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The New Dispensing Errors Defence - What Pharmacists Need to Know

on Tuesday, 01 May 2018.

New legislation came into force on 16 April 2018 which provides pharmacists with a legal defence for inadvertent dispensing errors.

The Pharmacy (Preparation and Dispensing Errors - Registered Pharmacies) Order 2018 has introduced defences to offences arising from preparation and dispensing errors, made by registered pharmacists and registered pharmacy technicians, at retail pharmacy premises.

The Order requires that the following criteria are met:

  1. The person who made the preparation or dispensing error must be a registered pharmacist or registered pharmacy technician, who was acting in the course of their profession, or must have been acting under the supervision of a registered pharmacist;
  2. The dispensing of the product must have taken place at a registered pharmacy;
  3. The sale or supply must have been in pursuance of a prescription or directions; and
  4. The pharmacy professional, or another appropriate person (such as the dispenser), took all reasonable steps to ensure that the patient was notified of the mistake, unless they reasonably formed the view that it was neither necessary nor appropriate to do so.

Such errors might include instances where the wrong medicine, strength or dosage are dispensed; an ingredient omitted or inadvertently added when making up the medicine, or where a medicine is dispensed to the wrong patient. The Order is intended to improve the reporting of dispensing errors, increase transparency and allow lessons to be learned, without the fear of prosecution.

It should be noted that this Order will only apply to these specific offences, under sections 63 and 64 of the Medicines Act 1968 and not to any other offences under that Act, nor the Human Medicines Regulations 2012.

It is envisaged that less prosecutions will now be brought against pharmacists, for inadvertent dispensing errors, given that they are no longer deemed strict liability offences. However, the Order is not a bar against any prosecution, but merely offers a potential defence that would still need to be successfully established during the course of a trial.  

The pharmacy professional could also still face investigation, at any stage, by the General Pharmaceutical Council and have fitness to practise proceedings brought against them. This could then entail an interim order being made for suspension from the register or conditions being imposed on the pharmacy professional's registration, until the Committee has reached a final decision.  

It remains to be seen whether this legislation will provide sufficient reassurance to pharmacists so as to make it more likely that inadvertent dispensing errors will now be reported.


For more information or questions on fitness to practise and compliance, please contact Andrew Andrews in our Regulatory Compliance team on 020 7665 0864.