Spotlight on Emergency Medicine

Credits: 1.00 CME / MOC
Real-World Antimicrobial Data in Clinical Practice: Broadening Coverage at the Bedside: A Clinical Forum℠
Thomas Lodise, PharmD, PhD
AKH Inc., Advancing Knowledge in Healthcare

Real-World Antimicrobial Data in Clinical Practice: Broadening Coverage at the Bedside: A Clinical Forum℠

Start

Activity Details

Free CME/MOC
1.0 AMA PRA Category 1 Credit(s)™/ABIM MOC point(s)
Released: December 30, 2020
Expires: December 29, 2021
60 minutes to complete

Provided By

This activity is jointly provided by AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC.

Target Audience

This activity is designed for infectious disease, critical care, and primary care clinicians.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Describe the importance of real-world evidence in clinical decision-making for antimicrobial selection
  • Evaluate real-world data (RWD) as it relates to off-label indications and novel endpoints for gram-positive antimicrobials
  • Apply RWD to ascertain the benefit of antibiotics against a wide spectrum of multidrug-resistant gram-negative bacterial infections

Activity Description

During this activity, Drs. Lodise, Reilly, and Jorgensen present the importance of applying real-world data for antimicrobials in clinical practice. Faculty review highlights from recent real-world evidence and clinical observations for oritavancin, ceftaroline, telavancin, meropenem-vaborbactam, and ceftazidime-avibactam.

Statement of Educational Need

Real-world studies (RWS) are an important means by which data from randomized clinical trials (RCTs) is validated in many different clinical settings. Real-world evidence provides key information on long-term outcomes, efficacy, and safety by gathering prospective or retrospective data from diverse patient populations. RCTs for antimicrobials are limited by strict inclusion and exclusion criteria which lowers patient acuity versus that seen in clinical practice, exclusion of patients at risk for adverse safety outcomes, and challenges in gaining consent from critically ill patients. In addition to evaluating various dosing regimens and providing a wide range of outcomes over time, RWS for antimicrobials include patients who are underrepresented in RCTs and those with resistant infections and higher disease severity. Data obtained from RWS can assist clinicians with therapeutic decision-making for their patients with serious bacterial infections.

Faculty

Chair
Thomas Lodise, PharmD, PhD
Professor
Department of Pharmacy 
Albany College of Pharmacy and Health Services 
Albany, NY 


Joseph Reilly, BS, PharmD, BCGP
Director, Residency Program
Clinical Pharmacist Specialist, Infectious Diseases
AtlantiCare Regional Medical Center
Egg Harbor Township, NJ


Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP
Pharmacotherapy Specialist
Department of Pharmacy
Mount Sinai Hospital
Toronto, ON, Canada


Disclosure Declaration

It is the policy of AKH Inc. and RMEI Medical Education, LLC to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of, or combination of, the following: attestation to non-commercial content; notification of independent and certified CME expectations; referral to National Faculty Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other faculty for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review. AKH Inc. planners and reviewers have no relevant financial relationships to disclose.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

Thomas Lodise, PharmD, PhD, has affiliations with:
Melinta, Merck, Shionogi Inc. (Consultant); Melinta, Shionogi Inc. (Speakers Bureau)

Joseph Reilly, BS, PharmD, BCGP, has affiliations with:
Cumberland, Melinta (Speakers Bureau)

Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP, has affiliations with:
Sunovion (Speakers Bureau)

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

AKH Staff and Planners
Dorothy Caputo, MA, BSN, RN, AKH Director of Accreditation, Planner, has no financial relationships to disclose.
Patricia Brignoni, AKH Director of Operations, has no financial relationships to disclose.

RMEI Medical Education, LLC
Sherri Kramer, MD, Senior Medical Director, has no financial relationships to disclose.
Sharon Powell, Editor, has no financial relationships to disclose.
The RMEI Medical Education planners and managers have nothing to disclose.

Accreditation Statement

Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC. AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants
NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 medical knowledge MOC points and 0 patient safety credit in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Instructions for Receiving Credit

Statements of credit will be awarded based on the participant reviewing the presentation, scoring a 70% on the post-test, and completing and submitting an activity evaluation. A statement of credit will be available upon completion of an online evaluation/claimed credit form. You must participate in the entire activity to receive credit. There is no fee to participant in this activity. If you have questions about this CME activity, please contact AKH Inc. at tbrignoni@akhcme.com.

Your Feedback is Important!

COMPLETE THE EVALUATION FORM AND YOU WILL BE ENTERED
INTO A DRAWING FOR A $100* AMAZON GIFT CARD!

*The expense for this gift card is solely funded by RMEI Medical Education, LLC.
No supporter funding was used for the expense of this gift card.

Rules and Regulations

This sweepstakes is managed by RMEI Medical Education, LLC (RMEI), a full-service medical education company. The winner will be selected via automated random drawing on a quarterly basis from among all eligible entries and notified through the contact information provided. In accordance with our privacy policy, we do not share your information with any third parties. By entering the sweepstakes, you grant RMEI permission to use your e-mail address to reach you for notification and prize fulfillment. Only individuals who complete the evaluation forms and provide contact information will be eligible to win. Open to those who have a US postal address and who are 18 years or older. Only one prize per person and per household will be awarded. The prize will be a $100 Amazon gift card.

Statement of Commercial Support

This activity is supported by an educational grant from Melinta Therapeutics, Inc.

Disclosure of Unlabeled Use and Investigational Product

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. and RMEI Medical Education, LLC specifically disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant's misunderstanding of the content.

Contact Information for Questions About the Activity

Please contact Nicole Neely at nneely@rmei.com for questions regarding this activity.

Activity Details

Free CME/MOC
1.0 AMA PRA Category 1 Credit(s)™/ABIM MOC point(s)
Released: December 30, 2020
Expires: December 29, 2021
60 minutes to complete

Provided By

This activity is jointly provided by AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC.

Target Audience

This activity is designed for infectious disease, critical care, and primary care clinicians.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Describe the importance of real-world evidence in clinical decision-making for antimicrobial selection
  • Evaluate real-world data (RWD) as it relates to off-label indications and novel endpoints for gram-positive antimicrobials
  • Apply RWD to ascertain the benefit of antibiotics against a wide spectrum of multidrug-resistant gram-negative bacterial infections

Activity Description

During this activity, Drs. Lodise, Reilly, and Jorgensen present the importance of applying real-world data for antimicrobials in clinical practice. Faculty review highlights from recent real-world evidence and clinical observations for oritavancin, ceftaroline, telavancin, meropenem-vaborbactam, and ceftazidime-avibactam.

