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CYTOTOXIC DRUG PREPARATION PRINCIPLES
1
1. What is cancer ?
Term cancer refer to a heterogeneous group of diseases caused by anImpairment of the normal functioning of genes, which lead to genetic damage
Cancer cells also known as tumors, or neoplasms.
2. Give me the characters of cancer?
They arise from a single abnormal cell, which continues to divide indefinitely.Uncontrolled growth, ability to invade local tissues, and ability to spread, or metastasize, are charecteristics of Cancer.
2S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Types
BenignMalignant
MalignantSolid tumors-carcinomas is of epithelial cellsEg. Lung, colon, breast.Sarcomas-connective tissue, eg bone- osteosarcomaEg muscle-leiomyosarcoma Hematological malignancies-LymphomasEg.Hodgkin and non-Hodgkin lymphomasLeukemias-tumors of blood forming elementsClassified as acute or chronic, myeloid or lymphoid
3S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Cells are dividing in higher proportion
Local invasiveness
Tendency to spread to other parts of the body
Less differentiated cell morphology
Tendency to retain some characteristics of the tissue of origin
4S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
5S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Viruses: Including Epstein-Barr virus (EBV), Hepatitis B virus (HBV) and Human papillomavirus (HPV)
Environmental and occupational exposures: Eg: Ionizing and ultraviolet radiation, exposure to chemicals (Vinyl chloride, benzene and asbestos)
Lifestyle factors: Eg: High-fat, low fibre diets, tobacco, ethanol use
Medication: Alkylating agents and immunosuppressant Genetic factors: Inherited mutations, cancer causing genes
(oncogenes), defective tumor-suppressor genes
6S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
WARNING SIGNS1. Change in bowel or bladder habits2. A Sore that does not heal3. Unusual bleeding or discharge4. Thickening or lump in the breast or
elsewhere5. Indigestion or difficulty swallowing6. Obvious change in a wart or mole7. Nagging cough or hoarseness
7S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Guidelines for screening: Because many cancers do not produce signs or symptoms until they have become large the goal of screening is to detect cancers early, when the disease is curable and to reduce mortality
8S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
CYTOTOXIC DRUGS
Cytotoxic drugs are the therapeutic agents intended for but not limited to the treatment of cancer. These drugs are known to be highly toxic to cells, mainly through their action on cell reproduction. Many have proved to be carcinogens, mutagens or teratogens
Cytotoxic drugs are increasingly being used in a variety of healthcare settings, laboratories and vertinary clinics for the treatment of cancer and other medical conditions such as rheumatoid arthritis, multiple sclerosis and auto-immune disorders
9S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
OCCUPATIONAL EXPOSURE
Drug preparation Pharmacist Drug administration Nurses and medical officers Handling patient waste Transport and waste disposal Laboratory staff, Spills Cleaning
Maintenance waste disposal staff
10S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Health effects attributed to cytotoxic drugs exposure among people preparing and administering cytotoxic drugs include:
Abnormal formation of cells and mutagenic activityAlterations to normal blood cell countFoetal loss in pregnant women and malformations in the offspring of pregnant womenAbdominal pain, hair loss, nasal sores and vomitingLiver damage
11S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
RISK CONTROL
Following risk control measures can be implemented for reducing the risk to the employee
Establishment of written policies and protocols to ensure the safe handling of cytotoxic drugsEffective planning and design of the workplaceUse of best practice control measures and specialised equipment such as cytotoxic drug safety cabinetsThe implementation of stringent handling proceduresTraining and education of employees
12S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Outsource cytotoxic drug preparation work from a company that specializes in that sort of work
Purchase cytotoxic drugs in ready to use form such as pre-filled syringes
Purchase cytotoxic drugs in the safest form available Review health and safety information about cytotoxic
drugs before making a decision to purchase Use facilities that meet recommended technical and
safety standards
13S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
ESTABLISHING CYTOTOXIC PREPARATION FACILITY
Cytotoxic clean room that houses a laminar flow cytotoxic drug safety cabinet or pharmaceutical isolator for drug preparation
Access only through an anteroom. A secondary barrier to prevent cytotoxic drug contamination of the outside environment should be provided by HEPA filters that supply filtered air to the clean room and the anteroom
14S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
