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Preventing medication related harm in surgical patients

Boeker, E.B.

Publication date2015Document VersionFinal published version

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Citation for published version (APA):Boeker, E. B. (2015). Preventing medication related harm in surgical patients.

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PART IIDevelopment and evaluation of medication safety interventions

M.A. Ramrattan

E.B. Boeker

K. Ram

D.M.T. Burgers

M. de Boer

P.F.M. Kuks

L. Lie-A-Huen

W.M.C. Mulder

M.A. Boermeester

International Journal of Clinical Pharmacy, 2014

CHAPTER 4Evidence based development of bedside clinical drug rules

for surgical patients

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Chapter 4

ABSTRACT

Background

Surgical adverse events constitute a considerable problem. More than half of in-hospital adverse events

are related to a surgical procedure. Medication related events are frequent and partly preventable. Due to

the complexity and multidisciplinary nature of the surgical process, patients are at risk for drug related

problems. Consistent drug management throughout the process is needed. The aim of this study was

to develop an evidence - based bedside tool for drug management decisions during the pre- and post-

operative phase of the surgical pathway.

Methods

Tool development study performed in an academic medical centre in the Netherlands involving an ex-

pert panel consisting of a surgeon, a clinical pharmacist and a pharmacologist, all experienced in quality

improvement. Relevant medication related problems and critical pharmacotherapeutic decision steps

in the surgical process were identified and prioritised by a team of experts. The final selection compri-

sed undesirable effects or unintended outcomes related to surgery (e.g. pain, infection) and comorbidity

related hazards (e.g. diabetes, cardiovascular diseases). To guide patient management, a list of bedside

surgical drug rules was developed using international evidence-based guidelines.

Results

55 bedside drug rules on 6 drug categories, specifically important for surgical practice, were developed:

pain, respiration, infection, diabetes, cardiovascular diseases and anticoagulation.

A total of 29 evidence - based guidelines were used to develop the Bedside Surgical Drug Rules tool.

This tool consist of practical tables covering management regarding 1) the most commonly used drug

categories during surgery, 2) comorbidities that require dosing adjustments and, 3) contra-indicated

drugs in the perioperative period.

Conclusions

An evidence-based approach provides a practical basis for the development of a bedside tool to alert

and assist the care providers in their drug management decisions along the surgical pathway.

77

Development of clinical drug rules

4

INTRODUCTION

In-hospital preventable adverse events are an important worldwide health care issue. One of the major

causes of in-hospital adverse events is the use of medication.1 Medication related events are widely

known as adverse drug events (ADEs).2 Especially surgical patients are at risk to experience an ADE.

First, more than half of all in-hospital adverse eventsare operation- or drug related.3 Second, surgical

patients frequently use drugs that are related to ADEs. 4,5 For example, the larger part of these patients

receive anaesthetics and analgesics during the surgical intervention and antibiotics and anticoagu-

lants during the post-operative period. Third, surgical patients are subjected to medication changes due

to the surgical intervention, due to the presence of comorbidities, and/or due to the multiple in-

hospital transfers during the surgical pathway. 6 During these multiple handovers between care-

providers, important information is often not transmitted, this can lead to patient harm.7,8

Studies on the nature of surgical ADEs (i.e. drug categories, patient populations) and potential risk

factors are scarce. A recentobservational cohort study in a surgical population showed an incidence

of 27.5 ADEs and 4.2 preventable ADEs per 100 admissions (15.4%). A quarter of these preventable

ADEs were severe or life threatening and mainly related to anticoagulant therapy.9 Moreover, surgical

patients older than 65 years, with a cardiovascular comorbidity or undergoing vascular surgery, have a

twofold risk for experiencing a preventable ADE.9 Also, inappropriate cessation of chronic drug the-

rapy can lead to an adverse outcome. For instance, withdrawing chronic cardiovascular drug therapy

for more than 1 day during a surgical admission causes a cardiac complication in 14%of the patients.10

Furthermore, specific attention should be paid to critical surgical process steps. It has been shown both

in claims review studies and in observational studies that the majority (53-70%) of surgical errors (in-

cluding drug related errors) occur in the pre-and postoperative stages in the surgical pathway rather

than the operating room.11-13 In addition, many adverse events orginate in the postoperative phase.14

Due to the complexity and multidisciplinary nature of the surgical process, a system approach for

preventing medication related problems seems an appropriate method.15 From this point of view the

practical bedside drug rules tool has been developed, focusing on the pre- and postoperative period of

the surgical patient on the surgical ward.

