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Recommended Guidelines for Medication Treatment
Even though stimulant medication treatment is generally believed to be a safe and effective treatment for most children with ADHD, based on the results of numerous studies, even proponents of such treatment would agree that they way in which meds are often prescribed is problematic. Among the problems that have been noted are: 1) the lack of a careful evaluation to establish that ADHD is a proper diagnosis prior to initiating treatment; and 2) failure to collect systematic information on a child's response to medication so that well-informed decisions about continued use can be made. As a result, many children are probably placed on stimulant medication who really do not have ADHD, and others who really have ADHD are not prescribed medication in a way that is likely to be as helpful as it could be. Evidence in support of the latter were results from the recent multi-modal treatment study of ADHD, where it was found that children treated with medication as part of the study did better than children who were treated with medication by community physicians.
In response to the recognition that medication treatment for ADHD is often not done in a careful and systematic way, efforts are underway to develop clear guidelines that such treatment should follow. Recently, a set of such guidelines was published by a group of ADHD experts (Plizka, S.R. et.al., (2000). The Texas children's medication algorithm project: Report of the Texas Consensus Conference Panel on the medication treatment of childhood ADHD. Journal of the American Academy of Child and Adolescent Psychiatry, 39, 908-927). This is an important effort because the authors attempt to provide - based on the best currently available evidence - a specific set of recommendations for how medication should be prescribed that is quite different from the far less-systematic approach that is generally used. These guidelines are summarized below.
Note: The authors of these guidelines emphasize, of course, that the use of medication treatment is predicated on the fact that the diagnosis of ADHD has already been carefully established.
Also, the authors do not specifically recommend that medication should always be the first or certainly the only treatment initiated, and specifically emphasize that psychosocial interventions (e.g. behavioral treatment) play an important role in the treatment of ADHD. Instead, if medication is going to be used, they try to lay out a careful and systematic procedure for doing this that can be feasibly implemented in most primary care settings.
Children who meet criteria for a manic episode, any psychotic disorder, or a pervasive developmental disorder would be excluded from the recommendations below.
It should also be noted that separate algorithms were developed for those children who have an anxiety or depressive disorder in addition to ADHD. The guidelines presented below apply to children diagnosed with ADHD but without either of these other types of disorders. For children with ADHD and either depression or an anxiety disorder, the trial begins with stimulant medication as described below, and then recommends the use of separate meds to treat the depression and/or anxiety symptoms depending on whether or not these show improvement when the ADHD symptoms are reduced. Space considerations do not enable me to include this entire algorithm.
I expect that other groups - particularly the American Academy of Pediatrics - may be issuing similar guidelines in the months ahead.
Recommended Procedure
The guidelines below are intended to apply to children with ADHD alone, as well as to those who have ADHD along with other types of conditions including oppositional defiant disorder or conduct disorder. The authors also note that although the recommendations below should be appropriate in the majority of cases, any stage can be skipped depending on the particular child's presentation.
Stage 1
Medication treatment for ADHD should begin with one of the stimulants. Typically this would be Ritalin/methylphenidate (methylphenidate is the generic form of Ritalin) or amphetamine (e.g. Dexedrine or Adderall). The authors note that there are no current clinical predictors indicating which child will respond to which stimulant. Thus, the choice of which type of stimulant to begin with is up to the physician and parent. (Note: Recently, however, several studies have been published to suggest that Adderall may be a more effective medication for the majority of children with ADHD and also requires fewer doses per day for most children. It may therefore be reasonable to begin a child's medication treatment with Adderall.)
The important point to note here is that medication treatment for ADHD should almost always begin with one of the standard stimulants, rather than with other types of meds or with a combination of meds. There may certainly be situations that warrant an exception to this recommendation, but one would want to be clear about why a deviation from this generally recommended place to start was being made.
The guidelines also specify the way in which medication should be prescribed and how the impact on the child's functioning should be monitored. A key point here is that a full range of doses should be used with the initial medication prescribed because body weight can not be used to predict what will be the best dose for an individuals child.
What this means specifically is that a child would be started on a low dose of whichever medication is tried initially, and each week the dose would be increased until a maximum recommended daily dose is reached. For example, for methylphenidate (MPH), the child would be started on a dose of 5 mg twice per day. Each week, the dose is raised by 5 mg so that in the 4th week, (4 weeks is the recommended length for this initial titration trial) the child would be receiving 20 mg twice per day, with the possibility of a 3rd dose during the day added at the physician's discretion.
