CADDAC was just notified of the recommendation by the Committee to Evaluate Drugs or CED (part of OPDP) as a follow-up on our advocacy efforts to have Intuniv XR covered under the Ontario Public Drug Plan.
The CED has recommended that Intuniv XR be reimbursed under the Exceptional Access Program (EAP) for children with ADHD who require adjunct (additional medication) to psychostimulants or are intolerant of psychostimulants and cannot be treated with atomoxetine or clonidine. More specific criteria will be developed by OPDP, but information on stimulant medication trials will be required as part of the EAP form to be filled out by physicians.
The CEDs recommendation will be provided to the Executive Officer of the Ontario Public Drug Programs who will make the final decision.
While not perfect, this is good news for those families who qualify for the Ontario Public Drug Program and whose children are being treated with Intuniv XR. If approved, this will allow children who have insufficient or no therapeutic benefit from other ADHD medication, or cannot tolerate stimulants, Strattera or clonidine to access to Intuniv XR.
This past weekend an important opinion piece, written by several prominent BC ADHD experts was published in “The Province”, a daily newspaper published in BC.
The piece entitled, “Opinion: ADHD is a real brain disorder requiring treatment, despite what some say” opens with a request that BC medical colleagues demand that the Therapeutics Initiative, which is government funded in the amount of 10 million dollars, be de-funded again. The opinion piece goes on to state that the report, or therapeutics letter, created by unnamed experts, most likely none of which are paediatricians or psychiatrists, cherry-picked research and grossly misrepresented ADHD evidence to support their ill-intentioned claims and prejudices. The ADHD experts equates the Therapeutic Initiative’s report, which questions the safety and validity of ADHD treatment, to a psychiatric version of the vaccination debate.
The comment piece outlines the abundance of current ADHD research and the impact of untreated ADHD and states that, “The increased use of ADHD medication in BC is heartening because it suggests that more children are being diagnosed and treated. However, with only four per cent of B.C. children receiving treatment, ADHD is still under-diagnosed and often goes untreated.” While the piece points out that medication is not required by everyone with ADHD, it also states that large review studies have shown and continue to show the benefits of treating ADHD with medication. Furthermore, these medications have been prescribed for more than 80 years.
It is extremely disheartening for those of us who work in the field of ADHD and for those who themselves have ADHD or family members affected by this disorder to be required to continually justify the diagnosis and treatment of a medical disorder that has been proven to be significant and real. What is even more worrisome is that the type of report published by the Therapeutics Initiative, which according to the ADHD experts would never have been published in a legitimate medical journal, was put out by the media only furthering the misinformation on ADHD.
The only way to stop this type of misinformation from continuing to be spread by the media with a goal of sensationalism is for those of us in the field and those impacted by ADHD to speak up.
Therefore, CADDAC sincerely congratulates and thanks these physicians, Drs. Diane McIntosh, BSc Pharmacy, MD, FRCPC, psychiatrist and clinical assistant professor, UBC; Derryck Smith, MD, FRCPC, psychiatrist and professor emeritus, UBC; Don Duncan, MD, FRCPC, psychiatrist and clinical assistant professor, UBC, clinical director, B.C. Interior ADHD Clinic; Dorothy Reddy, BSc, MD, FRCPC, research fellow, psychiatrist; Julia Hunter, BSc, MSc, MD, FRCPC, psychiatrist, for speaking out.
CADDAC strongly encourages families and adults impacted by ADHD to send a letter to the editor of any publication that furthers the spread of misinformation about ADHD, even when it is an opinion piece. The test that I use when reviewing an article on ADHD is to question whether the same bias and questioning about the validity of the disorder would occur if the mental disorder being discussed was depression.
Heidi Bernhardt
After receiving numerous e-mails from people unset about this article asking CADDAC to respond, CADDAC submitted this letter to the editor of the Vancouver Sun. Unfortunately the restricted number of words did not allow me to cover all the issues I had with this article, but the hope is that others will also contact the paper about this article.
Re Prescribing of ADHD stimulants has soared in B.C., agency warns
This is an unbalanced article, meant to sensationalize a very complex medical issue that continues to be misunderstood and stigmatized. It is rather shocking that this article only speaks about issues with behaviour and never mentions impairment in attention regulation which causes impairment in daily functioning, long term academic impairment and is the most frequent reason why physicians and parents choose to treat with medication. If 5 to 9% of children have ADHD, than 4% of children receiving medication might very well mean that we are finally doing a better job at diagnosing and treating ADHD. Research has shown that psychotherapy for children with ADHD is not beneficial, but educating adults who spend time with the child about the impairments that ADHD causes and how to support them is. Alan Cassels questions whether smaller classrooms will decrease prescribing of ADHD medication, but a better question would be why is BC not recognizing students with ADHD as at risk learners and educating their teachers on how to better support these students in the classroom?