Statement of Educational Need

Real-world studies (RWS) are an important means by which data from randomized clinical trials (RCTs) is validated in many different clinical settings. Real-world evidence provides key information on long-term outcomes, efficacy, and safety by gathering prospective or retrospective data from diverse patient populations. RCTs for antimicrobials are limited by strict inclusion and exclusion criteria which lowers patient acuity versus that seen in clinical practice, exclusion of patients at risk for adverse safety outcomes, and challenges in gaining consent from critically ill patients. In addition to evaluating various dosing regimens and providing a wide range of outcomes over time, RWS for antimicrobials include patients who are underrepresented in RCTs and those with resistant infections and higher disease severity. Data obtained from RWS can assist clinicians with therapeutic decision-making for their patients with serious bacterial infections.

Faculty

Chair
Thomas Lodise, PharmD, PhD
Professor
Department of Pharmacy 
Albany College of Pharmacy and Health Services 
Albany, NY 


Joseph Reilly, BS, PharmD, BCGP
Director, Residency Program
Clinical Pharmacist Specialist, Infectious Diseases
AtlantiCare Regional Medical Center
Egg Harbor Township, NJ


Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP
Pharmacotherapy Specialist
Department of Pharmacy
Mount Sinai Hospital
Toronto, ON, Canada


Disclosure Declaration

It is the policy of AKH Inc. and RMEI Medical Education, LLC to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of, or combination of, the following: attestation to non-commercial content; notification of independent and certified CME expectations; referral to National Faculty Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other faculty for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review. AKH Inc. planners and reviewers have no relevant financial relationships to disclose.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

Thomas Lodise, PharmD, PhD, has affiliations with:
Melinta, Merck, Shionogi Inc. (Consultant); Melinta, Shionogi Inc. (Speakers Bureau)

Joseph Reilly, BS, PharmD, BCGP, has affiliations with:
Cumberland, Melinta (Speakers Bureau)

Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP, has affiliations with:
Sunovion (Speakers Bureau)

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

AKH Staff and Planners
Dorothy Caputo, MA, BSN, RN, AKH Director of Accreditation, Planner, has no financial relationships to disclose.
Patricia Brignoni, AKH Director of Operations, has no financial relationships to disclose.

RMEI Medical Education, LLC
Sherri Kramer, MD, Senior Medical Director, has no financial relationships to disclose.
Sharon Powell, Editor, has no financial relationships to disclose.
The RMEI Medical Education planners and managers have nothing to disclose.

Accreditation Statement

Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC. AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants
NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 medical knowledge MOC points and 0 patient safety credit in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Instructions for Receiving Credit

Statements of credit will be awarded based on the participant reviewing the presentation, scoring a 70% on the post-test, and completing and submitting an activity evaluation. A statement of credit will be available upon completion of an online evaluation/claimed credit form. You must participate in the entire activity to receive credit. There is no fee to participant in this activity. If you have questions about this CME activity, please contact AKH Inc. at tbrignoni@akhcme.com.

Your Feedback is Important!

COMPLETE THE EVALUATION FORM AND YOU WILL BE ENTERED
INTO A DRAWING FOR A $100* AMAZON GIFT CARD!

*The expense for this gift card is solely funded by RMEI Medical Education, LLC.
No supporter funding was used for the expense of this gift card.

Rules and Regulations

This sweepstakes is managed by RMEI Medical Education, LLC (RMEI), a full-service medical education company. The winner will be selected via automated random drawing on a quarterly basis from among all eligible entries and notified through the contact information provided. In accordance with our privacy policy, we do not share your information with any third parties. By entering the sweepstakes, you grant RMEI permission to use your e-mail address to reach you for notification and prize fulfillment. Only individuals who complete the evaluation forms and provide contact information will be eligible to win. Open to those who have a US postal address and who are 18 years or older. Only one prize per person and per household will be awarded. The prize will be a $100 Amazon gift card.

Statement of Commercial Support

This activity is supported by an educational grant from Melinta Therapeutics, Inc.

Disclosure of Unlabeled Use and Investigational Product

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. and RMEI Medical Education, LLC specifically disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant's misunderstanding of the content.

Contact Information for Questions About the Activity

Please contact Nicole Neely at nneely@rmei.com for questions regarding this activity.

Emergency Medicine Presentations

1.00 CME / MOC
AKH Inc., Advancing Knowledge in Healthcare
Real-World Antimicrobial Data in Clinical Practice: Broadening Coverage at the Bedside: A Clinical Forum℠

Real-World Antimicrobial Data in Clinical Practice: Broadening Coverage at the Bedside: A Clinical Forum℠

Start

Activity Details

Free CME/MOC
1.0 AMA PRA Category 1 Credit(s)™/ABIM MOC point(s)
Released: December 30, 2020
Expires: December 29, 2021
60 minutes to complete

Provided By

This activity is jointly provided by AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC.

Target Audience

This activity is designed for infectious disease, critical care, and primary care clinicians.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Describe the importance of real-world evidence in clinical decision-making for antimicrobial selection
  • Evaluate real-world data (RWD) as it relates to off-label indications and novel endpoints for gram-positive antimicrobials
  • Apply RWD to ascertain the benefit of antibiotics against a wide spectrum of multidrug-resistant gram-negative bacterial infections

Activity Description

During this activity, Drs. Lodise, Reilly, and Jorgensen present the importance of applying real-world data for antimicrobials in clinical practice. Faculty review highlights from recent real-world evidence and clinical observations for oritavancin, ceftaroline, telavancin, meropenem-vaborbactam, and ceftazidime-avibactam.

Statement of Educational Need

Real-world studies (RWS) are an important means by which data from randomized clinical trials (RCTs) is validated in many different clinical settings. Real-world evidence provides key information on long-term outcomes, efficacy, and safety by gathering prospective or retrospective data from diverse patient populations. RCTs for antimicrobials are limited by strict inclusion and exclusion criteria which lowers patient acuity versus that seen in clinical practice, exclusion of patients at risk for adverse safety outcomes, and challenges in gaining consent from critically ill patients. In addition to evaluating various dosing regimens and providing a wide range of outcomes over time, RWS for antimicrobials include patients who are underrepresented in RCTs and those with resistant infections and higher disease severity. Data obtained from RWS can assist clinicians with therapeutic decision-making for their patients with serious bacterial infections.

