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Authors = Paul G. Royall ORCID = 0000-0002-7101-2776

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22 pages, 12632 KiB  
Article
Stability of Medicines Transported by Cargo Drones: Investigating the Effects of Vibration from Multi-Stage Flight
by Katherine Theobald, Wanqing Zhu, Timothy Waters, Thomas Cherrett, Andy Oakey and Paul G. Royall
Drones 2023, 7(11), 658; https://doi.org/10.3390/drones7110658 - 3 Nov 2023
Cited by 6 | Viewed by 3420
Abstract
The timely distribution of medicines to patients is an essential part of the patient care plan, and maximising efficiency in the logistics systems behind these movements is vital to minimise cost. Before drones can be used for moving medical cargo, medical regulatory authorities [...] Read more.
The timely distribution of medicines to patients is an essential part of the patient care plan, and maximising efficiency in the logistics systems behind these movements is vital to minimise cost. Before drones can be used for moving medical cargo, medical regulatory authorities require assurance that the transported products will not be adversely affected by in-flight conditions unique to each drone. This study set out to (i) quantify the vibration profile by phases of flight, (ii) determine to what extent there were significant differences in the observed vibration between the phases, and (iii) assess the quality of flown monoclonal antibody (mAb) infusions used in the treatment of cancer. Vibrations emanating from the drone and transmitted through standard medical packaging were monitored with the storage specifications for mean kinematic temperature (2–8 °C) being met. Vibration levels were recorded between 1.5 and 3 g, with the dominant octave band being 250 Hz. After 60 flights, the quality attributes of flown infusions regarding size integrity were found to be no different from those of the control infusions. For example, the particle size had a variation of less than 1 nm; one peak for Trastuzumab was 14.6 ± 0.07 nm, and Rituximab was 13.3 ± 0.90 nm. The aggregation (%) and fragmentation (%) remained at 0.18 ± 0.01% and 0.11 ± 0.02% for Trastuzumab, 0.11 ± 0.01% and 2.82 ± 0.15% for Rituximab. The results indicated that in the case of mAbs, the quality assurance specifications were met and that drone vibration did not adversely affect the quality of drone-flown medicines. Full article
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28 pages, 2703 KiB  
Review
Enabling Safe and Sustainable Medical Deliveries by Connected Autonomous Freight Vehicles Operating within Dangerous Goods Regulations
by Andy Oakey, Matt Grote, Paul G. Royall and Tom Cherrett
Sustainability 2022, 14(2), 930; https://doi.org/10.3390/su14020930 - 14 Jan 2022
Cited by 8 | Viewed by 4028
Abstract
Health service providers in developed nations are responsible for 5% of their national carbon emissions, much of which originate from transport and supply chains. Connected autonomous freight vehicles (CAV-Fs) offer the potential to reduce this impact and enable lower cost operations, with trials [...] Read more.
Health service providers in developed nations are responsible for 5% of their national carbon emissions, much of which originate from transport and supply chains. Connected autonomous freight vehicles (CAV-Fs) offer the potential to reduce this impact and enable lower cost operations, with trials being explored across the world. Transportation and carriage regulations, particularly in relation to the movement of dangerous goods (DG) such as medicines and diagnostic specimens, have not been developed for and applied to this new transport mode, particularly where loads are unaccompanied. Through an audit of current legislation and practice, this paper evaluates current DGs regulations applied to the transportation of medical products and medicines by autonomous road vehicles. Where existing regulations are not appropriate for CAV-Fs, recommendations and adaptations have been proposed to support safe and practical application. Remote monitoring and tracking of vehicles are critical for ensuring load security, quick and effective incident response, and management of documents and communications between parties. Loading/unloading procedures are significantly more important than in crewed vehicles, with load segregation and recording of all activity being of key importance. Other recommendations relate to training provision, vehicle specifications, and product health monitoring. Full article
(This article belongs to the Special Issue Next Steps for Governance of Sustainable Mobility Innovations)
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24 pages, 900 KiB  
Review
How Do Dangerous Goods Regulations Apply to Uncrewed Aerial Vehicles Transporting Medical Cargos?
