Medication Shortages: Pills, Drugs and Politics
It is now February 2011 and the medication shortage remains. I had first become aware of the problem in November 2010, when my pharmacist informed me that she’d had to substitute another medication, since the only sleeping pill that seemed to fit my needs was not presently available. She’d not been able to give me any real reason other than she thought there was a shortage of some of the raw materials that came from China. The substitute tablet – when did pills become tablets? – didn’t agree with me, needless to say, and I began to try to find out why there was a shortage of a pharmaceutical that should be easy to manufacture. But, after a little research, I realized that I wasn’t the only person having difficulty sleeping.
Warnings about a shortage of medication in North America were being issued at the beginning of 2010 – shortages that, for a number of reasons, particularly issues related to labeling could lead to many errors and death. Even Propofol was in short supply and responsible for at least one death but, alas, the shortage was too late to save Michael Jackson.
And Christopher K. Kepp, writing in The Philadelphia Enquirer on 12 December 2010, noted that an ironic twist of the shortage of sedating drugs was that the death penalty had been put on hold in some States, although his article was written to draw attention to the real, human problems associated with the shortage.
Kepp, in the same article, quotes Hansen-Flaschen, chief of the Pulmonary, Allergy & Critical Care Division at the University of Pennsylvania Hospital,: “Almost all the shortages are generic drugs”, and suggests it’s because these drugs generate less profit than brand-name drugs, hence there are fewer manufacturers, that in turn leads to problems. Like my pharmacist, he noted that shortages or raw materials could lead to widespread shortages of medication.
“’Many people are telling me that in 30 years, it’s the worst they’ve ever seen it,’ says Michael Cohen, president of the Institute for Safe Medical Practices. He’s talking about drug shortages, which pharmacists, doctors and nurses are telling him are at unprecedented levels,” writes Katherine Hobson in her Health Blog on the Wall Street Journal’s Digital Version on December 9, 2010.
Up to this point, most people will agree with the facts - there's a shortage of medication; however, it’s when we begin to examine what are behind these facts that we enter the twilight zone and ask:
Should the shortage of medications be a big story? Do Americans recognize people are dying as a result? Would many politicians from either side of the aisle just prefer that the story go away? Do dollars from pharmaceutical companies compromise the media as well as the politicians? When did you first hear about the pharmaceutical shortage?
A number of reasons for the shortage are given by the pharmaceutical companies including nine of the most common ones issued on an ISPN Medical Alert from even earlier in the year, (July 29, 2010) and quoted in The Institute for Safe Medical Practices . A more full account of the reasons may be found at ASHP Report: ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. As this article is being written, another post has appeared on the Internet from CBC News. The story gives many of the same reasons but describes “Manufacturer mergers . . .” slightly differently: "Monopolization of production of a particular drug by manufacturers that result in immediate shortages when production problems occur," leading me to wonder if “manufacturer mergers” is a bit doublespeaky meaning “monopoly” or something pretty close.
The article points out that in October 70 per cent of 427 Canadian pharmacists said that the shortage had adversely affected their patients. Further, the article says that Canadians are experiencing a phenomenon that is world wide – but notably in the US. On the brighter side, the article does go to point out that there are some signs that this serious situation is easing.
The story itself seems to have had little play in the mainstream media, to date, other than the irony caused by the delay in death for some on death row because of the medication shortage earlier in the fall. An interesting aside reminding us of the seriousness of the debate surrounding the death penalty in some States is reported in an article on November 5, 2010 in AllGov. Tennessee sought to import sodium thiopental from the UK but was initially stalled by a group called Reprieve wishing to control it, since it would be used in an execution.
An increasingly important part of this and other stories concerning Pharmaceutical, Chemical, Petroleum, Gas, Agribusiness as well as the Food Industry is the public’s response. Car Manufacturers and many politicians as well as these mega-businesses have lost so much credibility with the public that they have greeted the reasons for their pills and other medical shortages with a certain amount of skepticism.
Part of one comment to Christopher K. Kepp’s, article (See comments ) by JJonah63 read: “. . . the pharmaceutical drug pushers want consumers to use the newer, more profitable, and often riskier drugs rather than generics. It's all about sales, not health.” Many of the other comments made suggested that readers thought that the greed of the pharmaceutical companies was the real reason for the pill shortage.
Lying, particularly when used in the service of greed, seems to have reached such epidemic proportions that the general public’s response to companies giving excuses for something that might have led to their increased profitability aren’t believed by increasing numbers. The growing distrust the public has for all of these industries and institutions should be as worrying to these industries as it is to the rest of us. A major TV station should be congratulated too; they tried to report on this story and posted on their Website:
When vital drugs run out, patients pay the price: 150 medications in short supply so far this year; deaths, injuries have followed
JoNel Aleccia’s MSNBC’s story continues to note that when generics undercut a brand name price many manufacturers stop production. In some cases shortages of generic drugs left others with little choice but to substitute a 50 milligram dose that cost less than a $1.00 for a brand name one costing over $180! Certainly the public deserve to hear the drug companies and their representatives answer questions relating to the shortage; their unwillingness to give interviews doesn't boost my confidence.
It’s easy to draw a parallel with a disturbing number of politicians who refuse to talk to media or only talk to known sympathizers. However, it is hard to believe that the requests for an interview would have been turned down if there had been more of a public outcry. But, who knows, perhaps large companies will adopt or have already adopted the example of some politicians and just hand-pick sympathetic media for interviews. Perhaps we should get used to large companies feeling that they don’t have to answer to the media and/or the public.
