Rewind to April last year. Has your confidence in the dispensary taken a dip since then? Are you more risk-averse, less confident about practices such as emergency supplies? And if, in the midst of your innumerable accurate transactions and interventions, you should make a mistake, do you feel less confident about reporting it so that the lessons can be learned by other pharmacists for the greater good of the profession and patients?
If your answers to the above questions are yes, you’re not alone. Community pharmacy representatives agree that the spectre of a criminal conviction for a one-off dispensing error has created a “climate of fear” in the sector.
It all started, in the sector’s wider consciousness at least, with the now infamous criminal conviction of locum Elizabeth Lee, who in April 2009 was given a suspended three-month jail term for a one-off dispensing error. It prompted an industry-wide campaign, parliamentary meetings, and negotiations between government officials, prosecutors and medicines regulators. Following Ms Lee’s appeal success in May (her original conviction was quashed and substituted for a separate offence, and her jail term substituted for a £300 fine), the case is now closed. But the issue it has raised for the sector as a whole is far from settled.
Has the Elizabeth Lee case reduced the risk to pharmacists of a criminal conviction for a one-off dispensing error?
Perhaps a little. The notoriety of the case has caused, pharmacy legal experts believe, a realisation among prosecutors and the judicial system that the heavy-handed approach taken with Ms Lee is counter-productive. And the quashing of Ms Lee’s conviction under section 85(5) of the 1968 Medicines Act does set a precedent in case law that only the owner of a pharmacy business can commit a labelling offence. However, as in Ms Lee’s case, this can simply be substituted for the section 64 offence of supplying a wrong item to the prejudice of the patient.
Has the case reduced the risk to pharmacists of a jail term if they are convicted of a criminal offence for a dispensing error?
Yes. Pharmacy law expert David Reissner, a partner at Charles Russell, says the prison sentence imposed on Ms Lee was “an aberration”, such sentences normally being applied only in manslaughter cases – and the Court of Appeal seemed to agree, calling Mrs Lee’s punishment “manifestly excessive”. Mr Reissner says: “The appeal court’s ruling may help another judge falling into error in a similar case.”
What impact has the Crown Prosecution Service’s guidance for prosecutors on the issue, released late last month, had?
Not a great deal, unfortunately. Joy Wingfield, professor of pharmacy law and ethics at Nottingham University and founder of the Pharmacy Law and Ethics Association (PLEA), says it “misses the point altogether”.
Pharmacist representatives had hoped the guidance would direct prosecutors not to prosecute in the case of one-off errors. Instead, it simply restated the factors prosecutors should take (and already be taking) into account when deciding whether or not to prosecute, including public interest. This leaves pharmacists, according to Mr Reissner, “at the whim of prosecutors who will not have the competence to appreciate the relative seriousness or importance of individual dispensing errors”. For this reason, pharmacist representatives believe prosecution should not be brought without consultation with the professional regulator which, Mr Reissner says, “should have the understanding of the profession and expertise to weight the gravity of any incident”.
How are errors by other healthcare professionals handled by prosecutors?
They’re not, usually. Except in the case of manslaughter, errors by healthcare professionals other than pharmacists are not normally a criminal offence. Instead, errors are dealt with by the relevant professional regulator – pharmacist representatives pushing for the decriminalisation of dispensing errors simply argue that pharmacists should have parity with this. Professor Wingfield explains: “Errors involving death of a patient should be considered jointly by the regulator and the Department of Health/CPS first, using the criteria already established for fitness to practise referral; only where there is prima facie evidence of grossly negligent, reckless or intentional commission of an error should a charge of gross negligence manslaughter be considered.”
Why is the decriminalisation of dispensing errors in the public interest?
Unsurprisingly, pharmacist representatives agree that the self-reporting of dispensing errors is discouraged by the threat of prosecution – a situation against the public interest. Professor Wingfield says: “In my view, the public interest demands that community pharmacists should be able to report all dispensing errors and possibly near misses to a centralised, anonymous and confidential reporting database without fear of criminal prosecution.
“Full and frank and open reporting is important because only then do you get a chance to analyse trends, frequencies and perhaps identify causes.”
