14 th May Pharmacy Voice. 4 Bloomsbury Square London WC1A 2RP T E

Transcription

1 Consultation response Department of Health Rebalancing Medicines Legislation and Pharmacy Regulation: draft orders under section 60 of the Health Act th May 2015 Pharmacy Voice 4 Bloomsbury Square London WC1A 2RP T E info@pharmacyvoice.com

2 Introduction We welcome the opportunity to respond to this consultation. Pharmacy Voice (PV) and its constituent member bodies have long called for a review of the penalties and sanctions for inadvertent dispensing errors. We believe that reducing the fear of criminal prosecution, by bringing the treatment of pharmacists and pharmacy technicians who make inadvertent errors more in line with that of other healthcare professionals, will help to encourage a culture of transparency, reporting and learning. As such, redressing current imbalances between legislation and regulation in such matters has considerable potential to increase patient and public safety. We welcome this consultation on a proposed solution to the issue, and the work that has been undertaken by the Rebalancing Programme Board to bring the proposals forward. This is a hugely significant development for the sector and profession - and may constitute a unique opportunity to develop pharmacy practice and improve patient outcomes. It is therefore essential that all changes made to current legislation have this intended effect. Ensuring that possible unintended consequences of, or further barriers to, change have been identified and resolved will be important to getting this right. Colleagues from across Pharmacy Voice s membership have significant and extensive experience of handling the kind of real-life, complex cases that need to be fully thought through in this way. We would therefore like to offer to meet with the Rebalancing Team to consider such scenarios and issues, to help stress-test the proposals before new legislation and regulations are finalised. If you would like to discuss this in more detail, or have any queries about the following responses to the consultation questions, please contact Elizabeth Wade, Director of Policy for Pharmacy Voice, via elizabeth.wade@pharmacyvoice.com Answers to consultation questions Question 1: Do you agree with our overall approach, i.e. to retain the criminal offence in section 64 and to provide a new defence for pharmacy professionals against prosecution for inadvertent dispensing errors, subject to certain conditions? Pharmacy Voice believes that the risk and fear of criminal prosecution for pharmacists and pharmacy technicians who make inadvertent dispensing errors should be removed. The handling of such events should be aligned for pharmacy and other healthcare professions, so that errors made in the course of professional practice are not treated as matters of criminal conduct but rather are subject to regulatory oversight and, where necessary, sanction. The most conclusive way of achieving this would be to amend section 64 to remove the dispensing of prescriptions from the scope of the offence. However, we recognise the conclusion that the Rebalancing Board has reached: that certain 2

3 circumstances mean section 64 cannot be removed from the statute books, but that a standard defence should protect registered pharmacy professionals and their staff from prosecution for inadvertent dispensing errors made when acting in the course of his or her profession. On the basis of understanding there is no alternative option that could be quickly agreed upon and implemented, Pharmacy Voice is willing to support this proposal as the only current opportunity to move things in the right direction for professionals and patients. While recognising that there is no universal definition of a dispensing error and that producing one may not be desirable, there is currently some lack of clarity over whether the new defence will cover all types of dispensing error. For example, some commentators have recently suggested that failing to label a medicine correctly by applying a label to the wrong product would remain a statutory offence with no defence under the Human Medicines Regulations. To give registrants confidence in the new arrangements we believe resolution of this issue needs to be clarified, and that the defence should apply in all equivalent circumstances. It will be important to recognise that these proposals are only one part of wider changes to the development, regulation and oversight of pharmacy practise, which also include revisions to the GPhC s approach to standard setting, inspection and fitness to practise procedures. In order for such changes to have the desired cumulative effect of improving transparency, learning, quality and safety, by establishing a just culture, it will be important to ensure they are consistent and aligned. For example, the GPhC s approach to handling fitness to practise referrals for single inadvertent dispensing errors should reflect the spirit and intent of the Rebalancing programme. It should also be noted that the new defence will not remove the possibility of prosecutions of pharmacy registrants by patients or their families and so cannot entirely remove their fears regarding the legal consequences of making errors. This again points to the need for a holistic approach to developing a just culture, in which the right balance is struck between managing risk and developing pharmacy practice in the interests of patients and the public. Question 2: Do you agree that, once a defendant has done enough to show that the relevant pharmacy professional might have been acting in the course of his or her profession, the prosecution should have to show, beyond a reasonable doubt, that the pharmacy professional was not acting in the course of his or her profession in order to secure a conviction? Yes, we agree that that it should be up to the prosecution to show, beyond reasonable doubt, that the pharmacy professional was not acting in the course of his or her profession. 3

