International Journal of Surgery Open 26 (2020) 97e100

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International Journal of Surgery Open

journal homepage: www.elsevier.com/locate/ijso

Research Paper

Drug safety management in the operation room of referral hospital:

cross-sectional study
Misganaw Mengie Workie, Wubie Birlie Chekol*, Demeke Yilkal Fentie, Yosef Belay Bizuneh,
Seid Adem Ahmed
Department of Anesthesia, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia

a r t i c l e i n f o a b s t r a c t

Article history: Background: Medication administration safety should always be at the forefront of anesthesia practices.
Received 11 May 2020 The incorrect preparation, labeling and injection of wrong medications are some of medication errors
Received in revised form occurring in the operation theatres.
3 August 2020
This audit was aimed to determine whether operation room drug safety management in our theatre
Accepted 4 August 2020
meet the audit standards or not.
Available online 18 August 2020
Methods: This audit was conducted from November 20 to 27; 2019. All surgical procedures done in Main
Operation Rooms of Referral Hospital were included.
Keywords:
Drugs safety management
Data were collected by direct observation using standardized checklist prepared from recommendations
Audit of Australian and New Zealand College of Anesthetists (ANZCA) and British Journal of Anesthesia (BJA)
Medication error guidelines. Data were collected prospectively before, during and after operation.
Results: Total of 50 surgical procedures were observed of their drug safety management before, during
and after operation. From those audit standards, only labeling of the injectable drugs was fully practiced.
However, swabbing of vial tops to minimize infection rate, formal organization of drug drawers and drug
administration time recording were not practiced at all.
Conclusions: Level of drug safety management in our operation theatre was unsatisfactory. So, added
vigilance is needed in standards that scored below the average and those audit standards that were not
practiced at all.
© 2020 The Author(s). Published by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction A study done in New Zealand identified an error of 1:133 an-

Potent intravenous drugs are frequently injected in anesthesia
practices. These drugs are often prepared and drawn up in syringes
some time before they are to be used [1]. Medication administra-
tion safety should always be at the forefront of anesthesia practices
[2]. Harmless administration of drugs in anesthesia includes on
time delivery of drugs, prevention of medication delivery errors
and reduction of the possibility to misdirect drug delivery [3].
Medication errors in operation rooms are common and most of
them reasoned as preventable. Researchers reported that similar
medication error and near miss rates as a commonly happened
problems and concern of anesthesia professionals [4].
* Corresponding author.
E-mail addresses: mengiemisganaw@rocketmail.com (M.M. Workie),
birliewubie@gmail.com (W.B. Chekol), dyilkal97@gmail.com (D.Y. Fentie),
yosefbelay90@gmail.com (Y.B. Bizuneh), seidadem34@yahoo.com (S.A. Ahmed).
esthetics; South Africa 1:274 anesthetics; Japan 1:450 anesthetics.
The most frequently occurring errors were absence of syringe or
vial swaps, additional or missed dose administration, mis-
calculations of dose, concentration and infusion rates. Additionally,
case reports identified that the potentially fatal errors including of
improper route of drug administration, pump programming errors,
drug dilution and concentration errors, allergic reaction and not
flushing the intravenous lines after drug deliberation [4e6].
Gargiulo et al. found that in 6.3% of cases in the Operation Room
microorganisms were injected in to patients central venous line
due to non-cleaned injection of drugs through the port [7].
Nanji et al. found that there were a phenomenon of high rates of
medication errors, which were 1 error from 2.2 surgeries [8].
The probability of wrong drug being given were because of
wrong syringe labels as well as the issues of color coding of am-
poules [1].
False labeling and failure of syringe swaps were the commonly
encountered errors; while wrong dose administration was the most

https://doi.org/10.1016/j.ijso.2020.08.002
2405-8572/© 2020 The Author(s). Published by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
98 M.M. Workie et al. / International Journal of Surgery Open 26 (2020) 97e100

