Consultation outcome

Proposal to enable pharmacy technicians to supply and administer medicines using patient group directions: consultation response

Updated 28 March 2024

Executive summary

A UK-wide public consultation to amend the Human Medicines Regulations 2012 (HMRs) to enable pharmacy technicians to supply and administer medicines using patient group directions (PGDs) was held from 18 August to 29 September 2023.

A PGD is a written instruction that allows healthcare professionals specified within the HMRs to supply and/or administer a medicine directly to a group of patients with an identified clinical condition. PGDs are not a form of prescribing.

The proposed policy would enable registered pharmacy technicians to use PGDs across England, Wales and Scotland in any setting including the NHS, independent and voluntary sectors. Pharmacy technicians in Northern Ireland are not a registered healthcare profession so amendments to the HMRs cannot currently allow pharmacy technicians in Northern Ireland to use PGDs. However, should pharmacy technicians in Northern Ireland become a registered healthcare profession, a further amendment to the HMRs may be made so they can also use PGDs.

To confirm, pharmacy technicians are not currently subject to statutory regulation in Northern Ireland and therefore all references to pharmacy technician regulation in this document refers to pharmacy technicians in England, Scotland and Wales.

The proposal builds on the NHS Long Term Workforce Plan (LTWP) by allowing pharmacy technicians to provide direct care for their patients and help free up pharmacists to provide more clinical NHS services. The number of pharmacy technicians is set to grow in the future and this proposal, combined with legislative changes to enable the NHS, and particularly community pharmacies, to make better use of the available skills mix and technology in pharmacies, will ensure pharmacy technicians can work most effectively as part of wider primary care teams and across the NHS.

However, these powers do not mean that organisations are required to implement the use of PGDs by registered pharmacy technicians. PGDs should only be used where there is clear benefit for patient care without compromising patient safety and where there are clear governance arrangements and accountability.

Introduction

The HMRs set out a comprehensive regime for the authorisation of medicinal products, including the sale, supply and administration of medicines. The powers which allow registered healthcare professionals to sell, supply and/or administer medicines to patients under exemptions are contained in part 12, when read with schedule 16 of the HMRs.

Regulated healthcare professionals have been able to take on further responsibilities for prescribing, supplying and administering medicines for many years. This supports patients to receive the medicines they require from the professional who is appropriately qualified to help them and means they do not need to see additional professionals simply to access these medicines.

The aim of this proposal is to make it easier for patients to get the medicines they need when they need them, while maintaining public safety. This will avoid the requirement for patients to see additional healthcare professionals just to receive medicines, where it is safe and appropriate to do so, thereby facilitating timely access to medicines, improving patient care and patient experience. The amendment would be implemented by a statutory instrument (SI) under enabling powers in the Medicines and Medical Devices Act 2021 (MMD Act).

The Secretary of State, in relation to England, Wales and Scotland and, in relation to Northern Ireland, jointly with the Department of Health for Northern Ireland sought views of the public and stakeholder organisations on these proposals via a public consultation which ran from 18 August to 29 September 2023.

The following section of this document discusses the analysis of the consultation responses in detail.

Summary and evaluation of responses

Approach to analysis

The Department of Health and Social Care (DHSC) and the Department of Health NI have analysed the responses and considered the feedback received. In doing so, we looked at the responses given to each of the questions posed as well as the information responders provided in the ‘free text’ sections of the consultation response survey, where people could share their views in their own words.

Key themes or topics in the responses were identified across each of the questions asked by the consultation.

Overview of the respondents

A total of 2,267 responses were received; 2,265 through this consultation’s page and 2 which came via email.

88% of responses were from individuals sharing their professional views, 6% from individuals sharing their personal views and experiences, and 6% were on behalf of an organisation.

92% of respondents stated that they were responding as a healthcare professional.

57% of respondents stated that they were responding as a pharmacy technician. 30% stated that they were responding as a pharmacist.  

Themes common across the responses

The consultation asked 4 policy questions to seek views on the proposal, the training requirements, safe access to medicines and the impact assessment, as well as providing the opportunity for respondents to give any further evidence (for or against). The most common theme from respondents was that this proposal would be beneficial for patients, the profession and the NHS. This included a strong belief that the patient journey would be improved because the treatment process would become more efficient, reducing delays and freeing up pharmacist time.

Pre-registration pharmacy technician training and the training required to use PGDs were recurring themes throughout all of the consultation responses.   

Consideration of responses to individual consultation questions

The consultation proposed that the HMRs should be amended to allow pharmacy technicians to supply and administer medicines under PGDs.

Question

Do you agree or disagree with the proposal to amend the Human Medicines Regulations (2012) to enable pharmacy technicians to supply and administer medicines to patients using PGDs?

Of those who responded to this question:

• 1,904 agreed
• 323 disagreed
• 40 said they didn’t know

Feedback from responses

84% of respondents agreed with the proposal to amend the HMRs to enable pharmacy technicians to supply and administer medicines to patients using PGDs. 14% disagreed and 2% didn’t know. The main themes mentioned by those who supported the proposal were based around efficiency, the development of the profession, existing training and regulation, as well as patient benefit and patient safety.

