The Pharmaceutical Journal
Vol 280 No 7485 p50-51
19 January 2008

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• Industrial pharmacists (4)
• Community pharmacy
• Responsible pharmacist (2)
• Package design
• The profession (2)
• The Society (3)
• Registration (2)
• Statins
• Retirement (2)
• Onlooker
• Caption competition

Letters to the Editor

Responsible pharmacist

Potential confusion

From Mr P. S. Rhodes, MRPharmS, and others

We would like to raise an issue arising from the “responsible pharmacist” consultation that appears to have been overlooked and which we consider could lead to confusion within the profession.

Within unlicensed pharmacy aseptic units in the hospital service (which operate under Section 10 Exemption to the Medicines Act) there is already a well established definition of “responsible pharmacist” in use that does not fit easily with the definition proposed in the current Department of Health consultation. The definitions of “responsible pharmacist”, and of the associated terms “authorised pharmacist”, and “chief pharmacist”, as stated in the ‘Quality assurance of aseptic preparation services’ national standards book, are given below:

Responsible pharmacist The pharmacist responsible for all aspects of the services within an aseptic preparation unit. The duties of the responsible pharmacist include the approval of all systems of work and documentation used in the unit. This person is also an authorised pharmacist.

Authorised pharmacist The person designated in writing by the responsible pharmacist to supervise the aseptic process and release the product for use.

Chief pharmacist The pharmacist responsible for the pharmacy services within a corporate body. In the context of this [national standards] book, for aseptic facilities not under the direct management control of the chief pharmacist, this responsibility lies with the most senior pharmacist.

‘Quality assurance of aseptic preparation services’, now in its fourth edition, is the recognised “defined NHS guidelines” for all hospital aseptic units in the UK which do not hold Medicines and Healthcare products Regulatory Agency manufacturing licences, ie, most NHS units.

The need for unlicensed aseptic units to operate to these standards, and therefore to use the definitions above, is enshrined in the guidance issued to the NHS in 1992 by the then Medicines Control Agency (now the MHRA) following the removal of Crown Immunity from NHS hospitals.

Within hospital aseptic units the responsible pharmacist has overall responsibility for the operation of the aseptic unit and the aseptic service whether he or she is present or not. The authorised pharmacist is personally responsible for the running of the unit during the time he or she is supervising the aseptic process and for the products prepared and released for use by him or her.

Without a change in primary legislation to amend the Section 10 Exemption to the Medicines Act 1968, the supervising pharmacist must be present while aseptic preparation is taking place, and therefore the current consultation to allow the responsible pharmacist to be absent would be illegal in this situation. This is the opinion of the MHRA and of the national NHS Pharmaceutical Quality Assurance Committee.

Any unit found to be in breach of this leaves itself or its trust liable to prosecution or, more likely, be given a critical failure during a QA audit, requiring immediate correction or risk a forced closure of the unit.

We recognise that hospital aseptic units are in the minority when compared with the number of community pharmacy and hospital dispensaries, and therefore would be willing to amend our definition so that “responsible pharmacist” becomes “accountable pharmacist” to avoid confusion with the definition used in the DoH consultation.

However, we intend to leave “authorised pharmacist” as it is, since “authorised” implies that this pharmacist is suitably competent to supervise the aseptic process and has the additional knowledge and skills necessary to do so, and is not merely a registered pharmacist as defined in the current “responsible pharmacist” consultation.

Should the current consultation approve the new definition of the responsible pharmacist, we will inform NHS hospital pharmacy aseptic units accordingly to avoid any confusion with the existing guidance as discussed above.

Peter Rhodes
Chairman
David Lovett
Vice Chairman
NHS Pharmaceutical Aseptic Services Group
Alison Beaney
Editor
Quality Assurance of Aseptic Preparation Services

Too many fanciful visionaries

From Mr D. R. K. Brown, MRPharmS

I would like to thank and congratulate Steven Curtis for his article on the “responsible pharmacist”, (PJ, 8 December 2007, p652). This is the first sensible article I have read on the subject and I wholeheartedly agree with him. There are too many fanciful visionaries in high places, whose radical and often ridiculous ideas for the future of pharmacy could be the ruin of our profession.

Our current workload is super-demanding; so the last thing we need is yet another plethora of new roles to perform. What is the point in spending years training for and learning to practise one job, only to delegate it and take on someone else’s role in turn?

If I had wanted to live in a consultation room I would have become a doctor. If I had wanted to take blood samples and give flu jabs I would have become a nurse. I just want to work in my dispensary and behind my counter like I envisaged when I embarked on this career.

I have yet to encounter any technician to whom I would feel confident delegating my checking role.

Remote supervision is a disaster in waiting. We need more pharmacists in each location, not fewer.

So, if Mr Curtis wishes to stand for President when the Royal Pharmaceutical Society’s replacement professional body is formed, I for one will vote for him. We need level-headed people with their feet on the ground to direct the way forward.

D. R. K. Brown
Nuneaton, Warwickshire

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