Health and Social Care Bill

Lord Clement-Jones Excerpts

Monday 19th December 2011 Lords Chamber

Moved by

[Lord Clement-Jones]

337A: After Clause 202, insert the following new Clause—
“Power to regulate pharmacists
(1) The Medicines Act 1968 is amended as follows.
(2) After section 58(6) there is inserted—
“(7) Subsection (2)(a) does not apply to the sale or supply of a medicinal product by a person lawfully conducting retail pharmacy business where the sale or supply is in accordance with a prescription and, having exercised all due diligence, believes on reasonable grounds that those requirements have been fulfilled.
(8) The activity under subsection (7) shall be regulated by the General Pharmaceutical Council.
(9) The General Pharmaceutical Council may take what steps it considers necessary under section 6(1) of The Pharmacy Order 2010 (S.I. 2010/231) in relation to a person who performs an activity referred to in subsection (7).”
(3) After section 64(5)(b) there is inserted—
“(6) Subsection (1) does not apply to the sale or supply of a medicinal product by a person lawfully conducting retail pharmacy business where the sale or supply is in accordance with a prescription and that person selling or supplying the product, having exercised all due diligence, believes on reasonable grounds that those requirements have been fulfilled.
(7) The activity under subsection (6) shall be regulated by the General Pharmaceutical Council.
(8) The General Pharmaceutical Council may take what steps it considers necessary under section 6(1) of The Pharmacy Order 2010 (S.I. 2010/231) in relation to a person who performs an activity referred to in subsection (6).”
(4) After section 85(5) there is inserted—
“(6) Subsection (1)(a) to (c) does not apply to the sale or supply of a medicinal product by a person lawfully conducting retail pharmacy business where the sale or supply is in accordance with a prescription and that person selling or supplying the product, having exercised all due diligence, believes on reasonable grounds that those requirements have been fulfilled.
(7) The activity under subsection (1) shall be regulated by the General Pharmaceutical Council.
(8) The General Pharmaceutical Council may take what steps it considers necessary under section 6(1) of The Pharmacy Order 2010 (SI 2010/231) in relation to a person who performs an activity referred to in subsection (6).”.”

[Lord Clement-Jones]

My Lords, the amendment has been tabled with the support and assistance of the Royal Pharmaceutical Society and has been designed as a new clause that amends the Medicines Act 1968. It is also designed to increase patient safety by removing barriers to a learning culture across the prescription dispensing process, and to remove the injustice that pharmacists alone, among healthcare professionals, face through criminalisation. Single dispensing errors should be treated in a proportionate way that retains the ability to prosecute those who have been negligent or who have committed a deliberate act but that does not penalise pharmacists who wish to declare a dispensing error in the interests of patient safety.

The role of pharmacy continues to be vital to communities throughout England. Pharmacists are at the forefront of providing advice to patients in an increasingly high-pressure environment. In 2010 nearly 927 million prescription items were dispensed in England. This is a 4.6 per cent rise on 2009 and a 67.9 per cent rise on 2000. Despite this, the error rate of dispensing remains minuscule.

What is the background to the current state of the law? Sections 58, 64 and 85 were inserted into the Medicines Act 1968 to regulate the quality of medicinal products being manufactured in pharmacies across the country. There were concerns that the production of these items, primarily creams and solutions that could be prepared to suit to individual needs of patients, required a legal standard of purity. Nowadays, the practice of creating preparations in community pharmacies is practically non-existent. However, these sections of the Medicines Act have been used in a way that they were not originally intended for: to prosecute a pharmacist who makes a single error while dispensing a medicinal product. The law as it stands makes a single error an automatic criminal offence that is punishable by up to two years in prison.

Why should we support this amendment? Currently, pharmacists are expected to declare dispensing errors in the knowledge that they will face prosecution if they do not do so. Clearly, any person who is either wilfully negligent or deliberately acts in a way to harm a person must face prosecution under criminal laws. This amendment would allow that to continue but would also enable a proportionate response for those who make an error. Minor errors should be learnt of and dealt with through improved practice rather than through discouraging healthcare professionals from feeling able to report errors. Decriminalising dispensing errors will be beneficial to patients and the pharmacy profession through the creation of a culture of learning.

The current system goes against the spirit of openness in which pharmacists and other healthcare professionals should be allowed to work, so as to enhance patient safety. This amendment, or something similar, is the right way in which to tackle this important issue. The passage of the current Bill presents an opportunity to tackle this, and one that should not be missed. I beg to move.

[Baroness Finlay of Llandaff]

My Lords, I support the amendment. It raises a very important issue, namely what happens when an error occurs. At the moment, there is an enormous disincentive for the pharmacist to do what one would say is the right thing, which is immediately to contact the patient, or their family, carer or nursing home, to try to put an immediate stop to the further use of that medication and to do all they can to correct the error. In the law as it is written at the moment there is an in-built incentive to a pharmacist to attempt a cover-up, to weigh up whether the error is a major or minor one or one which they might just get away with, or perhaps even to make a phone call that fudges the issue and tries to cover up the fact that they have made a dispensing error, and to reclaim the medication in another way.

