Consultation outcome

Pharmacy dispensing models and displaying prices on medicines: response to the 2016 consultation

Updated 11 November 2021

Introduction

This consultation sought views on proposed changes to medicines legislation. These changes were to:

1. allow independent pharmacies to make use of ‘hub and spoke’ dispensing models. A ‘hub’ pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for ‘spoke’ pharmacies that supply the medicines to the patient. There are usually many spoke pharmacies to one hub pharmacy. Currently, this can only happen across the same legal entity, meaning that large chains are able to operate this model, but smaller independent pharmacies are not. The aim of this policy was to facilitate the operation of hub and spoke dispensing models across different legal entities and to create a level playing field. Thus, making it possible for independent spoke pharmacies to make use of the services of hub pharmacies that are part of a separate business or to work together and invest in automation in one hub location.

2. allow the price of medicines and a statement on how the costs of medicines are met to be published on dispensing labels, should this be required for NHS medicines dispensed as part of the NHS pharmaceutical services. The aim of this policy was to reduce waste by reminding people of the cost of medicines, but also to improve patient care by increasing patient adherence to medicines.

3. clarify the current dispensing label requirements for monitored dosage systems (MDS) (medicine storage devices with compartments divided into days of the week and various times of each day) and medicines supplied under patient group directions (PGDs) (allow healthcare professionals to supply and administer specified medicines to pre-defined groups of patients, without a prescription). It is currently good practice to ensure that patients supplied with medicines pursuant to PGDs are provided with the same information as if the medicine had been issued pursuant to a prescription. The aim of this policy proposal was to ensure that a dispensing label must be applied to medicines supplied pursuant to PGDs or other forms of direction where the same issues arise. The policy proposal on MDS and in addition to the minimum requirements around information on the dispensing label would be to enable prescribers and pharmacists to include a description of the medicinal product, if they consider this appropriate, to aid understanding of which medicine is which.

4. redesign the pharmacists’ exemption in section 10 of the Medicines Act 1968, regarding the preparation and assembly of medicines, following a judgment of the Court of Justice of the European Union (Abcur v Apothek AB and others (C-544/13 and C-545/13)). The aim of these proposed amendments was to bring the law governing medicines in the UK (namely the Medicines Act 1968 and the Human Medicines Regulations 2012) into line with this recent European judgement.

The consultation was available online from 22 March 2016 to 17 May 2016.

Summary of responses received and the government’s response

In total there were 248 responses. Most of the responses were from pharmacists, members of a pharmacy team, or pharmacy owners.

A list of organisations that responded to the consultation can be found at Annex A.

Main findings from the consultation

While many respondents were supportive of allowing independent pharmacies to make use of hub and spoke dispensing models ensuring fairness for all pharmacies, there was concern about a number of the practicalities of hub and spoke dispensing across different legal entities.

Respondents were uncertain about the proposal to allow the price of medicines and a statement on how the costs of medicines are met to be published on dispensing labels. Concerns centred around unintended consequences, both in terms of the medicines that would carry a price on the label and those lower-value products that would not need to carry pricing information.

There was support for the proposed set of information to appear on the dispensing labels for MDS, particularly to provide a minimum requirement building on current good practice. There were concerns the regulations could be restrictive in nature, leaving contractors unable to make reasonable adjustments, or would create additional work. Similarly, there was also support for the application of a dispensing label in line with current best practice when supplied pursuant to a PGD, while noting concern over practicality and burden and the importance of professional discretion.

There were mixed responses from respondents on the part preparation of some pharmacopeia preparations (preparations of medicines made up in a pharmacy in accordance with the prescriptions of a pharmacopoeia and not in response to a prescription for a named patient) and other preparation in advance of the prescription being received. While some saw it as essential in meeting patient need, there were concerns over its place in hub and spoke dispensing. Respondents were supportive for pharmacists in a registered pharmacy to continue to be allowed to prepare ‘Chemist’s Nostrums’, unlicensed medicines that are prepared by the pharmacists with the intention of selling it over the counter (one that is not a prescription-only medicine). Although there is declining demand for this service, there continue to be instances where community pharmacies provide it and that should be allowed to carry on.

