Friday, December 30, 2011
Wednesday, December 21, 2011
Mechanisms of antibiotic action
Antibiotics target structures and pathways that are unique and important to bacteria such as cell wall synthesis, cytoplasmic membrane synthesis, protein synthesis, nucleic acid (DNA or RNA) synthesis and intermediary metabolism (McCallum, 2010).
A-Inhibition of cell wall synthesis:
Bacterial cell wall function and structure:
A cell wall maintains cellular integrity by countering the effects of osmosis when the cell is in a hypotonic solution. If the wall is disrupted, it no longer prevents the cell from bursting as water moves into the cell by osmosis (Dmitriev et al., 2005).
The major structural component of a bacterial cell wall is its peptidoglycan layer. Peptidoglycan is a huge macromolecule composed of polysaccharide chains of alternating N-acetylglucosamine (NAG) and N-acetylmuramic acid (NAM) molecules that are cross linked by short peptide chains extending between NAM subunits. To enlarge or divide, a cell must synthesize more peptidoglycan by adding new NAG and NAM subunits to existing NAG-NAM chains, and the new NAM subunits must then be bonded to neighboring NAM subunits (Meroueh et al., 2006).
You need to read more
Manual of Antibiotics: Method of Actions, Mechanisms of Resistance and Relations to Health Care associated Infections
http://www.amazon.com/Manual-Antibiotics-Mechanisms-Resistance-ebook/dp/B0050VQWXI
A-Inhibition of cell wall synthesis:
Bacterial cell wall function and structure:
A cell wall maintains cellular integrity by countering the effects of osmosis when the cell is in a hypotonic solution. If the wall is disrupted, it no longer prevents the cell from bursting as water moves into the cell by osmosis (Dmitriev et al., 2005).
The major structural component of a bacterial cell wall is its peptidoglycan layer. Peptidoglycan is a huge macromolecule composed of polysaccharide chains of alternating N-acetylglucosamine (NAG) and N-acetylmuramic acid (NAM) molecules that are cross linked by short peptide chains extending between NAM subunits. To enlarge or divide, a cell must synthesize more peptidoglycan by adding new NAG and NAM subunits to existing NAG-NAM chains, and the new NAM subunits must then be bonded to neighboring NAM subunits (Meroueh et al., 2006).
You need to read more
Manual of Antibiotics: Method of Actions, Mechanisms of Resistance and Relations to Health Care associated Infections
http://www.amazon.com/Manual-Antibiotics-Mechanisms-Resistance-ebook/dp/B0050VQWXI
Monday, December 19, 2011
Nanobacteria
term that is used in microbiology is nanbacteria. Nanobacteria have been claimed in last few years to cause a wide variety of diseases.
Nanobacteria are mineral-forming, sterile-filterable, slow-growing Gram-negative infectious agents [5]. They are detected in bovine/human blood and urine. Nanobacteria-like particles have been detected in synovial fluids of arthritis patients and were shown to gradually increase in number and in size in culture [6].
According to their 16S rDNA structure, nanobacteria belong to the alpha-2 Proteobacteria, subgroup, which includes the Brucella and Bartonella species. Nanobacterium sanguineum (nanobacteria) is the smallest self-replicating organism ever detected—at 50–500 billionths of a meter, 1/1,000th the size of the smallest previously known bacteria [7].
Nanobacteria have been claimed to be associated with a variety of human diseases manifested with pathological calcification. Their most remarkable characteristic is the formation of carbonate apatite crystals of neutral pH and at physiologic phosphate and calcium concentrations. The extracellular mineralization forms a hard protective shelter for these hardy microorganisms and enables them to survive conditions of physical stress that would be lethal to most other bacterial species. Nanobacteria are associated with human kidney stones and psammona bodies in ovarian cancer. Many researchers have thon the potential role these particles may play in the development of urologic pathology, including polycystic kidney disease, renal calculi, and chronic prostatitis. Recent clinical research targeting these agents has proven effective in treating some patients with refractory category III prostatitis [8].
Kidney stones can be debilitating and recur in 50% of patients within 5 years. Kidney stone formation is considered to be a multifactorial disease in which the defense mechanisms and risk factors are imbalanced in favor of stone formation [9].
One theory is that if nanoparticles accumulate in the kidney, they can form the focus of subsequent growth into larger stones over months to years. Other factors, such as physical chemistry and protein inhibitors of crystal growth, also play a role.
