Submitted:
13 June 2024
Posted:
13 June 2024
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Abstract
Keywords:
I. Introduction
II. Theoretical Framework
III. Methodology
I. Requirements for the Transportation, Storage and Marketing of Medicines
- The packaging of medicines must guarantee their transport in a safe and timely manner.
- Medications must be properly stored and properly identified in the area where the service is requested.
- Check that during the distribution of the products, the conditions of stability and quality of the medicine are maintained, especially those that require a cold chain.
- Have transportation that guarantees the quality and conservation of the product and its content.
- The transport of special control medications will be carried out in such a way as to guarantee their conservation, safety and preservation, and must also have the label “SENSITIVE CONTENT. TRANSPORT, STORE AND USE WITH CAUTION”
- Medications that require the preservation of their temperature (2-8ºC) must be transported in airtight refrigerators, with refrigerating batteries, or any other mechanism that allows the temperature to be preserved. It must be used exclusively for these medications and treated with caution.
- If possible, avoid the transportation of medications, medical devices and supplies with other types of substances or supplies that may generate contamination or deterioration.
- The box that contains the medications in a glass container or a fragile material They must be labeled “HANDLE WITH CAUTION”, “DELICATE”, “MAXIMUM SHELF”.
- Floors: These must be made of waterproof, resistant material and have a drainage system that allows easy cleaning and sanitation.
- Walls: Walls and walls must be waterproof, solid, easy to clean and resistant to environmental factors.
- Ceilings: Ceilings and ceilings should be more resistant, uniform and easy to clean and sanitize.
- Storage areas: Areas for storing medications and medical devices must be independent, distinguishable and marked, with controlled environmental conditions, temperature and relative humidity to guarantee their correct storage.
- Lighting: It must have a natural and/or artificial lighting system that allows for the proper conservation and identification of medications, as well as good handling of documents.
- Electrical installations: Ceilings in good condition, sockets, switches and protected wiring.
- Ventilation: It must have a natural and/or artificial ventilation system that guarantees adequate conservation of medications. Natural ventilation should not be understood as open windows and/or doors because it could allow contamination of medications with dust and dirt from the outside.
- Temperature and humidity conditions: The places where medications are stored must have mechanisms that guarantee the temperature and relative humidity conditions recommended by the manufacturer and permanent records of these variables; thermometers, hygrometers or other instruments can be used.
- Storage criteria: Medications will be stored according to pharmacological classification (drugs) in alphabetical order or other method as long as order is always guaranteed and confusion, loss and expiration during storage are minimized. This system must guarantee that the batch closest to expiration is the first to be dispensed.
- Affiliate information: The confidentiality, veracity and updating of the information of its affiliates must be guaranteed, to avoid inconsistencies and impossibility in the provision of medications at the place of residence or workplace with the due authorization of the affiliate.
- Scheduling the delivery of medicines: The delivery of medicines must be scheduled with the member at the place of residence or work when they authorize it. In the event that the member does not authorize the delivery of medications, this must be recorded.
- Personnel carrying out the delivery: The delivery of the medications will be carried out by a professional Pharmaceutical Chemist or a Pharmacy Regency Technologist with the skills to provide information to the user about the proper use of the medication and the importance of pharmacotherapy, among others. This information must be delivered verbally and in writing.
- Personnel: Own or contracted personnel who carry out this activity must have training and education in this regard.
- Documentation: There must be written procedures that describe at least the main operations that may affect the quality of medications, maintenance and cleaning of vehicles and facilities, handling conditions, safety and traceability, among others.
- Traceability: The traceability of medicines must always be guaranteed during all activities carried out for the delivery of medicines.
- Transport vehicles. Transportation must preserve the integrity and safety of the medications, protect them from extreme conditions of temperature, humidity, light or possible contaminants and maintain the conservation conditions at all times, complying with the technical specifications established by their manufacturers.
- Self-inspections. Periodic self-inspections must be carried out on all means of transport used for the delivery of medicines, especially in the risk aspects of the process, complying with current regulations related to these means of transport.
