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A New Defence To Dispensing & Preparation Errors In Community Pharmacy

Although the Department of Health has repeatedly expressed its intention to decriminalise community pharmacy dispensing errors over recent years, little in the way of tangible progress occurred until Tuesday 14 November, when Stephen Brine MP laid The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 before Parliament.

This Order will, if enacted, provide a defence to the offences under sections 63 and 64 of the Medicines Act 1968.  Section 63 governs adulteration of medicinal products and section 64 deals with sale and supply of medicinal products.  To date, the offences under these sections have been strict liability offences i.e. offences where a crime is committed even if the error is unintentional (and regardless of the level of patient harm).

The wording of the draft Order is technical and verbose (blame the lawyers!), but essentially a defence will exist in circumstances where:

  • the adulteration/dispensing took place at a registered pharmacy;
  • the defendant was a registrant (pharmacist or pharmacy technician) acting in the course of his or her profession, or was a person acting under the supervision of a registrant who was acting in the course of his or her profession;
  • the defendant/the person who adulterated the product/the supervising registrant did not know that the product was being or had been adulterated;
  • the product was sold or supplied on foot of a prescription or patient group direction or was an urgent supply prescription-only medicine;
  • before being charged, but on becoming aware of the error, all reasonable steps were taken to ensure that the patient was notified (unless it was reasonably considered not necessary or appropriate to do so).

When will the Order come into force?

The new legislation will come into force 28 days after a resolution has been passed by both Houses of Parliament to bring it into effect.  There is no published date for this to happen as yet.  However, based on the draft statutory instrument being numbered ‘2018/000’ it appears likely this will be sometime in 2018.

Will a dispensing error no longer be a criminal offence? 

No.  The provisions of the Medicines Act 1968 which mean that dispensing and preparation errors constitute criminal offences will remain in place.  However, there will now be a possible defence to such offences rather than them continuing as strict liability offences.

Will the new defences be available to hospital pharmacists and pharmacy technicians too? 

No.  In its consultation paper published in 2015, the Department of Health made this clear, but stated: “Hospital pharmacies are not required to be registered in the way community pharmacies are. We do want those working in unregistered hospital pharmacies to have the right to the same defence as those working in registered community pharmacies. The Board is looking at proposals for this now”.

Any other points of interest?

Under the terms of the Order, it is to be assumed that the defendant was acting in the course of his or her profession when they committed the offence unless the prosecution can prove beyond reasonable doubt that (a) the defendant used his or her professional skills for an improper purpose or (b) the defendant deliberately failed to have due regard for patient safety.

Is the draft Order a positive development? 

Yes, to my mind it really is a very significant and positive step forward for community pharmacy.  Hopefully the Order will progress into law within a matter of months and will mean that we no longer see the sad cases of competent, honest professionals criminalised for isolated and genuine errors.

Published inGPhCHealthcare RegulatoryPharmacists