ADHD Drug Shortages a Major Problem for US Physicians

Deborah Brauser

January 19, 2012

January 19, 2012 — Several top organizations may disagree over details of the ongoing attention deficit/hyperactivity disorder (ADHD) drug shortage in the United States, and how or even when it may get resolved; but for many prescribers across the country, it continues to be a very real and problematic situation.

In a story published last May, Medscape Medical News reported that multiple articles had been released about the short supply of drugs used to treat ADHD, including certain brands and dosages of dextroamphetamine with amphetamine (Adderall, Shire PLC) and methylphenidate (Ritalin, Novartis), especially in the generic versions of these medications.

This is a situation that the US Food and Drug Administration (FDA) has said is basically out of its control. The manufacturers have said that the shortages are a result of increased demand and quotas that were set too low by the Drug Enforcement Administration (DEA) for ingredients such as amphetamine salts. The DEA has said it is a problem that is occurring somewhere within the manufacturing process because "we believe plenty of supply exists."

One DEA representative reported that his organization sets manufacturer quotas designed to help thwart abuse by individuals, many of whom are of college age, who do not have ADHD and only want the drugs in order to get high.

This has led to many clinicians coming up with their own "work-around" solutions for helping individuals clinically diagnosed with the disorder to fill their prescriptions.

"For many of our patients, parents are calling multiple pharmacies and running from place to place. It's a real struggle for them, and they are certainly concerned and upset," Adelaide Robb, MD, child and adolescent psychiatrist at the Children's National Medical Center in Washington, DC, told Medscape Medical News.

Dr. Adelaide Robb

Dr. Robb, who is also the psychiatric liaison for the American Academy of Pediatrics (AAP) Committee on Drugs and chairs the Pediatric Psychopharmacology Initiative for the American Academy of Child and Adolescent Psychiatry (AACAP), said that colleagues at her hospital often themselves call the pharmacies to try to save time for their patients. They also keep up-to-date lists and pass on this information as soon as they get it.

Fear of abuse should not be the reason to make policy decisions that affect many [patients] that actually need these medications.

"Fear of abuse should not be the reason to make policy decisions that affect many children, teenagers, and adults that actually need these medications," said Dr. Robb.

End in Sight?

Currently, shortages for ADHD medications include the generic versions of Adderall and Ritalin, as well as Methylin ER and Metadate ER (intermediate- and long-acting forms of Ritalin).

In an interview with Medscape Medical News, Valerie Jensen, RPH, associate director of the Drug Shortage Program at the FDA, said that although her organization receives many complaints about shortages of different medications, the majority of complaints relate to ADHD drugs.

"This has really been an ongoing situation for several months where we've had hundreds of inquiries per week. And they are coming from all over the nation. There are a lot of upset patients, and we share their concern."

She noted that some patients have asked whether the shortages were caused by companies hoarding medications to drive up profits as demand has outstripped supply, "but we haven't found any evidence of this."

According to a report posted on the FDA's Web site, some shortages may warrant the organization's approval of the import of a foreign version of a product on a limited basis.

When asked whether the FDA would consider allowing ADHD drugs to be imported until the current situation passes, Ms. Jensen said "that's an issue we always consider. So if we find a company that is able and willing to import, that's something we always look at when there's a long-term shortage."

We're in constant communication with the manufacturers. And they're telling us that they do believe that there is an end in sight.

"However, with this situation, we're in constant communication with the manufacturers. And they're telling us that they do believe that there is an end in sight. They're making new product now. We don't have exact timelines on when that new production will be available, but we'll get that information on our Web site as soon as we can. And we hope to have it very soon."

When asked if "soon" meant within the year, Ms. Jensen replied "Oh, yes."

Executive Order

In addition to ADHD medications, other shortages have recently been reported for anesthesia drugs, cancer treatments, and some emergency medications.

In addition to ADHD medications, other shortages have recently been reported for anesthesia drugs, cancer treatments, and some emergency medications. A list of all current drug shortages is posted on the FDA's Web site.

