The Government has finally published an Order which, when it comes into force, will decriminalise dispensing errors by pharmacists. Or at least that is what the Order is meant to do, but it doesn’t quite meet its aims.
It’s been a long time coming: over 8 years since pharmacist Elizabeth Lee was given a suspended prison sentence for dispensing propranolol instead of prednisolone. The ensuing uproar by pharmacists led to calls for the decriminalisation of dispensing errors. After all, no other healthcare professional faces the risk of being sent to prison for making a mistake. Even when the Court of Appeal replaced Ms Lee’s suspended prison sentence with a fine, calls for decriminalisation continued.
The offence that was committed by Elizabeth Lee and, last year, by Martin White was an offence contained within the Medicines Act 1968 of supplying a medicinal product to someone “which is not of the nature or quality demanded by the purchaser.”
This provision was actually taken from post-war consumer legislation along with another provision within the Medicines Act which prevents “adulteration” of a medicinal product. In the post-war era of rationing and pharmacist compounding it is perhaps understandable why Parliament might want to protect consumers in this way. However, these provisions would seem to have little applicability to the modern world of pharmacy practice and the Government could arguably just have scrapped both of them; rogues supplying medicines unlawfully would still be caught by other provisions.
It took a while for the Government to sit up and take notice, but in early 2013 the Rebalancing Medicines Legislation and Pharmacy Regulation Board was set up to consider the problem.
For 2 years not a lot seemed to happen, and then in February 2015 the Department of Health (in conjunction with the devolved governments) published a consultation document on proposals to decriminalise dispensing errors. Except that the proposals did not amount to decriminalisation, which would have meant the removal of these offences from the statute book, but instead the introduction of statutory defences.
Almost 3 years passed since the draft Order was published as part of the consultation until finally, on 14th November 2017 the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 was laid before Parliament. No date has yet been given for when the 2018 Order will come into force, but it is likely to be early next year.
So what has the Committee been doing with the draft Order for the last 3 years? Well, it hasn’t been making any significant changes. The 2018 Order is virtually identical to the draft published in the February 2015 consultation. In fact there is only one change – the statutory defence will apply to medicines supplied in an emergency as well as to medicines supplied in response to a prescription. A sensible addition, but why did it take almost 3 years?
Whilst the profession will no doubt welcome the move towards, at least partial, decriminalisation, the 2018 Order is, unfortunately, still incredibly complex.
As I have already said, the Department of Health has chosen not to scrap the offences altogether but to introduce a statutory defence. That means that a pharmacist will still have committed an offence if he or she makes a dispensing error, but will avoid conviction if the pharmacist can prove to the court that he or she can meet the statutory defence.
That means the pharmacist will have to prove to the court that several facts apply.
Firstly, the medicinal product must have been dispensed at a registered pharmacy. Note the word ‘dispensed’ here. There is no statutory definition of ‘dispensed’ in the legislation. Given that the process of dispensing is usually understood to start with the taking in of a prescription and finishes when the medicine is handed to the patient, and not all of these actions will be done in the pharmacy (consider, for example, the use of a delivery driver), will a pharmacist be able to demonstrate that the medicine was ‘dispensed’ at a registered pharmacy? Also because these provisions only apply to dispensing at a registered pharmacy, they cannot be used by hospital pharmacies, which are not usually registered and will still be guilty of an offence where dispensing errors occur.
Next the person who dispensed the product must either be a registrant (pharmacist or technician) or a person ‘acting under the supervision of’ a registrant’; again note the word ‘supervision’, which is not defined anywhere and is often used to mean different things.
The pharmacist or technician will have to be ‘acting in the course of his or her profession’, which is also not defined. However, if a pharmacist tells the court that he or she was ‘acting in the course of his or her profession’ then it will be for the prosecution to prove to the court beyond doubt that the pharmacist was not.
The statutory defence will only apply to medicines supplied on prescription, including emergency supplies, so OTC sales are not caught and any pharmacist who supplies the wrong P or GSL medicine will not be able to rely on the statutory defence. This distinction is particularly difficult to understand because you might assume that the consequences of a Prescription Only Medicine error are likely to be more serious than an error involving a P or GSL medicine.
The incorrect supply must be the result of a mistake: a deliberate wrongful supply is not caught by the statutory defence. Where the person charged with an offence is not the person who ‘dispensed’ the product (for example where a company is charged in relation to an error by its staff) then the person who dispensed the product must also not have known of the error.
Finally, if the error comes to light before the defendant is charged with an offence, all reasonable steps must have been taken to ensure that the patient was told about the error unless it was reasonable to take the view that this was neither necessary nor appropriate. Again there is a potential uncertainty here as to whether the defendant has complied with the obligation to deal with the error by notifying the patient.
The consequence of the Order is that pharmacists who supply the wrong item have still committed a criminal offence, and will only know whether they will be found guilty when the court decides whether the pharmacist can satisfy all of the elements of the, complex, statutory defence. Given the uncertainty regarding some of the terms used within the defence and the partly subjective element, any pharmacist charged with a dispensing error offence will still face a great deal of worry.
But the problem for pharmacists doesn’t end there. There are two other offences which may be committed when a dispensing error occurs that aren’t caught by the draft Order at all.
Firstly, if the correct product is supplied but is mislabelled (for example the label gives the wrong product name) an offence is committed.
Secondly, a prescription only medicinal product can only be supplied in accordance with a prescription from an appropriate practitioner. If the pharmacist supplies the wrong product against a prescription, the pharmacist has unlawfully supplied a prescription only medicine without a prescription for that (wrongly supplied) medicine.
These concerns were raised at the time of the 2015 consultation, but have not been addressed. Perhaps the Department of Health took the view that this was just too difficult a problem to grapple with given that it has taken 8 years to get this far.
So the verdict on the 2018 Order? It’s certainly better than nothing, but the Government could have been much bolder and removed the threat of prosecution entirely.
This article was written by Noel Wardle, for more information please contact Noel at Noel.Wardle@crsblaw.com or +44 (0)20 7203 5395.