Training activity information
Details
Carry out an organisational risk assessment for a new injectable medicinal product and identify the appropriate location for preparation including any actions needed to mitigate risks
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- National guidance, including aseptic and wider legislation/guidance relating to this area
- Local standard operating procedures (SOPs)
- Local policy
- Practical application of legislation and guidance relating to aseptic products
- Risk assessment
- Risk management
- Capacity planning
- Action planning
- Organisational risk strategy including the wider clinical environment
- Communication with other HCPs
- Limits of practice
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What is the new injectable medicinal product for which you will be conducting a risk assessment?
- How does this activity relate to effective communication and applying organisational policies?
- What are the key outcomes you aim to achieve from this risk assessment, including the identification of a suitable preparation location and risk mitigation actions?
- What are the properties and potential hazards associated with the new injectable medicinal product?
- What national guidance is available on risk assessment of medicines?
- What are the relevant organisational policies and procedures for risk assessment, handling injectable medications, and pharmaceutical preparation environments?
- What are the different potential locations for preparation within the organisation?
- What risk assessment methodologies are commonly used in this context?
- Who are the key stakeholders you need to involve in the risk assessment process?
- What do you hope to learn about the process of conducting organisational risk assessments for new medicinal products?
- How will this activity improve your understanding of risk mitigation strategies in pharmaceutical preparation?
- What insights might you gain into the factors that influence the selection of appropriate preparation locations?
- Will you discuss the requirements and scope of the risk assessment with your training officer and pharmacy quality assurance personnel?
- Will you gather all available information about the new medicinal product, including safety data sheets and handling guidelines?
- Will you review the relevant organisational policies and risk assessment procedures?
- Will you consider the different preparation environments and their suitability for this product?
- Will you plan how you will document the risk assessment process and identified mitigation actions?
- What are your initial thoughts on conducting a risk assessment for a new medicinal product?
- Do you feel confident in your understanding of risk assessment principles and pharmaceutical safety?
In action
- How are you currently approaching the risk assessment for the new injectable medicinal product?
- What methodology or framework are you using?
- How are you considering potential hazards associated with the product and its preparation?
- How are you identifying potential risks and their likelihood and impact?
- What factors are you considering when determining the appropriate location for preparation?
- What mitigation actions are you proposing for the identified risks?
- Are you finding the identification of hazards or the assessment of risk likelihood and impact more straightforward?
- Where are you having to consciously apply your knowledge of pharmaceutical manufacturing, GMP, and risk management principles?
- Is your risk assessment systematically identifying potential hazards and associated risks?
- Are you clearly justifying your recommendations for the preparation location and risk mitigation actions?
- Are you ensuring patient safety is paramount in your assessment?
- Are you encountering difficulties in obtaining necessary information about the new product, assessing the likelihood and impact of specific risks, or identifying appropriate mitigation strategies?
- Are you developing a better understanding of pharmaceutical risk assessment methodologies, the specific risks associated with injectable medicinal products, or the importance of risk mitigation in ensuring patient safety and product quality?
- Are you applying your understanding of GMP, pharmaceutical quality systems, risk management, and aseptic processing?
- If your initial risk assessment is not comprehensive, are there other hazard identification techniques or risk analysis tools you could use?
- Would it be helpful to discuss your risk assessment findings and recommendations with your supervisor or colleagues with expertise in pharmaceutical risk management and aseptic preparation?
- Are you confident in your ability to conduct an organisational risk assessment for a new injectable medicinal product within your current level of training?
On action
- What were the potential risks you identified associated with the new injectable medicinal product?
- What factors did you consider when determining the appropriate location for preparation?
- What specific actions did you propose to mitigate the identified risks?
- What organisational policies or guidelines informed your risk assessment?
- What did you learn about the process of conducting an organisational risk assessment for a new medicinal product?
- How did this activity enhance your understanding of risk management principles in a pharmaceutical setting?
- What considerations are crucial when determining the appropriate location for preparing injectable products?
- How important is it to identify and implement risk mitigation strategies?
- How will this experience inform your approach to future risk assessments?
- What specific skills or knowledge related to risk management and pharmaceutical safety will you focus on developing further?
- How can you contribute to ensuring the safe introduction and preparation of new medicinal products within your department?
Beyond action
- Has the new injectable medicinal product been introduced into practice?
- Were the risk mitigation strategies you identified implemented? What has been the outcome?
- Have you been involved in other risk assessments for new products or processes since completing this training activity?
- Did your previous experience inform your approach?
- Have you discussed the principles of risk assessment with colleagues, particularly those involved in quality assurance or pharmacy manufacturing?
- Has this activity enhanced your understanding of applying organisational policies in the workplace, particularly in relation to safety and risk management?
- Are you more aware of potential risks associated with new medicinal products and the importance of a thorough risk assessment process?
- How has this training activity contributed to your understanding of the principles of managing small teams within a health service in relation to ensuring safe practices?
- What did you learn about the process of hazard identification, risk analysis, and control measure implementation that will be valuable in future roles involving medication safety or quality assurance?
- How will you approach future risk assessments, perhaps being more systematic or considering a wider range of potential hazards based on this experience?
- Has this training activity highlighted the importance of interprofessional collaboration and communication in ensuring medication safety?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Practice effective communication with a range of stakeholders using a variety of methods. |
| # 5 |
Outcome
Apply organisational policies in the workplace. |