In New Zealand we monitor the safety of prescription drugs through CARM - the Centre for Adverse Reaction Monitoring. The system is supposed to work like this: medical professionals report any adverse reactions or side effects they suspect may be related to prescription drug use. CARM collect these reports and they are analysed to identify any risks associated with particular medications. Here's why it doesn't work: medical professionals don't report.
Following my submission of an adverse reaction report in respect of Toran's death, I got an email from Dr Michael Tatley from Otago University who is the director of the New Zealand Pharmacovigilance Centre and Centre for Adverse Reactions Monitoring. He told me that CARM has on record 9 reports each of suicidal tendency (whatever that is!) and suicide attempt and 3 reports of completed suicide associated with Fluoxetine (Prozac) since 1989. I get three reports a month of suicides associated with Fluoxetine and CARM has recieved 3 in 22 years!
This shows how seriously doctors and other medical professionals take adverse reaction reporting and suicide prevention. It shows the current system for ensuring the safety of prescription drugs isn't working. Its hard not to laugh out loud at Medsafe's response to the failure of doctors to report adverse reactions "In June 2001, the CARM adverse reaction reporting form changed back to a pale yellow colour. This was partly due to a trainee intern survey at Dunedin Hospital in April 2001 that showed one barrier to reporting was lack of access to the reporting forms. It is hoped that a return to yellow might help to make it easier to find." Hmmm...you really think the colour of the form is the biggest barrier to reporting Medsafe?
Anyway, if we think medicine safety is important its up to us to do the reporting. As the families of those who have suffered adverse reactions including suicide, we need to be filing these reports. Its a simple process and takes very little time. The form is designed for medical professionals but probably the only technical term on it is the term rechallenge. In assessing whether an adverse reaction was caused by a drug, the assessors look for whether the drug caused the reaction on first being prescribed (challenge), the reaction disappeared when the drug was stopped (dechallenge) and the reaction re-emerged when the drug was restarted (rechallenge). This is what is referred to in the question about rechallenge. More information on how CARM assesses causality is provided on the Medsafe website http://www.medsafe.govt.nz/profs/adverse/causality.asp
It is vitally important that anyone who was taking or withdrawing from any medication at the time of their suicide has an adverse reaction report filed on their behalf. Medsafe is clear that they want suspected drug reactions reported and they will assess the information. Even where the drug use was a long time prior to the suicide it is important to report so we understand whether drugs have adverse effects long term. Anyone who wants help with deciding whether to file a report or filling out the reporting form can contact CASPER and we will help.
It is also important you don't assume your doctor will fill out the form and that even if you know they have, you also fill one out. Toran's file was reviewed by 7 psychiatrists and numerous other health professionals. Only one filed a report and I am not allowed to see it so don't know how accurate it is. I believe this person was his GP who only ever met him once. It was not the psychiatrist who prescribed the drug. As a reporter, I get information back from CARM that I would not get if I had not reported.
I have posted a link to the reporting form on the forum on this website under the Support section with a topic heading Adverse Reaction Reporting. You should also know that you can file an adverse reaction report with the company who manufacture the drug. Again this is a simple process involving a phone call. Please let me know if you need help with this too.
Building up a good base of information on the causes of suicide is critical to preventing it and this is an area in which we can be really pro-active.
Maria
