Harvey A.K. Whitney Award Lectures

Clinical Pharmacy in the 1980s

Will clinical pharmacy services in hospitals survive the 1980s? My
answer to that question is “yes.” I would like to share with you some
aspects of my yes answer and identify what hospital pharmacy practitioners
and pharmacy educators need to do differently in the 1980s to ensure that
clinical pharmacy services will survive and thrive.

Beginning in the mid–1960s, patient drug history interviews, pharmacist participation
in patient care rounds, adverse drug reaction reporting, patient drug therapy
monitoring, answering drug information requests, and patient discharge drug counseling
interviews provide specific examples of pharmacists’ clinical activities. Will
these services continue to be provided and supported financially in the remaining
years of this decade? Current rapid changes within hospital care, catalyzed by the
continually increasing costs of that care, make it mandatory that hospital pharmacists
assess the past and the present to plan for the future of clinical pharmacy services.

What has been learned since the beginning of the clinical pharmacy movement in
its modern context? The hopes and aspirations of the pioneers of pharmacists’ clinical
services focused on a desire to contribute to quality patient care by using their
drug knowledge, to be respected professional colleagues of physicians and nurses, to
be respected health care professionals, and to achieve a high level of personal satisfaction
with their chosen profession.

The professional literature of the mid–1960s documented many patient drug–related
problems in hospitals. The problems included medication errors,(1,2) adverse drug
reactions,(3-5) prolonged hospitalization as a result of adverse drug reactions,(3-5) drugdrug
interactions,(6) drug–laboratory test interactions,(7) IV admixture incompatibilities,
(8) and drug–induced diseases.(9) The pioneers of clinical pharmacy reasoned that,
given an opportunity, pharmacists located in patient care areas could reduce and
prevent many of these drug–related problems. Fortunately, there were some physicians,
nurses, and hospital administrators who were interested in improving drugrelated
services and expanding the role of pharmacists, and they allocated resources
to pharmacists to let them demonstrate what they could do. From the beginning,
pharmacists were confronted with the challenges to justify their performance, determine
costs, and prove the benefits. Skeptics and critics were plentiful and included
physicians, hospital administrators, and hospital pharmacists.

What has been accomplished? What can be stated with confidence in 1982? More
pharmacists are providing clinical services than ever before in university hospitals
and large and small community hospitals. Even so, clinical services are not provided
to patients and physicians in even a majority, let alone all, of U.S. hospitals.(10) More
pharmacy students are provided clinical clerkship learning experiences than ever
before. Even so, too many students question the future use of their clinical education.
Postgraduate educational programs on clinical subjects are plentiful, and the number
of postgraduate clinical residency programs increases each year. Pharmacist participation
in clinical drug research is increasing. International interest in clinical pharmacy
continues at a high level. Clinical services, education, and research by pharmacists
are at the highest level ever.

What are the principles, the givens, the truths of the past 15 years that will be the
basis for expansion in the 1980s? Each of these will be discussed in turn.
Pharmacists can provide effective clinical services if given the time, opportunity,
and drug information support. Performance requires knowledge of drugs and their
effects on people. It also requires the skill to apply knowledge and the ability to
communicate and to work well with others. A desire to perform and a commitment
to serve the drug–related needs of patients, physicians, and nurses whenever required
are essential. Drug information support gives the clinical staff more time to provide
services and also helps expand the scope of clinical practice.

Physicians will support and use the pharmacist’s clinical services.(11-14) Drug knowledge
and skill are the basis for a good working relationship with physicians. Knowledge must be specific and accurate; the information must be available and reliable.
Physicians must believe that the pharmacist’s knowledge and skill will assist them
and benefit their patients. Pharmacists and physicians must respect each other’s roles
and responsibilities.

Nurses will support and use the pharmacist’s clinical services.(11,12) Knowledge and
skill also are the basis for a good working relationship with nurses. They, too, must
believe that the pharmacist’s services will assist them and benefit their patients. As is
the case with physicians, these professionals must respect each other’s roles and responsibilities.

