..  . ..._._. , " : .,'". . ' :;... . , "-- - . ..--------..,-
, I 
THE CLINICAL ROLE OF THE

. COMMUNITY PHARMACIST

'RVICES. 
bt'dIa 
OFFICE OF INSPECTOR GENERAL 
OFFICE OF EV ALUA TION AND INSPECTIONS 
NOVEMBER 1990  .THE CLINICAL ROLE OF THE

COMMUNITY PHARMACIST

Richard P. Kusserow 
INSPECTOR GENERAL 
OEI-D1-B9-B9160  NOVEMBER 199"  EXECUTIVE SUMMARY 
PURPOSE 
The purpose of this study is to: (1) examne the current level of clinical seIVices available in 
community pharacy settngs, (2) identify barers that limt the availability of such seIVices 
and (3) suggest actions that can be taken to reduce barers and improve pharaceutical care 
for ambulatory patients. 
BACKGROUND 
This study expands on an issue identied in an earlier inspetion entitled "Medicar Drug 
Utilization Review." As outlined in that repon, the incidence.of mismedication among older 
adults is relatively high and reflects a number of systemic weakesses in the health care 
delivery proess. The role of the pharcist in managig drg therpy can be crtical, 
parcularly for older adults who may have complex drg regimens prescrbe for them by 
phary 
more than one physician. Our focus in this repor is on the community  settg and 
pharacy 
the clinical seIVices available to elderly ambulatory patients. Clinical  refers to 
functions performed by the pharcist on behal of the patient to identi, resolve and prevent 
drg-related problems.

frm: 
Our data were gathered  (1) a case study of community pharcists who provide a 
broad range of clinical servces to ambulator patients, (2) a review of relevant researh 
findings related to clinical pharcy  series of intervews with researhers, 
prctice, and (3) a 
academics and practitioners, as well as a focus group session with expert in the field. 
FINDINGS 
There is strong evidence that clinical pharmcy services ad value to patient care and reduce 
health care utilzation costs. 
Research demonstrates that clinical pharacy servces add value to patient care 
for both institutionalize and ambulatory patients.

Added value includes not only improvements in clinical outcomes and enhanced 
patient compliance, but also reuctions in health car costs associated with 
mismedication problems.

Clinical services are not widely provided in community pharmcy settings.  In the community pharmacy setting, signifcant barriers exist that limit the range of clinical 
services generally provided. 
pharcy 
Barers that impede provision of clinical  seIVices include the 
economic strcture of the retail pharacy industr, interprofessional conficts 
pharacy trining, 
. limitations on information available to pharacists, gaps in 
and uneven patient demand. 
There ar some community pharacists who provide a broad rage of clinical 
seIVices to their patients. Neverteless, the methods they use to overcome 
barers do not suggest simple or immedate solutions. 
RECOMMENDATIONS 
The Public Health Service and the Health Care Financing Admnistration, individually and 
collaboratively, should develop a strategy to reduce the barrers to clinical pharmcy 
amulatory elderly patients. 
services, parzicularly for 
The National Institute on Aging should tak a leadership role in developing risk indicators 
and treatment priorities for amulatory elderly patient. 
The American Pharmaceutcal Association (APhA) and the Amrican Association of Colleges 
of Pharmcy should develop standrds of practice that adress all components of clinical 
pharmcy care on the basis of patient need. 
maimu 
State governments should revise pharmcy practice acts to allow  use of technicians 
in community settngs. The APhA and State pharmcy associations should tak a leadership 
role in encouraging more extensive and effective use of technicians in commnity pharmcies. 
COMMENTS 
Ca 
Comments on the drt repon were received from the Health  Financing Admnistration 
(HCFA) and the Public Health SeIVice (PHS) within the Deparent. Whe PHS concured 
Medcaid 
with our recommendations, HCFA did not. The HCFA believes that curent State 
initiatives are adequate and sees no need for a larger collaboration effon with PHS. We 
warte 
continue to believe that a combined approach is 
Comments were also received from severa professional organizations includig the American 
Society of Consultant Pharacists, the American Association of Colleges of Pharacy, the 
American Pharaceutical Association, and the American Society of Hospita Pharacists. . All 
of these organizations were supponive of the recommendations made in the repon. Copies 
the comments received and our response to those comments appear in appendi VI.  .. . . . . ....   ....    .....    .....     .....    .....     .....     .....     .....     .......       .......       .......       .......       .......      . .....  .    .... ..     . .......     .....
. . . . . . . ..  ..  ...   .....     .....     .....     .....     .....     .... .   . ... .   ... .   . .... .    . .... .    . ......      ........        ........        ....... .      .. .... . .    . .. ... . .    . . .......        ........      . .......        ........     .  ......  .     .. ..... .     .  .. ......        ........        ........        .......      . .... .    . ... ...      ......      .......       .......       .......       ..... .    .. .. . .  ..   .. ....      ......      ......      ....    ...   ... .
TABLE OF CONTENTS 
EXECUTIVE SUMMARY 
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
FINDiNGS 
The four components of clinical pharmacy.. . . 
No clear standards to define the optimum mix of 
clinical services 
The added value of clinical pharmacy services 
Clinical services not widely provided in community 
pharmacy settings. 

. Barriers in community settings that limit the range of 
clinical services provided. . . 
RECOMMENDATIONS.. .. . . . . .. . . . . .. 
The U.S. Public Health Service and the Health Care 
Financing Administration. . . . . . . 
The National Institute on Aging. . .. . . . . .. . . . . . 
The American Pharmaceutical Association and the 
Pharmacy................ .

American Association of Colleges of 
State Governments. 

COMMENTS................................................ .

APPENDIX I 
The History of Clinical Pharmacy 
- 1
APPENDIX II 
Pharmacy Settings 
11- . . . . . . . . . . . . . . . . . . . . ..  ..  .. .  ..  ..  ... . 
.. .. .. ...  ...  ...  ...  ...  ...  ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ....   ... . . .. . . .. . . .. . . .. . ..  .. . . ...   ....   .. .. . ..  ...  ...  .. .. ...  . .. 
APPENDIX II
Case Study Methodology. . . . . . 
11 - 1

APPENDIX IV
Description of the four components of clinical 
pharmacy care. . . . . .  IV. 1
APPENDIX V
Endnotes. . . .  V. 1
APPENDIX VI
Detailed comments on the draft report and OIG 
response..  VI.  .-.--_u,-- . 
INTRODUCTION 
The purpose of this study is to: (I) examne the current level of clinical seIVices available in 
community pharacy settngs, (2) identify barers that limt the availability of such seIVices, 
and (3) sug.gest actions that can be taken to reduce barers and improve pharaceutical care 
for ambulatory patients. 
We undenook this study to examine more closely an issue rased in a previous repon entitled 
Medicare Drug Utilization Review." Drg Utiization Review (DUR) is also referred to as 
Drug Use Evaluation (DUE) and defined as a "strctur, ongoing, organizationally 
authorized quality assurace proess designed to ensure that drgs ar used appropriately, 
safely and effectively. 
The incidence of mismedication and adverse drg retions (ADRs) and other drg-related 
illness among older adults is relatively high. Beyond the incalculable human costs associated 
with mismedication among the elderly, there are signficant financial costs borne by patients, 
famlies, and public and private health insurers. One reent study conducted by the Caifornia 
State Assembly s Offce of Researh documented annual costs in that State of $340. 1 millon 
associated with hospitaizations of elderly patients for tratment of ADRs. 
One level of the health car delivery system that focuses specifcaly on drg therapy is that of 
clinical pharacy care, someties referr to as pharaceutical car. Its thee major 
functions on behalf of the patient ar: "(1) identifyig potential and actual drg-related 
problems, (2) resolving actual drg-related problems, and (3) preventig potential drg-related 
problems. " 3 
As the pharcy profession has maturd, the clinical care function has evolved and has gained 
increasing emphasis over the past decade. (For a discussion on the history of clinical 
pharacy see appendi I. 
This repon focuses on clinical seIVices available to ambulatory patients in community 
pharacy settigs. Community pharacy refers to wal-in pharacies in 
non-institutionalized settngs and includes chain drgstores, independent pharacies and 
phary 
apothecares. (Appendix n includes a detaed discussion of these and other 
settngs.) The role of the community pharacist in patient car can be crtical, parculaly for 
older adults who may have complex drg regimens prescrbe for them by more than one 
physician. In that context, policy makers and health care providers who are committed to 
improving the quality of care for the elderly and reducing health car utilization costs 
pharacy 
associated with drg therapy problems are turning more attention to the role clinical 
can play in achieving those goals. It is our hope that this repon wil assist them in expanding 
the level of pharaceutical care available to all patient groups,and pancularly older 
Americans at high risk of drg-related ilness.  Data were gathered for this study frm three major sources: 
a case study of community pharacists who provide a broad range of clinical 
seIVices to ambulatory patients (see the companion repon entitled, "The Clinical 
Role of the Community Pharcist: Case Studies," for a descrption of each 
. case study);

a review of relevant research findings related to clinical pharacy practice, 
pharacy 
including topics such as the cost!enefit of clinical  inteIVentions; the 
effects of clinical pharacy car on patient compliance; and the obstacles to 
clinical seIVices for ambulatory patients; and 
a series of inteIViews with researchers, academics and practitioners in the field of 
clinical pharacy as well as a focus grup session with expens in the field. -
(Appendix II includes a more detaled descrption of our case study methodology.
 FINDINGS

THERE ARE FOUR COMPONENTS OF CLINICAL PHARMACY PRACTICE: 
COLLECTION OF PATIENT INFORMATION, PROSPECTIVE DUR, PATIENT 
COUNSELING, AND PHYSICIAN CONSULTATION. EACH OF THESE 
COMPONENTS ENCOMPASSES A CONTINUUM OF POSSIBLE SERVICES. 
Clinical pharacy practice is composed of four major components: collection of patient 
information, Drg Regimen Review (DRR), patient counseling, and physician consultation. 
pharcy 
Research on clinical  that suppons this four-par analysis includes: the American 
Association of Colleges of Pharacy s (AACP) Committee Repon on Clinical SeIVices in 
4 the Amercan Pharaceutical Association 
Community Pharacy. Practice, s (APhA) 
Stadards of Prctice,  and Dennis Hellng s study of the functions of clinical pharacists in 
6 Our analysis is intended to be genera enough to apply to may pharacy 
famly practices.
priar  pharacy 
settings, though our  interest is in the clinical seIVice profile of community 
settings. 
Within each component of clinical pharacy, there is a rage of servces that define the 
pharcist 
s activities. In that context it should be noted that none of these components is 
simply either practiced or not practiced, in any settng. In eah of these components, Le., 
areas of practice, a pharacist may provide any combination of a wide rage of possible 
reuir 
seIVices. The intensity of these seIVices, in term of the resources  to perform them, 
vares greatly, raging from a minima level of seIVice to a maimal level. The level of 
settng, among individual 
seIVices provided also vares gratly among tys Of pharacy 
pharacists, and among patients and patient groups, even within a single pharcist

practice. The reasons for these varations in clinical practice ar discussed thoughout this 
repon. It should be noted that we ar not discussing only prevalent pratices, or even 
accepted stadads of practice, but all possible pratices. V1Ialy any pharacist in any 
setting can say, with some faiess, that she or he provides some level of clinical seIVices; 
there is vinually no such thing as a pharacist who provides no clinical car at al. 
The continuum of seIVices offered within each component afects but does not determne the 
For example, extensive data collection could enhance 
range of seIVices within the other thre. 
the pharacist s abilty to closely monitor a patient s regimen. Neverteless, a given 
seIVices. 
community pharacist could perform a maimal level of data collection, but stil provide only 
minimal or moderate monitorig  The following is a graphic display of each component. An expanded discussion of the full 
range of clinical pharacy seIVices is include in appendix IV. 
Collection of Patient Information 
From Patient 
present 
present patinrs
precrption aTe drgs  c:ncms  lab data 
drgs 
Min. 
allergies  pat drugs  course of tretment'  diagnostic data 
chronic conditions  . hospitaiztion 
From Physician 
Drug Regimen Review 
Screening and Evaluation of Data 
Computer Screens For:  Pharmacist Evaluates Data 
drg-dru  dru-dsease
dosge  interactons  interctons 
Min.  Max. 
duplications  drug-allergy 
interactions  Patient Counseling 
new prescriptions 
follow-up 
verbal  counseling 
writtn information

information and. 
nae of  chcking  checking 
explanation 
drugs  administrtion  compiiace  for ADRs 
Max.
Min. 
dosage  potetil chcking contating
ADRs  effectvene  noncompliant 
of drg  patients 
Physician/Pharmacist Consultation

cotat between 
colloction of pharacy
physician and  physician phones  wilh medic plctce:
pharmcist  pharacist to seek 
pharmact reviws 
to aulhorie  pharacist's advice 
on drg  medicl file of each patient 
prescription 
Max. 
Min. 
pharmacist phones  sharng of exam  in-prsn patient 
physician to discuss  data, la data  ca coference: 
therapeutic or pricing issues  diagnostic data  (famiiy practce model)  II.  THERE ARE NO CLEAR STANDARDS THAT DEFINE THE OPTIMUM MIX 
OF CLINICAL PHARMACY SERVICES IN THE CONTEXT OF INDIVIDUAL 
PATIENT NEED. 
In an ideal community setting, a pharcist would have the capability to provide maximal 
level seIVices in all clinical components for every patient in car. However, even in such a 
esettfinfgc, mieaJimnatlle vuel sseIeVic eos wfo urlde nost boe inudicratcede fors al. p atients, nor would they be an
mix of seIVices based on patient need, a number of questions must 
In determining the corrct 
be addrssed For example, what constitutes counseling that patients should receive? What is 
the minimum amount of information that should be provided to all patients? How should that 
themselves 
wrnen form, or both? Should pharacists 
information be conveyed-orally, in 
counsel the patient each time a drg is dispensed? Which patients should receive close 
. monitoring by pharaciststhat is, who are the high-risk patients in need of maimal level 
examnation of the functions 
seIVices? These are but a few of the issues that surace in a close 
pharacy. 
encompassed by clinical 
industr itself about these 
Unfonunately, there is litte consensus within the profession or the 
issues. Similarly, we could find very litte research in the scientic and academic 
needs. 
communities regarding stadads of clinical pharacy care as applied to patient .
nee 
determning patient  each approaching 
Two research projects that do addrss the issue of 
identied The fit is a study conducted by 
the problem from a dierent persective, were 
Koechler et al. at the University of Minnesota on indicators for the selection of ambulatory 
patients who warant close pharacy monitoring. The researhers developed six prognostic 
drg outcomes and 
indicators and conducted a retrospective char review to identify adverse 
outcomes 
their relationship to those indicators. The study documente evidence that adverse 
present incrased Patients with a history of 
incrased as the number of indicators 
appear at highest risk of adverse outcome. ? A second 
noncompliance (one of the indicators)  Strd 
stadads of car is reflected in the work of Linda 
approach that focuses specifically on 
stadazes 
developed an instrment that 
at the University of Florida. Strd has 
s data base, patient care activities, and therapeutic 
documentation of a clinical pharacist 
plans. Adherence to the functions within this schema would theoretically result in an 
risk 
patient. Pharcists would identiy and trat high-
individualize treaU1ent plan for each 
patients not by applying generaize indicators, but by charng individualizd risk profies 
for ambulatory patients clearly hold promise but 
These approaches to improving drg therapy 
understad that the 
require more practical application and testing to document their value. We 
study to determne categories of patients 
General Accounting Offce wil also be conducting a 
pharcy servces. In the near term, however, 
and drgs that require maxima level clinical 
pharacy  be resolved 
the question pf standardizing  seIVices based on patient need wil not 
easily.  II. 
THERE IS STRONG EVIDENCE THAT CLINICAL PHARMACY SERVICES 
ADD VALUE TO PATIENT CARE AND REDUCE HEALTH CARE 
UTILIZATI0N COSTS.

The value of clinical seIVices is substantiated by the scientific literature on the subject. A 
number of research projects conducted in institutional and ambulatory settings have 
documented this added value: 
A study conducted in six pharacies in Virginia measured the effect of 
pharacists' monitoring and educational seIVices provided to hypenensive 
patients. Results demonstrated bener compliance in the experimental group of 
bloo 
patients (44 of 70) than in the control group (23 of 66). Improved 
and 58 percent 
pressure was achieved in 74 percent of the experimenta group 
of the control group. 
A study in Memphis of non-institutionalize patients of a hospita outpatient 
s communication of
clinic measured the relationship betWeen the pharcist

information and patients ' compliance 
different levels of wrnen drg therpy 
that reeived the 
rates with antibiotic drg regiens. The experienta grup 
compliace rate of 84.7 percent while 
highest level of information had a mean 
those patients receiving less information had a compliance rate of 63 percent. 
A literature review of studies assessing costs and benefits of 
pharacist-conducted drg regimen reviews in skiled nursing facilities was 
decases in number 
published by Samuel Kidder in 1987. The studies showed 
of medications prescrbed per patient, hospitaizations, cost of medications and 
$220 million in 
other factors. Kidder s analysis projecte annual savings of 
pharcy 
resulting from clinical  inteIVentions. II 
avened health car costs 
Integrtion of clinical pharacy serces within a private medcal practice is one 
pharacists in 
technique that has been used on a limited basis to involve clinical 
primar car. Under this model, the pharacist provides a number of seIVices to 
the office, including drg therapy consultation with physicians, mon1it2o r(iUnngd oefr 
for each patient, and patient education and counseling. 
drg therapy 
this model pharcists do not dispense drgs.) An evaluation of one such 
practice by the University of Iowa was able to document favorable effects of 
pharacy  In a retrspective review of 
inteIVentions on patient car. 
for 
regarding specific drg therapy 
recommendations made by pharacists 
pharacists found that such 
patients, a peer review panel of physicians and 
recommendations resulted in favorable outcomes in patient care for tWo thirds of 
all cases. 13
 _.__.. -
_0'" 
In a demonstrtion project funded by the John A. Hanord Foundation of New 
York, high-risk elderly patients were enrolled in a randomized controlled tral 
prior to discharge frm a non-teaching community hospita in nonhern 
to clinical/diagnostic data 
Caifornia. The pharacist, who had access 
coordinated activities with attending physicians, provided intensive discharge 
' drg therapy for three months 
counseling to patients, and monitored patients
, home visits 
following discharge. (Monitoring included telephone consultation
and brown-bag sessions in the pharacist s offce.) Preliminar results from the 
study indicate that clinical pharacy inteIVentio!ls provided to the experimental 
group improved both patient compliance and the quality of physician prescribing 
patterns. 
A study conducted by researchers frm the University of Washington provided a 
range of clinical pharacy seIVices to elderly residents of a congrgate housing 
initial assessment in which problems of medication 
facilty. Following an 
drg 
compliance, regien comprehension, drg interations, and  storage were 
identified, clinical pharists provide the subjects with individualize 
instrctions, drg therapy counseling and regimen monitoring in their homes 
over a tWo-year period A final assessment of the project conducted one year 
after the inteIVention found a significant II percent decrase in the number of 
pres  tions taen and a 39 percent decrase in the number of medcations 
taen. 
The research projects descrbed above demonstrte that cliical pharcy seIVices add value 
to care for both institutionalize and ambulatory patients. Such value includes not only 
improvements in clinical outcomes and enhanced patient compliance, but also reductions in 
drg reactions. 
health care utilization costs associated with adverse 
WIELY PROVIED IN COMMUNIY 
IV.  CLINCAL SERVICES ARE NOT 
PHARMACY SETIINGS. 
pharacy was fit put into pratice in a 
As mentioned previously, the concept of clinical 
improve 
teaching hospita settng, and despite decades of evidence that such inteIVentions 
clinical outcomes and reuce overall health costs, clinical pharacy pratice has remained 
largely within the pUIiew of institutional settings. A large body of scientific evidence 
indicates that provision of clinical servces outside of institutional settngs is uneven and often 
inadequate. In terms of the typical pharacy practice at the community level, a number of 
studies have found that pharcists counsel only a small percentage of their patients, that 
consultations when they do occur are too brief, and that pharacists' decisions in regard to
16 An example of this researh is a study
patient car ar often inadequate and inappropriate.  drg 
conducted by the Foo and Drg Admnistrtion on patient reeipt of  information. 
Fewer than 60 percent of the patients studied received new (non-refill) prescrptions from the 
pharcist; the remainder received theirs from a clerk or cashier. "One in three subjects who 
pharacist said that they were told dictions for use, while 
received the prescription from a 
only one in ten subjects receiving the prescrption from a clerk or cashier said they received 
verbal directions for use. Precautionar and side-effect informtion was rarly provided, even 
(by) the pharacist.',

