Download Culture of Safety talking points

Culture of Safety
“Talking Points”
May 2011
Managers: Please cover the following topic with your staff.
This is basic information regarding a patient safety topic. Please take the concepts presented
below and modify them to apply to your staff’s role within the context of safe patient care. After
presenting this information, we suggest that you encourage open discussion with your
staff and have provided sample discussion-starting questions below.
Topic
Why?
What to Report?
How?
Example/Case Study
(If needed, change
example so that it is
applicable to your area)
Discussion Points
Where can I find
related resources?
Contacts for your
Questions
Remember to report Adverse Drug Reactions
 Serious/significant adverse drug reactions (ADRs) are defined as a
drug related reaction that causes or prolongs hospitalization, results in
death, requires significant intervention, or is an unusual reaction not
expected or not in product labeling.
 Reporting serious or significant ADRs to the KUH ADR program helps
us monitor for new trends in drug related reactions.
 Certain ADRs are forwarded to the FDA through the KUH reporting
program
 Reporting ADRs may impact drug labeling, which improves safety
data.
 Any serious or significant ADR, as defined above
 Reactions associated with NEW drugs (<3 yrs on the U.S. market) are
extremely important to report. Safety data regarding these drugs
often changes as they are used in more patients
 Absolute certainty is NOT required to report – If you highly suspect
that the drug is related, you should report the reaction
 ADRs with OTC meds, dietary supplements, or herbals/alternative
medicines are considered reportable.
 KUH collects data on significant and serious ADRs that occur during a
hospitalization or cause hospitalization.
You can report an ADR by various means:
1) Submit a PSN
2) Call the Drug Info Center (Ext 8-2328)
3) Notify your clinical pharmacist
Report information remains confidential. The reporter and the patient
information is not revealed. Only aggregate data is used
A patient experienced a prolonged bleeding reaction after taking a newly
marketed agent Pradaxa® (dabigatran) -- which caused hospitalization.
This reaction was reported in PSN and because it was a significant
reaction, data regarding the reaction was forwarded to the FDA. The FDA
is now investigating similar reports.
 Do you routinely report Adverse Drug Reactions in your area?
 How can you ensure that significant ADRs are being reported?
 PSN Reporting for ADR
Joyce Generali, MS,RPh, Director, Drug Information Center
Ext 82303