Clarification needed for one-off dispensing errors
From Mr G. W. Watson, MRPharmS
The article on accredited checking technicians (Retail Round-up, September 2008, p1) was interesting, particularly the reference to one of the technicians “making only six errors in four years”.
All humans are fallible, this is probably fairly typical of the error rate in most pharmacies and these are presumably those errors that reached the patients.
Perhaps, in light of the article, the Royal Pharmaceutical Society can have clarification of the policy for referral to the Investigating Committee. The Council has decided that single one-off dispensing errors should not be referred, does this mean one error per working lifetime, no more than one error every 18 months or does it not apply to technicians and their supervising pharmacists at all?
Geoff Watson
Barnard Castle, County Durham
Sarah Billington, Royal Pharmaceutical Society, responds
Sarah Billington, chief inspector, Royal Pharmaceutical Society
The statutory registration of pharmacy technicians is expected in early 2009, once Order 1B to the Pharmacy and Pharmacy Technicians Order 2007 has been laid before Parliament. At the current time, and in the absence of any statutory provisions governing pharmacy technicians, the Society is operating a voluntary register for pharmacy technicians.
As part of the registration process, pharmacy technicians sign up to a voluntary registration protocol that has been approved by the Society’s Council. They also agree to be bound by the Code of Ethics for Pharmacists and Pharmacy Technicians, and to be subject to investigation and be bound by the outcome of a disciplinary committee in cases involving impaired fitness to practise or misconduct. A copy of the current 2008 protocol can be found on the Society’s website.
In the case of an allegation or complaint made to the Society about an accredited checking technician, there are potentially a number of issues. If the pharmacy technician is not on the voluntary register then they do not currently come within the jurisdiction of the Society.
However, those pharmacy technicians that are on the voluntary register would be subject to an investigation and could be removed from that voluntary register should it subsequently be proved that they are unfit to practise or have committed misconduct.
At present, the pharmacy technician voluntary protocol does not include a mechanism to refer technicians to an investigating committee. The protocol simply provides that a fitness to practise allegation will be referred to an interim disciplinary committee.
However, the Society is taking steps to address this so if a fitness to practise issue arises involving a technician they will be dealt with using a procedure that is similar to the statutory system already in place to deal with pharmacists.
In relation to the issue regarding single one-off dispensing errors, the Society’s Council agreed, at its meeting in June 2008, that the threshold criteria should apply to cases involving pharmacists and registered pharmacy technicians.
The Council’s decisions on the threshold criteria and the types of cases suitable for non-referral, including dispensing errors, can be found on the Society’s website.
As to the supervising pharmacist’s role in the case of a dispensing error made by an accredited checking technician, the supervising pharmacist is ultimately responsible for the supply of medicines from the pharmacy. He or she may choose to delegate the dispensing and accuracy checking of prescriptions but that does not absolve him or her of the responsibility.
Accountability is a complex issue and the level of an individual’s accountability can vary depending on the specific circumstances. It is beyond the scope of this response to cover the issue of responsibility and accountability in detail but further information can be obtained from the Society’s website and previously published articles (PJ, 28 February 2004, p261; 3 July 2004, p35; and 6 January 2001, p10).
With regards to the correspondent’s specific query about the non-referral mechanism for a “single one-off dispensing error” and whether this means only one error per lifetime or a specific number of individual errors over a specific period. The short answer is no.
The Council did not consider the number or frequency of “single one-off dispensing errors” as a barrier to any single error being considered as suitable for non-referral. However, it did want to ensure that registrants take notice of any advice given and take steps where possible to prevent further errors.
Therefore, the Council has stated as one of the threshold criteria, that cases are likely to be referred to the Investigating Committee if “the Society had previously given advice that would have prevented the incident if it had been implemented”. Cases are looked at on an individual basis.
No dispensing without qualified supervision
From Mr G. Birkinshaw, MRPharmS
Staff in small private hospitals, small NHS hospitals, dispensing doctors and HM Forces can all dispense without qualified supervision by a pharmacist and there is practically no inspection of the premises. The Royal Pharmaceutical Society has never spoken out against these institutions yet we know how dangerous the situation is.
