DL McKnight (1) 1)St John of God Subiaco Hospital

A Wood(2) 2)School of Pharmacy, Curtin University

C Willis (2)

P Ng Cheong (2)

A Stafford(2)

Adverse Drug Reaction Reporting in a Private Hospital- Is it making a difference?

WHO adverse drug reaction (ADR) Definition: “a response to medication that is noxious, unintended and occurs at doses normally used in humans”1

Cost of ADRs to the Australian health system At least $650 million per annum2

The Government body responsible for monitoring ADRs is the Advisory Committee on the Safety of Medicines (ACSOM), formerly ADRAC

Drugs responsible for up to 70% of ADRs during hospitalisation2

Antibiotics, anticoagulants, cardiovascular agents, hypoglycaemic agents, antineoplastics and NSAIDs

Introduced a unique ‘Red Card’ Suspected Adverse Drug Reaction reporting system in 2001.

BACKGROUND

‘RED CARD’ REPORTING SYSTEM - FRONT

‘RED CARD’ REPORTING SYSTEM - BACK

Acknowledgements:

Pascale NgDavid McKnightAndrew StaffordRichard Parsons

CHARACTERISTICS OF ADVERSE DRUG REACTIONS IN A PRIVATE

PERTH HOSPITAL: A RETROSPECTIVE STUDY

Colin Willis and Alex Wood

Curtin University Ethics Approval number: PH-09-12

Retrospective analysis of ‘red cards’ (2001-2012)

Data recorded over two days during June 2012

Data was entered into an Access 2010 database

Drugs were classified using the Anatomical Therapeutic Chemical (ATC) classification system

Adverse reactions classified using the International Classification of Primary Care, second edition (ICPC-2 PLUS)

METHODOLOGY - STUDY PROCEDURE

SERIOUSNESS

The majority of ADRs were moderate in severity (69.2%)

A quarter of the ADRs were considered serious by the evaluating clinical pharmacist

Seriousness was used to characterise the remaining data Previous research focused on serious or fatal ADRs – our data included moderate ADRs

GENDER There was a higher frequency of ADRs in females compared to males

Previous research has found females have a higher rate of ADRs during hospital stay3

Currently no explanation for this trend, though it has been suggested that females are more likely to report ADRs4

Males had a higher proportion of serious ADRs compared to females (Chi-square test p<0.05)

33%

64%

3%

6%

72%

22%

REPORTING STAFF

ADRs were reported most frequently by pharmacists (57.6%) compared to nurses (22.3%) or doctors (5.9%)

Doctors reported a higher proportion of serious ADRs (41.3%) compared to pharmacists (27.5%) or nurses (23.3%)

Pharmacists (68.8%) and nurses (71.0%) reported a higher proportion of moderate ADRs compared to doctors (54.3%) (Chi-square test, p<0.05)

28%

71%

23%

3%

69%

6%

41%

8%

54%

75%

17%

SERIOUSNESS OF ADRS VS AGE GROUP

There was a higher proportion of serious ADRs in the 51-65 and 66+ year age groups There was also a higher proportion of moderate ADRs in the 0-30 and 31-50 year age

groups (Chi-square test, p<0.05)

ACSOM REPORTING

Our research found that serious ADRs were more likely to be reported to ACSOM (37.7%) compared to moderate (14.4%) or negligible (8.1%) ADRs (p = 0.000) This result is not surprising, since ACSOM places high priority on ADRs of a serious nature with

potential to significantly affect a patient’s management.10

74%

20% 49%

49%

A higher proportion of serious ADRs occurred in males

The majority of ADRs occurring at SJOG were of moderate severity

The top drug classes causing ADRs at SJOG were Opioids, antineoplastics, antibiotics and NSAIDs

Pharmacists reported more ADRs at SJOG than nurses and doctors

20% of all ADRs were reported to ACSOM; the more serious the ADR, the more likely it was to be reported

The elderly suffered from a higher proportion of serious ADRs

SUMMARY OF RESULTS

Adverse renal effects following Parecoxib use in peri-operative

patients

Patient Age Intra-op Parecoxib

No. of Parecoxib

doses

No. of hours <0.5mL/hr/kg

(No. of hrs Catheterised)

Rescue treatment

SCr (umol/L)

Other factors

involved

1

60

Yes

5

34 (60)

F, G

+

Nil

2

48

Yes

1

27 (36)

