Elizabeth Lee (pharmacist)

Elizabeth Lee was a pharmacist who was given a three-month suspended prison sentence for an inadvertent dispensing error, reduced to a fine of £300 on appeal.^[1] Her case was the catalyst of a substantial national effort in the UK to decriminalize inadvertent dispensing errors. She was defended by the Pharmacists' Defence Association between 2007 and 2010.^[2] The case has been used since that time in pharmacy education as an aid to explain the legislation applicable to the supply of medicines by pharmacists in the UK.

Dispensing error

On Thursday, 30 August 2007, Elizabeth Lee was working as a locum at Tesco Pharmacy, Dedworth Road, Windsor. A prescription was brought in to the pharmacy for 72-year-old Carmel Sheller, by Mrs. Sheller's daughter. It was for amoxicillin capsules (an antibiotic) for a chest infection and 40 prednisolone tablets 5 mg (a steroid) at a dose of eight per day, to be taken for wheezing and lung inflammation. The labels for the items were produced correctly but the label for prednisolone was applied to a box of propranolol tablets (used to treat high blood pressure, angina or heart arrhythmias).^[1][3]

It was a fairly busy day and the pharmacy dispensed approximately 300 prescription items. Elizabeth Lee worked a 10-hour shift, from 9 am until 7 pm, without a break, save for the time taken to eat lunch in the corner of the dispensary between dealings with prescriptions. The pharmacy could not function without her presence.^[4] The usual pharmacist and a dispensing assistant were on maternity leave.^[5]

The prescription labels were produced at 2:41 pm. A spokesman for Tesco said: "The shift length was not relevant to this dispensing error. In this case, the locum pharmacist started work at 9 am and the dispensing error took place around lunchtime. The pharmacist had staff working with her offering support at all times."^[6]

It is not known who labelled, assembled or handed out the prescription, but Elizabeth’s signatures were on the dispensing label, showing that she had checked the item.^[1]

Events after the error

Carmel Sheller took eight of the propranolol tablets in accordance with the dose on the label (which was intended to be for prednisolone). It was reported that after 10 minutes she lost consciousness, collapsed and was taken to hospital.^[3] She recovered from the effects of taking propranolol but later died in hospital on 2 September, of natural causes. The post-mortem found that the cause of death was heart failure, chronic bronchitis and lung cancer.^[7]

Legal prosecution

The Crown Prosecution Service (CPS) pursued a criminal prosecution of Elizabeth Lee for the dispensing error. A charge of gross negligence manslaughter was initially discussed but then excluded; in any event, the error did not cause the death.^[2]

On 2 April 2009, before the case went before a jury at the Old Bailey, a judge heard legal arguments in relation to the Medicines Act 1968. Lee faced charges under section 85.5 (supplying a label which falsely describes the product or which would likely mislead as to the product's uses or effects)^[8] and 64.1 (supply of a medicinal product not of the nature or quality demanded by the purchaser)^[9] of the act. Her defence team argued that section 85.5 could only be breached by a person carrying on a business – i.e. the owner of a business and that section 64.1 was designed in the 1960s to be used in situations where an adulterated product or a product of a poor quality was supplied – not for dispensing errors. The judge made it clear that these arguments were unlikely to succeed^[2] (though on appeal, the arguments in relation to section 85.5 were accepted; the arguments in relation to section 64.1 were not heard). The judge’s indication that the arguments would be unlikely to succeed created the risk that had Elizabeth Lee been found guilty after initially pleading not guilty, she would have received a more severe sentence. The charges carried a maximum sentence of two years in prison.^[7]

In UK law, a person who pleads guilty "may expect some credit in the form of a discount in sentence".^[10] Hence, following the legal argument, Lee changed her plea to guilty to section 85(5).

