It's easy to understand why millions of patients with cancer, attention deficit hyperactivity disorder, infections, heart disease, central nervous system conditions and pain get riled up when they learn there are shortages of drugs for what ails them.
It's more complicated to understand why this occurs -- and the precise reasons may be as different as the many medications involved. While patients caught up in drug shortages shouldn't go into a total tailspin about their situations, clearly this pharmaceutical problem needs continued attention and action.
Let's look first at the challenges of supply in cancer drugs. There's growing optimism among oncologists that many forms of cancer can be treated, controlled or even cured. But for some patients with the most virulent cancers, hope can narrow to a small range of treatment options, eventually zeroing in on the promise of perhaps one chemotherapy agent. You'd do anything to give a loved one a shot at receiving that promising drug. Imagine, though, your reaction if you learned its supply was so limited it was unavailable at a critical moment.
That's a scenario that outrages cancer patients and their families, and in the past year, it has turned real with such drugs as: paclitaxel (Taxol), for breast and ovarian cancer; doxorubicin (Doxil) for ovarian cancer; and methotrexate (Trexall, Rheumatrex) for various cancers and rheumatoid arthritis.
In the already precarious world of serious disease, a missed round of chemotherapy or other crucial pharmaceutical dose can seem to be the difference between good health and illness -- or even between life and death.
Alternative Therapies
It's fortunate, though, that there sometimes are alternative medications. When my own institution experienced a shortage of a drug for thyroid cancer (Thyrogen) last year, we set up a triage system. Those in most urgent need received the drug; others either postponed treatments or underwent an alternative protocol that was equally effective but made the patients feel poorly for a week or two. And while treatment proceeded in those cases without serious harm, patients across the country may not be so lucky. For example, a survey from the Institute for Safe Medication Practices, as reported in November, found that 25 percent of physicians said an error had occurred because of drug shortages. While cancer centers double, triple and quadruple check for accuracy of dose, using unfamiliar alternatives can't help but increase the odds of a mistake. An alternative drug, for example, might be given in a dose half the size or twice the size of that for the usual medication and errors can occur when practitioners are inexperienced with the alternatives.
Costs also increase with shortages. A brand-name substitute can add millions of dollars to the nation's health care tab when there are shortages in generics. Then, too, there are costs in added time for dose calculation and other management and safety issues as pharmacists and hospitals cope with shortages. A recent study estimated that managing drug shortages has cost the health care system $216 million annually.
Why It's Happening
Drug shortages occur, manufacturers report (according to the Food and Drug Administration's website), because of unanticipated increase in demand or due to shortages of raw materials. Also, some companies have experienced quality control and other manufacturing problems that take time to correct. Others have made business decisions to stop making older, less profitable drugs. If a company is the only supplier of a drug, it legally must notify the FDA six months before it anticipates a shortage of the medication. Still, the law lacks teeth. If a company fails to inform the FDA of a looming shortage, it faces no legal consequences.
In late October, however, President Obama signed an executive order directing the FDA to speed up reviews of new manufacturing facilities and to get manufacturers to report shortages earlier. That way, those in the distribution chain leading from manufacturer to drug stores, doctors' offices, hospitals and patients can more efficiently manage limited supplies before a shortage turns into a crisis.
A Complicated Problem
The problem of drug shortages is complex, with some underlying difficulties that are little understood. One example of an economic reality upset many in the oncology community last fall when an article in the New England Journal of Medicine laid much of the blame for cancer drug shortages on the way oncologists in private practice operate.
Chemotherapy drugs are not bought and sold like other drugs. Patients don't go to the drug store and fill a prescription for chemo treatments. Instead, they get it from their oncologists. This system evolved over decades because drugs for such treatments in earlier times were so toxic that they were best left in oncologists' specialized hands. The drugs once were inexpensive and oncologists bought the drugs at a low price and sold them at a substantial markup to help support their practices.
Fast forward to 2012 and a world in which brand-name versions of chemotherapy drugs can cost many times more than generics. Recent changes in Medicare laws have limited to 6 percent the markup that oncologists can receive to cover their practice costs. That can be a trivial amount when administering a generic drug that costs a few dollars, but a substantial amount for a brand name drug costing hundreds or thousands of dollars. The article's stunning example was a product called leucovorin, available generically since 1952. A new version of the drug, levoleucovorin, "reportedly no more effective and 58 times as expensive," came on the market in 2008. Use of the new product grew and eight months after its launch, there was a shortage of the older, generic product, further perpetuating the overuse of levoleucovorin. That means the health care system swallows the tab for the more expensive drug, and individual patients pay higher co-pays for a branded drug.
But even this example barely scratches the surface of medical payment realities. Oncologists are among the physicians who spend large amounts of time with patients and whose expertise is crucial in helping cancer patients make decisions. Since oncologists don't perform procedures, like surgery or colonoscopy, they're only reimbursed for time spent talking to patients and can be paid at about the same level as a physician advising a patient about a cough or a headache. The chemotherapy payments evolved, in part, to ensure that cancer doctors earn the income their expertise warrants. (In a future blog, I'll talk about the need for us physicians to accept changes in how we're paid to make financial incentives line up more fairly with our health care system's needs.)