Clinical services provided by pharmacists are accepted as appropriate for reimbursement
by private and government third–party payers. Precedence has been set in
many different parts of the country for pharmacists to be paid for clinical services by
third–party payers, and various methods have been developed for the payment of
clinical services.(15,16)

Patients do benefit from the pharmacist’s clinical services. Reduction of drug toxicity,
drug incompatibilities, inappropriate use, interactions, and adverse reactions
occur daily in clinical programs.(12) Specific examples of pharmacist–regulated therapy
that have been documented and evaluated include lower rate of bleeding complications
with heparin therapy, lower incidence of nephrotoxicity from the use of aminoglycosides,
reduction in serum drug concentrations of no useful clinical value, and
reduction in IV aminophylline toxicity.(a)

Well–planned and managed clinical pharmacy services are cost effective. Studies
that have included the costs for both clinical pharmacy services and drug distribution
have resulted in lower patient per day costs.(11) Reduction in drug–related problems
results in lower patient costs.

Other things we have learned include the following:

• Pharmacists’ activities for a comprehensive clinical service are
  greater than can be provided by a pharmacist in a regular workday.
  Supplying the combination of all clinical opportunities described in
  the literature exceeds an 8–, 10–, or 12–hour workday. Priorities must
  be established so that the most essential clinical activities are provided.
• Financial resources are limited. No pharmacy department will
  receive all the financial support desired for personnel. Again, service
  priorities must be established.
• Many hospitals cannot support decentralized pharmaceutical services;
  space for satellite pharmacies in the patient care areas may not
  be available. More often, the number of patients per nursing unit
  may be too small to support a decentralized service. For those
  hospitals, a centralized drug system with pharmacists in the patient
  care area only for selected clinical services will result.
• Use of pharmacy technicians to perform many of the drug distribu–
  tion tasks is essential to help free pharmacists for clinical services.
  Financial resources will not support one group of pharmacists for
  clinical services plus another group for drug distribution services.
• A centralized drug information service and a pharmacokinetics
  service are necessary to support and extend pharmacists’ clinical
  services; these areas require specialists and specific reference resources.
• Computer technology is of great assistance for drug distribution
  services. Maximum benefit of this technology has not yet been
  demonstrated and achieved for pharmacists’ clinical services.
• The demands on pharmacy management are greater for a clinical
  pharmacy program than for a traditional one. Requests for resources
  are greater and more complex. Pharmacist and physician interactions
  are frequent, and conflict can occur. Pharmacists in clinical
  practice need and request greater support to achieve their needs and
  expectations. The management decision–making process of the
  hospital or hospital system needs to be thoroughly understood;
  methods must be developed by the pharmacy director to substantiate
  requests for needed resources.

In summary, we have demonstrated that a clinical pharmacy program will improve
the quality of patient care in hospitals by reducing patient drug–related problems.
We have demonstrated that clinical pharmacy services can be provided on a
cost–effective basis. We have demonstrated that physicians and nurses will support
the clinical pharmacy program and use the pharmacist for drug information. We
have learned that the implementation of a successful clinical program needs welleducated
and committed pharmacists and competent managers. Together, staff and
managers can successfully implement cost–effective services to the benefit of patients,
physicians, nurses, and pharmacists. It has been a challenging and exciting period for
the profession of pharmacy.

The development of clinical pharmacy coincided with a massive influx of dollars
into hospital care. Government expenditures through Medicare and Medicaid plus
private health insurance have resulted in unparalleled growth of inpatient services in
U.S. hospitals. Many hospital management decisions for resource allocations before
1980 included revenue generation as an important part of decisions to implement
new services, and revenue generation was used as an essential part of requests for
approval to implement clinical pharmacy services. Revenue generation is no longer
the dominant factor of the hospital decision–making process in 1982. Expense management,
the operational cost for doing business, is the dominant factor. Business,
labor, and government have made it clear that they will no longer support the continually
high annual increases in hospital charges and costs regardless of the perceived
benefits.

