USOS EDUCATIVOS DEL RELATO DIGITAL

By the mid-1960s, frustrated with their constrained role and loss of professional identity, “pharmacists steeped in knowledge about drugs stepped out of the shackles of ‘count and pour’ practice and asserted themselves as ‘drug information experts’” (Higby, 1996, pp. 40- 41). In the US, clinical pharmacy emerged and the pharmacy profession was transforming itself (Zeind & McCloskey, 2006). The American College of Clinical Pharmacy (ACCP) defines clinical pharmacy as “that area of pharmacy concerned with the science and practice of rational medication use” (American College of Clinical Pharmacy, 2008, p. 816). It is the application of pharmaceutical expertise to activities and services which are aimed at maximising drug efficacy and minimising medication related problems (Lampert, Krähenbühl, Hersberger, & Schlienger, 2006).

According to Pearson (2007), with the emergence of clinical pharmacy there was a rapid move to extend and integrate new and diverse services, such as therapeutic drug monitoring services, into the pharmacist’s scope of practice. There was also a shift toward increased and closer interaction with the medical and other health care professions. Hepler and Strand (1990, p. 534) argued that this was an “introspective transitional stage, in which pharmacy pursued professional identity and legitimation”, and was characterised by pharmacists innovating and performing new functions and making “original contributions to the literature”. They further suggested that it was “an unavoidable response to the disappearance of the apothecary role and a necessary forerunner of professional maturation” (Hepler & Strand, 1990, p. 534).

16

Although this evolution toward clinical pharmacy started in the US in the 1960s, it was slower to occur in other regions of the world, only emerging in the 1970s in the United Kingdom (UK) (Walker, 1996) and only in the 1980s in South Africa (Summers, Summers, Rawnsley, & Hurwitz, 1987). Writing in 1987, Dowse and Kanfer (1987, p. 181) expressed the opinion that “Hospital pharmacy could be regarded as the embryonic stage of clinical pharmacy and in some of our hospitals today, the innovative hospital pharmacist may even be considered to be a prototype clinical pharmacist”.

Clinical pharmacy concepts and practices were largely developed within institutional pharmacy, where hospital pharmacists, who had previously been on considered to be on the margins of the profession, took the lead (Higby, 1996). Consequently the shift toward greater patient-focus and extended clinical roles was significantly less within community pharmacy settings (Gilbert, 1998b; Wiedenmayer, Summers, Mackie et al., 2006). A report by the US Department of Health and Human Services (1990), stated that despite much evidence that pharmacist provided clinical interventions, reduced health costs and improved clinical outcomes, “clinical pharmacy practice has remained largely within the purview of institutional settings” (p. 8), and that evidence indicated that “provision of clinical services outside of institutional settings is uneven and often inadequate” (p. 9). The report further suggested that the reasons for this included: a product-based reimbursement structure; underutilisation of pharmacy support personnel; inter-professional barriers, including a struggle for power and autonomy with doctors; lack of access to patient medical information; inadequate training; and a lack of patient demand for the services. Mrtek and Catizone (1989) argued that the lack of access to patient medical records and information was the primary barrier to provision of clinical services outside of a hospital environment.

Hepler and Strand (1990, p. 534) noted that the clinical role was slow to penetrate the profession, being unevenly adopted by pharmacists and pharmaceutical organisations, resulting in the profession becoming what they described as: “a collection of disputatious factions and splinter groups T a profession in search of a role T still unable to choose from a bewildering variety of functions and unable to overcome a variety of barriers to clinical practice”. This “uneven pace of change” within the profession was not unexpected, since in a consideration of role theory, as it relates to the health professions, Pendergast, Kimberlin, Berardo, and McKenzie (1995, p. 558) citing Lum (1978) noted that "professional socialisation proceeds at a more uneven pace and results in a less integrated professional self-image in those professions undergoing a transition in role definition." Furthermore Pendergast and colleagues (1995, p. 558) also suggested that an “inconsistent and conflict- ridden sense of identity among persons undergoing a significant shift in societal or personal

17

roles” is common and that in a profession which is in as much transition as pharmacy, “the variability in how pharmacists conceptualise their role is potentially great as is the range of role behaviours exhibited by members of the profession”.

