.. . ... _._. , 

: .,. . ;. , . ....,

, 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 

more than one physician. Our focus in this repor is on the community phary settg and 

the clinical seIVices available to elderly ambulatory patients. Clinical pharacy refers to 

functions performed by the pharcist on behal of the patient to identi, resolve and prevent 

drg-related problems.


Our data were gathered frm: (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 prctice, and (3) a series of intervews with researhers, 

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. 

Barers that impede provision of clinical pharcy seIVices include the 

economic strcture of the retail pharacy industr, interprofessional conficts 

. limitations on information available to pharacists, gaps in pharacy trining, 

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 

services, parzicularly for amulatory elderly patients. 

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. 

State governments should revise pharmcy practice acts to allow maimu 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 

Comments on the drt repon were received from the Health Ca Financing Admnistration 

(HCFA) and the Public Health SeIVice (PHS) within the Deparent. Whe PHS concured 

with our recommendations, HCFA did not. The HCFA believes that curent State Medcaid 

initiatives are adequate and sees no need for a larger collaboration effon with PHS. We 

continue to believe that a combined approach is warte 

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 

American Association of Colleges of Pharmacy................ .


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 VI. response.. 
.-.--_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 

apothecares. (Appendix n includes a detaed discussion of these and other phary 

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 

associated with drg therapy problems are turning more attention to the role clinical pharacy 

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, 

including topics such as the cost!enefit of clinical pharacy 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. 

Research on clinical pharcy that suppons this four-par analysis includes: the American 

Association of Colleges of Pharacy s (AACP) Committee Repon on Clinical SeIVices in 

Community Pharacy. Practice,4 the Amercan Pharaceutical Association s (APhA) 

Stadards of Prctice, and Dennis Hellng s study of the functions of clinical pharacists in 

famly practices.6 Our analysis is intended to be genera enough to apply to may pharacy 

settings, though our priar interest is in the clinical seIVice profile of community pharacy 

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 

seIVices. The intensity of these seIVices, in term of the resources reuir to perform them, 

vares greatly, raging from a minima level of seIVice to a maimal level. The level of 

seIVices provided also vares gratly among tys Of pharacy settng, among individual 

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 

range of seIVices within the other thre. For example, extensive data collection could enhance 

the pharacist s abilty to closely monitor a patient s regimen. Neverteless, a given 

community pharacist could perform a maimal level of data collection, but stil provide only 

minimal or moderate monitorig seIVices. 
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 precrption aTe drgs patinrs

drgs c:ncms lab data 

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 

drugs administrtion explanation 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 

to aulhorie pharacist's advice pharmact reviws 

prescription on drg medicl file of each patient 

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 

setting, maJimallevel seIVices would not be indicated for al patients, nor would they be an effcient use of resources. 

In determining the corrct mix of seIVices based on patient need, a number of questions must 

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 

information be conveyed-orally, in wrnen form, or both? Should pharacists themselves 

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 

seIVices? These are but a few of the issues that surace in a close examnation of the functions 

encompassed by clinical pharacy. 

Unfonunately, there is litte consensus within the profession or the industr itself about these 

issues. Similarly, we could find very litte research in the scientic and academic 

communities regarding stadads of clinical pharacy care as applied to patient .needs. 

Two research projects that do addrss the issue of determning patient nee each approaching 

the problem from a dierent persective, were identied The fit is a study conducted by 

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 

indicators and conducted a retrospective char review to identify adverse drg outcomes and 

their relationship to those indicators. The study documente evidence that adverse outcomes 

incrased as the number of indicators present incrased Patients with a history of 

noncompliance (one of the indicators) appear at highest risk of adverse outcome. ? A second 

approach that focuses specifically on stadads of car is reflected in the work of Linda Strd 

at the University of Florida. Strd has developed an instrment that stadazes 

documentation of a clinical pharacist s data base, patient care activities, and therapeutic 

plans. Adherence to the functions within this schema would theoretically result in an 

individualize treaU1ent plan for each patient. Pharcists would identiy and trat high-risk 

patients not by applying generaize indicators, but by charng individualizd risk profies 