The implementation and expansion of clinical pharmacy services in the 1980s will
be challenged by six external forces bearing down on the hospital. These include:
(1) federal and state government regulations and amount of payment for providing care
to Medicare and Medicaid patients, (2) price competition for government and privately
insured patients, (3) extension of cost limits to ancillary departments, (4) a
physician surplus, (5) medical liability and risk–management requirements, and (6)
accreditation and licensing requirements. Hospital pharmacy managers must develop
a complete understanding of these external forces and their probable impact on
hospital financial activities. Hospital pharmacy departments have already experienced
reduction in staff and service programs, denial of requests to implement or expand
clinical services, and freezing of institute, education, and other budget items. These
negative experiences – and I suspect more are yet to come – will test pharmacists’
belief in and commitment to providing clinical services for patients.

Four components of this new financial management era that will affect hospital
pharmacy services most directly, in my opinion, are cost control, new technology,
physician surplus, and new drugs.

In many states, hospital budgets are being controlled by governmental rate–setting
commissions. Other states are experimenting with price competition and contract
bidding for patients with the goal of reducing hospitalization costs. It is clear that the
increase in hospital budgets from year to year will be less than what has occurred in
the past decade. At the same time, the desires, wants, and needs of the medical staff
and each hospital department for financial support for personnel, capital equipment,
supplies, and services will far exceed available resources. The hospital pharmacy
department will be forced to “compete” more effectively for limited resources with
the medical staff and departments of pathology, radiology, nursing, information systems,
and others.

The pressure to control and reduce costs has accelerated the need for changes in
hospital organizational structures and relationships. Corporate reorganization, multihospital
relationships, and group purchasing programs are examples of such changes.
Patient enrollments in HMOs are increasing, and the number of patients with private
health insurance will decrease. How these changes will affect hospital pharmacy in
total is not yet clear. It is certain that physicians and patients who have a financial
stake in limiting use of health care services will lead efforts to reduce use of drugs, as
well as other diagnostic and therapeutic services.

Cost controls will have a particular impact on those hospital departments that have
a substantial supply cost component in reimbursement formulas; pharmacy is such a
department because of the cost of drug products. Dollar limits will be imposed on
ancillary departments. Pharmacy department funds are allocated for net revenue,
cost of drug products, and services provided by personnel. The greater the increase
in the cost of drugs, the less money will be available for personnel, unless the hospital
decides to reduce net revenue. Thus, as drug product costs go up, clinical services
personnel drop. The cost of drugs in U.S. hospitals is increasing each year. Successful
strategies by hospital pharmacy managers to limit the increase in the cost of drugs are
essential for the continued development of clinical services, despite promotional ef–
forts and tactics by pharmaceutical companies. Decisions about drugs to be used in
the hospital must be based on the best scientific information available. Efforts to
block or undermine objective drug formulary decisions of a hospital and medical
staff must be resisted vigorously.

Pharmacy managers must identify and explain the differences between financial
resources required for drug product costs and those for clinical services. We must
help hospital management, third–party payers, and government agencies understand
the difference between these two components as dollar limits are applied to the pharmacy
department. Without pharmacists’ clinical services, total patient costs will be
greater.(11)

Organ transplant surgery, CAT scanners, automated laboratory systems, and hospital
information systems are examples of expensive technology developed during
the past several years. New forms of technology – expensive technology – will continue
to be developed and financially supported. Some examples include nuclear
magnetic resonance to eliminate the traditional roentgenogram, additional automation
of the laboratory, hyperthermia controlled by computers for selected oncologic
conditions, and CAT scanners for interventional procedures in neurosurgery.

These technologies should result in better patient care; they will require substantial
capital allocations. How hospital management decides to support particular technologies,
or how much technology can achieve the same objective, will influence
resource allocation decisions for all hospital departments. You may be certain the
pharmacy department will be affected.

The pharmaceutical industry has predicted a “new era” in drug therapy with many
important advances in new drugs and drug delivery systems. There were more than
25 new drug entities approved in both 1981 and 1982. Over 160 drugs were in the
FDA approval process as 1982 drew to a close.

Initial experiences with recent new drugs include the following three factors: (1)
costs are three to five times more than existing similar products; (2) pharmaceutical
manufacturers used aggressive and extensive promotional practices; and (3) physicians,
nurses, and pharmacists have difficulty in keeping up with the new information.
To illustrate these factors, pharmacy and therapeutics committees are strained to
decide which new drugs should be added to the formulary, drug product costs per
patient day are increasing at rates exceeding 20%, and prescribers are confused about
which new drug to use because of the amount and type of new information.

