The Pharmaceutical Journal
Vol 271 No 7256 p33
5 July 2003

Society summary

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, 1992 to present

• Disposal of pharmaceutical waste
• Checking of paediatric dosages

Disposal of pharmaceutical waste

Pharmacists are reminded that prescription-only medicines are subject to control under the Special Waste Regulations 1996 (as amended) and should be disposed of only in accordance with that legislation.

Unwanted medicines in patients' own homes are defined as household waste and are not subject to control by the Special Waste Regulations. However, although many patients dispose of unwanted medicines as normal household waste, pharmacists should encourage the return of medicines to a pharmacy so that they can be disposed of safely, minimising the risk of environmental damage.

The situation with unwanted medicines in care homes is more complicated. Under the Controlled Waste Regulations 1992, all unwanted medicines in residential homes are regarded as household waste, but waste POMs in nursing homes must be controlled as special waste. However, the Care Standards Act 2000, which came into effect in April 2002, redefined both nursing and residential homes as care homes. The Environment Agency has advised that, for the purpose of the special waste regime, an assessment of whether the home is a nursing home or residential home will still need to be made, since this will determine whether the waste is special waste or household waste.

For the disposal of medicines returned by patients, pharmacists generally provide suitable receptacles in which waste is stored safely pending collection by a registered or licensed waste disposal firm. Pharmacists themselves do not normally need a waste management licence because an exemption from the licensing requirements permits the secure storage at a pharmacy, pending disposal, of waste medicines returned from households or residential homes (including medicines that are special waste).

However, any person who transports special waste in the course of their business or with a view to profit must be registered as a waste carrier with the local office of the Environment Agency (in England and Wales) or the Scottish Environmental Protection Agency. Pharmacists who are engaged to pick up waste in the course of their pharmacy business or with a view to profit will therefore need to be registered. Further details should be obtained from the Environment Agency (tel 08459 333 111) or SEPA (tel 01786 457 700).

The Environment Agency has advised that it does not believe that the unplanned collection of waste at a patient's request on a one-off basis falls within the definition of "course of their business". However, any regular arrangement to collect waste — for example, from a residential care home — would require registration. In all cases the waste must be taken directly to the pharmacy and arrangements made for its safe disposal.

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Checking of paediatric dosages

Pharmacists are advised to check carefully the dosage of any prescription for young children, particularly those that require administration by oral syringe.

In a recent case brought to the attention of the Society, a prescription was presented for spironolactone oral suspension 50mg/5ml, 3mg once daily, quantity 125ml. The pharmacist dispensed the product accurately, and labelled it as required by the prescriber.

The infant had previously received the suspension from a hospital, when a 1mg/ml formulation was supplied, together with an oral syringe, and the child had been administered 3ml of this strength suspension. When the pharmacist discussed the administration of the small dosage with the infant's mother, he was talking about a small dose of 0.3ml, but the infant's mother thought he was talking about 3ml, as she had been administering that amount previously. Eventually, the error was discovered, but only after the infant had been taking 10 times the required dosage for several months.

It would therefore be prudent to ask parents of young children, to demonstrate how they measure the required dosage, so that the pharmacist can be satisfied that the correct dosage will be administered.