The Pharmaceutical Society NI is working closely with the Department of Health NI, the GPhC and other key stakeholders to ensure that we are taking appropriate regulatory actions to support pharmacists during this extremely difficult period, whilst also protecting the public and maintaining the continuity of safe and effective pharmacy services.
We have published the following frequently asked questions and statements which pharmacists and the public should read:
Frequently Asked Questions
Frequently Asked Questions.
Q: Has the CPD Year 2019/20 been extended?
A: Yes, due to Covid-19, CPD Year 2019/20 has been extended to run for a 15 month period from 01 June 2019 until 31 August 2020.
Q: How does this affect the amount of CPD that I must submit in this year’s portfolio?
A: Although the CPD year has been extended to 15 months, the amount of CPD to be submitted remains unchanged. The minimum number of hours remains at 30 hours and the minimum number of cycles remains at 4 cycles.
Q: Can I submit cycles completed after 31 May 2020?
A: Yes, your portfolio can include CPD cycles undertaken and completed from 01 June 2019 to 31 August 2020.
Q: How will this affect CPD Year 2020/21?
A: CPD Year 2020/21 will run from 01 September 2020 until 31 May 2021. The amount of CPD will be reduced to reflect the shorter collection period – more details will follow
We are researching venues at present which will allow social distancing – an announcement will be made on venue and date as soon as they are finalised
We are researching venues at present which will allow social distancing – an announcement will be made on venue and date as soon as they are finalised
We will contact all pre-registration trainees with further details about how to apply
You need to agree this with your employer – you must normally complete a total of 52 weeks training as the sole pupil of a tutor to qualify for registration, after successfully completing the registration examination. Once you have completed 52 weeks satisfactorily you no longer need to be the sole pupil, but your activities will require the same level of supervision as at present, from a pharmacist
You may only be the registered tutor of one pre-registration trainee, and they must complete 52 weeks training as your sole pupil. In the exceptional circumstances this year, causing delay to the registration examination, you may become the tutor of an incoming pre-registration student provided an existing trainee for whom you are tutor has successfully completed 52 weeks of training
Our statement says The Chief Pharmaceutical Officer has advised that the Department will ensure pre-registration funding is available until the registration date in August, allowing trainees to remain in post with the agreement of their employer.
It is recommended that you only sit the registration examination when you feel that you are fully prepared and ready to do so. There is no compulsion to sit the registration examination in August, though it must be done within 18 months of sign off by your tutor after 52 weeks of training
Further information about eligibility requirements for the registration examination can be found in Chapter 10 of the Pre-registration Training Manual ( www.psni.org.uk/wp-content/uploads/2012/10/1.-PR-Trainee-Manual-2019-20-FINAL.pdf )which includes achieving a satisfactory 39 week appraisal as confirmed by your tutor, and have completed 45 weeks training
Yes, trainees need to complete all of the compulsory aspects of pre-registration training (including the reflective e-portfolio, e-learning modules, attendance at live training days and achieve a satisfactory final appraisal and attain a final declaration from your tutor and attain a pass in the registration examination) as a requirement for registration. Given the current challenges experienced by tutors and trainees, we will take a pragmatic approach to the normal expected interim deadlines for completion of the compulsory aspects but urge trainees and tutors to work together to make the best use of additional time available for training to effectively prepare for the registration examination and ensure that compulsory aspects of training are completed.
The Council’s policy found here www.psni.org.uk/wp-content/uploads/2020/04/Use-of-powers-for-temporary-registrations-of-persons-pdf.pdf sets out some factors which may be relevant to the question of whether restrictions on practice (conditions or revocation of temporary registration) are:
• necessary to protect the public.
• otherwise in the public interest; or
• in the interests of the temporary registrant.
Conditions or revocation of temporary registration is necessary to protect the public if there is information available which indicates that there is a risk to patients, colleagues or other members of the public if the pharmacist continues to practise without any restrictions.
