1
Q
ADE
A
- Unfavorable and unintended response to a drug
- Whether it is related to product or not
- Include medical errors, ADR, allergic rxns, and overdoses
2
Q
State of ADE Reporting
A
- Currently not requires by federal law/regulation to submit ADEs (difficult to enforce)
- Often part of institutional, state, or professional practice guidelines
3
Q
Barriers to HCP Reporting
A
- Many not reported since association isn’t recognized as casual
- Not recognized as safety concerns
- Unfamiliar with reporting process and its importance
- Takes too much time to report
4
Q
MedWatch
A
- Designed to expedite/broaden voluntary ADE reports by HCP and consumdesr
- Serious AE, non serious and unexpected, or potential to cause harm
- Should be submitted even when not certain the product caused the event
5
Q
Trial Limitations
A
- Small patient groups
- Short trials
- General population may use different drugs and have different comorbidities
- May be used differently by general population once approved for different conditions
6
Q
Serious ADE
A
- Fatal
- Life-threatening
- Permanently disabled
- Cause birth defect
- Require intervention to prevent permanent impairment/damage
- Potential for harm/close calls
7
Q
Non-serious/Unexpected
A
- Previously unidentified AE of drug
- Not on package insert
8
Q
Reports Include
A
- Description of AE
- Suspected/concomitant product therapy details
- OTCs, herbals, dietary supplements, recently D/Ced drugs
- Patient characteristics
- Clinical course of events/hospitalizations
- Relevant therapeutic measures such as laboratory data
- Information about response to dechallenge and rechallenge of medication
- Additional patient information
9
Q
How to Report
A
- Online
- Download and mail or fax report
- Can call 1-800-332-1088 for questions about the form
10
Q
Mandatory Report
A
- Form 3500A
- User facilities (medical devices)
- Manufacturers: biologics, drugs, human cells/tissues, OTCs, medical devices
11
Q
What happens to report?
A
- Captured in database
- FDA safety evaluator reviews the report
- Looks for similar reports
- Review division may consult with manufacturer
- FDA/manufacturer conducts further epidemiological studies or post-market clinical trials as needed
12
Q
Possible Reporting Outcomes
A
- Letters to HCP
- New warnings, precautions
- Modified CI
- Dose adjustments
- Required REMs program
- New/additional monitoring recommendations
- Request to change product design, packaging, or distribution
- Box warnings
- Mandatory recalls/withdrawals
13
Q
NM Significant ADE Definition
A
Drug related incident that results in harm to patient
14
Q
NM Incident Definition
A
Drug that is dispensed/administered in error that results in harm, injury or death
15
Q
NM Dispensing Error Definition
A
Prescription was dispensed from pharmacy differently than prescribed
16
Q
NM Harm Definition
A
Temporary or permanent impairment of the physical, emotional, or psychological fxn or structure of the body and/or pain requiring intervention
17
Q
PIC shall…
A
- Develop/implement a written error prevention procedure
- Report incidents, including relevant status updates, to the Board
- Board approved forms within 15 days of discovery
18
Q
BoP shall…
A
- Maintain confidentiality of information relating to the reporter and the patient identifier
- Compile/publish in newsletter and on Board website
- Report information and prevention recommendations
- Assure reports are used in a constructive and non-punitive manner
854
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Decks in class (7)
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