INVESTIGATING GENERICS: Healthcare Providers Call Out Issues With Generic ADHD Meds

FACT CHECKED

Over the past few months, MedShadow has examined inconsistencies in the quality of ADHD medications. Our reporting uncovered evidence that certain generic medications dissolve at different rates than the brand-name drug, leaving patients dealing with uneven dosing when prescriptions are filled from different manufacturers. We also identified problems with the FDA’s ability to regulate the labs that make these medications.

To complete the picture, MedShadow sought out perspectives often missing from the conversation — doctors and healthcare professionals who treat ADHD — and asked them to weigh in on our findings. Most respondents said they have witnessed patients dealing with new side effects or diminished effectiveness when switching between generic ADHD medications, and noted that their ability to help was limited. Their responses are below.

Richard E. Rhoden, M.D.
Location: Jackson, Mississippi
Years in practice: 53

Have you seen variable quality of ADHD medications in your practice? 

I definitely see problems of efficacy and potency among generic ADHD medications. When a patient reports their medication is suddenly not working, it’s often related to differences in the effectiveness of a new generic (although other factors have to be explored).

What do you do if you or a patient suspects that a manufacturer switch is responsible for a return of symptoms or new side effects? 

I explain to the patient how and why this can occur. We try to ascertain the manufacturer’s name (not the pill color that patients often report) and have the patient request a different manufacturer from the pharmacy. Ideally, they should request the manufacturer of a previously successful generic. Sometimes, we are able to substitute a brand name, depending on expense, insurance coverage, etc. I also encourage them to report the problem to MedWatch, the FDA’s reporting system. A key aspect to all this is educating the patient; often a pharmacist will maintain that all generics are the same, and that’s simply not true.

There are many related and complex issues here that contribute to the problem, but would require much more elaboration: overpriced brand drugs, poor insurance coverage, wide allowance of generic bioavailability differences from brand, supply chain problems, unwillingness/inability of pharmacy flexibility in stocking generics, quota limitations from the DEA, inadequate/infrequent FDA monitoring, foreign manufacture oversight issues, etc.

Patricia Pop, M.D.
Location: California
Years in practice: 8

Have you seen variable quality of ADHD medications in your practice? 

Yes, I’m certainly seeing this in my practice. About three years ago, the main issue was medication shortages. While shortages still occur, this year I’ve observed more concerns related to quality and evolving pharmacy regulations.

One challenge is that there’s no single, centralized, reliable source of up-to-date information for clinicians about manufacturer changes, quality issues, or patient-reported concerns. Updates are often scattered and hard to verify. Earlier this year, I came across an article discussing declining quality in some generic ADHD medications. Within weeks, several patients — some on the lowest available doses — reported new and unusual side effects, such as splitting headaches, which I had never previously encountered. Initially, I assumed these were isolated cases, but the pattern has persisted.

What do you do if you or a patient suspects that a manufacturer switch is responsible for a return of symptoms or new side effects? 

When this happens, I first try to identify the manufacturer and lot number, and if possible, work with the pharmacy to source the prior version; though this isn’t always possible and can add delays. Other options include trying a different manufacturer, adjusting the dose (often less helpful if issues occur at the lowest dose), changing the formulation or medication class, exploring non-stimulant options, and reinforcing non-medication strategies.

Unfortunately, there’s no centralized, user-friendly system for clinicians to track manufacturer quality issues, and insurers often require multiple generic trials before approving brand-name medication, after which coverage may still be limited. Patients can benefit greatly from knowing these issues occur and that there are concrete steps they and their clinicians can take together.

Ozan Toy, M.D., MPH
Location: Several states, telepsychiatry
Years in practice: 10

Have you seen variable quality of ADHD medications in your practice? 

As a psychiatrist who treats many patients with ADHD, I have witnessed this phenomenon firsthand. I have seen the impact of switching between different manufacturers’ ADHD medications on my patients. Patients often notice a significant decrease in efficacy or an increase in side effects when they are switched to a different brand. This phenomenon can be due to variations in the manufacturing process, inactive ingredients, and release mechanisms.

What do you do if you or a patient suspects that a manufacturer switch is responsible for a return of symptoms or new side effects? 

