The Doctor’s Advocate | Second Quarter 2015
A four-and-a-half-month-old male infant first visited the pediatric group in March 2009 (his brother and sister twins were also patients). He received the pneumococcal conjugate vaccine (PCV) Prevnar 7, which gave him protection against seven serotypes of pneumococcus.
In February 2010, the FDA approved the use of Prevnar 13, providing protection against an additional six serotypes of pneumococcus. The American Academy of Pediatrics recommended that children who had already received the Prevnar 7 vaccine should also be vaccinated with Prevnar 13.
This child was subsequently seen for well-child office visits on three occasions, but the Prevnar 13 vaccine was never administered. Here is the timeline:
In February 2012, the child—then three years, three months old—was taken to the emergency room with symptoms of fever, cough, vomiting, and increasing lethargy. The rectal temperature was 102.6 degrees. He was diagnosed with pneumococcal meningitis and received ceftriaxone and vancomycin. However, the infection progressed to encephalitis, subdural empyema, obstructive hydrocephalus, septic shock, and respiratory failure. He developed disseminated intravascular coagulation with multiorgan failure and was hospitalized in the ICU for six weeks.
It was discovered during his hospitalization that the pneumococcal strain was serotype 6A, which would have been covered by the Prevnar 13 vaccine. The treating physicians asked the child’s mother if he had received Prevnar 13. She asked a medical assistant in the pediatric practice, who reviewed the chart and told her that her child had not received Prevnar 13—nor had his twin brother and sister. They were promptly vaccinated. The child now has a permanent seizure disorder, vision impairment, bilateral profound hearing loss, and left hemiparesis.
An infectious disease expert said that the Prevnar 7 vaccination resulted in a 98 percent probability of protection against the seven serotypes of pneumococcus that caused 80 percent of pneumococcal disease in infants. He also stated that, while the Prevnar 13 vaccine protects against the 6A serotype, there was a decreased incidence of 6A disease in many children vaccinated only with Prevnar 7. However, when asked about the standard of care, the infectious disease expert stated that the Prevnar 13 vaccine should have been administered during either the November 2010 or the November 2011 visit.
All other experts stated that, because the Prevnar 13 vaccine contained the pneumococcal serotype 6A antigen, it would likely have protected the child from meningitis if it had been given to him. They noted that the FDA approved Prevnar 13 in February 2010 and that the vaccine was readily available by the May 2010 office visit and should have been offered at that time.
The American Academy of Pediatrics recommended that children who had been vaccinated with Prevnar 7 should also be vaccinated with Prevnar 13. The recommendation was well-known when this child was seen for routine office visits in 2010 and 2011. It was the pediatric group’s policy that the NP who examined a child during a well-child visit was responsible for seeing that the child’s immunizations were up to date. The pediatrician’s involvement was limited to cosigning the NP’s notes. The practice used a well-child template with boxes to check regarding immunizations. At the time of this incident, the template had a box for the Prevnar 7 vaccination but no box for Prevnar 13.
This tragic event is primarily the result of a system failure. The group did not have a written office policy that assigned a specific person the responsibility of systematically updating immunization policies to ensure compliance with FDA and medical specialty society recommendations and to ensure that each medical record was documented with up-to-date immunization tracking.
This case illustrates what patient safety is all about—a healthcare discipline that minimizes the incidence and impact of adverse events by redesigning systems and processes to reduce errors.
Parents whose child acquires an infectious disease that could have been prevented by an immunization they declined may feel remorseful and may subsequently claim that their physician never recommended or discussed vaccination with them.
This type of situation represents significant potential liability, especially at a time when more parents are questioning the safety and value of childhood immunization. For this reason, it is essential to document in the medical record all discussions with parents regarding the vaccination of their children. If the parents decline a recommended immunization, the discussion should be documented in detail and consideration given to using an informed refusal form, such as the “Refusal to Consent to Treatment, Medication, or Testing” sample form posted in our Informed Consent Resource Center.
Find more than 100 sample forms in our Informed Consent Resource Center at www.thedoctors.com/informedconsent.
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The Doctor’s Advocate is published by The Doctors Company to advise and inform its members about loss prevention and insurance issues.
The guidelines suggested in this newsletter are not rules, do not constitute legal advice, and do not ensure a successful outcome. They attempt to define principles of practice for providing appropriate care. The principles are not inclusive of all proper methods of care nor exclusive of other methods reasonably directed at obtaining the same results.
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Second Quarter 2015
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Industry and Company News: Second Quarter 2015