The General Pharmaceutical Council has published Acceptance criteria. This is intended to give guidance on matters which will be investigated when a concern is raised. Here are some bullet points from the criteria:
Individuals
- Not all departures from standards will call into question a professional’s fitness to practise, however, any matters referred to investigation should be able to be attributed to a serious or persistent departure from one or more of the standards.
Premises
- Where an issue appears to engage both professional and systems related issues, and is sufficiently serious, it will be opened for investigation in order to ensure that both the professional and systems issues can be looked at in a holistic manner.
Potential actions at triage
- In some cases, it can be obvious straightaway that a concern does not need to be investigated or referred to the Inspections team because it does not involve the sort of issue which could call into question a pharmacy professional’s fitness to practise, or indicate a serious failing in how a pharmacy is operating. We will normally close these matters with no further action, or possibly with signposting to another organisation.
- If a concern relating to an identified pharmacy professional or pharmacy premises is closed, a record of it will be kept within our internal case management system in accordance with our retention policy. This does not mean that an individual has some sort of negative finding against them, and we will not normally disclose the fact or detail of such closed concerns with any third party. However, it may be something that is considered if any future concerns are raised in relation that pharmacy professional, or pharmacy, and we may need to take into account such previous concerns if it appears that they form a pattern of similar issues.
Concerns that will be accepted
- When considering all concerns, we will first consider whether there may have been a breach of the relevant standards. If so, we will then go on to consider how serious any breach may be, and whether there are risks to the public, or risks to maintaining public confidence in the profession should a matter not be opened. When considering these matters, we will also bear in mind that part of our role as a regulator to declare and uphold proper standards, which may mean that action is necessary even if there are no longer continuing risks to patients.
Individual pharmacy professionals
Misconduct
- Misconduct can relate to both personal behaviour as well as professional issues such as mistakes made at work. Not everything that someone may do wrong will amount to misconduct, as the law requires an issue to be especially serious. Therefore, the fact that someone may have made an error of judgement, or demonstrated an isolated instance of negligence, does not necessarily mean that we will open a formal investigation. When we are considering whether an issue raised with us could be misconduct, we will ask ourselves:
- is the issue serious; for example, could it reasonably be viewed as disgraceful, outrageous or deplorable?
- is the issue something that seems to be part of a pattern of similar or related matters?
- if the issue is an isolated professional error, is it one which is particularly serious, such as being reckless or ignoring high risks?
Convictions
- The fact that someone has been convicted, cautioned or otherwise dealt with for a criminal offence does not necessarily mean that further regulatory action is necessary. Our role is not to punish people for a second time, and we recognise that that the criminal justice process can be sufficient to suitably deal with low level matters.
- We do, however, also have to bear in mind that more serious offences, or those relating to particular types of behaviour, can undermine public trust in the profession and therefore require further action.
Adverse health
- A fitness to practise issue will only arise where someone’s health condition is affecting their ability to provide services safely, and where there are inadequate measures in place to manage the impact of their condition on their work or on themselves.
Premises and systems
- Isolated dispensing errors not involving high risk medicines, and which have been appropriately dealt with, will not be likely to require inspection activity. Neither will issues which represent customer service type complaints.
- Matters not likely to require further inspection activity include staff members using reasonable professional judgement, even though the patient may be unhappy with the outcome.
Right of review
- Anyone who is dissatisfied by the decision to open or not to open an investigation or make a referral to the inspections team may request a review of that decision within 21 days.