Even when patient counseling is mandated by State board regulations, the amount of clinical 
seIVices provided by community pharacists may not incrase. A study conducted in Kansas 
after they were 
evaluated the effects of mandatory patient counseling regulations 2 year 
implemented and found that the new requirement had no effect on the amount or qualty of
18 In Washington, a State known for its progressive 
counseling provided by pharacists

clinical pharacy practices, a siIpilar study was conducte before and 10 years after passage 
of a madatory counseling regulation. The researchers' conclusions were that "it is dou btful 
maintag 
and using patient prof1es is 
that the amount of counseling and the incidence of 
significantly greater in Washingtn than in States that do not have mandatory regulations.', 
not in itself have any 
This evidence suggests that imposing a reguatory reuirment does 
positive effect on the gap in clinical servces available to ambulatory patients. 
pharacy practices to the community 
Barers that impede the transfer of routine clinical 
setting will be discussed in a subsequent finding. But here it should be noted that there is no 
conclusive evidence that the relatively low clinical seIVice level in community settngs is 
confined to a parcular tye of pharacy. Although some researhers have found that chain 
or discount outlet pharsts do not perform as well as those praticing in independent 
pharcies, others have found no significant dierences among tyes of community 
settings. 
pharcy 
On a similar note, there has been heated debate within the  profession about the 
pharcy 
provide clinical  servces to their 
ability of mal seIVice pharacies (MSPs) to 
patients. In the course of our study, we examined the seIVices provided by the larest 
for-profit MSP and the larest nonprofit MSP. In both cass, patient package insens that 
, side 
include information abo  t the name and purpose of the drg, proper administrtion
the prescrptions filled. In addtion 
effects, and precautions ar ifncrl uded in over 80 percent pofh arists 
both companies offer a toll- telephone seIVice with  available to answer 
patients ' questions about their drg regimens. As for prospective utiization review, each 
company uses automated screening processes to review dosage levels and interactions in the 
context of individual patient profiles, a practice that is alo common among chai and 
pharcists. 
independent 
Our conclusion from this review is that the differences in clinical seIVices provided by MSPs 
pharacists who 
versus other retal settings may be more theoretical than actual. In theory, 
ar 
have face-to-face contact with patients on a regular basis  significantly better equipped to  elicit information, counsel patients and monitor drg regimens" But given the J'latively low 
level of seIVices that are actually provided in community settings, there may be little 
difference in the inteIVentions received by patients, and in some cases, the information 
provided by MSP package insens may be more than patients receive from their neighborhood 
pharacist. 
IN THE COMMUNITY PHARMACY SEITING, SIGNIFICANT BARRIERS 
PROVIDED. 
EXIST THAT LIMIT THE RANGE OF CLINICAL SERVICES GENERALLY
Barrers Tha Impede Provision Of Clinical Phannacy Services Include The 
Economic Structure Of The Retail Phamacy Industr, Interprofessional Conflicts, 
Limitations On InfonnaJon Available To Phanacists, Gaps In Phannacy Training, 
And Uneven Patient Demand. 
1. THE ECONOMIC BARRIERS
Product-Based Reimbursement Structure 
One of the most formdable barers facing pharacists at the community level is the 
trsaction-based reimbursement strctu of the industr. For the most par, 
pharcists ' reimburements ar linked to the sale of a product rather than provision 
of servces. Though the retal level of the drg distrbution system has always 
operate in a competitive envinment, over the past decade competition has incrased 
dramtically with the burgeoning growt of mai servce pharacies and discount 
chains. Consequently, the economics of pratice tend to keep prices down and to 
compensate with higher volume. The result tyicaly is a focus on product and price 
rather than provision of clinical servces for which there is no economic incentive 
This aspect of the economic barer does not lend itself to an easy fix. Proposals to 
par reimbursement schedules as a 
add a clinical seIVice or counseling fee to thir-
means of encourging pharacists to provide a wider range of clinical seIVices (such 
as drg regimen review, patient counseling) ignore the economics of a retal practice. 
As long as the overall reimburement scheme is dictly tied to volume of trsactions, 
there wil be a strong incentive to increase number of sales rather than expand seIVices. 
In order to shift that incentive, the reimbursement for providig clinical servces (the 
clinical seIVice fee) would need to exceed the opponunity cost (the cost of the
pharcist s time that would otherwse be spent filing adtional prescrptions). 
Clearly, the overall program costs of providing such an incentive would be prohibitive.  UnderutiJizaon of Supportve Personnel 
pharacy 
Another aspect of the economic barer that effects the overall cost of 
pharacy technicians in community settings. The 
seIVices is the uneven use of 
pharcy technician is defined as "someone who, under the supeIVision of a licensed 
pharcist, assists in varous technical activities that do not requir the immediate 
for example, mantaning patient records; settng up, 
judgment of the pharcist..
packagin  nd labeling medication doses; and fillng routine orders for stock 
supplies.  To the extent that technicians perform these routine activities, the overal 
pharcy  (since technicians' tie is less costly than 
cost of each  trsaction is reduced 
pharcists ) and pharacists are frer to perform clinical seIVice functions for which 
they are uniquely qualified. 
The use of technicians, which in theory would do much to expand the clinical role of 
pharacy 
pharacists in community settings, is a highly controversial issue within the 
enormously from State 
profession. Regulations that govern the use of technicias var 
to State, and most often, State regulations that impose legal constrts on technicians 
s health and 
focus on the pharcists ' perceived self-interst rather than the public 
23 There is no documented evidence that technicians are less competent at 
safety.
pharcy 
perlormng routine  activities, and, in fact, tehnicians have been widely 
used in hospita settings for the past 20 years  Resistace to the use of supportve 
' fear that technicians wil replace 
personnel is a more a reflection of some pharacists 
them rather than supplement the servces they provide. As one expen in the field has 
espaly rapant in the community settng. ,, 
said, "Fear of job loss to technicias is 
tehnicians reflects a vivid 
A close examination of State regulations governing use of 
pictur of the contrvery that surounds ths issue. Nine States ban the use of 
pharcies altogether. Although the remaning States 
technicians in community 
is wide 
specifcaly forbid them, there 
offcially recognize technicians or do not 
varance among them in term of trning and educatpioneal rrefqouirrm,e nats, nlicdens ing and 
certfication procedures, duties they are permtted to 
pharcist/technician ratios. The degr of supervsion requir is also inconsistent 
26
among States. In at least 32 States a licensed pharist must be in the immedate 
physical presence of a technician while she or he is perorming duties. In 5 States, 
' immedate
pharcists must be accessible but not necessary in the technicians
presence. 
Beyond the legal constraits on the use of tehnicians, is the individual pharcist 
States that permt wide use of 
atttude about supportve personnel. Even in those 
to underutilize them out of fear that 
pharcists may choose 
technicians, individual 
their own professional value will be eroded. To the extent that this atttude prevails 
barer 
among pharacists and is reflected in legal constraints, a significant economic 
to provision of clinical seIVices wil remain.  2. THE INTERPROFESSIONAL BARRIER
In order for pharcists to improve the quality of drg therapy available for patients, they 
The pharacist 
must work effectively with physicians who ar responsible for prescrbing. 
clinical 
ability to communicate effectively with a prescrbing physician is a crcial aspect of 
practice. But there ar a number of impements to communication and collaboration betWeen 
Cale Kiberlin, in her research on 
community pharacists and physicians. Dr. 
pharcist-physician relationships, has identified three major categories: 
The community pharacist typicaly communicates

Environmntal barriers: 

constraits. 
with physicians by phone in situations that impose severe time 
exists be
This type of communication can intensify the distace that already 
tween the tWo prfessions and reduce the amount of patient information that 
can be exchanged. 
There is some evidence that phar-
Pharmcist hesitanc to commnicate: 

macists are apprehensive about interprofessional communication. In a discus
pharacists are 
sion of this phenomenon, one researher descrbes reasons why 
reluctat to chalenge physicias: "Because they ve ben socialze to believe 
that doctor knows besL...and despite voluminous literatu about inappropriate 
face a signficant atttudinal 
prescrbing by physicians. many pharistS...
They find it 
problem when attempting to deal with physicians on medcal tu...
diffcult to accept that physicians they deal with individualy can be prone to 
prescrbing errrs... (Pharacists also) tend to constatly compare themselves 
with physicians and fmd themselves coming up shon. 
Struggles for power and  Trationally, physicians have enjoyed a 
autnomy: 
hierahy of health car profes
dominant and autonomous position within the 
well as a tendency for 
sionals. This can lead to tension among professionals as .
their own grup, 
health professionals to interact primaly with members of 
tu can lead to
with only limited interchange betWeen professions. This in 

.29 In

us versus them mindset.' 
numerous misunderstadings as well as an "
terms of how physicians perceive pharacists in parcular, one study that sur
veyed physicians reponed that when physicians "respnded to what annoys 
crticize the pharist s com
them about pharacists, they overwhelmngly 
munication with patients, parcularly in advising or reommending drgs to 
them. 
when physicians are 
There is some evidence that interprofessional barers can be reduced 
educated about the extent of pharacists ' knowledge regarding drg therapy. In our own case 
pharacists in a 
study inteIViews we found that physicians who work collaboratively with 
pharacists as drg 
hospital setting are likely to be more awar of the potential value of 
1,.  practice in rura or smal communities 
advisors. Similarly, physicians and pharacists who 
, because 
appear to interact more effectively with one another than those in larger communities 
shar a higher proporton of patients' in their 
they are more famliar with one another and 
respective practices. 
3. THE INFORMATIONAL BARRIER
seIVices, they must have access to 
In order for pharacists to offer a full range of clinical 
the-counter (OTC) and prescrption 
pertnent patient information, including both over-
medications, drg allergies, and diseases/conditions. As highlighted in a recent GAO report 
One ara of complete agrment among physicians, pharcists and expens is the need for 
drg 
utilization review. ,, 
establishing a sound clinical data base for effective 
patients to provide them with basic profie 
For the most par, pharacists depend on 
information, and in many cases patients may not be able to do this, either because they are not
understad or reta what
given this information by their physicians or because they do not 
their physicians tell them. For lab test data and diagnostic infortion, which enhance the 
pharacist s ability to provide more sophisticate monitorig seIVices, pharacists must 
raly shar 
Other 
consult with the patient s physicians, and such information is 
these informtional gaps. When 
circumstaces descrbed in this report contrbute to 
patient profies 
pharcists do not routinely consult with patients because of tie constrnts, 
barers also inhibit exchange 
are not updated on a regular basis. Similarly, interprofessional 
of more complex patient data 
4. THE TRAINING BARRIER
Some pharcists lack adequate traiing in cliical pharacy skills. Such trning involves 
pharacology, as 
the development of both technical skills and knowledge concerning clinical 
well as practical skills in c  mmunicatio 
phareutical products and chai drgstors, 
In the era before the proliferation of 
a closer relationship with their patients than they have in . 
community pharacists often had 
respected pUIeyor of spialze knowledge and 
recent decades. The pharacist was a 
seIVices, and knew her or his patients relatively well, since there often was only one 
pharacists 
pharcist in a given community. These "preindustral" circumstaces gave 
Tody, only a minority of 
experience in communicating with both patients ranud  physicians. 
settngs wher they have litte 
older or practicing in 
pharcists, most of them 
pharacy scholar 
competition, derive clinical trning frm such circumstaces. One 
characterizes the clinical pharacy movement as an attmpt to restore "preindustral" values 
postindustral" setting. 
to a "
Since the clinical pharacy movement began in educational institutions 20 year ago, 
trned extensively in pharacokinetics and pharacodynamcs. More 
pharacists have been  recently, pharacy education has also wirnessed the introduction of communications trning _u 
based in behaviora psychology into pharacy currcula. Such trning encourages 
patients and 
pharcists to overcome the conventional barers to communication with both 
33 But despite the fact that it has been shown to incrase pharcists ' patient 
physicians.
counseling activities, and to improve patient compliance, systematic teaching and evaluation 
of patient communication skils are not common within schools of pharcy. 
BARRffR 
5. THE UNEVEN PATIENT DEMAND 
be eliminated, another impediment on the 
Even if the barers descrbed above could 
patient demad. In a 1986 study 
consumers ' side of the trsaction would remain-that of 
S. Foo and Drg Administration (FA), only thre percent to six 
commissioned by the U. 
percent of patient respondents, all of whom had obtaned a new prescrption within the 
previous four weeks, reponed that the  had asked their pharcist or physician for any 
3 These 

information about -their drg therapy.  data indicate strngly that most patients are

to discuss 
. either unawar of the risks associated with drg therapy or ar unwiling or unable 
drg is prescrbe or dispensed. 
them with a health car provider at the tie a 
The issue of risk sensitivity and its effect on patient demand for informtion has been the 
subject of severa recent studies conducte by health research and consumer advocacy 
36 In terms of consumer perception of medication-related risks, researh evidence 
groups. 
suggests that consumers do not assOCiate pharaceutical proucts with high risk. In one 
hazous 
activities, substaces, and 
study, researhers asked respondents to rate 90 
charteristics of 
regar to perception of risk, perception of benefits, and 
technologies with  haz, 
risk. When compared to other tyes of  p'haraceuticals were rated as " unknown" in 
terms of risk and less draded than other hazds. 
Even when low risk assessment is not a factor, there ar other impedments that may 
discourage patients frm consulting with pharacists in their role as drg advisors: 
Patients may not be aware 
Lack of knowledge about pharmacists
' exerzise:  admnistr
that pharcists ar highly knowledgeable about the appropriate 
In a 1984 study 
tion, interactions, and potential side effects of medcations. 
that sUIeyed 300 elderly patients to determne drg use patterns and relation
pharist 
in 6 patients mentioned the  as some
ships with pharcists, only 1 
38 Another study, conducted for 
ra 
one they would ask about prescrption drgs.

15 statements that descbed 
Schering Laboratories, asked consumers to 
their reasons for selecting the pharacy they used Raed in fit place by 
" while the state
consumers was "the pharacist fills prescrptions promptly, raed 
" was 
ment "the pharacist wil tell the patient all about the prescrption
39 The relative imponace placed on speed versus information 
in sixth place.
s effciency than 
may suggest that patients place more value on the pharacist 
on his abilty to provide advice.
 pharacist
Patients may not have direct contact with the 
Lack of availabiliry: 
 perceive the pharacist as unavail
when purchasing a prescrption drg or may 
pharacist, rather than a tech.. 
able for consultation. In pharacies where the 
s interaction may 
nician, conducts the counting and pouring activities, a patient 
be with a clerk who is stafing the front counter. In other cases, patients may 
perceive that the pharcist is too busy to answer questions. Consumers ' per
ception of pharacists ' unavailability was well documented in the Schering sur
raked the  feel pharacist 
vey previously cited. Respondents  statements "
" and "it' s easy to \jet pharacists to tak" in 
available to ask about medcations
seventh and eighth place (of 15 items), respectively. 
The architectural design of some pharacies may
Situational impediments: 

