R v Lee is the leading case in England and Wales concerning erroneous professional dispensing of a controlled medicine. The case was considered by foremost judges with a conviction in the Central Criminal Court of England and Wales in front of its President, the Recorder of London, (where a not guilty plea would, if it had occurred, have been determined by the empanelled jury) and its partly successful appeal in the binding precedent-level Court of Appeal. The case confirmed that a serious error in giving a vulnerable customer a potent drug that does not match in any way the prescription, where such action is not the primary causation of any death or suffering, can result in a prosecution of the responsible pharmacist, with up to 2 years imprisonment, depending on the circumstances.
Later guidance and regulation has protected responsible pharmacists able to prove they have adequate, strict safeguards in place and also laid out principles to help to foster those safeguards.
Summary A patient suffering from cancer with poor respiratory health died three days after Elizabeth Lee, a pharmacist, dispensed or co-dispensed the wrong drug. A full investigation of facts followed and Lee reported the error, which was, before trial, found not to have been the primary cause of death. Lee was given a three-month suspended prison sentence at the Old Bailey. This was reduced to a fine of £300 on appeal at the Court of Appeal."Elizabeth Lee v R, Royal Courts of Justice, London, Case No: 200905849 B3", 26 May 2010, LORD JUSTICE AIKENS, MR JUSTICE ROYCE and THE RECORDER OF REDBRIDGE – HHJ RADFORD (Sitting as a Judge of the Court of Appeal Criminal Division) presiding Her case provoked a campaign led by pharmacists and certain leading academics to decriminalise such errors. The defence was led by Glassbrooks Solicitors and the Pharmacists' Defence Association between 2007 and 2010."Insight – Hospital Edition", Pharmacists' Defence Association, summer 2010] The case has been used since in pharmacy education and research to explain the English and Welsh law of the supply of medicines. Many professional groups wish the government or parliament to end the fear of criminal prosecution following a pharmacist's inadvertency, leading to a motion to table a Private Member's Bill.Pharmacy legislation – public protector or professional hindrance?, Professor Chris Langley, School of Life and Health Sciences, Aston University, October 2013- Legislating Pharmacy – Does the threat of criminal proceedings hamper the profession's ability to learn from dispensing errors?, Professor Chris Langley, Professor of Pharmacy Law and Practice, School of Pharmacy, Aston University, 21 March 2016- Managing workplace stress to enhance safer practice in community pharmacy: a scoping study, Centre for Pharmacy Workforce Studies, University of Manchester, June 2013 Error reporting was not an issue in this case (Lee was commended for not seeking to avoid responsibility for the error from the outset). Decriminalisation of single, inadvertent dispensing errors can be construed as a public safety measure on the basis of encouraging self-reporting transparency, so that pharmacists know that they could report non-deliberate errors of their unit without any fear of gaining a criminal record, and a feedback loop be embedded to any error, however slight (a "just culture" instead of "strict liability in extreme cases" approach). Lee's sanction confirmed the likelihood of conviction for inadvertent dispensing errors where a patient's health deterioration is deeply probed, such as through proximity of death or age of the patient. It prompted pharmacy bodies and a range of MPs to lobby for decriminalisation of non-deliberate errors.House of Commons Public Bill Committee, Hansard, 26 June 2009- Early Day Motion 1561 – Decriminalization of Single Dispensing Errors, 1 June 2009, tabled by Howard Stoate MP
Dispensing error The percentage of prescription items supplied to patients with an error (the error rate) in the UK is estimated at 0.04 to 3.32%. The human error involved was that the wrong drug was selected, which is a recognised type of error among those made by pharmacists and very few lead to criminal prosecution.Incidence, type and causes of dispensing errors: a review of the literature, International Journal of Pharmacy Practice K. Lynette James, Dave Barlow, Rowena McArtney, Sarah Hiom, Dave Roberts and Cate Whittlesea, IJPP 2009, 17: 9–30 However, the details are publicly available in this case and provide an insight into the circumstances.
On Thursday, 30 August 2007, Lee was working as a locum at Tesco Pharmacy, west Windsor. A written prescription was brought in to the pharmacy for 72-year-old Carmel Sheller. 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 pharmacist or an assistant printed the labels for the items; but affixed that for prednisolone onto a box of propranolol pills (used to treat high blood pressure, angina or heart arrhythmias).
