SYMPOSIUM ON DRUG UTiliZATION 
REVIEW ISSUES 
SUMMARY REPORT 
tIlVICE$. 
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OFFICE OF INSPECTOR GENERAL 
OFFICE OF EVALUATION AND INSPECTIONS 
AUGUST 1990  SYMPOSIUM ON DRUG UTILIZATION 
REVIEW ISSUES 
SUMMARY REPORT 
Richard P. Kusserow 
INSPECTOR GENERAL 
OEI-01-89-89010  AUGUST 1990  SYMPOSIUM PRESENTERS
Dr. Jerome Avorn 
Associate Professor 
Harvard Medical School 
Director
Program for the Analysis of Clinical Strategies
Dr. Jerry Gurwitz 
Instructor in Medicine, 
Harvard Medical School 
Dr. Charles Hepler 
Chairman
Department of Pharmacy Health Care Administration
University of Florida 
Calvin Knowlton 
Associate Professor 
Philadelphia College of Pharmacy
President
Amherst Pharmacy 
Dr. Wayne Ray 
Director
Department of Pharmacoepidemiology, 
Vanderbilt University School of Medicine 
Moderator . . . . ..  ..  ...   ...   ...   ...   ...   ...   ...  ..
. . . . . . . . ..  ..  ..  ..  ..  ..  ..  ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ...   ..  ..  ..  ..  ..  ..  ..  ..  . .
TABLE OF CONTENTS 
Prescribing For The Elderly And Nursing Home Use. . 
Medication Prescribing And Utilzation In The Nursing Home: 
Literature Review 
Preventing Drug-Related Morbidity 
Intervention Opportunities In Community Pharmacy Practice 
Computerized Databases For Educational Drug Utilzation Review. . . 
Policy And Practice Recommendations For Drug Ut-.ization Review. . 
Research Questions Identified In The Symposium 
On Drug Utiization Review  . 19  SUMMARY REPORT 
The idea for this symposium began in mid-l989 when the Office of the Inspector General 
published a report on drg utilization review (DUR) and the Medicare Catastrophic Coverage 
Act. This report considered a number of issues: 
mismedication problems among the elderly; 
the gaps in the health care system that affect mismedication; and 
initiatives the Administration and the Congress could take to address some of those 
problems. 
When the original DUR report was released, it became clear that it identified several very 
complex problems. This symposium represented an attempt to expand on thos'  issues and to 
bring together scientists, practitioners, and policymakers to pursue these issues further. 
Prescribing For The Elderly And Nursing Home Use 
Dr. Jerr Gurwitz of Harvard Medical School began the symposium with a discussion from 
the physicians ' perspective of the unique aspects of prescribing for the elderly. He pointed out 
that pharacotherapy is perhaps the single most important medical intervention in the care of 
the elderly, and its proper performance requires a special understanding of the changes in 
physiology and pharmacology that occur with aging. Cross-sectional and longitudinal studies 
involving community-dwelling populations indicate that increasing age is often accompanied 
by reductions in the physiologic reserve of many organ systems, reductions that are separate 
from the effects of disease. The ability of an organism to maintain homeostasis in the face of 
an external threat often depends upon the reserve capacity of the hear, the lungs , the kidneys, 
the liver, etc. These changes have important implications for the biological basis of drug 
effects in the elderly.

Pharacokinetics is most simply defined as what the body does to a 
drg. Changes in 
pharacokinetics that occur with advancing age provide an important basis for concern about 
adverse drug reactions (ADRs) in the old. For certain medications, drg 
distrbution can vary 
importantly with advancing age. The volume of distrbution is the theoretical space in a given 
patient that is available for a paricular drug to occupy. An age-related increase in body fat at 
the expense of muscle can lead to a greater volume of distrbution in older patients for some 
medications. These changes are more prominent for drgs like diazepam and flurazepam 
highly-lipid soluble benzodiazepines prescribed for anxiety and insomnia. 
Pharacodynamics is  o a drg. The 
the study of the. sensitivity of the organism  aging process 
in the sensitivity to many medications commonly 
appears to be associated with an 
 increase 
prescribed to the elderly. Changes in pharmacodynamics, together with age-related changes in  pharacokinetics, could well be expected to place the elderly patient at some increased risk 
for ADRs. 
A few studies suggest a trend toward increasing risk of ADRs with advancing age, although 
this conclusion is open to question because none of the reviewed investigations controlled f0f 
potentially important covarates including clinical status, length of hospitalization, and 
number of medications taen concurrently. Findings do support, however, an obvious 
association between the number of drgs taken concurrently and the risk of ADRs. More 
importantly, the number of drugs that a patient is receiving is directly related to the number of 
coexisting diseases. 
The diagnosis of drg-induced illness in elderly patients is frequently complicated by the 
tendency by patients, families, and even physicians to mislabel many symptoms as signs of 
just growing old. " One maneuver with very useful diagnostic as well as therapeutic potential 
is the "therapeutic untral" of a medication of dubious value that is currently in a patier;r 
regimen. Older patients are at risk of accumulating layers and layers of drug therapy as they 
move through time. Medications used for symptomatic relief (e.  , of insomnia) are fairly easy 
to "prune  removal does not put the patient at significant medical risk. 
" as their  careful 
More challenging is the reassessment of medications that may be vital to the patient s regimen 
or may be presenting the risk of toxicity with no therapeutic benefit, such as digoxin 
quinidine, thiazides , antihypertensives, and anticonvulsants. Some clinicians may argue that if 
patients are stable and in no overt distress, it is too risky to change their regimen by removing 
drugs that may not be needed. However, it is often not appreciated that any medication that 
has the potential for toxicity with no continuing indication can represent a "time bomb" to a 
patient. 
The available evidence suggests some useful questions which physicians should use far more 
often concerning drgs prescribed for an older patient: 
Can I avoid using a drug here? 
a medication help with the patient s symptoms? 
Could  stopping 
Is this the lowest feasible dose? 
Does this drug have any particular side effects that are more likely to occur in an 
elderly patient? 
