International Journal for Quality in Health Care 2009; Volume 21, Number 1: pp. 44 –50 10.

1093/intqhc/mzn052
Advance Access Publication: 10 December 2008

The application of hazard analysis

and critical control points and risk
management in the preparation
of anti-cancer drugs
BRIGITTE BONAN, NICOLAS MARTELLI, MALIK BERHOUNE, MARIE-LAURE MAESTRONI,
LAURENT HAVARD AND PATRICE PROGNON
Department of Pharmacy, Hopital Européen Georges Pompidou, Paris, France

Abstract

Downloaded from http://intqhc.oxfordjournals.org by on May 18, 2010

Objective. To apply the Hazard Analysis and Critical Control Points method to the preparation of anti-cancer drugs. To
identify critical control points in our cancer chemotherapy process and to propose control measures and corrective actions to
manage these processes.
Setting. The Hazard Analysis and Critical Control Points application began in January 2004 in our centralized chemotherapy
compounding unit. From October 2004 to August 2005, monitoring of the process nonconformities was performed to
assess the method.
Methods. According to the Hazard Analysis and Critical Control Points method, a multidisciplinary team was formed to
describe and assess the cancer chemotherapy process. This team listed all of the critical points and calculated their risk
indexes according to their frequency of occurrence, their severity and their detectability. The team defined monitoring, control
measures and corrective actions for each identified risk. Finally, over a 10-month period, pharmacists reported each non-
conformity of the process in a follow-up document.
Results. Our team described 11 steps in the cancer chemotherapy process. The team identified 39 critical control points,
including 11 of higher importance with a high-risk index. Over 10 months, 16 647 preparations were performed; 1225 non-
conformities were reported during this same period.
Conclusions. The Hazard Analysis and Critical Control Points method is relevant when it is used to target a specific process
such as the preparation of anti-cancer drugs. This method helped us to focus on the production steps, which can have a criti-
cal influence on product quality, and led us to improve our process.
Keywords: Hazard Analysis and Critical Control Points method, anti-cancer drugs, risk management, quality management

Introduction chemotherapy compounding unit is faced with ever-growing

Anti-cancer drugs present toxicity risks for health workers
and patients [1 – 8]. It is recommended to centralize prep-
aration in the pharmacy to limit the occupational exposure of
health workers who come into contact with anti-cancer
drugs [9 – 11]. At the Georges Pompidou European Hospital
(HEGP, AP-HP, Paris), the production of cancer che-
motherapies has been centralized in the pharmacy since
2000. Between 2000 and 2004, this production doubled, and
currently tallies about 20 000 preparations per year. The
preparation of anti-cancer drugs is a complex process,
and many non-conformities can occur. Nevertheless, our
production needs and must guarantee high product quality
according to good practice guidelines [12 – 14]. Hazards
affecting quality can be defined as biological, chemical or
physical or as operations (according to the relevant legis-
lation) that are likely to cause illness or injury to patients or
health workers. Various approaches exist to identify risk
issues and improve the safety of a cancer chemotherapy
process, such as Failure Modes and Effects Analysis, Failure
Modes, Effects and Criticality Analysis, Probabilistic Risk
Assessment, Hazard and Operability studies or Hazard
Analysis and Critical Control Points (HACCP). Among these
approaches, we chose to apply the HACCP method to the

Address reprint requests to: Nicolas Martelli, Department of Pharmacy, Hopital Européen Georges Pompidou, 20 rue
Leblanc, Paris, France. Tel: þ33-156-093-244; Fax: þ33-156-093-247; E-mail: ph.upio@egp.aphp.fr

