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New incident reporting rules 'pose prosecution risk'

The threat of prosecution is a "barrier" to pharmacists reporting patient safety incidents, says Pharmacy Voice chief executive Rob Darracott

New funding requirements that prevent pharmacies from anonymously reporting patient safety incidents could put them at risk of prosecution, pharmacy leaders have warned.

New funding requirements that prevent pharmacies from anonymously reporting patient safety incidents could put them at risk of prosecution, pharmacy leaders have warned.

As part of the 2014-15 funding settlement announced on Monday, pharmacists will have to include the name of the pharmacy when submitting an error report to the National Reporting and Learning Service (NRLS). This would make it easier to learn from the errors and help NHS England identify pharmacies that reported "significantly below expected levels", PSNC said.

It is still a criminal offence for a pharmacist to make a dispensing error and Pharmacy Voice chief executive Rob Darracott said the threat of criminal sanctions was a "barrier" to reporting safety incidents.

"People will think twice about reporting to a centralised system," he told C+D. "Hopefully we will get some answers about that."

Royal Pharmaceutical Society president Ash Soni said he also had "significant concerns" about the "risk of self-criminalisation". Although increasing patient safety was a "really good thing", it seemed "a bit early" to expect pharmacists to report incidents without anonymity, he told C+D. 

Community Pharmacy West Yorkshire chief executive Robbie Turner told C+D that the ongoing campaign to decriminalise dispensing errors, which received backing from parliamentary lawyers in July, needed to go "hand-in-hand" with encouraging pharmacists to report errors.

"It will be a challenge to protect contractors and people who work in pharmacies from future prosecutions while also enabling them to continue to improve the service they offer patients," he said.

Mike Hewitson, owner of Beaminster Pharmacy in Dorset,said healthcare professionals had a "duty to be more open and honest" about dispensing mistakes so that they could learn from them.

A change to the rules

The new funding arrangements mean pharmacists will only be expected to report safety incidents that did - or could - have led to patient harm, rather than potential errors that were detected during a pharmacy's checking procedures.

PSNC said it had been "robust" in ensuring the requirements were "manageable" for pharmacies. The negotiator had persuaded NHS England that minimum reporting targets would "not be feasible" for most contractors and risked over-estimating the number of errors taking place, it said.

In July, NHS England accused the sector of "substantially" under-reporting errors and pointed out that only 7,919 medication incidents were reported by community pharmacies in England and Wales in 2012, despite an estimated 12.7 million serious incidents having occurred. 

Are you woried about the new rules?

We want to hear your views, but please express them in the spirit of a constructive, professional debate. For more information about what this means, please click here to see our community principles and information

Lance Roth, Manager

Once again the profession is biting the dust. PSNC has represented us well! - NOT! Be warned that reporting errors in this fashion does not only open us for a confrontation with the statutory bodies, but could potentially lead to further litigation from the patient concerned, and I predict will in future form part of our profiles on NHS Choice or even the GPhC's ranking website. This is Big Brother indeed! Strange that everybody seems quite happy to stand around with the 'stick' bit very little is being done to help us!

Gerry Diamond, Primary care pharmacist

Time to hang up the white coat and go drive a taxi or sell pizzas. I've paid my house off dont want someone taking it off me now....

Disillusioned Pharmacist, Community pharmacist

"Privilege against Self-Incrimination- The privilege against self-incrimination forbids the government from compelling any person to give testimonial evidence that would likely incriminate him or her during a subsequent criminal case."

The right to silence.

Where is Mr. David Reissner or the PDA? Surely they must have a view on this?

[email protected], Community pharmacist

One final point and possibly a counterargument. How anonymous do people think the situation is currently?

Check your IP address on the N3 line. How often does it change? Who assigns it? Who forces them to keep records?

[email protected], Community pharmacist

To me this looks like that comment, a good way to hide bad news.

First off the pharmacy is getting more money, but is actually getting less. Then hidden in the paperwork is the fact that there is no more anonymous reporting of errors.

