A TEXT BOOK OF CLINICAL PHARMACY PRACTICE

2
CLINICAL PHARMACY: AN
INTERNATIONAL PERSPECTIVE
Christopher Doecke

Learning Objectives

Upon completion of this chapter, the reader should be able

to:

Define the terms clinical pharmacy and pharmaceutical

care
Describe the origins of clinical pharmacy practice
List the factors that influence the development of clinical
pharmacy in different countries
Describe how clinical pharmacists can develop a good
working relationship with the medical profession

The Origins of Clinical Pharmacy

T hepractised
term clinical pharmacy has its origins in the hospital pharmacy
in the United States in the early 1960s. Clinical pharmacy has
been defined as the services provided by pharmacists to promote rational
drug therapy that is safe, appropriate and cost-effective. While the timing of
the emergence of clinical pharmacy practice has varied from country to
country, the reasons for its emergence have been remarkably consistent
worldwide. In many Western countries, a number of related issues coincided
to stimulate the demand for a more ‘clinical’ practice of pharmacy. These
included:

A reduced requirement for pharmacist prepared products

An increase in the number of pharmaceuticals
An increased awareness of drug related morbidity and mortality

Since the 1960s, the requirement for pharmacists to design and prepare
elaborate pharmaceutical formulations has declined as the pharmaceutical
industry took over this role. This left the pharmacist with the role of
dispensing finished products. This is an important and essential role, but has
limited impact on the patient’s health outcome. Further, much of this
dispensing function could be efficiently and safely undertaken by pharmacy
technicians or, more recently, automated systems under the supervision of a
pharmacist. This was seen as an opportunity for pharmacists to use their
professional training in more clinical ways, rather than an opportunity to
reduce pharmacist numbers.
Secondly, the number of pharmaceutical products available for human
consumption has expanded at a dramatic rate since the 1960s. This has
resulted from general advances in medicine, science and technology, with
improved drug screening and production methods. These general advances
have resulted in great improvements in disease diagnosis and monitoring,
along with a rapid expansion in therapeutic options. Together, this progress
has greatly increased the complexity of information in areas such as
pharmaceutical formulation, pharmacokinetics, dosing, pharmacodynamics,
adverse effects, drug interactions, patient compliance and
pharmacoeconomics.
The volume of new drugs and the complexity of information associated
with their use have made it very difficult for the medical profession to
maintain expertise in drug therapy as well as disease state diagnosis and
management. Pharmacists were thus a logical professional group to meet this
clinical need and work with the medical practitioner to achieve safer and
more effective use of drugs in patients, which consequently may result in
better patient health outcome.
Finally, as drug therapy has expanded, so has the opportunity for, and
incidence of, drug-related morbidity and mortality. While the understanding
that drugs can harm as well as benefit has been known for centuries, the focus
was originally always on chemicals as ‘poison’. Over the last 50 years, it has
become clear that it is not just the drug, but the way in which a drug is used
that influences both its effectiveness and its potential for harm. Again,
pharmacists were a logical professional group to guide and assist prescribers
and patients in the optimal use of drugs to minimise adverse effects and
maximise efficacy.
In summary, the decline in the pharmacist's traditional role in
compounding, occurring at the same time as an explosion in drug availability,
increased complexity of therapeutic options and increased awareness of the
potential for harm related to drug therapy, all coincided to create the
environment for the evolution of the clinical pharmacist.

Pharmaceutical Care and Clinical Pharmacy

During the evolution of clinical pharmacy in the United States, it was

recognised by some pharmacists that clinical pharmacy was often practised as
a series of services, without a clear uniting philosophy or ideal. The
termpharmaceutical carewas first used by Mikeal et al. in 1975 to define the
care a patient requires to assure safe and rational drug use. Brodie et al.
further elaborated the term in 1980 before Hepler and Strand in 1990
published a paper providing a conceptualization of pharmaceutical care that
has ultimately been widely accepted in the pharmacy and medical professions.
In essence, pharmaceutical care has the patient as the central focus and the
pharmacist directly interacting with the patient and medical practitioner to
care for the patient’s drug-related needs. The other central theme of
pharmaceutical care is that the pharmacist takes direct responsibility for the
quality of this care. This provides a strong framework for specific clinical
pharmacy activities to be coordinated towards the common goal of enhancing
the care of the individual patient.

