New GPhC Council members announced


Three new members have been appointed to the governing body of the General Pharmaceutical Council (GPhC).


The three new Council members – Rose Marie Parr, Selina Ullah and Yousaf Ahmad – will take up their positions on 01 April 2020.


The newly appointed Council members are replacing Alan Kershaw, Digby Emson OBE and Evelyn McPhail, who are standing down after serving two terms on the Council. Mr Emson will also be leaving his post as Chair of the Audit and Risk Committee.


GPhC Chair Nigel Clarke said:


“I am delighted to announce the appointments of Rose Marie, Selina and Yousaf. Each of them brings a wealth of high-level experience and expertise – they will be valuable assets to the Council.


“I’d also like to take this opportunity to thank our outgoing Council members for their dedicated service and wish them well for the future.”


Rose Marie Parr


Rose Marie Parr has been the Chief Pharmaceutical Officer for Scotland since 2015 and will be retiring from that role in July 2020. Rose Marie was previously chair of the Scottish Pharmacy Board of the Royal Pharmaceutical Society of Great Britain (RPSGB) and chair of the GPhC’s Board of Assessors, which oversees the registration assessment.


Rose Marie has also held posts in hospital pharmacy and roles at NHS Education for Scotland. Rose Marie also holds honorary professorships at both Scottish schools of pharmacy – Strathclyde University and Robert Gordon University.


Selina Ullah


Selina Ullah has over 25 years’ non-executive board experience. Selina is deputy chair and senior independent director of a large NHS hospital trust, board member of Locala Community Partnerships CIC, non-executive director of Accent Group and chair of various charities.


Selina has experience in regulation, professional standards and education, chairing board sub-committees on standards, education and workforce.


Yousaf Ahmad


Yousaf Ahmad is currently Chief Pharmacist of Care UK Healthcare group that covers primary, secondary, health in justice and residential care. Yousaf has extensive experience within secondary care, having worked primarily in large acute health boards in Scotland and in the Middle East. He has represented pharmacy at a national level through committee memberships with UKCPA and the RPS bodies.


Audit of GPhC activity highlights fitness to practise process concerns


The Professional Standards Authority (PSA) has published its review of the General Pharmaceutical Council’s (GPhC’s) performance against the PSA’s Standards of Good Regulation in 2018/19.


The PSA found that the GPhC met 20 out of 24 of the Standards of Good Regulation in 2018/19, including all of the standards relating to guidance and standards, education and training and registration.


For 2018/19, the PSA decided to carry out a targeted review of Standard 3 (Registration) and Standards 3, 5, 6, 7 and 8 (Fitness to Practise). The PSA also carried out an audit of 63 fitness to practise cases closed by the GPhC between 1 March 2018 and 28 February 2019.


Following this targeted review and audit, the PSA identified four out of ten of the fitness to practise standards were not met. Although the PSA did not consider that the concerns assessed through the audit had resulted in incorrect decisions being made, the PSA report highlights several areas requiring improvement. These areas included:


  • Improving record-keeping about fitness to practise cases.
  • Updating internal guidance on triaging cases, including our approach to issuing pre-investigating committee undertakings or informal guidance and warnings to pharmacy professionals.
  • Improving timeliness in progressing fitness to practise cases.
  • Improving communications with people involved in cases.
  • Improving reasoning for decisions at each stage.


In response, the GPhC has published an action plan setting out the improvements it is making to its fitness to practise procedures, many of which GPhC had already identified as priorities for 2019/20. The action plan sets out each area of concern identified by the PSA along with the GPhC’s response and expected timescales.


Key actions being taken include:


  • updating internal guidance on triaging cases, including the approach to issuing undertakings or warnings to pharmacy professionals, and making sure that guidance is consistently followed
  • an ongoing programme of training and development of staff to help improve timeliness of fitness to practise cases and communications with complainants and pharmacy professionals
  • introducing peer review and quality assurance of decisions to take no further action at triage.

GPhC Chief Executive Duncan Rudkin said:


“We are committed to using this feedback from the PSA to reflect, learn and work together so that we take forward the changes and improvements needed.


“We agree with the PSA’s assessment that we need to make improvements in some areas of our Fitness to Practise processes. We have put in place an action plan to make sure that these improvements are taken forward as a priority and embedded over the longer term. We will regularly review our progress against the action plan and report on this to our Council.


“We will also shortly begin a consultation on our Fitness to Practise strategy, which will provide an opportunity for a fundamental review of our approach to fitness to practise and how it needs to change to make it as proportionate, person-centred and effective as possible. We want to hear from as many individuals and organisations as possible through that consultation.”


