Linked to EAHP Statements

Section 1 - Introductory Statements and Governance: Statement 1.1
Section 3 - Production and Compounding: Statements 3.2, 3.3, 3.4
Section 6 - Education and Research: Statement 6.4

ACPE UAN: 0475-0000-22-027-L04-P. A knowledge-based activity.

Abstract

In the era of rising bacterial resistance, we are increasingly confronted with difficult to treat severe or chronic infections caused by multiresistant bacteria. Some of these infections are life-, organ- or limb-threatening, and in these situations (adjunctive) treatment with bacteriophages is sometimes considered. Bacteriophages have widely been applied, already for many years, in Russia and Georgia, but did not found their entrance in (Western) Europe thus far due to the readily available antibiotics. However, as the antimicrobial pipeline is virtually dry, and as we are confronted with antimicrobial resistance, there is a clinical need to evaluate the place of bacteriophages in our current anti-infectious armamentarium. Bacteriophages are often locally applied in chronic and debilitating infections, such as chronic osteomyelitis (as a last resort option in order to avoid amputation) and chronic upper respiratory infection, such as sinusitis (in order to avoid recurrent antibiotic courses). Next to this, bacteriophages are also sometimes systemically (intravenously) applied for severe acute infections, like severe sepsis or septic shock, caused by multiresistant bacteria.

Bacteriophages are not comparable from a development point of view to classic drugs, as targeted phages have to be identified and developed for the specific infecting pathogen, based on a ‘phagogram’. In Belgium, magistral preparations including phages for human applications are permitted since 2018. Furthermore, recent data on phage interactions with the immune system open new avenues for phage repurposing and their possible application in non-bacterial disorders.
In this session, a concise overview of different aspects related to the therapeutic use of bacteriophages will be provided. The session will be started by highlighting the history of bacteriophage use and previous experience with bacteriophages. The current clinical evidence, therapeutic indications and safety aspects will be discussed by an infectious diseases specialist. This will be followed by a discussion on the practical and regulatory aspects and the role of the pharmacist in compounding and dispensing. Finally, research needs for the near future will be highlighted.

Learning objectives
After the session, participants should be able to:

• Understand the therapeutic indications for bacteriophages;
• Understand the differences in development (insights in efficacy and safety) with classic drugs;
• Understand the pharmacy-related aspects of bacteriophage treatment (compounding and dispensing).

Educational need addressed
To learn and understand the history, current clinical evidence, therapeutic indications and safety aspects of bacteriophage use, practical and regulatory aspects and the role of the pharmacist in compounding and dispensing, research needs for the near future.

Keywords: Bacteriophages, regulatory aspects, multiresistant bacteria, phagotherapy, efficacy, safety