She was sentenced on 2 April 2009 by judge Peter Beaumont to three months in prison, and suspended for 18 months, with a requirement of supervision for 12 months. The charge against section 64(1) of the Medicines Act (sale of a medicinal product not of the nature or quality demanded by the purchaser) was allowed to ‘lie on file’. In UK law this means that the judge has decided that there is enough evidence for a case to be made, but that it is not in the public interest for the prosecution to continue, usually because the defendant has pleaded guilty to other charges.^[11]

The judge said Elizabeth Lee bore “no factual or legal responsibility for Mrs Sheller’s death”. He said he was impressed that she had taken full responsibility for the error from the outset, and noted that she had resigned from the RPSGB and determined not to work as a pharmacist again. He said a prison sentence was needed to ‘mark the gravity of the offence’ but the circumstances had persuaded him to suspend it.^[4]

It was reported that members of Mrs Sheller's family clenched their fists and mouthed 'yes' as Elizabeth Lee pleaded guilty.^[12] It was also reported that, following the original sentence, Carmel Sheller's son said "The sentence is not all that we would have hoped for but we understand the judge’s position... The pathologist’s report did not go to our favour and the manslaughter charge was dropped. In an ideal world we would have had the manslaughter charge." Asked about the manpower problems at the pharmacy, Mr Sheller said Mrs Lee should have spoken to her employers if she was concerned and said “She was the professional in charge. She was the person in the white coat we as the public trust, along with our doctors. You are trusting they have done their job.” ^[4]

The judge granted leave to appeal the conviction in spite of the guilty plea because, he argued, the proper scope and application of section 85(5) was sufficiently arguable and important to merit consideration by the Court of Appeal.

Royal Pharmaceutical Society of Great Britain (RPSGB) involvement

Elizabeth Lee resigned from the RPSGB register of pharmacists in late 2008.^[13] This was remarked upon by the judge in her sentencing on 2 April 2009. However, on 23 April 2009, the RPSGB refused to rule out disciplinary action and confirmed it had retained Elizabeth’s name on the non-practising register.^[14]

On 8 May 2009, the RPSGB registrar granted her request to leave the register voluntarily, because it was not in the public interest to pursue a fitness to practice case.^[15][16]

Coroner's inquest

On 5 March 2010, Berkshire East Coroner Peter Bedford found that the dispensing error made by Elizabeth Lee was not to blame for Carmel Sheller’s death.^[17] The verdict was recorded at Windsor Guildhall. Post-mortem blood samples showed trace amounts of propranolol and the coroner said the effects were likely to have been “so minimal” at the time of death that they could be “discounted as having any material effect”.^[18]

Appeal

Elizabeth appealed the criminal conviction and this was heard at the Royal Courts of Justice on 26 May 2010. The wording of section 85(5) of the Medicines Act 1968 indicated that it could only be breached by a person who was carrying on a business.^[8] The court ruled that Elizabeth Lee was not the person ‘carrying on a business’ and so the convictions under section 85(5) must be quashed.

In 2008, the Pharmacists' Defence Association commenced discussions with the Department of Health, CPS and the Director of Public Prosecutions about a CPS protocol relating to prosecutions under the Medicines Act 1968. In late 2009, prior to Elizabeth Lee’s appeal, the publication of the protocol was expected imminently. It was expected that the protocol would state that where gross negligence manslaughter charges had been excluded, the police and CPS should pass the case to the regulator and not pursue prosecution. This was intended to be an interim solution whilst changes to the Medicines Act 1968 were enacted to decriminalise dispensing errors.^[19]

At the appeal hearing, Elizabeth Lee’s defence team raised the issue of the CPS protocol, with the expectation that a more favourable appeal outcome might be obtained if the appeal was heard after its publication. However, the prosecution counsel, having conferred with a CPS legal representative, stated that talks on the protocols had reached an impasse and that therefore the release was not at all imminent. The prosecution team could not give a timeframe for its publication and indicated that it could take up to a year; the judges were left with the impression it could take several years.^[20] The protocol was ultimately published just three weeks after the appeal hearing, on 21 June 2010.^[21][22]

The appeal hearing proceeded in the absence of the protocol and the prosecution team, acting for the CPS, asked the judge to substitute the conviction under 85(5) of the Medicines Act 1968 for a conviction under section 64(1), which had been allowed to ‘lie on file’ during the initial hearing. They argued that in essence, the plea of guilty made in respect of section 85(5) demonstrated that Elizabeth Lee was guilty of a breach of section 64(1). Elizabeth Lee’s defence team asked for the section 64.1 charge to continue to lie on file since she had not pleaded guilty to it and the CPS protocol, when published, would likely mean that the CPS would no longer pursue a prosecution.^[20] The prosecution stated, however, that they would pursue a fresh prosecution for that breach if the issue was left to lie on file.

