Decriminalisation concerns – PDA writes to Pharmacy Minister

The PDA are concerned that the Rebalancing Board, charged with the responsibility to provide a wide ranging and appropriate amendment to the law, has failed to do so and has written to the Pharmacy Minister with an offer to help improve the situation.

Wed 28th March 2018 The PDA

The PDA are concerned that the Rebalancing Board, charged with the responsibility to provide a wide ranging and appropriate amendment to the law, has failed to do so and has written to the Pharmacy Minister with an offer to help improve the situation.

The nature of the PDAs role means that it has significant experience of supporting pharmacists who face the prospect of criminal prosecution when dispensing errors are made. Following the PDAs involvement in the Elizabeth Lee case where her nine month suspended prison sentence was dropped following a successful legal challenge in the Royal Court of Appeal, the PDA has been calling for the decriminalisation of dispensing errors and welcomes the government’s acceptance that inadvertent errors should not be criminalised.

The two new defences, that will come into law next month, will help in a limited range of scenarios. However, the PDA is concerned that many pharmacists will have been misled by some of the narrative surrounding this limited change to legislation, which is giving the impression that pharmacists no longer need to worry about the risk of criminal prosecution. In reality, there remain a number of areas in medicines legislation under which prosecutions for inadvertent dispensing errors may still occur. Given this, we cannot advise our members to error report without also making them aware of the continuing risks.

The PDA are disappointed that after five years of the Rebalancing Board’s considerations, a comprehensive solution has not been delivered. The PDA has consistently offered to join the Rebalancing Board in order to assist, but the Board have declined despite the expertise the PDA has in this area.

The content of the letter to the Pharmacy Minister is below and PDA are hopeful that the Minister will accept its offer of help.

Mark Koziol, Chairman of PDA said: “Steve Brine has made a personal commitment to getting this right and PDA would be pleased to help him deliver on that promise.  It benefits patient safety and benefits pharmacists to get this issue dealt with fully and properly as soon as possible.  The need to decriminalise pharmacy has been unresolved for far too long.

 


PDA’s Letter:

Steve Brine MP

Parliamentary under Secretary of State

Department of Health and Social Care

Richmond House

Whitehall

London

16th March 2018

Dear Steve,

Following the recent Royal Assent received for the (Preparation and Dispensing Errors–Registered Pharmacies) Order 2018, we wanted to place on record our appreciation for the commitment you have personally made towards this issue since you were appointed as Minister. As you are aware, progress has been slow for many years.

Whilst welcoming the acceptance that inadvertent errors should not be criminalised, we remain concerned that many pharmacists will have been misled by much of the coverage surrounding this change to legislation. Statements from some senior leaders in our profession have given the impression that decriminalisation of inadvertent dispensing errors has now taken place and that pharmacists are no longer at risk of prosecution as a result of this legislation. We are very clear that this is not the case.

As a Defence Association and Trades Union providing legal and professional assistance to over 27,000 pharmacists in the UK, our expertise in this matter is unparalleled and it is largely our employee and locum members who face the ongoing risk of prosecution for inadvertent errors. Whilst we are keen to provide a positive response to this legislation, and for your personal intervention in doing so, we would be failing in our duty to our members if we did not advise them that the risk of prosecution remains. The order only focusses upon two sections of the 68 Medicines Act and provides defences in certain circumstances. The work of the Rebalancing Committee did not consider other areas of the medicines legislation where risks of prosecution and even prison sentences for pharmacists in the event of an inadvertent dispensing error remain.

As the legislation comes into force next month, it might be hoped that we would see an increase in the level of reporting errors. However, given our concerns that prosecution risks remain, we cannot advise our members to error report without also making them aware of the continuing risks.

We have obtained independent legal advice from Queens Counsel, validated by pharmacy law specialists, which clarifies the current position for pharmacists. We have attached an abridged version of this advice to this letter for your consideration. In essence, the advice states clearly that there are only 2 limited circumstances where a pharmacist can rely on these new defences.

Furthermore, the defences are not applicable in all circumstances where an inadvertent dispensing error may have taken place in supply circumstances other than those under section 63 or section 64 of the Medicines Act.

We are concerned that the Rebalancing Board, charged with the responsibility to provide a wide ranging and appropriate amendment to the law, has failed to do so. We have consistently put our concerns to the Rebalancing Board and offered to participate in its work, but these offers have been rejected and our concerns appear to have been disregarded.

The board did not seek the widest possible support or contribution from the sector, including refusing to adequately involve the very organisation that has responsibility for and considerable expertise of defending pharmacists who are facing prosecution or regulatory sanction. For comparison, we could not imagine that the DoHSC or any other delegated board charged with responsibility with making similar changes affecting the medical profession would do so without engagement with the Medical Defence Unions.

The decriminalisation process has still some way to go if it is to achieve its stated objectives and we offer our assistance to seek changes to legislation to ensure that it provides the appropriate balance of protection for pharmacists and the public, through encouraging reporting and learning from incidents. Furthermore, we think it is essential and urgent that discussions take place with officials and the Crown Prosecution Service to clarify the advice for prosecutors.

We would welcome the opportunity to meet with you to discuss our concerns on behalf of pharmacists across hospital, community and primary care locations who remain at risk of prosecution as we are concerned that they are unlikely to increase their error reporting while the current situation continues.

We look forward to hearing from you.

Yours sincerely

 

Mark Koziol

Chairman

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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