frm  If the prescrption fill
discourage patients  consulting with pharacists. 
crowded with customers, the noise level and lack of
ing ara is small and  41 Furter, if the 
privacy wil not be conducive to effective communication.
pharcist 
operates from a floor rased above the level of where the patient 
ducterade thei.r vo ices in order to engage in conversa
stads, they may be forced to 
demonstrte that the quality of patient counseling 
tion. Severa studies have 
pharcist 
counseling is con
is clear!? effected by the envionment in which 
In some cases patients may be 
Communication skills/baseline informtion: 
generaly awar of potential risks but may not feel comfonable about asking 
Addition
specific questions, or may lack the necessar communications skills. 
foru
inforation frm which questions can be 
ally, the absence of baseline 
impement. There is some evidence that providing 
lated may also seIVe as an 
them to be more aggrs
patients with basic wrttn informtion wil encourage 
of Boston has developed 
sive in seeking consultation. Medical Strtegies, Inc. 
a public access softwar product to provide consumers with curnt informa
develope by the U. 
tion on medcations using patient package insen data 
scn 
touch  technology, PIC enables 
Pharacopoeial Convention. Based on 
patients to query a data base about prescrption or OTC drgs and obtan both 
progr  pharacy 
is in use in a number of 
print and scren displays. The PIC 
In our inter
settngs including independents, HMOs, and teaching hospitas. 
pharcists consistently repone a high 
views with a number of PIC users,  pharst 
level of customer satisfaction with the sece; one independent 
crted  incre in  all 
the PIC system with a significant  his customer bas. In 
cases. pharacists reponed that the informtion printouts stimulate questions 
frm 
patients and incrased the quality and quantity of verbal counseling 
provided. 
demad for more and better 
On a positive note, there is some evidence that patient 
information about drg therapy is incrasing. Research indicates that "in genera, over the  past decade, Americans have become more interested in issues afecting personal health and 
.43 Augmenting this overall 
some want more control over personal health decisions.' 
heightened interest in health car, consumer groups and nonprofit organizations such as the 
National Council on Patient Information and Education (NCPIE) have conducted public 
education campaigns to alert consumers to drg-related risks and to encourage them to seek 
more and better information from health car providers. 
We also identified several consumer-oriented information seIVices designed to respond to 
patients who ar not receiving information about their drg regimens frm pharacists or 
physicians. One such seIVice is the Medication Information SeIVice of Calfornia, a telephone 
hot line that has been in operation since 1979. The scIVice is designed to respond to callers 
questions on issues such as drg toxicity, side effects, drg interactions and safety of drg use 
during pregnancy. Over the life of the program, consumer inquires have steadily increased 
each year. Of the 3,00 inquires handled over the most reent 12-month period, 85 percent 
came from consumers, many of whom were referred to the seIVice by health care 
professionals; the remaining 15 percent ar frm health car professionals themselves. In 
sece 
addition to providing information to callers, the  also refers patients to physicians and 
hospitas when a reported drg problem appear crtical. 
There Are Some Community Pharmacists Who Provide A Broad Range OfClinicaZ 
Patnts. 
Nevertheless, The Methods They Use To Overcome 
Services To Their 
Immediat Solutions. 
Barrers Do Not Suggest Simple Or 
As mentioned previously, in preparng this report we conducted a case study of community 
pharcists who provide a broad rage of clinical servces to their patients. One objective of 
our study was to determe the method they have used to overcome obstales to clinical 
ar tyicaly a function of individual 
Our analysis indicates that their method 
patient car. 
skills and personal commtment (Case studies and analysis ar include in a companon 
report entitled, "The Clinical Role of the Community Pharacist: Cae Studies.") We note 
that the flexibilty inherent in managing one s own independent pharacy can enhance a 
pharcist  pharacy settng does not, in 
s abilty to apply these skills, but the independent 
guarte 
that a range of clinical servces wil be provided. 
. itself, 
We found no unusual envionmenta or maket conditions that allowed our case-study 
pharcists to develop clirical practices. All operate in highly competitive markets and 
pharacies, and MSPs. Populations SCIVed by 
compete for customers with chais, discount 
mor afuent 
the pharacists ar quite diverse, raging frm workng-class urban patients to 
suburban patients. In sum, these pharacists enjoy no external advantage over their 
colleagues. Instead, a combination of skills in clinical pharacy, business management, and 
image, appear to be the 
communications, coupled with an unusually strong professional self-
ingredients for a successful clinical pharacy practice.  thec:ase study analysis isthat tlis formula'cannot be duplicated easily 
r conclusion firi'
based reimbursement inceiltives or regulatory requirements. A vital 
either through trsaction-
question facing pharcists as .well as those who receive and reimburse pharaceutical 
pharacy care 
seIVices is whether the more advanced clinical  represented by our case-study 
mainstram practice. In devising methods to improve clinical 
pharcists can become par of 
pharcy car for older Americans, policy makers wil be faced with the formidable obstacles 
we have descrbed in this repon, none of which wil be easily remedied.  , " 
RECOMMENDATIONS 
THE PUBLIC HEALTH SERVICE (PHS) AND THE HEALTH CARE 
FINANCING ADMINISTRATION (HCFA), INDIVIDUALLY AND 
COLLABORATIVELY, SHOULD DEVELOP A STRATEGY TO REDUCE THE 
BARRIERS TO CLINICAL PHARMACY SERVICES, PARTICULARLY FOR 
AMBULATORY ELDERLY PATIENTS. 
There ar a number of compelling reasons for the Depament to assume a leadership role in 
enhancing pharceutical car for older Americans: 
problems associated with mismedcation present a significant theat to the health of 
Firt, the 
older Americans. Recognizing the serious natu of drg-related ilness, PHS has included in 
Year 200 Objectives for the 
its draft document  Prmoting Healtheventing Disease-
Nation," the objective of reucig the incidence of adverse drg reactions among older 
Americans by nearly 50 percent (from an estimated 17 pe 100,00 in 1986 to 8.5 per 100, 
in 200). The development of a strtegy as caled for in ths recommendation could be 
instrmenta in helping PHS achieve its state goal. 
Medcar progr for the incidence of 
Second, there is an ongoing cost borne by the 
Calforna that was 
drg-related ilness among beneficiares. Based on the reent study in 
for billons of 
cited earlier in this report nationwide hospitaiztion costs alone account 
progr 
Medcaid  absorbs the costs of hospitaizations, 
dollar each year. Additionally, the 
doctor visits, and institutional care that result from drg-related injures and ilnesses for older 
Medicar and 
Americans who are income eligible. The HCFA, in its role as manager of the 
Medicaid progrs, has a major stae in ensurg that costs of preventable ilnesses 
avoided 
reently 
Third, the Medicar Catastrphic Coverage Act (MCCA) of 1988, which was 
repealed, mandated a DUR system and included severa provisions designed to ensure that 
pharcy  These provisions were 
cenan clinical  seIVices be provided to al beneficiares. 
the 
Congrss that mismedcation problems ar a serious theat to 
based on a reognition by the 
pharacy servces can add signficant value to 
health of older Americans and that clinical 
designg a DUR 
Pror to repeal of the MCCA, HCFA was at work 
overal patient car. 
progr and developing regulations and stadas for parcipating pharacists. The scope 
an  Deparent
outside the 
and complexity of these taks were such that expert both within 

were doubtful that HCFA .could meet the implementation deadine. 
Repeal of the MCCA presents the Deparent with an opponunity to formulate a strtegy for 
improving drg therapy for the elderly in an environment fr of implementation deadlnes. 
drg benefit may not be proposed again in the near future, the overal 
. Although a Medicare 
patients is not likely to escape continued 
issue of drg-related problems among elderly 
111  attention of Congrss, the media or the public. Researh and policy development on this issue 
should begin now so that policy makers wil be equipped to respond effectively to future 
Congressional mandates. 
In that context, we recommend that HCFA and PHS develop a strategy that includes research, 
car 
demonstrtion and education effort to reuce each of the barers to clinical pharacy 
demonstrtion effort include inteIVentions to 
described in this repon. We strongly urge that 
For example, a project aimed at increasing patient demand could be 
address multiple barers. 
successful in rasing patients' expectations but have no effect on expanding clinical seIVices if 
addrssed. Additionally, we recommend that all research effons 
economic barers ar not 
measure the effect of clinical pharacy car on both tota cost and clinical outcome. 
vehicles that can be employed by HCFA and PHS to faciltate such 
There ar a number of 
effons, including the use of Medcaid waivers, Medcaid demonstration projects, and research 
and demonstration grts. Listed below ar examples ofinteIVentions that may be tested: 
reimburement to pharacists, measurng the costs and 
Test a capitated system of 
benefits (financial and therapeutic) of such a system, when compared to a 
product-based reimburement scheme. The capitate reimburement system 
would be based on a flat fee per beneficiar with financial penalties and rewards 
that are tied to clinical outcomes. 
In a demonstrtion project model, measur the costs and benefits of providing 
clinical pharacy monitoring for high risk ambulatory patients. Use the Medcaid 
nursing home modl which separtes the clinical monitoring functions from that of 
dispensing. Identify high-risk Medcaid patients by scning the Medcaid 
cen 
information system for patients who meet  crteria. For example, patients 
who are over 65, tae five or more medcations, have thr or more conditions 
identified as candidates. Clinical 
and/or thre or more physicians could be 
monitoring by a pharacist who is not dispensing the patient s drgs could be 
provided to an experimenta grup withn that pol of subjects and clinical and 
cost outcomes could be measur to determne the effects of the inteIVention. 
Study existing settings where lab and diagnostic data on ambulatory patients are 
costs and benefits of 
aleady available to clinical pharacists and document the 
such a system. There ar a number of famly pratices where such systems are 
alady in place, and evaluation of cost and effectiveness would provide a basis for 
scale. 
determning the value of encouraging duplication on a broader 
Medicar beneficiares with blank medication 
Furish an experimental group of 
chans and instrctions for use. Chans would be completed by physicians, 
pharacists and patients and would include information on the name and purpose  , and 
of both prescrption and OTC drgs, instrctions on administrtion
descrptions of side effects and significanradverse reactions. Patients would use 
chars to record their own panerns of use as well as any side effects they note. 
pharacists 
Chars would be presented by the patients to both physicians and 
during offce visits and whenever a prescrption is filled at the pharacy. This is a 
pharacists 
relatively inexpensive way to encourge improved counseling by both 
and physicians. 
Measure the outcomes among patients seIVed by pharaCists who complete 
mid-career trning progrs in patient counseling skills. As mentioned earlier 
trning in this ara has been less than adeuate for many pharacists; in order 
pharacy settngs, mid-carr trning 
expand clinical servces in community 
nee to be expande. 
opponunities wil 
II.  THE NATIONAL INSTITUTE ON AGING (NIA) SHOULD TAKE A 
LEADERSHIP ROLE IN DEVELOPING RISK INDICATORS AND 
TREATMENT PRIORITIES FOR ELDERLY, AMBULATORY PATIENTS. 
Although some genera categories of indicators and patient grups who ar at high rik of . 
ADRs have been identied, additional researh is neeed to defme more preisely those 
elderly patient groups who ar at highest risk and in gratest nee of close clinical monitorig 
of their drg therapy. The NI, which has long ben concerned with drg therapy for older 
should lead an effon to expand scientific 
adults and has considerable expenise in ths ara, 
knowledge regarng high risk indicators. 
II. THE AMERICAN PHARMACEUTICAL ASSOCIATION (APhA) AND THE 
AMERICAN ASSOCIATION OF COLLEGES OF PHARMACY (AACP) 
SHOULD DEVELOP STANDARDS OF PRACTICE THAT ADDRESS THE 
COMPONENTS OF CLINICAL PHARMACY CARE ON THE BASIS OF 
PATIENT NEED. 
pharacy profession about 
As mentioned previously, there is litte consensus within the 
stadads of car related to patient need Although the APhA has developed stadads of 
practice, those stada ar limted in severa ways: Firt, they wer develope from a 
natu. 
tak-inventory approach and ar not functional in  Second, they do not include a 
practical needs assessment model that can be used by the pharacist to assess needs, indicate 
interyentions, and identify patients who require maximal level seIVices.  stadads 
We therefore recommend that APhA and AACP work cooperatively to revise their 
of practice in a more functional context and to create a practical needs assessment model that 
nee 
practicing pharacists can use to determine patient 
IV. STATE GOVERNMENTS SHOULD REVISE PHARMACY PRACTICE ACTS 
TO ALLOW MAXIMUM USE OF TECHNICIANS IN COMMUNITY 
SETIINGS. THE APhA AND THE STATE PHARMACY ASSOCIATIONS 
SHOULD TAKE A LEADERSHIP ROLE IN ENCOURAGING MORE 
EXTENSIVE AND EFFECTIVE USE OF TECHNICIANS IN COMMUNITY 
PHARMACIES. 
pharcy 
activities such as packing and 
Underutilization of technicians to perform routine 
crates a major 
labeling medication doses and fillng routine orders for stock supplies 
settgs. 
economic barer to provision of a broad rage of clinical servces in community 
tehnicians rest within the pUIiew of 
Because laws and regulations governing the use of 
mamize use of techncians must be taen at the State 
individual States, initiatives to 
pharacy. 
government level in cooperation with State boards of 
If APhA assumes the tak of developing functional stadads of pratice (Recommendation 
II), it wil be well-positioned to lead an effon aimed at encourging more extensive and 
effective use of technicians in community pharacies. Defining the role of the pharacist as 
stadazing pharaceutical car functions should diute the fear that 
a cliical provider and 
technicians would replace pharcists, rather than supplement the servces they provide. The 
frm the State pharacy associations as well 
APhA should enlist assistace and consultation 
Phary  boar of 
as the National Association of Boars of  and the individual State 
pharcy in such an effon.  ....
COMMENTS

Within the Deparent of Health and Human SeIVices, the Public Health SeIVice and the 
The American 
Health Car Financing Administrtion (HCFA) provided comments. 
Pharaceutical Association, the American Society of Hospita Pharacists, the American 
Pharacy 
Society of Consultant Pharacists, and the American Association of Colleges of 
also commented. 
With the exception of HCFA, all commenters expressed suppon for the findings and 
recommendations. Most provided some technical suggestions and comments that we have 
ar commned 
included in the final draft. With the suppon and leadership these organizations 
pharacy servces and 
to providing, we look forward to initiatives that wil expand clinical 
who ar at high risk of drg-related ilness. In 
improve patient care, parcularly for groups 
appendix VI, w  present, in full, each set of comments and respond to each of them.  APPENDIX I 
THE HISTORY OF CLINICAL PHARMACY 
The Pharmacist: Drug Dispenser or Drug Advisor? 
drg 
and that of  advisor. 
always played a dual role: that of drg dispenser 
The pharcist has 
traiing 
It is primaly the latter role that emphasizes the use of cognitive skils. and extensive 
pharacist as a health care professional 
by the pharacist, and that seIVesto characterize the 
rather than merely a health car worker. This role as drg advisor is also known as the 
pharcist s clinical role. Though most of the tWentieth centu, the pharacist has been 
and 
characterized by many, inside and outside the profession, as a drg dispenser 
businessman. At the same time, however, some of those inside the profession have sought to 
promote the pharacist's clinical role, and rina th e last tWO decades, this professional role has 
gained ground both inside and outside the  of pharists. 1 
The Pil-Counter View

During the fist half of the twentieth centu, varous elements of the U. S. health car system 
incrased in prestige and sophistication, seIVg to overshadow pharacy. First, physicians 
intensified their process of professionalzation and enhanced their public status, separting 
, the 
their functions from, and placing them above, that of drg dispnsing. Abraam Flexner
encyclopedist of medicine, wrote in 1915 that pharists were not professionals, because 
' orrs. The Fedra Government shorty 
their function was simply to execute physicians 
pharcists the commssions in the Ared Forces that physicias and 
followed suit, denying 
others received. 
itslf, attention shifte toward drgs and away from 
Within the pharceutical community 
favore research in drg development, 
pharcists. After World War II, corporate financing 
and similar financing was not available for research in the more servce-oriented field of 
the conduits 
clinical pharacy. A common view was that pharacists seIVed merely as 
ary of 
through which the public gained access to an ever larger  incrasingly sophisticated 
s capacity to maage this flow of drgs to patients 
pharaceutical products. The pharacist 
shr. 
was given shon 
The Clinical Pharmacy Movement 
phary 
thinng originate in  education. 
The counteIVailing forces to this way of 
Educational institutions sought to enhance pharcy s stading as a profession by enlarging 
s functions commssioned 
their curcula. Beginning in 1932, following a study of pharacy 
Pharacy (AACP), the four-year Bachelor of 
by the American Association of Colleges of 
Science degree in pharacy was endorsed by national pharacy associations and became 
progrs, 
pharacy  year 
1960s, many colleges of  instituted five-
standad. In the 1950s and 
trning in the medcal aspects of drg therapy and in 
expanding currcula to include extensive 
T - 1
 , "

1960s, many schools 
more communications-oriented aspects of patient counseling. In the mid-
progrs  Pharacy (Phan) degres, 
began extending their  to six years, awarding Doctor of 
with the sixth year often devoted to a clinical clerkship with a practicing pharacist; about 40 
Phan 
programs now exist. 2 
pharacy in the 
The clinical pharacy movement accelerated within the subfield of hospita 
late 1960s and 1970s. Hospita pharcists began to work with physicians as par of a 
am that performed diagnosis and treatment collaboratively. Pharacists sometimes 
clinical te
DUR; and they 
went on rounds with physicians; they performed retrspective and prospective 
under fewer 
oversaw drg distrbution within hospitas. Hospita pharacists worked 
competitive pressures to meet a daly quota of transactions than retal pharacists, and they 
became freer to spend their tie analyzing data and performg seIVices unconnected to 
trnsactions. 
Now, in the 1980s, the clinical functions of-the pharacist have moved to the forefrnt of 
discussion in the field. Pharacy technicians and pharacy robots have proved able to fulfill 
including may pharacists-have long seen as 
the simple dispensing functions that may-
phary 
the pharacist s major tasks. Leaders in  and pharacy org  izations have
traiing, 
increasingly promoted those clinical functions for which pharacists receive unique 
as they have sought to ponry pharacy as a profession whose sUIVival is vital to public 
health. 
drg dispenser has 
The view of the pharacist as a drg therapy maager rather than merely a 
pharacy. A reent cour deision 
received tentative endorsement from entities outside 
characterized the pharacist s role as one of "risk maagement," analogous to the physician 
pharist 
role of "risk assessment," thus portayig the  as something more than a passive 
s instrctions. 
conduit for products and for the physician 
In sum, forces both inside and outside of pharcy seem to be moving the profession toward 
s clinical functions. But it is unclear at this time 
an increasing emphasis on the pharacist 
, still widespread, of the pharcist as 
whether these forces will successfully supplant the view
skils. 
litte to offer in the way of unique servces or analytc 
a drg dispenser, with 
Endnotes 
The Third Wave in Pharceutical Education: The Clical Movement;" 
Hepler C. 
American Journal of  51 :369-85, 1987. 
Pharmceutical Education, 
W., Manasse H.R., "Commitments to the Future of Pharacy: Review and 
Giblin P.
Drug Intellgence and Clinical Pharmcy, 
Opinion of the Phar.D. Curcular Debate, 
18(5): 420-27, 1984.

