Antimicrobial resistance: Understanding the Domino Effect

Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi, and parasites stop responding to antimicrobial agents. This resistance renders antibiotics and other antimicrobial treatments ineffective, making infections challenging or impossible to treat. This situation elevates the risk of disease spread, severe illness, and death.

World Antimicrobial Resistance Awareness Week (WAAW) is a global initiative to increase awareness and understanding of AMR. Celebrated annually from November 18 to 24, WAAW emphasizes the continued theme of “Preventing antimicrobial resistance together,” consistent with 2022. AMR threatens humans, animals, plants, and the environment, affecting all of us.

Azithromycin in the spotlight: Pharmacovigilance’s response to antibiotic resistance challenges

Certainly, pharmacovigilance recognizes the issue of antibiotic resistance. Besides, literature monitoring, a vital component of pharmacovigilance activities, consistently yields new insights into the challenge of antibiotic resistance. Examining azithromycin as an illustration sheds light on the workings of pharmacovigilance in addressing this concern.

Azithromycin belongs to the macrolide group of antibiotics. It can be administered orally or through injection to treat infections caused by Gram-positive and Gram-negative bacteria. These infections include, but are not limited to, those affecting the upper and lower respiratory tracts and community-acquired pneumonia. Additionally, the World Health Organization (WHO) has designated azithromycin as an antibiotic posing a higher risk of antimicrobial resistance, placing it on the WHO’s Watch list under the AWaRe classification.

EMA’s Alert: Reviewing azithromycin medications amid antimicrobial resistance concerns

Recently, within the search results on the DrugCard platform, a message from the EMA has emerged regarding initiating a review of medicines containing azithromycin. There is a growing concern about antimicrobial resistance to azithromycin in the European Union (EU). Given the widespread use of these medicines, a re-evaluation of the benefits and risks associated with the various approved uses of azithromycin is deemed necessary. The goal is to optimize its usage and minimize the risk of developing AMR.

For decades, medicines containing azithromycin, authorized through national procedures in the EU, have been in circulation. However, this has resulted in significant variations in product information, including indications, treatment dosage and duration, and pertinent safety details. These discrepancies undermine the rational use of antibiotics and antibiotic stewardship, potentially contributing to further developing antimicrobial resistance to azithromycin.

The acne dilemma: Azithromycin’s unapproved use sparks concerns of antimicrobial resistance

The off-label use of azithromycin and the potential development of resistance to the drug could complicate the treatment of other disorders. For instance, in 2020, dermatology researchers emphasized the increasing incidence of antibiotic resistance, underscoring the urgent need to restrict the unapproved use of azithromycin in acne patients. The conveyed perspective appeared in a letter to the editor published in the Journal of the European Academy of Dermatology and Venereology. Furthermore, DrugCards pharmacovigilance specialists recently uncovered a case of C. difficile-associated diarrhoea, likely stemming from the repeated use of the azithromycin regimen in treating acne vulgaris.

Case description:

A 41-year-old woman underwent a 6-week course of oral azithromycin at a dosage of 500 mg three times a week for the treatment of acne vulgaris. This marked her second round of antibiotic treatment for acne within ten months. Shortly after concluding the second azithromycin course, she sought medical attention at the clinic due to escalating abdominal pain and the occurrence of frequent, soft, bloody stools. The medical team initiated a comprehensive assessment, incorporating a complete blood count test, C. difficile toxin test, stool culture, and colonoscopy to determine the cause. The diagnosis revealed a C. difficile infection, confirmed by the presence of C. difficile toxin and the manifestation of symptoms.

The next steps: Mobilizing efforts for a healthier world

These illustrative examples encourage us to reflect on the issue of antimicrobial resistance. When considering the typical uses and recommended indications for antibiotics in clinical practice, it raises the question of whether antibiotics are always justified for treating diseases. The focus, however, should be on raising awareness and the actions each individual can take to address this problem.

As pharmacovigilance specialists, we must stay vigilant about emerging information, including insights from the literature. Considering each country’s unique antibiotic resistance patterns, placing importance on local medical literature might be the initial step. This underscores the current theme, emphasizing the need for collaborative efforts across various sectors to safeguard the efficacy of antimicrobials.