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ENDA Excipient Allergy Survey - v10012025

 

Thank you for your interest in participating in this survey!

 

Purpose of the Survey

The goal of this survey is to map allergic reactions to excipients commonly used in drugs.

 

Time Commitment

Completing this survey will take approximately 30 minutes. You can save your progress at any time by clicking on "resume later" and return to finish the survey later.

 

Opportunity for Co-Authorship

By completing the entire questionnaire, you have the option to be listed as a co-author in an eventual publication. If you are interested, you can provide your contact details later in the survey. Only one co-author per center can be included for adult and paediatric cases, respectively (see important information below).

 

Important Information

Please read the following carefully before starting the survey:

 

One respondent per centre

In order to exclude duplicate responses and data, each centre is limited to one respondent for adult and one respondent for paedriatric cases. Only these respondents will be considered as potential co-authors and should compile and input all data for their centre. In case multiple specialists submit cases from the same centre, we will ask you to clarify potential overlap and decide internally for co-authorship.

If you would prefer to circulate this survey within your centre before entering your data, you have the option to download the provided Word file.”

Definition of excipients

In this survey, excipients are defined as all agents added to drug formulations other than the active substance.

Based on literature and experience, the following (non-exhaustive) list of excipients contains the most well-described potential culprits of allergic hypersensitivity reactions: polyethylene glycols (PEG) or macrogols), polysorbates or Tween (incl. polysorbate 80 or E433, polysorbate 20 or E432), poloxamers, methylcelluloses (incl. carboxymethylcellulose or E466, hydroxypropylmethylcellulose or E464), gelatines (E441), mannitol (E421) and povidone (polyvinylpyrrolidone, E1201).

Definition of excipient allergy

In this survey, excipient allergy is defined as a combination of:

  1. A clinical history of type I immediate (IgE-mediated) or type IV delayed (T cell-mediated) hypersensitivity to one or more systemically administered drugs containing a common excipient

and

  1. Allergy testing (e.g. skin testing, provocation testing, in vitro and/or ex vivo testing) demonstrating with a high degree of certainty that the excipient and not the active ingredient was the most likely cause of the reaction(s).
This survey is anonymous.

The record of your survey responses does not contain any identifying information about you, unless a specific survey question explicitly asked for it.

If you used an identifying access code to access this survey, please rest assured that this code will not be stored together with your responses. It is managed in a separate database and will only be updated to indicate whether you did (or did not) complete this survey. There is no way of matching identification access codes with survey responses.