Download Labelling of injectable medicines administered in anaesthesia

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Labelling of injectable medicines administered in
anaesthesia.
Recommendations of the Spanish Society of Anaesthesiology, Critical
Care and Pain Therapy (SEDAR)1 , the Spanish Safety Reporting
System in Anaesthesiology and Critical Care (SENSAR)2 and the
Institute for Safe Medication Practices (ISMP-España)3 .
JI Gómez-Arnau1,2 , MJ Otero3 , A Bartolomé2 , C Errando1, D Arnal1,2 ,
AM Moreno3, G Puebla1,2, JM Marzal1,2 , JA Santa Úrsula1,2, R
González2 , M Pérez2 , S García del Valle1,2 , A González2 , A
Domínguez-Gil3 .
Correspondence: [email protected]
Conflict of interests
This work has been partially financed by Fondo de Investigaciones Sanitarias (PI 07/0654).
SENSAR has received financing from Ministerio de Sanidad, Política Social e Igualdad, CCAA
de Madrid and Drager Hispania, S.A. None of the authors attached to SENSAR have received
personal financing. ISMP- España has got financing from Ministerio de Sanidad, Política
Social e Igualdad and from CCAA de Castilla y León.
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INTRODUCTION
Errors involving medication represent an important health problem causing relevant welfare
and economic impact
1-3.
Besides, they provoke distrust in the patients and lack of
confidence in the professionals and the sanitary institutions. The development and
introduction of effective practice is being promoted with the aim to reduce drug errors and
to improve safety of the patients.
These recommendations, prepared by Sistema Español de Notificación en Seguridad en
Anestesia y Reanimación (SENSAR) and by Sociedad Española de Anestesiología,
Reanimación y Terapéutica del Dolor (SEDAR) in collaboration with Instituto para el Uso
Seguro de los Medicamentos (ISMP-España) are aimed to prevent medical treatment
mistakes caused by the lack of identification of the preparations and their route of
administration, which could be avoided with the adoption of basic measures. They include
the adoption of a code of standard colors for the labelling of syringes used in anaesthesia
that has been recommended by the European Union and is in use in other countries.
Together with the principal recommendations there are basic indications for the labelling of
other injectable drug preparations administered in this field, and advice for the
differentiation of administration routes at special risk.
SCOPE
1.- The aim of these recommendations is to standardize labelling and facilitate the
identification of syringes and containers (bags, bottles, etc) containing injectable
medicaments to be used during the anaesthetic procedure and to identify the route of
administration, in order to reduce the risk of medication errors.
2. These recommendations are very specific about the size, shape and color of the labels, the
minimum information they should contain and their placement.
3. The application of these recommendations does not preclude the health professional
from verification of the name of the drug, dose and expiration date shown in the labeling of
the original container.
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4. The use of a code of colors (which allows the identification of a medicament within certain
therapeutic group) to label the syringes is an aid to identification of drug groups, but it must
not replace the obligation of reading the label; so, before the drug is to be administered, the
anesthesiologist or the health professional must always verify properly the medicament and
its concentration.
5. These recommendations are applicable in operating rooms, anaesthetic procedures
outside the operating rooms and other places where the anaesthesia and sedation are
provided.
6. These recommendations do not apply to manufactured medicaments.
AIMS
1. To promote the use of safe practice for the identification of the drugs administered
to the patients and their routes of administration.
2. To standardize the labelling of syringes and containers with injectable medicaments
and their routes of administration.
3. To reduce the mistakes in the administration of injectable drugs and to improve
safety of the patients.
BACKGROUND
The preparation and administration of injectable medicaments is a complex process subject
to many possibilities of error. Several studies show high rates of errors related to the
preparation and administration of injectable drugs in different hospital settings (anesthesia,
critical care, emergency department, hospitalization units, etc). It is remarkable that one of
the reasons of these mistakes is the lack of standardization of the procedures 4-7. The reports
about safe practices in drug therapy recommend the adoption of basic measures to improve
the procedures and prevent these mistakes. Such recommendations are applicable to every
medical environment.
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The lack of labeling of injectable medicaments is one of the main causes of mistakes when
injectable drugs are used. Therefore, one of the basic practices should be that all the
containers and devices with medicaments should be labeled with full and legible labels to
identify clearly which medicament contains such device; this label must remain until the
medicament is administered8-12.
