PMNL

• Risk


  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


  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

  The process of identifying, assessing and controlling threats to an organization's capital, earnings and operations
• Main objective of risk management in pharmacy


  • Safety and well-being of a patient
• Risk management in pharmacy

  1. Having the necessary systems, processes, and skilled staff in place to minimize the likelihood of providing poor quality care

  2. Minimize the impact of damage

  3. Having mechanisms to learn from situations where despite having those systems something has gone wrong

  4. 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


  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
• Pharmacovigilance


  The science and activities relating to the detection and understanding of adverse effects of a medicine
• Postmarketing surveillance (PMS)


  • Useful for monitoring adverse effects for those that weren't seen or observed during pre-market clinical trials (e.g. Thalidomide - for pregnant women, caused unformed limbs/deformities to children)
• Risk management process

  1. Set objectives

  2. Risk identification

  3. Risk assessment

  4. Risk analysis

  5. Risk tolerance

  6. Risk mitigation
• Polypharmacy

  The use of multiple medicines (Taking 2 or more drugs)
• SALAD

  Sounds Alike and Look-Alike Drugs
• Administrative Order 2014-0034 requires all establishments to implement a risk management plan as a requirement for the issuance of an LTO or other organization
• FDA Circular 2018-013 provides guidance on the preparation of an RMP as a part of the FDA's requirements for the issuance of a LTO
• ISO 31000:2018 provides guidelines on managing risk faced by organizations and provides a common approach to managing any type of risk
• Leadership


  A process whereby an individual influences a group of individuals to achieve a common goal

  
• Leadership


  A process of social influence, which maximizes the efforts of others, towards the achievement of a goal

  
• Leadership


  Inspiring others to pursue your vision within the parameters you set, to the extent that it becomes a shared effort, a shared vision, and a shared success
• Leadership requires a person to influence others through social influence, not power, to get something accomplished
• Leadership requires others, who are not necessarily direct-reports, to get something accomplished
• Leaders carry out the leadership process by applying their leadership knowledge and skills (Process Leadership)

  
• Leaders' actions can be influenced by their attributes or traits, such as beliefs, values, ethics, and character (Trait Leadership)

  
• Factors of leadership


  • Leader
  • Followers
  • Communication
  • Situation

  
• Early leadership theories focused on what qualities distinguish between leaders and followers, while subsequent theories looked at other variables such as situational factors and skill levels

  
• Great Man Theories


  According to this point of view, great leaders are simply born with the necessary internal characteristics such as charisma, confidence, intelligence, and social skills that make them natural-born leaders

  
• Trait Theories


  Assume that people inherit certain qualities and traits that make them better suited to leadership
• Contingency/Situational Theories


  Focus on particular variables related to the environment that might determine which particular style of leadership is best suited for the situation
• Effective leadership is not just about the qualities of the leader, it is about striking the right balance leadership style, qualities of the followers and aspects of the situation

  
• Leadership style


  A leader's characteristic behaviors when directing, motivating, guiding, and managing groups of people

  
• Traits and preferences often appear only in certain situations or under specific circumstances (e.g. impatient while waiting in traffic)
• This question is one of the difficulties in using trait theories to explain leadership
• Contingency theories of leadership

  Focus on particular variables related to the environment that might determine which particular style of leadership is best suited for the situation
• According to contingency theory, no leadership style is best in all situations

  
• Effective leadership


  Is not just about the qualities of the leader, it is about striking the right balance leadership style, qualities of the followers and aspects of the situation

  
• In 1939, a group of researchers led by psychologist Kurt Lewin set out to identify different styles of leadership
• Authoritarian/Autocratic leadership


  • Provide clear expectations for what needs to be done when it should be done, and how it should be done
  • Strongly focused on both command by the leader and control of the followers
  • Clear division between the leader and the members
  • Leaders make decisions independently with little or no input from the rest of the group

  
• Researchers found that decision-making was less creative under authoritarian leadership
• Authoritarian leadership


  Best applied to situations where there is little time for group decision-making or where the leader is the most knowledgeable member of the group
• Participative/Democratic leadership


  • Democratic leaders offer guidance to group members, but they also participate in the group and allow input from other group members
  • Participative leaders encourage group members to participate but retain the final say in the decision-making process
  • Group members feel engaged in the process and are more motivated and creative
  • Democratic leaders tend to make followers feel like they are an important part of the team, which helps foster commitment to the goals of the group
• Delegative/Laissez-Faire leadership


  • Delegative leaders offer little or no guidance to group members and leave decision-making up to group members
  • Often leads to poorly defined roles and a lack of motivation
  • Tends to result in groups that lack direction where members blame each other for mistakes, refuse to accept personal responsibility, and produce a lack of progress and work
• Abraham Lincoln


  • Wrote the "Gettysburg Address" during the Civil War