Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers (edX)

Biosimilars present a rapidly growing area in pharmaceutical development, treatment options, and patient care that require an evidence-informed implementation approach.
As awareness and use of biosimilars increases globally, this course will provide information and guidance to support the effective and safe use of biosimilars in clinical settings among health care providers.
The course will focus on enhancing knowledge and skills to affect change in attitude and behaviour of health care providers related to biosimilars.
The course will utilize a modular approach to provide content that is accessible and informative to all learners, including pharmacists, physicians, nurses, students and young professionals, industry, and policy-makers.
This course may be eligible for continuing education credits through professional accreditation bodies.
The course will also provide learners with opportunities to develop skills in each of these knowledge areas, with the overall aim of improving patient-provider communication and perceptions of biosimilar use and establishing a consistent foundation among health care providers for communicating with patients about biosimilar treatment.
This course will build off of the material in BSS101 to provide advanced knowledge and skills related to use and implementation of biosimilar medications in clinical settings.
This course is part of the Originator and Biosimilar Biologics: For Patients and Healthcare Providers Professional Certificate.

What you'll learn

• Improve knowledge of originator biologic and biosimilar biologic medicines
• Understand scientific and clinical evidence to support appropriate cost-effective application of biosimilars across oncology, rheumatology, gastrointestinal disease, and other medical conditions
• Address misconceptions regarding use of biosimilars
• Identify the benefits and significance of biosimilar use in clinical practice and across jurisdictions
• Discuss implications of biosimilar use for clinical practice and patient education to optimize patient care and wellness

Syllabus

Module 1 - Understanding Biologics and Biosimilars
Learning Objectives:

1. Describe biologic medications, including how they are manufactured and how they are used in clinical practice
2. Describe biosimilar biologics, how they differ from generics and how they are used in clinical practice
3. Define inherent variability and comparability.
4. Discuss the requirements and process for demonstrating comparability of biosimilar biologics
5. Describe why biosimilar medications are important now

Module 2 - Regulatory Approval Process
Learning Objectives:

1. Describe the approval process for biosimilars in Canada, including general considerations for new drugs and special considerations for biologics
2. Compare and contrast the approval process for biosimilar biologics and originator biologics
3. Examine the safety and efficacy of biosimilars
4. Describe pharmacovigilience and adverse reporting mechanisms for originator and biosimilar biologics in Canada
5. Describe the authorization of specific indications for biosimilars
6. Distinguish interchangeability and switching in relation to biosimilars

Module 3 - Instilling confidence in patients about their care plan & ethical considerations
Learning Objectives:

1. Develop an awareness of ethics and ethical principles
2. Appreciate the ethical issues related to biosimilar biologics
3. Understand the factors that contribute to a trustworthy clinician-patient therapeutic relationship
4. Identify the communication skills needed to cultivate a trusting clinician-patient relationship, including with patients from diverse communities
5. Consider the broader structural influences on therapeutic trust within the context of biosimilar biologics

Module 4 - Discussing Biosimilars with your Patients
Learning Objectives:

1. Understand how patient expectations and beliefs impact treatment changes
2. Describe strategies to elicit patient perspectives on switching medications
3. Apply proven principles of patient-physician communication and motivational interviewing to discussions about switching medications
4. Identify strategies to create a positive mindset in patients for switching medications