If there are complaints against the big pharmaceutical manufacturers, such as seemingly constant advertising for drugs that you may or may not need or the potential for extremely high prices for some drugs, it would seem that the positive aspect of the multi-billion dollar largesse the drug companies acquire would be a wide availability of their products. You would be wrong.
A recent editorial in the New England Journal of Medicine along with a report from the Institute of Safe Medication Practices (ISMP) indicate that there is a massive drug shortage in the United States that is already causing significant barriers to patient care, and in some cases, causing death.
The American Society of Health System pharmacists released a list of 142 medications that are currently in short supply, with a bulk of the list being comprised of pain medications, sedatives, and chemotherapy drugs, but also on the list are many common antibiotics, vaccines, and heart medications. Interestingly, a majority of the short supply drugs on the list are injectables.
During the months of July through September of 2010, the ISMP surveyed over 1,800 healthcare providers (over two-thirds of them pharmacists) to get their feelings and experiences with the current drug shortage. The response was bleak, with respondents stating they felt no support from the Food and Drug Administration, and that not only was the drug shortage a serious public concern, but that it was approaching the level of a national public health crisis.
The shortage has already presented numerous obstacles to patient care. Over 80% of those surveyed experienced:
- lack of information about how long the drug shortage would last
- no warning from the manufacturer or the FDA about an upcoming shortage
- no guidance about alternatives that could be used
- no information about the cause of the shortage of the drug
- increased resources and hours spent on investigating the cause of the shortage and alternatives
- increased difficulty obtaining and alternatives
Other issues reported were increased financial impact, lack of alternatives, increased risk to patient safety because of alternatives, and internal conflict in the hospital, such as hoarding of medications in short supply and misdirected anger among the hospital staff because of the shortages.
Of course, patient safety is the most pressing concern. One in three physicians surveyed reported that they experienced an adverse outcome in patient care due to the shortage. In the report are accounts of four deaths that occurred directly from the shortage; two from substituting the more powerful painkiller hydromorphone for morphine when it was not available, one from giving a patient diluted epinephrine when the full strength was not available, and another from a bacterial infection when the needed antibiotic was unavailable.
One would think that with the tens of thousands of pharmaceuticals available, the issue of finding an alternative to a drug in short supply would be easy, but that's not the case. The ISMP highlighted several issues with alternative therapies. The most obvious problem is that sometimes there isn't an alternative, even with modern medicine's massive formulary.
In the case of some bacterial infections, the bacteria are only sensitive to a specific antibiotic, and if that particular one isn't available, the patient is at serious risk. But central to the issue of using an alternative medication is that the alternative is not the ideal drug for that situation. It may be a riskier treatment, or not as effective as the standard of care that's not available.
Also, using an alternative medication for something that's unavailable in turn quickly depletes the supply of the alternative, making it unavailable for the patients that need the drug that's being used as an alternative for their primary treatment.
The third issue that was raised was the unfamiliarity of using the new alternative treatment in place of something else. When something isn't the standard of care and there is no data to back up how an alternative treatment will be received by the patient, questions of dosage, frequency, and side effects quickly come up.
Why is this happening? The editorial on the subject in the New England Journal of Medicine notes that 46% of the drugs in question are sterile injectable drugs – liquid preparations to be introduced into the patients bloodstream through a syringe or intravenous line that must be completely clean and uncontaminated. These preparations require significant production time as well as the complicated facilities to manufacture them, facilities that not all drug manufacturers have.
In addition, when these drugs are produced, they are produced only in quantities that the market demands, so if there's a sudden increase in demand, healthcare providers will be in short supply. NEJM used the example of the anesthetic propofol – only three companies made it, and two of them pulled it off the market, Teva Pharmaceutical for a contamination issue (and decided to stop manufacturing it) and Hospira for particulate matter in the vials (Hospira has not started production again). This has left only APP Pharmaceuticals to produce propofol for the entire country.
More disheartening, according to NEJM, is the reality of economics. When a drug company loses a patent for a drug after ten years and it becomes generic, any company can produce it. This is good for patients, because the cost of the drug will go down. However, it often becomes less profitable for the drug company because the production costs stay the same, but the money brought in decreases significantly. In the harsh world of business, the utility of a product isn't an issue, profit is. Companies often abandon production of a useful and important drug and put their resources behind something that will bring in more revenue and profit. And no, the FDA does not have the authority to mandate a private company to produce a certain product.
The endpoint of this drug shortage is uncertain. In response to the shortage of propofol, for example, the FDA has temporarily allowed for the importation of the drug from a foreign manufacturer after they inspected and tested the drug and manufacturers facilities, but it is unlikely that this is a solution for all the drugs that are in short supply. Healthcare providers have been instructed to email the FDA with news of shortages as well.
As patients, the best one can do if faced with an illness or condition that requires a drug in short supply is to talk to your treating physician and get all the information you can about what's being done and what's being substituted in it's place. Until then, there's likely no solution other than to wait for the FDA to reach some kind of agreement with drug manufacturers to ramp up production. While extending a drug patent to last longer than ten years would make getting generic and therefore cheaper drugs more difficult, the current public health threat presented by this drug shortage suggests that keeping certain life-saving drugs profitable for pharmaceutical companies may be the best short term solution.