Development of Clinical Pharmacy Practice

The reasons why the pharmacy profession has moved towards clinical
practice are clear. It is also clear that this development has not been
consistent. This uneven development applies not only among countries, but
also between regions within a country, between individual hospitals within a
region and between pharmacy practice settings. This latter point is often
overlooked when clinical pharmacy is discussed. Often, only hospital- or
institution-based pharmacy services are considered. Clinical pharmacy is
relevant to all practice settings; however, it may evolve in different ways, as
can be illustrated by the development of pharmacy practice in Australia.
The majority of pharmacy practice in Australia is based in the community
setting, with pharmacist-owned retail shops offering a drug distribution
service by dispensing and selling medicines. This service mostly relates to the
dispensing of drugs subsidised by the Australian government. The income for
pharmacies has predominantly been from government-funded dispensing
fees and from profit margins on the products sold.
Hospital pharmacy is a much smaller practice area in terms of pharmacist
numbers. While funding comes again predominantly from the government, it
is not linked to the volume of drugs issued, as in the community pharmacy
setting. The significance of this fundamental difference has been that, as the
need for a more clinical practice of pharmacy arose, community pharmacists
were hampered in the development of clinical services because they were not
paid for anything other than drug distribution. On the other hand, hospital
pharmacists were able to respond by internal re-allocation of staffing
resources to support clinical pharmacy activity.
For example, a greater utilisation of pharmacy support staff freed up
pharmacist time in many hospitals. Variations in the ability to re-allocate
resources from hospital to hospital means that some differences do exist in
the level of services provided, but almost all Australian hospitals, both
government and private, provide at least basic clinical pharmacy services.
While the issue of payment is key to explaining why clinical pharmacy has
evolved in Australian hospitals at a much greater rate than community
practices, it is certainly not the only reason. Greater access to patient
information in hospitals, opportunities to develop relationships with medical
and nursing staff, and the teaching and research culture within hospitals have
all played a major role. In community pharmacy, the reason for prescribing is
often unclear, and other information that is necessary to ensure proper drug
use recommendations, such as the patient’s laboratory results, are
unavailable. Basic patient medication counselling is the most widely available
clinical service in Australian community pharmacies, because general advice
regarding medications can be offered without knowledge of the patient’s
medical history.
In Australia and other countries, clinical pharmacy initially developed to a
much greater extent in the acute tertiary care hospital setting; however, this is
now changing. Since 1997, the Australian government has provided funding
for some clinical pharmacy services in community settings. Medication
management services, such as the review of medications prescribed to
patients in geriatric homes, are now funded independently of drug
distribution. While these new services are still evolving, the practice models
currently being established require significant collaboration between the
patient’s primary care doctor and pharmacist. With these changes and
advances in information technology, it is likely that the differences between
clinical pharmacy roles in the community and hospital pharmacy practice
settings will gradually reduce.
Variations in the development of clinical pharmacy among different
countries have also resulted from many related and unrelated factors. The
balance between public and private health services, the relationship between
the medical and pharmacy professions, the education focus of pharmacy
undergraduate and postgraduate programmes and the willingness of
individual pharmacists to relinquish or delegate their established role in
distribution or manufacturing and adopt patient-focused clinical practice,
have all contributed to the speed of adoption of clinical pharmacy in different
countries. Despite these differences, it is clear from clinical pharmacy
development throughout the world that the stimulus and need for the services
in different countries are the same. When and wherever drugs are used
therapeutically, there is a need for pharmacists to work with medical
practitioners to assist and facilitate optimal and safe drug use.
In the United Kingdom, clinical pharmacy practice in hospitals has
developed along similar lines to that in Australia. In some other major
European countries, such as Germany, pharmacy education has retained a
strong chemistry and pharmacognosy focus, which has slowed the
advancement of clinical pharmacy practice. Undergraduate pharmacy
students in some European countries now have the opportunity to complete
electives overseas, and some of these students are choosing to complete
clinical placements in countries such as Australia. With time, this should
assist the development of clinical pharmacy in Europe.
Similarly, in some Asian countries such as India, Japan, Malaysia,
Singapore and Thailand, there is increasing appreciation of the role of
pharmacists in healthcare and increasing interest in clinical pharmacy
practice. Some undergraduate and postgraduate students from these
countries study in Australia and other countries, which increases their
understanding of the pharmacist’s role in healthcare. In 2000, the World
Health Organization sponsored the clinical training of pharmacists from
Malaysian government hospitals in Australia. These pharmacists are now
passing on their skills in clinical pharmacy to other pharmacists in Malaysia.