The aim of this study was to develop abedside tool for drug management decisions during the pre- and

postoperative period ofthe surgical pathway,based on evidence-based guidelines.

METHODS

Setting

This tool was developed in the Academic Medical Centre (AMC) in Amsterdam between January

2012 and September 2012.The aim was to develop a tool consisting of a set of evidenced-based bed-

side surgical drug rules to alert physicians on frequently occurring, severe ADEs during the surgical

pathway. In each rule pre- and postoperative actions were described. These actionsconsisted of drug

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Chapter 4

adjustments, additional laboratory or clinical monitoring or advice to check with other medical

specialities. From an educational point of view the potential harm was depicted for each rule as well.

In this way, the physician will be alerted on the relevance of his actions regarding medication ma-

nagement by using the bedside surgical drug rules.

Definitions

An adverse event is usually defined as an unintended consequence of the medical and surgical care

the patient received, not part of the natural progression of the disease or intrinsic risk of the operation

itself.16,17 The definitions for ‘ADE’ and ‘Harm’ used in this study were adapted from the Glossary of

Terms Related to Patient and Medication Safety by Expert Group On Safe Medication Practices.18

Adverse Drug Event (ADE):any injury occurring during the patient’s drug therapy and resulting either

from appropriate care, or from unsuitable or suboptimal care. ADEs include non-preventable Adverse

Drug Reactions (ADRs) during normal use of medication, and any harm secondary to a medication

error (preventable ADEs). Harm: temporary or permanent impairment of the physical, emotional, or

psychological function or structure of the body and/or pain resulting there from requiring interven-

tion. In this study also abnormal laboratory values will be counted as harm.

Development of the bedside surgical drug rules

This tool was constructed in six steps, as depicted in Figure 4.1. To make this bedside surgical drug

rules tool eligible for surgical patients, an expert team was used for thedevelopment, selection and

formulation ofeach evidence-based surgical drug rule. For each of these phases a consensus meeting

between the members of the expert team took place. The expert team consisted of consultant sur-

geons with extensive knowledge in surgery related patient safety issues, clinical pharmacologists, cli-

nical pharmacists and professionals experienced with quality improvement. Because of the mixture in

professional background within the expert panel the final set of rules has a practice-based approach.

This expert team was involved in all six steps taking the following criteria into account: each rule should

address:

a) a frequently occurring drug related problem in hospitalized surgical patients or

b) a potential ADE that can be influenced by direct intervention by the caregiver or

c) drug related harm that occurs sporadically, but with severe consequences.

Figure 4.1 The sequential steps, from adverse (drug) events to develop the bedside clinical drug rules for surgical

patients

Severe adverse events in surgery

Step 1

Adverse drug events

Drug and comorbidity categories

Potential drug related hazards

Evidence based guidelines

Bedside clinical drug rules

Step 2 Step 3 Step 4 Step 5 Step 6

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4

Step 1: Assessment

The initial assessment of the list of frequently encountered adverse events during the surgical process

(Figure 4.1) was performed by screening the different adverse event categories of the Dutch National

Surgical Adverse Event Registration System (LHCR).15

Step 2: Determination

Secondly, those adverse events that could be associated with medication (ADEs) were determined.

This step consisted of a selection of those surgical adverse events that could be caused by or associated

with adverse drug events.

Step 3: Identification

Thirdly, drug categories frequently involved in ADEs were identified. The included drug categories

could either involve hazards related to surgery, comorbidity or comorbidity related drugs. The drug

categories were categorized in accordance with the WHO Anatomical Therapeutic Chemical (ATC)

Classification System.

Step 4: Categorization

Based on these drug categories, potential drug hazards that could occur during the surgical pathway

were formulated.

Step 5: Literature search on evidence based guidelines

A literature search was performed on the medical database Pubmed, Cochrane, National Guideline

Clearinghouse (NGC) and NHS Evidence - National Library of Guidelines.

