Documentos de Académico
Documentos de Profesional
Documentos de Cultura
ABSTRACT
Cytotoxic drugs are used in the management of malignant diseases. They have been
found to be carcinogenic, teratogenic and mutagenic. There is growing concern that
the handling, preparation, administration and disposal of these substances may
constitute an occupational hazard. These guidelines aim to identify, and help avoid
or minimize occupational exposure to cytotoxic drugs and related wastes within
health care establishments. It is necessary that individuals involved in the use or
handling of cytotoxic drugs are made aware of associated matters relating to the
safe handling of such drugs.
INTRODUCTION
Cytotoxic drugs are therapeutic agents which are Personnel likely to be involved in these
known to be toxic to cells principally through processes are nurses, medical officers and
their action on cell reproduction and are pharmacy staff. The greatest risk of occupational
primarily intended for the treatment of cancer. exposure to cytotoxic drugs is during their
Currently there is no established data for safe preparation and administration. The need for safe
level of exposure to these drugs. While health handling of cytotoxic drugs is not confined to
care establishment workers involved in the injectable dosage forms only. For example, oral
handling of these group of drugs do not receive dosage forms may shed respirable dust, and
therapeutic doses, there is concern that unless when used to prepare oral suspensions, may
suitable protective measures are in place, these distribute dust and fragments. Other aspects of
personnel may be subjected to low level doses in patient care such as spill and waste management
the long term. may also pose a risk of occupational exposure.
reaction, which may result from direct developments, such as changes in technology
contact with skin or mucous membranes and preparation procedures. Validation of
• cytogenetic abnormalities and mutagenic accreditation criteria should occur at intervals no
activity related to biological uptake by greater than two years.
exposed personnel
• alteration to normal blood cell counts Personal Protective Equipment should be worn
• excretion of the drugs or metabolites in the by personnel using an approved cytotoxic drug
urine in exposed personnel safety cabinet to prepare cytotoxic drugs:
• symptoms including abdominal pain, hair • long sleeved coverall of impermeable
loss, nasal sores and vomiting material, e.g. made from bonded
• liver damage polyethylene fibre with a closed front and
• foetal loss in exposed pregnant women and elasticized cuff, with suitable head
malformation of the offspring of pregnant protection
women • overshoes of a similar impermeable material
• suitable respiratory protection
Although the long term effects of occupational • long PVC, surgical latex, or purpose
exposure to cytotoxic drugs are inconclusive, it manufactured gloves
is not appropriate to wait for indisputable
evidence of harm. Special precautions are required for the
laundering of used Personal Protective
Drug preparation Equipment (garments) which may be
contaminated with cytotoxic drugs. The
In general, the principle focus of safety during conditions required for the laundering of
cytotoxic drug preparation should be on: potentially contaminated items should be
• education and training of personnel established to:
• control of the working environment • protect laundry personnel who are involved
• adoption of safe working procedure in this process from cytotoxic drug residue
• prevent contamination of other materials
Education and training of health professionals in being laundered
cytotoxic drug preparation and handling is • ensure the garments are decontaminated
recommended to ensure that safe work practices prior to sterilization or reuse
are understood, developed, implemented and
maintained. Use of cytotoxic drug safety cabinet, Attention to occupationally related work practice
pharmaceutical isolators and other appropriate will maximize efficiency and productivity and
equipment is recommended to facilitate safe minimize operator errors. Cytotoxic clean room
preparation of cytotoxic drugs and to ensure that equipment layout should be designed properly.
products, operator and working environment are To determine appropriate work periods the entire
protected. In order to provide drug containment task should be assessed taking into consideration
and aseptic manipulation, all preparation of the:
cytotoxic drugs should take place in a separate, • level of concentration and visual control
dedicated cytotoxic safety cabinet or in required
pharmaceutical isolators. • precision of movements
• design of equipment and availability of
The health care establishment management is adjustable furniture, e.g. chairs, stools and
responsible for ensuring that personnel who are foot rests
designated to perform cytotoxic drug preparation • aesthetic effects of the working environment
procedures are provided with an accredited level
of training, and that they have attained Drugs and its storage area and equipment need to
proficiency prior to undertaking preparation be identified. Intravenous equipment and devices
procedures (8). Accredited training in drug containing cytotoxic drugs should be clearly
preparation procedures should be undertaken labelled with a permanent, adhesive and
prior to commencement of duties and when new recognizable cytotoxic drug label.
equipment is introduced or procedures changed.
