The General Pharmaceutical Council is the regulator. It has its own Inspectorate, currently employing about 30 inspectors. Inspectors visit pharmacists to monitor standards and investigate complaints against pharmacists. Every pharmacy is likely to be inspected once every five years and if an inspector considers it necessary, more frequently. An inspector may start formal disciplinary proceedings if a complaint is received, if there is persistent non-compliance, or if there are significant risks to patients.
Complaints investigated may be against registered pharmacists, registered pharmacy technicians, or pharmacy owners. They may be made by patients, members of the public, other healthcare professionals, primary care organisations, or other regulatory and enforcement authorities. Investigations may be protracted. The Council aims to complete investigations within six months.
In the course of an investigation an inspector is likely to interview the complainant and any witnesses, interview the registered pharmacist, registered pharmacy technicians or pharmacy owner, and will visit the registered pharmacy premises. The inspector may need to take witness statements from patients or other members of the public. Interviews of registered pharmacists, registered pharmacy technicians or pharmacy owners may be carried out under the provisions of the Police and Criminal Evidence Act 1984 i.e. under caution, and recorded. Inspectors may seize evidence in the course of their investigations. They have a number of legal powers under the Pharmacy Order 2010, including powers to :
- investigate allegations that a registered pharmacist or registered pharmacy technician's fitness to practise is impaired
- enforce the standards set by the General Pharmaceutical Council
- secure compliance with the Poisons legislation
- secure compliance with the provisions of the Medicines Act 1968
- enforce provisions of the Veterinary Medicines Regulations.
After all evidence is gathered, a decision is made as to whether or not to refer the matter to the Investigating Committee. If a complaint is not referred to the Investigating Committee the registered pharmacist, registered pharmacy technician or pharmacy owner will receive advice on how to improve their practices and the complaint will be recorded and may be taken into account in the event that further complaints are received.
If a decision is made to refer an allegation to the Investigating Committee, the person concerned must receive the following:
- a notice of referral to the Investigating Committee
- copies of all documentation, including summaries or relevant information to be placed before the Investigating Committee
- details of the criteria that will be applied
The notice of referral must:
- particularise the allegation
- set out any recommendations for disposal of the case made by the Registrar
- specify a date for the Investigating Committee meeting where they will consider the allegation which must be no less than 28 days after the date of service of the notice of referral
- inform the person of the Investigating Committee's powers
- invite the person to indicate no later than 21 days after the date of service of the notice whether the particulars of the allegation are admitted or denied
- invite written representations from the person no later than 21 days from the service of the notice
- inform the person that any of their written representations may be shown to the informant, if any, for comment
- inform the person that the Investigating Committee may seek further information from any source for the purposes of carrying out its functions, including from the person's employer.
The Investigating Committee is a screening committee which meets in private to consider all the available evidence, including the response of the registered pharmacist, registered pharmacy technician or pharmacy owner to the allegation, and to decide whether or not the allegation should be considered by the Fitness to Practise Committee. It may direct that further investigations be undertaken and may take specialist and legal advice. Its powers include powers :
(i) to issue a warning to the person concerned
(ii) to issue advice to the person concerned
(iii) to issue advice to any other person or body involved in its investigation
(iv) to dismiss the case
(v) in relation to a health allegation, to require the person concerned to undergo a medical examination
(vi) to agree undertakings
(vii) to refer the matter to the Fitness to Practise Committee
(viii) to initiate criminal proceedings
The person concerned must be informed of the decision made by the Committee no later than 10 days after the date which the decision was made. The notice must include the reasons for the decision and be accompanied by any legal advice considered by the Investigating Committee.
At any stage of the fitness to practise process, the General Pharmaceutical Council may refer the complaint to the Fitness to Practise Committee. If the Committee consider it is necessary for the protection of the public, in the public interest, or in the interests of the pharmacy professional, they may make an interim order for suspension from the Register or impose conditions on the pharmacy professional's registration.
The Fitness to Practise Committee must generally hold hearings in public but hearings relating to a health allegation or an interim order hearing must be held in private unless the Committee is satisfied that the public interest in holding a public hearing outweighs the interest of the person or any third-party in maintaining privacy. The Committee applies the civil law standard of proof i.e. on the balance of probabilities (i.e. 51%). The rules include provisions for service of documents on the person and for Case Management Hearings. Witnesses may be called by the parties and submissions may be made. The parties may be legally represented. Costs may be ordered.
If the committee determines that the fitness to practise of the person concerned is impaired it may: --
- issue a warning to the person concerned
- direct that details of the warning be recorded in the Register;
- direct that the person concerned be removed from the Register ;
- direct that the person concerned be suspended from the Register for up to 12 months ; or
- direct that the person concerned be subject to conditions imposed for the protection of the public or in the public interest or in the interest of the person concerned for up to three years.
An appeal may be made to the High Court against any decision by the Committee to remove from the register, suspend, or impose conditions. Appeals must be made within 28 days of the date on which the notice of decision was sent out.
If you are the subject of an investigation you should take advice at the earliest opportunity. It may be that your professional association or insurer will assist you. With their approval or if you wish to choose your own source of legal advice and assistance, we can advise you in these processes and can represent you throughout them.