2.2.4 Transition to pharmaceutical care

It was within this milieu of role confusion and dividedness that Hepler and Strand (1990) argued that as a profession, pharmacy would not find a common purpose and mission by clarifying, listing or defining new clinical functions but rather by conceptualising and identifying their patient-care responsibilities. They further argued that even the most sophisticated clinical functions, unless performed in the context of professional accountability and responsibility for the wellbeing of the patient cannot be considered as professional functions. Additionally they stressed that the practice of pharmacy needs to revive what it had lost: “T a clear emphasis on the patient’s welfare, a patient advocacy role with a clear ethical mandate to protect the patient from the harmful effects of T drug misadventuring.’” (Hepler & Strand, 1990, p. 534).

Early in the 1990s, this major shift in the philosophy of pharmacy practice, which Hepler and Strand (1990) had argued for, began to materialise. This shift was described by the term “pharmaceutical care”, defined by Hepler and Strand (1990, p. 535) as “the direct, responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient’s quality of life”. The outcomes referred to by Hepler and Strand (1990) in the definition include: 1. cure of a disease, 2. elimination or reduction of a patient’s symptomatology, 3. arresting or slowing of a disease process, and 4. preventing a disease or symptomatology.

2.3 Pharmaceutical care

2.3.1 Defining pharmaceutical care

The concept of pharmaceutical care materialised within clinical pharmacy, and the first description of it, by Mikeal, Brown, Lazarus, and Vinson (1975, p. 567) - “the care that a given patient requires and receives which assures safe and rational drug usage”, encompassed the concept of rational drug use and was more product-focused. In 1980, Brodie, Parish and Poston adopted a more social and outcomes oriented approach to defining pharmaceutical care when they stated that: “Pharmaceutical care includes the determination of the drug needs for a given individual and the provision not only of the drugs

18

required, but also of the necessary services to assure optimally safe and effective therapy. It includes a feedback mechanism as a means of facilitating continuity of care by those who provide it” (p. 276). With the Hepler and Strand (1990, p. 535) definition, the responsibility of the pharmacist within the context of a patient and outcomes focus, became the central theme.

According to Deselle (2009, p. 8) Hepler and Strand zealously stressed that pharmaceutical care was not simply comprised of a list of extended of clinical functions to be performed for every patient but that it was:

T a new mission and way of thinking that takes advantage of pharmacists' accessibility and the frequency to which they are engaged by patients – a way of thinking that engenders the pharmacist to take responsibility for managing a patient's pharmacotherapy to resolve current and prevent future problems related to their medications.

As Oltmann (2009, p. 18) states, pharmaceutical care thus implies “caring ‘about’ and ‘for’ clients/patients and involves commitment, concern and responsibility for outcomes”. This changes the focus of pharmacists away from a drug or product-oriented business and management role, towards a patient–centred care role.

The concept of pharmaceutical care therefore describes a social need and a patient-centred approach to meeting this need, through the development of a caring therapeutic relationship. It also provides a description of the practitioner’s specific responsibilities. Hepler and Strand (1990) suggested that the therapeutic relationship, central to pharmaceutical care, was based on a covenant between the patient, who grants authority to the provider, and the provider, who undertakes to exercise competence and commitment to the patient in meeting the patient’s medication related needs. This aspect of pharmaceutical care was later encapsulated in a definition by Cipolle, Strand, and Morley (2004) when they defined pharmaceutical care as: “a patient-centred practice in which the practitioner assumes responsibility for a patient’s drug-related needs and is held accountable for this commitment” Furthermore they suggested that:

Pharmaceutical care practitioners accept responsibility for optimising all of a patient's drug therapy, regardless of the source (prescription, non- prescription, alternative, or traditional medicines), to achieve better patient outcomes and to improve the quality of each patient's life. This occurs with

19

the patient's cooperation and in coordination with the patient's other health care providers. (Cipolle et al., 2004)

By the late 1990s the philosophy of pharmaceutical care had been accepted and adopted as the mandate for practice by numerous pharmacy organisations worldwide, including South Africa (Dunlop & Shaw, 2002; Farris, Fernandez-Llimos, & Benrimoj, 2005; Fjortoft & Zgarrick, 2001; van Mil, 2005; Williams, 2005). Subsequently, over the past two decades pharmacists, the pharmacy profession and pharmaceutical associations and organisations have worked to implement pharmaceutical care practice. Citing several authors, Daughton and Ruhoy (2009) suggested that worldwide, the history and evolution of pharmaceutical care and the approaches to the implementation thereof, have been very diverse and varied. Even the use of the term pharmaceutical care has been wide-ranging. Some authors, such as Kennie, Schuster, and Einarson (1998, p. 18) caution that “pharmacists must exercise discipline when using the term ‘pharmaceutical care’”. Arguing that it should not be used to describe pharmaceutical services, such as patient counselling, pharmacokinetic services, and medication review services, which they contend do not, on their own, constitute pharmaceutical care services. However, others, for example Farris and co-authors (2005, p. 1539) suggest that “in practical terms, pharmaceutical care means that pharmacists promise to do whatever possible to make sure the patient achieves positive outcomes from drug therapy”.