The first step is to consider the nature and extent of the risk. There might be a risk to the safety of patients, for example, if there is evidence that the pharmacist:
• has made a large volume of dispensing errors in a short period;
• is experiencing an alcohol or drug dependence which has affected their ability to practise safely and effectively.
The second step is to consider what action needs to be taken to deal with the identified risk. If the risk of the pharmacist repeating their behaviour is low, or if the level of harm which might result is low, it might not be necessary to restrict the pharmacist’s ability to practise. If the only way to properly deal with the identified risk is to restrict the pharmacist’s practice with conditions, or to stop the pharmacist from practising, it is likely that restrictions are necessary to protect the public.
It is likely to be rare for restrictions to be imposed only on wider public interest grounds. Restrictions can be justified as being in the public interest if there would be serious damage to the reputation of the profession as a whole if a pharmacist was not restricted in their practice.
For example, a pharmacist is charged by the police with a serious criminal offence. Even if the Registrar considers there is no ongoing risk of harm to the public, he might consider that the public’s confidence in the profession as a whole could be seriously damaged if there were no restrictions on the pharmacist’s practise.
A restriction on practise may be in the interests of the pharmacist if, for example, they are addicted to a controlled drug. As a pharmacist, they will have privileged access to medication. It might be in the interests of the pharmacist’s health for this access to be restricted or removed. In these circumstances, restrictions may also be necessary to protect the public.
In reaching a decision on whether to impose/ vary conditions or revoke registration, the Registrar will consider:
• the gravity of the concern;
• the nature of the evidence;
• the seriousness of the risk of harm to patients, including information about the likelihood of a further incident or incident being repeated;
• the seriousness of risk to members of the public if the pharmacist continues to practice unrestricted;
• whether public confidence in the pharmacy profession is likely to be seriously damaged if the pharmacist continues to practise without any restrictions;
• whether it is in the pharmacist’s interests to hold unrestricted registration – for example, the pharmacist may clearly lack insight and need to be protected from him or herself;
• whether the pharmacist has any previous fitness to practise findings;
• In weighing up these factors, the Registrar must carefully consider the proportionality of his decision. He should consider if it is proportionate in terms of dealing with the risk to the public (including patient safety and public confidence) and in terms of the impact of any action on the pharmacist’s own interests.
If the Registrar decides that some restriction on practise is required, he must then consider whether conditions would be a sufficient and proportionate response to the risk he has identified. He should only revoke registration if conditions would not meet his concerns adequately.
The completion of a Health and Social Care Board (HSCB) Situation Report during this emergency has been advised by the Department of Health and is being carried out in the context of proactive identification and management of risk.
The Situation Report is intended for the purpose of mitigating risk and to enable initiation of appropriate actions in risk management. The identification of orange or red status on the HSCB Situation Report is an objective assessment which should inform any professional judgements by the pharmacist. There is no intention to use a Situation Report analysis as a component of Fitness to Practise.
A pharmacist must, however, always act with due diligence to appropriately address any risks identified and assure safe practice.
Pharmacists are encouraged to reflect on the Code of Conduct Ethics and Performance which states the obligations on pharmacists, including amongst others:
• to exercise professional judgement in the best interests of patient and public safety;
• to be accountable for professional practice;
• to be answerable for any acts and/or omissions, regardless of the advice or directions from a manager, employer or another professional; and
• to justify their actions when asked to do so.
Principle 2 of the Code requires pharmacists to provide safe and quality care.
Patient safety is essential and lies at the heart of quality patient care. Patient centred care is delivered in a properly managed and safe environment by having working systems which are effective, simple and clear.
Pharmacists should proactively identify potential areas of risk in their practice and utilise learnings when things go wrong. Pharmacists’ obligations extend beyond the patient and immediate service user into the general community. Pharmacists should always act responsibly, in the public interest to ensure public safety, ensuring that all roles and responsibilities for functions related to the safety and quality of pharmacy services are clearly defined and governed.
