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Medication incompatibility in intravenous lines in a Paediatric Inten-sive

Care Unit (PICU) of Indonesian hospital

Article  in  Critical Care and Shock · August 2018

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Crit Care Shock (2018) 21:114-123

Medication incompatibility in intravenous lines in a Paediatric Inten- sive Care Unit (PICU) of Indonesian hospital Suci Hanifah, Patrick Ball, Ross Kennedy

Abstract Objectives: Currently, little is documented con- cerning the patterns of multiple concurrent med- ication use utilising single intravenous line. The in-line compatibility issues in Paediatric Inten- sive Care Units (PICUs) are not as well docu- mented as in adult patients either. This study closely examined the combination of medications used concurrently in a PICU, recorded how med- ications were used, and then investigated the in- line potential compatibility. Methods: This study was a mixed model designed first to identify retrospectively the patterns of multiple medication use at any single time of ad- ministration (STA). Secondly, a questionnaire was distributed to practitioners to elucidate their perceptions about incompatibility. Results: From a single lumen peripheral line in- vitro simulation, it was observed that three infu- sions typically met in sequential Y-sites and had the potential to interact. The combinations iden- tified were morphine+midazolam, midazo- lam+fentanyl+morphine, morphine+fenta- nyl+dobutamine, morphine+midazolam+keta- .

mine, and midazolam+dobutamine+norepineph- rine. Compatibility data covering simultaneous administration of three-or-more intravenous drugs was not found in 97.5% (n=120) of the cases. Most practitioners (92.9%) recognized in- compatibility. Many (46.4%) said they observed >3-10 in-line incompatibilities in a month. Most nurses (78.5%) reported using the manufacturer as their reference source for compatibility data. Flushing with clear fluid between doses was the most used method to prevent incompatibility (45.5%). Conclusions: It was a common practice to con- currently administer three or more medications: analgesics, sedatives, inotropes, and others, through the same port with major potential for incompatibility issues. Most of the literature is based on two drug comparisons with minimal in- formation on using combinations of three or more. Most practitioners’ understanding of the implications of the terminology of “incompatibil- ity not known or possible” for their patients ap- peared lacking.

Key words: Intravenous, drug utilization, drug incompatibility, critical care, paediatrics.

114 Crit Care Shock 2018 Vol. 21 No. 3

Address for correspondence: Suci Hanifah Jalan Kaliurang Km 14.4 Sleman, Yogyakarta 55582, Indonesia Tel: +6285643958700 Emails: suci.hanifah@gmail.com, suci.hanifah@uii.ac.id

From Pharmacy Department, Faculty of Science, Universitas Islam Indonesia (UII), Yogyakarta, Indonesia (Suci Hanifah), School of Pharmacy, Faculty of Science and Engineering, Wol- verhampton University, England, UK (Patrick Ball), and School of Biomedical Science, Charles Sturt University, New South Wales, Australia (Ross Kennedy).

Introduction In critical care, the majority of medications (>70%) are administered parenterally for faster action or due to patient’s inability to swallow oral medications. It is known that many patients will receive an average of 10 different medications in multiple doses during .

a single admission. (1) In paediatric practice, the re- quirement for multiple parenteral medications with limited venous access and fluid volume restriction frequently leads to concurrent administration of combinations of intravenous (IV) medications through a single line. Based on pharmaceutical for- mulation principles, this has the potential for physi- cal and chemical reactions, which when occurring in-line and directly entering the patient circulation, may lead to morbidity or mortality. (2,3) Anecdotal evidence suggests that insufficient attention is paid to this, which seems to be multifactorial and may include knowledge, time, workforce, and cost con- straints. (4) Literature reports on medication use have concen- trated on a single agent and infusion fluids or per- haps in combination with another, making it diffi- cult to evaluate in the context of multiple medica- tions being added at different access points into a single infusion system. (5,6) Also, laboratory mod- .