Incidentally, the gentleman mentioned in Aleccia’s article is a new grandfather. He has a six month year old grandson. He fears he won’t see him graduate. His explanation for the drug shortage: “It’s money, pure and simple.”
Also, the quote on the CBC Website: “’We had two deaths where there was a morphine shortage,’ Cohen said, explaining that a much more potent replacement drug, hydromorphone, was given at the level of the original, overdosing the patients.” Leaves me suspecting we’ll never really know the death toll from the shortage of medication.
It is very troubling that the public seem to be being denied information that either is having, has had, or might have a severe impact on the health of their loved ones or themselves. It is a riff on another existing strategy and says to the media, “Don’t ask – and we don’t tell.” On the other hand, there seem too many professionals who need the drugs for their patients who are critical of the drug companies even for not giving them enough notice of a coming shortage so that they could make alternate plans.
Stephen Lendman in his newsletter on July 20, 2010 posted an article entitled Public Anger and Distrust of Business and Government and gives some of the findings from a New People for the American Way Survey conducted in June, 2010. They suggest that Americans tend to see both Democrats and Republicans as part of the problem rather than the solution. The same survey showed that over three quarters of the public thought that corporations exercised too much political influence.
It’s all quite worrying, and I wish I had my sleeping pills.
February 7, 2011
The Preserving Access to Life-Saving Medications Act was introduced into the US Senate today. The legislation, sponsored by Sens. Amy Klobuchar (D., Minn.) and Bob Casey ( D., Pa.) would provide the FDA with key tools to help address and prevent shortages of prescription drug medications. (From the Facebook Page – Institute for Safe Medication Practices.)
Senator Amy Kobuchar's Home Page. The Senator seems to have been one of the first to acknowledge the importance of the medication shortage and try to pass legislation to ameliorate the harm to Americans and her home page is useful for helping keep abreast of this story.
We salute Senator Kobuchar but, sadly, the story will continue . . .
January 11, 2011
Mysteriously, the shortage in medications persist in the US and elsewhere. An attempt to improve the situation was mounted by U.S. Senator, Amy Klobuchar (D-Minn.); among other things, she sent a letter in December to FDA Commissioner Margaret Hamburg requesting action be taken to ensure adequate supplies of essential drugs. However, as things stand, there may not be a lot government can do to ensure the shortage come to an end and the situation is not repeated in future.
At this point, many individuals and families will have been affected by the shortage; however, it’s easy to view such a shortage as something of an aberration unless they have had the background story.
And it’s tempting to see a connection between the large amount of money the media receive from pharmaceutical companies and their unwillingness to investigate or report this threat in detail to folks who need some medications in hospital or at home. The shortage of any other product that is desperately needed by many would have received so much publicity that the situation wouldn’t have persisted. In democracies, when media fail to adequately report a problem and politicians are not in a hurry to address it, there’s a problem.
Luckily, the American Society of Health-System Pharmacists publish a page, Drug Shortages, that’s dedicated to drug product shortages as well as a current list of the drugs that are in short supply. It doesn't solve the problem but at least it keeps us informed. If we or our loved ones are taking any meds, it’s worth checking out. And even if you’re not personally affected by these shortages, it’s no reason to be complacent, since fate can take an unexpected turn and you might well need medication in the future.
January 28, 2011
Michael R. Cohen, President of the Institute for Safe Medication Practices, writing a guest blog at Philly.com on Monday, January 24, 2011 entitled, “Drug shortages are affecting more prescription drugs” says that the overall situation has eased somewhat but there are still very worrying shortages. Also, he noted that his organization, the Institute for Safe Medication Practices, had been working with The American Society for Clinical Oncology, the American Society of Health-System Pharmacists and the American Society of Anesthesiologists to solve these problems and released a report entitled, “Health Care Groups Urge Changes to Ease Nation's Drug Shortages Problems: Report from Summit Recommends New Approaches to Prevent Patient Harm, Minimize Disruptions in Care”, earlier this month. They had met with staff in Senator Amy Klobuchar’s (D, MN) office regarding the need for legislation. Hopefully, it will be introduced in the Senate before too long.
February 2, 2011
USA Today continues the steady trickle of news items highlighting the shortages of medications and very real and sometimes lethal consequences that result. Deaths and dosing errors continue to mount because some drugs are not available and because of errors made stemming from drug substitutions.
It remains troubling that patients are at risk because certain medications are no longer available. However, it’s somewhat encouraging that Senator Amy Klobuchar, D-Minn, wants a bill that would at least force companies to give the FDA long enough notice of shortages so that they can plan to alleviate the attendant risks.
One thing that is certain is that the story's far from over - check this space periodically for any updates.
April 14, 2011
Perhaps because the problem is perennial, the critical drug shortage receives surprisingly little coverage. I have only been able to find one reference this month in the popular media, although many hospitals around the country are still struggling to find life saving medicines.
December 8, 2011
Today the Huffpost gave us an update in an article entitled "Hospital Drug Shortages Present Costly Crisis." The article makes for disturbing reading for many – particularly some receiving cancer treatments. One hospital told of how they have been forced to purchase a drug for over $1,200 a dose that used to cost under $26. The article notes a number of deaths are related to the shortages and rather than the problem easing, it notes:
"So far this year, 210 drugs have been added to the list of those in short supply, one less than the total for all of last year, according to the University of Utah Drug Information Service, which tracks the shortages. That's triple the roughly 70 a year from 2003 to 2006, when shortages began to climb steadily."
Perhaps the amount of advertising on news stations by the pharmaceutical industry is a partial explanation why this story is so unreported.