Most pharmacy professionals can demonstrate the ability to do their job safely and effectively, and are therefore deemed “fit to practise”. They can remain on the Register of the General Pharmaceutical Council (GPhC), the pharmacy regulatory organisation of Great Britain, without restrictions. Being fit to practise means maintaining appropriate standards of proficiency, being of good health and good character, and following principles of good practice, as set out in the regulator’s various standards and guidance and other relevant best practice advice.
Fitness to practise can be impaired for several reasons, including misconduct, lack of competence, ill health and conviction of a criminal offence. Reacting to complaints raised by the general public and others is an important part of the GPhC’s role — and the number of complaints the GPhC received increased by 23% in 2013–2014 compared with 2012–2013.
The good news for pharmacists is that, while all complaints are investigated by the GPhC, two in five do not even leave the starting blocks because they fall outside its jurisdiction. These include allegations that are more than five years old, unless there is an issue of public protection or interest, and the following:
- claims of compensation;
- concerns about health professionals who are not registered with the GPhC;
- employment issues, for example, hours of work, employment contracts;
- faulty products, for example, hairsprays;
- contractual issues, for example, hours of opening, charges for private prescriptions;
- minor customer service issues.
How an inspector investigates a complaint will vary depending on the individual facts of a case. As well as speaking with the person who made a complaint, the inspector will usually talk to the pharmacist or pharmacy technician against whom the complaint has been made and any witnesses to the alleged incident. An investigation will also include a visit to the pharmacy premises where this incident took place. In serious cases, the registered professional, employees and pharmacy owners may be formally interviewed under caution by one of the inspectors, and evidence seized.
All cases are assessed against threshold criteria, which are used to decide whether to progress the complaint to the next stage: the Investigating Committee (IC). If it is not necessary to refer the complaint to the IC, the pharmacist or technician will receive a written explanation of the decision from the GPhC and, where appropriate, he or she may be directed to other organisations that can provide support. A registrant will also be notified in writing if a complaint is referred to the IC.
The IC is an independent committee, appointed by the GPhC, whose members meet in private to consider the written documentation provided by inspectors. There is no oral hearing at this stage. Using stated referral criteria, the IC can decide whether to close the case with no further action, issue a warning or letter of advice, or refer to a fitness-to-practise committee for further sanction.
Fitness-to-practise committee hearings are conducted in public by an independent panel, usually made up of three members (a chair, a registrant member and a lay member), and oral evidence can be given.
In the most serious circumstances, the IC registrar has powers to refer cases directly to the fitness-to-practise committee, and it can ask for ‘interim orders’, where registration can be suspended or conditions imposed on a registrant’s pharmacy practice immediately.
Fitness-to-practise committees use indicative sanctions guidance to help with their decision-making to ensure that decisions protect the public rather than punish the registrant. In a recent determination, for example, the committee was reminded that a finding of misconduct in the past does not necessarily equate to impairment of fitness to practise today.
The committee was also told to take account of the insight of the practitioner into the source of his misconduct, any remedial steps taken, and the risk of recurrence of such misconduct.
During a hearing, the fitness-to-practise committee must first decide if the facts presented about the incident are more likely to be true than not true. Once that decision has been made, the committee must decide if this means that the pharmacist or pharmacy technician is impaired in his or her fitness to practise. The committee will then consider any mitigating factors and agree on what action, if any, to take.
A general principle for applying sanctions is that the committee must consider whether or not the individual’s conduct or behaviour:
- represents an actual or potential risk to patients or to the public;
- has brought or might bring the profession of pharmacy into disrepute;
- has breached one of the fundamental principles of the profession of pharmacy;
- shows that the integrity of the registrant can no longer be relied upon.
Mitigating factors include full admission and cooperation from an early stage and throughout the investigation, with the individual demonstrating insight into the problem or incident. Other factors include repaying misappropriated funds and taking steps to prevent actual harm and to remedy or prevent recurrence of the misconduct. Additionally, those individuals with ill health or problems with addiction should demonstrate insight into their condition, be compliant with a treatment regimen, and provide evidence of voluntary regular attendance at recommended support services or lengthy abstinence from addictive substances.
Depending on the decision of the fitness-to-practise committee, a pharmacist or pharmacy technician may: receive a warning, the details of which should be recorded in the Register; be suspended from the Register for up to a year; have conditions imposed on his or her registration for up to three years; or be removed from the Register completely. The fitness-to-practise committee can also recommend that the GPhC initiates criminal proceedings against the individual, or require that he or she undergoes a medical examination as a condition of the ruling.
It currently takes an average of almost five months to close a fitness-to-practise case from the date a complaint was received. Case complexity will affect this time and, during 2013–2014, the average age of all unclosed cases was over nine months, with 29% of open cases being more than a year old. The GPhC has set its fitness-to-practise team a target of closing 95% of cases within 12 months.
The right to appeal
Registrants can also appeal some of the decisions made during the fitness-to-practise process. This includes decisions to remove or suspend the person from the Register or prevent a person from making further applications to be restored to the Register. Additionally, the registrant can appeal to alter any conditions placed on his or her registration.
An appeal has to be filed with the High Court (or lodged with the Court of Session in Scotland) and served on the GPhC within 28 days of the date the written notice was sent, or longer if the court allows it.
Changes to guidance
The GPhC has recently run a consultation about new draft guidance on fitness to practise. The guidance proposes removing the current list of mitigating factors. Instead, the committee may consider the circumstances of the incident and the behaviour and actions of the registrant and decide whether these could be considered mitigating or aggravating factors. Additionally, the guidance provides specific advice for cases involving sexual misconduct, dishonesty, duty of candour and raising concerns.
Once adopted by the GPhC, the new guidance will be used by the fitness-to-practise committees. However, because the fitness-to-practise committee is independent of the GPhC, it is not bound by the indicative guidance and will not be forced to follow the new guidance.
Pharmacy professionals found to be involved in incidents of sexual misconduct should usually be removed from the Register, unless there are clear mitigating circumstances.
Although all acts of dishonesty are considered serious, there should not be a presumption of removal from the Register. However, in cases where an individual acted dishonestly while carrying out their role as a pharmacy professional, or if the case involved intentionally defrauding the NHS or an employer, falsifying records, or dishonesty in clinical drug trials, removal should be considered as the only proportionate and appropriate sanction.
Duty of candour
The committee should not consider a registrant’s attempt to be candid with or apologise to a patient as an admission of misconduct. However, the guidance recommends sanctions at the upper end of the scale if a pharmacy professional is found to have taken deliberate steps to avoid being honest with a patient or carer, or to prevent someone else from being candid.
The committee should consider sanctions at the upper end of the scale, including removal from the Register, when cases involve a failure to raise concerns when patient safety is at risk.