Reported concern regarding the framework to monitor and manage medical issues in flight crew
Reporter would like to know what procedures [Operator] and/or Civil Aviation Safety Authority (CASA) has in place to manage the collection of information regarding concerns of possible side-effects, and side-effects following approved treatment/medication that have the potential to affect flight safety.
Specifically,
- who is responsible for managing this information?
- what analysis is conducted to identify any trends?
- if trends are identified, what is done with this information?
- who is responsible for sharing the information to the broader aviation and medical industries?
The operator advised that due to privacy concerns, all medical issues are handled by the certificate holders Designated Aviation Medical Examiner (DAME) and the CASA Aviation Medicine (AvMed) section in confidence. Recommendations from CASA and AvMed regarding the use of medication/treatment are followed. No formal response was received.
CASA AvMed provides general guidance on medication. SARS-CoV-2 vaccines and treatment available in Australia have been approved for use by the Therapeutic Goods Administration (TGA) and are therefore treated by CASA as any other immunisation or medication.
Part 67 of the Civil Aviation Safety Regulations 1988 outlines the responsibilities of the medical certificate holder. This includes:
• self-assessing their current symptoms and not exercising the privileges of their license if they do not feel well enough to do so;
• declaring any ongoing incapacity as required for their certificate; and
• consulting with their DAME regarding their fitness and/or return to fitness as required for their certificate.
From the CASA guidance information on COVID-19
• Asymptomatic and mild initial-COVID cases are to be managed in consultation with a DAME
• Long-Covid or severe cases are to be managed with a DAME and referred to AvMed
Regarding aviation specific hazards following vaccination, CASA did not provide any technical input to the TGA as there is no published information or research that they are aware of on the effect of altitude or sedentary position on vaccine issues. ‘According to John Hopkins university data in excess of 10 billion COVID vaccines have been administered globally and to the best of our knowledge there are no reports of vaccine reactions in the air - CASA acknowledge there are quite possibly a few but the incidence would be well below our risk acceptance level. ICAO and our 5 eyes colleagues globally follow similar practice of 24-48 hours grounding to be extra safe. The approach taken is - are there any immediate vaccination side effects e.g. fainting or anaphylactic reactions and our response is Yes - safety is ensured by 24 hour stand down.’
‘Any notification of mild to severe cases or reactions are reviewed by AvMed. These notifications have been few in number and therefore no formal analysis has been required or conducted. This information has not been provided to the TGA for awareness based on the TGA being able to obtain this information from the health department from the Covid vaccine questionnaire follow-ups.’
Medication suitability and considerations
The following response from AvMed includes the restrictions or conditions to be observed when using certain categories of medication. In respect of vaccinations the same risk assessment process applies.
Guide for Aviation Medical Examiners - Important Notes
A. General Principles
These principles apply all drugs whether herbal, homeopathic, obtained over-the-counter or on prescription. All the above may impact performance.
1. ALL drugs are to be considered hazardous, with a few limited exceptions as detailed in this document.
2. For all treatments, the safety-relevance of the CONDITION as well as the MEDICATION must be considered.
3. A change in medication (i.e. starting, finishing or altering the dose) is considered a ‘change in medical condition’ and must be reported to CASA within 5 working days if lasting for more than:
Class 1 - 7 days
Class 2 & 3 - 30 days
4. Pre-flight I'M SAFE [1] checklist: do not commence a flight if these conditions cannot be satisfied.
B. Adverse Effects to Consider
Unwanted, dose-related drug effects (e.g. blurred vision or drowsiness)
1. Hypersensitivity/allergic reactions
2. Idiosyncratic effects
3. Drug side effects that may occur in some of the population (eg, nausea, liver damage or bone marrow suppression)
4. Drug combination effects – potentiation
5. Drug interactions; particularly with alcohol, to increase risk of side effects or reduce activity of the drug/s.
C. Categories of Drugs
Category A May be used as per advice on CASA website
Category B Medications requiring ground trial AND DAME approval of use
Category C Medications requiring ground trial AND CASA approval of use
Category D Medications NOT acceptable for use
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ATSB Comment: The ATSB raised the following concern on behalf of several reporters. Initially focussed on the collection and analysis of data related to COVID-19 vaccines, the scope of the REPCON was broadened to include all approved medication and vaccines.
The ATSB is satisfied that a framework is in place to identify the suitability of medication/vaccines for use in the operational environment and the available guidance clearly defines the guiding principles and considerations when determining the suitability of medications for use by medical certificate holders.
The responsibility for reporting and monitoring adverse reactions is a joint responsibility between the medical certificate holder and the DAME with AvMed required to be notified of any cases where the illness/reaction affects the individuals ability to hold a medical certificate. CASA advises that reports of serious adverse reactions are reviewed by AvMed and in respect to COVID-19 vaccinations, have been ‘few and far between’. For this reason, the data has not been passed on to the TGA for further analysis. Additionally, the TGA have access to data from the broader community through the health department. The ATSB did not approach the TGA for comment.