Crit Care Shock 2018 Vol. 21 No. 3 115

els where two medications have been mixed to- gether at fixed concentrations in a test tube poorly reflect the way in which medications may also in- teract with residuals of another before or after, the IV fluids, and the infusion system (tubing, connect- ors, etc.), or for various periods of time at variable concentration gradients resulted from flow effects. Also, the role of pharmaceutical excipients in the formulation makes it impossible to extrapolate in- formation from one manufacturer’s formulation to an alternative product from a different manufac- turer. (7) A recent study has suggested that pharma- cists, who are usually consulted when information about incompatibility is not available, need to be aware of medication compatibility issues and that “no data available” should not be interpreted as safe to minimize such errors in their hospitals. (8) This preliminary study was used as the basis for identifying the problem of incompatibility in paedi- atric critical care setting in in-vitro real time simu- lated IV lines by closely observing and recording the practice and gathering information about ward staff experiences and reactions to what has been ob- served by pharmacists as incompatibility. Methods Study approach The setting of this research was the PICU in a teach- ing hospital in Java, Indonesia, which is considered a centre of excellence within the province. It is a leading centre from which other hospitals look for guidance. After a comprehensive review of litera- ture, a retrospective prescription chart review was conducted to establish the most common combina- tions of medications and the problems incurring during their administration. This was followed by a prospective observational study of medication ad- ministration practice and administration of a simple questionnaire on the perceptions of nursing and medical staff in relation to the problem of drug in- compatibility. Ethics approval for this study was obtained from the Charles Sturt University Human Research Ethics Committee (CSU HREC) on 18 September 2013 (2013/173). In addition, approval was also granted by Universitas Gadjah Mada Human Ethics Com- mittee (GMU HEC) on 31 July 2013 (KE/FK/733/EC). Hospital staff participation was voluntarily, and the return of completed question- naire was considered as an implied consent to par- ticipate. Data collection As an initial step, medical records for the period be- tween 1 June 2012 and 30 September 2013 were re- .

viewed to gain an adequate sample of medication usage patterns in the PICU and any recorded issues regarding incompatibility. Then, bedside observa- tions were undertaken for one month to confirm pat- terns of how medications were prescribed, prepared and administered as well as where medications were administered simultaneously. No staff information or identifiers were collected, and only the process sequence was recorded. Thirdly, a questionnaire was administered to nurses and resident doctors in- volved in drug preparation and administration. This was used to understand their perspective on incom- patibilities and to identify whether they perceived them as serious problems. The collected infor- mation was then analysed to establish an under- standing of the level of incompatibility problem and current prevention strategies in the PICU facility. All data collected in this phase was anonymous and no personal identifiers were used. Operational definitions adopted for drug admin- istration “Single time of administration (STA)” refers to the administration of more than one medication at a spe- cific timing, such as 8.00 o’clock in the morning or in the evening. The term “infusion-infusion” refers to the simultaneous administration of two medica- tions by infusion via a two-way connector. At any STA, if an intermittent or single bolus IV medica- tion is injected sequentially through a port into infu- sion tubing, the term “infusion-injection” will be used. Data analysis Data collected from the medical records was tran- scribed into a Microsoft Excel™ spreadsheet. To ensure that there was no missing data, the spread- sheet was crosschecked several times in sequence and randomly. The data regarding medication use and questionnaire responses were qualitatively ana- lysed. Results The retrospective medical record search yielded in- formation on 231 patients. There were 19 patients excluded due to missing measurable data fields in their records, and 212 patient records were consid- ered for further analysis, including the name of the medication, route, dose, administration time, and any reported incompatibility medication-related problems. Profile of multiple intravenous Patients in this PICU were administered an average of 1-6 drugs at one STA, mostly (89%) through a .

