Drug Shortages: A Public Health Crisis

By Rola Kaakeh, PharmD, CFPH

Health systems have experienced drug shortages of epic proportion in the last several years, and it shows no sign of slowing down. On a daily basis, health systems across the nation find themselves faced with the challenge of adequately managing an ever-growing number of new and existing drug shortages.

In 2010, 211 drug shortages were reported by the drug information service at University of Utah Health Care (UUHC). This year, 232 new drug shortages were reported by the UUHC through Oct 31st, 2011.(1) In 2011, the American Hospital Association (AHA) surveyed 820 community hospitals across the US and found that 99.5% of hospitals reported experiencing one or more drug shortage in the last six months, and nearly half of hospitals reported experiencing a drug shortage on a daily basis.(2)

Drug shortages have occurred in all therapeutic categories. The most common drug shortages have occurred in the following categories, with data reported by the AHA survey:

Anesthesia and surgery-related drugs: 95% of hospitals experienced an anesthesia and surgery-related drug shortage. Another survey conducted by the American Society of Anesthesiologists (ASA) in April 2011, reported 90% of anesthesiologists currently experience a drug shortage of at least one anesthetic.(3)

Drugs for emergency care: 91% of hospitals experienced a shortage of emergency care drugs.

Cardiovascular drugs: 90% of hospitals experienced a shortage of cardiovascular drugs.

Gastrointestinal drugs: 89% of hospitals experienced a shortage of gastrointestinal drugs.

Drugs for pain management: 88% of hospitals experienced a shortage of pain management drugs.

Other drug categories experiencing shortages include oncology, sterile injectables, and infectious diseases.

Numerous reasons for drug shortages exist including such factors as natural disasters, lack of available raw or bulk materials, manufacturing difficulties, regulatory issues, recalls of the affected or related products, discontinuation of the drug, business decisions, and “unknown reasons”- the most common and frustrating reason.

Many have argued that the main cause of drug shortages is purely economic. If the profit margins are not sufficient, manufacturers may decide to no longer make the product. This is commonly seen with older generic medications. Left with little or no advance notice regarding the reason of occurrence or duration of a drug shortage, health professionals must scramble to meet patient needs.

Drug shortages impact drug therapy, add to costs, and most importantly, affect patient care. When a shortage occurs, there may be a delay in treatment or the drug can be replaced with a less effective or more expensive alternative. In some cases, no alternatives are available, and must patient make do without the medication. This can lead to significant adverse effects, including increased morbidity and mortality.

According to the ASA survey, ten percent (10%) of respondents postponed or cancelled procedures as a result of shortage, and nearly half reported longer operating room and recovery times.(3) Sixty two percent (62%) of the AHA Survey respondents reported delayed treatment. Fifty three (53%) of the respondents were unable to provide recommended treatment, and 58% reported patients received less effective drug.(3)

There are several patient care concerns that result from such substitutions. Thirty two percent (32%) of the AHA survey respondents reported experiencing an adverse outcome.(2) Several medication errors have occurred when prescribers are not familiar with the new products, resulting in near-misses or actual errors. In 2010, the Institute of Safe Medication Practices (ISMP) surveyed more than 1800 health care practitioners and reported concerning findings. Thirty five percent (35%) of respondents experienced a near-miss error, while 25% experienced actual errors. (4)

When drug shortages occur, costs to patients and health systems rise. The alternative drug products used may not be covered by patient’s insurance or may require a higher co-payment, resulting in an increased cost to the patient. Health systems have been forced to buy from the “gray market” (which charges markups up to 3000%, especially for some chemotherapy treatments) to obtain certain drugs. According to a survey conducted by Premier, Inc, drug shortages cost U.S. hospitals at least $200 million annually through the purchase of more expensive generic or therapeutic substitutes.(5)

Drug shortages also require considerable multidisciplinary personnel resources to manage them. A study published in October in the American Journal of Health-System Pharmacy titled “Impact of Drug Shortages on U.S. Health Systems” addressed the burden drug shortages pose on health systems.(6) In collaboration with the American Society of Health System Pharmacists (ASHP), researchers at the University of Michigan surveyed 353 directors of pharmacy across the United States to quantify the personnel resources required to manage the drug shortages, define the extent to which recent drug shortages impacted health systems nationwide, and to assess the adequacy of information resources available to manage shortages.

Key findings include:

1. Pharmacists and pharmacy technicians in health-systems spent a median of 17 hours per week managing drug shortages.
2. The labor costs associated with managing shortages in health systems translated to an estimated annual impact of $216 million nationally.
3. More than 90% of respondents agreed that drug shortages were associated with an increased burden and increased costs today compared to two years ago.
4. Thirty-two percent of respondents reported reallocating existing staff to manage drug shortages, pulling them away from other high-impact activities.
5. Eighty percent of respondents agreed or strongly agreed that drug shortages changed practice.
6. Seventy percent of respondents felt the information resources available to manage drug shortages are less than good.
7. Drug shortages did not vary by geographic location of health system.

Associations such as the American Hospital Association (AHA), American Society of Health-System Pharmacists (ASHP), American Society of Anesthesiologists (ASA), American Society of Clinical Oncology (ASCO), and Institute for Safe Medication Practices (ISMP) have advocated for more regulatory action.

The Preserving Access to Life-Saving Medications Act,(7) sponsored by U.S. Senator Amy Klobuchar (D-MN) and Bob Casey (D-PA), was introduced earlier this year. The bill requires manufacturers to report actual or potential interruptions in production that could result in a drug shortage, the development of criteria to identify drugs vulnerable to a shortage to ensure continuity of drug supply, and revision of the definition “medically necessary” to account for drug-use factors.(8)  Rep. Diana DeGette (D-CO) and Rep. Tom Rooney (R-FL) sponsored a House bill which penalizes those companies that do not comply with the new reporting requirements.

“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available – that’s not right. This common-sense solution will help set up an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible. As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA and health care providers so patients don’t lose access to the medications they depend on.” –U.S. Senator Amy Klobuchar (7)

Will these bills be the golden ticket to the end of drug shortages? No, but they will allow the Food and Drug Administration (FDA), health systems and practitioners to anticipate and plan for any future shortages accordingly. This will help reduce the burden on patients and health systems. On October 31, 2011, President Obama signed an executive order to help address the drug shortages crisis. While this may not address the direct cause of shortages, it acts as a step to emphasize to Congress the need to pass the bill.

Components of the executive order include broadening the reporting of potential drug shortages, measures to fight price gouging, addressing the pending legislation by allowing FDA to establish a voluntary notification process, and increased staffing resources for the FDA Drug Shortages Program.(9) Until more developments arise, sadly, patients and health systems are subject to the cost and patient safety consequences of the drug shortages.