Algorithm Frequently Asked Questions
The below content is responses from Dr. Mela to questions sent to him from caregivers. Dr. Mela’s responses to each question may be helpful for you as you consider using the medication algorithm for FASD.
Before reading the below content, if you are not familiar with the medication algorithm, learn more about it here: https://canfasd.ca/algorithm/
Non-pharmaceutical approaches should be used before any medication options are tried for each patient. These include ensuring that the patient has sufficient dietary, exercise, and sleep support, and establishing family, psychosocial, and community supports. Other nonpharmacological interventions include functional behaviour analysis, behavioural management, and environmental modifications. For more information see the published article here: https://jptcp.com/index.php/jptcp/article/view/681
NON-PHARMACEUTICAL APPROACHES — My daughter has an overly heightened nervous system, and she can misread cues and misinterpret threats. She can think you are yelling at her when you are talking in a normal tone. She has rigid thinking and is unable to take on other’s perspectives. What would be the best place to start: Therapy or occupational therapy? Or can medication help with these symptoms? She is already on Guanfacine, which helps with other symptoms.
Whenever possible we should always start with non-pharmaceutical treatment options. Therefore, therapy and occupational therapy should be first, if it is safe. If, for instance, she was hurting anyone, including the therapist, waiting for the effect of therapy to emerge may be counter-productive in certain circumstances. Some of the symptoms you mentioned fall into the hyperarousal and cognitive inflexibility clusters, and medications listed under this cluster can be considered once the non-pharmaceutical options have been exhausted. At times social communication training and emotion recognition training while managing sensory stimulation issues may suffice.
SIDE EFFECTS — I am a pharmacist and well aware of side effects of medications. My 14 years old daughter gained so much weight on Olanzapine which was prescribed to help her sleep and because she complained of hearing a voice telling her to kill herself and her family. After I showed your algorithm to the paediatrician, they added Risperidone and Valproate. I am concerned about hair loss in my daughter and ovarian cysts reported as side effects on females. Can you suggest other medications with less side effects?
Thanks for sharing your knowledge of medications and experience of your daughter. I am pleased you have a physician who appears fully engaged with helping your daughter. No doubt, those side effects of medications are one of the down side of medications. We recognized that in the development of the algorithm. As a result, we not only recommend non-psychotropic medication interventions such as exercise, nutrition and sleep as the first step in the algorithm. In the article accompanying the algorithm, the “experts recommended that clinicians first use non-pharmacological interventions, including functional behavior analysis, behavioral management, and environmental modifications, before pharmacotherapy. Such comprehensive psychosocial interventions have the potential to reduce stress, improve adaptive functions, and provide meaningful participation in school and work-related activities”. Once these approaches are used, the physician can then adhere with the steps on the algorithm. This will reduce side effects by offering one medication at a time and maintaining a favorable benefit risk ratio.
NO FASD DIAGNOSIS — Can/should this algorithm be used when FASD is suspected but not yet diagnosed?
That is a clinical question. For adults, we recommended that at least prenatal alcohol exposure should be present to qualify. In children, we recommended that a formal diagnosis be completed
NO FASD DIAGNOSIS — Many individuals do not have a formal FASD diagnosis (due to various reasons such as being too young, no confirmation of prenatal alcohol exposure, etc.). However, there are many individuals where FASD is highly probable. Is there a harm in applying the algorithm for these individuals without a formal FASD diagnosis?
Clinically, doctors would prefer to have a formal diagnosis to justify treatment (including applying the algorithm), so efforts should be made to get the right diagnosis. In desperate situations where waiting for a diagnosis will result in harm, the benefits of trying the algorithm could be clinically argued surpass the risk.
MANAGING MULTIPLE DIAGNOSES — When someone has FASD and other diagnoses, how can caregivers identify for which disorder their doctor is prescribing medication? For example, doctors may think they’re prescribing medication for a personality disorder, but the symptoms are actually a manifestation of FASD. If a family comes and tells the doctor, “I want to use this algorithm,” the doctor may think “we’re already medicating for bipolar” but realistically they need a mood stabilizer or another medication. So many individuals with FASD have diagnosis on top of diagnosis.