4 Pharmacists, like other healthcare professionals, have to make difficult decisions on occasion, for instance when other healthcare professionals are not available, or in an emergency situation. Different pharmacists may make different decisions in similar circumstances. However, where the pharmacist was using their skills and competence to make a professional judgement, had no reason to believe those skills and competencies were impaired, and was acting - as they considered it at the time - in the best interest of the patient, it should be accepted that they were acting in the course of their profession. Question 3: Do you agree the two proposed illustrative grounds that the prosecution could rely on to establish that the pharmacy professional was not acting in the course of their profession, if they were proven beyond reasonable doubt? We support the use of illustrative grounds but consider more need to be included to help professional colleagues understand the nature of the changes, their intention and expected application. While case law is being established the Department needs to ensure that prosecutors have sufficiently detailed guidance to be able to interpret the new regulations in the spirit in which they are intended. As noted in the introduction to this response, we would be happy to work with the Rebalancing team to help develop illustrative scenarios and guidance. Question 4: Do you agree that where a pharmacy professional does not follow procedures established for the pharmacy and an error takes place, this should not, on its own, constitute grounds for a decision in criminal proceedings that the pharmacy professional is not acting in the course of their profession? Yes, established procedures hold for the majority of the time, but there will be instances when the pharmacy professional, in their professional judgement, acts outside the procedures in the best interest of the patient. Question 5: Do you agree that for the defence to apply, the sale or supply of the medicine must have been in pursuance of either a prescription or (in the case of sales) directions from an appropriate prescriber? We agree with this general principle, but believe this issue requires further clarification. For example, we are not clear if the defence would hold when an emergency supply is made for an item which a patient has previously received on prescription a scenario frequently encountered by pharmacy teams. We would also note that, as written, the defence may not hold if a pharmacist independent prescriber wrote and dispensed a prescription him/herself. While we would not support this as good practice there may be occasions where this is in the best interest of the patient. 4

5 Clearly, as part of implementation the pharmacy professions will need to consider the impact of these changes in terms of how we think about the effective workings of pharmacies, and how different pharmacy professionals might need to be involved in sales and supplies for the new defence to hold. On occasion, if may be difficult or even impossible to rely on this specific defence. We believe that how pharmacy professionals would approach their role in those circumstances would be a matter for professional guidance and judgement. Question 6: In your view, should it be part of a defence where someone is charged with a dispensing error that if an appropriate person at the pharmacy knew about the problem before the defendant was charged, all reasonable attempts were made to contact the patient unless it was reasonably decided not to do so? Yes. We believe that pharmacy professionals and owners should be open and honest when responding to patients who question whether an error has taken place, and should take proactive, timely remedial action if they discover an error which could cause patient harm, and where informing the patient is in their best interests. We agree that anyone identifying or suspecting that an error had been made must report their suspicion to the appropriate person (as identified in paragraph 75 of the consultation) for investigation prior to contact with the patient being made. The appropriate person should then decide what action needs to be taken. This action should include making reasonable attempts to notify the patient unless they believe it is not necessary or appropriate to do so in the particular circumstances of the case. In such an event, the reason for not informing the patient should be recorded. When this process has been followed it should be considered as part of the defence. We believe some of the specific points in the section of the consultation document on notification require further consideration. Paragraphs 84 and 85 of the consultation document identify that there is an extra onus on the pharmacy owner in regard to notification, reflecting the particular responsibilities that arise out of their corporate duty of candour. If the owner does not know about an error and the registrant who is most directly professionally accountable for the error does know but unreasonably does nothing, then the owner remains potentially liable to prosecution. We understand this is intended to provide a strong incentive for owners to remain vigilant regarding what is happening in their pharmacy businesses. However, we do not believe it will always be reasonable that failings on the part of a pharmacist necessarily lead to a liability on an owner. Similarly, as proposed in paragraph 86, if a pharmacist is supervising a non-registrant dispensing a product and the dispenser of the product knows that there is a problem but 5

6 does nothing about it, the supervising pharmacist cannot rely on their own ignorance of the problem as a way of avoiding liability. The document suggests that if they have not been involved in the actual supply of the product, the likelihood is that they could only be prosecuted under section 64 as a secondary party to the offence, so there would need to be further aggravating factors for a supervising pharmacist still to face possible prosecution in these circumstances. We do not feel this it is sufficiently clear what such aggravating factors might be or, more generally, that the case has been made that this additional onus on supervising pharmacists is reasonable in all cases. We believe that further thinking is required in relation to both scenarios, in order to achieve an appropriate balance between the incentive for vigilance and the reasonableness of liability for actions that may be unknown due to the deliberate acts or omissions of an individual making an error. Question 7: Do you agree that the unregistered staff involved in the sale or supply of a medicine (including, for example pharmacy assistants who hand over medicines that have been dispensed or van drivers who deliver medicines to patients) or the owner of the pharmacy where a dispensing error occurs should potentially be able to benefit from the new defences? Yes Question 8: Do you agree that the defence should not apply in cases where unregistered staff involved in sale or supply of medicine deliberately interfere with the medicine being sold or supplied at or from the pharmacy? Yes Question 9: Do you agree with the overall approach to the new defence in section 67B in relation to the offence in section 63, i.e. to retain the criminal offence and provide a new defence subject to essentially the same conditions as will apply in relation to section 64? If you think different, additional or fewer conditions should apply, could you explain what, if any, conditions you think should apply. We agree with this approach. Question 10: Do you agree that in relation to GPhC, the obligation to set standards in rules should be removed? We support a move to standards which are outcome-based rather than prescriptive requirements, leading to an improvement in patient safety. We believe that the GPhC 6