Mineral forming nanobacteria are active nidi that attach to, invade, and damage the urinary epithelium of collecting ducts and papilla forming the calcium phosphate center(s) found in most kidney stones. Scientists at NASA have used multiple techniques to determine that nanobacteria infection multiplies faster in space flight simulated conditions than on earth [9].
Nanobacteria are considered to initiate kidney stone formation as they grow faster in a microgravity environment and may explain why astronauts get kidney stones on space missions. This discovery may prove to be critical for future exploratory missions to the moon and Mars. For further proof to this hypothesis, screening of the nanobacterial antigen and antibody level in flight crew before and after flight would be necessary. This concept also opens the door for new diagnostic and therapeutic techniques addressing nanobacterial infection in kidney stones.
Nanoparticles, isolated from renal stones obtained at the time of surgical resection, have been analyzed and propagated in standard cell culture medium [10]. Nanoparticles were isolated from the majority of renal stones. Isolates were sensitive toward selected metabolic inhibitors and antibiotics and contained conserved bacterial proteins and DNA. These findings suggest that renal stone formation is unlikely to be driven solely by physical chemistry; rather, it is critically influenced by specific proteins and cellular responses, and understanding these events will through lights toward new therapeutic targets. Using high-spatial and energy resolution near-edge x-ray absorption fine structure at the 25-nm spatial scale, it is possible to define a biochemical signature for cultured calcified bacteria, including proteins, polysaccharides, nucleic acids, and hydroxyapatite [11].
These preliminary reports suggest that nanoparticles isolated from human samples share spectroscopic characteristics with calcified proteins.
Nanobacteria is claimed to be associated with cardiovascular diserases. Scientists at the Mayo Clinic have examined surgical specimens from patients with cardiovascular pathology to predict the presence of nanobacteria [12]. Analysis of areas with positive immuno staining identified spheres ranging in size from 30 to 100 nm with a spectral pattern of calcium and phosphorus (high-energy dispersive spectroscopy).
Nano-sized particles cultured from calcified but not from non calcified aneurysms were recognized by a DNA-specific dye, incorporated radiolabeled uridine, and after decalcification, appeared via electron microscopy to contain cell walls. Therefore, nanometer-scale particles can be visualized in and cultured from human calcified cardiovascular tissue. In a further study nanoparticles were found near plaque-filled arteries in animal models. The study suggests that nanoparticles potentially represent a previously unrecognized factor in the development of arteriosclerosis and calcific arterial disease [12].
Nanobacteria are mineral-forming, sterile-filterable, slow-growing Gram-negative infectious agents [5]. They are detected in bovine/human blood and urine. Nanobacteria-like particles have been detected in synovial fluids of arthritis patients and were shown to gradually increase in number and in size in culture [6].
According to their 16S rDNA structure, nanobacteria belong to the alpha-2 Proteobacteria, subgroup, which includes the Brucella and Bartonella species. Nanobacterium sanguineum (nanobacteria) is the smallest self-replicating organism ever detected—at 50–500 billionths of a meter, 1/1,000th the size of the smallest previously known bacteria [7].
Nanobacteria have been claimed to be associated with a variety of human diseases manifested with pathological calcification. Their most remarkable characteristic is the formation of carbonate apatite crystals of neutral pH and at physiologic phosphate and calcium concentrations. The extracellular mineralization forms a hard protective shelter for these hardy microorganisms and enables them to survive conditions of physical stress that would be lethal to most other bacterial species. Nanobacteria are associated with human kidney stones and psammona bodies in ovarian cancer. Many researchers have thon the potential role these particles may play in the development of urologic pathology, including polycystic kidney disease, renal calculi, and chronic prostatitis. Recent clinical research targeting these agents has proven effective in treating some patients with refractory category III prostatitis [8].
Kidney stones can be debilitating and recur in 50% of patients within 5 years. Kidney stone formation is considered to be a multifactorial disease in which the defense mechanisms and risk factors are imbalanced in favor of stone formation [9].
One theory is that if nanoparticles accumulate in the kidney, they can form the focus of subsequent growth into larger stones over months to years. Other factors, such as physical chemistry and protein inhibitors of crystal growth, also play a role.
Mineral forming nanobacteria are active nidi that attach to, invade, and damage the urinary epithelium of collecting ducts and papilla forming the calcium phosphate center(s) found in most kidney stones. Scientists at NASA have used multiple techniques to determine that nanobacteria infection multiplies faster in space flight simulated conditions than on earth [9].
