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Paracetamol availability and overdose in Ireland   Back Bookmark and Share
Laffoy Marie
New regulations for the control of paracetamol come into force in October 20011. These are greatly welcomed and should lead to a reduction in paracetamol poisoning. Existing conditions for the sale and supply of paracetamol (Irish Medicines Board (IMB), 1997), which have no statutory basis, state that non-pharmacy outlets should only sell emergency supplies of paracetamol in a maximum pack size of 12 tablets; just one pack should be sold on each occasion2. This study found that non-pharmacy outlets do not comply with these IMB conditions. Paracetamol poisoning remains the most common form of overdose requiring hospital admission in Ireland. Admissions increased by 29% between 1993 and 1999. The new regulations will give effect to the IMB conditions.
Author : Laffoy Marie, Byrne G, Scallan Elaine

Abstract

New regulations for the control of paracetamol come into force in October 20011. These are greatly welcomed and should lead to a reduction in paracetamol poisoning. Existing conditions for the sale and supply of paracetamol (Irish Medicines Board (IMB), 1997), which have no statutory basis, state that non-pharmacy outlets should only sell emergency supplies of paracetamol in a maximum pack size of 12 tablets; just one pack should be sold on each occasion2. This study found that non-pharmacy outlets do not comply with these IMB conditions. Paracetamol poisoning remains the most common form of overdose requiring hospital admission in Ireland. Admissions increased by 29% between 1993 and 1999. The new regulations will give effect to the IMB conditions.

Introduction

Paracetamol is a commonly used medicine. It is widely available, cheap and usually safe when taken correctly. Paracetamol is used in suicide attempts. Overdose is a frequent cause of hospital admission on both sides of the Atlantic where it is the most common identifiable cause of fulminant hepatic failure.3, 4, 5
The aims of this study were to establish whether hospital admissions due to paracetamol overdose in Ireland dropped when the IMB revised conditions for the supply and sale of paracetamol in 1997 and to determine compliance of non-pharmacy outlets with the conditions.

Methods

Data on hospital admissions were obtained from the Hospital Inpatient Enquiry System (HIPE). One hundred non-pharmacy outlets in Dublin were surveyed to determine compliance with the IMBs conditions. The outlets, selected arbitrarily, were in the main residential / shopping areas. In each outlet a researcher attempted to buy two packs of any paracetamol product containing 24 tablets or four packs containing 12 tablets i.e. four times more than the conditions of sale stipulate. Four packs of 12 tablets were sought when packs of 24 tablets were not available.

Results

Paracetamol overdose was the main reason for hospital admission due to poisoning between 1993 and 1999, responsible for one-quarter of all poisoning admissions.
 

Table 1aNumber of paracetamol overdose admissions to   hospital 1993-1999
Year
1993
1994
1995
1996
1997
1998
1999
Male
404
408
430
425
466
514
475
Female
707
754
872
866
995
956
958
Total
1111
1162
1302
1291
1461
1470
1433
% Yearly   +4.6% +12.0% - 0.8% +13.2% +0.6% -2.5% change

Hospital admissions from paracetamol overdose increased by 29% between 1993 and 1999, Table 1a. Females had almost twice as many admissions as males. The admission rate per 100,000 population increased from 31.1 to 38.3, Table 1b. The rate of increase was more than twice as high in females than males. The mean length of hospital stay was 2.5 days (1 to 149 days). Admissions dropped by only a 1.9% since IMB conditions were revised in 1997.
 

Table 1b Paracetamol admission rate per 100,000 national   population 1993-1999
Year
1993
1994
1995
1996
1997
1998
1999
Admission rate (male)
22.7
22.9
24.0
23.6
25.6
27.9
25.6
Admission rate (female)
39.4
41.8
48.1
47.4
54.0
51.2
50.8
Admission rate (total)
31.1
32.4
36.2
35.6
39.9
39.7
38.3

HIPE data were 99% complete regarding poisoning intent except in 1998 and 1999 which were 94.8% and 92.2% complete respectively. Between 1993 and 1999 the proportion of overdoses that were intentional rose from 54.4% to 72.3% (female increase: 56.3% to 74.1%; male increase: 51.1% to 68.6%). Approximately 50% of intentional overdose admissions were in the 15-24 age group. Intentional overdose was unusual in children and over 65, Figure 1.

