INQUEST INTO THE DEATH OF: MARIE TANNER Details Name of Deceased: Marie Tanner Date of Death: January 21, 2002 Place of Death: Peterborough Regional Health Centre Cause of Death: Cardiac Arrest Caused by the Intravenous Injection of Concentrated Potassium Chloride By what means: Accidental Age of Deceased: 83 Location of Inquest: Peterborough Date of Inquest February 9, 2004 February 12, 2004 Release date of Verdict: February 12, 2004 Key Recommendations of Note for Hospitals The jury made several recommendations. Although not all of the recommendations are directed at hospitals, they may still be of interest. The jury recommended: 1. Concentrated potassium chloride be removed from patient care areas outside the pharmacy of all hospitals and health care facilities. 2. Health Canada work with the pharmaceutical manufacturers to ensure that potassium chloride concentrate and other concentrated electrolytes be packaged in such a fashion that they are immediately distinguishable from other vials of medication by quick visual inspection or touch and include the highly visible warning DILUTE BEFORE USE or MUST BE DILUTED. 3. That all hospitals implement protocols for initial response to incidents concerning unexpected death or near death. This protocol shall include, but is not limited, to the following: That immediate notification of the coroner be made after the most pressing needs of the patient have been met in the event of death. That the appropriate hospital personnel be immediately notified of the incident and the scene be preserved and not disturbed. That a pre-designated individual shall be assigned and trained to secure, preserve, and record details of an incident scene until the arrival of internal investigative personnel, the coroner, and other external investigative authorities, such as the police. 4. The Chief Coroner in the Province of Ontario issue a written directive to all provincial Coroners that, when notified of a death, they provide clear instructions regarding scene preservation until the arrival of the Coroner and other investigative authorities.
Key Recommendations of Note for Hospitals (cont d) Coroner s Comments: Recommendations 3 and 4 resulted from the fact that in this case, the scene was not secured following the incident and essential evidence was lost. Fortunately it was not relevant in this case because all the individuals involved freely admitted exactly what they had done. However, if that had not been the case, it would have been difficult to reconstruct the scene appropriately. In Recommendations 3 and 4, the jury is outlining that hospitals should have a protocol in place which will ensure that in a sudden unexpected death after the administration of a medication, the scene is preserved and not disturbed until the arrival of the police and the coroner. 5. That all hospitals adopt a standardized medication safety report program such as ISMP Canada s Analyzer, for the centralized collection, analysis, and distribution of data. The compiled data is expected to be freely disseminated to all hospitals and health care facilities and the Ontario College of Nurses, Coroner s Comments: The expert witness had indicated that there is not a standardized medication safety report available in all hospitals and it is not used every time a medication error occurs. As a result of this information not being freely available and distributed, medication errors are under-reported. By using a safety report on medication errors, it would help to identify the true instance of medication errors and obviously corrective steps could be taken. 6. That hospitals review their training policies to increase the requirement for mandatory training in lieu of self-help programs in the areas of administration of medication and best practices. 7. All similarly situated medication carts shall be organized and equipped with the same stock medications and supplies in a uniform and consistent manner. Coroner s Comments: Evidence was heard during the inquest that not all the medication carts were standardized, and therefore it increased the risk of picking the wrong medication from the cart. 8. That hospitals and health care facilities review their current protocol regarding Do not resuscitate requests to consider the use of resuscitation in the event of preventable death occurring due to human error or unnatural causes. Coroner s Comments: In this case, there was a DNR order on Mrs. Tanner in the event that she died, but that order was if she died of natural causes and does not apply for a death occurring as a result of human error or unnatural causes. In this case, resuscitation was not attempted, even though death occurred as a result of a medication error, but the evidence clearly showed that unfortunately even if resuscitation had been attempted, it would not have been successful due to the fatal nature of the potassium chloride. 9. The recommendations made by Mr. David U, President and CEO, Institute for Safe Medication Practices Canada presented below: Recommendations to the hospitals: Hospitals should take immediate steps to ensure that no concentrated potassium chloride ampoules/vials are accessible to staff within the hospital, outside of the pharmacy. Hospitals should take steps to ensure that other concentrated electrolytes including potassium acetate, potassium phosphate, and sodium chloride, greater than 0.9%, are not available in patient care areas. Hospitals should purchase commercially available potassium chloride (KCl) pre-mixed dilute solutions and make them available on all nursing floors. 2
The Pharmacy and Therapeutics Committee and the Medical Advisory Committee should develop and approve a policy to standardize potassium chloride solutions to be ordered by physicians. Hospitals should evaluate the need for an automatic substitution for potassium chloride based on the standard solutions approved for use. The Pharmacy should prepare all other non-standard concentration KCl solutions that are not commercially available. These solutions may be required for neonatal intensive care unit and/or pediatric unit. A pharmacist should be on-call to provide guidance and advice on issues dealing with potassium chloride after normal hours of pharmacy operations. Hospitals should consider stocking the concentrated KCl 40 mmol/20ml size ampoule/vial ONLY in the night-cupboard for emergency use. A fluorescent warning label Fatal if Injected Undiluted should be visibly affixed to each and every ampoule/vial. In addition, the ampoule/vial should be packed in a zip lock bag that later serves to indicate to Pharmacy that an ampoule/vial has been used during the night. For special units and other unique situations (such as the use of dialysate for peritoneal dialysis) where a small quantity of KCl solution is needed, hospitals should consider the use of the partially diluted KCl pre-mixed mini-bags for drawing up the required amount for infusion. The Pharmacy and Therapeutics Committee should