116 Crit Care Shock 2018 Vol. 21 No. 3

peripheral venous cannula (PVC). Over one third of the patients (32.5%) received three infused medica- tions concurrently through one line with other med- ications administered by a bolus injection merged into the infusion line at a ‘Y’-site. Therefore, a med- ication group was defined as the combination of medications administered simultaneously through one line (infusion-infusion) or consecutively at one STA through one extension (infusion-injection). From a review of the medical records, it was found that there were more than 100 different groups of infusion-infusion and infusion-injection amongst the 212 sample patients. Figure 1 shows the fre- quency of the top 20 groups of drugs by frequency of occurrence among the study samples. The top 20 medication groups included various an- algesic, sedative, and inotropic drugs. The most fre- quent groups were morphine+midazolam (15.6% frequency), morphine+fentanyl+midazolam (9.4% frequency), and morphine+fentanyl+dobutamine (6.6% frequency). In one STA, infusions met injections (intermittent medications) in the following descending order of frequency: paracetamol, cefotaxime, furosemide, ranitidine, meropenem, ampicillin, phenobarbital, phenytoin, metronidazole, chloramphenicol, acy- clovir, fluconazole, gentamicin, and methylpredni- solone. Potential problem of incompatibility Incompatibility is defined as the potential for a chemical reaction, displacement of particles, precip- itation, jell formation, or other interactions arising from medications coming together in the tubing, such as drug-solution or drug-drug including infu- sion-infusion and infusion-injection or drug-equip- ment. Using recent literature, a two-dimensional compatibility chart could be developed (Figure 2), which shows that 73.6% of medications had their information available on the PICU hospital website database; of these, 57.3% appeared compatible, while 16.2% were incompatible in solution. To identify the compatibility of co-infusions with simultaneous administration in a ‘Y’-site, a chart was developed which more closely resembled the practice. Table 1 was developed to represent a pos- sible compatibility chart (infusion-injection) based on actual experience in practice. Unlike the two-di- mensional chart, using recent literature, many frames were missing (97.5%; n=120) from this chart. Problem of IV drug incompatibility faced by health practitioners During the one-month period of bedside observa- .

tion of practitioners’ practice in administering par- enteral infusion, it was found that practitioners did not appear to pre-consider IV drug compatibility, in- cluding definitions, prior to commencing admin- istration. Some nurses asked for an explanation of what incompatibility is and how it occurs. Other nurses asked how to distinguish incompatibility from thrombophlebitis and the differences between incompatibility and drug interaction. There were also questions about when flushing should be used in relation to medication administration. The questionnaire was administered to nurses (n=22) and resident medical doctors (n=6) who were in charge of the preparation and administration of IV drugs in PICU for more than a month, and all staff (n=28) returned the completed survey. There was no consultation with or input from clinical phar- macists in the ward on the preparation or admin- istration of drugs. The answers from nursing staff and resident medical doctors to the questionnaire are shown in Table 2. All the nurses reported that they had observed drug incompatibilities during their employment at PICU. Only four of the doctors reported observing incom- patibilities. The doctors reported that they had ob- served less than three incompatibilities in the month prior to the survey, whereas about 59% of nurses re- ported observing 3-10 incompatibilities in the same period. In this context, incompatibility refers to a visible colour change in the line or the appearance of a ‘flash’ of powder, as medications come to- gether, but not other possible incompatibility, which does not cause physical characteristic changes. Although the doctors reported observing less than three occlusions in the previous month, about 45.5% of nurses observed 3-10 occlusions and about 54.5% observed more than 10 occlusions. However, all the doctors and nurses had reported that their per- ceived occlusions were not due to drug incompati- bilities. The staff had linked the occlusion to having been caused by a technical problem or blood clot- ting occlusion. With respect to prevention of incompatibility, prac- titioners (78.6%) usually referred to pharmaceutical manufacturers although some (21.4%) reported that they used the “Handbook on Injectable Drugs” (Trissel, 2014) instead; however, on investigation, the book was found to be located in the pharmacy not readily accessible in the ward. Most (45.5%) managed incompatibility by flushing with sodium chloride 0.9%. However, most nurses (68%) and all the medical doctors reported that they considered drug incompatibility issues as beyond their respon- sibilities. A range of drugs was reported to be involved in the .