On the basis of the responses to the consultation, the government decided to pause work on all 4 proposals. However, the government committed – via a Parliamentary Written Answer given by the Minister on 7 June 2016 and in a letter of the same date from the Department of Health and Social Care (DHSC) to pharmacy stakeholders’ representative bodies – to further engagement.

Proposal 1: hub and spoke

Question 1: do you agree that we should remove the impediment in medicines legislation that prevents the operation of ‘hub and spoke’ dispensing models across different legal entities?

Question 2: do you agree that in the Human Medicines Regulations we should not impose any restrictions as to which ‘hub and spoke’ models can be operated?

Overall approach

The consultation document asked whether we should remove the legal impediment preventing hub and spoke dispensing across different legal entities. We received a range of views, with some respondents seeing the benefits of the proposal. However, there were also concerns, with a significant proportion of respondents saying they could not support the proposals in their current form.

Respondents who supported the proposal felt that removal of the legal impediment was required in order to provide fairness for all pharmacies, given that some can already operate dispensing in this way. However, many of these respondents also expressed caution around what exactly would be permitted within and between different legal entities when the impediment was removed.

Respondents who disagreed felt that hub and spoke risked removing patient interaction with a pharmacist. There was also concern that the DHSC had not presented adequate evidence of potential efficiencies or safety benefits.

Respondents also pointed to a number of concerns including around patient data, liability, implications for the supply chain, speed of access to medicines in an emergency, and risks to the existence of small community pharmacies. A number of themes were mentioned in response to this question, including the potential for impact on competition, the supply chain, patient safety and duplication of work.

A significant number of respondents agreed that there should be no restrictions as to which hub and spoke models could be operated. They generally felt that there nevertheless must be some oversight and governance of the way in which this was done.

Respondents who disagreed expressed concerns with the hub being able to send medicines directly to the patient, due to issues around liability as well as patient access to a pharmacist. There were also concerns that hub and spoke models might not work for urgent prescriptions that need to be started immediately and that a set of national standards should be established.

Government response

We note there was some support for the proposals. The department agrees that there are a number of further considerations that would benefit from greater clarity.

The government decided not to progress with amending legislation at the time but committed to work with stakeholders to understand further how we facilitate hub and spoke safely, enabling access to support efficiency and ensuring the whole sector is able to benefit fairly. We will consider input from this consultation in any future work around hub and spoke dispensing. A further consultation on hub and spoke dispensing will be necessary and we are committed within that to providing more depth to our proposals and explaining our approach around areas of concern, including responsibility between the hub and the spoke.

The registration and regulation of pharmacies

Question 3: do you agree that ‘hubs’ should continue to be registered pharmacies?

Question 4: do you think ‘hub and spoke’ dispensing raises issues in respect to the regulation of pharmacies? If so, please give details.

A large majority of respondents agreed that hubs should be required to be registered pharmacies in order to ensure patient safety and maintain accountability. Respondents said there should be clarity over governance and the General Pharmaceutical Council’s (or in Northern Ireland, the Pharmaceutical Society of Northern Ireland) responsibility for standards and inspection. Some thought hubs should be held to current standards and others that there should be bespoke standards for hubs, particularly for inter-company hub and spoke models. A small number of respondents thought that the Medicines and Healthcare products Regulatory Agency should have a role in regulating hubs.

The majority of respondents agreed that the proposals raised issues in respect of the regulation of pharmacies, primarily around accountability and governance including where liability and risk would lie. Respondents also raised concerns around safety and responsibility for dispensing errors. A common theme was the concern around regulating a process across different legal entities and how that would be approached by the regulators, and the need for a consistent set of standards.

Government response

The government recognises that there was a clear preference from respondents that hubs should be registered pharmacies, and noted the considerations raised by respondents in terms of the regulation of pharmacies and recognised the importance of clear accountability.

The government decided not to progress with amending legislation at the time but committed to work with stakeholders and consider input from this consultation. We are committed to publishing a further consultation on hub and spoke dispensing when we are ready to take these proposals forward again.

