At The Being Well Center, we have developed a particular expertise in the use of medication in the treatment of ADD/ADHD. To achieve a high degree of success when it comes to medication treatment for ADD/ADHD we have found that it is commonly necessary for us to use off-label medication doses and regimens (i.e., for any medication dosage form, dosage regimen, population, or other use presently not mentioned in the FDA approved manufacturers’ marketing guidelines). Predictably this can magnify the inherent fear many patients, family members, uninformed physicians, and pharmacists have about the stimulant medications and can put us at odds with insurance companies that are increasingly restricting their formularies for ADD/ ADHD medications by imposing arbitrary quantity limits for these medications and failing to reimburse off-label uses of stimulant medications to treat ADD/ADHD.
Key Facts for Medication and ADD
Here are some key facts that combat misinformation and fear in the use of medication to treat ADD/ADHD:
- Manufacturer labeling including dosage guidelines for Ritalin and Dexedrine, the early forerunners of the methylphenidate and amphetamine-based stimulants of today, were initially approved by the FDA many decades ago. This was at a time prior to the more rigid approval standards used today. Original documents used by the manufacturers to support their prescribing guidelines (which were ultimately approved) provided no scientific basis for the recommendations made, but rather, anecdotal feedback from a small collection of physicians who had experience prescribing the medications at that time.
- These approved labels including manufacturer’s prescribing guidelines were subsequently grandfathered in when the United States Federal Food, Drug and Cosmetic Act (FD&C) was updated and amended. Therefore, books, clinical articles, professional society association pamphlets, drugstore/pharmacist printouts, package inserts, and other materials which use the FDA approved manufacturer’s marketing guidelines (i.e., the PDR) as the basis for their recommendations are probably the least scientifically reliable and valid pieces of information available to physicians to use in making informed decisions about stimulant medication dosages.
- The manufacturer of a newer methylphenidate formulation, Concerta, worked out agreements with the FDA to get approval for its labeling and dosage guidelines without having to undergo extensive and expensive dosing studies provided that it adhered to dose recommendations that were equivalent to the FDA approved, yet unscientifically-determined, dosage recommendations for Ritalin. This means that the FDA approved manufacturer’s prescribing guidelines for one of the most popular medications used to treat ADHD, Concerta, are more than 50 years out of date.
- The FDA has set a standard for medications used to treat ADD/ADHD that, to receive approval, manufacturers must demonstrate a 30% reduction in core symptomatology in blinded controlled trials in groups of individuals with and without ADD/ADHD using responses on FDA approved questionnaires or through behavior ratings from structured observations of subjects. The goal for pharmaceutical companies is to generate data to meet this standard for approval by using the lowest dose that shows group efficacy and the lack of deleterious side effects not what was the most effective dosage for individual participants. While this standard may be appropriate for manufacturers with regards to approval for marketing their products to the masses, it is out of sync with the real world realities of finding and using the most effective dosing regimens to properly treat an individual with ADD/ADHD. Most experts now agree that clinicians treating individuals with ADD/ADHD should be striving to provide 100% symptom relief (i.e., remission) throughout the entire waking day. Logically, this means that many ADD/ADHD patients might require dosages that are at variance with FDA approved manufacturer’s marketing guidelines in order to receive optimal care.
- Once a drug is approved for use, it would be illegal for a pharmaceutical company to market it or make recommendations that are at variance with the original FDA approved guidelines even when years of clinical practice and the medical literature might suggest significant variations are warranted. Furthermore, senior management of pharmaceutical companies have told us and others that there is no incentive, in fact, significant disincentives, (i.e., exorbitant costs of conducting additional research to meet current FDA requirements and enhanced liability exposure) for them to generate more data with costly new trials to support approval of secondary indications or expanded dosages when off-label use is so common (40-60% of all prescriptions written) and sales of these products are so strong.
- FDA approval of manufacturer’s marketing guidelines sets the parameters by which pharmaceutical companies can market their products to physicians and the public. However, they are not intended to dictate medical care. In fact, by the provisions of the FD&C Act, once a medication is approved by the FDA for marketing, physicians can prescribe it off-label for whatever conditions and at whatever dosage schedule they deem necessary to meet a given patient’s needs. In fact, off-label use of medications is an accepted and valuable part of quality care of a patient when used by physicians ethically and according to their best knowledge and judgment. Many organizations and experts have weighed in on the off-label use of medications and the consensus would appear to be that it represents good medical practice when the following pre-requisites are meet:
- The prescriber has experience and familiarity with the medication and the patient being treated
- No other alternatives are available
- Sound medical evidence in the published literature and/or other expert physicians support the intended use
- Efficacy and safety are closely monitored and documented
Therefore, off-label use of stimulants above or outside of the FDA approved manufacturer’s recommended dosage schedule in marketing materials by experienced healthcare providers is not only permissible, but could actually be indicated to meet certain individual patient needs when there is either justification in the medical literature or evidence that peers with similar training and experience are prescribing them in this fashion. We will provide information in this white paper that confirms that both of these criteria are met when it comes to off-label use of stimulant medications for ADD/ADHD.
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