https://www.cidrap.umn.edu/news-perspective/2022/07/stewardship-resistance-scan-jul-15-2022
Stewardship / Resistance Scan for Jul 15, 2022
Antibiotic-resistant M pneumoniae;
Antibiotic regulatory approval reforms
Filed Under:
Antimicrobial Stewardship;
Pneumonia
Study shows global rise in macrolide-resistant Mycoplasma pneumoniae
Antibiotic resistance, one of the most common causes of community-acquired pneumonia (CAP) in children, has risen dramatically over the past two decades, according to a study published this week in JAMA Network Open.
To analyze global patterns, temporal trends, and regional variations in macrolide-resistant Mycoplasma pneumoniae (MRMP) infections, a team of South Korean researchers conducted a systematic review and meta-analysis of 153 studies from 150 articles published prior to Sep 10, 2021.
They found the worldwide proportion of MRMP infections rose from 18.2% in 2000 to 41% in 2010 to 76.5% in 2019. When the proportion of MRMP infections was classified by World Health Organization (WHO) region, a significant increasing trend was observed in the Western Pacific region (from 17.1% in 2000 to 71.2% in 2011 to 76.5% in 2019), but trends did not change significantly over time in other WHO regions.
The highest proportion of MRMP infections was observed in the Western Pacific region (53.4%), followed by the South East Asian region (9.8%), the region of the Americas (8.4%), the European region (5.1%), and the Eastern Mediterranean region (1.4%). Among the M pneumoniae variants associated with resistance to macrolides, A2063G was the most commonly identified (96.8%), followed by A2064G (4.8%).
When study populations were classified by children, the proportion of MRMP infections was highest in studies that comprised only children (37%).
M pneumoniae causes an estimated 30% to 40% of CAP cases in children globally. Macrolide resistance is one of the possible causes of refractory M pneumoniae infections, which are difficult to treat and have been associated with increased long-term complications and higher medical costs. The study authors say antibiotic overuse, especially of macrolides, may be behind the rise in MRMP infections.
"The results of the present study provide helpful information on the proportion of MRMP infections and may be used to overcome the disease burden of MRMP infections via the establishment of appropriate therapeutic strategies," they wrote.
Jul 11 JAMA Netw Open study
Report: Reforms could boost antibiotic access in emerging markets
A new report from the One Health Trust suggests more regulatory flexibility is needed to accelerate the approval of new antibiotics in emerging markets.
In their analysis of the regulatory framework for antibiotic approval in three middle-income countries—South Africa, India, and Brazil—researchers with the One Health Trust (formerly the Center for Disease Dynamics, Economics & Policy) found that the national regulatory bodies in the three countries have taken steps to expedite the registration of medicines, including, in some cases, granting flexibility in clinical trial requirements for drugs targeting unmet public health needs.
In South Africa, for example, a strategy for prioritizing regulatory review of new medicines for HIV, tuberculosis, and cancer has been introduced, and the COVID-19 pandemic has led to expedited assessments of clinical trials for COVID-19 treatments.
Likewise, officials in Brazil have introduced priority pathways for rapid approval of drugs relevant to public health, and Indian authorities have drafted a plan to reduce the time to drug approval. However, antibiotics and multidrug-resistant infections aren't explicitly included in the list of eligible drugs and indications in any of these accelerated approval frameworks.
Going forward, the report recommends that regulatory agencies in emerging markets create a specific category for antibiotics that target serious and life-threatening infections within the framework provided for accelerated approval pathways, leverage existing programs for expedited drug approval, and increase regulatory authorities' capacity to deal with the complexity of antimicrobial resistance (AMR) and novel clinical trials. They also call for more collaboration and harmonization with drug regulatory agencies in high-income nations.
The report argues that while it is crucial to create new financial incentives and reform the antibiotic development market to create a sustainable pipeline of new antibiotics, regulatory reforms to accelerate approval of new antibiotics can also help boost their development and improve access in the parts of the world where they are most needed.
"The growing burden of AMR will need to be addressed with new antibiotics," One Health Trust Director Ramanan Laxminarayan, PhD, MPH, writes in the report. "Unless we significantly rethink and revise current processes for regulatory approvals, the burden of AMR will keep increasing."
Jul 12 One Health Trust report
Stewardship / Resistance Scan for Jul 15, 2022
Antibiotic-resistant M pneumoniae;
Antibiotic regulatory approval reforms
Filed Under:
Antimicrobial Stewardship;
Pneumonia
Study shows global rise in macrolide-resistant Mycoplasma pneumoniae
Antibiotic resistance, one of the most common causes of community-acquired pneumonia (CAP) in children, has risen dramatically over the past two decades, according to a study published this week in JAMA Network Open.
To analyze global patterns, temporal trends, and regional variations in macrolide-resistant Mycoplasma pneumoniae (MRMP) infections, a team of South Korean researchers conducted a systematic review and meta-analysis of 153 studies from 150 articles published prior to Sep 10, 2021.
They found the worldwide proportion of MRMP infections rose from 18.2% in 2000 to 41% in 2010 to 76.5% in 2019. When the proportion of MRMP infections was classified by World Health Organization (WHO) region, a significant increasing trend was observed in the Western Pacific region (from 17.1% in 2000 to 71.2% in 2011 to 76.5% in 2019), but trends did not change significantly over time in other WHO regions.
The highest proportion of MRMP infections was observed in the Western Pacific region (53.4%), followed by the South East Asian region (9.8%), the region of the Americas (8.4%), the European region (5.1%), and the Eastern Mediterranean region (1.4%). Among the M pneumoniae variants associated with resistance to macrolides, A2063G was the most commonly identified (96.8%), followed by A2064G (4.8%).
When study populations were classified by children, the proportion of MRMP infections was highest in studies that comprised only children (37%).
M pneumoniae causes an estimated 30% to 40% of CAP cases in children globally. Macrolide resistance is one of the possible causes of refractory M pneumoniae infections, which are difficult to treat and have been associated with increased long-term complications and higher medical costs. The study authors say antibiotic overuse, especially of macrolides, may be behind the rise in MRMP infections.
"The results of the present study provide helpful information on the proportion of MRMP infections and may be used to overcome the disease burden of MRMP infections via the establishment of appropriate therapeutic strategies," they wrote.
Jul 11 JAMA Netw Open study
Report: Reforms could boost antibiotic access in emerging markets
A new report from the One Health Trust suggests more regulatory flexibility is needed to accelerate the approval of new antibiotics in emerging markets.
In their analysis of the regulatory framework for antibiotic approval in three middle-income countries—South Africa, India, and Brazil—researchers with the One Health Trust (formerly the Center for Disease Dynamics, Economics & Policy) found that the national regulatory bodies in the three countries have taken steps to expedite the registration of medicines, including, in some cases, granting flexibility in clinical trial requirements for drugs targeting unmet public health needs.
In South Africa, for example, a strategy for prioritizing regulatory review of new medicines for HIV, tuberculosis, and cancer has been introduced, and the COVID-19 pandemic has led to expedited assessments of clinical trials for COVID-19 treatments.
Likewise, officials in Brazil have introduced priority pathways for rapid approval of drugs relevant to public health, and Indian authorities have drafted a plan to reduce the time to drug approval. However, antibiotics and multidrug-resistant infections aren't explicitly included in the list of eligible drugs and indications in any of these accelerated approval frameworks.
Going forward, the report recommends that regulatory agencies in emerging markets create a specific category for antibiotics that target serious and life-threatening infections within the framework provided for accelerated approval pathways, leverage existing programs for expedited drug approval, and increase regulatory authorities' capacity to deal with the complexity of antimicrobial resistance (AMR) and novel clinical trials. They also call for more collaboration and harmonization with drug regulatory agencies in high-income nations.
The report argues that while it is crucial to create new financial incentives and reform the antibiotic development market to create a sustainable pipeline of new antibiotics, regulatory reforms to accelerate approval of new antibiotics can also help boost their development and improve access in the parts of the world where they are most needed.
"The growing burden of AMR will need to be addressed with new antibiotics," One Health Trust Director Ramanan Laxminarayan, PhD, MPH, writes in the report. "Unless we significantly rethink and revise current processes for regulatory approvals, the burden of AMR will keep increasing."
Jul 12 One Health Trust report