Faculty

Chair
Thomas Lodise, PharmD, PhD
Professor
Department of Pharmacy 
Albany College of Pharmacy and Health Services 
Albany, NY 


Joseph Reilly, BS, PharmD, BCGP
Director, Residency Program
Clinical Pharmacist Specialist, Infectious Diseases
AtlantiCare Regional Medical Center
Egg Harbor Township, NJ


Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP
Pharmacotherapy Specialist
Department of Pharmacy
Mount Sinai Hospital
Toronto, ON, Canada


Disclosure Declaration

It is the policy of AKH Inc. and RMEI Medical Education, LLC to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of, or combination of, the following: attestation to non-commercial content; notification of independent and certified CME expectations; referral to National Faculty Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other faculty for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review. AKH Inc. planners and reviewers have no relevant financial relationships to disclose.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

Thomas Lodise, PharmD, PhD, has affiliations with:
Melinta, Merck, Shionogi Inc. (Consultant); Melinta, Shionogi Inc. (Speakers Bureau)

Joseph Reilly, BS, PharmD, BCGP, has affiliations with:
Cumberland, Melinta (Speakers Bureau)

Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP, has affiliations with:
Sunovion (Speakers Bureau)

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

AKH Staff and Planners
Dorothy Caputo, MA, BSN, RN, AKH Director of Accreditation, Planner, has no financial relationships to disclose.
Patricia Brignoni, AKH Director of Operations, has no financial relationships to disclose.

RMEI Medical Education, LLC
Sherri Kramer, MD, Senior Medical Director, has no financial relationships to disclose.
Sharon Powell, Editor, has no financial relationships to disclose.
The RMEI Medical Education planners and managers have nothing to disclose.

Accreditation Statement

Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC. AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants
NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 medical knowledge MOC points and 0 patient safety credit in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Instructions for Receiving Credit

Statements of credit will be awarded based on the participant reviewing the presentation, scoring a 70% on the post-test, and completing and submitting an activity evaluation. A statement of credit will be available upon completion of an online evaluation/claimed credit form. You must participate in the entire activity to receive credit. There is no fee to participant in this activity. If you have questions about this CME activity, please contact AKH Inc. at tbrignoni@akhcme.com.

Your Feedback is Important!

COMPLETE THE EVALUATION FORM AND YOU WILL BE ENTERED
INTO A DRAWING FOR A $100* AMAZON GIFT CARD!

*The expense for this gift card is solely funded by RMEI Medical Education, LLC.
No supporter funding was used for the expense of this gift card.

Rules and Regulations

This sweepstakes is managed by RMEI Medical Education, LLC (RMEI), a full-service medical education company. The winner will be selected via automated random drawing on a quarterly basis from among all eligible entries and notified through the contact information provided. In accordance with our privacy policy, we do not share your information with any third parties. By entering the sweepstakes, you grant RMEI permission to use your e-mail address to reach you for notification and prize fulfillment. Only individuals who complete the evaluation forms and provide contact information will be eligible to win. Open to those who have a US postal address and who are 18 years or older. Only one prize per person and per household will be awarded. The prize will be a $100 Amazon gift card.

Statement of Commercial Support

This activity is supported by an educational grant from Melinta Therapeutics, Inc.

Disclosure of Unlabeled Use and Investigational Product

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. and RMEI Medical Education, LLC specifically disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant's misunderstanding of the content.

Contact Information for Questions About the Activity

Please contact Nicole Neely at nneely@rmei.com for questions regarding this activity.

Activity Details

Free CME/MOC
1.0 AMA PRA Category 1 Credit(s)™/ABIM MOC point(s)
Released: December 30, 2020
Expires: December 29, 2021
60 minutes to complete

Provided By

This activity is jointly provided by AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC.

Target Audience

This activity is designed for infectious disease, critical care, and primary care clinicians.

Learning Objectives

Upon completion of this educational activity, participants should be able to:

  • Describe the importance of real-world evidence in clinical decision-making for antimicrobial selection
  • Evaluate real-world data (RWD) as it relates to off-label indications and novel endpoints for gram-positive antimicrobials
  • Apply RWD to ascertain the benefit of antibiotics against a wide spectrum of multidrug-resistant gram-negative bacterial infections

Activity Description

During this activity, Drs. Lodise, Reilly, and Jorgensen present the importance of applying real-world data for antimicrobials in clinical practice. Faculty review highlights from recent real-world evidence and clinical observations for oritavancin, ceftaroline, telavancin, meropenem-vaborbactam, and ceftazidime-avibactam.

Statement of Educational Need

Real-world studies (RWS) are an important means by which data from randomized clinical trials (RCTs) is validated in many different clinical settings. Real-world evidence provides key information on long-term outcomes, efficacy, and safety by gathering prospective or retrospective data from diverse patient populations. RCTs for antimicrobials are limited by strict inclusion and exclusion criteria which lowers patient acuity versus that seen in clinical practice, exclusion of patients at risk for adverse safety outcomes, and challenges in gaining consent from critically ill patients. In addition to evaluating various dosing regimens and providing a wide range of outcomes over time, RWS for antimicrobials include patients who are underrepresented in RCTs and those with resistant infections and higher disease severity. Data obtained from RWS can assist clinicians with therapeutic decision-making for their patients with serious bacterial infections.

Faculty

Chair
Thomas Lodise, PharmD, PhD
Professor
Department of Pharmacy 
Albany College of Pharmacy and Health Services 
Albany, NY 


Joseph Reilly, BS, PharmD, BCGP
Director, Residency Program
Clinical Pharmacist Specialist, Infectious Diseases
AtlantiCare Regional Medical Center
Egg Harbor Township, NJ


Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP
Pharmacotherapy Specialist
Department of Pharmacy
Mount Sinai Hospital
Toronto, ON, Canada


Disclosure Declaration

It is the policy of AKH Inc. and RMEI Medical Education, LLC to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of, or combination of, the following: attestation to non-commercial content; notification of independent and certified CME expectations; referral to National Faculty Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other faculty for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review. AKH Inc. planners and reviewers have no relevant financial relationships to disclose.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

Thomas Lodise, PharmD, PhD, has affiliations with:
Melinta, Merck, Shionogi Inc. (Consultant); Melinta, Shionogi Inc. (Speakers Bureau)

Joseph Reilly, BS, PharmD, BCGP, has affiliations with:
Cumberland, Melinta (Speakers Bureau)

Sarah Jorgensen, PharmD, MPH, BCPS, BCIDP, AAHIVP, has affiliations with:
Sunovion (Speakers Bureau)

The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this activity:

AKH Staff and Planners
Dorothy Caputo, MA, BSN, RN, AKH Director of Accreditation, Planner, has no financial relationships to disclose.
Patricia Brignoni, AKH Director of Operations, has no financial relationships to disclose.

