How to protect yourself from complaints to the regulator
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Complaints to the regulator are always an unwelcome distraction from the important work that pharmacists do every day, but unfortunately, they are increasingly common, write Daniel Martin and Arabella Dulcie
As recently reported, the General Pharmaceutical Council (GPhC) issued improvement notices to branches of Jhoots Pharmacy following subpar inspections that uncovered various failings.
Improvement notices are one of the tools at the regulator’s disposal when dealing with pharmaceutical businesses. When faced with allegations against individual pharmacists, the GPhC likewise has a range of sanctions it can impose if its Fitness to Practice Committee sees fit to do so.
A cursory look at the regulator’s website shows that since October there have already been 11 hearing outcomes published, of which suspensions of varying lengths were the most common. A suspension prevents a professional for practising pharmacy for up to 12 months and is of the most serious reprimands available other than removal from the register.
Given the serious impact and public nature of GPhC reprimands, it’s key that pharmacy professionals take extra care to comply with the professional standards. We regularly advise professionals facing investigation and set out here what typically happens when the GPhC investigates and how best to safeguard you and your practice.
Types of complaint
Complaints considered by the GPhC can vary from dispensing errors to professional incompetence, such as improper storage of medication impacting its safety, failures to maintain complete prescription records or anything else that may suggest a lack of necessary knowledge, skill or judgement to practice pharmacy safely.
Pharmacy is a high-risk sector where errors can result in grave harm to patients. It is unsurprising therefore that formal sanctions may extend beyond misconduct proceedings. For example, accusations of dishonesty could also be criminal in nature and therefore can result in police involvement. There is also the clear and prevalent risk of the diversion of prescribed substances onto the illicit market, which has resulted in significant prison sentences for pharmacists involved.
Similarly, if serious non-compliance contributes to the death of a patient, this may attract the attention of a coroner who can call the professional to give evidence at inquest. This in turn could lead to a negligence claim.
What happens once a complaint is submitted to the GPhC?
The regulator first vets complaints to assess whether a patient’s safety could be at risk or public confidence in pharmacy could be affected.
The GPhC have the power to arrange a site visit, take witness statements, collect evidence and ask the person under investigation for further information. At this point, the regulator will consider whether to provide the professional under investigation with a copy of the complaint to permit a response. We often have clients approach us for advice only after they have submitted a response. However, early advice is key. It’s important to remember that an investigator will look for inconsistencies however minor, so preparing a watertight response is of utmost importance.
If the investigator believes there is a case to answer, then the matter will be referred to the Investigation Committee. At the core of its decision-making, the regulator must have regard both to the conduct of the professional under investigation and the wider public interest, given that their role is to safeguard the reputation of the sector.
If the matter progresses beyond that, to the Fitness to Practice Committee, there will be a public hearing. Unless there are exceptional factors, usually related to an individual’s physical or mental health, it is rare for a panel to allow an application for anonymity.
What should pharmacists do to protect themselves?
Firstly, it’s key to be familiar with the professional standards set out by GPhC, and to apply them consistently in practice. For example, the requirement to ‘behave in a professional manner’ should influence every interaction. It’s good practice to treat every written communication as if it will one day be read at a hearing.
We would always advise anyone who faces an allegation to seek early advice. It’s often important to retrace steps and gather relevant documentation. Implementing a smart strategy from the outset will reduce the risk of escalation. Membership of a professional body such as the Pharmacists’ Defence Association is always advised as it can ensure you receive appropriate representation.
Prevention is usually better than cure. Pharmacists should protect themselves by keeping up to date with developments in the sector and training, adopting a patient-centred approach, maintaining accurate records and avoiding obvious pitfalls wherever possible. But if the worst should happen, seek help straightaway and get professional advice.
Daniel Martin is a partner and head of the business crime and regulation team at JMW Solicitors in London. Arabella Dulcie is an associate practising in regulatory defence