Nanobacteria are considered to initiate kidney stone formation as they grow faster in a microgravity environment and may explain why astronauts get kidney stones on space missions. This discovery may prove to be critical for future exploratory missions to the moon and Mars. For further proof to this hypothesis, screening of the nanobacterial antigen and antibody level in flight crew before and after flight would be necessary. This concept also opens the door for new diagnostic and therapeutic techniques addressing nanobacterial infection in kidney stones.
Nanoparticles, isolated from renal stones obtained at the time of surgical resection, have been analyzed and propagated in standard cell culture medium [10]. Nanoparticles were isolated from the majority of renal stones. Isolates were sensitive toward selected metabolic inhibitors and antibiotics and contained conserved bacterial proteins and DNA. These findings suggest that renal stone formation is unlikely to be driven solely by physical chemistry; rather, it is critically influenced by specific proteins and cellular responses, and understanding these events will through lights toward new therapeutic targets. Using high-spatial and energy resolution near-edge x-ray absorption fine structure at the 25-nm spatial scale, it is possible to define a biochemical signature for cultured calcified bacteria, including proteins, polysaccharides, nucleic acids, and hydroxyapatite [11].
These preliminary reports suggest that nanoparticles isolated from human samples share spectroscopic characteristics with calcified proteins.
Nanobacteria is claimed to be associated with cardiovascular diserases. Scientists at the Mayo Clinic have examined surgical specimens from patients with cardiovascular pathology to predict the presence of nanobacteria [12]. Analysis of areas with positive immuno staining identified spheres ranging in size from 30 to 100 nm with a spectral pattern of calcium and phosphorus (high-energy dispersive spectroscopy).
Nano-sized particles cultured from calcified but not from non calcified aneurysms were recognized by a DNA-specific dye, incorporated radiolabeled uridine, and after decalcification, appeared via electron microscopy to contain cell walls. Therefore, nanometer-scale particles can be visualized in and cultured from human calcified cardiovascular tissue. In a further study nanoparticles were found near plaque-filled arteries in animal models. The study suggests that nanoparticles potentially represent a previously unrecognized factor in the development of arteriosclerosis and calcific arterial disease [12].
Wednesday, December 14, 2011
Nanotechnology and Advances in Medicine
Nanotechnology is an emerging technology with enormous potential in information and communication technology, biology and biotechnology, medicine and medical technology. Nanotechnology refers to the a new area of science in which systems are designed and manufactured at the scale of the atom, or the nanometer scale. More specifically nanotechnology deals with structures of less than 100 nanometer (nm). One nm is 1 billionth of a meter. there are two approaches in nanotechnology: bottom-up and top-down. The first approach, the bottom-up, involves manipulating small numbers individual atoms or more complex molecules, into structures typically using minute probes. The second, top-down, approach implies controlling processes to force atoms and molecules to build-up themselves to desired locations and/or structures.
Novel nano- and bio-materials, and nano devices are fabricated and controlled by nanotechnology tools and techniques, which investigate and tune the properties, responses and functions of living and non-living matter, at sizes below 100 nm. The potential medical applications are predominantly in detection, diagnostics (disease diagnosis and imaging), monitoring, and therapeutics. The availability of more durable and better prosthetics and new drug-delivery systems are of great scientific interest and give hope for cancer treatment and minimum invasive treatments for heart disease, diabetes and other diseases. Many novel nanoparticles and nanodevices are expected to be used, with an enormous positive impact on human health. The vision is to improve health by enhancing the efficacy and safety of nanosystems and nanodevices.
Novel nano- and bio-materials, and nano devices are fabricated and controlled by nanotechnology tools and techniques, which investigate and tune the properties, responses and functions of living and non-living matter, at sizes below 100 nm. The potential medical applications are predominantly in detection, diagnostics (disease diagnosis and imaging), monitoring, and therapeutics. The availability of more durable and better prosthetics and new drug-delivery systems are of great scientific interest and give hope for cancer treatment and minimum invasive treatments for heart disease, diabetes and other diseases. Many novel nanoparticles and nanodevices are expected to be used, with an enormous positive impact on human health. The vision is to improve health by enhancing the efficacy and safety of nanosystems and nanodevices.