RMEI Medical Education, LLC
Sherri Kramer, MD, Senior Medical Director, has no financial relationships to disclose.
Sharon Powell, Editor, has no financial relationships to disclose.
The RMEI Medical Education planners and managers have nothing to disclose.

Accreditation Statement

Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and RMEI Medical Education, LLC. AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physician Assistants
NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 medical knowledge MOC points and 0 patient safety credit in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Instructions for Receiving Credit

Statements of credit will be awarded based on the participant reviewing the presentation, scoring a 70% on the post-test, and completing and submitting an activity evaluation. A statement of credit will be available upon completion of an online evaluation/claimed credit form. You must participate in the entire activity to receive credit. There is no fee to participant in this activity. If you have questions about this CME activity, please contact AKH Inc. at tbrignoni@akhcme.com.

Your Feedback is Important!

COMPLETE THE EVALUATION FORM AND YOU WILL BE ENTERED
INTO A DRAWING FOR A $100* AMAZON GIFT CARD!

*The expense for this gift card is solely funded by RMEI Medical Education, LLC.
No supporter funding was used for the expense of this gift card.

Rules and Regulations

This sweepstakes is managed by RMEI Medical Education, LLC (RMEI), a full-service medical education company. The winner will be selected via automated random drawing on a quarterly basis from among all eligible entries and notified through the contact information provided. In accordance with our privacy policy, we do not share your information with any third parties. By entering the sweepstakes, you grant RMEI permission to use your e-mail address to reach you for notification and prize fulfillment. Only individuals who complete the evaluation forms and provide contact information will be eligible to win. Open to those who have a US postal address and who are 18 years or older. Only one prize per person and per household will be awarded. The prize will be a $100 Amazon gift card.

Statement of Commercial Support

This activity is supported by an educational grant from Melinta Therapeutics, Inc.

Disclosure of Unlabeled Use and Investigational Product

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. and RMEI Medical Education, LLC specifically disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant's misunderstanding of the content.

Contact Information for Questions About the Activity

Please contact Nicole Neely at nneely@rmei.com for questions regarding this activity.

0.50 CME
The France Foundation
Diagnosis of Thrombotic Thrombocytopenic Purpura (TTP)

Diagnosis of Thrombotic Thrombocytopenic Purpura (TTP)

Start

Activity Details

Free CME
0.50 AMA PRA Category 1 Credit(s)
Released: December 14, 2020
Expires: December 13, 2021
30 minutes to complete

Accredited By

Target Audience

This activity is intended for hematologists, emergency medicine physicians, critical care physicians, and primary care providers.

Learning Objectives

Upon completion of this course, the participants should be able to:

  • Differentiate acquired TTP from hereditary TTP
  • Recognize cardinal features in the presentation of TTP
  • Diagnose TTP accurately using recommended tests
  • Distinguish between TTP and other disorders in a differential diagnosis

Statement of Educational Need

Given the recent updates in research, progress in diagnosis and treatment, and the rarity of TTP and its associated 90%+ mortality rate if untreated, it is imperative that physicians become conversant with the disorder and the new information associated with its recognition, diagnosis, and treatment.

Faculty

Katerina Pavenski, MD, FRCPC
Head, Division of Transfusion Medicine
St. Michael’s Hospital
University of Toronto
Toronto, Canada

Katerina Pavenski, MD, FRCPC, has served as a consultant for Alexion, Sanofi, and Takeda. She has received contract research support from Sanofi.

Conflict of Interest Policy/Disclosure Statement

In accordance with the ACCME Standards for Commercial Support, TFF and the ISTH require that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF and the ISTH resolve all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all their educational programs. Furthermore, TFF and the ISTH seek to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF and the ISTH are committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

Accreditation Statement

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The France Foundation (TFF) and the International Society on Thrombosis and Haemostasis (ISTH). TFF is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

Physicians
TFF designates this enduring activity for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses
Nurses certified by the American Nurses Credentialing Center (ANCC) may utilize activities that are certified by ACCME-accredited providers toward their requirement for certification renewal by the ANCC. A certificate of attendance will be provided by TFF, an ACCME-accredited provider.

Instructions for Receiving Credit

  1. Review the activity objectives and CME/CE information.
  2. Complete the CME/CE activity.
  3. Complete the online posttest. A score of 100% is required to complete this activity. The participant may take the test until successfully passed.
  4. Complete the CME/CE evaluation/attestation form. This form provides each participant the opportunity to comment on how participating in the activity will affect their professional practice; the quality of the instructional process; the perception of enhanced professional effectiveness; the perception of commercial bias; and his/her views on future educational needs.
  5. Credit documentation/reporting:
    • If you are requesting AMA PRA Category 1 Credits™ or a certificate of participation—your CME/CE certificate will be available for download.

Statement of Commercial Support

This activity is supported by educational grants from Shire and Sanofi Genzyme.

Disclaimer Statement/Disclosure of Unlabeled Use

TFF and the ISTH present this information for educational purposes only. The content is provided solely by faculty who have been selected for their recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. TFF, the ISTH, and the commercial supporter(s) assume no liability for the information herein.

TFF and the ISTH require CME faculty (speakers) to disclose when products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational. This includes any limitations on the information that is presented, such as data that are preliminary, or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration-approved labeling. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. TFF and the ISTH do not recommend the use of any agent outside of the labeled indications. If you have questions, contact the Medical Affairs Department of the manufacturer for the most recent prescribing information.

Contact Information for Questions About the Activity

If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or info@francefoundation.com.

Activity Details

Free CME
0.50 AMA PRA Category 1 Credit(s)
Released: December 14, 2020
Expires: December 13, 2021
30 minutes to complete

Accredited By

Target Audience

This activity is intended for hematologists, emergency medicine physicians, critical care physicians, and primary care providers.

Learning Objectives

Upon completion of this course, the participants should be able to:

  • Differentiate acquired TTP from hereditary TTP
  • Recognize cardinal features in the presentation of TTP
  • Diagnose TTP accurately using recommended tests
  • Distinguish between TTP and other disorders in a differential diagnosis

Statement of Educational Need

Given the recent updates in research, progress in diagnosis and treatment, and the rarity of TTP and its associated 90%+ mortality rate if untreated, it is imperative that physicians become conversant with the disorder and the new information associated with its recognition, diagnosis, and treatment.

Faculty

Katerina Pavenski, MD, FRCPC
Head, Division of Transfusion Medicine
St. Michael’s Hospital
University of Toronto
Toronto, Canada

Katerina Pavenski, MD, FRCPC, has served as a consultant for Alexion, Sanofi, and Takeda. She has received contract research support from Sanofi.

