ADHD through the lifespan
Goodman DW. Mental Illness in Primary Care. Oxford Press. 2015. (book chapter)
Goodman DW. Mental Illness in Primary Care. Oxford Press. 2015. (book chapter)
On September 30, 2015, The New York Times ran an article in the Tuesday Science section on ADHD in older adults. I was interviewed for the article and discussed a former patient age 73 who was first diagnosis with ADHD by me and successfully treated. The article is an introduction into an important clinical area for ADHD heretofore ignored. As we discovered, 60% of children will continue to have ADHD symptoms to an impairing degree into adulthood. The presumption is that ADHD in adults will simply continue throughout one’s life. However, the research is only just accumulating to support this assumption. The largest collection of research in this age group is published by my colleagues in Amsterdam and additional research from other research groups around the world.
Early this year I wrote an article for CHADD’s Attention Magazine on issues related to diagnosis and treatment of ADHD in older adults. The diagnostic issues and treatment considerations in older adults are more complex. In brief, diagnosis needs to consider medical illnesses, medications, history of head trauma, and other medical illness that worsen thinking ability. Treatment consideration are complicated by the presence of medications and medical illnesses that might limit the use of ADHD medications. Older patients and families considering an evaluation for possible ADHD should see a psychiatrist or mental health professional who has expertise and experience treating adults with ADHD.
Remember, while attentional changes occur in those of us over age 50, the cornerstone for the diagnosis of ADHD is the presence of symptoms since childhood that are relatively chronic and unchanged over one’s life and that these symptoms cause impairment in daily functioning. A comprehensive evaluation of all possible psychiatric and medical is critical for the accuracy of the diagnosis.
David W. Goodman, M.D., FAPA
In my periodic entries of insurance companies’ denial of ADHD medication dosing, I offer you this recent example.
A female in her late 20s treated for ADHD with a combination of Adderall XR and Strattera. Strattera adds a benefit for her executive function not optimized with Adderall XR. I carefully dosed the Strattera upward and suggested increase to 120 mg daily.
Well, the folks at BlueCross Northeastern Pennsylvania denied the dose “As per the FDA recommended dosing guidelines for Strattera in adults the maximum dose is 100 mg per day.” Correctly stated per the package insert for Strattera. “There are no data that support increased effectiveness at higher doses. Therefore medical necessity for 120 mg of Strattera per day has not been met.”
This last statement is a misrepresentation of the purpose of a drug package insert. In fact, the adult registration trial for Strattera submitted to the FDA lists the dose that was used as up to 120 mg daily. Registration trials are designed for the purpose of seeking drug approval for a specific disease state. This research DOES NOT answer the question “If the patient is suboptimally treated with x dose, will they improve further with a higher dose?” So the logic of their denial is a misrepresentation of research for the sole purpose of constricting treatment and conserving money, in my opinion.
Yet more damage is done with these letters. People reading these letters may think the doctor is over-dosing them and not considering safety issues. This is simply not true since safety data on medications are routinely undertaken at much higher doses. There was no unusual safety concern with Strattera at 120 mg daily in the adult registration trial.
It is unfortunate that I find myself blogging about the denial of medication authorizations for my patients who clearly need better outcomes from their medications. While these companies have set up appeal processes, this tends to administratively time consuming without any guarantee that the medical necessity and logic of the dose request will be reviewed with the patient’s interest in mind.
So, what can YOU do if this happens to you? Here are the steps:
1. Call the insurance company and respectfully explain why you need your medicine. If the person is unresponsive, ask to speak to supervisor. If you don’t get to speak to someone with authority, ask if the conversation is being recorded and tell them to “tag” the audio file so that the State Insurance Comissioner’s Office with be able to listen to the audio file. Now, write down the date and time.
2. File a complaint with your state insurance commissioner’s office. You can find the contact information online by searching “<your state> insurance commissioner office”. In your complaint, which should only be one page (no reads anymore), state your brief history of medication history and why it is necessary to have the new dosing authorized for coverage. Write that you spoke with the insurance on what date and time.
In my experience, more often than not, you’ll be getting your approval. However, no guarantees. Good luck.
