 after11 months and STS 122 after 19 months storage aboard ISS. Analysis of all flight samples along with ground-based matching controls was completed and results were compiled. Conclusion: Evaluation of results from the shuttle (1) and ISS increments (2) indicate that the number of formulations degraded in space increased with duration of storage in space and was higher in space compared to their ground-based counterparts. Rate of degradation for some of the formulations tested was faster in space than on Earth. Additionally, some of the formulations included in the medical kits were unstable, more so in space than on the ground. These results indicate that the space flight environment may adversely affect the shelf life of pharmaceuticals aboard space missions.

Du, Brian J.↗

Are Medications Involved in Vision and intracranial Pressure Changes Seen in Spaceflight?

Some crewmembers have experienced changes in their vision after long-duration spaceflight on the ISS. These impairments include visual performance decrements, development of cotton-wool spots or choroidal folds, optic-disc edema, optic nerve sheath distention, and/or posterior globe flattening with varying degrees of severity and permanence. These changes are now used to define the visual impairment/intracranial pressure (VIIP) syndrome. The reasons for these potentially debilitating medical issues are currently unknown. The potential role of administered medications has not yet been examined, but it is known that many medications can have side effects that are similar to VIIP symptoms. Some medications raise blood pressure, which can affect intracranial pressure. Many medications that act in the central nervous system can affect intracranial pressures and/or vision. About 40% of the medications in the ISS kit are known to cause side effects involving changes in blood pressure, intracranial pressure and/or vision. For this reason, we proposed an investigation of the potential relationship between ISS medications and their risk of causing or exacerbating VIIP-like symptoms. The purpose of this study was to use medication usage records for affected and unaffected crew to determine if use of particular medications seemed to correlate with VIIP occurrence or severity.

Wotring, V. E.↗

Are Medications Involved in Vision and Intracranial Pressure Changes Seen in Spaceflight?

Some crewmembers have experienced changes in their vision after long-duration spaceflight on the ISS. These impairments include visual performance decrements, development of cotton-wool spots or choroidal folds, optic-disc edema, optic nerve sheath distention, and/or posterior globe flattening with varying degrees of severity and permanence. These changes are now used to define the visual impairment/intracranial pressure (VIIP) syndrome. It is known that many medications can have side effects that are similar to VIIP symptoms. Some medications raise blood pressure, which can affect intracranial pressure. Many medications that act in the central nervous system can affect intracranial pressures and/or vision. About 40% of the medications in the ISS kit are known to cause side effects involving changes in blood pressure, intracranial pressure and/or vision. For this reason, we have begun an investigation of the potential relationship between ISS medications and their risk of causing or exacerbating VIIP-like symptoms.

Wotring, V. E.↗

Information Technology: A Tool to Cut Health Care Costs

Old Dominion University embarked on a project to see how current computer technology could be applied to reduce the cost and or to improve the efficiency of health care services. We designed and built a prototype for an integrated medical record system (MRS). The MRS is written in Tool control language/Tool kit (Tcl/Tk). While the initial version of the prototype had patient information hard coded into the system, later versions used an INGRES database for storing patient information. Currently, we have proposed an object-oriented model for implementing MRS. These projects involve developing information systems for physicians and medical researchers to enhance their ability for improved treatment at reduced costs. The move to computerized patient records is well underway, several standards exist for laboratory records, and several groups are working on standards for other portions of the patient record.

Mukkamala, Ravi↗

Shuttle Orbiter medical system equipment/supplies evaluation

The effectivity was evaluated in zero gravity of several medical equipment and supply items flown in the Shuttle Orbiter Medical System (SOMS). Several procedures listed in Medical Operations Medical Checklist, JSC 1732 were also evaluated. Several items were drawn out of the kits and tested on the KC-135. In two different flights, the following elements were examined: (1) measuring IV flow (drip chamber, one way flow valve, and air/fluid separator); (2) chemstrip protocol for urine analysis in zero-gravity; and (3) tamper resistant seals for injectable medications.

