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Draft Pharmacy Order 2009
Q. What is the progress of the draft Pharmacy Order 2009?
Q. What is the position in relation to restricted titles under the draft Pharmacy Order 2009?
Q. How will the GPhC benefit pharmacists and pharmacy technicians?
Q. In a nutshell, what are the major changes that will directly affect me?
Q. Why are there no provisions for a non-practising register?
Q. What happens if I am on the RPSGB non-practising register now and wish to join the GPhC register in the future?
Q. As an overseas pharmacist currently on the RPSGB practising register, will I be able to remain on the practising register of the GPhC?
Q. I am an overseas pharmacist currently on the RPSGB non-practising register. Will I be able to remain on the GPhC register?
Q. Why are there no provisions for student registration in the draft Pharmacy Order 2009?
Q. Why does the regulator need more powers in relation to premises?
Q. What will happen to my 'old' certificate?
Q. Why has the definition of 'practising' been changed?
Q. Is it the case that only patient-facing pharmacists and pharmacy technicians need to register with the GPhC?
Q. When will pharmacy technicians need to register?
Q. Why are there no details in the draft Order on certain subjects such as CPD, standards for premises, etc.?
Q. Will pharmacists who don't provide services to the public have to register with the GPhC?
A. The Department of Health, on behalf of the Secretary of State, and the Scottish Ministers issued the consultation on the draft Pharmacy Order on December 9th 2008. The consultation ran for 13 weeks and ended on March 9th 2009. More than 230 people attended five consultation events held in London, Leeds, Edinburgh and Cardiff, including an event specifically for patients and the public, and there were more than 195 written responses to the consultation, which closed on 9 March 2009, plus over 50 letters, and e-mails to officials.
The draft Pharmacy Order consultation follows a statutory process, which means Ministers considered the full consultation report and made necessary amendments to the draft Order before it went to the Joint Committee on Statutory Instruments for further scrutiny. The Department of Health and Scottish Government published the consultation report in June 2009 http://www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_100891
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A. PRLOG considered a report on the early findings from the consultation response and recognised the strength of feeling that had been expressed on the issue of the restricted titles. Following discussion, and in the context that the main aim and objective of the GPhC is to protect the public, the PRLOG confirmed its support for the continuation of the use of ‘pharmacist’ and ‘pharmacy technician’ as the restricted titles. With the exception of the RPSGB, the remainder of the PRLOG advised that there is no need for the GPhC to hold a non-practising register. It was agreed that public protection was in part achieved through clarity for the public as to the currency of pharmacists’ and pharmacy technicians’ registration status, skills and knowledge and that such clarity is of paramount importance. It was noted that there was nothing to prevent people from describing themselves as retired pharmacists or retired pharmacy technicians, but the current position in the draft Pharmacy Order is that use of the titles ‘pharmacist’ and ‘pharmacy technician’ is restricted to those individuals registered with GPhC. There is to be no non-practising register.
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A. The draft Pharmacy Order introduces a number of new provisions, which may affect the way that you practise. These include:
- New powers for the GPhC to set standards for owners, superintendent pharmacists in relation to pharmacy premises and the carrying on or management of a retail pharmacy business in order to ensure the safe and effective practice of pharmacy. Failure to comply with these standards could ultimately result in removal of the premises from the register and/or the imposition of a fine and/or disqualification proceedings.
- There is now an explicit link between setting standards and safe and effective practice;
- Powers to request information from owners of premises;
- Powers to require a statement by a pharmacy owner or directors of bodies corporate in relation to criminal offences and or investigations into professional conduct;
- Provisions for registration of pharmacy technicians and pharmacy premises in an emergency and the imposition of conditions on such registrations by the Registrar;
- Provision for the setting of a framework for CPD, which then allows the GPhC to set out the specific CPD requirements in criteria;
- Provisions for the GPhC to adopt a flexible approach to fee setting for premises and individuals.
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A. In line with the view that the GPhC should only register those who are appropriately qualified, fit to practise and have met continuing professional development requirements, the proposal is that a non-practising register should not be maintained. Pharmacists and former pharmacists who do not wish to register with the GPhC could nevertheless join the professional leadership body.
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A. It is anticipated that the GPhC will not have a non-practising register; this means that you could transfer to the RPSGB practising register prior to the establishment of the GPhC, subject to the submission of the appropriate application form for change of status and payment of fees. (Forms available at www.rpsgb.org)
[NB If you have been on the non-practising register for more than 5 years you are recommended to undertake a return to practice course.]
Alternatively, once the GPhC is established you could make an application for registration on the GPhC register. At that point, you would be required to submit all relevant documentation to prove entitlement to register, together with the required fee.
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A. The draft Order includes provisions that state that a person is not entitled to be registered with the GPhC if they do not intend to practise in Great Britain, the Channel Islands or the Isle of Man. There are also provisions within the draft Order that will ensure that all practising registrants are transferred to the GPhC. At the point of transfer of regulatory functions from the RPSGB to the GPhC, your practising registration status will be automatically transferred across.
The GPhC will be looking at its policy for overseas registrants. Much of the detail around registration will be contained within the detailed standards and Rules to be made under the draft Pharmacy Order. The standards are currently available for consultation at http://www.chre.org.uk/consultation/175/ until 12th January 2010 and the Rules are likely to be consulted on in early 2010. In addition to this, the education procedures and registration criteria are available for consultation at http://www.pharmacyregulation.org/getinvolved/consultations/index.aspx until 15th February 2010.
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A. The GPhC will not have a non-practising register, so your registration will not automatically transfer to the GPhC.
The draft Order includes provisions that state that a person is not entitled to be registered with the GPhC if they do not intend to practise in Great Britain, the Channel Islands or the Isle of Man. There are provisions within the draft Order that will ensure that all practising registrants are transferred to the GPhC. The GPhC will be looking at its policy for overseas registrants. Much of the detail around registration will be contained within the detailed standards and Rules to be made under the draft Pharmacy Order. The standards are currently available for consultation at http://www.chre.org.uk/consultation/175/ until 12th January 2010 and the Rules are likely to be consulted on in early 2010. In addition to this, the education procedures and registration criteria are available for consultation at http://www.pharmacyregulation.org/getinvolved/consultations/index.aspx until 15th February 2010.
If you want to ensure that you retain registration without a break, you should join the RPSGB’s practising register prior to the transfer of regulatory functions to the GPhC (anticipated in Spring 2010). Information on how to move to the practising part of the RPSGB’s register can be found on the RPSGB’s website http://www.rpsgb.org/registrationandsupport/registration/#up
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A. Most regulators do not have a system of undergraduate student registration in place. It is the Government’s view that education and training providers are ideally placed to identify and deal with student fitness to practise by carrying out pre-education checks to discover any factors which might either indicate prospective students’ unsuitability for training as a pharmacist or pharmacy technician, or which might identify areas where they may need extra support.
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A. It is right that the regulator has appropriate powers to ensure that any pharmacy it registers and/or maintains on its register is fit for purpose. As the GPhC has GB wide coverage, there is the ability to apply a consistency of minimum standards across England, Scotland and Wales in relation to both NHS and non-NHS activities. It is expected that the GPhC will work closely with the policy makers within the Governments to ensure that duplication of regulation and inspection is kept to a minimum. The GPhC also has a duty to co-operate with various groups when exercising its functions, including those concerned with the employment of registrants, pharmacy owners, and persons using or needing the services of registrants. Effective regulators have a range of sanctions that can be applied to ensure that regulation is proportionate.
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A. Certificates issued by the RPSGB will not be valid as proof of registration with the GPhC and will not confirm registration as a pharmacist or pharmacy technician. There are provisions within the draft Pharmacy Order that require the Registrar to issue a notice of registration, where an application for entry or for renewal of an entry in the register is granted. Whilst it is unlikely that you will be required to return your RPSGB certificate, no decisions have been made on this so far. The notice of registration for the GPhC will be in a form agreed by the GPhC’s council and is yet to be determined.
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A. The opportunity has been taken to amend the definition of ‘practising’ to include advice giving in relation to preparation, assembly, sale and supply of medicines rather than the narrower definition in the Pharmacists and Pharmacy Technicians Order 2007 (the current legislation) which referred to advice in relation to ‘dispensing and use’ of medicines. The broader definition ensures greater clarity and acknowledges that preparation and assembly are integral parts of the supply of medicines.
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A. No, anyone who wishes to practise as a pharmacist or pharmacy technician and use the restricted titles ‘pharmacist’ or ‘pharmacy technician’ must be registered as such on the GPhC register. Registration with a regulatory body confirms that an individual is fit to practise. There are many examples of pharmacists and pharmacy technicians whose roles do not include delivery of care to individual patients or services directly to members of the public, however their roles do impinge on patient safety, often very significantly through signing off patient group directions, releasing batches of products, setting local and national policy for the use of medicines for example – for these individuals the need for registration with the professional regulator is unambiguous. Indeed many employers require registration as a safeguard to ensure that the individual is up to date, bound by a code of conduct and/or ethics and is fit to practise in their chosen field e.g. academia, industry etc. Many organisations require certain functions to be performed by registrants and others require a registrant to be accountable for delivery.
The definition of practising in the draft Order reflects this breadth of practice and is as follows:
‘…..if whilst acting in the capacity of or purporting to be a pharmacist or a pharmacy technician, that person does any work or gives any advice in relation to the preparation, assembly, dispensing, sale, supply or use of medicines, the science of medicines, the practice of pharmacy or the provision of healthcare’.
Maintenance of registration will also ensure that you are kept up to date with the regulatory developments within the profession. This is of particular importance as the GPhC’s functions include:
- Setting standards of education and training, continuing professional development and conduct
- Ensuring those standards are met, through the accreditation of education and training, and assessment of applicants for initial, renewed and restored registration
- Registration of qualified, competent practitioners
- Operating fitness to practise procedures to protect the public.
Involvement of pharmacists and pharmacy technicians in the education of prospective registrants and within the pharmaceutical industry and other non-patient facing jobs is an essential element in the development of the pharmacy profession in these areas.
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A. The statutory register of pharmacy technicians will open in July 2009. Initially, the RPSGB, as the current regulator, will hold the register. Pharmacy technicians who have work experience and a vocational qualification will be able to apply to join the statutory register until 30 June 2011 under 'grandparenting' arrangements put in place to ease the transition to regulation for pharmacy technicians. After this date, registration will require a specific qualification.
Once the GPhC is established, all technicians who are registered with the RPSGB will transfer automatically to the GPhC. Pharmacy technicians will be notified in writing when their registration transfers. The grandparenting arrangements will continue with the GPhC until 30 June 2011. After this date, the title 'pharmacy technician' will be restricted to those on the GPhC register. Those individuals who are currently practising or intend to practise as pharmacy technicians are encouraged to register as soon as possible.
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A.In order to ensure maximum flexibility for the regulator, there are a number of provisions within the Order that allow the GPhC to make Rules and standards covering the issues mentioned above. Rules and standards made by the council need to be consulted on with various stakeholders, but they do not need to go through time-consuming Parliamentary processes. This means that Rules and standards can be amended quickly to keep pace with the rapidly changing pharmacy profession and regulatory environment.
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