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Paracetamol recall: a natural experiment influencing analgesic poisoning

David Gunnell
MJA2002; 176 : 561-563

To the Editor: A potentially important, if somewhat crude, means of suicide prevention involves restricting the availability of commonly used methods. In 1967, for example, restrictions on barbiturate prescribing in Australia led to declines in its use for suicide and in overall suicides.1 A crucial concern with this approach is that distressed individuals might use alternative, more lethal, methods. In Britain, there is just such a concern in relation to recent legislation restricting the availability of paracetamol.2

Analysis of the natural experiment investigated by Balit and colleagues3 does not, however, provide useful insights into the impact of paracetamol sales restrictions. Their most consistent finding was that, despite restricted availability for the period studied, paracetamol accounted for about 10% of all contacts with the two poisons information centres in both time periods.

In Britain, in 1998, paracetamol purchases from chemists and supermarkets were restricted rather than banned.4 Up to 16 g (32 tablets) may be purchased from pharmacies and 8 g from supermarkets. The aim was not to prevent overdose but to reduce its severity. Presumably, over the periods studied by Balit et al, paracetamol was simply unavailable. As their analysis is based on calls to poisons information centres rather than on the clinical records of people presenting to hospital, they could not assess whether changes in paracetamol availability influenced indicators of severe poisoning — death and liver damage. A decline in the number of severe paracetamol poisonings, without a change in total episodes of paracetamol overdose, might be considered the most important end-point.

Attention is drawn to statistically significant rises in calls concerning ibuprofen in one centre and aspirin in the other. The clinical significance of these observations is questionable. Overdoses of ibuprofen are less harmful than paracetamol,5 and the significant rise in aspirin overdose represents an increase from two calls per year to five per year — an increase of only three calls. Of note is the fact that the largest absolute decline in calls related to paracetamol (from 423 per year in 1997–1999 to 370 per year in 2000). Furthermore, as only two time points are compared, it is impossible to determine whether the increases reflect year-on-year changes in use of particular drugs for overdose, as might occur with increased ibuprofen sales.

Legislation seeking to influence patterns of harm through changing the availability of drugs which are beneficial when used safely should be monitored carefully.4 Balit et al do not provide convincing evidence concerning the effects of paracetamol sales restrictions on population health.

  1. Oliver RG, Hetzel BS. An analysis of recent trends in suicide rates in Australia. Int J Epidemiol 1973; 2: 91-101. <PubMed>
  2. Gunnell D, Hawton K, Murray V. Use of paracetamol for suicide and non-fatal poisoning: world-wide patterns of use and misuse. Suicide Life Threat Behav 2000; 30: 313-326. <PubMed>
  3. Balit CR, Ibister GK, Peat J, et al. Paracetamol recall: a natural experiment influencing analgesic poisoning. Med J Aust 2002; 176: 162-165. <eMJA Full text> <PubMed>
  4. Hawton K, Townsend E, Deeks J, et al. Effects of change in legislation on pack size of paracetamol and salicylate on self-poisoning in the United Kingdom: before and after study. BMJ 2001; 322: 1203-1207. <PubMed>
  5. Perry SJ. Streete PJ. Volans GN. Ibuprofen overdose: the first two years of over-the-counter sales. Hum Toxicol 1987; 6: 173-178. <PubMed>

(Received 28 Mar 2002, accepted 24 Apr 2002)

Department of Social Medicine, Canynge Hall, Bristol, UK.

David Gunnell, Senior Lecturer in Public Health Medicine and Epidemiology.

Correspondence: Dr D Gunnell, Department of Social Medicine, Canynge Hall, Whiteladies Road, Bristol, BS8 2PR, UK. d.j.gunnellATbristol.ac.uk

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Anthea Steans
MJA 2002; 176 (11): 562

To the Editor: In their recent article,1 Balit et al concluded "restriction of paracetamol-containing products may inadvertently increase poisoning with potentially more toxic agents". As manufacturers of one brand of ibuprofen tablets and the only brand of ibuprofen suspension in Australia, we would like to comment on the article and its conclusion.

We understand that the objective of the audit was to determine whether the occurrence of paracetamol and non-paracetamol analgesic deliberate self-poisoning and accidental paediatric poisoning was affected by two periods of recall of paracetamol products.

