Antibiotic Shortages Worsening in United States

Janis C. Kelly

April 23, 2015

Shortages of antibacterial drugs increased dramatically after 2007 and currently affect 26 drugs, nearly half of which are needed in treating multidrug-resistant infections, according to a new study.

Farha Quadri, from the Department of Emergency Medicine, George Washington University, Washington, DC, and colleagues report their findings in an article published online April 23 in Clinical Infectious Diseases.

Analysis of 2001 to 2013 drug shortage data from the University of Utah Drug Information Service database showed that 148 antibiotics were in shortage at some point during the study period. Before July 2007, there were an average of 9.7 drugs on shortage per month. This nearly doubled to 17.9 drugs per month from that point through December 2013 (P < .001).

Most of the shortages involved broad-spectrum antibiotics, and almost half (46%) involved antibiotics used to treat high-risk pathogens, including Clostridium difficile, carbapenem-resistant Enterobacteriaceae, methicillin-resistant Staphylococcus aureus, and Pseudomonas aeruginosa. The number of shortages increased at a rate of 0.35 additional drugs/month (95% confidence interval [CI], 0.22 - 0.49) from July 2007 to December 2013, and the median duration of shortage was 188 days.

On average, 14.2 drugs were on shortage each month during the study period (95% CI, 12.8 - 15.5), but 32 drugs (22%) were in shortage multiple times. These included meropenem (seven shortages), cefotetan (five shortages), piperacillin-tazobactam (five shortages), azithromycin (four shortages), aztreonam (four shortages), and nafcillin (four shortages).

"Many shortages involve gold-standard therapies. For example, aztreonam treats life-threatening infections caused by gram-negative bacteria in patients allergic to penicillin and trimethoprim-sulfamethoxazole (TMP-SMX) for treatment of Pneumocystis pneumonia.... TMP-SMX shortages are compounded because it is produced by a single manufacturer," the authors explain.

"Seventy-three drugs (49%) were listed as having no alternative production source. Use of therapeutic alternatives include lower efficacy rates and higher toxicity. The shortage of TMP-SMX necessitating treatment with alternatives, such as clindamycin and primaquine, has led to delayed care, as well as refractory cases of [Pneumocystis pneumonia]," the authors add.

The cause for the sudden increase in shortages after 2007 is uncertain, but the authors note that it coincided with a US economic downturn.

The data highlight a need for better strategies to reduce the effect of shortages on clinical practice, including better communication, alternative treatment algorithms when the first choice for therapy is unavailable, and better tracking of local antibacterial supplies. "In half of cases, physicians and nurses learn about drug shortages from pharmacy staff, often when the pharmacy is unable to dispense the medication," the authors write.

The researchers also recommend that manufacturers be required to report shortages earlier and that multidisciplinary guidelines be developed to improve antimicrobial stewardship.

"We found a tremendous number of drugs that are used to treat life threatening infections that just were not available," senior author Larissa May, MD, also from the Department of Emergency Medicine, George Washington University, said in a news release. "There are implications that patients may not do as well clinically or potentially even die because these agents are not available."

Table. Drugs Currently on Shortage

Drug Name Total Days of Shortage
Piperacillin-tazobactam 1858
Cefotaxime injection 1542
Meropenem 1114
Ampicillin-sulbactam 1052
Azithromycin injection 599
Gentamicin injection 574
Cephalexin suspension 535
Ciprofloxacin 500 mg tablets 442
Clindamycin injection 394
Vancomycin 373
Cefpodoxime 344
Cefuroxime injection 185
Sulfamethoxazole-trimethoprim injection 165
Ticarcillin-clavulanate 123
Ceftazidime 69

Adapted from Quadri et al.

The authors have disclosed no relevant financial relationships.

Clin Infect Dis. Published online April 23, 2015.

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