In October 2011, President Obama signed an executive order directing the FDA to take action against these supply shortages, saying that the situation has endangered patients.

Although some critics complained that the executive order was not specific enough, Ms. Jensen said it did encourage increased early notifications from manufacturers of potential shortages. In fact, so many of these notices are now coming in that the FDA has hired more personnel to deal with the extra workload.

"We think that the notifications have definitely helped us to be able to prevent more shortages," she explained.

Ms. Jensen added that when shortages do occur, the FDA reaches out to companies and asks what, if anything, they can do to help.

"A lot of times, they may need something like a new raw material supplier approved or a new manufacturing line because something has gone wrong. And we can help with that," she explained.

"In the case of ADHD medications, we're not hearing about anything that the FDA can do, but we'll continue to ask. The quota issues, however, are completely outside of the FDA's realm and not something we can really comment on."

Quotas or Distribution?

Several reports, including a Wall Street Journal article that quoted a spokesman for Shire PLC (which manufacturers Adderall XR), have blamed the current ADHD medication shortage on the DEA, saying that the quotas that have been set for manufacturers are too low to meet increasing demand.

However, according to Special Agent Jeffrey T. Scott, a spokesman for the DEA, this is not the case.

"The process is a complex dance between the DEA, the pharmaceutical industry, and the doctors who prescribe these medications. It's important to know that it's a long chain, and DEA is only one link," Special Agent Scott told Medscape Medical News.

"We're responsible for releasing for production purposes a certain amount of one of the active ingredients in these Adderall-type drugs. When determining the quota of amphetamine salts allocated to these manufacturers each year, it involves a lot of data and estimation: of legitimate medical need, of retail consumption based on prescriptions dispensed, and of the manufacturers' disposition history and forecast."

Special Agent Scott said that the production quotas are then used to make multiple products, including different formulations and dosages, which are under the sole discretion of the manufacturers.

He noted that quotas can be revised by the DEA mid-year "if a change is warranted" because of increased sales or exports, new manufacturers entering the market, new product development, or recalls.

"After looking at a lot of the data, we believe that to say there is currently a shortage is perhaps not very nuanced. There may be shortages in certain areas of a certain formulation or certain dosage or generics vs brand names, but that doesn't necessarily reflect an overall shortage or that the quota in and of itself is low," he said.

At least in theory, there are sufficient quantities of this stuff in the supply chain inventory to really meet the need for the US.

"At least in theory, there are sufficient quantities of this stuff in the supply chain inventory to really meet the need for the US," Special Agent Scott said.

Nevertheless, the DEA did decide to increase production quotas in 2012 from 50,000 kg to 56,000 kg of methylphenidate and from 18,600 kg to 25,300 kg of amphetamine.

"Given the interest in this and the calls that we've gotten, we have upped the overall quota a little bit. But internally we're still convinced that we were pretty close to right on the overall amount of amphetamine salts out there for manufacturers in 2011," said Special Agent Scott.

"It's incumbent upon DEA, and we take it seriously, to make sure that everyone who has a legitimate medical need can get the medicines they need. But conversely, it's incumbent upon the manufacturers and distributors to make their products available."

In a statement sent to Medscape Medical News, Julie Masow, director of External Communications and Media Relations for Novartis, said that "some active pharmaceutical ingredient shortages for [ADHD] drugs that have primarily affected our competitors" have resulted in an increased demand for products from both Novartis and its subgroup Sandoz.

"We are experiencing intermittent, short-term shortages of our methylphenidate HCl (Ritalin and generic Ritalin) and dextoamphetamine plus amphetamine (generic Adderall) products due to manufacturing capacity constraints in trying to meet the increased demand, which means that there is currently not enough product to fill all of our customer orders at the wholesaler level," said Ms. Masow.

"We are working diligently to supply the demand for these products for appropriate patients."

