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Adverse Drug Reaction Reporting in a
Private Hospital- Is it making a
difference?
DL McKnight (1)
A Wood(2)
C Willis (2)
P Ng Cheong (2)
A Stafford(2)
1)St John of God Subiaco Hospital
2)School of Pharmacy, Curtin University
BACKGROUND
 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 annum 2
 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 hospitalisation 2
 Antibiotics, anticoagulants, cardiovascular agents, hypoglycaemic agents,
antineoplastics and NSAIDs
 Introduced a unique ‘Red Card’ Suspected Adverse Drug
Reaction reporting system in 2001.
‘RED CARD’ REPORTING SYSTEM - FRONT
‘RED CARD’ REPORTING SYSTEM - BACK
CHARACTERISTICS OF ADVERSE
DRUG REACTIONS IN A PRIVATE
PERTH HOSPITAL: A
RETROSPECTIVE STUDY
Acknowledgements:
Pascale Ng
David McKnight
Andrew Stafford
Richard Parsons
C o l i n W i l l i s a n d A l ex Wo o d
Curtin University Ethics
Approval number: PH-09-12
METHODOLOGY - STUDY PROCEDURE
 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)
SERIOUSNESS
 The majority of ADRs were moderate in severit y (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
 T h e re w a s a h i g h e r f re q u e n c y o f A D R s i n fe m a l e s co m p a re d to m a l e s
 P rev i o u s re s e a rc h h a s fo u n d fe m a l e s h av e a h i g h e r ra te o f A D R s d u r i n g h o s p i ta l s tay 3
 C u r re nt l y n o ex p l a n a t i o n fo r t h i s t re n d , t h o u g h i t h a s b e e n s u g g e s te d t h a t fe m a l e s a re m o re
l i ke l y to re p o r t A D R s 4
 M a l e s h a d a h i g h e r p ro p o r t i o n o f s e r i o u s A D R s co m p a red to fe m a l e s ( C h i - s q u a re te s t
p<0.05)
6%
72%
3%
64%
33%
22%
REPORTING STAFF
 A D R s w e re re p o r te d m o s t f re q u e nt l y by p h a r m a c i st s ( 5 7 . 6 % ) co m p a re d to n u rs e s
( 2 2 . 3 % ) o r d o c to rs ( 5 . 9 % )
 D o c to rs re p o r te d a h i g h e r p ro p o r t i o n o f s e r i o u s A D R s ( 4 1 . 3 % ) co m p a re d to p h a r m a c i st s
( 2 7 . 5 % ) o r n u rs e s ( 2 3 . 3 % )
 P h a r m a c i st s ( 6 8 . 8 % ) a n d n u rs e s ( 7 1 . 0 % ) re p o r te d a h i g h e r p ro p o r t i o n o f m o d e ra te A D R s
co m p a re d to d o c to rs ( 5 4 . 3 % ) ( C h i - s q u a re te s t , p < 0 . 0 5 )
3%
69%
6%
71%
8%
75%
28%
23%
54%
41%
17%
SERIOUSNESS OF ADR S
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 3150 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%
49%
20%
49%
SUMMARY OF RESULTS
 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
Adverse renal effects following
Parecoxib use in peri-operative
patients
•
•
•
•
Summary: Patients Data
Patient
Age
Intra-op
No. of
Parecoxib 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
+
Yes
1
27 (36)
F, PC
++
74
Yes
3
15 (48)
F, G
+
4
78
Yes
1
9 (12)
F, G
N/A
Nil
Ang-II
HTN,
NIDDM
ACE-I
HTN
Irbesartan/
HCT
2
48
3
5
63
Yes
1
59 (60)
F, G
+++
Nil
6
63
Yes
2
15 (24)
F, G
-
7
64
Yes
1
10 (36)
G
+
8
63
Yes
2
23 (48)
F, G
+
9
42
Yes
4
12 (60)
F, G
+
Nil
ACE-I
HTN
NIDDM
Imp. Liver
Fxn
ACE-I
HTN
Australian Adverse Drug Reactions Bulletin
Volume 23, Number 3, June 2004
Parecoxib - one shot only
Parecoxib sodium (Dynastat) is a recently marketed parenteral COX-2 inhibitor which is approved for a single
peri-operative dose for the management of post-operative pain. The Australian Drug Evaluation Committee
recommended 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 involved
renal impairment with elevated creatinine and/or oliguria, including four cases of acute renal failure. Multiple
doses of parecoxib were given in six cases, with patients receiving up to five doses. The other seven patients
received only one dose, but two had risk factors: one was also taking a diuretic and an angiotensin II receptor
antagonist; 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 patients
most at risk are those mentioned in the Precautions section of the product information, including those with
impaired 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!
Pharmacist’s Recommendations on NSAID
Usage
•
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
Reduction in reports of diarrhoea from
Diclofenac Suppos after
recommendations introduced
Time
frame
SVD
AD
CS
Total No. of
births 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%
reports
% of
ADR
Introduction of Tramadol dose regimens (2004)
to multimodal pain therapy led to 36 Suspected
Adverse Drug Reactions, classified as:A common side-effect
21
A more severe ADR
9
An allergic reaction
2
itching and swelling.
Other
4
grand mal seizure
Total
36
Patient Characteristics; Serotonin
Medications; Dose effects:
Class
Sex
Age < or
> 65 yrs
=Meds or Dose < or >
Zero Meds 400mg dpd
Side
Effects
10F : 11M
19 : 2
5 : 16
19 : 2
Serious
9F : 6M
7:8
13 : 2
11 : 4
19F : 17M
26 : 10
18 : 18
30 : 6
Total
Tramadol Adverse Reactions (ADR’S)
• 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
Rocuronium Anaphylactic Reactions in
Perioperative areas 2012/13
• 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.
Value of an Adverse Drug Reaction
reporting scheme
• 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.