develop and approve a policy on maximum concentration for KCl allowable in IV solution, as well as on maximum infusion rate for KCl. All physicians orders on potassium chloride infusion must indicate instructions for dilution and the infusion rate. Physicians orders such as Give KCl 20 meq bolus is NOT acceptable. The word bolus is misleading as it is often interpreted to mean give by direct injection. Hospitals should consider the use of pre-filled saline (sodium chloride) flush syringes that are commercially available. Recommendations to Government Agencies, Coroners, and the Ontario Hospital Association The Ontario Hospital Association and all healthcare professional associations should remind and encourage their members to report medication errors and other hazardous situations to the Institute for Safe Medication Practices Canada, a non-profit independent organization established to collect and analyze medication error data for information sharing and learning purposes. In this way, hospitals can be notified of important safety issues outside their own domain. The Ministry of Health and Long-Term Care should establish a central repository for medication errors to identify trending and to develop actions for prevention. The Ontario Ministry of Health should provide a long term, sustainable support to ISMP Canada to support a continuing medication safety support program for the healthcare system in Ontario. These include a continuing effort to further assist hospitals in Ontario to eliminate hazards on potassium chloride use, as well as on other high alert drugs. The Ministry or Department of Health of the other provinces should start implementing a similar medication safety support system of ISMP Canada. Specifically they should adapt intervention programs to education and ensure a constraint function to eliminate the hazards of potassium chloride use. 3
Health Canada should mandate the pharmaceutical industry to perform Failure Mode and Effect Analysis on new products to be submitted for approval. This proactive method of analysis will identify failure modes that could potentially cause harm to patients. Health Canada should require changes in current labeling and packaging of potassium chloride concentrate injection to reduce the potential for confusion. Health Canada should establish a formal structured program monitoring safety issues involving product-related medications errors post-marketing. The Canadian Council of Health Services Accreditation should recommend that Canadian hospitals remove concentrated electrolytes including concentrated potassium chloride, potassium phosphate, potassium acetate, and sodium chloride greater than 0.9 percent solutions from patient care areas. Coroner offices across Canada should share reports and other related information on patient deaths involving medication errors among themselves, as well as with the Institute for Safe Medication Practices Canada. Recommendations to Pharmaceutical Industry: In cooperation with Health Canada, pharmaceutical companies that manufacture and market concentrated potassium chloride ampoules and vials in Canada should immediately address the issue of look-alike ampoules and vials of potassium chloride concentrate injection. In addition, adequate warning systems should be addressed on the package label. In cooperation with Health Canada, pharmaceutical companies and intravenous solution companies should address and meet hospitals potassium chloride premixed dilute solution concentration requirement. In cooperation with Health Canada, pharmaceutical companies should implement the Failure Mode and Effects Analysis test in the product s name, label and container of existing marketed products, as well as new products. (In the US, FDA has proposed a Concept Paper for pharmaceutical companies to conduct a premarketing risk assessment to ensure that a product s proprietary name, established name, container label, carton labeling, package insert, and/or packaging do not advertently contribute to medication errors 1 ) 10. The Ministry of Health provide additional funding to hospitals and health care facilities to assist in the implementation of the above recommendations. 1 Concept Paper, Pre-marketing Risk Assessment, Centre for Drug Evaluation and Research, FDA. http://www.fda.gov/cder/meeting/group1final.pdf 4
Summary Marie Tanner was an 83-year old female who had been in hospital with a fractured hip. Following surgery, she had a Central Venous Catheter (PICC) inserted. On the 21st of January 2002, she was being transferred to the x-ray department and it was decided that her IV should be removed from the PICC Line to make transport easier. Her nurse removed the IV Line and prepared to flush the PICC Line with saline and heparin. Unfortunately, instead of heparin, the nurse injected potassium chloride and Mrs. Tanner immediately had a cardiac arrest and could not be resuscitated. The nurse immediately recognized her mistake. In 1999, another patient died in the same hospital when injected with concentrated potassium chloride. Although corrective action was taken by the hospital at that time, it obviously did not prevent this most recent death, and accordingly it was decided that an inquest should be held. The evidence at the inquest indicated that after the first death, the hospital directed the pharmacy to supply pre-mixed diluted potassium chloride IV solution to the nursing units. Unfortunately, concentrated potassium chloride was still available on the units in a locked medication room. Earlier that morning, the nurse had taken two vials of potassium chloride both containing 20 meq from the locked medication room to add to an IV solution on another patient. When she arrived at that patient, she realized that only 20 meq of potassium chloride was needed, but she failed to return the other vial of potassium chloride to the locked medication room. She kept that vial in her pocket. When she later took normal saline and heparin from the medication cart, she also put those vials in her pocket. Since the vials of potassium chloride and normal saline look similar, she unfortunately injected potassium chloride to flush the Line, instead of normal saline. There was no disagreement among any of the witnesses regarding the events that took place. The nurses directly involved gave evidence, as did the Vice President and Chief Nursing Officer who indicated the changes that have occurred in the hospital regarding potassium chloride since this death. Contact The Coroner s Jury Verdict & Recommendations highlights inquests of interest to hospitals. These inquests either relate to deaths in hospital or the coroner s jury, in these inquests, has made recommendations directed at hospitals. Although coroner s jury recommendations are not legally binding, hospitals may wish to review and consider them, as may be appropriate. For further details or a full copy of the verdict, please contact Cyrelle Muskat at (416) 205-1378 or cmuskat@oha.com. 5