Sunday, December 11, 2011
Obesity linked to bacteria
Can bacterial flora in gut be linked to obesity? How?Metabolic syndrome is a group of obesity-related metabolic abnormalities that increase an individual’s risk of developing type 2 diabetes and cardiovascular disease. Here, we show that mice genetically deficient in Toll-like receptor 5 (TLR5), a component of the innate immune system that is expressed in the gut mucosa and that helps defend against infection, exhibit hyperphagia and develop hallmark features of metabolic syndrome, including hyperlipidemia, hypertension, insulin resistance, and increased adiposity. These metabolic changes correlated with changes in the composition of the gut microbiota, and transfer of the gut microbiota from TLR5-deficient mice to wild-type germ-free mice conferred many features of metabolic syndrome to the recipients. Food restriction prevented obesity, but not insulin resistance, in the TLR5-deficient mice. These results support the emerging view that the gut microbiota contributes to metabolic disease and suggest that malfunction of the innate immune system may promote the development of metabolic syndrome.
Coated from Published Online March 4 2010
Science 9 April 2010:
Vol. 328 no. 5975 pp. 228-231
DOI: 10.1126/science.1179721
•Report
Metabolic Syndrome and Altered Gut Microbiota in Mice Lacking Toll-Like Receptor 5
Matam Vijay-Kumar1, Jesse D. Aitken1, Frederic A. Carvalho1, Tyler C. Cullender2, Simon Mwangi3, Shanthi Srinivasan3, Shanthi V. Sitaraman3, Rob Knight4, Ruth E. Ley2 and Andrew T. Gewirtz1,*
+
http://www.sciencemag.org/content/328/5975/228.abstract
Coated from Published Online March 4 2010
Science 9 April 2010:
Vol. 328 no. 5975 pp. 228-231
DOI: 10.1126/science.1179721
•Report
Metabolic Syndrome and Altered Gut Microbiota in Mice Lacking Toll-Like Receptor 5
Matam Vijay-Kumar1, Jesse D. Aitken1, Frederic A. Carvalho1, Tyler C. Cullender2, Simon Mwangi3, Shanthi Srinivasan3, Shanthi V. Sitaraman3, Rob Knight4, Ruth E. Ley2 and Andrew T. Gewirtz1,*
+
http://www.sciencemag.org/content/328/5975/228.abstract
Tuesday, December 6, 2011
Guide for Handling Cytotoxic Drugs-What Health care Should Know?
To ensure all workers are aware of, and understand the risks associated with the handling and
use of cytotoxic drugs and related waste.
Teaching points:
1.1 Risks associated with occupational exposure to cytotoxic drugs and related waste:
• health risks and toxic effects
• reproductive health risks.
1.2 Rationale for use of cytotoxic drug therapy.
1.3 Legislative requirements for the management of cytotoxic hazards, MSDSs, risk assessment, employer
and worker obligations.
1.4 Institutional policies and procedures.
1.5 Definitions; cell replication; drug classifications, pharmacological actions; rationale for use.
Identification of those drugs which are mutagenic, teratogenic and carcinogenic. Cytotoxic drugs as a
class of drugs:
• define ‘carcinogenic’ ‘mutagenic’ and ‘teratogenic’
• concepts of cell replication
• drug classifications and pharmacological action on cellular reproduction.
1.6 Health surveillance for workers working with cytotoxic drugs;
• health assessment of workers after unprotected exposure to cytotoxic drugs:
° rationale
° health assessment required in response to an unprotected exposure
• principles for initial and ongoing health assessment:
° rationale for personnel management
° the purpose of health assessment
° limitations of current health surveillance methods.
1.7 The importance of accurate record keeping (e.g. an activity log, records of spills and penetrating
injuries). Storage requirements for health surveillance documentation to ensure confidentiality,
perpetual safe keeping and retrieval.
1.8 Incidents and spill management
1.9 Safe disposal methods for cytotoxic drugs and related waste. Safe storage, packaging, consigning and
transport of cytotoxic waste:
• the rationale for the identification, segregation and safe handling of cytotoxic waste
• institution policies and procedures as they apply to:
° segregation of cytotoxic waste
° containment of cytotoxic waste
° transport of cytotoxic waste
° management of cytotoxic drug and related waste spills.
1.10 PPE requirements, including, selection, use, fit, maintenance, storage, cleaning and disposal.
To train workers in the safe preparation of cytotoxic drugs.