II. Requirements to Use an RPAS
- Any natural or legal person, public or private, national or foreign, who plans to carry out UAS operations without profit.
- Any natural or legal person, public or private, national or foreign, that plans to carry out operations with UAS for commercial purposes.
- All military, customs and police entities that, as an integral part of State aviation, require the operation of unmanned aircraft for the development of their missionary activities, unless they are involved in public order (OP) operations.
- The identification number assigned by the UAEAC
- Full name of the person who registered the UA before the UAEAC
- Email
- UAEAC email
- Open Category: This corresponds to non-commercial operations carried out with UA, with a maximum operating weight of 25 kg gross weight, which includes all elements that are on board and connected during takeoff. It is important to remember that registration of the UAS in the UAEAC database is mandatory.
- Specific category: This corresponds to operations with a UA of any weight not exceeding 250 kg gross weight at takeoff, which includes the elements that are on board and connected to the aircraft, carried out by natural or legal persons, national or foreign, for commercial purposes and public entities that do not belong to state aviation. It is important to remember that the registration of the UAS in the UAEAC database is mandatory, any flight carried out in this category can only be carried out by a UAS pilot, in addition to the fact that said flight must have an issued UAS flight authorization. by the UAEAC and that the manned aviation operation will always have priority over any UAS operation.
- Certified Category: This corresponds to RPAS operations whose flight conditions and purposes of use are similar to those of manned aviation. All RPA will require a type certificate, an airworthiness certificate, will operate in accordance with instrument flight rules and its remote pilots will have a remote pilot license, aeronautical medical certificate and specific training in the RPA that they operate.
- Night flight: For open or closed category, the UA must have factory lights that are on and make it visible without exceeding 750 meters measured horizontally from the fixed position of the UA operator and have the support of a UA observer. In the specific category, the UAS pilot must have a night flight addition to his or her certificate of suitability. In addition, this type of flight is not authorized under any circumstances for cargo transportation activities, that is, Drone Delivery.
- Flight in urban area: Operations carried out near or within areas with urban infrastructure, populated and/or urbanized, must, in addition to the requirements demanded by the category in which they carry out their operations, comply with the following: The UA cannot be flown to less than 30 meters measured horizontally from a person outside the operation; You may not fly less than 30 horizontal or vertical meters from any building, without exceeding 400 feet (122 m) above the ground; and only VLOS can be operated.
- Autonomous flight: In each autonomous flight (asynchronously programmed), the responsibility for the UAS operation and compliance with the applicable conditions of this regulation will fall on the UAS operator and the UAS pilot who designed the flight plan and/or programmed the UA, as well as of whoever takes the control commands, activates and/or deactivates the UA. The ability to take control of the UA and monitor the flight paths and status of the aircraft in real time must be maintained at all times. Autonomous flight operations are limited to a distance of 750 meters measured horizontally from the fixed position of the takeoff or launch point of the UA, considering that the landing point may or may not be the same takeoff or launch point. If the operation requires exceeding this distance, the operator must obtain authorization from the UAEAC for an operation in a specific category. The operator must have a UAS flight management technological system that demonstrates the tracking and command of the UA, which allows measuring the maximum communication delays with the UA.
- Serious injury to any person or loss of consciousness.
- Collision of the AU against any element of infrastructure or damage to private or public property on the surface.
- Collision of the AU with another UA.
- Collision of the AU with a manned aircraft, on the ground or in flight.
- Collision of the UA with fauna
- Simple image or data capture.
- Aspersion.
- Dispersion.
- Support in response to public calamity, disaster or emergency, in accordance with the provisions of section 100.335 of this regulation.
- Operations may only be carried out in unrestricted or limited airspace for UAS operations.
- The flight may not exceed 400 feet in height.
- The UA must remain within the VLOS of the person operating the UA, without exceeding, in any case, a distance of 750 meters measured horizontally from the fixed position of the UA operator.
- The operation must be carried out in visual meteorological conditions (VMC) and daylight hours; However, night operations may be carried out as long as the rules established for that condition for each type of operation are met.
- The UA must not be operated within 30 meters, measured horizontally, of any person not directly associated with the operation.
