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The Pharmaceutical Journal
Vol 277 No 7421 p430
7 October 2006


Society summary

 Law and Ethics Bulletin

An occasional feature, prepared in the Royal Pharmaceutical Society’s Professional Standards Directorate, to highlight problems and inquiries currently being handled

Law and Ethics Bulletin, 2001 to present

• Sale of paracetamol
• Products containing citronella oil or eucalyptus oil
• Strychnine no longer approved for mole control


Sale of paracetamol

In the light of a recent study of individuals admitted to hospital for acute paracetamol overdose (Postgraduate Medical Journal 2006;82:520), pharmacists are reminded of the need to exercise their professional judgement when they meet requests for large quantities of paracetamol.

Restrictions on the pack sizes of non-effervescent tablets or capsules of paracetamol available from both pharmacy and non-pharmacy premises were introduced in 1998 following changes to legislation. The changes were designed to improve the safety of over-the-counter painkillers because of concern about the number of deaths and serious morbidity connected with overdosing and evidence that many people who intentionally overdose use products that are readily available in the home. 
The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980, as amended, limits the pack size of non-effervescent paracetamol products. Pharmacies may not sell packs containing more than 32 non-effervescent tablets or capsules and may not lawfully supply more than 100 non-effervescent tablets or capsules, or a combination of both, to any one person at any one time.

Pharmacists are advised to use their professional judgement when meeting a request for large quantities of paracetamol. The appropriateness of supplying more than one pack of 32 paracetamol tablets or capsules should be assessed on a case-by-case basis and pharmacists must be satisfied that a decision to supply, or indeed refusal to supply, large quantities of paracetamol is in the individual’s best interests. Pharmacy staff must be appropriately trained to deal with requests for large quantities of paracetamol and able to recognise when referral to the pharmacist may be necessary.

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Products containing citronella oil or eucalyptus oil

UPDATE (14 October 2006)
Clarification: products containing citronella oil or eucalyptus oil

Citronella oil and eucalyptus oil (among other active substances) have been “identified” under the Biocidal Products Directive (BPD)(98/8/EC), which means that biocidal products containing those active substances had to be removed from the EU market by 1 September and cannot be stored for any purpose (except for export and disposal).

The Health and Safety Executive website provides further information and has a list of biocidal products currently approved under the Control of Pesticides Regulations that are affected. Pharmacists are advised to check the list and remove from sale biocidal products containing citronella oil or eucalyptus oil (PDF 2.1MB).

There will be no phased withdrawal as it was the industry’s responsibility to ensure that no biocidal products containing such active substances remained on the EU market after 1 September. Pharmacists should contact the suppliers of biocidal products affected by this for further advice.

For further advice, the HSE can be contacted(tel 0151 951 3535; e-mail biocides@hse.gsi.gov.uk).

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Strychnine no longer approved for mole control

Pharmacists are reminded that since 1 September 2006, strychnine is no longer approved for purchase or use for mole control. Therefore no supplies for this intended use should be made.

Strychnine is classified as “Special Waste” and to dispose of unwanted stock appropriately, the local Environmental Agency should be contacted. Consignment notes will have to be completed before it can be removed and there may be a charge for the removal. If stock is accepted back from authorised users for destruction, the pharmacist would be responsible for ensuring it was disposed of as special waste and would incur the costs.

Pharmacists, however, are not required to take strychnine back from authorised users. It is the user’s responsibility to arrange the safe disposal through a licensed waste collector. (PJ 2005:275:360.)

Further information is available from the Pesticides Directorate website.

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