Control of health professionals and their staff
Introduction
Most countries, usually by legislation, will control and regulate their healthcare professionals. Why do they do this? First, imagine the situation where anybody could call themselves a pharmacist, dentist, nurse, dietitian without the need for any relevant qualifications, skills and knowledge or integrity. Then, imagine if these self-named healthcare professionals could set-up in premises to offer services, advice and medicines. Would you want such an individual to drill your teeth, prescribe medicines or offer advice? Most certainly not is probably your reply. For this reason, all countries want their healthcare professionals to be suitably qualified, highly competent and with integrity. But how is this achieved? The normal process is to put in place an independent regulation system.
Healthcare regulation systems
Regulation aims to provide properly qualified and competent healthcare professionals. In the UK, although this is not dissimilar to other countries (see below), a system of regulatory bodies has been established. These bodies are independent of the profession they are regulating. The Professional Standards Authority for Health and Social Care, until recently the Council for Healthcare Regulatory Excellence (CHRE), scrutinizes and oversees the work of the individual regulatory bodies for healthcare and social work. In this role, it considers good examples of regulatory practice in one regulatory body and disseminates to all the other regulatory bodies. In addition, it will review and report on individual regulatory bodies on a regular basis.
Regulatory bodies may regulate just one profession, for example, the General Medical Council (GMC) regulates only medical doctors. Some regulatory bodies will regulate two professions, for example, the Nursing and Midwifery Council (NMC) regulates both nurses and midwives, which share a common pre-registration educational training. Other regulatory bodies regulate the whole of the professional team, for example, the General Dental Council (GDC), which regulates dentists, dental nurses, dental technicians, clinical dental technicians, dental hygienists, dental therapists and orthodontic therapists. Similarly, the General Pharmaceutical Council (GPhC) regulates the whole of the pharmacy profession, namely pharmacists and pharmacy technicians along with the premises in which they work. For healthcare professions with relatively small numbers of members, compared with some of the other professions, for example, medicine and pharmacy, it would not be efficient or cost-effective to have an individual regulatory body and so the Health and Care Professions Council (HCPC) has been established. This regulatory body covers about a dozen professions, including dietitians, paramedics, physiotherapists, radiographers and social workers.
In other countries, a similar system of regulation occurs. For example, in South Africa, pharmacists must register with the South African Pharmacy Council, which is the statutory, regulatory body. Its objectives include the control, promotion and maintenance of standards of pharmaceutical education and pharmacy practice. It also plays a role in the control and maintenance of the professional conduct of registered pharmacists. In Saudi Arabia, the Pharmacy Board of the Saudi Food and Drug Authority acts as the regulatory and registration body for pharmacy. In very small countries such as Bermuda, which does not offer its own pharmacy degrees, overseas trained pharmacists are employed, usually, with US, Canadian or UK degrees. They are required to undertake a 1-month pre-registration training to acquaint themselves with the Bermudan system before taking a pre-registration examination. Success in the examination will allow the individual to register as a pharmacist with the Pharmaceutical Council of Bermuda.
In many countries and in many professions, in addition to the regulator, there will be a professional body. For example, medical doctors have the British Medical Association (BMA) as their professional body. Similarly, pharmacists in England, Scotland and Wales are regulated by the GPhC and have the RPS as their professional body (see Ch. 14). Professional pharmacy organizations exist in South Africa, including the Pharmaceutical Society of South Africa, to professionally represent pharmacists. Similar professional bodies exist alongside the regulator in other countries and states, such as, New Zealand, Australia and Texas.
In Northern Ireland, the Pharmaceutical Society of Northern Ireland (PSNI) is both the regulator and the professional body. This dual system of regulator and professional body used to exist in the rest of UK and New Zealand up to a few years ago.
The work of regulatory bodies
The aim of any regulatory body is to protect the public by ensuring that their registrants are competent and remain competent to undertake their professional roles. Most regulatory bodies have a council which is made up of representative members from the profession and lay members, usually in an equal number. These members may be elected or, as is the case with the GPhC, can be appointed. The GMC, GPhC and GDC have a Chief Executive and Registrar who leads the organization. The Pharmacy Act of 2010 set-up the GPhC as the regulator for pharmacy.
A consideration of regulatory bodies shows that there are a number of common tasks.
Maintaining a register of members
All regulators maintain an up-to-date register of members, with members’ names and addresses and date of first registration. These registers are available to employers and the public, so that a person, who claims registration, can be checked. In addition, these registers may include further relevant qualifications, for example, the NMC will identify specialist practitioners and nurse prescribers. The register of the GPhC will identify, by annotation, any further qualifications or responsibilities that the registrant has. Currently, these are qualifications as an independent and/or a supplementary prescriber. They will also indicate if the registrant is a superintendent pharmacist. A superintendent pharmacist has overall responsibility for all pharmaceutical issues within that organization. Any person who is registered with a regulatory body is allowed to use the legally ‘protected title’ of that body, for example, pharmacist, pharmacy technician, nurse, physiotherapist, etc. If the person is not registered with the regulator, it is an offence to use the ‘protected title’. Normally, a registrant of a regulatory body has to renew their registration on an annual basis and pay a fee. The fee is used to pay the administration costs of the regulatory body.
Initial registration
Regulatory bodies require certain conditions to be met before initial registration can take place. These ensure that the person applying to be registered is competent to deliver the services they are required to deliver and do not have any reasons why they are unable to perform due to ill health. The regulator must also ensure that the person is of good standing and will uphold the professional standards by being a person of good reputation. In order to meet the required conditions, the person applying to the register must possess an accredited qualification, make some form of declaration about their health or have a medical review and make a declaration or have a police check to show that they have no convictions for any crimes.
In order to register as a pharmacist, an individual must have acquired a degree from an accredited degree course; have successfully completed 52 weeks of pre-registration training at an approved place with a recognized tutor; and have passed the registration exam. As part of the registration process, they must make declarations about their health and character. This whole qualification process must usually be completed within 8 years. On initial registration, some regulatory bodies allow full registration and others just provisional registration. The GPhC allows full registration, whereas the GMC only allows provisional registration with a licence to practice. After successful completion of Foundation programme year 1, the provisional registrant can apply for full registration.
Staying on the register
After initial registration, the registrant will have to re-register annually. Re-registration is not automatic and most regulators require certain conditions to be met before considering re-registration. These conditions will, usually, include a declaration of any conviction or warnings received from the Courts. Serious conviction could mean that re-registration may not be possible or be subject to certain restrictions (see later). Most regulators will require the applicant for re-registration to have undertaken some form and amount of CPD (see Ch. 6) during the previous year. CPD is rapidly becoming a mandatory requirement for continuing registration as a pharmacist in other countries, for example, Saudi Arabia requires 60 credits over 3 years. Other countries simply require the pharmacist to undertake CPD, while yet others, including the UK, require the keeping of written records which might then be reviewed by the regulator.
Some regulators will require evidence that the applicant has worked in practice for a certain, minimum, number of hours in the previous year or number of years. The NMC has strict requirements on hours of work in practice situations. All regulators will require a re-registration fee.
Revalidation
Revalidation is the process by which the regulator can be assured of a registrants fitness to practice. It is defined by the GPhC as: ‘The process by which assurance of continuing fitness to practice of registrants is provided and in a way which is aimed primarily at supporting and enhancing professional practice’.
The GMC is the first UK regulator to require revalidation as part of the health re-registration process (see Ch. 6). The GMC claim it is a process to give patients ‘extra confidence that their Doctor is up to date and fit to practice’. The revalidation takes place every 5 years and is based on an appraisal being conducted using a set of principles. Other regulators such as the GPhC and the HPCP, currently, have working parties considering the principles and methods of revalidation.
Leaving and returning to the register
Non-payment of fees or if a registrant is found not to be ‘fit to practise’ will mean removal of a person’s name from the register. There may be reasons why a person might choose to have their name removed from the register. This might be a permanent removal, for example, when they retire, or it might be a temporary removal, for example, a career break or if they are leaving the country. Most regulators have a formal system of notification if a registrant wishes to remove their name from the register.
A person who has formally left the register can usually re-register under certain conditions. These conditions will depend on the time off the register and the regulator but, usually, involve a ‘return to practice’ course and/or some period of time under the supervision of registrant and/or some completion of CPD or even re-assessment.
Registration of non-UK healthcare professionals
All regulating bodies in the UK have systems in place for registering non-UK healthcare professionals. These overseas professionals are usually divided into those from the European Economic Area (EEA) and those applicants from elsewhere in the world. Each group is dealt with separately and will have to produce acceptable qualifications before being accepted onto a UK register. In some cases, the applicant may have to acquire an additional UK qualification or additional professional practice or sit English language tests or attend an induction course or a combination of these before being considered for registration. All applicants will require a police check from their home country.
EEA pharmacists
Pharmacists, and most other professions, who are registered or eligible to register in their own country are able to register in the UK. For pharmacists, they are required to complete an application form to be entered onto the register.
Overseas (non-EEA) pharmacists
In order to be registered in the UK, they must first have a pharmacy qualification and be registered or able to register as a pharmacist in the country from which they got their qualification. Then they must complete an Overseas Pharmacists Assessment Programme (OSPAP). This is a postgraduate qualification, which has been accredited by the GPhC. They must then follow the same route to qualification as a UK graduate by completing 52 weeks of pre-registration experience and the registration examination.
Recognition and accreditation of pre-registration qualifications
All regulatory bodies set standards for pre-registration qualifications, most of these being accredited degrees.
Accreditation of courses
The regulatory bodies will visit the educational institutions that offer professional qualifications, which entitle the student to register with that regulatory body. They do this in order to check that the course produces students that are suitable for registration. The accreditation process is rigorous and may impose conditions on the curriculum and the educational institution. In some cases, the educational qualification may include extensive placements in the professional setting and the development of a required level of competence. Some accredited qualifications may allow the concomitant graduation and registration, for example, nurses, physiotherapists and dentists. Pharmacy in the UK is different from this, in that after obtaining an accredited degree in pharmacy, graduates have to undertake a year of pre-registration training under the supervision of a pharmacist and pass the registration examination before applying for registration with the GPhC. However, there are proposals for concomitant graduation and registration in pharmacy by integrating the pre-registration experience into the 4-year pharmacy degree, leading to a 5-year integrated degree.
In pharmacy, the accreditation process in conducted to a set of standards produced by the GPhC and involves appointed accreditors visiting the various Schools of Pharmacy on a 6-yearly basis, with an interim practice visit 3 years after the full accreditation visit.
A code of practice
All regulatory bodies have some form of code of practice or standards of conduct, performance and ethics. An overseas example is the South African Pharmacy Council, which produces ‘Rules for Good Pharmacy Practice’ and a list of products that should not be sold in a community pharmacy. These codes state the standards expected of registrants (see Chs 8 and 9). Breaches of the standards may constitute a Fitness to Practise (FtP) issue. Within England, Scotland and Wales, the GPhC produces the ‘Standards of conduct ethics and performance’, which includes seven principles for how a pharmacist or pharmacy technician should behave. Failure to meet these principles could lead to a pharmacy professional being removed from the register. In addition to this, the GPhC produces guidance to help pharmacy professions to understand the standards required around such topics as confidentiality and gaining consent.
A formal system of reporting registrants and dealing with FtP issues
In order to protect the public, all regulatory bodies have a reporting system, in which members of the public, employers, colleagues and other healthcare professionals can report a registrant if they consider they have acted in an unprofessional or criminal way or any other action that could bring the profession into disrepute. Each regulatory body will have a robust system to investigate such allegations that are reported to them. If an allegation is considered to be serious enough that it might affect the professional’s FtP, then the allegation could be investigated by the regulator and if appropriate could result in the registrant appearing before a disciplinary committee, or if the allegation against a registrant is considered to be the result of a health issue, then a health committee. These committees will have various powers including the right to:
Dismiss the case as the allegation is unfounded or warrants further action
Issue a warning to the registrant which will then be used if a further allegation is raised
Impose conditions on the practice of the registrant such that they are restricted in what they can do in practice
Suspend or remove the name of the registrant from the register. Some regulators might suspend a registrant pending further investigation of the allegation. Removal from the register is usually for a period of time and the registrant is informed what they have to do before they reapply to go back on the register or for how long they will be off the register before they can be considered for re-registration.
There is normally an appeal system which the registrant can go through if they believe they have been treated unfairly.
Key Points
The aim of all healthcare regulators is to protect the public
All healthcare professionals must be registered with a regulator in order to practice
The GPhC regulates UK pharmacy
All regulators maintain a register
All regulators have a code of practice for registrants
All regulators have a system for disciplining registrants and removing them from the register