Though the most common age group for accidental paracetamol poisoning was also 15-24, the pattern of accidental poisoning differed from intentional overdose, as children under the age of 5 accounted for approximately 20% of admissions, Figure 2.

Purchases of 48 paracetamol tablets (either 2 x 24 packs or 4 x 12 packs) were successfully made in each shop, Table 2. In three shops a sales assistant commented on the researchers presumed poor health and one hesitated when asked for 4 packs of paracetamol but did not comment. No retail outlet displayed the IMBs conditions of sale nor information on paracetamol dangers. All tablets were sold in blister packs.
 

Table 2 Type of retail outlet visited
Type of shop
No. = %
Large supermarket
30
Mini-market 
24
Smaller shops / newsagents
29
Petrol stations
17
Total
100

The quantity and variety of paracetamol on sale reflected the size of the shop. Large supermarkets stocked a wide variety of paracetamol products in pack sizes of 24 tablets and displayed them prominently in the cosmetics section. Smaller shops generally stocked a 12-tablet pack, had a smaller variety of products but often 2-3 different types. In petrol stations paracetamol was usually limited to one or two product types, available as a 12 pack, and in some cases these were stored behind the counter.

Discussion

Paracetamol poisoning is a serious public health issue. It is the main drug used in self-poisoning6 and the most common cause of hospital admission from poisoning in Ireland. It is a concern that admissions increased by 29% since 1993 as most cases are young people.

Paracetamol poisoning is related to its availability6. There is a strong positive association between sales trends and non-fatal overdose. Ready availability was associated with 43% of hospital admissions from self-poisoning in the UK7. In the US, paracetamol accounted for 4.1% of deaths from poisoning reported to American Poisons Centres in 19978 and most were deliberate self-poisonings. Reduction in the quantity of paracetamol available as a single purchase might reduce suicide and paracetamol related liver failure9.

Young people commonly and naively take paracetamol in suicide gestures10,11. They lack insight of the serious complications associated with misuse and they underestimate the potential for toxicity. One study of 569 adolescents found that 42% felt that paracetamol could do no harm and 50% overestimated the fatal dose10. These findings together with the wide availability of paracetamol were considered to contribute to its frequent use in adolescent suicidal behaviour12.

Gazzard found that none of the 48 patients they interviewed would have taken paracetamol had they known of the 2-3 day interval before the onset of serious symptoms and only five received the drug on prescription13.

The IMBs (1997) conditions for the sale and supply of paracetamol were designed to reduce the incidence and consequences of overdose. These conditions, without statutory backing, have little influence on sales from non-pharmacy outlets, as seen by the mere 1.9% reduction in admissions sine 1997. The IMB conditions are being ignored as:

  1. Sales in excess of the guidelines (12 tablets) are easily made
  2. Large supermarkets sell packs of 24
  3. Supermarkets display large quantities and a varieties of paracetamol
  4. Stocks are not limited to emergency supplies.
Following the introduction of legislative limitations on paracetamol sales in the UK (1997)14 a substantial reduction in paracetamol hepatotoxicity occurred. This was considered to be directly related to the legislative changes in availability15 rather than any increased awareness of the dangers of paracetamol as knowledge does not deter use6. Other UK research found a 21% reduction in the occurrence and a 64% reduction in the severity of overdoses presenting to accident and emergency departments since the legislation was introduced16. This significant change in overdose behaviour was attributed to both the introduction of blister packs and reduced availability. In Ireland blister packs are used routinely but with little associated reduction in poisoning. Therefore, it is likely that legislation in relation to limiting supply is the main contributory factor in reducing of paracetamol poisoning in the UK. The new regulations in Ireland will give statutory effect to the IMB guidelines. However, their strict enforcement is essential if real health gain is to occur.