International Journal for Quality in Health Care vol. 21 no. 1

Published by Oxford University Press 2008 44

preparation of anti-cancer drugs. The HACCP method is a
systematic method for the identification, assessment and
control of safety hazards. Historically, the HACCP program
has been considered as a food safety management system,
but its use has been successfully applied to medical products
[15, 16]. The risk analysis, following the guidelines of the
HACCP method and the monitoring of critical steps during
the process, was applied to the preparation of anti-cancer
drugs [17, 18]. Our analysis led us to establish a preventive
monitoring system based on an effective concept for quality
assurance. The experience of this HACCP application is
described in this study.
Methods
Setting and study period
The study was conducted in the chemotherapy compounding
unit of the pharmacy department at the Georges Pompidou
European Hospital (HEGP, AP-HP, Paris). All medication
orders are entered by a physician, using a computerized pre-
scription system (CHIMIOw Computer Engineering w, Paris,
France, 1996 – 2000). Only physicians, allowed to prescribe
chemotherapies, have access to the prescription system. The
pharmacist checks the validity of the prescription (i.e. pre-
scription date, compliance with the chemotherapy protocol,
calculated dose, blood test results, etc.). Next, a pharmacy
technician prepares the anti-cancer drug in a positive pressure
isolator. An analytical control of the preparation is performed
by a pharmacist prior to dispensing. Finally, preparations are
delivered and dispatched to the different oncology units.
The implementation of the HACCP method began in
January 2004 with the formation of the HACCP team. To
assess the efficiency of the HACCP method, monitoring of
non-conformities was performed from October 2004 to
August 2005.
The HACCP team
A team was formed to define the scope of the HACCP plan.
This team represented all of the relevant disciplines. It was
composed of three pharmacists (head of the chemotherapy
compounding unit, head of the pharmacy quality unit and
head of the pharmacy department, who is also an analytical
control expert), eight pharmacy technicians, three physicians
(from the Hospital Chemotherapy group), a public health
nurse and six experts: a microbiologist, two biomedical
engineering experts, an environmental expert, two technical
experts and an air conditioning expert. The head pharmacist
of the chemotherapy compounding unit who has academic
training (from an Engineering School) in risk management
led the HACCP team.
HACCP analysis
First, the HACCP team drew up a full description of the
product and constructed a flow diagram. It covered all steps
The HACCP method in the preparation of anti-cancer drugs
of the cancer chemotherapy process to which the HACCP
concept was applied. The HACCP team checked and
evaluated the whole process according to seven principles:
(i) analysis and identification of potential risks (hazard analy-
sis); (ii) identification of critical control points; (iii) definition
of limits (target levels and critical limits); (iv) in-process
control (critical control points monitoring); (v) the establish-
ment of corrective measures; (vi) the confirmation system
(HACCP system verification); (v) the documentation system
( procedures and records).
The application of these aspects was partly facilitated by a
computerized program (HACCP Expressw, Version 2000)
developed by Controls, Studies and Formation for Food
Quality Improvementw (CEFAQ w, Barcelonne du Gers,
France, 2000) [19]. This program helped us to summarize
and analyse all the collected data. This work was performed
in compliance with the ISO 9000:2000 standard.
The HACCP team listed all of the critical points that
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could occur at each step of the process. A hazard evaluation
was conducted in which the severity of the potential hazards
and the probability of their occurrence were estimated.
Control measures and monitoring of the critical control
points were defined, if any existed for the considered hazard.
Corrective actions were planned for each critical control
point. Then, the HACCP team established quality documents
( procedures, operating instructions, etc.) and record-keeping
files related to each critical control point.
Critical control points’ risk index
To assess criticality for each control point, a risk index was
developed. The criticality was expressed as a risk index,
which was calculated as the product of the frequency of
occurrence, the severity and the detectability scores (risk
index ¼ occurrence  severity  detectability) [20, 21]. The
scoring system is detailed in Table 1. The HACCP team
reported each score based on published studies and the
experience of experts. The risk index for each critical control
point was used to rank risks by importance. If the risk index
obtained was higher than 50, the critical control point was
strictly monitored. If the risk index fell between 25 and 50,
the critical control point was regularly monitored. If the risk
index was lower than 25, the critical control point was moni-
tored less frequently. Only critical control points with a risk
index higher than 50 are treated in this article.
Table 1 Scoring system for critical control points’ risk index
in the HACCP programme
Score
...........................................................
1 5 10
....................................................................................
Detectability Easy Moderate Impossible
Occurrence Improbable Likely Frequent
Severity Low Moderate High
45
Bonan et al.

