A four year old child being treated for attention deficit disorder (ADD) and sleep disorder suffered sudden cardiac arrest and death, with medication toxicity implicated as a factor.
- Proper medication monitoring for dose and frequency requires careful communication between the primary care physician and referring physicians.
- Patients can be helpful, but are not always reliable for critical information that should be shared directly between clinicians, such as clinical concerns that require follow-up.
- When multiple physicians are ordering medications for the same patient, extra attention to dosage and interactions is necessary.
- Patients and parents of minor patients require information about significant risks associated with their medications.
A four-year-old boy with a complex neurological diagnosis including pervasive developmental disorder, ADD and sleep disorder, was under the direct care of a pediatrician since birth.
He was referred to a behavioral specialist for severe behavioral complaints, and the specialist started him on 500 mg of clonidine at bed time. He recommended that the child be closely monitored for side effects, including blood pressure and pulse. A consult letter containing this information was sent to the pediatrician who later stated he never received it.
Five months later, the child was referred to a sleep specialist, who started him on 1500 mg of chloral hydrate, one dose before bedtime. The child was seen by the sleep specialist twice and the specialist documented 11 telephone communications. According to the sleep specialist, medication risks were reviewed with the family.
When the sleep specialist saw the child four months later, he learned that sleep medications had been switched several times by the family, alternating between Benadryl, chloral hydrate, and hydroxyzine. The family had initially switched medications due to a concern that the choral hydrate was causing a rash. The specialist encouraged the family to carefully chart any visible changes or side effects, and he requested that the medications only be changed after clinical consultation. The sleep specialist documented this conversation in the medical record.
Over the next several months, behavior and sleep issues again worsened. The pediatrician suggested the parents administer a second dose of chloral hydrate during the night when the child woke up. The family then routinely administered two doses during the night.
Six months after the second appointment with the sleep specialist, the patient underwent surgery for a benign neoplasm (tumor) of the right temporal lobe. During the anesthesia work up, the parents were told the child was on a “whopping dose” of the chloral hydrate. Anesthesia did not communicate this concern to the pediatrician. The child was placed on steroids after surgery, and initially showed improvement in behavioral and sleep issues.
Upon the patient's discharge from the hospital, the neurologist re-started both the clonidine and chloral hydrate. Pharmacy called the pediatrician to question the high dose of the chloral hydrate. Since he didn't have much experience with the medication, the pediatrician reviewed a pediatric dosage text, but did not consult the sleep specialist who initiated the drug.
Several months later, the child collapsed at home immediately following a second dose of chloral hydrate, and died of a cardiac arrest. Although an acute overdose was not identified, evidence of elevated concentrations of clonidine and chloral hydrate was found in the body.
The parents sued the pediatrician, the behavioral specialist, and the sleep specialist, alleging the physicians failed to:
- make the parents aware of the cardiac side effects of the medications (clonidine and chloral hydrate).
- monitor the child for medication side effects.
- provide access to appropriate specialty care because of gate-keeping for the managed care organization.
The case was settled in the medium range. Parents reportedly settled because they were sympathetic to the pediatrician after learning of the death of his 5-year old son due to a medication reaction.
- Although other physicians recommended and resumed existing medications, the pediatrician continued al the prescriptions, and was unfamiliar with some of the medications he prescribed.
When required to refill prescriptions started by another physician, the prescribing physician should familiarize him/herself with the recommended dosage and significant side effects. When deciding on a significant increase in the medication dosage, consider discussion with the specialist who prescribed the medication. A prescribing physician is accountable for being familiar with the rationale, dosage and frequency of medications he or she is ordering. Any pharmacy concerns regarding strength or frequency can serve as a “red flag,” warranting review of the prescribed medication.
- The patient was not monitored for medication toxicity.
Primary physicians must be familiar with serious side effects of medications in order to be aware if a monitoring plan is needed and follow through appropriately. Communication with the specialist who initially prescribed the medication will be helpful in determining what monitoring is required.
- The family maintained they were denied access to specialists because of cost-containment, citing statements by providers, such as; "you have seen enough people" and "you've been seen by big city consultants."
Frequent requests for services and lengthy explanations may be viewed in a negative light by physicians. In turn physician responses may transmit an unintended negative overtone. Regularly-scheduled family meetings, setting clear expectations, and involving social services can enhance positive communication. Detailed discussion must occur when the primary care provider determines that specialty care is not required. Conversation should include eliciting the reason for the request, discussing whether the request can be addressed within the existing provider network and reason for denial or alternatives. In addition, patients/families should be provided with the process and contacts to register their concerns with appropriate administrators for immediate review and resolution.
Risk Management Perspective
- Lack of direct communication between the pediatrician and the specialists reduced the pediatrician's effectiveness.
Patients can be helpful in relaying information from other providers, but relying on patients for critical information is inappropriate. Primary care providers and specialists have a responsibility to ensure that the handoff of vital information reliably occurs. The specialist is responsible for written communications outlining the treatment plan, as well as directly communicating with the primary care physician when necessary. Specialists who do not consider themselves responsible for ongoing care should alert the primary provider of this. The primary provider has an equal responsibility in ensuring that he/she views consult reports and queries the specialist with any outstanding concerns or questions.
Legal Defense Perspective
- Meticulous documentation of patient visits and telephone communications with the family supported the defense of the sleep specialist against the claim that he authorized an inappropriate increase in medication dosage.
Thoughtful documentation of patient interactions, including review of the diagnosis, treatment recommendations, and the content of telephone conversations, is critical to establishing a defense. Careful documentation also enhances the perception that the care itself was careful and methodical.