| By Greg Jaklewicz, Abilene Reporter-News, Texas | |
| McClatchy-Tribune Information Services |
A new drug used by those with Alzheimer's disease, such as
"I am very concerned," said Embry, who six years ago recognized the early signs of Alzheimer's -- her father had it -- and since has aggressively fought the onset of the disease.
Namenda is the brand name for memantine HCl, a drug that treats the memory loss and mental changes from dementia, which signals Alzheimer's.
Walk to End Alzheimer's
The annual September Walk to End Alzheimer's begins at
Namenda (also known as Namenda IR) has been used in combination with the drug Aricept (donepezil HCl), a
The maker of Namenda,
The XR drug is a 28 milligram capsule that is taken once daily and can be broken apart to mix with food, for those unable to take the tablet. It is extended release, as opposed to immediate release of Namenda.
Namenda XR treats moderate to severe Alzheimer's disease.
Namenda phaseout
Sales of the Alzheimer's drug Namenda are being discontinued as it goes generic and
When she first tried Namenda XR earlier this year, 66-year-old Embry said, "I could tell a huge difference."
Of the original Namenda, she said: "It wasn't working for me. I felt myself slipping."
But patients cannot easily find the XR version. When refilling orders or placing new prescriptions, patients found pharmacies were not being resupplied with the drug. Production, it seems, has not met demand.
"It's true," saidJames McCoy , the pharmacist who owns James McCoy's Drug Store in northeast Abilene . He has a waiting list and feels lucky when he checks his computer to see a two-bottle allocation. Bottles contain 30 capsules.
"It happened this morning," he said Monday. "When I checked back later, there were none."
On Wednesday, he could order two more bottles.
Embry was down to six pills, she said, when she discovered that pharmacies inAbilene could not get Namenda XR.
"We made calls -- my husband made the calls -- and I cried all day. I don't do that much," she said.
IN THE MEANTIME
According to theAmerican Society of Health-System Pharmacists' website, "Forest states the reason for the shortage of Namenda XR capsules is manufacturing delay. Forest states the reason for discontinuing the Namenda immediate-release tablets is to focus on the Namenda XR extended-release capsules."
Mindy Bannister , a caseworker at the local Alzheimer's Association office, said the demand for the Namenda XR was underestimated. She said she was told it will take Forest four to six months to catch up. Embry has heard it will be six months to a year.
On Wednesday,David Belian , director of global media relations for Activis, emailed the Reporter-News : "We are aware that some pharmacies have experienced temporary supply issues with Namenda XR. Demand for Namenda XR has been steadily increasing over the past several months, exceeding expectations. We are currently releasing additional supply ... to meet this higher demand. We are in the process of resolving supply constraints and are working with wholesalers to deliver product as rapidly as possible."
McCoy said he can fill Namenda orders, and some physicians have resubmitted prescriptions for the original drug while keeping a standing order for the newer version.
"We get a lot of scripts every day and we put those in a queue that we fill as soon we can get (the drug)," he said. "Yes, some people are doing without it."
Namenda XR in 7 mg doses is available.
But patients cannot easily find the XR version. When refilling orders or placing new prescriptions, patients found pharmacies were not being resupplied with the drug. Production, it seems, has not met demand.
"It's true," said
"It happened this morning," he said Monday. "When I checked back later, there were none."
On Wednesday, he could order two more bottles.
Embry was down to six pills, she said, when she discovered that pharmacies in
"We made calls -- my husband made the calls -- and I cried all day. I don't do that much," she said.
IN THE MEANTIME
According to the
On Wednesday,
McCoy said he can fill Namenda orders, and some physicians have resubmitted prescriptions for the original drug while keeping a standing order for the newer version.
"We get a lot of scripts every day and we put those in a queue that we fill as soon we can get (the drug)," he said. "Yes, some people are doing without it."
Namenda XR in 7 mg doses is available.
Theoretically, someone with Alzheimer's could take four of 7 mg capsules of Namenda to equal one 28 mg XR capsule. But price comes into play.
A bottle of the 7 mg dosage costs the same as a bottle of the 28 mg dosage, meaning a month's supply of the lesser dosage would cost four times as much. Insurance companies, McCoy said, are not going to go for that.
"Why would they?" he asked.
Said Bannister, "We're recommending to everyone not to let the supply get low and call your pharmacy every day."
That paid off for Embry. After calling local pharmacies and even some inDenver and Dallas with no luck, she called one in the Kansas City, Kansas , area. She is from that state and the
pharmacist on the phone ironically recognized her name. His mother, he said, went to college with Embry.
He found one bottle of Namenda XR and overnighted it to her. Embry has been able to build a three-month supply.
The shortage baffles Bannister.
"It's dicey right now," Bannister said. "I've been here six years and never once did it cross my mind there would be a shortage."
WHY A SHORTAGE?
On its website, Forest has alerted caregivers and health care providers of its plan to discontinue Namenda in 5 mg and 10 mg tablets in favor of Namenda XR. It advises caregivers to contact health care providers to avoid a disruption in treatment.