by Matt Grote, Tom Cherrett, Andrew Oakey, Paul G. Royall, Simon Whalley and Janet Dickinson
Drones 2021, 5(2), 38; https://doi.org/10.3390/drones5020038 - 13 May 2021
Cited by 29 | Viewed by 11097
Abstract
Commercial operations of uncrewed aerial vehicles (UAVs or drones) are expanding, with medical logistics using UAVs as part of health service supply chains being targeted. The ability to transport cargos that include items classified as Dangerous Goods (DG) is a significant factor in [...] Read more.
Commercial operations of uncrewed aerial vehicles (UAVs or drones) are expanding, with medical logistics using UAVs as part of health service supply chains being targeted. The ability to transport cargos that include items classified as Dangerous Goods (DG) is a significant factor in enabling UAV logistics to assist medical supply chains, but DG regulations for air transport have developed from the perspective of crewed aircraft and not UAVs. This paper provides an important audit of the current DG regulations, best practice in their application and the development of much-needed new governance that will be required to fully exploit UAVs for the safe transport of DG in medical logistics. Findings from the audit provide a summary of the circumstances and potential challenges resulting from the application of DG regulations as they stand to UAV operations, particularly for medical logistics, and convenient guidance on the practical implications of DG regulations for UAV operators. The main conclusion is that this is an under-researched domain, not yet given full consideration in a holistic way by regulators, governments, industry bodies, practitioners or academia. Full article
(This article belongs to the Special Issue Drones for Medicine Delivery and Healthcare Logistics)
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26 pages, 28168 KiB  
Article
Quantifying the Effects of Vibration on Medicines in Transit Caused by Fixed-Wing and Multi-Copter Drones
by Andrew Oakey, Tim Waters, Wanqing Zhu, Paul G. Royall, Tom Cherrett, Patrick Courtney, Dennis Majoe and Nickolay Jelev
Drones 2021, 5(1), 22; https://doi.org/10.3390/drones5010022 - 13 Mar 2021
Cited by 34 | Viewed by 10465
Abstract
The concept of transporting medical products by drone is gaining a lot of interest amongst the medical and logistics communities. Such innovation has generated several questions, a key one being the potential effects of flight on the stability of medical products. The aims [...] Read more.
The concept of transporting medical products by drone is gaining a lot of interest amongst the medical and logistics communities. Such innovation has generated several questions, a key one being the potential effects of flight on the stability of medical products. The aims of this study were to quantify the vibration present within drone flight, study its effect on the quality of the medical insulin through live flight trials, and compare the effects of vibration from drone flight with traditional road transport. Three trials took place in which insulin ampoules and mock blood stocks were transported to site and flown using industry standard packaging by a fixed-wing or a multi-copter drone. Triaxial vibration measurements were acquired, both in-flight and during road transit, from which overall levels and frequency spectra were derived. British Pharmacopeia quality tests were undertaken in which the UV spectra of the flown insulin samples were compared to controls of known turbidity. In-flight vibration levels in both the drone types exceeded road induced levels by up to a factor of three, and predominant vibration occurred at significantly higher frequencies. Flown samples gave clear insulin solutions that met the British Pharmacopoeia specification, and no aggregation of insulin was detected. Full article
(This article belongs to the Special Issue Drones for Medicine Delivery and Healthcare Logistics)
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21 pages, 5397 KiB  
Article
An Evaluation of the Drone Delivery of Adrenaline Auto-Injectors for Anaphylaxis: Pharmacists’ Perceptions, Acceptance, and Concerns
by September Beck, Tam T. Bui, Andrew Davies, Patrick Courtney, Alex Brown, Jef Geudens and Paul G. Royall
Drones 2020, 4(4), 66; https://doi.org/10.3390/drones4040066 - 9 Oct 2020
Cited by 26 | Viewed by 8883
Abstract
Anaphylaxis is a life-threatening condition where delays in medical treatment can be fatal. Such situations would benefit from the drone delivery of an adrenaline auto-injector such as EpiPen®. This study evaluates the potential risk, reward, and impact of drone transportation on [...] Read more.