When discussing efficiency, respondents made points about relieving the burden on other professionals, increasing capacity within the system, allowing for greater use of skills mix and allowing the pharmacist more time for independent prescribing. It was noted that this would be very beneficial in supporting the overall NHS system. Points around development of the profession included the ability to maximise the profession’s potential, upskilling pharmacy technicians to work to their full scope of practice, and ultimately make the career more appealing to recruit and retain skilled staff.

Many respondents also stated that the pre-registration training for pharmacy technicians is extensive and that registered pharmacy technicians are regulated by the General Pharmaceutical Council (GPhC).

Organisations that responded to this question were mainly supportive.

Quotes from organisations

GPhC, said:

In principle, we support legislation that enables the optimal contribution of pharmacy technicians, allowing effective use of pharmacists and a wider skill mix in pharmacy teams… The legal structure provided by PGDs allows for a safe supply and/or administering of medicines to a pre-defined group of people. The addition of pharmacy technicians to the list of healthcare professionals permitted to supply and/or administer under a PGD will allow them to supply and/or administer medicines through a framework which defines responsibilities for ownership and has clear governance arrangements. Furthermore, PGDs specifically define additional training requirements. Training is key; technicians who work in different settings may have varying levels of experience and confidence and need additional support initially…  a pharmacy technician working under a PGD must recognise and work within the limits of their knowledge and skills, and refer to others when needed.

Royal Pharmaceutical Society, said:

Skill mix is vitally important in delivering modern and efficient pharmacy services. Increasing the opportunities for pharmacy technicians to further develop their role has the potential to strengthen the foundation for pharmacy practice across all sectors. As managing the health of patients becomes more complex, with multiple long-term conditions and more complex medicines and therapies, the need for pharmacists to focus on clinical and therapeutic interventions is increasing. The supply and administration of medicines under a PGD should be reserved for situations where this offers an advantage for patient care, without compromising patient safety. The 3 country visions for pharmacy, across RPS, all strongly support the development of the whole pharmacy team, fully utilising the skill mix of all members to release the clinical capacity of pharmacists.

Boots UK, said:

Allowing pharmacy technicians to administer medicines to patients using PGDs will increase their professional and clinical capabilities and enhance the skill mix within community pharmacy settings, freeing-up pharmacists’ capacity. This will help increase access to nationally and locally commissioned services for patients which in turn will reduce demand on other parts of primary care and help the NHS address the current backlog of care. Overall, we encourage DHSC to take a holistic approach to the development of the clinical and professional skills of the pharmacy workforce. In particular, it is critical that pharmacists are able to use independent prescribing qualifications. This should be accompanied by appropriate funding and service opportunities to allow all pharmacists to become independent prescribers and use their qualification and pharmacy technicians to be able to use PGDs.

The responses from individuals were supportive and provided evidence that included the same themes as above, as well as points about pharmacy technician’s extensive knowledge of medicines and how increasing access to medicines would reduce waiting times and improve patient outcomes.  

Quotes from individuals

This will be an important part of the growing and expanding role that pharmacy technicians have. To increase the skills of the pharmacy technician workforce improves job satisfaction, recruitment, skill mix and the patient experience. The knowledge and skills of the workforce are more than capable to take on this additional role - in whatever sector they are working in.

Pharmacy technicians supplying medicines under PGDs is an enabler for patients accessing their medicines in a timely manner and avoiding delays in treatment and improving health outcomes. There is also a great value here in supporting workloads in GP practices and playing a greater role in clinics. In addition to this, where there are more pharmacists becoming independent prescribers and taking more in-depth clinical roles, pharmacy technicians skillset will now need to expand to deliver greater number of functions. Supplying medicines under PGDs seems to me the next logical step.

Those who disagreed with the proposal mostly stated that pharmacy technicians do not have the requisite training to operate under a PGD because they lack clinical competence and assessment skills. They did not agree that Level 3 training was sufficient for PGDs and saw variable standards of training within the profession. Also, respondents felt that this would negatively impact patient safety, where pharmacy technicians are used as a cheaper option to deliver services. Another common issue raised here was that it would just shift the burden to another profession rather than eliminating it, and that this would add to the pharmacy technician workload without increasing their pay.

Those who indicated ‘Don’t know’ could generally see the benefits of the proposal but had similar reservations to the ‘Disagree’ issues mentioned above.

Pre-registration training

In the consultation we explained that pre-registration trainee pharmacy technicians undertake a 2-year training programme and must achieve GPhC-approved education that meets the 2017 initial education and training standards.

Question

Do you agree or disagree that the 2-year pre-registration training equips pharmacy technicians with the appropriate knowledge and skills to complete the training requirements which allow them to use PGDs?

