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A product of the Society of Infectious Diseases Pharmacists Education Center (SIDPEC)

 
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Activity Description

This learning activity is a self-directed review of online resources and references; there is no required video or webinar. Pharmacists can obtain continuing education credit after reviewing relevant links included on the IDStewardship.com site, reviewing the supplemental activity description, and successfully completing an online assessment. Relevant links for each assessment question are outlined below.

Background

COVID-19 is a novel coronavirus that emerged in late 2019 and rapidly reached global pandemic status, which has led to a surge in literature regarding potential drug therapy options. Among comprehensive resources available to healthcare providers, IDStewardship.com has compiled available treatment information on a “Coronavirus (COVID-19) Resources for Pharmacists” web page (IDStewardship.com/coronavirus-covid-19-resources-pharmacists/) to help pharmacists keep up with these rapidly changing data. This learning activity represents a collaboration between IDstewardship.com and the Society of Infectious Diseases Pharmacists’ Board Certified Infectious Diseases Pharmacist (BCIDP) Recertification Committee.

Pharmacists involved in the management of infectious diseases are expected to be experts in understanding and communicating issues related to use of antimicrobials. In the case of COVID-19, no medications are FDA-approved for treatment or prophylaxis of these infections. Based on limited in vitro data and small studies, providers are considering off-label use of common drugs used for other indications, including lopinavir/ritonavir, chloroquine and hydroxychloroquine, and biologic modifiers such as corticosteroids and interleukin-6 inhibitors. Pharmacists must familiarize themselves with these medications in addition to investigational treatment options such as remdesivir. This learning activity is focused on understanding the pharmacokinetics, proposed dosing, potential risks, adverse events, drug-drug interactions, and presumed benefits of these off-label or investigational therapies.

Pharmacists should be able to speak to available resources, such clinical recommendations from the Centers for Diseases Control and Prevention (CDC), World Health Organization (WHO), and the U.S. Food and Drug Administration (FDA). Other useful websites, including the SIDP COVID-19 resource center and Contagion Live, provide useful summaries of existing or anticipated data surrounding COVID-19 therapeutics. Understanding the limitations of available studies is important for BCIDPs as they advise providers on treatment decisions for individual patients and assist with developing safe, evidence-based guidelines for patient selection, drug selection, and monitoring.

To Complete This Activity

After reviewing the recommended resources on the IDStewardship.com “Coronavirus (COVID-19) Resources for Pharmacists” page, participants will complete an assessment focused on drug therapies under investigation for COVID-19 infection in order to earn 1 hour of credit.

References to review for Question #1:

• Centers for Diseases Control and Prevention (CDC) Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19)
• Transmission of Corona Virus by Nebulizer – a serious, underappreciated risk!

References to Review for Question #2:

• A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe COVID-19 Infection
  • Editorial: COVID-19 The Search for Effective Therapy
• University of Liverpool: At-a-Glance Summary of Interactions with Experimental COVID-19 Therapies

References to Review for Question #3:

• Chloroquine package insert
• Hydroxychloroquine package insert
• Examination of hydroxychloroquine use and hemolytic anemia in G6PDH-deficient patients
• Urgent guidance for navigating and circumventing the QTc prolonging and torsadogenic potential of possible pharmacotherapies for COVID-19

References to Review for Question #4:

• Infectious Diseases Society of America (IDSA) Guidelines on the Treatment and Management of Patients with COVID-19.
• Effective Treatment of Severe COVID-19 Patients with Tocilizumab (pre-print, file posted on IDStewardship.com COVID-19 page

References to Review for Question #5:

• Remdesivir for severe acute respiratory syndrome coronavirus 2 causing COVID-19: an evaluation of the evidence.
• Remdesivir Clinical Trials (Gilead Website)
• Clinicaltrials.gov(Study Identifiers: NCT04292899, NCT04292730, NCT04280705)

References to Review for Question #6:

• Treating COVID-19 – Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics
• Expanded access. How to submit a request (FDA Website).

References to Review for Question #7:

• COVID-19: a recommendation to examine the effect of hydroxychloroquine in preventing infection and progression
• Is Hydroxychloroquine a possible post-exposure prophylaxis drug to limit the transmission to healthcare workers exposed to COVID-19?

Learning Objectives

The target audience for this activity includes pharmacists. At the completion of this activity, the participant will be able to:

• Summarize issues related to dosing, pharmacokinetics and administration for drugs being investigated or used off-label for COVID-19.
• List expected side effects, drug interactions and monitoring needed for investigational and off-label therapies for COVID-19.
• Outline the potential benefits of investigational and off-label therapies by examining clinical data, including in vitro, observational and randomized controlled trials in COVID-19.
• Describe the limitations of preliminary data when applied to an infection such as COVID-19.

Faculty

Timothy P. Gauthier, Pharm.D., BCPS-AQ ID
Infectious Diseases & Antimicrobial Stewardship Pharmacist
Editor-In-Chief www.IDstewardship.com & www.LearnAntibiotics.com

CE Accreditation

Release Date: 04-15-2020
ACPE Expiration Date: 04-15-2021
BCIDP Expiration Date: 10-15-2020

Pharmacists

This activity is jointly provided by ProCE, Inc. and the Society of Infectious Diseases Pharmacists. ProCE, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-9999-20-220-H01-P has been assigned to this home study, knowledge-based activity. This activity is approved for 1.0 contact hour (0.1 CEU) in states that recognize ACPE providers. Completion of the evaluation and the post-test with a score of 70% or higher are required to receive CE credit. No partial credit will be given. Statements of completion will be issued online at www.ProCE.com, and proof of completion will be posted in NABP CPE Monitor profiles.

BCIDP

The Society of Infectious Diseases Pharmacists (SIDP) is accredited by the Board of Pharmacy Specialties (BPS) as a provider of board certified infectious diseases pharmacist (BCIDP) credit. A BCIDP statement of credit will be issued online upon successful completion of a post-test and online evaluation. The post-test must be successfully completed in only one attempt. No partial credit will be given. BCIDP accreditation begins 04/15/2020 for this activity and is available for six months from this date.

Recertification Criteria for Infectious Diseases Pharmacy: BCIDP recertifying via continuing education are required to earn 100 hours of continuing education credit provided by the joint program offered by the American College of Clinical Pharmacy (ACCP) and the American Society of Health-System Pharmacists (ASHP) and/or the Society of Infectious Diseases Pharmacists (SIDP). Infectious Diseases Pharmacy Specialty Recertification Courses offered by any of the approved providers may only be completed for recertification credit up to two times, in nonconsecutive years, during the 7-year recertification cycle. Candidates should note that there are expiration dates associated with earning BPS recertification credit. BPS will only award recertification credit for modules based on the completion and submission date of the post-test assessment. For example, a module completed and submitted on October 20 of a particular year will only be credited for that year, even if the due date of the post-test is in January of the following year. View all recertification criteria on the BPS website at https://www.bpsweb.org/recertification/recertification-by-continuing-education

Disclosure

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants any significant financial interest or affiliation with companies that manufacture or market products discussed during their presentation. Timothy Gauthier is the owner of Charlie Rose, LLC (IDStewardship.com), a consultant for Pattern Bioscience, and a consultant for DoseMe by Tabula Rasa HealthCare..

Funding

This activity is provided by ProCE, Inc. and SIDP.

    

The material presented in this CE activity does not reflect the views of ProCE, LLC or the commercial sponsor. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.