Thank you. I will.
Having 50 of our recommendations adopted by the accrediting body influences 3,700 health care sites and exemplifies how learning from reports and their analysis can lead to knowledge translation and proactive system enhancements.
I would like to take this opportunity to provide you with some examples relevant to Health Canada's regulatory mandate.
The first photograph I have for you is a picture of a transdermal patch introduced into the market. Because the patch was almost invisible, practitioners in emergency departments reported not knowing that patients were receiving a highly potent narcotic; the patches were being missed. The manufacturer responded very quickly and added both the name and colour to the patch, as seen on the next page. Medication patches are relatively new, and these incidents inform the need to include regulatory guidelines for labelling of patches.
On the next page you'll see two bags. The bag on the right, which is intended for pharmacy use only, was inadvertently infused intravenously instead of the IV solution on the left. We received three reports, one of an incident leading to serious harm, and we knew that in the U.S. there had been a fatality reported due to a similar error. We worked with the manufacturer, and they changed their label, as seen on the next page. This is a significant improvement.
There is still opportunity to improve the packaging of the bag. Until we make it impossible to connect a product not for IV use to an IV line, such dangers continue to exist.
On the next page you'll see two ampoules that were mixed up and reported as a near miss. The risk for harm is high. We have worked with individual manufacturers to improve such labelling, and we've provided an example of how the labelling can be improved on the next page, where you see the upper ampoule with print on glass and the lower ampoule.
We think printing critical information directly on glass should not be permitted. Ultimately this learning needs to be incorporated into regulations or guidelines so that the knowledge is translated into current and future manufacturing practices.
The next example is interesting because the label meets regulatory requirements for display of concentration. However, the product is not prescribed in millimoles; it is ordered by the physician in grams, and the conversion is not an easy calculation. We acted after only one report. The manufacturer quickly changed its label and thanked us for not just identifying the problem, but for providing recommendations for improvement. Note that this company took the extraordinary step of removing their logo from the label in order to give prominence to critical information.
In the last example we show five neuromuscular blocking agents. Neuromuscular blocking agents have been identified as high-alert drugs, which means that the drugs, when involved in an error, have a high incidence of causing harm. Three of the manufacturers voluntarily chose to follow our advice to place a warning on the top of the vial and two did not. This is a good example of a situation in which we could evaluate the recommendation together and, if it is reasonable, make it a requirement, again so that the learning is not lost on future products.
The key message is that underlying practice errors are opportunities for system enhancements to help prevent recurrence. Unless underlying risks are mitigated, it could be predicted that the errors will repeat again and again.
A key component of reporting programs is the follow-up and analysis and being responsive. For medication incidents, this includes identifying whether there are preventive strategies. It is also important to demonstrate to reporters that they have made a difference through their efforts to report, and this will in turn increase reporting.
ISMP Canada is aware of Health Canada's plans and initiatives to strengthen post-marketing surveillance, such as additional regulatory authorities post-market with labelling, and we would like to offer our assistance where possible.
Thank you.