A combined search term using the different keywords (Mesh-terms and free-text) to retrieve articles

was used on the selected drug hazards , comorbidities and drugs as defined in table 1, added to these

terms were (separated by ‘OR’):

1. Terms to retrieve articles related to surgery: ‘surgery’, ‘operation’, ‘preoperative’,‘postoperative’,‘perioperative’.

2. Terms to retrieve articles on medication: ‘drug’, ‘drugs’,‘medication’,’pharmacology’,‘pharmacological’ ‘pharmaceutical’.

3. Terms to retrieve articles with the best evidence:‘guideline’, ‘pathway’,’protocol’. Limits were English, Dutch and Publication date from 2006.

Step 6: Selection of Bedside Surgical Drug rules

Based on the retrieved guidelines, the surgical drug rules for each problem group were defined. This

selected set of rules form a practical tool of common drugs in the surgical pathway and the pre- and

postoperative actions needed. These actions consist of drug adjustments, additional laboratory, and/

or clinical monitoring or advice to consult other specialities.

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RESULTS

Coherently with steps 1 to step 3 we identified surgical adverse events that were associated with an

adverse drug event. The backbone of the bedside drug rules was formed by initial assessment of the

list of frequently encountered adverse events which can occur during the surgical process (Figure

4.1, step 1). Examples were: extensive intra-operative or postoperative bleedings, postoperative pul-

monary embolism or surgical site infections. The next step (step 2) consisted of a selection of those

surgical adverse events that can be caused by or associated with adverse drug events. For this purpose

the expert panel was consulted.Subsequently, the expert panel determined which drugs can be invol-

ved in these events, and therefore should be identified as a potential hazard in the peri-operative period.

We formulated four types of drug related hazards that could occur in each category:

(a) the type of surgery, taking in consideration that the regular way of administration of drugs, for

example orally, was temporarily not available. (b) drugs prescribed for a comorbidity could negatively

affect the hemodynamic circumstances during surgery (e.g., coumarines in patient with high risk for

trombo-embolism and abdominal surgery). (c) the surgical intervention could affect the pharma-

codynamic and pharmacokinetic circumstances of the drug (e.g., digoxin intoxication due to fluid and

electrolyte imbalance). (d )necessary dose adjustments of drugs used during surgery because of renal

and/or liverimpairment. An overview of these drug related hazards due to surgery, comorbidity or

comorbidity related drugs is stated in table 1.Six categories were identified: pain, respiratory, infec-

tion, diabetes, cardiovascular, and anticoagulant management (table 4.1).

A literature search was performed by two authors (MR, EB) on the medical database Pubmed,

Cochrane, National Guideline Clearinghouse (NGC) en NHS Evidence - National Library of Guide-

lines from 2006 to 2012. The search for evidence-based guidelines, step 5, yielded a total of 29 relevant

guidelines, of which 2 guidelines were relevant for multiple categories. Divided by each category:

Pain management: five relevant guidelines.19-23 Respiratory management: three relevant guidelines.24-26

Infection management: eight relevant guidelines.27-34 Diabetes management: three relevant guidelines.35-37

Cardiovascular management: six relevant guidelines.33,38-42 Anticoagulant management, six relevant

guidelines.41,43-47

Eventually, 55 bedside surgical drug rules were defined and categorized in the six categories. In this

way the tables of the bedside surgical drug rules tool were created (Appendix 4.I: Table 4.I-VI). Each

rule consisted of patient/disease factors, preoperative actions, postoperative actions and potential

harm of the related ADE.The drug rules cover the most commonly used drug groups or comorbidity

issues during the surgical pathway. The potential harm, that can occur when the proposed action is not

performed, was listed in the drug rule tables.

