Introduction

The NPA welcomes the opportunity to comment upon the draft Order.  The NPA agrees that it is important to ensure that the professional regulatory framework is reviewed to ensure that it takes account of pharmacists’ changing professional roles and to ensure the delivery of safe, high quality care.

General Comments

The NPA recognises that the draft Order is one part of an overhaul of regulation of all professions and that there will inevitably be a need for some consistency in approach.  However we do not believe this necessarily translates into a “one size fits all” approach.  In particular recognition should be given to the fact that pharmacy has regulated itself well in the past.  Whilst modern healthcare requires greater co-operation and collaboration amongst healthcare professionals, the distinct roles and responsibilities of different professions need to be recognised.  Against this background, the NPA is approaching this as a true consultation rather than a fait accompli. 

There is a need to maintain a sense of proportionality.  The NPA fully accepts the need to ensure that regulation encourages and promotes a safe and quality service, and ensures that the trust people place in pharmacists and technicians is well placed.  The Order sets out a framework for regulation and the full impact of the Order will be felt in the way the various requirements of the Order are implemented in practice.  However, we hope and trust that the implementation of the Order will strike the appropriate balance between ensuring a safe and quality service on the one hand and the ability to carry out practice on the other.  It should also reflect pharmacy’s sound record on regulation.

The proposed fitness to practise regime – and associated disciplinary and other procedures – will place an additional administrative burden on our members.  The costs associated with this burden will need to be met and must be factored in to ongoing remuneration negotiations.  So too must the indirect impact on costs associated with the increased salary and other benefits that pharmacy technicians will expect in recognition of their increased professional status and responsibility.

The Order must strike the appropriate balance between ensuring a safe and quality service on the one hand and the ability to carry out practice on the other. 

The NPA notes that the Order covers pharmacists and pharmacy technicians in equal measure.  The NPA sees technicians as a very important player in the pharmacy team and by taking on roles traditionally undertaken by pharmacists will be a key component of ensuring that pharmacists adopt new roles into day to day practice.  However, in doing this, pharmacy technicians will, in the vast majority of situations, work under the supervision of pharmacists and as such are a “dependant” profession.  This relationship does not appear to be reflected in the Order.  The clear distinction between the roles and responsibilities of pharmacists and technicians is something that has been taken into account in Scotland where there appears to be some reluctance to accept mandatory registration. 

The Order gives considerable power to the Council to “make rules” pursuant to many of the Articles in the Order. Whilst we understand that there will need to be delegated authority in respect of many of the provisions of the Order and expect that the Council will be diligent in exercising their powers, we believe there should be control over how these powers are exercised.  We would be grateful for clarification on this point.

Article 38 requires pharmacists and technicians to have “adequate and appropriate” indemnity arrangements. Whilst “adequate” is easy to understand as being the depth and breadth of cover and the overall amount of indemnity, it is not clear why the word “appropriate” is necessary.  In the context of the Order “appropriate” could be interpreted in a number of ways and could refer to:

• whether the affected registrant is a pharmacist or pharmacy technician
• appropriateness to the tasks being undertaken or the environment in which practice is being conducted
• the organisation providing the cover

Notwithstanding the possible interpretations, it is difficult to see why the word appropriate is necessary; it seems to us that “adequate” should be sufficient.  We would appreciate clarification on this point.  We should point out that the NPA has particular interest in this point because through its subsidiary, Chemist Defence Association (an insurance company regulated by the Financial Services Authority (FSA)), it is a provider of professional indemnity cover to community pharmacists.

The draft Order permits the Council to make rules about what is an “adequate and appropriate” indemnity arrangement for the purposes of the article and may make rules it considers appropriate in connection with the information to be provided by registrants on their professional indemnity arrangements.  We would be grateful to have further information on how it is proposed the Council would exercise its powers in making such rules.  With respect to the Council, we do not believe they have particular experience with insurance.  And, whilst we fully accept the council will need to be assured practicing pharmacists and technicians have adequate professional indemnity cover and thus have the powers to request this information form insurers, we would have a concern if the information requested went beyond this – to include perhaps information on previous claims record and so on.

We turn now to the questions in the consultation.

Q1. Have you identified any significant elements of the Pharmacy Act 1954 which are not reflected in the draft Pharmacists and Pharmacy Technicians Order?

We have not identified any significant omissions.

Q2. Do you think the change of name of the register from the “Register of Pharmaceutical Chemists” to the “Register of Pharmacists” is helpful? Can you suggest a more suitable name for the register?

The NPA agrees that the change of name to “Register of Pharmacists” would be helpful.

Q3. Do you support the proposal to establish a statutory Register of Pharmacy Technicians for Englandand Walesto be maintained by the Royal  Pharmaceutical Society of Great Britain? Can you suggest a more suitable arrangement for the statutory regulation of pharmacy technicians?

Pharmacy technicians are a key component of the pharmacy workforce and will be vital if pharmacists are to take on newer roles associated with the new contract and other aspects of developing pharmacy practice.  The impact of these changing roles on the profession and the need to make best use of pharmacy staff are at the centre of the current debate on skill mix and will be reflected in regulations pursuant to the Health Bill which is currently making its way through Parliament and which will re-define the supervisory requirements on pharmacists.  Although the debate around supervision is not new, the context in which it is currently being conducted is.  We know that a consultation on technician registration has taken place and that the general view appears to be in favour of mandatory registration of technicians.  However, the views on and appetite for registration amongst those technicians working in community pharmacy is mixed.  On this point we note the different positions being adopted between Scotland and England and Wales.  It is not clear how Scotland intends to take forward the regulation of technicians.  It has been suggested that it would be beneficial to have a common system throughout Great Britain.  In order to achieve this, it seems to us that before moving forward with the proposals, the reasoning behind Scotland’s different positioning needs to be fully understood.

The NPA favours technician registration but our view is that it should be, as now, on a voluntary basis.  It is to be assumed that the current consultation will elicit views from technicians on the appetite for mandatory registration.  However, should support for mandatory registration be less than compelling we believe that registration of technicians should be taken forward at a modest pace to ensure that the technician workforce as a whole recognise and accept its benefits.

Q4. Do you think it is helpful for the Society’s registers to be divided into two parts to distinguish between practising and non-practising pharmacists or pharmacy technicians? Is there any further division of the registers which might be appropriate?

The NPA believes it is helpful to have a split register between practising and non-practising pharmacists.  Having said this, a lot will depend on the definition of “practising” which is the feature of Question 6.  We will return to this in our response to that question.

Q5. Do you agree that it is desirable that those who are recognised as practising pharmacists or pharmacy technicians should be required regularly to demonstrate they are keeping up to date with developments? Can you suggest other, or more suitable, continuing obligations for registrants than the ones already set out in the draft Order?

The NPA agrees that it is desirable for practising pharmacists and technicians to demonstrate regularly that they are keeping up to date.  We believe that the most appropriate way for doing this would be through the maintenance of a CPD portfolio.  This portfolio should be relevant to the field of practice within which the practitioner operates.  We note that Article 39 gives the proposed CPD Committee the powers to determine the form and content of the CPD requirements.  We believe that these should be proportionate and in line with what is necessary to strike a balance between ensuring competence but not so onerous as to interfere with day to day practice.

Q6. Do you consider the definition of practising contained in the draft Order adequate? If not, how would you suggest that the definition might be improved?

We believe that the definition given in the proposed order is too narrowly drafted.  The proposed definition contrasts with that currently used by the Society:

A practising pharmacist is a member or fellow of the Society who undertakes any work in, or gives advice in relation to, the science of medicines or the practice of pharmacy or healthcare.  The frequency and location of practice does not matter.

The proposed definition is narrower and restricts practising as undertaking any work or giving advice in relation to

• the dispensing or use of medicine
• the science of medicines
• the provision of healthcare

We recognise that the Order has been drafted against the background of ensuring patient safety and so the definition is in large part predicated on patient contact.  The pharmacy degree is a broad science degree and therefore covers a wide range of topics around the science and practice of pharmacy and the source, preparation, action and use of medicines.  Post registration, pharmacists may find themselves practising in situations that will fall outside the proposed definition – for example in management, administration, marketing and PR or journalist positions.  We therefore believe that a wider definition is needed and would suggest that, in line with the current definition, the proposed definition in the Order be expanded to include the undertaking of any work, or giving advice in relation to, “the practice of pharmacy”.

Q7. Do you agree that the proposal to endorse registration certificates with the part of the register on which the registrant is entered provides an element of added public protection? Bearing in mind the penalty/sanctions contained in articles 20 (for pharmacists) and 29 (for pharmacy technicians) of the draft Order, do you agree that public protection considerations are adequately addressed and that the administrative convenience and expense arguments are justified?

Having a certificate indicating practising status may give consumers some confidence, but the use of certificates is an expensive and inefficient means of providing this assurance.  A certificate in itself is no measure of actual status and is therefore unlikely to add much in the way of public protection.  There will be an administrative workload and expense in ensuring that up to date certificates are in issue.  We need to ensure that any measures are cost effective and necessary as any costs will increase the cost of services to patients.  In our view the correct way forward is through the development and use of an electronic register.

Q8. Do you consider that electronic versions of the pharmacists’ and pharmacy technicians’ lists which can be updated continuously are better than an annually published paper list? Can you suggest any other more accessible and economic way in which the lists could be presented?

The NPA agrees that electronic registration lists are the most appropriate way forward and are preferable to a paper list.  However, the electronic list will need to be subject to regular updates – in our view carried out on a daily basis.  In addition to any list however, there will need to be some means of identity checking so that those engaging pharmacists and technicians know that the registration details provided correspond to the individual providing them. 

So, alongside this question, consideration needs to be given to the process by which those operating pharmacies will be able to keep track of pharmacists and pharmacy technicians’ registration status.  Community pharmacy is a dynamic sector relying heavily upon a peripatetic workforce.  Registration status checking will therefore need a robust IT system capable of delivering required information on a timely basis.  And the onus for checking should not be left exclusively to the engagor; those seeking employment or engagement must be prepared to comply with any new arrangements. The system will create an administrative burden for those engaging pharmacists which will need to be reflected in the costs associated with providing the service.  We refer here to earlier comments on the need to adopt a proportionate approach.   

It is our view that given the large number of issues associated with how a system of registration and identity checking will be administered in practice, this should be the subject of a separate consultation exercise. 

Q9. Do you support the proposals for the collection of additional information by the Registrar contained in the draft Order? Do you think there is any other information which the Registrar could usefully collect as part of the registration process?

We are confused by the term “additional information”.  We note that the Order gives power to the Society to collect “in particular” the name of a registrant and his or her home address and detail of fitness to practise information.  This seems to us to be sufficient to support registration.  We would be grateful to have detail of what additional information might be considered useful in this context before commenting further.

Q10. Do you think the link between registration as a pharmacist and membership of the Society should be removed from the draft Order?

Yes we do.  The draft Order is about regulating pharmacy in the context of a safe and quality service.  As we see it, registration as a pharmacist – and inclusion in Part 1 of the Register – will be evidence of a pharmacist or technician being fit to practise.  We do not see how membership of the Society adds anything to this and can therefore see no utility in the maintenance of any link between registration and membership.

Linked to this question – and to the definition of practising – is the need to be able to differentiate the status of different groups of pharmacists.  At present, MRPharmS is synonymous with being a practicing pharmacist.  The introduction of a split register – between practising and non-practising will require the introduction of a new way of differentiating pharmacist status.

Q11. Do you think an express legislative reference to consideration of “attitudes and behaviours” as part of the process of determining whether an applicant is “appropriately qualified” would be helpful? How would you consider these attitudes and behaviours could best be assessed?

The NPA is concerned about the potential inclusion of the consideration of “attitudes and behaviours” in the pre-registration process.  Consideration of attitudes and behaviours will be totally subjective and thus difficult to implement in practice.  We understand that the purpose of this aspect of the Order is to ensure that pharmacists and technicians who lack the appropriate attitudes and behaviours are not put in front of patients.  Whilst outliers are fairly easy to envisage, we have a concern that the boundaries of what constitutes an unacceptable attitude or behaviour will be extremely difficult to define.  We have concerns that potential registrants who may happen to have challenging views – either professional or otherwise – may fall outwith what may be considered “acceptable” by any interview panel and thus find themselves excluded form the profession.  Such a situation would be undesirable.  Professional growth and innovation is predicated upon the ability of individuals or groups to challenge existing boundaries and we have concerns that an over-zealous approach to “attitudes and behaviours” may stifle this.   We understand that frameworks for objectively assessing these criteria are available but we would like to have more detail on the proposals here to ensure there is an absence of bias or prejudice from the process before we could support this proposal.

If any person was rejected registration on the basis of their “attitude or behaviour”, there would need to be explicit reasons given, coupled to an appeal process.  Further, the consideration of attitudes and behaviours would put the UK process out of kilter with European legislation where no such process exists.

Q12. Do you agree that the emphasis in the draft Order on ensuring that a registrant’s fitness to practise remains unimpaired strengthens the public protection function of the Society? Can you suggest a more effective way of fulfilling this objective?

The NPA agrees that the emphasis on fitness to practise in the draft Order strengthens the public protection function of the Society.  However, as we have already said, whilst we support fully a robust fitness to practice regime, we believe any requirements must be proportionate.

Q13. Do you support the proposal to extend the powers of the Society to collect information from other people related to the fitness to practise of its registrants? Are there any further powers you feel the Society should have in respect of fitness to practise issues?

And

Q14. Do you think that reference to a court in these circumstances is the most appropriate approach? Do you agree that 14 days is an appropriate time limit to trigger action?

Whilst we do accept the need to have robust fitness to practice procedures, we do have concern about the powers this proposal would give to the Society.  Before we are able to comment in an informed way on this proposal we would need further information on how and in what circumstances these powers would be exercised.  On the information available to us, we believe the powers go too far – to the extent of serving a Court Order on affected individuals.  We also have concerns about what can happen to any information collected by the Society.  For example, could the Society then be required to disclose any information gathered in response to a request under the Freedom of Information Act?

We are unable to comment in any more detail because it is unclear as to the extent to which these powers would be used and under what circumstances. It may be that these powers are necessary, but if they are and the proposal is adopted, we would suggest that the 14 day response time is too short.  We would suggest that 28 days is a more appropriate time period.

Q15. Do you support the proposal to extend the powers of the Society to share information on a registrant’s fitness to practise where they feel it is in the public interest to do so? If not, how else might public interest and protection considerations be satisfactorily addressed?

The NPA supports this proposal.

Q16. Apart from the criteria proposed in article 48 of the draft Order, can you suggest any other grounds on which a registrant’s fitness to practise may be adjudged to be impaired?

We cannot think of any other grounds.

Q17. Do you support the proposal that the Registrar should be able to refer cases directly to the Health Committee or Disciplinary Committee and ask the committee to consider the issue of an interim order where circumstances dictate the need for such action?

We note that the proposal is to give the Society powers in “prescribed” circumstances.  We support this proposal in principle on the basis that there will be times when an immediate referral – and interim order - is needed.  However, we would reserve final judgment until we have seen what the prescribed circumstances are.  The general position is, and should be, that referrals should come through the Investigation Committee.  This process should only be used in extremis where urgent action is needed to protect the public.  

Q18. Do you support the proposal to replace the current Statutory Committee with the group of new statutory committees? Do you think the right titles have been selected for the new committees? Do you think there is a need for any further statutory committees and, if so, what are your reasons for thinking this?

We support in principle the proposal to replace the current Statutory Committee with the new committees.  The consultation contains only scant detail on the role and remits of the Committees, so fuller comment cannot be made before we have more detail of the roles and remits of the different Committees and how they will work in practice.  Clearly the replacement of a single statutory committee with six new ones (although some of the committees will subsume the roles of some existing committees within the society) will result in increased cost.  This once again flags the need to maintain proportionality in implementing the proposals.  The costs associated with the new regulatory regime will fall on the membership.  Given that membership fees will be paid by individual pharmacists and technicians, the scope for increasing the fees is limited.  We would welcome sight of any cost estimates associated with implementation of the new regulatory framework.

We note the proposal to introduce an Investigation Committee.  We believe that this Committee should adopt an active role in assessing and filtering cases to ensure that only those cases that should be are referred on to the Disciplinary or Health Committees.  At present, there is a tendency for the Legal Infringements Committee to refer virtually all cases to the Statutory Committee.  This in turn puts pressure on the Statutory Committee and creates delays in cases being heard.

Consideration will need to be given to the make up of the new committees.  Of particular importance will be the need – in the case of cases related to practice matters - to include professional members who have relevant experience in the field of practice to which the complaint or investigation relates.

We have not identified any omissions from the proposed list of committees.

Q19. Do you support the proposal to make the Education Committee one of the Society’s statutory committees? Do you agree that this will clarify the previous uncertainty about the precise derivation of the Society’s education powers?

We support in principle the proposal to make the Education Committee a new statutory committee.  However, our ability to comment is limited given the lack of detail provided in the consultation on the role and remit of this committee.

Q20. Do you agree that the functions proposed for the Continuing Professional Development Committee are appropriate? Can you suggest any other functions that the CPD Committee might reasonably fulfil?

The functions proposed for the CPD Committee, as set out in the document, seem reasonable.  However the document points out in paragraph 40 that the functions of the CPD Committee will be determined by Council.  It is therefore difficult to comment, in anything other than outline, on the proposed functions.

Q21. Do you think that the proposal to have a Registration Appeals Committee is sensible? Do you think it will provide a more efficient route to resolving most appeals or slow down the whole process of securing a just resolution of outstanding registration issues?

The Registration Appeals Committee is concerned simply with appeals against registration decisions and stands apart from the appeals process for decisions taken by either the Health Committee or Disciplinary Committee.  We cannot see the logic of splitting appeals in this way.  We are particularly concerned with the proposal that a further appeal of any decision by the Registration Appeals Committee be referred to the County Court.  We do not believe a County Court would have the necessary skills or expertise to deal properly with appeals in this specialist and complex area.

Q22. Is there anything else about the contents of the draft Order on which you would specifically like to comment?

Article 55

If a pharmacist or technician has been struck off, by Article 55, they cannot apply for restoration for a minimum period of five years.  This contrasts with the current position where there is no time limit.  Why has a time limit now been introduced? And why five years?

Article 56

Article 56 specifies an appeal period of 28 days.  This contrasts with the current period of three months.  We cannot see any reason for the shortening of this period, particularly given the fact that additional powers would allow – for example – for the suspension of pharmacists where necessary to protect the public.  A 28 day appeal period is far too short a time for affected pharmacists to prepare a full appeal.  We believe that this should be extended to the three months currently allowed.