- Any operation whose UA operator flies in first person view (FPV) must have an observer, in order to maintain line of sight with the UA without optical aids, who must maintain constant communication with the UA operator.
- In a prohibited area.
- In a restricted area.
- In a dangerous area.
- In a training area.
- In a no-drone flight zone – ZNVD.
- In a BVLOS operation area.
- For profit or commercial purposes.
- For carrying out transportation activities, including live animals.
- To throw objects (solid or liquid) from the air.
- To carry out training flights.
- To perform swarm type operations.
- Within a radius of 2 kilometers (1.1 nautical miles) around any place where the President of the Republic is located.
- Less than 2 kilometers (1.1 nautical miles) horizontal distance measured from the perimeter of military or police bases, penitentiary centers and critical infrastructure of the country.
- At an airport and/or within a radius of 9 kilometers (4.8 nautical miles) measured from the aerodrome reference point (ARP), however, between 6 and 9 km measured from the ARP, the open category operation, but the flight height shall not exceed 200 feet (61 m) above the lowest threshold elevation; At a heliport (or helipoint or helideck) and/or within a radius of 3 kilometers (1.6 nautical miles) measured from the heliport reference point (ARH).
- Simple image or data capture.
- Capture of images or data for surveillance and private security purposes.
- Capturing images or data for mass media.
- Aspersion.
- Dispersion.
- Swarm.
- Cargo transportation (“Drone Delivery”)
- Missionary activities of public entities.
- Instruction.
- Have a UAS operator certificate issued by the UAEAC, whose operation specifications will include the UAS pilots and the UAS equipment with which they are authorized to develop UAS operations.
- Have registered with the UAEAC the technological equipment that is not an integral part of the factory of each of its UA and that is associated with the operation to be developed.
- Have the civil liability policy(s) required by this regulation, in the terms of the second paragraph of article 1901, in accordance with articles 1827, 1835 paragraph 1 and 1842 of the Commercial Code, and other applicable legislation.
- Plan and execute operations in compliance with the stipulations of the UAS operator's MO and the manufacturer's manual(s).
- The UAS operator will designate, through the Chief of UAS Pilots, the personnel required for each operation, assigning the UAS pilot in command, who will be responsible for the entire operation on behalf of the UAS operator.
- Carry out the respective operational safety risk analysis, according to the type of operation and specific flight conditions, including the identification and prioritization of hazards, risk analysis and evaluation along with risk mitigation strategies.
- Obtain the UAS flight authorization issued by the UAEAC for the operation according to the procedure established in this regulation.
- When required, the UAS pilot must have portable air band VHF radio transmitter and receiver equipment in order to establish aeronautical communications with the corresponding ATS units, for which: The ATS unit may indicate an alternative means or the most pertinent communication with a UAS pilot, if necessary; The UAS pilot must comply with the instructions given by the corresponding ATS unit.
- Comply with all operating conditions of the open category and those corresponding to operations in the specific category, according to the type of operation and the expected flight conditions.
- Any certified UAS operator that requires deviation from the provisions for the specific category must send a special request for authorization to the UAEAC indicating the related deviations, the reasons and the technical and operational conditions with which it will manage and mitigate any operational risk that is clear. and previously identified.
- Maintain its structural elements and control systems in accordance with the manufacturer's instructions to ensure optimal operation.
- Any modification or alteration in the configuration or technical characteristics that affects in any way the flight and/or operation capabilities or characteristics of the UA must be expressly approved by its manufacturer.
- The remote command and control system must not generate any interference with other aeronautical systems.
- The following systems must be present in the UA and function correctly: A C2 system that complies with what is described in section 100.420 of this regulation; An autopilot system; A satellite navigation system; A launch and/or recovery system (if required), for normal, abnormal and emergency conditions; All factory systems fully functional (including lights, sensors and other original parts).
- All devices installed for the execution of a certain type of operation such as optical sensors, loading and unloading systems, spraying or dispersion systems, among others, must function correctly, in accordance with the manufacturer's specifications.
- For night flight, the UA must have lights (for example, navigation) that make it clearly visible.
