ABSTRACT
Microbiological and physicochemical analysis were carried out on 50% samples of different brands of dextrose water intravenous infusions sold in major Pharmacies in Umuahia. All samples were analysed within their expiry dates. The samples were categorized according to the percentage of dextrose in water. Forty-eight percent (48%) of the samples were contaminated with either bacteria or fungi. The fungi count ranged from 1 to 2.3 cmf/ml and the bacteria count ranged from 1 to 2 cmf/ml. Seven (7) viable microbial species were isolated; two gram positive bacteria (Staphylococcus and Bacillus), one gram negative bacteria (Klebsiella), three filamentous fungi (Aspergillus, Fusarium, and Penicillium) and yeast-like fungi (Candida). Candida species had the highest occurrence in both 5% dextrose water and 10% dextrose water with 16% and 24% respectively while Klebsiella, Staphylococcus, Fusarium and Penicillium had the lowest occurrence of 4%. Physicochemical analysis was conducted to determine the Ph, total solid (TS), turbidity, osmolarity and titratable analysis. It was further subjected to analysis of variance (ANOVA) which revealed no significant difference (P<0.05) among the different samples. However, there were significant differences among the values in the total solids in 5% dextrose water which ranged from 4.00±0.53 to 4.55±0.19 and in the osmolarity values of 10% dextrose water sample from different sources which ranged from 526.60±2.30 to 538.60±8.79 but it is slightly negligible. Microbial contaminants in a Pharmaceutical preparation may induce disease in the consumer without necessarily producing spoilage of the product. Therefore, its presence or the product is crucial.
TABLE OF CONTENTS
Title page i
Certification ii
Dedication iii
Acknowledgement iv
Table of contents v
List of tables viii
Abstract ix
CHAPTER ONE
1.0
INTRODUCTION 1
1.1
Aim
and objectives 4
CHAPTER TWO
2.0 LITERATURE
REVIEW 5
2.1
Dextrose water Intravenous injections 5
2.2 Water for infusions 7
2.3 Microbiological contamination of infusion
therapy 8
2.4 Causes of microbiological contamination
of infusion therapy
10
2.5 Risks associated with microbiological
contaminated infusions
11
CHAPTER THREE
3.0 MATERIALS AND METHOD 15
3.1 MATERIALS 15
3.1.1 Sample Collection 15
3.1.2 Media used and preparation 15
3.2 METHOD 15
3.2.1 Microbiological analysis 15
3.2.2 Isolation and Identification of microbes 16
3.2.3 Characterisation of isolates 16
3.2.3.1 Characterisation of fungi isolates 16
3.2.3.2 Characterisation of Bacteria isolates 17
3.2.3.2.1 Gram Staining 17
3.2.3.2.2 Catalase test 17
3.2.3.2.3 Citrate test 18
3.2.3.2.4 Oxidase test 18
3.2.3.2.5 Indole test 18
3.2.3.2.6 Coagulase test 18
3.2.3.2.7 Carbohydrate Fermentation 19
3.2.4
Determination of Occurrence 19
3.2.5 Physicochemical analysis 19
3.2.5.1
Determination of Ph 19
3.2.5.2
Determination of turbidity 20
3.2.5.3
Determination of Titratable acidity 20
3.2.5.4
Determination of Total solid 20
3.2.5.5
Determination of osmolarity 21
3.2.6
Statistical analysis 21
CHAPTER FOUR
4.0
RESULTS 22
CHAPTER FIVE
5.0 DISCUSSION AND RECOMMENDATIONS 37
5.1 Discussion 37
5.2 Conclusion 39
5.3 Recommendations 40
REFERENCES 41
APPENDIX
List of Tables
Table Page
1. Identification of
bacterial isolates 24
2. Identification results
for fungi isolates 25
3a. Pharmacies and
attributes of 5% dextrose water 26
3b. Pharmacies and
attributes of 10% dextrose water 27
4a. Microbial
contaminants isolated from 5% dextrose water 28
4b. Microbial contaminants
isolated from 10% dextrose water 29
5a. Percentage occurrence
of the microbial isolates from 5% dextrose water 30
5b. Percentage occurrence
of the microbial isolates from 10% dextrose water 31
6a. Average microbial
count of microbes isolates from 5% dextrose 32
6b. Average microbial
count of microbes isolates from 10% dextrose 33
7. Percentage of
contaminated sample 34
8a. Statistical analysis
of 5% dextrose 35
8b. Statistical analysis
of 10% dextrose 36
CHAPTER ONE
1.1 INTRODUCTION
The
parenteral route of administration is generally adopted for medicaments that
cannot be given orally, either because of patient’s intolerance, drug
instability, or poor absorption via the enteral route. In the unconscious
patient, parenteral administration is the only safe and most effective means of
administering medicaments through the intravenous route (The pharmaceutical
Codex, 1994). Sterile intravenous fluids, popularly called “Drips”, are large
volume parenteral products which consists of single dose injections with a
volume of 100 to 1000ml.
It
is generally mandatory that microorganisms or their products must not be
present in sterile pharmaceutical products throughout its shelf life (PHLS
Working Party, 1971; European Pharmacopeia, 2000). Pharmaceutical preparations are
regarded contaminated or spoilt if, low levels of acutely pathogenic
microorganisms or higher levels of opportunist pathogens are present, if toxic
microbial metabolites persist even after death or removal of any microorganism
originally present, or if chemical changes have occurred in the product (Hugo
and Russell, 1992).