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4

Table 4.1 | Categories of drug related problems and the potential hazards

Problem Related drugs Patient comorbidity Hazard type encountered

Surgery related

Pain management Opioids

Anti-inflammatory drugs

Pregnancy

Liver function disorder

Renal function disorder

B,D

D

D

Respiratory

management

Corticosteroids COPD *

smoking habit

B

B

Infection

management

Antibiotics Liver function disorder


Diabetes

Endocarditis risk

D

D

B

B

Comorbidity related

Diabetes

management

Sulphonylurea

Biguanides

Insulin

Renal function disorder C

Cardiovascular

management

Digitalis glycosides

Beta-blocking agents

Lipid modifying agents

Statines

Calcium channel blocking

agents

Diabetes A,B

Anticoagulant

management

Vitamin K antagonists

Antithrombotic agents

Platelet aggregation

inhibitors

Heparin

Deep venous thrombosis

Atrial fibrillation

Liver function disorder


Valvular disease

A,B

Hazard types: A)normal administration route not available, B) comorbidity related drug negative effect on surgery,

C) surgery affects pharmaco-kinetic an dynamic circumstance of the drug, D) dose adjustment needed

DISCUSSION

In this study, we constructed evidenced-based bedside surgical drug rules to alert physicians on fre-

quently occurring, severe ADEs during the surgical pathway. For each drug category pre- and

postoperative actions are described. These actions consist of drug adjustments, additional labora-

tory or clinical monitoring or advice to check with other medical specialities. From an educational

point of view the potential harm is depicted as well. In this way, the physician is alerted on the rele-

vance of his actions regarding medication management. Despite the worldwide attention for adverse

events in health care, it seems to be an on-going challenge to develop a tool which prevents ADEs. Be-

cause of the diversity of drugs, the variety of drug-related problems in the health care process ADEs

are not easily recognized, prevented or even detected.

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Chapter 4

During the last decade, many different intervention methods or tools to prevent drug-related events

have been proposed. These interventions include technology based interventions such as compute-

rized physician order entry systems and bar code technology as well as team based interventions, such

as completing the multidisciplinary team with internal medicine physicians, clinical pharmacologists

or clinical pharmacists.48,49 These interventions contribute to a reduction of ADEs to some extent,

however, most of these interventions are costly, time consuming or place the physician (in training) in

a dependent and passive role with respect to recognition of medication safety issues. Moreover, many

interventions cannot be provided continuously (24 hours a day). No studies were found in the litera-

ture on the development of any tool for medicine management in surgery.

In contrast to medical patients, surgical patients are physically transferred from the admission ward

to various locations such as holding area (prep ward) before surgery, operating room, recovery room

or ICU, and back to a hospital ward. Each location has different caregivers as well as medication de-

cisions for various reasons related to a surgical intervention.3 The present tool focused on the main

drug related hazards (low-hanging fruit) in a systematic, categorized way, in parallel with the surgical

pathway. The drug groups and drug related hazards that were addressed in this study, comply with

the findings of large studies on the nature of adverse drug events; analgesics, antibiotics and anti-

coagulants were most frequently accountable for medication related events.50-52

It should not be underestimated that medication related errors also occur in the theatre. In this

study, however, the focus is the peri-operative (before and after surgery) period of the surgical process

on the ward. Logistically this process is separated with respect to location and medical responsibility

from the process in the operating theatre. Therefore, the bedside clinical drug rules for surgical

patients focus on increased awareness on the ward before and after surgery to reduce drug related

problems. Peri-operative drug-related problems can occur due to withdrawal of therapeutic effect or

even a rebound syndrome from discontinuation of chronic drug therapy, unmasking or worsening

disease symptoms. This is a potentially important, but less recognized, problem in the postopera-

tive period. These effects occur at a time of considerable surgical and metabolic stresses, including

other coincidental postoperative complications. The management of this aspect of surgical care ap-

pears relatively haphazard as several studies have confirmed that peri-operative drug interruption

is commonly unintentional.53,54 Patients taking cardiovascular medicines are at particular risk. A

prospective study reports that of 216 patients in the UK undergoing surgery over one-quarter of

cardiovascular patients do not receive their prescribed medication preoperatively and over 60% does

not receive their medication on the day of surgery.54

Epidemiologic studies of surgical adverse events in surgical populations describe surgery-related

events such as bleedings related to surgery, and wound infections being most common as well as

a variety of postoperative complications such as pulmonary complications, gastrointestinal compli-

cations, cardiac arrhythmias, and fluid and electrolyte disturbances.55-57 We assume that, by optimizing

drug management through implementation of the bedside surgical drug rules, often harm can be

prevented or reduced.

