The Pharmaceutical Journal
Vol 280 No 7496 p418-419
5 April 2008

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, 2001 to present

• Retrievable audit trail
• Multiple packs
• Advice on the use of cough and cold products in children

Retrievable audit trail

Following a recent case considered by the Society’s Investigating Committee, pharmacists are offered the following information in relation to maintaining a retrievable audit trail of the pharmacist responsible for the provision of each pharmacy service.

The Professional Standards for Pharmacists and Pharmacy Technicians in Positions of Authority states that you must ensure that clear lines of accountability exist and a retrievable audit trail of the health professional taking responsibility for the provision of each pharmacy service is maintained.

When maintaining an audit trail, you are strongly advised to have systems in place that will answer the question: who did what and when? There are several ways to ensure that a verifiable audit trail is in existence:

• It is strongly recommended that you use the “dispensed by/checked by” boxes on dispensing labels. This advice is given in guidance produced by the Society entitled “Risk minimisation with regard to dispensing and checking” (PDF 90K). This will identify who checked and who dispensed the prescription. You must ensure that the initials are legible.

• You should also maintain a record of the pharmacist who undertook the clinical check. One way of doing this may be to initial the prescription.

• Maintaining a record of the pharmacist in personal control provides information on who was responsible for supplying the dispensed medicine. If there is more than one pharmacist in the pharmacy, consider other ways to identify who made the supply. Again, initials could be placed on the prescription, or on the label of the dispensed medicine.

• As technology develops, there may be ways for pharmacy computer systems to record this information.

Maintaining a verifiable audit trail is a matter of clinical governance and a code of ethics requirement. It protects not only the public but also you as an individual, as the audit trail assists with identifying what went wrong when an error occurs.

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Multiple packs

Following a recent case considered by the Society’s Investigating Committee, pharmacists are offered the following information in relation to the supply of multiple packs of the same medicine.

Principle 1 of the Code of Ethics for Pharmacists and Pharmacy Technicians states that you must make the care of patients your first concern. In complying with this you must encourage the effective use of medicines and be satisfied that patients, or those who care for them, know how to use their medicines. When patients are provided with multiple packs of the same medicine, you must consider ways to advise the patient that these packs must be taken one after the other or sequentially.

The risk of confusion is increased if a patient is supplied with medicine from more than one manufacturer, since the different packaging from different manufacturers may lead the patient to believe the products are different medicines.

The Society’s guidance on “Risk minimisation with regard to dispensing and checking” (PDF 90K) advises that if multiple containers are required the label should state: “This is one of … containers”. Alternatively, pharmacists could label each pack as “1 of X”, “2 of X”, etc.

The National Patient Safety Agency has produced “Design for patient safety: a guide to the design of dispensed medicines”. This advises: “Always label each container when a medicine is supplied in multiple packs. Include information to indicate that each container is one of a number holding the same medicine.”


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Advice on the use of cough and cold products in children

This bulletin aims to provide additional information on the Medicines and Healthcare products Regulatory Agency (MHRA) advice on the use of cough and cold products in children under two years of age.

The MHRA reviewed the safety and efficacy of cough and cold products in children and advised that cough and cold products containing certain active ingredients will no longer be licensed for children under the age of two years.

The active ingredients involved are:

• Brompheniramine, chlorphenamine and diphenhydramine (antihistamines)

• Dextromethorphan and pholcodine (antitussives)

• Guaifenesin and ipecacuanha (expectorants)

• Phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline (decongestants)

The Royal Pharmaceutical Society issued guidance in response to the MHRA advice (PDF 50K) and recommended that pharmacists review how these products are stored and sold.

Products with updated advice on their packaging and in the patient information leaflets should be in pharmacies and stores by October 2008.

In the meantime, a leaflet for parents and carers is available with additional information concerning management of coughs and colds in children, toddlers and babies (PDF 220K). Non-pharmacy outlets have been informed of the situation via the British Retail Consortium.

Products directly targeted at children under two years to be removed from open display Six products directly targeted at children under two years (ie, positioned for young babies because of their name, pictures of babies on the pack, etc) should be removed from open display until they have been repackaged with new dosage instructions and updated advice. They will still be available under the supervision of a pharmacist, for children over the age of two years.

•Asda Childrens Chesty Cough Syrup
•Boots Chesty Cough Syrup 1 yr Plus
•Boots Sore Throat and Cough Linctus 1 yr Plus
•Buttercup Infant Cough Syrup
•CalCough Chesty
• Childrens Chesty Cough (Bell’s)

Products authorised for use in children up to six years of age Single ingredient analgesic products containing paracetamol and ibuprofen are not affected. Parents can still give these to children to manage pain and fever.

The MHRA website contains a table entitled “Products authorised for use in children up to 6 years of age which can be sold as before”. The products cited in the table should no longer be supplied for use in under-twos but, because they are not directly marketed at this age group, they do not need to be removed from open display.

This list is as fully comprehensive as the MHRA could make it. However it should be noted that not all products are currently marketed and some products have more than one authorised product name and may be marketed under alternative names.

If a medicine has more than one indication but includes coughs and colds, the advice on supply to under-twos still applies even if the product is not specifically being sought for management of coughs and colds.

The advice on supply to under-twos does not apply to any products that do not have cough or colds included as part of the licensed indications.