T - ')  APPENDIX II 
PHARMACY SETTINGS 
Pharacists practice in a varety of settngs. Because the terms that refer to these different 
settings are  in discussions of pharacy, defining them will clarfy the 
fruently used 
discussion in this repon. 
As the term "community pharcy" is used in the literature on pharacy, it refers to walk
independents. 
pharcies in non-institutionalized settngs. It includes chai drgstores and "
Independent pharacies ar the most trditional setting: here, the chief pharacist also 
fsuncetionlsl a so a snmalll ybus indessrpegrsosn. ".A pothecares" ar those independent pharacies that
phary. 
In hospitas, 
Institutional pharacy" includes both hospita and nuring home 
pharcists oversee dictly the distrbution of drgs to patients and collaborate with

physicians on the proper coure of medcation thoughout a patient s stay in the hospita. In 
pharcists  drgs, which is left 
nursing homes,  usually do not oversee the distrbution of 
In this settng, they ar usualy "consultat pharacists" who 
nurses and other cargivers. 
arve at the nursing home once each month to perform the chan reviews mandated by 
Medcaid. 
Home health care pharacy" addresses a patient population that is less ambulatory than 
those who come to a wal-in pharacy, but usually mere ambulatory than those in fully 
institutionalize settigs. Home health car covers a wide rage of car settngs, some more 
institutional than others, and some that should be considere community settngs, for our 
conclusions 
this lare field exhaustively, our 
puroses. Because we have not researhed 
concerning "community pharacy" are not as applicable to home health car as to other 
pharcies. Speakg 
community pharacy settngs, namely chains and independent 
pharcy 
generally, this repon focuses on the car of ambulatory patient populations and 
settngs that seIVe them. 
II - I
 APPENDIX II 
CASE STUDY METHODOLOGY 
fold: 
The purpose of conducting the case study was tWo-
pharacy practice; and 
to obseIVe and document activities that comprise clinical 
to identify (in the case of clinical pharacists who practice in traditional 
community settings) the barers they face in providing pharaceutical care to 
barers. 
their patients and to determine the methods they use to overcome those 
- Given that objective, we mae a purosive selection of pharsts who were identied by 
members of professional and researh organzations as practitioners who provide an unusually 
broad rage of clinical seIVices to their patients. A number of organiztions and individuals 
Phareutical 
were helpful to us in identifyig a candidate pool, includig the American 
Association, the American Association of Colleges of Pharacy, the University of Florida 
College of Pharcy, and the University of Marland College of Pharacy. We made 
durg which 
selections from an initial pool of 35 candidates based on telephone intervews 
we solicited information about the natur of the phart s practice, the population seIVed, 
the pharcist s therapeutic specialty, and her/his wingness to parcipraute  in the case study. 
and suburan 
Our fmal selection was based in pan on geogrphical diversity; urban, 
practices ar represented. Although we sought candidates who practice in chai, independent 
and apothecar settngs, only the latter tWo are represented. None of the candidates 
pharacies. 
nominated practice in chain 
The pharacists selected for our study are listed below: 
Julee Alexander 
Lifesource, Inc. 
900 Lakspur Lading Cirle, Suite 250 . 
Larkspur, CA 94939 
Nancy Culberson 
Pharcy 
Lexington Famly Prctice 
O. Box 460
Lexington, SC 29072 
II
 "-'-
,.-.. --..

-.-
Madeline Feinberg

Accredited Surgical Company 
9515 Gerwig Lane, Suite 131 
Columbia, MD 21046 
Lind Garrelts 
Jon  s Pharacy 
S. 906 Monroe
Spokane, WA 99204 
Howard J uni 
Capitol Drug Center 
2007 E. County Rd. E 
White Bear Lake, MN 55110 
Calvin Knowlton 
Pharacy 
Amherst 
332 Lumbenon Rd. 
O. Box 56
Lumbenon, NJ 08048 
3-dy 
obseIe the pharacist s practice over a 2- to 
In each case, we made site visits to 
period. In the case of the four pharacists who pratice in trtional community settgs 
(Knowlton, Juni, Garlts, and Culberson), we conducte extensive intervews with the 
pharcist and other sta on site, physicians who were famia with the pharacist's 
practice, and patients seIVed by the pharacist. We also obseIVed the pharcist in practice 
and reviewed the information systems they use to suppon clinical activities.  APPENDIX IV 
THE FOUR COMPONENTS OF CLINICAL PHARMACY CARE 
(1) Collection of Patient Information
Collection of Patient Information 
From Patient 
preent  pret
patinfs
prescrption concs  lab data 
OTe drgs 
drgs 
Min. 
allergiesl  pat drugs  course of treatmenV  diagnostic data 
chronic conditions  hospilaiztion 
From Physician 
strctu 
Much of our analysis of clinical pharacy is  around the trsfer of informtion, 
which is a vita tool reuir by all those involved in providing clinical servces to patients. 
The first task the pharcist must perform in ordr to provide cliical car is to collect 
information from the patients themselves and from the physicians. Thus, data collection is in 
pharacist. 
itself a major function of the clinical 
Patnts 
Information from 
The pharcist can collect a wide rage of informtion frm the patient At the most basic 
level, she or he wil inquir about what prescrption drgs the patient is presently tag. The 
pharcist may also ask about any allergies the patient may have and matya ingqu.i r about what 
over-the-counter (OTC) or nonprescrption drgs the patient is presently  Still at a 
faily basic level- pharacists collect this inforation-ar the patient 
though not al 
diseases and other conditions, as well as the patient s weight, height and age, which afect 
s drg 
dosage levels. At the next level is informtion that a pharcist can collect on a patient 
drg use, past OTC drg use, and past 
use history. This' includes the patient's past prescrption  drg 
ilnesses. Finally, the pharacist may inquire about the patient s concerns about the 
regimen, such as whether previous reactions to other medcations wil reoccur. 
drg 
The pharacist most likely gets all this information dictly frm the patient. (OTC 
from the patient, since these drgs are usually
information typically can be obtaned 
 only
purchased without the express instrctions of a physician, and often ar not purchased at a 
single phanacy or at any pharacy, with the result that no.complete record of their purchase 
exists anywhere except in the patient s memory. 
Informaton from Physicilns 
In addition to collecting this informtion frm the patient, as well as determining the patient 
obtan data frm the patient s physician or 
main concerns and questions, the pharcist can 
physicians that can be useful in managig the patient s drg therapy. Most basic here ar the 
the patient's blood 
statistics-though the pharacist may ocasionally read 
patient's vita 
Next is informtion
pressure or perform cholesterol screnings, if State law allows. 

concerning the patient's genera coure of medical tratment, both present and past, including 
patient 
hospitaizations. Finally, the physician can shar with the pharacist data from 
lab tests (e.g. bloo or liver function tests), and inormation concerning the diagnosis, which 
could help the pharacist understand why the physician has prescrbed a cenan drg. This 
information is readiy available to a pharist workng in a more institutionalze settg 
tyically 
such as a hospita, a nursing home, ora home health agency, where physicians 
cooperate closely with pharcists. But it is not routinely available to pharacists working in 
pharacists we spoke with al said that 
a community settng. The practicing community 
among the information about a patient that they usually do not possess, lab test data and 
diagnostic data would be the most helpful to them if they had it  (2) Drug Regimen Review (DRR)
Drug Regimen Review 
Screening and Evaluation of Data 
Computer Screens For:  Pharmacist Evaluates Data 
drug-drug  drug-dsease
dosage  interactons  interctons 
Max. 
Min. 
duplications  dru-alergy 
interactions 
that pharacists conduct is 
In the community setting, the most useful tye of review 
prospective utiization review, performed at the point of sale. Retrspective review usually is 
performed by third-par providers or nuring home pharcists who sUIey large data bases 
community pharacists do not 
in order to discern large-scale prescrbing pattrns. Most 
oversee such a large pool of prescrptions, nor do they have the son of regulatory perspective 
appropriate tak for them. We have hear of no 
that would mae retrspective DRR an 
and it seems to lie outside the 
community pharacist who performs retrspective DRR, 
continuum of community practice. 
against drg-related iless is a manual or 
The first line of defense the pharacist can employ 
indications. At the most basic 
automate review of new prescrptions for potential counter-
drg) dosage informtion. 
level, the review may screen for missing or improper (for a given 
pharcist 
On a more sophisticate level, the review may include whatever informtion the 
softar 
drg history. An automated review uses computer  that 
has collected on the patient's 
can be progrmed to scren for therapeutic duplications in a patient s drg regimen, which 
s therapy. Becomig 
ar involved in a patient 
can occur especialy when multiple prescrbers 
drg, 
rage of drg interactions, including drg-
more complex still is a screening for a wide 
drg-allergy, drg-diet and drg-disease interactions. It should be noted that if an automated 
var 
ar programmed to spot can 
system is used, the number of interactions software packages 
greatly.  a computerized system wil have to examine those prescriptions the 
The pharcist who uses 
computer identifies as potentially harful in order to determine the appropriate course of 
action. The pharacist will look for the same type of problem the computer has looked for, 
drg 
and wil use professional judgment to decide how to proceed: whether to dispense the 
with a waring to the patient of potential hazds, to dispense it without a waring, or to 
contact the prescriber in order to seek a change in the prescrption. 
identification of 
Pharacists use computer programs primarly to save time-to speed the 
potentional drg interactions. If a pharacist has the time, a personal examinarion of all new 
scrtiny prescrptions could receive at the 
prescrptions is the highest level of professional 
progrs 
in this case, computer 
point of sale. But often, pharacists ar simply too busy, and 
are trmendously helpful tools. 
(3) Patient Counseling
Patient Counseling 
new prescriptions 
follow-up 
verbal  counseling 
wrttn information

information and 
chng
name of  chcking
drugs  administrtion  explanation  copiiac:  for ADRs 
Max. 
Min. 
dosage  potentil chcking contactng
ADRs  effectvene  noncompliant
of drg 
patints 
In this component, the pharcist trsfers informtion to the patient with the aim of ensurig 
tang the medcation, (2) how she is to tae it, and 
that the patient understads (1) why she is 
(3) what to expect (expected outcomes, side effects and what to do in each situation) Again
we find a wide varation in the level of counseling in both its form and content. In practice, 
information can be conveyed in wrnen and/or oral form, and it can be given in person 
though the mail, or by telephone.  Forms and Physical Settngs of Counseling 
StUdies indicate that wrtten information given alone is the least effective form of counseling, 
frm drgs. 1 The minimal 
in terms of retention of knowledge and incidence of side effects 
form of wrtten information is an auxiliar label placed diectly on the contaner in which the 
drg is dispensed, and which gives the drg s name, the number of dosage units. and possibly, 
very brief instrctions concerning admnistrtion. A recent sUIey of 400 community 
pharcists found that all of those questioned used these labels, and that 68 percent of their 
2 But as 
patients received them. indicated above, the impact of such labellng on patient 
knowledge is highly questionable. . Con taining far more information ar the patient package 
insert (PPls) produced by the U.S. Pharcopoeial Convention CUSP), which include fairly 
pharacists either 
complete side effect and interaction information; some community 
purchase these leafets or receive them frm pharacy organizations. Other soures of wrtten 
information include leafets disnibuted to pharacists by drg manufacturrs and, 
drgs, drg classes, or conditions that pharacists produce 
occasionally, leafets on 
themselves. But researh indicates that even PPls, which ar as complete as virally any 
wrtten counseling can be, ar inferior to ora counseling. 
Oral communication is key to effective patient counseling by most accounts. One Canadian 
study found that a combination of wrttn and ora information given to patients was 
successful in incrasing their knowledge of their medcations, and in reucing and preventing 
mismedication, in almost any settng: in a private or nonprivate face-to-face settng or on the 
telephone. The same study indicated that private face-to-face counselig, conveying both oral 
and wrtten informtion, is the most effective form of counseling, even if not the only 
3 This suggests that the element of privacy, whether in person or on the 
effective form.
telephone, is crcial to effective patient counseling.

Addtionally, in-person counseling provides patients with the opportnity to ask questions 
about the drg the pharacist has not answere, or questions about the information the 
pharcist has given them. The pharcist can also probe for any questions, concerns, or 
' par and veriy that the patent understads crtical inormation. 
uncertnties on the patient
InfonnaJon Conveyed

agai cover a wide rage, frm minimal 
The .specific informtion conveyed to patients once 
prscbe
to maximal. The most basic information the pharacist can give the patient is the 
drg s name, and number of dosage units. Fundaenta as this information is, if it is simply 
tyed on the botte s label and not reinforced verbally, the patient may well not retan it. 
adstrtion 
Moving to the next level, the pharcist can explain the drg s prope  to the 
patient, even, in the case of an unusual admnistrtion mechanism, such as an inhaler, showing 
the patient how to tae the drg. The pharacist can explai precisely how the patient should 
coordinate tang the drg with eating, and what foos to avoid, and can give instrctions on 
how and where the drg should be stored. 
T" r  More complex is the scientific information pharacists might give a patient. They can 
explain the drg s intended effect, and tell the patient when she or he can expect relief if the 
it should. They can also war the patient about potential side effects and 
drg works as 
adverse interactions. 
Follow-up ActivitieslM onitoring 
, which is when 
All this information can be conveyed at the time of the initial prescrption
most pharacists do most of their patient counseling. Occasionally, however, they raise their 
counseling activities to a higher level through the practice of followup counseling. They 
might check a patient s compliance at the first refill, and at subsequent refills, or they might 
monitor the effectiveness of the drg therapy at subseuent visits, and check for signs of side 
effects or ADRs. Pharacists can also contact patients, either by mail or by phone, who have 
not come in to the pharacy for refills at the expected time. In the case of the most 
, a pharacist wil check 
personalized attention  on patients regularly, not just at refil times. 
Prsently. in community settings, such a practice can be found in smal home-health 
pharcies. that have a relatively low patient-to-sta ratio. Any followup activity at all 
pratice. 
however, should be viewed as an unusually intense patient counseling 
(4) PhysicianIharmacist Consultation
Physician/Pharmacist Consultation 
contact between
 coloction of pharacy 
physician and physician phones 
.:prhairmcist. pharacist Ie seek  wi medica prctce;

pharmact reviews 
to authrie pharacit's advce 
on drg medical file of each patient
Ptio 
Max.
. Min.

in-prsn patnt 
pharmcist phones  sharng of dexaam,  
physicin to discuss  data, la  ca coferenc; 
mod) 
therapeutic or pring issues  diagnostic data  (family practce  .... ..
physician is of key imponace to 
The flow of information between the pharacist and the 
clinical pharacy. The primar contact between physicians and pharacists occurs when a 
prescrption is ordered either by phone or in wrting. 
Pharmacist-Initiated Contact 
The most basic contact made by a pharacist is for the purpose of receiving authorization to 
, may have 
fill a prescrption. In some cases, the pharacist, after reviewing the prescrption
concerns about the dosage level or the length of fill prescrbed, or about potential side effects 
and interactions, and may contact the physician to discuss them. If the physician cannot 
satisfy the pharacist's concerns about a potential hazd to the patient s health resulting from 
the use of the drg, the pharist may seek to have the physician change the prescrption. 
individual 
some States, such as Washington, individual pharacists can arange with 
physicians to change prescrptions, within clear limits on their own, if they think it is 
express permssion of the 
warted. By and large, however, pharacists must seek the 
physician to mae changes in a prescrbed therapeutic regien. Seeking such changes when 
increasingly expected 
appropriate is at the hean of the risk management that pharacists ar 
to perform. . 
Pricing Issues 
A pharacist might also contact a physician to discuss pricing issues involved with a 
prescrption; this is more unusual, in most wal-in settngs, than contactig a physician to 
discuss therapeutic issues. (Discussion over prcing is less unusual in an HMO settng, where 
incentives 
payment to both pharacists and physicians may be capitate and where there ar 
drg 
to dispense lower-priced drgs. ) A less expensive generic substitute for the prescrbed 
may be available, or a less expensive non-generic substitute, and the pharcist may wish 
drg. If a patient is paying cash for 
dispense one of these in place of an expensive prescrbed 
pany insurance, overal 
is most pressing, but even if a patient has third-
the drg the matter 
lowere if a less expensive drg is dispensed, so a pharcist might 
systems costs wil be 
Agai, in many States, 
contact a physician to discuss price-relate substitution in any case. 
pharcists ar free to substitute generics for prescrption drgs without permssion from the 
prescrber; there is no State, however, where community pharacists can substitute less 
therapeutic substitutes for more expensive drgs without the 
expensive pharaceutical or 
prescrber s express permssion. 
fuer 
The issue of these pharaceutical and therapeutic substitutes merits  discussion. 
Pharaceutical alternates include drgs that ar no longer on patent, but contan the same 
active ingrents as a much higher-priced drg that is manufactu with  tent protetion in 
slightly from the old drg: it may be changed 
a dierent form. The new drg is changed 
from a pil into a caplet, or the dosage may be doubled; but chemically it is the same as the old
drg.  drg in its 
Nonetheless, the manufactuer emphasizes the unique quality of the new 
drg. 
det!rling, suggesting as strongly as it can that it is somehow more effective than the old 
Effective brand-name product positioning with prescrbers, 
As one pharacist has obseIVed, "
coupled with a relative lack of comparative price information for patients and prescrbers,  drg prices largely independent of 
have enabled manufacturers to establish single-source 
proucts. It is not unusual to find a ten-fold 
therapeutic uniqueness or cost of comparative 
its pharaceutical alternate). 
price differential (betWeen a single-source drg and 
5 .

pharacist contats a physician to request a 
Therapeutic substitution is initiated when a 
diuretic to another that is less costly. 
change in the prescription drg, for example, from one 
Although therapeutic interchange is common in maaged car settings and hospitas, it is rae
in the COmnunity setting.
Physician-Initiated Contact 
pharacist 
More unusual, and charctering a closer interprofessional relationship than the 
pharcist. The 
contacting the physician, is the physician seeking consultation with the 
physician, for example, might want to ask the pharcist about the effects-and risks-of an 
unfamliar drg or drg class. Clearly such contact implis a great deal of professional respect 
parcularly close professional 
for the pharacist on the physician s pan. If the two enjoy a 
relationship, they may be awar of which patients they both car for, and the physician may 
contact the pharacist to ask about a parcula patient s progrss, or to seek advice on 
in pharcy settgs. 
unusual in most wal-
prescrbing for the patienL Such contat is quite 
Also unusual is the sharg of a physician s examnation data lab test data and diagnostic 
pharsts raly 
data on patients with a pharacisL As noted above,  possess these data 
when performng DUR, but they indicated they would fmd such information valuable. 
Institutonal Contact 
pharcists is 
Unusually close contact between physicians and  faciltated in. an 
institutionalize settng beause the two professionals ar locate in the same building or area. 
This is usually not the case in a community settng, but if it is, then contact is faciltated 
greatly. One pharcy we visited is collocated with severa famly practice physicians 
offices, and all the kinds of contact descrbed here occur there. Even in this settng, however, 
the discussion between physicians and pharacists concerned individual patients, and only as 
arose. 
parcular questions or problems 
pharacisL and 
Still more intensive would be regular patient car conferences involving 
Ths kind 
of all patients could be discussed 
physicians, in which the tratment and progrss 
of patient car conference occurs in teaching hospitas, but almost never in the community 
conferences were held weekly in which all 
settng. In one of the pharacies we visited such 
clinical sta parcipated but not physicians, and the progress of 
staf pharacists and other 
all the pharacy s patients was discussed. This was possible only because of the pharacy 
small patient load. 
IV - 8  -....
.. ---_u .
Endnotes 
McBean BJ., Blackburn J.L., "An Evaluation of Four Methods of 
Pharacist-Conducted Patient Education,  Canaian Pharmcy Journal  115: 167-172 
1982. 
Ascione FJ. et al., "A SUIVey of Patient Education Activities of Community 
Pharacists,  7: 359-66, 1985. 
Patient Education and Counseling, 
McBean, 167 -172. 
Pharcy: 
Knowlton C., "The Practice of Community  InteIVention Opponunities 
S. Depanent of Health 
Toward Optimizig Medication Use" (Washington D.  : U.
and Human SeIVices, Symposium on Drg Utiization Review, 1989), 9, photocopied. 
Ibid., 9.
 APPENDIX V

