Cara Menyuntik Obat Propofol

Safe Injection Practices for
Administration of Propofol
CECIL A. KING, MS, RN; MARY OGG, MSN, RN, CNOR
ABSTRACT
Sepsis and postoperative infection can occur as a result of unsafe practices in the
administration of propofol and other injectable medications. Investigations of infec-
tion outbreaks have revealed the causes to be related to bacterial growth in or
contamination of propofol and unsafe medication practices, including reuse of
syringes on multiple patients, use of single-use medication vials for multiple pa-
tients, and failure to practice aseptic technique and adhere to infection control
practices. Surveys conducted by AORN and other researchers have provided addi-
tional information on perioperative practices related to injectable medications. In
2009, the US Food and Drug Administration and the Centers for Disease Control and
Prevention convened a group of clinicians to gain a better understanding of the issues
related to infection outbreaks and injectable medications. The meeting participants
proposed collecting data to persuade clinicians to adopt new practices, developing
guiding principles for propofol use, and describing propofol-specific, site-specific,
and practitioner-specific injection techniques. AORN provides resources to help
perioperative nurses reduce the incidence of postoperative infection related to med-
ication administration. AORN J 95 (March 2012) 365-372. © AORN, Inc, 2012. doi:
10.1016/j.aorn.2011.06.009
Key words: sterile injectable medications, propofol, sepsis, safe injection prac-
tices, safe medication administration.
D
uring the past 10 years, there has been In 1990, one year after propofol was ap-
growing concern regarding postoperative proved for use, the Centers for Disease Control
infections associated with the handling of and Prevention (CDC) investigated four clusters
injectable medications; more specifically, clusters of postsurgical infections and hyperthermic re-
of sepsis and postoperative infections have oc- actions.4 The investigators traced the infections
curred related to the use of propofol.1 Propofol is and reactions to several factors, including ex-
a sterile, IV, lipid-based, emulsive anesthetic trinsic contamination of the agent that resulted
agent. It was approved by the US Food and Drug from lapses in aseptic technique during the han-
Administration (FDA) in 1989 and has been dling of the medication, use of propofol by in-
widely used in the United States since that time.2 fusion pump, and preparation of the infusion
As a lipid-based emulsion, this medication is pump by one anesthesia provider. The same
known to support bacterial growth.3 infusion pump, syringe, and provider were
doi: 10.1016/j.aorn.2011.06.009
© AORN, Inc, 2012 March 2012 Vol 95 No 3 ● AORN Journal 365
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March 2012 Vol 95 No 3 KING—OGG
TABLE 1. Propofol Handling Guidelines1
US Food and Drug Administration

recommendations General product insert guidelines
Vials of propofol and prefilled syringes are intended Strict aseptic technique must always be used when handling
for single (ie, one patient) use. sterile injectable medications.
Begin infusion immediately after drawing up or Propofol should be inspected before use for particulate
opening the vial of medication. matter, discoloration, or evidence of separation of the
Infusion from prefilled syringes or vials must begin emulsion.
within 6 hours of opening/filling the syringe. Do not use if contaminated.
Propofol that is infused directly from a large volume Fill syringes or spike the vial immediately before administration
(eg, 100 mL) vial is to be limited to one patient and to each patient.
must be infused within 12 hours of opening the vial Disinfect the rubber stopper with 70% isopropyl alcohol.
or spiking the stopper. Discard unused portions within 6 hours of filling syringes or 12
hours after spiking a large volume vial for infusion.
1. DIPRIVAN® (propofol) Injectable Emulsion. 451094A/Issued: February 2008. US Food and Drug Administration. http://www.accessdata.fda.gov/
drugsatfda_docs/label/2008/019627s046lbl.pdf. Accessed December 8, 2011.
identified as risk factors in two of the infected During a 10-year period from 1998 to 2008, 35
patients.4 documented outbreaks of hepatitis occurred in
These outbreaks of infection prompted the nonhospital health care facilities (eg, pain clinics,
pharmaceutical company that manufactures propo- endoscopy clinics, hemodialysis centers), which
fol to add language to the product circular stating put more than 60,000 patients at risk for develop-
that “strict aseptic technique must always be ing bloodborne pathogen infections.11 These out-
maintained during handling . . .”5 and preparation breaks were traced to
of propofol for injection. The FDA issued propo-
reuse of syringes on multiple patients,
fol administration guidelines based on recommen-
single-use medication vials used for multiple
dations from the CDC,4 the American Society of
patients,
Anesthesiologists,6 and the Anesthesia Patient
failure to practice aseptic technique, and
Safety Foundation7 that are similar to the
failure to follow fundamentals of infection
manufacturer’s recommendations summarized in
control practices.11
Table 1. All recommendations were based on the
following facts: In 2002, the Oklahoma State Department of
Health investigated an unexplained outbreak of
Propofol is a lipid-based emulsion that sup-
hepatitis C (HCV).12 All the infected patients had
ports bacterial growth.8
been treated for pain at the same outpatient clinic.
Bacterial contamination increases rapidly over
The Oklahoma health department was able to test
time.9
795 (88%) of the patients who had been treated
Disinfection of propofol ampules or vials be-
since the clinic opened and found that 71 patients
fore opening considerably reduces the risk of
had contracted HCV and 31 had contracted hepa-
bacterial contamination of the medication.8
titis B during 2002. Interviews with staff mem-
Disodium edetate, which inhibits bacterial growth, bers regarding injection practices revealed that
was added to propofol in 1996; as a result, the care providers used a single needle and syringe
incidence of propofol injection infections was to administer three different sedation medica-
reduced but not eliminated.10 tions. In addition, these providers used the
366 AORN Journal