Patient needs for safe and effective drug therapy have not changed. The drugrelated
problems identified in the mid–1960s exist today in too many U.S. hospitals.
For example, in recent years articles have identified problems of inaccurate dosage
calculations in pediatrics by physicians and nurses,(17) a high rate of medication errors,
(18) theophylline–induced seizures in accidentally overdosed neonates,(19) and nosocomial
bacteremias.(20,21) The new drugs add complexity to drug use in hospitals. Traditional
drug systems and interprofessional relationships must be modified to meet
patient needs. In my opinion, new drugs will accelerate the implementation of clinical
pharmacy services; safer and more effective patient drug therapy will result.

Many more physicians will be in practice by 1990 than at present. Authors on the
subject of physician surplus predict and describe how the relationships – including
financial – among physicians, as well as between physicians and hospitals, will change.
Economics of health care, income, and consultation fees will dominate the discussions
and decisions associated with these relationships. The physician surplus will
contribute to hospital and medical price competition and to the deregulation of the
health care industry.

Physicians exert a strong influence on hospital operations and resource allocation
decisions. More physicians are expressing concerns about costs for each line item
charged in the hospital, including drugs and pharmaceutical services. Questions are
being asked about pharmacy department costs and patient charges and how these
charges can be reduced. Pharmacy’s answers must candidly include the point that
changing physician demands can help reduce pharmacy operational costs. The reduction
of inappropriate prescribing, prescribing of high–cost drugs that are not more
effective than less expensive drugs, and widespread use of orders for p.r.n. drugs by
physicians would lower pharmacy operational costs.
A physician surplus could have an impact on clinical pharmacy services. Drug
therapy monitoring and patient assessment by pharmacists could revert back to the
physician. As more physicians become available and there is less work for them to do
in direct patient care, conflicts for drug therapy consultations and associated fees
could develop. More physicians could resist the development of the pharmacist’s
clinical role.

In summary, the financing of hospital care is in the initial stages of a revolution.
Patients, government, business, and labor have made their message clear: reduce the
spiraling costs of hospital care. Patients’ needs for quality clinical services must not
get lost in this financial revolution. The needs of patients, physicians, and nurses for
clinical drug information and safe medication systems will be greater in the 1980s
than ever before, but we have to document this. Experience and personal opinion
will not protect the progress we have made.

The expansion of clinical pharmacy services to all hospital patients who need them
in this era of price competition, coupled with new drugs and technology, presents
unique challenges and opportunities to pharmacists and pharmacy educators. How
well hospital pharmacy practitioners and educators recognize the opportunities and
develop specific methods and strategies to prepare, perform, and defend cost–effective
clinical services will determine how many patients in U.S. hospitals will receive
the benefits in this decade. To help ensure success, I offer the following comments for
your consideration and appropriate action.

Hospital pharmacy societies exist to promote the interests of their members. I
suggest a more important reason for their existence is the development and expansion
of clinical pharmacy services for patients in hospitals. I challenge each and every
organized hospital pharmacy society to develop a strategic plan committed to the
implementation of clinical services for patients in all hospitals within its specific geographical
area. This strategic plan would include (1) identification of patients who
need clinical services; (2) the best method to provide and document the services; (3)
resolution of the technician–use question; (4) recognition of the political, legal, and
economic hurdles to overcome; (5) identification of educational programs needed for
both staff and managers; and (6) active solicitation of physician, nurse, and hospital
management involvement and support to achieve the objectives.

I do not believe the standard method of society operations of councils, houses of
delegates, and boards of directors can be successful in meeting this challenge. The
subject is too big and complex to tolerate the slowness of usual society program development.
What I am recommending is for each society to develop a special study
group or task force of pharmacy managers and clinical staff who will meet several
times a year for the 2–4 years required to develop a comprehensive strategic plan. If
hospital pharmacy societies at all levels accept this challenge, state societies could use
the findings of each local society and the ASHP could use the findings of each state to
develop an overall national strategic plan.