ENDNOTES 
Definition of Drug Use Evaluation developed by the American Society of Hospita 
Drg 
Pharacists, included in the "ASHP' s Guidelines on the Pharcist s Role in 
Use ' Evaluation. 
Consequences
Medication Risks Among the Elderly: Cures, Cautions and 
Steffen R., 

pA.
(Assembly Offce of Research, State of Caifornia Assembly, 1989) 

Hepler C.D., Strnd L., "Definition of Pharaceutical Car, " (Depanent of Phar
macy Health Cae Administration, University of Florida, 1989) p. 
Pharacy 
Caer B.L., "Repon of the Comminee on Clinical Servces in Community 
50:190- 1986. 
Prctice,  American Journal of PharmceUtical Education, 
Kalman S.H., Schlegel J.E, "Stadads of Practice for the Profession of Pharacy, 
NS19 (3) : 21-35, 1979.
American Pharmcy, 

Helling D.K., "Famly Prctice Pharacy SeIVice: Par II, 
Drug Intelligence and Clinical Pharmcy, 16:35-48, 1982. 
Koechler J.A. et al., "Indicators for the Selection of Ambulatory Patients Who Warant 
46:729-32, 1989. 
Pharcist Monitorig, 
American Journal of Hospital Pharmcy,

Strd L.M. et al., "Documenting the Clinical Pharist s Activities: Back to 
22:63-66, 1988.
Basics,"  Drug Intellgence and Clinical Pharmcy, 
McKenney J.A. et al., "Effect of Pharacist Drg Monitoring and Patient Education 
Contemporary  1:2, 50-56, 1978.
on Hypenensive Patients," 
 Pharmcy Practice, 
10.  Share T.R. et al., "Patient Compliance with Antibiotic Regiens,  American Journal 
31:479- 1974.
of Hospital Pharmcy, 

11.  Kidder S.W., "Cost-Benefit of Pharacist-Conducted Drg Regien Reviews, "  The 
Consultant Phannci  394-398, SepuOct 1987. 
12.  Juhl R.P. et al., "The Famly Prctitioner-Clinical Pharacist Group Practice: A Model 
Clinic,  8:572-75, 1974.
Drug Intellgence and ClinicalPharmcy, 

13.  Brown D.J. et al., "Evalua,tion of Clinical Pharacist Consultations in a Famly Prac
tice Offce,  36: 912-15, 1979.
American Journal of Hospital Pharmacy,

v - I  pp. 
14.  Results of a demonstrtion projet funded by the John A. Harord Foundation- of New 
University of California in 
York. The projectis direted by Helene Lipton PhD. of the 
San Francisco at El Caino Hospital in Mountain View, California. In the course of 
completing our fieldwork, we visited El Camno Hospita and inteIViewed the project 
who car for the patients in the study 
sta, hospital administrtors and physicians 
Harord 
findings have been presented to the  Foundation and a 
group. Prliminar 
final repon wil be completed in March 1990. 
Drg 
15.  Hammarlund E. et al., "The Effects of  Counseling and Other Educational
Strtegies on Drug Utilization of the  23:2, 165-170, 1985.

Elderly,"  Medical Care, 
16.  Kimberlin c., "Communications," chapter in Werteimer A., Smith M. , ed.,  Pharmacy 
Practice: Social and  3d ed. (Baltimore: Williams and Wilkins, 
Behaioral Aspects, 
1989) pp. 159-78. 
See Also: 
Knapp D.A. et al., "The Pharcist as Drg Advisor," in Werteimer and Smith, 
l00-105. 
Th 
Werteimer A.I. et al., "More on the Pharacist as Drg Consultat:  Case 
7:58-61, 1973.
Studies,"  Drug Intellgence and Clinical Pharmcy, 
VandeIVeen R.L et al., "The Pharacist as Drg Consultat-Five Years Later,"  Drug 
7:58- , 1973.
Intellgence and Clinical Pharmcy, 

Drg 
Jang R. et al., "An Evaluation of the Value of  Related SeIVices in Neighborhood 
2:21-38, 1975.
Pharacies,"  Drugs and Health Care, 
Rowles B. et al., " The Pharacist as Compounder and Consultat Drug Intellgence 
8:242- , 1974.
and Clinical Pharmcy, 

Puckett EJ. et al., " Contemporary Phar
Pharacist/atient Counseling Prtices," 
1:67-71, 1978. 
macy Practice 
Ross S. R. et al., " The Effect of a Mandatory Patient Counseling Reguation on the 
Prctices of Pharacy Prctitioners, " Contempora Pharacy Practice, 6469, 1981. 
Mason H.L. et al., "Medcation Counseling Behaviors and Attitudes of Rural Com-
18:409- , 1984.
munity Pharacists,"  Drug Intellgence and Clinical Pharmcy, 

15, 1989. 
Hammel R.W., "Barers to Appropriate Consultation,"  Wisconsin Pharmcist, 58:4, 
14-
V - 2
 , "  " p. 
OPE Study 67 
Patient Receipt of Prescription Drug Informtion 
17. 
Morrs L.A. et al., 
S. Foo and Drg Administrtion, September 1983. p 21. 
prepard for the U.
18.  Ross S. et al., "The Effect of Mandatory Patient Counseling Regulation on the Coun-
Pharacy  Contemporary Pharmcy Practice, 4:2,
seling Practices of 
Practitioners," 
64, 1981.

19.  Capbell, R.K. et al., "Compliance with Washington State s Professional Practice 
pA7, 1989.
Regulations: 1974 vs. 1987,"  American Pharmacy, 
 NS29:5, 
20.  Kimberlin  Communications," p. 164. 
to Maximize Their 
21.  Knapp D.A., "Barers Faced By Pharacists When Attempting 
43, 357
Contrbution to Society,  American Journal of Pharmceutical Education, 
359,  979 
22.  Molzon J.A., "Legal and Prfessional Issues Related to the Use of Pharacy Tech
proceegs from the 
nicians as Supportve Personnel," ( Anaheim, Caifornia: 
American Society for Pharcy Law Annual Meetig, April 9, 1989)photocopied,  pA.
23.  Ibid. 
24.  Ibid. 
25.  Ibid., p. 
26.  Ibid. 
27.  Kimberlin, "Communications," p. 170. 
28.  Knapp, "Barer's Faced," p.359. 
29.  Kimberlin, "Communications,  171 
The Scher
30.  Pharmcists and Physicians: Atttudes and Perceptions of Two Professions, 
ing Repon V, (New Jersey: Schering Laboratories) 1983. 
S. General Account-
31.  HCFA' 
s Proposed DUR System Ignores Quality of Care Issues, 
ing Offce, July 1989.

32.  Hepler C.D., "The Thir Wave in Pharaceutical Education: The Clinical Movement, 
51:361-385, 1987. 
American Journal of Pharmaceutical Education, 

v - 3  , "

33.  Bilow J.A. et al., "A Comprehensive Communication Skils Progr in a Four- Year
Pharacy Currculum,  American Journal of PharmaceUtical Education, 48:42-
1984. 
34.  Kimberlin  Communications. 
A National Surey of Prescription Drug Informtion Provided to
35. 
Morrs L.A. et al., 

S. Foo and Drug Admnistrtion, 1986, 
OPE Study 73, prepard for the U.
Patients, 
36.  Institute for Health Policy Analysis of the Georgetown University Medical Center, 
Prscrption Drgs" (Isle of 
workshop on "Communicating the Benefits and Risks of 
Palms, South Carolina, March 1988) and National Council on Patient Information and 
Education" conference on "New Frontiers in Patient Education" (Washington, D. 
May 1989). 
Prscrption Drgs," 
37.  McCalum D.B. et al., "Communicating the Benefits and Risks of 
Monograph 106, prepar for the Institute of Health Policy Analysis, Georgetown 
University Medical Center, 1989, p. 
38.  Smith M. et al., "A Study of Pharacists' Involvement in Drug Use by the Elderly, 
18:525-29, 1984. 
Drug Intellgence and Clinical Pharmcy, 
Schering Repon IV, (New Jersey: 
39.  Pharmcist Perception Versus Consumer Realities, 
Schering Laboratories) 1982. 
40.  Ibid. 
41.  Knapp, "Barers Faced," p. 358. 
42.  Ludy J.A. et al., "The Patient-Pharacist Interaction in Two Ambulatory Settgs-Its
Drg  Drug Intelligence and Clinical
Relationship to Patient Satisfaction and  Misuse," 
11:81-89, 1977. 
Pharmcy, 
Journal of the 
Beardsley R.S. et al., "Prvacy As A Factor in Patient Counseling," 
NS 17:366-68, 1977.

American Pharmceutical Association, 

of Pharacist-Conducted Patient 
McBean BJ. et al., "An Evaluation of Four Method 
115:167-172, 1982.
Education,"  Canaian Pharmcy Journal, 
43.  McCallum, p. 
44.  Marks M.R., "A Medication Sleuth at the End of a. Phone Line,"  California P har

macist  33:3  1985; also, telephone inteIView with Richard Oksas, July 1989. 
V  APPENDIX VI 
DETAILED COMMENTS ON THE DRAFT REPORT AND DIG RESPONSE  -------- - - ......
. r

(c. 
Memorandum 
r"Y''
APR 10  'W""
Dlte 
A6sistant Secretary for Health 
From 
OIG Dra ft Report6 "The Clinical Role of the Community

Pharmaci6t. " and " The Clin1  al Role of the Community
Subject 
Pharmaci6t: Case Studie6

In6pector General, OS 
'To 
Attached are the PHS comment6 on the 6ubj ect OIG draft reports.

We generally agree with the content6 of the draft reports and

concur with the recommendations directed to PHS. We will

develop and implement by October 31, 1990. a 6t rategy to reduce

barriers l 
ical pharmacy 6ervice6, particularly for 
elde  atients. We sre a160 working on increasing our 
'v
knowledge in developing risk indicators and treatment

priorities for elderly ambulatory patients.

Our co cents on the recommendation to the American

Pharmaceutical AS60ciation and American AS60ciation of Colleges

of Pharmacy present alternatives for developing a uniformed

review process for pharm cists in their patient encounters.

Mason, M. D., Dr.
 COMMENTS OF THE PUBLIC HEATH SERVICE ON THE OFFICE OF INSPECTOR 
GENERA  I OIG) DRAT REPORTS " THE CLINICA ROLE OF THE 
COMMUNITY . PHACIST, " OAI-01-89-89l60, AND 
THE . CLINICAL ROLE OF THE COMMITY PHACIST: CAE STUIES. 
OAI-01-89-89l6l 
General Comments

dilem 
facing comunity 
The reports effectively capture the 
pharmacists rega=ding the implementation of progressive patient

clinical pharmcy services.
oriented pharmacy services, i.  e.,  pharmcy 
The reports should have a positive impact on the 
pproefesrsisono byn idsen.t ifying the most significant barriers to the

provision of pharmceutical care for patients, especially older

Pharmcy in the 21st 
A recent strategy planning conference on .
Century, n held in Oc  er 1989, examned many of the major issues

confronting pharmacy today and projected for the next 15

years. The consensus statements of the conference support the

findings of these reports. The participants included

practi tioners, 
pharmacy leaders, selected representatives of 
governent and 
consumer groups, and  corporate health care
Sumry 
decision makers. A copy 
of the Executive  (Attachment A) 
is attached.

We regre  the OIG inspectors did not include in their

the 
inspection and caSE studies the Indian Health Service (IHS) 
pharmacy program. IHS has nearly 30 years of experience in

pharmcy services with extensive utilization 
providing clinical 
of patient consultation. The IHS practice model has elimnated

most of the barriers described in the eIG report.

The PHS comments on the eIG recommendations that pertain to PHS

are presented below. Additional comments regarding alternative

viewpoints are also included, which we believe would strengthen

The additional coments 
the overall content of the report. 
rela te to (1) the concept of a needs based system, and (2) the

description of clinical services, especially the graphic

representation in App'endix IV of the eIG report.

eIG Recommendation I. 
The Public Health Service (PHS) and the Health Care Financing

Adinistration 
(HCFA), individually and collaboratively, should
develop a strategy to reduce the barriers to clinical- pharmacy 
amulatory elderly patients. 
services, particularly for  Page 2

PHS Comment

We concur, noting that it is essential to develop a strategy that

includes research, demonstration, pahnadr medcuyc asteirovnic eefsf oarst sd etsoc rribeedduc e

each of the barriers to clinical 
by OIG. PHS welcomes the opportunity to develop strategies to

pharmcy services for amulatory 
reduce the barriers to clinical 
patients, with emphasis on older persons.

IHS has extensive experience in the provision of proqressive

pharmaceutical care and is the prototype of a functional practice

pharmcy services concept 
model that clearly demonstrates the 
described in the report. IHS will develop a descriptive strategy

for reducing barriers to clinical services and demonstrate its

application by September 30, 1990.

The Bureau of Health Professions in the Health Resources and

Services Administration, PHS, will further develop the strategy

described abov  in collaboration with IHS and HCFA. The strategy

will be developed and implemented by October 31, 1990.

OIG Recommendation II.

The National Institute on Aging (NIA) should take a leadership

role in developing risk indicators and treatment priorities for

elderly amulatory patients. 
PHS Comment

We concur. NIA has taken action to increase its knowledqe in the

area of geriatric pharmacology, includinq the areas of risk

amulatory 
indicators and treatment priorities for elderly 
patients. NIA has recently published a Request for Applications

(RFA) : "Pharmcology in Geriatric Hedicine" which solicits

pharmco
research applications on druq utilization reviews, 
epidemiology, and . other areas related to the improvement of 
Tw million 
medication prescribinq and use by older persons. 
dollars have been set aside for this RFA. Scientific review of 
proposals will be accomplished by a special initial review

qroup in June 1990, with secondary review to be completed at

the September 1990 meetinq of the National Advisory Council on

anticipated that approximtely 8-10 hiqh quality 
Aqing. It is 
applications will be funded with startinq dates of

December 1, 1990.

accomlished 
However, this recommendation may be more effectively 
exprt panel from appropriate

if conducted in conjunction with an 
PHS agencies and professional orqanizations. Indicators cbaen  abte 

may 
developed but they will only tell you which patients 
 -..
-.- \.. --  __.
Page 3

high risk (..v  - ..x",a  gh risk). What is needed is a 
I.. .. 
coments on

shortened practical needs assessment process (see 
recommendaptiaotnie InItI t.o  bdeelotew)rm thnaet  hciasn/ hbeer  upsaerdt iactu leaarc hn eeendc ofuonrt er

wi th each 
clinical intervention. In addition, the term adverse drg
outcome
negative  or  adverse 
reactions is too limiting. The term 

should be substituted because it includes such important items as

treatment failure due to inappropriate drug use.

Technical Comments

Needs Based Concept

. The 
Paqe 6, Paraqraph 2 question raised in this

paragraph is the key issue in the report and can be

comunity 
c1 up as follows: How can the 
ist determne what services are needed at each

patient encounter and provide them in a practical and

timely manner?

Paqe 6, Paraqraph 3 . The statem nt is accurate in its 
assessment that there is little consensus regarding

pharmcy care as applied to 
standards of clinical 
patient need. There are good reasons for that, and

,;"H:: l."E:c:so;ms may add difficulty to the implementation 
T.Ec  mrendations II. and III. 
nf 
e., each

First, patient needs vary with time, i.
evaluation of patient needs is like a snapshot of a

moving or changing object. This constant change makes. 
it very difficult to set standards based on needs that

are useful. Initial 
encounters with patients who are 
on multiple drug regimens and those whose diseases are

not adequately controlled, will require more

patient is 
comprehensive services. Once that 
stabilized, the need for intensive monitoring will

monitoring those 
drastically decrease. To continue 
patients intensively just because they are on multiple

drug regimens would be an inappropriate use of

approaches 
pharmacists' professional time. Therefore, 
like the one proposed by Koechler, et a(lA.,J i)n,  the

American Journal .of Hospital Pharmacy  which 
incorrectly assume a continual high level of need, will

pharmcy efforts. The authors point 
resul t in wasted 
out these problems and others in their discussion

section including the fact that a large percentage of

patients that need intervention did Dot fall into their

cri teria for service.  Page 4

needs and the 
determne patient 
Second, the ability to 
extent to which these services are provided is not

consistent among pharmacists because of the following

reasons and other factors: 
the extent of the database available to the

pharmacist; 
thp. knowledge of the pharmacist in both drug and 
disease information; and

pharmcist to collect and 
the ability of the 
integra.te drug, disease, and patient data to
identify and solve drg rela  ed problems. 
Pace 6, Paraqraph 4 . Two approaches were cited and

listed as Q  erent perspectives. A casriemfulla rr esvuibejwe c
ts 
the articles listed and other work on 
by these authors revealed that these are not different

perspecti ves, but were v riations of the same concept.

Dr. Linda Strand' s work was developed to teach students

a ski 11 not generally taught in pharmcy school. 
Primarily, pharmaceutical education has been

tation. 
accomplished through memorization and requrgi 
Clinical pharmacy practitioners have long recognized

solving
tshkati lsltsu.d ents were not taught clinical problem .
Dr. Strand has formlized a process that 
forces (teaches) students to utilize clinical problem

solving skills via the collection anddr gin tegration of

databases. 
patient and disease databases with 
s work on

This is one of the end products of Dr. Strand'
student-centered problem oriented teaching methods.

The difficulty with her comprehensive approach is that

it is very time consumng and, therefore, is not 
practical to use for all outpatients in a busy pharmacy

practice setting. 
Recognizing the difficulty of providing a comprehensive

approach to all patients, the authors of the 

article try to find a process to identify those

patients that most nee  a comprehensive approach to

clinical pharmcy services (Dr. Strand' s process). 
based process did not

Unfortunately, their criteria-
address changing needs over time, plus it failed to

pidhenatirfym aa lcaryge  piernctenetargev oef npattiienotsn .wh o 
required
 Page 5

What both studies ignore is the medical model- of

patient needs asseSBment which operates on the

assumption that all patients at each encounter get

their needs assessed via a more practical but shortened

version of the comprehensive approach of the

tradi tional 
complete history and physical. 
Needs Based Conce t

Recommendation III. 
Paqe 20

Rather than focus on developing a set of needs based

standards, priority should be placed on developing a

pharmcists 
. practical 
standardized review process for 
e., a shortened

to use for each patient encounter, i.
based 
s process. Needs 
practical version of Dr. Strand'
sta..
darcs for every patient may be impossible due to 
the constantly changing nature of individual patient

pharmcists
needs and the variability among individual 
in their ability to assess patient needs. This process 
would be directly comparable to the medical approach of

One 
patient needs assessment (see diagram below). 
pharmcy 
approach which uses a shortened practical 
simlar to the 
medical model, 
needs assessment process, 
has been developed by IHS as presented in Attachment B.

