In the Journals

Community hospitals ‘likely’ to use new antibiotics for off-label indications

Ryan Bariola, MD, FIDSA
Ryan Bariola

A review of the initial use of seven new antimicrobial agents at six community hospitals in western Pennsylvania revealed that uptake occurred within 1 to 2 years of FDA approval, and researchers observed that ceftolozane-tazobactam and ceftazidime-avibactam were more frequently chosen for off-label use.

“Providers in community hospitals are likely to use new antibiotics, especially those with broad activity against gram-negative bacteria, for indications other than what the FDA initially approves,” Ryan Bariola, MD, FIDSA, clinical associate professor of medicine and medical director of the CHASE program at the University of Pittsburgh Medical Center, told Infectious Disease News. “This is probably understandable due to the problems of antimicrobial resistance that community hospitals also face.”

According to the study, antimicrobial trials tend to focus on complicated UTIs or acute bacterial skin and soft-tissue infections (ABSSTIs), instead of conditions like bacteremia, osteomyelitis or hospital-acquired pneumonia, which leave clinicians with agents that may have limited or unproven efficacy for the condition they are trying to treat. Antimicrobial stewardship programs can provide support by monitoring and limiting the use of antimicrobials when efficacy is unproven, but facilities like community hospitals do not always have that resource.

Bariola and colleagues conducted a retrospective study to review the initial use and uptake of oritavancin, dalbavancin, tedizolid, ceftolozane-tazobactam, ceftazidime- avibactam, peramivir and isavuconozonium. Data for each agent included the medical records for up to the first 10 unique adult patients at each hospital, for a total of 103 patients, and only the initial FDA indications for each were assessed.

Although five of the hospitals had an infectious disease physician on staff who was involved with 80% of the study cases, none of the hospitals had a pharmacist with ID training or certification. Moreover, pharmacists from each hospital said that they had “inadequate time for addressing antimicrobial usage.”

When assessing by hospital, the median time to first use of the newly approved FDA agents ranged from 14 to 39 months. When they looked at median time by agent, first use ranged from 12 to 25 months.

The most common agents used were oritavancin, ceftazidime-avibactam, tedizolid and ceftolozane-tazobactam, which were administered to 35, 23, 20 and 14 unique patients, respectively. Of these agents, 60% of use was for FDA-approved indications.

Of the cases tedizold was used in, 100% were for ABSSTIs, compared with 80% for oritavancin. Additionally, ceftazidime-avibactam was used to treat complicated UTIs 30% of the time compared with ceftolozane-tazobactam, which was used 7% of the time.

Ceftazidime-avibactam and ceftolozane-tazobactam were used for an FDA-approved indication in 21% of cases compared with 87% for tedizolid and oritavancin. Additionally, ceftazidime-avibactam and ceftolozane-tazobactam were used empirically in 24% of cases compared with 74% for tedizolid and oritavancin.

The most common off-label indications oritavancin was used for were bone and joint infections and bacteremia, whereas ceftazidime-avibactam was used to treat osteomyelitis, pneumonia and ABSSTIs.

The researchers rarely observed susceptibility testing of the newer agents, reporting seven tests performed for ceftazidime-avibactam and two for ceftolozane-tazobactam

“Compared to academic medical centers, community hospitals may have less resources to dedicate towards antimicrobial stewardship, yet antimicrobial overuse and antimicrobial resistance are just as problematic for community hospitals,” Bariola said. “Hospital pharmacists and antimicrobial stewardship efforts in these hospitals must be ready for off-label use of new agents as soon as they are added to formulary. Keeping up with relevant literature regarding use of new agents beyond what the FDA-approved package insert indicates is very important, both for hospital pharmacists and ordering providers.” – by Marley Ghizzone

Disclosures: Bariola reports serving as an advisory board member for Mayne Pharma. All other authors report no relevant financial disclosures.

Ryan Bariola, MD, FIDSA
Ryan Bariola

A review of the initial use of seven new antimicrobial agents at six community hospitals in western Pennsylvania revealed that uptake occurred within 1 to 2 years of FDA approval, and researchers observed that ceftolozane-tazobactam and ceftazidime-avibactam were more frequently chosen for off-label use.

“Providers in community hospitals are likely to use new antibiotics, especially those with broad activity against gram-negative bacteria, for indications other than what the FDA initially approves,” Ryan Bariola, MD, FIDSA, clinical associate professor of medicine and medical director of the CHASE program at the University of Pittsburgh Medical Center, told Infectious Disease News. “This is probably understandable due to the problems of antimicrobial resistance that community hospitals also face.”

According to the study, antimicrobial trials tend to focus on complicated UTIs or acute bacterial skin and soft-tissue infections (ABSSTIs), instead of conditions like bacteremia, osteomyelitis or hospital-acquired pneumonia, which leave clinicians with agents that may have limited or unproven efficacy for the condition they are trying to treat. Antimicrobial stewardship programs can provide support by monitoring and limiting the use of antimicrobials when efficacy is unproven, but facilities like community hospitals do not always have that resource.

Bariola and colleagues conducted a retrospective study to review the initial use and uptake of oritavancin, dalbavancin, tedizolid, ceftolozane-tazobactam, ceftazidime- avibactam, peramivir and isavuconozonium. Data for each agent included the medical records for up to the first 10 unique adult patients at each hospital, for a total of 103 patients, and only the initial FDA indications for each were assessed.

Although five of the hospitals had an infectious disease physician on staff who was involved with 80% of the study cases, none of the hospitals had a pharmacist with ID training or certification. Moreover, pharmacists from each hospital said that they had “inadequate time for addressing antimicrobial usage.”

When assessing by hospital, the median time to first use of the newly approved FDA agents ranged from 14 to 39 months. When they looked at median time by agent, first use ranged from 12 to 25 months.

The most common agents used were oritavancin, ceftazidime-avibactam, tedizolid and ceftolozane-tazobactam, which were administered to 35, 23, 20 and 14 unique patients, respectively. Of these agents, 60% of use was for FDA-approved indications.

Of the cases tedizold was used in, 100% were for ABSSTIs, compared with 80% for oritavancin. Additionally, ceftazidime-avibactam was used to treat complicated UTIs 30% of the time compared with ceftolozane-tazobactam, which was used 7% of the time.

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Ceftazidime-avibactam and ceftolozane-tazobactam were used for an FDA-approved indication in 21% of cases compared with 87% for tedizolid and oritavancin. Additionally, ceftazidime-avibactam and ceftolozane-tazobactam were used empirically in 24% of cases compared with 74% for tedizolid and oritavancin.

The most common off-label indications oritavancin was used for were bone and joint infections and bacteremia, whereas ceftazidime-avibactam was used to treat osteomyelitis, pneumonia and ABSSTIs.

The researchers rarely observed susceptibility testing of the newer agents, reporting seven tests performed for ceftazidime-avibactam and two for ceftolozane-tazobactam

“Compared to academic medical centers, community hospitals may have less resources to dedicate towards antimicrobial stewardship, yet antimicrobial overuse and antimicrobial resistance are just as problematic for community hospitals,” Bariola said. “Hospital pharmacists and antimicrobial stewardship efforts in these hospitals must be ready for off-label use of new agents as soon as they are added to formulary. Keeping up with relevant literature regarding use of new agents beyond what the FDA-approved package insert indicates is very important, both for hospital pharmacists and ordering providers.” – by Marley Ghizzone

Disclosures: Bariola reports serving as an advisory board member for Mayne Pharma. All other authors report no relevant financial disclosures.