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Insight: Shortage of ADHD drug Adderall seen persisting

2012-01-02 10:28:14

By Toni Clarke | Reuters

BOSTON (Reuters) - A shortage of Adderall, which is used to treat attention

deficit hyperactivity disorder, shows little sign of easing as manufacturers

struggle to get enough active ingredient to make the drug and demand climbs.

Adderall, a stimulant, is a controlled substance, meaning it is addictive and

has the potential to be abused. The Drug Enforcement Administration tightly

regulates how much of the drug's active pharmaceutical ingredient (API) can be

distributed to manufacturers each year.

The system is designed to prevent the creation of stockpiles that could be

diverted for inappropriate use. Adderall and other stimulants are popular with

students who may not have ADHD but are seeking to improve their test scores.

The DEA authorizes a certain amount of the API in Adderall - mixed amphetamine

salts - to be released to drugmakers each year based on what the agency

considers to be the country's legitimate medical need.

Increasingly that estimate is coming into conflict with what companies

themselves say they need to meet demand for the drug, which is reaching

all-time highs. In 2010, more than 18 million prescriptions were written for

Adderall, up 13.4 percent from 2009, according to IMS Health, which tracks

prescription data.

Concerns are now rising among patient groups and doctors that the shortages

seen in 2011 will continue into this year. Many orders remain unfilled,

manufacturers say, and it may take several months before ingredient authorized

under the new 2012 quota can be turned into new product.

"I am very concerned about the future," said Ruth Hughes, chief executive of

Children and Adults with Attention Deficit/Hyeractivity Disorder (CHADD). "No

one seems to have much inventory to get us through the months ahead."

ADHD is one of the most common childhood disorders. An average of 9 percent of

children between the ages of five and 17 are diagnosed with ADHD per year,

according to the Centers for Disease Control and Prevention.

Symptoms include difficulty staying focused, hyperactivity and difficulty

controlling behavior. If they are not properly medicated, children with ADHD

may act out and be held back in class; adolescents might engage in impulsive,

risky behavior; adults are at greater risk of being fired from their jobs.

"There are real major life impacts for people not having access to medication,"

Hughes said. "Someone needs to own this problem and take the initiative to fix

it."

RIPPLE EFFECT

Adderall is made in several dosages and formulations. Shire Plc makes Adderall

XR, a more expensive extended release version of the drug. Authorized generic

versions of Adderall XR are sold by Teva Pharmaceutical Industries and Impax

Laboratories Inc.

Shorter-acting instant release forms are made by Sandoz, a unit of Swiss

drugmaker Novartis AG, as well as by CorePharma LLC and Teva. It is the

shorter-acting versions of the drug that are currently in shortest supply.

The full scope of the shortage is unclear. Patients have been scrambling since

mid-year to find pharmacies carrying the drug. Some have been switched to other

medications such as Adderall XR or Ritalin, a rival drug known also as

methylphenidate. But companies do not always track which pharmacies have their

product at any given time.

"We don't monitor the distribution system, but we do know that all our

customers are on back order right now," said Teva spokeswoman Denise Bradley.

Teva sells to wholesalers and distributors as well as to some hospitals and

specialty pharmacies - and all have orders placed but not filled.

Hughes said CHADD, along with the American Academy of Child and Adolescent

Psychiatry, another advocacy organization, has recently started to track where,

geographically, the calls about shortages are coming from.

Quantifying the problem is particularly urgent since the Adderall shortage is

now also spilling over and causing shortages of Ritalin. Sandoz, which makes

generic forms of both drugs, is straining to meet increased demand for both

products.

"There is currently not enough product to fill all of our customer orders at

the wholesaler level," said Julie Masow, a spokeswoman for Novartis, in an

email.

TENSIONS FLARE

The problem is particularly troublesome since no one really agrees on its

cause.

Under the quota system, drugmakers receive enough material to meet what the DEA

estimates will meet the legitimate needs of American patients, but not enough

to build inventory. The DEA says recent shortages were not caused by an

insufficient quota but by marketing decisions taken by the companies.

"Any shortage of these products is therefore a result of decisions made by

industry regarding manufacturing or distribution," Barbara Carreno, a DEA

spokeswoman said, though she declined to specify those decisions.

She noted that there are currently more than 200 drugs in short supply in the

United States, most of which do not contain controlled substances and have

nothing to do with the DEA.

"There is no reason to think that the same market forces that are causing those

shortages are not playing a part in these," Carreno said.

President Barack Obama recently issued an executive order demanding that the

Food & Drug Administration address these shortages, which mostly affect generic

injectable drugs that companies are no longer making as they are not as

profitable as newer products.

For their part, Adderall manufacturers say they are working flat out to meet

demand, and say the DEA does not always approve enough material in time for

them to supply customers.