Maidlow, Kristin↗

Biomedical support systems

Biomedical support hardware for SMEAT consisted basically of two systems, the inflight medical support system, and the operational bioinstrumentation system. The former is essentially a diagnostic and therapeutic kit; the latter is a belt equipped with sensors worn by the crewman to permit monitoring of his vital signs. Special attention was given during to the use and verification of the items in the systems so that changes required in the equipment could be pinpointed and effected prior to the Skylab mission. During the in-chamber testing, evaluations were made of the effectiveness of the proposed microbiology procedures, techniques, equipment, and the stability of media and reagents over the extended period of storage.

Brockett, R. M.↗

Automatic Sprout Grower

Self-contained seed-sprouting system provides environment for sprouting seeds quickly and easily. Sprouting container standard 6-oz package for dehydrated food and drink mixes in Space Shuttle. About 4 g of dry alfalfa or radish seeds vacuum-sealed in each cup, like freeze-dried foods. Sixteen cups suspended in tray. Air-and-water inlet tube links each cup to system of tubes and solenoid valves alternately furnish air and water and remove stale air. Peristaltic pump supplies water from vinyl medical-fluid bag. Small diaphragm pump supplies and exhausts air. Small circuit board times movements of air and water. Kit offers advantages to home gardeners. Apartment dwellers use it for steady production of homegrown sprouts even though they have no garden space.

Sauer, Richard L.↗

Pharmacovigilance in Space: Stability Payload Compliance Procedures

Pharmacovigilance is the science of, and activities relating to the detection, assessment, understanding, and prevention of drug-related problems. Over the lase decade, pharmacovigilance activities have contributed to the development of numerous technological and conventional advances focused on medication safety and regulatory intervention. The topics discussed include: 1) Proactive Pharmacovigilance; 2) A New Frontier; 3) Research Activities; 4) Project Purpose; 5) Methods; 6) Flight Stability Kit Components; 7) Experimental Conditions; 8) Research Project Logistics; 9) Research Plan; 10) Pharmaceutical Stability Research Project Pharmacovigilance Aspects; 11) Security / Control; 12) Packaging/Containment Actions; 13) Shelf-Life Assessments; 14) Stability Assessment Parameters; 15) Chemical Content Analysis; 16) Preliminary Results; 17) Temperature/Humidity; 18) Changes in PHysical and Chemical Assessment Parameters; 19) Observations; and 20) Conclusions.

Daniels, Vernie R.↗

Shuttle freezer conceptual design

A conceptual design for a kit freezer for operation onboard shuttle was developed. The freezer features a self-contained unit which can be mounted in the orbiter crew compartment and is capable of storing food at launch and returning with medical samples. Packaging schemes were investigated to provide the optimum storage capacity with a minimum weight and volume penalty. Several types of refrigeration systems were evaluated to select one which would offer the most efficient performance and lowest hazard of safety to the crew. Detailed performance data on the selected, Stirling cycle principled refrigeration unit were developed to validate the feasibility of its application to this freezer. Thermal analyses were performed to determine the adequacy of the thermal insulation to maintain the desired storage temperature with the design cooling capacity. Stress analyses were made to insure the design structure integrity could be maintained over the shuttle flight regime. A proposed prototype freezer development plan is presented.

Proctor, B. W.↗

Antimicrobial Medication Stability During Space Flight

The current vision for manned space flight involves lunar and Martian exploration within the next two decades. In order for NASA to achieve these goals, a significant amount of preparation is necessary to assure crew health and safety. A mission critical component of this vision centers around the stability of pharmaceutical preparations contained in the space medicine kits. Evidence suggests that even brief periods of space flight have significant detrimental effects for some pharmaceutical formulations. The effects observed include decreases in physical stability of drug formulations of sufficient magnitude to effect bioavailability. Other formulations exhibit decreases in chemical stability resulting in a loss of potency. Physical or-chemical instability of pharmaceutical formulations i n space medicine kits could render the products ineffective. Of additional concern is the potential for formation of toxic degradation products as a result of the observed product instability. This proposal addresses Question number 11 of Clinical Capabilities in the Critical Path Roadmap. In addition, this proposal will reduce the risks and/or enhance the capabilities of humans exposed to the environments of space flight or an extraterrestrial destination by identifying drugs that may be unstable during spaceflight.