- Submit to the UAEAC a detailed description of the C2 link configuration and the procedures in case of loss or deterioration of communication.
- If using a communications service provider, have a map that supports the coverage of the link service in the area where the operation is planned and during the time it will take.
- Identify the limitations of the C2 link, according to the type of specific operation requested (for example: antenna blocking, range limit, antenna power and radiation pattern, infrastructure that blocks the signal, among others).
- Be constituted as a legal entity.
- Have a UAS operator certificate issued by the UAEAC that authorizes you to carry out this type of aerial operation.
- The weight of the load to be transported may not exceed 50 kg and, in any case, the PBMO will not exceed 250 kg; If the cargo weighs more than 50 kg (without exceeding 250 kg of PBMO), the UAS operator must request special flight authorization from the UAEAC, informing about the nature and quantity of the cargo, as well as the route through which will be transported, in order to carry out a special study of said request. In these cases, dangerous goods cannot be transported.
- If the operation is carried out for commercial purposes (profit motive), the UAS operator must have an operating permit for public cargo transportation. If the transport will be carried out as external cargo, the operation permit will refer to special aerial work in that modality, all in accordance with the RAC 5 standard of the Aeronautical Regulations of Colombia.
- The UAS arranged for the operation must be duly registered with the UAEAC.
- The UA(s) will be subject to validation by the UAEAC regarding their technical aptitude for this type of operation, which may be supported by a certification issued by the manufacturer that reports on tests. in cargo transportation (“Drone Delivery”) of at least 250 hours or by the civil aviation authority of an ICAO Member State, for the specific UA model intended to be used.
- UAS pilots and the Chief UAS Pilot must have training from the manufacturer regarding the operation and handling of the UAS.
- The UAS pilots and the Chief UAS Pilot must have the specific additions to their certificate of suitability required to carry out the cargo transportation operation (“Drone Delivery”), as the development of said operation is planned, as well as additions weight up to 250 kg, BVLOS, as required.
- To transport dangerous goods in an unmanned aircraft, the UAS operator must have a specific authorization in accordance with the provisions of standard RAC 175 of the Aeronautical Regulations of Colombia.
- All UAS operator personnel handling dangerous goods on the ground must have specific certified training of at least 40 hours in the safe transport of dangerous goods by air, as indicated in section 175.316 of the RAC 175 standard, in compliance with the standards of ICAO Annex 18 and the technical instructions on the safe transport of dangerous goods by air determined in ICAO Document 9284.
- All personnel involved in the cargo transportation operation (“Drone Delivery”), including the Chief UAS Pilot, must have specific certified training of at least 20 hours regarding the safe transportation of dangerous goods by air.
- The UAS operator must guarantee the stability and reliability of the C2 links during all flight phases, including emergency maneuvers.
- The UAS pilot in command of the operation must constantly monitor weather conditions throughout the cargo transportation operation (“Drone Delivery”), ensuring that VMC conditions are maintained.
- The operation of multiple aircraft on the same scheduled route (without being considered a swarm) will be evaluated by the UAEAC and will be subject to the respective UAS flight authorization.
- UAS operators who carry out operations other than cargo transportation (“Drone Delivery”) must designate a Chief UAS Pilot exclusively for this activity, with a different one for other operations.
- The analysis and management of operational safety risks for the specific cargo transportation operation (“Drone Delivery”).
- Description of the droneports, detailing the physical characteristics of the infrastructure that you plan to build and/or use, in accordance with this type of operation.
- Emergency response plan in the cargo transportation operation (“Drone Delivery”), which must describe the activities to be carried out by the personnel involved in the operation in the event of an accident or incident.
- Generate a numbered cargo declaration, guide or manifest, detailing the type of merchandise transported in each UAS operation.
- Comply with all current and applicable regulations on the transportation of cargo or goods by air.
- Have civil liability insurance for loss or damage to the transported goods or assets, in addition to those corresponding to liability for damage to third parties on the surface (RCE) or collision (collision with other aircraft).
- Live animals may not be transported.
- Flight planning, including the use of specialized software for this type of aerial operation.
