A Complaint Involving the Dispensing of the Controlled Drug Diazepam Liquid for a Child

The Professional Conduct Committee (PCC) heard an inquiry into a complaint which had been made in 2018 in which a parent had been supplied with a controlled substance, Diazepam 2mg/5ml oral solution, for their child.

While the medicine supplied was labelled with the correct dosage the duration of treatment had not been clearly specified on the dispensing label. This resulted in the child receiving Diazepam over a period of five weeks, instead of for three days as intended by the prescriber.

  • The parent presented a prescription for the child to the pharmacy which read: ‘Diazepam 2.5mg BD PRN. PO,3/7’. Instructions on the prescription stated that it was to be taken twice daily for three days.
  • The pharmacist dispensed a 100ml bottle of Diazepam 2mg/5ml oral solution and labelled the bottle “6.25MLS TO BE TAKEN TWICE DAILY AS REQUIRED”, with no limit of three days clearly specified on the label.
  • The pharmacist gave evidence before the PCC of having verbally advised the child’s parent that the Diazepam should only be administered for three days.
  • The child’s parent stated that they had no recollection of being informed by the pharmacist that the medication should be administered for a period of three days.
  • The pharmacist gave evidence that they did not want to decant 37.5 ml from the 100ml bottle for fear of compromising the integrity of the product. The pharmacist stated that they had instead carried out a calculation to determine how much of the oral solution of Diazepam required to be administered in order for the dose of 2.5mg to be administered, they also checked the British National Formulary for Children (BNF for Children) to ensure appropriate dosage. The pharmacist however had failed to include the duration of treatment on the dispensing label.
  • The error was identified when the child was admitted to hospital for one day with behavioural issues which were thought likely to be secondary to withdrawal from medication taken on and off over a period of five weeks.

Important Learnings

Learnings from this complaint should be shared with all staff members and standard operating procedures (SOPs) should be reviewed to mitigate the risk of a similar incident in your pharmacy.

This complaint highlights the following important learning points:

  • Prior to the dispensing of each prescription, pharmacists have a legal obligation to review the pharmaceutical and therapeutic appropriateness of the medicine therapy for the patient. The pharmacist must also ensure that the patient and/or their carer/guardian have sufficient information and advice for the proper use and storage of the medicine.
  • Following the pharmaceutical and therapeutic review, if the pharmacist has concerns with regard to the content of the prescription, they should discuss these with the prescriber. If the prescriber cannot be contacted, consider what other options are available to clarify any queries on the prescription. 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.
  • Children and infants are particularly vulnerable to drug overdose and side effects. It is essential that extra time and care is taken to ensure not only that the correct medicine is supplied and the parent/carer has accurate and detailed information regarding dosing amount, but that the frequency and duration of treatment is also clearly labelled on the medicine and easily understood by the patient and/or their carer/guardian. Pharmacists should not rely solely on oral advice when labelling significantly reduces the risk of misunderstanding.
  • A thorough and robust checking mechanism must be in place when dispensing medicines. To minimise the risk of human error a double check system must be in place where at all possible, this should involve two members of staff in the dispensing process. If the pharmacist is working on their own, they should ensure that they have a mental break between the assembly and labelling of the medicine and doing the final check, to reduce the risk of errors.
  • SOPs should always be followed to ensure that a process is carried out consistently, accurately and completely by all staff members involved, in line with legislation and good practice and to minimise the risk of errors.

Further reading to help you review your practice:
Guidelines on the Counselling and Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business
Advice on Controlled Drug (CD) Compliance (May 2017)
Safe Prescribing and Dispensing of Controlled Drugs (October 2017)
Misuse of Drugs Regulations 2017 Practice Update (October 2017)
Advice on Standard Operating Procedure's (SOP's)