At the end of each week, parent and teacher ratings of the child's behavior (the recommended scale is the Abbreviated Conners Rating Scale, a 10 item measure of ADHD symptoms) and a side effects scale developed by the authors. As long as side effects are reported to be mild or non-existent, the increase to the next dose occurs - even if it appears that the child has done well on the current dose. The quantitative data from the Conners Scales is combined with clinical impressions to obtain an overall sense of the child's degree of improvement on a 1 ("very much improved") to 7 ("very much worse) scale. (This scale is called the Clinical Global Impressions Scale - i.e. CGI).
After the 4-week trial is concluded, the child and parent meet with the physician to determine whether any of the doses used during the trial yielded significant benefits in the child's functioning (i.e. a CGI rating of either 1 or 2), and, if so, what the most effective dose was. Assuming no intolerable side effects were observed, this would be the dose the child is maintained on.
The really important point here is that regardless of which medication a parent and physician choose to start the child on, there is an initial 4-week trial in which a range of different doses are used and systematic ratings of the child's functioning is obtained from parents and teachers after a week on each dose.
The reason this is so important is that physicians often stop a child's trial at the lowest dose that seems to produce benefits. Thus, if a child is reported to do better on the initial dose prescribed, this is the dose the child is often maintained on. The problem with this is that, in many cases, even though the child received some benefit on the initial dose, he or she would do substantially better were a higher dose to be tested. As a result, many children are maintained on doses of stimulant medication that really fail to provide the child with as much benefit as would be possible.
By trying a child on a full range of doses, and comparing standardized behavior ratings on these different doses, the likelihood of finding the best dose for the child increases dramatically. Although not specifically stated in the guidelines, if a child's response to two different doses seems to be equivalent, one would generally maintain the child on the lower dose. If a child clearly did better on a higher dose, however, and no adverse side effects were reported, then it would make sense to continue the child on the dose that provided the greatest benefit. For some children this will be lower doses and for others it will be higher doses. Because this can not be determined in advance, a procedure like that recommended here is essential.
(Note: It should be noted that these guidelines do not advocate the use of a placebo-controlled trial in which parents, teachers, and children are unaware of when the child is on medication and when the child is on a placebo. The authors of these guidelines did not issue this recommendation because they did not feel it would be practical for physicians to routinely implement such a trial.
One especially important benefit of using a placebo-controlled trial, however, is that sometimes what can seem to be side effects to the medication are actually reactions that occur during the placebo week as well. In the absence of a placebo trial, there is not really a good way to detect this. Unfortunately, when this occurs, a child's medication can be stopped because of apparent side effects that are really just a placebo response. In addition, sometimes what looks like a very positive response to medication is really just a placebo response as well.)
Stage 2
If the child fails to respond to the first stimulant tried, or has side effects that make its long-term use inappropriate, the same procedure is repeated using a stimulant not used in Stage 1. The range of doses appropriate for that particular medication would be used across a similar 4-week trial period.
The important point here is that one does not give up on stimulants if a favorable response is not obtained to the initial stimulant tried. In many cases, a child who does not respond well to the first type of stimulant used - or who experiences adverse side effects - will respond quite well with no side effects to a different stimulant. So, before moving to an entirely different class of medications, or giving up on meds altogether, a second stimulant would first be tried.
Stage 3
Some children will not respond favorably to either stimulant tested in the first 2 stages. In this case, the recommendation is to move on to pemoline (i.e. the brand name is Cylert) and use a similar titration trial procedure using the range of doses appropriate for this medication.
Because of the concerns about the potential for adverse effects on liver functioning, the authors stress that pemoline requires that liver functioning must be monitored twice monthly. In addition, parents need to be made fully aware of the potential risks. And, the use of pemoline would only be suggested if the stimulants tried initially were not effective in managing the child's ADHD.
The authors noted that as a result of these concerns, many parents and physicians will prefer to skip this stage and go directly to stage 4. (Note: As new stimulant medications receive FDA approval and come on the market, the guidelines may change to trials of additional stimulants before moving on to a new class of medication.)