Impact of, and evidence around, these proposals

Question 5: do you have any comments on the assumptions for our impact assessment (Annex C of the consultation document) for the proposal to make ‘hub and spoke’ dispensing possible across legal entities?

Question 6: are you aware of or able to provide evidence that ‘hub and spoke’ dispensing is more efficient and cost-saving, including according to the scale of the ‘hub’ operation?

Question 7: are you aware of or able to provide evidence that ‘hub and spoke’ dispensing is safer, including according to the scale of the ‘hub’ operation?

Those who were aware of or able to provide evidence around efficiencies and costs said that response and turnaround time for discharge prescription had improved and enabled more efficient dispensing through automation, although this was in the context of a hospital pharmacy model. Respondents also reported savings on staff costs.

The majority of respondents were not aware of or able to provide evidence for the efficiency and safety of hub and spoke dispensing. Some gave examples of hub and spoke arrangements that had not produced efficiencies or were not financially viable. Some respondents accepted the potential to release staff capacity, but also highlighted that the complexity of a new system could create duplication or potential for errors elsewhere in the process, outweighing the benefit of any capacity released within the spoke pharmacy. Respondents also expressed concern about costs involved in setting up hubs that would be passed on to spokes, such as capital investment (for example in automation and technology) and redesigning processes, as well as the potential for additional costs not currently incurred, such as deliveries or transport between hubs and spokes.

In response to question 7, those who said there was evidence of improved safety mentioned improved dispensing accuracy (use of 2D barcode) and data entry. Respondents noted the link between improved accuracy and use of automation. Respondents generally felt this would be better suited or more cost effective for larger hubs capable of investment in technology and systems.

However, the majority of respondents raised a number of concerns around safety, particularly around:

• the introduction of more steps in the dispensing process creating more opportunity for errors
• security of data transfer between hub and spoke entities
• reduced face-to-face contact with patients
• interaction with Falsified Medicines Directive authentication checks

Respondents also raised concerns about errors associated with greater automation, for example creating more opportunity for data entry errors and increasing the need for checks throughout the process. There was a general view that picking errors could be reduced, although in the context of instructions needing to be accurate and there being sufficient checks.

Government response

We recognise the complexity and with it the need to be careful to ensure there is not an increase in errors with increased steps, nor duplication or costs.

We are grateful to those who took the time to provide evidence and comment on the assumptions. The government decided not to progress with amending legislation at the time but committed to work with stakeholders and consider input from this consultation in future work.

Proposal 2: prices of medicines on dispensing labels

Question 8: before changes can be made for the price to be displayed on NHS dispensed medicines, enabling amendments need to be made to the Human Medicines Regulations 2012. Do you agree with these amendments to the Human Medicines Regulations 2012?

Question 9: are you aware of any other evidence that supports the impact of patients’ understanding of the prices of health services on their behaviour, including from local initiatives? If so, please give details?

Question 10: do you have any views on the proposed implementation in the NHS in England? If so, please give details?

Summary of views

Of those commenting on the policy aim of placing prices on all medicines dispensed by the NHS in England, while there was some support, the majority of respondents queried the policy mechanism. Respondents questioned how medicines would be valued, cost of implementation, the impact valuation would have on adherence and perception, potential links to other policies, as well as the practical consideration in terms of the change to labels.

Many expressed the view that the proposal could devalue medicines under £20, where pricing would not need to be included, but could unintentionally skew perception, including around the payment by taxpayers, prescription charges, waste, or the importance of that treatment with patients taking the view that a lower value treatment meant that their condition was not perceived as requiring treatment. Where medicines are high cost there was concern over divergence, risk of theft, or patients not wishing to burden the NHS and not adhering to the treatment regimen. With regard to the addition of pricing information on the label, it was noted that it could detract from other important information and that labels are already full. Including the overall cost of the medicines bill, as an alternative, was also proposed.

In regard to the consideration of other evidence, the majority of the respondents said they were not aware of any. Where they responded positively, suggestions focused around utilising pharmacist experience of working in healthcare to help better understand patient behaviour.

There were largely negative views from respondents on the proposed implementation of pricing on medicine labels. Many responses raised concerns that implementing the policy could have unintended negative consequences. Many respondents also felt that the lack of evidence would need to be addressed before making any decision.

