It was only a year ago that the news headlines highlighted the story of three infants dying at an Indiana hospital due to overdoses of heparin used to flush vascular access lines.
ISMP issued a warning at that time in its September 21, 2006 Newsletter. The automated dispensing cabinet on the neonatal unit had been inadvertently stocked with heparin vials containing 10,000 units/mL. Nurses were used to drawing heparin from 10 units/mL vials from that cabinet and did not notice the difference (the ISMP Newsletter had photos of the vials, noting their similarity). ISMP pointed out the hazards of stocking automated medication dispensing machines, especially on neonatal and pediatric units because they are especially high-risk patients. They noted that a double check of all medications as they leave the pharmacy is important but not fool-proof. They also made a renewed call for vigilance for look-alike/sound-alike (LASA) items and strongly recommended use of barcoding as a patient safety tool. They pointed out that even when bedside barcoding is not available, barcode systems are available for many of the automated dispensing machines to help ensure proper stocking of those machines.
ISMP said in that 2006 Newsletter that “similar medication errors could probably happen in most hospitals”. Sadly, it has occurred again under almost identical circumstances, though this time without apparent harm to the infants affected. These cases made national headlines because 2 of the 3 infants receiving the errant dosages were children of actor Dennis Quaid. Lucian Leape, M.D., the most well-known authority on medical errors, pointed out that such errors can occur even at facilities with good track records, noting that Cedars-Sinai has been a leader in patient safety.
Baxter, manufacturer of the products reported to have been used in the incidents at both hospitals, had issued an alert to hospitals (including photos of the vials that might be mixed up) in February 2007 and had begun repackaging to make the two dosage strengths more distinctive. However, many hospitals had continued to use old stock of these medications and had not yet switched over to the newly repackaged drugs.
ISMP, in its November 29, 2007 Newsletter, reiterated its recommendations about double checks of all drugs leaving the pharmacy destined for floor stock and using barcoding. It also suggested using prefilled syringes of heparin flush solutions rather than using vials of heparin flush on the units. They also have a link to a recording of a February 2007 presentation about the Indiana cases. And they remind facilities to make sure they replace any old stock with the newly repackaged stock from Baxter. The ISMP Newsletter then editorializes about our failures to adopt a true learning culture and to be truly mindful about safety.
According to the LA Times, Cedars-Sinai has apparently removed all heparin used for peripheral IV flushes from the pediatric unit and will instead use only a saline solution for flushes for both pediatric and adult units. In addition, the higher concentration heparin vials will be stored separately in the pharmacy from heparin in the lower concentration. They will also be retraining all nursing and pharmacy staff in medication administration. They are also contemplating a barcoding system.
Anticoagulants remain high-alert drugs and Joint Commission has added a new national patient safety goal for 2008: 3E Reduce the likelihood of patient harm associated with the use of anticoagulation therapy.
Fortunately, there does not appear to have been any actual patient harm in the most recent cases. However, the occurrence of these incidents and the preceding ones provides some valuable lessons learned.
They serve as a good reminder that double checks remain weak solutions in any root cause analysis. Human error rates in many industries show error rates of 10% or higher when someone checks the work of someone else. So even though you should not abandon your double checks before medication administration, you must have other protections in place as well.
Secondly, Joint Commission requires facilities to incorporate failure mode and effects analysis (FMEA) into their quality improvement activities. When we are asked what problems a facility might consider for a FMEA, hi-alert drugs are always at the top of our list. Doing FMEA for processes related to anticoagulants is important not only in helping to prevent errors but may also be very valuable in helping you to respond quickly and appropriately to prevent patient harm in the event that such an error actually occurs.
Thirdly, Joint Commission also requires your organization systematically review look-alike/sound-alike medications as part of your medication safety program. Too many organizations spend most of their time on the “sound alike” portion and not enough time on the “look alike” side, especially looking at packaging and labeling.
A fourth lesson is more philosophical. There are certain medications that clinical staff often don’t consider to be ”medications”. Heparin flushes are probably one of those. IV solutions are another. We need to do a better job of reminding staff about all potentially dangerous things.
Fifthly, automated dispensing machines have been a godsend for most organizations and have undoubtedly contributed to improvement in both efficiency and patient safety. However, they do bring their own set of potential problems. You should be looking to ensure that they are tied to other technological patient safety initiatives such as barcoding and computerized physician order entry (CPOE). In the meantime, consider them as another topic for FMEA.
Lastly, think about how your organization responds to alerts that are put out by critical incidents occurring anywhere. Don’t wait for something bad to happen at your facility. Make sure that part of your routine patient safety activities is responding to alerts put out by the FDA, ISMP, Joint Commission, your state Department of Health, or other reputable organizations that issue alerts. One item on your monthly quality improvement/patient safety agenda should be “Industry Alerts and Concerns” and someone should be charged with scanning the appropriate resources for such alerts.
Update: See also our April 2008 What’s New in the Patient Safety World column “More Neonatal Incubator Fires, More on Nosocomial UTI’s, More on 1000-Fold Heparin Overdoses” and our May 2008 What’s New in the Patient Safety World column “UK NPSA Alert on Heparin Flushes” and our July 15, 2008 Patient Safety Tip of the Week "Heparin Flushes.....Again!"
In addition to this month’s column above, there are 2 important new patient safety resources we’d like to point out:
(1) an excellent paper by ECRI Institute on how to get ready for the CMS final rule on Hospital-Acquired conditions. There is also a video and podcast available. You'll see that you should already have the coding end up and running now even though payment won't be withheld until October. It gives good recommendations on putting together a multidisciplinary team to get ready for this.
(2) AHRQ has made available 17 patient safety toolkits produced under it's Partnerships in Implementing Patient Safety (PIPS) grant program. We’ll be reviewing some of these in future Tip of the Week columns.