Symposium paricipants agreed that it takes precise attention to the individual characteristics 
of a patient in deciding on appropriate drug use. It is diffcult to establish simple age-based 
rules or algorithms that will be useful in all cases. The types of guJdelines identified by Dr. 
Gurwitz, however, can be of great value. The regulatory or policy implications are that there 
must be a cooperative effort among those who are involved in science, regulation, and policy  , "

formulation in the creation of such guidelines. Determining appropriate drg 
use also requires 
that particular attention be given to patient and family satisfaction with the medication as well 
as its clinical effectiveness. 
There are few firm, fast rules in gerianic pharacology, but following the very simple 
principle which says  start low - go slow" may be the best rule a physician can use in 
prescribing medications for older patients  and even that is not a very rigorous principle. 
There is interest at the regulatory level in 
learing more about the effects of drgs on the 
elderly. Specifically, the National Institute on Aging and the FDA have expressed the concern 
that so few data are available on drug testing in elderly populations. 
With increased consumer involvement in our society and our ability to communicate much 
more thoroughly, there is an important opportunity to see to it that users of medications are 
playing as active a role as possible in interacting with health care professionals. For example 
there is at least one drug company that has started to produce ",ell designed
, easy to read
large print statements of potential drug reactions, and they are providing them with 
prescriptions. That is technically called for in FDA regulations
, that a user has a right to ask 
for information about adverse drg reactions, but, in fact, it is nOt actively provided in most 
instances. Likewise, the American Association of Retired Persons (AARP) maintains an active 
program of geriatrically-oriented patient education leaflets for members who use their 
pharacy service. Increased interaction between the users of medications and professionals 
involved in the prescribing and dispensing of 
drgs can make up for some of this deficit in 
compliance. 
While the FDA approves a drg for one indication, physicians are then free to use it for other 
indications. The FDA does not approve it for one age group and then prohibit or prevent a 
physician from using a drg tested in one age group on an age group which has not been 
tested. The solution wil go wanting until the responsibility is placed on all pars of the drug
development, approval , and use process. Efficacy and toxicity in the elderly are often 
determined primarly by whether clinicians and patients are using drgs intellgently. 
Medication Prescribing And Utiization In The Nursing 
Home: Literature Review 
The nursing home setting is an area of particular concern for drg 
utilization review in the 
elderly. A number of studies have suggested approaches designed to reduce inappropriate 
prescribing and drg utilization in this environment. Therefore, a review of this literature was 
prepared for this symposium by Jerry Avorn, M.  , Jerry Gurwitz, M.  , and Stephen B. 
Soumerai , Sc.  , of Harard Medical School. In contrast to the wide range of approaches 
which have been evaluated and implemented in the hospital setting, interventions in the 
nursing home have centered around consultant pharacist activities. Although these activities 
are now Federally mandated in all nursing homes, their review found that much of the 
evaluation of such programs has been methodologically inadequat 
, and there is little evidence 
from adequately controlled studies to document their impact or cost-effectiveness. No data  exist on the quality of implementation of such consultant 
pharacist programs on a large 
scale, to address the important question of whether nominal "paper compliance" producing a 
minimum number of written recommendations per month is more common than actual impact 
on quality of care. By contrast, face-to-face educational interventions directed at physicians 
have been shown to be effective in improving prescribing for several medications. 
Polypharacy is the rule rather than the exception in the nursing home. A 1976 study by the 
Office of Long Term Care based on a sample of 3,458 nursing home patients reported an 
average 6. l drgs per patient, with some patients receiving over 20 different medications. 
There is compellng evidence to suggest that medications are frequently used inappropriately 
reported that as nursing home practice size 
in many nursing homes. A 1980 study by Ray  et al. 
increased, doctors were found to prescribe more antipsychotic medication per patient. 
Antibiotics' are another class of medication whose utilization in the long-term care setting has 
been evaluated. A possible consequence of the excessive use of antibiotics is the development 
of increasingly virulent bacterial strains, forcing reliance on potentially more toxic and 
expensive antibiotic regimens. Additionally, the underuse of potentially belleficial medications 
represents another kind of problem in nursing home drg use. 
The general lack of organized medical staff in nursing homes further impairs the ability to 
institute educational programs or to enforce standards of drg usage in this setting. Since 
approximately 50 percent of all medication orders for nursing home patients are written by the 
physician with directions for PRN (take as needed) administration, the nursing staff, by 
default, take responsibility for a substantial proportion of prescribing decisions. In addition 
the bulk of direct care for nursing home patients is provided by nurses ' aides , who often have 
little experience or formal trainIng, and who experience high turnover rates. The expectations 
and demands of patients and their families must also be considered. The pressures exerted by 
patients and family members both for and against the prescribing of many medications can be 
enormous. In addition , a factor of paricular importance is the frequent inadequacy of staff 
making it more likely that "chemical restraints
" wil be applied rather than interpersonal 
non-pharacologic solutions. 
Approaches to Improving Drug Prescribing and Utilzation in the Nursing Home 
Controlled Trials 
Studies employing these research designs provide the opponunity to control for non-
program
influences in the evaluation of a paricular nursing home intervention. The comparability of 
the control impacts on the ability to generalize from the results of such studies. 
Time-Series Studies 
The essence of the time-series design is a frequently repeated periodic measurement in a 
group or individual, with introduction of an intervention into this time series of measurements.  One-Group Pre-test/Post-test Design 
Conclusions based on the results of such studies are open to question due to the lack of a 
control group, the limited number of observations, and the associated difficulties in 
controllng for confounding factors extraneous to the intervention being studied. 
While drugs are often indispensable in the medical care of elderly nursing home patients
, the 
inappropriate use in this setting is of great concern. Medications can become a substitute for 
careful diagnostic maneuvers and/or effective non-pharacologic therapies, increasing the 
risk of serious adverse drg reactions in this already vulnerable population. In an era of cost 
containment and rising drg costs, the overuse of medications can also divert resources from 
more important purposes. 