During the ongoing pandemic emergency, our top priority in relation to Fitness to Practise is public protection and patient safety. We will continue to receive and log complaints and concerns, these will
be risk assessed and those which present an immediate risk to the public will be advanced if they meet the threshold for interim order. Other cases will be advanced should the risk assessment change or when the current emergency is over.
We will either hear or adjourn any cases currently listed and will list only the following type of case going forward:
1. Initial interim order applications
2. Interim order review hearings
3. High Court applications to extend interim orders
4. Substantive Fitness to Practise review hearings
All other face to face Statutory Committee hearings are being postponed and no new ones will be scheduled until further notice – this allows us to prioritise interim order and substantive order reviews.
In conjunction with the Chair of the Statutory Committee, we are considering arrangements to progress as many priority cases as possible by virtual hearings and case management reviews, and are also exploring the holding of some hearings on papers alone, with the agreement of the parties. We will communicate arrangements directly to the people involved in individual cases.
Joint Regulatory Statement
The UK Healthcare regulators released a recent statement on how we would regulate during the pandemic, which outlines that the current context will be taken into account provided registrants had followed standards and exercised their professional judgement. The statement is available on our website at : www.psni.org.uk/news/joint-regulators-statement-on-covid/
We are grateful for the understanding of all those involved in these processes during this time.
What will happen to existing cases?.
We are mindful that many of our registrants are heavily involved in the response to the Covid-19 pandemic or may be ill or having to self-isolate due to the virus. We do not wish to add unnecessarily to the pressure that pharmacists are under at this difficult time.
We must, however, continue to protect the public and maintain confidence in the pharmacy profession. In order to balance our public protection role and our understanding of the pressures facing the pharmacy profession, our fitness to practise focus for the foreseeable future will on those priority cases where the evidence we have indicates an immediate risk to patient and/or public safety, which may require an interim order application to be made. All other fitness to practise investigations will be suspended, unless a risk assessment suggests a change in their urgency, until the situation improves.
We will inform complainants and pharmacists involved in current investigations of this approach and support them where possible.
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We will receive and document all new complaints about pharmacists, however, we will assess each complaint in relation to the potential risk to patients and the public. We will make interim order applications where we consider the evidence suggests there is an immediate risk to patient and/or public safety.
Profiteering during the current challenging situation by
inflating prices of shortage products risks bringing the profession into
disrepute. We are reminding pharmacy owners and pharmacy professionals that they need to continue meeting our standards at all times during the pandemic. We do however recognise that shortages can engender increases with suppliers and distributors of products – if you are concerned you should take the matter up with your pharmacy in the first instance.
Do not go into a pharmacy, GP or hospital if you or someone
you live with has coronavirus symptoms (high temperature or a new, continuous cough). You can ask someone else to collect your medicines for you, or order online. Read the Public Health Agency advice on what to do if you or a family member has symptoms of coronavirus.
do?
We understand the challenges you are facing in getting your
medicines while you self-isolate. We also recognise that pharmacies are working under significant pressure at the moment because of coronavirus and may not have enough capacity or resources to deliver medicines to everyone who is self-isolating. We would recommend you ask neighbours, friends or family if they would be able to collect your medicines on your behalf and then phone you
just before leaving them on the doorstep for you to collect.
Yes, we will receive and document all new complaints about
pharmacists, however, we will assess each complaint in relation to the
potential risk to patients and the public. The majority of complaints we will not actively investigate at this time, rather we will prioritise those cases that may impact on immediate patient safety, making interim order applications where we consider the evidence suggests there is an immediate risk to patient and/or public safety
You must follow all government advice in relation to self-isolation. Do not go into your training site if you or someone you live with has symptoms of coronavirus for the period of isolation set out by the government.
For trainees: Do not worry if you need to take some days over the normal 42 days of permitted leave during your training because of the need to self-isolate. We will take a flexible and proportionate approach in these circumstances.
We ask that you contact us via email at pre-registration@psni.org.uk if you do exceed the total 42 day training absence limit . You do not need to contact us until you go over the 42 day limit.