Putcha, Lakshmi↗

Shuttle Kit Freezer Refrigeration Unit Conceptual Design

The refrigerated food/medical sample storage compartment as a kit to the space shuttle orbiter is examined. To maintain the -10 F in the freezer kit, an active refrigeration unit is required, and an air cooled Stirling Cycle refrigerator was selected. The freezer kit contains two subsystems, the refrigeration unit, and the storage volume. The freezer must provide two basic capabilities in one unit. One requirement is to store 215 lbs of food which is consumed in a 30-day period by 7 people. The other requirement is to store 128.3 lbs of medical samples consisting of both urine and feces. The unit can be mounted on the lower deck of the shuttle cabin, and will occupy four standard payload module compartments on the forward bulkhead. The freezer contains four storage compartments.

Copeland, R. J.↗

Surgical Instrument Restraint in Weightlessness

Performing a surgical procedure during spaceflight will become more likely with longer duration missions in the near future. Minimal surgical capability has been present on previous missions as the definitive medical care time was short and the likelihood of surgical events too low to justify surgical hardware availability. Early demonstrations of surgical procedures in the weightlessness of parabolic flight indicated the need for careful logistical planning and restraint of surgical hardware. The consideration of human ergonomics also has more impact in weightlessness than in the conventionall-g environment. Three methods of surgical instrument restraint - a Minor Surgical Kit (MSK), a Surgical Restraint Scrub Suit (SRSS), and a Surgical Tray (ST) were evaluated in parabolic flight surgical procedures. The Minor Surgical Kit was easily stored, easily deployed, and demonstrated the best ability to facilitate a surgical procedure in weightlessness. Important factors in this surgical restraint system include excellent organization of supplies, ability to maintain sterility, accessibility while providing secure restraint, ability to dispose of sharp items and biological trash, and ergonomical efficiency.

Campbell, Mark R.↗

In-flight medical support system

The In-flight Medical Support System for Skylab was designed to provide the onboard Crew Physician or Scientist Pilot (or other crewmember if the Scientist Pilot was unable to act) with information adequate to make diagnostic assessment of those injuries or illnesses most likely to occur in the Skylab environment. The necessary diagnostic, therapeutic, and laboratory equipment needed to diagnose and to render first aid, resuscitative or supportive measures was stored in the Skylab Orbital Workshop. The resupply kit containing refrigerated laboratory and drug resupply items was stored in the Command Module.

Chassay, C.↗

Emergency medicine and the airline passenger

Problems related to immediate medical care in case of in-flight emergencies are discussed with reference to such critical types of medical emergencies as obstructed airway, cardiac dysfunction, trauma, hemorrhage, hypoxia, and pain. It is shown that training flight attendants to deal with in-flight medical emergencies and to use first-aid support equipment and essential and useful drugs may later help with stabilization of a victim and allow continuing the flight to the scheduled destination without the need for a diverted landing. Among the steps suggested in order to upgrade inflight welfare and safety of passengers are the development of an advisory circular by the FAA covering standardized training for flight attendants, regulatory action requiring upgrading of the present rudimentary first-aid kit, and the enactment of Good Samaritan legislation by the U.S. Government.

