Clinical Practice Review ISSUE 2 MARCH 2005

THE ROYAL WOMEN’S HOSPITAL QUALITY AND SAFETY UNIT NEWSLETTER

Penicillin Anaphylaxis

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Web news

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Medication safety

4

Why mothers die

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BPAP

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Adverse drug reaction bulletin

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Penicillin Anaphylaxis Penicillin is a medication that we

week the index case occurred. The

GBS antibiotic resistance is still low

prescribe and administer countless

final results of this audit are discussed

with 2.8% resistance to erythromycin1.

times throughout the day in all

on page three of this newsletter.

Maternal colonisation for GBS is

specialities at The Royal Women’s Hospital. The potential for anaphylactic reaction is always there whether or not there is a known history of sensitivity to a medication in any particular patient. In December an obstetric patient was

Andrew Buettner (Deputy Director of Anaesthetics) reminded the audience of the classical signs of anaphylaxis (hypotension, urticaria, angioedema and bronchospasm). These signs of anaphylaxis, if uncontrolled/untreated,

quoted to be 25% with transmission to colonisation of the infant being 50% to 75% and infant sepsis 1% to 2%.

Penicillin is a medication that we prescribe and administer countless times

given intrapartum intravenous penicillin,

could rapidly progress with fatal

as she was known to be positive for

consequences to death occurring from

Group B Streptoccocus (GBS), only

airway obstruction and/or cardio-

to have an anaphylactic reaction to the

vascular collapse. Anaphylaxis usually

Suzanne also described the results

medication within minutes resulting in

happens within minutes but can first

of an unpublished audit of perinatal

life threatening consequences for both

occur up to an hour after exposure to

chemoprophylaxis for prevention of

mother and baby. The response to this

the allergen. In 20% it may follow a

EO GBS where penicillin allergy status

emergency was appropriate and

biphasic response.

for patients was documented 2.

timely by members of the midwifery, obstetric, anaesthetic and paediatric staff and should be commended. This incident provided the basis for an informative and at times lively Grand Round held on the 3rd of March.

Suzanne Garland (Director of Clinical Microbiology & Infectious Disease) gave an informative presentation, more on the background to why GBS prophylaxis is prescribed in pregnancy. The mortality rate for early onset neonatal GBS disease (EO GBS) in

throughout the day

She had conducted this audit of patient histories within the hospital in conjunction with the pharmacy department. Of the 136 cases audited, 10 (7%) were documented as allergic to penicillin, 103 (76%) no allergies were known and 23 (17%) no penicillin allergy status was documented.

Georgiana Chin (Principal Registrar,

1979 was 40% which has since fallen

Senior Registrar and Fellow in Quality

to 10% in 2002. This has been the

Karl Bleasel (Clinical Immunologist,

& Safety) initially set the scene by

result of intrapartum chemoprophylaxis

RMH) presented a detailed and

describing the background history and

of GBS carriers identified by either

interesting account of all things

events that occurred in this index case.

GBS screening or risk based

immunological and in particular, relating

She then went on to describe the

programmes (the only proven

to anaphylaxis to penicillin. He pointed

interim analysis of an audit that Nicola

prevention strategies for EO GBS).

out that only 25% to 33% of penicillin

Bryan (Senior Registrar and Fellow in

Although we have made reductions

anaphylaxis deaths are history positive

Quality & Safety) and herself had done

in EO GBS, rates for late onset infantile

with 80% of patients who claim to

looking at documentation of allergies in

GBS disease (LO GBS) have remained

be allergic have no demonstrable

obstetric admissions during the same

stable.

antibodies (IgE) to penicillin.

1

1

An audit of allergy documentation

CONT. PG 1

He discussed a number of tests

With respect to the index case, he

Les Reti asked “Is there a protocol

that are used in immunology to prove

said it was unusual for a person to

for the patient who says I think I’m

sensitivity to a particular allergen, such

get a reaction to penicillin and not to

allergic to penicillin?”

as skin prick testing (SPT)/intradermal

amoxycillin without a problem as

testing (ID), radio-allergo-absorbscent

was the case this time (it is usually

test measuring IgE to a specific

observed in reverse). He said he would

allergen (RAST), and tryptase. He also

have advised giving the penicillin in

discussed the reliability of patient recall

this context.

with regards to determining allergy. With a flourish of studies and statistics he proved that no test is infallible and

Karl Bleasel replied, “Actually no. We encourage people to get tested to find out.” The last word was left to Jeremy Oats (Clinical Director of Obstetrics

An animated question time ensued

& Gynaecology) who had chaired the

following the speakers.

meeting. After a meeting illustrating

patient histories can be unreliable.