Not Just Cancer
While a lack of cancer drugs hit most people especially hard, shortages in other areas can have consequences just as severe. Reported drug shortages nearly have tripled to 178 in 2010 from 61 in 2005. The Institute for Safe Medical Practices reported a death when a patient who responded only to the antibiotic amikacin died when that drug was not available; numerous surgeries and procedures have been cancelled or postponed because of shortages of neuromuscular blockers, drugs used to anesthetize patients; and a patient receiving an alternative to morphine was given an overdose of the alternative and needed to be transferred to an ICU. Shortages also have been reported for drugs used in the treatment of infection, heart disease, central nervous system conditions and pain. More than 80 percent of the products in short supply are generic, according to the IMS Institute, which provides information services for the health care industry. That means patients seeking alternatives will often get the brand-name drug -- along with a higher co-payment.
The bulk of the drug shortages have been with so-called sterile injectibles -- drugs stocked in hospitals and doctors' offices and administered by health care providers. A federal regulation may be one cause of those shortages, says my colleague Rita Shane, director of Pharmacy Services at Cedars-Sinai. The regulation states that pharmaceuticals cannot be stored longer than the manufacturer indicates. While there are other evidence-based sources of information on how long a drug can be stored, often with evidence that the shelf-life is actually longer than indicated by the manufacturer, pharmacies strictly adhering to the regulation's requirement that the information come from the manufacturer are needlessly discarding safe drugs.
ADHD and Drug Abuse
But even as consumers faced a spike in the expected co-pay for this one type of medication, shortages suddenly have developed across the country in generic forms of prescription drugs for attention deficit hyperactivity disorder or ADHD.
Congress has been sufficiently concerned about shortages of ADHD drugs and has written to two drug companies, in essence asking them to prove they're not manipulating the market by slowing down manufacture of cheaper, generic drugs. Letters from members of the House of Representatives went out on Jan. 17 to Shire Pharmaceuticals (maker of Adderall XR and its generic alternative) and Novartis (maker of Ritalin and its generic alternative) asking for a detailed breakdown since 2007 of their manufacture of branded and generic forms of the drugs.
As parents of kids with ADHD drive from drug store to drug store looking for a pharmacist with Ritalin or Adderall, they might think about another complicating factor in this situation: concern about drug abuse. Demand for these drugs is extremely high, due to increasing numbers of children, teens and even adults diagnosed with ADHD. But these drugs also are stimulants and controlled substances, so the Drug Enforcement Administration is involved, setting quotas on how much manufacturers can supply.
What You Can Do
If you experience problems finding a drug, check the FDA's website to see if it's reported in short supply.
If the medication you need does not appear on the list but you're having troubling finding it, you can report a shortage to the FDA: drugshortages@fda.hhs.gov.
If you find that a drug you need may be in short supply, talk to your MDs -- oncologists, surgeons, anesthesiologists and others. Discuss the alternatives, including their side effects, dosing regimens and results you might expect if a drug you're accustomed to is in short supply. You and your physician can discuss, too, if your pharmacy can provide a drug in a different dosage that still meets your needs (two 25 mg pills rather than one 50 mg pill to be taken at one time).
A word of caution: I strongly suggest that you do not order a needed medication from an Internet site -- some of these sites provide fake medications that are ineffective or harmful. In brief, then, my prescription for patients affected by drug shortages is: don't panic. Many individual situations, disconcerting as circumstances may be, can be managed. On a national level, however, the continuing challenge of supply and demand of all manner of resources connected with U.S. health care should keep us all worrying, thinking and strategizing. The answers never will be easy, but for our health's sake, we've got to keep pressing ourselves and our leaders to find them.
Marilyn Wedge, Ph.D.: Why Bébé Doesn't Have ADHD
We DO NOT have all these options available to us as you state.
Another point I want to make is that it is very important for every child to participate in clinical trials that can. Because there are only roughly 3000+ children per year across the entire country diagnosed with Leukemia each year it is very important to have the data and results from each case to provide real data and results if we want to have any hope for better outcomes. COG is a wonderful example of how different oncology groups/institutions work together to achieve better results. There isn't the competition like in other cancers (breast cancer for example) to have the best treatment they are all working together to beat this pooling their efforts and collaboration. Changing a child's treatment protocol because of drug shortages (Methotrexate) does a few things. It could make them ineligible to continue to participate in the trial (which as I stated above is very important) and since the change has not been effectively studied it could change that child's survival chances.
I don't know about you, but I want my 5 year old son to stay on protocol because it has been tried and tested and currently give him the best hope for long term survival. My child is not a guinea pig and should not be give alternatives because Big Pharma and our capitalistic society deems his chemo not worth of producing.