PAT!ENT NEEDS ASSESSMET PROCESS

Comprehensive . Strand' approach  Complete physical 
workup  and history

Impractical and too

time consumng for 
use in every patient

encounter. 
Lited 
Practical shortened  Not developed
 history and
version  physical based on

chief eomplaint (problem

Maybe some combination

Applied at every  of lES approach

(process) and AJP
patient encounter 
approach (indications) 
Outcomes 
Succeuful  Identified
Large % Sma II %  PS%  Sa: s requiring 
successful requiring more succenful. Dx 
intervention  comprehensive  and treated  comuhensi ve

workup
needs assessment
 ,-;-:"~ ~~ ., "

Page 6

A practical snortened version of the comprehensive approach

resu  ) successful needs assessment and intervention
tS 1n l 

in the vast majority of patients, and (2) identification of

do not 
those requiring comprehe sive evaluation. Physicians 
perform a complete history and physical on every patient

they encounter. They reserve that time for those who need

it most.

Descri  ion of Clinical Pharmac Services 
?ep  findinqs, " and 
esentat+on',
pharmcy services into four groups 
The breakdown of clinical 
is generally correct. However, the assumption that within

each component there is a continuum and the description,

especially the graphic representations, of that supposed

continuum is inaccurate andlor misleading.

tient Counselinq, " Paqe S  This graph

creates confusion and inaccuracy rather than clarifying

concepts because it attempts to illustrate a continuum

that does not exist. Instead, it describes a

combination of apples and oranges, including

(DUR), pharmacist 
prospective drug utilization review 
agement of chronic patients, and some patient

activities. 
consul tation 
'tour 
dJ1V, " 
Compo  ts of C:+inica:+ Pharm 
rt:,  on o  ent Informtion, " Paqe 
C::ra'O 
IV-
While most of the important items are listed, they are

grouped improperly by source rather than by patient

need-based continuum that this report is trying to
describe and propose. The reason for the pharmcist 
dete:mne what type and 
collecting a database is to 
intensity of clinical pharmcy services the patient 
needs. The continuum should address which type of data

are most important to dete:mne patient needs. Where 
the pharmacist obtains the data, e.g., from a medical

record, patient profile, physician interview, or

patient interview, is a totally separate issue and is a

function of the practice environment and the

pharmacist' s professional comtment to provide 
clinical services.
 " ""'
"'=
Page 7

. PI'TaOT!lph-, " (2\ Prospective DruCl
1',.  ;r,  eview DUR 
Uti 1"  r.
The report dces not clearly define the DUR. Based on 
what is included in the report, it appears to be too

narrowly defined around ADRs and drug interactions. 

more appropriate definition of CUR appears on page

paragraph 2, of the introduction, i. 
e ., a review of the 
patient, drug, and disease databases to provide those

functiolls listed in the 
second half of the paragraph. 
IHS utili2 
the term  negative patient outcomes 

encompass those three functions. The focus of clinical

pharmacy practice is this review process to determine

the need for pharmacy intervention at each patient

encounter. 
Attachment C presents the IHS standards of
practice. 
Standard I of the IHS standards is a more 
comprehensive version of a prospective CUR process.

pharmcist compares 
In prospective CUR processes the 
therapy against the criteria such as those listed in

the IHS standards. How much, how well, and whether the

determned by: 
DUR is done at all is 
the extent of the database available to the

pharmcist 
thp. knowledge of the pharmacist in both drug and 
disease informtion 

pharmcist to collect and 
the ability of the 
integrate drug, disease, and patient data to

identify and solve drg 
related problems1 
the pharmacist' s efficiency in performng item c, 
pharmcist has optiml data, 
and once the 
knowledge, integration skills, and efficiency

(i terns a-d), th n workload becomes a factor 1 and 
corni tment for providing these services. 
hs on faCle U!APpendj.x IV-4 on Prospective DUR 
Once again as in the collection of patient informtion,

