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RISK
It is the chance or probability, high at one extreme and low at the other, that a person could be harmed or experience an adverse health outcome if something goes wrong, together with an indication of how serious the harm could be.
RISK MANAGEMENT
It is a written document that details the organization’s risk management process. This process starts by creating a team of stakeholders across the organization to review potential risks to the organization
Risk management involves:
✔Having the necessary systems, processes, and skilled staff in place to minimize the likelihood of providing poor quality care
✔Having mechanisms to learn from situations where despite having those systems something has gone wrong
✔Identifying and minimizing the potential for harm or adverse health outcomes if something goes wrong as a result of a pharmacy’s activities and services
RISK MANAGEMENT SYSTEM IN PHARMACY
This is a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions.
Set Objectives
Risk Identification
Risk Assessment
Risk Analysis
Risk Tolerance
Risk Mitigation
WHAT ARE THE RISK MANAGEMENT PROCESS
Set Objectives
First, the team members need to review business objectives, such as product development or third-party business partnerships.
By starting with business objectives, the risk management process aligns with current as well as future goals.
Risk Identification
The second step in creating a risk management plan lies in reviewing digital assets such as systems, networks, software, devices, vendors, and data.
Cataloging these assets then allows the team members to identify risks to the assets
A risk, or uncertain event, can be a positive or negative condition that has a financial, operational, or reputational impact.
Risk Assessment
After identifying risks, the risk management team needs to assess the risk.
Positive risks, such as early product delivery, can also lead to negative risks, such as a customer’s inability to meet a payment schedule. The organization needs to foresee risks in order to find a way to analyze their potential impact.
Risk Analysis
For each risk identified and assessed, the team must look at the likelihood the event will occur and then estimate impacts to the business if it does occur. Multiplying likelihood by the estimated impact can give insight into a risk’s effect.
A risk with a low likelihood leads to a devastating financial impact. Meanwhile, a risk with a high likelihood may have no impact. Part of the quantitative or qualitative analysis is creating the risk assessment matrix.
This allows the risk management team to use the risk analysis and assign ratings such as high, medium, or low.
Risk Tolerance
After assigning risk ratings, the team works to determine whether it will accept, transfer, mitigate, or refuse a risk.
The team may decide to accept a low-risk potential event that is not likely to occur and would have little impact if it did; however, they may also choose to refuse a high-risk potential event that is highly likely to occur and would have a large impact.
Risk Mitigation
For accepted risks, the team must create a set of risk mitigation strategies. For every risk that an organization accepts or transfers, it needs to define responses to issues that can occur. In information security, this means setting controls to protect data from cybercriminals.
contingency plan
Thus, the risk mitigation strategies act as a ——— in case the event occurs to help limit the defined impact.
Administrative Order 2014-0034
Section V – General Guidelines
FDA CIRCULAR 2018-013
What are the RISK MANAGEMENT IN PHARMACYREGULATORY BASIS
ISO 31000:2018
Risk Management - Guidelines
Provides guidelines on managing risk faced by organizations
Provides a common approach to managing any type of risk