SAFE INJECTION PRACTICES www.aornjournal.org
same needle and syringe to administer these has led to outbreaks of serious postoperative
medications to all of the patients treated that health care-associated infections.
day. Results of the investigation suggest that It is essential to use strict aseptic technique
the infections were transmitted from patient to when handling propofol, as mandated by the
patient after a provider used a syringe and nee- manufacturer’s written instructions.
dle on a patient positive for hepatitis and then
used the same syringe and needle to administer MEDICATION PRACTICES SURVEYS
medication to subsequent patients. The outbreak In July 2009, AORN conducted a random elec-
stopped when the practice of reusing syringes tronic survey of 500 of its 40,000 members to
and needles stopped.12 determine their current practice for handling
In 2007, investigation of an outbreak of HCV propofol. A total of 410 members completed the
at an endoscopy center revealed that five of the survey for a response rate of 82%. Seventy-two
six infected patients had undergone procedures on percent of the respondents practiced in a hospital
the same day.13 Direct observation of the center’s setting (ie, academic, community, rural), and 28%
personnel demonstrated that they inappropriately of the respondents practiced in ambulatory sur-
reused syringes and used single-dose medication gery centers or endoscopy units. The highest per-
vials on multiple patients. Clean needles and sy- centage of respondents (ie, 36%) worked in facili-
ringes were used to withdraw medication from a ties with five to 10 ORs (Figure 1), and most
single-use bottle of propofol. The medication was respondents worked in ORs in which an average
injected through the patient’s IV. If more propo- of 51 to 100 surgical procedures were performed
fol was needed, then the same syringe with a per week (25%) (Figure 2). The majority of the
clean needle was used to withdraw more medica- respondents (87%) reported that, in their facilities,
tion. Investigators theorized that backflow from anesthesia providers (eg, physicians, certified RN
the patient’s IV or the needle may have contami- anesthetists) draw up propofol medication prod-
nated the syringe with HCV, thereby contaminat- ucts for administration (Figure 3). When asked
ing the vial. The remaining medication was used how often the vial of propofol was typically ac-
on subsequent patients.13,14 cessed, 50% reported once, whereas 44% reported
The findings of the investigations into these witnessing the same vial being accessed two to
various outbreaks of postoperative infections may three times. Six percent of respondents reported
be summarized into four major points that relate seeing the same vial of propofol being accessed
to safe injection practices. more than four times (Figure 4). When asked if
Propofol is a lipophilic
IV injection that is
known to support AORN Resources
the growth of
AORN guidance statement: safe medication practices in periopera-
microorganisms.
tive settings across the life span. In: Perioperative Standards and
The addition of a preser-
Recommended Practices. Denver, CO: AORN, Inc; 2011:605-611.
vative to propofol only
inhibits microbial growth, Watch for these new and updated AORN resources in spring
it will not prevent it. and summer 2012
There is quantitative evi- Safe Medication Administration Tool Kit
dence that extrinsic mi- AORN Medication Safety video
crobial contamination Periop 101: A Core Curriculum™ Medication and Fluids module
and cross contamination
AORN Journal 367

Figure 1. The number of ORs.
there were multiple accesses to a vial of propofol patient, 62% noted that one to three steps were
for the same patient, 68% answered “yes” and involved in this process (Figure 5). Fifty-eight
32% answered “no.” The majority of respondents percent of respondents reported that their facility
(82%) reported that multiple accesses to the vial had a policy or procedure in place to prevent con-
of propofol for different patients did not occur. tamination of propofol medication products.
Most facilities routinely stock 20 mL (44%) and Pugliese et al15 conducted an online survey of
50 mL (39%) vials of propofol, and the majority multidisciplinary clinicians in 2010 at different
of respondents (70%) reported that different vol- types of health care organizations. A total of
umes of propofol were not being used outside of 8,035 clinicians (eg, nurses, physicians, anes-
the OR. When asked the number of steps in- thesia professionals, dentists, surgical technolo-
volved from initially accessing the propofol gists) responded. The researchers included
container to administering the medication to the 5,446 respondents who administered parental
Figure 2. The average number of cases per week.
368 AORN Journal

