The PDA put the idea of a CPS protocol to the government in the aftermath of the custodial sentence given at the original trial. The protocol was to apply in cases of one-off dispensing error that involved a death, but where gross negligence manslaughter had been excluded by a police investigation. The intention was to ensure that rather than instigate criminal proceedings, the police would hand such matters to the professional regulator, the RPSGB, to take any necessary action.
Whilst the guidance contains some modest improvements for pharmacists, it also contains bad news, additionally, parts of the guidance simply do not reflect the reality of pharmacy practice.
We examine the detail of the guidance.
The Good News
The new February 2010 Code for prosecutors
The main code for prosecutors was actually updated in February 2010. This already provides some additional protection from prosecution for pharmacists. It may have even been informed by the political furore around the Elizabeth Lee situation. Within the list of tests that prosecutors should consider when deciding to prosecute or not has been added a brand new test which states; “that the suspect has been subject to any appropriate regulatory proceedings.” This new test is a public interest factor weighing against a prosecution. However, professional disciplinary action is taken after criminal cases have concluded, so this new test as it stands would have been unlikely to offer any assistance. However, the pharmacy legal guidance published on June 21st, adds more comfort, as it states; “Has regulatory or remedial action been taken (against a pharmacist or technician), or is it likely to be taken?” The addition does give slightly more comfort. If the pharmacy regulator has given notification of an intention to take regulatory action, then this may reduce the chances of a prosecution.
Notification of the Medicines Act review
The guidance states that the forthcoming review of the Medicines Act is expected to change how it deals with human error in a pharmacy and it sets a timeframe for the changes for 2012. Despite stating that until the law is changed, the existing code and pharmacy legal guidance should be used, we believe that the very existence of these statements in the guidance is beneficial. If there are any similar cases in the near future, then we will be using this statement to explain to the police that pharmacy prosecutions should be handled with care.
Clarification of what the Medicines Act was intended for
Our research concludes that the part of the Medicines Act that has been used by the police (Section 64.1) to deal with dispensing errors was not designed to deal with dispensing errors, but to tackle situations where dishonest medicines suppliers and manufacturers were providing adulterated or below standard medicines to the public – probably to maximise profits.
This ‘construction’ (as the judges would call it), would have formed an important plank of our defence argument had we had the opportunity to defend Elizabeth Lee’s Section 64.1 offence. We now find, couched in the first line of the CPS guidance the sentence “The Medicines Act 1968 exists to protect patients from unscrupulous suppliers of medicines.”
This statement underpins our arguments if we defend a pharmacist in the future, for it is obvious that a pharmacist who makes a human error is patently not an unscrupulous supplier of medicines.
The Bad News
Responsible Pharmacist (RP) regulations
Embellished at the heart of the guidance is the principle that it is the RP who is now required to establish, maintain and keep under review procedures to ensure that a pharmacy is operating in a safe and effective manner. The RP will need to (and we quote) demonstrate that he or she had put in place and operated written standard operating procedures, defining individual responsibilities and accountabilities, establishing procedures for identifying and remedying poor performance and ensuring that members of the dispensary team are suitably trained and competent to undertake the tasks for which they are responsible.
The reality is far detached from this position. Many community and hospital pharmacists will recognise that employers are extremelyreluctant to allow their RPs to have anything like this level of control. The pharmacy in which they work IS STILL being controlled by their employer or by someone other than the RP. The PDA is dealing with cases where RPs are either being disciplined by employers, or have been dismissed because the employer does not allow them to exercise their statutory duties under the RP regulations (see pages 6 and 7).
As the guidance gives a false impression to prosecutors, it increases the exposure of RPs and it moves employers even further away from the consequences of their actions.
The Public interest factors
The guidance identifies several ‘public interest factors’ that prosecutors should explore when considering pharmacist prosecutions. The questions that it asks appear to be demonstrative of only a superficial grasp of pharmacy practice.
For example;
- Is there any evidence that the pharmacist, technician or any other person has made other dispensing errors?