Although
Pharmaceutical Manufacturers strive under Good Manufacturing Practice (GMP) to
ensure quality of their products, occasionally this is not achieved due to
inadequate analytical facilities, lack of properly trained personnel, or
indeterminate errors during quality control process (Aluoch-Orwa, et al., 1995). Contamination is a
recurrent problem and can have fatal consequences particularly with intravenous
products. In Nigeria survey of intravenous products by the National Agency for
Food Drug Administration and Control (NAFDAC) in 2004, out of 566 samples
comprising 42 brands from 8 manufacturers, 9 brands of dextrose 5%, dextrose
4.3% in 0.18% NaCl, Darrows half strength, and dextrose 50% failed the
microbiological specification for intravenous fluids, thereby prompting NAFDAC
to institute recall of the contaminated products (Atata, et al., 2007).
Microbial
contamination of injections and infusions often result from poor sterilisation
management, obsolete equipment, inappropriate production environment, and poor
quality packaging (Caudron, et al., 2008).
Parenteral nutritions and intravenous fat emulsions can become contaminated
during preparation and infusions, with fungal pathogens (Kuwahara, et al., 2010) especially Candida albicans has the ability to
either grow very well or sustain prolonged viability in all nutritional
intravenous products. Infusion fluids requiring compounding or the addition of
medications to the fluid container were found to produce 7% of primary
bloodstream infections when those fluids were prepared (Macias, et al., 2010).
Septicemia arising from the administration of
contaminated fluids is a particular complication and concern in intravenous
therapy. Organisms which have been associated with infusion septicaemia
include; Staphylococcus, Klebsiella, and
Candida. The genus Candida has been incriminated as one of
the notorious contaminants of infusion fluids giving rise to fungal septicaemia
after infusion therapy (Goldman, et al., 1993).
Candida krusei is a commonly isolated
opportunist pathogen responsible for serious septic infections in susceptible
patients (McQuillen et al., 1994). In
the year 2005 and 2006, administration of Candida
albicans contaminated parenteral fluid was responsible for a major outbreak
of systemic candidosis in India (Kuwar, et
al., 2011). Pathogenic agents have been reported transmitted by direct
contact or indirectly via contaminated instruments and intravenous fluids with
fungal colonization and invasive candidosis in babies at Neonatal intensive
care units (Rao, et al., 2005). For
more than two decades, candida albicans and
C. parapsilosis have been recognized
to pose significant danger to preterm infants, causing candidemia, particularly
catheter related, bloodstream infections, with a crude mortality rate of 23% to
50%.
The
risk factors include prematurity, cathethers, parenteral nutrition, intravenous
fluids and intubation (Polin and Siman, 2003). Recently, Vagna and Henao (2010)
described the manifestations of meningitis by Candida to include disseminated candidiasis in premature infants,
ventricular drainage devices infections and chronic isolated meningitis which
were directly related to access of Candida
albicans, Candida parapsilosis and Candida
tropicalis to the central nervous system through the bloodstream.
In
90% of patients with fungemia and endocarditis owing to infection with the
genus Paecilomyces, the predisposing
factors were found to be peritoneal dialysis, contaminated intravenous fluids
and medicaments (Marzec and Heron, 1993). The high glucose concentration of
both dextrose infusions and dialysate
fluids render them optimal media for fungi growth, even in dialysate fluids
where Paecilomyces variotii was
isolated and incriminated as the aetiology of peritonitis in a patient (Elamin et al., 2010).
Acute
systemic infections and deaths have resulted from the administration of
contaminated fluids where invasive infections caused by fungi were the major
causes of morbidity and mortality in the immunocompromised patient (Cornelius, et al., 1998). The Reuters News reported
the death of nine patients in an Alabama hospital as a result of outbreaks of
infection from a batch of contaminated intravenous fluids (Peggy, 2011). In
addition, sixteen pregnant women were reported dead in India Hospital after the
administration of contaminated dextrose intravenous fluids that led to
infection, excessive bleeding and multiorgan failure (Rajalakshmi, 2011).
In
the tropical countries such as Nigeria, Pharmaceutical preparations are
frequently stored under conditions of high temperature (Av= 310C) and high
relative humidity (Av= 75%); and may be dispensed in non-protective packaging
(Blair, et al., 1998). While the
presence of a few microbial survivors in an injection after production is often
unlikely to induce infection, considerable growth can occur during storge prior
to administration thereby yielding highly infective or toxic products (Hugo and
Russell, 1992). While these products were intended to mitigate diseases and
death, more infections and deaths are rather often initiated worldwide, most
especially in developing countries, by such unwholesome drugs. Although Alouch-
Orewa, et al., 1995 reported
substantial failure in the available content of the active ingredients of some
commercial intravenous infusion in Kenya, Atata et al., 2007 reported on microbiology qualities of some intravenous
fluid in Nigeria.
1.2 Aim and objectives
This
research is aimed at establishing a physicochemical and microbiological fitness
of some of the dextrose intravenous water sold in major Pharmacies in Umuahia.
It is achieved by the following:
1. Determination
of Microorganisms in dextrose water infusion.
2. Identification
of possible pathogens found in dextrose water.
3. Determination
of physicochemical properties of dextrose in
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