Increasing the frequency, quality and breadth of adverse drug

215 Pages·2005·1.84 MB·English

Increasing the frequency, quality and breadth
of adverse drug reaction reporting
by consumers and health professionals

Geraldine Michelle Moses
BPharm PGradDipClinPharm

School of Pharmacy,
University of Queensland

A thesis submitted in partial fulfilment of the requirements
for the degree of Doctor of Clinical Pharmacy

May 2005
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Statement of originality

The work presented within this thesis is, to the best of my knowledge, original except
as acknowledged in the text. None of the material described within has been
previously submitted, either as whole or in part, for a degree at the University of
Queensland or any other university.

………………………………………..
Geraldine Moses
BPharm (UQ) PGradDipClinPharm (UQ)

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Acknowledgements

Firstly, I would like to thank my supervisor and colleague, Ms Treasure McGuire, for
her leadership, support and enthusiasm through the four years of this research. The
birth of my daughter in February 2003 was an unforseen interruption that Treasure
handled unflinchingly. I thank her for the personal and professional growth our
continuing collaboration brings, as well as the benefits our work confers on the wider
community in terms of Quality Use of Medicines.

I would also like to thank my UQ-based supervisor Dr Lisa Nissen for her support,
advice and limitless patience in completing this thesis. I would also like to
acknowledge the support of other UQ-based colleagues along the way including Dr
Carl Kirkpatrick, Dr Lynne Emmerton, Professor Sue Tett and Mr Frank May.

I would also like to express my gratitude to the following organisations and
individuals who were involved in the study:

• Staff of the Education and Information Unit of Mater Pharmacy Services who
assisted in taking ADR calls when all the phones were ringing, including Dr
Angela Dean, Greg Kyle, Alicia McNamara, Jenny Whitty, and our
administration assistant Brooke Innis.
• The Quality Use of Medicines Section of the Department of Health and Aged
Care who saw the value in this research project and provided the financial
support for it to be undertaken.
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• Dr John McEwen, Dr Patrick Purcell, Dr Ian Boyd, Dr Tim Matthew, Dr
Richard Hill, Dr Kerri McKay and all the ADRAC staff for their expert
assistance, provided so generously throughout the study period.
• Bristol Myers Squibb and Merck Sharp and Dohme, who provided financial
support for the catering at the health professional workshops.
• Consumer support groups, particularly the Epilepsy Association, Arthritis
Foundation, Thyroid Association, Scleroderma Association and the Irritable
Bowel Support group for publicising the SER Line in their regular newsletters;
• The health professional organisations who assisted with subject recruitment as
follows-
(cid:131) Brisbane Inner South Division of General Practice;
(cid:131) Australian Dental Association;
(cid:131) Queensland Branch of the Pharmaceutical Society;
(cid:131) St Vincent’s Nursing Service, Brisbane, Toowoomba, Bundaberg, and
Gold Coast; and
(cid:131) St Luke’s Nursing Service;

Finally, thanks must go to my mother, my husband, my parents-in-law, my sisters,
and my daughter whose patience and support throughout this testing time has been
abundant. I will always be grateful.
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ADDITIONAL PUBLICATIONS AND PRESENTATIONS BY THE
CANDIDATE RELEVANT TO THIS THESIS, BUT NOT FORMING PART
OF IT.

Published papers

• Moses GM, McGuire TM. Final report: QUMEP Grant No.PJ570. Increasing the
frequency, quality and breadth of adverse drug reaction reporting by consumers
and health professionals. 6th January 2003.

• Moses GM. Introducing the Adverse Medicine Event Line 1300 134 237.
Australian Prescriber 2004; 27(2): 5

• Moses, GM. Hidden dangers of herbal medicines. The Flame. Newsletter of
Epilepsy Qld. December edition, 2001

• Moses, GM. Reporting drugs reacting badly. Choice Magazine- web edition.
http://www.choice.com.au/viewArticle.aspx?id=102537&catId=100409&tid=100
008&p=1 Published:September 2001.

Presented papers

• McGuire TM, Moses G.M. Increasing the frequency, quality and breadth of
adverse drug reactions reporting by consumers and health professionals- "The
ADR project". Proceedings of the National Medicines Symposium, National
Convention Centre, Canberra, 21-22 March. 2002.

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• Moses GM, McGuire TM. Adverse Drug Reactions to Complementary Medicines.
SHPA Queensland State Branch Conference, Hilton Hotel, Brisbane. 2 November,
2002.

• Moses GM. Involving consumers in Reporting Adverse Drug Reactions-
preliminary results of the ADR project. Association of Regulatory and Clinical
Scientists, Annual Congress, Darling Harbour Convention Centre, Sydney. 4 June
2003

• McGuire TM, Moses GM. Increasing the frequency, quality and breadth of
adverse drug reactions reporting by consumers and health professionals- "The
ADR project". Paper presented to First Safety & Quality Conference, Burswood
Convention Centre, Perth. 14-16 July, 2003.