Findings 
Although it is generally accepted that well-designed clinical trials of pharacologic 
interventions should serve as the basis for rational medication prescribing, health care delivery 
interventions are rarely subjected to the same quality of evaluation. Of the many research 
designs employed in the review literature, only one utilized an adequate control group. 
Further, the intervention being tested should be implemented in such a way that the influence 
of extraneous factors on measured outcomes of interest is minimized. Finally, the "active 
ingredient" of the intervention must clearly be defined. For example, the term "drug utilization 
review" can mean different things, from a simple review of the physician order book to make 
cenain that regulatory policies are being enforced, to scheduled face-to-face interactions with 
medical and nursing staff employing sophisticated educational protocols. 
Several other methodological issues were identified in the literature review conducted by Dr. 
Avorn and colleagues. They are summarized below. Factors drving prescribing in the nursing 
home are more complex than either the acute care hospital or outpatient settings, where 
physicians are the predominant decisionmakers. These differences must be taken into account 
in all regulatory or educational efforts. In measuring outcomes, if reported changes in 
medication "orders" include PRN medications, which many patients never use, any 
conclusions about the impact on actual drug utilization must be questioned. Reductions in 
PRN medications are often reported to comprise a large proportion of the favorable effect of 
intervention. However, many PRN orders are never administered. Programs to improve drug 
utilization and prescribing in the nursing home must also be evaluated in economic terms, 
ideally comprising a comparative analysis of at least two alternative programs in terms of both 
their costs and consequences. The economic implications of an improvement in drg 
therapy 
which reduces patients ' utilization of more expensive resources (e.  , acute hospitals) must 
also be considered. 
Unfortunately, very few published studies have attempted to address the issue of clinical 
outcomes resulting from changes in drug utilization in nursing home patients. Assessment of 
clinical outcomes is essential for the complete evaluation of any pr.ogram designed to improve 
medication prescribing and drug utilization. Examples of important clinical outcomes might  include: (1) changes in the incidence of adverse drg effects (overall or specific reactions) 
following implementation of a drg utilization review program; (2) changes in the cognitive 
behavioral, and functional status of nursing home patients associated with a program to 
improve prescribing of psychoactive medications; and (3) changes in the incidence of falls 
following a program designed to limit the occurrence of hypotensive episodes associated with 
antihypertensive medications. 
Implications for Future Research and Policy 
(1)	 Little evidence currently exists with which to evaluate the effectiveness of the current 
nationally mandated program of DUR by consultant pharacists. 
(2)  Facec.to-face educational interventions directed at physicians and focusing on principles 
of geriatric pharacology have been shown to be effective in improving prescribing to 
nursing home patients of selected medications. 
(3)	 The prominent role played by the nurses and aides in the utilization of many other 
medications in this setting suggests that educational interventions must involve nursing 
staff. 
(4)  Any study designed to evaluate the tre impact of intervention on drug Utilization must 
provide data concerning doses of medication administered to patients rather than merely 
ordered. " 
(5)	 Greater attention must be'paid to the actual clinical and economic outcomes of any such 
interventions. 
New methods for improving drg prescribing and utilization must be developed and tested. 
For example, computer-assisted feedback of therapeutic decisions has been shown to be 
effective in improving care in the ambulatory setting; the technology is readily available to 
incorporate such a strategy into the nursing home setting. However, widespread 
implementation of any new intervention must be preceded by careful evaluation according to 
rigorous standards of health services research, particularly in this vulnerable population. 
Following presentation of the literature review, symposium paricipants addressed strategies 
that should be employed in both institutional and ambulatory settings to improve the accuracy 
of drug use in elderly patients. It was agreed that the doctor, pharacist, nurse, family 
member, and patient must be involved in the following processes: 
Taking a very careful medication history  to get a feeling for what is going on in 
the complex patients, including use of over the counter (OTC) drugs. (In the 
nursing home this is somewhat more practical because OTC drugs are dispensed by 
the same people who dispense the prescription meds. That is not the case in 
outpatient care.  - " , "

Brown Bag" reviews  brown bag" has become a metaphor which came from 
having patients put all their medications in a brown bag to bring to the caregiver 
who would go over them and throwaway drugs that were outdated, abused, or not 
used intellgently. This process should be ongoing in the nursing home , and is 
critical to what ought to happen in drg regimen review in long-term care. 
Cautious withdrawal of all drgs with dubious indication: This advice sometimes 
causes controversy among physicians who may feel  I've got a patient who has 
been on quinidine for the last 20 years. Either I don t remember why I put her on it 
or the doctor who put her on it has been dead for l5 years, but I'm reluctant to take 
her off and have an arhythmia occur." However, Dr. A vorn argued that a cautious 
withdrawal is probably safer than having patients take potentially dangerous drugs 
if no one can figure out why they need them. 
a program supported by the Harford Foundation , Dr. Avorn and colleagues developed an 
In 
educational intervention to reduce overuse of psychoactive drgs in the nursing home setting. 
It consisted of four in-service training sessions for nurses; four in-service sessions for aides; 
and three one-on-one visits with prescribing physicians in their offices by a pharmacist! 
educator. Preliminary indications are that such an intervention can be effective in reducing 
excessive use of sedative drgs in the nursing home. 
Staffing is one of the major problems confronted in operating an educational intervention 
program. What is needed is a nucleus that has the clinical expertise to define the areas that wil 
be the subject of the educatiomil intervention, and knows enough about the use of computers 
and evaluation techniques to identify the providers to be educated, as well as to evaluate the 
effects of the program. The work done by such a skiled and highly motivated group must then 
be translated into the everyday world of actual health care delivery systems. 
Staffing within the nursing home is of critical importance. Unless more money is put into 
improving staffing, problems wil be encountered in changing the prescribing of psychoactive 
is not necessarly an issue of the size of the staff, but rather the atmosphere in the 
drugs.  It 
facility. 
The consultant pharmacist is not fully utilized for retrospective drg utilization review by 
long-term care (nursing home) facilities. Many consultant pharacists find themselves 
charged with the responsibility of preparing a nursing home for a Medicaid inspection, but not 
truly interacting with patients or with other professionals regarding patient-specific matters. 