Austin, Gregory, and Martin (2006) assert that despite many diverse local and national adaptations on the concept and implementation of pharmaceutical care, specific core concepts of pharmaceutical care have been widely accepted and adopted. Central to these concepts is the “special and covenantal nature of the ‘patient-pharmacist’ relationship” (Austin et al., 2006, p. 534). The relationship is built upon the pharmacist’s duty to serve the patient and an ethical responsibility to act in the patient’s best interests and forms the foundation of the profession. The practice of pharmaceutical care makes explicit the pharmacist’s responsibility to the patient for the prevention of medicine-related illness (Austin

et al., 2006; Cipolle et al., 2004).

It needs to be noted that confusion still exists around pharmaceutical care and pharmacy practice terminology. The International Pharmaceutical Federation (FIP) Pharmacy Education Taskforce, whose role it is to develop and guide pharmacy education globally, as recently as 2010, found themselves “ensnared in the tangled web of pharmaceutical care terminology” and suggested that the discussion to which this entanglement gave rise perhaps “mirrors a much larger, often intense debate among the wider profession over

20

terminology” (Whitmarsh, Futter, Rouse, Bates, & Anderson, 2010, p. 134). Therefore, the terms clinical pharmacy and medicines management, in relation to pharmaceutical care will be discussed, before giving consideration to the drivers for and implications of pharmaceutical care.

2.3.1.1 Pharmaceutical care and clinical pharmacy

“Clinical pharmacy” is still a commonly used term in both pharmacy practice and in the related literature. It is used to describe the services performed by pharmacists in all practice settings, where medicines are prescribed, dispensed or used and describes the activities “oriented to the analysis of population and individual needs of medicines, ways of administration, patterns of use and effects of drug therapy” (Lampert et al., 2006, p. 59). The European Society of Clinical Pharmacy (2010) defines clinical pharmacy as a health specialty that describes the activities and services of the clinical pharmacist in developing and promoting the rational and appropriate use of medicinal products and devices. Whilst the United Kingdom Clinical Pharmacy Association (2009) describes clinical pharmacy as encompassing the knowledge, skills, and attitudes required by pharmacists to contribute to patient care. By describing clinical pharmacy as “an area of pharmacy involved with the science, practice, activity and service to develop and promote the rational and appropriate use of medicines, in the interest of the patient and community” the South African Society of Clinical Pharmacy (South African Society of Clinical Pharmacy, 2012) also include a patient focus in their definition of clinical pharmacy.

Following the emergence of the concept and philosophy of pharmaceutical care, the American College of Clinical Pharmacy (2008, p. 816) redefined clinical pharmacy as:

T. a health science discipline in which pharmacists provide patient care that optimises medication therapy and promotes health, wellness, and disease prevention. The practice of clinical pharmacy embraces the philosophy of pharmaceutical care; it blends a caring orientation with specialised therapeutic knowledge, experience, and judgment for the purpose of ensuring optimal patient outcomes.

This definition specifically encompasses the philosophy of pharmaceutical care, includes a “care” as an aspect and focuses on patient outcomes. Ahmed (2010) argues that no matter how clinical pharmacy is defined, in essence, it is about the provision of pharmaceutical care

21

to the patient. Clinical pharmacy therefore embraces the pharmaceutical care philosophy and merges a caring patient-orientation with specialised medication and therapeutic knowledge, experience, and professional judgment for the purpose of ensuring optimal patient outcomes. Thus, the clinical movement of the 1960’s which attempted to secure greater legitimation and identity for pharmacy as a profession, through the identification and development of new clinical functions, can be seen as having both, given birth to the pharmaceutical care movement and in the process, found its own greater purpose through an enhanced patient focus.

2.3.1.2 Pharmaceutical care and medicines management

In the UK, medicines management is defined by the National Prescribing Centre as “the entire process by which medicines are selected, procured, delivered, prescribed, administered and reviewed to optimise the contribution they make to produce informed and desired outcomes of patient care” (Anon, 2002). Although the term is often used interchangeably with pharmaceutical care (Whitmarsh et al., 2010), Simpson (2001, p. 150) suggested that the terms are not synonymous, and that medicines management is broader in scope than pharmaceutical care: ‘‘Pharmaceutical care is a type of medicines management Tbut medicines management is not pharmaceutical care.”