common medical error. Distraction, haste, stress and decreased minimize infection rate for each case, formal organization of drug
vigilance will all increases medication errors [9]. drawers and work spaces and recording of every drug adminis-
Supplying of color coded ampoules, checking of all ampoules tration time were not practiced at all (Table 2).
and labeling and drawing up of one drug at a time are some of the
crisis management during anesthesia as part of preventative stra-
4. Discussion
tegies [10].
A study performed in England on checking drug administration
This audit determined whether drug safety management meets
during anesthesia concluded that double checkup through two
standards or not. Medication errors continued as a leading cause of
person and electronic verification could have prevented 58% of the
morbidity and mortality in hospitalized patients. These concerns
medication errors and enhances patient safety. However confir-
are exaggerated during the perioperative period; during regular
mation with second person was not forever practicable since it
use of numerous medications, the rapidity of medication prepara-
depends on the accessibility of second person during medication
tion and administration and the general pace of clinical environ-
administration [11].
ment [13].
Anesthetists are responsible for safe drug administration. In
Anesthetists should be alert for specific challenges of drug
anesthesia practices there have been many drugs accessible for
deliberation during perioperative period and their duty to apply
each anesthetic that might have similar color coding, labeling and
safe exercises. Anesthetists are often the only accountable person
positioning of the medications in the carts. These situations will
for prescription, preparation, administration, documentation and
create the possibility of human errors in both pharmacists and
monitoring of clinical effects of high risk medications. These
anesthesia professionals. Attention should be stressed every day in
medications are mainly administered in a time critical situation in
anesthesia, but a system that allows providers to choose, prepare,
stressful conditions [3].
label and administer medications without secondary verification is
Complete drug safety management is so vital for the quality of
wasteful and prone to mistakes. The incorrect preparation and la-
patient care. There should be 100 compliance's for each item the
beling of medications, injection of wrong medications, non-
audit standard. In this audit there was 100% compliance for labeling
documented deliberation of drugs and improper charging of pa-
during drawn up of drugs.
tients for drugs will result in errors which should be evaluated
On the other hand, standards including avoidance of similar
according to their expected consequences, not their existent out-
drug packaging and presentation, retention of an empty ampoule
comes. If errors are encountered soon after the event, the possible
after each case in an accessible container and drugs drawn up and
consequences can be decreased or even prevented [2].
located in proper receptacle in a formal and orderly fashion were
In current medical practices, Medication errors move to a high
below 50% of the standards. The possible reasons for inadequacy of
cost in both human suffering and extra costs of health cares. In USA,
drug safety management might be due to under qualified protocols
it has been estimated that adverse drug issues cost a single teaching
in the setup.
hospital $5.6 million of which $2.8 million was preventable. As a
Troubles incidental to the administration of medications made
specialty, the preparation and deliberation of medication were core
up of 30%. The commonly problems encountered were over dosage
clinical activities [12].
(20%) and giving the wrong drugs (17%). Outcomes ranged from no
Medication errors were common error done by human which
change (47%) through to death in 15 reports (1.25%). Thus, drug
ranges from 1 in 20 administration events, to 1 in 133 anesthesia
related problems were usual and many had grave consequences
episodes [3,4].
(10).
This audit will provide for anesthetists in all features of safety
Out of 205 claims for medication errors, there were only two
related with use of medications involved in anesthesia, sedation,
cases of neglection, four cases of incorrect route and no cases of
local anesthesia and to guarantee safe handling, documentation,
repetition. There were 50 cases of substitution (24%), 35 cases of
and suitable access to medications used in Anesthesia.
insertion (17%), 64 cases of incorrect dose (31%) and 50 cases of
others (24%). Drug infusions were involved in 30 cases (15%).
2. Methods
However, major cause of drug error is misidentification of drug
ampoules or vials. Confusing, inaccurate or incomplete labels
This clinical audit was conducted from November 20 to 27;
contributed to 21% of the actual or potential drug errors reported
2019. All surgical procedures done in a referral hospital of main
[14].
operation rooms were included.
In our study, swabbing of the vial tops to minimize infection rate
Data were collected through direct observation using a stan-
for each case, formal organization of drug drawers and work spaces
dardized checklist prepared from recommendations of ANZCA and
and recording of every drug administration time were not practiced
BJA guidelines. Descriptive statistics were performed using SPSS
at all.
version 20. The article has been registered with UIN of resear-
An audit on standards for labeling and storage of anesthetic
chregistry5586. The STROCSS Checklist [17]. Data were collected
medications found out that only 15% were compliant with proper
prospectively before; during and after operation with Standardized
drug labeling whereas compliance for the presence of patient
Questionnaire Checklists (Table 1).
identity on narcotic syringes was 24%. There was compliance with
proper labeling in 63% drug preparations whereas, compliance with
3. Results
patient ID stickers was 57% on narcotic syringes [1].
A total of 50 surgical procedures were observed of their drug
safety management before, during and after operation. From those 5. Conclusions and recommendations
audit standards; only labeling of the intravenous drugs was fully
practiced. Factors that achieved below the average standards were The level of drug safety management in our operation theatre
avoidance of similar drug packaging and presentation, retention of was unsatisfactory when compared with the recommendations of
an empty ampoule after each case in an accessible receptacle and the BJA guidelines and ANZCA recommendations. Factors that
drugs drawn up and placed in suitable container in a formal and achieved below 50% of the standards were avoidance of similar
logical manner. On the other hand; swabbing of the vial tops to drug packaging and presentation, retention of an empty ampoule
 M.M. Workie et al. / International Journal of Surgery Open 26 (2020) 97e100 99