Teaching points – to include Module 1, plus:
2.1 Facility requirements:
• minimum requirements for a cytotoxic preparation facility as defined by AS 2567-2002:
Laminar flow cytotoxic drug safety cabinets and AS 2639-1994:Laminar flow cytotoxic drug
safety cabinets - Installation and use
106
• principles of clean spaces, their creation and maintenance as described in AS 1386.1-1989:
Cleanrooms and clean workstations - Principles of clean space control:
° essential elements necessary for the preparation of cytotoxic drugs—clean room, air handling
system, peripheral rooms, cytotoxic dispensing facility (e.g. laminar air flow equipment,
isolators, cytotoxic drugs safety cabinet)
° their function and use
• management of the cytotoxic preparation facility:
° operation of the cytotoxic drugs safety cabinet or isolator
° maintenance of the preparation facility
° approved devices/equipment used in preparing cytotoxic drugs
° management of cytotoxic spills
° management of contaminated waste generated in the preparation of cytotoxic drugs
° preparation records
• certification reports
• activity logs
• pressure differential records
• environmental monitoring.
2.2 Aseptic preparation of a cytotoxic product.
• principles of aseptic preparation of parenteral solutions
• specific requirements for aseptic preparation in cytotoxic drug safety cabinets or isolators.
2.3 Quality assurance measures required for preparation cytotoxic drugs.
2.4 Safe techniques for cytotoxic drugs. Health and safety hazards posed by handling cytotoxic drugs in
powder and liquid form:
• routes of absorption associated with occupational exposure
• hazards involved when cytotoxic drug aerosols are liberated into a workplace.
2.5 Packaging requirements for the safe presentation and receipt of prepared cytotoxic drugs in individual
packing:
• labelling and packaging requirements for the presentation of prepared cytotoxic drug doses
• procedure for dealing with broken tablets and capsules
• rationale for the use of primary (e.g. a syringe closure), secondary (e.g. the spill-proof overwrap
containing the syringe) and tertiary (e.g. the spill-proof outer transport container) containers for
the maintenance of product integrity and its safe handling.
2.6 Safe storage and transport of cytotoxic drugs in concentrated from:
• legislative requirements for the storage and transport of cytotoxic drugs
• rationale for specific procedures essential for the storage and transport of cytotoxic drugs
• risks associated with the different presentations of cytotoxic drugs
• institutional policy and procedures as they apply to receipt of goods, storage of goods, transport
of goods, management of cytotoxic drug and related waste spills.
2.7 PPE requirements:
• function and use of PPE—demonstrate appropriate use of PPE:
° selection
° putting on
° concurrent use
• cleaning, laundry and disposal of used PPE.
2.8 Waste management principles of waste containment and segregation:
• contaminated waste disposal
• contaminated patient waste
• cytotoxic waste storage and transport requirements.
2.9 Management in the community.
2.10 Incidents and spill management.
2.11 Record keeping.
To train workers in the safe administration of cytotoxic drugs.
Teaching points - Module 1, plus
3.1 Risks associated with administration for operator and patient:
107
• physical and chemical characteristics of these drugs as they pertain to occupational safety:
° differences in potential risk between lyophilized drugs, powdered and liquid filled preparations
° substances requiring protective containment
• cytotoxic drugs and their rationale for use:
° cure, control, prophylaxis and palliation
° drug dosages, routes of administration, delivery methods, calculation of body surface area
° cytotoxic drug protocols.
3.2 Principles of safe handling for all routes of administration. Safe administration techniques for
cytotoxic drugs:
• health and safety hazards posed by handling cytotoxic drugs in liquid form:
° routes of absorption associated with occupational exposure
° hazards involved when cytotoxic drug aerosols are liberated into a workplace
• packaging requirements for the safe presentation and receipt of prepared cytotoxic drugs in
individual packing:
° labelling and packaging requirements for the presentation of prepared cytotoxic drug doses
° procedure for dealing with broken tablets and capsules
° rationale for the use of primary (e.g. a syringe closure), secondary (e.g. the spill-proof
overwrap containing the syringe) and tertiary (e.g. the spill-proof outer transport container)
° containers for the maintenance of product integrity and its safe handling
• identifying safe routes of administration—principles of safe handling and administration of
cytotoxic drug injections:
° demonstrate correct and safe use of cytotoxic drug injectables
° identify variety of routes by which cytotoxic drugs are administered
° identify appropriate blood values and assessments prior to drug administration
• principles of safe handling and administration of cytotoxic drug infusions:
° identify appropriate equipment for management of infusions of cytotoxic drugs
° demonstrate correct technique for the connection and disconnection of cytotoxic drug
administration equipment
• principles of safe handling and administration of oral and topical cytotoxic drugs:
° demonstrate no-touch technique in the administration of oral cytotoxic drug doses
° no-touch application technique and drug containment procedures when applying topical
cytotoxic drugs
• reasons for the selection of differing vascular access techniques for parenteral cytotoxic drugs:
° demonstrate techniques of vein access appropriate for intravenous administration of various
cytotoxic agents
• selection of a vascular access site for vesicant and irritant cytotoxic drug administration:
° identify appropriate vascular access site for the cytotoxic drug used
° identify drugs that are vesicants and those that are irritants
• principles of safe handling and administration of intrathecal cytotoxic drugs:
° identify cytotoxic drugs that can be safely administered by intrathecal route
° calculate intrathecal drug doses
° identify risks associated with accidental intrathecal administration of vinca alkaloids
° identify strategies to reduce risk of accidental intrathecal administration of vinca alkaloids,
including transport, packaging, labelling, checking and administration
• safe procedures for the emergency cessation of cytotoxic drug administration (e.g. adverse
reaction), demonstrate systematic approach to the containment of cytotoxic drugs during
emergency cessation
• management of extravasation—identify critical steps for the management of extravasation
• packaging requirements when transporting cytotoxic drugs within the treatment unit:
° principles of package containment for cytotoxic drug transport within the treatment unit
° transport requirements following the addition of needles to prepared syringes.