Another well know mistake is the wrong route administration. It is very common that a
patient has more than one access for different parenteral routes allowing interconnection;
this can provoke some confusion between the administration routes13-15. To prevent these
mistakes there are certain measures mainly based in using a device with a specific
connection which does not permit the medicament to be administered through the wrong
route (provided it has been commercialized), to verify in that precise moment that the route
is the correct and to identify the different administration routes, especially those of high risk
(epidural, intrathecal, intraarterial)13-15.
During the anaesthetic procedure there is a high possibility of making mistakes in the
administration of medicaments, as several drugs use to be simultaneously administered. It is
known that there is one mistake of every 133 anaesthetic procedures16. The proportion of
mistakes that affect to the patients is great than in other areas and it is due to the
characteristics of the drugs used in this field17. It is estimated that one in 20 mistakes is
serious and one in 250 is mortal18. The most frequent medication errors in anaesthesia
include the confusion of syringes and blisters, mistakes with the administration devices, and
those with the route of administration, especially between the intravenous and epidural
routes18-19. In Spain anaesthesia-related medication errors are a big part of all the mistakes
recorded20.
There are many recommendations to prevent the mistakes of drug administration in
anesthesia. These include the usefulness of reading the labelling of the medicament; to label
the syringes and the bottles containing medicaments with a standard and correct label;
double checking each medicament before its administration; to place suitably the drugs in
the anaesthesia trays or cars; to stock properly the drugs in drawers and cupboards21-24.
Recent recommendations in the USA propose, as well, the standardization of drug
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concentrations, speed of administration, etc; adoption of new technologies for
administration; use of medicaments prepared by pharmacy services and the introduction of
a culture of safety25.
The recent Declaration of Helsinki about safety in anaesthesia recommends, explicitly, that
all medical institutions must develop protocols and provide specific labels for syringes used
during anaesthesia26-26bis. The guidelines of safety and quality in anaesthesia of the European
Union, support that these labels must follow an international code of standard colors27. The
recommendations compiled in this work show the adoption of this code of colours, solutions
for the labelling of other preparations of injectable drugs administered during the
anaesthetic procedures and the routes of administration.
These recommendations could follow beyond the operating room, due to the necessity of
treatment to be continued (i.e. epidural analgesia); so, in a concrete hospital setting it is
important that all health care workers know the recommendations. Considering the possible
turnover of health care professionals and that of patients (inside the hospital), or among
health services and institutions, SENSAR, SEDAR and ISMP-España consider that it is
necessary to establish national standards to normalize the labelling of syringes and
containers with drugs and the administration routes; this would avoid the difference in
procedures between departments, institutions and even regional variations.
Labelling of syringes containing injectable drugs
There are several recommendations for the user-applied labelling of syringes containing the
injectable medicaments used during the anaesthesia. The professional societies of many
countries have adopted the same code of colours to identify the therapeutic groups of those
medicaments usually used in anaesthesia with the aim to have an international standard
system for that purpose28-38. It should be noted that Great Britain and Ireland are using
different codes depending on the hospitals until 2003, when decided to adopt the standard
codes used in USA, Australia and New Zealand in spite of the problems involved35-39-40.
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The list below shows some of the recommendations and international standards for the
labeling of syringes that contain medicaments, according to the current regulations for
anesthesia and critical care:
USA. Published by the American Society of Anesthesiologists in 2004 and reviewed in 200928,
the guidelines are based on standards published by the American Society for Testing and
Materials (ASTM) and the International Organizations for Standardization (ISO) 29-30.
Canada. Has developed the standards of Canadian Standards Association of 1998, reviewed
in 2010 by the Canadian Anaesthesiologist’s Society 31-32.
Australia and New Zealand. Compiled in the Guidelines for the Safe Administration of
Injectable Drugs in Anaesthesia, published by the Australian and New Zealand College of
Anaesthetists, according to the standards AS/NZS 4375 from Joint Technical Committee HT/7
published in 199633-34.
Great Britain and Ireland. The Anaesthetist Association of Great Britain and Ireland (AAGBI)
and the Royal College of Anaesthetist (RCA) published jointly, in 2003 the report Syringe
Labeling in Critical Care Areas, which was reviewed in 200435-36.
France. The Société Française d’Anesthésie et de Réanimation (SFAR) published in 2006
Prévention des erreurs médicamentenses en anesthésie. Recommandations de la SFAR37.
Italy. The Societá Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva (SIAARTI)
published in 2007 Syringe labeling in Anesthesia and Intensive Care38.
The identification of the medicaments used in anaesthesia through a standard code of colors
is a strategy adopted by many of the countries. SENSAR, SEDAR and ISMP-España consider a
good deal to promote the establishment of this safety practice in order to reduce drug errors
in anaesthesia; they also support the adoption of this standard code for the labelling of
syringes.
