Access new MTM opportunities
Your MTM Center may be eligible to participate in pharmaceutical manufacturer (or “pharma”) programs. Some of these programs will require you to report Adverse Events (or ”AEs”) if they are identified while completing these MTM interventions. In order to view these pharma opportunities, you must review the Adverse Event reporting information below and attest that you understand. Upon completing the attestation, TIPs for pharma-sponsored programs will appear (if your MTM center is eligible) within your MTM opportunities queue. You may download a copy of Adverse Event reporting information here or view it in the Resources section on the Outcomes platform.
In this training you will learn:
- The definition of an Adverse Event (AE)/Adverse Drug Reaction (ADR)
- How to know which MTM opportunities, TIPs or programs expect you to report AEs/ADRs
- What to do if you identify AEs/ADRs
Definition of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
Adverse Events (AE)/Adverse Drug Reactions (ADRs):
Any untoward or undesirable medical occurrence in a patient linked in time with the use of a pharmaceutical/ medicinal product or medical device and which does not necessarily have to have a causal relationship with this treatment or may or may not be considered related to the product.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product, from withdrawal of the product, and any failure of expected pharmacological action.
Overview of Adverse Events (AEs)/Adverse Drug Reactions (ADRs) reporting program
“The FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report to the products’ manufacturers. If a manufacturer receives a report from a healthcare professional or consumer, it is required to send the report to FDA as specified by regulations.” ỻ
Normally healthcare professionals are voluntary reporters of AEs/ADRs, however in certain pharma-sponsored programs, you, the pharmacist, are required to report any AEs you may identify. The obligation of the manufacturer to report events is extended to you, as a pharmacist, during participation in these pharma-sponsored programs.
ỻ Source: Questions and Answers on FDA's Adverse Event Reporting System (FAERS); 08/03/2020
Identifying and reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR)
You will know a TIP requires AE/ADR reporting if an adverse event is encountered if you see “If any adverse events or product complaints are identified” in the TIP overview, as shown below.
If you encounter an AE/ADR while delivering an MTM service for programs that require AE/ADR reporting, the TIP overview will provide specific instructions on how to report AEs/ADRs. Within those instructions, note important requirements such as reporting timeline and the program ID.
When reporting AEs/ADRs, additional information will be needed to submit a report. This information may include, but is not limited to:
- Patient name
- Date of birth
- Description of adverse event
- Medication name
- Dosage
- Medication directions
- Source of adverse event report (i.e. type of patient or caretaker interaction, patient education, etc.)
Next steps
After completing the attestation, pharma-sponsored TIPs for your eligible patients will appear (if your MTM center is eligible) within your MTM opportunities queue. Always refer to the TIP overview for specific requirements and instructions related to the intervention.