Figure 3. Health care professionals who administer propofol.
medications in the final analysis and excluded searchers calculated the practice of reusing a sy-
clinicians who do not prepare or administer pa- ringe but changing the needle for more than one
rental medications. The survey contained ques- patient to be 1% and the practice of reusing the
tions about injection safety, frequency of perform- syringe for additional doses from the same multi-
ing injections, and how the respondents obtained dose vial to be 15%.15
injection safety information.15 In this survey, 30%
of respondents reported accessing a single-dose THE FDA SAFE USE (PROPOFOL) HEALTH
vial more than once, in contrast to the 50% of the PROFESSIONALS MEETING
AORN survey respondents who had witnessed To gain a better understanding of the issues re-
this practice in perioperative settings. The major- lated to the outbreak of infection, the FDA and
ity of respondents (ie, 66%) reported using a the CDC convened a group of clinicians on July
multidose vial for more than one patient. Re- 29, 2009, to assess the problem.16 In attendance
Figure 4. The number of times that the propofol vial is accessed.
AORN Journal 369

Figure 5. The number of steps involved in accessing a vial of propofol.
were FDA and CDC staff members, anesthesiolo- practices guidelines (eg, aseptic technique,
gists, nurse anesthetists, pharmacists, gastroenter- hand hygiene, standard precautions) and
ologists, and perioperative and gastroenterological manufacturer’s instructions for preparation and
nurses. Health care professionals attending the handling of medications.
conference identified and prioritized issues related resolution of confusion surrounding the manu-
to the safe handling of injectable medications that facturer’s written instructions and information
needed to be addressed, including (eg, single access, single use).
a coordinated policy from professional associ-
implementation of universal standards of prac-
ations (eg, the American Association of Nurse
tice as they relate to practice guidelines (eg, Anesthetists, AORN, the American Society of
collection of evidence-based data, develop- Anesthesiologists, the Anesthesia Patient
ment of practice guidelines for all settings, Safety Foundation) regarding practice
description or definition of specific administra- guidelines.
tion techniques). practical applications of the US Pharmacopeia
education across cultures and disciplines as to that address the use of sterile medications re-
what are acceptable and unacceptable medica- lated to anesthesia practice.17
tion administration practices. The meeting participants proposed the next
clearly defined meanings and definitions of steps, which included collecting data to per-
practice terminology related to medication ad- suade clinicians to adopt new practices; devel-
ministration (eg, product labeling, single use, oping guiding principles for propofol use that
single access). would be adaptable to any practice setting; and
site-specific handling management guidelines describing injection techniques that would be
that address the issues of cost, pressure for propofol specific, site specific, and practitioner
efficacy, and quick turnover times in free- specific.
standing ambulatory facilities. As a result of the 2009 meeting, the FDA
direct observations that monitor compliance has taken a broader-based approach to some of
and competency related to following best the issues that were raised. As a regulatory
370 AORN Journal

