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Rebalancing Update – Commencement of Dispensing Errors (Registered Pharmacies) Order

From 16th April 2018, registered pharmacy professionals in England, Scotland, Wales and Northern Ireland, will be able to make use of new defences in the event of inadvertent preparation and dispensing errors in registered pharmacies. On this date the provisions contained in the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018, will take effect. A copy of the legislation can be found by following this link  to The Legislation. This latest development represents the fruition of several years of work to remove the threat of criminal prosecution, as part of wider changes for rebalancing between professional regulation and criminal law. Alongside other key stakeholders UK wide, the Forum has been an active participant on the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board from its inception and in helping to shape this legislation and will continue to do so as the programme of work continues.

In welcoming the legislation the Chair of the Pharmacy Forum NI Sheelin McKeagney stated, “Addressing the issue of criminal prosecution, represents an important step in not only alleviating what has long been a source of considerable concern for colleagues but also in ensuring that the professional consequences for pharmacists, who make dispensing errors, will be much more in keeping with handling errors made by other healthcare professionals. As a profession we are fully focused on patient safety and the highest standards of service delivery. These changes also afford an opportunity to embed an open culture which encourages error reporting and candour. This development should encourage the profession  to learn from mistakes rather than simply to fear them and thus enhance safety and practice and prevent future harm.”

Why is this important?

  • The threat of criminal prosecution for inadvertent dispensing errors has now been removed for pharmacy professionals, in registered pharmacies
  • It is hoped that this will improve error reporting and support an open culture in which patient safety can be improved through a process of reporting, sharing and learning from mistakes
  • The legislation ensures that dispensing errors by pharmacists in a registered pharmacy, are in line with handling errors made by other healthcare professionals

Pharmacy Forum NI Manager Julie Greenfield, “With the introduction of these new defences in the event of inadvertent preparation and dispensing errors in registered pharmacies, coupled with those provisions existing in the Medicines Act, an opportunity now exists for the profession to take up the challenge of encouraging and fully embracing error reporting. As a profession, we can build on our reputation of delivering the highest standards of patient care and ensure that safety remains a paramount consideration.”  

Context

These changes are in the context of efforts by Government, to address the balance between legal requirements, statutory requirements and professional practice.  It is intended that professional practice should be enforced by registration sanctions, rather than by criminal courts. The wider rebalancing programme for pharmacy is focused on improving pharmacy services for patients and the public and reducing and removing barriers to the development of pharmacy practice and new pharmacy services. This work is vital to enable the transformation of pharmacy services and to assist the future development of pharmacists’ roles. You can find out more about the work of the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board by following the this link to The Programme Board.

Changes to the Law

Until this point, pharmacy professionals were at risk of prosecution under section 63 (adulteration of medicinal products) and section 64 (sale of any medicinal product which is not of the nature or quality demanded by the purchaser) of the Medicines Act 1968 in the event that they prepare or dispense medicines erroneously. Under the new legislation, the following changes will apply:

  • This Order offers a defence to these criminal offences, if certain conditions are satisfied. As follows;
  • The error must have been made by a registered pharmacy professional, working in a pharmacy registered with the General Pharmaceutical Council (GPhC) or Pharmaceutical Society of Northern Ireland (PSNI) and have been acting in the course of their profession;
  • The sale or supply must have been in pursuance of a prescription or directions; and
  • They or another responsible person must also have taken prompt steps to notify any affected patients when the error came to light, unless they reasonably formed the view that this was not necessary (for example they know the patient already knows), for this defence to apply.

This Order extends to England, Wales, Scotland and Northern Ireland. The Order will come into effect in all four countries at the same time. The Order was made by the Queen on Thursday 8 February 2018. Following this, a Commencement Order was signed by the Privy Council on 21 March 2018 – bringing into effect the new defences (Article 4 of the Order) from 16 April 2018.  This will apply to the whole of the UK. As per Government guidance, the new provisions will be reviewed within 5 years of entering into force. PLEASE NOTE: This Order applies only to pharmacy professionals making inadvertent preparation and dispensing errors in registered pharmacies. Hospital pharmacies are generally not registered and do not have the same governance arrangements.  Whilst this Order does not provide a legal defence to preparation and dispensing errors occurring outside of a registered pharmacy, prosecutors have been advised as to plans to consult on an Order in respect to extending the defences. A separate Order providing defences to section 63 and section 64 of the Medicines Act 1968, in the case of an error made by a pharmacy professional in a hospital or other pharmacy service (e.g. in care homes and prisons), and there are plans to consult on draft proposals shortly.

Ken Jarrold, Chair of the Rebalancing Medicines Legislation & Pharmacy Regulation Board said that while, “This is a great success for the Board…it is important that pharmacy professionals working in other settings should also be able to make use of these new defences…I encourage the pharmacy community to engage with the consultation to ensure that we have got it right.” This Order provides a defence for registered pharmacy professionals (and those being supervised by them) working in a registered pharmacy only. Other individuals, such as herbalists or retail outlets, like shops and garages, cannot take advantage of this defence as they are not subject to professional or system regulation.    If a medicine is dispensed from a registered pharmacy, unregulated individuals involved will also benefit from the defence. For example, dispensers, counter assistants and pharmacy delivery drivers. However, if they knowingly make a change, for example switching the medicine for a different medicine, the defence would no longer apply. In addition, under general criminal law where patient harm occurs or where there is pre-meditated criminal intent, pharmacy professionals may be prosecuted on the same basis as any other health care professional and professional sanctions can also be administered, if warranted, by the General Pharmaceutical Council / the Pharmaceutical Society of Northern Ireland where errors occur. If you would like to find out more about the impact of the legislation, there is a helpful Q&A document available. Please follow this link to the Q&A Document.

Future Proposals

The Forum remains fully committed to working with fellow stakeholders on the Rebalancing Board to ensure that the new provisions outlined, are extended to hospital pharmacists at the earliest possible opportunity.  Additionally, work is already underway in a number of key areas, including:

  • Pharmacy Owners, Superintendent Pharmacists & Responsible Pharmacists – Proposals to clarify the roles, accountability and competence of pharmacy owners and superintendents and the roles of responsible pharmacists. This is due to proceed to consultation in the coming months. We will keep you updated on progress.
  • Supervision – Reviewing the medicines legislation and developing new proposals to remove legislative barriers to the development of new models of pharmacy service while still ensuring patient and public safety.
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