Additionally, the threat of prosecution could lead to defensive practice and reluctance to develop novel services, to the detriment of patients. The PDA says it is aware the Lee case has already caused some pharmacists to avoid “more risky” practice such as emergency supplies.
So will one-off dispensing errors ever be decriminalised?
There is still hope. Medicines regulator the MHRA is expected to carry out a full review of the 1968 Medicines Act by 2012; pharmacy legal experts agree amendments to the Act are the only way to fully remove the risk of prosecution to community pharmacists. And two weeks ago the MHRA revealed to C+D that amendments could be fast-tracked ahead of the review, with parliamentary agreement. Mr Reissner points out this will depend on parliamentary time being available; but before his inauguration, new health secretary Andrew Lansley said he would look to change the law within the first year of Parliament. (There is unlikely to be, Mr Reissner notes, any agreement not to prosecute where a dispensing error causes death.)
In the meantime, the Pharmacists’ Defence Association (PDA), which represented Ms Lee in her appeal, is “relishing the opportunity to wrestle with the law”, according to chairman Mark Koziol, and makes the point that pharmacists should not be prosecuted under the section 64 offence (or, indeed, under the 1968 Medicines Act at all), should the opportunity of another case arise.
How do the above issues affect pharmacy technicians?
A lot. A recent High Court decision made clear that pharmacy technicians face the same risk of prosecution as pharmacists if they supply an incorrect product. Further, the CPS has clarified it is a viable defence for a pharmacist in the event of a dispensing error if (s)he can demonstrate that a pharmacy technician failed to follow the protocol laid down by the responsible pharmacist. Mr Koziol explains: “This creates a perverse incentive for pharmacists to undertake only an initial clinical check and then simply require technicians to work under a protocol that requires them to dispense and check.”
What should I do if I make a dispensing error?
There will in the future be a legal duty to report errors, Mr Reissner says. In the meantime, pharmacists have professional responsibilities to report errors – and a failure to do so could lead to professional disciplinary action. However, the PDA stresses that pharmacists should report to a source where their anonymity can be protected. The National Patient Safety Association’s National Reporting and Learning System is anonymous and contributes to national learning to improve patient safety. Employers often have their own reporting systems.
Timeline – the road to decriminalisation of dispensing errors
Pharmacist Elizabeth Lee, locuming in a Tesco Pharmacy in Windsor, dispenses propanolol against a prescription for prednisolone. The patient collapses as a result of taking the prednisolone and is admitted to hospital; she recovers from the effects of the dispensing error but later dies from other, natural, causes.
Ms Lee is arrested on suspicion of gross negligence manslaughter. She is interviewed, fingerprinted and photographed, a sample of her DNA is taken and her house is searched before she is released on police bail.
After attending the police station four times to extend her bail, Ms Lee is formally charged with two counts under the 1968 Medicines Act.
After two magistrates’ court and two Crown Court hearings, Ms Lee is tried at the Old Bailey, where the judge rules that she was not responsible for the patient’s death. Ms Lee changes her not guilty plea to one of guilty in respect of the first charge under section 85(5) of the 1968 Medicines Act (which relates to false labelling) and is sentenced to a three-month suspended jail term. The second charge, under section 64(1) of the Act (which relates to the supply of a medicinal product “not of the nature or quality demanded by the purchaser”) is ordered to lie on file.
An industry-wide campaign to decriminalise one-off dispensing errors includes an online petition that gains 12,000 signatures of support.
England’s chief pharmacist Keith Ridge promises a deal with the Crown Prosecution Service (CPS) to protect pharmacists from criminal prosecution for one-off dispensing errors.
Coroner’s report confirms that Ms Lee’s dispensing error did not cause the patient’s death.
The CPS delivers guidance on the prosecution of dispensing errors but it falls short of pharmacists’ expectations and fails to remove the threat of criminal prosecution for one-off mistakes.
The MHRA says the door is open to fast-track a change in the law to protect pharmacists against criminal prosecution for one-off dispensing errors, ahead of a planned full review of the 1968 Medicines Act.
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