In addition to the importance of a spirit of openness, there is an actual safety issue here. We know from looking at medicine and nursing that when you make it easier for people to admit immediately that they have made an error and to do all they can to correct that error, they are much more likely to handle things in an open and honest way and to learn from it. Certainly I say to all my junior staff, “I know that you will make mistakes. The only thing that I will hold against you for the whole of your career is if you do not immediately notify whoever is the consultant covering you at the time. Mistakes will happen, but you must let people know immediately and take every step to correct them”. I do not see why we should be treating pharmacists in law in a way that works against that type of principle and which is inappropriately punitive.

--- Later in debate ---

[Earl Howe]

My Lords, the amendment relates to an important issue: the concerns among pharmacists about the risk of prosecution where they normally follow good professional practice but make an inadvertent dispensing error. I am very grateful to my noble friend for raising this issue. I warmly welcome the opportunity to discuss it and have been listening carefully to the points made.

We are on the record as saying that we intend to take legislative action to address the issue. We want to see a learning culture that encourages the reporting of dispensing errors so that any helpful lessons can be learnt. The noble Baroness, Lady Finlay, was quite right about that. However, we need to make any changes in ways that continue to protect patients under the law. The noble Baroness, Lady Pitkeathley, drew our attention to that aspect.

Section 64 of the Medicines Act 1968 provides that,

“No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser”.

This is a strict liability offence, and contrary to what my noble friend stated it does not relate only to pharmacists. Various other healthcare professionals could be affected, as well as other parties who are not subject to professional regulation. Guidance issued to government prosecutors in 2010 has been helpful, but we recognise that it does not remove the underlying problem.

My noble friend is to be commended for raising this issue, but the terms of the proposed amendment present a number of problems that we would need to work through before an appropriate drafting solution could be found. It does not cover other healthcare professionals affected by the current legislation, and in relation to pharmacy it covers only a proportion of pharmacy activity—retail pharmacy—and only where a pharmacist is responding to a prescription. The amendment does not address the different arrangements for the professional regulation of pharmacists that apply in Northern Ireland. There is also some ambiguity as to how it would be determined in practice: that is, whether a pharmacist would be subject to the revised provisions in this amendment. The amendment extends beyond Section 64 and would also change Section 58, on prescription-only medicines, and Section 85, on the labelling of packages and containers of medicinal products, of the Medicines Act 1968.

The legislative ramifications of the issue are therefore quite complex, and I am sure my noble friend will appreciate that we need to get this right. However, let me assure him that we have listened very carefully to the debate and the representations made to us, and that we will continue to work with all relevant parties to find a solution. I also wish to reiterate our commitment to bring forward a suitable legislative change at the earliest possible opportunity. I hope that with those assurances my noble friend will feel able to withdraw his amendment.

[Lord Clement-Jones]

My Lords, I thank the Minister for his response. I also thank all noble Lords and noble Baronesses who have spoken in the debate. I should at the outset have declared an interest as chairman of the council of the School of Pharmacy. My noble friend the Minister has pointed out, quite rightly, that the amendment as drafted only covers the pharmacy profession. He has also pointed out a point picked up by almost all the speakers in the debate, namely that the essence of the provision is the ability to admit and correct error, which is vital in these circumstances.

I welcome very much the forensic way in which the Minister responded to the amendment. I did not think that it was the kind of amendment that would cause Ministers to throw their hands up in the air and say, “Wonderful! We will put this in the Bill”. It needs refining. One of the key issues is that it currently only relates to retail pharmacy. Obviously, it should cover hospital pharmacy as well. There are also issues about Sections 58 and 85 in Northern Ireland.

The Minister has assured us that he has listened very carefully and that he intends to legislate at the earliest possible opportunity. That phrase was very carefully chosen, I am sure, as my noble friend always chooses his words extremely carefully. If the Minister would indicate that, if humanly possible, this will be inserted either on Report or at Third Reading—as the Bill provides a very good opportunity to include reform—I think that the pharmacy profession and others which, as he said, are subject to this kind of disproportionate criminal liability will be extremely happy. I am sure that they would be very grateful to the noble Lord if he could make sure that that was the case. The Minister is not indicating that he is going to say anything further—but maybe he will.

[Earl Howe]

My Lords, let me simply say that my noble friend’s exhortation has been very firmly registered.

[Lord Clement-Jones]

My Lords, the Minister chooses an even more felicitous phrase. I thank him, and I look forward to further progress during the course of this Bill. In the mean time, I beg leave to withdraw the amendment.

Amendment 337A withdrawn.