Government response

The government decided not to progress with amending regulations at the time.

Medicines waste and improving patient adherence is being actively tackled through a variety of other policy measures, such as medicines optimisation being led by NHS England and Improvement.

Proposal 3: labelling of medicines supplied under patient group directions and monitored dosage systems

Question 11: do you agree with the set of information that is proposed to appear on the dispensing labels for MDS?

Question 12: are there practical issues with what is proposed that would make application difficult in practice? If so, please give details.

Question 13: do you have views on the proposed flexibility for the information to appear on a combination of both the outer and immediate packaging?

Summary of views

Overall, there was support for the principle of the proposal and that patient safety should be paramount. The proposal was welcomed as it is concerned with ensuring that there will be a standard minimum requirement for information, but there was a request for some flexibility to allow for professional discretion.

A large majority of the respondents cited that, in principle, this is already current professional good practice and its introduction would support adherence. But there was concern that the proposals could lessen the information currently provided, or leave contractors unable to make reasonable adjustments. Further clarity was requested in respect to the type of MDS and that changes take account of working practice so that regulation does not become restrictive in nature. There was wider concern that issues around the use of MDS needed a thorough review and would not be solved through changes to labelling guidelines.

In respect to PGDs, it was noted examples where the addition of a dispensing label would be impractical or burdensome and that the label can provide no addition benefit to the patient. Some respondents noted that professional discretion should be permitted.

Some respondents noted that adhering to current good practice does not cause them problems from a practical perspective. However, many respondents were concerned over the time it would take and that it would create additional work. Automation may not be economical for smaller pharmacies. There was the suggestion of piloting to understand further the practicality of the proposals.

Government response

The government acknowledges the support for the proposal noting the desire to ensure there was adequate flexibility. The government remains committed to finding a solution and to consider the issue further. We are committed to publishing a further consultation on labelling of medicines supplied under PGDs and MDS when we are ready to take these proposals forward again. Input from this consultation will be considered in any future considerations.

Proposal 4: redesigning the ‘pharmacists’ exemption’ in section 10 of the Medicines Act 1968

Question 14: do you think pharmacies that supply medicines to other healthcare settings, for example, ‘hub’ pharmacies and some hospital pharmacies, will need to part-prepare some pharmacopoeia and other preparations in advance of the prescription being received? If so, please provide examples of the sorts of part preparation that are necessary

Question 15: do you think that pharmacists in a registered pharmacy should continue to be allowed to prepare ‘Chemist’s Nostrums’? If so, could you provide us with examples of ‘Chemist’s Nostrums’ that are being prepared?

Question 16: is there anything else you would like to raise with regards to the proposals for restructuring the pharmacists’ exemption?

Summary of views

There were mixed responses from respondents on the part preparation of some pharmacopeia and other preparations in advance of the prescription being received. Some respondents were supportive, particularly in respect to common medicines. The volume of unlicensed prescribing means that pre-preparation is essential to meet patient need. The requirement to supply with reasonable promptness was also cited. However, there was concern about how this would fit with modern dispensing practices, its suitability within a hub and spoke model between different legal entities, and concerns that increased complexity increases risk. Others were uncertain, seeing both positives and negatives with such an approach. Some respondents asked for further clarity as to the scope of what was being referred to under the term ‘pharmacopeia preparation’.

Overall, there was support for pharmacists in a registered pharmacy to continue to be allowed to prepare ‘Chemist’s Nostrums’ (see the introduction for definition of Chemist’s Nostrums). While there was an appreciation that the demand for such items had reduced over time, the preparation of Chemist’s Nostrums remains a component of the skills and professional practice of a pharmacist. The continuing discretion to prepare Chemist’s Nostrums remains valuable to some patients and there are instances where community pharmacies provide this service and that should be allowed to carry on. Some respondents cited the continued need for flexibility in this area. However, some respondents felt that Chemist’s Nostrums no longer had a place in evidence-based medicine supply.

Government response

The government response recognised the diverse views from respondents. Amending legislation was not progressed at the time.

Equality assessment

Question 17: do you have any comments on the initial equality assessment or evidence that we should consider in the development of final equality assessment?