7 should be required to consult with and have regard to relevant stakeholders when developing standards, and this should not be restricted to Ministers. Paragraph 111c refers to associated premises. We assume that this would include premises used in hub-and-spoke arrangements. With new models of working including distance selling pharmacies, more use may also be made of prescription collection points to enable patients to collect medicines dispensed at a pharmacy some distance from where they live or work. Guidance is needed as to whether premises such as this are deemed to be associated premises. Question 11: (for respondents in Northern Ireland): Are you content to place a statutory duty on PSNI to set standards for registered pharmacies? We have no comment on this. Question 12: Do you agree with the approach we are taking to breaches of premises standards by pharmacy owners? We generally agree, and support moves to facilitate more proportionate sanctions by the pharmacy regulator in cases of breaches of premises standards. However, under the proposal that failures to comply with premises standards are treated as fitness to practise matters, we are unsure of the possible consequences if there is a breach in just one of a contractor s multiple pharmacy premises. We do not believe it would be appropriate if a judgement that a pharmacy owner is unfit to carry on the retail pharmacy business safely and effectively due to a failure to ensure compliance in one pharmacy, should necessarily have implications for the registration of all of their premises. We would welcome greater clarity on this point. Question 13: Do you agree with the changes to provide for publication of GPhC reports and outcomes from pharmacy inspections? We support the principle of transparency as a mechanism for quality improvement, and agree that in this context and where there is now publication of the inspection reports for other NHS-funded and operated organisations - the reports and outcomes from pharmacy premises inspections should be made available to the public. However, in order to have the desired outcome of improving patient confidence, choice and outcomes, it is vital that the inspection, rating and reporting system itself is fair and fit for purpose. Reporting findings that could be spurious due to the inspection approach, or reporting them in a way that does not give a fair and reasonable account of the standards in place within a pharmacy, is not in the interests of patients or the public, or of the healthcare system. 7

8 We believe that the issue of inspection grading (both the naming of the grade bands and the distribution of the grades) needs to be addressed before reports are published. The current grading system is not in line with those used by the CQC or OFSTED, for example, and does not provide a fair picture of the standards delivered across the community pharmacy network. According to our latest survey (August 2014-February 2015) more than 80% of the pharmacies inspected by the General Pharmaceutical Council under its new inspection model were considered satisfactory. This does not reflect a normal distribution pattern and we believe does not reflect accurately the quality of community pharmacies in Great Britain. We do not believe that publication of gradings achieved under the current system will promote public confidence in the capability and competence of pharmacy teams or facilitate informed patient choice. In order to fully support changes to provide for publication of GPhC reports, therefore, we would need assurances that the regulator will first work with our members and take account of their views, and those of other relevant stakeholders, to ensure the inspection reports and reporting process will meet the needs of the public and of the health and care system. This means ensuring they have the confidence and acceptance of owners and pharmacists. One particular issue that members are concerned about is the potential availability of reports which do not reflect the current status of a pharmacy. For example, if a pharmacy had taken immediate remedial action after receiving a poor grading so that the premises should be reassessed as meeting the satisfactory grade, we believe the report should be updated, rather than remaining available to the public with a poor grading until the next full GPhC Inspection. We also believe that pharmacy owners should be able to check their reports for accuracy before publication. We are working with the GPhC to help shape their inspection and reporting regime, and would urge the Department to support and encourage continued engagement with the sector on this matter. Question 14: Do you agree with the changes to the GPhC powers to obtain information from pharmacy owners? We agree with the majority of changes in principle. However, as with our comments above regarding the inspection reports, we would want to work with the regulator and other stakeholders to clarify and agree the details of when and how the GPhC can require pharmacy owners to provide information through its rules. In particular, we would want to ensure that the frequency and nature of information requests, or requirements to maintain data, are reasonable and proportionate. Impact Assessment We will provide further information on the impact assessment in due course, in the next few days, as agreed with the Rebalancing Team. 8

9 Pharmacy Voice Pharmacy Voice is an association of trade bodies which brings together and speaks on behalf of community pharmacy. Pharmacy Voice is formed by the three largest community pharmacy owner associations, Association of Independent Multiple pharmacies (AIMp) Company Chemists Association (CCA) and National Pharmacy Association (NPA), which together provide a unified voice for community pharmacy 9