Clinical Pharmacy in Hospitals

As mentioned earlier, clinical pharmacy had its origins in hospitals, where

distribution functions could be delegated to technicians under the general
supervision of pharmacists. This enabled pharmacists to leave the dispensary
and enter wards where they could directly interact with medical staff, nursing
staffand patients. In many cases, this was driven by the enthusiasm of
individual pharmacists with a desire and ability to expand the role of the
pharmacist within a medical team. This transition often initially involved a
service called ‘ward pharmacy’ rather than clinical pharmacy.
Ward pharmacyhas been defined as a system where the pharmacist visits
wards regularly to monitor for completeness and accuracy of prescriptions, is
available for consultation by medical and nursing staffand ensures that the
drug distribution system is operating correctly. Often, this is an important
stepping stone to a more extensive clinical pharmacy service, particularly in a
setting where less experienced and/or less educated pharmacists are the only
ones available to undertake ward-based services.
As the education, training and experience of ward-based pharmacists grew,
so did the breadth of and demand for their services. At a local level, the
appreciation of the value of the experienced and knowledgable clinical
pharmacist by medical and nursing staff was often a key reason for the
development and expansion of services in individual hospitals. Over time,
participation in medical ward rounds, medication history taking, drug
therapy selection, therapeutic drug monitoring services, provision of drug
information, adverse drug reaction monitoring and prevention, drug use
evaluation and research and teaching have become activities that now form
the basis of contemporary clinical pharmacy practice.
Given the complexity of modern drug therapy, it was not surprising that
clinical pharmacy practice across the full range of medical and surgical
patients soon became too much for a generalist pharmacy practitioner. This
has resulted in a variety of specialist clinical pharmacy practitioners in areas
such as oncology, psychiatry, geriatrics, cardiology and nephrology, to name
but a few. In countries such as the USA, these specialty practices are now
endorsed by professional and registering bodies with defined accreditation
criteria
As the practice of clinical pharmacy has grown and developed in hospitals,
so has the evidence of the benefits to patients and to hospitals. Studies have
clearly shown that clinical pharmacy improves drug therapy and overall
patient health outcome, reduces drug-induced illness and the length of
hospital stay, and reduces both drug costs and total health costs. Despite this,
the need for the cost justification of clinical pharmacy services has not
diminished as the models of health system funding continue to change.
However, the justification of services is dependent on the financial frame of
reference for an individual hospital or health service. Results of financial
benefit obtained in one country may not always be applicable in another
country with different cost structures. However, the benefits of clinical
pharmacy services to improved drug use, patient well-being and health
outcome are likely to be similar between health services and different
countries.

Clinical Pharmacy in the Community

As outlined earlier, the expansion of clinical pharmacy services to community

patients in Australia was limited by the lack of reimbursement for these
services. The same has been true in other Western countries. This situation is
now changing, in response to evidence that pharmacist involvement in drug
therapy review and management could improve the health outcome. The
Australian government now pays accredited pharmacists to undertake a
formal review of medication regimens for patients living either in the
community or in homes for the elderly. Pharmacists must undertake
additional study to become accredited to provide this service, and a referral
from the patient’s doctor is required. The pharmacist then conducts a Home
Medicines Review (HMR) by visiting patients in their own home to identify
and help resolve any medication-related problems. These are then
summarised in a written report to the patient’s doctor. The service requires
no payment from the patient as the government covers the full cost.
Other areas where clinical pharmacy may extend into the community
setting in the future include collaborative prescribing and the management of
anti-coagulation for patients taking warfarin.

