The use of monitored dosage systems for patients in residential homes might
no longer be appropriate if pharmacists had to record batch details of dispensed
medicines under the proposed European general product safety directive (GPSD),
the Royal Pharmaceutical Society’s chief scientist (Professor Tony Moffat)
has said.
Writing to the Department of Trade and Industry, which is consulting about implementing
the directive in the United Kingdom, Professor Moffat said that the GPSD and
the patient pack initiative could create problems for community pharmacists.
Both were designed to protect the integrity of products throughout the supply
chain and could cause problems in the recording of batches issued and in the
recall of defective products from consumers.
However, despite the concerns raised above, Professor Moffat said that the Society
did want to see medicines included within the remit of the directive.
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| Batch number recording and patient information leaflet requirements might make MDS use "no longer appropriate" |
The main reason for this was that the existing legislation on medicines safety,
the Medicines Act 1968, only applied to licensed medicines.
A survey carried out by the Society had found that 99 per cent of community
pharmacies sold one or more types of unlicensed or complementary medicinal product,
including dietary supplements, herbal or homoeopathic products, essential oils
and flower remedies.
The provisions of the GPSD, with regard to reporting adverse events, recalling
products from consumers and informing manufacturers and the authorities of defective
products, if implemented, would apply to unlicensed medicines.