Individuals diagnosed with a disorder may embrace it as an identity and have problems switching to a new diagnosis when new information is received, especially as adults. The same can be said of physicians as well. Physicians can get attracted to the ‘best’ explanation of the patient’s presentation. The key is to develop a good relationship with the doctor and present a strategy that starts with acknowledging that you are all doing your best. The next step in the strategy includes suggesting to the doctor that the change in diagnosis is based on solid facts and for the good of the patient, the family and for the doctor as well.
REDUCING MEDICATIONS IN YOUNG ADULTS — Can young adults who have FASD be weaned off medications as they mature?
Yes but only if it is safe and as long as the principles of enhancing functioning are followed. There is evidence that adequate and appropriate support for individuals enhances functioning. Therefore, weaning off medications will depend on the levels of support and functioning of the adult. We should discourage the mistaken belief that, “As the individual ages, the problems disappear.”
REDUCING MEDICATIONS — My child has been on 17 medications in 5 years and is currently on seven. He is still struggling with aggressive behaviours. How could we detox him safety so that we can begin again on your algorithm? How long do we endure increased side effects when trying a new medication to see the true effect of the medication?
The principles to adopt are: Adopt a collaborative approach with physicians and all caregivers. Ensure the child is stable and functioning. If the child is not stable and functioning, you need to determine what are the risks of having the side effects compared to having the benefits of too many medications. Next, identify the goals that will inform the anticipated changes in medications. If a decision is made to reduce and/or stop some of the medications, the physician may want to identify the clusters of the algorithm from the past clinical picture (symptoms that the patient has displayed). The physician should also determine the resources available to the caregivers. Choose the clusters that impair functioning the most for the patient, and continue the medications recommended under those clusters. For instance, keep the stimulants like Concerta if the hyperactive cluster was identified as the most impairing. Then decide what cluster least was impairing to functioning, or what medication is not on the algorithm, and start a process of reduction and discontinuation. Your physician should closely monitor the process and the medications should be reduced slowly. Re-evaluate the decision to reduce/remove medications if reducing a medication worsens the clinical picture (overall symptoms). Remember that the overall goal of medication management is that the list of benefits from all medications outweigh the resulting and inevitable side effects. This process may take a long time and therefore patience, close monitoring, and active documentation of objective changes are very necessary.
REDUCING MEDICATIONS — How do you apply the algorithm for a patient if you're “working backwards”? For instance, my kids are on multiple medications, which were started before their FASD diagnoses, and then more medications were added over time. Is there any way to work on reducing medications to find out if the medications currently prescribed are even helping or necessary?
Doctors are familiar with strategies to change medications. Sometimes this can include stopping all medications to start the right medication. At times doctors can try what is called a “crossover,” which is when a current medication is reduced in stages at the same time as a new medication is being introduced, until the original medication can finally be discontinued. With a “crossover” strategy, the patient will take both medications, and once stability has been achieved with the new medication, the physician will remove and discontinue the unwanted medication. The physician will consider this strategy while being aware of the properties of the medication and the required goal of treatment.
It is important when “working backwards” or reducing current medications to determine which is the most function-impairing cluster(s), and consequently what medications are indicated for the cluster(s). If the symptoms presented by the patient currently, or in the past, fall under a certain cluster, the next step is to determine the level of impairment from that cluster, as well as whether that cluster should be considered as a major target for treatment. With help from the caregivers, the physician should decide which cluster is major (most impairing) and which is minor. Medications that are recommended on the algorithm for the most impairing cluster should be the last to be discontinued. Medications that are not on the algorithm should then be removed. Next, medications that are on the algorithm for minor clusters should be removed. Discontinuing medications should follow the same principles as introducing medications: improved functioning is the target and goal, consider the balance of benefits and risks (side effects), and start with a low dose and increase slowly.
DOSING FOR EFFECTIVENESS — Can you explain why our doctor said that giving two 1mg Intuniv pills at the same time will make the medication last longer compared to only taking one 1mg pill? Wouldn’t each of the pills have the same timeline for effectiveness?
The timeline for effectiveness will last the same for 1 or 2 mg, except if the benefit of 2 mg is so effective that it will extend beyond the time limit expected for 1 mg to work. As well, sometimes the residual effects of the medication accumulates over time, and not just end at the end of the effectiveness timelines (otherwise called the “half-life” of the medication/drug).
