"Drug Shortages: A Deadly Problem With No Cure in Sight"

[ILADVOCATE]

http://www.dailyfinance.com/story/drug-shortages-a-deadly-problem-with-no-cure-in-sight/19783927/

"Drug Shortages: A Deadly Problem with No Cure in Sight"
By MELLY ALAZRAKI
  If gasoline or jobs or milk were in short supply, we'd all know about it. But unknown to most Americans, the country is now in the grips of a life-threatening drug shortage. Medical professionals are quite aware of it, however, and they're deeply concerned.
  So is the Food and Drug Administration. Unfortunately, the FDA's hands are pretty much tied when it comes to taking steps that could ease this crisis. It's powerless to demand that a drug company produce a particular medication simply because it's becoming dangerously unavailable.
How bad is this situation? A recent survey of health care professionals found the U.S. is experiencing drug shortages of "epic proportion that are often associated with third-world countries." This unprecedented, and growing, shortage of critically important medications is affecting care and endangering patients' lives.
"For the past year-and-a-half we've seen quite an escalation in the report of drug shortages," says Bona Benjamin, director of Medication-Use Quality Improvement with the American Society of Health-System Pharmacists (ASHP). "And resolving the shortages is becoming more difficult."
  A Warning in July
   Injectable drugs used in hospitals are those most in short supply. Oral drugs or those filled at the local pharmacy are not as prone to shortages. The affected drugs include vital medications such as chemotherapy, antibiotics, analgesics (painkillers), anesthetics and more. Such shortages can compromise therapy or delay treatment, putting patients at risk -- sometimes even of death.
  The Institute for Safe Medication Practices in July clearly warned of the severe problem. An ISMP survey of more than 1,800 health care practitioners (68% of them pharmacists) from July to September revealed at least two deaths as a result of a morphine shortage when a substitute was misused.
  Respondents were most alarmed by the use of less desirable, unfamiliar and often more expensive alternative drugs. They were concerned of potential for errors, poor patient outcomes or preventable adverse drug events. For example, using a substitute of an unavailable drug resulted in an overdosing error that led to the death of a 16-year-old boy in an emergency room, ISMP President Michael Cohen wrote in July.
In another example, the diuretic furosemide, "is in very very short supply," the ASHP's Benjamin says. APP, American Regent, and Hospira all make the drug but couldn't explain the shortage, according to the ASHP. "This is a real problem because many patients who are acutely ill need a diuretic to help them remove unwanted fluids. As a result, the only other drug in the same class is now in a shortage situation, too," says Benjamin. "Some hospitals can't get either drug."
   "It's Pretty Serious"
At least "with the diuretic situation, despite the shortage, there are some alternatives," Benjamin explains. But when it comes another category with a shortage, oncology drugs -- used to treat cancer --"there isn't really an alternative agent," she says. When asked how doctors treat cancer patients in such cases, Benjamin quite frankly says, "Well, they can't in some situations." She adds: "We've heard that patients have been halted in mid-therapy and that some of the research trials had to be halted. It's pretty serious."
"You have to picture yourself telling a cancer patient that you have effective therapy, except that one of the components of that therapy is unavailable," says Dr. Michael Link, a pediatric oncologist and president-elect of the American Society of Clinical Oncology (ASCO). "And at a time when the patients themselves are under such stress, they don't need you to add to it."
Link says "a multitude of drugs" have recently become unavailable, adding, "some of them, unfortunately, are key drugs used for multiple different cancers in adults and children, and are key players in management." Some of them have possible workarounds or substitutions, "but in other cases there is not a good substitution," he says.
Chemotherapy drugs such as doxorubicin, etoposide, vincristine and cisplatin that treat breast, gastric, ovarian, thyroid, small cell lung, lymphoma and other cancers, unfortunately have no recognized standard alternatives for the majority of clinical situations, Link said in a previous interview with ASCO.
"This is where things are getting more worrisome, and patient care is clearly being affected," Link told DailyFinance. The options are to use an alternative, to leave out a drug from a regimen or to delay treatment, none of which is good. Cancer patients' lives, including children's, are at risk, and the shortages can hurt their survival.
  "One of the important things is that we don't want to add to the worry that patients undergoing cancer therapy already have," says Link. "It's important for them to talk with their physician to make certain whether the problem will affect them, what solutions can be offered to them and whether there's anything they have to be concerned about at all."
It's difficult to listen to the level of frustration revealed by doctors, pharmacists and health care professionals who deal with this problem daily. Commenting on when an alternative for a lifesaving drug also became unavailable, one respondent to the ISMP survey said: "I guess patients just have to die." Another asked: "What do I tell our breast and lymphoma patients? You had a curable disease, but not anymore because there is no drug available?"
  Common Causes
   This isn't what anyone would expect in today's advanced Western world. Early in November, the American Society of Anesthesiologists, ASCO, the ASHP, and the ISMP conducted a drug-shortage summit aimed at understanding the situation's scope, discussing necessary changes in public policy and developing an action plan. Also participating in the summit were pharmaceutical manufacturers, wholesalers and distributors, the FDA and others.
Some common causes for the shortages include manufacturing difficulties, natural disasters that affect production, reductions in the supply of raw materials (of which 80% come from outside the U.S.), unexpected increases in demand, voluntary recalls, manufacturer business decisions, FDA enforcement actions to ensure public safety and artificial shortages due to stockpiling.
The chemotherapy drugs listed earlier are in short supply mainly because generic-drug maker Teva's (TEVA) California plant was shut down following an FDA warning letter on manufacturing violations. Other producers can't keep up with the increased demand.
Both the ASHP and FDA maintain drug-shortage lists. The FDA's includes nearly 60 medically necessary products. The ASHP list is even more comprehensive, with over 140 drugs.
  