These approaches to improving drg therapy for ambulatory patients clearly hold promise but 

require more practical application and testing to document their value. We understad that the 

General Accounting Offce wil also be conducting a study to determne categories of patients 

and drgs that require maxima level clinical pharcy servces. In the near term, however, 

the question pf standardizing pharacy seIVices based on patient need wil not be resolved 

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 

patients (44 of 70) than in the control group (23 of 66). Improved bloo 

pressure was achieved in 74 percent of the experimenta group and 58 percent 

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


different levels of wrnen drg therpy information and patients ' compliance 

rates with antibiotic drg regiens. The experienta grup that reeived the 

highest level of information had a mean compliace rate of 84.7 percent while 

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 

published by Samuel Kidder in 1987. The studies showed decases in number 

of medications prescrbed per patient, hospitaizations, cost of medications and 

other factors. Kidder s analysis projecte annual savings of $220 million in 

avened health car costs resulting from clinical pharcy inteIVentions. II 

Integrtion of clinical pharacy serces within a private medcal practice is one 

technique that has been used on a limited basis to involve clinical pharacists in 

primar car. Under this model, the pharacist provides a number of seIVices to 

the office, including drg therapy consultation with physicians, monitoring of 12 (Under 

drg therapy for each patient, and patient education and counseling. 

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 inteIVentions on patient car. In a retrspective review of 

recommendations made by pharacists regarding specific drg therapy for 

patients, a peer review panel of physicians and pharacists found that such 

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 

Caifornia. The pharacist, who had access to clinical/diagnostic data 

coordinated activities with attending physicians, provided intensive discharge 

counseling to patients, and monitored patients' drg therapy for three months 

following discharge. (Monitoring included telephone consultation, home visits 

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 

facilty. Following an initial assessment in which problems of medication 

compliance, regien comprehension, drg interations, and drg 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 

health care utilization costs associated with adverse drg reactions. 

IV. CLINCAL SERVICES ARE NOT WIELY PROVIED IN COMMUNIY 

PHARMACY SETIINGS. 

As mentioned previously, the concept of clinical pharacy was fit put into pratice in a 

teaching hospita settng, and despite decades of evidence that such inteIVentions improve 

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. 
conducted by the Foo and Drg Admnistrtion on patient reeipt of drg 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 

received the prescription from a pharacist said that they were told dictions for use, while 

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 

evaluated the effects of mandatory patient counseling regulations 2 year after they were 

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 

that the amount of counseling and the incidence of maintag and using patient prof1es is 

significantly greater in Washingtn than in States that do not have mandatory regulations.', 

This evidence suggests that imposing a reguatory reuirment does not in itself have any 

positive effect on the gap in clinical servces available to ambulatory patients. 

Barers that impede the transfer of routine clinical pharacy practices to the community 

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. 

On a similar note, there has been heated debate within the pharcy profession about the 

ability of mal seIVice pharacies (MSPs) to provide clinical pharcy servces to their 

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 

include information abo t the name and purpose of the drg, proper administrtion, side 

effects, and precautions ar included in over 80 percent of the prescrptions filled. In addtion 

both companies offer a toll-fr telephone seIVice with pharists 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 

independent pharcists. 

Our conclusion from this review is that the differences in clinical seIVices provided by MSPs 

versus other retal settings may be more theoretical than actual. In theory, pharacists who 

have face-to-face contact with patients on a regular basis ar 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 

EXIST THAT LIMIT THE RANGE OF CLINICAL SERVICES GENERALLY PROVIDED. 

