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California patients in pain amid prescription opioid shortage. What’s causing the issue

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Chronic pain patients say they are struggling in the face of a national shortage of prescription opioids, preventing them from getting the medicine their doctors prescribed.In some cases, the sudden inability to get their medication has sent them into withdrawal. Northern California patients in pain “I’m in a huge amount of pain right now,” John Black, of Marysville, said.Black said he was diagnosed with multiple sclerosis 25 years ago, but the medication he took for that led to other issues.“Prednisone caused avascular necrosis, which is a dying of the blood supply or the end of the bones, which in turn caused me to have two and now three hip replacements,” he said. “I’ve had colon cancer, fistulas, you name it.”Black said he and his doctor spent a few years trying to find a medication that would work for him to manage the pain. Eventually, he said, his doctor prescribed hydrocodone and acetaminophen tablets. However, when he went to pick up his prescription medication in November, he said his pharmacy told him that they were all out because of a national shortage.“I keep coming back day after day,” he said. “They sent me after 15 years of being on medication into withdrawals for no fault of my own.”In Tracy, veteran Ubbo Coty has been experiencing a similar struggle. His challenges began while serving in the U.S. Air Force.“I did seven deployments, four combat tours,” Coty said.In 2006, he said, he broke his right foot.“I had seven surgeries on it,” he explained.Eventually, he found that led to a new problem.“I’ve got a neuroma. So, the pain, it’s like a chronic pain problem,” Coty said.He said his doctor prescribed Norco, a combination of hydrocodone and acetaminophen, because nothing else seemed to work. Yet, lately, he said his pharmacy has been telling him his medication is on backorder.“I couldn’t walk my service dog. I couldn’t do things I normally do,” Coty said about the pain he was having to endure without his prescribed medication.Black said it made it difficult to volunteer at 93Q, a nonprofit community radio station in Marysville, where he spreads the word about events and fundraisers in the area and interviews local leaders.“All I want to be able to do is give back to the community, and this thing is not allowing me to do it,” he said.Health care professionals try to help Tracey Fremd has been a nurse practitioner for 35 years, specializing in pain management for 17 years.“In all my practice in pain management, I’ve never seen a shortage of opiates to treat my pain patients as I have in the last six months,” she said.Fremd said stopping medication like that all of a sudden instead of tapering can lead to withdrawal symptoms, like fever, chills, nausea, vomiting and confusion.“Most of them don’t require hospitalization, but in the higher doses, you’re at risk for seizure, and you’re at risk for death,” Fremd said.She is concerned for her patients, saying her staff is now spending a lot of time making calls to patients and pharmacies to figure out what medications will not have adverse affects on patients and are actually in stock at pharmacies.“That has led to approximately 30 to 40% more workload on my staff and myself in the last 2 to 3 months as it kind of has worsened,” she explained.What’s causing the shortage?In determining what factors may have led to the shortage, KCRA 3 Investigates reached out to the Food and Drug Administration (FDA) first.By their definition, the agency said that there was no shortage.“The FDA is not aware of a current shortage of hydrocodone. For your background, the FDA receives information provided by manufacturers regarding their ability to supply the market, as well as market sales data on the specific products, then lists drugs on its shortages website once it has confirmed that overall market demand is not being met by the manufacturers of the product. The FDA does not consider a product to be in shortage if one or more manufacturers are able to fully supply market demand for the product.”However, the American Society of Health-System Pharmacists (ASHP) said it tracks drug shortages differently and has been looking into shortages of hydrocodone and oxycodone over the past year. You can find details on drug shortages at ASHP’s website.“We look at whether or not patients on the front lines or health care practitioners are able to procure the medication,” said Michael Ganio, the senior director of pharmacy practice and quality at ASHP.Ganio said there may be a few reasons for the current shortage of prescription opioids, starting with the Drug Enforcement Agency (DEA), which sets a limit each year on how much of the pain pills can be made. “The bad news is that toward the end of the calendar year, we think some of the shortages may have been due to those DEA quotas,” he said.Some companies may have been restricted from making more while others might not even meet their quotas because of unexpected production issues, Ganio said.Regardless, despite thousands of complaints from concerned citizens, the DEA has reduced quotas for manufacturers year after year to combat the opioid crisis.An alarming number of overdose deaths have been fueled by the misuse and abuse of pain pills, which has since sparked thousands of lawsuits against drug companies, pharmacies and distributors.Black and Coty feel like they are now caught in the middle, the unintended consequences of procedures intended to protect the public.”Don’t punish the people that really do have to take it,” Coty said.”There are people going through withdrawals that should not be, I’m talking 90-year-old women,” Black said. “It’s unconscionable.”The DEA did not respond to multiple inquiries from KCRA 3 Investigates.However, manufacturers and pharmacists said the DEA is trying something new this year, setting limits for drugmakers quarterly instead of annually.Pharmacists are hopeful that it will help the agency make adjustments throughout the year if one company is meeting its quota and another is not, but manufacturers worry that it could actually make the market more unpredictable and unstable.In the meantime, for patients dealing with drug shortages, Ganio asked people to be patient with their pharmacies.”I know it’s an extremely disruptive shortage. It’s very frustrating,” he said. “A lot of the pharmacies are understaffed, or they’re dealing with flu season, and seasonal antibiotics are being used more frequently now. So, those pharmacies are busy.”Fremd suggests people call their pharmacy a few days before refilling a prescription to find out if their medication is in stock.If it is not, then they should find out what is available and talk with their doctor about possible, safe alternatives, she said.