Conflict of Interest Policy/Disclosure Statement

In accordance with the ACCME Standards for Commercial Support, TFF and the ISTH require that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF and the ISTH resolve all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all their educational programs. Furthermore, TFF and the ISTH seek to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF and the ISTH are committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

Accreditation Statement

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The France Foundation (TFF) and the International Society on Thrombosis and Haemostasis (ISTH). TFF is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

Physicians
TFF designates this enduring activity for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses
Nurses certified by the American Nurses Credentialing Center (ANCC) may utilize activities that are certified by ACCME-accredited providers toward their requirement for certification renewal by the ANCC. A certificate of attendance will be provided by TFF, an ACCME-accredited provider.

Instructions for Receiving Credit

  1. Review the activity objectives and CME/CE information.
  2. Complete the CME/CE activity.
  3. Complete the online posttest. A score of 100% is required to complete this activity. The participant may take the test until successfully passed.
  4. Complete the CME/CE evaluation/attestation form. This form provides each participant the opportunity to comment on how participating in the activity will affect their professional practice; the quality of the instructional process; the perception of enhanced professional effectiveness; the perception of commercial bias; and his/her views on future educational needs.
  5. Credit documentation/reporting:
    • If you are requesting AMA PRA Category 1 Credits™ or a certificate of participation—your CME/CE certificate will be available for download.

Statement of Commercial Support

This activity is supported by educational grants from Shire and Sanofi Genzyme.

Disclaimer Statement/Disclosure of Unlabeled Use

TFF and the ISTH present this information for educational purposes only. The content is provided solely by faculty who have been selected for their recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. TFF, the ISTH, and the commercial supporter(s) assume no liability for the information herein.

TFF and the ISTH require CME faculty (speakers) to disclose when products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational. This includes any limitations on the information that is presented, such as data that are preliminary, or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration-approved labeling. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. TFF and the ISTH do not recommend the use of any agent outside of the labeled indications. If you have questions, contact the Medical Affairs Department of the manufacturer for the most recent prescribing information.

Contact Information for Questions About the Activity

If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or info@francefoundation.com.

1.00 CME / CNE / CPE
AcademicCME
Managing Hemorrhagic Complications and Bleeding Risks Associated with Platelet P2Y12 Inhibitor Therapy

Managing Hemorrhagic Complications and Bleeding Risks Associated with Platelet P2Y12 Inhibitor Therapy

Start

Managing Hemorrhagic Complications and Bleeding Risks Associated with Platelet P2Y12 Inhibitor Therapy

Activity Details

Free CME/CNE/CPE
1.0 AMA PRA Category 1 Credit(s)
1.0 Contact Hour(s)
Released: December 2, 2020
Expires: December 1, 2021
60 minutes to complete

Accredited By

Target Audience

Interventional and clinical cardiologists, cardiothoracic and trauma surgeons, and emergency medicine/critical care specialists, as well as other clinicians, including nurses, NPs, PAs, and pharmacists who manage patients with P2Y12 inhibitor-related bleeding risks.

Learning Objectives

  1. Review the scientific basis for benefit from P2Y12 inhibition as well as the bleeding risks that result from therapy and understand the known epidemiology of clinically significant bleeding complications with these agents
  2. Analyze and understand the different perspectives of various specialists on the chronic use of P2Y12 inhibitor therapy
  3. Review current management strategies for P2Y12 inhibitor-associated bleeding risks, as well as therapies still in development
  4. Review in detail the rationale and methodology of a phase 3 clinical trial that identifies patients suitable for ticagrelor reversal and follow its execution as the science of managing patients with ticagrelor-associated hemorrhage and procedural bleeding risk

Activity Description

Antiplatelet therapy is an essential part of secondary prevention of cardiovascular events.  In particular, dual antiplatelet therapy (DAPT)—the combination of aspirin with an oral P2Y12 receptor antagonist—is the predominant approach in patients with acute coronary syndromes (ACS), coronary-artery stenting, or previous myocardial infarction (MI). The three oral P2Y12 receptor antagonists that are in use are clopidogrel, prasugrel, and ticagrelor.

An unavoidable limitation of all three oral P2Y12 receptor antagonists is increased bleeding risk from platelet inhibition, which persists for several days after drug cessation. Establishment of hemostasis can be challenging in patients with major bleeding, such as intracranial or gastrointestinal hemorrhage. In addition, urgent invasive procedures, especially emergency procedures, are associated with an increased risk of periprocedural bleeding. If an emergency procedure is indicated, the surgeon or proceduralist must proceed while accepting the increased bleeding risk, often after empirically providing platelet transfusions, despite the ineffectiveness of such transfusions in reversing the antiplatelet effects of P2Y12 inhibitors. If an urgent procedure is indicated, the proceduralist must either proceed while anticipating the increased bleeding risk or postpone the procedure for several days while accepting the risks associated with delaying a clinically indicated procedure. American College of Cardiology Foundation–American Heart Association, European Society of Cardiology, and other society guidelines recommend cessation of oral P2Y12 receptor antagonists at least 3 to 7 days before surgery.  Currently, no reversal agents for P2Y12 receptor antagonists are known. Unlike the other P2Y12 receptor antagonists, ticagrelor is a reversible inhibitor, which makes the development of a specific reversal agent for ticagrelor feasible.

In this program Drs. Pollack and Bhatt discuss the clinical need for a reversal agent for antiplatelet therapy, as well as an ongoing trial of the first such drug.  They also comment on the difficulties faced by today’s clinical researchers during the ongoing COVID-19 pandemic.

Statement of Educational Need

Health care team members need to understand the most recent clinical trial data regarding managing hemorrhagic complications and bleeding risks associated with platelet P2Y12 inhibitor therapy.

