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.

In the USA, the approach was to adopt unit dose dispensing and pursue decentralisation of pharmacy services. In the UK, the unification of the prescription and the administration record meant this document needed to remain on the hospital ward and required the pharmacist to visit the ward to order medicines. Clinical pharmacy thereby emerged from the presence of pharmacists in these patient areas and their interest in promoting safer medicines use. This was initially termed ‘ward pharmacy’ but participation in medical ward rounds in the late 1970s signalled the transition to clinical pharmacy.

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).

Table 1.1 Drug use process (DUP) indicators

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).

Despite the level of activity that intervention monitoring revealed, together with evidence of cost containment and a broadly supportive health care system, frustrations began to appear. These, in part, stemmed from a lack of certainty about the fundamental purpose of clinical pharmacy and from tensions between the drive towards specialisation in clinical pharmacy and the need to improve services of a more general level in hospitals and other care settings.

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.

Table 1.2 Definitions of clinical pharmacy, pharmaceutical care and medicines management

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).

The scale of the misadventure that these findings reveal, coupled with increasing concerns about the costs of drug therapy, creates an opportunity for a renaissance in clinical pharmacy practice, providing that it realigns strongly with patient safety, cost-effectiveness and prevention of ill health. In practice, community pharmacists may be uniquely placed to help reduce the level of medication-related morbidity in primary care by virtue of their accessibility and existing relationships.

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:

• Collecting information on medication history using the most recent and accurate sources of information to create a full, and current, list of medicines;

• Verifying this list against the hospital drug chart and ensuring that any discrepancies are identified and acted upon;

• Documenting and communicating any changes, omissions or discrepancies.

This process requires the name of medicines, dosage, frequency and route of administration to be established for all medicines taken prior to admission. The information collected as part of medicines reconciliation is a pre-requisite for medication review, which is a process which considers the appropriateness of treatment and the patient’s medication-taking behaviour.

Pharmaceutical consultation

Structured postgraduate education has served to improve the knowledge of clinical pharmacists but fully achieving the goals of pharmaceutical care has proved more challenging. Part of the difficulty has been the requirement to place the patient at the heart of the system, rather than being a relatively passive recipient of drug therapy and associated information. To deliver pharmaceutical care requires more than scientific expertise. It mandates a system that describes the role and responsibilities of the pharmacist and provides the necessary infrastructure to support them in this role and, secondly, a clear process by which the pharmacist can deliver their contribution to patient care.

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.

Table 1.3 Key elements of the care process

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