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 

add a clinical seIVice or counseling fee to thir-par reimbursement schedules as a 

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 

Another aspect of the economic barer that effects the overall cost of pharacy 

seIVices is the uneven use of pharacy technicians in community settings. The 

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 

judgment of the pharcist..for example, mantaning patient records; settng up, 

packagin nd labeling medication doses; and fillng routine orders for stock 

supplies. To the extent that technicians perform these routine activities, the overal 

cost of each pharcy trsaction is reduced (since technicians' tie is less costly than 

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 

pharacists in community settings, is a highly controversial issue within the pharacy 

profession. Regulations that govern the use of technicias var enormously from State 

to State, and most often, State regulations that impose legal constrts on technicians 

focus on the pharcists ' perceived self-interst rather than the public s health and 

safety.23 There is no documented evidence that technicians are less competent at 

perlormng routine pharcy activities, and, in fact, tehnicians have been widely 

used in hospita settings for the past 20 years Resistace to the use of supportve 

personnel is a more a reflection of some pharacists ' fear that technicians wil replace 

them rather than supplement the servces they provide. As one expen in the field has 

said, "Fear of job loss to technicias is espaly rapant in the community settng. ,, 

A close examination of State regulations governing use of tehnicians reflects a vivid 

pictur of the contrvery that surounds ths issue. Nine States ban the use of 

technicians in community pharcies altogether. Although the remaning States 

offcially recognize technicians or do not specifcaly forbid them, there is wide 

varance among them in term of trning and educational requirments, licensing and 

certfication procedures, duties they are permtted to perfor, and 

pharcist/technician ratios. The degr of supervsion requir is also inconsistent 

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, 

pharcists must be accessible but not necessary in the technicians 26 ' immedate

presence. 

Beyond the legal constraits on the use of tehnicians, is the individual pharcist 

atttude about supportve personnel. Even in those States that permt wide use of 

technicians, individual pharcists may choose to underutilize them out of fear that 

their own professional value will be eroded. To the extent that this atttude prevails 

among pharacists and is reflected in legal constraints, a significant economic barer 

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 

must work effectively with physicians who ar responsible for prescrbing. The pharacist 

ability to communicate effectively with a prescrbing physician is a crcial aspect of clinical 

practice. But there ar a number of impements to communication and collaboration betWeen 

community pharacists and physicians. Dr. Cale Kiberlin, in her research on 

pharcist-physician relationships, has identified three major categories: 

Environmntal barriers: 
 The community pharacist typicaly communicates


with physicians by phone in situations that impose severe time constraits. 

This type of communication can intensify the distace that already exists between 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 discussion of this phenomenon, one researher descrbes reasons why pharacists are 

reluctat to chalenge physicias: "Because they ve ben socialze to believe 

that doctor knows besL...and despite voluminous literatu about inappropriate 

prescrbing by physicians. many pharistS...face a signficant atttudinal 

problem when attempting to deal with physicians on medcal tu...They find it 

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 autnomy: Trationally, physicians have enjoyed a 

dominant and autonomous position within the hierahy of health car professionals. This can lead to tension among professionals as .well as a tendency for 

health professionals to interact primaly with members of their own grup, 

tu can lead to with only limited interchange betWeen professions. This in 
 .29 In


numerous misunderstadings as well as an "us versus them mindset.' 

terms of how physicians perceive pharacists in parcular, one study that surveyed physicians reponed that when physicians "respnded to what annoys 

them about pharacists, they overwhelmngly crticize the pharist s communication with patients, parcularly in advising or reommending drgs to 

them. 

There is some evidence that interprofessional barers can be reduced when physicians are 

educated about the extent of pharacists ' knowledge regarding drg therapy. In our own case 

study inteIViews we found that physicians who work collaboratively with pharacists in a 

hospital setting are likely to be more awar of the potential value of pharacists as drg 

1,. 
advisors. Similarly, physicians and pharacists who practice in rura or smal communities 

appear to interact more effectively with one another than those in larger communities , because 

they are more famliar with one another and shar a higher proporton of patients' in their 

respective practices. 