With an estimated three dispensing errors per pharmacy per week in the UK, it will not be difficult to establish that a pharmacist has made previous dispensing errors, especially if error logs are being used. We are concerned that this ‘other dispensing errors’ test will result in a further reluctance to make error log entries amongst pharmacists to the detriment of the public.
The guidance asks other questions that we believe that the CPS will not be able to properly address because it does not have the expertise. Negligence must be assessed in consultation with those who know what pharmacy negligence is i.e. the pharmacy regulator. This is not a role for the police.
These considerations include;
- What was the seriousness of the dispensing error, were the drugs (sic) particularly dangerous or poisonous in themselves, requiring very careful handling and additional checks to be in place, or was the dosage dispensed substantially greater than that prescribed or substantially beyond the usual treatment range?
- What is the culpability of those involved in the dispensing error, was it simply an error or is there evidence of recklessness or intent?
The Perverse Incentive
Due diligence defence
A substantial section of the guidance deals with what it calls due diligence defence. The thrust of this is that (and we quote) if a person can prove that he or she exercised all due diligence to secure that the (Medicines Act) would not be contravened and that the contravention was due to the act or default of another person, he or she has a defence to a criminal charge.
The guidance makes reference to the potential liability that is faced by pharmacy technicians in the event of an error. For example if an RP establishes or operates to a robust protocol which places a registered pharmacy technician in charge of the dispensary with the pharmacist undertaking only the initial clinical assessment of a prescription.
Should the pharmacist then decide to work with patients directly in the consultation room, the counter or another area of the hospital pharmacy whilst the technicians undertake the dispensing and handing out of the prescription to the patient or ward, then in this example, a straightforward dispensing error would see the registered dispensing technicians criminally liable, but leave the pharmacist with a good defence. This position leads to the prospect (perhaps unintentionally) that pharmacists may be better off (from a criminal liability point of view) in distancing themselves from the dispensing process. We are aware that this situation is, for operational and general staff availability reasons already relatively common in hospital pharmacy, but not so in community pharmacy. We argue that for the community sector, where larger dispensary teams are few and far between, that this prospect cannot be in the public interest. If ever there was a sign that the pharmacy regulator needs to take the lead and that the Medicines Act is in desperate need of an overhaul, then surely, this is it!
So what is the verdict?
We asked the CPS for a protocol that made clear that police led prosecutions of pharmacists for one-off dispensing errors were not appropriate and where gross negligence manslaughter had been excluded these cases should be handed to an authority that had the expertise to deal with them. These cases should be handled by the pharmacy regulator as a professional disciplinary matter and not as a criminal prosecution.
However, what we got was not a protocol but instead some non obligatory legal guidance which does not deliver this objective. What does not appear to be understood is that once the authorities are involved in trying to prosecute a pharmacist, particularly when a death is involved, then emotive and subjective factors may drive criminal proceedings, even when gross negligence manslaughter has been excluded. At that stage, it is easy to see how there may still be a tendency to overtly argue the public interest irrespective of the non obligatory ‘general guidance’ contained in the new CPS publication.
If ever there was any doubt about the extent the CPS will pursue their ‘suspect’, one needs only to study the report of the Appeal Court hearing.
There is nothing contained in this guidance to guarantee another Elizabeth Lee situation does not arise again.
Where to go from here?
We need an urgent review of the 1968 Medicines Act.
The MHRA continues to undertake the review of the 1968 Medicines Act and this is scheduled to be completed by 2012. However, the PDA will now be putting considerable pressure on the government to accelerate its efforts in this area; we need a much quicker change to the Act, even if only to the offending sections in the interim. Whilst the prosecution threat persists, pharmacists may be reluctant to participate in error log reporting, let alone be keen to undertake new pharmacy roles.
We will seek to influence the timing of the review process and also its final outcome. With the detailed understanding of the 1968 Medicines Act acquired for this case, we are well placed to express expert opinion for the benefit of pharmacists. We are aware that other pharmacy organisations are also feeding in their views.
Further to that, we are set to discuss our concerns about the CPS legal guidance with the government with a view of securing some improvements.
Finally, we stand ready to defend any other pharmacists from prosecution in the event that the law is not changed first.