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It is important to outline that the use of drugs in anaesthesia has its own characteristics
because during an anaesthetic procedure it is usually required only one drug from each
therapeutic group and the anaesthesiologist prescribe, prepare, label and administer the
medication itself they are going to use41. Outside the operating rooms, it is possible to use
several medicaments from the same group, so it is not convenient to label the syringes
following this code of color42-44.
Labelling containers of injectable medicines
There are not specific standards in anaesthesia about labeling of bags, bottles, syringes for
infusion pumps or other containers or devices which contain drugs. Nevertheless, the
characteristics of this labelling must not be different from those used in other fields, except
that the concentration must be clearly write and readable.
SENSAR and SEDAR, in collaboration with ISMP- España want to promote a practice of safety:
to label correctly all the bottles containing injectable medicaments according to the
recommendations of the different institutions
8-12, 45.
Likewise, this standard includes the
minimum information that must appear in the labels for the medicaments used.
The prevention of mistakes due to confusion of the epidural and intrathecal routes is specially
remarkable in the field of anaesthesia and pain therapy. Therefore, our proposal is to use the
yellow color for the labels of containers of medicaments assigned to epidural and intrathecal
routes, according to the recommendations of the National Patient Safety Agency46 which
other countries are already using12.
Each institution must consider the system already established for the labelling of bags, bottles
or other containers with injectable medicaments, which are prepared in different facilities, in
order to have standard criteria for the whole institution. Since the patients can be moved
from the operation room to other wards with drug perfusions and infusion devices, the steps
to be taken must follow a protocol and must reach a consensus with other health
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professionals and units within the institution (nursery, critical care facilities, cardiology,
emergency, hospital pharmacy, etc).
Labelling of administration lines
Several organizations have recommended to put labels to identify the administration lines at
special risk (i.e. epidural, intrathecal, intraarterial) in patients who receive medicaments
through different routes13-15.
There is not a code of colors established worldwide. Exception are the epidural and
intrathecal routes being yellow the color12,46 and the intraarterial route being red the color
chosen 12,47. Even more, some organizations do not support the use of a code of colors (except
again for the epidural and the intrathecal) because its efficacy has not been evaluated in the
prevention of mistakes and there is not a standard approved worldwide13,15.
SENSAR and SEDAR, in collaboration with ISMP-España recommend to label the infusion lines
and the use of the mentioned colors according to the system in Australia and New Zealand 12.
On the other hand, the three organizations support the development and introduction of
specific devices for each route with different systems of connection, as they seem effective
barriers to avoid mistakes. Nowadays there are specific systems for the administration of
medicaments through enteral feeding lines48 and in a short time there will be specific
connection devices for the neuraxial route46.
As in the case of the labeling of bags or bottles containing injectable drugs, it is advisable that
the measures adopted in each institution (while there are not other of widespread use) to
identify the administration routes, have to follow a protocol and reach a consensus with the
rest of health professional and units (nursery, critical care, cardiology, emergency, hospital
pharmacy, etc).
RECOMMENDATIONS
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1. General Recommendations
1.1.
Labelling of syringes, bottles and routes.
1.1.1. The syringes, bottles and bags containing medicaments must have labels clearly
identifying the drug contained. If the content of a syringe, bag, etc is not
correctly labeled, it must never be administered.
1.1.2. The protocols for labelling of syringes and other bottles containing drugs do
not preclude the mandatory identification of the medicament in its original
container; besides, it is essential to read carefully the instructions in order to
make the correct preparation and administration provided by the
manufacturer.
1.1.3. The preparation, labelling and administration of the drug must be carried out, if
possible, by the same person.
1.1.4. Once the syringes and bags are prepared with the medicaments, they must be
immediately labeled. Preparing and labelling a syringe with a drug can not be
started until the previous one is not finished. Do not prepare drugs for several
patients simultaneously.
1.1.5. Time between preparation and administration must be as short as possible.
1.1.6. Once the medicaments are prepared, must be placed in a standard position on
the trays, in the operating rooms or any other places in which the anaesthetic
procedures could be performed, and they must follow a predefined and
standard order all around the institution. Drugs assigned to different
administration routes will be allocated in different places.
1.1.7. One injectable drug should not be used for different patients. The injectable
drug that is not used in that patient, should be thrown away.
1.1.8. The medication administered must be quoted in the anaesthesia record, in the
medication sheet or in any other section of the patient medical record.