However, our concern is that the article's conclusion — "may inadvertently increase poisoning with potentially more toxic agents" — is not linked to any long term outcomes nor any follow-up regarding ongoing sequelae. This conclusion might give the impression that ibuprofen is more toxic than paracetamol when taken in an overdose situation, whether deliberate or accidental. It might also give the impression that overdoses of ibuprofen leave the patient with ongoing morbidity.

In addition, we note that the percentage change in deliberate self-poisonings at both the NSW Poisons Information Centre (PIC) and the Hunter Area Toxicology Service for the periods when paracetamol was restricted, although seemingly large and statistically significant for the PIC, both came from a very low base (0.9% and 0.8% of all calls, respectively).

  1. Balit CR, Isbister GK, Peat J, et al. Paracetamol recall: a natural experiment influencing analgesic poisoning. Med J Aust 2002; 176: 162-165. <eMJA Full text> <PubMed>

(Received 11 Mar 2002, accepted 24 Apr 2002)

Boots Healthcare Australia Pty Ltd, North Ryde, NSW.

Anthea Steans, Director, Technical and Quality.

Correspondence: Dr Anthea Steans, Boots Healthcare Australia Pty Ltd, Locked Bag 2067, North Ryde, NSW 1670. jane.parkerATbhint.com

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Corrine R Balit, Geoffrey K Isbister, Andrew H Dawson and Ian M Whyte
MJA Print ISSN: 0025-729X Online ISSN: 1326-5377 3 June 2002 176 11 563

In reply: There appears to be some misunderstanding about both the conclusions and the methodology of our study.1 We showed that when the availability of one analgesic (paracetamol) decreased, the use of the next most available analgesic increased in deliberate and accidental self-poisonings. We did not look at the relative toxicity of the analgesics, but referred to the published literature on acute paracetamol and ibuprofen overdoses in children, noting that serious complications of acute overdose in children have only been reported with ibuprofen.2-4

Data reported in the study not only included a poisons information centre, but also included data from hospital presentations. The Hunter Area Toxicology Service (HATS) manages all patients with poisoning in the Newcastle region and is based at the Newcastle Mater Misericordiae Hospital. The limitation of the small sample size in the HATS data was discussed in the article, highlighting the fact that, as this was an opportunistic study, it was not possible to increase the sample size. However, the conclusions drawn were based on two different data sets, with a much larger sample size for the NSW Poisons Information Centre data.

Overdose is a significant public health problem that requires appropriate post-marketing vigilance. For drugs that are commonly taken in overdose, it is important to take advantage of opportunities to assess the potential effect of any change in availability.

  1. Balit CR, Isbister GK, Peat J, et al. Paracetamol recall: a natural experiment influencing analgesic poisoning. Med J Aust 2002; 176: 162-165. <eMJA Full text> <PubMed>
  2. Oker EE, Hermann L, Baum CR. Serious toxicity in a young child due to ibuprofen. Acad Emerg Med 2000; 7: 821-823. <PubMed>
  3. McGuigan MA. Common culprits in childhood poisoning: epidemiology, treatment and parental advice for prevention. Paediatr Drugs 1999; 1: 313-324. <PubMed>
  4. Isbister G, Whyte I, Dawson A. The pediatric forum: pediatric acetaminophen poisoning. Arch Pediatr Adolesc Med 2001: 155: 417-418.

(Received 26 Mar 2002, accepted 24 Apr 2002)

NSW Poisons Information Centre, The Children's Hospital, Westmead, NSW.

Corrine R Balit, BPharm, Pharmacist.

Department of Clinical Toxicology and Pharmacology, Newcastle Mater Misericordiae Hospital, Newcastle, NSW.

Geoffrey K Isbister, BSc, MB BS, Toxicology Registrar; Andrew H Dawson, FRCP(Ed), FRACP, Senior Staff Specialist, and Associate Professor, Department of Clinical Pharmacology, University of Newcastle; Ian M Whyte, MB BS, FRACP, Director, and Associate Professor, Discipline of Clinical Pharmacology, University of Newcastle.

Correspondence: Ms C R Balit, NSW Poisons Information Centre, The Children's Hospital, Locked Bag 4001, Westmead, NSW 2145. corrinebalitATaol.com

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©The Medical Journal of Australia 2002 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377