The Guild of Healthcare Pharmacists welcomes the opportunity to comment on the Impact Evaluation of the Responsible Pharmacist Regulations and we are grateful to the Royal Pharmaceutical Society and the Professional Forum of the Pharmaceutical Society of Northern Ireland for the invitation as a key stakeholder to participate in all stages of the project.  It is recognised that of the sample of 1845 Pharmacists affected by the regulation responding those from hospital represented around 22% and primary care 7%.  Our view is that the Responsible Pharmacist Regulations have clearly defined and clarified the legal accountability, but this report provides an opportunity for the profession through its professional bodies and membership organisations to empower the profession to implement it successfully in practice.  

The first major point noted from the report is that those pharmacists working in hospitals or primary care were more likely to be content with most of the elements of their job and there were higher significant differences from the total for the job satisfaction overall, levels of responsibility, amount of support and training and the frequency and length of breaks.   In primary care, there was also a significant difference in satisfaction with the number of hours worked.   In both sectors, there was even a higher significant difference compared to community pharmacists with regard to satisfaction with pay, although there is no breakdown by band of staff involved.  The difference appears even more pronounced when you exclude independent pharmacies and compare the situation to large multiples and supermarkets, which similar to the managed sector employ large numbers of pharmacists.  They raised particular concerns on the “commercialisation” of the pharmacist role and the recent introduction of non-pharmacy managers.  From a workload perspective the majority of hospital pharmacists who act as responsible pharmacists spent less that 25% of their time in this role.

It is significant to GHP that may hospital pharmacists learnt about the responsible pharmacist regulations through membership organisations and/or staff meetings rather than employers.  Both staff side organisations and NHS Employers should however take credit for the suggestion in the report that hospital pharmacy and the pharmacists employed have a high level of confidence in the safety systems, appear free to undertake more clinical roles ensuring they feel they operate in a challenging and supportive working environment with the above high levels of job satisfaction.  This is perhaps best highlighted in the fact that less than a quarter of hospital pharmacists feel the need to be more professionally empowered compared to over half of those in community pharmacy and two thirds of those in supermarkets.

In the original consultation, GHP suggested a three tier model of Superintendent/Chief Pharmacist responsible for the overall broad professional, operational and strategic aspects of the whole service delivery, the Responsible Pharmacist who implements safe systems of supply and holds clinical accountability for those systems and a duty pharmacist, who is present in the dispensary and responsible for the daily supervision and individual transactions.  Whilst this model was not accepted the process of consultation was useful in that it provided an opportunity to highlight to both the Department of Health and the regulators how existing medicines legislation was unfit for purpose in relation to hospital practice and the need to address the whole act in relation to hospitals.  These problems raised in the consultation were addressed in the short term by joint working involving professional bodies, the regulators at the RPSGB and MHRA, the Department of Health and GHP representing staff side that provided an interim set of guidance.

In practice, hospitals have the opportunity to undertake the sale and supply of medicines to patients within its own “corporate body” under exemption of the business of the hospital granted by Section 55 of the Medicines Act.  Hospital will only need to have a responsible pharmacist in place to undertake supplies outside of the employing organisation, which for most hospitals is a minority of the time if at all.  This of course highlights an ethical dilemma in that if the regulations through specific accountability are about increasing safety and improving clinical freedom surely the public would expect similar if not higher standards in hospitals, which often have more seriously ill patients, receiving more complex medicines that can be specifically prepared and often manipulated within those hospital pharmacies prior to supply.

We do have some areas of disagreement with the conclusions drawn in the report. The initial one being that there appears to be a lack of understanding of the above legal position in relation to the sale and supply of medicines in hospital such that one conclusion is one of a poor operational and strategic fit between the regulations and the needs and/or structures of hospitals of the role of the responsible pharmacist.  There is even a suggestion from an option raised at the stakeholder meeting that the regulations be disapplied.  As we have discussed the concerns we have relate to the Medicines Act rather than RP regulations.   In reality working as a responsible pharmacist has not change the role in a hospital pharmacy as highlighted by nearly two thirds of hospital pharmacists in the survey stating it had made no difference to their practice.  It is not clear how disapplying the regulations would be enacted in hospital pharmacies that are operated, due to differential tax reasons, by non-hospital suppliers or commercial companies who would have the regulations to protect the public in community pharmacy but not hospital pharmacy should they be disapplied?

There is also in our view a misconception that the Responsible Pharmacist is perceived as a managerial role rather than legal and professional role.  This is highlighted by the report as conflicting with traditional patient safety practices and hierarchies in hospitals and is further evidenced in the underlying theme that the responsible pharmacist needs to directly manage or “assert their control over other pharmacists” and being responsible for someone else’s professional practice and every detail of each transaction that take place within the registered pharmacy and even at ward level.  This again is perceived to cause difficulties in hospitals, which have multiple pharmacists and technicians involved in the supply process working within a multi-professional and multi-disciplinary team environment with agreed standards and systems and the choice of  access to varying levels of experience and expertise.

We feel that moving forward and spending less time on existing regulation but investing in work to provide a clearer and modernised definition of supervision would greatly assist in clarifying the responsibility of the whole pharmacy team and equally importantly how a system of clinical supervision as well as the supervision of transactions ensures safe improved practice and better pharmaceutical practitioners.  There is in our view little or no point in discussing absence and its role in relation to patient care without moving forward to supervision.

We do agree with the report on the need for the profession and regulators to further clarify the role of superintendent in relation to responsible pharmacist.  This should be undertaken in an enabling rather than detailed and restrictive manner enhancing the professional autonomy of the practicising responsible pharmacist, whilst ensuring that accountability and responsibility equates to professional control.  This again should be defined as a professional and legal rather than pure managerial relationship as each pharmacist is an independent professional practitioner. There should normally be no circumstance for a superintendent to over-rule and direct the professional practice of the responsible pharmacist.

The focus on empowerment is important as it is clear that in some areas there has been an over emphasis on the process and precision of the supporting procedures, detail of the regulations and sadly who is personally liable should systems fail.  It may be appropriate that professional discretion in the interests of the patient needs to be encouraged within the broad context of professionally agreed standards and frameworks, capacity plans and individual practitioner credentialisation.   It may also be worth revisiting the powers already within the regulations to determine the experience and competencies required by a responsible pharmacist, particularly in the case of novice practitioners before a pharmacist is able to undertake this role.