[brice1967]

I agree with most you said but will respectfully take exception in regards to pricing.  Now I do understand that price will fluctuate in regards to production and demand, but I also know that some medicine is overly expensive and big pharma has no problem cutting CEO's some giant, giant bonuses and golden umbrellas.  Most of them, regardless of what one may tell you, are doing just fine and managing to get folks paid.  (Some doctors are guilty of writing scripts unwarranted.... it even happens in this little sleepy mountain town)

As for meeting demand.... I'm not so for sure what method they use to assume who will have bronchitis, who will get the flu shots...(which by the way varied in price around here between $20 & $30 within a 20 mile radius....) and pain meds...  I'd guess that if they over produce one year, they'd cut back.... the price then goes up to cover losses from the previous year.  (Guessing, I am simply guessing)  Then you take your name brands then the generics..... I don't know.  

I personally feel as if pharmaceutical outfits aren't always on the up and up.  I've had my meds vary in price a few times in a year.  I am being treated for a couple pretty popular things... 2 there are a generic option, one there is not.  (That one is brutal, with insurance)

As for producing things in this country, oh yeah I'd love to see it.  I'm not going to knock unions, but I'll knock unions.... unskilled labor positions that pay better than $20 per hour is a bit much.  That guy will never work for a penny less.  

We have made things so unsavory in this country when it comes to business.  Corporations are running out of the country, but some good news is coming from Texas.  Texas has become very corporate friendly.... maybe, just maybe price of goods will come down, cost of living will come down, wages will come down and then we can all afford to live and work here.  (I know a gentleman who just spent damn near $60,000 for a pickup truck..... in 1996 I spent a bit more than $18,000 for a 3/4 ton.....)

[specialmom]

Well, the things we take for granted.  We so often bash pharmaceutical companies as money making hogs when in reality, they do provide a great service to people by making the medications they need.

My hubby is in the shipping buisness and Brice, it is not as simple as you think.  The FDA is not on a loading dock where meds sat in the sun and reached a temperature that requires the whole shipment be dumped, or in a factory half way across the world watching what happens as the drug is produced, etc.  

And drugs aren't like all goods and services.  To find the right amount to produce, well it would be ever changing unlike things like milk that everyone needs all the time.  Say we have a terrible flu season and secondary infections become extrememly common (bronchitis, sinusitis, etc.) that require antibiotics to treat.  Well, they'll run short unless someone accurately predicted the need.  That is hard to do all the time.  Same with cancer treatments or anything else.  Probably more so with very specialized treatments.

I don't believe by law that a drug company can over charge for something that is in shortage.  But . . . if they continue to have shipping issues that cost the manufacturer, prices can go up.  

I wish things could change in our country to encourage production here.  Americans willing to work for less (yep, that has to happen based on cost savings companies get by having foreign factories), laws supportive of American companies, etc.  Wouldn't that be great if they could bring production home?  

[brice1967]

IMO, if the FDA cant regulate any production they are probably in the wrong business.  There has to be an entity out there..... Demand should warrant production.  Is this government in action, taking away competition so only 1-2 companies are producing any 1 drug at the time???  Look, I know nothing about pharma.... I do find it a bit ironic that Obamacare is supposed to bring insurance and healthcare to the masses (people who dont have it) and the cost of the 3 meds I have to take daily went up a few bucks.... coincidence????