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For a few specific drug related items it is clear that one may directly prevent adverse events. For

example, checking for timely cessation of anticoagulant agents may directly prevent peri-operative

bleeding. However, superimposed on other imperfections or near misses within the surgical pathway,

it is difficult to distinguish a clear one-on-one relation between an adverse drug events and a surgical

adverse event. Nevertheless, experience from the SURPASS study showed that focus and increasing

awareness on critical items within the surgical pathway is associated with reductions in complications

and mortality in patients undergoing surgery.7 The bedside surgical drug rules tool may also create

an opportunity to merge with a surgical checklist such as SURPASS.7 In a digital version of this sur-

gical checklist, connecting certain checklist items to related drug rules may create an underlying manual.

A limitation of our methodology might be that we chose to focus on drug rules that can be applied

to surgical procedures in general. The most common comorbidities and medication used in surgical

patients are discussed here. Prevention of ADEs in specific patient populations with rare comorbidities,

medication use or specific fields of surgery were not selected for this study. However, these patient

groups might benefit even more from tailored drug rules.

In order to take hold of these drug related hazards during the surgical process, different methods

of interventions such as computerized physician order entry systems and clinical decision support

systems and ward based pharmacy have been suggested.48,49 Though, these interventions contribute

to reduction of ADEs to some extent, widespread implementation is hampered by high costs and the

time consuming character.

CONCLUSIONS

Patient safety has been a top priority for more than a decade, and there is an urgent need for solutions.

In this study, we constructed bedside surgical drug rules, based on evidence-based guidelines to alert

physicians on frequently occurring, severe ADEs during the surgical pathway. For each drug category

pre- and postoperative actions are described as well as the potential harm inflicted when the advised

actions are not taken. In this way, the physician is alerted on the relevance of his actions regarding

medication management. The use of the bedside surgical drug rules in daily practice is likely to lead to

increased awareness on medication safety issues by physicians. These rules focus on issues with proven

hazard for adverse drug events, however, its positive effect on the prevention of these hazardous

events needs to be evaluated in future studies. The bedside surgical drug rules may offer an easy to

use and inexpensive intervention to improve medication safety in daily practice.

The final publication is available at Springer via http://dx.doi.org/[ 10.1007/s11096-014-9941-x]

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Vascular Surgery, Fleisher LA, Beckman JA,

Brown KA, Calkins H, Chaikof EL, Fleischmann

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88

Chapter 4

APPENDIX 4.I-VI

Table 4.I Pain management

PAIN MANAGEMENT

Patient/ disease

features Preoperative actions Postoperative actions Potential harm

Drugs

Opioids

Respiratory

comorbidity

Check respiratory status Check level of alertness,

careful titration of the dose

against effect

Respiratory depression

Opioids

Impaired bowel

function

Limit duration of opioid

use (

89


4

Patient/ disease


Patient comorbidities

Renal Function

Disorder

(GFR: ≤30 ml/

min/1,73m2)

Check renal function Avoid NSAIDs.

Alternatives: alfentanil,

buprenorphine, fentanyl,

ketamine, paracetamol,

sufentanil and oxycodon

Increased renal failure,

nefrotoxicity

Liver Function

Disorder (ALT

three times upper

limit of normal

or major liver

resection)

Check liver function Lower dosage of tramadol,

paracetamol, local

analgesics

Increased liver failure,

hepatoxicity

Pregnant patient Check pregnancy term with

gynaecologist

Safe drugs: paracetamol,

codeine, local

bupivacaine,lidocaine,

mepivacaine, prilocaine

Harmful effects fetus

Pregnant patient

PONV

Check pregnancy term with

gynaecologist

metoclopramide Nausea and vomiting,

harmful effects fetus

Contra indicated drugs/drug use alerts

Known allergy for

analgesic drug

Avoid drug with registered

allergy. If its use is strictly

indicated, perform graded

challenge with 10% of

required dose and have

adrenaline available on

demand

Avoid drug with registered

allergy.If strictly necessary,

have adrenaline available on

demand

Allergic reaction

Evidence based guidelines [19-23]