Summary of views

Forty-six respondents provided comments on this question. The majority of responses were focused on the impacts of proposal 1 (hub and spoke).

Respondents were concerned that the proposals would mainly impact pharmacy staff. The proposals were seen as potentially having a disproportionate impact on women. The majority of pharmacy technicians and support staff are female and these roles are most likely to be impacted by the increased use of automation. There was also concern in regards to the disproportionate impact on owners of independent pharmacies, a significant proportion of whom are from Black and minority ethnic backgrounds. There was also a more general concern that changes to dispensing models would have a greater impact on patients in rural areas. Concerns were also raised about the potential for increased costs to patients.

Some respondents also commented on proposal 2 (prices of medicines on dispensing labels), expressing concern that this could put patients off ordering or taking medicine due to the perceived cost.

In relation to proposal 3 (monitored dosage systems) one respondent thought there could be potential for disproportionate impact on elderly patients or those with early stages of dementia, as additional information, while meant to make it better could lead to confusion.

Government response

We will consider these potential impacts in taking forward any proposals.

The Human Medicines (Amendment) (No.2) Regulations 2016

Question 18: do you have any comments on the draft Human Medicines (Amendment) (No. 2) Regulations 2016?

Summary of views

Around 29 respondents provided comments on this question. Common themes raised were:

1. difficulty for the layperson in understanding what the existing regulations would look like once amended, making it easier to follow what the changes would be
2. terminology: for example, in relation to hub and spoke, use of assembly or dispensing should reflect the reality of the processes being undertaken but should also be clearly defined
3. the scope seems wider than what was proposed in the consultation document

Government response

We will take these comments into account when taking forward any proposals.

Specifically on hub and spoke proposals, we are engaging with stakeholders to develop clear and practical models to form the basis of a further consultation. Ultimately, through engagement and a public consultation, we want to ensure we have the right approach to allow all pharmacies to benefit fairly from hub and spoke dispensing.

In the context of any future consultation on these matters, we will further consider how we make draft regulations clearer and easier to follow.

Annex A: list of respondents

There were 247 responses to the consultation. These represented a broad range of views from across the UK pharmacy sector and beyond, including individual pharmacists, NHS organisations, professional bodies and stakeholder groups. A list of some of the organisations responding is below.

• The Association of the British Pharmaceutical Industry

• Alliance Healthcare

• ASDA

• Blackpool Clinical Commissioning Group

• Boots

• Bromley Clinical Commissioning Group

• Celsio UK

• Colchester Hospital University NHS Foundation Trust

• Community Pharmacy Scotland

• Community Pharmacy Wales

• Dispensing Doctors Association

• Genetic Alliance UK

• General Pharmaceutical Council

• Healthcare Distribution Association UK

• Healthcare Improvement Scotland

• Leeds Teaching Hospitals NHS Trust

• Leicester City Clinical Commissioning Group

• Medicines 4 U

• NHS Scotland Directors of Pharmacy

• NHS Specialist Pharmacy Service

• National Pharmacy Association

• North East Essex Clinical Commissioning Group

• Parkinson’s UK

• The Patients Association

• Pharmaceutical Society of Northern Ireland

• Pharmacists’ Defence Association

• Pharmacy Voice

• Pharmacy 2 U

• The Pharmaceutical Services Negotiating Committee

• The Royal College of Physicians

Annex B: analysis of responses

Analysis of responses: hub and spoke

The data below represents an accurate reflection of the input for each question under the consultation. However, there were a small number of instances where within the response it was clear that an answer provided in the comment box was actually in response to a different question (that is, the respondent identified the correct question number in their response and their answer corresponded to that question). In those cases, the input provided by the respondent has been reflected in the narrative above.

Question 1

Do you agree that we should remove the impediment in medicines legislation that prevents the operation of ‘hub and spoke’ dispensing models across different legal entities?

• Yes: 69 (28%)
• No: 70 (28%)
• No response: 108 (44%)

Question 2

Do you agree that in the Human Medicines Regulations we should not impose any restrictions as to which ‘hub and spoke’ models can be operated?

