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a scales of justice imageNovember 16 2017

The regulatory changes which will decriminalise dispensing errors have been laid before Parliament but are not expected to come into effect until 2018.

The draft of The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 will amend the Medicines Act 1968 and introduce new defences relating to preparation errors and dispensing errors.

It will apply to pharmacists and pharmacy technicians working in community pharmacies and follows work conducted by the Rebalancing Medicines Legislation Board. This was, in part, set up to address concerns arising from a prosecution in 2009 of a pharmacist for a dispensing error; on appeal, a suspended sentence was quashed. An earlier case, involving the death of an infant in 1998 due to preparing peppermint water at the wrong concentration, has overshadowed discussions about the application of the Medicines Act since then.

The first part of the new regulatory amendments relates to the offence of adulterating a medicinal product, and whether or not the product was sold or supplied. The defence will require, if the product is not sold or supplied (section 67A) that:

  • the person who adulterated the product either was a registered pharmacist or registered pharmacy technician who was acting in the course of his or her profession, or was acting under the supervision of such a registrant
  • the adulteration took place at a registered pharmacy;
  • the defendant did not know that the product was being – or (if it was being offered or exposed for sale or supply) had been – adulterated.

If an adulterated product is sold or supplied (section 67B), then for a defence:

  • the person who adulterated the product either was a registered pharmacist or registered pharmacy technician who was acting in the course of his or her profession, or was acting under the supervision of such a registrant;
  • the adulteration took place at a registered pharmacy;
  • the product must have been sold or supplied in pursuance of a prescription or directions, or be an emergency sale or supply of a prescription only medicine;
  • if an appropriate person (such as the dispenser) becomes aware of the mistake, all reasonable steps must be taken to ensure that the patient is notified of the mistake, unless the appropriate person reasonably forms the view that it is neither necessary nor appropriate to do so.

The second part relates to a dispensing error around the sale or supply of a medicinal item not in accordance with what was requested or prescribed (section 67C). The explanatory notes say the defence is similar to section 67B.

Two new sections are added to the Medicines Act. The first, 67D, puts a duty on the prosecution to show that a pharmacist or pharmacy technician defendant was not acting in the course of his or her profession, and that the person deliberately failed to have due regard for patient safety.

The second part 67E includes a definition of “adulteration” in relation to a medicinal product: “the addition of a substance to, or the abstraction of a substance from, the product, so as to affect injuriously its composition.”

Commenting on the announcement, the General Pharmaceutical Council’s Chief Executive, Duncan Rudkin, said: “Openness and honesty when things go wrong is a core part of the standards for pharmacy professionals. This change in legislation will remove a barrier to improved reporting and learning from errors and we are pleased to see continuing progress towards changing this legislation.

“We look forward to a governmental consultation next year on removing the threat of criminal sanctions for dispensing errors made by pharmacists working in settings other than registered pharmacies. We have consistently been clear that single dispensing errors do not in our view constitute a fitness to practise concern, if there is not a wider pattern of errors or significant aggravating factors.”

The Royal Pharmaceutical Society’s Chief Executive, Paul Bennett, has also welcomed the piece of legislation. “This is a welcome move and marks the beginning of the end for the automatic criminalisation of inadvertent dispensing errors,” he said.

“Addressing this historical imbalance between professional regulation and criminal law will help foster a learning culture, encourage the reporting of errors and ultimately support patient safety.

“The Royal Pharmaceutical Society and others have campaigned to keep this in front of policymakers over a number of years and we appreciate that this has been a long journey for the profession.

“We will continue working with the Rebalancing Board as it seeks to develop similar proposals for hospitals and other pharmacy settings. We hope that it will now take this opportunity to build on this important milestone and engage with wider stakeholders.”

The legislation has been awaited since at least 2015, when MPs asked questions in Parliament. The date in the order, 2018, reflects that the draft Order now has to be approved by each House of Parliament.

Links:
Legislation.Gov.UK draft Order: ‘The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018’                   
GPhC comment                
RPS comment    
Today’s Pharmacist coverage of MPs questioning timing of legislation in July 2015

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