Relationship with the Medical Profession

One of the most important aspects of practice for clinical pharmacists is their
relationship with medical practitioners. While many clinical pharmacy
activities such as counselling can be undertaken directly with the patient,
other interventions rely on a co-operative working relationship between the
pharmacist and the prescriber. For example, co-operation from the medical
practitioner is required to enable the implementation of significant changes
to therapy recommended by the clinical pharmacist. Good collaborative
relationships with the medical profession depend on mutual respect, and on
the pharmacists demonstrating clearly their commitment to the welfare of
patients under the physician’s care. Individual relationships can also be
strengthened by participation in non–patient care activities, such as research
and educational activities. Specialist clinical pharmacists have the opportunity
to strengthen relationships with specialist medical practitioners in their fields
by providing high-level clinical support and specialised drug information.
From a historical perspective, the factors that resulted in the need for
clinical pharmacists were also recognised by the medical profession and
resulted in the creation of a new medical specialist, the clinical
pharmacologist. The American College of Clinical Pharmacology was
founded on September 11, 1969 by a group of eminent physicians who
recognised the need for a new medical specialty to bridge the gap between the
well-established discipline of basic pharmacology and drug use in humans.
While the evolution of clinical pharmacists and clinical pharmacologists
commenced at about the same time in the 1960s with similar broad goals,
differences have emerged with time. Clinical pharmacology remains a small
but important discipline of medicine. Its influence on individual patient
outcome, however, relies on consultation requests from other medical
practitioners. Most specialist medical groups are often well- informed about
the range of medications they regularly use. The need for another medical
opinion from a pharmacology specialist is often not considered necessary.
The clinical pharmacist, on the other hand, is able to identify problems and
issues without specific consultation and is therefore in a significantly better
position to contribute positively to individual patient care.
While it has been difficult for clinical pharmacologists to have a broad
impact at the patient level, they have excelled in many areas. These include
drug utilisation at the hospital or regional level through their involvement in
drug committees, establishment of drug use guidelines, therapeutic drug
monitoring services and clinical toxicology services. These valuable services
coupled with their critical role in medical research and education has meant
that clinical pharmacologists have had a major impact on improved drug use
globally.
The overlap in focus and interest between clinical pharmacologists and
clinical pharmacists has the potential for conflict between the two
professional groups. In most cases, however, collaboration between clinical
pharmacologists and clinical pharmacists is mutually beneficial.
An important milestone in the history of clinical pharmacy development in
the United States was the publication of an editorial by Lundberg, entitled
‘The clinical pharmacist’, in the Journal of the American Medical Association
in 1983. The editorial traced the history of the development of clinical
pharmacy and endorsed the role of clinical pharmacy in patient care. This
public endorsement from a conservative medical body was of huge assistance
in legitimising clinical pharmacy in the eyes of the broad medical profession.
More recently, the American College of Physicians and the American
Society of Internal Medicine jointly published a position paper on their
current perspective on the scope of pharmacist practice in the United States.
The paper supports collaborative practice between physicians and
pharmacists but opposes independent pharmacist prescribing rights. The
paper also provides the reader with a useful overview of United States
legislation, defining responsibilities for pharmacists in the United States.
In Western countries, the healthcare needs of an ageing population have
resulted in a shortage of doctors, nurses and other healthcare professionals. In
the United Kingdom and some other countries, this shortage has resulted in
nurses and pharmacists taking on supplementary or independent prescribing
roles within their specialised area of practice. UK pharmacists who wish to do
this must complete a university-based course recognised by the Royal
Pharmaceutical Society of Great Britain. They must also undertake a
programme of practice-based learning under the supervision of a medical
practitioner. The goal is to ensure that pharmacist prescribers are competent
to practise as specified by the National Prescribing Centre, UK.
 In Australia, nurse practitioners are permitted to prescribe certain drugs
and under certain conditions, and it is possible that in the future, pharmacists
with appropriate training may follow their UK colleagues in this area. High-
quality accreditation programmes and careful negotiation will be essential to
ensure that this extension of the pharmacist’s role does not adversely affect
good relationships with medical colleagues.

Clinical Pharmacy Education

The change in pharmacy practice focus from a product to a patient would not
have occurred without parallel changes in the pharmacy undergraduate and
postgraduate curriculum. In fact, it was essential that pharmacy educators
embraced the vision of clinical pharmacy very early in its origin. The
inclusion of therapeutics and clinical pharmacy as core subjects was
fundamental to the continued progress of clinical pharmacy. Again, there has
been variation from country to country in this regard, which has also
influenced the speed of clinical pharmacy development in some countries.
As well as course content, the course length and style of teaching has also
evolved with time to meet the needs of the profession. In the United States, a
Doctor of Pharmacy degree, which requires four years of education beyond
the minimum two years of pre-pharmacy study, has become the standard for
hospital clinical practice. These undergraduate programmes are supported by
postgraduate general residencies, specialty residencies and fellowships to
further prepare clinical pharmacists for practice. In addition, and to
complement this, certification for selected areas of specialty practice may also
be required.
In other countries such as the United Kingdom, Australia and New
Zealand, the duration of undergraduate programmes has increased to a
minimum of four years, with a clear focus on clinical pharmacy and
therapeutics. These undergraduate changes are complemented by structured
postgraduate clinical pharmacy programmes ranging from diploma to
doctorate levels. In addition, a period of supervised pre- registration
experience is required before practice registration.
 The style of teaching is also an important consideration when preparing
clinical pharmacy practitioners. While pharmacology and the basis of
therapeutics can be effectively taught didactically, practical therapeutics and
clinical pharmacy require significant practice-based training to be taught
optimally.

