Services for you & your family

Pharmacists

Our support for Pharmacy professionals

We can assist if your fitness to practise is being called into question whether by assisting preparing you for interview by inspector, preparing a response to the Inspector or Investigating Committee or representing to you in connection with proceedings before the Fitness to Practise Committee.
We are also experienced in dealing with matters which invoke Interim Orders hearings.
We are here to assist you in connection with your business and all its compliance requirements or with inspections/investigations.

Background

The General Pharmaceutical Council (GPhC) replaced the Royal Pharmaceutical Society on 27/09/2010 as the governing body responsible for the regulation of pharmacists, pharmacy technicians and premises in the UK . It is their aim to maintain and promote the safety and well being of the public and patients and to ensure compliance with new regulatory framework applying to licences, registration, fees and continuing professional development. The new regulatory framework invoked tighter procedural requirements especially in the Fitness to Practise arena.

See www.pharmacyregulation.org and in particular the Standards applicable to pharmacists and pharmacy technicians and to pharmacy premises in the UK.

Council

The governing body of the GPhC is the Council which consists of 14 lay and registrant appointed members. It was formed under the Pharmacy Order 2010. Three statutory committees were also formed to undertake the regulatory functions responsible for investigating a registrants’ Fitness to Practise, and conducting Registration Appeals. The investigation Committee, The Fitness to Practise Committee and the Appeals Committee.

The GPhC is unique among healthcare professional regulators because it has its own Inspectorate. They have separate divisions within the UK covering different regions.

The inspectors have two main roles:

Inspection visits

To inspect registered pharmacy premises in order to monitor and secure compliance with relevant legal requirements and professional standards.

Investigations

To investigate complaints and allegations involving registered pharmacists or registered pharmacy technicians.

In addition to the above, inspectors provide advice on compliance issues and liaise with other regulatory and enforcement agencies, including the Care Quality Commission as well as local Primary Care Organisations.

It is common for an enquiry/ complaint or investigation to be conducted at Inspector level and for this to be referred to caseworkers within the Fitness to Practise arena.

Fitness to Practise

Cases can involve complicated issues which relate to the competence or performance standards and compliance with the rules and personal misconduct/potential health impairment factors and new procedural frameworks ensure each and every complaint or concern is investigated rigorously. Notice of Referral to the Investigation Committee is sent with the supporting documentation to the Registrant and the matter will be put before the Investigation Committee if it satisfies the threshold criteria

The Investigating Committee acts as a screening committee deciding whether cases referred to it should go to the Fitness to Practise Committee. It meets in private and does not hear oral evidence.

The Committee will consider all documents and recommendations placed before it by the Registrar and any written submissions made by the registrant involved in the allegation. It may also:

direct that further investigations be made,
obtain advice from a legal, clinical or other specialist adviser, and
adjourn consideration of the allegation until any further information has been obtained, any comments from the informant, if any are received, or any reports where the person concerned has undergone a medical examination.
After it has considered the allegation the Investigating Committee can:
issue a warning to the person concerned,
issue advice to the person concerned,
issue advice to any other person or body involved in its investigation,
dismiss the case,
in relation to a health allegation, require the person concerned to undergo a medical examination,
agree undertakings,
refer the matter to the Fitness to Practise Committee, or
initiate criminal proceedings.

After the Investigating Committee has considered the allegations, they must inform the person concerned no later than 10 days after the date upon which the decision was made and must include the reasons for the decision and any legal advice considered by the Investigating Committee.

Where the Investigating Committee has decided not to refer an allegation to the Committee the notice must inform the registrant that the Investigating Committee may nevertheless reconsider the allegation in the circumstances set out in rule 12 of the Pharmacy Order 2010.

Interim Orders

During this time your practice can be put on hold or restricted-

Under Article 56, where the Fitness to Practise Committee is satisfied that:

it is necessary for the protection of members of the public or;

is otherwise in the public interest or;

is in the interests of the registrant

for an entry in the Register relating to a registrant to be suspended or to be made subject to conditions, the Committee may make an order that the entry in question be suspended for a period not exceeding 18 months or that the entry in question be conditional upon the registrant complying, for a period not exceeding 18 months, with such requirements as the Committee thinks fit to impose. It is subject to review within 6 months.

If there is a case to answer the case is referred to the Fitness to Practice Committee :

Hearings

The Fitness to Practise Committee is required to consider all cases referred to it. Where an allegation or matter is referred to the Committee it must determine whether or not the fitness to practise of the person in respect of whom the allegation is made is impaired. The procedure for hearings is set out in Part 6 of the GPhC Fitness to Practice Rules Order of Council 2010. The Fitness to Practise Committee holds hearings in public. Any hearings regarding health allegations, or interim order hearings, are held in private. If the Committee is satisfied that the public interest in outweighs the interest of the registrant concerned or the third party in maintaining their privacy, then the hearing is held in public (Rule 39). The Committee may receive any evidence (including oral evidence) subject only to the requirements of relevance and fairness. The Committee may consider a breach of the standards of conduct, ethics and performance into account when deciding if the registrant's fitness to practice is impaired The Committee uses the civil standard of proof.

Documents

Prior to a hearing, the Council must serve on the person concerned the documents. Then, that person must serve on the committee secretary an agreed time approximation for the length of the hearing and a completed listing questionnaire.

Case Management Meetings

Any time preceding a hearing either party may serve on the secretary and the other party a written request for a case management meeting. The request must include the reason for seeking a case management meeting, state what directions are sought and whether the person making the request seeks the participation of the parties at the meeting or if the issues can be managed without oral representations. The Committee secretary will send a copy of the request, along with any other material relevant, to the chair. The chair must concur with the request unless he concludes it is unnecessary or the request is an abuse of process (rules 19, 20 and 21).

Notices of hearing and costs

A Notice of Hearing must be served on the registrant, not less than 28 days before the hearing, unless the registrant agrees otherwise (rule 16).

No less than twenty-four hours before the hearing, the parties are must exchange a schedule of costs and to serve a copy of their schedules on the Committee Secretariat (rule 46(1)).

Sanctions available to the Fitness to Practise Committee:

If the Fitness to Practise Committee determines that the fitness to practise of the person concerned is impaired, it may:
Give a warning to the person concerned.
Give advice to any other person or other body involved in the investigation.
Remove the registrant from the Register
Give a direction that the entry in the Register of the person concerned be suspended, for such period up to 12 months.
Place conditions on the registrant's registration for up to three years.
The Registrar must notify the registrant of any decision made by the Committee, including the reasons for the decision and any right of appeal. In practice, this is done by the Committee Secretariat.
If the Fitness to Practise Committee decides person’s ability to practice is not impaired, it may:
Give a warning to the registrant
Give advice to the registrant, or any other person or organisation involved in the investigation
The Committee can also:
Recommend that the GPhC Council initiate criminal proceedings
Require a registrant to undergo a medical examination