3.3 PPE requirements—function and use of PPE—demonstrate appropriate use of PPE:
• selection
• putting on
• concurrent use
• cleaning, laundry and disposal of used PPE.
3.4 Safe disposal methods for cytotoxic agents and equipment involved in administration:
principles of waste containment and segregation as applied to cytotoxic drugs
• appropriate containers required for cytotoxic waste disposal
• understand the principles of waste containment and procedures for the disposal of cytotoxic
sharps
• procedure for disposal of related cytotoxic drug administration equipment
• safe disposal procedure of PPE.
3.5 Incidents and spill management:
• management of cytotoxic drug spills:
° warning and notification requirements for cytotoxic drug spill management:
- isolation and warning procedures
- remedial action in the event of a spill
- procedure for requesting assistance
° PPE requirements for cytotoxic drug spill management
° principles and procedures for cytotoxic drug spill management:
- equipment necessary to contain the cytotoxic spill
- decontamination solutions or substances for cytotoxic containment
- effective use of cytotoxic spill equipment and decontaminants
- containment and disposal of cytotoxic drug spill materials
° action required when an unprotected exposure to workers occurs (e.g. topical, mucous
membrane, or penetrating injury exposure), identify the appropriate health assessment required
in response to unprotected exposure
° post-spill procedures:
- reporting procedures
- health assessment and follow-up.
3.6 Patient education requirements and ethical considerations.
3.7 Patient handling:
• management of contaminated body substances from patients undergoing and following cytotoxic
drug therapy:
° major pathways of body excretion of unchanged cytotoxic drugs or active drug metabolites
° protective period for safe handing of cytotoxic drug body substances:
- standard excretion times (up to seven days)
- drugs which are excreted over prolonged periods (see appendix 3)
- factors which may delay excretion
° procedures for safe handling of body substances and soiled materials used for patient care:
- use of PPE
- procedures for containment and disposal
- special safety precautions associated with contaminated waste material from catheters,
peritoneal dialysis, colostomies etc.
3.8 Management in the community.
3.9 Record keeping.
3.10 Storage and packaging requirements (for transportation and handling).
To ensure all workers are aware of, and understand the risks associated with the handling and
use of cytotoxic drugs and related waste.
Teaching points:
1.1 Risks associated with occupational exposure to cytotoxic drugs and related waste:
• health risks and toxic effects
• reproductive health risks.
1.2 Rationale for use of cytotoxic drug therapy.
1.3 Legislative requirements for the management of cytotoxic hazards, MSDSs, risk assessment, employer
and worker obligations.
1.4 Institutional policies and procedures.
1.5 Definitions; cell replication; drug classifications, pharmacological actions; rationale for use.
Identification of those drugs which are mutagenic, teratogenic and carcinogenic. Cytotoxic drugs as a
class of drugs:
• define ‘carcinogenic’ ‘mutagenic’ and ‘teratogenic’
• concepts of cell replication
• drug classifications and pharmacological action on cellular reproduction.
1.6 Health surveillance for workers working with cytotoxic drugs;
• health assessment of workers after unprotected exposure to cytotoxic drugs:
° rationale
° health assessment required in response to an unprotected exposure
• principles for initial and ongoing health assessment:
° rationale for personnel management
° the purpose of health assessment
° limitations of current health surveillance methods.
