Earlier this year, the U.S. Food and Drug Administration Anti-Infective Drugs Advisory Committee voted to approve two agents for the treatment of skin and skin structure infections caused by gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA):
- Sivextro (tedizolid phosphate), manufactured by Cubist Pharmaceuticals, is administered daily and comes in either an oral or intravenous formulation.
- Dalvance (dalbavancin), manufactured by Durata Therapeutics, is administered as an IV weekly treatment.
Both of these antimicrobials have been added to a slowly growing list of new antimicrobial agents. As drug manufacturers continue to expand the availability of antimicrobial agents, hospital clinicians will continue to advance as good stewards of antimicrobial use. A strong formulary review process is critical to evaluate new antimicrobials coming out on the market.
The Infectious Diseases Society of America (IDSA) developed Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship to help acute care hospitals develop their programs. The guidelines suggest formulary restriction and pre-authorization as one of two core strategies that provide the foundation for an antimicrobial stewardship program. Regardless of the type of formulary restrictions deployed, all healthcare providers have the duty to ensure these new antimicrobials are used appropriately for the correct patient population.
The more common methods of formulary restrictions are: requiring pre-authorization – such as restriction to infectious disease physician, or meeting pre-approved appropriate use criteria.
Developing appropriate use criteria during the formulary review process can be an alternative to labeling something as a “restricted antimicrobial.” Appropriate use criteria should be developed by the pharmacy with the assistance of an antimicrobial stewardship committee (with infectious disease physician oversight) or with input from a Pharmacy and Therapeutics committee. The criteria developed should be evidenced-based or be in compliance with the FDA-approved indications for use.
Pharmacists will want to make sure that appropriate use criteria guidelines are easy to access by all hospital clinicians. A key component to a successful antimicrobial stewardship program is educating appropriate use criteria to not only the pharmacists, but also other medical staff.
Pharmacists play a critical role in ensuring proper use of antimicrobials, both old and new. Developing a strong formulary review process is one important step in building an antimicrobial stewardship program.
About Justin Clark, PharmD, MAD-ID
Justin Clark is currently the Fellowship Coordinator and Pharmacy Clinical Program Manager for Pharmacy OneSource. Justin has nine years of hospital pharmacy experience, including his most recent position as the Pharmacy Clinical Coordinator at an acute care hospital in North Texas.
Justin earned his Doctorate of Pharmacy from the University of Louisiana at Monroe College of Pharmacy and completed a Pharmacy Practice Residency at Louisiana State University Health Sciences Center-Shreveport. He has extensive Antimicrobial Stewardship training and certification through MAD-ID. He is also a member of the American Society of Health-System Pharmacists (ASHP) and the Louisiana Society of Health-System Pharmacists (LSHP).