SWITCHING MEDICATIONS DUE TO SIDE EFFECTS — Last spring we increased my 10 year old’s Fluoxetine dose from 20 mg to 30 mg. She was also taking Abilify after coming off Risperidone because of excessive weight gain. It seemed as if Abilify did nothing, so we put her back on Risperidone. Then our pharmacist suggested that the increase in Fluoxetine might have caused the increased aggression and moodiness (this was about a month after the increase). Is it possible to know in advance whether switching the Fluoxetine to another medication would improve her symptoms (perhaps because it is a new medication she has not tried before)? It seems with any combination of medications we have to stop or start new ones within about 6 months to a year.
If your daughter had visits that are more frequent with your physician, then the physician would be able to change the medication and determine if the cause of the agitation, aggression, and moodiness is from the Fluoxetine. One thing to note is that the increase in Fluoxetine will likely cause agitation and moodiness for only about three to five days, and then revert back to the benefits she had prior to the change. Risperidone and Abilify can both reduce agitation, but there is individual variation, where a medication will work in one person but not on another. I think this may be the case here, where a medication may not be effective for your daughter simply due to individual variation. However, it is unlikely that Fluoxetine would be causing such problems when it seemed to have worked at 20mg. Another possibility to explore with your pharmacist is whether the Fluoxetine may be causing an increased level of Abilify in your child’s system and lead to side effects (this is called an “extrapyramidal effect”). If your daughter is experiencing a side effect called “akathisia,” then there is a specific type of treatment to follow.
AREAS WITHOUT RESEARCH
CBD and FASD — Is there research on CBD for FASD?
In a study with five individuals with FASD, use of cannabinoids (specifically cannabidiol –CBD) was associated with reduction in disruptive behavior. This was not a controlled study and so it is thin evidence but seems intuitive to assume it should help. First, it was shown that CBD helped in autism for the same indication.
CBD and FASD — What are the recommendations for CBD? Are there any recommendations for certain brands or formulations that might be best, or how to handle dosing?
It is a little too early yet to recommend specifics due to insufficient research evidence on CBD.
Resources in our province — Is there a resource list of other Psychiatrists/Pediatricians/general Physicians who are familiar with this algorithm and FASD so we can get referrals within our own provinces?
Dr. Ana Hanlon-Dearman – Pediatrician – Manitoba
Dr. Hasu Rajani – Pediatrician – Alberta
Dr. Rod Densmore – Family Physician – British Columbia
Dr. Mansfield Mela – Forensic Psychiatrist – Saskatchewan
Journal article with the algorithm — Where do we find the journal article to which you referred which includes the information about the algorithm? Can I share the link or a copy of the article with my daughter's new psychiatrist?
You can share the below link, or a copy of the article, with any clinicians who are working with your family member. The article is “open-access” which means it can be downloaded and read by anyone without a subscription to the research journal.
The article is published online at this website: https://jptcp.com/index.php/jptcp/article/view/681
The reference for the article is: Mela, M., Hanlon-Dearman, A., Ahmed, A. G., Rich, S., Densmore, R., Reid, D., … & Loock, C. (2020). Treatment algorithm for the use of psychopharmacological agents in individuals prenatally exposed to alcohol and/or with diagnosis of fetal alcohol spectrum disorder (FASD). Journal of Population Therapeutics and Clinical Pharmacology, 27(3), e1-e13.
We invite feedback from clinicians on how effectively the algorithm worked with their patients, clinicians can complete a survey here: /algorithm/
QUESTIONS ON SPECIFIC SYMPTOMS
Sleep & Anxiety — What are your thoughts on the medication Mirtazapine for nighttime sleep and anxiety?
Apart from a possible side effect of weight gain that can be problematic, it is a good medication for most people. It is better as an antidepressant, but it can help anxiety and taking it improves sleep.
Hyperactivity & Sleep — Can you take one medication that can help hyperactivity and sleep and cut out the melatonin?
Clonidine and Straterra are the possible options that both help with hyperactivity and sleep. Clonidine is listed in the algorithm under the hyperarousal cluster. On the other hand, melatonin is quite natural and it is a good option to help with sleep. Melatonin is not listed in the algorithm because we do not have a sleep cluster. However, melatonin is recommended in the published article accompanying the algorithm.
Cognitive inflexibility — Is Adderall effective for cognitive inflexibility and/or hyper sexuality?