Of those who responded to this question:

• 1,406 agreed
• 630 disagreed
• 231 said they didn’t know

Feedback from responses

The results indicate a significant level of support for this proposal, with 62% of respondents in agreement that the 2-year pre-registration training adequately equips pharmacy technicians to use PGDs. 28% stated that they disagreed and 10% didn’t know. An analysis of these responses has shown that the main themes centred around efficiency, leveraging the skills of pharmacy technicians, and enabling pharmacists to allocate their time more effectively.  

Among those who supported the proposal, the dominant response was that pharmacy technicians possess sufficient training and expertise to responsibly handle PGDs. They emphasised the potential to expand and capitalise on the technicians’ existing skill set, thereby allowing pharmacists to focus on more clinically complex tasks. However, within this group, there were respondents who, despite agreeing in principle, expressed reservation about granting pharmacy technicians full independence. They encouraged for the use of PGDs by pharmacy technicians under pharmacist supervision. Therefore, although supportive of the use of PGDs by technicians, this view appears contradictory in the context of freeing up pharmacists’ time.

The primary reason for disagreement was that many believed that a 2-year training period is insufficient for pharmacy technicians to operate using a PGD. They also highlighted concerns about the lack of adequate clinical training and experience necessary for engaging with patients and offering essential consultation skills. However, some individuals suggested that this might vary depending on the individual’s experience and competence to apply clinical knowledge.

Quotes from organisations

National Pharmacy Association, said:

Registered pharmacy technicians are registered healthcare professionals accountable to GPhC regardless of their route of training. Individual registered pharmacy technician should determine whether they have the appropriate knowledge and skills for them to use a relevant patient group direction. Ultimately, as the accountable pharmacists, the responsible pharmacists and superintendents pharmacists need to consider which PGDs are suitable for use by pharmacy technicians. Furthermore, responsible pharmacists will ultimately determine how PGDs operate whilst they are in control of a pharmacy.

Quotes from individuals

I agree that the 2-year pre-registration training equips pharmacy technicians with the appropriate knowledge and skills to complete the training requirements necessary for them to use patient group directions. This training provides them with a solid foundation in pharmaceutical knowledge, dispensing skills, and understanding of medications. Additionally, pharmacy technicians undergo a structured educational program that prepares them for their roles as registered healthcare professionals. With this background, they are well-positioned to undergo further training specific to patient group directions, which would enable them to supply and administer medications safely and effectively under appropriate supervision and protocols.

I feel that not all newly qualified registered pharmacy technicians have enough clinical knowledge. I feel that they would need post qualification experience of at least 2 years to ensure that their clinical knowledge has been used in practice and built upon in a real time setting.

Safe access to medicines

In the consultation we proposed that the governance involved in developing a PGD ensures there is clear accountability, delegation, monitoring and a structured work programme for reviewing, updating and re-authorising PGDs.

Question

Do you agree or disagree that allowing pharmacy technicians to supply and/or administer under a PGD will enable safe access to medicines for patients?

Of those who responded to this question:

• 1,892 agreed
• 309 disagreed
• 66 said they didn’t know

Feedback from responses

83% of respondents agreed that the proposal will enable safe access to medicines for patients. 14% stated that they disagreed and 3% didn’t know. Analysis of the responses has shown that the main themes in this area are:

In the main, the majority who agreed with this criteria said that working under PGD will improve efficiency and enable safe access to medicines for patients. The very nature of their role means they must have a high regard for patient safety. Pharmacy technicians adhere to stringent guidelines and procedures. Under existing legislation all pharmacy technicians are regulated and accountable to the GPhC. They also have revalidation requirements which offer an additional layer of protection to patients. These high standards and the standards set by the GPhC are there to protect the wellbeing of patients and provide safe access to medicines.

Participants also said that each PGD outlines the training and competencies needed to operate under it; pharmacy technicians already have the knowledge and skills and with the appropriate training, they are well placed to operate under PGDs. Additionally, safe access to medicines for patients will also be guaranteed by the robust process and additional training for PGDs.

A key point that this proposal will make the best use of skill mix within the pharmacy industry was again highlighted here. Respondents stated that it will improve efficiency and ensure safe supply and administration of medicines, reducing delays whilst improving patient care and outcomes. Furthermore, it will address health disparities, and reduce the pressure on other health care professionals.

Several organisations stated that during the COVID-19 pandemic, registered pharmacy technicians were able to administer COVID-19 vaccines via alternative mechanisms. They adhered to guidelines safely and accurately, which demonstrates that they will be capable of working to PGDs. However, pharmacy technicians could not administer medicines without the involvement of other health care professionals, which prevented pharmacy technicians from operating in the most effective way. A point was made that following the specific training, pharmacy technicians were active in the vaccination success which saw up to 150 million COVID-19 doses administered to date.

The majority of respondents who disagreed with this were “individuals sharing their professional views”. Most claimed that the 2-year pre-registration training did not provide pharmacy technicians with the skills and knowledge necessary to enable them to use PGDs. They stated that this could compromise patient safety and lead to medical errors, stating that pharmacy technicians lack training as well as the appropriate experience to make clinical decisions. 