Childhood cancer research through COG and other organizations does not work like adult cancer studies. We don't have a multitude of options or treatments to choose from. Heck, we weren't even given a choice on what protocol to follow. COG is very very careful not to treat our children as guinea pigs and just test any new drug on them willy nilly. It has to be tried and tested for long long periods of time and they are extremely careful when introducing new protocols and are very quick to pull a protocol if it is shown to not be effective or even harmful. This is rightly so.
Crain filled for my ADD meds, I’m considering blowing it off. Mostly because of all the negative stuff I have found out since articles about these dangerous treatment drugs began pouring out daily. For a while everyone in America was living in a fantasy world where it was somehow for kids and adults to take amphetamines on a weekly basis. Then when they couldn’t get them, they realized they were dependant on them and it has opened my eyes to the real underlying issue which is how can I treat my ADD WITHOUT prescription drugs? Anyone have any idea? I know there is some herbal remedies that don’t make you alert and there are some less herbal remedies that wake you up like addieups. Any advise please pass on!
From the Blog:
"Drug shortages occur, manufacturers report (according to the Food and Drug Administration's website), because of unanticipated increase in demand or due to shortages of raw materials. Also, some companies have experienced quality control and other manufacturing problems that take time to correct. Others have made business decisions to stop making older, less profitable drugs"
Read the above paragraph carefully it is copied from the Blog. First we see that the author doesn't actually believe what he is quoting.
Because he knows the although the information comes from the government, it is really propaganda from Big Pharma.
Read the last sentence for the truth.
Also consider that Toyota, among other giant corporations managed return to full production within a couple of months of having their entire facilities devastated by the tsunami, and a radiation leak.
Has their been an epidemic of cancer that has resulted in unexpected demand?
In my first draft I had used that word. I didn't use it for two reasons.
I was afraid stop people from reading what I wrote, and because I wanted people to come t that conclusion on thier own.
Which you clearly did.
Faved.
In Canada the average oncologist earns between C$60,000 and 190,000
See: http://www.payscale.com/research/CA/Job=Physician_%2F_Doctor,_Oncologist/Salary
Is there any other American or international, multi-billion dollar that cannot keep up with demand for its product?
Maybe some toys are in short supply at Christmas time.
Of course there is the old excuse of "malpractice insurance" and "student loans" that are driving physicians onto food stamps.
Let's See:
"Across states, for example, a large insurer in Minnesota charged base premium rates of $3,803 for the specialty of internal medicine, $10,142 for general surgery, and $17,431 for OB/GYN in 2002 across the entire state".
Yes and we all know about student loans. Of course no other college graduates have loans. Are they still paying off loans from their $300,000 plus side income?
Costs are much higher in Florida.
see: http://www.policyalmanac.org/health/archive/medical_malpractice.shtml (2003)
I have not been able to find an estimate for malpractice insurance for oncologists in 2012. If someone has that information, that would be excellent.
In fact it is clear, that the entire issue is about money. Money for the doctors, who don't want to spend time with the patient, even if it just means supervising the nurse, for a couple of minutes.
Money for Big Pharma, And, of course for insurance companies, who will increase their profits by charging more.
Then we are told that part of the problem is the oncologists don't want to use effective, less expensive drugs, because it is less profitable to them. (Read the blog, they get a percentage commission on the price of the drug)
"Since oncologists don't perform procedures, like surgery or colonoscopy, they're only reimbursed for time spent talking to patients and can be paid at about the same level as a physician advising a patient about a cough or a headache".
Oh my, oh my, oncologists are underpaid. "OMG more American just struggling to get by".
The median income for an oncologist is $300,000 in salary, and of course s/he has many other sources of income.
See: http://www1.salary.com/Oncologist-salary.html
The average salary for an oncology nurse is $65,000. Of course it is s/he who spends the time with the patient, not the doctor, who has four more patient rooms working.
See: http://www1.salary.com/Staff-Nurse-RN-Oncology-salary.html
This Blog is a wonderful defense of the greed of Big Pharma.
It is not a "complicated problem". GREED
"If a company is the only supplier of a drug, it legally must notify the FDA six months before it anticipates a shortage of the medication. Still, the law lacks teeth.
If a company fails to inform the FDA of a looming shortage, it faces no legal consequences".
Maybe the FDA should use the same excuse that The Security and Exchange Commission likes to use, their is a shortage of lawyers to do enforcement work. And, its too difficult. No money.
Does anyone know if there are the shortages of these medications in India, which manufactures many drugs for the American market? How about availability in Canada or China for that matter?
I work as an RN in a hospital OR, and we've had shortages and backorders of some really common, well established medications lately. Two that come to mind are bupivacaine (an injectible local anesthetic) and indigo carmine (an injectible dye excreted by the kidneys, used in urology cases). Both of these have been on the market for MANY years. They are not new drugs where the drug company hasn't been able to judge market need, nor are they excessively complicated or difficult to manufacture.
If I didn't know any better and was the cynical sort, I'd suspect that the "shortage" was imaginary, designed to ramp up demand (and coincidentally, price).