Barber (2001, p. 210) proposed that the medicines management concept originated within organisations responsible for the payment for medicines and consequently sought to “manage them”. He further suggested that in this context “management” refers to rationalising the use of medicines primarily for the benefit of the organisation, rather than for the patient. He did, however, acknowledge that despite its origins, newer definitions of the concept, such as the definition of the National Prescribing Centre, have a greater patient focus.

In the US the concept of medication therapy management (MTM), defined as: “a distinct service or group of services that optimise therapeutic outcomes for individual patients that are independent of, but can occur in conjunction with, the provision of a drug product” (Bluml, 2005, p. 566) also has its origins in funding organisations. Medication therapy management was first introduced in the Medicare Prescription Drug, Improvement, and Modernisation Act of 2003. The Act makes provision for both the compulsory development and provision of MTM programs for eligible beneficiaries of Medicare Prescription Medication Benefits as part of their benefits, and also payment to the service providers of such programs. MTM programs are aimed at optimising therapeutic outcomes through improved medication use

22

and thereby reducing the risk of adverse events, including adverse drug reactions.(Ramalho de Oliveira, Brummel, & Miller, 2010)

With the emphasis on services and medication it would appear that MTM is almost a departure from the emphasis on the patient-pharmacist relationship and the patient-focus, central to pharmaceutical care. However, McGivney, Meyer, Duncan-Hewitt et al. (2007, p. 620) proposed that MTM, as intended in the Medicare Prescription Medication Benefit, may be seen as a means of implementing the philosophy of pharmaceutical care in practice, albeit for a defined patient population. They argued that MTM is underpinned by the concept of pharmaceutical care, which requires that pharmacists accept responsibility and accountability for the medication-related needs of patients. Furthermore MTM includes a variety of strategies, such as patient counselling, motivational interviewing, patient assessment, patient education, documentation, follow-up, and inter-professional collaboration in order to adequately meet the specific medication therapy needs of patients. (McGivney et al., 2007)

Ramaldo de Oliveira and co-authors (2010) also support the opinion that MTM is the provision of pharmaceutical care services to a defined group of patients. Furthermore they suggest that “programs of this kind represent the pharmacy profession’s shift from a product focused to patient-centred practice “ (Ramalho de Oliveira et al., 2010, p. 187).

2.3.2 Drive for pharmaceutical care

The transition to pharmaceutical care has been driven by many factors including influences both external and internal to pharmacy and arising from within the profession. Knowlton and Penna (1996a) describe the external forces as:

1. Epidemiologic, including an increasingly aging and culturally diverse patient population and an increasing average number of multiple chronic diseases per patient, resulting in healthcare being sought from a variety of practitioners who prescribe medication as part of their therapeutic treatments.

2. Communication and technological advances which are: increasing the nature, scope and availability of medication and healthcare information to patients; improving the facilities available to healthcare professionals for the storage, transfer, access and analysis of patient data; and expanding the variety of medications available and the efficacy, potency and risk profiles of available medications.

3. Ethical changes associated with shifts from “provider paternalism to informed consent” (p. xiv), and greater patient autonomy and empowerment.

23

4. Economic: the increased utilisation of costly medication has resulted in third party payors attempting to limit healthcare spending by increased control over the use of medication.

They suggest that “this combination of externalities is creating health care situations in which patients are being treated by multiple prescribers with highly potent and risky medications within an anachronistic drug use system” (Knowlton & Penna, 1996a, p. xiv). Furthermore, they argue that situations such as this are responsible for the rise in mortality and morbidity indicators resulting from adverse pharmacotherapeutic outcomes and an increase in healthcare expenditure (Knowlton & Penna, 1996a).

There is much evidence in the literature to support this argument. Classen, Pestotnik, Scott Evans, Lloyd, and Burke (1997) demonstrated that the occurrence of medicine-related adverse events significantly prolonged the length of hospital stay and increased costs. A meta-analysis of prospective studies concerned with the incidence of medicine-related adverse reactions resulting in hospital admissions was undertaken by Lazarou, Pomeranz, and Corey (1998) who concluded that medicine-related drug reactions could constitute the sixth leading cause of death in the US. In the US ambulatory healthcare setting in 2000, an estimated US$177.4 billion was spent on the management of medicine-related morbidity, and medicine-related hospital admissions accounted for approximately 70% of these costs