Clinical pharmacology and therapeutics

Clinical pharmacology and therapeutics i Description of the specialty and clinical needs of patients Clinical pharmacologists employed within the NHS usually combine their specialty with work as a general physician. About half of their time involves the supervision of acute medical admissions, managing medical inpatients and running outpatient clinics. These individuals will normally have another clinical specialty interest (for example cardiovascular risk management, toxicology) and will take a particular interest in prescribing issues on behalf of their employing NHS body. The mission of the specialty is to improve the care of patients by promoting safe and effective use of medicines and to evaluate and introduce new therapies. 1 Therefore, clinical pharmacologists will often make wider contributions to the NHS clinical service. At a local level this may involve leading the drug and therapeutics committee, developing and maintaining a drug formulary, assessing new products, creating prescribing guidelines, reviewing medication incidents and promoting evidencebased therapeutics. Some consultants may play a leading role in a medicines information service for local prescribers, usually with the support of a clinical pharmacist. At a national level, consultants in clinical pharmacology and therapeutics occupy many positions within key bodies such as the National Institute for Clinical Excellence (NICE), the Medicines Control Agency (MCA), the Committee on Safety of Medicines (CSM), the Joint Formulary Committee overseeing publication of the British National Formulary, the Medicines Commission, and adverse drug reaction monitoring (pharmacovigilance) schemes. The National Poisons Information Service (NPIS) is run almost exclusively by NHS clinical pharmacologists. The work programme of a consultant in clinical pharmacology and therapeutics varies greatly, depending on the job setting. At the time of the last College Census, approximately two-thirds of consultants in clinical pharmacology and therapeutics held academic appointments within universities. 2 While having a service commitment, many of these individuals will have a strong research emphasis in their work that will contribute to knowledge about drug actions and their clinical usage. They will also play an important role in the planning and delivery of undergraduate teaching in therapeutics. Other clinical pharmacologists at consultant level are employed by the pharmaceutical industry and are involved in the development of new drugs and early clinical trials in patients. Some also hold joint appointments with academic units or trusts, a trend that may grow in the future. ii Organisation of the service and patterns of referral Primary, secondary and tertiary levels Clinical pharmacologists are active in promoting safe and effective use of medicines at all levels. At the primary care level they develop and maintain formularies; at the secondary level they may lead the drug and therapeutics committee or run a drug information service; at a tertiary level they may be involved in organisations such as the CSM adverse drug reaction monitoring system, the NPIS and health technology assessment. 93

CONSULTANT PHYSICIANS WORKING WITH PATIENTS Clinical networks and community arrangements The viability of local clinical networks is restricted by the small number of consultants. However, clinical pharmacologists often come together at national level in the setting of the CSM adverse drug reaction monitoring system, the NPIS and health technology assessment. Relationship with other services/agencies Clinical pharmacologists will usually have a close relationship with one or more of the following: clinical pharmacy service chief pharmacist medicines information unit medical director finance director clinical risk management committee primary care prescribing adviser director of public health regional adverse drug reaction monitoring centre local health authority. Complementary services The work of clinical pharmacologists in promoting safe and effective use of medicines is complemented by a clinical pharmacy service. Pharmacists often play an important role in supporting the work of professional committees, providing information about medicines, preventing and reporting medication incidents, and reporting adverse drug reactions. Some consultants will require an efficient laboratory service to support therapeutic drug monitoring or the assessment of poisoned patients. In some circumstances, the work of a clinical pharmacologist may involve close collaboration with a department of public health. iii Working with patients: patient-centred care Patient choice, opportunities for education and promoting self-care Clinical pharmacologists will not only be practitioners of patient-centred care within their own clinical area but, as part of their mission to deliver rational therapeutics, will also promote improved understanding of drug therapy issues and support concordance about prescribing decisions between local prescribers and their patients. These objectives may be achieved through education of doctors (at undergraduate and postgraduate levels) with emphasis on patient involvement in therapeutic choices, informed consent, and promotion of self-care, and through education of patients by disseminating relevant patient information. Clinical pharmacologists will also endeavour to improve the efficacy and safety of medicines through promotion of evidencebased medicine, development of guidelines and shared care protocols. They will, wherever possible, liaise with patient groups and lay representatives when developing prescribing policies. 94