There is no standard of practice for the consultant pharacist; professional training is lacking 
in geriatrc pharacology; very little is taught in American schools of pharmacy or medicine 
about geriatrcs; and systematic instrction in the proper use of drgs is not getting proper 
attention.  , "

It is possible the private sector wil get involved in drg utilization review before the Federal 
Government enters it on a large scale. The concern for DUR in the private sector is coming 
from several sources: employers who pay for drg 
benefits, insurance companies , and HMOs. 
Preventing Drug-Related Morbidity 
The symposium next turned to a discussion by C. Douglas Hepler, Ph.  , of the University of 
Florida regarding the role of the pharacist in preventing drug-related morbidity (DRM). Dr. 
Hepler called attention to one estimate (Southwick) that places the cost of drg-related ilness 
in the U.S. at around seven bilion dollars annually. By contrast  therapeutic failure" is an 
intermediate medical care outcome in which drug therapy does not secure the necessar result 
in an acceptable time period. It can result in therapeutic substitution or the addition of new 
therapy; the progress of disease; and the prolongation of symptoms and disability. Drug 
ther:1 :fY can cause the appearance of new symptoms such as adverse drug reactions and side 
effects, ct.-ug toxicity, or drug interactions with food or other drugs. 
Drug-rl-,ated morbidity may be caused by a number of factors: inappropriate prescribing, 
inappropriate delivery, inappropriate patient behavior, or inappropriate monitoring of drug 
therapy. Unresolved drug-related problems may lead to drug-related morbidity, which
, if 
unresolved, may lead in turn to drug-related mortality. 
A drg-related problem is a circumstance of drug treatment that actually or potentially 
interferes with the patient 
s experiencing an optimum outcome of medical care. Strand  el af. 
(l989) have identified eight caregories of drug-related problems. 
The patient has a medical problem that requires drug therapy (a drg indication) but no 
drug has been prescribed for that indication. 
A drg indication exists but the wrong regimen has been ordered. 
A medical problem is being treated with too little of the correct drug 
(subtherapeUtic 
dose ). 
A medical problem exists as the result of a patient s not receiving the drug, e.  , for
pharaceutical, psychological, sociological, or economic reasons. 
The patient has a medical problem that is being treated with too much of the correct 
drug (toxicity). 
The patient has a medical problem that is the result of an adverse drug reaction or side 
effect. 
The patient has a medical problem that is the result of a drug-drug, drg-food, drug-
laboratory interaction.  The patient is taking a drg for no medically valid indication. 
In order to prevent drg-related morbidity, the problem must be recognizable, the morbidity 
must be foreseeable, and the cause(s) must be controllable. Deciding what is preventable 
(recognizable, foreseeable, controllable) requires a standard of care. However, there is no 
consensus standard of care for drg therapy. In addition, there is no consensus standard for the 
drug use process. It is unsafe to assume that physicians, pharacists, and nurses somehow will 
detect, prevent, and resolve drug- related problems. Monitoring is an especially weak point in 
drug use, paricularly in ambulatory care. 
Varous studies indicate the prevalence of DRM. However, there are significant 
methodological problems with many of the DRM studies. They don t define the concept of 
preventabiiity. To further understand preventable DRM requires: a standard of care for the 
drug use process; epidemiological data regarding preventable DRM (applied standard of care); 
and consensus or, imerpretation of the epidemiological data. 
The pharacist can playa much larger role in preventing, detecting, and resolving 
drug-related problems. Pharacists are suited by education, availability (Manasse, 1988), and 
location in the drug use process. Some pharacists have already begun new functions related 
to preventing DRM, under the names of "clinical pharacy" or "therapeutic monitoring. 
Others call these functions "Prospective Drug Use Review. " The purpose of pharaceutical 
care is to achieve definite outcomes that improve a patient s quality of life by means of 
detecting, preventing, and resolving drg-related problems. Pharaceutical care should be 
integrated with the other elements of health care, but the pharmacist accepts direct
responsibility for the quality o(that care. 
The literature shows that some drug-related morbidity can be prevented, and that pharacists 
can contribute significantly to achieving that goal. This wil require significant changes in the 
philosophy and organization of the practices of many 
pharacists. The pharmacist must 
recognize new purpose and responsibility; acquire additional competence; obtain resources 
and develop relationships; and find rewards in the new practice. 
The Food and Drug Administration assessment of the impact of adverse drug reactions is that 
there are 27,000 to 28,000 reported adverse reactions annually, with hospitalization or death 
resulting from 19 percent of the cases. However, these figures may be quite below what is 
actually occurrng. Although good data on costs are lacking, it is possible that the figure could 
reach four bilion dollars in terms of bearng the load for the treatment of the consequences of 
drug-related disease. There is no systematic reporting for treatment failure, and that could 
mean that the four bilion dollar figure is not really indicative of the problem, which could be 
much larger than anticipated. 
At present, pharacists remain outside the medical "information loop." They need to learn 
how to tie information about drg use and the drug user together and relearn the idea of 
focusing on individual patients. Pharacists should be held accountable for what they do and 
evaluated for their ability to prevent drug-related morbidity. The profession might look to the  Federal Government and agencies such as HCFA for standards of practice or training. Dr. 
Hepler stated that the mission of HCFA, however, is financing, and only very recently has it 
become involved in quality care issues. It is possible that the "Effectiveness Initiative 
developed by the Department of Health and Human Services to focus on outcomes in quality 
care, could be an indication of greater awareness at the Federal level. 
The responsibility for training, retraining, or resocializing pharacists might fall to the 
employer in the case of the thousands of pharacists who work for chain stores. But unless 
the employer is given some incentive or penalty for training or not training, cooperation will 
be minimal. One way the Government can help is by setting up demonstration projects. An 
advantage of demonstration projects is the fact that the effect on economic and clinical 
outcomes can be evaluated. 
