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5. Dosage forms used for cytotoxic medicines Cyclophosphamide: sterile white powder in a vial for reconstitution
Methotrexate: clear yellow aqueous isotonic solution for injection, or yellow lyophilized powder of methotrexate sodium.
Cisplatin: yellow white frez-dried powder reconstituted with water or saline
Parenteral administration can be administered via the following routes:
By a syringe
By slow bolus injection into a cannula
By addition of cytotoxic agent into an infusion fluid and administered over a predetermined infusion period
6. Monitoring exposure of personnel I- The Ames test for mutagenisty
Organism: salmonella typhimurium, which is susceptible to reversion back to prorotrophy in presence of mutagens.
The urine of subject handling cytotoxic agents were tested.
The test may not be sensitive with very low levels of chronic exposure.
Urine of cigarette smokers was found to be mutagenic.
7. II- Sister chromatid exchange
The arrangement of generic material in a chromosome.
Clastogen is a substance which causes chromosome damage
Sensitive test at very low chlastogen levels.
Positive results have occurred with some drugs as phenytoin, caffeine, ethanol, oral contraceptive and cytotoxics
8. Glossary of Terms
Acute toxicity: where a toxic effect occurs immediately or shortly after a single exposure.
Antineoplastic: anti cancer.
Cancer: a malignant tumor which can spread to other organs of the body, distinct from a benign tumor which cannot. (Although leukaemia and some other malignant diseases are not solid tumors, they meet other criteria for cancer and can be, and often are, included under this definition.)
Carcinogen: an agent which is responsible for the formation of cancer.
9. Carcinogenic: capable of causing cancer. Chemotherapy: the treatment of disease by chemical substances. Chronic toxicity: harmful effects of a chemical which occur after repeated or prolonged exposure. Chronic effects may also occur some time after exposure has ceased. Cytogenetics: the study of the structure and functions of the cells of the body, with particular reference to the chromosomes. Cytotoxic: destructive to living cells. Excreta: any waste matter eliminated from the body Extravasation: leakage of cytotoxic drug from the vein into the surrounding tissue. Metabolite: in physiology, any product yielded by or taking part in the chemical processes essential to life.
11. The Health and Safety in Employment Act 1992, puts the primary responsibility on the employer to provide a safe and healthy work environment by identifying and effectively managing any hazards associated with the work.
The employers’ overall responsibilities are to identify potential or actual hazards, evaluate the health risks, and to institute effective controls over the hazard.
The Act requires that, where possible, significant hazards must be eliminated;
and where a hazard cannot be eliminated, isolation should be considered.
When the hazard cannot be practicably eliminated or isolated, the effects of the hazard must be minimized by various means, such as engineering controls or by personal protection
21. During drug preparation, a variety of manipulations are performed which may result in aerosol generation, spraying, and splattering. Examples of these manipulations include: the withdrawal of needles from drug vials; the use of syringes and needles or filter straws for drug transfer; the opening of ampoules; and the expulsion of air from the syringe when measuring the precise volume of a drug.
Pharmaceutical practice calls for the use of aseptic techniques and a sterile environment. Many pharmacies provide this sterile environment by using a horizontal laminar flow work bench
26. Chronic Effects
The greatest cause for concern among health care workers is not the acute but the long-term effects of occupational exposure to cytotoxic drugs. Many published studies are inconclusive and little is known of the long-term effects of exposure to small quantities of cytotoxic drugs over an extended period of time.
The possibility that the carcinogenic threshold may be a cumulative one, indicates that any exposure to cytotoxic drugs should be minimized.
28. Procedures for Handling Cytotoxic Drugs and Related Wastes
The primary focus of safety during the use of cytotoxic drugs must be on :
Control of the working environment;
Safe work practices; and
Education and training of personnel.
The preparation and reconstitution of cytotoxic drugs should only be undertaken by specially trained nominated personnel, working under appropriate conditions which protect workers and the environment as well as protecting the integrity of the product.
36.
B. The work surface of the safety cabinet should be covered with plastic-backed absorbent paper. This will reduce the potential for dispersion of droplets and spills and facilitate cleanup. This paper should be changed after any overt spill and at the end of
each work shift.
37. C. Personnel preparing the drugs should wear :
unpowdered latex surgical gloves and a disposable gown with elastic or knit cuffs.
Gloves should be changed regularly and immediately if torn or punctured.
Protective clothing should not be worn outside of the drug preparation area.
40. E. If a chemotherapy dispensing pin is not used, a sterile alcohol pad should be carefully placed around the needle and vial top during withdrawal from the
septum.
45. J. Contaminated needles and syringes, I.V. tubing, butterfly clips, etc., should be disposed of intact to prevent aerosol generation and injury. Do not recap needles. Place these items in a puncture resistant container along with any contaminated bottles, vials, gloves, absorbent paper, disposable gowns, gauze and other waste. The container should then be placed in a box labeled,
"Cytotoxic waste only," sealed and disposed of according to Federal, state and local requirements. Linen contaminated with drugs, patient excreta or body fluids should be handled separately.
46. K. Hands should be washed between glove changes and after glove removal.
L. Cytotoxic drugs are categorized as regulated wastes and therefore, should be disposed of according to Federal, state and local requirements.
51. Guidance for chemotherapy trained nurse administering chemotherapy when pregnant:
It is advised that in the 1st trimester no chemotherapy is handled or administered.
In the 2, 3 trimesters it is considered safe to administer chemotherapy but only using infusion bags and not by bolus injection.
To further minimize exposure, staff should be offered goggles and masks, gloves and aprons routinely used.
Disposal of chemotherapy should be via a foot operated yellow bin labelled Cytotoxic Waste to reduce risk of spillage.
The universal prohibition of eating and drinking when administering chemotherapy is emphasized.
