Patient safety spotlight: the risks of prescribing and supplying medicines to children
In the first of a new series of Regulate articles highlighting patient safety issues we encounter during inspections and through other intelligence-gathering, our Clinical Fellow, Aileen O’Hare introduces this article about dispensing errors involving children. Paediatric specialist clinical pharmacy colleagues from Evelina Children’s Hospital consider how to address and prevent dispensing errors in medicines for children and highlight action points and resources to help pharmacy teams avoid similar situations.
Harm caused to children through inadvertent under and overdosing of liquid medicines is not a new issue and paediatric medications errors affect around 13% of paediatric prescriptions. Often this is due to a change in concentration of the liquid supplied without the person administering it being aware of the change, resulting in an incorrect volume and dose being administered with potentially severe, even fatal consequences. It’s important to be aware of the risks associated with providing medicines to children, and the importance of stringent prescribing, ordering, dispensing, checking, and counselling processes.
A recent case, highlights the need for pharmacy teams to identify and mange risks relating to the dosing and supply of paediatric specials liquid medications.
The case relates to a 13yr old child with a complex diagnosis of epilepsy, treated with Clobazam, in addition to Cannabidiol, Zonisamide and Lacosamide. The child was prescribed Clobazam oral suspension 5mg/5ml, Dose: 7mg (7ml) once daily.
The community pharmacy dispensed Clobazam oral suspension 10mg/5ml instead of 5mg/5ml, which was furthermore incorrectly labelled as ‘5mg/5ml: Take 7ml (7mg) daily’ the parent continued to administer 7ml, resulting in the child receiving 14mg of Clobazam instead of the intended 7mg dose.
After approximately one month the parent noticed the dispensing error and reported it. A few weeks prior to this, the parent had conveyed increasing unsteadiness to the child’s neurologist, which was ultimately attributed to the incorrect dose.
This case raises questions as to whether the following standards for registered pharmacies had been met during the dispensing process:
1.1 The risks associated with providing pharmacy services are identified and managed
2.2 Staff have the appropriate skills, qualifications and competence for their role and the tasks they carry out, or are working under the supervision of another person while they are in training
4.2 Pharmacy services are managed and delivered safely and effectively
4.3 Medicines and medical devices are:
- safe and fit for purpose
- stored securely
- supplied to the patient safely
Preventing dispensing errors in medicines for children
Responding to the points raised in this case, we asked paediatric specialist pharmacists at Evelina Children’s Hospital, Helen Cooper (Specialist Paediatric Pharmacist, Kings College Hospital NHS Foundation Trust) and Nanna Christiansen (Associate Chief Pharmacist – Children’s Services, Guys and St Thomas’ NHS Foundation Trust), to give some action points and tips on how pharmacy teams could address these issues, and what information and guidance is currently available to support safe and effective care.
Pharmacy action points
There are many strategies that pharmacy teams across all sectors of healthcare could adopt to prevent paediatric dispensing errors. There are a variety of mechanisms to minimise the risk of error with liquid medicines such as:
Ordering, dispensing, and checking processes
- Request an independent second check on the strength of liquid formulations prescribed and ordered. Liquid medicines of differing strengths are often listed consecutively on electronic prescribing and ordering systems, increasing the potential for mis-selection.
- When dispensing a liquid medicine, take care to double check the strength when picking the item.
- Build in an independent second check to the dose calculations, administration, and labelling instructions of liquid medicines.
- Review storage arrangements of different strengths of the same formulation (which may or may not be the same drug), and medicines with look-alike packaging.
Patient, Parent or Carer Counselling processes
- Ask the patient, parent, or carer what medicine they are expecting i.e., a particular brand or strength of medicine.
- Ask the patient, parent, or carer if they have been supplied with the medicine before, and check if they have any patient held documentation relating to the specific formulation and strength.
- Supply a patient information leaflet (if one is available) from Medicines for Children.
- Visually check medicines with the patient, parent or carer when handing them out.
- Confirm the administration and dose instructions, both in terms of mg and mls to give/take, with the patient, parent, or carer.
- Ensure the patient, parent or carer feels empowered to challenge any prescriptions in the future that are different to what they are expecting or have previously been supplied with.
Tips for prescribing and supplying medicines
If a child requires a particular formulation, strength, or brand of medicine that may have not been prescribed or supplied before, or staff are unfamiliar with, you will need to consider how to select the most suitable product.
Here are some key points you may find helpful to consider:
- Is supporting information available to help you chose the formulation, such as an unlicensed liquid supply letter from a hospital pharmacy team, or a hospital discharge summary?
- Can you undertake a medicines reconciliation review using resources such as the patient, carer, GP and/or hospital medical records to gain information on the previous liquid medicines the child has received?
- If the prescription is unclear or high risk check the intention with the prescriber or specialist team.
- Is a particular formulation, strength or brand recommended in your local formulary, or nationally by the Neonatal and Paediatric Pharmacist’s Group (NPPG) or BNF for Children?
- Ensure the formulation, strength, brand and supplier are clearly annotated on the prescription
- Prescribe and label the dose as a quantity and a volume, for example: ‘Take 5mg (2.5ml)’
- Consider where to store the product – should it be separated from a similar looking medicine, for example?
- Does administration require a syringe? If so, supply a correctly sized one to help with accurate dosing and explain how to use it
- Does the Medicines for Children website have a patient information leaflet that could be supplied with the medicine?
- Is a complex dose (as a quantity and volume) calculation required? Are current staff competent to perform this calculation or is additional training required? Is there an alternative product that allows for an easier calculation?
- Is the excipient profile of the product appropriate for your patient?
Further information and guided reading
- The RCPCH and NPPG provide a joint list of approved specials which are incorporated in the BNF for Children drug monographs.
- The Royal Pharmaceutical Society outline the professional standards in Professional standards pescribing Specials: Guidance for Prescribers, April 2016
- The Royal Pharmaceutical Society, UK have developed professional guidance for the procurement and supply of specials. December 2015.
- The NPPG have published a position statement on choosing an appropriate oral liquid for a child
- Publications such as Prescribing errors in children: why they happen and how to prevent them. The Pharmaceutical Journal. Conn et al. March 2021 highlight the medication safety risks of prescribing for children.
- The Medicines for Children: Unlicensed Medicines leaflets provide information for patients, parents and carers.