It might be advantageous to link the dispensing fee to counseling, especially at a time such as 
now when robots and compUters art handling much of what was once the job of the 
pharacist. A possible model might be that a dispensing fee is not paid when the function is 
turned over to a computer or machine, but when the pharmacist takes time to counsel the 
patient, whether the prescription is filled or not, a dispensing fee might be appropriate. No 
matter what is done or how it is done, the pharmacist must have individual accountability in 
the drug utilization review process, and the performance of individual pharmacists should be 
tracked. 
Intervention Opportunities In Community Pharmacy Practice 
The perspective of the community pharacist was analyzed by Calvin Knowlton , president of
Amherst Pharacy, Lumbenon, New Jersey. He argued that pharacists in community
pharacy practice, whether independent or chain settings, are slowly shifting their focus from 
the drug product to the patient. Although community pharmacists have always been available 
to respond to patient inquiries, until now their priority has been directed to the drug product. 
It has not been an easy task for community practitioners tb adopt a more proactive 
patient-attention style, noted Mr. Knowlton. The change in priority has been an evolving 
process, not an event. The newer pharacists seem to be nudging the profession to re-orient 
its mission. Amidst the constraints of the commercial backdrop of the majority of community 
pharacies and the highly technical nature of pharacy education, the pharacy graduates of
the past decade are intent on moving the profession in a more humanistic direction. While 
prescription or non-prescription  mainstay and preeminent domain of 
drg  products  are stil the 
the practice, the  patient-centered  approach apparently is more satisfying to contemporar
community pharacy practitioners. Patients taking multiple drgs from one or more 
physicians need someone to monitor and intervene to reduce the chance for drg-drg
interactions and/or drug-disease state incompatibilities. Community pharmacists (if not 
constrained by "management  ) are increasingly welcoming the opportunity to fulfill the role 
drug therapy monitors. 
of outpatient  Approximately l70 000 pharacists are currently practicing in traditional settings. These 
settings include: 50 000 chain pharacists; 75,000 independent pharmacists; and 45 000 
hospital pharacists. The community pharacists (chain and independent) practice in 
approximately 50 000 pharacies and fil over l.6 billion outpatient prescriptions annually. A 
varying number of these prescriptions are filed by mail-order pharacies (estimated to be 
about 2 percent). 
Activities performed by community 
pharacists have changed to reflect more patient-oriented
approaches. These include hypertension monitoring and screening, patient education regarding
self-care testing equipment (such as glucose monitoring machines), and providing patient
information or literature. Although community pharacists assert that drg distrbution
requires over 50 percent of their time, some have stated that drg information and patient care
activities encompass 25 percent of their time. Sixteen to l8 percent 
of community
pharmacists ' time is devoted to management and/or business tasks. Many community
pharacists practice a form of "hospital phdfmacy" within the community setting by serving 
as the pharmacy provider and/or consultant to nearby nursing home facilities. 
Perhaps the most important outcome of the evolving drg-to-patient paradigm shift of focus
will be to encourage community 
judgmental intervention on behalf of (or 
!Jharacists to use 
in conjunction with) patients. This opportunity exists both before and after filling a 
prescription. Yet, this judgmental intervention is constrained by the lack of formal authority to 
alter the prescription. 
Prior to filing a prescription, c9mmunity pharmacists have an opportunity to bring the patient 
into the decisionmaking process regarding certain aspects of the drg 
therapy. As the health 
care infrastrcture continues to move in the direction of patient autonomy via the process of 
informed consent (and away from the paternalistic model in which "
the health care provider
knows all and wil decide for me  ), pharacists could enable patients to select from a limited
menu of prescription drug therapy options. These include the use of generic substitution; 
pharaceutical alternatives (e.  , use of inexpensive short-acting vs. costly long-acting drgs);
therapeutic interchange (i.  , when the pharacist contacts the physician and, on behalf of the 
patient, requests a change in the prescription drug); the provision of smaller starter doses; or 
the use of protocols, in which (for managed care settings) a pharmacist provides input 
regarding cost-comparison data for treatment of a particular disease. Step-care protocol 
developed with active physician input is an alternative 
, creative, prospective DUR method
which considers both quality of drg care and economy of drug care. 
Community pharacists are able to help patients with prescription drug education (but formal 
pedagogical, prescription drg education is also needed, staning in the elementary schools).
Nuances are plentiful and important but not always obvious; but prescription 
drgs can now 
be demystified, standardized, and understandable. Some policy options embodying these 
concepts are: 
require current Pharmacy and Therapeutics Committees in each nursing home to 
perform DUR (both prospective and retrospective);  require all pharacies serving Medicaid patients (as a condition of participation) to 
perform prospective patient profie reviews; 
require all pharacies serving Medicaid patients to counsel patients on each new 
prescri;Jtion; 
policymakers and organizational decisionmakers ought to consider restoring the 
elasticity of the prescription drug market demand by retiring the fixed-dollar 
prescription deductible; and 
the Government should establish criteria to seek rebates directly from drug 
manufacturers based upon drug utilization for Medicaid patients. 
The profession of pharmacy is poised to contribute to enhance the quality and efficiency of 
medication usage in the country. Community pharmacists, panicularly, ought to be 
encouraged to apply their cognitive resources to improve the drug distribution function which 
they have responsibly discharged. While pressures from witain the profession nudge 
practitioners to adopt a stronger patient-centered standard, external mandates from the public 
sector decisionmakers would be a favorable catalyst for change. 
In the discussion following the presentation of Mr. Knowlton s paper, symposium paricipants 
indicated that until the 1950's, pharacists were compounding and recommending drugs for 
patients but with the passage of the Durham-Humphrey legislation in 1952, pharacists were 
constrained from prescribing or' getting involved with treatment decisions regarding 
the drug
products on their shelf. That constraint now has put them in a situation in the community 
pharacy of possible termnal displacement as they find themselves just "counting, pouring, 
licking, and sticking. 
