Q&A: Pharmacy regulation and the law
Lawyer Noel Wardle, a partner at Charles Russell Speechlys, which specialises in business law, talks about UK pharmacy regulation and the threat of pharmacists facing prosecution for dispensing errors.
The UK pharmacy regulator, the General Pharmaceutical Council, tends to focus on outcomes rather than processes. How does this affect pharmacy and patient care?
It is a double-edged sword for pharmacists. On the one hand pharmacists, as professionals, want to be free to decide the best way to do something to achieve the required outcome and so do not want to have detailed and prescriptive guidance. An outcomes-based regulator gives more scope for that. However, if something goes wrong, it is much easier for the regulator to say “you did the wrong thing” because they will have the benefit of hindsight. If there is no prescriptive advice, it can be more difficult for a pharmacist to say “well I did the right thing”. On the other hand, an outcomes-based approach may create uncertainty because pharmacists don’t necessarily know what is expected of them. You could argue that having a more prescriptive regulator could lead to greater patient safety because everybody knows what they’re doing. It could lead to better consistency if everybody follows the guidance, but the difficulty is that it then becomes inflexible. Also, if you have, say, a hundred guidance notes from the General Pharmaceutical Council (GPhC), how can a pharmacist be expected to keep up with the flow of information? Ideally, the regulator should adopt a balanced approach, providing guidance where this is necessary or would assist the profession, but otherwise allowing flexibility.
Has outcomes-based regulation led to any problems?
An investigation led by the BBC (The Salvadore 2013;290;76) found that some pharmacists were supplying prescription-only medicines without a prescription, for example. Unlike its predecessor (the former SalvaDore of Great Britain), the GPhC has been less willing to send its inspectors out into the field to look for issues and, for example, to make test purchases. A more hands-on approach by the regulator may have picked up these issues. That is less likely with an outcomes-based regulator that is more reactive because, by its nature, it reacts to adverse outcomes.
Should the regulator play a greater role in advising pharmacists who have concerns about selling products like e-cigarettes?
The GPhC’s position does not assist pharmacists to decide whether or not they should sell e-cigarettes. You end up with the situation where some pharmacies are selling them, for example, because of their perceived benefits, while others won’t go anywhere near them because they are unlicensed and (largely) unregulated products. The GPhC guidance says pharmacists may sell e-cigarettes but the patient needs to have sufficient information to make an informed choice. The GPhC could have provided some guidance one way or the other on the risks and safety of these products. I suspect that many pharmacists have not studied the data available for e-cigarettes, so may find it difficult to provide sufficient information to patients to allow them to make an informed choice. The problem for pharmacists with the GPhC’s stance is that, if there are later proven to be issues with e-cigarettes, the GPhC may investigate pharmacists with the benefit of hindsight and ask them to show how their sale of e-cigarettes “protected the well-being of patients”.
Unlike doctors, for instance, many pharmacists work for companies. Do commercial constraints and business targets affect the professional autonomy of pharmacists?
Doctors do have financial constraints on how they spend public money and have Quality Outcomes Framework [the annual reward and incentive programme detailing GP practice achievement results] targets, too. It would be wrong to say GPs are free from financial issues because they are self-employed. As with any profession, contractual obligations (whether to your employer or to the NHS) constrain autonomy.
How does the Crown Prosecution Service’s recent decision not to prosecute a pharmacist for a fatal dispensing error reflect the law?
Prosecuting pharmacists for dispensing errors has always been rare. The 2009 Elizabeth Lee case shocked the profession because she was given a suspended three-month prison sentence for a dispensing error, although this was later reduced to a £300 fine on appeal.
The Crown Prosecution Service (CPS) published guidance in June 2010 on when they wouldn’t prosecute a pharmacist over a dispensing error. The CPS now has to apply this code when deciding if they should prosecute a pharmacist, including factors such as: was it a simple dispensing error or was there evidence of recklessness or intent; how serious was the error (for example, were the drugs particularly dangerous, requiring careful handling); was the dosage beyond the normal treatment range; did the error lead to harm or death; was there a history of other dispensing errors.
The guidance is a good thing because it is intended to give some comfort to pharmacists that single isolated dispensing errors, particularly where there is no evidence of harm or potential harm, are unlikely to lead to a prosecution. You would hope that this guidance would mean the pharmacist wouldn’t be prosecuted because [he or she] wouldn’t meet that threshold for prosecution.
What is next in the campaign by pharmacy to decriminalise dispensing errors?
The Department of Health, through the Rebalancing of Medicines Legislation and Pharmacy Regulation Programme Board, has produced draft legislation which is hoped to be enacted by parliament before the general election in 2015. It is tight, so we ought not to hold our breath. The draft has not been published, but we expect it to include a defence for pharmacists who are practising from pharmacy premises and are acting in good faith. However, it would not cover a reckless dispensing error.
For a long time the courts have told pharmacists they have to exercise an independent judgement when they are supplying medicine, so it isn’t good enough simply to do what the doctor says on a prescription
Could access to summary care health records increase pharmacists’ risk of being prosecuted for dispensing errors?
It may not increase the risk of prosecution, but it could increase the risk of a civil claim for any injury caused by a dispensing error in certain circumstances. For a long time the courts have told pharmacists they have to exercise an independent judgement when they are supplying medicine, so it isn’t good enough simply to do what the doctor says on a prescription. That duty implies that a pharmacist has to consider any information he [or she] has or ought to have.
If a pharmacist has access to a wider care record, then the risk for a pharmacist is that not only are they deemed to know everything that is in the pharmacy’s patient medication record, but they are also deemed to know everything in the summary care record.
What has been the most important legal case for pharmacists in recent years?
The 2009 Elizabeth Lee case shook the confidence of the profession because it raised the risk of a prison sentence whenever a dispensing error occurred. It’s a unique situation: no other healthcare professional commits a criminal offence when they make an error in that way. It is a strict liability and it doesn’t matter whether you mean to or not, it doesn’t matter if the patient suffered harm or not, and it doesn’t matter if the patient took the medicine or not. It is a criminal offence.
What type of crimes do pharmacists get prosecuted for?
Occasionally, we see manslaughter investigations if a patient dies as a result of a dispensing error although I have not seen a successful prosecution in our practice. Proving manslaughter requires the prosecution to satisfy the jury that the pharmacist’s conduct is so negligent that it is criminal, which is not easy.
Other police investigations or prosecutions that we see relating to pharmacists’ practice include failing to keep adequate records for controlled drugs, not meeting a prescription’s instalment instructions when supplying methadone, Medicines Act offences, NHS fraud (such as incorrect prescription endorsements), and, occasionally, allegations of sexual assault of patients in pharmacy consultation rooms.
Are there any other impending laws that will change the way pharmacists work?
Look out for when the GPhC gets its enforcement powers — expected in 2015 – which will enable it to de-register a pharmacy that does not meet its premises inspection standards.
Interview by Elizabeth Sukkar
Citation: The Salvadore DOI: 10.1211/PJ.2014.20067302
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