Non-conformities monitoring
Each non-conformity was systematically collected during the
production process. This follow-up was used to assess the
HACCP program and to submit specific corrective actions
for each critical control point. At the chemotherapy com-
pounding unit, non-conformities were collected by pharma-
cists and pharmacy technicians and reported in a follow-up
document over 10 months. Each page of this report form
was divided into four parts: the name of the event reporter,
a description of the non-conformity detected, the step of the
process which was concerned and the corrective action
undertaken. To help the reporter, a complete list of possible
events (for each step of the process) was included in the
document. If the event was not mentioned in the list, the
reporter could explain it briefly as a free comment.

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Results
Characterization of the process
According to the recommendations of the HACCP team, the
whole process was characterized by 11 steps: (i) prescription;
(ii) pharmacist validation; (iii) selection; (iv) decontamination;
(v) material preparation; (vi) prescriber dispensing order;
(vii) sterilization process; (viii) preparation; (ix) validation of
the sterilization; (x) physicochemical control; (xi) delivery.
The team checked on-site the relevance of the flow chart
described in Fig. 1.

Description of the product
The HACCP team defined the product as an individual
sterile anti-cancer drug preparation. Moreover, this medical
product can be delivered in a container, syringe or an
infusor. The product is cytotoxic and sterile. Consequently,
precautions are required to protect pharmacy technicians
during the handling and preparation process.
Critical control points analysis and corrective
actions
Among the 11 steps, we identified 11 critical control points
of higher importance (39 overall) with a calculated risk index
above 50. The critical control points and their risk indices
are detailed in Table 2. From October 2004 to August 2005,
16 647 preparations were made up by the chemotherapy
compounding unit for 1335 patients. During the same
period, pharmacists and pharmacy technicians reported 1225
non-conformities in the follow-up document. In the present
study, we described only the non-conformities of the 11 criti-
cal control points of higher importance, which represented
94% (1157 non-conformities) of the total non-conformities
reported. The number of non-conformities for each critical
control point is shown in Table 3.
Prescription errors. Pharmacists validated 8511 prescriptions
over this period. The most frequent error was the choice of a
wrong protocol by the oncologist. The monitoring of this
Figure 1 Flow chart of the anti-cancer drug preparation
process.
critical point consists of checking protocol reference
documents and the patient medical file. The pharmacist calls
the oncologist to modify the prescription as a corrective action.
Computerized prescription system errors. To control this point,
the pharmacist must calculate the dose required on his or
her own and check the prescription’s consistency with the
chemotherapy protocol. If a system error occurred (like a
bug), only the software editor can fix the problem.
Drug storeroom temperature conditions. The temperature of the
drug storeroom was measured daily. During the study period
(226 days), 193 (85%) temperature reports were higher than
the warning level (temperature between 158C and 188C or
228C and 258C) and 33 (25%) reached the action level
(temperature up to 258C or down 158C).
Compounding sheet errors. A wrong batch number (drugs,
containers or infusors) may be reported on the
compounding sheet. This type of error was considered as a
non-conformity and should be closely and systematically
monitored by the pharmacy technician. Among 11 866
compounding sheets considered, there were 693 non-
conformities (5.84%) reported. To reduce these errors, the
use of an intermediate storage system within the
compounding room with a unique batch number for each
product was established.