An interim step occurred in the early 70' s when capitation money came from the Government 
into the colleges of pharacy. There was money and no shortage of students. Money was 
supplied to local hospitals and pharmacy staff people and faculty people were placed in local 
hospitals as teachers, in par giving birth to the idea of hospital clinical pharmacy. During that 
time a new degree was created for those people entering pharmacy. Also
, as a result of 
Medicare, the consultant pharacist s role evolved in the nursing home setting. Through all of 
this, however, there has not been any focus on community pharmacy. More and more 
pharmacists are going to work for chains - however, chain pharmacies 
fil less that 
percent of the prescriptions that are filed in this countr. Most prescriptions are stil filled in 
independent pharacies. 
Statistics also show that 70 percent of practicing pharacists are happy with their jobs 
although happiness is not the most important indicator of their performance. There should be 
. more focus on the question "Are pharacists satisfied with providing suboptimal service 
when they know they are capable of doing much more?" There are some internal mandates for 
change in pharacies. A recent conference on "Pharmacy in the Twenty-first Century  identified three key areas of need: the pharacy in the community has to demonstrate its 
value; higher expectations are needed in the practice of pharacy; and there should be 
standards of care of pharacy practice. In addition to these needs, nursing homes should be 
urged to gear up their therapeutics committees and include mandatory prospective and 
retrospective drug utilization review on their agenda with pharacist input on those 
committees. 
Computerized Databases For Educational Drug Utilzation Review 
In the final presentation, Wayne A. Ray, Ph.  , of Vanderbilt University, discussed the use of 
computerized databases for educational drug utilization review. Educational drg utilization 
review, which works by educating prescribers and other caregivers, can be an important 
component of the drug utilization review program. The advantages of this method are that it is 
minimally intrusive upon the physician-patient relationship; it improves the physician 
knowledge base and may thus l1ave benefits that accrue to persons other than those in the 
target population or receiving the target drug; and it has good provider acceptance. Much of 
the research in the field of educational drg utilization review has employed computerized 
databases. Computerized medical care databases frequently originate from systems for 
providing medical care to a defined population in which pruviders are reimbursed by a single 
third pary. For administrative reasons, these systems often maintain files that identify the 
persons belonging to the system and contain brief summaries of the medical care the members 
receive. These files include the enrollment fie, the pharmacy fie, the provider fie, and 
several other fies. 
Enrollment fie. The enrollment file enumerates persons who are members of the defined 
population. 
Pharmacy fie. The most crucial file for the purposes of drg utilization review is the 
pharmacy file. This fie includes records of prescriptions filled at the pharmacy in outpatient 
practice. 
Provider fie. The provider fie enumerates the physicians who provide care for the members 
of the defined population. 
The first step in drug utilization review is specification of the therapeutic area of interest. This 
requires selection of the drg or group of drgs for which prescribing is to be improved. The 
next step in a program of educational drg utilization review is the identification of those 
physicians or other caregivers who are to receive the educational program. To be cost 
drg 
effective,  utilization review should focus on those providers who frequently use the 
target drgs. Given the provider group to receive the educational program, the next step is the 
intervention, or presentation of the educational materials to the providers. The only method 
. that has been proven to be effective is a personal visit. Evaluation is an essential component of 
drg 
educational  utilization review. It is needed to assess the effica,cy of the educational  program and to define subgroups of nonrespondent providers for whom different methods 
may be required. 
The detailed information on the use of prescription medications in a defined population is the 
primar 
strength of computerized databases for educational drug utilization review. This 
permts one to identify high volume 
prescribers of target drgs, who can then be selected to
receive the educational intervention. The availability of this database then 
permts rapid and
economical evaluation of intervention efficacy. 
The key limitation of computerized databases is the lack of clinical detail that would permit 
more precise definition of substandard prescribing. For example
, some diuretics may induce
hypokalemia. With appropriate monitoring of serum potassium
, this adverse effect can be
prevented by provision of supplemental pOtassium. However
, all patients receiving diuretics
certainly do not need potassium supplements. With most computerized databases, there is no 
way to identify patients who should have received potassium supplement 
there is no direct way to identify physicians whose prescribing in this areab iUst  sduibds tnaontd, aarndd.  thus
Educational drug utilization review creates a better environment for both the patient ard the 
physician. The changes that are created in the physician 
s knowledge base wil have wider
effects than the specific program in which he or she is involved. For those reasons 
educational drg utilization review should be a very large part of 
drg 
utilization review
programming. It has been proven to work in a research setting. The challenge now is to find 
out how to implement it in the real world 
the world of Medicaid programs run by people
who have quite a few pressures on what they do in the realm of health maintenance 
organizations. 
The DUR provisions of the Catastrophic Care statute placed too much emphasis on a very 
limited display of a few prescriptions in a pharmacist 
s office and the idea that from that one
would be able to markedly improve prescribing. The emphasis could have been shifted more 
to educational drug utilization review. There may be a role for compUterized 
but it should not be the centerpiece of a DUR program. In screening for drug ibnatseeradc sticorenes ning,
there are a lot of programs oUt there that generate many false positives. 
In the proposed implementation stage of the Catastrophic Care drug benefit, HCFA took a 
very mechanized approach. The intent of the law might have been that DUR should occur at 
the pharacist level, as well as other points in the process. The use of computerized screens to 
identify "prescribing problems" was not written into the Catastrophic Care Act; rather
HCFA' s proposed method of complying with its view of Congressional intent. Howev,e rit  was
pharacists in the countr  , most
have compUterized profiing systems in place now that are far more
sophisticated than the system HCFA proposed. 
Following Dr. Ray s presentation, participants nOted that while the educational approach is
good, for the individual patient at the time the patient is beginning therapy, the educational 
approach may be too late. The combination of the 
pharacist providing pharaceutical 
and collaborating with the physician could offer something immediate for the patient, whcialere  the educational approach is designed to make longer-term changes in physicians ' prescribing 
behavior. Physician education and pharaceutical care don t compete, but there has been 
tension in this debate throughout the last year over the relative value of each approach. 