When a patient expresses concerns about their medication not working after a switch, I always take the time to thoroughly review their symptoms and discuss potential reasons for the change in effectiveness. In many cases, I trust the patient’s experience and recommend they switch back to the original brand or adjust the dosage of the new medication to compensate for any perceived differences in effect.

In terms of handling medication switches, it is crucial that they do not make any changes to their medication without discussing it with me first. I also advise patients to keep a record of their medication history, including brand and dosage, to help identify any patterns in their symptoms.

In addition, I would like to emphasize the importance of individualized treatment for patients with ADHD. Each person may respond differently to different medications, and it is important to find the right fit for each patient. I also believe that more research needs to be done on the impact of switching between different brands of ADHD medication.

Cooper Stone, D.O.
Location: Philadelphia, PA
Years in practice: 5

Have you seen variable quality of ADHD medications in your practice? 

This is not an issue I commonly notice, but when it does occur, it’s usually confounded by other variables. More often than not, when a difference is noted by a patient, further questioning reveals that the patient had begun taking their stimulant with (or just after) breakfast, with their morning coffee, or their tea. All of these can affect how many of the stimulant medications work and reduce their efficacy. This is most common in patients who previously took their medications on an empty stomach and/or didn’t usually have their breakfast until later.

In other instances, patients changed their sleeping patterns and are sleeping less. We know reductions in sleep quality can have a profound impact on executive function and other symptoms of ADHD. Therefore, while the differences can be due to generic vs brand name, it’s important to investigate further before jumping to conclusions, as the difference may be entirely due to confounding variables.

What do you do if you or a patient suspects that a manufacturer switch is responsible for a return of symptoms or new side effects? 

Medication switches or attempts at prescribing the brand name are always preceded by a risk and benefit discussion with the patient. Not all methylphenidate is the same, for example, as they have different delivery mechanisms, releasing the drug at different rates, lasting for different amounts of time, etc. If we go the route of fighting insurance for a brand-name approval, it may cause unpredictable and variable delays in the patient receiving a very important medication that is critical for their function. If the patient understands this and still wants to pursue that route without any guarantee of approval, it can be done.

Sina Nikayin, M.D.
Location: Connecticut
Years in practice: 11

Have you seen variable quality of ADHD medications in your practice? 

Yes, we do encounter these issues from time to time, and not just with ADHD medications. The differences are likely more noticeable with medications that have an immediate effect, like stimulants or benzodiazepines, compared to something like an SSRI (selective serotonin reuptake inhibitor), where the onset of action is slower, and the overall absorption and steady plasma levels are more important than small dose variability or differences in absorption rate.

If a patient is just starting a medication, it’s also less likely they’ll notice a manufacturing difference, since it may be attributed to the medication not working for them overall. So, this issue is much more likely to be seen with refills.

While generic medications contain similar active ingredients, the inactive components, production processes, and other factors can vary between manufacturers and cause variability. This is uncommon, but something every provider should keep in mind.

What do you do if you or a patient suspects that a manufacturer switch is responsible for a return of symptoms or new side effects? 

What many patients don’t realize is that the manufacturer is often listed on their pill bottle label. Checking this can help identify whether a refill came from a different producer, which then could be considered as a possible reason for changes in effect or side effects. If a refill isn’t working as well and I suspect a manufacturing difference, I typically try to return to the manufacturer that was effective for the patient. You can even call pharmacies and ask which manufacturers’ medications they have in stock. If that’s not possible, I may consider a brand-name as a backup, or another generic manufacturer, especially when the cost difference between brand-name and generic is significant.

Amanda V. Porter, Ph.D., APRN
Location: Ohio
Years in practice: 12

Have you seen variable quality of ADHD medications in your practice? 

YES! It’s a huge hassle and incredibly frustrating when pharmacies change a generic manufacturer without notifying me or the patient. I have many, many patients who are sensitive to a change in the generic manufacturer of Adderall, specifically.

What do you do if you or a patient suspects that a manufacturer switch is responsible for a return of symptoms or new side effects? 

When a patient informs me that their medication has stopped working overnight, or that they are experiencing a sudden and new side effect despite having been on their medication for some time — my first question is always ‘did you just pick up a new refill?’ because likely there has been a change in generic manufacturer. To top it off, since Adderall is a controlled substance, the patient can be stuck for up to 90 days without access to a medication that improves their quality of life.