Heidi Bernhardt
A Follow-up in our recent post "Changes to Stimulant Medication Treatment in BC - Why Should You be Concerned?"
A revised draft of the Safe Prescribing Guidelines was released by the College of Physicians and Surgeons of British Columbia (CPSBC) on April the 26th 2018. In the previous Guidelines or “Practice Standard”, the College required annual urine drug screens or pill counts for all adults on stimulant medication. They also prohibited the prescription of sedatives or opiates in any adult being treated with a stimulant.
The new proposed Practice Standard – Safe Prescribing of Opioids and Sedatives – has removed stimulants from the previous document altogether and the proposed Standard applies only to prescribing of opioids and sedatives.
CADDAC, along with the Canadian ADHD Resource Alliance (CADDRA) advocacy committee members, actively campaigned against the previous document since its launch in 2016. Both organizations are very pleased that the College has responded to these efforts and removed stimulant medication from these guidelines.
CADDAC would like to thank those of you who responded to our call to action and contacted the College and your MLAs about this issue.
Access CADDRA response HERE
Access the new draft document (focusing exclusively on opiates and sedatives) HERE
Provided to CADDAC by Gina Pera author and educator
In recent years, biomedical research has identified many "drug-response genes.” These are genes that wield a substantial impact on how people react to medications.
Several companies are making consumer-level tests available, with ADHD medications as well as with medications for depression and more. These purport to identify the kind of drug-response genes the consumer might have. For now, these tests require a physician’s prescription. That does not mean, however, that every physician ordering these tests know how to correctly interpret the results.
The point of this blog series: to help mental healthcare consumers understand how these test results might prove useful—and how the results are extremely limited.
Though far from perfect, these tests can now provide valuable insights into what drugs, at what dosage, might be best for treating your or your loved one’s ADHD— and which drugs might pose complications.
Points to note:
ADHD Gene Testing Series: A Recap
Part 1 provides an overview to the topic of genetic testing as it relates to ADHD medication-response.
Part 2 shares testing results for my husband (who has ADHD) and me (who does not), along with my husband’s personal reactions to our disparate genes.
Part 3 defines what is meant by the term genotyping test. Briefly, it’s a test that informs you of your genetic particulars. Specifically for our purposes in this blog series, it refers to tests that identify which variants of the drug-response genes known to be associated with ADHD medications that you have.
Part 4 explains how, when, and why this data might prove helpful, delving more deeply into the topics of pharmacokinetics (what your body does to the medication) and pharmacodynamics (what the medication does to the body).
Part 5 reminds that genotyping data provides only one piece of the puzzle. There are many other factors that can affect how well a medication works for you, including overall health factors and co-existing conditions.
Part 6 looks at the specifics of Gina’s testing results,
Part 7 looks at the specifics of Gina’s testing results,
For more information of Gina's books and blog please access:
Is It You, Me, or Adult A.D.D.?
Recently the College of Physicians and Surgeons of BC (CPSBC) developed and published guidelines for safe prescribing of drugs with potential for misuse and diversion. These guidelines were developed for the prescribing of opiates, through a lens of addiction. Unfortunately ADHD stimulant medications were also included in these guidelines. While CADDAC and CADDRA applaud guidelines for opiates, yearly urine drug screening and/or pill counts for patients receiving ADHD medication have no benefit and have not been implemented by other provinces. If a physician suspects their patient, any patient, has an issue with addiction, protocols for this are already in place. Including ADHD stimulant medication in these guidelines is unnecessary, ill-informed and will deter the treatment of ADHD in British Columbia.
What will this mean to those being treated for ADHD?
From now on, those receiving ADHD medication will be required to present themselves with 24 hours’ notice to a designated lab for a yearly routine drug screen. This drug test will screen for opioids, amphetamines (found in ADHD amphetamine medication), and THC (found in cannabis). Screening cannot be done for Methylphenidate based medication. Other drug screens can be requested as well. The patient will be given a special sample bottle, must go into a room without their wallet or coat and produce a sample. Alternately, or in addition to urine tests, physicians are being asked to conduct random pill counts requiring the patient to bring in the prescribed pills for counting on a specific day.
In addition, physicians will now be unable to prescribe stimulant medication used to treat ADHD with anxiety medications (benzodiazepines) or sedative hypnotics used to treat sleep problems. And certain pain medications will not be prescribed to a patient taking stimulant medication.
As well as the stigmatization and shaming of patients with ADHD and their families this will result in a decline in the number of family physicians and paediatricians willing to prescribe stimulant medication. These guidelines promote the perception that prescribing stimulant mediation is a problem with similar risks to prescribing opiates. There is no data or research to back up this perception. We have already seen a steep decline in the number of stimulant ADHD medications being prescribed in BC resulting in more untreated ADHD. The resulting side effects and socioeconomic costs of untreated ADHD have been well documented.