• Yes: 41 (17%)
• No: 108 (44%)
• No response: 98 (40%)

Question 3

Do you agree that ‘hubs’ should continue to be registered pharmacies?

• Yes: 219 (89%)
• No: 7 (3%)
• No response: 21 (9%)

Question 4

Do you think ‘hub and spoke’ dispensing raises issues in respect to the regulation of pharmacies? If so, please give details.

• Yes: 209 (85%)
• No: 9 (4%)
• No response: 29 (12%)

Question 5

Do you have any comments on the assumptions for our impact assessment (Annex C) for the proposal to make ‘hub and spoke’ dispensing possible across legal entities?

214 respondents (87%) provided comments on at least one of the assumptions.

Question 6

Are you aware of or able to provide evidence that ‘hub and spoke’ dispensing is more efficient and cost-saving, including according to the scale of the ‘hub’ operation?

• Yes: 15 (6%)
• No: 206 (83%)
• No response: 26 (11%)

Question 7

Are you aware of or able to provide evidence that ‘hub and spoke’ dispensing is safer, including according to the scale of the ‘hub’ operation?

• Yes: 10 (4%)
• No: 209 (85%)
• No response: 28 (11%)

Analysis of responses: prices of medicines on dispensing labels

Question 8

Before changes can be made for the price to be displayed on NHS dispensed medicines, enabling amendments need to be made to the Human Medicines Regulation 2012. Do you agree with these amendments to the Human Medicines Regulations 2012?

• Yes: 63 (26%)
• No: 87 (35%)
• No response: 97 (39%)

Question 9

Are you aware of any other evidence that supports the impact of patients’ understanding of the prices of health services on their behaviour, including from local initiatives? If so, please give details?

• Yes: 23 (9%)
• No: 132 (53%)
• No response: 92 (37%)

Question 10

Do you have any views on the proposed implementation in the NHS in England? If so, please give details?

• Yes: 87 (35%)
• No: 59 (24%)
• No response: 101 (41%)

Analysis of responses: labelling of medicines supplied under patient group directions and monitored dosage systems

Question 11

Do you agree with the set of information that is proposed to appear on the dispensing labels for MDS?

• Yes: 104 (42%)
• No: 37 (15%)
• No response: 106 (43%)

Question 12

Are there practical issues with what is proposed that would make application difficult in practice?

• Yes: 87 (35%)
• No: 46 (19%)
• No response: 114 (46%)

Question 13

Do you have views on the proposed flexibility for the information to appear on a combination of both the outer and immediate packaging?

• Yes: 106 (43%)
• No: 42 (17%)
• No response: 99 (40%)

Analysis of responses: redesigning the ‘pharmacists’ exemption’ in section 10 of the Medicines Act 1968

Question 14

Do you think pharmacies that supply medicines to other healthcare settings, for example ‘hub’ pharmacies and some hospital pharmacies, will need to part prepare some pharmacopoeia and other preparations in advance of the prescription being received? If so, please provide examples of the sorts of part preparation that are necessary.

• Yes: 45 (18%)
• No: 74 (30%)
• No response: 128 (52%)

Question 15

Do you think that pharmacists in a registered pharmacy should continue to be allowed to prepare ‘Chemist’s Nostrums’? If so, could you provide us with examples of ‘Chemist’s Nostrums’ that are being prepared

• Yes: 106 (43%)
• No: 42 (17%)
• No response: 99 (40%)

Question 16

Is there anything else you would like to raise with regards to the proposals for restructuring the pharmacists’ exemption?

35 respondents (14%) provided further comments.

Analysis of responses: equality assessment

Question 17

Do you have any comments on the initial equality assessment or evidence that we should consider in the development of final equality assessment?

46 (18%) respondents provided comments.

Question 18

Do you have any comments on the draft Human Medicines (Amendment) (No. 2) Regulations 2016?

28 respondents (10%) provided further comments.

Note on data

Every effort has been made to accurately capture the responses that were received. In some cases, respondents preferred to provide narrative responses to the yes or no options offered and did not select either. We have also endeavoured to ensure answers that clearly referred to another question in the consultation were matched with the appropriate question in this response.