Monitoring and preventing drug shortages a job that is overseen by the FDA. The FDA has no authority to require companies to make drugs. Instead it works with industry, healthcare professionals and patients to prevent and lessen the severity of drug shortages. The FDA works with companies who manufacture drugs that are in shortage to communicate and work to make the drug more available. Manufactures are not required to report expected shortages, or how long the shortages are expected to last. This reporting is done on just a voluntary basis, though the FDA strongly encourages the drug manufactures to make this information known.
Drug shortages are an increasing problem in the United States. Many of the drugs that do become scarce are older generic drugs that are less profitable. In other cases, something goes wrong during the manufacturing of the medication, and the process has to be stopped. When just one or two companies are manufacturing a drug, and they have to stop making it, there is a deficit and the supply dips below the demand, resulting in a shortage. The FDA works with other manufactures that make the same drug to increase the production so they can help to compensate for this loss. It works to prevent shortage and to reduce the impact of a shortage. However, this is not always enough to compensate for this loss.
U.S. Drug Shortages From 2001 To 2010
(http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs)
The effects of a drug shortage can be devastating. Drug shortages are causing doctors and drug manufactures to ration medications. Some of the medications that have been in shortage include: chemotherapy agents, anesthetics, antibiotics, electrolytes needed for nutrient solutions, blood pressure medication and much more. It can lead to death in some cases. Some patients have to go without the medication as doctors reserve to use it for the most critical patients. This can lead to doctors using different drugs, or combining other drugs, but this can lead to errors and a change in the therapeutic effect of the drug when alternative medications are used. There is no perfect alternative to the prescribed drug.
There are a couple steps that can happen right off the bat to combat and lessen this emerging crisis. First, the FDA can have a tighter regulation on the reporting by manufactures of drug shortages and the extent of predicted deficits. Also, if multiple companies were to make the same drug, if something happened during the manufacturing process of one drug, the other companies would be able to pick up the slack and lessen the effect of the shortage on the market.
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs
Vanessa,
ReplyDeleteGreat addition to complement the previous post. I was wondering about the graph you included and exactly what it depicted?
I just think that the drug shortage is extremely unfortunate, especially since the main cause is economic. An Obama administration analysis suggested that the problem is the result of rising demand, especially for cancer drugs, and the inability of companies to increase production to meet the demand. I wish we could simply increase drug production to meet the demand, but this solution does not seem economically feasible at this time. I hope that tighter control of the FDA will relieve the shortage, but I am not sure how it will given that the FDA does not have the authority to force drug companies to increase production.
ReplyDeletehttp://www.huffingtonpost.com/2011/10/31/drug-shortage-fda_n_1068476.html
The graph shows the number of new drugs reported in shortage in the US from 2001 to 2010. It shows that in the past few years the number of drugs in shortage has been inclining. If the FDA does not take action, this trend may continue to increase in future years.
ReplyDeleteJennifer,
ReplyDeletePart of the executive order is that the FDA and Justice Department are working together to investigate the extreme prices for some drugs in the pharmaceutical market. What is interesting about the shortage of cancer drugs is that oncologists have an incentive to prescribe more expensive drugs to their patients. Cancer drugs are purchased straight from the doctor, not the pharmacy. This led the pharmaceutical companies to stop manufacturing the generic drugs because oncologists weren’t prescribing them. And now there is a shortage in some cancer drugs. I think it is about time that an investigation be opened and that this issue is looked into. Doctors should not receive a monetary incentive for prescribing more expensive drugs to their patients that have the same effect as a drug that is a fraction of the cost.
http://articles.latimes.com/2011/nov/02/news/la-heb-cancer-drug-shortage-20111102
I did a little reading about the economics about the drug shortage because I had little background information in this area. Wow, it's a pretty complex situation! Drug companies are driven by being profitable and by trying to decrease the risk for a monetary loss. As a result, the companies that are currently manufacturing drugs aim to make just enough of a certain drug so they know that they will be able to sell all of it. If they make too much of a drug, they will be "in the hole" with whatever materials they could not unload. Another issue is that the companies that are currently producing may need to invest in very expensive equipment to increase production. This is a risk for them because the demand for the drug may not always be as high. It seems to me that there is little to no incentive for the drug companies to increase their production, so why would they? If there is one thing that we have learned about the drug industry is that they are probably not driven by the consumer's (patient's) best interest.
ReplyDeletehttp://aspe.hhs.gov/sp/reports/2011/drugshortages/ib.shtml
With almost the entire world on one type of medication, and the fact that many drugs are literally saving peoples lives, something major has to be done! I have yet to find any laws that are being passed to help fix this situation...I will keep my eyes out for any information I come across.
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