Emporia pharmacies, medical centers and patients are feeling the pinch of a national drug shortage.
According to the Associated Press, President Barack Obama on Monday signed an executive order, mandating that the Food and Drug Administration take action in three related areas:
• broadening its reporting of potential drug shortages
• accelerating reviews of applications to change production of drugs facing potential shortages
• giving the Justice Department more information about possible instances of collusion or price-gouging.
The escalating problem has resulted in patient endangerment, deaths in some areas of the country, as well as the potential for price gouging by suppliers to the medical community, the AP reported. In Alabama this spring, nine deaths were reported and 10 patients harmed because of bacterial contamination of a hand-mixed batch of liquid nutrition given when the sterile pre-mixed liquid was not available.
Drugs reported in especially short supply by the AP are cancer drugs, anesthetics, drugs used in emergency medicine and electrolytes needed for intravenous feeding.
“Hospitals have been forced to buy from secondary suppliers at huge markups,” the AP reported. “Surgeries and cancer treatments have been delayed. ...
“Major causes of drug shortages are said to be quality or manufacturing problems, or delays in receiving components from suppliers. Drug makers also discontinue certain drugs in favor of newer medications that are more profitable. The FDA does not have authority to force drug makers to continue production of a drug. ...
“Shortages have tripled in recent years and show no signs of slowing,” the AP reported.
No oversight
“It’s nationwide,” said Glen Hadaway, pharmacist and owner of Grave’s Drugs, 609 Commercial St. “We’re really suffering, just like every place is, and this is almost 100 percent the FDA’s fault with their regulations and their faulty implementation of them.
“One won’t question their motives, but the result of their decisions is causing just extreme disruption in the legitimate drug market.”
He compared the FDA to the old fiefdom system, where feudal lords controlled their own estates and didn’t communicate or cooperate with each other. The FDA has the power to control production, without answering to any other entity.
“They’re truly autonomous in the decisions they can make,” Hadaway said. “That’s fine if they’re right; it’s terrible if they’re wrong. There’s no check-and-balance on the FDA and they’re just a series of fiefdoms. ... You can get one individual who makes one decision that affects the whole nation, and there’s really no oversight. And that’s what’s wrong with the FDA.”
While members of the local medical community may agree that the lack of oversight on FDA’s powers and policies is a major factor in the shortages, Hadaway identified additional causes for concern.
Unreliable outsourcing
“Another reason the consequences are really starting to happen is that the pharmaceutical industry in the United States is disappearing,” Hadaway said.
“It’s being shipped overseas to China and India. Not only do you have the distance problem, you also have that if anything happens in their market, we don’t have the industries to pick up and make it. ... Do you know that no flu vaccine is made in the U.S. anymore? It just illustrates the consequences of government policies. They’re driving the manufacturing out of this country.”
He attributed some of that change to regulations and the FDA’s interpretations of them.
At the turn of the 20th century, Hadaway said, Congress passed laws to clean up the drug-manufacturing process.
“They were really beneficial ... but in many cases, they’ve outlived their usefulness,” Hadaway said.
“That’s not to say you shouldn’t have some regulations. You should. But they (the FDA) just carry it too far. ... They need more oversight. They need more accountability, which they don’t have right now.”
Hadaway runs what is known as a “compounding pharmacy,” which can blend ingredients to doctors’ specifications.
“We can make most of these drugs, but the FDA doesn’t want us to. So they create a shortage and they don’t want us to handle it. And that’s another thing.”
Anticipating need
Hadaway and other locals who distribute prescription drugs have tried to keep a step or two ahead of the situation, but shortages do occur.
“We do our best and we buy from multiple suppliers and we’ve had drugs when everybody else in town has been out, but that doesn’t exempt us from potentially being in the same situation,” he said.
James Wicoff, vice president of medical services and pharmacy director at Newman Regional Health, said that the hospital has been coping successfully with drug shortages, primarily through the efforts of pharmaceutical buyer Susan Simpson.
“Mrs. Simpson spends up to two hours a day — a sizable investment in a pharmacy department of our size — finding items which are in short supply or same-drug class alternatives,” Wicoff said. “The physicians have faced the necessity of using alternative medications at times, but we have been spared patients’ experiencing adverse effects from the shortages.”
Borrowing
from ‘family’
The shortages have affected the Central Care Cancer Center, 1401 W. 12th Ave., though the center has the advantage of being part of a multiple-location service.
“There is a drug shortage out there for sure, but it all depends on the type of cancer,” said Justin Branine, department manager at the center. “... I imagine most oncology offices or clinics have some type of issue. What sets this cancer center apart from other cancer centers (is) ... we are in different locations throughout the state of Kansas and in Missouri. Our clinics are able to share drug costs and also meds.
“If a patient in Newton is receiving a specific drug and a patient in Emporia is receiving the same type of drug, if there’s a shortage, sometimes we’re able to have the drug on-hand at one of our other clinics.”
Another advantage for cancer patients is that once a diagnosis has been made, consultations about treatments have been completed, a plan set in place by the patient and the medical team, and a port installed in the patient to allow easy intravenous medicating, the center has already made arrangements to bring in the necessary drugs.
When shortages do occur, the patient and the medical professionals get together as a team to talk about alternatives, he said. Medication Y may be the preferred treatment nationwide, but Medication X might be just as effective for the patient.
“Well, Y hasn’t been available for 30 days,” Branine said, giving an example of a possible conversation. “... Do you want to wait or do you want to go ahead and make that other choice? ... Just because Y says you’re going to have this doesn’t mean that X isn’t going to give you something better. Everybody reacts differently; side effects may be worse, but they might not be to you.”
Delays and occasional gaps in supply frustrate the professionals who provide medications for everything, from infections to cancers.
“It would be a whole lot better if we didn’t have to deal with that type of stuff and it was out there at less cost and easier for patients,” Branine said.
reddog (K. B. Thomas Jr.) says...
http://mydailyconcerns.com/white-hous...
November 1, 2011 at 6:28 p.m. ( permalink | suggest removal )