Mal Fisher (Anaesthetics) stated that,

that anaphylaxis can occur in patients

Tryptase which is sent off immediately

“The only people in his experience to

where allergies were known and also

after onset of anaphylaxis (peaks at 30

have died with anaphalyxis were those

de novo he asked, “Could this event

to 60 minutes but can remain elevated

with an epidural. Vasodilation works

happen again? Unfortunately yes

for 6 to 12 hours) is very helpful if

against you at the time”.

would have to be the answer.”

positive but useless if negative.

During the question time there was a

Is desensitisation the answer? Not

discussion between Andrew Buettner

necessarily as it is 80% effective, takes

and the anaesthetists and obstetricians

4 hours of small doses which are

in the audience regarding timing of

slowly increased and which can result

delivery following an anaphylactic

in a reaction in 20%. Where possible,

reaction. Andrew concluded that the

an alternative medication should be

sooner a baby is delivered after the

References

used.

reaction, the better the outcome for

1. Stylianopoulos A, Garland S et al. Aust

Georgiana SM Chin Principal Registrar, Fellow in Quality & Safety Unit

NZ J Obstet Gynecol 2002;42:543-4.

mother and baby.

2. Kent MacMillan, Garland S, Wong S et.al unpublished.

Management of Anaphylaxis in obstetric patients •

Call ‘Adult Code Blue’

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Send tryptase specimen (consult with lab)

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‘ABC’ (airway/breathing/circulation)

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CPR (cardiopulmonary massage) with

(O2 and wide bore IV fluids)

BLS (basic life support) and ALS

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Stop drug administration

(advanced life support) to protocol.

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Adrenaline is cornerstone of management

•

•

- 0.3–0.5ml 1:1000 (300–500ug) IM adults

With

- 0.1 ml/kg 1:10000 IM in children

•

- Doses may be s/c in milder cases

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Manual or left lateral uterine displacement

Severe cases

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Perimortem caesar consider by four

Early intubation

- IV adrenaline (monitored patient)

minutes and perform by 5 minutes for

- Early intubation (airway swelling)

gestation >20 weeks.

Supplemental therapy - IV fluids 2L crystalloid (? Colloids)

Andrew Buettner

- Antihistamines (H1 and H2 )

Deputy Director of Anaesthetics

- Steroids ( hydrocortisone 1–5 mg/kg)

2

GRAND ROUND MARCH

An audit of

allergy documentation Was this an isolated case?

She was found to have demonstrable

While the treating clinicians took

allergies to many common house-

the correct precautionary measures,

hold products and some common

documentation in this case had

medications. A lengthy letter from

deficiencies. Poor documentation can

her immunologist was in the

contribute to preventable penicillin

‘correspondence’ section of her notes,

reactions. To identify our deficiencies,

yet her allergies were documented

Nicola Bryan and Georgiana Chin

only in the antenatal record.

(Fellows in Quality & Safety) performed as audit of obstetric patients admitted during the week in December when this incident occurred. The aim was to identify our documentation of patient allergies.

important to clarify this with the patient so they understand that they are not ‘allergic’ and to offer the best possible

a medication then the alert sheet in the

reportedly allergic to.

documentation that each obstetric patient should have. It is important to remember that ‘no known allergies’ is a relevant negative and should be clearly written. It is also helpful to all clinical staff that the nature of the adverse reaction is clearly stated – especially if the reaction to penicillin

in hospital medicine and offers a

And it’s free.

as the ‘1st line’ antibiotic they are

This would seem to be the minimum

provides learning for professionals

as a side effect and not an allergy. It is

potentially life-threatening reaction to

place and also on a medication chart.

Then bmjlearning is for you. It

everyday learning needs.

not as effective at treating the problem

antenatal record card in the designated

Do you enjoy interactive learning?

antibiotics but this should be regarded

patient allergies? For a patient with a

should be documented in the patient

evidence based learning resources?

range of services to support your

care. Substituted antibiotics are often

clearly marked. Obviously an allergy

Are you looking for up to date and

Many patients vomit with certain

Where is the best place to document

front of the patient history should be

http://www.bmjlearning.com

So how can we improve this? The first step seems to be to raise consciousness of all staff to the