agency, the FDA is looking at the language that implementing aseptic technique when prepar-
is used on various products to see how well it ing sterile medications and solutions for
communicates to and is understood by the injection.
health care professionals who need to read and Unsafe practices include
use it.18 In addition, the FDA is looking at the
pooling or combining vial contents;
issue of standardization of terms used on manu-
reusing a syringe or needle to withdraw medi-
facturer labels, evaluating which terms are pref-
cation from a multidose vial;
erable and whether standardizing terms would
re-entering a single-use vial, ampule, or
be beneficial. After completing its analyses, the
solution;
FDA may provide guidance to industry and to
reusing a syringe or needle on any patient;
FDA reviewers on additional issues that they
and
should consider when evaluating new medica-
using the same syringe or needles to adminis-
tion applications. For example, the FDA has ter medications to multiple patients.19
been evaluating fill amounts, closures on liquid
In the 2010 survey by Pugliese et al,15 60% of
injectables, and other factors that could contrib-
the respondents selected their professional organi-
ute to the way these products are used.18
zation as their most frequent source of practice
Shortages of propofol that began in November
information. AORN continues to provide educa-
2009 have further complicated the situation. Man-
tional and evidence-based practice resources to
ufacturers have stopped production and recalled
members and the industry related to safe medica-
several lots. The shortage is a result of quality
tion practices related to the handling and adminis-
control issues and decreasing profit margins.19 At tration of medications and solutions.
present, only one manufacturer in the United
States is producing propofol. Future regulatory
initiatives may develop as a consequence of these References
1. Postmarket drug safety information for patients and
issues. providers. Information for healthcare professionals:
propofol (marketed as Diprivan and as generic prod-
ucts). http://www.fda.gov/Drugs/DrugSafety/Postmarket
DrugSafetyInformationforPatientsandProviders/
CONCLUSION ucm125817.htm#.TtUiFvNryTw.email. Accessed No-
There is a growing concern about the risks for vember 29, 2011.
2. Orange Book: approved drug products with therapeutic
transmitting infections during routine health
equivalence evaluations. 2011. US Food and Drug Ad-
care procedures requiring IV medications. Out- ministration. http://www.accessdata.fda.gov/scripts/cder/
breaks of infection have occurred with increas- ob/docs/temptn.cfm. Accessed November 29, 2011.
3. Diprivan® 1% injectable emulsion propofol for IV ad-
ing regularity. The gap between what is recom- ministration [product insert]. Wilmington, DE: Astra
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.com/pi/diprivan.pdf. Accessed October 18, 2011.
regarding safe injection practices must be ad- 4. Centers for Disease Control. Postsurgical infections
dressed. Safe medication practices may be sum- associated with an extrinsically contaminated intrave-
nous anesthetic agent—California, Illinois, Maine, and
marized as Michigan, 1990. MMWR Morb Mortal Wkly Rep. 1990;
39(25):426-427, 433.
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.htm. Accessed May 16, 2011.
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the Practice of Anesthesiology. 3rd ed. Park Ridge, IL:
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7. Berry AJ, ed. Recommendations for Handling Paren- cal Quality. http://www.ipqpubs.com/wp-content/
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Pittsburgh, PA: Anesthesia Patient Safety Foundation; December 8, 2011.
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8. Zacher AN, Zornow MH, Evans G. Drug contamination vised to halt use of propofol from tainted lots. CDC
from opening glass ampules. Anesthesiology. 1991; Health Alert Network. http://emergency.cdc.gov/HAN/
75(5):893-895. han00296.asp. Accessed November 28, 2011.
9. Sosis MD, Braverman B. Growth of Staphylococcus
aureus in four intravenous anesthetics. Anesth Analg. Resources
1993;77(4):766-768. 1 Syringe, 1 Patient, 1 time: Safe Injection Practices. One
10. Jansson JR, Ozaki M, Kimura S, Fukada T. Propofol and Only Campaign. http://www.oneandonlycampaign
EDTA and reduced incidence of infection. Anesthes .org/. Accessed November 28, 2011.
Intensive Care. 2006;34(3):362-368. Injection safety. Centers for Disease Control and Prevention.
11. Thompson ND, Perz JF, Moorman AC, Holmberg SD. http://www.cdc.gov/injectionsafety/. Accessed November
Nonhospital health care-associated hepatitis B & C vi- 28, 2011.
rus transmission: United States, 1998-2008. Ann Intern Safe Injection Global Network. The World Health Organiza-
Med. 2009;150(1):33-39. tion. http://www.who.int/injection_safety/sign/meetings/
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patients receiving pain remediation treatments. Infect The CDC’s role in safe injection practices. Centers for Dis-
Control Hosp Epidemiol. 2004;25(7):576-583. ease Control and Prevention. http://www.cdc.gov/
13. Centers for Disease Control and Prevention. Acute hep- injectionsafety/CDCsRole.html. Accessed November 28,
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MMWR Morb Mortal Wkly Rep. 2008;57(19):513-517. http://www.cdc.gov/hepatitis/. Accessed November 28,
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.org/hepc-investigation/index.php. Accessed November Outer Cape Health Services, Provincetown,
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16. US Food and Drug Administration (FDA) Safe Use
flict of interest in the publication of this article.
(Propofol) Health Professionals Meeting. July 29, 2009. Mary Ogg, MSN, RN, CNOR, is a periopera-
Rockville MD.
17. USP ⬍797⬎ Guidebook to Pharmaceutical Compounding— tive nursing specialist for AORN, Inc, Denver,
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18. US Food and Drug Administration. Questions and an- flict of interest in the publication of this article.
swers on propofol shortage. International Pharmaceuti-
372 AORN Journal


Cara Menyuntik Obat Propofol

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Safe Injection Practices for

TABLE 1. Propofol Handling Guidelines1

US Food and Drug Administration

366 AORN Journal

AORN Journal 367

Figure 1. The number of ORs.

Figure 2. The average number of cases per week.

368 AORN Journal

Figure 3. Health care professionals who administer propofol.

Figure 4. The number of times that the propofol vial is accessed.

AORN Journal 369

Figure 5. The number of steps involved in accessing a vial of propofol.

370 AORN Journal

AORN Journal 371

372 AORN Journal

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