The Future

Clinical pharmacy has been evolving for over 50 years. One of the most
exciting recent developments is the introduction of clinical pharmacy
education and practice in countries such as India, where these services have
previously been limited. In countries where clinical pharmacy services have
predominantly been located within hospitals, we are now seeing them
adopted in other healthcare settings.
The key to the continuing development of clinical pharmacy services
internationally will be demand from patients for safer and more effective drug
therapy, coupled with greater recognition of the pharmacist’s expertise in
evaluating drug information and evidence from medical literature. The
opportunity exists for significant expansion of existing clinical pharmacy
services. The concept that a healthcare team is required to meet all the
complex health needs of patients is now well- established. The clinical
pharmacist should be a primary member of such teams.
The level of uptake internationally will depend on many factors. These
include the willingness of pharmacy educators to provide courses that prepare
practitioners for clinical work, the willingness of pharmacists to delegate drug
distribution to technician support staff, the support of medical colleagues and
recognition by healthcare funders that clinical pharmacy is a fundamental
and cost-effective core health service that independently improves patient
healthcare outcome.

KEY MESSAGES

Clinical pharmacy has evolved in many countries around the

world for similar reasons.
 These reasons include a large increase in the number of
drugs available, an increase in the complexity of therapy and
a need for the safe and effective use of drugs. These demands
have occurred as the requirement for pharmacists to prepare
elaborate formulations has diminished, thus freeing them to
undertake clinical pharmacy activities to improve the quality
use of medicines.
This evolution has been varied, resulting in differences in the
level of clinical pharmacy practice among countries, and
within countries between different hospitals and other
practice settings.
Clinical pharmacy is most effective when it is practised
within a healthcare team in close collaboration with the
medical and nursing professions.

Further Reading

American College of Physicians and American Society of Internal Medicine.

2002. Pharmacist Scope of Practice.Ann Intern Med136:79–85.
Bond CA, Raehl CL and Franke T. 2001. Clinical pharmacy services,
pharmacy staffing, and the total cost of care in United States
hospitals.Pharmacotherapy20(6):609–21.
Boyko WLJ, Yurkowski PJ, Ivey MF, Armitstead JA and Roberts BL. 1997.
Pharmacist Influence on Economic and Morbidity Outcomes in a Tertiary
Care Teaching Hospital.American Journal of Health- System
Pharmacy54:1591–1595.
Brodie DC, Parish PA and Poston JW. 1980. Societal Needs for Drugs and
Drug-Related Services.Am J Pharm44:276–8.
Gattis WA, Hasselblad V, Whellan DJ and O’Connor CM. 1999. Reduction in
heart failure events by the addition of a clinical pharmacist to the heart
 failure management team; results of the Pharmacist in Heart Failure
Assessment Recommendation and Monitoring (PHARM) Study.Arch
Intern Med159:1939–45.
Hepler CD and Strand LM. 1990. Opportunities and Responsibilities in
Pharmaceutical Care.Am J Pharm53:75–155.
Hughes J, Donnelly R and James-Chatgilaou G. 2001.Clinical pharmacy: a
practical approach. The Society of Hospital Pharmacists of Australia.
Johnson JA and Bootman JL. 1997. Drug-Related Morbidity and Mortality
and the Economic Impact of Pharmaceutical Care.American Journal of
Health-System Pharmacy54:554–558.
Kaboli PJ, Hoth AB, McClimon BJ and Schnipper JL. 2006. Clinical
Pharmacists and Inpatient Medical Care. A Systematic Review.Arch Intern
Med166:955–964.
Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, Erickson JI et al.
1999. Pharmacist participation on physician rounds and adverse drug
events in the intensive care unit.JAMA282:267–70.