1.7 The importance of accurate record keeping (e.g. an activity log, records of spills and penetrating
injuries). Storage requirements for health surveillance documentation to ensure confidentiality,
perpetual safe keeping and retrieval.
1.8 Incidents and spill management
1.9 Safe disposal methods for cytotoxic drugs and related waste. Safe storage, packaging, consigning and
transport of cytotoxic waste:
• the rationale for the identification, segregation and safe handling of cytotoxic waste
• institution policies and procedures as they apply to:
° segregation of cytotoxic waste
° containment of cytotoxic waste
° transport of cytotoxic waste
° management of cytotoxic drug and related waste spills.
1.10 PPE requirements, including, selection, use, fit, maintenance, storage, cleaning and disposal.
To train workers in the safe preparation of cytotoxic drugs.
Teaching points – to include Module 1, plus:
2.1 Facility requirements:
• minimum requirements for a cytotoxic preparation facility as defined by AS 2567-2002:
Laminar flow cytotoxic drug safety cabinets and AS 2639-1994:Laminar flow cytotoxic drug
safety cabinets - Installation and use
106
• principles of clean spaces, their creation and maintenance as described in AS 1386.1-1989:
Cleanrooms and clean workstations - Principles of clean space control:
° essential elements necessary for the preparation of cytotoxic drugs—clean room, air handling
system, peripheral rooms, cytotoxic dispensing facility (e.g. laminar air flow equipment,
isolators, cytotoxic drugs safety cabinet)
° their function and use
• management of the cytotoxic preparation facility:
° operation of the cytotoxic drugs safety cabinet or isolator
° maintenance of the preparation facility
° approved devices/equipment used in preparing cytotoxic drugs
° management of cytotoxic spills
° management of contaminated waste generated in the preparation of cytotoxic drugs
° preparation records
• certification reports
• activity logs
• pressure differential records
• environmental monitoring.
2.2 Aseptic preparation of a cytotoxic product.
• principles of aseptic preparation of parenteral solutions
• specific requirements for aseptic preparation in cytotoxic drug safety cabinets or isolators.
2.3 Quality assurance measures required for preparation cytotoxic drugs.
2.4 Safe techniques for cytotoxic drugs. Health and safety hazards posed by handling cytotoxic drugs in
powder and liquid form:
• routes of absorption associated with occupational exposure
• hazards involved when cytotoxic drug aerosols are liberated into a workplace.
2.5 Packaging requirements for the safe presentation and receipt of prepared cytotoxic drugs in individual
packing:
• labelling and packaging requirements for the presentation of prepared cytotoxic drug doses
• procedure for dealing with broken tablets and capsules
• rationale for the use of primary (e.g. a syringe closure), secondary (e.g. the spill-proof overwrap
containing the syringe) and tertiary (e.g. the spill-proof outer transport container) containers for
the maintenance of product integrity and its safe handling.
2.6 Safe storage and transport of cytotoxic drugs in concentrated from:
• legislative requirements for the storage and transport of cytotoxic drugs
• rationale for specific procedures essential for the storage and transport of cytotoxic drugs
• risks associated with the different presentations of cytotoxic drugs
• institutional policy and procedures as they apply to receipt of goods, storage of goods, transport
of goods, management of cytotoxic drug and related waste spills.
2.7 PPE requirements:
• function and use of PPE—demonstrate appropriate use of PPE:
° selection
° putting on
° concurrent use
• cleaning, laundry and disposal of used PPE.
2.8 Waste management principles of waste containment and segregation:
• contaminated waste disposal
• contaminated patient waste
• cytotoxic waste storage and transport requirements.
2.9 Management in the community.
2.10 Incidents and spill management.
2.11 Record keeping.
To train workers in the safe administration of cytotoxic drugs.
Teaching points - Module 1, plus
3.1 Risks associated with administration for operator and patient:
107
• physical and chemical characteristics of these drugs as they pertain to occupational safety:
° differences in potential risk between lyophilized drugs, powdered and liquid filled preparations
° substances requiring protective containment
• cytotoxic drugs and their rationale for use:
° cure, control, prophylaxis and palliation
° drug dosages, routes of administration, delivery methods, calculation of body surface area
° cytotoxic drug protocols.
