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SOP for serious and unexpected adverse drug experience.
Anyone out there have a template for an SOP to determine whether a complaint represents a serious and unexpected adverse drug experience? Just had a friendly visit with the FDA.
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2 Replies
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Thank you for bringing this topic to my attention, I’m currently writing SOPs but didn’t think of that.
I looked into it and found this: http://www.bioline.org.br/pdf?dv09005 It’s not an SOP but an elaboration on EU guidelines, but it might still give you a starting point.
On a side note, I believe that “adverse drug experience” isn’t quite the right term in this context as it refers to drugs, which I imagine you aren’t selling. “Adverse reaction to cosmetics” or “adverse event” might bring you more targeted results when searching and also be more suitable in the title of an SOP. -
In Switzerland, health authorities provide everything online. It has a stupid name if you want to find it using Google: ElViS. EDIT: Forgot to mention, you have to create an account and that’s something usually reserved to registered health professionals such as physicians and pharmacists in order to avoid everyone from sending in panic hype stuff.Since an unexpected adverse reaction to a drug or similar might also be a first of its kind, there is no flowchart or the like you could use. Simply fill in the online-form on ElViS should you suspect a known or new more or less adverse reaction and authorities take it from there.I don’t know how it works in the US but if we get a friendly visit from the local FDA-pendant, they would also give us the required information
. Maybe ask your physician or pharmacist how they handle such affairs?
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