[ILADVOCATE]

"...No Authority Over Business Decisions
"We're doing everything we can within our current regulatory authority," says Valerie Jensen, associate director of the FDA's drug-shortages program. "We're working to resolve every drug shortage on our list. It's a very long list right now, and it's been long throughout this year. We've resolved a lot of them, but we still have a lot of them that we're working on."
Jensen explains: "What we can do is work with a company on its manufacturing problems." The FDA tries to resolve these as quickly as possible while ensuring public safety. "Also, if a firm has expired inventory of a needed drug and it can give us data to support a longer expiration date, we're glad to review that," she adds.
But when it comes to a company's business decisions, the FDA has no authority. Some companies have decided it's not worth their trouble to produce a certain drug anymore. Such was the case when Teva decided to discontinue the widely used anesthetic propofol. Basically, Teva said it's too hard to make and barely profitable.
  A recent trend concerns discontinuation of older products that aren't as profitable as newer ones or that have to regain FDA approvals -- a resource-intensive process. Others simply take lower precedent in production over more profitable drugs.
"Right now we just don't have any authority at all to require companies to increase production or to require other firms to come on the market," Jensen says. FDA also can't require firms to continue making a product, and drugmakers aren't required to report shortages or discontinuations, except for sole manufacturers in certain circumstances.
"We would like to have them report on all discontinuations and shortages, but that's not something we can require, just encourage them to do," Jensen says. She explains that early notifications from manufacturers on issues that could cause shortages have been most helpful because, she says, "many times we can resolve the issue before it becomes a shortage."
Formal Notifications Are Needed
  Indeed, lack of advance notice has been a major concern. "We have a situation where companies can just stop making a drug without notifying the FDA, or anyone as a matter of fact. And the first time you find out about it is when you can't get the supply," ISMP President Cohen says.
He explains that early notifications would also give doctors, pharmacists and nurses time to find a potential substitute and learn about it so that dispensing errors can be minimized. "We think there should be formal notification to the FDA so the agency would be able to help facilitate the manufacturing of the drug," he adds.
"We realize that this has significant impact on patients, so we're doing everything that we can," Jensen says. But is the FDA or the Health and Human Services Department doing all it can? Jensen declines to discuss creating public policy to deal with this problem, and the HHS didn't respond to repeated attempts to get comment.
Benjamin would certainly like to see a more comprehensive public policy to deal with the shortages. "There are a number of actions the agency can take to prevent, forestall or mitigate the effects of the shortage," she says. "In rare, but critical cases, the FDA can authorize importation of a drug."
Can Incentives Help Solve the Problem?
At least one U.S. Senator, Amy Klobuchar (D-Minn.), is paying attention. Klobuchar sent a letter in December to FDA Commissioner Margaret Hamburg requesting "immediate action" to ensure adequate supplies of essential drugs. Klobuchar said she'll also introduce legislation in January that would require pharmaceutical companies to notify the FDA when they decide to limit or discontinue production of drugs, and give the FDA the authority to expedite approval for substitute treatments or the importation of drugs.
Public funds have long been used to ensure supply of important products. The Food, Conservation and Energy Act of 2008 provides for agricultural programs through fiscal year 2012, continuing a long history of agricultural subsidies as well as energy, conservation, nutrition and rural development.
Similarly, the HHS is providing incentive programs for converting to electronic health records. And the FDA is promoting the development of orphan drugs -- those that treat rare diseases -- through incentives and grants. With some shortages stemming from business decisions, why shouldn't the FDA develop an incentive program to manage the drug shortage problem?
"Incentives have been discussed as a way to manage shortages," Benjamin says. "Expedited review of approved new drug applications, supplemental applications and new or altered production lines have been suggested. How effective these would be has yet to be determined."
Less Time to Treat Patients
What about some type of incentive payment for companies reporting early about possible shortage-causing problems? Cohen adds: "I don't know exactly how that would work, but to me, that is one of the most critical needs legislative-wise."
And what about those taking advantage of the situation and charging exorbitant prices for drugs in short supply, or the inequitable distribution of drugs, or hoarding? Who should make sure that such practices don't happen?
Doctors, hospitals and pharmacists spend more and more resources on managing the shortage problem instead of treating patients. "Whatever the cause, drug shortages have become a key patient-safety concern in health care today," the ISMP wrote back in July, adding that there isn't "a glimmer hope for any improvement in the near future." There should be no shortage of public awareness and concern over this situation."