If you are self-isolating but are otherwise well, we recommend that you use the time to progress what remaining aspects of training you have and avail of on-line resources such as those provided by NICPLD.
We can assure you that we are working through these issues as quickly as we can, with a view to facilitating the completion of the pre-registration programme leading to registration, whilst acknowledging the exceptional and extremely difficult circumstances you are all working under.
We have made the decision to postpone the Registration Examination in June and October. We will look to reschedule these assessments for a later date(s), either towards the end of this year or early in 2021, once the situation is clearer.
We are now working as quickly as possible to develop plans for the period between now and the rescheduled examinations, including the possibility of a form of provisional registration for current pre-registration trainees. We are carefully considering what options will be in the best interests of pre-registration trainees, pharmacy services and the general public, whilst protecting patient safety.
Please see our joint statement with the GPhC for further information: www.psni.org.uk/wp-content/uploads/2020/03/PSNI-GPhC-Joint-Statement-Pre-registration-Training-2020-26.03.20.pdf
In relation to appraisals and portfolio aspects of training, and in line with the recent joint regulatory statement, we are encouraging tutors to use professional judgement to assess risks in the delivery of safe care, in the first instance, to prioritise patient care (informed by relevant guidance in the values and principles set out in the professional Standards) and similarly to make those professional judgements in relation to aspects of pre-registration training and assessment. We understand that at certain times many trainees will be required to work apart from their tutors and be unable to follow training plans. It is important that trainees are properly supported and supervised and working with pharmacist support and guidance. We know many will be approaching their next appraisal and will be receiving automatic prompts via the online portfolio, please be assured that we will take a pragmatic view on submission and ask that tutors and trainees do likewise, completing what can be completed in the circumstances.
During this difficult period, it will be essential that systems are in place so that trainee wellbeing is supported and that trainees are not operating outside their current competency.
We would assure tutors and trainees that we are working as quickly as we can to resolve these matters and aim to produce more detailed guidance as soon as we can.
Please discuss this with your training provider and tutor- there may be parts of your training that can be done online. You can progress what remaining aspects of training you have and avail of on-line resources such as those provided by NICPLD.
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At this stage, we are placing around 264 pharmacists in Northern Ireland onto the time-limited register, who have left the permanent register in good standing within the last 3 years. If an individual does not wish to be placed on the time-limited register, they are able to opt out.
No, at the moment only those who have left the register in good standing in the last three years are determined to be fit, proper and suitably experienced.
Council have agreed a policy that the test for fit, proper and suitably experienced, at this stage, relates to persons who left the register in good standing in the last three years – other applicants, who provide additional credentials including suitable qualifications, may join this register as long as the Registrar is satisfied that they are suitably experienced, fit and proper.
No, should you not wish to be re-registered at this time please email registration@psni.org.uk with the words re-registration opt-out in the title of the email.
No, you do not need to pay a registration fee to join the time-limited register.
Please speak to your employer about what arrangements will be in place for indemnity cover. Further information is available at www.npa.co.uk/insurance/professional-indemnity-insurance/locum-pharmacists/
Yes. The Northern Ireland Centre for Pharmacy Learning and Development has arranged an on-line resource to assist with return to practice. This is available at: www.nicpld.org/rp/
The UCA has agreed to assist with placement – they can be contacted at natalie@uca.org.uk and further information may be found at www.uca.org.uk/sign-locum-membership . You may also choose to independently find employment.
Please follow the most recent government advice relating to keeping well during this period and discuss this with your employer.
You must give due consideration to your health and well-being before opting in to stay on the time-limited register and practice pharmacy. Please refer to the most recent government guidance when making your decision. Not all roles are patient facing. Depending on your skills, experience and location, you may be able to carry out roles that don’t involve face to face contact with patients. Please speak with your employer.
