A new clinical trial introduces adverse drug event reporting to select pharmacies

Updated on July 16, 2021 (Originally posted on May 6, 2021) The Tablet

ActionADE will monitor the impact of communicating adverse drug events through PharmaNet

By Angela Poon

Nearly a decade after the planning began for ActionADE, a B.C. research project focused on preventing adverse drug events (ADEs) in patients presenting to hospitals, a randomized control trial is set to begin this spring. The first project of its kind in Canada, data will be collected from 3,000 patients over the next 18 months to two years, testing the efficacy of a software program designed by the ActionADE research team to help prevent the occurrence of repeat ADEs.

“I’m really delighted that it’s finally happening,” says Dr. Corinne Hohl, ActionADE project co-lead. “It does feel like a large achievement to have finally gotten here. There were so many roadblocks. As a scientist, it’s the most exciting time when you can really test your idea.”

According to ActionADE’s website, ADEs are recognized as one of the leading causes of death in North America. In Canada, ADEs cause or contribute to 1.7 million emergency department visits annually, accounting for about 1 in 9 adult visits to the emergency department. In B.C., ADEs are responsible for 240,000 emergency room visits each year. More importantly, ActionADE estimates that at least a third of these occurrences are repeat events, which could have been prevented with more effective channels of communication between the members of a patient’s health-care team.

ActionADE first stemmed from Hohl’s experiences as an emergency medicine physician at Vancouver General Hospital (VGH), where she witnessed countless patients suffering from repeat ADEs. She began researching these occurrences through the Centre for Clinical Epidemiology and Evaluation at Vancouver Coastal Health Research Institute.

Corinne Hohl

ActionADE first stemmed from Dr. Corinne Hohl’s experiences as an emergency medicine physician at Vancouver General Hospital (VGH), where she witnessed countless patients suffering from repeat ADEs.

“As a physician, I was seeing a lot of these types of adverse drug event cases. We found that a lot of patients were coming in and out of emergency departments and they were being re-exposed to the same or same class of medications that had previously caused harm,” says Hohl. “The next logical step was to try and find a solution to this problem knowing that the current system doesn’t work very well for patients. You have all of these disconnected systems that don’t communicate very well.”

In 2010, Hohl met fellow Centre for Clinical Epidemiology and Evaluation scientist Dr. Ellen Balka, whose research specializes in the design and implementation of information technology in the health sector. As project co-leads, the pair formed ActionADE, in an effort to offer concrete solutions for the prevention of repeat ADEs. Rather than develop a reporting system that would operate independently, they wanted to create a program that would complement existing programs in use across a patient’s circle of care, including hospitals, physicians’ offices and pharmacies, so that the records could follow a patient through his or her health-care journey. The project was awarded a Partnerships for Health System Improvement grant from the Canadian Institutes of Health Research (CIHR) in 2012.

“We used that grant to do what I call due diligence research—a systematic review looking at all the existing software that dealt with adverse drug events internationally,” says Balka. “We also obtained information about all of the fields in all of those existing software programs and looked at what the shortcomings of those systems were. We were able to sort the fields into different categories and use that as a starting point to figure out what fields would be critical for collecting data about adverse drug events.”

Dr. Ellen Balka

Dr. Ellen Balka's research specializes in the design and implementation of information technology in the health sector.

The team was able to develop a preliminary design of the system, through a high degree of engagement from its initial users, including on-site observations of pharmacists in hospitals and community settings, as well as physicians, to better understand work processes. User feedback helped the team cycle through several iterations of the system on paper, in preparation for building the software program. With resources from a second CIHR grant in 2015, which also included a financial contribution from the College of Pharmacists of British Columbia, ActionADE implemented the system locally at VGH, continuing to receive and incorporate feedback as the team collected further data. A third grant from CIHR in 2019 allowed the project to move into its third phase—integrating the proprietary program with PharmaNet so that ADEs can be easily communicated with community pharmacists. This was accomplished with the support of the Ministry of Health, who came on as a project partner in 2018.

“We needed to develop a system with the primary aim of making it connect appropriately so the information can follow the patient,” says Hohl. “There are many standalone medical applications that are not integrated with anything else and that’s really what we need to move away from. We don’t need more apps; we need more communication.”

On Dec. 7, 2020, the project reached a major milestone when the first ADE was reported live in PharmaNet. Building upon this success, the project is expected to begin its randomized control trial in May 2021. The ActionADE software will independently randomize patient data, choosing to either transmit the data through to PharmaNet or retain the data within the local system, which is the current standard. This will allow the research team to better understand the incremental effects of having the automated information flow to community pharmacies compared to standard care.

PharmaNet will share ADE information to all users of the PharmaNet system, however two of PharmaNet’s biggest community pharmacy systems—Kroll and ARI, with a possible third joining soon—have modified their software to improve the display of ADE information and the recording of clinical interventions by pharmacists subsequent to viewing ADE alerts.

Participating sites include: VGH, UBC Hospital, St. Paul’s Hospital, Mount Saint Joseph Hospital, Lions Gate Hospital, Richmond Hospital, Squamish General Hospital, and Whistler Health Care Centre. This information will allow community pharmacists to assess the safety of a particular drug prescribed to their patient, in light of their past ADE. The trial is expected to run 18 months to two years, or until just over 3,000 events are captured.

Hohl anticipates ActionADE will make a big impact on a community pharmacist’s quality of care for patients. Historically, pharmacists often have no way of knowing whether a patient has experienced a past ADE, unless expressly communicated by the patient.

“I really hope that it will put community pharmacists at the centre of a safety evaluation, just to make sure that the medications the patient is getting are appropriate and, in the patient’s best interest,” she says. “It will generate more communication and, I hope, bring that community pharmacist into that circle of care.”

While the long-term future of this project is dependent on an entity—such as the Ministry of Health or a health authority—eventually taking ownership over the software, Hohl notes that the data alone will be a major boon for patient safety.

“[The data] opens up a world of opportunity for science. We’re going to start generating a lot of data that will be helpful for researchers. As a by-product of these physicians and pharmacists communicating adverse drug events to community pharmacies to prevent repeat adverse drug events, you can also just mine that data to understand what the most common adverse drug events are, and what types of patients get them. There’s a whole secondary component to this.” For more information, visit actionade.org.

Mandatory reporting

Several initiatives to increase the safety surrounding medication use have recently come into effect in B.C., in an effort to better protect patients.

The Protecting Canadians from Unsafe Drugs Act, more commonly known as Vanessa’s Law, came into full effect on Dec. 16, 2019, making it mandatory for all hospitals in Canada to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of the reaction or incident being documented. Vanessa’s Law empowers Health Canada to order recalls, impose tougher penalties for unsafe products and compel drug companies to review labels or do further testing on products.

And in September 2019, the College of Pharmacists of BC approved a motion to require mandatory anonymous medication incident reporting in all pharmacies across the province by 2022. Standards, criteria, bylaw and policy changes are currently being developed in the hopes of implementing the new regulations by next year. Currently, Saskatchewan, Manitoba, New Brunswick, Nova Scotia, and Ontario pharmacies are all required to report medication incidents.

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