The Future Pharmaceutical Regulatory and Professional Bodies and Their Impact on Practicing Pharmacists - Essay Example

The Future Pharmaceutical Regulatory and Professional Bodies: Their Impact on Practicing Pharmacists Introduction In February of 2007, the UK Government came out with a White Paper on reforms in the regulation of health professionals. Entitled Trust, Assurance and Safety – The Regulation of Health Professionals in the 21st Century, the paper is the aftermath of various recommendations, inquiries and consultations conducted by governmental and non-governmental entities on the need to strengthen and modernise the health professions. One of the salient points of the White Paper is the proposal to establish regulatory bodies for the respective health professions that are independent from the Government and from the health professionals themselves (RCGP Summary Paper 2001 p 1). The consequence of this to the pharmacy profession in Great Britain is significant considering that its governing body is a dual function entity – both performing regulatory role and professional leadership function. The present set up of the Royal Pharmaceutical Society of Great Britain (RPSGB hereafter) therefore, runs counter to the Government’s present thrust which is to make health professional regulatory bodies totally independent to be credible to the public. In line with this, the RSPGB is set to demerge its two functions through the creation of a separate regulatory body to be called General Pharmaceutical Council (GPhC hereafter) and a separate new professional body, both to take place in 2010 (About the Society 2009). Role of the General Pharmaceutical Council (GPhC) The need to establish a separate regulatory body for the pharmacy profession demerged from the present RPSGB structure was underpinned by Lord Carter of Coles, who headed the Working Party on Professional Regulation and Leadership in Pharmacy in early 2007. In the foreword of the Party’s Report at the conclusion of its review, he said that the justification of a new and separate regulatory body for the profession was keeping in step with the shift in the functional direction of pharmacists from its original “‘product-focused service’ to a truly clinical profession, directly caring for patients and the public” (MPI 2007 p 4). Subsequently, the Health and Care Act 2008 paved the way for the creation of the GPhC (s 5, § (2) (1A), Schedule 8). At present, consultations are being undertaken for draft Pharmacy Order 2009, a secondary legislation which will lay down the details of the establishment of the GPhC (DH 2009). In addition, an independent group, called the Pharmacy Regulation and Leadership Oversight Group (PRLOG) chaired by Ken Jarrold CBE, was created to render advice to Ministers in the setting up of the GPhC (Pharmacy Regulation and Leadership Oversight Group 2009). The primary role of the GPhC is regulatory – that is, the policing of the pharmacy profession, the practising pharmacists, and pharmacy premises. The Carter Report proposed several functions of the GPhC and broadly categorised them into four: “setting and promoting standards; education and training; registration, and; fitness to practise.” Since it will exercise regulatory functions, GPhC will have the power to lay down the rules or standards that it will implement in the areas of education and training, proficiency in the practise of the profession and in the conduct of the practise of the profession. The Council shall also be responsible for the regulation of the education and training of pharmacists and pharmacy technicians including setting the standards for courses, institutions and qualifications as well as overseeing the continuous education of registered pharmacists called Continuing Professional Development (CPD) which will soon become mandatory. It shall also be responsible for registering pharmacists, pharmacy technicians, and retail pharmacy premises. Finally, the Council shall likewise be responsible for determining whether a registered pharmacist or pharmacy technician has fitness to practise the profession which it shall carry out by investigating reports of fitness to practise cases and if necessary, adjudicate such cases (Report of the Working Party on Professional Regulation and Leadership in Pharmacy 2007 pp 13-15). Role of the Professional Representative Body Following the publication of the said White Paper, the RPSGB commissioned an inquiry into the establishment of a possible new professional leadership body anticipatory to its demerger from its regulatory function. It was chaired by Nigel Clarke and at the conclusion of its inquiry in 2008, it recommended the establishment of a new Professional Body. A Transitional Committee (TansCom hereafter), was subsequently created to flesh out the details. Again chaired by Nigel Clarke, TransCom conducted extensive and open consultations with different pharmacy groups and individual pharmacists to determine the general consensus in re the proposed professional leadership body. After 15 months of such consultations, it published The New Professional Body for Pharmacy – The Prospectus. The Prospectus, which was adopted by the RPSGB Council on February 3, 2009, will serve as the blueprint of the proposed Professional Body for Pharmacy (New Professional Body for Pharmacy takes Shape 2009 p 1). According to the Prospectus, the proposed Professional Body shall be an inclusive, rather than an exclusive, organization. It will welcome to its fold, on a voluntary basis, practising pharmacists, non-practising pharmacists, even retired pharmacists, and pharmacy students. In addition, anyone involved in pharmacy, like pharmaceutical scientists who are not graduate of pharmacy, are also welcome as well as pharmacists practising and registered outside of the UK (TransCom 2008, p 15). The primary modification in the new Body however, is the promise of wider and more effective “core” services to its members. These are to materialise mainly in the forms of professional support, professional development and education, networking and leadership representation and advocacy. The TransCom envisioned the proposed Body to provide professional support to its members through its various facilities and services like libraries, helpdesks and information services. The proposed Body can likewise help the members gain more expertise and retain his or her status in the pharmacy register through professional development and education. Training courses and resources, for example, can help the member in the revalidation process, the mandatory Continuing Professional Development (CPD), and make headway in his professional advancement. As usual, affiliation in a big organisation is an opportunity for networking and gaining contacts with other professionals. Membership in the proposed Body, with an open membership to all local, national and international pharmacists, is certain to provide this benefit as well. A role however, that the proposed Body will hopefully be actively and vigorously exercising, is leadership representation and advocacy through lobbying, media promotion of the practise of the pharmacy profession and initiating researches geared for the growth of the profession (TransCom 2008 pp 8-10). Discussion The demerger of the RPSGB into two bodies for the purpose of creating a separate regulatory body from the professional leadership body will entail an impact that can only be significant on the practising pharmacist in Great Britain. An evident effect of the demerger is that the focus of each body will be limited to regulation and professional leadership, respectively. The regulatory body will therefore be able to concentrate its attention to policing the practise of the profession, the practitioners themselves and the pharmacy premises whilst the professional body will limit its attention to leading and serving its members. The end result is more efficient, more effective and more potent regulatory and professional leadership bodies. This should be a welcome development to all Great Britain pharmacists considering that the pharmacy profession is on the verge of experiencing a historic turn of events. As previously stated, pharmacy in the 21st century will veer away from a product-type of service to become a clinical profession, an opportunity to “join the premier league of health professions” (The Future of Pharmacy 2009 p 1). In addition, this shift will entail a graver and more serious responsibility on the part of the pharmacists towards the public and having two effective, more focused and separate regulatory and professional bodies will better prepare them for this challenge. A Professional Body which focuses its attention alone to assisting and helping its members without the added burden of performing regulatory functions, a seemingly contradictory function, should be a welcome development to the 21st practising pharmacist. This is because the advent of new government policies set out initially in the White Paper Trust, Assurance and Safety signify new and formidable challenges in the practise of the profession. The impending mandatory Continuing Professional Development (CPD) for Pharmacists and Technician Pharmacists will require these professionals assistance from the Professional Body which can provide the necessary accredited training courses to its members. A steeper challenge for the practising pharmacist however, is revalidation which was likewise proposed in the White Paper and set to be formally introduced in 2012. Revalidation is the process, done periodically, with which a practising pharmacist will be required to prove that he or she is “fit to practise” the pharmacy profession and therefore, maintains the status of his or her name on the regulatory body’s registry. The introduction of this process to the pharmacy profession can be daunting to the average practising pharmacist and a supportive Professional Leadership Body can help ease the tension. Whilst the Government is resolute in imposing policies to the end that it will result in raising the standard of the pharmacy profession in the UK, the average practising pharmacist, who is on the receiving end, may find them initially overwhelming. The creation of a regulatory body, for example, for the sole purpose of policing the practitioner and the profession and whose composition will be intentionally non-partisan and non-sympathetic to him, will be potentially intimidating. A supportive Professional Leadership Body which will be a strong representative and voice of the pharmacist in the Government, the Parliament, the media, and the public and even in the Regulatory Body can level the playing field for him. On the other hand, the creation itself of a separate regulatory body – the GPhC - which will realise the Government’s intent to raise the bar for the profession and the practitioner will certainly create a big difference in the life and on the practise of any pharmacist in Great Britain. Whilst the former and current regulatory body for pharmacy is no stranger to the practising pharmacist, the RPSGB being also pharmacy’s professional leadership umbrella organisation staffed by fellow pharmacists, the proposed GPhC will be a completely new entity partially composed of people who will not be coming from the pharmacy profession. This could be unsettling, especially so that GPhC will wield the power to determine a pharmacist’s future in the profession. However, from a practical point of view, a demerged regulatory body can only be good for the practising pharmacist and the future of pharmacy in Great Britain. It will put the pharmacy profession at par with the other health professions because it will signal a more serious and more stringent policy towards the profession. This will impact favorably in the public’s mind and raise its perception of and confidence in the profession which is what the Government is actually aiming considering that pharmacists will now be given more significant roles like the power of medicine prescription. On the other end of the spectrum, a more focused and credible regulatory body armed with the power to determine, among others, the fitness to practise of pharmacists can be a potent catalyst to motivate the practising pharmacist to professional excellence. The proposed GPhC can literally be the sword of Damocles hanging over head of the practising pharmacist impelling him to excel at every turn. Conclusion The proposed demerger of the RPSGB into a regulatory body – the GPhC – and a yet to be named Professional Leadership Body is well underway. The demerger which is set to officially materialise in 2010, was initially and indirectly proposed in the DH White Paper and statutorily realised in the subsequent Health and Care Act 2008 which enable the official creation of the GPhC. The RPSGB which is a dual-function entity – a regulatory and a professional leadership body – commissioned the Clarke Inquiry to look into the viability of forming a fresh professional leadership body parallel to the establishment of a new regulatory body. Favorably recommending its establishment, the Clarke Panel was soon followed by the TransCom which was tasked to thresh out the details, viz., structure, policies and functions, of the aforesaid body. The guaranteed creation of a regulatory body and a parallel professional leadership body in 2010 will certainly make a significant impact on the practising pharmacist. Not only is he faced with the possibility of losing his practise in the event that he will not be able to prove his fitness to practise - not only once in his professional lifetime but periodically - and by a body whose composition will be, for all intents and purposes, unsympathetic to him. However, such impending demerger can only redound to his benefit. A demerged RPSGB will imply that the professional leadership can only exist as his ally to assist him to meet the new government policies towards the professions and not take on another face when it puts on its regulatory function. A more efficient service to its members unfettered by regulatory functions is therefore in the offing. In addition, a separate regulatory body will create a better public perception of the profession as well as serve as a catalyst for the practising pharmacist to excel in the professional field. References: 2007, Report of the Working Party on Professional Regulation and Leadership in Pharmacy, Department of Health 2008, Report of An Independent Inquiry Into a Professional Body for Pharmacy (The Clarke Inquiry) 2008 The Future of Pharmacy, RPSGB, http://www.rpsgb.org/pdfs/clarkerpsgbsubmissionsumm.pdf 2009, About the Society, Royal Pharmaceutical Society of Great Britain, rpsgb.org, http://www.rpsgb.org/societyfunctions/aboutthesociety/ 2009, Creating a New Professional Regulator for Pharmacy: Health Care and Associated Professions – the Draft Pharmacy Order 2009, DH, http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_091681 2009, New Professional Body for Pharmacy takes Shape, Press Release, RPSGB, http://www.rpsgb.org.uk/pdfs/pr090203.pdf 2009, Pharmacy Regulation and Leadership Oversight Group, RPSGB, http://www.dh.gov.uk/en/Managingyourorganisation/Humanresourcesandtraining/Modernisingprofessionalregulation/Pharmacyprofessionalregulation/DH_081562 Department of Health 2007, Trust, Assurance and Safety – The Regulations of Health Professionals in the 21st Century, London: The Stationery Office Health and Care Act 2008. Opsi. http://www.opsi.gov.uk/acts/acts2008/ukpga_20080014_en_1 TransCom, 2008, The New Professional Body for Pharmacy - The Prospectus, http://www.transitionalcommittee.com/data/prospectus/english/Prospectus-English.pdf Read More