For those clinicians who enjoy a challenge, we recommend that you visit bmjlearning. Recent learning modules have been ‘Pelvic inflammatory disease’, ‘Hepatitis C’, and ‘Overactive bladder, diagnosis and treatment’. There are four different categories. GPs. Hospital doctors, nurses and practice managers.

potential problem related to poor documentation of allergies. Now we

You may log in as a guest and

have to improve documentation. On

wander through the myriad of

asking patients in clinic, delivery suite,

opportunities offered, such as:

antenatal ward or emergency whether

team learning, self appraisal,

they are allergic to any substances it

courses and conferences etc.

should be clearly marked on all

bmjlearning is owned by the BMJ

relevant paperwork and a patient wrist

Publishing Group Limited.

band detailing this should be attached. Clear details of the allergy are undoubtedly helpful, be it skin rashes

Susan Braybrook

or throat swelling. We would also

Clinical Audit Coordinator,

During the week concerned, 178

suggest to all staff that it is prudent to

Quality & Safety Unit

women were admitted for obstetric

document ‘no allergies’ if this is the

reasons. We looked at each history

case – it is then clear to al that the

for documentation of allergy status.

patient has been asked.

is ‘throat swelling’!

In total 33 patients had some allergy documented in one or more of the three sites that we considered essential locations for such information. Only six patients out of this 33 had their allergy documented in all three locations; that is, the alert sheet, the medication chart and the

As a final point we should remember that allergy status can change both in response to new medication and also escalation of existing allergies. It is then important for us to ask these questions on each and every admission to hospital.

antenatal history. There were some particularly

Nicola Bryan

concerning case examples. One

Senior Registrar,

woman had recently undergone allergy

Fellow in Quality & Safety Unit

testing at The Alfred Hospital prior to her pregnancy. 3

Medication Safety – Do you remember your first drug error? GUEST EDITORIAL Why will most of us as reasonably

So why did I make a mistake and what did I learn?

intelligent, skilled and well-

I made the drug error for two reasons,

meaning clinicians make a drug

firstly a change in clinical area can

error during our careers?

mean the same drug is administered

To air the pain and humiliation of my drug error I feel the need to place it in some context. After six years of nursing I embarked upon my midwifery career in 1982, when the climate of incident reporting was one of blame. I had previously been working in

•

direction of Helen Patterson (Neonatal Educator and MSC member) have had a medication safety blitz in November 2004. Creative initiatives were developed

differently, and secondly I read one

by the nurses, highlighting the

thing and did something different. I

importance of clinician involvement

have over time recovered from my

in the solutions. The making of a

public flogging and recognise this

video, education sessions, large

approach does more harm than good,

calculators for drug rounds,

the system learns nothing and under

prizes etc all contributed to have

reporting is the result.

oncology, where when a patient was

The Medication Safety Committee was

vomiting we gave Maxalon IV. In

established under the guidance of Les

Maternity, many Caesarean Sections

Reti and Mary Draper in April 2003.

were still being performed under G.A.

Neonatal Services under the

a positive effect in raising the profile of medication safety. •

Better Prescribing and Administration of Medications at The Women’s is a six month

when women often vomited post-

I had always regarded myself

operatively. With my most recent

as careful and meticulous, so

experience as an oncology nurse to

how could this happen to me?

inform me, I automatically gave the Maxalon IV instead of IM as ordered.

federally funded quality project currently underway. The Project Officer is Lis Moloney who has established a Reference Group with reporting to the MSC and

This may not seem a huge error, but as

The Terms of Reference are available

the Quality & Safety Unit. Clinical

a student midwife one is fair game for

in the Policy & Procedure manual

Champions across disciplines are

a public flogging. My punishment was

however the aim of the MSC is to

currently being sort – please put

a severe warning from the Supervisor,

provide an important risk management

your hand up!

the Head of the Midwifery School was

function through review of trends in

notified so that my misdemeanor could

medication incidents and specific

be added to my record, and I was

serious incidents. The committee is

made to ring the Obstetrician and

concerned with establishing a culture

explain why I had thought the Maxalon

of identifying and reporting incidents

should be given IV rather than IM as

to facilitate organisational learning and

he had ordered.

improvement, and takes a pro-active

I had always regarded myself as careful and meticulous, so how could this happen to me? •

reduce the likelihood of error.

Did I think about not reporting my Did I deliberately administer the Did my past clinical experience influence the error? Yes.

•

Are we more likely to make a drug error when we change clinical areas? Yes.

