By Ed Silverman // June 30th, 2010 // 7:26 am
There have been numerous claims that a medication caused a suicide, but few lead to sweeping changes. In Canada, however, the suicide of 18-year-old Sarah Carlin, who had taken the Paxil antidepressant, is a clear exception. Following a coroner’s inquest, Canada’s provincial and federal governments were told to ensure patients are better informed about drug risks, tighten regulations on drugmakers and establish an independent agency to regulate medications.
“If these things had been in place at the time Sara was prescribed Paxil, she would be alive today,” her father, Neil Carlin, said outside court. “We consider this a great victory…We are truly confident that if these are acted upon there will be young lives saved down the road.”
For more than a year before her death, Sara had been taking Paxil, an anti-depressant, which Health Canada warns can increase the risk of suicidal events in children and adolescents under 18. The teenager hanged herself in her parents’ basement in May 2007. The inquest made numerous recommendations, which you can see if you keep reading…
Of the various recommendations, the one that is garnering the most discussion appears to be the creation of a Drug Safety Board to investigate the side effects and issue warnings to the public, doctors and hospitals. The inquest specifically recommended the new board not receive any funding from drugmakers. Drugmakers must also report all adverse events to Health Canada within 30 days.
A Glaxo spokeswoman writes to says the drugmaker “is supportive of appropriate recommendations designed to prevent similar tragedies from occurring in the future, and will give the recommendations addressed to the broader pharmaceutical industry our full attention and consideration. Sara Carlin’s death was a tragedy and we continue to express our deepest sympathies to her family.”
1. The Ministry of Health and Long-Term Care (MOHLTC) should develop a Drug Information System. This system would promote:
• Patient safety in the prescribing and dispensing of drugs.
• Collection and compilation of data in a single repository for all drugs dispensed for all Ontarians.
• Research into drug and patient safety.
2. The Drug Information System should track and monitor all drugs dispensed in Ontario regardless of who is paying for the prescription.
3. The Drug Information System should collect, compile and release data upon request to scientists such as those studying population-based health outcomes at the Institute for Clinical Evaluative Sciences.
4. The Ministry of Health and Long-Term Care should commit to developing a province-wide suicide prevention strategy as has occurred in other provinces such as Alberta.
5. The objectives of the province-wide suicide prevention strategy should include:
• Enhanced mental health and well being for Ontarians.
• The education of the public to de-stigmatize mental health disorders, including depression and substance abuse disorders.
• Improving intervention and support for Ontarians affected by depression and substance abuse.
• Improving intervention and treatment for those at risk of suicide.
• Increased efforts to reduce access to lethal means of suicide.
• Increased research activities in Ontario on suicide, suicidal behaviour and suicide prevention.
• Improved suicide and suicidal behaviour-related surveillance systems.
• Inform and educate the media into strategies when reporting deaths due to suicide to prevent ‘copy cat’ suicides from occurring.
6. Strategies in the province-wide suicide prevention strategy should be humane, effective and evidence based, respectful of community and culture-based knowledge, inclusive of research, surveillance, evaluation and reporting and reflective of evolving knowledge and practices.
7. The ministry of Health and Long-Term Care of Ontario and Government of Ontario should commit to supporting the development of a national suicide prevention strategy for all Canadians.
RECOMMENDATIONS FOR THE ONTARIO COLLEGE OF PHYSICIANS AND SURGEONS AND THE ONTARIO COLLEGE OF FAMILY PHYSICIANS
8. The Ontario College of Physicians and Surgeons and the Ontario College of Family Physicians should develop practice guidelines and training to family physicians on administering and monitoring the use of selected serotonin reuptake inhibitors (SSRIs). Those guidelines should include, but not be limited to the following:
Prior to prescribing SSRIs the physician should:
• Give the patient a physical examination.
• Request laboratory investigations, including drug screen where appropriate.
• Inform the patient of the benefits and risks, inclusive of rare and serious side effects of SSRIs.
• Inform the patient of all reasonable alternative treatments.
• Inform the patient of the treatment plan should SSRIs be prescribed.
• Discuss with the patient alcohol and substance abuse as confounders in the illness.