46
 The HACCP method in the preparation of anti-cancer drugs

............................................................................................................................................................................................................................................
Total
Commercial product defects. Before use, commercial products

50

50
50
50
50

50

50
50
125
100

100
(drugs or containers) were systematically checked. For
example, particles or crystals inside drug solutions (due to
Severity inappropriate storage conditions) can be identified. As a
corrective action, the pharmacy technician must put the
10

10
10

10
10
10
10
10
5
5

5
product in quarantine and inform the physicochemical
control laboratory that a thorough analysis should be
Occurrence

performed.
Microbial contamination. Microbial contamination rates were
evaluated twice a month on both positive pressure isolators
5

1
5

5
1
5
1
1
1
10
10

used. To monitor this critical point, target, warning and

Detectability

action levels were defined by the HACCP team using the

same template as Swanson et al. [22] and Ljungqvist et al.
[23]. During the study period, no microbial contamination
was reported.
1

5
1
1
1

5
5
10

10

Analytical non-conformities. Two methods were used to

The risk index (RI) is the product of the frequency of occurrence (O), the severity (S) and the detectability (D) scores (RI ¼ O  S  D).
qualitatively and quantitatively check anti-cancer drug
Microbial contamination of the positive pressure isolator

Chemical contamination of the positive pressure isolator

products: high performance liquid chromatography and flow

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injection analysis [24]. In our unit, most of the products can
Differences between prescription and preparation

be controlled by these methods (fluorouracil, cisplatin,

oxaliplatin, carboplatin, docetaxel, paclitaxel and cyclopho-
sphamide). A non-conformity was defined as a measured
Computerized prescription system errors
Drug storeroom temperature conditions

concentration outside of the +15% range regarding the con-

Table 2 Risk index of the 11 critical control points of higher importance identified by the HACCP team

sidered dose or a non-recognized spectrum of the controlled

drug. The analytical control of the preparation started in
January 2005. Among 4683 controls performed between
Commercial product defects

Analytical non-conformities

January 2005 and August 2005, 4552 (97.2%) were within

Packaging nonconformities
Compounding sheet errors

the range.
Critical control points

Chemical contamination. No control system has been

Needle-stick injuries
Prescription errors

developed to assess this critical point in the chemotherapy

compounding unit.
Differences between prescription and preparation. Sometimes,
preparations are not in accordance with the initial
prescription. The pharmacy technician who checks the
preparation before delivery can detect various errors such as
the wrong intravenous bag solution or the wrong volume of
the infusor. All failed products are systematically destroyed
No.

1
2
4
16
25
26
28
30
35
36
37

and prepared again.

Packaging non-conformities. This type of non-conformity is
Preparation and validation of the sterilization

also detected by the pharmacy technician who checks the

preparation before delivery. The most frequent abnormality
Prescription and pharmacist validation

was bag leakage. As a corrective action, failed products are

automatically prepared again.

Discussion
Physicochemical control
Material preparation

A risk analysis of the anti-cancer drugs preparation process

has already been conducted using different methods like
Failure Modes and Effects Analysis or Failure Modes,
Effects and Criticality Analysis [21]. To our knowledge, the
Selection

Delivery

present study is the first to apply the HACCP method to a

cancer chemotherapy process.
Step

The importance of process controls has increased.

Controls enhance product quality and traditionally consisted
8 and 9
1 and 2

of post-process product testing. In case of non-conformity,

this type of testing occurs too late and leads to fresh prep-
No.