•

meaning clinicians will make a drug error and implement changes to

drug incorrectly? No. •

understand why most of us well-

Did this experience make me

next drug error? Yes. •

language our purpose is to better

value a policy of open disclosure? No (I now do!). •

role in medication safety. In plain

Did I understand the ‘Five Rights’ of drug administration? Yes.

The MSC is an excellent example of a multidisciplinary team working towards a common goal. Our membership contains medical, pharmacy, nursing, midwifery, education, and quality unit representatives. While our title may seem somewhat ‘dry’ we engage in some lively debates. I would like to acknowledge the enthusiasm and commitment of all members.

Gail Wilkinson

Recent MSC initiatives include:

Program Manager,

•

Maternal Fetal Medicine Unit

Ruth Bergman of the Quality & Safety Unit prepares a half yearly and annual report which analyses the ‘how, when and why’ of medication incidents. This information then guides the committee’s work and directs system changes, policy development and/or education accordingly.

4

Why mothers die BPAP During a recent study trip to England, I

The risk of recurrence should be

Better Prescribing

attended an all day forum of the North

identified at booking and risks

and Administration

West Region of the NHS in Liverpool

discussed. The major risk factors

of Medications Project

on Why Mothers Die, based on the

for PND were a previous psychiatric

report from the Confidential Enquiry

episode and maternal family history.

into Maternal Deaths 2000 to 2002.

Her view was the there were two

The major direct causes of maternal

useful screening questions – have you

deaths were pulmonary embolism and

ever been admitted to a psychiatric

haemorrhage. The major indirect

unit? and has any maternal relative

causes were cardiac conditions, mostly

had any mental illness following child

acquired, and suicide. If you looked at

birth? She spoke of the need to

With the support of the Quality

the full 12 month period following birth,

develop better expertise in managing

& Safety Unit and Medication

as the Enquiry did, then suicide is the

psychiatric illness around childbirth.

Safety Committee Lis Moloney

leading cause of maternal death.

In 40 percent of the deaths from

Until the end of July 2005 The Royal Women’s Hospital is undertaking a project to look at issues around the errors reported in prescribing, dispensing and administration of medication.

has been seconded part time to coordinate this.

Twenty percent of those who died from

cardiac conditions, the review found

direct and indirect deaths booked late,

problems with care and noted the

The aim is improved safety

35 percent were considered obese

importance of being careful about

and will include:

and 14 percent had revealed violence

reports of chest pain. As in Victoria,

•

in the home. The issues which were

deaths from post partum haemorrhage

discharge medication charts in

identified from review of individual and

were rising. Jim Neilson from Liverpool

Feb) and a repeat to determine

aggregate data were the importance

Women’s Hospital spoke about the

a change in the rate and nature

of social exclusion, ethnicity, obesity,

importance of ‘fire drills’, women at risk

psychiatric illness, heart disease and

being in the right hospital setting, the

caesarean section. Fourteen women

involvement of haematologists and

who died were asylum seekers.

having consultants present. Longer

Margaret Oates from the University of Nottingham spoke about psychiatric

term, the Enquiry is considering doing a special topic on caesarean section.

A baseline audit (done from

of errors. •

Production of some educational materials for training and to sustain the impact of outcomes.

•

The recruitment and training of peer educators both medical and nursing/midwifery to provide

deaths, cautioning about the small

Deaths from pre-eclampsia or

numbers and drawing old and new

eclampsia have fallen but 46% of these

lessons. Features of the deaths of

deaths were regarded as potentially

Find out more or volunteer

women with psychiatric illnesses

preventable and a priority for improved

for peer support contact

were the importance of the first three

care. Pre-eclampsia Community

[email protected]

months after child birth and the

Guidelines have been developed to

Ext. 3329 (Wed/Thurs).

atypically violent means women used

assist early recognition and are

to kill themselves. The women were

available on www.apec.org.uk

older, had no class association, had

and published in the BMJ

Elisabeth Moloney

previous children, were mentally well

(http://bmj.bmjjournals.com )

Midwife,

during pregnancy and half had a

in early March.

Project Officer

previous psychiatric history, half following child birth. For women with post natal depression (PND), 50% will have an onset by 7 days, 75% by day 16 and 100% by day 90. Women with past histories of severe mental illness following delivery have a 1 in 2 to 1 in 3 chance of recurrence. Margaret spoke passionately about

ongoing training.

Quality & Safety Unit The Confidential Enquiry demonstrates the value of looking at both individual and aggregated data. The report shows that the social model of health matters and that improvement is required in service organisation and communication as well as clinical care. The report can be found on www.cemach.org.uk

risks associated with PND, the importance of not confounding it with mild depression and anxiety, and the

Mary Draper

need to have a management plan

Manager,

documented in the antenatal record

Quality & Safety Unit

by week 34.