• McGuire TM, Moses GM. Who should report adverse medicine events - health
professionals or consumers? Paper presented to Society of Hospital Pharmacists
of Australia, 26th Federal Conference, National Convention Centre Canberra, 14-
16 November 2003.

• Moses GM, McGuire TM. Complementary Medicines – Are they safe? Australian
Rheumatology Association, 46th Annual Scientific Meeting, Cairns Exhibition
Centre, Cairns. 22 May, 2004

• Moses G, McGuire T. Consumer-style ADR reporting - a progress report from the
Adverse Medicine Events Line. Paper presented to National Medicines
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Symposium: Quality Use of Medicines – Time for total integration, Brisbane
Convention and Exhibition Centre, Brisbane, 28-30 July 2004

• McGuire TM, Moses GM, Shea S, Hildebrand A, Sutton J. Statin-induced
musculoskeletal adverse events - an audit of calls to the AME Line. Paper
presented to National Medicines Symposium: Quality Use of Medicines – Time
for total integration, Brisbane Convention and Exhibition Centre, Brisbane, 28-30
July 2004.

• McGuire TM, Moses GM. The Adverse Medicine Events Line - the first 1000
calls. Poster presented to 2nd Australasian Conference on Safety and Quality in
Health Care, National Convention Centre, Canberra, Australia, 9 - 11 August 2004

• McGuire TM, Moses GM, Shea S, Hildebrand AM, Sutton J. Statin-induced
musculoskeletal adverse events - an audit of calls to the AME Line. Poster
presented to 2nd Australasian Conference on Safety and Quality in Health Care,
National Convention Centre, Canberra, Australia, 9 - 11 August 2004

• McGuire TM, Moses GM. Consumer-reported adverse medication events: What
is it telling us? Invited Paper - Plenary Session. Australasian Pharmaceutical
Science Association (APSA): Towards Safer Medicines, Carlton Crest Hotel,
Melbourne, 4-7 December. 2004
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Abstract

Background: Since the 1960’s, a world-wide system of spontaneous adverse drug
reaction (ADR) reporting has provided a centralised means for monitoring post-
marketing drug safety. However, under-reporting to this system remains a major
problem. In addition, whether consumers should participate is controversial and
largely unexplored.

Aim: This study investigated whether the intervention of a pharmacist-operated
telephone helpline and/or an educational workshop could increase the number, quality
and breadth of ADRs reported to the Australian Adverse Drug Reaction Advisory
Committee (ADRAC) by consumers and health professionals (HPs) and how the
results of each group would compare.

Method: Two independent studies were conducted. In the HP study, 381 doctors,
nurses, pharmacists, dentists and complementary medicine (CM) practitioners were
recruited and randomly assigned to one of four intervention groups: 1) access to the
ADR Reporting Hotline; 2) small-group workshop on ADR reporting; 3) access to the
Hotline AND the workshop or 4) no intervention (controls). The number of ADRAC
reports submitted by participants in the two years prior to the study (1999-2000) and
during the study (2001-2002) was compared.

In the consumer study, a pharmacist-operated 1300 telephone helpline was established
through which ADRs could be reported or enquired about. Marketing of the service
was limited to the state of Queensland, and after 22 months, call data were audited.

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Results: The HP hotline received 108 calls over the study period, mostly from
pharmacists (61%) and doctors (29.6%). Average call duration was 21.3 minutes.
Fifty-two ADRAC reports were generated, resulting in a signal to noise ratio (SNR)
for the hotline of 48.1% or 1:1. A further 52 reports were independently submitted by
participants to ADRAC, giving a total of 104 reports for the study, 19% of which
were serious. Data analysis confirmed that ADR reporting increased significantly
(p<0.05) in all intervention groups, to three to four times pre-study rates whereas
reporting in the control group fell slightly.

In contrast, the consumer helpline received 972 calls throughout the study period,
with television and radio being the most effective forms of marketing. At 24.3
minutes, average call duration was not dissimilar from HP calls. Callers were
predominantly female (79.5%) and middle aged (49.4% aged 51-70 years); 84.6%
called regarding themselves and the remaining 15.4% calling on behalf of a
significant, most frequently a spouse, parent or child. Of the 750 potential adverse
drug events, only 13% were assessed by the helpline as being not medication-related.
A total of 336 ADRAC reports were submitted, giving a SNR of 34.5% or 1:2.

Consumers reported a broad range of symptoms associated with a wide range of
therapeutic drug classes. The novelty of consumer ADRAC reports was demonstrated
by 13.4% being associated with CMs, 2% concerning recently marketed drugs and
15.6% of reactions not listed in the medicine’s product information. Training and
protocols ensured that ADRAC reports submitted by helpline pharmacists were of
consistently high quality, 62% of which were probable or certain, and 13.1% serious
(involving hospitalisation).
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Conclusions: ADR reporting by HPs improved marginally with education and
assistance to reduce the burden of reporting. The number, breadth and quality of
ADRs reported by consumers via a pharmacist-operated helpline demonstrated that
consumers can make a positive contribution to pharmacovigilance, which
complements existing HP ADR reporting systems.

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