- Pre-flight and preparation of aeronautical, electronic, infrastructure equipment and any element that will be used during the operation.
- Normal operation for all phases of the flight (takeoff, climb, cruise, descent, approach and landing or recovery) and any other operational condition that, given the nature of this air operation, requires to be described.
-
Load and unload merchandise, indicating parameters, tools and practices associated with both the equipment and loading, unloading and delivery capacities, as appropriate, considering the following:
- a)
- The UAS operator must demonstrate to the UAEAC that the merchandise delivery system, both in loading and unloading, is safe and does not represent a risk to operational safety.
- b)
- The MO must describe in detail the cargo and/or merchandise security systems that guarantee their stability and restraint in all phases of the flight.
- c)
- If the UA does not have the capacity to perform a hover flight, the MO must consider the procedures and maneuvers necessary to perform holding circuits.
- Abnormal and emergency operation for all phases of the flight, establishing the different operational considerations for each case, including geographical areas arranged for forced landings.
- The SMS of a UAS operator must: Be established in accordance with the components and elements of the structure listed in RAC 219; and Adjust to the size of the UAS operator and the complexity of its aviation products or services, proportional to the size of the organization, the nature and complexity of the operation and the dangers and risks associated and inherent to the activities carried out by the operator.
- Every UAS operator must: Develop a plan that facilitates the implementation of the SMS; Collect, analyze and protect, as well as share and exchange data and information on operational safety to the UAEAC; and apply the principles for the protection of data and information on operational security.
- Hazard identification. The UAS operator will define and maintain a process to identify the hazards associated with its operations, taking into account, at a minimum and not limited to: Hazards to operational personnel; Dangers to personnel outside the operation; Hazards on land (natural and artificial obstacles); Dangers in the air (due to failures in operation); Strategic dangers (due to interaction in manned aircraft airspace); Dangers due to changes in current applicable regulations; Dangers of change management.
- The evaluation and mitigation of operational security risks. The UAS operator will use the TRE (Technology, Regulation and Training) methodology as the main basis for the implemented defenses and evaluating decision making in accordance with the established risk index and the tolerability matrix.
III. Background
- Additional Documentation: Includes specific courses and certifications, in addition to demonstrating flight hours and registering both the drone and the operator.
- Insurance Policy: Must include a third-party damage policy to cover possible incidents during flight operations.
IV. Results
1. Proposal for the Transportation of Medicines through Open Category RPAS
- Medication Wrapping: Medications must be properly packaged to ensure their integrity and safety during transport. This includes the use of containers that maintain the stability of the medication and, if necessary, preserve the cold chain through the use of Styrofoam refrigerators with frozen gel. With the ability to reach hard-to-access areas, drones are poised to fill critical gaps in the healthcare logistics chain [26].
- Stability and Quality Conditions: It is crucial that the appropriate temperature and humidity conditions recommended by the manufacturer are maintained during distribution. For medications that require controlled temperature, mechanisms must be used to ensure these conditions until the point of delivery.
- Documentation and Traceability: The traceability of medicines must be guaranteed throughout the delivery process. This involves keeping detailed records of transportation and storage conditions, as well as having written procedures that describe operations that may affect the quality of medicines.
- Regulatory Compliance: RPAS must operate within the regulations established for the open category, which include weight and height restrictions (maximum 400 feet) and the obligation to maintain the operator's VLOS line of sight. Drones offer a greener alternative for medical deliveries, reducing the carbon footprint compared to traditional transportation methods [27].
- Operator Certification: Operators must be properly trained and certified to handle RPAS in this category, following established safety and operating procedures.
- Flight Planning: Detailed planning of the flight route must be carried out, ensuring that restricted areas are avoided and that the path is safe for the operation of the UA.
2. Proposal for the Transportation of Medicines through Special Category RPAS
- Packaging and Safety: In addition to standard packaging requirements, medications must be transported in reinforced containers and labeled as "sensitive contents" to ensure their protection and prevent damage during flight. A detailed analysis of how a leading healthcare provider integrated drones into their supply chain, resulting in faster delivery times and reduced costs [29].