Concerns were also raised by respondents in relation to the following:

• risks that PGD use will be driven by cost savings and the process exploited by those with vested interest
• pharmacy technicians do not meet the competency framework requirement of National Institute for Health and Care Excellence (NICE)
• pharmacy technicians might make mistakes which could be life threatening
• this places additional responsibilities on the pharmacy technician which is outside their knowledge and expertise
• pharmacy technicians are not trained in making professional judgement. This is a requirement of PGDs

The majority of those who replied in the “don’t know” category stated that pharmacy technicians would be able to provide safe access to medicines if they have the proper training governance in place and regularly updated their training. However, there were concerns about the lack of clinical knowledge and competency which places considerably more responsibility on the pharmacy technicians which could also put patients at risk.   

The National Pharmacy Association (NPA) agreed with the proposal but suggested pharmacy technicians hold appropriate indemnity insurance as they would be accountable for their decisions, including actions and omission when using PGDs to supply and administer medicines which are currently subject to a registered pharmacist.

Quotes from organisations

Association of Pharmacy Technicians UK, said:

The proposal supports home countries’ visions and workforce plans. Registered pharmacy technicians can use their medicines expertise to help make every contact count, providing patients with the appropriate treatment at the right time, reducing delay and further health interventions. The proposed use of PGDs will enable patients to access the medicines and services they require promptly and effectively, avoiding the risks associated with delayed care, improving patient outcomes and addressing health inequalities. This is an appropriate use of skill-mix to best utilise the workforce, including other pharmacy professionals, to use their clinical expertise in treating more complex cases as independent prescribers. Utilising pharmacy technicians’ clinical skills in pharmacy teams will significantly impact patients, enabling safe access to medicines. Community pharmacies will be able to provide more services in rural areas with reduced access to healthcare professionals, for example emergency contraception supply, flu and COVID-19 vaccination and so on.

Royal Free Hospital NHS Foundation, said:

Pharmacy technicians can provide a safe and a competent service once all the necessary training is given in administration as well as using their experience in pharmacy and knowledge on drugs.

Royal Pharmaceutical Society, said:

Pharmacy technicians are integral to the provision of pharmacy services. Pharmacy technicians who undertake these additional responsibilities would continue to adhere to the same principles of practice that apply to pharmacists including competency-based training and assessment of skills and knowledge. PGDs are designed to mitigate risk as far as possible, with clear inclusion and exclusion criteria to reflect the decision-making skills of those using them. As with all healthcare professionals, it is critical that pharmacy technicians should only work within their competence and can demonstrate competence prior to starting a particular PGD. Pharmacy technicians must be supported with appropriate training to reflect the needs of a particular PGD and have ongoing support in place.

Community Pharmacy Workforce Development Group, said:

Allowing pharmacy technicians to supply and/or administer medicines under a PGD can enable safe access to medicines for patients. Pharmacy technicians are registered and regulated health professionals who are already able to supply medicines under a number of legal routes, such as patient specific directions. The addition of pharmacy technicians to the list of people able to supply medicine under a PGD builds on this, increasing clinical capacity within community pharmacies by removing the need for dedicated intervention from a prescriber. The government and the NHS must ensure appropriate safeguards are in place to enable pharmacy technicians to safely supply and administer medicines and ensure that accountability appropriately sits with the pharmacy technician when they work under a PGD. In addition, all pharmacy technicians should be required to undertake a declaration of competence undertaken, and there should be ongoing monitoring and assurance of the PGD undertaken by the commissioner.

Boots UK, said:

Boots UK have had positive and successful experiences of using pharmacy technicians to supply and administer vaccinations to patients via our private prescriptions for flu vaccinations and the National Protocol for the administration of COVID-19 vaccinations. These pathways have been accompanied by robust standard operating procedures and clinical governance. We have increased access to services for patients and received positive feedback from pharmacy.

Generally, responses from individuals were within the profession. Respondents who agreed stated that with the relevant training, competencies and support, pharmacy technicians can safely supply and administer supply medicines to patients. They are registered professionals, accustomed to working their scope of practice and have a good knowledge of how to administer medicines safely. Clinicians often rely on their advice for medicines administration.

Some individuals stated that PGD use will help pharmacy technicians to develop and expand their skill set and be more independent. It could also motivate them to stay within the profession when currently many in the health care professions are struggling to retain staffing levels. 

The audit of PGDs alongside mandatory training will provide ongoing assurance and quality improvement.

A common theme amongst responders who disagreed stated that inadequate training would prevent the pharmacy technician from carrying out this function effectively, stating that the 2-year training programme does not equip them with the knowledge and ability to utilise PGDs.    

In addition, some felt that a pharmacist must undergo several years of training to understand the medical and clinical aspects around PGDs. Any short cut of the system could result in mistakes and endanger patients’ lives. It was suggested that if the proposal goes ahead, it could lead to unfair practices such as profit making by paying the pharmacy technicians less than a pharmacist who currently uses PGDs.