1.1.9. It is necessary to label the ends of the tubes or lines used to administer the
medicaments through the epidural, intrathecal and intraarterial routes.
1.1.10. If possible, it is better not to use interchangeable systems of administration or
infusion, with non-matching connections for the different administration
routes.
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1.2. Complementary Recommendations
To label clearly and completely the injectable drugs used in anaesthesia is a good
practice to prevent the mistakes of medication, but it is not the only one existing. The
aim of this report is not to exhaustively report all safety practices. Here, due to their
relevance, we remind some complementary measures.
1.2.1. The stockage of medicaments must be organized and standardized in all the
operating rooms, drawers and cupboards, carts, trays or other devices used to
identify them correctly and to avoid confusion.
1.2.2. There must be a limit for the amount of drugs and its presentations. If possible,
it should be avoided to stock and to use more than one concentration49
especially of drugs at risk, such as morphine, phenylephrine and heparin.
1.2.3. Drugs used for regional anaesthesia procedures as well as the neuromuscular
blocking agents must be stocked in a specific and differentiated area49.The vials
and blisters containing concentrated solutions of potassium chloride should
not be stocked into the operating room.
1.2.4. It is recommended to do a protocol, and to standardize concentration and
dilutions of the high-risk injectable infusion drugs. The concentrations should
be the same that those in the emergency/resuscitation/critical care areas.
1.2.5. If possible, the administration of medicaments will be verified by a second
person who should check both the drug and the concentration. It is advisable
to automatize the procedure through an electronic verification system (i.e. bar
code). The medicaments intended for the epidural or intrathecal routes should
have to be checked by a second person.
2. Labelling of syringes
2.1. Size and characteristics
Each label measures should be 35 to 45mm long and 15 to 25 mm wide. They must stick
properly, with a special adhesive characteristics, to avoid to come off the syringe.
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The paper they are made must allow to write with ballpoint or other pens with
permanent ink.
2.2.
Color
It must be adjusted to the colors showed in Table 1. These colors are those of the
Pantone scale.
Antagonistic drugs will be differentiated with diagonal bars of 1 mm long of the same
color of the agonists. These bars will have a slope of 45º and will alternate with 1 mm
white bars. The name of the medicament is writting in the middle of the label without
any bar around. The color of the text will be black to produce bigger contrast, except for
the adrenaline and succinylcholine, whose names will be written over a black stripe in
the same color that was used for the background.
The text will be written in Arial typography with a minimum size of 10 to facilitate
reading.
2.3.
Information contained in the label
The label will show at least: the generic name of the drug and its concentration
expressed in ml (i.e. 5mg/mL). The concentration must not be expressed as a proportion
(i.e. 1:1000; 1:10.000)12,50, 51..
In the case of drugs with similar names, it is advisable to remark in capital letters the
different letters52-54 (TALLman lettering) in order to reduce the possibility of confusion.
Measurement units accepted worldwide should be used and the use of abbreviations
prone to error should be avoided55. Specially, it is advisable to avoid the use of the Greek
letter mu “µ”,” for “µg”, and it is preferred to use “mcg” or “microgram”. Use "mL"
instead of “cc”.
If there is an automated system with bar code or similar, the label should include such a
code.
2.4.
Label placement
Labels must be stuck horizontal (long axes of the label and syringe aligned) allowing the
reading of the syringe graduation lines.
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Table 1. International color code system for the labeling of syringes containing
medicaments.
Therapeutic Group
Benzodiazepines
Antagonists of
benzodiazepines
Hypnotics
Non depolarising
neuromuscular blocking agents
Antagonists of not depolarising
neuromuscular blocking agents
Depolarising neuromuscular
blocking agents
Examples*
Diazepam, midazolam
Flumazenil
Tiopental, propofol,
ketamine
Vecuronium, rocuronium,
atracurium, cisatracurium
Neostigmine,
sugammadex†
Succinylcholine
Opioids
Opioids antagonists
Morphine, fentanyl
Naloxone
Local anesthetics
Antiemetics‽
Lidocaine, bupivacaine
Droperidol, ondansetron,
dexametasone
Atropine
Haloperidol,
clorpromazine
Ephedrine
Anticholinergic agents
Neuroleptics‽
Vasopressors, except
adrenaline
Adrenaline‡
Hypotensive agents
Adrenaline
PantoneR Colour Ħ
Orange 151
Orange 151 with
diagonal white bars
Yellow
Red 811
Red 811 with diagonal
white bars
Upper part: name in red
811 over black bottom.