Chris Davis set a club record last year with 53 home runs. Yet, his presence in the media now has more to do with his ADHD and suspension for the use of Adderall. This has been a set of unfortunate circumstances since Mr. Davis has ADHD which was diagnosed years ago and treated with ADHD medication. The article in the Baltimore Sun newspaper February 27, 2015 reviews and clarifies the current status with Mr. Davis and his provision for a therapeutic use exemption (TUE).
I was interviewed for the article to provide background on ADHD, medications, treatment, and the increased attention by professional sports to formalize a process by which players can be appropriately identified with ADHD and permitted to take medication for this disorder. It is my hope that professional sport leagues, international sports leagues, and college sports consider adopting a clear protocol for diagnosis and treatment according to experts in the ADHD field. In doing so, we can identify athletes without ADHD who seek to take stimulants for performance enhancement and penalize them accordingly while allowing those with ADHD to seek and follow their treatment.
David W. Goodman, M.D.
You might think you’re exercising good judgment by enhancing your health and wellbeing by taking herbs and supplements. While the scientific research with replicated studies is limited, the nutraceutical companies have spent billions promoting their use. Yet now, the real problem is uncovered. The New York Times recently published a story on a investigation into herbs and supplements and found several companies whose products sit on shelves at national pharmacy chains don’t contain the ingredient on the label. UGH. Feeling trick and swindled. You bet. Read the full story here.
While I don’t discourage my patients from pursuing complementary and alternative treatments, understand that regulatory oversight and scientific research is critical in determining the real utility of treatments. Without this, marketing under the guise of education becomes the detrimental order of the day.
Thank you for your interest.
For those of you who follow my blog and others who have stumbled upon it, I wanted to bring this opportunity to your attention. Shire Pharmaceutical annually provides these scholarships to help students with ADHD get ahead. If you are interested and eligible, please look into this.The 2015 Scholarship program will award $2,000 and one year of ADHD coaching services* to each of 50 recipients in the United States. Adults with ADHD who are pursuing higher education are encouraged to apply. |
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Deadline: February 18, 2015 |
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Students may apply and learn more at ShireADHDScholarship.com. |
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Scholarship Questions? Please call 1-855-474-7432 |
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Who Can Apply |
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The scholarship program is for legal residents of the United States who: |
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Void where prohibited by law. Contest is subject to all federal, state, and local laws, and full rules and regulations. |
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*Coaching services provided through the Edge Foundation. |
Almost everyday insurance companies request pre-authorization for stimulant medication for my patients. While many of these requests are approved, many others are not. One obstacle to approval is stimulant dosing. Insurance companies routinely deny coverage for any stimulant dose that exceeds FDA drug label maximum dose. You might believe this is a safety issue and insurance companies are serving you well. I’d like to believe this too. Unfortunately, their decisions are often a guise for cost savings.
In order for you to understand the process, you need to know how the FDA approves the dosing of medication that it approved for a disease/disorder. Let’s take Concerta for example. The registration trial submitted to the FDA was conducted in the U.S. (Adler L, et al) with another trial conducted in German. The U.S. trial for adults had a dosing started at 36 mg in the morning and could be adjusted up to 108 mg in the morning if the subject had not achieved a predetermined improvement level. The FDA approved Concerta 72 mg as the maximum daily dose in adults. Why? Didn’t you say the trial went to 108 mg a day?
Yes, I did. The FDA decided that the higher doses (90 and 108 mg daily) didn’t produce any greater improvement than 72 mg daily. However, the trial was not designed to answer the question “If you don’t response to 72 mg, would your ADHD symptoms decline with 90 or 108 mg?”. Well then, of the subjects in the trial, what was the distribution of doses amongst all the adult subjects? (Remember, the researcher could increase Concerta dose if the subject hadn’t improved to a defined threshold on an ADHD rating scale)
Dose(mg) % of subjects
36 34%
54 15%
72 18%
90 15%
108 21%
So, you’ll notice that 36% (15+21) of adult subjects needed a dose over the FDA max daily dose. That’s 1 out of 3 subjects. Imagine that you are that patient whose ADHD needs a higher dose. Imagine that your doctor, unfamiliar with this research, tells you he can’t prescribe at doses higher than FDA approved max daily doses. Imagine that your insurance company denies what would otherwise be an effective dose. Imagine that you believe that the FDA max dose is related to safety (it’s not in this case). Imagine that the insurance company uses language to intimate safety concern.