- Temperature and Humidity Control: For medications that require temperature-controlled storage, containers with integrated refrigeration systems should be used to ensure temperature stability during transport.
- Training and Procedures: The personnel in charge of handling and transporting these drones must receive specific training on the safe handling of medications and maintaining the conditions necessary for their conservation.
- Self-inspections and Safety: Periodic inspections must be carried out on the drones and containers used to ensure that they comply with current safety and conservation regulations.
- Flight Authorization: It is mandatory to obtain a flight authorization from the UAEAC and follow a detailed risk analysis that includes the identification and mitigation of hazards. Drones offer a new level of efficiency and reliability in medical supply distribution, particularly in disaster response scenarios [30].
- Airworthiness Requirements: Drones must meet strict technical conditions, including control systems, satellite navigation and autopilot. They must also have cargo security systems.
- Special conditions: The operator must demonstrate that the delivery system is safe and does not represent operational risks. Additionally, there must be detailed procedures for all phases of the flight and for emergency situations.
3. Proposal for the Transportation of Medications in the Military Field
- Militarized Packaging: Medications must be packed in reinforced containers that are resistant to impacts and adverse conditions, such as sudden changes in temperature and humidity. These containers must be clearly labeled for correct identification and handling.
- Refrigeration Systems: To maintain the cold chain for medications that require it, containers must be equipped with advanced refrigeration systems that ensure thermal stability throughout the journey, even in extreme conditions.
- Protection and security: Additional security measures should be implemented to protect medications during transport, including real-time tracking systems and contingency procedures in case of emergencies.
- Rigorous Documentation: Traceability and documentation must be exhaustive, including detailed records of transport and storage conditions, as well as verification of package integrity upon arrival.
- Advanced Technical Capabilities: UAs equipped with autonomous flight technology, advanced navigation systems and secure communication capabilities to operate in hostile environments.
- Security and Resilience: Redundant systems to ensure mission continuity in the event of technical failures. Detailed procedures for managing emergencies and abnormal operations.
- Compliance with Military Regulations: UAs must comply with specific military safety and operational regulations, including the need to obtain type and airworthiness certificates.
V. Conclusion
Abbreviations
| AAAE | State Aviation Aeronautical Authority. |
| AAC | Civil Aeronautics Authority. In this regulation, it refers to the aeronautical authority of any other ICAO Member State. |
| AGL | Height above ground level. |
| ARP | Aerodrome reference point. |
| ATC | Air traffic control service. |
| ATS | Air traffic services. |
| BVLOS | Visibility beyond line of sight. |
| CDM | Collaborative decision making. |
| CEAC | Civil Aeronautics Training Center (according to RAC 142). |
| CIA | Aeronautical training center (according to RAC 2). |
| CIAC | Civil Aeronautics Training Center (according to RAC 141 and 147). |
| DCI | International Common Denomination. |
| DONA | Directorate of Air Navigation Operations. |
| EVLOS | Extended line-of-sight visibility. |
| FPV | First Person Vision. |
| MCM | Maintenance control manual. |
| MO | Operations Manual. |
| WHO | World Health Organization |
| OVA | Virtual learning object. |
| PMBO | Maximum Gross Operating Weight. |
| PMU | Unified Command Post. |
| PRM | Medication Related Problems |
| PRUM | Problems Related to the Use of Medications |
| RACAE | Colombian Aeronautical Regulation of State Aviation. |
| RCE | Extracontractual Civil Liability. |
| RPA | Remotely Piloted Aircraft. |
| RPAS | Remotely Piloted Aircraft System. |
| SAA | Secretariat of Aeronautical Authority. |
| SARPS | Standards and Recommended Practices published by ICAO. |
| SMS | Operational safety management system. |
| SSNA | Secretariat of Air Navigation Services. |
| UA | Unmanned aircraft. |
| UAEAC | Unidad Administrativa Especial de Aeronáutica Civil. |
| UAS | Unmanned aircraft system. |
| VLOS | Visibility in line of sight. |
| VMC | Visual Meteorological Conditions. |
| VTOL | Vertical takeoff and landing. ZNVD No drone flight zone. |
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