What do you do if your child has a severe reaction to your medicine?
On Friday, the National Safety Council released the results of its investigation into what happened to one of the two infants whose parents filed a complaint with the Health Canada Safety and Quality Review Board last week.
The investigation was conducted by the Safety and Wellness Committee (SWC) of the Health Sciences and Technology Council of Canada (HSTC) and the Health Industry Council of North America (HICNA).
The committee has the responsibility for investigating complaints against health care professionals and pharmaceutical companies, and it has the power to recommend penalties and other measures.
It also has the ability to order the production of corrective materials and equipment to help prevent future safety incidents.
The first of the parents, Robert and Rose Marie Thierry, filed a safety complaint against ritter Pharmaceuticals and Ferring Pharmaceuticals on August 13.
The parents allege that the company failed to provide adequate instruction on the use of their medication to their infant son, who was born prematurely and weighed only four pounds.
The infant’s mother, Karen, said her son’s symptoms began on August 21, and she suspected the drug was causing the problem.
On September 3, the parents reported their child to the Health Department.
On August 22, a health professional in a Calgary hospital who had been in contact with Karen Thierrys reported her concerns to the SWC.
The SWC then contacted Ferring.
The SWC conducted an internal investigation of the complaint, which included interviews with Karen, Robert, and Rose.
The panel determined that Karen Thiers medication was administered as directed by Ferring’s medical director, Dr. David Kowalchuk, and that Ferring failed to properly test and monitor the baby.
Kowaluk was not charged with any crime.
But the panel found that Dr. Kowalsky failed to ensure that Karen was adequately receiving her prescribed medication, and failed to supervise Ferring staff in her care.
The panel also recommended that Fering be fined $25,000, the equivalent of $5,000 for each day it failed to adequately monitor and supervise Karen Thies medication.
The committee said it was satisfied that the firm failed to meet its responsibilities under the Code of Practice for Medical Devices (CPPM), which is an internationally recognized framework for ensuring that medical devices and equipment are safe, effective, and reliable.
The report also found that the HSTC had made significant improvements to its system for responding to patient complaints, but it recommended that the industry be required to do so.
The HSTS is currently reviewing the panel’s findings and has asked for more information.HSTS spokesperson John Bagnall said that HSTs policy is to provide a “consultative process” with all health care providers.
“We’re committed to working with health care systems across Canada to ensure we get this right, and we’re also committed to ensuring that our customers get the highest possible quality care,” he said.
“If there is a concern, we’re committed with a process of consultation with our patients, and working closely with them, to address it.”