Abstract

 

There is a substantial amount of evidence, including recent fatalities, to support the view that the
pharmaceutical industry should be concerned over the potential contamination of non-sterile dosage
forms by Burkholderia cepacia. It is not one of the micro-organisms named in the pharmacopoeias
against recommendations to use selective media to confirm absence from non-sterile products, and
few, if any, pharmaceutical quality control laboratories ever attempt its selective isolation. It is
suggested that because of this the occurrence of Burkholderia cepacia in pharmaceutical products
may well be under reported. Nonetheless, selective media have been developed for isolation of
Burkholderia cepacia from clinical specimens and it is suggested that there is enough information
available from these other media to allow development of suitable selective media for pharmaceutical
applications.
 

Key words: Burkholderia cepacia , Pseudomonas cepacia , Respiratory disease , Selective isolation,
Objectionable micro-organisms, Commercially available media

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1. Introduction

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Burkholderia ( Pseudomonas) cepacia was first isolated and described I as a phytopathogen 
responsible for a bacterial rot of onions. Over recent years the nomenclature of this group of 
organisms has changed. Formerly known as Pseudomonas cepacia, the species was moved to the new 
genus, Burkholderia, in 1992.
Burkholderia cepacia is a Gram-negative rod I .6-3.211m in length. It is a strict aerobe and a 
chemo-organotroph with an optimum growth temperature of 30 to 35°C. It is found in soil, water and 
on plants. It can survive on the skin for up to 60 minutes, on a moist surface for up to one week, 
and in biofilms  in  water for  years. Nonetheless, Butler et al2 expressed the view that it is an 
exaggeration to describe it as widely distributed or ubiquitous in nature.
Burkholderia cepacia is inherently resistant to multiple antibiotics and can metabolise diverse 
organic substrates3. The organism's unusually broad metabolic capabilities enable it to survive and 
proliferate in water-based environments.
In the early 1970s, it was found to be a human pathogen causing mild respiratory disease and 
urinary tract infections. In the 1980s, it was confirmed to cause life threatening pulmonary  
infections  in  cystic  fibrosis  patients. The complications caused by Burkholdheria cepacia have 
a mortality rate of 80%. This species and Pseudomonas aeruginosa enhance each other in their 
effects in cystic fibrosis patients to cause major problems.

 

In 1971, Burkholdheria cepacia was reported as the causative organism of "foot rot" in U.S. troops 
on swamp training exercises in northern Florida; it was also isolated from troops serving in 
Vietnam4.
The US Center for Disease Control5 is of the opinion that Burkholderia cepacia poses little medical 
risk to healthy people. However, people who have certain health problems like weakened immune 
systems or chronic lung diseases, particularly cystic fibrosis, are susceptible to infection with 
potentially fatal consequences.
In  agricultural  microbiology, Burkholderia cepacia's ability to metabolise almost anything 
available to it, even the chlorinated hydrocarbons6 which are commonly found in commercial 
pesticides and  herbicides  have  led  to  its consideration as an environmental bioremediation 
agent. A strain of Burkholderia cepacia has also been developed as a seed and root inoculant, which 
can suppress fungal growth on conifer seedlings7. Due to the human health problems that 
Burkholderia cepacia can cause, cmTently the US Center for Disease Control and the US Environmental 
Protection Agency have declared a moratorium against Burkholderia cepacia pesticides and 
herbicides.

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Concern to the pharmaceutical industry

Micro-organisms are comparatively rarely named in FDA's website list of recalls (Enforcement 
Reports). However, there are 45 instances applying to pharmaceuticals recalled from the US market 
since 1992. Thirteen of these applying to pharmaceuticals and three applying to cosmetics (Table 1)
name Burkholderia cepacia. No other named micro-organism has been associated with recalls as frequently as Burkholderia cepacia.
It is of interest that the 1998 recall of cetyl pyridinium chloride mouthwash arose as a result of 74 patients at two hospitals in Arizona having been found to have respiratory tract cultures positive for Burkholderia cepacia in the period August 1996-June 19988. All of these patients had been mechanically ventilated and all had received routine oral care which included swabbing with the mouthwash. Cultures of unopened bottles of the mouthwash grew Burkholderia cepacia. None of the infected patients had medical conditions typically  associated with infection with Burkholderia cepacia ( eg., cystic fibrosis or chronic granulomatous disease).