Who is the PSNC representing?
In what way do they think they are representing us?

How on earth did they think to agree to a proposal that pays less and forces us to criminalise ourselves?

How can they look themselves in the mirror? They obviously have no respect for the people they represent.

As the PSNC is obviously not representing us, how do we go about ending any connection between pharmacy and the PSNC?

Meera Sharma, Community pharmacist

If reporting errors anonymously hasn't produced any kind of learnings/patterns and this has been going on for at least a year. Then where is the evidence that identifiable reporting is miraculously going to result in some great big report?! Why is it "robust" to carry out exercises for the sake of it if not a single pattern/lesson has been produced. This just amounts to useless data collation.

Peter McAuley, Community pharmacist

The NRLS is a misnomer. It is just NRS. It is just a reporting system. There is no learning, as there is no feedback to errors that are reported.
When did they last issue any learning points?
If there is no learning, why bother reporting?

Dipen Shah, Community pharmacist

Just a thought ... And I may be wrong so please correct me here. Isn't there the right not to incriminate onself? Or am I getting this wrong?

Lance Roth, Manager

It is against your Human Rights as enshrined in the EU Charters to incriminate yourself.

Michael Stewart, Community pharmacist

Astounded that this has been agreed to as part of the funding settllement.

The whole point of the NRLS is to analyse types of error across the whole NHS to look for patterns which will then inform best practice to improve patient safety.

Stating the pharmacy name can have no impact on the learnings from this analysis.

The ONLY possible reason for identifying the pharmacy is to monitor how many errors occur at each pharmacy. How does this fit with the NHS 'no-blame' culture?

The previous clinical government requirement of reporting all patient safety incidents (including near misses) was impractical - an impossible workload.

This new requirement is unworkable as long as dispensing errors remain a criminal offence.

This can only have a negative impact on the reporting of errors and hence on patient safety.

Short-sighted and ill-conceived. Is the year 1984?

N O, Pharmaceutical Adviser

""PSNC said it had been "robust" in ensuring the requirements were "manageable" for pharmacies.""

Do the PSNC follow some kind of exclusive dictionary that none of the Pharmacists have access to and the words in that dictionary seem to have meaning that are completely different to reality.

"robust" -- what have they done to claim this?

"Manageable" -- again, how? any guidance issued and AGREED by pharmacies?

One more ridiculous effort from PSNC to support nonsensical contractual agreements.

N O, Pharmaceutical Adviser

You kidding me? Who on earth will sign his own death warrant?

And for one more stale joke -- "significant concerns" is this what we expect from the leader of our professional body, who are questioning the professional credentials of non-members? Sir it is a MAJOR CONCERN. And no one will report any such incidence (unless the patient has reported them) to anyone if they will be indicted, hence your talk about improving patient safety is safe in a BIN till there is a clarity on PROSECUTION. So it is an URGENT matter, if you are interested in helping the pharmacy sector.

""Mike Hewitson, owner of Beaminster Pharmacy in Dorset,said healthcare professionals had a "duty to be more open and honest" about dispensing mistakes so that they could learn from them.""

Mr. Hewitson, what will you do by the great learning experience when you are tried in a criminal court and struck off from the register ?? GPs are healthcare professionals, and they have been asked only to apologise if they made a mistake and there is no mention of reporting it to anyone !!! Be truthful to yourself first and see how many you have reported so far in your own career? and what were the outcomes?

It is so easy for these so called leaders to issue statements that are most of the time obvious and then no follow up with some kind of action to protect the sector. Ridiculous.

Mike Hewitson, Superintendent Pharmacist

I've made my fair share of error reports on to NLRS. It isn't big brother, and reporting an error doesn't mean that you are going to initiate criminal proceeding against yourself. In fact, if you look at the actions that GPhC have taken, you could actually say that reporting the error, being open and transparent about what has happened puts you in an eminently better position should either criminal or professional sanctions follow. We all have a duty of candour when it comes to error reporting, that has only been reinforced by the Francis Report. My local CCG and old PCT were both welcoming of error reports, it shows a commitment to quality not the other way around.