Table 1
Standardized questionnaire checklists.

Questionnaire Checklists Target Evidences Data sources

Medications are available immediately in any 100% ANZCA [16] Direct observation
anaesthetising location (epinephrine/adrenaline,
propofol, muscle relaxants and local anaesthetics
Similar packaging and presentation of drugs should be 100% BJA (by R.J. Direct observation
avoided where possible Glavin) [15]
All injectable drugs should be labelled when drawn up 100% ANZCA [16] Direct observation
The label on any drug or ampoule or syringe should be 100% BJA (by R.J. Direct observation
carefully read before a drug is drawn up or injected. Glavin) [15]
Drugs should be drawn up using one syringe and one 100% ANZCA [16] Direct observation
ampoule at one time. The label on the ampoule should be
checked, and matched to that on the syringe.
If there is an interruption to the process of drawing up then 100% ANZCA [16] Direct observation
the syringe contents should be discarded and the process
restarted.
Drugs should be drawn up and labelled by the anaesthetist 100% BJA (by R.J. Direct observation
who will administer them. Glavin) [15]
A complete drug history, including information on allergies 100% ANZCA [16] Direct observation
and other adverse reactions, should be obtained
explicitly from the patient or relative/carer where
relevant, and/or the patient's clinical record prior to the
administration of any drugs.
Formal organization of drug drawers and workspace should 100% BJA (by R.J. Direct observation
be used. Glavin) [15]
It is the responsibility of the anaesthetist to minimize the 100% ANZCA [16] Direct observation
risk of infection by swabbing vial tops
The empty ampoules used for that patient, are retained in 100% ANZCA [16] Direct observation
an accessible receptacle.
Drugs drawn up should be placed in an appropriate 100% ANZCA [16] Direct observation
receptacle in a logical and orderly fashion.
Drugs drawn up for emergency use should be located 100% ANZCA [16] Direct observation
separately in the anesthesia work space.
After drug utilization all partially used syringes containing 100% ANZCA [16] Direct observation
drugs should be discarded.
Sharps, contaminated items and Retained glass ampoules, 100% ANZCA [16] Direct observation
used syringes should be placed in a suitable robust
container.
An accurate record of every drug administration, including 100% ANZCA [16] Direct observation
the drug name written in full, dose of the drug and the
route and time of administration, is essential for safe
management of patients.
An accurate time of administration each drug recorded. 100% ANZCA [16] Direct observation

Table 2
Factors that were Audited Based on Recommendations of BJA Guideline and ANZCA on Drug Safety Management in Comprehensive Specialized Hospital.