Quotes from individuals

I work with many pharmacy technicians who are having to supply medicines under patient specific directions or prescriptions because they are unable to use a patient group direction. Allowing this will enable safe access for patients while simultaneously reducing workload for other clinicians.

The governance, training and risk assessment in place for those professions who already work under PGDs will remain in place for pharmacy technicians, therefore maintaining the safe access to medicines and further benefits already demonstrated by the included professions. This is an extension of professionals using the protocols, not changes to the fundamental process.

I would agree if robust systems ensure only those with enough knowledge and experience are able to supply and administer.

Alleviating the pressures on other healthcare professionals can help to maximise all members of the team when it comes to healthcare and patient safety. It will allow more members of the healthcare team to provide the treatment to patients that need it in both a safe and timely manner.

The listed PGDs in the consultation: emergency hormonal contraception (EHC) and flu, are valid examples of where a pharmacy technician could provide a PGD service well. However, there are PGDs in community pharmacy that require a level of patient-drug interaction, drug-drug interaction and drug-condition interaction, that a pharmacy technician would not be prepared for and would likely be put in a position to supply against regardless of confidence level because business needs would dictate it. I have worked with fully qualified pharmacists who are not prepared to use professional decision making within the scope of a PGD, I worry that the training a pharmacy technician completes being less than that of a pharmacist could put patients in a situation where supplies are not made or are delayed due to the lack of training and the resulting lack of access to other healthcare professionals.

Additional evidence in support of the proposal

Question

This proposal is to allow registered pharmacy technicians to supply and administer medicines using a PGD. Do you have additional information in support of this proposal?

Feedback from responses

Analysis of the responses has shown that the main themes in this area are very similar to those previously stated when answering more generally about the policy. The most common of these themes were based around making the system more efficient and relieving the burden of pressure from other professionals; developing the pharmacy technician profession and developing a natural career progression pathway; and the training and regulation that all registered pharmacy technicians must achieve in their career. In terms of developing the profession, a number of respondents noted the positive contribution that pharmacy technicians made to the mass vaccination campaign during the COVID-19 pandemic. 

In addition to this, several respondents discussed the guidance and clarity that is embedded within every PGD and how pharmacy technicians are well versed in a systematic way of working such as this. This governance provides clear and specific directions to the professional that will minimise any risk. It was noted that an individual working under a PGD is signed off locally, and that pharmacy technicians have been involved in authoring PGDs but have not been able to operate under them.

Quotes from organisations

Pharmacy2U, said:

… would like to commend the recent Vision for Community Pharmacy commissioned by Community Pharmacy England and developed by the Nuffield Trust and The King’s Fund. Developed in consultation with stakeholders across the sector, including ourselves, the vision highlights the importance of equipping pharmacy technicians to provide much of the dispensing role and therefore free-up pharmacist capacity for more complex and high-risk medications, as well as clinical care. To that end, we believe that this proposal will be a key enabler to the transition to a more clinically-focused pharmacy sector, supporting both government and sector ambitions for the future of pharmacy.

Humankind Charity, said:

Our organisation is fully supportive of this proposal. There will, of course, need to be internal considerations such as potential remuneration discussions for extended roles and exploring indemnity insurance for the extended role but this should not be a barrier to the wider acceptance and introduction for this legislation.

Lincolnshire Partnership NHS Foundation Trust, said:

Specialist MH pharmacy technician roles in MH trusts is growing and it’s an under-utilised workforce in terms of skill set. Pharmacy technicians are very familiar with working to their organisational standard operating procedures. This way of working is complementary to the way they will be required to work under PGDs.

Boots UK, said:

… have had positive and successful experiences of using pharmacy technicians to supply and administer vaccinations to patients via our private prescriptions for flu vaccinations and the National Protocol for the administration of COVID-19 vaccinations. These pathways have been accompanied by robust standard operating procedures and clinical governance. We have increased access to services for patients and received positive feedback from pharmacy technicians thanks to the widening of their scope of practice and job satisfaction. We view this proposed regulatory change as an enabler to increase the use of pharmacy technicians to deliver more services and subsequently enable community pharmacists to increase their own scope of practice to enhance the level of clinical care that can be provided by the community pharmacy sector.

Centre for Pharmacy Postgraduate Education, said:

Centre for Pharmacy Postgraduate Education has over 15 years of experience of supporting pharmacy technicians after they qualify. Throughout this time we have found the learners to be reflective, self-aware and keen to advance. As a group they know that their gaps in skills and knowledge are and work actively within the pharmacy and wider healthcare team both to develop themselves and to assure safety. There is a lack of consistency in the ongoing support and supervision provided to pharmacy technicians, particularly in community pharmacy where they are dependent on a single pharmacist for guidance and for role modelling of professional behaviours. Assuring improved educational and clinical supervision of pharmacy technicians in single handed practices is likely to be of benefit to enhance professional behaviours in practice.