Mohler, S. R.↗

Fibroblast Growth Factor-23 in Bed Rest and Spaceflight

Many nutritional factors influence bone, from the basics of calcium and vitamin D, to factors which influence bone through acid/base balance, including protein, sodium, and more. Fibroblast growth factor 23 (FGF23) is a recently identified factor, secreted from osteocytes, which is involved in classic (albeit complex) feedback loops controlling phosphorus homeostasis through both vitamin D and parathyroid hormone (PTH) (1, 2). As osteocytes are gravity sensing cells, it is important to determine if there are changes in FGF23 during spaceflight. In extreme cases, such as chronic kidney disease, FGF23 levels are highly elevated. FGF23 imbalances, secondary to dietary influences, may contribute to skeletal demineralization and kidney stone risk during spaceflight. Presented with an imbalanced dietary phosphorus to calcium ratio, increased secretion of FGF23 will inhibit renal phosphorus reabsorption, resulting in increased excretion and reduced circulating phosphorus. Increased intake and excretion of phosphorus is associated with increased kidney stone risk in both the terrestrial and microgravity environments. Highly processed foods and carbonated beverages are associated with higher phosphorus content. Ideally, the dietary calcium to phosphorus ratio should be at minimum 1:1. Nutritional requirements for spaceflight suggest that this ratio not be less than 0.67 (3), while the International Space Station (ISS) menu provides 1020 mg Ca and 1856 mg P, for a ratio of 0.55 (3). Subjects in NASA's bed rest studies, by design, have consumed intake ratios much closer to 1.0 (4). FGF23 also has an inhibitory influence on PTH secretion and 1(alpha)-hydroxylase, both of which are required for activating vitamin D with the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D. Decreased 1,25-dihydroxyvitamin D will result in decreased intestinal phosphorus absorption, and increased urinary phosphorus excretion (via decreased renal reabsorption). Should a decrease in 1,25- dihydroxyvitamin D be necessary to reduce intestinal phosphorus absorption, calcium absorption will also proportionally be reduced, potentially leading to skeletal demineralization. Demineralization of bone can increase kidney stone risk, a medical issue that could prove detrimental to mission success. Given the interrelationships described above, we sought to determine circulating FGF23 concentrations in spaceflight and ground analog studies to better understand the potential effects of dietary phosphorus on bone and calcium metabolism. We analyzed serum from ISS astronauts participating in studies of bone biochemistry, including the Nutrition SMO and Pro K experiments, and we also evaluated FGF23 during extended-duration bed rest. Serum intact FGF23 levels were determined using an ELISA kit from Kainos laboratories in Japan. While initial evaluation of the data showed no changes over time during flight or bed rest, evaluation continues of FGF23 data in light of dietary factors, PTH, vitamin D status, and other biochemical and endocrine factors.

Bokhari, R.↗

Microbiological Contamination of Spacecraft

The International Space Station (ISS) Phase1 Program resulted in seven US astronauts residing aboard the Russian Space Station Mir between March 1995 and May 1998. Collaboration between U.S. and Russian scientists consisted of collection and analyses of samples from the crewmembers and the Mir and Shuttle environments before, during, and after missions that lasted from 75 to 209 days in duration. The effects of long-duration space flight on the microbial characteristics of closed life support systems and the interactions of microbes with the spacecraft environment and crewmembers were investigated. Air samples were collected using a Russian or U.S.-supplied sampler (SAS, RCS, or Burkard,) while surface samples were collected using contact slides (Hycon) or swabs. Mir recycled condensate and stored potable water sources were analyzed using the U.S.-supplied Water Experiment Kit. In-flight analysis consisted of enumeration of levels of bacteria and fungi. Amounts of microorganisms seen in the air and on surfaces were mostly within acceptability lin1its; observed temporal fluctuations in levels of microbes probably reflect changes in environmental conditions (e.g., humidity). All Mir galley hot water samples were within the standards set for Mir and the ISS. Microbial isolates were returned to Earth for identification of bacterial and fungal isolates. Crew samples (nose, throat, skin, urine, and feces) were analyzed using methods approved for the medical evaluations of Shuttle flight crews. No significant changes in crew microbiota were found during space flight or upon return relative to preflight results. Dissemination of microbes between the crew and environment was demonstrated by D A fingerprinting. Some biodegradation of spacecraft materials was observed. Accumulation of condensate allowed for the recovery of a wide range of bacteria and fungi as well as some protozoa and dust mites.