Procedures should be in place to ensure that For drug storage, the quantities of cytotoxic
accredited staff are kept informed of new drugs stored in pharmacy departments, wards,
CPE article: Managing cytotoxic products
clinics and satellite pharmacies should generally to provide prepared cytotoxic drug doses.
be restricted to the quantities for short term use.
A dedicated area for the storage of cytotoxic Drug administration
drugs should be provided in pharmacy
departments and storage areas. Use of a Nursing, medical and other personnel may be
dedicated area facilitates quick and efficient involved in administering oral, parenteral and
containment and management of a spill. topical cytotoxic drugs. A number of factors
influence their level of risk of exposure to
Oral solid cytotoxic doses should be individually cytotoxic drugs during administration. Exposure
packaged. Automatic tablet counters, or other may occur due to contamination from solid or
equipment which may generate particulate liquid spills or splashes and needle stick injuries.
matter, should not be used in the packaging of
cytotoxic drugs. If a prepared therapy has to be Many factors contribute to the risk of exposure,
transported on-site, it should be in a transport including:
container which is of sufficient strength to • poor technique, improperly used or
prevent leakage of its contents and should be inappropriate equipment
securely closed and labelled with cytotoxic • patient behaviour, when it increases the
warnings. Cytotoxic drugs should not be difficulty of administration, for example, if
transported in pneumatic automated tube the patient is uncooperative
systems. • the route of administration, for example, the
risk of splashes in the eyes of the operator or
Standard operating procedures for the assistant during an intrathecal injection is
preparation of cytotoxic drugs should be increased owing to the proximity of the face
documented and should include: to the injection site
• using specially dedicated equipment in a • an inappropriate working environment
pharmacy to provide containment of powder
where there is a requirement for It is important that practitioners identify the level
compounding cytotoxic preparations risk, then use appropriate work practices and
• operational specifications for the use of Personal Protective Equipment to minimize the
cytotoxic drug preparation facilities risks.
including cytotoxic drug safety cabinet
• initial and ongoing validation of operator All staff administering cytotoxic drugs should be
competence appropriately trained (9) in the following aspects
• reconstitution procedures of cytotoxic drug handling and demonstrate
• routine and emergency cleaning and proficiency prior to commencing duties:
decontamination protocol • potential occupational hazards
• spill management • approved work practice
• maintenance and certification of equipment • specialized operator techniques
and facilities • waste containment and handling
• availability of drug safety information • spill management techniques
• documentation and records • proper use of Personal Protective Equipment
• maintenance of daily records
• labelling and packaging for transport The following Personal Protective Equipment
internally or externally should be considered for use during
administration of cytotoxic drugs:
Health care establishments which are unable to • a particulate respirator type mask
provide facilities, equipment and training to • a long sleeved gown of impermeable
employees, should not undertake to provide a material
cytotoxic drug service. Alternative arrangements • safety spectacles or goggles
could include: • long PVC, surgical latex, or purpose
• purchase and supply of the prepared manufactured gloves
cytotoxic drug in a single dose delivery unit.
• establishment of supply arrangements with a Personal Protective Equipment should be
health care institution which has the required removed following completion of procedures and
facilities, equipment and trained personnel appropriately cleaned or disposed of.
