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Standards and rules development
Q. Why is the Department of Health, rather than the GPhC, leading the development of standards and rules under the draft Order?
Q. What types of standards and rules are being developed?
Q. Why does the Department of Health need to develop new education standards for the GPhC when the RPSGB has only recently developed new standards in this area?
Q. Who is involved in developing the new standards and rules for the GPhC?
Q. What standards are likely to be developed for pharmacy owners and what sanctions are there for failure to comply?
Q. What plans does the GPhC have to engage with organisations representing locums?
Q. Many locums are concerned that the GPhC will place unfair or unreasonable burdens upon them, by, for example, failing to recognise the difficulties likely to come about as a result of the Responsible Pharmacist legislation. What is your/the GPhC’s view of these regulations?
A. In order to keep the project to establish the GPhC on target to open in 2010, and subject to the involvement of the Chair and council designate, the PRLOG advised that the Department of Health (DH) should undertake the initial standards and Rules development work. The draft standards were accordingly made available for consultation on the CHRE website. The GPhC Council has now considered the responses to this consultation and will reconsult on revised drafts under its own name before decisions are finalised. The GPhC is currently consulting on draft Rules.
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A. The draft Pharmacy Order provides the GPhC with a number of powers to set standards and make Rules and statutory instruments. In particular, the GPhC has the power to set standards for education and training, CPD and proficiency, ethics, conduct and performance, and pharmacy owners, superintendent pharmacists and premises. Some of these standards will be in Rules, which are statutory instruments. There are many other examples of Rule making powers in the draft Order e.g. Rules for registration, fitness to practise, fees etc.
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A. As the new pharmacy regulator, the GPhC needs to set its own standards for education. However, the work that has already been set in train by the RPSGB's Education Committee, the profession and academia to develop new education and training standards for pharmacists will not be wasted. The DH has built on this valuable work as part of the wider standards programme and these standards have been subject to a 12 week consultation which concluded on 12 January 2010.
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A. The Pharmacy Order includes a high level provision about the GPhC's duty to co-operate. This should form part of establishing a capacity for horizon scanning from the outset so that the GPhC stays ahead of practice, anticipates change and developments before they occur and reflects them back into its standard setting and other functions. In doing so, it will need to proactively manage a network of stakeholders, including (but not restricted to) those listed in the Pharmacy Order. The GPhC is currently developing its own stakeholder engagement programme.
A wide range of stakeholders were involved in the development of the draft standards including pharmacy professionals from academia, industry, primary care, other regulators, professional body, pharmacy owners, superintendent pharmacists, employees and veterinary pharmacists etc. Over 50 stakeholders were directly involved with the standards development workshops that ran throughout the summer 2009. In addition to this, the DH also engaged with others who were unable to attend the workshops in order to get the broadest possible stakeholder coverage. In view of the importance of ensuring that the patients and the public are at the forefront of standards and Rules development for the GPhC, the DH ran separate patient and public engagement focus group events to obtain their input. Patients and the public were also involved directly in the standards development workshops.
After consideration of the response to the CHRE consultation on the draft standards, the GPhC council has taken the decision to revise the draft standards and hold further public consultation before they are adopted. The council has agreed some interim measures for consultation in April 2010 that will enable the GPhC to keep on schedule and take on the regulatory role in 2010 while maintaining business continuity for registrants.
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A. The initial development of standards for pharmacy owners and superintendent pharmacists, conduct, ethics and performance, education and training, proficiency and CPD was facilitated by the DH in conjunction with a number of stakeholders, including the public, and these were consulted upon by CHRE. Following consideration of the response to that consultation, the GPhC Council is proposing to consult on draft interim standards for pharmacy owners and superintendent pharmacists, to take effect when the GPhC acquires operational responsibility. A revised draft set of standards will then be produced for consultation at a date to be determined.
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A. Engagement with stakeholders, including locum pharmacists and employers, will be very important for the GPhC. The GPhC will have a statutory duty to consult with representatives of registrants and employers before setting standards. It will also have a duty to have 'proper regard' to the interests of registrants and groups within the professions.
Locums and other stakeholders have already had an opportunity to give their views on the proposed role and functions of the GPhC through the various consultations on the legislation, standards and procedures. The current Rules consultation and the impending further consultation on the draft standards will create a further opportunity to engage in the process of standards and rules development.
The GPhC will be working on stakeholder engagement mechanisms during the shadow period before it takes up responsibility for regulation.
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A. It is too early to say how the GPhC will operate in this area. The RPSGB will retain its regulatory responsibilities until regulation transfers to the GPhC.