Pierson, D. L.↗

Automated Fluidics Device for Extraction and Quantification of miRNA Biomarkers From Blood

Radiation Assessment DuRing Exposure And long-Duration Spaceflight (RADREADS) demonstrates space-compatible point-of-care technology for quantitative biological monitoring of blood miRNA biomarkers in response to long-term low dose radiation exposure. This individualized monitoring approach will inform targeted treatment strategies to maximize medical resource utilization by accounting for individual susceptibility to radiation-related illnesses. As human spaceflight progresses beyond Earth’s magnetic shielding, radiation exposure poses a significant risk to astronaut health and safety. Extended operation in this environment comes with an increased risk of radiation exposure, leading to higher risks of radiation sickness, cancer, central nervous system effects, and degenerative diseases. While conventional physical dosimetry techniques capture radiation dose, individualistic susceptibility to radiation damage is varied. Multiple characteristics, including age, body weight, sex, genetics, and immune status, have been found to influence radiosensitivity (Liu et al. 2011, and Bouffler 2016). This differential response necessitates individualized monitoring and targeted treatment strategies to maximize medical resource utilization; however, a practical diagnostic platform for quantifying long-term, low dose radiation-induced tissue damage does not currently exist. MicroRNAs (miRNAs) are a class of small, non-coding RNAs that regulate gene expression by mediating the degradation of messenger RNA. The levels of particular miRNAs are influenced by biological processes such as inflammation and serve as biomarkers for a variety of conditions including cancer (Singh et al. 2017). MicroRNAs are found in various bodily fluids and are amenable to collection via liquid biopsies, providing a minimally invasive and easily quantifiable readout for a variety of radiosensitive reporters. A preliminary signature of 15 spaceflight sensitive miRNA has been identified in rodent and human studies, including miR-21-5p, miR-24-3p, miR-92a-3p, miR-17-5p, miR-16a-3p, miR-34a-3p, and miR-223-3p. These targets generally increased expression with radiation dose and linear energy transfer, though variation between individuals is not yet described. Current gaps in the field include a lack of understanding of longitudinal biological responses to long-term, low dose radiation exposure and the absence of space-compatible point-of-care technology for quantitative biological monitoring. In this body of work, we aim to develop an automated bleed-to-read system to process whole blood for the detection of miRNA biomarkers in order to monitor individualistic responses to radiation exposure. This will be achieved via separating serum (or plasma) from whole blood, followed by extraction, amplification, and quantification of the miRNA using a RT-qPCR reaction. Previously, the WetLab-2 hardware enabled execution of a RT-qPCR reaction aboard ISS; however, it is a manual system that requires crew manipulation and bulky components (Parra et al. 2017). To address these issues, automated fluid handling hardware was developed for each stage of sample preparation. Extraction of total RNA is achieved by sequentially pumping reagents through an off-the-shelf nucleic acid binding column (miRNeasy Serum/Plasma Advanced Kit, Qiagen). This approach eliminates several manual pipetting and centrifuging steps and limits the use of toxic chemicals commonly found in other sample processing techniques. The resulting elution will then be automatically dispensed for RT-qPCR analysis using a compact rotary qPCR (Mic qPCR Cycler, Bio Molecular Systems) that will improve spaceflight compatibility by removing bubbles from the detection region, another challenge highlighted by WetLab-2 (Parra et al. 2017). Efforts are also being made to simplify the RT-qPCR reaction to a 1-step air-dryable mix to improve long-term reagent stability at room temperature and reduce system complexity. By automating the RT-qPCR processes via microfluidic manipulation, RADREADS will reduce crewmember hands-on time and enable the personalized detection of radiation-induced tissue damage during long duration missions. Minimally invasive, longitudinal monitoring of individual’s response to radiation exposure will inform how the physiological system responds to long-term low dose space radiation and enables development of targeted countermeasures by the medical team. Ultimately, this portable technology will require minimal technical expertise and can also be used to monitor miRNA biomarkers associated with other diseases.

Tristen Head↗