Risques liés aux médicaments injectables Risiken von ...files.chuv.ch/internet-docs/pha/enseignement/pha_conf_gsasa2006... · médicaments injectables-Risiken von Parenteralia

Risques liés auxmédicaments injectables

-Risiken von Parenteralia

Valia Humbert-Delaloye

congrès GSASA23-24 novembre 2006

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1650 1750 1850 19501700 1800 1900 2000

steam engines

railway

carphoto

telephone

PVCpiston motor

rubber plane

lyophilisation

fridge

vaccinationantibiotics

scanner, MRI

xenograft

blood circulation

injection on dog

infusions

injectionson humains

Pravaz syringe

hollow needle

Codex : injection solutions

transfusion catheters

polymeric venous

catheters

plastic syringes

Ph.H. V : iniectabilia

Codex : parenteral

route

transfusions prohibited

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intravenous administration

neutral pH � avoid pain

osmotic pressure ≈ plasma � avoid cell lysis

no particles � avoid many effects

� cross protective skin barrier

� direct contact with blood

sterility � avoid infections

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infusion line obturation

phlebitis

pulmonary impairment : mecanical obstruction, thromboembolism, granulomatous pneumonia, ARDS, pulmonary hypertension, death.

renal impairment : interstitial nephritis, granulomatous glomerulonephritis

ophtalmic, cardiac, hepatic, splenic impairment

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rapid action

systemic action

complete absorption

alternative to enteral route

less ADR on gastrointestinal tract

absence of smell or taste problems

numerous risks

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pain at the injection point

necessity of appropriate equipment

necessity of trained nurses

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preparation

administration route

administration rate

incompatibilities

physico-chemical instability

microbiological contamination

extravasation, local reactions, anaphylaxis, clotting, air embolism

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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination

potential preparation errors (14-20 %)dissolution solvent : volume and typedilution solute : volume and typefinal concentration

consequencespainhyper-, hypoosmolarityinstabilityincompatibilities

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causesmental calculationignorance

strategies to reduce the riskinformation : Compendium, databases, labels, order entry systemsuse of standard solutions : tables, labels


! ��

databases

labels

order entry systems

� �! ��

Preparation

Administration route

Administration ratePhysico-chemical instabilityIncompatibilitiesMicrobiological contamination

potential errors in administration routeperipheral instead of central linei.v. instead of sc/im (or opposite)i.t. instead of i.v.i.v. instead of per os

consequencespainthrombophlebitisinjection of particlessystemic action : e.g. ↑ heart rate, ↑ blood pressure, paralysis, …, death

strategies to reduce the riskinformationcentral catheter (dobutamine, amiodarone, …)

more diluted drugsorder entry systemsdifferent syringes (i.v. / per os)specific labelling and packaging of i.t.

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Preparation



causesignoranceconfusionno other route availableimprecise medical order

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Preparation



• route of administration highlighted

• labels on the syringe

• Luer slip syringes for i.t.

• i.t. transport + storage in separate container

• loud reading of drug labels

• vincristine in mini-infusion (extravasation)

• time interval

Fernandez CV et al. J Pediatr Hematol Oncol 1998; 20(6) : 587-590

i.t. administration of vincristine� paralysis, death

� �! ��

PreparationAdministration route

Administration rate

Physico-chemical instabilityIncompatibilitiesMicrobiological contamination

potential errors in administration rate(18-38%)

overinfusion (more frequent)underinfusion

consequencesoverinfusion : hypotension, pain, nausea, vertigo, flushing, volemic overload, asystole, anaphylaxis, deafness, …

underinfusion : too lowconcentrations � inefficiency

� �! ��

PreparationAdministration route

Administration rate

Physico-chemical instabilityIncompatibilitiesMicrobiological contamination

causesmental calculationerroneous pumps useignorance

strategies to reduce the riskinformation : Compendium, databases, labels, order entry systemsuse of standard solutions : tables, labelsuse of intravenous medication safety systemlearning + training


! ��

databases

labels

order entry systems

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PreparationAdministration routeAdministration ratePhysico-chemical instability

IncompatibilitiesMicrobiological contamination

potential incompatibilitiesbetween several drugs given togetherbetween drug and solventbetween drug and container

ü physical incompatibilities- visible (precipitate, color, gas)- prevention : avoid mixtures

adapt concentrations

ü chemical incompatibilities- often invisible (e.g. redox, hydrolysis,…)- hardly preventable

