Friday, October 11, 2013

Canada --Liberal introduce bill tightening regulation of hospital pharmacies

The Ontario Liberals introduced legislation Thursday that would increase oversight of hospital pharmacies, a move suggested by an independent investigator after last spring's massive chemotherapy medication error.
The bill, called the Enhancing Patient Care and Pharmacy Safety Act, would give the Ontario College of Pharmacists (OCP) the responsibility to develop regulations and start licensing and inspecting hospital pharmacies. The bill also includes mandatory reporting requirements when health care issues are identified and information-sharing guidelines for regulatory bodies, authorities and hospitals. Shortly after Easter weekend, the public learned that more than 1,200 patients at five hospitals - including 290 at Windsor Regional Hospital - had been receiving doses of two chemotherapy drugs that were weaker than their doctors had prescribed over the course of about a year. Hospitals had outsourced the time-consuming and potentially hazardous job of mixing the drugs with saline solution to Marchese Hospital Solutions, a private company.

A third-party investigation determined miscommunication over labelling and concentration standards was to blame for the watered-down doses.
The scandal put a spotlight on a regulatory grey area surrounding pharmaceutical practices known as compounding and admixing. Health law and guidelines allow pharmacists to modify and combine drugs to suit the needs of individual patients, but outside companies performing the service in bulk blurred the lines between compounding and drug manufacturing.
After the chemotherapy underdosing story broke, Windsor Regional went back to mixing the chemotherapy drugs in-house. The new legislation would bring that practice, along with the rest of the operations of Ontario hospital pharmacies, under the scope of the OCP.
The bill still has to gain the support of opposition parties and pass through the legislature before it becomes law. However, Ontario College of Pharmacists spokeswoman Lori DeCou said the college has already started preparing for its new role and wants to start licensing and inspecting hospital pharmacies as soon as possible.
"Are we going to be able to be in a hospital within the next couple of months? No. But is it going to drag into years? That's not our expectation," DeCou said.
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