Generally, responses from individuals were also positive about the proposal and raised similar issues in response to this question. There was a strong link made between this proposal and the ambitions of the NHS LTWP, particularly with reference to the plans for pharmacist prescribing from 2026 onwards.

Further points were raised about pharmacy technician pay and staffing levels. Several respondents stated that pharmacy technicians should be paid more for the extra responsibility of operating under a PGD. Others pointed out the effect this proposal might have on staffing levels and NHS capacity across the whole system, if more people are recruited to this profession. There were also concerns about the ability to recruit enough pharmacy technicians to maintain this proposed way of working.

Some respondents also noted that this proposal would be useful in a hospital setting in order to optimise workflow and utilise pharmacy technicians’ knowledge of medicines.

Quotes from individuals

The consultation information refers to private services. It will be necessary to ensure that training for pharmacy technicians (and others) includes the understanding about additional signatures of registered manager and nominated individual for PGDs in private hospitals and/or clinics - such information may not be provided through SPS training as NHS focused and is not currently clear in NICE guidance.

This proposal offers the opportunity for pharmacy professionals to provide seamless care for patients. The function of the pharmacist as an independent prescriber can only be complimented by this proposal. In a secure mental health setting, the opportunity for pharmacy-led clinics both for in patients and community patients would give our patients parity and support a move towards independent living in a very real way. Across the healthcare system, the expectations of all staff is expanding quickly, and this proposal offers a very safe way to move forward for technicians, patients and pharmacy as a healthcare team.

Pharmacy technicians are very familiar working under SOPs and protocols. They are aware of their limitations and know when to refer and escalate. With the current state of workforce in the NHS there is a real need for this happen.

With regards to the military, this proposal would free up a lot of appointments for doctors and medics. Giving them more time to deal with more demanding patients. I suspect it would lessen the burden on civilian GP practices in the same way.

… with more responsibility and training needing to be undertaken, I would imagine the majority of technicians would be expecting some form of pay increase. How the delivery of these services in community are paid for by the NHS would need to be re-evaluated to provide the extra funding needed for pharmacies to recruit, train and retain these staff.

Fully support the changes. Reminder to ensure that all people operating PGDs must be locally signed off to be competent, and that sign off is clear that the professional making that declaration accepts their own accountability.

As a pharmacy technician I have authored many PGDs but never been able to follow them, which is nonsensical.

PGD creation has good governance and therefore should be clear to those issuing medicines using them. This is particularly true if pharmacy technicians were involved in their development alongside other relevant HCPs.

Additional evidence for why the proposal should not go ahead

In the consultation, we asked the following:

Question

This proposal is to allow registered pharmacy technicians to supply and administer medicines using a PGD. Do you have additional information for why this proposal should not go ahead?

Feedback from responses

The predominant responses to the question revolved around disagreement with the proposal for pharmacy technicians to administer medicines using PGDs. The respondents centred on several key themes such as insufficient training, increased workload, and the technician training not being near the same level that pharmacists undergo.

Respondents voiced concerns about the already high workload in pharmacies and how adding the responsibility of administering medicines through PGDs without a corresponding increase in pay could potentially drive pharmacy technicians out of their profession. Some also expressed worry that this proposal might lead to pharmacists reconsidering their career paths, as it does not align with the extensive training they undergo. Pharmacists typically take up a 4-year master’s degree, along with a year of pre-registration training. However, the 2-year course for pharmacy technicians responsible for some tasks traditionally carried out by pharmacists, was seen as a point of disagreement.

Another disagreement was the belief that a 2-year training period is adequate for pharmacy technicians to handle PGDs. Concerns were also raised regarding the lack of sufficient clinical training and experience required to effectively engage with patients and offer essential consultation skills.

Quotes from individuals

Higher responsibilities for no extra pay for healthcare professionals that don’t carry the necessary clinical knowledge or experience. Compared to entry requirements and the training undertaken on the pharmacy MPharm it is an inadequate suggestion that will be risky to patient safety based on the proposed training that will be seen to ‘bring them up to speed’ in 2 years versus the 5 years and countless exams and objective structured clinical examinations (OSCEs) pharmacists do.

Pharmacy is already a stretched sector in healthcare adding extra responsibilities would have an impact on pharmacy technicians leaving the sector due to being overwhelmed. Pharmacy technicians would expect an increase in wages in line with this responsibility which would add pressure to the economy.

Evaluating the impact assessment

Alongside the consultation, we published an accompanying impact assessment to evaluate the costs, benefits and risks of this proposal.

Question

Do you agree or disagree that the consultation stage impact assessment gives a realistic indication of the likely costs, benefits and risks of the proposal?

Of those who responded to this question:

• 1,326 agreed
• 264 disagreed
• 677 said they didn’t know

Feedback from responses

58% of respondents agreed that the impact assessment gives a realistic indication of likely costs, benefits and risks; 12% stated that they disagreed and 30% didn’t know.

