Risk Management Overview

Risk Management

• Risk is the chance or probability of harm
• Risk management is a written document detailing an organization's risk management process
• The process involves a team of stakeholders reviewing potential risks

Risk Management - Involves

• Having the necessary systems, processes, and skilled staff to minimize likelihood of poor quality care
• Having mechanisms to learn from situations where something has gone wrong
• Identifying and minimizing potential for harm or adverse health outcomes if something goes wrong due to pharmacy activities

Risk Management System

• A set of pharmacovigilance activities/interventions that identifies, characterizes, prevents, or minimizes risks relating to medicinal products, including effectiveness assessment

Risk Management Process - Set Objectives

• 1st step involves team members reviewing business objectives like product development or partnerships
• Aligns risk management process with current and future goals

Risk Management Process - Risk Identification

• 2nd step involves reviewing digital assets, such as systems, networks, software, devices, vendors, and data to allow team members to identify risks to the assets

Risk Assessment

• 3rd step is assessing the risk
• Positive risks like early product delivery, can lead to negative risks like customer inability to pay
• Organizations must foresee risks to analyze potential impact

Risk Analysis

• 4th step looks at the likelihood of events and estimates impacts to the business
• Multiplying likelihood by estimated impact gives insight into risk's effect
• Low likelihood = potentially devastating financial impact
• High likelihood = potentially no impact
• Risk assessment matrix creation is part of the quantitative or qualitative analysis, which allows rating risks as high, medium, or low

Risk Tolerance

• 5th step determines whether to accept, transfer, mitigate, or refuse a risk
• A team may accept the potential to have a low-risk event that is not likely to occur and would have little impact if it did occur.
• A team can also refuse a high-risk potential event that is very likely to occur and would have a large impact if it did occur.

Risk Mitigation

• 6th step creates risk mitigation strategies for accepted risks
• Organizations define responses to issues that can occur
• Information security sets controls to protect data from cybercriminals
• Risk mitigation strategies are a contingency plan to limit the defined impact if an event occurs

Risk Management in Pharmacy Regulatory Basis

• Administrative Order 2014-0034 covers licensing of establishments engaged in manufacture, clinical trials, distribution, importation, exportation, and retailing of drug products, and other authorizations
• All establishments must implement a risk management plan to receive an LTO
• FDA Circular 2018-013 provides guidance on preparing an RMP as part of FDA requirements for LTO issuance
• ISO 31000:2018 provides guidelines on managing risks for organizations, offering a common approach

Leadership

• Leadership is a process where someone influences a group to achieve a common goal
• It's a process that maximizes others' efforts
• Leadership inspires others to pursue a vision within parameters, becoming a shared effort, vision, and success

Leadership Factors

• Leader must have an honest understanding of personal strengths and weaknesses
• Followers determine if a leader is successful
• Successfully convince followers that you are worthy of being followed

Leadership - Followers

• Leadership requires different styles based on the people
• Know your people by understanding the needs, emotions, and motivation of human nature

Communication

• Leadership communicates through two-way, mostly nonverbal communication

Leadership - Situation

• All situations are different so decisions must be made via best judgement

Theories of Leadership

• Theories explain how/why people become leaders
• Theories attempt to define the behaviors people must adopt to improve their leadership abilities in different situations
• Early debates in the leadership world were whether people are born leaders or learn it
• Recent theories say nature vs. nurture
• Early leadership theories focused on qualities that make leaders and followers different, which lead to situational factors

Great Man Theory

• Great leaders born with internal characteristics (charisma, confidence, intelligence, social skills)
• Capacity for leadership is inherent
• Great leaders are born, not made
• Leaders portrayed as heroic, mythic

Trait Theory

• People inherit qualities/traits that make them better suited to leadership
• Gordon Allport identified 3 levels of personality traits (cardinal, central, secondary)

Contingency Theory

• Focus on variables related to environment, which determines the best leadership style
• 4 leadership styles exist

Leadership Styles

• Leadership involves leader's characteristics/behaviors when directing, motivating, guiding, and managing groups
• Leaders motivate performance and innovation
• Kurt Lewin's 1939 research identified different leadership styles

Authoritarian

• Autocratic leadership provides clear expectations -- aka command by the leader and control of the people
• There is a strict division between leader/members
• Decision-making happens independently meaning it is less creative
• Applied when there is little time for group decision-making, or the leader has special knowledge

Participative

• Democratic leadership offers guidance, allows input, and makes followers feel an important part of the team
• This encourages commitment to the group goals
• Group members are engaged and more creative

Delegative

• Laissez-faire leadership results in low demands on leader + inability for followers to work independently
• Delegative leaders offer little guidance & let the group do the decision making
• Poorly defined goals & lack of motivation occur often

Additional Leadership Styles

• Transformational leadership motivates/inspires followers and directs positive change
• Transformational leaders are emotionally intelligent, energetic, and passionate
• These leaders are committed to the company's success, while also helping members fulfill their dreams
• Provides higher performance and better group satisfaction

Transactional Leadership

• Sees leader-follower relationship as transactional to get work completed in exchange for compensation & creates clearly defined roles
• This method allows more direction and supervision + provides motivation for good performance

Situational Leadership

• Hershey and Blanchard's Leadership Styles include telling, selling, participating, delegating, & SLII leadership styles
• Behavioral theory focuses on leader's actions, observing and teaching
• Specific behaviors differentiate leaders and followers

Participative Theory

• Takes input of others
• Ideal leadership style is the input of others
• Rewards and punishments will improve the organization, supervision and group performance and are often used in business settings
• Incentives should be given when employees are successful
• Punishment should be issued when employees fail

Relationship Theories

• Transforms the connections between leaders and followers
• Helps group members see the importance of the task
• Leaders motivate and inspire people

Commitment

• Starts in the heart
• Actions = real commitment

Competence

• Happens with everyday effort
• Includes those who see what needs to happen, make it happen, or can make the right choices
• Must show up every day, keep improving, follow through, and inspire others

11 Characteristics of Leadership

• Character: is based in heart, words and actions must match
• Charisma: mystical, but can be improved
• Courage: gain strength by looking fear in the face and dealing with principle as well as reliance on intuition (rational thought)
• Keys: Focus on priorities, be generous, show initiative, listen and be passioniate
• Be Positive: have a positive attitude and you must be responsible
• Solve Problems: Must solve problems as well as be self-disciplined -Servant-heart: You must be a willing and able servant (skill based), put others ahead of yourself
• Teachability: Always have growth, even with success