Stage 4
In stage 4, it is recommended that the clinician and parent select either bupropion (i.e. a newer type of antidepressant; the non- generic name is Wellbutrin) or one of the tricyclic antidepressants (e.g. TCAs, imipramine or nortriptyline). There is no data currently available to suggest which of these antidepressants is more effective for ADHD than the other. If a TCA is prescribed, heart rate monitoring (i.e. ECG) at baseline and during treatment is indicated. The authors note that bupropion should not be used in children with a seizure disorder.
As with the stimulant medications, a range of doses appropriate for these particular medications would be used. For the tricyclics, parent and teacher rating scales are collected after each week, and the first week where significant improvement is reported would be the dose the child is maintained on. Thus, on the tricyclics, one does not necessarily go through the full range of doses. For bupropion, because it can take as long as 4 weeks to obtain benefits, the behavioral rating data is not obtained until the end of the trial.
Stage 5
If the first antidepressant tried does not produce a beneficial result, or is accompanied by adverse side effects, a second type of antidepressant would be tried as the next step.
Stage 6
If a positive response has still not been obtained, the final recommendation is a trial of clonidine. The authors note that the safety and efficacy data for the use of clonidine for the treatment of ADHD is not as well established as one would like. If clonidine is tried, they note that office visits are required each week to monitor blood pressure and pulse, and that these indices should be obtained with the child both lying down and standing. A child would generally take clonidine for 2 to 8 weeks at the maximum dose tolerated to assess its response, with a total daily dose ranging from .05 mg/day to 4 mg/day. After the child has been on the maximum dose tolerated for 3 to 4 weeks the behavioral rating data would be collected and the CGI rating made. If the CGI score is 1 or 2 (i.e. the child is rated as very much improved or much improved) and there are not troublesome side effects, he or she would be maintained on that dose.
Summary And Recommendations
It is important to emphasize once again that these guidelines are not intended to convey the impression that every child with ADHD should necessarily be treated with medication. The authors note that non-medication options can certainly be considered prior to beginning the medication algorithm, and that even if medication treatment is initiated, psychosocial interventions will often be a very important part of a child's treatment.
The authors are also careful to note that the management procedure they outline always need to be used in the context of the individual clinical situation and the clinician's judgment about what is most appropriate for an individual patient. Thus, these guidelines are not published with the intent that they be rigidly followed in every situation.
Instead, the value of these guidelines is that they provide physicians with a systematic approach to medication treatment that should result in a greater likelihood that such treatment can provide the child with the maximum gains from medication that are possible. They also educate parents about an approach to medication treatment that has been developed by experts in the field based on the best data currently available. Should your child's medication treatment for ADHD be substantially different from what is discussed in these guidelines (for example, your child is being treated simultaneously with multiple medications) it would seem reasonable to inquire about the reasons for this with your provider.
If your child is taking a conventional stimulant medication, but was not initially tested with a full range of different doses, you should consider the possibility that the dose your child is being maintained on would not be the optimal one. You may also wish to discuss this with your child's physician. (Note: If you are using the ADHD Monitoring System to track how your child is doing at school on a regular basis you should be in a good position to evaluate how well your child's symptoms are being managed. If they are clearly being managed quite well, there would generally not be any reason to consider an adjustment to treatment. If they are not, however, then such adjustments would be important to consider with your child's physician.)
New data that may influence the guidelines described above may certainly be published in the future, of course, and new and hopefully more effective medications for treating ADHD are being developed. As these changes occur, the guidelines for medication treatment will change as well. (You can find the web site where such changes would be posted by going here, although when I recently checked, the ADHD treatment algorithm was not yet posted.)
One important aspect of medication treatment not covered in these guidelines is the need to monitor a child's treatment on an ongoing basis even after a maintenance type and dose of medication has been decided on using an approach such as that described. Remember, even when a child's symptoms are being managed well, this can change over time for a variety of different reasons. Thus, the fact that a particular medication is working well at one point in time does not guarantee that things will still be going well later on. Monitoring a child's functioning over time in a consistent and systematic way can thus be critical to promoting a child's healthy long-term development.
Note: This article originally appeared in Attention Research Update, an online newsletter written by Dr. David Rabiner, a Duke University psychologist and former member of CHADD's Professional Advisory Board. You can learn more about Attention Research Update and sign up for a free subscription at www.helpforadd.com.