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Pharmacy news Adverse drug reactions bulletin available at http://www.tga.gov.au (Volume 24, Number 1, February 2005). Reported this: Table 1: Selected adverse reactions of some complementary medicines.

Table 2: More serious adverse reactions with tramadol.

Complementary medicine

Adverse reaction

Reaction

No. of reports

Aristolochia species* * Not a permitted ingredient in Australia

Confusion

36

Renal failure

Hallucinations

30

Bee products

Anaphylaxis

Convulsions

26

Black cohosh (Cimicifuga racemosa)

Liver impairment

Serotonin syndrome

20

Echinacea species

Allergic reactions

Increase in blood pressure

14

Ginkgo biloba

Interaction with warfarin Å® bleeding

Hypersensitivity reactions

12

Guarana (Paullinia cupana)

Caffeine overdose

Hepatic reactions

10

St John’s wort (Hypericum perforatum)

Reduced efficacy of cyclosporin, oral contraceptives; Serotonin syndrome with SSRIs, tramadol

Warfarin interaction

Parecoxib – one shot only

(range 1–19) days. Tramadol was the

Monitoring of INR should be

(Volume 23, Number 3, June 2004).

only suspected drug in 11 cases,

considered when tramadol is

but in 14 other cases the patient

started in patients taking warfarin.

ADRAC has, to date, received

was taking additional drugs which

20 reports of adverse reactions

may lower the seizure threshold,

associated with parecoxib, and 13

including propofol, bupropion,

of these involved renal impairment

hydrocortisone, morphine, and

with elevated creatinine and/or

tricyclic anti-depressants. One

oliguria, including four cases of

patient had a history of epilepsy,

acute renal failure. Multiple doses of parecoxib were given in six cases, with patients receiving up to five

and was also taking carbamazepine and phenytoin.

5

The use of tramadol has increased rapidly, with PBS dispensings of oral formulations rising from 23,000 in 2000 to 580,000 in 2001 and over 1,100,000 in 2002. Prescribers should be alert to the more serious adverse reactions, especially those of a neuropsychiatric nature.

doses. The other seven patients

Tramadol may cause serotonin

received only one dose, but two had

syndrome, particularly when it is

risk factors: one was also taking a

used at high doses or in com-

diuretic and an angiotensin II

bination with other agents increasing

receptor antagonist; and the other

serotonin levels1. In 16 of the 20

As of 31 January 2005 the

had pre-existing mild diabetic

cases, the patient was taking

Committee on Safety of Medicines

nephropathy. The patients were

potentially interacting medicines

(CSM) recommend Digesic® be

including moclobemide, SSRIs,

withdrawn from the market over the

tricyclic antidepressants,

next 6–12 months as the efficacy of

sibutramine and St John’s wort.

is poorly established and the risk of

aged 41–78 (median 66) years. Tramadol – four years’ experience February 2003). ADRAC has received 354 reports in association with tramadol. The most common reactions include nausea, vomiting, sweating, dizziness, rash,

Increases in hepatic enzymes were reported in 10 cases. One patient developed hepatic failure and died. All times to onset were short (range 1–19 days; median 9 days).

tremor and headache. The more

Tramadol may interact with warfarin

serious adverse reactions reported

to decrease prothrombin activity,

are presented in Table 2.

although the mechanism is

For the cases of convulsions, the median time to onset was two

Please let the associate editors have your views on the contents of this newsletter, or any other matters involving clinical practice which may be of interest to our readers.

the UK market

toxicity in overdose, both accidental and deliberate, is unacceptable. For further information follow this link: http://www.info.doh.gov.uk/doh/emb roadcast.nsf/0/4FC9DCA8C804C27 B80256F9A004AB459/$File/CEM20 05-2.doc?OpenElement

unknown 2. ADRAC has received

Molika In

five reports of this interaction.

Senior Pharmacist

Mary Draper, telephone (03) 9344 2722 or email [email protected] Susan Braybrook, telephone (03) 9344 2606 or email [email protected] The Quality and Safety Unit homepage www.rwh.org.au/quality_rwh Nicola Bryan, email [email protected] Georgiana Chin, email [email protected] 6

050706 Designed by the Educational Resource Centre, 2005

(Volume 22, Number 1,

Digesic® (Dextropropoxyphene; Paracetamol) withdrawal from