Crit Care Shock 2018 Vol. 21 No. 3 117

incompatibilities observed (Figure 3). The most frequent medications involved, reported by both doctors and nurses, were phenytoin and phenobar- bital. Interestingly, inotropic drugs were also viewed as problematic by the doctors (66.7%) but less so by the nurses (22.7%). Discussion The likelihood of incompatibility increases with the increasing number of medications at any STA. Re- ducing the number of drugs per STA may be possi- ble by spacing the administration of injections, but this may fit poorly into nursing routines and is com- plicated for slow or continuous concurrent infu- sions. This is more complicated in paediatrics pop- ulation when only a small volume of fluids can be infused and multiple access sites are not possible due to the age of patients. This may increase cost and workload of ward staff and lead to medication errors. (9) When a single lumen PVC is utilized, a rule to use separate lumen for each drug may become impossi- ble. Additionally, in one single PVC, several infu- sions flow in each piece of tubing and meet with the other infusions or injections at a 3-way stopcock or other connector where incompatibility reactions can occur. In contrast, incompatibility seems rarely to be reported when two IV drugs are administered concurrently in critical care. The potential for in- compatibility between consecutive IV injections ap- pears to be avoidable if practitioners are accustomed to flushing with clear fluid before and after medica- tion delivery provided that the solution and volume used have been validated for the system in use; how- ever, in small infants, the volume and electrolyte ad- ministered with the flushes may be significant. Though rare, it may still occur as a fixed route for three common groups: amine/cardioactive drugs, analgesic/sedative, and parenteral nutrition in sepa- rated lumen that cannot be implemented because of the non-availability of multi lumen catheters in this unit. However, the frequency of this occurrence is not known and missing from the chart mimicking practice (Table 1). This study’s finding regarding the increased risk of incompatibility between three or more medications concurs with that of other works being understudied. (7,10) Therefore, the de- velopment of a three-dimensional (or more) chart for each infusion group administered in conjunction with an injection is a benefit to the current body of knowledge in the area of parenteral therapy for pae- diatric patients. Based on the questionnaires, nurses were more likely to encounter and observe drug incompatibili- ties and occlusion of the infusion line than doctors .

as this is an inherent part of their practice responsi- bilities as drug administration specialists. However, most of the nurses felt that, even though they are drug administration specialists, managing compati- bility is beyond their expertise and responsibility. Therefore, the lack of ward pharmacy services in this PICU appears to be an integrated part of the in- compatibility problems. Fahimi (2015) found that drug incompatibility problems are frequent and need to be dealt with as they are one of the leading medication errors. (11) On further investigation, it was found that manufac- turer information sheets were commonly used as a reference by nurses though they actually provided insufficient information on compatibility. This is also in accordance with a previous study which dis- covered that many practitioners lacked awareness of compatibility and how to source trusted information about it. (8) In addition, Kanji (2010) stated that nurses often ran concomitant drugs without suffi- cient understanding of drug compatibility. (12) Another finding was that the PICU practitioners have insufficient training on how to manage incom- patibility issues effectively. This study also identi- fied vast variation in medication groups and admin- istration protocols, which seems to be confusing for nurses, leaving them at the risk of causing admin- istration errors. Camire (2010) found a correlation between a higher level of knowledge and a reduc- tion in errors. (13) Incompatibility is commonly classified by nurses as relating to the medication injected rather than the process. Most injections, such as acyclovir, ampicil- lin, furosemide, phenobarbital, phenytoin and mero- penem, have a basic pH (>7) or high pKa and will theoretically cause precipitation when in low pH so- lutions such as 5% glucose (pH 4-4.5). It is well known that the high pKa of these drugs means that relatively high pH levels are required to sustain drugs in solution and they are very prone to precip- itation during dilution if the pH is allowed to drift too low. (14) Considering this, it is deemed neces- sary to undertake assays of compatibility to fill in the missing frame of the chart (Table 1). Bertsche (2008) found that having a protocol reduced incom- patibility from 5.8% to 2.4%. (8) Thus, the provi- sion of IV compatibility data is a fundamental phar- macy service in critical care. (15) Overall, these present findings have illustrated the recurrent problems of incompatibility and lacked recognition and understanding. The lack of a ward pharmacist in PICU may contribute to the low awareness level. This appears to differ from hospi- tals in some developed countries where pharmacist contribution is considered helpful in two-thirds of .