"Serious Outcomes"

While the causes of the drug shortages and "who is to blame" discussions continue to be debated, what steps can clinicians take in the meantime? How can you treat an individual with a disorder when the medication you think is best is also extremely hard to find?

"We have seen shortages of both generic stimulants and branded stimulant medications in all 3 of our jurisdictions," said Dr. Robb. Her hospital serves the District of Columbia, the state of Maryland, and the Commonwealth of Virginia.

"Creative solutions are definitely needed. Even families with a 90-day prescription, which allows them to mail it off to a Medco or other long-term pharmacy, are finding shortages," she said.

Dr. Robb noted that calling around to pharmacies near a patient's residence or work location to see if a prescription is in stock "shouldn't be a big issue" for clinicians.

"That's part of what we do as people who take care of kids and families. What's tougher is for families who don't have time, or who are working, or who may not have the gas money to go searching."

Other possible remedies, such as switching patients to a more readily available medication, can have their own complications. Although treatments such as atomoxetine, guanfacine, and clonidine are not in short supply, Dr. Robb noted that they have a lower success rate for treating ADHD than do stimulants.

"So the risk that you take as a clinician is that a patient switched off a stimulant that works but is no longer available has to go through a transition, which may take 4 to 6 weeks to get to the right dose. And then you have to deal with the consequences of being under or partially treated while making that switch."

She noted that a colleague recently reported that an adult patient with ADHD who could not get his prescription filled was switched to a different type of ADHD medication "that he didn't do so well on." Subsequently, the patient was fired as a result of poor work performance.

What we're seeing as child clinicians is our patients being suspended from school, due to things like running in the school bus, and college students who can't pass their tests or even hand in their papers on time because they ran out of their medication.

"His ADHD, which had been under good control for 6 years on the job, was no longer being effectively treated," said Dr. Robb. "And what we're seeing as child clinicians is our patients being suspended from school, due to things like running in the school bus, and college students who can't pass their tests or even hand in their papers on time because they ran out of their medication."

"These are not minor difficulties. These are serious outcomes from not getting the medicines that are prescribed."

What Now?

Dr. Robb said another issue is that many insurance companies, knowing that stimulants are first-line treatment for ADHD, often make those medications the most financially reasonable.

"As a clinician, you may have to go through extra phone calls or paperwork to get the patient approved for a nonstimulant prescription. And I wonder this: if we switch everyone to nonstimulants, will those then go into shortage because its demand will become much higher than expected?"

For now, she recommends that clinicians tell patients or families to contact their regular pharmacy before time to refill their prescriptions and to ask whether an adequate supply can be ordered in time. If not, she suggests asking the pharmacy if they can call around and find out what locations will have the needed stock by a certain date.

"When we've talked to our colleagues around the country, this is a problem everywhere. We've heard from people from South Dakota to Florida to Hawaii and all areas in between," said Dr. Robb, who noted that the AACAP is in contact with the AAP on these issues.

"We've also been speaking with the drug shortage division of the FDA and with the DEA to work together as a team to try and figure out how we can best serve the children and the adults that we care for with ADHD," Dr. Robb said.

"I don't see this as a stalemate and think everyone has the best interests of these patients in mind. But I think we really need to work on some creative solutions."

She explained that regulations currently state that a prescription for a controlled substance must be picked up at one time in the same location. So, for example, a patient could not pick up a 2-week supply at their usual pharmacy and then have another pharmacy across town send over the remaining 2-week supply of a monthly prescription.

"Even relaxing that regulation so that a pharmacy could fill the remainder of a prescription when it became available would make things easier for families. And that's the type of things we should be thinking about."

Dr. Robb said other organizations such as the US Department of Health and Human Services and the US Congress also need to get involved and start helping in decreasing current drug shortages.

The bottom line is that we need to work as a group to help our patients now.

"We've had shortages of stimulants before and we got through it. The bottom line is that we need to work as a group to help our patients now."

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