The Pharmacist Defence Association has expressed an opinion on the PSA findings. They have said that it is essential that any regulatory system retains the confidence of registrants, patients and the public and while all other aspects scored full marks in the PSA’s annual review of the GPhC, there were several issues raised about its fitness to practise processes. We welcome the fact that the GPhC have now published an action plan designed to address those issues.


The PDA specialist regulatory lawyers routinely advise and represent pharmacists and pharmacy students subject to fitness to practise investigations and they have said that they have a constructive professional relationship with the GPhC through which they highlight procedural concerns and identify improvements based upon the cases we are involved. They say this is to help ensure that registrants are treated fairly, and the natural anxiety associated with a regulatory investigation is kept to an absolute minimum.


Mark Pitt, PDA Director of Defence Services said:


“Fitness to practise processes are a necessary part of being a regulated health profession; however, such processes must operate to the highest standards in the interests of all involved.  Regardless of the process being followed by the regulator, the PDA will always seek to secure a fair and just outcome for our members, including on many occasions getting the case closed without further action.


“Pharmacists and pharmacy students almost never expect to become involved in a fitness to practise investigation during their professional career, but when it happens it can have a devastating impact on their lives and health.


“I encourage pharmacists and pharmacy students to join the PDA so that we can provide comprehensive support at the very early stages of an investigation in order to secure the best outcome. The PDA is a membership-based organisation and only current members can benefit from our full package of support.”


Specialist fitness to practise solicitor Andrea James wrote an article summarising her concerns after the ruling. You can read the response by clicking here.


GPhC propose significant increase in premises registration fees



The General Pharmaceutical Council (GPhC) is consulting on proposals to increase registration fees for pharmacy premises from £262 to £365.


In this consultation, the GPhC is seeking views on whether the fees paid by pharmacy owners should cover the full costs of regulating pharmacy premises.


The GPhC has said that the consultation marks the first phase of a wider review of the GPhC’s longer-term fees strategy, which will also consider areas such as longer fixed-term fees and flexible fee options (for those on parental leave, for example).


GPhC Chief Executive Duncan Rudkin said:


“We recognise the financial pressures that pharmacy owners are under and any uplift in fees is only proposed when necessary.


“Since 2013, we have introduced significant changes in how we regulate and inspect pharmacies, improving the effectiveness of our regulatory approach and bringing benefits to patients, the public and pharmacies. We are proposing this change now because we need a robust and sustainable financial framework with fees that reflect the true cost of regulation.


“We welcome views on our proposals.”


A spokesperson from the National Pharmacy Association commented:


“GPhC is proposing to levy a big percentage increase at a time when community pharmacy finances are already under immense pressure. We cannot possibly support such a steep increase in fees for pharmacy regulation.


“GPhC says it needs to cover its costs, however pharmacy contractors are bound to ask if the regulator is working as hard as pharmacies themselves to deliver efficiencies. We will now take soundings from NPA members and give our formal, detailed response to GPhC in March.”


The consultation on fees for pharmacy premises is open from 7 January to 31 March 2020. The first phase of the consultation runs from 7 January to 31 March 2020. If adopted, the new arrangements would come into place from October.



GPhC announce new training requirements for pharmacy support staff


The Council of the General Pharmaceutical Council (GPhC) has agreed on new education and training requirements and learning outcomes for all pharmacy support roles.


The Council decided to introduce the new requirements after considering the feedback received from consultation and engagement with the pharmacy sector, pharmacy support staff, pharmacy professionals, members of the public and education and training providers.


In response to the feedback received, the Council agreed that the GPhC should continue to set requirements for the education and training of pharmacy support staff and to accredit courses.  The requirements will also now cover all support staff who have roles in:


  • Dispensing and supply of medicines and medical devices.
  • Advising on the use of medicines and medical devices.
  • Assisting in the provision of pharmacy services.


The previous requirements only covered medicines counter assistants and dispensing assistants.


The requirements, including the learning outcomes, have also been updated to make sure that they reflect developments in pharmacy practice and the workforce since they were first introduced in 2005. This includes core skills that all pharmacy support staff need to achieve, including communication skills for patient-centred care.


Alongside the requirements, a set of updated criteria for use in the accreditation of courses has also been developed.


At the meeting, the Council agreed on some amendments to the requirements which will now be made before the final requirements are published.


In 2020, the GPhC will set and communicate the date from which any new courses will need to meet the revised criteria for accreditation.


Duncan Rudkin, Chief Executive of the GPhC said:


“Pharmacy support staff play a very important role in providing pharmacy services to patients and the public. All members of the pharmacy team must have the education and training they need to undertake their important roles safely and effectively.


“I want to thank everyone who took part in our consultations and engagement on our proposals. We have made significant changes to our original proposals based on their feedback and look forward to implementing our new approach.”