The Catastrophic Care Act clearly called for prospective review and also called for an 
educational program. What is needed is a comprehensive and systematic review of therapy 
not just what can be seen from a profie. The patient needs to be consulted and the 
professional must get integrated into the medical database in order to prevent drug-related 
morbidity. Although the law did attempt to speak to educational programs, it was in the 
implementation phase that problems arose. 
There is a major deficit in medical education in therapeutics, and this deficit is amplified in 
the area of geriatrics. What can be done in the wake of this deficit is to catch the errors and 
clean up after them every time they occur, or since the same people are making the errors over 
and over it would be better in the long TUn to tr to educate them to do it right. 
Policy And Practice Recommendations For Drug Utilization Review 
On day two, the symposium participants re-convened for a panel discussion with active 
involvement of all attendees. The panel was given a twofold task by Dr. Avorn, who chaired 
the discussion: 
Par one  Given that in the coming decade there wil be more governmental 
payment for medica ions used by the elderly; given that there already is such 
payment at the non-Federal level through various State programs; given that even 
if there weren t such payment, extensive medication use by the elderly would stil 
present major questions of health care delivery and medical care expenditures; as 
we gear up for the next set of bills and programs and consider those already in 
place, what would be the model DUR system those around the table would like to 
see? 
Part two - What research needs must be addressed in order for us to know more 
about DUR and how it ought to be performed, and how do we want to guide those 
efforts in the next several years? 
There are many aspects of how DUR systems work about which we do not know. The list of 
research issues is extensive: 
We know that educ itional drg utilization review programs work in small-scale 
settings run by academically oriented groups. Wil they work as well when they are 
run on a larger scale?  We need to study educational drg utilization review in more diffcult settings and 
for more difficult clinical problems, such as the nursing home and the use of 
psychotropic drugs. 
Does the widely promoted computerized feedback DUR model actually work? 
What is the role of the pharacist in the outpatient setting? 
Paricipants noted that peer review organizations (PROs) could prove to be one mechanism for 
drg 
addressing  utilization review. However, this would be appropriate only if the 
Government is wiling to allocate funds and resources to the task. PROs could argue that 
although this is very important, there are other pars of the mandate that they cannot fully 
complete at this point because they do not have enough resources. 
GAO has done a series of studies looking at the activity of the PROs with respect to drug 
utilization review. Two questions emerged: (l) Do PROs have the expertise, manpower, and 
access to data that would permit them to do appropriate drg utilization reviews? (2) What is 
the advantage? This could come to a head in some years ahead as the PROs are required to 
move into outpatient care. Suddenly, PROs could find themselves heavily involved with the 
appropriateness of prescribing practices. 
A loose nOtion of managed care is becoming prominent in health care. It is implemented in 
very different ways in different systems. What is needed is a standard, whether it is formulated 
by the Government or a public-minded private non-profit. We need a model of drug utilization 
review that takes into account all the operational aspects of making a DUR system work. The 
marketplace does not necessarly come up with the right sort of utilization management tools. 
If we are to have strategies for the dissemination of this kind of innovation, they have to be 
multi-pronged. They have to include some Government demonstrations and conferences with 
public and private providers who are doing DUR in an intelligent and scientific way.
The whole intent ofDUR should not be seen merely as "error pick-ups," but as an educational 
activity. However, in a managed care environment, where there are finite resources, the 
bottom line is always a factor. In the for-profit sector money is ultimately the priority, and 
there is concern that in some managed care organizations, money wil be the entire focus. 
There is an additional problem to consider when examining the question of managed care: the 
group that probably deserves the greatest priority is the debilitated elderly, who are receiving 
the most medication and are probably the most at risk for adverse drg effects. The debilitated 
elderly are not moving into these managed care situations in large numbers. 
The Feedback DUR Model, which is based on retrospective reviews of pharaceutical 
interventions, was not represented at the symposium. It has been dismissed as not being 
rigorous, although it is possibly the most common kind of DUR. The Feedback DUR Model is 
not represented in the body of well done  here appears to be no study 
, well controlled studies.  that meets the standards of scientific research which shows that it works. However, since it 
seems to be such a popular model, it should be tested more extensively. 
Dr. Avorn presented three models to ilustrate the limitations and strengths of the way 
academia operates, the way the private sector does things, and the Government approach. 
Because each has problems, consideration should be given to taing the best parts of each and 
bringing them together in future studies of DUR: 
Academic approach  There is enormous attention to methods. This prolongs the 
time necessary to perform and evaluate a project, and it is done on a small scale 
because that is the only way one can do something that carefully. Often the 
intervention is performed without attention to its cost-effectiveness. Detailed 
evaluations eventually emerge. 
Government approach  For political reasons it is very difficult to do a 
randomized controlled trial: one cannot say that some States or that somt. older 
people are going to get DUR and some are not. Programs are implemented on a 
massive scale , but program conceptualization, design , and evaluation are often the 
imperfect products of consensus and political necessity. 
Prvate sector approach  Interventions are brought to market rapidly, but the 
evaluation component is often neglected, and in the case of some of the examples 
presented, more than neglected. In some instances, it may even be scrupulously 
hat have to do with commercial interests. Efficiency and 
avoided for reasons 
cost-effectiveness are well tracked, but " bottom line" considerations may 
overwhelm those of quality if the two conflict. 
A question which needs to be examined is: "Is there a way that we could take the carefulness 
of the academic approach and couple it with the operational abilities of the Government 
approach and the zeal of the private sector approach to produce a well-evaluated public or 
private product - a product that lends itself to a definition of what it actually does and what 
its outcome is?" There is a real opportunity here to marr some of the academic and the 
operational in DUR with the data open to everybody. There now exists a window of time and 
opportunity. Knowing that DUR wil come up again in a few years, decisions should be made 
on how best to take advantage of this window. 