no continuum exists and the continuum presented in both

graphs consist more of how it is done rather than what

needs to be done.
 ~~~
page 8

tie  4 and IV-
t C  5elinq, Paqes IV-
Paqe IV-4, Paraqraph 3 . The first statement on patient 
informtion is 

counseling about pharmcists giving 
incorrect. The ultimte outcome of . patient counseling 
. understanding of how to 
is to verify the patient' 
That 
appropriately take the medication prescribed. 
requires the patients to understand: (1) why they are

taking the medication, (2) how they are to take it, and

(3) what to expect (i.e. expected outcomes, side
efrec 
and what to do in each situation). 
Paqe IV-S, Paraqraph 2 . IRS' s 3D years of experience 
in patient counseling confirms the efficacy of private

face-to-face consultation as the preferred mode. In 
addi tion, research and experience have identified a

determning
potentially even more important factor in 
the efficacy of patient counseling. Learning has been 
shown to be increased when the person receiving the

information becomes actively involved in the process.

pharmcy they have 
By the time patients reach the 
already received some degree of education from the

physician or other provider, previous experience,

and/or personal research. 
IRS uti lizes all three of these principles in

unseling patients (private face-to-face, active

involvement of the patient, and utilization of prior

pharmcist 
knowledge). Using open ended questions, the 
verifies that the patient understands critical

information. If incomplete understanding is detected,

The 
the pharmacist merely fills in the gaps. 
consultation concludes with the patient verbalizing or

the patient demonstrating his/her understanding of key

elements. This is a patient needs based approach to 
presents a sumary 
patient consultation. Attachment C 
outlining the interactive, patient needs based approach

pharmcists. 
to patient consultation taught to IRS 
araqr  Since the purose of
ph 4 
S , 
?caae ounseling is to improve compliance, i.e., "make the 
patient better, 
" informtion regarding expected 
outcomes and unexpected effects are among the most

critical elements that patients need to understand.

Among the major causes for noncompliance are the

patient' 
s lack of understanding of: 
what the medication is supposed to do (desired

effect) I 
what to do if it does not happenl and
 ..;... 
Page 9

ed things might happen (adverse

:. w,c;cpe:c 
effects), and what to do if they occur.

Paqe IV-6. Paraqraph 2. Follow UP Activities and 
Moni torinq

This paragraph discusses prospective DURs, or what the

IHS calls pharmcist managed therapy (Standard 6, IHS

Standards of Practice (see Attachment D), not patient

pharmcist 
consultation, and belongs under DUR or under 
managed care. It describes the patient need assessment

process that occurs when patients on chronic

medications come in for refills. Therefore, the

informtion 
statement that they (the scientific 
pharmacists) raise their counseling to a higher level

should be eliminated. 
Graph  " Physician Consultation, . Paqe rv-
A better term for this section would be

Physician/Pharmacist Interaction/Communication.
There are four basic reasons for pharmcist-physician 
communications: 
Physician telephones a prescription to the

pharmcist. 
Physician collects or verifies portions of

patient/disease State/drg database.

During the needs based prospective DUR, the

pharmacist detects a therapeutic problem with

safety, patient effectiveness, appropriateness, or

cost effectiveness of the prescribed therapy and

calls to resolve it prior to dispensing.

The physician calls to request advice or

information about a drug, what drug to prescribe

in a particular situation, etc. Only this case is

a classical consultation in the physician to

pharmacist tradition.

Graph " Physician Consultation, . Paqe 5 
There is no continuum depicted in the grap

consists of who does the calling, where they are

located, etc., rather than a continuum of functions

regarding sophistication of pharmcist-physician 
communication.  ..... 
Page 10

Recor....;:;:dation  T"!T  Reqardinq Maximal Level of Service, 
Paqe 
maximl level 
The statement that APhA/AACP prescribe a 
of service is inaccurate. This assumption and the

graphic depictions (graphs 1-4, pages 4-5) do not

follow the methods used by national standard setting

organizations to develop professional standards of

Probably the 
practice and the APhA/AACP standards. 
preeminent organization in the field of standard

setting and compliance monitoring is the Joint

Commission on Accreditation of Health Careit
 s 
Organizations (JCACO). JCACO, through 
experience, has looked at health care delivery

functions and has developed a prescribed process to set

Tnp st  ndards. In each functionaolp atriema,l .t he range of 
services stretches from none to  Once the 
range is established, they select their standard

somewhere between none and optiml and define this as a

minimal standard. 
Care Fuction 
Heal th 
none 
::.inima 1

This approach was used to promulgate the APhA/AACP

standards of practice. The standards, which are

operational standards, are miniml, 
and lie definitely 
There are 
to the none side of the graphic depiction. 
Bome shortcomings in the design of the APhA/AACP

standards that need to be modified. 
Considering that 
the standards (1) were a first attempt to design

national standards, (2) represented a consensus among

pharmcy
representatives from all areas of 
practice, and (3) utilized a limting 
approach based on 
a task inventory analysis, the document still

represents appropriate miniml 
standards for the 1990s. 
Wha t needs to be done is to tie up those standards so

that they are functional rather than task inventory

based. This 
process should involve representatives 
from other major professional organizations.

s need

In addition, a shortened version of Dr. Strand'
based approach (a pharmcy version of the medical

approach) should be developed for use at ea h patient

encounter. This process will be quick, take Care of  Page 11

the vast majority of patient needs, identify those who

need comprehensive time consumng services, maximize
limi ted professional pharmcy resources, and achieve 
improved patient outcomes and cost savings

Other Comments

A national task group should be formed to develop a

intervention. 
shortEned pr ctical version of Dr. Strand' s process

modeled after the medical approach that can be used at

each encounter to determne the need for intensity

The" APhA/AAC? involve other professional organizations 
and redo their standards of practice based on

inventory . 
functional rather than task 
Broaden the definition of prospective DUR to include

all adverse outcomes.

Pharmcy Settings. 
Appendix II, page 11-1, . It is 
unclear where managed care practice and mail service

care settings 
fall in the definition. Certain managed 
resemble community pharmcies while others are more

like insti tutions 

Also include roil service and managed care settings in

Appendix II, .Pharmacy Settings.
 OIG RESPONSE TO PHS' COMMENTS-

We ar grteful to PHS for its very thoughtful and constrctive response to the drt repon. 
The PHS' s concurrence with the recommendations directed to it represents a significant 
parcularly for patient populations that suffer 
committment to improving pharaceutical care, 
most from drg-related ilness. 
We agre that the Indian Health SeIVice provides an excellent practice model for 
for not including it in our case studies was that ilS more 
pharaceutical care. Our reason 
closely resembles a managed care system rather than a more typical community setting as 
defmed for puroses of our repon. This is not to say, however, that the ilS model has not 
influenced the practice of high quality clinical car in community pharacy settngs. In the 
expert in the field who 
course of conducting our study, we inteIViewed a number of 
consistently referrd to the ilS system as exemplar. Several of Ute most influential leaders 
in the field of pharceutical care trned with the ilS and have devote much of their 
trsferrg ilS stada to other practice settgs. We acknowledge 
professional carers to 
the ilS's reputation for innovation and excellence in clinical pharacy car and regrt that 
of maaged car and 
the scope of the study did not permit a more extensive examnation 
institutional settings.

Our responses to PHS' s technical comments ar as follows: 
Standrd setting and  We agre with PHS and have 
needs assessment process: 
Il. 
made revisions in our discussion of Recommendation 
Description of components of clinical  We appreciate the thorough 
pharmcy: 
crtique PHS has provide We have made a number of the suggeste changes 
ma al 
text. We have not  suggested chan
in both grphic presentations and 
ges for severa reasons: Firt, the descrption of components as presente in 
spectrm of servces that currntly exists, 
the repon is meant to descrbe the 
exist in a nees-based
and not, as PHS suggests in its comments, what 
 should
system. Second, the four-component descrption is not meant to present the 
best or the only constrct by which the functions of pharceutical car can 
understoo. Essentialy, it reflects the way in which our case-study phar
descrbed their work as well as the obseations we 
macists and other expert 
it seIVes only as an 
made in those practice settngs we visite Consequently, 
stadad. Third, 
analytical and descrptive tol in ths repon, rather than as a 
pharacy as we descrbed 
because the individual components of the clinical 
them in the repon ar dynamc and relate to one another in complex ways, 
some individual functions do not fit neatly within a single component. For ex
ample, the PHS makes a goo case for including what we have called "follow
up counseling" under the DRR component, rather than the Patient Counseling  component. We submit that because the tasks involved in "follow-up" counsel
ing include data collection, DRR and patient counseling. there is not one fit for 
this pancular function. Our decision to classify it as we have was drven by 
the fact that most of our case-study pharacists perceive it as par cif their coun
seling role. 
Again, we thank PHS for its support and for its incisive comments, which we believe have 
improved the quality of the repon.  ,-C' 
11"1 ..
.te 
D(Y
GAaild Rm. WiilternstkQy, Prh .""
"ro""  t -
. OIG Draft Report: '"e Clcal Role of the Community Phacit, 
SIJJect 
OAI-Ol-89-89160, and "Te Clcal Role of the Community Pharmacit: 
Cae Studies," OAI-Ol-89.89161 
'To 
The Inpeor General 
Offce of the Secretary 
One of the repons address the 
We have reviewed the subjeCt repons. 
clica 
barrers to the proviion of  servces to camab ulatory patients in community 
studies of community 
phannacy settings. The ot.her repon presents  clica 
raee of these 
pharmacists who have sua-.eeded in providing a broad 
servces. 
sttegy, indivdua and with 
recommend that HCFA develop a 
The report 
clca pharcy 
the Public Health Servce, to reduce barrers to providing 
concu with 
servces, pacularly for ambulatory elderly patients. We do not 
clca pharmcy 
ba a strateI) to improve 
recommendation. HCFA aleady 
Thoug the maged cae intitie, 
servces though its manged care intiative.  uttion 
teti& drg  revew systems 
many $tgte Medicaid prOaram have or are 
ca1:d for in 
kid of cordinated care 
and capitation programs that encourage the 
:t.: repon did not address these effort by HCFA 
the OIG report Unfortnately, 
and the: States. 
for outptients is cmme1y lited in scpe 
Medicare coerage of drgs 
and, for the most par dpoh DaOtc piay.  for drgs that ambulatory bencefaiocita res could 
apply to 
Thus th remmendations 
obtain from communty 
Medd  Medica beneficies. 
the non- popWaQon of 
the Medica outpatient drug 
Moreor, bescaues of trhe lvited sccope eof  s.
to establih the comprehensive drug
benefit, we do not have sufcient data fies 
to monitor the effectiveness of 
utiltion revew program tht would be needed

clinica pharacy  ..""
For Medcad, however. coeraee of presption dres is optional for the 
vaessiiIcantl 
States. The lcve.l of outpatient drug coerage  acros the States. 
ccct 
Although $;.;  ; lrOci  broad Federa requirments. they 
admiterig 
responsible for  their own Medicaid program. Thus whie no single
strategy developed by HCFA to reduce baers to clic: phaacy servce 
would be applicable to all States, seera States (e.&- Caorna and Kentucky) are 
clica pharcy 
leaders in providing  servccs to the elderly in community
pharcy settgs. It is unortunate that the 010 report doc not r  these 
importnt effort in ths area. 
al 
HCF A is  engaged In reseach and demonstrtion project studyg 
method to reduce the inappropriate us of c1p by the elderly. The Uniersity 
ca 
. of Wisconsin has developed a set of quaty  indicators that us Medcad drg 
and hospitaJ clai to monitor quality of cae in Medicad nuring homes. The 
Miesota 
University of  is studyg the us of pschotropic drgs among nuring 
home residents. To the eXtent nuring homes ar servd by community 
pharacies for their patients' drg needs these studies wi 
help to develop 
HCFA' s strategy. The role of the communty pharacy in the cae of nuring 
. home patients is another area not well cored in the Ola repon. 
With the recent repeal of the Medicae Catatrophic Coerage Ac: drug 
belicfit, we are reaessing our resech and demonstration priorities in the drug 
wi 
we develop our strateiY, we  consider OIO' 
area.  As  s suggestion tht
include research, dcmonst!  tion and education effort to reduce baer5 to clinical 
pharmacy care. 
Thank you for the opportnity to revew and comment on these draft 
report.  OIG RESPONSE TO HCFA's. COMMENTS 
We thank HCFA for reviewing the report and regrt its nonconcurrence. We are pleased to 
note that HCFA already conducts several activities that parally address the spirit of our 
recommendations. Nevertheless, we believe that the problem of drg-related ilness is 
wart a 
depanmenta response 
sufficiently crtical to  more strcture and comprehensive 
that combines the best effons of HCFA and PHS.  American  ""ue, f#
2215 ConS\lutlO 
Pharmaceutical  Nilil Prfesl
Wa-hlngton, DC 20037  Phfr 
Association  (202) 628-410 FAX (202) 783-2351  Th  of 
March 6 , 1990

Richard P. Kusserow

ral 
Inspector Gc 
Department of Heal  and Human Services 
Washi:ngton , DC 20201 
Dear Mr. Kussero

The American Pharmaceutical Association is pleased to respond to the

draft report of the Office of the Inspector General entitled "

Clinical 
E",.- c. L c:co_. mitv Pharmacist . As the national professional 
, we are gratified by the substantial analysis that 
society of pharmacists 
our profession has received in recent reports from your office. More 
e are pleased that the critical role that pharmacists play

importantly. 
in providing quality health services to patients is finally becoming

better understood at the federal level. We appreciate the department'

recogni tion of APhA' s leadership role for the prof ssion on these issues. 
Our comments include both general reflection on the report
, its findings

lon  , a. well as specific responses to the recommendations
and recommenda 

addressed dir  cr.ly tC' APhA. We ask that they be carefully considered in 
the preparatior. of the final report on this subject.

We are extremely enthusiastic about both the substance and tone of this

draft report. Your office, through a thoughtful process of information

collection 
, site visits and staff analysis has developed a report which 
articulates many of the critical elements of progressive pharmacy

practice that APhA has espoused for many years. To that end, our

comments, and criticisms , are offered in the spirit of a shared mutual

interest in advancing the profession of pharmacy and the services it

tients . 
offers to pa 
The draft report states that its focus is on the services available to

elderly ambulatory patients in the community pharmacy setting. However

the concepts, principles and practices outlined 1n the report apply

universally to all patients that pharmcists serve. In our previous

comments to you on the OIG report on "Medicare Dru  Utilization Review

, we did note the particular need that elderly 
in March of last year 
magement of their 
patients have for effective review and  medication 
regimens. The drug therapy of eiderly patients is often complex as a 

result of multiple diseases , multiple prescribers and physiological and

other changes in medication response as a result of the aging process.

But complex regimens and informational needs are certainly not exclusive

to the elderly.

In that same letter , we drew some distinctions , both operational and

semantic 
, bet,,'een the OIG terminology of "prospective DUR" and the
profess io  ' s concepts of " drug usage evaluation 
" or DUE. We would  .:.
Richard P. Kusserow

MArch  6 I 
reiterate that the assessment of a patient's current drug therapy prior

to the ini t:iation of a change (new medication added , medication deleted. 
dosage change , etc. ) is more appropriately referred to as drug regimen

review (DRR). This key feat:ure of professional practice 
is the sole 
province of pharmacists, and is the pivotal point at which the unique

knowledge , skills and competence of the pharmacist can be brought to bear 
thn
to improve the quality of patients ' drug therapy. It is far aore 
prcblE  i1=  :ificaticn and resolution" or " risk management" as described
in t e draft 
report:. Rather, it is the opportuity for pharmcists
working wi th patient: 
and prescribers, to better assure high quality 
therapeutic outcomes.

that: let:ter that 
We also suggested in  because the term DUR is often 
associated purely with quantitative assessments of drug use 
, the term

drug usage evaluation (DUE) better describes the type of structured

qua  ,. - "'Coo, f.rocess that assures safe, effective and economical

medication use. The March 1989 OIG report on this subject very

effectively noted that quality of care issues are a principal reason for

such progran:s. 
RESPONSE TO FINDINGS AN THE OVERALL REPORT 
As ment:ionec previously, APhA believes that the draft report was

deve loped in a sound and balanced manner, and offers substantial

inLor  r.c i  ght. The observation by OIG staff of commity
practice. around the United States where clinical services are currently

AP 
being provided was a critical element of the report, and  applauds
effort. 
OIG for that: 
APhA i. in general agreement with the five findings outlined in the body

of the report:

Findin2 I 
o There are four components of clinical pharmcy pract1ee: collection 
of patient information, prospective DUR, patient couseling and

physician consultation. Each of these components encompasses a 
continuum of possible services.

We have previously stated our concerns about the term .
prospective DUR"

and will not rei terate that here. 
We would submit that certain screening 
activities and physical assessment funetions
, e.g. blood pressure

monitoring, should logically be included in the diagram depicting

collection of patient: information. Further. we suggest the addition of 
such activit:ies as drug-food interaction screening, evaluatio

laborat:ory data and assessment of 
patient compliance as part of the drug
regimen revie  process diagram. . The process begu 
in the patient 
information collection phase is dynamic, rather than static, and is

integral to the effective drug regimen review function of the

pharmacist. It is also critical to note that the pharmacist is not

simply a screener of information but analyzes
. interprets and acts upon

the data presented. This should be reflected in the diagram as well.  ..-----..-....
. . . 
Richard P. Kusserow

March 6 . ' c -,

P,:!?e 
The diagram describing pdtient counseling activities includes both

information exchange and monitoring functions , each having a necessary

feedback loop and interaction with the patient. Similar information

sharing and exchange functions are depicted in the physician consultation

diagram. As the 
continuum oY these functions proceeds it becomes clear 
pharmcist and patient 
that direct , face-to-face contact betWeen  and a 
close  lationship with the physician (or other prescriber) 
. collegial r 
ize the quality of the pharmacy services provided.

are essential tc 

Thus' we would suggest that the report' s statement in another section that 
differences in clinical services provided by (mail order pharmacies 

versus other (community) settings may be more theoretical than actual" is

not supported either by the model presented in the report, or by the

experiences of the OIG staff in their site visits to the pharmacists

described in the report' s case studies. 
Findin2 Jr 
optim 
o There are no clear standards that define the  mix of 
clinical pharmcy services in the  context of individual patient
need. 
APhA agrees that pharmacy is still maturing as a clinical profession, and

that much addition"l wcrk :-emains to be done .in identifying standards of 
clinically-oriented pharmacy care. We are currently working with the

Cclleges of Pharmcy 
American As  (AACP) in a process of 
oci,,"ion  oi
examination and revA1 irlAcion of the Standards of Practice for the

Profession of Pharmacy that were jointly developed by the tWo

organizations in the 1970's. That process may reveal opportunities to

incorporate additional standards to address this issue.

Findin2 III

o There is strong evidence that clinical pharmcy aervices add value 
to patient care and reduce health care utilization coats.

Needless to say. we are extremely gratified to have eIG reach a

conclusion that the profession has been sharing with others in the health

care and regulatcry communities for several years. This acknowledgment

should finally help set the stage for fundaental Change in analyzing the 
costs and benefi ts of pharmaceutical care. and for the development of

progressive payment methodologies for pharmacists' clinical and cognitive

services. 
Findin2 IV

comity 
o Clinical services are not widely provided tu  pharmcy
settings. 
The case studies present a very exciting and encouraging picture of

several current practices and the potential for clinical practice in the

communi ty pharmacy. However, the draft report accurately notes that

these services are unevenly provided in the communicy pharmacy setting.
 Richard P. Kusserow

March ( 
Page -
Yhile this is regrettable, the barriers to the provision of these

services 
, outlined in Finding V, are a critical contributor to this 
problem. We believe that it will be necessary for the profession,

governent 
. other providers , patients and purchasers of care to work 
cooperatively if these barriers are to be overcome.

Findin2 V

. 0 A. Barriers that impede provision of clinical pharmcy services 
include the economic structure of the retail pharmcy industry.
interprofessional conflicts, limitationa on informtion 
available 
to pharmcists. saps in pharmcy trainin and uneven patient demand.

o B. There are some commity pharmciata 
who provide a broad range 
of clinical services to their patienta. Nevertheless, ' the methods 
y use to overcome barriers do not auggeat aimle or imediate

solutions. 
The barriers identified in Finding V-A are substantial. 
APhA believes

that the discussion of them found in the draft report presents an

excellent and accurate sumary. 
We take particular note of two items 
wi thin the economic area , primarily because of their relationship to 
recommendations cade to APhA in the report.

We stronglY concur 
 hat the focus on product-based reimbursement for

pharmacy s  r\'i  , while excluding compensation for cognitive services, 
is a critical negative incentive for the development of these services.

APhA' s Cognitive Services Working Group, established in 1987
, has focused 
substantial effort on identifying and promoting the value of compensation

' cognitive services. 
for pharmacists  We have appended to this letter for 
your review a bibliography developed by the Working Group on this

subject. APr  is sincerely interested in working with governent and

other health policy groups to address this fundaental barrier. . 
APhA also supports the effective and appropriate use of pharmacy

technicians in various types of pharmacy practice. 
The draft report is

accurate in stating that the issue remains one of controversy within the

profess ion. However, APhA believes that the training and use of

qualified pharmacy technical personnel under the supervision of

pharmacists will enhance pharmcists 
' abilities to render the
professional and clinical services that pharmcists 
, uniquely, are able 
to provide.

APhA believes that these findings, along with our comments about them,

can contribute substantially to a better understanding by p01icy makers

of the potential for enhanced clinical pharmacy practice in the community

setting.  Richard P. Kusserow

March 6 , 1990

-Page-
RESPONSE TO RECOMMNDATIONS 
The draft report' s recommendations are made to the U. S. Pulic Health 
Service (USPHS), the Health Care Financing Administration (HCFA), the 
NIA), APhA, AACP, state governents and

National Institute on Aging 

state pharmacy associations. Consistent with our comments above, APhA

supports: 
o the recommendation that the US PHS and HCFA , individually and
collaboratively.... . develop  a strategy to reduce the barriers to 
clinical pharmacy services, particularly for ambulatory elderly

patients. 
The types of demonstration projects and research grants outlined in this

recommendation appear to offer real opportunities to measure the effects

of clinical i'harn:iocy on patient outcom s J! health care costs. APhA 
would encourage USPHS and HCFA to consider these recommendations to them

and would be very willing to work cooperatively with these organizations

in appropriate ways to assist in the process.

... take a leadership role in 
o the recommendation that the NIA 
developing risk indicators and treatment priorities for elderly,

ambulet 
ry patients. 
his recommendation, with the understanding

APhA generally supports 

mentioned abovp that pll patient categories ultimtely deserve

appropria te leve 1 of clinical pharmcy services at the community level. 
The elderly, however, are certainly deserving of focused initial efforts

in this area. APhA would strongly encourage NLA, should it accept this

recommendation, to actively involve the pharmacy and medical professions

in any work it undertakes in this area.

o the recommendation that APhA and AACP .. . develop  standards of 
practice that address all components of clinical pharmacy care on

the basis of patient need.

This recommendation, made directly to us, is both encouraging and

daunting. APhA is currently engaged in a project with AACP to revalidate

and , as appropriate , further evolve the profession s Standards of 
en originally conducted in 1978, this project was envisioned

Practice. 
as the first step in a multi-step process to determine practice

standards 
, define the necessary competencies to practice at the level of 
pharmcists 
the standards , and develop programs to assure  obtained and 
maintained those competencies. APhA remains committed to this activity, 
subject of course to staff and budgetary resources.  ertainly 
We would 
welcome the opportunity to compete for federal grants or other resources

to support this activity if they were to be made available.

e recognize the need .for evolving standards to encompass the activities

and services of contemporary clinical practice. Nevertheless , much work

must be done to address the barriers identified in this report before a

truly national standard of clinical pharmacy care can be developed. 

are pleased to take the recommendation under advisement and will make

every effort to keep the departm.nt informed of progress in this area.  .., ... 
Richard P. Kussero

Mo...... 
Page 
governents.. . 
o the recommendation that state  revise pharmacy 
practice acts to allow maximu use of technicians in community

settings. .. (and that) APhA and the state pharmacy associations

. . . take a leadership role in encouraging more extensive and
effective use of technicians in commity pharmcies. 
pharmcy technician by the 
Following Ln  aciopcion of current policies on 
APhA House of Delegates in 1988, APhA has been exploring the development

of new materlals to assist pharmacists in the training and effective

utilization of pharmacy technicians. These materials, once developed

would be made available to state associations to use as appropriate in

their activities in this area. 
Several states have evolved rather 
sophisticated programs for pharmcy technician 
training and certification 
and are willing to share information and experience with other state

col1."&"". ...v ..re 1ncerested. AP agrees tht a more thorough 
examinatio  of the effective use of technicians in community pharmacy 
, and will seek opportuities to 
practice is warranted  work with other 
national associations and state pharmacy associations on this issue.

In closing, we once again commend the OIG for its comprehensive and

commity pharmacist. 
important draft report on the clinical role of the 
APhA eagerly seeks the opportunity to work with you whenever possible and

ce patient-oriented 
appropriate to adva  pharmcy practice in all settings. 
cJ. 
. Gans. Pharm. D.

ive Vice President

0475K/900381  OIG RESPONSE TO APHA's COMMENTS 
We thank APhA for its careful consideration of the repon and applaud the association 
willngness to implement our recommendations on stadad settng and expanding the use of 
pharacy technicians. We acknowledge that these complex issues wil require thoughtful and 
pharacy 
creative solutions and we believe that with APhA' s leadership, clinical  seIVices can 