F, PC

++

Ang-II HTN,

NIDDM

3

74

Yes

3

15 (48)

F, G

+ ACE-I HTN

4

78

Yes

1

9 (12)

F, G

N/A

Irbesartan/ HCT

5

63

Yes

1

59 (60)

F, G

+++

Nil

6

63

Yes

2

15 (24)

F, G

-

Nil

7

64

Yes

1

10 (36)

G

+

ACE-I HTN

NIDDM

8

63

Yes

2

23 (48)

F, G

+ Imp. Liver

Fxn

9

42

Yes

4

12 (60)

F, G

+ ACE-I HTN

Summary: Patients Data

Australian Adverse Drug Reactions BulletinVolume 23, Number 3, June 2004

Parecoxib - one shot onlyParecoxib sodium (Dynastat) is a recently marketed parenteral COX-2 inhibitor which is approved for a singleperi-operative dose for the management of post-operative pain. The Australian Drug Evaluation Committeerecommended approval for parecoxib at a single dose only, because of concerns about the safety of multiple doses.

ADRAC has, to date, received 20 reports of adverse reactions associated with parecoxib, and 13 of these involvedrenal impairment with elevated creatinine and/or oliguria, including four cases of acute renal failure. Multipledoses of parecoxib were given in six cases, with patients receiving up to five doses. The other seven patientsreceived only one dose, but two had risk factors: one was also taking a diuretic and an angiotensin II receptorantagonist; and the other had pre-existing mild diabetic nephropathy. The patients were aged 41-78 (median 66)years.

It is clear that parecoxib can cause renal impairment and the risk is increased with multiple doses. Those patientsmost at risk are those mentioned in the Precautions section of the product information, including those withimpaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

Adverse Drug Reaction (Diarrhoea) to Diclofenac 100mg suppos in Obstetric

Patients (Naproxen suppos discontinued)

Don’t give me those!

• Use the oral route if tolerated

• Avoid or administer rectally on a prn basis

• Limit length of rectal use at 100mg BD to 2 days then review use

• Consider alternative NSAID

• NB. Supps. may cause irritation on insertion – THIS IS NOT AN ADVERSE REACTION

Pharmacist’s Recommendations on NSAID Usage

Time fram

e

SVD AD CS Total birth

s

No. of ADR

reports

% of ADR

1/12/02 to

30/04/03

373 227 577 1177 40 3.4%

1/5/03 to 30/09/03 356 248 607 1211 13 1.1%

Reduction in reports of diarrhoea from Diclofenac Suppos after

recommendations introduced

Introduction of Tramadol dose regimens (2004) to multimodal pain therapy led to 36 Suspected

Adverse Drug Reactions, classified as:-A common side-eff ect 21

A more severe ADR 9

An allergic reaction 2

Other 4

Total 36

itching and swelling.

grand mal seizure

Class Sex Age < or > 65 yrs

=Meds or Zero Meds

Dose < or > 400mg dpd

Side Eff ects

10F : 11M 19 : 2 5 : 16 19 : 2

Serious 9F : 6M 7 : 8 13 : 2 11 : 4

Total 19F : 17M 26 : 10 18 : 18 30 : 6

Patient Characteristics; Serotonin Medications; Dose effects:

• More severe ADR’s to Tramadol likely with use concomitant serotonergic medications

• When take two or more tramadol preparations concomitantly

• difficult to predict- noxious and unintended, but dose plays a role

• mean daily dose/day of > or equal to 400mg a day, is NOT a good predictor

Tramadol Adverse Reactions (ADR’S)

• 4 cases of Anaphylaxis to Rocuronium at induction of anaesthesia

• Inc. HR, Dec. BP, rash- Met MER criteria admitted to ICU

• 2 patients surgery cancelled• Recovered with supportive treatment in 24 hrs• Patients referred for Allergy testing at SCGH• Incidence rate higher than expected• Hospira/ACSOM- no reports to date.

Rocuronium Anaphylactic Reactions in Perioperative areas 2012/13

• Valid means to identify adverse events as they occur following new/change of practice in public sector, amplified on larger numbers in private practice.

• Opportunity for review and collaborative research with a University

• Currently use an electronic data base and reports tabled at various hospital committees, as well as recoded on Incident Management System.

• Enhances patient safety, communication and education.

Value of an Adverse Drug Reaction reporting scheme