118 Crit Care Shock 2018 Vol. 21 No. 3

compatibility cases (16) and can reduce errors by 66%. (17) Accordingly, the current study supports the need for clinical pharmacists to be involved in the development of infusion protocols in PICU. The role of pharmacists should be extended to critical care services. (18,19) According to the international guidance on competency from the Society of Criti- cal Care Medicine, the prevention of incompatibil- ity falls within the competency and responsibility of clinical pharmacists. (20) This study has provided preliminary information on the incompatibility problems in PICU and ad- dressed the urgency of incompatibility assays for three and more concurrent medications. The identi- fication of incompatibility must be interpreted with caution as the numbers and percentages do not ex- press the actual frequency of incompatibility in every single case, but they are based on the most frequently listed medications and conditions, which have the potential for incompatibility. This study may be limited to reflect incompatibility problems in Indonesia, which can be different from other countries. Based on the findings, the current study proposes that hospitals should provide staff with education sessions in the area of parenteral drug compatibility to raise the level of awareness regarding this critical issue. Appropriate professional development short courses can also relay information, refresh the knowledge, and increase awareness of practitioners concerning incompatibility. (21)

Conclusions Based on the medical records of 212 paediatric pa- tients, the majority were administered multiple medications using three simultaneous infusions and an injection. The five main drug groups in this PICU were morphine+midazolam, midazolam+fenta- nyl+morphine, morphine+fentanyl+dobutamine, morphine+midazolam+ketamine, and midazo- lam+dobutamine+norepinephrine. Additional med- ications may also be administered as bolus or inter- mittent, including ampicillin, acyclovir, cefotaxime, chloramphenicol, gentamicin, phenytoin, methylprednisolone, metronidazole, meropenem, phenobarbital, phenytoin, and ranitidine. ‘Y’-site incompatibility occurred during the dwell time with other infusions and injections as they were administered with a one-lumen catheter (no separate line). Based on a review of the literature, much in- formation (97.5%, n=120) is missing from the infu- sions-injections compatibility chart with regard to the most frequently administered combinations. The responses from the questionnaires have shown that most practitioners (92.9%) encountered incom- patibility during observation, mainly with pheny- toin, although most did not have sufficient under- standing of incompatibility problems and manage- ment. The 78.5% practitioners used manufacturer information to check the compatibility data. To pre- vent incompatibility, flushing was used by 45.5% nurses, while 39.3% chose to change drugs, and 17.9% reported to the doctors.

Table 1. Compatibility amongst medication groups, infusion with injection Infusion Drug groups

W ith

ou t i

nj ec

tio n

Injection drugs Intermittent

A cy

cl ov

ir

A m

pi ci

lli n

C ef

ot ax

im e

C hl

or am

ph en

ic ol

D ex

am et

ha so

ne

Fu ro

se m

id e

G en

ta m

ic in

M er

op en

em

Ph en

ob ar

bi ta

l

Ph en

yt oi

n

R an

iti di

ne

Pa ra

ce ta

m ol

M et

ro ni

da zo

le

Fl uc

on az

ol e

Midazolam, morphine C ? ? ? ? ? ? ? ? ? ? ? ? ? ? Morphine, midazolam, fentanyl

C ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Morphine, fentanyl, do- butamine

? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Midazolam, morphine, ketamine

C ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Fentanyl, dobutamine, norepinephrine

? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Midazolam, dobuta- mine, norepinephrine

? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Legend: C=compatible; ?=no data available (no recent compatibility study or information in the literature to answer).

