to bAE or not to bAE
A patient reports being prescribed Eliquis for their atrial fibrillation. Is this a reportable adverse event?
What is NO. Atrial fibrillation is one of the primary indications of taking Eliquis. Mentions of reasons why the patient is prescribed the medication is not considered a reportable event.
In Q1 of 2024, the Patient Ops team reported 87 adverse events associated with this pharmaceutical manufacturer, comprising more than half of all adverse events reported during the entire quarter across all manufacturers. Which pharmaceutical manufacturer is this?
Who is Bristol-Myers Squibb?
Serious or non-serious?
Death
What is Serious?
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You must guess the word and properly define it!
What is Pharmacovigilance?
The science and activities related to detection, assessment and prevention of adverse effects or any other safety related issues of pharmaceutical products throughout their lifecycle
Where's waldo? Lantus, Toujeo, Soliqua, Multaq, Synjardy, Asmanex, Dulera, Xarelto, Trulicity, Mounjaro, Eliquis
What is Synjardy?
Synjardy is the only medication on the list where Sempre does not have an active contract. Therefore, Adverse Event mentions for this medication do not need to be reported to the manufacturer.
An Eliquis patient reports being in rehab. What should we do?
What is Not Report? We would not report this as an adverse event unless accompanied by a medical event like a hospitalization, stroke, procedure, etc.
This pharma partner introduced the world's first commercial insulin in 1923.
Who is Eli Lilly?
Serious or non-serious?
Stroke
What is non-serious?
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You must guess the word and properly define it!
What is Standard Operating Procedure (SOP)?
A documented set of instructions outlining the steps and protocols for carrying out specific tasks or activities within an organization.
The most common side effect of taking this medication is unwanted bleeding including: nosebleeds or light bruising.
What is Eliquis?
A patient reports their doctor took them off of Asmanex because it wasn't helping their asthma. Is this a reportable adverse event?
What is YES? This is reportable because of Lack of Effect.
This pharma partner was the first worldwide supplier of the injectable polio vaccine followed by the first influenza, meningitis, and rabies vaccines.
Who is Sanofi?
Serious or non-serious?
Cancer
What is non-serious?
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You must guess the word and properly define it!
What is Lack of Effect?
A situation where a treatment, medication, or intervention fails to produce the desired or expected outcome or has minimal impact on the intended target or condition
We cannot support patients taking this medication for weight loss.
What is Mounjaro?
A Trulicity patient reports their last pen not administering the medication. What should we do?
What is Report as a Product Complaint?
This pharma partner was formed through a spinoff from Merck.
Who is Organon?
Serious or non-serious?
Hospitalization
What is serious?
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You must guess the word and properly define it!
What is Reconciliation?
process of comparing two sets of records, documents, or data to ensure that they are consistent, accurate, and in agreement with each other. at sempre, this means cross checking AEs reported to pharma partners with AEs received by Sempre
The most common side effects of this medication are Nausea, GI upset, Stomach Pain and Vomiting.
What is Ozempic?
A patients spouse leaves a voicemail on Saturday morning that the patient can be unenrolled from the TRU program because they passed away. What should we do?
What is report within 24 hours?
Eli Lilly considers this a Priority Event and must be reported within 24 hours, even on a weekend.
Our newest pharma partner to the Sempre platform, whose funded med is a blood thinner to treat and prevent blood clots.
Who is Janssen?
Serious or non-serious?
Chemotherapy
What is non-serious?
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You must guess the word and properly define it!
What is Unexpected Therapeutic Benefit?
a positive outcome or effect of a treatment, medication, or intervention that was not initially anticipated or intended
The generic name of this med is Rivaroxaban. Name that med!
What is Xarelto?