CPE article: Managing cytotoxic products
retention and security should be achieved and • record of time spent in the preparation and
maintained. Employees should receive duplicates administration of cytotoxic drugs
of health surveillance test as soon as available. • activity logs including name of the drug and
Employees who are pregnant, breast-feeding or activity undertaken)
planning parenthood and involved in the • protective equipment used (e.g. cytotoxic
preparation or administration of cytotoxic drugs drug safety cabinet, Personal Protective
should be informed of the risks of reproductive Equipment)
effects and possible effects on foetal • unusual equipment (e.g. for managing
development. Personnel required to perform spills).
these may elect to not to do so. In such cases
appropriate and suitable alternative duties must In view of the long latency for some toxic
be provided. effects, each employee should receive, on
termination of employment, a statement
Employees should report any effects of, or indicating the cytotoxic drugs used and results of
exposure to cytotoxic drugs related to handling any biological monitoring carried out.
of the drugs or contaminated waste. The report
should be made to the supervisor through the CONCLUSION
normal workplace incident reporting procedures.
Any near miss incident or accident involving the Although there are many reports and studies that
handling of either cytotoxic drugs or waste, have been carried out to show the relationship
should be investigated to determine the cause. between cytotoxic exposure and risk to health, it
Appropriate action to prevent a recurrence is still difficult to confirm it. This is perhaps due
should be determined and taken. A listing of to the small sample size, difficulty in quantifying
personnel approved to undertake cytotoxic drug exposure or protection used and latency period
preparation and administration should be between exposure and health effects. Despite
maintained. these limitations, there is enough information to
warrant prudent action when handling cytotoxic
The management is responsible for maintaining, drugs. Therefore, the safe handling of cytotoxic
in perpetuity (e.g. 25 years minimum), the drugs is an issue that must be addressed in health
following records for employees handling care settings.
cytotoxic drugs:
• accreditation or training status and type and
extent of training period
See next page for the CPE questions
*****
REFERENCES
1. Curran CF, Luce JK. Accidental acute exposure to 6. Gibson JF, Gompertz D, Hedworth-Whitty RB.
doxorubicin. Cancer Nursing 1989; 12: 329-31. Mutagenicity of urine from nurses handling
2. Anderson RW, Puckett WH, Dana WJ, et al. Risk cytotoxic drugs. Lancet 1984; 1: 100-101.
of handling injectable antineoplastic agents. Am J 7. Rodriquez P, Yap CY. Abnormal blood results
Hosp Pharm 1982; 39:17-23. found in pharmacists preparing cytotoxics. Aust J
3. Hirst M, Tse S, Mills DG, et al. Occupational Hosp Pharmacy 1991;21:39.
exposure to cyclophosphamide. Lancet 8. New South Wales Work Cover. Guidelines for
1984;1:186-88. handling drugs and related waste in health care
4. Benhamou S, Callous F, Saneho-Garnier H, et al. establishments. 1995. 2edn. New South Wales
Mutagenicity in urine from nurses handling Government.
cytotoxic agents. Eur J Cancer Oncol 1986; 9. Moore TD, Hale KM, Cortese LM, et al.
22:1489-1493. Managing employee apprehension toward
5. Falck K, Crohn P, Sorsa M, et al. Mutagenicity in handling cytotoxic drugs. Am J Hosp Pharm
urine from nurses handling cytotoxic drugs. 1984;41:2618-2623.
Lancet 1979;1250-1251.
CPE article: Managing cytotoxic products
1. The most common routes of occupational hazard from handling cytotoxic drugs are
A. accidental injection, gastric absorption
B. direct contact, gastric absorption
C. inhalation, direct contact
D. mucosal absorption, inhalation
4. The advantage of having a dedicated area for storage of cytotoxic drugs in pharmacy
departments is to
A. facilitate searching of stock
B. facilitate quick and efficient containment and management of spill
C. provide proper stock management
D. provide better control and monitoring of cytotoxic drugs usage
5. Standard operating procedures for preparation of cytotoxic drugs should include those
below, EXCEPT
A. documentation and record
B. reconstitution procedures
C. maintenance and certification of equipment
D. potential hazard of cytotoxic drugs
6. The following are the variables that can be considered in determining occupational hazards
of cytotoxic drugs to health personnel, EXCEPT
A. chemical properties of the drugs
B. toxic effects of the cytotoxic drugs
C. type of exposure
D. cofactors such as dietary habit