10
11
3
5

aration of the product. This new preparation delays the

47
Bonan et al.
Table 3 Number of nonconformities detected for the 11 critical control points of higher importance identified by the
HACCP team
No. Step
.............................................................................................................................................................................
1 and 2 Prescription and pharmacist
validation
3 Selection
5 Material Preparation
8 and 9 Preparation and validation
of the sterilization
10 Physicochemical control
11 Delivery
delivery and is a waste of time for health workers (especially
for pharmacy technicians and nurses) and patients. Finally,
destroyed preparations are lost and are economically unac-
ceptable. With the HACCP method, non-conformities are
detected by in-process monitoring and are corrected with
defined actions. This approach has underscored the strong
points and weaknesses of our cancer chemotherapy process.
Many critical control points have been highlighted thanks to
the HACCP team’s efforts. The risk index calculation helped
to identify the most important critical points and to establish
our priorities in terms of risk management.
Nevertheless, the HACCP method did not always provide
solutions to all of the issues raised, and may even hide some
issues. For example, ‘microbial contamination of the com-
pounding room’ did not obtain a high-risk index (.50),
while ‘microbial contamination of the positive pressure isola-
tor’ did. However, the microbial contamination of the com-
pounding room should be taken into account because of its
potential impact on the isolator sterility. This item is a good
indicator of the area’s hygiene quality. It also gives infor-
mation about hand hygiene practices of pharmacy technicians
who carry out manufacturing in the positive pressure isolator.
We can also consider another issue highlighted by the
HACCP, such as the monitoring of the drug storeroom
temperature. This monitoring showed that 85% of tempera-
ture reports were higher than the warning level. The main
explanation is that most of these reports were performed
during the hot season. Moreover, the temperature range
defined for the warning level was inadequate and was recon-
sidered. The high temperature range for the warning level
was modified to 24 – 258C.
Among the 11 critical points of greater importance
described, we did not draw up corrective actions or monitor-
ing for some of them. Chemical contamination hazards
cannot be monitored for the time being in our department.
48
No. Critical control points Number of
non-conformities
detected (n ¼ 1157)
1 Prescription errors 60
2 Computerized prescription system errors 12
4 Drug storeroom temperature conditions 226
16 Compounding sheet errors 693
25 Microbial contamination of the positive pressure 0
isolator
26 Commercial product defects 17
28 Chemical contamination of the positive pressure 0
isolator
30 Needle-stick injuries 2
35 Analytical nonconformities 131
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36 Differences between prescription and preparation 8
37 Packaging nonconformities 8
However, informing pharmacy technicians of the importance
of wearing nitrile gloves at all times inside the compounding
room and of the importance of changing their nitrile gloves
every 30 min should represent an alternative solution to
contain this hazard [25 – 27]. On the other hand, no correc-
tive action appears to be adequate for needle-stick injuries.
The use of needle-free medical devices could be a preventive
action to protect handlers and reduce the risk of exposure to
anti-cancer drugs [28]. Thereafter, this risk could be avoided
definitively. To reduce prescription errors and provide for
better working conditions, we decided to reorganize prescrip-
tion planning in close cooperation with the oncologists [29].
As far as possible, oncologists prescribe cancer chemothera-
pies several days before the patient’s arrival. Depending on
the anti-cancer drug’s stability, we prepared and stored the
preparations until the prescriber dispensing order was
received. These early prescriptions allowed us to regulate the
activity and improve handling conditions. The prescription
validation by the pharmacist also takes place earlier, which
improves the detection of prescription errors. Finally, some
corrective actions defined in our process may not be appli-
cable for use in other hospitals. For example, the intermedi-
ate storage system in the compounding room with a unique
batch number for each product implies a significant daily
production and the systematic control of the products
ordered.
The HACCP is a precise method that highlights issues
and explains a complex process in detail. This method is
helpful for focusing on the production steps, which may
have a critical influence on the quality of the product. With
the HACCP method, we can concentrate our limited
resources on the identified critical points. Finally, the hazard
analysis also provides a revision of the documented data
such as standard operating procedures, production and
check-up protocols.

On the other hand, the HACCP method is extremely
demanding on time and human resources. This point rep-
resents the major limitation of the method. Risk indexes
were obtained based on the experience of HACCP team
members and hindsight of the cancer chemotherapy process.
The criticality of the different points may not be relevant and
can be open to discussion. Scores for the different critical
control points were calculated on the basis of explicit and
objective criteria insofar as possible.
In conclusion, the present study demonstrates the interest
of the application of the HACCP method in the preparation
of anti-cancer drugs. The efficiency of the HACCP method
is relevant when this method is used to target a specific
process. Critical points were identified and led to improve-
ment of our process. Following the implementation of the
corrective actions, a reassessment of our process is planned
in view of the future certification of our unit.
Acknowledgements
The authors would like to thank Frédéric Blondel, Adeline
Cacic, André Chantefort, Corinne Dayot, Didier Delapierre,
Mezian Oufella, Claude Picard, Yannick Ponthou, Alain
Saussereau, Chantal Vaisberg and Vincent Villeneuve for
their involvement on the HACCP team.
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Accepted for publication 30 October 2008
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