“Everyone has acknowledged that this particular situation has really brought to light a gap in regulatory authority over these entities”
—Lori DeCou, Manager of Communications, Ontario College of Pharmacists
The Ontario government is giving the Ontario College of Pharmacists (OCP) the authority to inspect drug preparation premises (DPPs) as part of the province’s plan to better protect the safety of drugs purchased by hospitals.
On May 15, 2013, the government brought in new regulations and took other actions, in response to the distribution of diluted chemotherapy drugs from Mississauga-based Marchese Hospital Solutions. More than 1200 cancer patients at 4 Ontario hospitals and 1 in New Brunswick were treated with the intravenous medication that had been diluted with too much saline.
The revelation of the error in late March exposed a weakness in oversight, as Marchese and other DPPs weren’t specifically regulated.
“Everyone has acknowledged that this particular situation has really brought to light a gap in regulatory authority over these entities,” says Lori DeCou, manager of communications for the OCP. “That’s why there has been a real speed to stepping up and coming up with solutions.”
The OCP has traditionally had the authority to accredit community pharmacies and to regulate pharmacists and, more recently, pharmacy technicians. The quickest way to give the College new regulatory powers over DPPs was to expand its authority over the pharmacy professionals working in the facilities.
“It would have been more problematic and would have taken more time to open up the Drug and Pharmacies Regulation Act (DPRA) and give the College the authority to inspect an additional place,” says Ms. DeCou.
The College and the province agreed instead to amend the Regulated Health Professions Act (RHPA) and the Pharmacy Act to give the OCP the authority to inspect premises where a pharmacist or pharmacy technician engages in or supervises drug preparation activities. At the same time, the Ontario government is also bringing in a regulation that requires hospitals to purchase drugs only from accredited, licensed or otherwise approved suppliers. This would eliminate the potential for a DPP to use a nonpharmacy health professional to prepare drugs to get around the OCP inspection rule.
“It’s the combination of the 2 regulatory changes that really closes the gap,” says Ms. DeCou.
The new Pharmacy Act regulation requires a pharmacist or technician working or preparing to begin work at a DPP to inform the OCP, which will then have 60 days to do an initial inspection.
The new regulations give the College 150 days (5 months) from the date of filing (May 15) to identify the premises where its members are working and to have inspected those premises. The OCP is now in the process of developing inspection standards, as well as hiring and training inspectors.
Beyond the regulatory change, the Ontario government has set up an independent review to determine how the underdosing and hospital distribution of the chemotherapy drugs occurred and to recommend ways to prevent future incidents.
Leading this review is Jake Thiessen, the founding director of the University of Waterloo’s School of Pharmacy, who has previously advised both the Ontario and federal governments.
Dr. Thiessen will be supported by a working group that includes the OCP, Cancer Care Ontario, Health Canada, the New Brunswick government and people from the affected hospitals.