As each society makes such a commitment, many aspects of society operations will
be clarified. Programs for continuing education, residencies, and pharmacy student
teaching will be clarified. The needs of the membership will be better met by the
society. I hear over and over again that hospital pharmacy societies do not meet the
needs of the members. What is more important than helping the members cope with
their daily practice and prepare for the future?

Without competent and effective management, clinical services will not be successfully
developed, implemented, and maintained. To ensure that adequate resources
are allocated for clinical services is a pharmacy management task. It is unfortunate
that the Board of Specialties of the American Pharmaceutical Association and selfproclaimed
clinical expert groups exclude hospital pharmacy management from their
ranks. Hospital pharmacy management is a specialty within pharmacy; it has a unique
body of knowledge and skill requirements to contribute.

Schools of pharmacy are not preparing graduates for management positions. At
the minimum, schools need to identify students with the aptitude and potential for
leadership and provide them with principles of management in their educational
program.

The profession’s rush to clinical practice has also decreased the number of residencies
with management emphasis. The American Society of Hospital Pharmacists needs to
accelerate the development of standards for an advanced residency in management.

Six specific areas of clinical pharmacy management need study and review; these
areas are the following:

1. The hospital management’s decisionmaking process, including how
   decisions are made and by whom and what data and justification are
   required for a program proposal.
2. The working relationship between the director of pharmacy and
   immediate supervisor, including the requirements for a good working
   relationship.
3. The proper location of the pharmacy department in the hospital’s
   organizational structure, specifically determining if pharmacy is a
   clinical or material department and to what level of management the
   pharmacy director reports.
4. Management methods to produce both financial and clinical results,
   including a good work measurement system.
5. Methods to increase productivity of the staff, including how computer
   technology and other techniques can be used most effectively
   for clinical services and drug distribution systems.
6. Developing essential skills to function effectively in interdisciplinary
   situations.

 

Hospital pharmacy societies must play an important role in developing and fostering
greater management expertise within hospital pharmacy. In my judgment, this
demands a high priority of attention by society leadership.

The first step for successful implementation of a clinical pharmacy program is a
definition of the services to be provided. This definition must be made by the pharmacy
staff. If the pharmacy staff does not know what it wants to do and why, how can
hospital management, medical, and nursing staffs be expected to support the proposed
changes? The definition will include each clinical activity to be provided by
pharmacists, as well as the expected benefits for patients, physicians, and nurses.
With these definitions and a personal commitment to succeed, pharmacy managers
and staff can be successful.

“How to study your own hospital” and “what patients need clinical services” are
two questions that need better answers before clinical services will expand in hospitals.
It is important to realize that hospital specificity determines what and how services
are provided. People in key management positions (administration, nursing, pharmacy,
and medical staff leadership) and hospital goals, objectives, and facilities are
all important factors to be considered in the design of cost–effective services for a
hospital. As a result, pharmacy management must develop methods for studying any
hospital that will produce the best program design for that hospital. Data to be collected
and analyzed will include (1) patient types and number of patients per service,
(2) number of hospital service areas, (3) systems for the delivery of drugs and number
of doses administered per patient day by dosage form and by time of day, (4) medical
staff visit patterns to the hospital, and (5) pharmacy department workload and facilities.
These data will translate into decisions of centralized versus decentralized systems,
scope of unit dose drug packaging programs, personnel requirements, and impact
on nursing time and that of other hospital personnel. This is an excellent topic
for seminars, resident projects, and graduate student research.

Inherent in the question of which patients need clinical services is the suggestion
that not all patients need pharmacists’ clinical services. Those who do need clinical
services need to be identified; knowing the number and type of patients will determine
a reasonable staffing requirement and, therefore, costs for services. This is a
selective approach that fits well with the era of cost limits, and it is an approach that
I believe hospital management will support. A study of a hospital patient population
should focus on selected drugs: drugs in which dosage is affected by quick changes in
patient status, drugs that require serum concentrations, drugs that interact with other
drugs, and drugs that could have a toxic effect on blood, kidneys, or liver.