Standards Number of patients Number of patients Percentage of

who audited based who meet the audit patients who meet
on standards standards the standards (%)

Are medications available immediately in any anaesthetising location? 50 40 80%

Is similar packaging and presentation of drugs avoided? 50 6 12%
Are all injectable drugs labelled when drawn up? 50 50 100%
Is labelling on any drug or ampoule or syringe carefully read before a drug is 50 45 90%
drawn up or injected?
Is drawn up using one syringe and one ampoule? 50 38 76%
Is syringe contents discarded and restarted if there is interruption? 50 26 52%
Are drugs drawn up and labelled by the anaesthetists who will administer 50 48 96%
them?
Is there a complete drug history? 50 47 94%
Is there any formal organization of drug drawers and workspace? 50 0 0%
Are anaesthetists tried to minimize the risk of infection by swabbing vial tops? 50 0 0%
Do the empty ampoules are retained in an accessible receptacle 50 4 8%
Are drugs drawn up and placed in an appropriate receptacle in a logical and 50 14 28%
orderly fashion?
Are dugs drawn up for emergency use located separately in the anesthesia work 50 49 98%
space to avoid inadvertent administration?
Are all partially used syringes containing drugs safely discarded after 50 32 64%
utilization?
Are there appropriate disposal of sharps and contaminated items placed in a 50 38 76%
suitable robust container?
Are drug administration, including the drug name, dose of the drug and the 50 36 72%
route administration recorded?
Are the drug administration time was recorded? 50 0 0%
100 M.M. Workie et al. / International Journal of Surgery Open 26 (2020) 97e100
after each case in an accessible receptacle and drugs drawn up and
placed in a suitable container in a formal and orderly manner.
On the other hand; swabbing of the vial tops to minimize
infection rate for each case, formal organization of drug drawers
and work spaces and recording of every drug administration time
were not practiced at all.
So, added vigilance is needed in standards that scored below the
average and those audit standards that were not practiced at all. We
recommended to have qualified protocols for drug safety man-
agement for the setup.
Ethical approval
Not required.
Funding
Not required.
Author contribution
This work was carried out in collaboration among all authors. M.
M. Workie; was involved in conception and design of the study,
drafting of the manuscript, data acquisition, revising of the
manuscript critically for important intellectual content and
approval of the version of the manuscript to be published. W. B.
Chekol; acquisition of the data, drafting of the manuscript, analysis
and interpretation of data and approval of the version of the
manuscript to be published. D. Y. Fentie was involved in revising of
the manuscript critically for important intellectual content and
approval of the version of the manuscript to be published. Y. B.
Bizuneh was involved in revising of the manuscript critically for
important intellectual content and approval of the version of the
manuscript to be published. S. A Ahmed was involved in revising of
the manuscript critically for important intellectual content and
approval of the version of the manuscript to be published.
Conflict of interest statement
There is no conflict of interest among the participants of this
article.
Guarantor
Misganaw Mengie Workie (M. M. Workie), Wubie Birlie Chekol
(W.B. Chekol), Demeke Yilkal Fentie (D. Y. Fentie), Yosef Belay
Bizuneh (Y.B. Bizuneh), Seid Adem Ahmed (S.A. Ahmed).
Research registration number
Researchregistry5586.
Appendix A. Supplementary data
Supplementary data to this article can be found online at
https://doi.org/10.1016/j.ijso.2020.08.002.
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