This blog features:
- Definitions and why RMP matter for businesses.
- Risk Management in Pharmacovigilance
- Risks associated within Pharmacovigilance.
- Findings and effective measures
Table of Contents
Definition
RMP: Risk Management Plan
A plan for managing risks, also known as a Risk Mitigation Plan, is a crucial document for any process or business. It helps to identify potential risks, missing information, assesses their impacts, and outlines strategies for responding to these risks.
“Mitigation: the act of reducing how harmful, unpleasant, or bad something is”.
Although it is impossible to cut risks entirely from any project or innovation, it is possible to minimize them through effective risk management techniques.
WHO’s Definition of RMP
Pharmacovigilance is defined by the World Health Organization (WHO) as the science and activities involved in detecting, evaluating, understanding, and preventing adverse reactions or any other medicine-related problems.
Risk Appetite:
The aggregate amount (level and types) of risk WHO wants to assume in pursuit of its strategic objectives (and mission).
Risk:
It can be defined as a potential uncertain event which could affect the achievement of the WHO’s objectives and expected results.
Risk Management:
It is the process of identifying, prioritizing and responding to risks across an organization. It includes activities to realize
opportunities while mitigating threats.
The Significance of Risk Management for All Businesses
Risk management involves a team of professionals who are responsible for evaluating potential risks and taking appropriate actions to mitigate them.
These individuals possess adequate knowledge about the processes within the organization and can identify the internal and external factors that may pose risks.
It is the primary responsibility of the risk management team to prevent adverse consequences by devising a comprehensive road-map for risk avoidance.
“Risk management is not about eliminating uncertainties; it’s about navigating them strategically. In the face of challenges, it empowers us to make informed decisions, transforming risks into opportunities and ensuring a resilient path forward.”
Risk involves in pharmacovigilance
Scope
Its scope has evolved to incorporate a systems-based approach to monitor and improve the safe use of medicines by minimize the important risks of
a medicinal product.
Simply put, pharmacovigilance involves monitoring the safety of medicines and taking necessary actions to reduce risks and increase benefits.
In risk management plans, dealing with process-related activities is quite straightforward. Think of it like watching what goes in (opening) and ensuring it comes out at the exit. Simply put, what goes in should come out.
Drafting the RMP
To develop an RMP, the document must align with the GVP module and include the following components.
Essential Inclusion of RMP Development
- The identification or characterisation of the safety profile of the medicinal product
- The planning of pharmacovigilance activities
- The planning and implementation of risk minimisation measures
The key components mentioned above are organized into checklists as outlined below:
Checklist for writing or assessing an RMP
- Safety specification
- Pharmacovigilance plan
- Plans for post-authorisation efficacy studies
- Risk minimisation measures
- Summary of the risk management plan
Each of the mentioned categories should have an assigned individual in a designated role.
Risk Mitigation Strategy by WHO
Table: 1
| Level of Risks | Definition | Risk Acceptability |
|---|---|---|
| Averse | Tendency to avoid immediately | ⋄ A high level of risk cannot be accepted ⋄ Immediate action required to bring down to low as reasonably possible (ALARP) |
| Minimal | Mitigation must be developed as soon as possible | ⋄ ALARP action must be taken ⋄ Resources should be allocated accordingly |
| Cautious | A moderate level of risk can be accepted in pursuit of impact | The related risk should be monitored regularly to ensure that any change in circumstances is detected and that opportunities for mitigation are identified and implemented |
| Open | A significant level of risk can be accepted | The exposure to internal factors may remain unmitigated temporarily, if necessary, to seize opportunities. |
✍️ Note: These are baselines which generally apply when dealing with individual risks. When faced with dilemmas in managing risks affecting different success factors, please refer to “Operationalizing Risk appetite” in the risk appetite statement.
Common place of risks within pharmacovigilance process
Common areas include:
- Timely submissions
- Backlog management
- Upholding quality standards
- Ensuring confidentiality
- Preventing data loss
Key takeaways
- Create transparent and well-drafted documents for clear assessments in managing various situations.
- Provide comprehensive training for everyone on effective actions during critical situations.
- Identify the ofte occurring areas of common risks.
- Risk is omnipresent. No rusk without risk. Risks are inevitable.
- The nature of risks varies depending on your business type.
Wrap up
In the important world of pharmacovigilance, where we handle crucial data, risks are a big deal. We’ve shared our take on understanding these risks, but we know we might have missed something in keeping an eye on them.
These activities should be robust enough to minimize the chances of harm and ensure that the benefits of the product outweigh the risks.
If you’ve got insights or things we missed, let us know in the comments. We hope you found clarity and learned something valuable from our blog!
References:
- Science direct
- EMEA risk management proposal
- Elsevier
- Reference journal of clinical studies
- WHO Publications
- ncbi
- EMA scientific guideline
FAQ:
Define risk
What are the potential risks that every businesses may encounter?
2. Operational Risks
3. Strategic Risks
4. Reputational Risks
5. Compliance Risks
6. Human Capital Risks
7. Environmental Risks
What is Risk Management Plan?
Risk Management in Pharmacovigilance
Process to follow to protect risk in pharmacovigilance
2. Address such risks may result in submission delays
3. Preventive measures fo active surveillance, clinical or epidemiological trials, specialized training, or restricted access
4. Minimize the chances of harm and ensure that the benefits
5. Plan must also include a communication strategy to ensure that risk reduction procedures
Leave a Reply