An added result of these biased guidelines will be increased costs to BC healthcare for unnecessary tests and additional physician visits. For additional details access BC Advocacy
What can you do about it?
Since 2010 CADDAC has shared our concerns about the direct substitution of methylphenidate ER-C, a generic medication, for OROS® methylphenidate (Concerta) with Health Canada. This was done through documentation, caregiver and patient survey results and several face to face meetings.
A Canadian research paper reviewing data on this issue, was recently published in the Clinical Therapeutics Journal on drug therapy. The new paper, “Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases” looked at treatment failure adverse events of generic versions of OROS® methylphenidate (Concerta).
The research paper reported that a 10-fold higher reporting rate of therapeutic failure adverse events was found with the Canadian generic product, methylphenidate ER-C (Teva product) as compared to OROS® methylphenidate (Concerta). Although adverse events are more typically thought of as additional unwanted effects of a drug (e.g. a headache or rash), if a product fails to produce its expected intended clinical effect, or fails to produce its clinical effect for the intended duration, there may be an adverse outcome for the patient, including an exacerbation of the condition for which the product is being used. The Health Canada Guidance on Reporting Adverse Reactions to Marketed Health Products provides the example of a patient whose condition is well-stabilized, but deteriorates when the patient changes to a different brand or receives a new prescription as an example of an unusual failure in efficacy, which is a reportable adverse event.
Additionally, the study compared Canada-US data and demonstrated that this 10-fold increase in Canadian therapeutic adverse events was very similar to data seen with a US generic product by Mallinckrodt. This US product's bioequivalence status has been removed by the FDA and it is being considered for further regulatory action. Adverse consequences for patients, such as disruptions in academic performance, school suspensions, and onset of adverse social behaviors, showed similarities between the US and Canadian generics. The Canadian study data reported that “Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 22.2% of cases.” US reports for the methylphenidate ER generic product identified adverse impacts on social functioning in more than 30% of cases.
The paper also highlighted differences in the generic medication from the brand Concerta Plasma (blood) concentrations. The generic product concentrations peaked approximately 2 hours earlier and declined more rapidly than those of Concerta. As one would expect, adverse event time of day data, showed “overdose like” symptoms to be more common in the morning and lack of efficacy to be more common in the afternoon. Methylphenidate ER-C, was reported not to be effective throughout the duration of the day in 42.6% of Canadian cases, with this early loss of efficacy occurring in the afternoon for 64.3%. Signs or symptoms of too much methylphenidate exposure were also reported in 13.5% of the cases with 58.1% occurring in the morning. Therapeutic failure occurred within one week of starting treatment with methylphenidate ER-C in 72.1% of the cases.
CADDAC’s experience was included as well, “Since the market approval of the first generic drug in Canada, the Centre for ADHD Awareness Canada (CADDAC), a patient advocacy group, has received reports of issues with generic methylphenidate ER medications, including shortened or reduced clinical effects and adverse events.”
The paper concluded that “The results of the current study are consistent with a growing literature pointing to a potential safety issue with the methylphenidate ER-C generic product. Taken together, this information suggests that an investigation should be conducted by Health Canada, to evaluate the potential differences between methylphenidate ER-C and OROS® methylphenidate. If important differences are identified, this would further suggest that the bioequivalence metrics currently used to support the interchangeability of OROS® methylphenidate with methylphenidate ER-C may not be adequate.”
Earlier this year Health Canada (HC) released a notice regarding consultation on the proposed modification to bioequivalence standards for this type of medication. In September, CADDAC contacted HC expressing our pleasure with this review, but asked whether any decisions made would also impact medications that had already been approved for bioequivalency. This is information is important because the medication for ADHD in question would fall under this category. If this was not to be the case, CADDAC wanted to know whether labeling informing patients that this medication was approved under old guidelines would be required. CADDAC has yet to hear back from Health Canada.
It was with great interest that I reviewed an Australian study looking at academic achievement in students with ADHD during the period from childhood to adolescence. Having spent the last twenty years speaking with researchers, parents, educators, school boards and Ministries of Education across Canada I firmly believe that this study highlights the same situation that we have here in Canada.
The study published in the Journal of Developmental and Behavioral Pediatrics showed that 40% of students with ADHD were not reaching minimum standards for literacy and numeracy in at least one academic area such as writing or math. Based on test results in year seven, which is equivalent to our grade seven, 73% of students with ADHD had a problem with writing and almost a quarter scored below the minimum standard. By year nine things had become worse; 54% of students still had difficulties, however now 37.5% did not reach the minimum standard. What was also interesting was the fact that boys had far greater difficulty with writing than girls. The lead researcher, Nardia Zendarski said that they had expected to see a gap in academic success for students with ADHD, but not such a large gap.