However, there has been a disruption and it falls on the drugmaker.
"You can blame the pharmaceutical company for not being prepared," McCoy said, not happy that he cannot promptly serve his customers.
Embry agreed.
"With the number of baby boomers now of this age, they should have been forewarned," she said. "Somehow money is involved."
Bannister said a Forest institutional representative who now and then comes by the local office had this response when asked about the shortage: "We goofed."
On Monday, the plot thickened.
TheNew York attorney general filed an antitrust lawsuit against Activis, which acquired Forest Labs in February for $25 billion . The lawsuit claims the company is forcing patients to switch to its new version of the drug to negate the effects of generic Namenda, which could be cheaper.
A bottle of the 7 mg dosage costs the same as a bottle of the 28 mg dosage, meaning a month's supply of the lesser dosage would cost four times as much. Insurance companies, McCoy said, are not going to go for that.
"Why would they?" he asked.
Said Bannister, "We're recommending to everyone not to let the supply get low and call your pharmacy every day."
That paid off for Embry. After calling local pharmacies and even some in
pharmacist on the phone ironically recognized her name. His mother, he said, went to college with Embry.
He found one bottle of Namenda XR and overnighted it to her. Embry has been able to build a three-month supply.
The shortage baffles Bannister.
"It's dicey right now," Bannister said. "I've been here six years and never once did it cross my mind there would be a shortage."
WHY A SHORTAGE?
On its website, Forest has alerted caregivers and health care providers of its plan to discontinue Namenda in 5 mg and 10 mg tablets in favor of Namenda XR. It advises caregivers to contact health care providers to avoid a disruption in treatment.
However, there has been a disruption and it falls on the drugmaker.
"You can blame the pharmaceutical company for not being prepared," McCoy said, not happy that he cannot promptly serve his customers.
Embry agreed.
"With the number of baby boomers now of this age, they should have been forewarned," she said. "Somehow money is involved."
Bannister said a Forest institutional representative who now and then comes by the local office had this response when asked about the shortage: "We goofed."
On Monday, the plot thickened.
The
In a statement, AG Eric T. Schneiderman said: "A drug company manipulating vulnerable patients and forcing physicians to alter treatment plans unnecessarily, simply to protect corporate profits, is unethical and illegal."
The patent for Namenda XR is through 2029.
Bannister said the association was alerted three to four weeks ago there was a shortage of XR. Two weeks ago, she said, clients told her that their calls to pharmacies were turning up none of the drug inAbilene . This is not solely a local problem, she said. It's one that the national Alzheimer's organization has become aware. Those ordering Namenda XR by mail also cannot get the drug.
Belian wrote the shortage is not widespread: "At this time, the majority of pharmacies and wholesalers inthe United States have supply."
That's not what local folks are finding.
"I think we called every pharmacy inAbilene and some in the surrounding areas and were told they didn't have any," Bannister said.
Embry compared the situation to that of a diabetic suddenly finding there is no supply on insulin.
EFFECT ON MANY
TheAbilene office serves more than 7,000 clients in 14 counties of the 40-county North Central Texas Chapter of the Alzheimer's Association. That number, Bannister said, does not include those unaware they have Alzheimer's.
Bannister said that stopping the drug or combinations of drugs would have a negative cognitive effect on the person with Alzheimer's. Should the patient restart using the drug, he or she could not make up the memory and mental capacities that were lost.
"It doesn't take long," she said of stopping the medication.
She said having a drug that at least helps with the effects is a positive for those with Alzheimer's and/or their caregivers -- they know they are doing what they can to slow the effects of the disease. The drug does not cure nor does it slow the onset of Alzheimer's but it helps with the progression of memory loss and other mental changes the disease brings.
Embry wants to remain a voice for those with Alzheimer's as long as she.
"I'm one of the lucky ones. I'm in the know," she said. "The little things I do are for the people who can't talk. I am going to fight this."
The patent for Namenda XR is through 2029.
Bannister said the association was alerted three to four weeks ago there was a shortage of XR. Two weeks ago, she said, clients told her that their calls to pharmacies were turning up none of the drug in
Belian wrote the shortage is not widespread: "At this time, the majority of pharmacies and wholesalers in
That's not what local folks are finding.
"I think we called every pharmacy in
Embry compared the situation to that of a diabetic suddenly finding there is no supply on insulin.
EFFECT ON MANY
The
Bannister said that stopping the drug or combinations of drugs would have a negative cognitive effect on the person with Alzheimer's. Should the patient restart using the drug, he or she could not make up the memory and mental capacities that were lost.
"It doesn't take long," she said of stopping the medication.
She said having a drug that at least helps with the effects is a positive for those with Alzheimer's and/or their caregivers -- they know they are doing what they can to slow the effects of the disease. The drug does not cure nor does it slow the onset of Alzheimer's but it helps with the progression of memory loss and other mental changes the disease brings.
Embry wants to remain a voice for those with Alzheimer's as long as she.
"I'm one of the lucky ones. I'm in the know," she said. "The little things I do are for the people who can't talk. I am going to fight this."
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