View source for Pharmacopedia:Adverse Event Reporting

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Pharmacopedia medicine pages include a feature that lets readers share their experiences with a medicine. This page explains what that feature is, what it is not, and where to go if you need to report a suspected adverse drug reaction to a regulatory authority.

== What this feature is ==

The reader-experience report is a way for you to tell us what you experienced when taking a medicine -- positive, negative, or neutral. We use these reports to understand how Pharmacopedia readers describe their experiences, to flag topics that may deserve more editorial attention on the page, and (once enough reports accumulate) to surface anonymized aggregate patterns in the Patient perspective layer.

Reports are voluntary. You are never required to submit one. Submitting a report does not give Pharmacopedia or any affiliated party access to your medical records or any data beyond what you type.

== What this feature is not ==

'''This feature is not a registered adverse event reporting system.'''

Pharmacopedia is not a spontaneous adverse event reporting program under FDA regulation (21 CFR Part 314.81), a MedWatch equivalent, or any other regulated reporting mechanism. Submitting a report here:

* Does not notify the FDA, the CDC, or any other regulatory or public health authority.
* Does not fulfill any legal or regulatory obligation a clinician, manufacturer, or institution may have to report an adverse drug reaction.
* Does not result in your report being forwarded to any government body or shared with the drug's manufacturer.

'''If you are a clinician, pharmacist, or manufacturer with a mandatory adverse event reporting obligation, you must report through the appropriate regulatory channel (FDA MedWatch or equivalent). A report to Pharmacopedia does not satisfy that obligation.'''

== What happens to reports ==

Reports are held internally. No individual report is published or shared. A minimum threshold of distinct submissions must accumulate before any aggregate signal from reports is displayed on a medicine page (the threshold is set to protect individual privacy). When a signal does appear on a page, it is an anonymized aggregate count with no information that could identify any submitter.

Pharmacopedia editorial staff may review reports in aggregate to identify patterns worth editorial attention. Reports are not sold, licensed, or shared with commercial entities. See [[Pharmacopedia:Refusals]] for the full list of data commitments.

== If you think you are having an adverse drug reaction ==

Reader-experience reports are not the right channel if you need help or need to file an official report.

'''For immediate danger:''' Call 911 or your local emergency services. Do not delay for any other step.

'''For poison exposure or overdose:''' Contact Poison Control: 1-800-222-1222 (US). Online chat also available at www.poison.org.

'''To file an official adverse event report:'''

* '''United States:''' FDA MedWatch -- www.fda.gov/safety/medwatch. Consumers and clinicians can file. MedWatch forms are free and available online.
* '''Canada:''' Health Canada MedEffect -- www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
* '''United Kingdom:''' MHRA Yellow Card -- yellowcard.mhra.gov.uk
* '''European Union:''' EudraVigilance (for professionals) or the national competent authority for your country
* '''Australia:''' TGA Adverse Event Management System -- www.tga.gov.au/reporting-adverse-events

These programs exist so that regulators can detect safety signals across large populations. Pharmacopedia is reference and reader-experience; official pharmacovigilance belongs with the programs above.

== Privacy ==

Reader-experience reports are subject to the [[About:Privacy|Privacy Policy]]. In brief: reports are stored internally, not sold, not shared with commercial entities, and not published at the individual level. The anonymization threshold means an individual report cannot be traced once it is part of an aggregate.

== See also ==

* [[About:Privacy|Privacy Policy]]
* [[Pharmacopedia:Refusals|Refusals (what Pharmacopedia will never do)]]
* [[Pharmacopedia:Terms of Use|Terms of Use]] (Section 5 covers the regulatory framing of this feature)

[[Category:Pharmacopedia policy]]

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''Effective date: pending Mark Elliott, MD sign-off.''