Responses highlighted that there may be additional costs associated with recruitment and training issues for pharmacy technicians and thought it likely that it would be the community pharmacies who would bear the burden of these costs. Respondents stated that there will be financial implications during the early implementation stage, however these will be justifiable given the long-term prospect that this will be more advantageous to the individual professional, leading to increased salaries, better job opportunities and further training and development. 

Those in agreement also stated that the costs, benefits and risks identified in the impact assessment have been fairly evaluated and therefore do not believe there will be a risk to pharmacy technicians safe supply and administration of medicines via PGDs. However, it was emphasised that training and support costs for PGDs will need further consideration due to the limited data available for analysis. 

Quotes from organisations

Company Chemist Association, said:

The impact assessment rightly recognises the additional training costs which will be borne by pharmacy businesses … The impact assessment fails to recognise that upskilling technicians and giving them additional responsibilities is likely to drive up the salaries of technicians beyond current levels, resulting in additional financial pressures for pharmacy businesses. Therefore, it is important that these proposals are seen as a way to increase the clinical capacity of community pharmacy. These proposals will not reduce the cost base of delivering services when compared to services delivered by a pharmacist.

Pharmacy2U, said:

Pharmacy2U does not feel well-placed to comment on the potential costs and monetised benefits set out in the impact assessment. We would however strongly agree with the non-monetised benefits that DHSC has identified of allowing pharmacy technicians to supply and administer under a patient group direction, across improving patient experience and quality of care, releasing pharmacy sector efficiency and cost-effectiveness, and clarifying lines of clinical responsibility.

Community Pharmacy NI, said: The impact assessment is an estimate and is not NI specific and doesn’t consider factors unique to this region. NI will not immediately see the operational benefits of these proposals as we do not yet have registered pharmacy technicians.

Joined Up Care – Derbyshire, said:

This gives a realistic proposal of the benefits and risks.

The responses from individuals mainly agreed that the impact assessment gives a realistic indication of the likely costs, benefits and risks of the proposal. However some individuals stated that it did not take into consideration the implications of costs, benefit and risks associated with Northern Ireland.

Concerns were raised as to whether the scheme could be open to exploitation due to the costs involved. Some were unsure as to whether the financial assessments are correct, but it is made clear in the impact assessment that these are best estimates “derived utilising the median of our variable ranges, resulting in a downwards bias due to the multiplicative nature of variables used within our assumptions”. Other respondents were concerned that there are insufficient registered professionals to make the proposal work.

It was also stated that the impact assessment does not specifically address the main issues concerning community pharmacy, suggesting that some technicians might lack the required clinical knowledge for PGDs. Some respondents felt that the business opportunity for profit making could take precedence over patient safety concerns.

Quotes from individuals:

I agree with the overview of the consultation and the benefits pharmacy technicians working under PGDs will provide for the patient and the healthcare workforce as a whole. This will help the integrated care system (ICS) develop and shape their services, increasing access to services and medicine experts.

I agree with some of the impact assessment for Option 1. However, other key non-monetised costs by main affected groups: we disagree that the costs of developing PGDs will rise due to pharmacy technicians being able to use them. PGDs are developed where there is a need and the current professionals (nurses, pharmacists and so on) will be using them. The inclusion of pharmacy technicians in the legislation will not increase the cost of PGD development as this already happens and is therefore a current cost. Of course if a new service using a PGD is developed solely because pharmacy technicians are the only professionals who will supply against it, then there may be extra costs. However, we believe that PGDs are developed where there is a need and not because a specific staff group can use them.

Next steps

Following the analysis of consultation responses and the clear support for the proposal, we will progress work to amend the HMRs to enable registered pharmacy technicians to supply and administer medicines under a PGD.

Legal duties

The general equality duty that is set out in the Equality Act 2010 requires public authorities, in the exercise of their functions, to have due regard to the need to:

• eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act
• advance equality of opportunity between people who share a protected characteristic and those who do not
• foster good relations between people who share a protected characteristic and those who do not

We do not believe that the proposal detailed here would have adverse or different impacts on individuals with protected characteristics. The proposal would support pharmacy technicians to provide certain treatment to patients directly. The reduction in unnecessary delays would benefit any patient attending a practice where pharmacy technicians were administering or supplying under a PGD.

The National Health Service Act 2006 contains a number of overarching duties on the Secretary of State for Health and Social Care which apply to every action undertaken in relation to the NHS and public health. These duties include those outlined below.

The duty to continue to promote a comprehensive health service in England (section 1)

We believe this proposal supports the duty to promote a comprehensive health service in England as it supports utilisation of the skills of the whole pharmacy team, allowing them to maximise their contribution in the provision of clinical services. The use of PGDs by registered pharmacy technicians means that certain clinical services can be offered without requiring a prescribing professional to supply and administer medicines themselves or to assess the patient and write a PSD. This will free up pharmacists’ time which could be used to focus their clinical expertise on treating more complex cases as independent prescribers. This is pertinent as initial education and training reforms for pharmacists will see pharmacists become independent prescribers from the point of registration from 2026 onwards.

