A complaint involving the incorrect supply of the high tech medicine Enbrel® Injection to a minor

The Professional Conduct Committee (PCC) recently heard a case in which a minor was supplied with twice the prescribed dose of their medicine Enbrel® (etanercept) solution for injection, over the course of approximately one year. It was clear from the detail of the case that the pharmacist had dispensed the medicine in error from the original prescription. This error was repeated in the subsequent supplies as the patient medication record (PMR) was referred to rather than checking or endorsing the original prescription. When a second prescription was received, the wrong dose was still supplied to the patient for a further 6 months. The error was only realised when a third prescription was presented at the pharmacy in respect of the same patient. The pharmacist then informed the patient’s parent of the error. The inquiry heard that the pharmacist did not inform the superintendent for the pharmacy of the dispensing error, or the patient’s GP or treating consultant that the patient had received an overdose of their medicine for 11 months.

The superintendent pharmacist learned of the dispensing error through queries subsequently raised by the patient’s parents approximately 2 months after the error was discovered. However, the superintendent pharmacist also did not inform the patient’s GP or treating consultant of the dispensing error and the consequential overdose the patient had received.

Important Learnings

The case highlights learnings for all pharmacists in ensuring safe supply of medicines:

  • The original hard copy prescription must be clinically reviewed by the pharmacist before each dispensing. It is a core professional role of the pharmacist to perform a pharmaceutical and therapeutic review of all prescriptions dispensed to ensure the medicine is safe and appropriate for the patient to take. This is a requirement for each supply of a medicine and should be given due time and concentration for every patient, and at each dispensing.
  • 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 labeling of the medicine and doing the final check, to reduce the risk of errors. Particular attention should be paid to sound-alike, look-alike drugs and different strengths of the same drug.
  • When dispensing a medicine from a repeat prescription it must be checked against the original hard copy prescription. Dispensing a medicine from the PMR on the computer risks compounding or perpetuating an initial dispensing error.
  • A repeat prescription should be endorsed with each supply recorded. This is a legal requirement that allows the supplies to be recorded on the prescription and provides an opportunity to check the original prescription, confirm the prescriber’s directions and the validity of the prescription, as well as identify an error made on a previous dispensing. It also provides a hard copy audit trail for the supply of the medicine for the patient, you and your colleagues
  • The way a pharmacist handles a medication error has a direct effect on the patient, and also affects the likelihood of another medication error occurring at the pharmacy. When you discover an error, whether it is an error made by you or by someone else, it is vital that you take immediate action to minimise harm to the patient. Whilst the actions you take will depend on the incident, ensuring the health and wellbeing of the patient must be your first priority. This must include contacting the patient (or their parent or carer as appropriate) to inform them of the error and any necessary actions they need to take to minimise the potential harm, for example seeking immediate medical review. You must be satisfied that the patient understands what has happened, the potential effects and what they need to do next. You should also contact the relevant healthcare professionals involved in the patient’s care to inform them that the patient has received treatment different to that prescribed, and discuss any potential harm to the patient, any consequences for the patient outcomes and any monitoring or other actions needed.
  • It is important that a pharmacy has an error management procedure for recording and reporting errors and near misses which sets out how and where they should be recorded and who should be contacted in the event of an error happening. This allows the pharmacy to ensure that errors and near misses are recorded and reviewed regularly and any procedures are revised and updated so that other patients can be protected from harm from similar incidents. PSI have issued advice on medication error management which should be consulted for further details.

Further reading to help you review your practice: