A Complaint Involving the Dispensing of Zantac Syrup 75mg/5ml for an Infant.

The Professional Conduct Committee (PCC) heard a complaint in which an infant had been supplied with a medicine labelled with the incorrect dose.

The infant’s parent presented a handwritten prescription to the pharmacy which read: ‘Zantac 75mgs/5mls, ∙3ml tid x 300mls'
The zero before the decimal point of the dose had been omitted. Instructions on the prescription also stated: ‘weight dependent’.
The prescription did not state an age or date of birth and the infant was not present in the pharmacy.
There was only an opened bottle of Zantac 75mg/5ml Syrup in the pharmacy. The pharmacist gave evidence that they checked the Patient Information Leaflet (Package Leaflet) to check the shelf life of the product when it is opened, as well as to read the other information on the leaflet. The pharmacist spoke to the infant’s parent to ascertain if they were happy to accept an opened bottle of 290mls, which they confirmed they were.
The pharmacist misread the prescription as 3ml (rather than 0.3).The pharmacist believed that the prescription related to a child because of the inclusion of the words ‘weight dependent’ on the prescription and presumed that the doctor had calculated the appropriate dose for the child’s weight. The pharmacist made no inquiry of the parent presenting the prescription as to the age or weight of the child.
The pharmacist dispensed the incorrect dose of Zantac and labelled the bottle accordingly, as: ‘GIVE THREE ML THREE TIMES A DAY AS DIRECTED’.
The dispensing error resulted in the infant receiving 45mg three times daily, rather than 4.5mg three times daily, as intended.
The error was identified by another healthcare worker six days later and the infant was taken to hospital and kept in overnight for observation.

Important Learnings

Learnings from this complaint should be shared with all staff members and you should review your own practice to help ensure a similar incident does not happen in your pharmacy.

This complaint highlights the following important learning points:

The pharmacist has a legal responsibility to review each prescription prior to dispensing and supply of the medicine to ensure that the medicine is safe and appropriate for the patient.
Ranitidine is often prescribed for infants ‘off label’ and therefore the relevant dosing information may not appear in the product’s Package Leaflet or Summary of Product Characteristics (SmPC). Therefore the dose should be checked using a reliable resource, for example, the BNF for Children. The infant’s weight will be needed to calculate the dose. In the absence of this information, a reliable average weight for age table (for example as given in the BNF for Children) can be used to calculate the dose. However, it is important to either see the infant or check with the parent or carer to ensure the value chosen is a good approximate. The infant’s actual weight should be obtained as soon as possible and the dose re-calculated to ensure it is appropriate.
Where at all possible get another colleague to check your workings. This does not necessarily need to be another pharmacist. Explaining your workings and logic to another member of staff can be enough to identify an error that may otherwise have been missed.
Do not rely on the doctor to calculate the correct dose; you must be satisfied with the clinical appropriateness of all medicines that you dispense.
If the dose on the prescription is not clear you should contact the prescriber to confirm. If the prescriber cannot be contacted, consider what other options are available to confirm the correct dose. For example, contact the pharmacy department in the hospital where it was first prescribed or another doctor in the practice if it was initiated by a GP.
Regulation 7 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, sets out the requirements for a legally valid prescription. It is a legal requirement for the prescription to specify the age of the patient if they are under 12 years old. If this information is omitted, the pharmacist can still dispense the prescription but they must exercise due diligence and care, and be satisfied that it is safe to do so.
The appropriate dose of ranitidine for an infant will often be a fraction of a millilitre. It is important to highlight this to the parent or carer and to supply an oral syringe that can accurately measure the correct volume.
The pharmacist must be mindful that the shelf life of Zantac liquid once it is open is 28 days and to highlight this to the parent or carer.
The pharmacist also has a legal responsibility to ensure that the infant’s parent, or their carer, has sufficient information and advice for the proper use and storage of the prescribed medicine. You should confirm understanding of this information; this can also serve as a final check and help to identify an error that may otherwise have been missed.
Consider what you would do if you discovered a dispensing error in your pharmacy; who would you contact? As well as the patient and/or their carer and the doctor, this may include for example the manufacturer of the product and the National Medicines Information Centre to ascertain further information on the product. Where would you refer the patient to? What information would be necessary to provide to the patient and/or their doctor?
An error log should be completed for all errors made in the pharmacy, and the staff members involved should be informed of the error. Recording errors should not be used as a way to blame individuals, but rather to encourage an environment of openness and learning, so that procedures can be reviewed and amended, and practices changed to guard against similar errors happening again.

The November/December 2012 PSI Newsletter highlighted an increase in the number of complaints reported to the PSI relating to errors made during the dispensing of prescriptions for children. The article also outlined a range of Risk Reduction Tips to help pharmacists review and improve their own practice.