Agenda

  1. Inhibiting the Platelet P2Y12 Receptor: Efficacy and Safety
  2. Clinical Perspectives on Bleeding, Bleeding Risk, and Its Management in P2Y12 Inhibition
  3. Rationale and Methodology of a Phase 3 Placebo-Controlled Trial of a Specific Reversal Agent for a P2Y12 Inhibitor
  4. Challenges in Executing Clinical Trials in the Acute Care Environment

Course Chair

Charles V. Pollack Jr., MA, MD
Clinician-Scientist
Department of Emergency Medicine
University of Mississippi School of Medicine
Jackson, Mississippi

Faculty

Deepak L. Bhatt, MD, MPH
Executive Director of Interventional Cardiovascular Programs
Brigham and Women’s Hospital Heart & Vascular Center
Professor of Medicine, Harvard Medical School
Boston, Massachusetts

Disclosures of Conflict of Interest

It is the policy of AcademicCME that all faculty, instructors, and planners disclose real or apparent conflicts of interest relating to the topics of this educational activity.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity:

Charles V. Pollack Jr., MA, MD (Course Chair)
Grant/Research Support: AstraZeneca Pharmaceuticals; PROVEPHARM INC.
Consultant/Advisor: AstraZeneca Pharmaceuticals

Deepak L. Bhatt, MD, MPH
Grant/Research Support: Abbott; Afimmune Limited; Amarin Corporation; Amgen Inc.; AstraZeneca Pharmaceuticals; Bayer AG; Boehringer Ingelheim International GmbH; Bristol Myers Squibb Company; Cardax, Inc.; Chiesi USA, Inc.; CSL Behring; Eli Lilly and Company; Eisai Co., Ltd.; Ethicon Inc.; Ferring Pharmaceuticals; Forest Laboratories; Fractyl Laboratories, Inc.; Idorsia Pharmaceuticals Ltd; Ironwood Pharmaceuticals, Inc.; Ischemix; Lexicon; Medtronic; Pfizer Inc.; PhaseBio Pharmaceuticals; PLx Pharma Inc.; Regeneron Pharmaceuticals Inc.; Roche; Sanofi; Synaptic; The Medicines Company

Accreditation Statement

In support of improving patient care, AcademicCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team.

Designation of Credit

AcademicCME designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.

AcademicCME designates this enduring material for a maximum of 1.0 CNE Contact Hour, including 1.0 Pharmacotherapeutic Contact Hour (Provider Number P0491).

AcademicCME designates this continuing education activity for 1.0 CPE Contact Hour (0.10 CEU) of continuing pharmacy education credit (JA4008190-0000-20-020-H04-P).

Participants should claim only the credit commensurate with the extent of their participation in the activity.

Method of Participation

In order to claim credit, participants must complete the following:

  1. Read the learning objectives, accreditation information and faculty disclosures at the beginning of this activity.
  2. Complete the Pre-Activity Questions.
  3. Read or Review the activity content.
  4. Complete the Post-Activity Test Questions and Evaluation.
  5. Learners who receive a grade of 70% or better on the Post-Activity Test Questions and complete the Evaluation will receive appropriate credit as indicated (CME, CNE, and/or CPE credit).
    CPE credit will be posted to the learner's CPE Monitor profile within 60 days of completion.
    CME and CNE credit will be issued appropriate certificate of completion.
    Others may request a "certificate of completion".
  6. Learners should claim only the credit commensurate with the extent of their participation in the activity.

Statement of Commercial Support

This activity has been supported by an independent educational grant from PhaseBio Pharmaceuticals.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. AcademicCME and PhaseBio Pharmaceuticals do not recommend the use of any agent outside of the labeled indications.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Contact Information for Questions About the Activity

For all CME/CE inquiries or special needs, please contact admin@academiccme.com or 610-687-3300.

Managing Hemorrhagic Complications and Bleeding Risks Associated with Platelet P2Y12 Inhibitor Therapy

Activity Details

Free CME/CNE/CPE
1.0 AMA PRA Category 1 Credit(s)
1.0 Contact Hour(s)
Released: December 2, 2020
Expires: December 1, 2021
60 minutes to complete

Accredited By

Target Audience

Interventional and clinical cardiologists, cardiothoracic and trauma surgeons, and emergency medicine/critical care specialists, as well as other clinicians, including nurses, NPs, PAs, and pharmacists who manage patients with P2Y12 inhibitor-related bleeding risks.

Learning Objectives

  1. Review the scientific basis for benefit from P2Y12 inhibition as well as the bleeding risks that result from therapy and understand the known epidemiology of clinically significant bleeding complications with these agents
  2. Analyze and understand the different perspectives of various specialists on the chronic use of P2Y12 inhibitor therapy
  3. Review current management strategies for P2Y12 inhibitor-associated bleeding risks, as well as therapies still in development
  4. Review in detail the rationale and methodology of a phase 3 clinical trial that identifies patients suitable for ticagrelor reversal and follow its execution as the science of managing patients with ticagrelor-associated hemorrhage and procedural bleeding risk

Activity Description

Antiplatelet therapy is an essential part of secondary prevention of cardiovascular events.  In particular, dual antiplatelet therapy (DAPT)—the combination of aspirin with an oral P2Y12 receptor antagonist—is the predominant approach in patients with acute coronary syndromes (ACS), coronary-artery stenting, or previous myocardial infarction (MI). The three oral P2Y12 receptor antagonists that are in use are clopidogrel, prasugrel, and ticagrelor.

An unavoidable limitation of all three oral P2Y12 receptor antagonists is increased bleeding risk from platelet inhibition, which persists for several days after drug cessation. Establishment of hemostasis can be challenging in patients with major bleeding, such as intracranial or gastrointestinal hemorrhage. In addition, urgent invasive procedures, especially emergency procedures, are associated with an increased risk of periprocedural bleeding. If an emergency procedure is indicated, the surgeon or proceduralist must proceed while accepting the increased bleeding risk, often after empirically providing platelet transfusions, despite the ineffectiveness of such transfusions in reversing the antiplatelet effects of P2Y12 inhibitors. If an urgent procedure is indicated, the proceduralist must either proceed while anticipating the increased bleeding risk or postpone the procedure for several days while accepting the risks associated with delaying a clinically indicated procedure. American College of Cardiology Foundation–American Heart Association, European Society of Cardiology, and other society guidelines recommend cessation of oral P2Y12 receptor antagonists at least 3 to 7 days before surgery.  Currently, no reversal agents for P2Y12 receptor antagonists are known. Unlike the other P2Y12 receptor antagonists, ticagrelor is a reversible inhibitor, which makes the development of a specific reversal agent for ticagrelor feasible.

In this program Drs. Pollack and Bhatt discuss the clinical need for a reversal agent for antiplatelet therapy, as well as an ongoing trial of the first such drug.  They also comment on the difficulties faced by today’s clinical researchers during the ongoing COVID-19 pandemic.

Statement of Educational Need

Health care team members need to understand the most recent clinical trial data regarding managing hemorrhagic complications and bleeding risks associated with platelet P2Y12 inhibitor therapy.

