Exserohilum rostratum – Credit CDC
# 6646
One of the basic tenets of modern medicine is Primum non nocere, or `First, do no harm’. And while that is undoubtedly the goal of every practitioner, sadly, it doesn’t always work out that way.
Whether by accident, misdeed, or miscalculation - sometimes a patient’s health is made worse by the treatment they receive from the healthcare system.
When that happens it is called an Iatrogenic (from the Greek iatros, physician & genein, to produce) illness or injury.
HCAIs (Health Care Associated Infections) or HAIs (Hospital Acquired Infections) fall under the Iatrogenic umbrella, and according to the AHRQ :
HAIs are the most common complication of hospital care and are one of the top 10 leading causes of death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002. The financial burden attributable to these infections is estimated at $28 to $33 billion in excess health care costs each year.
As we watch the rising number of fungal meningitis cases among recipients of steroid preparations from an New England compounding pharmacy, it may surprise many to learn that a strikingly similar tragedy occurred a decade ago.
The year was 2002, and the origin was – once again – a compounding pharmacy, this time in South Carolina. While number of cases was fewer - and the type of fungus was different - the narrative is hauntingly familiar.
This from the CDC’s MMWR of December 2002:
Exophiala Infection from Contaminated Injectable Steroids Prepared by a Compounding Pharmacy --- United States, July--November 2002
In the United States, pharmacists compound medications to meet unique patient drug requirements or to prepare drug products that are not available commercially (1). In September 2002, the North Carolina Division of Public Health (NCDPH) was notified of two cases of meningitis caused by a rare fungus in patients who had received epidural injections at outpatient pain management clinics.
This report describes five cases of fungal infection associated with contaminated drugs prepared at a compounding pharmacy. Clinicians should consider the possibility of improperly compounded medications as a source of infection in patients after epidural or intra-articular injections.
In this case, the contamination was eventually linked to an improperly maintained and operated autoclave.
An investigation of compounding pharmacy A by the South Carolina Board of Pharmacy (SCBP) found improper performance of an autoclave with no written procedures for autoclave operation, no testing for sterility or appropriate checking of quality indicators, and inadequate clean-room practices as outlined in the American Society of Health-System Pharmacists (ASHP) guidance for pharmacy-prepared sterile products (2)
Of particular concern was the revelation that: Cases occurred up to 152 days following an injection.
The source of suspected contamination at the NECC facility in Massachusetts has not been determined, but yesterday the FDA announced that unopened vials from one of the batches of recalled methylprednisolone acetate were found to harbor Exserohilum rostratum.
Last night, the Annals of Internal Medicine published a perspective by John R. Perfect, M.D. who dealt with the South Carolina outbreak ten years ago. Dr. Perfect is Chief of the Division of Infectious Diseases at Duke University Medical Center.
The article is free, informative, and much worth reading in its entirety.
Iatrogenic Fungal Meningitis: Tragedy Repeated
John R. Perfect, MD
Ann Intern Med. 18 October 2012
Recent reports of fungal meningitis cases caused by contaminated corticosteroid injections demand that we remember prior lessons learned, while scrambling to care for currently affected persons even before all the facts are in hand.
In 2002, the Centers for Disease Control and Prevention (CDC) detailed 5 cases of Exophiala (Wangiella) dermatitidis meningitis or arthritis related to contaminated, injectable, preservative-free methylprednisolone acetate prepared from a compounding pharmacy (1).