Before offering employment, your potential employer will ask for the following information:
• your Time-limited Registration number (which can be found on our website at www.psni.org.uk), a form of identification and proof of address
• the date you left the professional register of pharmaceutical chemists
• the area of pharmacy you practiced in
• your assessment of your level of competency
• to provide information relating to any health or conduct issues that might affect your fitness to practise
All employers have been written to and informed of this course of action and will be aware of the Covid-19 temporary register and who is on it. Employers will be asked to assure themselves that those individuals presenting for employment are those on the Covid-19 temporary register and that individuals are aware of no issues in relation to competency and health which might impair their fitness to practise.
We will assess any concerns raised. The decision to remove someone from the Covid-19 temporary register rests with the Registrar of the Pharmaceutical Society.
The UK Healthcare regulators released a recent statement on how we would regulate during the pandemic, which is intended to reassure registrants that context would be taken into account provided registrants had followed standards and exercised their professional judgement. The statement is available on our website: www.psni.org.uk/news/joint-regulators-statement-on-covid-19/
No. Our normal registration and CPD requirements will not apply to those joining the Covid-19 temporary register.
No, your previous annotations on the register will not stand if you are on the Covid-19 temporary register.
These would not be dealt with by way of any Fitness to Practise proceedings but where there were justifiable concerns the Registrar would have the power to remove you from the Covid-19 temporary register .
If concerns are raised about an individual’s fitness to practise who is on the time-limited register, the Registrar has the power to remove them from the time-limited register immediately.
In an emergency, we have powers under the Coronavirus Bill 2020 to temporarily register fit, proper and suitably experienced people to act as pharmacists to help protect public health. Please contact registration@psni.org.uk with any queries.
Pharmacists will not be required to submit the normally required CPD portfolios by 01 June 2020 and will be provided with two months’ notice of a new submission date later in 2020. The decision on setting a new submission date will be context specific and will be taken in consultation with the Department of Health NI. It is important that pharmacists maintain the necessary skills and knowledge to perform their role, we are not seeking documented proof of activity at this time
No, this decision does not preclude pharmacists from doing CPD at a time when they may need to rapidly improve their skills but it removes the burden of writing it up on the online portal and submitting it by 01 June 2020. It is recommended that, where possible, pharmacists maintain their professional development activities and learning.
No, to accommodate this change for the 2019/20 CPD year, adjustments will be made to the requirements for the 2020/21 CPD year which will be shortened in length and the quantity adjusted accordingly. All pharmacists will be informed of the necessary changes in the 2020/21 CPD year when a submission date for the 2019/20 CPD year has been agreed.
At this stage, we are placing around 300 pharmacists in Northern Ireland onto the time-limited register, who have left the permanent register within the last 3 years. If an individual does not wish to remain on the Covid-19 temporary register, we will remove them.
No, at the moment only open those who have left the register in good standing in the last three years and are determined to be fit and proper.
Council have agreed a policy that the test for fit and proper, at this stage, relates to persons who left the register in good standing in the last three years – other applicants, who provide additional credentials including suitable qualifications, may join this register as long as the Registrar is satisfied that they are suitably experienced, fit and proper.
No, should you not wish to be re-registered at this time please email registration@psni.org.uk with the words re-registration opt-out in the title of the email.
No, you do not need to pay a registration fee to join the Covid-19 temporary register.
Please speak to your employer about what arrangements will be in place for indemnity cover.. Further information is available at www.npa.co.uk/insurance/professional-indemnity-insurance/locum-pharmacists/
The Department of Health has arranged for the UCA Locum Agency to assist with the placement of pharmacists in Northern Ireland – they can be contacted at natalie@uca.org.uk. Further information may be found at www.uca.org.uk/sign-locum-membership
Please follow the most recent government advice relating to keeping well during this period and discuss this with your employer.
You must give due consideration to your health and well-being before opting in to stay on the Covid-19 temporary register and practice pharmacy. Please refer to the most recent government guidance when making your decision. Not all roles are patient facing. Depending on your skills, experience and location, you may be able to carry out roles that don’t involve face to face contact with patients. Please speak with your employer.