3.2 Principles of safe handling for all routes of administration. Safe administration techniques for
cytotoxic drugs:
• health and safety hazards posed by handling cytotoxic drugs in liquid form:
° routes of absorption associated with occupational exposure
° hazards involved when cytotoxic drug aerosols are liberated into a workplace
• packaging requirements for the safe presentation and receipt of prepared cytotoxic drugs in
individual packing:
° labelling and packaging requirements for the presentation of prepared cytotoxic drug doses
° procedure for dealing with broken tablets and capsules
° rationale for the use of primary (e.g. a syringe closure), secondary (e.g. the spill-proof
overwrap containing the syringe) and tertiary (e.g. the spill-proof outer transport container)
° containers for the maintenance of product integrity and its safe handling
• identifying safe routes of administration—principles of safe handling and administration of
cytotoxic drug injections:
° demonstrate correct and safe use of cytotoxic drug injectables
° identify variety of routes by which cytotoxic drugs are administered
° identify appropriate blood values and assessments prior to drug administration
• principles of safe handling and administration of cytotoxic drug infusions:
° identify appropriate equipment for management of infusions of cytotoxic drugs
° demonstrate correct technique for the connection and disconnection of cytotoxic drug
administration equipment
• principles of safe handling and administration of oral and topical cytotoxic drugs:
° demonstrate no-touch technique in the administration of oral cytotoxic drug doses
° no-touch application technique and drug containment procedures when applying topical
cytotoxic drugs
• reasons for the selection of differing vascular access techniques for parenteral cytotoxic drugs:
° demonstrate techniques of vein access appropriate for intravenous administration of various
cytotoxic agents
• selection of a vascular access site for vesicant and irritant cytotoxic drug administration:
° identify appropriate vascular access site for the cytotoxic drug used
° identify drugs that are vesicants and those that are irritants
• principles of safe handling and administration of intrathecal cytotoxic drugs:
° identify cytotoxic drugs that can be safely administered by intrathecal route
° calculate intrathecal drug doses
° identify risks associated with accidental intrathecal administration of vinca alkaloids
° identify strategies to reduce risk of accidental intrathecal administration of vinca alkaloids,
including transport, packaging, labelling, checking and administration
• safe procedures for the emergency cessation of cytotoxic drug administration (e.g. adverse
reaction), demonstrate systematic approach to the containment of cytotoxic drugs during
emergency cessation
• management of extravasation—identify critical steps for the management of extravasation
• packaging requirements when transporting cytotoxic drugs within the treatment unit:
° principles of package containment for cytotoxic drug transport within the treatment unit
° transport requirements following the addition of needles to prepared syringes.
3.3 PPE requirements—function and use of PPE—demonstrate appropriate use of PPE:
• selection
• putting on
• concurrent use
• cleaning, laundry and disposal of used PPE.
3.4 Safe disposal methods for cytotoxic agents and equipment involved in administration:
principles of waste containment and segregation as applied to cytotoxic drugs
• appropriate containers required for cytotoxic waste disposal
• understand the principles of waste containment and procedures for the disposal of cytotoxic
sharps
• procedure for disposal of related cytotoxic drug administration equipment
• safe disposal procedure of PPE.
3.5 Incidents and spill management:
• management of cytotoxic drug spills:
° warning and notification requirements for cytotoxic drug spill management:
- isolation and warning procedures
- remedial action in the event of a spill
- procedure for requesting assistance
° PPE requirements for cytotoxic drug spill management
° principles and procedures for cytotoxic drug spill management:
- equipment necessary to contain the cytotoxic spill
- decontamination solutions or substances for cytotoxic containment
- effective use of cytotoxic spill equipment and decontaminants
- containment and disposal of cytotoxic drug spill materials
° action required when an unprotected exposure to workers occurs (e.g. topical, mucous
membrane, or penetrating injury exposure), identify the appropriate health assessment required
in response to unprotected exposure
° post-spill procedures:
- reporting procedures
- health assessment and follow-up.
3.6 Patient education requirements and ethical considerations.
3.7 Patient handling:
• management of contaminated body substances from patients undergoing and following cytotoxic
drug therapy:
° major pathways of body excretion of unchanged cytotoxic drugs or active drug metabolites
° protective period for safe handing of cytotoxic drug body substances:
- standard excretion times (up to seven days)
- drugs which are excreted over prolonged periods (see appendix 3)
- factors which may delay excretion
° procedures for safe handling of body substances and soiled materials used for patient care:
- use of PPE
- procedures for containment and disposal
- special safety precautions associated with contaminated waste material from catheters,
peritoneal dialysis, colostomies etc.
3.8 Management in the community.
3.9 Record keeping.
3.10 Storage and packaging requirements (for transportation and handling).
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