PONV = Post-operative nausea and vomiting; NSAIDs = Non steroid anti-inflammatory and antireumatic

drugs; PPI = Proton Pump inhibitor; GI = gastrointestinal; GFR = glomerular filtration rate; ALT = Alanine

transaminase

Table 4.I Continued

90

Chapter 4

Table 4.II Respiratory management

RESPIRATORY MANAGEMENT

Patient/ disease


Drugs

Chronic

corticosteroids

Start systemic steroids

stress scheme intravenously

or orally

Continue systemic steroids

stress scheme intravenously

or orally when oral intake

is possible

Exacerbation COPD

Patient comorbidities

Smoking habit Preferably smoking

cessation or reduction no

later than 6-8 weeks before

surgery

Monitor respiratory rate

and oxygen saturation

Increased risk of

pulmonary complications

(e.g. infections, apnoea)

Obstructive sleep

apnoea

Determine whether the

patient with obstructive

sleep apnoea is a candidate

for ambulatory surgery

- Monitor oxygenation

and ventilation closely

(especially when sedatives,

anaesthetics and analgesics

are administrated),

- Local or regional

anaesthesia is

recommended instead of

sedatives, anaesthetics and

analgesics

Respiratory and cardiac

arrest, potentially death

Asthma and COPD Pulmonary function test

for assessing the lung

function.

Optimize lung

function with inhaled

bronchodilators in

combination with

corticosteroid therapy (if

necessary)

Effective analgesia.

Continuation of prescribed

respiratory medication.

Early mobilisation, deep

breathing and positive

pressure breathing

Exacerbation COPD

Young healthy

athletic adult males

None Monitor respiratory rate

and oxygen saturation

Increased risk

of pulmonary

edema secondary

to postextubation

laryngospasm


Hypnotics, sedatives

and opioids

Secure airway Monitor respiratory rate

and oxygen saturation,

alternatives: local or

regional anaesthesia,

gabapentine

Respiratory depression,

apnoea

Evidence based guidelines ref [24-26]

COPD = Chronic Obstructive Pulmonary Disease

91


4

Table 4.III Infection management

INFECTION MANAGEMENT

Patient/ disease


Drugs

Antibiotic

prophylaxis

(according to

national guidelines)

Give antibiotic prophylaxis

< 30 min before:

- Clean surgery involving

the placement of a

prothesis or implant

- Clean-contaminated

surgery

- Contaminated surgery

- SSI, generalized infection

Antibiotic

treatment

(According to

national guidelines)

Give antibiotic treatment

(in addition to prophylaxis)

to patients having surgery

on a dirty or infected

wound

Continue antibiotic

treatment. Register stop

date

SSI, generalized infection

Dressing - Protect the surgical wound

with a dressing 24-48 hours

postoperative, beyond 48

hours is not recommended.

Change dressings with

hand hygiene and a sterile

technique

SSI, generalized infection

Comorbidities

Renal Function

Disorder

(GFR: ≤30 ml/

min/1,73m2) or

patient on dialysis

Adjust the dose of

antibiotic if excreted by the

kidney

Adjust the dose of

antibiotic if excreted by

the kidney and monitor

drug concentrations when

possible

Too high or low plasma

levels of the drug

Valvular heart

disease

Endocarditis prophylaxis

recommended only

in dentalprocedures

manipulating or perforating

oral mucosa, amoxicillin 2

g orally, 30 to 60 minutes

prior to the procedure, Not

recommended in GI or GU

procedures

- Endocarditis

92

Chapter 4

Patient/ disease


MRSA carrier In case of high risk

surgery: prophylaxis:

