Seattle Children’s says its safety procedures failed in overdose death of 15-year-old boy

Seattle Children’s has “embarked on a system-wide assessment of” how its staff prescribes all high-risk drugs to prevent the type of prescribing errors that led to the death of a 15-year-old boy last March, Dr. David Fisher, the hospital’s medical director, said in a press conference Tuesday.

The boy, Michael Patrick Blankenship, died after he had been prescribed fentanyl, a powerful pain medicine.

Blankenship had been prescribed the medicine after he had undergone a routine teeth extraction and dental cleaning at Seattle Children’s March 9th.

Last week, the boy’s mother, Tamy Jarbo-Blankenship, filed a wrongful death lawsuit in King County Superior Court.

According to Mr. Chris Davis, the Seattle attorney representing the mother, the lawsuit names Seattle Children’s Hospital and Dr. Barbara L. Scheller, DDS and Dr. Soultana Chatzopoulos, DDS.

At the time, Dr. Sheller was program director of the Dental Residency Program and Dr. Chatzopoulos, a resident.

Dr. Fisher said Blankenship had been prescribed the fentanyl in a transdermal-patch form, which delivers the drug through the skin, because the boy, who was autistic, could not tolerate pills or liquid medications.

However, because the fentanyl patch is so potent, Dr. Fisher said, it should only be prescribed to people who have been on opioid drugs long enough to build up a tolerance.

Prescribing fentanyl transdermal patches for acute post-operative pain was not standard practice at Seattle Children’s, Dr. Fisher said.

Opioids are morphine-like drugs that are commonly used to control pain. However, high doses of opioids can kill by slowing and even stopping breathing.

These and other effects of opioids are less pronounced in patients who have developed tolerance from long use of opioid drugs.

The U.S. Food and Drug Administration specifically warns that the fentanyl patch should only by used to treat moderate to severe chronic pain in opioid-tolerant patients who need round-the-clock pain control for several days and should not be used for acute post-operative pain.

Michael Blankenship

Blankenship was found dead in his bed the morning after his dental appointment.

A postmortem exam by the King County Medical Examiner found that the cause of death was due to intoxication with fentanyl and ketamine, a short-acting sedative commonly used for dental and medical procedures.

“When we learned of the patient’s death, we immediately reviewed the clinical record and conducted a detailed root-cause analysis to determine why our usual medication safety checks did not prevent this tragic error,” Dr. Fisher said.

“While this medication was prescribed and dispensed with the intention of providing the best care for the patient, in this case both the delivery system and the dose were inappropriate,” Dr. Fisher said.

Fisher said Blankenship’s prescription had gone through what was the hospital’s routine three-step safety process: first, the prescription had been ordered by a provider, then “double checked” by a nurse, and finally “triple checked” by a pharmacist.

Despite these safeguards, the prescription of fentanyl patch, which was usually reserved for Seattle Children’s cancer patients with chronic pain, was issued to Blankenship.

Dr. Fisher said that no individual staff would be disciplined for the error.

“A thorough investigation revealed that this was not the fault of any one individual. Our detailed root-cause analysis identified that this occurred because our processes failed at multiple points. We have since changed the way we prescribe and administer fentanyl patches,” Dr. Fisher said.

But Seattle attorney Chris Davis, who is representing the Blankenship family, singled out Dr. Barbara Sheller in a press release from his office.

“We have hired nationally recognized medical experts to examine the facts of this case,” Attorney Chris Davis says. “All of them state that Michael never should have been given the drug and that the physician who prescribed it, Barbara L. Sheller, DDS, likely had not even bothered to check to see if the drug and dosage was appropriate and safe. One expert went so far to say that he has never seen a more egregious and indefensible case of malpractice in 26 years of consulting on medical negligence cases.”

The lawsuit alleges Dr. Chatzpolous, a dental resident who was assisting Dr. Sheller during the boy’s surgery, wrote the prescription for the fentanyl patch for the highest dose available.

The medical records, however, do not indicate whether Dr. Sheller was consulted about the prescription, Davis said.

Dr. Fisher said under the new system prescriptions for fentanyl must also be approved by a pain specialist and undergo an additional check in the the pharmacy to make sure the drug is being prescribed appropriately.

Children’s will extend its review of its procedures for prescribing other drugs, starting with opioids and then others drugs that pose significant risks, Dr. Fisher said.

“We can never bring back this child or fully understand to what level we have devastated their family. We are deeply sorry for the family and will do everything in our power to ensure this never happens to another child at Children’s,” Dr. Fisher said.

To learn more:

• Read Dr. Fisher’s full statement below.
• Visit the Web site of The Davis Law Group, which has additional details about the lawsuit.
• Read the FDA’s warning on the fentanyl transdermal patch issued earlier this month.
• Visit the National Library of Medicine’s information page on fentanyl transdermal patch.

Statement by Dr. David Fisher on September 29th

Seattle Children’s Hospital Strives to Learn from a Fatal Medication Error

At Children’s we continually strive to improve the quality and safety of the care we provide. However, despite the work that we do to improve our medication and safety systems – errors are still possible. We want you to be aware of a fatal medication error that occurred at Seattle Children’s.

We prescribed and dispensed a high-dose fentanyl patch for outpatient post-operative pain control to a teenager with special needs who could not tolerate pills or liquid medicines. The patient died at home on the night of surgery, from an inadvertent narcotics overdose. We can never bring back this child or fully understand to what level we have devastated their family. We are deeply sorry for the family and will do everything in our power to ensure this never happens to another child at Children’s.

When we learned of the patient’s death, we immediately reviewed the clinical record and conducted a detailed root-cause analysis to determine why our usual medication safety checks did not prevent this tragic error. While this medication was prescribed and dispensed with the intention of providing the best care for the patient, in this case both the delivery system and the dose were inappropriate. We immediately notified the family of our error and apologized. A thorough investigation revealed that this was not the fault of any one individual. Our detailed root cause analysis identified that this occurred because our processes failed at multiple points. We have since changed the way we prescribe and administer fentanyl patches.

Based on our review, we have initiated several actions:

• We quickly changed our process for prescribing and administering fentanyl patches. Clinicians now must get approval from our pain medicine specialists. This ensures that a practitioner with the most expertise in chronic and acute pain management is weighing the risks and benefits of using a fentanyl patch delivery system in each patient before a prescription is given to a family.
• We reported this event to the Wash. Department of Health, as required by law. We also completed a report to the FDA, which is voluntary.
• We added information to our medication database that highlights the indications and contraindications for the use of a fentanyl patch. Specific language was added around what patients qualify for this type of medication, under what circumstances it can be used, and about monitoring for response and adverse events. We are providing comprehensive information to patients, families and other practitioners before fentanyl patches are used. Children’s pharmacists also designed and now use a special safety screening tool to ensure that the therapy is appropriate for each patient.
• We are looking for additional areas of risk where we can apply prospective safety process improvements to other high risk medications. We have embarked on a system-wide assessment of all high risk drugs used in our facility. We are committed to a multidisciplinary effort to identify and fix gaps in our medication processes. We are addressing all opiate pain medications as our initial area of focus.

This incident reinforces the fact that there is still work to be done to eliminate the potential for error in our processes. Providing a safe and healing environment for our patients and families is always our highest priority.

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