January 24, 2014 - Prescription drugs administered by physicians are the fourth leading cause of death in Canada and the United States.
The Conservative Government of Canada introduced 'Protecting Canadians from Unsafe Drugs' Act (Vanessa's Law) last December, a new patient safety legislation which will identify and expeditiously recall potentially unsafe medications and reduce adverse drug reactions.
Vanessa's Law applies to prescription and over-the-counter drugs, vaccines, gene therapies and medical devices that will protect Canadian families and children from unsafe medicine by:
- Requiring strong surveillance including mandatory adverse drug reaction reporting
- Recalling unsafe products
- Imposing tough new penalties for unsafe products including jail time and new fines of up to $5 million per day instead of the current $5,000
- Providing the courts with discretion to impose even stronger fines if violations were caused intentionally
- Compelling drug companies to revise labels to clearly reflect health risk information including updates for health warnings for children
- Compelling drug companies to do further testing on a product especially when issues are identified with certain at-risk populations such as children.
Vanessa's Law is in honour of the late daughter of Terence Young, Conservative PM for Oakville, Ontario. In 2000, his 15-year-old daughter died of a sudden heart attack while taking a prescription drug called Prepulsid to treat a stomach disorder. The family was not informed about the drug’s potentially fatal side effects and they did not know that the U.S. Food and Drug Administration had advised against prescribing the medication to patients that had eating disorders, arrhythmia, cardiac disease or electrolyte imbalance.
Adverse drug reactions account for roughly 25% of emergency room visits and hospital admissions.
When Vanessa died, Health Canada was in the process of reviewing the drug and concurrently the manufacturer withdrew Prepulsid from the market. Health Canada received 44 reports of potential heart-rhythm abnormalities, including 10 deaths associated with the drug and in the United States, Prepulsid was associated with 341 serious adverse reactions and at least 80 deaths.
Last year David Bruser, Jesse McLean and Andrew Bailey of the Toronto Star completed an analysis of Health Canada’s adverse-reaction database and found that children as young as 6 who were taking ADHD drugs had suffered strokes, convulsions, depression, amnesia, hallucinations, chest pains and psychotic disorders, and some had committed suicide.
Their analysis concluded that while Health Canada collects adverse-reaction reports, it does not communicate to the public the magnitude of these side effects. They found no evidence the regulator analyzes the data it collects therefore allowing the industry to govern itself.
Terence Young’s campaign for increased regulation of prescription drugs paved the road towards the proposed legislation giving Health Canada greater power to eradicate unsafe medications in the marketplace.
"Today, we have introduced Vanessa's Law, a law that would protect Canadians and help ensure that no drug that is unsafe is left on store shelves," said Minister Ambrose.
"It is difficult to overstate the impact this bill will have for Canadians who take prescription and over the counter drugs," said MP Terence Young.
"It represents a quantum leap forward in protecting vulnerable patients and reducing serious adverse drug reactions. It is absolutely necessary to reduce deaths and injuries caused by adverse drug reactions, 70% of which are preventable, and will serve Canadians extremely well."
“We truly are changing the face of the pharmaceutical industry and the healthcare system to make it more transparent, accountable and responsible,” said federal Health Minister Rona Ambrose.
U.S. Clinical Research Study
Drug manufacturers are not required to conduct research that proves medications are safe for our children.
According to a five year clinical research study and analysis led by Kenneth Mandl, MD, MPH, and Florence Bourgeois, MD, MPH at Boston Children's Hospital, there are major discrepancies between the amount of paediatric clinical research and the number of children who suffer from those diseases citing a relative lack of industry funding and support. Children bear nearly 60% of ten major global diseases and only 12% of the clinical trials for those diseases are focused on children.
Approximately 60% of the prescriptions given to children are off-label - treating a condition for which it has not been tested or approved. Drug manufacturers are not required to conduct research that proves medications are safe for our children.
Prescription drugs that are used as prescribed by physicians are the fourth leading cause of death in Canada and the United States.
More than 58% of the paediatric trials they surveyed were conducted with only government or non-profit funding while nearly 65% of adult trials had industry funding.
When it comes to medication efficacy and safety for children there is an undeniable lack of knowledge. Children and adults respond to medications differently, therefore, many medications on the market today are not specifically approved for children.
"Children are severely underrepresented in clinical research, despite several national and global efforts aimed at addressing their medical needs," said Dr. Kenneth Mandl, Director of the Intelligent Health Laboratory in Boston Children's Informatics Program. "Without proper information in paediatric safety and efficacy, doctors are often left with little choice but to extrapolate from adult studies when prescribing medications for children."
"But children are not small adults; they metabolize drugs differently than adults do, and their developing bodies may respond differently," stated Dr. Florence T. Bourgeois.
Drug manufacturers do not have an incentive to complete paediatric trials citing that most diseases are uncommon in children - but after looking at more than 2,400 clinical trials conducted between 2006 and 2011, Dr. Bourgeois and her colleagues noted that all the trials focused on conditions for which children make up a large share of patients.
U.S. drug manufacturers can extend their marketing rights for a drug including a study on the effects in children if the Food and Drug Administration (FDA) requests it and as well, the FDA has the authority to require paediatric studies of certain medications.
"Congress has helped increase studies for children by passing legislation that gives companies financial incentives to conduct paediatric studies and to require them to study a product they are developing for adults if the disease also occurs in children," stated Sandy Walsh from the FDA Office of Media Affairs.
"This new legislation [Vanessa's Law] is a welcome arrival for our healthcare system," said Gail Attara, the Chair of the Best Medicines Coalition, a patient advocacy group.
"It would give providers and hospitals better information to make the best choices when prescribing medications - which is good news for patients."
For more information on the ‘Protecting Canadians from Unsafe Drugs’ Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17), please visit the Health Canada information web page and questions and answers web page.
Vanessa’s Law – Quantum Leap in Drug Safety for Canadians - Terence Young, M.P. Oakville
Heartburn Pills that Cause Heart Attacks, Anti-depressants that Lead to Suicide – Maclean's Magazine
Off-Label Prescribing: What You Don't Know Could Hurt You – PharmaWatch Canada
Canadian Adverse Reaction Newsletter – Health Canada