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Stewardship / Resistance Scan for Jun 03, 2020
Slight drop in inappropriate antibiotics; Regulatory process for antimicrobials
Filed Under:
Antimicrobial Stewardship
US study finds small decline in inappropriate outpatient antibiotics
The proportion of unnecessary antibiotic prescriptions issued by US physicians' offices and emergency departments (EDs) decreased minimally from 2010 through 2015, driven mainly by a decrease in unnecessary prescriptions for children, researchers reported yesterday in Clinical Infectious Diseases.
For the study, researchers from the Centers for Disease Control and Prevention (CDC), the University of Utah, and Boston Children's Hospital used the National Ambulatory Medical Care and National Hospital Ambulatory Medical Care surveys to identify visits to physicians' offices and EDs and antibiotic prescriptions for 2010-11, 2012-13, and 2014-15.
They used a tiered diagnosis system from previous CDC studies to assign a single diagnosis based on the most likely indication for antibiotics, with diagnoses characterized as acute respiratory infections (ARIs) and other conditions. Antibiotic-inappropriate ARIs included asthma, allergy, bronchitis, bronchiolitis, influenza, non-suppurative otitis media, viral upper respiratory infection, and viral pneumonia.
For each period, the researchers calculated the mean annual number of visits and antibiotic prescriptions per 1,000 population. Rates and percentages were calculated overall, for ARIs, antibiotic-inappropriate ARIs, other conditions, and each condition for all ages and by age-group.
They used previous CDC methods to assess the percent of unnecessary antibiotic prescriptions and calculated the mean annual number of unnecessary prescriptions per 1,000 people as the difference between actual and necessary rates.
Overall, there was an 8% decline in antibiotic prescriptions from physicians' offices and EDs from 2010-11 through 2014-15, and a 26% decline in prescriptions for ARIs. The percent of antibiotic-inappropriate visits with antibiotic prescriptions was similar in 2010-11 and 2014-15 overall and in all age-groups.
Thirty percent of antibiotic prescriptions in 2010-11 were unnecessary, compared with 28% in 2014-15. Among children 0 to 19 years of age, unnecessary prescribing declined by 32%, but it did not change among adult age-groups.
"Increased stewardship efforts are needed, especially among clinicians who treat adults, to reach the National Action Plan goal of reducing inappropriate antibiotic prescribing by 50% by 2020," the authors of the study concluded.
Jun 2 Clin Infect Dis abstract
Regulatory period found similar for antimicrobials, non-antimicrobials
An examination of drugs approved by the US Food and Drug Administration (FDA) since 1984 found no evidence that the regulatory approval process for antimicrobials is more time consuming than it is for non-antimicrobials, researchers from Brigham and Women's Hospital and Harvard Medical School reported yesterday in The Lancet Infectious Diseases.
To better understand the array of regulatory pathways the FDA has adopted to expedite the regulatory process for drugs addressing serious unmet needs and how those pathways have impacted drug development and review times, the researchers examined all new drugs and biologics approved by the agency from 1984 through 2018.
They then broke those products down into antimicrobials and non-antimicrobials and recorded each drug's use of the Orphan Drug Act, fast-track, priority review, accelerated approval, and breakthrough therapy programs, as well as dates of investigational new drug application, new drug application, and new drug approval.
The results of the analysis showed that 1,065 new drug products were approved during the study period. Of those, 178 were antimicrobial products, which were more likely than non-antimicrobial products to benefit from priority review (103 [58%] of 178 vs 402 [45%] of 887, P = 0.0023), fast-track designation (58 [37%] of 157 vs 151 [19%] of 814], P < 0.001), and accelerated approval (23 [18%] of 129 vs 67 [9%] of 711, P = 0.0046) and less likely to have Orphan Drug Act designation (25 [14%] of 178 vs 267 [30%] of 887, P < 0.0001).
In addition, median time from investigational new drug application to approval was shorter for antimicrobial than for non-antimicrobial drugs (5.9 years vs 7?6 years, P < 0.001).
"We did not find evidence that antimicrobial development is more time-consuming than non-antimicrobial development or that regulators have been excessively rigid in their approach," the authors wrote.