Do we have to have a real catastrophe before something is done? I remember, 40 years ago, an inspector told me things are going on behind the scenes and things will change. I remember thinking “pigs might fly”.
With the formation of a new inspectorate, its motto must be “no dispensing without qualified supervision and be prepared to inspect anywhere”.
The new professional body must be vociferous in supporting it — no more toadying to the medical profession and politicians.
G. Birkinshaw
Bakewell, Derbyshire
Reference to manslaughter is misconceived
From Mr J. N. Glassbrook, MRPharmS
As the solicitor to Elizabeth Lee, I wish to clarify some points about her case.
Mrs Lee made a mistake in the checking of a prescription for Carmel Sheller, for which she immediately admitted responsibility, recorded the fact in writing and informed her employers. In other words she behaved in a thoroughly decent and professional way.
Mrs Sheller was admitted to hospital. The propranolol mistakenly dispensed has a short half life and by the time Mrs Sheller died the amount in the body would have fallen by a factor of about 105. Mrs Sheller’s unfortunate death was not related to the dispensing error but due to her various pre-existing illnesses. Hence any reference to manslaughter is misconceived.
Mrs Lee had an unblemished record in every aspect of her life. Her barrister, Christopher Hudson, who has been in criminal practice over 20 years, wrote of her: “I have never seen so many testimonials speaking in such favourable terms — these are the people who know Elizabeth Lee well.”There was nothing extraordinary about the error made, only with the vigour with which the prosecution was pursued. If this tragic case precipitates a change in the law at least some good may yet come from it. Otherwise any pharmacist who is less than 100 per cent perfect will remain in serious jeopardy; statistically the average pharmacist is said to make a dispensing error every month.1
Nick Glassbrook Glassbrooks Ltd
Reference
1. Ashcroft D, Morecroft C, Parker D, Noyce P. Patient safety in community pharmacy: understanding errors and managing risk. London: Royal Pharmaceutical Society, 2005.
Concentrate on causes, not consequences
From Mr S. A. Malcolm, MRPharmS
It is a perversity of English law that chance plays such a large part in the punishment of an act of negligence. If a carelessly placed pot plant should fall from my balcony and smash harmlessly below then it is unlikely that I would suffer any penalty but should it land on the head of a passer-by and kill him or her then I might well be facing criminal proceedings.
Similarly with a dispensing error I doubt that criminal charges would be brought if one mild analgesic was inadvertently dispensed in place of another with no adverse effect on the patient. There might well be a different attitude, however, if a drug was dispensed that caused serious harm even though there was no qualitative difference in the negligence that brought about the two outcomes.
There is a difference between an error made in a moment of inattention and that made by someone who is, for example, under the influence of alcohol or who is deliberately not supervising the dispensary. Logic suggests that any change in the law should concentrate on the nature and causes of the negligence and place little weight on its consequences.
I hope that Elizabeth Lee, who by all accounts has been a conscientious pharmacist, reconsiders her decision to resign from the Register and that the Royal Pharmaceutical Society is minded to reinstate her. She has my greatest sympathy.
Stewart Malcolm Non-Practising Pharmacist Bures, SuffolkWe must insist on decriminalisation
From Mr P. J. McMillan, MRPharmS
When the judge gave Elizabeth Lee a suspended three-month jail sentence for a dispensing error, he stated: “The public are entitled to expect the highest standard of care from those responsible for the dispensing of medication — that is why the offence exists as a criminal offence punishable with imprisonment.”
I agree that pharmacists must be held accountable for their actions, but fear of prosecution does not prevent errors and a suspended jail sentence is not a suitable punishment for dispensing mistakes such as this.
Humans are imperfect and errors are inevitable even in the best run organisations. A 2002 study in hospital pharmacies found an error rate of 18 errors per 100,000 items dispensed, and over the 10-year recording period 7,158 dispensing errors were recorded. Of these 328 were considered to produce moderate, serious or fatal adverse effects.1 Prednisolone was the drug most commonly involved in dispensing errors in this study.
Nine years ago, the Department of Health recognised two key points regarding errors.2 These were (i) that the best people can make the worst mistakes and (ii) that errors fall into recurrent patterns, ie, the same set of circumstances can provoke similar mistakes, regardless of the persons involved.