Agenda

  1. Inhibiting the Platelet P2Y12 Receptor: Efficacy and Safety
  2. Clinical Perspectives on Bleeding, Bleeding Risk, and Its Management in P2Y12 Inhibition
  3. Rationale and Methodology of a Phase 3 Placebo-Controlled Trial of a Specific Reversal Agent for a P2Y12 Inhibitor
  4. Challenges in Executing Clinical Trials in the Acute Care Environment

Course Chair

Charles V. Pollack Jr., MA, MD
Clinician-Scientist
Department of Emergency Medicine
University of Mississippi School of Medicine
Jackson, Mississippi

Faculty

Deepak L. Bhatt, MD, MPH
Executive Director of Interventional Cardiovascular Programs
Brigham and Women’s Hospital Heart & Vascular Center
Professor of Medicine, Harvard Medical School
Boston, Massachusetts

Disclosures of Conflict of Interest

It is the policy of AcademicCME that all faculty, instructors, and planners disclose real or apparent conflicts of interest relating to the topics of this educational activity.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity:

Charles V. Pollack Jr., MA, MD (Course Chair)
Grant/Research Support: AstraZeneca Pharmaceuticals; PROVEPHARM INC.
Consultant/Advisor: AstraZeneca Pharmaceuticals

Deepak L. Bhatt, MD, MPH
Grant/Research Support: Abbott; Afimmune Limited; Amarin Corporation; Amgen Inc.; AstraZeneca Pharmaceuticals; Bayer AG; Boehringer Ingelheim International GmbH; Bristol Myers Squibb Company; Cardax, Inc.; Chiesi USA, Inc.; CSL Behring; Eli Lilly and Company; Eisai Co., Ltd.; Ethicon Inc.; Ferring Pharmaceuticals; Forest Laboratories; Fractyl Laboratories, Inc.; Idorsia Pharmaceuticals Ltd; Ironwood Pharmaceuticals, Inc.; Ischemix; Lexicon; Medtronic; Pfizer Inc.; PhaseBio Pharmaceuticals; PLx Pharma Inc.; Regeneron Pharmaceuticals Inc.; Roche; Sanofi; Synaptic; The Medicines Company

Accreditation Statement

In support of improving patient care, AcademicCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team.

Designation of Credit

AcademicCME designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.

AcademicCME designates this enduring material for a maximum of 1.0 CNE Contact Hour, including 1.0 Pharmacotherapeutic Contact Hour (Provider Number P0491).

AcademicCME designates this continuing education activity for 1.0 CPE Contact Hour (0.10 CEU) of continuing pharmacy education credit (JA4008190-0000-20-020-H04-P).

Participants should claim only the credit commensurate with the extent of their participation in the activity.

Method of Participation

In order to claim credit, participants must complete the following:

  1. Read the learning objectives, accreditation information and faculty disclosures at the beginning of this activity.
  2. Complete the Pre-Activity Questions.
  3. Read or Review the activity content.
  4. Complete the Post-Activity Test Questions and Evaluation.
  5. Learners who receive a grade of 70% or better on the Post-Activity Test Questions and complete the Evaluation will receive appropriate credit as indicated (CME, CNE, and/or CPE credit).
    CPE credit will be posted to the learner's CPE Monitor profile within 60 days of completion.
    CME and CNE credit will be issued appropriate certificate of completion.
    Others may request a "certificate of completion".
  6. Learners should claim only the credit commensurate with the extent of their participation in the activity.

Statement of Commercial Support

This activity has been supported by an independent educational grant from PhaseBio Pharmaceuticals.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. AcademicCME and PhaseBio Pharmaceuticals do not recommend the use of any agent outside of the labeled indications.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Contact Information for Questions About the Activity

For all CME/CE inquiries or special needs, please contact admin@academiccme.com or 610-687-3300.

1.00 CME / CNE / CPE
AcademicCME
Advances in the Management of Acute and Chronic Hyperkalemia

Advances in the Management of Acute and Chronic Hyperkalemia

Start

Activity Details

Free CME/CNE/CPE
1.0 AMA PRA Category 1 Credit(s)
1.0 Contact Hour(s)
Released: October 20, 2020
Expires: October 19, 2021
60 minutes to complete

Accredited By

Target Audience

Community and community hospital-based generalist and specialist physicians, nurses, and pharmacists who manage patients with hyperkalemia.

Learning Objectives

  • Assess for hyperkalemia risk in patients with underlying diseases like heart failure, diabetes, or chronic kidney disease
  • Understand and differentiate among therapies for temporizing, acute, and chronic therapy for hyperkalemia
  • Analyze the latest evidence-based data for hyperkalemia therapeutics to inform clinical decision making in an era of advanced treatment of heart failure, diabetes, and chronic kidney disease

Activity Description

Hyperkalemia and its important cardiometabolic comorbidities are increasingly common, while the most frequently used acute therapy to lower potassium levels for over five decades is now recognized as being associated with serious adverse effects. Over the last four years, clinical trial data has identified newer and safer therapeutic options. The goals of better potassium management include facilitation of guidelines-recommended therapy for heart failure and hypertension, and support of the patient with chronic renal disease. In this unique program, we will discuss new and improved options for managing hyperkalemia acutely and chronically. This information will impact the practices of emergency medicine physicians, hospitalists, internists, cardiologists, nephrologists, and other clinicians.

Statement of Educational Need

Health care team members need to understand the most recent clinical trial data regarding the treatment of management of patients with hyperkalemia.

Agenda

  • Understand the Hyperkalemia Risk in Patients With Heart failure, Diabetes, or Chronic Kidney Disease
  • Acute and Temporizing Management of Hyperkalemia
  • Data Analysis and Interpretation: Applicability to Practice of Newer Potassium Binders

Faculty

Charles V. Pollack Jr., MA, MD, FACEP, FAHA, FACC, FESC
Clinician-Scientist
Department of Emergency Medicine
University of Mississippi School of Medicine
Jackson, Mississippi


Javed Butler, MD, MPH, MBA
Chairman and Professor
Department of Medicine
University of Mississippi Medical Center
Jackson, Mississippi


Disclosures of Conflict of Interest

It is the policy of AcademicCME that all faculty, instructors, and planners disclose real or apparent conflicts of interest relating to the topics of this educational activity.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity:

Charles V. Pollack, Jr., MA, MD, FACEP, FAHA, FACC, FESC (Course Chair)
Relationship Identified With:
Grant/Research Support: AstraZeneca Pharmaceuticals; Boehringer-Ingelheim Pharmaceuticals; CSL Behring.