intranasal mupirocin and

a glycopeptide should be

considered for antibiotic

prophylaxis

If a SSI needs antibiotic

treatment: antibiotic

regimen should include

activity against locally

prevalent MRSA stains

SSI

Diabetes Optimize blood glucose

levels

Optimize blood glucose

levels

SSI

Smoking Encourage stop smoking - SSI

Hair Do not remove hair

routinely. If hair needs to

be removed, use electric

clippers with a single use

head on the day of surgery

- SSI

Contra indicated drugs/ drug use alerts

History of

anaphylaxis,

immediately after

penicillin

Do not administer

prophylaxis with penicillin

and beta-lactams

Use alternatives according

to local guidelines

Do not administer therapy

with penicillin and beta-

lactams

Use alternatives according

to local guidelines

Allergic reaction


GFR = glomerular filtration rate

Table 4.III Continued

93


4

Table 4.IV Diabetes management

DIABETES MANAGEMENT

Patient/ disease


Drugs

Non-insulin

medication

(tablets): acarbose,

meglitinide,

sulphonylurea

Omit morning dose Restart the normal pre-

surgical regimen if the

patient can eat and drink

without nausea and vomiting

Poor glycemic control

Insulin, 3,4 or 5

injections daily

Basal bolus

regimens

Omit the morning and

lunchtime short acting

insulins. Keep the basal

unchanged. Check blood

glucose on admission

Restart the normal pre-





Insulin, 3,4 or 5

injections daily

premixed insulin

Halve the morning dose

and omit lunchtime dose.

Check blood glucose on

admission

Restart the normal pre-





Non-insulin

medication (tablets):

DPP-4 inhibitor,

GLP-1 analogue

Omit on the day of surgery Restart the normal pre-





Non-insulin

medication

(tablets): metformin

(procedure

not requiring

contrast medium),

Pioglitazone

Administer as normal Administer as normal Poor glycemic control

Insulin, once daily No dose change, check

blood glucose on admission

Leave evening meal dose

unchanged


Insulin, twice daily Halve the usual morning

dose, check blood glucose

on admission


unchanged


Insulin, twice daily:

separate injections

of short acting and

intermediate acting

Give half of intermediate

acting only in the morning.

Check blood glucose level

on admission


unchanged


94

Chapter 4

Patient/ disease


Comorbidities

Renal Function

Disorder

(GFR: ≤30 ml/

min/1,73m2)

Check renal function,

Sodium level, Potassium

level, glucose the day

before surgery. Omit

metformin when fasting

starts

Monitor renal function,

Sodium, Potassium, glucose

regularly

Restart the normal

pre-surgical regimen if

the patient can eat and

drink without nausea and

vomiting

Hyperkalemia


Contrast medium If a patient on metformin

has a GFR less than 50

mL/min/1.73m2: Omit

Metformin on the day of

the procedure

Restart metformin 48

hours after the procedure

or postpone if GFR is not

recovered yet

Increased renal failure,

nefrotoxicity


DPP-4 =Dipeptidyl peptidase-4 inhibitor; GLP =Glucagon-likepeptide; GFR = glomerular filtration rate

Table 4.IV Continued

95


4

Table 4.V Cardiovascular management

CARDIOVASCULAR MANAGEMENT

Patient/ disease


Drugs

Diuretics used for

hypertension

Omit on the day of surgery.

Check electrolytes (K, Mg)

and correct for possible

electrolyte disturbances

Check electrolytes (K and

Mg) Restart when oral

intake is possible

Fluid/electrolyteimbalance

Hypopotassemia < 2.5

Diuretics used for

hearth failure

Continue intravenously

perioperative

Restart orally when oral

intake is possible

Heart failure

- Calcium channel-

blockers

- Beta blocking

agents

- Lipid modifying

agents

Continue regular oral

regimen until surgery

Restart orally when oral

intake is possible

(rebound) Hypertension

ACE inhibitors/

angiotensin II

receptor blockers/

renin inhibitor

Omit 24 hours prior to

surgery

Restart when patient is

hemodynamic stable

Continuation of

preoperative use can

exacerbate intraoperative

hypotension

Comorbidities

Endocarditis

prophylaxis in

patients with

valvular heart

disease

Recommended only

in dental procedures

manipulating or perforating

oral mucosa. Not

recommended in GI or GU

procedures

- Endocarditis


Haloperidol,

cisapride, citalopram

Avoid use when the patient

has an known prolonged

QTc interval or torsades

des pointes

ECG monitoring.

Maximum dose Citalopram:

40mg

Cardiac dysrhythmia

Evidence based guidelines ref [33, 38-42]

ACE = Angiotensin converting enzyme; GI = gastrointestinal; GU = genitourinary

96

Chapter 4

Table 4.VI Anticoagulant management

ANTICOAGULANT MANAGEMENT

Patient/ disease


Drugs

VKA: Low

thrombo-embolic

riska

Discontinue

phenprocoumon 4

days prior to surgery

or Acenocoumarol 2

days prior to surgery.

