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PJ Online homeThe Pharmaceutical Journal
Vol 274 No 7343 p390-391
2 April 2005

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· Anticoagulation services
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· PI insurance (2)
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Letters to the Editor

PI insurance

Standard operating procedures (SOPs)

To insure or not to insure? (Mr G. Southall-Edwards)

The relationship between SOPs and PI insurance (Dr R. J. Schmidt)

To insure or not to insure?

From Mr G. Southall-Edwards, MRPharmS

R. S. Boorman (PJ, 19 March, p334) makes the case for all pharmacists having their own professional indemnity insurance, whatever their employers may say that they provide. He is correct in stating that there is nothing to stop the employer (or its insurers) from going after the negligent employee and seeking to reclaim damages paid out by virtue of his or her actions, which may have resulted in a claim against the employer by reason of the latter’s “vicarious liability” for these actions.

A claim was made on such a basis in Lister v Romford Ice and Cold Storage Limited [1957] AC 555 and the House of Lords decided that the employer should recover damages against the negligent employee, who had injured his father while acting in the course of his employment. Since the result was likely to lead to a flood of similar claims, the government of the day indicated that it intended to legislate to prevent such actions becoming a serious threat to industrial relations; the response was a gentleman’s agreement between the government and the major insurers that they would not in future seek to recover damages which they had paid out on behalf of employers of negligent employees. To my knowledge, this non-legally binding agreement continues to be the case.

The National Pharmaceutical Association’s “we never have and we never would” statement, which appeared below Mr Boorman’s letter, is a reiteration of similar words in The Journal last year (PJ, 15 May 2004, p606), which I said then in my letter in the same issue, were “a gratuitous promise, unsupported by consideration”. By this I meant that although I do not doubt the NPA’s sincerity, it has not made a statement which is legally binding upon it.

Although the makers of the statement may have had good intentions at the time of making it, I wonder what their underwriters would force them to do in the event that, say, a dispensing error were to lead to serious and permanent brain damage in an up-and-coming, high-earning professional person aged, say, 30 years, necessitating life-long care and compensation for loss of amenity, plus a huge claim from the relatives for loss of their dependency on the victim’s prospective earnings. This is the nightmare scenario for insurers — far worse than any sudden death arising from an error, because the victim in my example would survive to need expensive care.

If such an event were to occur, damages could well run to over £300,000 at current rates; faced with such a pay out, would the NPA’s underwriters let them keep their “gentleman’s agreement”? The answer is unknown, but the safe way to ensure that no locum or employee is ever in such a situation and to ensure that his or her interests are properly defended, is to carry one’s own professional indemnity/defence insurance, whatever the contractor or employer may provide through its own insurers. Remember that when there is a conflict between the interests of the employer and the employee, the NPA is bound by its constitution to assist its member in preference to the employee; where does that leave the servant of the more fortunate master?

As Mr Boorman observes, we live in an increasingly litigation-conscious society with a burgeoning number of claims being fuelled by the ready availability of “conditional fee” arrangements and much television and other media advertising of their availability. The purchase of one’s own PI insurance costs not much more per year than the average locum or pharmacist employee can earn in a day before tax; is it worth taking any risk for such a small saving, whether or not it can be offset against income tax liability?

Graham Southall-Edwards
Barrister-at-Law
Tyrol, Austria


The relationship between SOPs and PI insurance

From Dr R. J. Schmidt, MRPharmS

R. S. Boorman’s letter (PJ, 19 March, p334) and John D’Arcy’s reply from the National Pharmaceutical Association regarding public liability insurance seem to miss the point as regards standard operating procedures and professional liability. Judging by the commentary provided by Mr Boorman, I am not sure that his employers (or their advisers) understand the nature and purpose of the written SOPs that they have introduced.

The Royal Pharmaceutical Society requires community pharmacies to carry out their dispensary activities in accordance with SOPs. These are the documentary evidence of the existence of a quality system in the dispensary, and describe the way in which things are done in order to ensure that a consistent, effective and safe service is provided. They are part of a wider quality system that starts at the beginning of the supply chain where a medicine is manufactured, and which should extend up to the point at which a dispensed medicine is taken by or administered to a patient. So, if a patient experiences an unexpected problem, it should be possible to follow the trail back through the quality system to the root cause of the problem and then, if necessary and appropriate, to make changes to procedures (and hence to SOPs) that lessen the probability of the problem reoccurring.

In part, SOPs simply explain the mechanics of how things are done in the pharmacy to which they apply, eg, how the prescription charge is to be rung into the till, how the tablet counter is to be used, or how the dispensary computer back-up is to be performed. In part, SOPs also import guidance provided by the Society’s “Medicines, ethics and practice” guide. In part, they also import good practice generated from the experiences of others. In turn, properly implemented SOPs become an extension of each employee’s contract of employment — a matter that seems not to be widely recognised. Any employees who are obliged by their employers to comply with an SOP should be trained with the SOP in mind. The fact that training has been given and received should then be properly documented, with both the trainer and the trainee adding their dated signatures to the staff training sheet associated with that particular SOP. A dispensary SOP needs also to be ratified by the superintendent pharmacist on behalf of the employer because of its status as an extension of employees’ contracts of employment.

Once implemented, an SOP becomes an evolving document that is changed whenever a better way is found of doing the activities covered by that SOP. A particularly important feature of an SOP is that it is a powerful management tool that can be used to engage staff as “stakeholders” if they can be encouraged to contribute to the evolution of their SOPs. The corollary to this is that SOPs that are not properly implemented (merely “introduced”) serve no real function. Indeed, it could be argued that any pharmacy that has not properly implemented its SOPs has, de facto, failed to comply with the Society’s requirement that dispensary SOPs should have been in place in all community pharmacies since 1 January 2005. This is a patient safety issue and, therefore, any failure to comply with the requirement represents a disciplinary matter in which the Society’s inspectors should now be taking great interest.

Mr Boorman states that he is uncomfortable with certain aspects of the SOPs with which he is expected to comply. On making representations to his employer, he is told that the SOP in question has to remain as it stands because it represents “company policy”. This immediately tells me that the SOP cannot have been properly implemented. If the matters over which Mr Boorman has taken issue with his employer relate directly to the delivery of the pharmaceutical service from his dispensary then he, as the pharmacist in control of the dispensary, surely has the right to amend the SOP if, by doing so, a perceived risk to patient safety is reduced. The superintendent pharmacist has no right to interfere in this matter of professional judgement unless he can provide a reasoned and evidence-based argument as to why the SOP should not be changed. Citing “company policy” is neither a reasoned nor sufficient argument. Indeed, if the proposed amendment does represent a better and safer way of doing the things in question, then the superintendent pharmacist is also then professionally obliged to consider implementing the amended SOP across all branches — and thanking his employee pharmacist for his contribution to quality and safety of services provided by the company.

Clearly, if an employee pharmacist can make a professional judgement that a certain activity is best carried out in one way while a superintendent pharmacist believes it is better for that activity to be carried out in a different way, then there will surely come a time when this conflict of professional opinion will translate to an apportionment of blame for a dispensing error. If an employee pharmacist has (as I believe he has) the professional right and duty to amend dispensary SOPs as he sees fit, then he should also recognise the importance of having his own personal professional indemnity insurance. If the superintendent pharmacist fails to ratify local SOPs, a serious conflict of interest will arise in the event that an action is brought against the company for a dispensing error perpetrated under an unratified local SOP. The public declaration by the NPA’s chief executive that the association “has never sought to recover any losses from an uninsured employee … and has no intention of doing so” may come back to haunt him.

Richard J. Schmidt
Barnoldswick, Lancashire

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