Before offering employment, your potential employer will ask for the following information:
• your Covid-19 temporary Registration number (which can be found on our website at www.psni.org.uk), a form of identification and proof of address
• the date you left the professional register of pharmaceutical chemists
• the area of pharmacy you practiced in
• your assessment of your level of competency
• to provide information relating to any health or conduct issues that might affect your fitness to practise
All employers have been written to and informed of this course of action and will be aware of the Covid-19 temporary register and who is on it. Employers will be asked to assure themselves that those individuals presenting for employment are those on the TCovid-19 temporary register and that individuals are aware of no issues in relation to competency and health which might impair their fitness to practise.
We will assess any concerns raised. The decision to remove someone from the Covid-19 temporary register rests with the Registrar of the Pharmaceutical Society.
No. Our normal registration and CPD requirements will not apply to those joining the Covid-19 temporary register.
No, your previous annotations on the register will not stand if you are on the Covid-19 temporary register.
These would not be dealt with by way of any Fitness to Practise proceedings but would be addressed consistent with the Council’s published policy www.psni.org.uk/wp-content/uploads/2020/04/Use-of-powers-for-temporary-registrations-of-persons-pdf.pdf
If concerns are raised about an individual’s fitness to practise who is on the Covid-19 temporary register, the Registrar would addressed such concerns consistent with the Council’s published policy www.psni.org.uk/wp-content/uploads/2020/04/Use-of-powers-for-temporary-registrations-of-persons-pdf.pdf .
Statements relating to Regulation during Covid-19
21 January 2021 – Joint UK Chief Pharmaceutical Officers and Pharmacy Regulators’ letter – Supporting pharmacy professionals throughout the COVID-19 pandemic
15 January 2021 – Letter to all registrants from the Chief Pharmaceutical Officer Cathy Harrison
13 January 2021 – Joint regulators’ statement Covid-19
27 November – Joint statement to pharmacy workforce from the CPOs and Regulators
14 September – CPD Requirements for CPD year 2020/21
31 July – Pre-Registration update
29 July – Letter to Pharmacists concerning the sale and supply of COVID-19 rapid antibody testing kits
9 July – Trevor Patterson, CEO and Interim Registrar, has made the following announcement concerning CPD submissions for 2019/20
19 June – Health and Well Being reminder
17 June – Registration Examination – Tuesday 11 August 2020
1 May – Registration Examination process 2020
30 April – Application process to Register as a Pre-registration Trainee Pharmacist in 2020-21 now open
24 April – Covid-19 Temporary Register application process (for pharmacists) now open
23 April – Use of powers for temporary registration of persons under the Pharmacy (NI) Order 1976, as modified by the Coronavirus Act 2020
10 April – Covid-19 Pre-registration Update
09 April – Welcome for RPS Ethical Decision Making Framework
09 April – Statement on Collection and Delivery Services
08 April – Clarifying Statement – Regulatory Approach
03 April – Covid-19 Temporary Register Now Operational
31 March – Delay in Pharmacist Retention Process 2020
30 March – Our approach to Fitness to Practise during the Covid-19 Pandemic
30 March – Joint statement on Social Distancing in pharmacies.
30 March – Personal Protective Equipment PPE Update to service
27 March – Pre-registration Training and Covid-19
26 March – PSNI GPhC Joint Statement – Pre-registration Training 2020
25 March – Pre-registration Training and Covid-19
24 March – Covid-19 Temporary Register
19 March 2020 – Postponement of 2020 CPD Submission
19 March 2020 – FAQs – Postponement of 2020 CPD Submission
19 March 2020 – Coronavirus (Covid 19) and Pre-registration Training
19 March 2020 – Pre-registration Tutor Course 2020 – Postponement
18 March 2020 – Joint statement from the GPhC and the Pharmaceutical Society NI
03 March 2020 – Joint regulators’ statement Covid19
Information Sources