PART 2 Clinical pharmacology and therapeutics iv Interspecialty and interdisciplinary liaison The nature of medicines management activities means that clinical pharmacologists often have important relationships with many other specialist groups and primary care colleagues. Clinical pharmacologists often have medical subspecialties, particularly in cardiovascular medicine, where liaison with other clinical groupings such as cardiology and stroke medicine will be important. It is also likely that they will work as part of a multidisciplinary team (MDT) involving pharmacists and nurses in the pursuit of medicines management and when carrying out clinical trials. v Delivering a high quality service Characteristics of a high quality service a well-organised and efficiently run drug and therapeutics committee drawing on relevant local expertise an agreed local formulary development and regular review of local prescribing policies that support safe, evidence-based and cost-effective prescribing contribution to clinical risk management through regular review of medication incidents appropriate levels of adverse drug reaction reporting by local prescribers regular high quality education in rational prescribing for undergraduates and postgraduates early review of, and advice concerning, poisoned patients. Resources required for a high quality service in clinical pharmacology inpatient medical beds (approximately 15 20) to support acute medical services with appropriate levels of nursing support junior staff support, including a specialist registrar (SpR), for the admission of unselected acute general medical cases outpatient facilities with access to clinical laboratory services and space for teaching clinical laboratory facilities, which may include access to special investigations such as drug assays, sometimes necessitating collaboration with other specialists (eg clinical biochemists) research facilities, which may include protected beds for clinical research together with appropriately trained nursing staff, laboratory facilities with technical support, or computer hardware for data management secretarial support for inpatient and outpatient activities, and other managerial responsibilities private office space, including appropriate IT facilities and space for filing library facilities teaching facilities for undergraduates and postgraduates, including image projection facilities to support the training of SpRs, including research facilities and computer and wordprocessing support an adequately staffed clinical pharmacy service including the facility to provide a medicines information service study leave and support for continuing professional development (CPD). 95

CONSULTANT PHYSICIANS WORKING WITH PATIENTS vi Quality standards and measures of the quality of specialist services Quality and standards in clinical pharmacology are largely expressed by local prescribers in the primary and secondary care sector in relation to the approach to medicines usage, rather than by clinical pharmacologists alone. The measurement of quality and standards in relation to the provision of a clinical pharmacology service is, therefore, problematic. However, potential means to ensure and measure quality include adherence to widely applicable national guidelines, dissemination of relevant prescribing information, implementation of cost-effective prescribing patterns and audit of prescribing practices. CLINICAL WORK AND/OR LABORATORY WORK OF CONSULTANTS IN CLINICAL PHARMACOLOGY Clinical pharmacologists have very varied patterns of working but most NHS and academic consultants are accredited in both clinical pharmacology and therapeutics and in general internal medicine (GIM) as their second specialty. However, the skills of clinical pharmacology and therapeutics are generic and fully applicable to other medical specialties. There are a small number of consultants who also practise in geriatric medicine, paediatrics, oncology, respiratory medicine or cardiology, and it is likely that the number of such consultants will increase as more varied training schemes are established. Contributions made to acute medicine Clinical pharmacologists have traditionally taken a particularly active role as general non-organbased physicians in the on-call rota for the supervision of receiving and triaging acute emergency admissions. These duties should be undertaken with the support of an appropriate number of junior doctors including a SpR. Acute general medical admissions should, ideally, be admitted to a medical admissions unit with appropriate staffing levels and access to emergency investigations. 3 The on-call rota should not normally be more onerous than one in five. Each period of acute admitting must include a post-take ward round with the junior staff who were involved in the admission process. In some services two ward rounds may be required in a 24-hour period. Consultants who are responsible for the review of poisoned patients have more frequent postreceiving ward rounds. Direct clinical care Inpatient work Activities will normally be devoted to supervising the management of general medical patients and the specialist work of the individual consultant. This work typically requires two ward rounds per week at fixed times. 4 The number of inpatients for which the consultant team is responsible should not normally exceed 20. Part of this time will be dedicated to inpatient referrals for patients with pharmacological or toxicological problems. Consultants expect to work in an adequately staffed ward with the appropriate facilities and ancillary services to care for a typical casemix of general medical patients. They should have the support of at least one junior doctor who has completed general professional training. 96

PART 2 Clinical pharmacology and therapeutics Outpatient work Time will be allocated for seeing new patient referrals, including emergency referrals, and followup after discharge from A&E or a hospital ward. Consultants normally provide this service with the support of junior staff and must allow time for their supervision. It is reasonable to expect that assessment of a new patient will take approximately 30 minutes and follow-up patients approximately 15 minutes. Trainees require more time and should not work in isolation. A typical clinic might include four to six new patients and 10 15 follow-up patients. These sessions should include time for dictating clinic letters and administrative matters relating to the outpatient service. Some clinical pharmacologists also provide specialist clinics, for example in cardiovascular risk management or epilepsy. Patients are sometimes referred with specific therapeutic, toxicological or other drug-related problems. Specialist investigative or therapeutic procedures Clinical pharmacologists will not normally undertake specialist procedures other than those that arise from other specialty activities. Specialist on call The most likely on-call commitment to arise from a clinical pharmacology service is to provide emergency advice about the management of poisoned patients. This activity will usually be supported by a poisons information service and clinical pharmacologists may offer advice on a regional basis. Some academic specialists may have ongoing out-of-hours commitments to subjects involved in clinical trials. Clinically related administration Clinical pharmacologists will have administrative duties in keeping with their clinical workload. They may also be called upon to write specialist reports related to medication issues. Work to maintain and improve the quality of care This work encompasses duties in clinical governance, professional self-regulation, CPD and education and training of others. For many consultants at various times in their careers it may include research, serving in management and providing specialist advice at local, regional and national levels. While supervision and management of general medical patients is a major direct contribution to the NHS service, most consultants in clinical pharmacology and therapeutics take on other roles that contribute indirectly to achieving local NHS service objectives and standards. These activities usually focus on the management of medicines in primary and secondary care, for example: leading or playing an important role in the activities of the drug and therapeutics committee and overseeing the use of drugs in both hospital and primary care managing a local drug formulary, which may be jointly agreed with a local GP editing and facilitating the production of local prescribing guidelines for common medical problems taking a lead role in reporting adverse reactions and reviewing local medication incidents 97

CONSULTANT PHYSICIANS WORKING WITH PATIENTS undertaking health technology assessment, which might involve reviewing new and established drugs for clinical- and cost-effectiveness auditing and reviewing patterns of local drug use with the aim of maximising effective and safe use of medicines in the NHS. All of these activities make an important contribution to achieving local objectives in clinical effectiveness, clinical risk management and clinical governance. Clinical pharmacologists are likely to play a major role in auditing and investigating local drug-related incidents. Some consultants may provide a drug information service, often with the support of a clinical pharmacist. This may include a therapeutic drug monitoring service to advise on the management and prevention of medication errors, and an advice service on drug overdoses and management of adverse effects. Some consultants have a specialist interest in forensic pharmacology and provide expert advice in coroner s, criminal and civil cases. There should be adequate provision for all of these important public health and additional service commitments within a job plan. ACADEMIC MEDICINE Approximately two-thirds of consultants in clinical pharmacology and therapeutics hold academic posts, which accounts for the particularly diverse contributions that the specialty makes to the delivery of healthcare. Consultants in major teaching centres play a key role in the design and delivery of teaching in therapeutics to medical students. 5 For new medical graduates, prescribing drugs is a major activity and one that is associated with significant clinical risk. For these reasons therapeutics remains an important theme within any medical curriculum and requires appropriate support from clinical teachers. Clinical pharmacologists are also involved in the delivery of postgraduate training in therapeutics to other health professionals within the NHS, including GPs, nurses and pharmacists. Research is a fundamental part of the work of many clinical pharmacologists. It may involve clinical research in patients and healthy volunteers, and some individuals lead teams of laboratory-based researchers. Drug-related research activities make an important contribution to the local and national NHS research and development strategy, providing important long-term benefits for patient care. The success of these activities will depend on the availability of suitable clinical and laboratory areas, recognition of the need for protected research sessions, and the support of appropriately trained clinical and technical staff. Clinical pharmacologists often have an important role on (or chair) local and multicentre research ethics committees because of their expertise in drug-related research. WORKFORCE REQUIREMENTS FOR CLINICAL PHARMACOLOGY AND THERAPEUTICS The 2001 consultant Census reported that there were 60 WTE consultants in clinical pharmacology and therapeutics in England and Wales, equivalent to one per 870,000 of the population. 6 The following calculation reflects the number of consultants needed to ensure that there are sufficient clinical pharmacologists to contribute to national bodies, and to provide a high quality local service with particular emphasis on medicines management, toxicology and academic activities such as teaching and research. The workforce will also contribute to the care of unselected acute general medical admissions. The calculation takes into account several important trends: 98

PART 2 Clinical pharmacology and therapeutics Drugs account for an increasing proportion of NHS expenditure (currently 15% of the total) and there are pressures to prescribe newer, more expensive medicines. There is a requirement to contain costs by adopting agreed formularies, and making rigorous assessments of clinical- and cost-effectiveness of new drugs. New medical schools are opening and there has been a significant expansion in medical student numbers to around 6,000 annually. Acute general medical admissions are increasing year on year. The increasing burden on physicians running a specialty service (eg gastroenterology, cardiology) is creating difficulties in providing acute medical cover. Junior doctors hours of work are decreasing. Working time directives will have an impact. Clinical pharmacology is one of the few specialties with decreasing numbers at present. Sufficient consultants are required to deliver the academic programme, including teaching. There is a strong case to be made for having one WTE clinical pharmacologist in every large district general hospital (DGH) for acute medicine and to address the specialty needs of the trust and the local primary care trust (PCT). It is estimated, therefore, that the workforce requirement for consultants in clinical pharmacology and therapeutics is approximately 200 WTE. This number of consultants is based on providing: one WTE consultant per DGH serving a population of 250,000 (with an expected annual drug expenditure of 60 million) one WTE consultant per 180 medical students in training (of whom there are there are now 36,000) three consultants per medical school (assuming that half of these hold academic contracts, implying that the expansion in consultant numbers will be predominantly in the NHS). This figure requires an expansion in consultant numbers of at least 10% per annum over the next decade. Following the successful joint initiative of the NHS Executive and the Association of the British Pharmaceutical Industry, the number of trainees in clinical pharmacology has increased in the past few years. The scheme acknowledges the shortage of trained individuals and their importance to the future use of drugs in the NHS. Twenty-five SpRs expect to complete training by 2004. CONSULTANT WORK PROGRAMME/SPECIMEN JOB PLAN The following tables summarise the range of activities undertaken by consultant physicians in clinical pharmacology and therapeutics with responsibilities in GIM, alongside the recommended workload and the allocation of programmed activities (PAs) (considered to be a period of four hours). The job plan is based on a commitment of 10 PAs per week, although the typical working pattern of a clinical pharmacologist will involve a number of extra PAs. Suggested work programmes have been provided for a consultant working in a university teaching hospital and one in a DGH. Academic clinical pharmacologists will normally hold a full-time university contract (the full-time salary being paid by the university) and an honorary (unpaid) NHS contract. The honorary contract will normally include not more than five NHS PAs, of which no more than 3.5 will be 99

CONSULTANT PHYSICIANS WORKING WITH PATIENTS devoted to direct clinical care activities (as defined in the 2003 consultant contract). The award of these concurrent contracts recognises the contribution that academic consultants make, both directly and indirectly (eg medicines management, pharmacovigilance, safe and effective prescribing) to the NHS clinical service. This arrangement also recognises that the activities carried out on behalf of the NHS are valuable for the delivery of high quality teaching and research. The job plan of an academic clinical pharmacologist will be made by agreement between the consultant, the dean and the medical director of the NHS body (or their nominated representatives), and will take full account of the principles set out in the Follett Report concerning the relationship between academic and clinical workload. 7 The academic contract will include responsibilities for research, undergraduate teaching and administration relating to these and other NHS duties. In some cases it will be the university department as a whole that makes a commitment to provide a fixed number of PAs to the NHS service, allowing for more flexible participation of individual academic consultants in clinical duties. 100

PART 2 Clinical pharmacology and therapeutics CONSULTANT WORK PROGRAMME/SPECIMEN JOB PLAN FOR AN ACADEMIC CLINICAL PHARMACOLOGIST WORKING IN A UNIVERSITY TEACHING HOSPITAL BASED ON 10 PROGRAMMED ACTIVITIES Programmed activities Activity Workload (PAs) Direct clinical care Emergency duties arising from acute receiving (24 hours) 10 15 patients 0 1 Inpatient (ward rounds, referrals, MDT meetings) 10 15 patients 0 1 Outpatient clinics 5 10 patients 0 1 Administration directly related to patient care (eg referrals, notes, complaints, correspondence with other practitioners) 0.5 1 Public health duties, eg medicines management: running drug and therapeutics committee, managing a formulary, developing prescribing policies, health technology assessment, drug information services 0 2 Supporting professional activities (SPA) Work to maintain and improve eg CPD, postgraduate teaching 1.5 on average the quality of healthcare and training, management of doctors in training, audit, job planning, appraisal, revalidation, contribution to service management and planning, clinical governance activities Other NHS responsibilities eg Caldicott guardian, clinical audit lead, Local agreement clinical governance lead, undergraduate and with trust postgraduate dean, clinical tutor, regional education adviser, medical management responsibilities External duties eg work for national NHS bodies, work for Local agreement other external bodies (eg Medicines and with trust Healthcare Products Regulatory Agency, CSM, NICE, Royal Colleges, General Medical Council, Postgraduate Medical Education and Training Board, British Medical Association), NHS disciplinary procedures, NHS appeals procedures, advisory appointments committees. Academic duties Teaching undergraduates 1 2 Research 2 4 University administration 1 101

CONSULTANT PHYSICIANS WORKING WITH PATIENTS CONSULTANT WORK PROGRAMME/SPECIMEN JOB PLAN FOR A NHS CONSULTANT CLINICAL PHARMACOLOGIST WORKING IN A DISTRICT GENERAL HOSPITAL BASED ON 10 PROGRAMMED ACTIVITIES Programmed activities Activity Workload (PAs) Direct clinical care Emergency duties arising from acute receiving (24 hours) including dealing with poisoned patients 20 30 patients 1 2 Inpatient (ward rounds, referrals, MDT meetings) 20 25 patients 1 2 Outpatient clinics 15 20 patients 1 2 Administration directly related to patient care (eg referrals, notes, complaints, correspondence with other practitioners) 1 2 Public health duties, eg medicines management: running drug and therapeutics committee, managing a formulary, developing prescribing policies, health technology assessment, drug information services 1 2 Supporting professional activities (SPA) Work to maintain and improve eg CPD, teaching and training, management 2.5 the quality of healthcare of doctors in training, audit, job planning, appraisal, revalidation, research, contribution to service management and planning, clinical governance activities Other NHS responsibilities eg Caldicott guardians, clinical audit leads, Local agreement clinical governance leads, undergraduate and with trust postgraduate deans, clinical tutors, regional education advisers, medical management responsibilities External duties eg work for national NHS bodies, work for other Local agreement external bodies (eg Medicines and Healthcare with trust Products Regulatory Agency, CSM, NICE, Royal Colleges, General Medical Council, Postgraduate Medical Education and Training Board, British Medical Association), NHS disciplinary procedures, NHS appeals procedures, advisory appointments committees 102

PART 2 Clinical pharmacology and therapeutics Note: The allocation of PAs worked by a consultant clinical pharmacologist will be variable. Most job plans are likely to involve extra PAs beyond the standard 10, allowing consultants to undertake other responsibilities and external duties (outlined above) in addition to the standard job plan. This is particularly important in clinical pharmacology where a relatively small number of consultants are strongly represented in national bodies such as the Medicines and Healthcare Products Regulatory Agency (MHRA), NICE, CSM and NPIS. There will be times in the career of a consultant when management and national duties increase to the extent that they will need to be reflected within the standard 10 PA job plan. Consultants who hold academic posts are likely to share NHS responsibilities with other academic colleagues, reducing the commitment to the clinical service when compared to full-time NHS colleagues. References 1. Royal College of Physicians. Clinical Pharmacology and therapeutics in a changing world. Report of a working party. London: Royal College of Physicians, 1999. 2. The Federation of the Royal Colleges of Physicians of the United Kingdom. Census of consultant physicians in the UK, 2003. Data and commentary. London: RCP, 2003. 3. Federation of Royal Colleges of Physicians of the UK. Acute medicine: the physician s role. Proposals for the future. Aworking party report of the Federation of Medical Royal Colleges. London: Royal College of Physicians, 2000. 4. Royal College of Physicians. Governance in acute general medicine. Recommendations from the Committee on General (Internal) Medicine of the Royal College of Physicians. London: RCP, 2000. 5. Maxwell SRJ, Walley T. Teaching prescribing and therapeutics. Br J Clin Pharmacol 2003;55:496 503. 6. Federation of Medical Royal Colleges. Census of consultant physicians in the UK, 2001. Data and commentary. London: RCP, 2001. 7. Follett B, Michael Paulson-Ellis M. A review of appraisal, disciplinary and reporting arrangements for senior NHS staff with academic and clinical duties. A report to the Secretary of State for Education and Skills, September 2001. 103