Jun 2 Lancet Infect Dis abstract
Stewardship / Resistance Scan for Jun 03, 2020
Slight drop in inappropriate antibiotics; Regulatory process for antimicrobials
Filed Under:
Antimicrobial Stewardship
US study finds small decline in inappropriate outpatient antibiotics
The proportion of unnecessary antibiotic prescriptions issued by US physicians' offices and emergency departments (EDs) decreased minimally from 2010 through 2015, driven mainly by a decrease in unnecessary prescriptions for children, researchers reported yesterday in Clinical Infectious Diseases.
For the study, researchers from the Centers for Disease Control and Prevention (CDC), the University of Utah, and Boston Children's Hospital used the National Ambulatory Medical Care and National Hospital Ambulatory Medical Care surveys to identify visits to physicians' offices and EDs and antibiotic prescriptions for 2010-11, 2012-13, and 2014-15.
They used a tiered diagnosis system from previous CDC studies to assign a single diagnosis based on the most likely indication for antibiotics, with diagnoses characterized as acute respiratory infections (ARIs) and other conditions. Antibiotic-inappropriate ARIs included asthma, allergy, bronchitis, bronchiolitis, influenza, non-suppurative otitis media, viral upper respiratory infection, and viral pneumonia.
For each period, the researchers calculated the mean annual number of visits and antibiotic prescriptions per 1,000 population. Rates and percentages were calculated overall, for ARIs, antibiotic-inappropriate ARIs, other conditions, and each condition for all ages and by age-group.
They used previous CDC methods to assess the percent of unnecessary antibiotic prescriptions and calculated the mean annual number of unnecessary prescriptions per 1,000 people as the difference between actual and necessary rates.
Overall, there was an 8% decline in antibiotic prescriptions from physicians' offices and EDs from 2010-11 through 2014-15, and a 26% decline in prescriptions for ARIs. The percent of antibiotic-inappropriate visits with antibiotic prescriptions was similar in 2010-11 and 2014-15 overall and in all age-groups.
Thirty percent of antibiotic prescriptions in 2010-11 were unnecessary, compared with 28% in 2014-15. Among children 0 to 19 years of age, unnecessary prescribing declined by 32%, but it did not change among adult age-groups.
"Increased stewardship efforts are needed, especially among clinicians who treat adults, to reach the National Action Plan goal of reducing inappropriate antibiotic prescribing by 50% by 2020," the authors of the study concluded.
Jun 2 Clin Infect Dis abstract
Regulatory period found similar for antimicrobials, non-antimicrobials
An examination of drugs approved by the US Food and Drug Administration (FDA) since 1984 found no evidence that the regulatory approval process for antimicrobials is more time consuming than it is for non-antimicrobials, researchers from Brigham and Women's Hospital and Harvard Medical School reported yesterday in The Lancet Infectious Diseases.
To better understand the array of regulatory pathways the FDA has adopted to expedite the regulatory process for drugs addressing serious unmet needs and how those pathways have impacted drug development and review times, the researchers examined all new drugs and biologics approved by the agency from 1984 through 2018.
They then broke those products down into antimicrobials and non-antimicrobials and recorded each drug's use of the Orphan Drug Act, fast-track, priority review, accelerated approval, and breakthrough therapy programs, as well as dates of investigational new drug application, new drug application, and new drug approval.
The results of the analysis showed that 1,065 new drug products were approved during the study period. Of those, 178 were antimicrobial products, which were more likely than non-antimicrobial products to benefit from priority review (103 [58%] of 178 vs 402 [45%] of 887, P = 0.0023), fast-track designation (58 [37%] of 157 vs 151 [19%] of 814], P < 0.001), and accelerated approval (23 [18%] of 129 vs 67 [9%] of 711, P = 0.0046) and less likely to have Orphan Drug Act designation (25 [14%] of 178 vs 267 [30%] of 887, P < 0.0001).
In addition, median time from investigational new drug application to approval was shorter for antimicrobial than for non-antimicrobial drugs (5.9 years vs 7?6 years, P < 0.001).
"We did not find evidence that antimicrobial development is more time-consuming than non-antimicrobial development or that regulators have been excessively rigid in their approach," the authors wrote.
Jun 2 Lancet Infect Dis abstract