#design #fail: Do Oral Vaccines need a Redesign?
Oral Vaccines given by Injection!
Wow, major #design #fail.
RotaTeq (left) and Rotarix are vaccines for preventing rotavirus (a common cause of vomiting and diarrhea in kids). They are supposed to be administered by mouth (NOT an injection), but according to this report by CDC, the vaccines have been mistakenly administered by injection, according to the Vaccine Adverse Event Reporting System.
There were 39 reports of administration by injection (33 for RV1 and six for RV5). This included a cluster of six reports involving RV1 by a nurse who did not receive proper training or read the package insert. Nineteen of the 39 reports (49%) documented an adverse event; irritability (seven cases) and injection site redness (five) were the most commonly reported adverse events. Thirty of 39 reports (77%) did not have an explanation for the error; for those that did, reasons included misinterpreting package insert instructions, confusing the RV1 oral applicator syringe with a syringe for injection, confusing the RV1 vial with a vial used for injectable vaccine, inadequate training, and not reading the package insert….
The JAMA article which highlighted the CDC report followed up with the following:
The CDC recommends that health workers follow instructions in the package insert for proper administration.
Yes everyone should read and follow the instructions, but I wonder if there are other design decisions that could have been made to avoid this issue.
The report highlighted 33 injection events for Rotarix (RV1) and six for Rotatec (RV5). It sort of makes sense.
Looks just like a Syringe with more Adverse Events!
Look at Rotarix above; it looks exactly like an injectable syringe, with a clear vial with a plunger and a rubber stopper! 33 events where it was given mistakenly as an injection!
Looks less like a Syringe with Fewer Adverse Events!
Look at RotaTeq; it definitely looks different from a syringe with a different shape than a cylinder, and has no rubber stopper or plunger. 6 events where it was given mistakenly as an injection!
Design does make a difference in health
I am not sure why you would ever make an oral medication look just like an injectable, but I would conclude that design does make a difference in improving health outcomes and avoiding medical errors! The rates reported seem to be lower than for other medications, like inadvertent injections of the Epi-Pen for example; nonetheless we should be designing systems, medications, and technologies that make sense to human beings, so that we can achieve zero adverse events.
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Postscript (9/12/16): This is an interesting example of the application of the wrong metaphor for oral vaccine design. Think carefully about the metaphors you choose, and how you implement them! For more about metaphors and medical devices, check out this blogpost: The Role of Metaphor in Design.
