Friday, August 22, 2014
Inquirer Daily News

A recurring vaccine error puts infants at risk

With hundreds of reports of young children consistently getting the wrong form of a certain vaccine, leaving them vulnerable to the disease, you would think that the industry and regulators would gather national experts, take the time to thoroughly examine the problem, and implement prevention measures.

A recurring vaccine error puts infants at risk

Mix-ups of the adult and children forms of the whooping cough vaccine have led infants more vulnerable to ending up with the disease. (AP Photo)
Mix-ups of the adult and children forms of the whooping cough vaccine have led infants more vulnerable to ending up with the disease. (AP Photo)

With hundreds of reports of young children consistently getting the wrong form of a certain vaccine, leaving them vulnerable to the disease, you would think that industry and regulators would gather national experts, take the time to thoroughly examine the problem, and implement prevention measures. But not so for a problem that’s been known about for at least 6 years – a mix-up between the pediatric and adult forms of whooping cough vaccine.

I’ve been writing in professional journals and newsletters about this particular vaccine mix-up since 2006, when we first heard about it through our national reporting program. A September 7, 2010 blog also covered the topic on Philly.com and I’ve also spoken about the problem formally at both FDA and the Center for Disease Control and Prevention (CDC). My colleagues and I have also corresponded with regulators in writing on several occasions.

Infants should be getting avaccine called "DTaP" or diphtheria, tetanus, and acellular pertussis, which protects against three diseases. Older children and adults get a booster shot of "Tdap" or tetanus, diphtheria, and acellular pertussis once and additional boosters of tetanus and diphtheria every 10 years. The children’s vaccine has more of the diphtheria, tetanus and pertussis components, which is indicated by the use of upper case “D” “T” and “P.” The version for older children, teens and adults uses a lower-case "d" “t” and "p." The problem is, by mistake, too many kids are getting the adult booster shot in error, which is too weak to provide them with protection.

An infant/child who gets Tdap would need to be revaccinated. That is, if the error is recognized. Some are not and the child remains unprotected. The Immunization Action Coalition Web site, which is supported by CDC and the National Center for Immunization and Respiratory Diseases, does advise health professionals on what to do in case of an error. But neither the CDC nor the FDA Web sites provide error prevention strategies or help educate parents and health professionals about how errors happen and what can be done about them.

Children who aren’t vaccinated at all present a much bigger problem, by far, than vaccine errors. But why should we accept even a single child being placed at risk by a very preventable error. Especially when it’s become clear that much of what we are seeing is related to the vaccine abbreviations and nomenclature, error prone federal labeling and packaging regulations, poor vaccine documentation processes, technology issues, and lack of emphasis on error prevention methods directed at health professionals and parents. I won’t detail prevention measures here, but these are all problems we’ve largely been able to deal with successfully with other drug products, so why not vaccines?   

The NBC Today Show had a report last week about an outbreak of whooping cough (pertussis) in Washington State.The state health department there has called it an epidemic, with hundreds of cases reported – six times more than last year. Another outbreak was reported last week in Denver. To the best of my knowledge, neither of these situations involves vaccine errors. My point, though, is that kids who live in these areas are at greater risk if their vaccine was given incorrectly.

Singed in my mind forever is a case I saw during rounds at the former Temple Children’s Hospital a few years ago. It was devastating to watch a tiny baby with whooping cough fight for his life, trying to breathe with his airways full of mucous. View the Today show video I linked to above and also take a moment to listen to what a baby with whooping cough sounds like here (click on “classical whooping cough with lots of whooping”). I can only imagine how incensed a parent would be if they brought their infant to a doctor’s office or clinic for vaccination and later learned the baby was placed at risk due to an error, especially if it was during a known outbreak.

The current situation is unacceptable and we plan to redouble our efforts with the federal agencies until it’s resolved. But what should parents do? Office routines may differ, but for all vaccines, not just diphtheria, tetanus and pertussis, staff should provide a printed information sheet beforehand that details the name and purpose of each vaccine the child will be getting. When it’s time to give the vaccine, nurses should read the name aloud, with simultaneous confirmation by the parent. Staff and parent should work together using a vaccine documentation log on the patient's chart, confirming the lot number and expiration date as part of the verification process with both the nurse and parent signing off and dating the log. These double checks can help to make sure that a mix-up does not occur.

 


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About this blog
Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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