Rest: red 811
Blue 297
Blue 297 with diagonal
white bars
Grey 401
Salmon 156
Green 367
Salmon 156
Violet 256
Upper part: name in
violet 256 over black
bottom.
Rest: violet 256
Violet 256 with diagonal
white bars
White
Nitroglycerine, urapidil,
hidrazaline
Miscellaneous
Oxitocine, antibiotics,
heparine
* The examples included are representative of the medicaments of each group; they are not
restrictive.
Ħ Pantone is a registered scale colour (see http://www.pantoneespana.com/pages/pantone/color_xref.aspx)
† The supplier of sugammadex provides labels for its allocation in the anesthetic record and
in the patient treatment sheet.
‽ Neuroleptics are used in the perioperative period as antiemetics. Droperidol has been
included specifically as antiemetic according to the authorized indications. Dexametasone
has been included as antiemetic although it is also used for other purposes.
‡It is advisable to have prefilled syringes.
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3. Labelling of containers of injectable medicines.
All bags, bottles, pump syringes or other containers or devices which contain
medicaments prepared to be administered, must be identified with user-applied labels.
3.1.
Size and Characteristics
The size of the labels should be 70 to 110 mm long and 50 to 70 mm wide for bags and
bottles, and 45 to 65 mm long and 25 to 35 mm wide for pump syringes. They must be
firmly stick to avoid release. The paper of the label must allow to write with a ballpoint
or other pens with permanent ink.
3.2
Color
Labels must be white, except those assigned to medicaments to be administered by the
epidural or intrathecal routes, which should be yellow.
The text must be black, Arial letter typography or similar, minimum size 10 or 12 points.
3.3.
Information contained in the label
The label must offer, at least, the following information:
-
Generic name of the medicament
-
As in 2.4. in the case of similar names, it is advisable to remark in capital letters those
different letters (i.e. DOBUTamine-DOPamine)52-54.
-
Total amount of the added medicament (i.e. 500mg) and total volume of fluid in the
bottle, expressed in mililiter (i.e. 100 mL)
-
Concentration of the medicament expressed in unit/mililiter (i.e. 5 mg/mL).
The concentration must not be expressed as a ratio (i.e. 1:1000; 1:10.000)12, 50, 51
-
Complete name of the patient
-
Number of medical record or date of birth (depending on the second ID used in each
institution)
In addition, if necessary, it is important to write the following information:
-
Administration route. It will be always included in those assigned to medicaments to
be administered through epidural and intratechal routes with a size of letter of, at
least, 12 points, bold typography.
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-
Infusion speed.
-
Infusion time.
-
Date and hour of preparation.
-
Stability or expiring date if it is less than 24 hours.
Measurement units accepted worldwide should be used, and the use of abbreviations prone
to error avoided55. Specially, it is advisable to avoid the use of the Greek letter mu “µ”, for
“µg”, the use of “mcg” or “microgram”should be preferred. Use "mL" instead of “cc”.
The name of the medicament, its amount, the concentration and the patient’s name should
be written in bold, with a size of letter bigger than the rest of the information.
In the case there is an automated system with bar code or similar, the label should include
such a code.
3.4.
Label placement
Label must be placed in such a way that does not interfere the information provided by
the manufacturer in the original container.
4. Labelling of Lines
It is necessary to identify all tubes or equipment lines used to administer medicaments,
monitoring, etc. corresponding to high-risk of administration routes (epidural, intrathecal
and intraarterial).
4.1. Size and Characteristics
Labels must have 2 symmetrical sides of, at least, 40 mm long and 20 mm wide joined by
an isthmus of 20 mm up to 30 mm long and 10 mm wide, so the isthmus can “hug” the
line while the back of the 2 main sides can be joined and remain as a flag. The surface of
both back of labels must stick.
4.2. Color
The background colors to identify each administration route will be the following:
Epidural route
Yellow
Yellow Pantone
Intrathecal route (spinal) Yellow
Yellow Pantone
Intraarterial route
Red 1787 Pantone
Red
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The text must be black, and Arial letter with a size of, at least, 12 points the
typographic characters.
4.3.
Information contained in the label
The label must offer the following text:
Epidural route
EPIDURAL
Intrathecal route (spinal) ESPINAL
Intraarterial route
4.4.
IntraARTERIAL
Label placement
The line must be identified with two labels: one in the proximal (patient) side and the
other in the distal one (container). In the case an infusion pump is used, then it is
convenient to place another label just under or over the infusion device.
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