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The Francis Report

1 December 2013

Pharmacists and pharmacy owners should not be complacent about the absence of any reference to pharmacy in the Francis report on the lack of care at Mid-Staffordshire Hospital. The Government's response to the report’s numerous recommendations indicates that pharmacy practice will not escape unchanged.

One of the key recommendations is that there should be guidance on staffing levels. The Government accepts this in principle, while saying it is for regulators to have regard to evidence-based guidance and benchmarks, and undertake effective risk assessments when changes to numbers or skills of staff are under consideration.

As regulator, the GPhC has published standards requiring pharmacy owners to have enough staff, suitably qualified and skilled, for the safe and effective provision of the services provided. The Royal Pharmaceutical Society does not seem to think this is sufficient, and is calling on NICE to produce guidance for safe staffing levels. It wants pharmacy owners to have a detailed understanding of their workforce”.

The RPS language is heavy on jargon, referring to “leaders of pharmacy providers”, “workforce” and “staffing of organisations” as well as “publishing data about staffing levels”. This gives the impression that the RPS thinks all pharmacies are large multiples.

Since 2005, the Drug Tariff pharmacy owners have been entitled to practice payments if they employ a minimum level of dispensing staff calculated by reference to prescription volume. In view of what happened at Mid-Staffs it certainly seems sensible that NHS England should re-examine staffing levels within the community pharmacy contractual framework. The question is: can anything more be done to ensure minimum levels are met?

The way the Drug Tariff incentivises pharmacy owners seems to me a sound approach, based on business practicalities. Once appropriate minimum staffing levels are determined, they need to be policed. This can only happen through inspections or, in the event of an incident, through investigation. This means that the intervals between inspections needs to be kept under review. Sanctions can be imposed on a pharmacy owner who has failed to ensure sufficient staffing, but once an incident has occurred, the imposition of sanctions will not put right harm to a patient.

What other measures can we expect to see following the Government’s response to the Mid-Staffs scandal? Arrangements for error logs and near miss logs will come under review as part of the determination to impose on healthcare professionals a duty of candour. It is likely that in any fitness to practise proceedings, the GPhC will take into account whether or not concerns have been raised promptly, and whether the pharmacist in question acted appropriately when discovering that an error had been made. The duty of candour is also likely to impact on plans to decriminalise dispensing errors.

Naturally, deliberately giving out the wrong tablets will remain an offence (even though section 64 of the Medicines Act has never been needed for such an occurrence, and there are other criminal offences with which a pharmacist Sweeney Todd could be charged). When death is caused by gross negligence, because in such cases it has always been possible to prosecute a healthcare professional for manslaughter and cases of corporate manslaughter can also be brought.

Only a few weeks ago, a doctor responsible for a patient’s death received a 30-month prison sentence. The Government may bring in a new offence of causing death or serious injury through breach of fundamental standards, but this is only likely to apply to hospitals and care settings.

Finally, pharmacy owners may find themselves under a specific obligation to address non-compliance by employees with standard operating procedures. It remains to be seen whether such a responsibility can be enforced in relation to locums.

For more information please contact David Reissner, Partner

T: +44 (0)20 7203 5065