Regulatory spotlight turned on general practice pharmacist competency

As the number of pharmacists working within general practice has increased, the PDA has noticed an upturn in queries from this group, in line with our predictions.

Thu 27th June 2019 The PDA

Recent developments are causing us some concern and we have decided to publish this statement.

We utilise our expert legal, employment and professional teams to provide the best support possible for members; in many cases we can show that what our member did was justified. From analysis of recent cases we are finding a lack of appreciation for developing the necessary experience and competence required to take on the responsibility for prescribing and particularly diagnosing conditions.

Regulatory organisations and senior NHS bodies in a small number of cases are questioning the competence of the pharmacist to undertake the duties they were involved in. We are therefore advising all members currently involved in or considering a move into diagnosis and prescribing (the highest risk activity both from a patient safety and an liability risk perspective) to dedicate some time to reflecting on their experience and training and identifying which areas they feel competent to practice in and which areas require further training or additional support from another clinician.

We are aware that some opinion leaders in the primary care arena have expressed irritation in the past with the “Boundaries of Clinical Practice” (BCPS) document which we recommend that our members complete before choosing an appropriate level of indemnity cover; they have claimed that filling it in was not necessary. This view may be compounded by the advent of the Clinical Negligence Scheme for General Practice which means that clinical negligence cover is available without individual clinicians having to make any sort of application or declaration of their experience.

The PDA believes that the following incidents we outline suggest that consideration of competence and training needs is essential and would have been time well spent for the pharmacists involved, not only to protect patients but to avoid the stress and trauma which invariably accompany regulatory investigations.

  • Pharmacist returning to general practice after a break of several years referred to the pharmacy regulator by the employer due to allegations of errors and near misses whilst carrying out audits, medicines reconciliation and clinics.
  • Pharmacist working on a locum basis investigated by NHS England for providing evening clinics from a branch practice with no doctor available on the premises for clinical supervision.
  • Pharmacist with limited general practice experience providing patient facing care as part of triage service identified as potential risk to patients by a regulator requiring further investigation.
  • A Pharmacist with no prior general practice experience taken on to provide minor ailment clinics. When asked about an unrelated health issue, an unchaperoned examination took place resulting in a minor problem being erroneously diagnosed. Patient subsequently placed on urgent 2-week wait pathway and diagnosed with cancer.

In addition, we have been asked to advise pharmacists who, having not yet completed their IP qualification (again with no prior general practice experience), want to know if there are any fast-track training courses they could undertake to enable them to prescribe in additional therapeutic areas (e.g. diabetes, respiratory) as soon as possible after they had completed their IP.

There are a variety of emerging roles in primary care which pharmacists are well equipped to take on; however, it is essential that careful preparation is made to build up relevant experience and that robust governance and supervision arrangements are in place whilst competence is gained in new areas of practice.

The risk management training which PDA provides with Morph Consultancy introduces the concept of operating as a consummate professional versus operating as a maverick. We strongly believe that all pharmacists must be able to show, when their actions come under scrutiny that they are working as consummate professionals and they need to adopt working practices which can be relied upon to support such a claim in the event of a regulatory investigation or inquest. The absence of these working practices could support an allegation of maverick behaviour. Such behaviour can also result in mistakes and harm to patients and could seriously damage the profession as a whole, as well as threaten this new area of practice.

Key learning points

  • Complete a Boundaries of Clinical Practice Statement and review it periodically with your clinical supervisor. The ability to present your BCPS when an incident has occurred provides any investigator with tangible confirmation that you have considered and planned your areas of practice and that you reflect on your practice regularly. You can find the BCPS here.
  • ‘Minor ailments’, triage or walk-in clinics are not necessarily a safe and easy introduction to general practice. You may be making undifferentiated diagnoses which is one of the areas of highest risk from a patient harm and liability risk perspective. In order to fulfil this role as safely as possible, an additional clinical practice qualification such as the Advanced Clinical Practice MSc would be desirable.
  • A post-graduate clinical pharmacy diploma (or equivalent) provides some of the key supporting skills required for monitoring and reviewing medicines safely and effectively.
  • If you are asked by your employer to undertake new duties for which you feel you are not suitably skilled or experienced, show your employer your Boundaries of Clinical Practice Statement (BCPS) and use it to justify your concerns about undertaking tasks for which you are unprepared. Always seek advice from your defence organisation before agreeing to proceed, as they can advise based upon experience gained from providing support to their members; treat advice from individuals (however enthusiastic and well meant) with caution.
  • Attaining the IP qualification is just the start and cannot confer all of the requisite knowledge and skills – these are built up over time and it is advisable to continue with supervised consultations for some months after qualification to allow for further development of skills, experience and confidence. Indeed, many NHS organisations require newly qualified non-medical prescribers to undergo a period of preceptorship before they can prescribe unsupervised.


Doctors have to undergo an additional 3 years of training to qualify as a general practitioner; 18 months in hospital and 18 months in a training practice. The PDA believes that if pharmacists are expected to shoulder a wide range of prescribing and in some cases diagnosing responsibilities within emerging primary care structures, then similar levels of training and support should be provided.

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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