A Complaint Involving the Dispensing of the High Tech Medicine Enbrel® Injection

The Professional Conduct Committee (PCC) heard a complaint in which a patient had been supplied with the High Tech medicine Enbrel® (etanercept) 50mg solution for injection, without a valid prescription on multiple occasions over a 14 month period. This contributed to a situation where the patient did not attend clinical review with their Consultant Rheumatologist for over 2 years. This was brought to the attention of the PSI by a HSE primary care pharmacist and the patient’s Consultant Rheumatologist. As a result, the PSI initiated an investigation into the pharmacy, to review the documentation relating to the supply of Enbrel® to this patient, and the general systems that were in place in relation to the dispensing of Enbrel® generally.

  • The Authorised Officer's investigation led to a review of the relevant prescriptions at the pharmacy, which identified that two pharmacists had supplied the patient with Enbrel® 50mg injection after the expiry date of the last prescription issued by the Consultant Rheumatologist.  This resulted in the supply of this medicine on 11 separate occasions over a 14 month period, without a valid prescription or any clinical review.    
  • The Authorised Officer noted that the last valid prescription authorising the supply of Enbrel® 50mg injection for the patient was not endorsed, as required by the legislation.  If this requirement had been followed it would have assisted the pharmacists in identifying that the prescription was not in date and that the patient required a clinical review.
  • During the investigation the Authorised Officer requested to review the prescriptions used to authorise eight supplies of Enbrel® to other patients.  Seven of the eight prescriptions retrieved and presented for review were not endorsed to show the date and quantity of supply to the patient, as required by the legislation.

Important Learnings

The PSI is very concerned about the number of complaints raised involving the incorrect supply of High Tech medicines, and in particular the supply of Enbrel®, leading to potential harm to patients.  This issue has been highlighted to pharmacists on numerous occasions along with PSI guidance on Good Dispensing Practice for the High Tech Scheme.

If you are a superintendent or supervising pharmacist, we urge you to review this area of practice in your pharmacy regarding the safe supply of medicines to patients, under the High Tech scheme.  You should review your pharmacy procedures for dispensing and supply of High Tech medicines and ensure everyone in the pharmacy is in compliance of such procedures.  All pharmacists should ensure that they are clear on the requirements of the High Tech scheme, the contents of the PSI guidance and ensure that these medicines are handled and dispensed with due care and safety to their patients.  

We would like to highlight the following important learnings from this inquiry:

  • When dispensing a medicine from a repeat prescription it must be checked against the original prescription at each dispensing to ensure the prescription is legally valid and remains therapeutically appropriate for the patient. Carrying out this check will also ensure any errors made on the initial dispensing are identified and not repeated.
  • During the inquiry, it was highlighted that a note specifying the date of review for the last valid High Tech prescription was included in the comments box on the Patient Medication Record, however this was not picked up on at the point of dispensing.  Information recorded in the Patient Medication Record can provide useful notes and reminders about a patient’s care, however this can easily be missed and should not solely be relied upon for continued supply. You are personally responsible for ensuring each supply of medicine you make has been authorised by an appropriate prescriber and is therapeutically appropriate for the patient.
  • A prescription issued for a High Tech medicine is subject to the same legal controls as any other prescription. The maximum validity period for any prescription issued (excluding schedule 2 and 3 controlled drugs) is six months from the date of issue. This ensures that the patient receives ongoing clinical review at appropriate intervals and is central to ensuring the safe use of these medicines.  Some High Tech prescriptions may specify an earlier date of patient review and care must be taken to ensure the prescriber’s instructions are correctly interpreted and followed. A prescription dispensed outside its expiry date can result in the patient not receiving the necessary clinical review, which could potentially result in harm to the patient.
  • Where a patient requests a High Tech medicine without a valid prescription or past the validity period of a prescription, the pharmacist should first contact the consultant responsible for the patient's care to check if the patient needs to be reviewed and continuation of treatment is intended. If this is not possible, the patient’s GP should be contacted.  All relevant interactions should be documented in full.
  • The need to have a valid prescription for each supply should be highlighted to the patient, to ensure their understanding of the legal controls that are in place and the need for their condition and medication to be reviewed by either their consultant or GP on a regular basis.
  • It was noted that a Standard Operating Procedure (SOP) on ‘dispensing’ was in place in the pharmacy at the time the supplies were made. It provided that all prescriptions must be assessed for any legal and clinical issues prior to dispensing to ensure that the medication is clinically appropriate for the patient and legally valid. It is apparent that this procedure was not followed at the time of dispensing Enbrel® to this patient or it would have been identified that the prescription was expired. SOPs should be followed at all times to ensure that a process is carried out to a consistently high standard by all staff members involved, in line with legislation and good practice, and to minimise the risk of errors.
  • Dispensing procedures in place in your pharmacy should specifically address the particular requirements for supply of High Tech medicines.  The superintendent and supervising pharmacist are responsible for ensuring that staff involved in the supply of medicines under the High Tech scheme are trained on the relevant procedures. Training records should be maintained to document this.
  • Regulation 7 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) requires that where a prescription is dispensed in part, the person who dispenses it shall record on the prescription the quantity of each product supplied, the date of supply and the name and address of the pharmacy where the prescription was supplied. Regulation 7 also requires that where the dispensing of a prescription has been completed in full, the person who dispensed it shall write or print prominently the word “dispensed” on the prescription.  As well as being a requirement of legislation, this provides a hard copy audit trail for the supply of the medicine for you and your colleagues.  This also provides an opportunity to confirm the prescriber’s directions and the validity of the prescription as well as identify an error made on a previous dispensing. This is an important part of the overall structure and control of the supply of prescription-only medicines and should not be ignored.  
  • An error log must be completed for all errors made in the pharmacy, the staff members involved informed of the error, and appropriate follow-up regarding the patients care provided. 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 a similar error occurring again.

Further reading to help you review your practice: