Fatality inquiry report makes recommendations about use of chloral hydrate

Alberta’s Ministry of Justice has published a report of a fatality inquiry into the death of an eight-year-old girl who died in January 2014. The autopsy report indicated the cause of death was trichlorethanol toxicity based on an accumulation of trichlorethanol, believed to be the result of receiving chloral hydrate as a long-term treatment for insomnia. The case is complicated, and interested pharmacists can learn more by reading the full report. As part of the inquiry, three recommendations were made by an expert witness:

1. Chloral hydrate can be used as a short-term measure to assist with sleep in children transitioning to different care situations. The usual dose is in the range of 50 mg/kg to a maximum dose of 1,000 mg. Given that tolerance to the hypnotic effect of chloral hydrate is known to develop within 10 to 14 days, this should be factored into the treatment plan and consideration should be made to wean or stop chloral hydrate shortly after the transition is accomplished. Chloral hydrate is not an appropriate drug for long [term] use to assist in sleeping in children.
2. Chloral hydrate should be prescribed with this in mind and should be prescribed for a defined period of time. It would be prudent not to have an automatic refill order for chloral hydrate but rather to thoughtfully assess the need and safety of prescribing before re-filling a prescription for chloral hydrate.
3. Chloral hydrate therapy should be monitored on a regular basis to evaluate dose, efficacy, and safety. The therapeutic plan for chloral hydrate should include considerations as to when therapy should be weaned/stopped.

In addition to sharing the recommendations of the report, ACP is sharing the following guidance which is similar to that provided by the College of Physicians and Surgeons of Alberta to physicians:

We encourage pharmacists to consider the recommendations from the report in conjunction with the advice in the peer-reviewed literature that suggests pharmacotherapy for insomnia in children should be limited and that chloral hydrate in particular should not be used for insomnia,^1,2 or its use should be substantially limited due to safety, side effects, and tolerance concerns.³

Furthermore, each time a prescription is dispensed, it is incumbent on the pharmacist to determine the appropriateness of each prescription. This includes understanding and considering whether the drug is indicated only for short-term use.  Pharmacists are reminded that as per Standard 6.2 “…when considering the appropriateness of a refill prescription, additional relevant factors that a reasonable pharmacist would consider in the circumstances include, but are not limited to:

1. continued need for the drug,
2. the date of the last fill,
3. patient compliance with drug therapy, and
4. the patient’s response to the drug therapy.”

Any time there is a loss of life, especially when it’s related to how health care was provided, it’s devastating to everyone involved. It’s up to all of us to learn from this and do everything we can to prevent it from happening again.

¹ Owens, Judith A. “Pharmacotherapy for insomnia in children and adolescents: A rational approach.” In A. G. Hoppin (Ed.), UpToDate (2019). https://www.uptodate.com/contents/pharmacotherapy-for-insomnia-in-children-and-adolescents-a-rational-approach#H655649244 (accessed August 27, 2019).

² Owens, Judith A. “Pharmacotherapy of pediatric insomnia.” Journal of the American Academy of Child and Adolescent Psychiatry 48, no. 2 (2009): 99-107.

³ Felt, Barbara T. & Chervin, Ronald D. “Medications for sleep disturbances in children.” Neurology Clinical Practice 4, no. 1 (2014): 82-87.