PDA urgent guidance for all PDA members following a number of critical incidents involving GP practice-based pharmacists

The PDA defends pharmacists when things go wrong, but it also supports members in ensuring that they practice safely and effectively in order to prevent them from getting into difficulty in the first place through avoiding critical incidents that may harm patients.

Tue 19th November 2019 The PDA

Although the incidents referred to in this communication relate to GP Practice-based pharmacists and those working in online pharmacies, we have decided to send the guidance to all members irrespective of their area of practice.

This is primarily because the principles underpinning safe practice are the same in all sectors of pharmacy and secondly, because we are aware that many community and hospital pharmacists are either currently contemplating a move to GP Practice-based work or are in the process of attaining their independent prescribing qualification.

Our defence team has become increasingly concerned about incidents of unsafe practice which have started to emerge as the number of independent prescribers working in GP practices has risen. We have seen a number of serious incidents recently and are currently in the early stages of dealing with cases where patient deaths have been reported.

We raise as a root cause, the issue of competency once more – serious harm to patients causes untold distress to patients, their families and to the pharmacists involved.

Some of these recent cases are linked in some way to pharmacists prescribing inappropriately or offering poor advice, often underpinned by an assumption of competence which was ill-founded and we cannot impress upon members strongly enough the importance of seriously considering their levels of experience and skill at all times BEFORE making a clinical decision and  issuing a prescription.

If you are about to prescribe a medicine for the first time significant levels of caution should be used, even if you have routinely supplied that medicine previously in a community pharmacy setting – the two settings or activities should not be conflated, or experience in one assumed to automatically confer expertise in the other.

The following are high-risk scenarios:

  • Undertaking prescribing or providing clinical advice for patients who are not physically present
  • Undertaking prescribing for patients without reference to their clinical records
  • Undertaking prescribing for walk-in patients where a diagnosis may be required
  • Prescribing alternative medicines due to shortages (particularly where the medicine to be replaced is a member of a high-risk group such as opiates and/or you are unfamiliar with the use of your chosen replacement). We would suggest checking with a GP or a colleague with relevant specialist experience and ensuring any online or print reference sources that are relied upon are both appropriate for the scenario in which you are prescribing and that you keep a note of those you relied upon.

Risks of online pharmacies

We are also aware of the significant proliferation of online pharmacies offering a choice of POMs for sale and the risks associated with prescribing under these circumstances since the prescriber cannot see the patient or examine them directly. In addition, the prescriber will usually have no access to the patient’s clinical notes. In some cases we are aware that employers in online pharmacies may place expectations upon their pharmacist employees to prescribe high-risk POMs, such as controlled drugs or medicines for conditions that require regular monitoring, without any communication with the patient’s GP, either to check that a medicine has been prescribed before or to advise the GP of the supply made. We would regard this as unsafe and unacceptable practice.

The issue of remote prescribing is deemed so serious that High-level principles for good practice in remote consultations and prescribing have been produced which are co-authored and agreed by a range of healthcare regulators and organisations.

We would urge all members with prescribing responsibilities (wherever they work) to adopt these principles in their daily practice, to regularly reflect on their competency and to contact the PDA should they find themselves expected to adopt practices which they believe are unsafe. [The PDA has produced the Boundaries of my Clinical Practice Statement (BCPS) form to facilitate reflection on competency and we urge all prescribing pharmacists to complete such an exercise at their earliest opportunity. Those who do so only after a critical incident has already occurred will find it of relatively limited benefit in terms of the defence of their reputation].

We would also remind members that whilst the GPhC principles include expectations on the conduct of employers, healthcare professionals are responsible for their own conduct and will be held accountable for their actions regardless of whether the organisational systems and culture within which they work are also deemed unsafe or inappropriate.

You can find a copy of the high-level principles here.  

You can find the earlier PDA article on competency including a link to the BCPS form here.

You can find the PDA response to the GPhC consultation on Guidance for Pharmacist Prescribers here.

If something goes badly wrong

In the event of a critical incident, any subsequent investigation (for example a coroner’s inquest, police or regulatory investigation) will not only examine the conduct of the pharmacist to establish if it caused harm, but also whether the pharmacist was acting within or outside of their competence. In such a situation, the Boundaries of my Clinical Practice Statement (BCPS) could help to demonstrate that the pharmacist had properly assessed their competence prior to engaging in a particular prescribing episode or clinical service and was therefore not working as a maverick in a professional vacuum but as a considered professional.

The authorities will also study carefully the behaviour of the pharmacist AFTER any critical event has occurred. Did the pharmacist demonstrate insight into what they had done, did they take immediate and appropriate action or did they try to downplay an incident or retrospectively create an explanation? What did they say to a patient or the family of a patient, what exact words were used? Were they contrite and what did they write in the initial incident report form?

All of these can be used as evidence in any subsequent investigation. Any remarks made in the immediate aftermath of the incident which demonstrate a lack of insight, judgement or appreciation of the gravity of the matter could be highly damaging to the pharmacist’s prospects. Such comments can cause damage irrespective of what the pharmacist later says in front of a formal investigating body after further reflection.

It is vital that in the event of something serious occurring, pharmacists contact the PDA immediately as expert advice on immediate next steps can be provided.

Related link

Further advice to independent prescribers involved in private online pharmacy services

 

 

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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