The judges considered recommending a retrial in respect of the section 64.1 charges but considered that Elizabeth had no desire for further court appearances. Her legal team said "It would be like returning to the scene of a road traffic accident".^[23] Subsequently, Elizabeth Lee conceded and the conviction under section 85(5) was substituted for a conviction under section 64(1). She was ordered to pay a fine of £300.^[2][24][25]

The appeal judge noted the considerable impact that the events had had on both the family of Carmel Sheller and on Elizabeth Lee, and also the ‘very many letters which speak of her [Elizabeth Lee's] good character and many good works’. By the time of the appeal Elizabeth had taken a job as a cleaner in her church, having decided never to practice again as a pharmacist and having withdrawn from the register of pharmacists held by the RPSGB.^[1]

Ministerial comment

Tesco faced no legal action as a result of the case. Shadow Minister for Health and Pharmacy Minister Earl Howe said in June 2009 that "The risk to the public comes not from dodgy pharmacists, but from potentially dangerous working practices. Tesco seems to be noticeably reticent in admitting that they may have had some contribution to the error that occurred. When a pharmacist is made to work regular 10-hour shifts, you cannot put the entire blame on that one individual. Supermarkets and major pharmacy multiples cannot wash their hands of the health and safety implications which their pharmacists are subject to."^[26]

The All-Party Parliamentary Group for pharmacy met on 16 June 2009 in the House of Commons to investigate the impact of the Elizabeth Lee case on community pharmacists. The Chairman, Howard Stoate MP, tabled an Early Day Motion calling for a change in the law. He said "I don't think anybody quite appreciated what could happen to a pharmacist who made a simple human error just on one occasion and is automatically criminalised by the current law. As far as I'm aware there are no other professional groups, certainly within the NHS to which that applies.”^[6]

Personal consequences

A report on the personal consequences of the case for Elizabeth Lee said "Of course you feel for Ms Sheller’s family. Ms Lee’s mistake can’t be brushed aside and forgotten about. A grandmother’s health suffered as a result and she later died – of an underlying condition and not the error. If that was my grandmother or yours we would feel angry and want justice. But my overriding sentiment after attending Ms Lee’s Court of Appeal hearing last week is that justice hasn’t really been served. Everything indicates Ms Lee is an exceptionally honest and dignified person. She quit as a pharmacist as soon as her error came to light. She has shunned the limelight – repeatedly stressing her desire to pursue a quiet life... she has always spoken of her sorrow for what she did, extended her condolences to Ms Sheller’s family and never tried to make excuses... For Ms Lee the personal cost of this case has been vast. It was impossible to reconcile the wan individual who sat before the court last week with the vibrant woman of three years ago. In the quest to avenge one life, another has been destroyed... that seems a tragic loss for both pharmacy and society as a whole."^[27]

Aftermath and impact on pharmacy in the UK

Elizabeth Lee’s prosecution caused widespread concerns that it would lead to non-reporting and under-reporting of dispensing errors by pharmacists, adversely affecting patient safety and the ability to learn from mistakes.^[28]

In June 2009, following Elizabeth Lee’s conviction, the RPSGB carried out a survey which found that almost half the pharmacists questioned would reassess whether they would record dispensing errors in an error log. More than 12,000 pharmacists signed a petition calling for the law to be repealed. Issues with workplace pressure also surfaced, with 4% of pharmacists in a survey carried out by Chemist and Druggist saying that they had contemplated suicide as a result of the stress.^[6]

A national effort to decriminalize dispensing errors was catalyzed by the case. One report said of Elizabeth Lee, "It’s up to us to complete the job and ensure her legacy is as the pharmacist who brought an end to criminal prosecutions for dispensing errors."^[27] Attempts to change the law are still ongoing as of 2016.

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