Comprehensive and cost–effective clinical pharmacy services require extensive use
of pharmacy technicians. Quality patient care and the vested self–interest of our profession
can no longer tolerate failure to resolve the use and training of technicians.
Hospital pharmacists cannot let the archaic attitudes and thinking of many community
and hospital pharmacists, state boards of pharmacy, pharmacy organizations, and
employee pharmacist organizations block the proper and necessary use of pharmacy
technicians in hospitals. Every industrialized country in the world uses pharmacy
technicians in providing pharmacy services. Technicians are used extensively in the
manufacture of drugs and intravenous solutions. Yet, as soon as the drug product
passes through the door of a pharmacy, only a pharmacist can look at, handle, count,
and package the drug products. Restrictive ratios of one technician and one pharmacist
for inpatient services must be resisted. Flexibility is needed to determine pharmacy
department staffing in the 1980s and to ensure the growth and development of our
profession in clinical practice.

Most clinical pharmacy programs have not yet evolved to the extent that the combination
of clinical services and distribution is greater than can be provided by a
single pharmacist. If more pharmacists cannot be hired to expand clinical pharmacy
services, then distribution tasks must be delegated to pharmacy technicians. Pharmacists
must realize that wherever the level of technician performance is drawn, the
pharmacist’s capacity is also defined. The less technicians are allowed to do, the less
pharmacists will be able to do.

Pharmacy education is entitled to accept some of the credit for the successful implementation
of clinical services. Without a pharmacy education that gave sufficient
confidence to the pioneers of clinical services, the accomplishments of the past 15
years would not have been realized.

The challenges before pharmacy education are even greater if clinical pharmacy
services are going to be fully effective. These challenges include three elements: knowledge–
in–depth, research, and service.

Clinical pharmacists require the broad knowledge and skills of a generalist in
the use of drugs. Specific knowledge, or knowledge–in–depth, is also required. Clinical
teaching must include assignments that require the student to learn at least
one subject in great depth. The student must experience the time required, the
amount of literature to be reviewed, how to make judgments on the subject matter,
and the self–confidence that results from knowledge–in–depth. The skills developed
from this experience will be used throughout the graduate’s career as drug
information changes.

Greater participation by schools of pharmacy in research to help implement changes
in professional practice is needed. It would be helpful if schools of pharmacy would
take more of a lead role in the needed research. It must be recognized that research
limited to university hospitals is not sufficient. Research in large, medium, and small
community hospitals is also required.

Each school of pharmacy that uses hospitals as sites for student teaching should
assist in the development of comprehensive clinical services. Students need to learn
in environments where the clinical faculty members perform the services the students
are being educated to provide after graduation. Credibility is lost when the
services at the teaching sites are less than complete.

Teaching, research, and service are the responsibilities of a school of pharmacy.
Faculty members need to recognize the importance of clinical services to their own
personal growth and support. Without continual growth and success in the profession,
how long will pharmacy education and, therefore, faculties continue to be supported?
When faculty members finally realize the importance of the success of clinical
pharmacy, many conflicts within pharmacy education can be resolved, and educational
programs will advance.

Pharmacy is a service profession, and the pharmacist’s mission is to serve the drugrelated
needs of patients, physicians, and nurses. Drug therapy in the modern hospital
is a primary modality of patient care. Most hospital patients receive drugs, and the
number of drug orders and doses prepared and administered is staggering. The pharmacy
leadership in each hospital should ask the following questions: What are the
drug–related problems in my hospital? What are the alternatives for solving these
problems? What are the roles for the pharmacists in my hospital? I am confident that
clinical pharmacy services is the answer to these questions.

The 1980s is a decade of rapid change in the financing of hospital care. It is a
decade of opportunity for pharmacists. Clinical pharmacy services can reduce costs,
increase hospital efficiency, and improve the level of patient care in a cost–effective
manner.

A clinical pharmacy practice brings its own rewards to the pharmacist. To be an
expert in the clinical use of drugs presents a lifelong challenge of learning and selfstudy.
It brings professional respect from physicians and nurses and places the pharmacist
in the mainstream of caring and healing. A career in clinical pharmacy is an
open–ended opportunity for those who seek its rewards.

***

Any references cited in this lecture are available in the PDF version.

Originally published in Am J Hosp Pharm. 1983; 40:223-9.
© 1982, American Society of Health-System Pharmacists, Inc. All rights reserved.
Posted with permission.