We acknowledge the support of the Economic and Social Research Institute in providing HIPE data and of the Irish Medicines Board for their valuable advice.

Correspondence:

Laffoy Mariearie,
Department of Public Health,
Eastern Regional Health Authority,
Dr. Steevens Hospital,
Dublin 8.
Telephone: 00 353 1 6790700.
Fax: 00 353 1 6710606

References

  1. Statutory Instrument: S.I. 150 of 2001. Medicinal Products (Control of Paracetamol) Regulations, 2001, Dublin, Stationery Office.
  2. Drug Safety Newsletter; Notification of changes in availability of OTC medicines; Paracetamol. Irish Medicines Board. 1997; 4: May 1997
  3. Makin AJ, Wendon J, Williams R. A-7 year experience of severe acetominophen-induced hepatotoxicity (1987-1993). Gastroenterology 1995; 109: 1907-1916.
  4. Malone K, McCormack G, Malone JP. Non-fatal deliberate self poisoning in Dublins north inner city-an overview Ir Med J 1992;85:132-5.
  5. Schiodt FV, Atillasoy E, Shakil AO, Schiff ER, Caldwell C. Aetiology and outcome for 295 patients with acute liver failure in the United States. Liver Transpl Surg 1999; 5:1, 29-34.
  6. Hawton K, Ware C, Mistry H, Hewitt J, Kingsbury S, Roberts D, Weitzel H. Why patients choose paracetamol for self-poisoning and their knowledge of its dangers. Br Med J 1995; 310(6973):164.
  7. Bialas MC, Reid P, Beck P, Lazarus JH, Smith PM, Scorer RC, et al. Changing patterns of poisoning in a UK health district between 1987-1988 and 1992-1993 Q J Med 1996; 89:893-901.
  8. Litovitz TL, Klein-Schwartz W, Dyer KS, Shannon M, Lee S. Powers M. 1997. Annual report of the American Association of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 1998; 16: 443-97.
  9. Gunnell D, Hawton K, Murray V, Garnier R, Bismuth C, Fagg J, Simkin S. Use of paracetamol for suicide and non-fatal poisoning in the UK and France: are restrictions on availability justified? J Epidemiol Community Health 1997; 51:175-179.
  10. Harris HE, Myers WC. Adolescents misperceptions of the dangerousness of acetaminophen in overdose. Suicide Life Threat Behav 1997; 27(3) 274-7.
  11. Myers WC, Otto TA, Harris E, Diaco D, Moreno A. Acetominaphen overdose as a suicidal gesture: a survey of adolescents knowledge of its potential for toxicity. J Am Acad Child Adolesc Psychiatry 1992; 31 (4):686-90.
  12. Gilbertson RJ, Harris E, Pandey SK, Kelly P, Myers W. Paracetamol use, availability, and knowledge of toxicity among British and American adolescents. Arch Dis Child, 1996; 75 (3): 194-8.
  13. Gazzard BG, Davis M, Spooner J, Williams R. Why do people use paracetamol for suicide? Br Med J. 1976; 24: 1 (6003): 212-3.
  14. Statutory instrument 1997 No. 2045. The Medicines (Sale or Supply) (Miscellaneous Provisions) Amendment (No. 2) Regulations 1997. United Kingdom.
  15. Prince MI, Thomas SH, James OF, Hudson M. Reduction in incidence of severe paracetamol poisoning. Lancet 2000; 355 (9220); 2047-48.
  16. Turvill JL, Burroughs AK, Moore KP, Change in occurrence of paracetamol in UK after introduction of blister packs. Lancet 2000; 355 (9220) 2048-9.

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