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concentrationpHlightoxygensalting outions : Mg2+, Ca2+, Fe3+

temperaturesolvent systemadsorption, adherencedissolution rate

causes

consequencesphysical : precipitate, inefficiencychemical : product destruction � inefficiency,

toxicity

Ø multiple lumina catheter

$ ��! ��#��



proximale distale

médiane

voie distalevoie médiane

voie proximale

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Ø softwarenot convincing

Vogel et al. Anaesthesist 2003; 52(5) : 409-412

Ø colors (Schaffhausen)promising but limited accuracy

Ø tablesappreciated but

limited accuracy

Ø pharmacistcostly

Ø laboratory teststime problems

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• 34 beds university hospital adult ICU

• patients receiving >1 iv drug in the same line

• compatibilities between pairs of frequent drugs :

observation after 0, 15, 30, 60 min, 2, 4, 24 hwhite and black background

4 tests :1 : 1 mix1 : 4 mix4 : 1 mix1 : 1 no mix

• visual tests

• published data

CHUV(4242 pairs)

0.9 %

0.2 %

0.8 %

5.8 %

20.7 %

24.3 %

47.3 %

litt

incompatible (higher concentration)

incompatible (same or lower concentration)

controversial informations

no information

uninterpretable data

compatible (lower concentration)

compatible (same or higher concentration)

CHU Nancy (242 pairs)

litt

5.0 %

2.0 %

70.0 %

-

23.0 %

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0.7 %

0.7 %

0.02 %

0.02 %

17.2 %

20.3 %

61.1 %

labo

potential instabilitieswrong solvent / solutelimited products shelf life

causesignorancetoo long conservation

strategies to reduce the riskinformation : Compendium, databases, labelslight protection (Adalat�, Nimotop�, …)

��'��! ��#��

PreparationAdministration routeAdministration rate

Physico-chemical instability


consequencesinefficiencytoxicity

! ��%�"�& �$ ��



7121 observed preparations : - 2733 bags- 4388 syringes

no date : 17.5 %

invisible date : 22.8 %

respected validity : 57.0 %

unrespected validity : 2.7 %(insulin, furosemid, norepinephrin, …)

unknown validity : 40.3 %

� systematic labelling� frequent check

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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilities

Microbiological contamination

potential contaminationscontaminated infusionscontaminated lines

causesnumerous manipulationsmultiple-dose vialstoo long conservationsensitive products (dextrose, propofol)multiple lines, high number of luminacentral venous lines

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PreparationAdministration routeAdministration ratePhysico-chemical instabilityIncompatibilities


consequences :bloodstream infections (3-5% in ICU)

1 infection=$ 6000 - $ 400001 infection=prolonged length of stay(1 week)

strategies to reduce the risklimited conservation : 24 h drugs, 72 h lineslimited manipulationsscrupulous hand washingsingle-dose vialsdecontamination of rubber stoppersterile syringe + needle for each sampling

) ��! ��

LabellingCalculationStabilityAdministration routeIncompatibilities


contaminated iv line :coagulase-negative staphylococci, S. aureus

contaminated infusions :Gram neg bacilli, water organisms : Klebsiella, Enterobacter, Serratia, Pseudomonas

contaminated blood + lipid emulsions :Staphylococci

contaminated TPN :Candida, Enterobacter, Gram neg aerobic bacilli

Cunha B.A. Crit Care Clin 1998; 14 : 339-346

others (case reports) :HCV, P. falciparum

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intrinsic contamination :- during manufacturing- rare, widely spread- eg. 378 cases of Enterobacter in 25 hospitals,

13.4 % mortality rate

Muder R.R. Infect Control Hosp Epidemiol 2001; 22(3) : 134-5

extrinsic contamination : - break in aseptic technique- hard to recognize, isolate cases- fever, hypotension

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no conservativelipidic emulsion : bacterial + yeast growth� in vitro studies : contamination

in vivo : limited contamination (nonaseptic technique)

• fever, infections, sepsisK. pneumoniae, Moraxella osloensis, C. albicans, E. cloacae, S. marcescens, S. aureus, HCV, E. Coli, P. aeruginosa, S. epidermidis

� no need of laminar air flow

but � immediate use� single-use material� 8 h conservation

� 1 vial/person� desinfection� hand washing

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many advantages

injectable drugs :

several and various risks, from preparation to administration

� information

� focus on « at risk » situations

� initial learning + training(good handling technique)

http://www.chuv.ch/pha/pha_home/pha_enseignement/pha_ens_seminaires.htm

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Risques liés aux médicaments injectables Risiken von ...files.chuv.ch/internet-docs/pha/enseignement/pha_conf_gsasa2006... · médicaments injectables-Risiken von Parenteralia