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Pharmacovigilance: An Introduction to Postmarketing Drug Safety Surveillance

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

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Activity Description

Adverse drug events and adverse drug reactions can have considerable clinical and economic costs because they can lead to emergency department visits, hospitalization, and prolongation of hospitalization. Pharmacists are ideal health care professionals to assist with adverse event surveillance and reporting. This activity will provide pharmacists with education on several topics surrounding post-marketing drug safety surveillance, with particular emphasis on how adverse event reports are reported, collected, and analyzed by the U.S. Food and Drug Administration. In addition, the strengths and limitations of post-marketing drug safety surveillance will be discussed. Finally, recent safety information related specifically to antimicrobial products will be reviewed.

Learning Objectives

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

  • Define pharmacovigilance, adverse drug events, and adverse drug reactions.
  • Summarize how adverse event reports are reported, collected, and analyzed by U.S. Food and Drug Administration (FDA).
  • Identify strengths, limitations, and components of post-marketing drug safety surveillance.
  • Describe how FDA communicates new safety information to the public, including new safety information related to antimicrobial products.


Timothy Jancel, PharmD, MHS, BCPS-AQ ID, BCIDP
Division of Pharmacovigilance
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

CE Accreditation


Release Date: 12-05-2019
Expiration Date: 12-05-2022
BCIDP Expiration: 12-05-2020

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 0221-9999-19-528-H04-P has been assigned to this home study knowledge-based activity (initial release date 12-5-2019). This activity is approved for 1.5 contact hours (0.15 CEU) in states that recognize ACPE providers. Participants must complete the online post-test and activity evaluation to receive pharmacy CE credit. No partial credit will be given. Statements of completion will be issued online at, and proof of completion will be posted in NABP CPE Monitor profiles.


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 12/05/2019 for this activity and is available for one year from this date.


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. Dr. Jancel has no relevant commercial or financial relationships to disclose.


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.