B: Emphasize to physicians that best practice monitoring patients for drug-related adverse events arising from the introduction of SSRIs includes a regime in which the physician should monitor the patient with weekly visits for the first month, biweekly visits for the second month, and with a following visit in the third month. This effectively would monitor the period of time with the greatest risk for the development of serious drug-related adverse events.
C: Encourage physicians to utilize tools created to monitor both disease symptoms and adverse events of patients undergoing treatment with SSRIs. An example of such a tool is the SSRI Monitoring Form for Children and Adolescents developed in June of 2009 by the British Columbia Children’s Hospital in Vancouver, British Columbia.
D: Emphasize to physicians that while having due regard for the relevant health privacy legislation in the jurisdiction of the medical practitioner relevant to capacity and consent; patients undergoing treatment should be encouraged, repeatedly if necessary, to allow communication and engagement of family members, guardians and/or trusted friends by their treating physicians to ensure that the patient and their supports are aware of the nature of their disorder and the potential side effects of prescribed medications and can assist in the monitoring for adverse drug-related events.
RECOMMENDATIONS TO THE ONTARIO HOSPITAL ASSOCIATION
9. The Ontario Hospital Association should inform its hospital members that patients suffering with mental health disorders including depression, anxiety and substance abuse and attempted suicide may present for treatment to their hospitals and emergency department. While respecting the Personal Health Information Protection Act, 2004 every effort should be made to obtain consent from the patient to allow the release of the medical records compiled to the patient’s treating family physician.
RECOMMENDATIONS TO HEALTH CANADA
10. In order to maximize the effect of Health Canada Advisories detailed drug-related adverse events, Health Canada should consider that the Health Advisories:
• Be succinct.
• Clearly set out the warning.
• Should clearly set out the body of evidence giving rise to the warning.
• Should be specific.
• Should be profiled in a way to attract the physician’s attention.
11. Health Canada, as a regulator of companies seeking drug approval, should make their approval contingent on receiving results of all clinical trials from the drug manufacturers.
RECOMMENDATIONS TO REGULATED HEALTH PROFESSIONALS
12. All colleges legislated under the Regulated Health Professions Act, 1991 should require mandatory reporting to Health Canada by its members of serious drug-related adverse events as defined by Health Canada.
RECOMMENDATIONS TO THE PUBLIC HEALTH BRANCH OF THE MINISTRY OF HEALTH AND LONG-TERM CARE AND THE MINISTRY OF EDUCATION
13. These two ministries should develop an educational program regarding mental health and substance abuse for the adolescents and youth of Ontario’s school system. The circumstances of the death of Sara Carlin as presented at the inquest may be of assistance in the development of this program. The program should seek to inform the adolescents and youth in its schools that suffering with mental health disorders including depression and anxiety is common at their age. In addition the program should:
- Seek to de-stigmatize these illnesses.
• Provide information that these conditions are treatable.
• Emphasize the importance of abstinence from alcohol and other substances as utilizing these may contribute to mental health disorders and precipitate suicidal ideation and suicide.
RECOMMENDATIONS TO THE ONTARIO COLLEGE OF PHARMACISTS AND THE ONTARIO PHARMACISTS’ ASSOCIATION
14. When a prescription is filled the patient should receive a standardized and plain language information leaflet based on the product monograph. The information provided to the patient should include:
• What the medication is for.
• What the risks of taking the medication are.
• Under what conditions the medication should not be taken.
• Interactions with the medication.
• The proper use of the medication.
• Side effects and what to do about them.
RECOMMENDATIONS TO THE CANADIAN DRUG MANUFACTURERS’ ASSOCIATION
15. Drug companies should be required to report to Health Canada all serious adverse events associated with their drugs from all foreign jurisdictions within 30 days of the adverse event.
RECOMMENDATIONS TO THE CANADIAN FEDERAL GOVERNMENT
16. There should be an arms length body independent from Health Canada called the Drug Safety Board, which is solely dedicated to drug safety, which reports to Parliament, which is funded by the Federal Government and which receives no money from drug companies. Amongst its mandated responsibilities should be drug safety research, investigating adverse reactions and issuing warnings to the public and health care professionals and hospitals.