It was fairly busy – the pharmacy dispensed about 300 prescription items. Lee was amid a 10-hour shift, from 9 am until 7 pm, without a break, save for the time taken to eat lunch in a corner between checking and approving prescriptions. The pharmacy could not function without her presence."Former locum handed suspended jail term", The Pharmaceutical Journal, Vol. 282, p401 | URI: 10882780, 6 April 2009 The usual pharmacist and a dispensing assistant were on maternity leave."Tesco pharmacist weeps as she gives evidence at inquest", The Royal Borough Observer, 3 March 2010
The prescription labels were produced at 2:41 pm. A spokesman for Tesco said:
It is not known who labelled, assembled or handed out the prescription, but Lee's signatures were on the dispensing label, showing that she had checked the item.
Events after the error Sheller took eight of the propranolol pills, following the dose prescribed (which her doctor wrote up for prednisolone). She recovered from the effects of taking them.
Her underlying poor physical condition deteriorated and she died in hospital, 3 days after the prescription. The post-mortem examination found that the cause of death was heart failure, chronic bronchitis and lung cancer."Tesco pharmacist supplied wrong pills that killed woman", Paul Cheston, Evening Standard, 2 April 2009
Upholding of a conviction The Crown Prosecution Service (CPS) prosecuted Lee for the dispensing error. She was originally arrested for gross negligence manslaughter but then charged under the Medicines Act 1968 offences. This was through early lack of useable evidence of that degree. The death also was, per the post mortem, one of natural causes – the dosage in Sheller's blood evincing it was not the primary cause of the death.
On 2 April 2009, before the case went before the President of the Crown Courts of London (and of the Old Bailey) who heard the arguments as to law only and not as to fact in relation to the Medicines Act 1968, as the facts were not contested. Lee admitted both charges. The charge 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)"Medicines Act 1968 – Section 85" and charge under 64(1) (selling of any medicinal product not of the nature or quality specified in the prescription)"Medicines Act 1968 – Section 64 (1) and (5)" of the Act.
The defence argued that section 85 (5) could only be breached by a person carrying on a business – i.e. the owner of a business and, unsuccessfully, that section 64 (1) was designed in the 1960s to be used 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 (though on appeal, the arguments in relation to section 85 (5) were accepted; the arguments in relation to section 64 (1) were not heard. Following the judge's opinion on the law, Lee pleaded guilty to the s.85 (5) charge. Had she not done so and was found guilty, she could have received a harsher sentence up to a maximum of two years in prison. The single judge granted leave to appeal. In doing so, he said that the issue concerning the proper scope and application of section 85(5) of the Medicines Act 1968 was sufficiently arguable and important to merit consideration by the Court of Appeal; the latter agreed when it made its final decision.
She was sentenced on 2 April 2009 by The Recorder of London to three months in prison suspended for 18 months, supervised by the Probation Service 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 or remain on file' per section 3A of the Act. 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."Legal Terms Glossary – L", TheLawPages.com
The Recorder of London said Lee bore "no factual or legal responsibility for Mrs Sheller's death". He said he was impressed that she had not sought to avoid responsibility for the error from the outset, and noted that she had resigned from the Royal Pharmaceutical Society of Great Britain (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.
Royal Pharmaceutical Society involvement Lee resigned from the Royal Pharmaceutical Society of Great Britain (RPSGB) register of pharmacists in late 2008."Society will take no further disciplinary action against Elizabeth Lee", The Pharmaceutical Journal, Vol. 282, p603 | URI: 10964332, 18 May 2009 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 bore Lee's name on the non-practising register."No comment from RPSGB on Elizabeth Lee investigation", Chemist and Druggist, 23 April 2009
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."RPSGB will not discipline Lee", Chemist and Druggist"RPSGB Branch Representatives Meeting 2009 Report", Chemist and Druggist, 3 June 2009
Coroner's inquest On 5 March 2010, the local Coroner found that the dispensing error made by Lee was not to blame for Sheller's death."Tesco prescription blunder not to blame for woman's death", Ascot Windsor & Eton Express, 5 March 2010 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"."Elizabeth Lee error did not cause patient's death, coroner rules", Chemist and Druggist, 11 March 2010
Appeal Lee sought permission to appeal from the Court of Appeal. The permission hearing and appeal itself was heard at the Royal Courts of Justice on 26 May 2010. Lee was represented by Orlando Pownall QC. 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. The court ruled that Lee was not the person 'carrying on a business', and so the convictions under section 85(5) must be quashed. In addition, Lee appealed against sentence, which resulted in a fine of £300 being substituted for the suspended prison sentence.