Rising drug shortages posing serious risk to patients

By guest blogger Michael Cohen:

You may recall that I wrote about a growing national drug shortage problem back in July. We’ve always had occasional problems with temporary unavailability of certain medications, but what we were hearing from colleagues around the country was much more than the occasional unavailability of a needed medication. The volume of drugs in short supply seemed to be taking on a crisis proportions. Many of the most commonly used emergency drugs, pain medications and anesthetics were said to be scarcely available or no longer available at all.

Health care workers also were telling us that they were being forced to come up with alternative medicines or even postpone treatments or surgeries. Of major concern was an increasing risk to patients that began to surface, as health care workers, unfamiliar with proper use of replacement drugs, occasionally erred when prescribing or administering them to patients.

We decided to survey pharmacists, nurses, physician assistants, pharmacy technicians and medication purchasers across the country to gauge how serious the situation actually is. The results, representing responses from more than 1,800 healthcare practitioners, were published in our September 23, 2010 issue. As mentioned in the article, frustrations, difficulties, and patient safety concerns came across loud and clear.

Our study ran this summer from July to September. The results show that the problem is much worse than imagined. In fact, many respondents believe the conditions associated with drug shortages during the past year have been the worst ever, without a glimmer of hope for any improvement in the near future. They feel unsupported by the Food and Drug Administration (FDA) and perplexed regarding why the US is experiencing drug shortages of epic proportion that are often associated with third-world countries. Respondents clearly believe the public is severely impacted by this issue, and several suggest that the problem has risen to the level of a national public health crisis.

Of greatest concern was the potential for errors and poor patient outcomes caused by absent or delayed treatment or preventable adverse drug events associated with alternative drugs or dosage forms; the lack of advanced warning about an impending shortage; and precious clinical hours lost to time-consuming activities required to manage drug shortages.

About one in four respondents reported actual errors and one in five reported adverse patient outcomes during the past year due to drug shortages. Among the toll, four patient deaths and a patient awakening during surgery! Approximately one in three (35%) respondents reported that their facility had experienced a near miss during the past year due to a drug shortage. As many as one in three (33%) physicians reported an adverse outcome caused by drug shortages. Many felt the frequency of errors and adverse outcomes due to drug shortages is much greater than reported, and that not being aware of events did not mean they were not happening, but instead, not reported.

In one bizarre situation, the drug shortage actually contributed to a life saved when one of the drugs used to carry out the death penalty in California became unavailable.

Respondents also voiced a growing concern that secondary markets (often called gray or black markets) seem to be able to gain access to drugs that are no longer available to healthcare providers through usual sources. These secondary markets contact pharmacists to advertise availability of scarce drugs, often at exorbitant prices. Some pharmacists expressed worry about the quality of products from secondary sources and felt that the exorbitant prices breach ethical lines, particularly when the drug in short supply is an essential lifesaving medication. Further conflict between healthcare providers and drug companies arises from what appears to be allowing select groups of individuals to still have access the drug or to be given a preferential warning about impending shortages so they can stockpile the drugs.

Most people probably aren’t even aware of the shortage let alone its impact. It’s mostly been a hospital situation and most of the drugs are injectables. Also, except for coverage of our study in a Wall Street Journal blog and broadcast by alocal TV station news program or two, the news media has largely ignored the issue, with little done so far to investigate handling of the shortage problem, which might put some pressure on legislators to learn more about its impact and what is needed to alleviate it.

Along with colleagues in medicine and pharmacy, we plan to co-convene a public meeting with FDA and other key stakeholders representing the pharmaceutical industry, healthcare practitioners, regulatory authorities, and medication safety experts to explore and articulate the scope of this problem, and to develop a plan to reduce the occurrence of drug shortages and better manage them when they occur. More effective FDA oversight, a comprehensive early warning system, and patient safety and outcomes placed ahead of anyone’s profit margins are goals we hope to begin to explore at this meeting.

In our hospital newsletter last week, we provided hospitals with guidelines for safe management of the shortage until this problem is largely resolved.

For information on the Institute for Safe Medication Practices' consumer website go www.consumermedsafety.org
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