I expect it would be helpful to reduce impulsivity in the hyperactive cluster. If cognitive inflexibility is thought to contribute to the hypersexuality, then Risperidone, Olanzapine and Abilify are the recommended treatment options. Occasionally, hormonal interventions may be needed to address hypersexuality. Finally, of course, never neglect the important role of non-medication approaches to address symptoms. This will include understanding the origin of the hypersexual behavior and thought.
Cognitive inflexibility — What are best ways to deal with cognitive inflexibility?
Apart from the medications listed under the cognitive inflexibility cluster on the algorithm, there are multiple psychological and social approaches. One intervention that may be helpful for cognitive inflexibility is Cognitive remediation therapy. There is not much research on interventions that target cognitive inflexibility specifically, but interventions that target overall executive functioning may be helpful. These interventions include physical activity (the FAST Club as described in Orr et al., 2018, https://doi.org/10.1123/apaq.2017-0137) and the Alert Program (as described in Wells et al., 2012, https://doi.org/10.5014/ajot.2012.002691). Some other options (for which we do not currently have research evidence but may likely be helpful) include mentalization, use of games, direct experiments, environmental support, distractions, cognitive control training, cognitive restructuring, and/or cognitive flexibility training.
Impulsivity — My daughter is 14 and has been on Concerta since being diagnosed with FASD at age 6. Is there a medication that she could try to help with symptoms of impulsivity?
Concerta should have been sufficient to help. Apart from adjusting the dose of Concerta, I will suggest some additional strategies for managing impulsivity: 1) Target self-esteem, use journaling, talking with a trusted person, mindfulness, and 2) If there is agitation and aggression, consider treating the cognitive inflexibility cluster.
IDENTIFYING SYMPTOM CLUSTERS
Treating multiple clusters — How do you treat a patient who has two prominent clusters? Currently our son exhibits symptoms of both the emotional regulation and cognitive inflexibility clusters and is on Sertraline only. Would he benefit from taking something for the latter domain?
It is possible that he could benefit from medications under either the emotional regulation cluster, or the cognitive inflexibility cluster, but first the cluster that is most impairing needs to be identified. Your doctor should be able to identify which cluster is causing more problems. If the doctor is not able to identify the more impairing cluster, then they will judge which of the two recommended medications for the two clusters is better to prescribe first. This judgement will be based on the chemical properties of each medication. It is not recommended to start two medications at the same time, because you will not be able to decipher which one was effective/ineffective.
Medication options for each cluster — Is there more than one medication under each cluster that a patient can try?
Yes. There are at least two medication choices for each of the first and second line recommendations. The exception is the cognitive flexibility cluster, which has only Risperidone as the recommended medication. Please work with your clinician to determine which medication is best for an individual patient. Physicians know that medications can come from different subgroups or classes and will choose accordingly.
Identifying symptom cluster — Is the best approach to treat the most troubling symptom in an individual patient? Rather than looking for a medication to address all of a patient’s symptoms (if a patient’s various symptoms fall under more than one cluster, or even most or all of the clusters)?
If a patient has symptoms representing all four clusters, a clinician should systematically address them. By choosing the most impairing cluster, you make caring for someone with FASD easier, and you may unintentionally alleviate the symptoms that fall under the other clusters (waiting to be treated). Introducing one medication at a time is recommended to reduce potentially harmful side effects, understand the body’s response to each and manage drug-to-drug interactions.
Identifying symptom cluster — My daughter is on a number of different medications. She has had a number of troubling symptoms in the past, including suicidal ideation and anxiety. Over the last year, her pediatrician and psychiatrist have added a number of new medications. Currently she is doing quite well and her psychiatrist does not want to change her medication. My question is how many clusters can we consider at one time for a given patient?
First, thanks for sharing a success story. Our first principle is do not change anything if a patient is functioning adequately (i.e., “if it aint broke, don’t fix it”). The number of clusters to address depends on the clinical features/symptoms the client presents with. Once a target clusters is identified, clinicians should work systematically to eliminate the negative effect of that cluster and therefore improve function. There are four clusters in the algorithm, and we hope that feedback on the algorithm will help us to refine the clusters and the medications recommended (if needed).
Treating multiple clusters — Can a patient take two different medications for symptoms of two different clusters? In our case, our teen takes Adderall but gets rebound symptoms at night. After a few years of noticing hyper-arousal at night, we recently put her on Clonidine for sleep.
Yes, if the clusters are prominent and deserve individual treatment.