March 16, 2021
Better labelling lowers the risk of harm: HealthPRO and ISMP Canada partner to develop guidelines
HealthPRO and ISMP Canada are addressing the need for guidelines around the design and content of chemical labels, crucial for the safer use of APIs (Active Pharmaceutical Ingredients) in pharmaceutical compounding.
In 2016, Melissa Sheldrick’s 8-yr old son Andrew died as a result of a selection error made by a compounding pharmacy. Label design was identified as one of the contributing factors in the error.
A Safety Bulletin from ISMP Canada (May 25, 2017) delved into the details of Andrew’s case and among their recommendations was labelling compounding chemicals with unique item numbers. HealthPRO recognized the impact of the problem and added the Chemical Abstracts Services (CAS) Registry Number® to its online contracting portal accessed by over 1,300 healthcare facilities across the country.
Now, ISMP Canada and HealthPRO are collaborating to pursue a more concerted approach to the labelling gap.
Drug compounding in a time of drug shortages – not to mention the heightened demand created by a pandemic – is an essential, but inherently risky process. Part of that risk, says Christine Donaldson, HealthPRO’s Vice President, Pharmacy, can be attributed to the lack of regulatory guidelines around safe label design.
Without those guidelines, the quality control process as chemicals arrive at manufacturing facilities can be even more challenging. “The raw chemicals or APIs are imported in bulk quantities, then repackaged and sold in smaller containers for use in pharmacy compounding,” says Sheldrick, who now works as Patient and Family Advisor for ISMP Canada. “What goes on those containers is left up to quality control at each individual company.”
Environmental scan confirms gaps
As a first step in the Chemical Labelling Project, last year ISMP Canada did an environmental scan to identify the oversight for chemical labelling and the organizations that are doing it. The scan confirmed that gaps exist and steps are now underway to create an Advisory Panel to provide feedback on best practices and create recommendations for Health Canada.
“The goal of the Panel,” says Sheldrick, “is to have a complement of people from various parts of healthcare who know the process and can share their knowledge and ideas about the packaging and labelling of APIs. With all those different perspectives around one (virtual) table, we can start to create the fixes.”
Sheldrick and Donaldson are hopeful the conversation will encompass not just safe label design but good practices around label content.
The project has pretty aggressive timelines, but Donaldson is confident a lot can be accomplished by the spring. “Some of the challenges include the current labelling software used by chemical suppliers and how quickly they can create changes to existing products,” she says.
Naturally, there are costs associated with those kinds of changes and so the project team is focusing on the small steps that can be implemented quickly. “We recognize there are barriers and that every company is different,” says Sheldrick. “We want to help facilitate whatever can be done to increase safety.”
After talking to pharmacists for years, Sheldrick knows the desire for an improved process is there. “They don’t want to be involved in an error that causes harm, let alone death.” She praises HealthPRO’s forward-thinking and proactive approach in making a company’s inclusion of the CAS RN® in their proposal a large part of the suppliers’ product quality score.
The high volume of compounding done in hospital pharmacies – notably products for paediatric patients and geriatric patients who have trouble swallowing – Donaldson says points to the clear need for better labelling guidelines. “Safe labels are a critical step for ensuring the right drug is selected from the start to eliminate the chance of patient harm.”
A step in the right direction
It’s still early days, but the project partners are glad the ball is finally rolling on improving the chemical labelling process. At some point, the guidelines will need official approval from Health Canada but that’s down the road. “We’re keen to advocate for change that forces errors out of our complex system of product selection, including the addition of CAS numbers,” says Donaldson.
“I call this Andrew’s project,” says Sheldrick. “On a personal level, to feel this kind of support is huge. It’s coming from the collaboration of all these different organizations – HealthPRO, ISMP Canada, Health Canada, the pharmacists, the associations, and industry – a lot of people coming together to effect change. We’re all striving to improve safety and this is definitely going to help.”