By: Jimmy Johnson, PharmD Candidate c/o 2012
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Drug shortages have become more and more of an issue in the health care industry. There are over 200 drugs on the Food and Drug Administration’s (FDA) drug shortage list – a number that has tripled in the last five years.1 The largest impact has been on anesthesia and oncology drugs. Injectable agents, such as propofol (a drug commonly used to induce anesthesia and sedation), are more likely to be in short supply because of their complex production and storage, as well as their likelihood of contamination.2 But who is to blame for the increase in drug shortages, and what can we do to resolve this situation?
First let us consider who benefits at a time of drug shortage. Contrary to popular belief, the drug manufacturers that normally supply these medications do not profit in these circumstances. Their goods are unable to be produced / sold, and profits stagnate. Small wholesalers, on the other hand, commonly practice price gouging. There have been instances where $12 dollar leukemia drugs were sold for $990 per vial.3 And if you think that is bad, well, it gets worse.
Most people have never heard of the term “grey market.” This refers to the legal, yet questionable, practice of purchasing medications from unofficial and / or unoriginal sources. It has been associated with reports of dosage errors, improper storage, and drug counterfeiting. Although this seems unethical, it is what some institutions resorted to in order to obtain medications for their patients. However, drug shortages are not limited to hospitals – let us not forget that clinical research trials require medications to formulate guidelines and make recommendations for optimal treatments. The shortages can also extend to compounds in the pipeline (in development). Newer drugs are compared to drugs currently on the market to determine benefits versus the current standard of therapy.
The people who ultimately suffer the most are the patients. Some drugs on the shortage list can be therapeutically-substituted until more supplies come in. Alas, what about medications that cannot be so easily replaced? Patients undergoing chemotherapy treatments are on strict regimens with medications specific for the type of cancer they have. Is it fair to make them wait when every missed dose is a step closer to metastasis? When Hospira, the global market leader for generic injectable pharmaceuticals reported a shortage on Levophed®, intensive care units (ICUs) had to allocate their supplies to the most critical patients. And will giving everyone else a therapeutic substitute produce the same outcomes? In many of these situations, the answer is inevitably no.
On November 1st 2011, President Obama made an executive order in an attempt reduce the instances of these shortages. His plan includes “broadening reporting of potential shortages of certain prescription drugs, speeding up reviews of applications to begin or alter production of these drugs and providing more information to the Justice Department about possible instances of price gouging.”3 Although it might not solve everything, it’s a start.
So, what can manufacturers do? Communication seems to be a major factor in whether a drug shortage occurs or not. Logically, it would make sense for drug manufacturers to alert the FDA that there may be some sort of problem with production or quality control, and that they may run low on supplies in the foreseeable future. Realistically, this does not always happen. There is currently no rule that forces manufacturers to alert the FDA about possible shortages (but it has been proposed). It is up to both the drug companies and the FDA to work together to establish better lines of communication. If this cooperation does not pan out, laws may be necessary to enforce better compliance from drug manufacturers to report this important information to the FDA. If so, the FDA would be able to respond by informing other drug manufacturers and asking them to prepare for the shortage (by increasing production of the scarce drug). Furthermore, this would allow alerts to be sent out to hospital pharmacists sooner, eventually leading to regulations on drug dispensing.
The FDA cannot force companies to produce more of a drug. It can, however, provide some sort of financial incentive, such as waiving certain fees. Largely, complaints from drug companies seem to be “regulatory compliance and product quality issues.”2 Although drug manufacturers are trying to meet the FDA’s guidelines for good manufacturing practices (GMPs), remediation of a drug can cause significant delays in its production. However, this is not something that should be compromised. If the FDA finds an issue with the manufacturing process at a drug company, its actions serve to protect the patients.
As outlined in President Obama’s plan, the FDA could also expedite the review for a drug manufacturer who has altered the drug manufacturing process in order to meet good manufacturing practices (known as remediation). Remediation is where a lot of the delay in drug production occurs. Many manufacturing facilities are in India and China, and are making the review of these facilities more arduous and time consuming. According to an article in the New York Times, “nearly half of all shortages followed inspections that found serious quality problems, including injectables that had glass shards, metal filings, and bacterial and fungal contamination.”3 It is obvious that the FDA’s policies are there for good reason. The generic drug industry is working with the FDA by providing nearly $300 million (annually) to hasten inspections and drug applications.
Finally, if the government can regulate price hikes for gasoline, then should it not do the same for life saving medications? Perhaps a law could be enacted to prevent price gouging by small wholesalers who take advantage of emergency situations like drug shortages.
All in all, resolving the increase in drug shortages is not something that can be done overnight. Neither is it something that can be fixed by the actions of the drug manufacturers alone. It will take a combined effort from both, the FDA and drug companies, to fend off the rising tide of drug shortages.
Only time will tell if these recommendations can make a difference in preventing future drug shortages.
SOURCES
- Bernhard B. US Facing Serious Shortage of Drugs. Boston Herald.com. Date Updated 10.30.11. Date Retrieved November 1, 2011 from http://www.bostonherald.com/jobfind/news/healthcare/view/20111030us_facing_serious_shortage_of_drugs/srvc=home&position=also
- Helwick C. Continuing Drug Shortages a Problem for Anesthesiologists. Medscape. Date Updated 10.28.11. Date Retrieved November 1, 2011 from http://www.medscape.com/viewarticle/752541
- Harris G. Obama Tries to Speed Response to Shortages in Vital Medicines. The New York Times. Retrieved November 1, 2011 from http://www.nytimes.com/2011/10/31/health/policy/medicine-shortages-addressed-in-obama-executive-order.html?_r=2