Chronic pain patients say they are struggling in the face of a national shortage of prescription opioids, preventing them from getting the medicine their doctors prescribed.

In some cases, the sudden inability to get their medication has sent them into withdrawal.

Northern California patients in pain

“I’m in a huge amount of pain right now,” John Black, of Marysville, said.

Black said he was diagnosed with multiple sclerosis 25 years ago, but the medication he took for that led to other issues.

“Prednisone caused avascular necrosis, which is a dying of the blood supply or the end of the bones, which in turn caused me to have two and now three hip replacements,” he said. “I’ve had colon cancer, fistulas, you name it.”

Black said he and his doctor spent a few years trying to find a medication that would work for him to manage the pain. Eventually, he said, his doctor prescribed hydrocodone and acetaminophen tablets.

However, when he went to pick up his prescription medication in November, he said his pharmacy told him that they were all out because of a national shortage.

“I keep coming back day after day,” he said. “They sent me after 15 years of being on medication into withdrawals for no fault of my own.”

In Tracy, veteran Ubbo Coty has been experiencing a similar struggle. His challenges began while serving in the U.S. Air Force.

“I did seven deployments, four combat tours,” Coty said.

In 2006, he said, he broke his right foot.

“I had seven surgeries on it,” he explained.

Eventually, he found that led to a new problem.

“I’ve got a neuroma. So, the pain, it’s like a chronic pain problem,” Coty said.

He said his doctor prescribed Norco, a combination of hydrocodone and acetaminophen, because nothing else seemed to work. Yet, lately, he said his pharmacy has been telling him his medication is on backorder.

“I couldn’t walk my service dog. I couldn’t do things I normally do,” Coty said about the pain he was having to endure without his prescribed medication.

Black said it made it difficult to volunteer at 93Q, a nonprofit community radio station in Marysville, where he spreads the word about events and fundraisers in the area and interviews local leaders.

“All I want to be able to do is give back to the community, and this thing is not allowing me to do it,” he said.

Health care professionals try to help

Tracey Fremd has been a nurse practitioner for 35 years, specializing in pain management for 17 years.

“In all my practice in pain management, I’ve never seen a shortage of opiates to treat my pain patients as I have in the last six months,” she said.

Fremd said stopping medication like that all of a sudden instead of tapering can lead to withdrawal symptoms, like fever, chills, nausea, vomiting and confusion.

“Most of them don’t require hospitalization, but in the higher doses, you’re at risk for seizure, and you’re at risk for death,” Fremd said.

She is concerned for her patients, saying her staff is now spending a lot of time making calls to patients and pharmacies to figure out what medications will not have adverse affects on patients and are actually in stock at pharmacies.

“That has led to approximately 30 to 40% more workload on my staff and myself in the last 2 to 3 months as it kind of has worsened,” she explained.

What’s causing the shortage?

In determining what factors may have led to the shortage, KCRA 3 Investigates reached out to the Food and Drug Administration (FDA) first.

By their definition, the agency said that there was no shortage.

“The FDA is not aware of a current shortage of hydrocodone. For your background, the FDA receives information provided by manufacturers regarding their ability to supply the market, as well as market sales data on the specific products, then lists drugs on its shortages website once it has confirmed that overall market demand is not being met by the manufacturers of the product. The FDA does not consider a product to be in shortage if one or more manufacturers are able to fully supply market demand for the product.”

However, the American Society of Health-System Pharmacists (ASHP) said it tracks drug shortages differently and has been looking into shortages of hydrocodone and oxycodone over the past year. You can find details on drug shortages at ASHP’s website.

“We look at whether or not patients on the front lines or health care practitioners are able to procure the medication,” said Michael Ganio, the senior director of pharmacy practice and quality at ASHP.

Ganio said there may be a few reasons for the current shortage of prescription opioids, starting with the Drug Enforcement Agency (DEA), which sets a limit each year on how much of the pain pills can be made.

“The bad news is that toward the end of the calendar year, we think some of the shortages may have been due to those DEA quotas,” he said.

Some companies may have been restricted from making more while others might not even meet their quotas because of unexpected production issues, Ganio said.

Regardless, despite thousands of complaints from concerned citizens, the DEA has reduced quotas for manufacturers year after year to combat the opioid crisis.

An alarming number of overdose deaths have been fueled by the misuse and abuse of pain pills, which has since sparked thousands of lawsuits against drug companies, pharmacies and distributors.

Black and Coty feel like they are now caught in the middle, the unintended consequences of procedures intended to protect the public.

“Don’t punish the people that really do have to take it,” Coty said.

“There are people going through withdrawals that should not be, I’m talking 90-year-old women,” Black said. “It’s unconscionable.”

The DEA did not respond to multiple inquiries from KCRA 3 Investigates.

However, manufacturers and pharmacists said the DEA is trying something new this year, setting limits for drugmakers quarterly instead of annually.

Pharmacists are hopeful that it will help the agency make adjustments throughout the year if one company is meeting its quota and another is not, but manufacturers worry that it could actually make the market more unpredictable and unstable.

In the meantime, for patients dealing with drug shortages, Ganio asked people to be patient with their pharmacies.

“I know it’s an extremely disruptive shortage. It’s very frustrating,” he said. “A lot of the pharmacies are understaffed, or they’re dealing with flu season, and seasonal antibiotics are being used more frequently now. So, those pharmacies are busy.”

Fremd suggests people call their pharmacy a few days before refilling a prescription to find out if their medication is in stock.

If it is not, then they should find out what is available and talk with their doctor about possible, safe alternatives, she said.

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