GPhC outline five key areas to consider before prescribing



The Council of the GPhC has approved new guidance for pharmacist prescribers to ensure that they provide safe and effective care when prescribing.


The Guidance for pharmacist prescribers covers five key areas that pharmacist prescribers must consider in order to prescribe safely and effectively. These are:


  1. Taking responsibility for prescribing safely.
  2. Keeping up to date and prescribing within their level of competence.
  3. Working in partnership with other healthcare professionals and persons seeking care.
  4. Prescribing considerations and clinic judgement.
  5. Raising concerns.


In response to feedback from a public consultation earlier this year, the GPhC has made a number of changes to their initial proposals, including adding further examples of prescribing in different settings and strengthening the guidance in relation to online prescribing of high-risk medicines.


The guidance emphasises that pharmacist prescribers must be able to justify their decisions and use their professional judgement in the best interests of the person receiving care, in all contexts, for example when providing a pharmacy service online or when working as part of a multidisciplinary team in a hospital, or in a community mental health team.


The guidance also sets out when prescribers should consider whether any extra safeguards are needed, for example, when prescribing antibiotics online or medicines likely to be abused or misused such as opioids.


Included within the guidance are a range of key questions that prescribers should ask themselves when prescribing in order to ensure they are providing person-centred and safe and effective care. The GPhC has also included links to other sources of relevant information and guidance, including from other regulators.


As of 20 November 2019, there are 58,085 pharmacists on our register, of which 9,142 are also independent prescribers.


Duncan Rudkin, Chief Executive of the GPhC said:


“This new guidance comes at a time when we are seeing rapid growth in the number of pharmacist prescribers working across a variety of settings throughout Great Britain. We have seen the number of prescribers on our register double since 2016. This new guidance clearly outlines what they need to consider in order to provide safe and effective patient-centred care.


“Furthermore, the guidance sets out the responsibilities of organisations that employ pharmacist prescribers, including having risk management and governance arrangements in place to protect patient safety.”


You can read the new guidance here.


Crackdown on online pharmacy supply of high risk medicines



The General Pharmaceutical Council (GPhC) has identified that some online pharmacies have supplied high-risk medicines including opiates and sedatives to patients without appropriate steps being taken by the pharmacy owner, prescriber, responsible pharmacist or other members of the team. It has been found that check to ensure that the medicine being prescribed and dispensed was clinically appropriate for the patient were not made.


These patient safety concerns were identified during recent pharmacy inspections which looked at whether online pharmacies were meeting the standards for registered pharmacies and following updated guidance published in April this year.


The updated guidance on providing pharmacy services at a distance made clear that some categories of medicines are not suitable to be supplied online unless further safeguards have been put in place to make sure they are clinically appropriate for patients. This includes medicines liable to abuse, overuse or misuse, or when there is a risk of addiction and ongoing monitoring is important, such as opiates and sedatives.


In response, the GPhC is taking enforcement and regulatory action where appropriate against the owners of these registered pharmacies, as well as individual pharmacy professionals involved in both the prescribing and supply of medicines where their conduct may have fallen short of professional standards. The GPhC are also taking forward Fitness to Practise investigations against a number of superintendent pharmacists, pharmacist independent prescribers and responsible pharmacists.


Improvement notices and conditions on a pharmacy’s registration have been imposed; for example, conditions restricting the supply of controlled drugs by the pharmacy.


The chief executive of the GPhC, Duncan Rudkin, has this week written to the owners of online pharmacies and asked them to provide information on the actions they have taken to follow the new guidance and make sure patients access pharmacy services online safely. This information will be used to proactively prioritise the GPhC’s inspection programme.


Duncan Rudkin, Chief Executive of the GPhC said:


“I want to reassure patients and the public that we are taking robust action against the small number of online pharmacies and pharmacy professionals who through their actions have put the safety of patients at risk. I have also written to online pharmacy owners to obtain details of how they are keeping patients safe online and following our guidance.


“I have made clear that pharmacy owners need to make sure that they have the right safeguards in place to make sure all medicines they supply are clinically appropriate for their patients.


“When prescribing and supplying high-risk medicines such as opioids, it is not acceptable to rely solely on information provided by the patient via an online questionnaire; the prescriber needs to take other steps such as consulting with the patient, reviewing medical records and contacting the patient’s GP, as outlined in regulatory standards and guidance. (1)


“Patient safety is our central focus, and we are continuing to work closely with other regulators involved in regulating online primary care services, governments and other stakeholders across Great Britain to improve the quality of care for patients online.”


(1) Prescribers are expected to follow relevant regulatory standards and guidance such as the GMC’s Good Medical Practice and the GMC’s guidance on prescribing. The GPhC is currently developing prescribing guidance for pharmacist independent prescribers.