Javed Butler, MD, MPH, MBA
Relationship Identified With:
Consultant/Advisor: Amgen Inc.; Array; AstraZeneca Pharmaceuticals; Bayer AG; Boehringer Ingelheim; Bristol-Myers Squibb Company; CVRX Inc.; G3 Pharmaceuticals; Innolife; Janssen Scientific Affairs LLC.; Luitpold Pharmaceuticals, Inc.; Merck & Co.; Medtronics; Novartis Pharmaceuticals Corporation; Relypsa Inc.

Accreditation Statement

In support of improving patient care, AcademicCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team.

Designation of Credit

AcademicCME designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.

AcademicCME designates this enduring material for a maximum of 1.0 CNE Contact Hour (Provider Number P0491).

AcademicCME designates this continuing education activity for 1.0 CPE Contact Hour (0.10 CEU) of continuing pharmacy education credit (UAN #: JA4008190-0000-20-007-L04-P).

Participants should claim only the credit commensurate with the extent of their participation in the activity.

Method of Participation

In order to claim credit, participants must complete the following:

  • Read the learning objectives, accreditation information and faculty disclosures at the beginning of this activity.
  • Complete the Pre-Activity Questions.
  • Read or review the activity content.
  • Complete the Post-Activity Test Questions and Evaluation.
  • Learners who receive a grade of 66% or better on the Post-Activity Test Questions and complete the Evaluation will receive appropriate credit as indicated (CME, CNE, and/or CPE credit).
    CPE credit will be posted to the learner's CPE Monitor profile within 60 days of completion.
    CME and CNE credit will be issued appropriate certificate of completion.
    Others may request a "certificate of completion".
  • Learners should claim only the credit commensurate with the extent of their participation in the activity.

Statement of Commercial Support

This activity has been supported by an independent educational grant from AstraZeneca Pharmaceuticals.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. AcademicCME and AstraZeneca Pharmaceuticals do not recommend the use of any agent outside of the labeled indications.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Contact Information for Questions About the Activity

For all CME/CE inquiries or special needs, please contact admin@academiccme.com or 610-687-3300.

Activity Details

Free CME/CNE/CPE
1.0 AMA PRA Category 1 Credit(s)
1.0 Contact Hour(s)
Released: October 20, 2020
Expires: October 19, 2021
60 minutes to complete

Accredited By

Target Audience

Community and community hospital-based generalist and specialist physicians, nurses, and pharmacists who manage patients with hyperkalemia.

Learning Objectives

  • Assess for hyperkalemia risk in patients with underlying diseases like heart failure, diabetes, or chronic kidney disease
  • Understand and differentiate among therapies for temporizing, acute, and chronic therapy for hyperkalemia
  • Analyze the latest evidence-based data for hyperkalemia therapeutics to inform clinical decision making in an era of advanced treatment of heart failure, diabetes, and chronic kidney disease

Activity Description

Hyperkalemia and its important cardiometabolic comorbidities are increasingly common, while the most frequently used acute therapy to lower potassium levels for over five decades is now recognized as being associated with serious adverse effects. Over the last four years, clinical trial data has identified newer and safer therapeutic options. The goals of better potassium management include facilitation of guidelines-recommended therapy for heart failure and hypertension, and support of the patient with chronic renal disease. In this unique program, we will discuss new and improved options for managing hyperkalemia acutely and chronically. This information will impact the practices of emergency medicine physicians, hospitalists, internists, cardiologists, nephrologists, and other clinicians.

Statement of Educational Need

Health care team members need to understand the most recent clinical trial data regarding the treatment of management of patients with hyperkalemia.

Agenda

  • Understand the Hyperkalemia Risk in Patients With Heart failure, Diabetes, or Chronic Kidney Disease
  • Acute and Temporizing Management of Hyperkalemia
  • Data Analysis and Interpretation: Applicability to Practice of Newer Potassium Binders

Faculty

Charles V. Pollack Jr., MA, MD, FACEP, FAHA, FACC, FESC
Clinician-Scientist
Department of Emergency Medicine
University of Mississippi School of Medicine
Jackson, Mississippi


Javed Butler, MD, MPH, MBA
Chairman and Professor
Department of Medicine
University of Mississippi Medical Center
Jackson, Mississippi


Disclosures of Conflict of Interest

It is the policy of AcademicCME that all faculty, instructors, and planners disclose real or apparent conflicts of interest relating to the topics of this educational activity.

The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity:

Charles V. Pollack, Jr., MA, MD, FACEP, FAHA, FACC, FESC (Course Chair)
Relationship Identified With:
Grant/Research Support: AstraZeneca Pharmaceuticals; Boehringer-Ingelheim Pharmaceuticals; CSL Behring.

Javed Butler, MD, MPH, MBA
Relationship Identified With:
Consultant/Advisor: Amgen Inc.; Array; AstraZeneca Pharmaceuticals; Bayer AG; Boehringer Ingelheim; Bristol-Myers Squibb Company; CVRX Inc.; G3 Pharmaceuticals; Innolife; Janssen Scientific Affairs LLC.; Luitpold Pharmaceuticals, Inc.; Merck & Co.; Medtronics; Novartis Pharmaceuticals Corporation; Relypsa Inc.

Accreditation Statement

In support of improving patient care, AcademicCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team.

Designation of Credit

AcademicCME designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.

AcademicCME designates this enduring material for a maximum of 1.0 CNE Contact Hour (Provider Number P0491).

AcademicCME designates this continuing education activity for 1.0 CPE Contact Hour (0.10 CEU) of continuing pharmacy education credit (UAN #: JA4008190-0000-20-007-L04-P).

Participants should claim only the credit commensurate with the extent of their participation in the activity.

Method of Participation

In order to claim credit, participants must complete the following:

  • Read the learning objectives, accreditation information and faculty disclosures at the beginning of this activity.
  • Complete the Pre-Activity Questions.
  • Read or review the activity content.
  • Complete the Post-Activity Test Questions and Evaluation.
  • Learners who receive a grade of 66% or better on the Post-Activity Test Questions and complete the Evaluation will receive appropriate credit as indicated (CME, CNE, and/or CPE credit).
    CPE credit will be posted to the learner's CPE Monitor profile within 60 days of completion.
    CME and CNE credit will be issued appropriate certificate of completion.
    Others may request a "certificate of completion".
  • Learners should claim only the credit commensurate with the extent of their participation in the activity.

Statement of Commercial Support

This activity has been supported by an independent educational grant from AstraZeneca Pharmaceuticals.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. AcademicCME and AstraZeneca Pharmaceuticals do not recommend the use of any agent outside of the labeled indications.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Contact Information for Questions About the Activity

For all CME/CE inquiries or special needs, please contact admin@academiccme.com or 610-687-3300.