Crit Care Shock 2018 Vol. 21 No. 3 119

Table 2. Incompatibility problem according to health practitioners based on questionnaires Questions and choice of answers Responses to questions

Nurses (n=22) Doctors (n=6) Duration of work in PICU - <1 year 0 6 - 1 to <5 years 2 0 - 5 to <10 years 13 0 - ³10 years 7 0 Occurrence of incompatibility - Have you ever observed drug incompabilities at PICU Sardjito? • Yes 22 4 • No 0 2 - How often have you observed drug incompatibilities within the last month? • <3 4 6 • 3-10 13 0 • >10 4 0 • No answer 1 0 - Have you observed an infusion line occlusion? • Yes 22 5 • No 0 1 - How often did you observe an occlusion within last month? • <3 0 6 • 3-10 10 0 • >10 12 0 - Were those occlusions associated with incompatibility? • Yes 0 0 • No 22 6 - What medications have you observed

drug incompatibilities with? Various answers given; see Figure 3

- What incompatibilities have proved hard to manage?

Phenytoin (22) Phenytoin (4) Phenobarbital (20) No answer (2) Diazepam (2)

Prevention of incompatibility - Is there any protocol for preventing in-

compatibility? Yes (10), flushing No (12) Did not know (0)

Yes (0) No (6) Did not know (0)

- What reference do you use to have a look at information regarding incompatibility?

Manufacturers (16) Book* (6)

Manufacturers (6)

- How can you manage the incompatibility or line occlusion?

Spooling or aspira- tion (10)

Spooling or aspira- tion (0)

Changing with the other (8)

Changing with the other (3)

Reporting to senior or doctor (4)

Reporting to senior or doctor (1)

No answer (2) Legend: *=Trissel’s “Handbook on Injectable Drugs”.

120 Crit Care Shock 2018 Vol. 21 No. 3

Figure 1. Top 20 simultaneous infusions in PICU

Crit Care Shock 2018 Vol. 21 No. 3 121

0 5 10 15 20 25 30 35

Morphine+Midazolam Morphine+Fentanyl+Midazolam

Morphine+Fentanyl+Dobutamine Morphine+Midazolam+Ketamine

Midazolam+Dobutamine+Norepinephrine

Fentanyl+Dobutamine+Norepinephrine Morphine+Midazolam+Dopamine

Morphine+Fentanyl Morphine+Dobutamine+Norepinephrine

Midazolam+Dopamine Fentanyl+Midazolam

Fentanyl+Midazolam+Ketamine Morphine+Midazolam+Dobutamine+Epinephrine

Morphine+Dopamine Morphine+Dobutamine+Norepinephrine

Morphine+Fentanyl

Morphine+Midazolam+Dopamine+Norepinephrine Morphine+Midazolam+Ketamine+Epinephrine

Morphine+Ketamine Morphine+Norepinephrine+Ketamine

Number of Patients

Figure 2. Two-dimensional compatibility chart of the 22 top drugs in PICU Legend: C=compatible; I=incompatible; ?=no data available. Figure 3. Frequency of reported drug incompatibility occurrences

122 Crit Care Shock 2018 Vol. 21 No. 3

0,0

20,0

40,0

60,0

80,0

100,0

120,0

Phenyto in

Phenobarb ita

l

Fu rosemide

Ampicil lin

Inotro pic D

rug

Gen tam

yci n

Meropenem /Im

ipen em

Diaz epam

Intra lip

id

Propofol

Insu lin

Calc ium Gluco

nate

Fr eq

ue nc

y of

re po

rt in

g (%

)

Nurses Doctors

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References

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