The outcome of this imagination? UNDERTREATMENT. Persistent symptoms and daily impairments.
I provide this information so that my patients are educated about the state of the art for ADHD treatment and how to understand the avalanche of information available. Make the distinction between being informed by information and being educated by information.Being informed means having access to the information. Being educated means you understand how to interpret the information. The internet provides the former, I hope your physician provides the later.
Over the years, it has been challenging for psychiatrists to manage the risks of psychiatric medications in patients who considered childbearing, become pregnant, and chose to breastfeed. And while there is some information on many psychiatric medications, there remains little in regards to stimulant medications. Unfortunately, there is no registry for stimulant exposed pregnancy by which we can gain insight into their relative risk. The information we do have is related to animal research or people who have been active substance abusers. Very little of this research helps me in discussing evidence-based medication decisions with my patients. In my capacity as a researcher, I have had conversations about creating a stimulant pregnancy exposure registry with the pharmaceutical companies involved in ADHD but to no avail as yet.
With the proposed FDA changes in drug label for pregnancy and lactation, I hope we’ll have a better method of reviewing and evaluating relative risks and patients/families will be better informed.
The following article was distributed today, December 8, 2014 by the American Psychiatric Association, Psychiatric News Alerts.
On Wednesday, the Food and Drug Administration (FDA) published a final rule that will set new standards for presentation of information concerning pregnancy and breastfeeding on labels of prescription drugs and biological products. The rule goes into effect June 15, 2015. “The [current] letter category system [A, B, D, and X] was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.” The information provided under the new labeling requirements will be divided into the following categories:
Pregnancy: Containing information such as dosing and potential risks to the developing fetus and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug.
Lactation: Containing information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.
Females and Males of Reproductive Potential: Containing information about pregnancy testing, contraception, and infertility as it relates to the drug.
“The new system is potentially more informative and more useful than the old grading system, … [but] a great deal will depend on the content of the information that is provided under the new requirements, particularly for psychotropic medicines,” stated Nada Stotland, M.D., a professor of psychiatry at Rush University and an expert in OB-GYN psychiatry, in an interview with Psychiatric News. “If the information provided is reasonable and clear, it should help decrease the anxiety both psychiatrists and patients may feel regarding these medication decisions.” Stotland, a former APA president, emphasized that psychiatrists must continue to inform the public about multiple treatment options—including psychotherapies and social support therapies—that can safely aid in lessening symptoms of mental illnesses during pregnancy. “If left untreated—or unsuccessfully treated—mental illness can have adverse consequences for both mother and child,” she emphasized.
David W. Goodman, M.D.
If you’re reading this blog, you are one of the millions of people who now use the Internet to gain information on medical issues. In a recent survey of consumers, this is where people are looking for medical information.
Most accessed online resources:
53% web M.D.
22% Wikipedia
19% health magazines and websites
16% advocacy group websites
12% YouTube
10% Facebook
10% blocks
9% Pharma company websites
(results from third annual national consumer survey by Makovsky Health and Kelton, 2014)
I would like to take this opportunity to direct your attention to the attitude magazine website that has a large number of webinars from noted academic and professional experts in ADHD. For many with ADHD it’s often easier to watch a video on a specific ADHD topic then to read a book. While many with ADHD can sit and read for extended periods of time, it always struck me as odd that clinicians referred patients to books knowing their ability to sustain attention would be limited, especially in the evening when it medication affect us dwindled.
Explore the webinars on this site as a can be extremely helpful. On this blog site, I will continue to direct my patients in readers to reliable sources of information and clinical insights from my practice not available elsewhere.
Since many of my patients are on this antidepressant, I am posting the FDA warning issued this morning. Below is a copy of the text. Please see the link at the bottom of this blog for additional information.
AUDIENCE: Pharmacy, Psychiatry, Family Practice
ISSUE: Pfizer Inc. issued a voluntary recall of one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules. This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg in addition to the Effexor XR capsules.
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.
This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.
BACKGROUND: These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products.
RECOMMENDATION: Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. Patients with affected product should notify their physicians and/or return product to their pharmacies.
Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET).
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the press release, at: