1 Clinical pharmacy process
Clinical pharmacy, unlike the discipline of pharmacy, is a comparatively recent and variably implemented form of practice. It encourages pharmacists and support staff to shift their focus from a solely product-oriented role towards more direct engagement with patients and the problems they encounter with medicines. Over the past 20 years there has been an emerging consensus that the practice of clinical pharmacy itself should grow from a collection of patient-related functions to a process in which all actions are undertaken with the intention of achieving explicit outcomes for the patient. In doing so, clinical pharmacy moves to embrace the philosophy of pharmaceutical care (Hepler and Strand, 1990).
Development of clinical practice in pharmacy
The emergence of clinical pharmacy as a form of practice has been attributed to the poor medicines control systems that existed in hospitals during the early 1960s (Cousins and Luscombe, 1995). Although provoked by similar hospital-centred problems, the nature of the professional response differed between the USA and the UK.
Medication safety may have been the spur but clinical pharmacy in the 1980s grew because of its ability to promote cost-effective medicines used in hospitals. This role was recognised by the UK government, which, in 1988, endorsed the implementation of clinical pharmacy services to secure value for money from medicines. Awareness that support depended, to an extent, on the quantification of actions and cost savings led several groups to develop ways of measuring pharmacists’ clinical interventions. Coding systems were necessary to aggregate large amounts of data in a reliable manner and many of these drew upon the eight steps (Table 1.1) of the drug use process (DUP) indicators (Hutchinson et al., 1986).
DUP stage | Action |
---|---|
Need for a drug | Ensure there is an appropriate indication for each drug and that all medical problems are addressed therapeutically |
Select drug | Select and recommend the most appropriate drug based upon the ability to reach therapeutic goals, with consideration of patient variables, formulary status and cost of therapy |
Select regimen | Select the most appropriate drug regimen for accomplishing the desired therapeutic goals at the least cost without diminishing effectiveness or causing toxicity |
Provide drug | Facilitate the dispensing and supply process so that drugs are accurately prepared, dispensed in ready-to-administer form and delivered to the patient on a timely basis |
Drug administration | Ensure that appropriate devices and techniques are used for drug administration |
Monitor drug therapy | Monitor drug therapy for effectiveness or adverse effects in order to determine whether to maintain, modify or discontinue |
Counsel patient | Counsel and educate the patient or caregiver about the patient’s therapy to ensure proper use of medicines |
Evaluate effectiveness | Evaluate the effectiveness of the patient’s drug therapy by reviewing all the previous steps of the drug use process and taking appropriate steps to ensure that the therapeutic goals are achieved |
The data collected from these early studies revealed that interventions had very high physician acceptance rates, were made most commonly at the ‘select regimen’ and ‘need for drug’ stages of the DUP, and were influenced by hospital ward type (intensive care and paediatrics having the highest rates), pharmacist grade (rates increasing with grade) and time spent on wards (Barber et al., 1997).
Pharmaceutical care
The need to focus on outcomes of medicines use rather than dwelling only on the functions of clinical pharmacy became apparent (Hepler and Strand, 1990). The launch of pharmaceutical care as the ‘responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life’ was a landmark in the topography of pharmacy practice. In reality, this was an incremental step forward, rather than a revolutionary leap, since the foundations of pharmaceutical care as ‘the determination of drug needs for a given individual and the provision not only of the drug required but also the necessary services to assure optimally safe and effective therapy’ had been established previously (Brodie et al., 1980).
The delivery of pharmaceutical care is dependent on the practice of clinical pharmacy but the key feature of care is that the practitioner takes responsibility for a patient’s drug-related needs and is held accountable for that commitment. None of the definitions of pharmaceutical care is limited by reference to a specific professional group. Although pharmacists and pharmacy support staff would expect to, and clearly can, play a central role in pharmaceutical care, it is essentially a co-operative system that embraces the contribution of other professionals and patients (Table 1.2). The avoidance of factionalism has enabled pharmaceutical care to permeate community pharmacy, particularly in Europe, in a way that clinical pharmacy and its bedside connotations did not. It also anticipated health care policy in which certain functions, such as the prescribing of medicines, have been extended beyond their traditional professional origins to be undertaken by those trained and identified to be competent to do so.
Term | Definition |
---|---|
Clinical pharmacy | Clinical pharmacy comprises a set of functions that promote the safe, effective and economic use of medicines for individual patients. Clinical pharmacy process requires the application of specific knowledge of pharmacology, pharmacokinetics, pharmaceutics and therapeutics to patient care |
Pharmaceutical care | Pharmaceutical care is a co-operative, patient-centred system for achieving specific and positive patient outcomes from the responsible provision of medicines. The practice of clinical pharmacy is an essential component in the delivery of pharmaceutical care |
Medicines management | Medicines management encompasses the way in which medicines are selected, procured, delivered, prescribed, administered and reviewed to optimise the contribution that medicines make to producing informed and desired outcomes of patient care |
Medication-related problems
When the outcome of medicines use is not optimal, a classification (Box 1.1) for identifying the underlying medication- related problem (MRP) has been proposed (Hepler and Strand, 1990). Some MRPs are associated with significant morbidity and mortality. Preventable medication-related hospital admissions in the USA have a prevalence of 4.3%, indicating that gains in public health from improved medicines management would be sizeable (Winterstein et al., 2002). In the UK too, preventable medication-related morbidity has been associated with 4.3% of admissions to a medical unit. In nearly all cases, the underlying MRP was linked to prescribing, monitoring or adherence (Howard et al., 2003).
In prospective studies, up to 28% of accident and emergency department visits have been identified as medication related, of which 70% are deemed preventable (Zed, 2005). Again, the most frequently cited causes were non-adherence and inappropriate prescribing and monitoring. The cost of drug-related morbidity and mortality in the US ambulatory care (outpatient) population was estimated in 2000 to be $177 billion. Hospital admission accounted for 70% of total costs (Ernst and Grizzle, 2001). In England, adverse drug reactions (ADRs) have been identified as the cause of 6.5% of hospital admissions for patients over 16 years of age. The median bed stay with patients admitted with an ADR was 8 days representing 4% of bed capacity. The projected annual cost to the NHS was £466 million, the equivalent of seven 800-bed hospitals occupied by patients admitted with an ADR (Pirmohamed et al., 2004).
The rate for adverse drug events among hospital inpatients in the USA has been quantified as 6.5 per 100 admissions. Overall, 28% of events were judged preventable, rising to 42% of those classified as life-threatening or serious (Bates et al., 1995). The direct cost of medication errors, defined as preventable events that may cause or lead to inappropriate medicines use or harm, in NHS hospitals has been estimated to lie between £200 and £400 million per year. To this should be added the costs arising from litigation (DH, 2004).
Benefits of pharmaceutical care
The ability to demonstrate that clinical pharmacy practice improves patient outcomes is of great importance to the pharmaceutical care model. In the USA, for example, pharmacists’ participation in physician ward rounds has been shown to reduce adverse drug events by 78% and 66% in general medical (Kucukarslan et al., 2003) and intensive care settings (Leape et al., 1999), respectively. A study covering 1029 US hospitals was the first to indicate that both centrally based and patient-specific clinical pharmacy services are associated with reduced mortality rates (Bond et al., 1999). The services involved were medicines information, clinical research performed by pharmacists, active pharmacist participation in resuscitation teams and pharmacists undertaking admission medication histories.
In the UK, the focus has been also on prevention and management of medicine-related problems. Recognition that many patients either fail to benefit or experience unwanted effects from their medicines has elicited two types of response from the pharmacy profession. The first response has been to put in place, and make use of, a range of postgraduate initiatives and programmes to meet the developmental needs of pharmacists working in clinical settings. The second has been the re-engineering of pharmaceutical services to introduce schemes for medicines management at an organisational level. These have ranged from specific initiatives to target identified areas of medication risk, such as pharmacist involvement in anticoagulation services, to more general approaches where the intention is to ensure consistency of medicines use, particularly across care interfaces. Medicines reconciliation on hospital admission ensures that medicines prescribed to in-patients correspond to those that the patient was taking prior to admission. Guidance in the UK recommends that medicines reconciliation should be part of standard care and that pharmacists should be involved as soon as possible after the patient has been admitted (NICE and NPSA, 2007). Medicines reconciliation has been defined as:
Pharmaceutical consultation
Pharmaceutical care is predicated on a patient-centred approach to identifying, preventing or resolving medicine-related problems. Central to this aim is the need to establish a therapeutic relationship. This relationship must be a partnership in which the pharmacist works with the patient to resolve medication-related issues in line with the patient’s wishes, expectations and priorities. Table 1.3 summarises the three key elements of the care process (Cipolle et al., 1998). Research in chronic diseases has shown that self-management is promoted when patients more fully participate in the goal-setting and planning aspects of their care (Sevick et al., 2007). These are important aspects to consider when pharmacists consult with patients. In community pharmacy, one approach to help patients used their medicines more effectively is medicines use review (MUR). This uses the skills of pharmacists to help patients understand how their medicines should be used, why they take them and to identify any problems patients have in relation to their medicines, providing feedback to the prescriber if necessary. Two goals of MUR are to improve the adherence of patients to prescribed medicines and to reduce medicines wastage.
Element | Purpose |
---|---|
Assessment | The main goal is to establish a full medication history and highlight actual and potential drug-related problems |
Care plan | This should clearly state the goals to optimise care and the responsibilities of both the pharmacist and the patient in attaining the stated goals |
Evaluation | This reviews progress against the stated patient outcomes |
Clinical guidance on medicines adherence emphasises the importance of patient involvement in decisions about medicines (NICE, 2009).
Recommendations include that health care professionals should:
Medicines-taking behaviour
Intentional (or deliberate) non-adherence may be due to a number of factors. Recent work in health psychology has shaped our understanding of how patients perceive health and illness and why they often decide not to take their medicines. When people receive information about illness and its treatment, it is processed in accordance with their own belief systems. Often patients’ perceptions are not in tune with the medical reality and when this occurs, taking medicines may not make sense to the individual. For example, a patient diagnosed with hypertension may view the condition as one that is caused by stress and, during periods of lower stress, may not take their prescribed medicines (Baumann and Leventhal, 1985). Consequently, a patient holding this view of hypertension may be at increased risk of experiencing an adverse outcome such as a stroke.