Currently we have a system in place which will produce dispensing errors, and which leaves individual pharmacists at risk of prosecution when these inevitable errors occur.
We must insist on (not just support) the decriminalisation of one-off dispensing errors. We need to develop a culture that records, investigates and addresses the reasons for errors and near misses. We need true corporate responsibility for the set of circumstances which lead to these errors which match our individual responsibilities. This will drive the change in the system that is needed.
Only then will patients really receive the highest standards of care from those responsible for the dispensing of medicines.
Paul McMillan Hospital Pharmacist GlasgowReferences
1. Roberts DE, Spencer MG, Burfield R, Bowden S. An analysis of dispensing errors in NHS hospitals. International Journal of Pharmacy Practice 2002;10(Suppl):R6.
2. Department of Health. An organisation with a memory. London: Department of Health, 2003.
Need to pay for a safe and effective dispensing service
From Mr C. A. Boucker, MRPharmS
If Elizabeth Lee’s resignation from the register of the Royal Pharmaceutical Society were a protest at the ridiculous situation whereby a judge chose to use legislation that pharmacy organisations believe is “not fit for purpose” as a means to placate a family looking for retribution, then I would have applauded her decision. However, it was not, and the profession should unanimously encourage her to reconsider.
Your news item mentioned the impact of an unreasonable working environment on Mrs Lee’s performance, and the Society’s Workplace Pressure online survey suggests that 50 per cent of pharmacists experience similar conditions. To suggest that this can be resolved through communication between employees and employers is remarkably simplistic. We work in an established culture where it is expected that pharmacists will forgo statutory rest and meal breaks so that pharmacies can function without interruption.
This culture is perpetuated by the demands of customers, the desire of some pharmacists, through need or greed, to work without breaks, and the “open all hours” business models of many employers.
As our paymasters continue to move finances away from the “menial” task of dispensing and into clinical services, the situation can only get worse. What is the benefit of a medicines use review to a patient if it contributes to an environment conducive to an increase in dispensing errors?
We need to press the government so it recognises the need to pay properly for a safe, effective dispensing service and as a profession we need to decide who is responsible for ensuring that appropriate working conditions are implemented.
Colin BouckerGloucester
There but for the grace of God go I
From Mr D. R. Thomas, MRPharmS
I am sure that many members of the Royal Pharmaceutical Society will express great sympathy and support for Elizabeth Lee when reading of her unfortunate situation and judgment (PJ, 11 April 2009, p401). I am reminded of the phrase “there but for the grace of God go I”.
In light of the present Workplace Pressure campaign started by the Society can we assume that Tesco will receive a reprimand as this is surely warranted.
Hopefully Mrs Lee will reconsider her decision not to practise as a pharmacist in the future and, if she does, the Society should give her its support.
David R. Thomas Feltham, MiddlesexWas Elizabeth Lee the correct defendant?
From Dr G. E. Appelbe, FRPharmS
When the Medicines Act was promulgated in 1968, a significant proportion of it was taken from earlier acts and section 64 was copied from the Food & Drugs Act 1955.
From my time as a member of the Royal Pharmaceutical Society’s Law Department staff, I do not recall a single criminal case in which I was involved being brought under s64. The reason for this was because the section was intended to cover the situation where a substandard product had been supplied, not dispensing mistakes made.
Pharmacists will recall that, in the 1960s, a large proportion of medicines in pharmacy were made up extemporaneously. Only a small proportion of prescriptions were filled by the provision of a proprietary product. Hence there was a much greater need for s64.
In 2009 the section is redundant and has outlived its usefulness. It appears that the Crown Prosecution Service now favours bringing a manslaughter charge when a dispensing error occurs and uses s64 as a fallback when the manslaughter charge fails.
No wonder the judge in the case of Elizabeth Lee (PJ, 11 April 2009, p401) asked the Crown why the case was in his court and what happened to the Magistrates Courts.
I sat as an expert witness for Mrs Lee throughout the hearing at the Old Bailey on 2 April (2009) and noticed the distress she had suffered in this case, which had started for her in July 2007 when first charged with manslaughter and led her to resign as a member of our profession.
Mrs Lee made a mistake. However, she did not supply a substandard product but a licensed proprietary one and this was a valid defence to the original charge.