"Our production facilities are currently running at maximum capacity for

Adderall utilizing all available API," said Teva's Bradley. "The catalyst for

the problem is the quota system, not the business."

The DEA sets its aggregate quota at the beginning of each year, taking into

account past quota levels, inventory levels and company sales forecasts. But

the DEA's assessment of what a company needs may not be the same as the

company's own estimates. It is an ongoing process of negotiation.

"DEA can come back and say, 'we agree with your forecast and issue everything

you want,' or they may come back and say 'we don't think you need that much,'

and they give you 75 percent," said Matt Cabrey, a spokesman for Shire.

Early last year, Shire suffered shortages of Adderall XR. "It was directly

related to the API quota," Cabrey said. In June 2010, Shire calculated that API

was running too low. It applied to the DEA for more, but did not receive the

additional supply until December. It typically takes Shire three months to then

make the product and get it to customers.

As a result, Cabrey said, there were shortages of Adderall XR in January and

February last year and supplies did not return to normal until March and April.

The company said there are no shortages of Adderall XR, though some patients

say even that is now hard to get hold of.

Amy Alkon, 47, who writes a syndicated column on dating and manners, began

taking Adderall for her ADHD about five months ago after Ritalin stopped

working for her. This week she spent hours on the phone trying to find a

pharmacy that could fill her prescription - and she couldn't find Adderall or

Adderall XR.

"I have gone to the biggest medical centers in the Los Angeles area, I've

called countless pharmacies and they have no pills," she said. "Nobody has

anything."

For Alkon, the prospect of the shortage continuing is alarming. Adderall, she

said, has changed her life, allowing her to organize her thoughts and tamp down

what she calls a "tornado" of activity in her brain.

CONTROLLED SUBSTANCES

The DEA, while insisting its quota for 2011 was sufficient, nonetheless revised

it upwards in December.

"We increase the aggregate so that we will have enough to respond to specific

companies if their requests for more amphetamine salts are justified and

needed," said Carreno. "The companies can and do request more amphetamine

salts, and we can and do respond to those requests throughout the year."

Simply increasing the overall national quota, however, does not address company

complaints that it takes DEA months to approve individual requests for new

product.

Asked why it might take the agency months to approve a company's request, the

DEA said it is required by law to balance providing enough API to meet the

legitimate needs of patients while protecting the public from any diversion of

potentially lethal substances.

"We do our best to accomplish both missions, and the quota system is part of

the process for achieving this," Carreno said.

That is not good enough for CHADD's Hughes or other advocacy groups, who plan

to lobby both the DEA and drugmakers to find a solution to the shortages.

"When you have a controlled substance problem, the DEA has to be involved in

fixing it," said Hughes. "It is not sufficient to say it is an industry

problem. We need to figure out how to build more flexibility into the system."

The DEA controls roughly 400 basic substances, in addition to derivative

products such as salts and ethers.

The chemicals are divided into five schedules. Schedule 1 drugs include illegal

substances such as heroin. Scheduled II drugs, such as Adderall and other

stimulants, have a medical use but a high potential for abuse. Schedule III

drugs have a somewhat lower abuse potential and include the painkiller Vicodin,

while Schedule IV drugs include the tranquilizers Klonopin and Ativan. Schedule

V substances include cough medicines such as Robitussin.

Adderall is popular on college campuses, even among those who do not have ADHD

but want a performance boost. Students may trade the drug or get it from their

siblings or parents.

Stimulants appear to work in patients with ADHD by increasing the availability

in the brain of the chemicals dopamine and norepinephrine, which both appear to

help regulate attention and executive function. Their effects differ slightly

depending on the drug, and some people respond better to one than another.

"In every suburban high school and in colleges there is a significant

underground economy around stimulants," said Harry Tracy, a psychologist and

publisher of NeuroPerspective, a monthly publication focusing on central

nervous system disorders. "Adderall can go for $5 to $10 a pop."

Physicians say it can be challenging to sort out who is a legitimate patient

and who might seek the drug simply to enhance performance.

"Trying to determine the best thing to do can be a quandary at times because

there is this question of whether the person is trying to get the medication

for nonmedical reasons," said Steven Cuffe, a child psychiatrist and Chairman

of the Department of Psychiatry at the University of Florida College of

Medicine.

Right now patients are trying to scrape by, either by traveling long distances

to fill prescriptions or switching to other products even if they don't work as

well or are more expensive. But these are temporary workarounds and without a

structural change manufacturers and advocate groups fear the problem will

linger or even worsen.

"This does not seem to be a short-term solvable problem," Hughes said.

(Additional reporting by Ransdell Pierson and Lewis Krauskopf in New York,

Jessica Wohl in Chicago; Editing by Michele Gershberg, Martin Howell in New

York.)