Professor Harriet Hiscock, a consulting paediatrician with the Murdoch Children's Research Institute that ran the study, said problems arose for students with ADHD particularly in English subjects, due to issues with writing, spelling and grammar. "They're quite sophisticated things that we learn how to do," she said. The frontal lobe of the brain, which we know is not as developed in children with ADHD, is used in this type of task.
Remarkably, 75% of children looked at in the study were on medication to increase their attention. This fact led Ms. Zendarski to state, "ADHD medication has its place but it doesn't seem to improve long-term academic outcomes … it doesn't address the core academic skills." She went on to say, "We should stop focusing on the argument around whether these kids should be medicated or not and start focusing on providing services and support that they need to reach their full potential. These programs could be used to support all kids with learning difficulties.”
"We need to look further back and see when the problems start — do these problems start for kids as early as grade one?" said Professor Hiscock. "And if they're not picked up and addressed, particularly in primary school, then these kids get into high school where it becomes harder, the work becomes more complex. So we're seeing the problems become worse."
Professor Hiscock went on the say, “The solution is not clear cut, but better support and training of teachers would be a good start. More support around literacy and numeracy teaching, probably it's got to be small groups, more individualised teaching."
Tracy-Ann Pettigrew a mother with two sons with ADHD went back to university to study special education in order to assist her sons with school. There's not a lot of understanding by mainstream teachers about how to teach kids with additional learning needs and it's a tough gig," she said. "I am hoping that this will facilitate some meaningful change, so that teachers can learn the skills that they need to learn to be able to support these kids."
Ms Zendarski closed by says, “As education is a key determinant of overall quality of life and health, I can't think of a better area to concentrate our efforts,"
Access the Institute’s REPORT
Access articles on the study:
Over the past 25 years I have spoken to tens of thousands of parents struggling with the question of whether to give their child medication to treat their ADHD. In all that time I have never come across one parent who was thrilled at the thought of medicating their child. Most parents express doubt, concern and have countless questions. Some refuse outright to even consider medication as a treatment option even when their child is clearly struggling at home, in school and during social situations. I must confess that even with a background in psychiatric nursing I had to think about the decision and it took quite some time for my husband to come around to the idea.
I also think that second guessing yourself on the decision you made, for many years even decades, after the fact is quite common. I receive many calls from parents asking if I think that they are responsible for their child’s failure at school and work because they refused to try medication when the child was younger. Or, they ask if it is what caused their child's involvement with the law and/or with self-medicating with substances. No one can answer these questions nor should they try. When asked, I steer parents away from the past and towards the present and future. What can and should be done now to set up the best individualized, balanced, multi-modal treatment approach possible. It may include medication, or it may not, but it should always be more than just medication. On the other hand, I also receive calls from adults who never received medication as a child, have been able to weather the storms, and have come out stronger because of it.
So it was with great interest and delight that I watched a YouTube video by Jessica McCabe, a young actress, writer and YouTube personality with ADHD. The video is captioned “To My Mom who Drugged Me”. Don’t be alarmed by the title, you’ll be wonderfully surprised by the message Jessica shares. While she addresses the topic of medication in the video she shares so much more. She expresses how she felt as a child with ADHD, what her mother’s understanding and support meant to her, and the profound difference it made in her life.
Watch the VIDEO
Access an ARTICLE on the video
Access Jessica’s web site How To ADHD
A new study published on May 10 in the journal JAMA Psychiatry looked at ADHD, driving and medication. The study tracked more than 2 million American adults who had been diagnosed with ADHD for a period of 10 years. The data was accessed from health insurance claims from more than 100 health insurers and reviewed inpatient and outpatient hospital visits due to motor vehicle collisions (MVCs) and filled prescriptions.
The study looked at over 2 million patients identified with ADHD, over the age of 18, with half over the age of 33. The study found that men’s risk of a motor vehicle accident decreased by 38% during the months they filled their prescriptions and women’s risk decreased by 42%.
The study team also estimated that 22 % of accidents could have been avoided if people with ADHD were on their medication during the entire study period.
The lead author Zheng Chang, of the Karolinska Institute in Stockholm, Sweden stated that the study most likely underestimated the effect of medication on car crashes because only those accidents serious enough to warrant medical intervention through a hospital were included in the numbers. The data also did not include car crashes were someone died.
Considering the high prevalence of ADHD and its association with motor vehicle collisions along with the high rate of MVCs resulting in injury or death these findings should be looked at very seriously.
To access further details
Study published in JAMA Psychiatry. Published online May 10, 2017.doi:10.1001/jamapsychiatry.2017.0659
http://www.livescience.com/59047-people-taking-adhd-medications-may-have-fewer-car-accidents.html
