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Standards and policy
Introduction
The Pharmacy Order 2010 directs the GPhC to set standards for pharmacists, pharmacy technicians, pharmacy owners and superintendent pharmacists which include standards for education and training, registration, fees, and conduct, ethics and performance. Standards were drafted and, together with supporting guidance and policy documents, went out for consultation, which closed on 12th January 2010. Prior to that consultation the standards, guidance and policy documents were available for review on the GPhC website from 6-18th September.
In addition to the development of standards, the GPhC will develop policies that explain how we will carry out important areas of work such as patient and public involvement and responding to complaints.
Standards policy
The GPhC will adopt a more dynamic approach to regulation through the increased use of standards frameworks, rather than through detailed legislation. To facilitate this approach, the provisions contained in the Pharmacy Order 2010 are broad, allowing the detail to be set out as frameworks of standards. These, unlike legislation, can be updated quickly as it a non-statutory process. This will enable the GPhC to be more responsive to, and up to date with, developments in pharmacy than has previously been possible. The GPhC will use a principles-based approach to standards rather than detailed, rules-based frameworks, thereby encouraging and supporting professionals to comply with standards while still enabling innovation. When setting standards, the GPhC will consider the following:
- patient focus
- outcomes
- stakeholder involvement
- consistent terminology across the standards-setting arena
- ensuring that minimum standards are met, but also that overall quality is improved
- the language of compliance
- horizon-scanning — looking at new risks
- existing standards
- regulatory gaps
- a principles-based approach.
While there will be additional responsibilities involved in complying with the standards, the GPhC will try to ensure that the regulatory burden associated with this is not overly onerous.
For the first time, there is an explicit link between standards-setting and safe and effective practice, so the GPhC will have to show that practice will be improved by the standards it sets. Importantly, the GPhC will look at the work of other regulators to avoid duplication, encourage harmonisation and work towards ensuring that the regulation of pharmacy professionals is at the same level as that of other healthcare professions.
Standards development
The development of the standards for the GPhC by the Department of Health began in November 2008, with a workshop bringing together 50 people from the three countries to discuss existing standards, evidence of compliance and gaps in information sources. The work continued across summer 2009 with a further series of standards development workshops for professionals and patient/public representatives, and with focus groups for patients and the public in England, Scotland and Wales. The output of the patient and public focus groups was fed into the main workshops responsible for developing the standards.
The workshops cover three work groups (see diagram below). The workshops have focused on drafting the standards and:
- providing the background to the standards development work to ensure that everyone understood the rationale
- agreeing key principles for regulation and for standards development work in order to ensure consistency
- advising stakeholders of the work already set in train by the RPSGB's Education Committee, the profession and academia to develop new education and training standards for pharmacists and pharmacy technicians; this would then be used as the basis for the GPhC's standards development work in this area together with the practice frameworks for pharmacists and pharmacy technicians that will be used for the basis of the proficiency standards
- addressing gaps and overlaps between the sets of draft standards
- the use of consistent terminology across the draft standards.
Early drafts of the standards were shared with key stakeholders. The Department of Health also asked stakeholders in particular fields of practice to peer review the documents to ensure they were relevant to all sectors.
Five sets of standards were developed. More details about each set, and about what the standards mean for pharmacy professionals, are available in the following sections:
[Ahead of the formal statutory consultation the draft standards were available for review from 6-18 September 2009.]
This was intended to give pharmacy professionals and other stakeholders a chance to feed in comments at an early stage, and ensure that the standards developed are fit for purpose.
In 2010, after the formal consultation, GPhC Council reviewed the draft standards. Any amendments necessary will be made ready for the opening of the GPhC in 2010, parliamentary timetable permitting.
The GPhC has a duty to consult with registrants, prospective registrants, employers of registrants, professional bodies, users of registrants' services, commissioners or funders of registrants' services and those involved in education and training of registrants.
Key policy principles
When assuming its regulatory responsibilities, the GPhC will apply the following approaches, depending on the context:
- reactive — monitors inputs
- responsive — monitors processes
- proactive — targets outcomes for quality improvement
- risk-based — targets resources.
The GPhC will regulate in accordance with the Hampton principles in order to be:
- proportionate
- accountable
- consistent
- transparent
- targeted.
Note that the Council for Healthcare Regulatory Excellence (CHRE) proposed a sixth principle, which will also apply:
The GPhC will allocate resources according to an assessment of the risk to patient safety. It will focus on encouraging compliance as well as on enforcement strategies, and will prioritise areas based on their impact on patient safety and public confidence. This will ensure proportionate regulation.
Assessing, securing and enforcing compliance
The Pharmacy Order 2010 provides the GPhC with the following sanctions relating to regulation:
- advice
- warnings
- undertakings
- conditional registration
- performance assessment measures
- suspension
- cancellation of registration
- improvement notices
- fines
- prosecution.
This range seeks to ensure that the regulator can use the most appropriate sanction in order to secure compliance.
Use of information — collection and analysis
The GPhC aims to avoid overburdening those being regulated. Therefore, a key part of developing regulatory standards will be mapping exercises to identify what standards already exist, where information lies, and what information the regulator may need to access. Information-sharing protocols will be a vital component of successful regulation by the GPhC.