I spend 6 days a week working as a pharmacist in my pharmacy, so I'm as coalface as anyone else on here.

The outcome is the interesting bit, because there is currently little or no feedback to individuals or organisations who make errors, so the introduction of Medication Safety Officers within large organisations and NPA (representing the smaller organisations) is a positive move which could help to close the feedback loop.

The removal of criminal sanctions for single dispensing errors is coming, DH is actively working on the issue.

Now my turn to ask you a question, how many pharmacists were actually prosecuted last year for single dispensing errors? The threat is there, and I live with it every day, as you do. But it is how the rules are interpreted which are important.

[email protected], Pre-reg graduate

Most of your comments do make sense theoretically. But, I have few questions in line with Michael's response.

1. What have we learnt so far with the existing system? Of course apart from some organisations blaming the Pharmacists (please note they haven't named others) for under-reporting.

2. If there were not many errors reported anonymously, then what are the chances any more reports will come to the front when the reprters name is disclosed in open?

3. What is the NRLS trying to acheive? I know there is a lot of mention to "patient safety" millions of times, but how exactly are they going to reduce the errors by more errors being reported? Do they have any plans or steps to prove the mistakes can be done with forever?

4. Please read more carefully the FtP cases and you will find that many people were subject to FtP cases by the Multiples, after tey quit, for errors they comitted during their employment. So lets not even talk about the GPhC and its FtP, they are an inpredictable jokers ready to strike you down on any opportunity presented to them.

Michael Stewart, Community pharmacist

1. What have we learnt so far with the existing system?

There have been some learnings shared - although not a great deal.

Probably the most well-known is the change to dispensing of methotrexate - recommendations to only prescribe and dispense 2.5mg tablets instead of 10mg. This was in response to widespread errors of dosing.

The last report (2009?) by NRLS/NPSA can be found at

There are various resources that have been informed by analysis of previous errors.

So I think the current system was working to some extent - I guess it is a question of resource and priority. But am I right in thinking NPSA no longer officially exists since the NHS reforms?

[email protected], Pre-reg graduate

Let's assume (and I am sure that is the point) that these error reports are used primarily for recommendations like the methotrexate ones, then won't it suffice to ask for anonymous suggestions from Pharmacists across the board on what kind of errors can happen and what could lead to these errors rather than asking what happened and how it happened and who did it?

This way you get what you want and we can all learn something and implement steps to avoid these from occurring. Can't we?

Michael Stewart, Community pharmacist

"then won't it suffice to ask for anonymous suggestions from Pharmacists across the board on what kind of errors can happen and what could lead to these errors"

Actually - I think this has already happened. I remember a year or so ago a request for suggestions for 'never' events - i.e an event that should 'never' happen in pharmacy - for example dispensing ear drops instead of eye drops. or a daily dose of methotrexate (again).

Don't ever remember seeing any follow up to that......

Michael Stewart, Community pharmacist

Yes that would work too - although difficult to get meaningful data on the likely frequency of a safety incident - which is also useful to have. Its a balance between likelihoof of incident and severity of outcome.

The 'who did it' bit is irrelevent to patient safety, but now it has become relevant. It will be a brave phamacist that reports an error that hasn't already been taken further by patient/GP/GPhC.

Levels of reporting are already low - lets see how low it will go now.....

And the reason behind us losing anonymity? - look out for a future funding settlement where your practice payment is reduced in proportion to the number of errors made in your pharmacy....

Rajive Patel, Community pharmacist

Mike Hewitson, owner of Beaminster Pharmacy in Dorset,said healthcare professionals had a "duty to be more open and honest" about dispensing mistakes so that they could learn from them.

Agreed Mr Hewitson, however, who wants to learn from mistakes, behind bars!

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