The duty as to improvement in quality of services (section 1A)

We believe this also contributes to improvement in the quality of services via facilitating timely access to medicines. The ability for additional healthcare professionals to supply and/or administer medicines where it is safe and appropriate to do so will provide patients with more options for receiving the right treatment, at the right time, reducing delay. This will contribute to better patient outcomes by better using the skill mix within healthcare professions to provide additional capacity to treat patients providing new routes for access to pharmaceutical services.

Under current legislation, the only mechanism by which registered pharmacy technicians can supply and administer medicines is where they are authorised to do so by a PSD. As registered healthcare professionals, this does not fully utilise the skills and knowledge of registered pharmacy technicians who could use their education and training to supply and administer medicines safely under a PGD. If PGDs were in place, registered pharmacy technicians could administer specific medicines under an appropriate PGD without requiring the intervention of trained prescribers. This will enable registered pharmacy technicians to take responsibility for their decision to administer and supply medicines in accordance with the written PGD.

The duty as to reducing inequalities (section 1C)

PGDs provide a structured framework which permits certain healthcare professionals to supply and/or administer medicines to a pre-defined group of patients. Increasing the accessibility of medicines for those within the defined patient group could help free capacity for appointments within other parts of the healthcare system. Any patient that falls outside the pre-defined group cannot be treated under that PGD and must be referred to an independent prescriber for an individual assessment.

Legal basis and assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021

The Medicines and Medical Devices Act 2021 (MMD Act) came into force on 11 April 2021. We propose to make legislative changes using powers in part 2 of the act, which provides powers to make, among other things, amendments to the HMRs.

This consultation is conducted in line with the consultation requirement in section 45(1) of the act.

Section 2 of the act provides that patient safety must be the overarching objective of the appropriate authority when making regulations. Section 2 requires that when assessing whether regulations would contribute to the objective of safeguarding public health, the appropriate authority must have regard to 3 factors:

1. the safety of human medicines and where there is an impact on safety that the benefits of making the regulations outweigh the risks
2. the availability of human medicines
3. the likelihood of the relevant part of the United Kingdom being seen as a favourable place which to: carry out research relating to human medicines - conduct clinical trials - manufacture or supply human medicines

As set out in section 2(3) of the act, where regulations under section 2(1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.

The appropriate authority is the Secretary of State for Health and Social Care in relation to Great Britain and, in relation to Northern Ireland, the Department of Health NI, or the DoH NI and Secretary of State jointly.

We assessed the above proposals against each of the factors set out in section 2 for the public consultation exercise and our assessments remain the same.

Continued monitoring of patient safety

PGDs make one named healthcare professional responsible for assessing a patient and supplying or administering a medicine to them. PGDs are useful where assessment and treatment follows a clearly predictable pattern. Within a PGD the suitability of supply and/or administration is determined by a set of instructions which directs the healthcare professional in their assessment of the patient. This is known as ‘the direction’. Any patients who fall outside of the pre-defined patient group within the PGD will be referred to an independent prescriber for an individual assessment.

PGDs are developed by multi-professional groups with extensive expertise, requiring a significant amount of time and resource to develop and implement. Once implemented, PGDs are subject to ongoing monitoring. All users of PGDs, including registered pharmacy technicians, are required to undertake additional training, as defined in each PGD, to be able to supply and administer any medicines under the relevant PGD. In addition, NICE guidelines recommend that organisations should agree and undertake a planned programme of monitoring and evaluation of PGD use within the service.

For all the reasons explained above, the likelihood of any increased risk of inappropriate administration of medicines is considered to be very low and is outweighed by the benefits of this proposal.

Increased availability of medicines and services

The policy has the potential for individuals to receive the treatment they need faster than if they needed to wait for another healthcare professional to prescribe, supply or administer the medicine they require. Allowing registered pharmacy technicians to undertake more clinical services via a PGD will also increase capacity for pharmacists to focus their clinical expertise and prescribing skills. Ultimately, this gives patients access to a wider range of services delivered by healthcare professionals with the right level of skills at the right time, supporting better patient healthcare outcomes and reducing the need for appointments in other parts of the healthcare system.

UK favourability to supply medicines

This proposal has the potential to have a positive impact on the UK being seen as a favourable place to supply medicines. It demonstrates that the UK has the adaptability to evolve its service design to meet the medicines requirements of local populations and to develop the capabilities of its healthcare professionals. The utilisation of the skills of pharmacy technicians will help to expand the range of patient-facing clinical services which can be offered within community pharmacies and enable registered pharmacy technicians to contribute more as part of multi-professional teams in other settings. This will improve safe and timely access to medicines, reducing delays in care. This demonstrates a forward-thinking approach to the provision of medicines which we believe will influence the likelihood of the UK being seen as a favourable place in which to supply human medicines.