Paracetamol availability and recent changes in paracetamol poisoning: is the 1998 legislation limiting availability of paracetamol being followed? | Postgraduate Medical Journal

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Paracetamol availability and recent changes in paracetamol poisoning: is the 1998 legislation limiting availability of paracetamol being followed?

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Re: Article relating to Paracetamol in the Postgraduate Medical Journal (2006; 82:520)
Priya R Sejpal
Published on: 1 November 2006
Authors' comment
Dr Shaun L Greene
Published on: 7 August 2006

Published on: 1 November 2006
Re: Article relating to Paracetamol in the Postgraduate Medical Journal (2006; 82:520)
- Priya R Sejpal, Pharmacist
Dear Editor
In my capacity as Professional Ethics Pharmacist at the Royal Pharmaceutical Society (the professional and regulatory body for pharmacists), I have been asked to write to the Postgraduate Medical Journal on behalf of the Royal Pharmaceutical Society’s Law and Ethics Committee.
An article relating to the sale of paracetamol from registered retail pharmacy premises and non-pharmacy premises...
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Dear Editor
In my capacity as Professional Ethics Pharmacist at the Royal Pharmaceutical Society (the professional and regulatory body for pharmacists), I have been asked to write to the Postgraduate Medical Journal on behalf of the Royal Pharmaceutical Society’s Law and Ethics Committee.
An article relating to the sale of paracetamol from registered retail pharmacy premises and non-pharmacy premises was published in the Postgraduate Medical Journal on 7th August 2006.
The article referred to a survey of 107 individual who were admitted to hospital for acute paracetamol overdoses. It stated that one patient had purchased an excessive amount from a pharmacy (the study quotes an excessive amount as being more than 32 tablets). The study also attempted to determine how many pharmacies would be prepared to sell more than an alleged “restricted amount” of paracetamol (the study quoted the amount as 32 tablets) and stated that researchers were able to purchase more than the “restricted amount” in 4 out of the 8 pharmacies visited.
The article claims that legislation limiting OTC availability of paracetamol is not being followed in South London. However, it does not appear that any of the pharmacies referred to in the study have acted unlawfully. Specifically, the article stated ‘pharmacies are allowed to sell a maximum of 32 tablets containing 500mg of paracetamol’. The study also stated that they were able to purchase more than the restricted amount of paracetamol (at least 40 or more tablets instead of the maximum of 32)’.
The Prescription Only Medicines (Human Use) Order 1997, as amended, classes one hundred non-effervescent paracetamol tablets or capsules, or more, as a Prescription Only Medicine. A pharmacist may therefore lawfully sell up to100 non-effervescent paracetamol tablets or capsules to a person at any one time.
Legislation came into force on September 16 1998, regarding the pack sizes of paracetamol that are available from both pharmacy and non- pharmacy premises. The changes were designed to improve the safety of over the counter painkillers following concern about the number of deaths and serious morbidity connected with overdosing and evidence that many patients who intentionally overdose, use products that are readily available in the home. These measures included pack size restrictions and additional safety warnings with instructions to the patient on what to do in the event of an overdose.
The pack size of paracetamol tablets available as a General Sale List (GSL) medicine is restricted to sixteen tablets. Pack sizes of thirty two paracetamol are only available from registered retail pharmacy premises
A pharmacist may lawfully sell 3 x 32 non-effervescent paracetamol tablets or capsule to a person at any one time. Similarly a non-pharmacy retail outlet can lawfully sell 6 x16 paracetamol tablets or capsules. However, the Code of Ethics, for pharmacists, currently states:
Pharmacists must not promote inappropriate or excessive consumption or use of medicines or their misuse, injudicious or unsafe use which may be injurious to health.
Pharmacists must therefore use their professional judgement when they receive requests for large quantities for paracetamol.
While none of the pharmacies in the study appear to have contravened current legislative requirements, the Royal Pharmaceutical Society is in the process of producing guidance for pharmacists about the sale of paracetamol to remind them of the legal and professional considerations of selling multiple packs of paracetamol. However, it was considered important to high-light to the Postgraduate Medical Journal, the inaccuracies in the article in relation to the legal requirements governing the sale of paracetamol.
Yours sincerely
Miss P Sejpal Professional Ethics Pharmacist
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Conflict of Interest:
None declared.
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Published on: 7 August 2006
Authors' comment
- Dr Shaun L Greene, Guy's & St Thomas' Poisons Unit
- Other Contributors:
  Dr Paul I Dargan, Dr Alison L Jones
Dear Editor,
Further to our paper published today, we would like to take the opportunity to make it clear that the MHRA actions in September 1998 operated at two levels. The first of these was legislation that limited pack-sizes of paracetamol. The second of these was a recommendation from the MHRA that advised voluntary restraints to prevent multiple packet sales. Both of these recommendations have been common...
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Dear Editor,
Further to our paper published today, we would like to take the opportunity to make it clear that the MHRA actions in September 1998 operated at two levels. The first of these was legislation that limited pack-sizes of paracetamol. The second of these was a recommendation from the MHRA that advised voluntary restraints to prevent multiple packet sales. Both of these recommendations have been commonly referred to in numerous other studies and subsequent publications in the literature as "the legislation". [1-3]
Despite the legislation, paracetamol remains the most common drug ingested by patients presenting with self-poisoning in the UK. [1] Our study showed that the voluntary MHRA code advising limitation of sales of multiple packs of paracetamol is not being adhered to in a sample of outlets in South London. Therefore the pack-size legislation appears not to be achieving its aim of decreasing the amount of paracetamol available in the home. This is important because paracetamol in the home is the source in approximately half of acute paracetamol overdoses. [4]
One of the limitations of our study is that it looked only at one geographical area. Extrapolation of these findings to the rest of the UK would be inappropriate without further studies.
Yours sincerely
Dr Shaun Greene
Dr Paul Dargan
Dr Alison Jones
References
1. Hawton K, Simkin S, Deeks J, Cooper J, Johnston A, Waters K, Arundel M, Bernal W, Gunson B, Hudson M, Suri D, Simpson K. UK legislation on analgesic packs: before and after study of long term effect on poisonings. BMJ 2004; 329: 1076
2. Morgan O, Griffiths C, Majeed A. Impact of paracetamol pack size restrictions on poisoning from paracetamol in England and Wales: an observational study. Journal of Public Health 2005;27:19-24
3. Morgan O, Majeed A. Restricting paracetamol in the United Kingdom to reduce poisoning: a systematic review. J Public Health 2005;27:12–18
4. Hawton K, Ware C, Mistry H, Hewitt J, Kingsbury S, Roberts D, Weitzel H. Why patients chose paracetamol for self poisoning and their knowledge of its dangers. BMJ 1995;310:164-8
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Conflict of Interest:
None declared.
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