car 
be expanded to improve patient  significantly. 
On a more technical note, we have made changes in terminology suggested by APhA and have 
s role in analyzing and evaluating patient data. 
added language to emphasize the pharacist  r-IJlI"'I  l.rl.:II
L!:U1 
4630 Montgomery Avenue 
Bethesda. MD 20814 
(301) 657.300 
Apr il 11. 1990

Richard ,. Kusserow

Jnspector General

Departme  t of Hea.th and Human Services 
Room 5250 
Cohen Bu i Id ing 
330 Independence Avenue. SW

Washington,  2C2C= 
RE:  Draft OIG Report:  The Clinical Role of the Community Pharmacist 
Dear Mr. Kusserow:

The American Society of Hospital Pharmacists (ASBP) is the national

professional organization which represents over 24,
000 pharmacists who

practice in 0rganized health-
care settings such as hospitals, home-care

agencie:;. 
I,E  - t,. me llJtenance organizations, outpatient clinics, and skilled 
nursin 
P is pleased to provide comments on the draft eIG 
'" t;

report entitled. The Clinical Role of the Communit  Pharmacist. 
ASHP is encouraged by the eff 
ice of the Inspector General's increasing

recognition of the importance of the pharmacist'
s role by its study and

analysis of clinical services and by eIG'
s increased willingness to work with

organizat ions represent ing the pharmacy profession. We also 
appreciate the

will ingness of the eIG' s staff to study and understand issues of importance to

the profession. The eIG staff has captured much of the 
essence of the dilemma

facing the community pharmacy regarding the implementation of progressive,

patient-
oriented pharmacy services. 
The fundamental purpose of the profession of pharmacy is to serve a. a force

in society for ensuring safe and appropriate use of drugs. 
Pharmacists should

pursue this goal by promoting optimal use of drugs, including the prevention

of improper or uncontrolled use of drugs, and by providing authoritative drug

information to other health-care professionals, patients: and the public.

Institutional pharmacists have been engaged in the review and asse 
sment of
the drug therapy of individual patients for many years. 
Our members, and the

profession as a whole, have the education, technical expertise, and

professional responsibility and mission to perform those activities that come

under the rubric of clinical pharmacy services.

Pharmacists dedicated 10 advancing rational drug therapy in organized healtHre sellng  The profession of pharmacy involves a good deal more than just dispensing

med i ca t ions. Pharmacy is a knowledge-based system, which renders a health 
service by concerning itself with understanding drugs and their effects upon

people. ASHP bel ieves tha t pharmacists should develop and provide clinical 
pharmacy services commensurate with the needs of each organized health-care 
setting and individual patients in that setting. ASBP' s philosophy on the

pharmacist' 
s clinical role is stated in the .ASBP Statement on the 
Pharmacist' s Clinical Pole in Organized Health-Care Settings , which is 
included in the apr  diy.. 
Pharmacists in organized health settings have provided progressive, clinical

services for over a decade. The success of clinical services is based on (1)

preparation and use of complete and centralized medication information for all

patients: 
(2) prospective or concurrent routine monitoring of the drug therapy 
of pat ients: and (3) ongoing communication and education between physicians,

pharmacists, a:.- Qt:. ". health-care professionals. 
The comments that are contained in this letter are a compilation of

observations from ASHP members with expertise in providing clinical

pharmaceut ical services in ambulatory settings. Additionally, ASBP' s comments

on the draft eIG report are based on the tenets stated in the previous

paragraphs and on a knowledge base of clinical services developed through

years of experie ce in the institutional setting.

GENERAL COM!IE:I'::; 
It is our understanding that the original report on elinical services

was requested as a study of the feasibility of these services with

regard to drug use in the elderly because coverage for outpatient drugs

was to expand wi th the passage of the Medicare Catastrophic Coverage
Act. It is 
also our understanding that since the repeal of the Act that 
clinical pharmaceutical services are being studied for use with state

Medicaid programs.

Although the elderly clearly represent a large, vulnerable high-risk

group, we believe that the focus of the eIG report was unnecessarily

narrow. Given the expanded use of the recommendations from the report,

it would seem a visable to include other patient populations at high

risk in the case studies and recommendations from the report. Examples

of other patient populations include pediatric patients, patients with

chronic renal failure, cirrhotic patients with ascites, immunosuppressed

patients, patients who are on multiple medications, and patients with

poorly controlled diseases like refractory 8eizure disorders.

II. 
The draft report states that it discusses all possible pharmacy 
practices. The ASHP reviewers did not agree; it did not appear that the

typs of 
case study methodology permitted the identification of ALL 
ambulatory, community-based practices. Analyses of the following major  . ,

ty-pe. . JJ.  phoHm..cy. pract ices were not included in the report: their 
inclusion would appear to strengthen the recommendations made by the

repcrt and would provide a better rounded view of the practice

environment: 
Health maintenance organizations

Ambula tory services offered through the Veteran s Administration

Primary and ambulatory care offered through the Indian Health Service

In each of these practice areas, there are outstanding examples of

clinical services that are being offered to ambulatory patients. ASHP 
would be happy to provide you with the names of practitioners in each of

these settings who could provide your office with important feedback.

I II.  The interc  angable use of the terms and concepts of drug utilization 
rev iew (DUR) and pros  ve moni tor ing throughout the report creates
ect
confusion. As the definition 
on page 1 states: " formal ' program 
DUR is a 
that uses comparison with explicit standards or eriteria with a planned

follow-up to improve care' and Pract ice. 
" In the communi ty sett ing, the 
clinical pharmacist usually perform DUR, as deseribed. The preferred

term for use in the OIG report is .prospective assessment and

monitoring, or " drug regimen review and monitoring" (DRA). These terms 
involve clinical assessment of the patient by following a elinically

appropr iate i:1ter"ention (changing therapy or monitoring carefully for

efficacy and toxicity) in light of the risk-benefit ratio for the

individual patient. In this case, the professional's judgement is based

upon general knowledge (of drugs, diseases, patient behavior, ethics,

. professional experience, not on explicit criteria. 
and economics) and
SPECIFIC COMMENTS AND RECOMMENATIONS FOR CHGES 
There are two major structural areas within the document that need to be

reviewed and revised. They include the eoncept of a needs-based system and

the descr ipt ion of 
clinical services. 
The Needs-Based Concept

A. Page 6, paragraph 2: The question raised in this paragraph is the

key issue in the report and can best be summarized as: Bow can the

communi ty pharmacist determine what services are needed at each

patient encounter and provide them in a practical aDd timely manner?

B. Page 6. paragraph 3: This paragraph includes the statement that 
there is little consensus regardiDg standards of practice for

clinical pharmacy care as it applies to patient need. There are  goo  ~~~
reasons tor this. and those reasons may negate the practicality of

implementing Recommendations II and III from the report.

First. individual patient needs are highly variable. Initial

encounters with patients who are on multiple drug regimens and those

whose diseases are not adequately controlled, will required core

comprehensive clinical services. Once the patient is stabilized, the

need for intensive monitoring will decrease markedly.

. Second , the  ability to determine patient needs and the extent to 
which these  on the follow ing
clinical services are provided depends 
factors: 
1. The availability of the patient' s medical and medication

information to the pharmacist.

2. Th of the pharmacist' s education and training.

3. The pharmacist' s ability to collect and integrate drug. disease

and patient data to identify and solve drug-related problems.

Additional barriers to implementing clinical pharmacy services are

Directions for clinical

outlined in the enclosed report entitled. 
practice in pharmacy  Although this proceedings document is five

years old. it still contains much germane information on the

implementatiOn of clinical services.

C. Recommenca t ion:  Needs-Based Concept 
Rather than focus on developing a set of needs-based standards,

pr ior i ty should be given placed on developing a pract ical 
standardized review process for pharmacists to use for each patient

encounter. This 
process would be directly comparable to the medical 
approach of patient needs assessment. In the medical approach, a

limited history and physical is completed based on the chief

complaint and problem. With this method, only a small percentage of

the patients require a more comprehensive needs assessment. One

approach which uses a shortened practical pharmacy needs assessment

process. similar to the medical model, has been developed by the

s an appendix.

Indian Heal th Service and is attached 

II. 
Description of Clinical Services 
These comments are directed toward Appendix IV. The breakdown of

clinical services into four general component.s is generally- correct. 
However, the assumpt ion that within each component there is -a continuum 
and the description of that assumed continuum--especially the graphic

representa t ions--are inaccurate and/or misleading.  Information 
ollect ion of Pat ient 
A. 
While most of the important components of the collection of patient

information are included in the diagram and narrative, they are

grouped improperly by the source of the information. The source from

which the pharmacist obtains the data (e.g. a medical, record,

patient profile, physician interview, or patient interview) is a

function of the practice environment. They are also affected by the

pharmacist' s profes5ional commitment to provide clinical services. 
. These components should be listed by the patient need-based cont inuum 
which is being proposed in the report. The graphic continuum should

also address which type of data is most important to determine the

pat ient' s needs. 
B. Prospective Drug Utilization Review
The report does not clearly define drug utilization review (DUR).

Based on the information included in the report. it appears to be too

nar rowly focused on adverse drug react ions and drug 
interact ions. 
The more appropriate definition of DUR appears in paragraph four of

the introduction; this definition would be stated as follows:

DRUG UTILIZATION REVIEW is a review of the patient. drug. and

disease databases to provide the following outcomes for the

patient: 
(1) Identifying potential and actual drug related
problems: (2) 
Resolving actual drug-related problems 1 and (3) 
Preventing pcter.tial drug-related problems.

In prospect i ve DUR processes, the pharmacist compares the therapy 
against the criteria such as those included in the enclosed ASBP

Criteria for DruQ Use Evaluation. How much,

publication entitled. 

how well. and whether DUR is done at all is determined by:

1. The availability of a comprehensive patient database including

medica  . medication. and patient data. 
2. The capability of the pharmacist to collect and integrate drug.

disease, and patient data to identify and solve drug-related
problems. 
3. The pharmacist' s commi tment . to providing clinical services. 
In the descr ipt ion of this component on page IV-3, the graphic does

not depict a continuum. And. the 
information provided in both the 
graphic and the narrative consist more of bow prospective DUR is

done. rather than what needs to be done.
 _.._-_ ~~~
C. Patient Counseling
F'igure J on page IV-4 has the same problems that have been outlined 
for the other graphics in the report. It creates confusion and

presents inaccuracies rather than clar ifying concepts because it 
attempts to illustrate a continuum that does not exist. It describes

a combination of other clinical components including prospective DUR,

pr'r 
management of chronic patients, and patient counseling
activities. 
The last paragraph on page IV-4 contains some incorrect information;

The tirst sentence about pharmacists giving information back to the

patient is inccrrect. The ultimate outcome of patient counseling is

to verify the patient' s understanding of how to appropriately take

the medicuat.i.o n prescribed. This outcome requires that the patient

II) why they are taking the medication: (2) how they 
are to take it; and (3) what to expect from the medication (i.

expected outcomes, side effects, and what to do in all situations).

Additional information on patient counseling is included in the "ASHP 
statement on the pharmacist's role in institutional patient education

programs " and "ASHP guidelines on pharmacist-conducted patient 
cou  seling  . which are attached in the appendix. 
In paragraph 2 on page IV-S, pharmacists ' experience confirms that

the most effective mode for effective patient counseling is face-to-

Additionally, the . 
C= =  learning curve has been shown to 
crease when the person receiving the information becomes actively

involved in the process. 
A successful counseling program should use
three pr inciples in working with patients: private, face-to-face 
interaction; patient' s active involvement in the process; and use of

the patient' 
s existing knowledge. Using open-ended questions, the 
pharmacist verifies that the patient understands critical

informat ion. If errors in understanding are detected in this

process, then the pharmacist fills in the gaps. The consultation

concludes with the patient verbalizing or demonstrating their

understanding of key elements.

In paragraph 4 on page IV-S, the pharmacist should also convey

additional information. Since the purpose of counseling is to

improve compliance and make the patient better, information regarding

the expected outcomes and unexpected effeets is among the eritical

elements that the patient needs to understand. The major causes for

noncompliance are patient lack of understanding of: what the 
medication is suppose to do (desired effect): what to do if it does

not happen; what unexpected things might happen (adverse- effects; and 
what to do if they occur.

The section on follow-up activities and monitoring actually discusses

prospective DUR; it belongs in the section on prospective DUR because

it describes the patient-need assessment process that occurs when
 .._
v.. v ...unic medications come in for refills. Therefore, the 
statement that this type of follow-up requires unusually intense

patient counseling should be deleted. An additional concept which

might be considered for inclusion in this section involves the

pharmacist evaluating requests for refills: this involves integrated

activities of monitoring, counseling, and prescribing under delegated

physician authority. 
D. Physician Consultation
. The following term should be used to re-title and for reference in

this SECt ion: .Physician-pharmacist Interaction : communication is

also a major component in this interaction. There are four basic

reasons for physician-pharmacist communications:

1. Physici",. "i.l:,. in prescription to pharmacist. 
2. Pharmacist collects or verifies portions of patient/disease-
state/drug database.

ient 
3. Pharmac i st detects a therapeut ic problem wi th safety; pat 
veness, appropr iateness, or cost-effectiveness of the

effect 
prescri 
ed therapy (during needs-based prospective DUR) and calls 
physician to resolve issue prior to dispensing.

. 7..  : c:,,  to request advice or information about a drug or 
what drug to prescribe given a specific set of circumstances.

Th i 5 is the only one of the four reasons that is a classic 
consul ta t ion between physician and pharmacist. 
Physician 
Additionally, in this section, in Figure 4, entitled .
Consultation 
" on page IV-6, there is no continuum depicted in the
graphic. It 
consists of who does the calling, where they are 
located, etc. rather than a continuum of functions addressing the

sophist icated physician/pharmacist interaction. 
COMMENTS 0:; RECOMMENDATIONS

Recommendation II, page 20: Developing risk indicators and treatment

pr ior i ties may be an unwise use of resources given the frequent changes 
s needs. Indicators 
in the nature of each patient'  eould be developed, 
but they will only identify the patients whO MAY be at high risk (not

hort, 
those who are at high risk). What is actually needed 
is a 
pract ical needs assessment 
process that can be used at each-patient 
encounter to determine their particular need at that time for clinical

pharmacy intervent ion.  Additionally. in. this section, the 
term ADR is too limiting. The term, 
negative or adverse outcome" should be substituted because it include

such important items as treatment failures due to inappropriate drug

use. 
II. 
Recommendation III. page 20: The statement that the APhA/AACP prescr ibe 
a maximal level of service in all aspects of clinical care is

inaccurate. This assumption and the graphic depictions in figures 1-4

indicate a mi5unde 5tanding of the method used by national standard

tting organizations to develop professional standards of practice in

general. 
Generally, the standard-setting process involves establishing the range

of services/activities for each function on a continuum from none to

opt imal. Once the range is established. the standard is selected

some  en none and optimal, and this is defined as a minimal 
hCI' 
standa:d. A?:  tandards, which are operational standards, are
;/!I.!K.. 
minimal. Given its age, 
the document can be revised to a relatively 
small deg:ee and still represent appropriate minimal sst.a ndards for

clinical pharmacy in community settings in the 1990'  Primarily, what 
needs to be done with these standards is to revise them so that they are

functionally-based instead of task-inventory based.

clinical 
ASHP has alsc develo ed numerous standards and guidelines on
pract ice for its members. The pertinent standards have been enclosed in 
this letter. 
the appendi 
III. 
Summary of Recommended Revis ions 
A. Eliminate Recommendations II and III and substitute a variation of
comments Band C below.

B. Recommend that APhA/AACP revise their minimal standards of practice
task-inventory, 
based on cur rent pract ice and funct ional, rather than 
componen t s. 
C. Recommend that a joint, nat ional task foree be formed to develop a

shor tened, pract ical process modeled after the medical approach; this

process can be used at each patient encounter to measure the need for

the intensity of each clinical intervention.

D. Broaden the definition of prospective drug utilization review to
include all adverse outcomes.

E. Recommendations for Appendices III and IV
the Indian Health 
1. Include other ambulatory settings, sueh  as 
Service. Veterans Administration, and health maintenance

organizations in the case studies.  _-,- --.
2. Revise Appendix IV to clarify the functions under each component
and eliminate or revise the graphic representations.

CONCLUSION 
ASHP appreciat
 The
. the opportunity to review the OIG draft report entitled. 

Cl inical RQle  Communi tv Pharmacist . The growth of pat ient-or iented.
c! 
clinical ' pharmacy services  effective 
is crucial to the efficient, safe. cost-
care of the drug therapy of all patients. If you have any questions about

these comments or if ASHP can provide additional information on pertinent

topics. please feel free to contact my office.

Sincerely. 
(!J
/I 
Oddis. Sc.

Vice President 
lag040920w 
cc:  Mary Ann Chaffee: DHHS/OIG/OEI 
Attachments  OIG RESPONSE TO ASHP's COMMENTS

We thank ASHP for its thoughtful comments. We note that ASHP and PHS 
ar of one mind 
on a number of the issues rased. For that reason, most of responses to ASHP' s comments are 
contained in our response to PHS. Again, we note that the scope of our study did not allow us 
to include managed car and institutional settings in our case studies. even though there are 
excellent practice models to be found in those settings. Similarly, we recognize the limitations 
of our focus on elderly patients, but we believe that eliminating barers to clinical pharacy 
will improve patient care for all patient populations, parcularly those at risk of drg-related 
illness.  ----
:;:,  (';-, :jj:;':":::,:', :''.   ,".  ).  -.  _., --- .
American Soiety of

Consultant Pharmacists 
230 Nrn Stee! Sout 
ArI  n. VUgii'lio 
928.n 
(73) 
Mzrcn 28, '99 
Rj:hard F. Kw  E"Ow 
a1 . 
In'  Ge:1e 
;-E'N 
: Cone . B.  il':::'g 
332 lJdet'enden:e Avenue, S\\ 
. IX 
\\a.,hinb'! on  20201 
rAa.."  K-.,"c..:w. 
ClcaJ 
\";. a.. "'  \ or, tle two  RolPe hof ctlie t: 
Commun. y:: :P"fn Iaer' mC"cc:::ln:m'e ra,n
 d '"e Qicdraa rer t,R  ole of the Comunty 
for 
Cl:!a'!mo eSr:'u e',e ;E . We evae?:,O wIce: gt;ozo. lf:C t.h. eth tei dee ltaoy  isr eresdpon dcigo top yioeurs  of thes rerepestort to ou 
we cou. ircorpnle the views of pnctcig consultat 
leade 
:, sc: Iha: 
ii\tc our COInents 
:=~Lc:LC. 
Tne consu.le:.: vie.,. of tthe  r ",'h:. re\iewe: thes report is thI thes are
e'l:ei7k  :. ...e:: 
 C::ne in  of underslandig the subjf! anpdh aaCcCy"t esl)e' aessse iinrb'
aspe' of provjci:1g chnica  c: 
D.' :r Lo,e p:';.:. . f and  nei=ati\'e  plea 
ti'" co:-""7,  C:::""f:' v-' " aJ" pi  C'la:  to se tht your  studiE!
: pharci;.'. ",.ho provide services to long  residents. 
;jE-': cc:r.;.:.  ter  cae
t..z:, ",ith the "grying of A%erica," th importnt area of 
TncrL i'..  r,  regne: 
pr.a.'".  c;- even more  for the vauable and 
a:y pra::l.e ..-i  beome provie: to elderl)' reents ir varow home 
ne.essar: servi:e: tht are 
e;"  :-, c:-, 
seces provided to nuring 
plea.E"': thz: your repon citec constant 
V. e a a1;:  mp;  0; a &uccesfu non-prouct relalec reimbursent 
lIC\me  , a.' 81,  We must point out, however,
ir"en:;ve systen-, for clca1 pharmcy  &eT\ices.  beee 
tha  ,r. reir:,!-!lr!oE'  enl a"angemp  are made privatelcy : wh 10ng term
fadlj  . adminitntor an constat phadsts in  the 
acared  mistrator re.ognes the positive impact.cm patient cae  phcaocnsiutlsU lI
constat 
phzrm::ts can mae. However. tht payment to  Is not 
spcay 
governt thd par  Medcaid an Medcar, 
recognied by  payozs. 
rema prouct rete. Your rert identies 
where the only payment incentive 
intive 
wher the  Is prouct=baec. 
payment 
the problems irherent in a &ystem  $(j

. .
MI. Ri  . E:. J(usseTow 
Mach 2., 199 
Page Two 
ma  towa iden\:b  ten 
Your draf report alo  good inti steps  the long 
drg 
ca accre to 
heath care savings tht  the overa health cae system :whenf uer 
therapy is properly  fuy conc  menl To 
maged.  We with tht 
have  an arcle by Dr. 
confi tht  conclusion, we  enose a reprit  oC  clcal 
Kidder of HCFA tht re\'iews several publihed report indicatig tshti gnnt 
pharmcy ser.'ices in the nuring home envinment can produce 
savings to lhe overa  elderly America. 
heaL". cae costs  oC
ha made a goo start towad workig on 
these issues
We believe that vour  officpe  r.acy ard 
of great IDpon.,1J"  10  dthie spu blic we seIVe. To fuer th work, we 
invite your office to meet with us to  what we believe is the major barrer to
clcal phac") SEn.;ces identied in your rert, naely the product-baed 
reiburement incentive S)'Slem. We stad ready to work with your offce to 
identify sit  be intiated ard managed. We believe tht
where a pilot stud)'  coud 
reimburseent 
such a sr.Jc\ could produce conclusive e\;dence tht the 
incenu \'1: for cin.ca1  provided outcome 
pharmcy must be chnged to a  servce
woul 
oriented system and tht in doing so, patient cae  improve and the overall 
':c.  system would deceae. 
costs IL' tj"  J ,,;.;,  ed heath  care 
We look forward :v m  tig v,;th your sta in the near futu. 
"tJ 
R Tim Webster

Diector
Exective 
Rn\
' /haJ 
Enclosure 
cc: Asistant Inpector General Michael Mangano 
RegionaJ lrpf'rr General Mark R. Yessia, PhD  OIG RESPONSE TO ASCP's COMMENTS 
We thank ASCP for its suppon of our recommendations and commend the organization for its 
willngness to pancipate in pilot projects to reduce barers to clinical pharacy practice.  '" ! , ,

AMRICAN ASSOCIATION 
PHACY 
OF COLLEGES OF 
March 8, 1990 
Mr. Richard P. Kusserow 
Inspector General 
Department of Health and Human Servces 
Washington, DC 20201 
r Mr. Kussero". 
Thank you for the opportnity to reew the tWo dra reort,  PThhea C1l'int:ic al Role of tbe 
COlnmunity Pharmactt  The Clinical Role of the Community  Case Studies.
Q\' erall, the report araend  ver well wrtten, comprebenlve and 
accurately reflect the
opportnities and barers confontig pharacits In thei abilty to enance the public health 
in the community settg. 
speca 
I am pleased to offer  diraed 
these comments,  The Clinical Role of rbe 
at 
Community Pbarmctsr 
 v.1th the hope that these remdaireksd w i asist you and your collcag'":s 
eport. My comments are 
:.S you prepare the fin:!! 
 at three areas: 
Issues related to Drug Utition Revew 
(DUR); " 
Functions perfonned by community pharacits In provding clinical SC"""L' S 111 
ambulatory care settings; and 
clca 
Cost effectiveness of ambulatory  pharaceutica serces. 
Drul! Utilization Re-iev,"

:I!l  one offers a definition of DUR attributed to Rucker. MCP prefers the definitioll ,., 111 I: 
which has been adopted by the American Sodety of Hospita Pharacits: 
dn'g use evaluation program is ad setrgctnur ed, ongmng, oranizatioll''''1
authoried, qualiry-assurance process  that drugs are 1/.''/
to  en 
appropriately, safe/)' and effctently. 
1\  copy of the ASHP Guidelines on the phannacist s role In drug use evaluation is cn, I.
your infonnation. This definition, and these prindples ul....." ..,
, ar applicable to the amb
sctting with slight modification in language only. 
1426 Prince Srr.. . Alexandria. Virgnia 22314 . (703) 739.2330  . '
"'''''-'
,riM'"'' '"I 

P:lge Two 
Functions Performed bv Pharmacists

The Findings secton of the Repon and Istse Agppse.d ix contan desptions of the activities 
performed by phanacists in ambulatory  They are prested in a spectrum of
clca 
schematic diagrms to' i1ustrat  minimum and maxum degee of  servces. Recent 
events in the profession h vc shed considerable light on the clica role of pharmacists
practicing in all environments of cae, especily the community phanacy environment. The 
profession 'sponsored the second Phannacy in the 21st Century Conference in October, 1989. 
Strd) 
The keynote paper presented at the Conference (Hepler and  is enclosed for your
information. It  pba7"eulcai 
elaborates on the theme of  care  as the philosophy of
pharmacy practice, and describes functions peonned by phannacits 
in rendering 
phanaceutical cae.

Please note specically pages 10 and 11 which offer a deted anis of drug-related ilness.
aler 
It is clear that drug-drug. drug-disease and drug- Interctons, as lited In the Repon,
comprise a relatively small ponion of what may go wrong with phanacotherpy in patients.
Computer screen will not routiely and 
effcientl detect many of the problems listed by
Hepler and Strand. The only feasible method to low 
the Incidence of drug.related ilness
is to increase the access of patients to phanaceutica ca. 
Also enclosed is a Background Paper from the MCP Commision to 
Implement Change in
Pharmaceutical Education. It describes the mision for phanacy practce and the 
functions
pharmacists perform ir. ti:ncering phanaceutical care. 
These tWo documents offer new insights into the reponsibilities 
of phanacists in all areas of 
barer 
care. A5 your repon points out, there are numerous  which prevent the wide
availabilty of pharaceutical care to ambulatory patients. None of thes barers is absolute,
Our challenge is to identify and implement methods to prode incentives to pharmacists for
providing phannaceutical care. 
COSt EffeCtiveness of Communit\. Pharmaceutical Serces 
The Repon concludes that there is strong evdence which support 
the thesis that clinical
pharmacy servces add value to patient 
care. Three natinal organiztions, the American
Association of Colleges of Pharmacy, the America Phanaceutica Asociation llId the 
Pharmaceutical Manufacturers Association, sponsored a Task Force exmining the cost
effectiveness of phannaceutical produCt and 
pharacy serces. The R  on, cllrrenrly
undergoing final review, will be sent to you when avlable. One chapter in the Report
discusses the COSt effectiveness of pharmacy servces docmentig the 
YOluminous literatUre
verifying the observation that phannacy servces add signficant vaue 
to total patient c:lr
services. 
.- '___._n
 /!,

, . 
March 8, 1990 
P:!ge Three 
det 
In conclusion, the Inspector General's Repn outles In succct  the need for clinic:!l
pharmaceutical servces in the community envionment and the barers to their full
implementation. MCP 
",;11 consider caefll thos remmendations addressed to It and will
join with other orgartions in pharacy to enure that 
the beeftS of ambulatory clinical
ph3rmacy are made available to as broad a population 
of patientS  possible. 
Sin 
Carl E. Trlnca, Ph.

Executive Director 
CET:jnc 
enclosures  ' -
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