Manslaughter was a charge that should never have been brought against her. Sense prevailed when this charge was dropped, and she pleaded guilty to a labelling offence under the Act instead.
There was no logic or justice when she was given a custodial sentence, albeit suspended, for what was a simple labelling offence under the Act.
Another contentious matter was whether she should have been charged with anything at all. In other words, was she the correct defendant?
Section 52 of the Medicines Act requires that the supply of medicines (not on the General Sale List) may only be made by a person lawfully conducting a retail pharmacy business, from a registered pharmacy and by or under the supervision of a pharmacist.
Section 69 sets out a person carrying on a retail pharmacy business shall be taken to be a person lawfully conducting such a business, this includes a pharmacist owner, or body corporate.
It follows that any supply has to be made by the person lawfully conducting a retail pharmacy business, not by the counter assistant and not by the supervising pharmacist.
Mrs Lee was working for a body corporate, which was responsible for the supply.
In my view, this case should never have been brought as a criminal offence. Dispensing mistakes are professional not criminal matters.
Gordon Appelbe
London
Lives of patients in jeopardy
From Mr G. A. Teal, MRPharmS
Tesco should be brought to account for allowing Elizabeth Lee to work without a break for 10 hours at a time (PJ, 11 April 2009, p401). The pharmacy section could easily have been closed for an hour at some stage during the day.
A coach driver is not allowed to drive for 10 hours non-stop because passengers’ lives would be endangered. So why should a pharmacist be allowed to work for 10 hours non-stop, thus putting the lives of patients in jeopardy?
It seems to me that, in spite of their altruistic advertisements for staff in The Pharmaceutical Journal, the multiple organisations are imposing atrocious working conditions on the pharmacists they employ.
Perhaps the Royal Pharmaceutical Society’s inspectors should look into this matter when they are doing their rounds.
G. A. Teal
Oxford
Public safety and commercial expediency
From Mr P. Gornall, MRPharmS
I, like many others, was saddened to read of the case of Elizabeth Lee (PJ, 11 April, p401). I fear an injustice of Kafkaesque proportions has been done.
An exemplary pharmacist has been convicted of a misconceived criminal offence, which she had no intention of committing and which did not cause the patient’s death. It is repugnant. I support the campaign to decriminalise dispensing errors.
Section 64 of the Medicines Act 1968, under which this conviction was obtained, has been described as anomalous and not fit for purpose. Just how anomalous is shown if we consider the case if the patient had actually died as a result of the dispensing error and a manslaughter charge had been brought.
For a criminal conviction for involuntary manslaughter, gross negligence is required. Mere carelessness is not enough, negligence showing such disregard for the life and safety of others amounts to a crime against the state and deserves punishment (so the case law has it).
It is hard to see Mrs Lee’s conduct as being so negligent. The likely outcome would have been no criminal conviction. Rather, civil proceedings would have allowed an apportionment of liability, which in this case surely was partly that of Tesco.
Tesco had control of the pharmacy, it organised staff cover (thus was responsible for staff training) and controlled the working environment. It has emerged that two members of staff at Tesco’s pharmacy were on maternity leave. Could relief staff not have replaced them?
To my mind, Tesco’s response to this case has been extremely arrogant. It has said that it will not be changing its standard operating procedures and that this was an isolated incident. This might have been an isolated conviction but was it, statistically, an isolated error?
It is clear that such companies cannot, in effect, be allowed to police themselves between infrequent Royal Pharmaceutical Society and primary care trust inspections.
Like other safety-critical industries, such as the airlines, we need enforceable regulations to ensure the safety of the public.
At the least, we need all prescriptions to be dispensed and checked by two individuals; we need minimum staffing levels dependent on prescription volumes and the number and type of other services provided, such as medicines use reviews, emergency hormonal contraception, minor ailments services, nicotine replacement therapy schemes and the like.
There should be a maximum number of prescriptions that one pharmacist alone should be expected to check and above which a second pharmacist is to be employed. Statutory breaks should be compulsory for all pharmacists.
Public safety is too important to be left in the hands of those who place it second to commercial expediency. It may suit the grocery trade but not the pharmacy profession.
Paul Gornall
Preston, Lancashire