Much can also be done in terms of paricipation by pharacists. There ar some things that 
the community pharacist could do as an individual, drawing on an extensive body of 
knowledge in pharmacy. Pharacy students generally start out wanting to perfornl 
patient-related services. They are taught that in school but when they enter the real world, they 
frequently are shocked by policies and procedures of places where they go to work, and they 
. cannot implement much of what they have learned. One of the ways to empower phamlacists 
is for them to have their own pharmacy practices, which are likelYJo be patient-oriented.  An avenue available through Medicaid for DUR is claims data. They have been used for
research in the past. Yet claims data are often available with a very long lead-time, which
could result in retrospective review two or three years later. There are real research
possibilities with data which can be used as a key into the system once it is determined what
those claims data mean and how they can best be used.
It wil be unfortunate if Government doesn t tae some leadership on DUR issues, because 
without some initiative coming from the center, other forces wil make DUR less significant. 
One has to wonder why the knowledge base which has been developed in hospitals with 
Pharacy and Therapeutics Committees cannot be brought into some type of educational 
intervention committee on an outpatient basis, where physicians and pharacists get together 
for ongoing DUR discussions. 
It is possible to consider other laboratories to  utilization review and education.
tr out drug 
The Public Health Service supports some 600 community and migrant health centers around
the countr. One of the advantages of doing research in the system is having a complete and
long-term profile of drug use. Resources are built into the system for continuing education.
Another is the Indian Health Service, which provides a billon dollars a year in health care
coverage. They are atypical because of the population served, but again it is essentially a
closed provider system.

We are in a primitive state concerning prospective DUR and we are not even sure what the 
name of it should be. That is because we are not yet in total agreement about what the process 
really is. One of the things that has been very helpful is all the new thoughts that were 
introduced in this symposium on exactly what the process is and what the goal is  the goal 
is taking better care of elderly people and not wasting anybody s money in the process. There 
are a lot of ways that can be done. Some of them may involve computers, some of them may 
not. Some of them may involve steps that happen before the dispensing and before the 
prescribing, but some of them don 
Despite the nearly-implemented program that would have accompanied Catastrophic 
Coverage, we should not be so sure of ourselves that we know all there is to know about
DUR. We wil need to spend the next several years gearing up in as many different ways as
possible. Dr. Avorn concluded the discussion by nOting that whether or not one believes in the 
marketplace of commerce in shaping health care delivery, the marketplace of ideas works, 
even if it works slowly. If a given intervention or program isn t working, sooner or later
people are going to walk away from it. We need to  many options as we can and then
tr as 
perhaps, by mid-decade, we wil have objective data on what works and what does not in
DUR on which to base large-scale programs. RESEARCH QUESTIONS IDENTIFIED

IN THE SYMPOSIUM ON DRUG UTILIZATION REVIEW

Prepared by Jerry A vorn
, M. 
The fact that the symposium brought together policymakers, regulators, geriatrcians, 
pharacists, health services researchers, and a number of other individuals from many sectors 
of the health care delivery system made it possible to approach the topic of 
drg 
utilization
review for the elderly in a multidisciplinary way, and led to a number of provocative 
discussions that might otherwise never have taken place. A number of themes emerged as 
areas in need of further research for health policy planning and optimal patient care. These are 
summarzed briefly below: 
Several approaches exist to drug utilization review
, but nOt all of them have been
subjected to rigorous and methodologically acceptable evaluation. Systematic studies 
should be conducted of each of the modalities listed below considering outcomes that 
include both economic measures (cost of drgs as well as total cost of medical care) and
clinical outcomes (quality of prescribing, frequency of adverse effects, and patient 
satisfaction). Because of the importance of the issue at hand
, these must be conducted in
a randomized controlled format if the results are to be of maximum utility. 
consultant pharmacist services, as currently mandated for long-term care facilities; 
a. 
retrospective compute  based screening of prescriptions with feedback 
b. 	 of the
printouts thus generated to physicians; 
proactive face-to-face education of physicians concerning proper medication use 
c. 	
academic detailing 
concurrent computer screening of prescriptions at the pharmacy 
d. 
prior to dispensing. 
Of these, only (c) has been subjected to careful study in the recommended manner. 
Is it feasible for the community-based pharacist to engage in more effective drug
utilzation review, and if so how can this be facilitated? Much controversy exists 
concerning the actual and potential utility of having typical community-
based 
pharacists engage in evaluations of drg regimens, taking steps to improve them when 
necessar. In such studies, particular attention should be devoted to the issue of 
economic incentives , including both the need to fill large numbers of prescriptions in 
many commercial settings, as well as the question of what services are or should be 
provided in exchange for the 
currntly automatic dispensing fee.  With the inevitable automation of prescription data and other health care claims data 
what is the optimal approach to capturing and linking information in order to facilitate 
drug utilization review, parcularly for the elderly? Specifically, 
What data elements should be collected? 
a. 
What linkages between prescription data and clinical data are appropriate and 
b. 	
feasible? 
To whom should such information be made available? 
c. 
What screening procedures should be used to identif cases in need of drug 
d. 	
, and to what use should such information be put once it has been 
utilzation review
processed? 
The current U.S. health care system offers a large number of settings in which 
innovative drg utilization review strategies could be pilot tested in a careful manner 
before they are mandated nationally. These include the varous State Medicaid 
programs, State pharacy assistance for the elderly programs, health maintenance 
, professional review organizations, the Veterans 
organizations, private insurers
Adminstration, the Deparment of Defense, health care systems, and numerous smaller 
HHS-supported health care delivery systems, among others. How can experimentation 
be encouraged in these settings to inform future policy decisions? 
Considerable gaps stil exist in our knowledge of the scientific basis for proper drg use 
in the elderly. While research continues in the areas of health care delivery outlined 
above, parallel research must be conducted, ideally through the National Institute on 
Aging, on the pharacological basis of the recommendations that are to be 
implemented in any drug utilization review system. This would include more research 
on the pharacokinetics and pharacodynamics of commonly used medication in the 
aged, appropriate dosing adjusted for normal aging and for frail geriatrc patients, and 
(through collaboration with the Food and Drug Administrtion) systematic post-market 
surveilance to help identify the magnitude of and risk factors for adverse effects of 
concern in an older population.