WORK ORGANISATION AND LAYOUT DESIGN
The level of concentration and visual control required
Precision of movements needed
Design of equipment and availability of adjustable furniture such as chairs, stools and footrests
Storage requirements
Potential noise sources
15S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
ADDITIONAL CONSIDERATION IN DESIGNING AND SETTING UP CLEAN ROOM
Provision of access for cleaning
Incorporation of smooth and durable work surfaces and furniture
Installation of recessed lights
Limitation of the number of surfaces and shelves, to minimize particles shedding or the accumulation of particulate matter
16S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
ADDITIONAL CONSIDERATION IN DESIGNING AND SETTING UP CLEAN ROOM
Installation of an accessible emergency shower outside the anteroom
Maintenance of an effective airlock between the cytotoxic suite and external environment
Ensuring all equipment used is dedicated to the cytotoxic clean room
17S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
ADDITIONAL CONSIDERATION IN DESIGNING AND SETTING UP CLEAN ROOM
Change room facilities for changing into personal protective equipment
Provision of a means of communication between the clean room and other areas
Installation of a manometer to monitor the pressure differential within the cytotoxic suite and record daily differential pressure readings
18S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
ADDITIONAL CONSIDERATION IN DESIGNING AND SETTING UP CLEAN ROOM
Consideration of the installation of a manometer alarm in case of adequate pressure differentials
Installation of a spill switch that reverses the airflow, minimizing contamination to the external environment
19S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Use of luer-lock syringes and fittings to keep connections together
Use of luer-slip syringes [only if luer-lock connections are incompatible] such as intrathecal needles
Use of syringe to syringe connectors when transferring solution from one syringe to another
20S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Use of wide bore needles to reconstitute and draw-up cytotoxic drugs
Use of filter needles only when the cytotoxic drugs has been removed from a glass ampoule, or if particulate matter is visible
Use of air venting devices to equalize pressures and to prevent the passage of powder, aerosols and liquids
METHODS OF CONTROL IN DRUG PREPARATION EQUIPMENT
21S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
STANDARD OPERATING PROCEDURE FOR PARENTERAL PREPARATION
Standard operating procedure for parenteral preparations should be documented, and stress the need to:
Avoid using cytotoxic drugs supplied in glass ampoule. If glass ampoules must be used, open with an ampoule breaker
Use techniques that avoid the generation of pressure differentials
22S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
SOP FOR NON-PARENTERAL PREPARATION
Specific additional standard operating procedures for non-parenteral cytotoxic drug preparations includeUsing purpose dedicated equipmentMaking mixtures by dispersing tablets in waterNot crushing tablets in an open mortarNot counting tablets or capsules my machineCleaning equipment immediately after use with a strong alkaline detergent with pH greater than or equal to 10
23S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
PERSONAL PROTECTIVE EQUIPMENT
Coverall or gownHead coveringClosed footwear and overshoesProtective gloves-long enough to cover the elasticized
cuffs of gowns or coverallsProtective eyewearRespiratory protective device
24S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
EQUIPMENT MAINTENANCE
Inspection of cytotoxic drug safety cabinets, isolators and high efficiency particulate air filters (HEPA) filters
Keeping test records and a summary of results in a place accessible to employees
Not using a cabinet that has failed, until the fault has been rectified
Performing microbial and air-particles testing routinely, and recording the results
25S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
CLEANING DRUG PREPARATION FACILITIES
Clean daily
Use a dedicated mop and bucket
Treat all equipment as potentially contaminated
Provide personal protective equipment
26S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Drug packaging: Cytotoxic drugs should be packaged in a
labelled, sealed, leak-proof container, with outer bags heat-sealed where possible, ensuring the container:
Offers protection from light when required Protects the drugs from breakage in transit Contains leakage if breakage occurs Has a childproof lid
27S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
Containers used for transporting prepared cytotoxic drugs should be:
Hard-walled and robust
Made from molded foam or other suitable packaging material capable of protecting the product from a shock equivalent to a drop of one meter onto a concrete surface
Securely closed and labeled with cytotoxic warning
28S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)
29S.Aravinth Vijay Jesuraj,
M.Pharm,DPMM,(PhD)