Standard LMWH

prophylaxis administered

periprocedurally

Start VKAs on the day of

surgery

Stop LMWH with INR in

therapeutic range or after

at

least 5 days

Bleeding, thrombo-embolic

event

VKA: High

thrombo-embolic

riska

Discontinue

phenprocoumon 4

days prior to surgery or

acenocoumarol 2 days

prior to surgery. Start a

therapeutic LMWH 3

days before procedure

with last dose 24 h before

procedure Standard LMWH

prophylaxis administered

periprocedurally


surgery and LMWH on

day 1, 2 or 3, depending on

Haemostasis Stop LMWH

when INR in therapeutic

range (after at least 5 days)


event

VKA: Procedures

with low bleeding

risk

Continue VKA therapy

with

INR in therapeutic range

Thrombo-embolic event

VKA: Procedures

with high

bleeding risk

Discontinue VKA therapy

and treat with a LMWH as

described for low- or high-

risk patient


surgery



at least 5 days


event

VKA: Urgent

surgical procedure

Fresh-frozen plasma or

prothrombin complex

concentrate or or

recombinant factor VIIa

(rFVIIa) in addition to low-

dose i.v. or oral vitamin K is

recommended


surgery



at least 5 days

Bleeding

Antithrombotic

agents

Rivaroxaban

Dabigatran

Check if stopped at least 24

hours before surgery

Start LMWH until

discharge. Restart

Rivaroxaban after discharge

Bleeding

97


4

Patient/ disease



inhibitors

Clopidogrel

Check with cardiologist

if stop is allowed. If bare

metal stent is placed within

6 weeks prior to surgery:

continue. If drug eluted

stent is placed within 12

months prior to surgery:

continue

Check PPI interaction:

replace esomeprazol/

omeprazol for other PPI

Continue or restart as soon

as possible

Check PPI interaction:

replace Esomeprazol/

Omeprazol for other PPI

thrombo-embolic event


inhibitors

Acetylsalicylic acid

Continue, except when

intracranial surgery will be

performed, omit 10 days

before

Continue or restart as soon

as possible

thrombo-embolic event,

bleeding

Comorbidities

Patient undergoing

major general

surgery

Thromboprophylaxis is

recommended: LMWH,

LDUH or Fondaparinux

Thromboprophylaxis is

recommended: LMWH,

LDUH or Fondaparinux

thrombo-embolic event

Heparin Induced

thrombocytopenia

Omit heparin or LMWH.

Alternative: Lepirudine and

monitor APTT

or Danaparoide


surgery

Stop Lepirudine or

Danaparoide with INR in

therapeutic range

Thrombocytopenia,

bleeding

Renal Function

Disorder

(GFR: ≤30 ml/

min/1,73m2)

LMWH and Rivaroxaban

and Dabigatran not

recommended.

Alternative: unfractioned

Heparin

Impaired renal function

Liver Function

Disorder (ALT

three times upper

limit of normal

or major liver

resection)

LMWH and Rivaroxaban

and Dabigatran not

recommended.

Alternative: unfractioned

Heparin

Impaired liver function

Table 4.VI Continued

98

Chapter 4

Patient/ disease



Antibiotics or PPI Check INR frequent in

patient on VKA

Increased INR

Secondary Bleeding

Evidence based guidelines ref [41, 43-47]a Low thrombo-embolic risk: Biological prosthetic heart valve (>3 months); Mitral valve repair (>3 months);

Atrial fibrillation without any highrisk (Prior ischaemic stroke, transient ischaemic attack or systemic embolism,

mitral stenosis or prosthetic heart valve) or without > 1 moderate risk factor (Age > 75 years, hypertension,

heart failure, left ventricular ejection fraction 3 months) and mild

thrombophilia. High thrombo-embolic risk when the patient does not comply with these criteria.

VKA = Vitamine K antagonist; LMWH = Low molecular weight heparin; INR = international normalized

ratio; PPI = proton pump inhibitor; LDUH = Low-Dose Unfractionated Heparin

Table 4.VI Continued