Anaphylaxis is a life-threatening condition where delays in medical treatment can be fatal. Such situations would benefit from the drone delivery of an adrenaline auto-injector such as EpiPen®. This study evaluates the potential risk, reward, and impact of drone transportation on the stability of adrenaline during episodes of anaphylaxis. Further, this study examines pharmacists’ perceptions on drone delivery—pharmacists approved the use of drones to deliver EpiPen® during emergencies but had concerns with drone safety and supply chain security. Laboratory simulated onboard drone conditions reflected typical missions. In these experiments, in vitro model and pharmaceutical equivalent formulations were subjected independently to 30 min vibrations at 5, 8.43, and 13.33 Hz, and temperature storage at 4, 25, 40, and 65 °C for 0, 0.5, 3, and 24 h. The chiral composition (an indicator of chemical purity that relates to molecular structure) and concentration of these adrenaline formulations were determined using ultraviolet (UV) and circular dichroism spectroscopy (CD). Adrenaline intrinsic stability was also explored by edge-of-failure experimentation to signpost the uppermost limits for safe transportation. During drone flight with EpiPen®, the temperature and vibration g-force were 10.7 °C and 1.8 g, respectively. No adverse impact on adrenaline was observed during drone flight and laboratory-simulated conditions shown by conformation to the British Pharmacopeia standards (p > 0.05 for CD and UV). This study showed that drone delivery of EpiPen® is feasible. There are more than 15,000 community pharmacies and ≈9000 GP surgeries spanning the UK, which are likely to provide achievable ranges and distances for the direct drone delivery of EpiPen®. The authors recommend that when designing future missions, in addition to medicine stability testing that models the stresses imposed by drone flight, one must conduct a perceptions survey on the relevant group of medical professionals, because their insights, acceptance, and concerns are extremely valuable for the design and evaluation of the mission. Full article
(This article belongs to the Special Issue Drones for Medicine Delivery and Healthcare Logistics)
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20 pages, 4201 KiB  
Article
An Evaluation of the Delivery of Medicines Using Drones
by Michelle Sing Yee Hii, Patrick Courtney and Paul G. Royall
Drones 2019, 3(3), 52; https://doi.org/10.3390/drones3030052 - 27 Jun 2019
Cited by 79 | Viewed by 18720
Abstract
This study tests the impact of drone transportation on the quality of a medicine. Modelling the critical process parameters of drone flight, the effects of temperature and vibration on insulin were investigated using the pharmacopoeia methods. The medicine, Actrapid, (3.5 mg/mL of insulin), [...] Read more.
This study tests the impact of drone transportation on the quality of a medicine. Modelling the critical process parameters of drone flight, the effects of temperature and vibration on insulin were investigated using the pharmacopoeia methods. The medicine, Actrapid, (3.5 mg/mL of insulin), was flown by a quad-rotor drone. Insulin stored between −20 and 40 °C for 30 mins, and subjected to vibration (0–40 Hz, 25 °C, 30 mins) passed the pharmacopeia tests. Dynamic light scattering identified the active tetrameric and hexameric forms of insulin post testing. Vibration frequencies during drone flight were between 0.1 and 3.4 Hz. There was no evidence of visible insulin aggregates following the drone transportation. The differences in UV absorbance readings between flown Actrapid and controls were insignificant (p = 0.89). No adverse impact of drone transport on insulin was observed. This study provides supporting evidence that drone transportation of medicinal products containing insulin is feasible. The authors recommend that when considering the drone delivery of medicines five tests need to be applied. These tests must determine the safe flight time and range, the quality of the medicine post flight, the onboard conditions experienced by the medicine, the security of the drone supply chain and the effect of drone failure on both the medicine and the environment. Full article
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