3. THE INFORMATIONAL BARRIER

In order for pharacists to offer a full range of clinical seIVices, they must have access to 

pertnent patient information, including both over-the-counter (OTC) and prescrption 

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 

establishing a sound clinical data base for effective drg utilization review. ,, 

For the most par, pharacists depend on patients to provide them with basic profie 

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 

consult with the patient s physicians, and such information is raly shar Other 

circumstaces descrbed in this report contrbute to these informtional gaps. When 

pharcists do not routinely consult with patients because of tie constrnts, patient profies 

are not updated on a regular basis. Similarly, interprofessional barers also inhibit exchange 

of more complex patient data 

4. THE TRAINING BARRIER

Some pharcists lack adequate traiing in cliical pharacy skills. Such trning involves 

the development of both technical skills and knowledge concerning clinical pharacology, as 

well as practical skills in c mmunicatio 

In the era before the proliferation of phareutical products and chai drgstors, 

community pharacists often had a closer relationship with their patients than they have in . 

recent decades. The pharacist was a respected pUIeyor of spialze knowledge and 

seIVices, and knew her or his patients relatively well, since there often was only one 

pharcist in a given community. These "preindustral" circumstaces gave pharacists 

experience in communicating with both patients and physicians. Tody, only a minority of 

pharcists, most of them older or practicing in ru settngs wher they have litte 

competition, derive clinical trning frm such circumstaces. One pharacy scholar 

characterizes the clinical pharacy movement as an attmpt to restore "preindustral" values 

to a "postindustral" setting. 

Since the clinical pharacy movement began in educational institutions 20 year ago, 

pharacists have been trned extensively in pharacokinetics and pharacodynamcs. More 
recently, pharacy education has also wirnessed the introduction of communications trning _u 

based in behaviora psychology into pharacy currcula. Such trning encourages 

pharcists to overcome the conventional barers to communication with both patients and 

physicians.33 But despite the fact that it has been shown to incrase pharcists ' patient 

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 

Even if the barers descrbed above could be eliminated, another impediment on the 

consumers ' side of the trsaction would remain-that of patient demad. In a 1986 study 

commissioned by the U. S. Foo and Drg Administration (FA), only thre percent to six 

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

. either unawar of the risks associated with drg therapy or ar unwiling or unable to discuss 

them with a health car provider at the tie a drg is prescrbe or dispensed. 

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 

study, researhers asked respondents to rate 90 hazous activities, substaces, and 

technologies with regar to perception of risk, perception of benefits, and charteristics of 

risk. When compared to other tyes of haz, 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: 

Lack of knowledge about pharmacists ' exerzise: Patients may not be aware 

that pharcists ar highly knowledgeable about the appropriate admnistrtion, interactions, and potential side effects of medcations. In a 1984 study 

that sUIeyed 300 elderly patients to determne drg use patterns and relationships with pharcists, only 1 in 6 patients mentioned the pharist as some38 Another study, conducted for 

one they would ask about prescrption drgs.


Schering Laboratories, asked consumers to ra 15 statements that descbed 

their reasons for selecting the pharacy they used Raed in fit place by 

consumers was "the pharacist fills prescrptions promptly," while the statement "the pharacist wil tell the patient all about the prescrption" was raed 

in sixth place.39 The relative imponace placed on speed versus information 

may suggest that patients place more value on the pharacist s effciency than 

on his abilty to provide advice.

Patients may not have direct contact with the pharacist Lack of availabiliry: 


when purchasing a prescrption drg or may perceive the pharacist as unavailable for consultation. In pharacies where the pharacist, rather than a tech.. 

nician, conducts the counting and pouring activities, a patient s interaction may 

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 ' perception of pharacists ' unavailability was well documented in the Schering survey previously cited. Respondents raked the statements "feel pharacist 

available to ask about medcations" and "it' s easy to \jet pharacists to tak" in 

seventh and eighth place (of 15 items), respectively. 

The architectural design of some pharacies may Situational impediments: 


discourage patients frm consulting with pharacists. If the prescrption filling ara is small and crowded with customers, the noise level and lack of 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 

stads, they may be forced to rae their voices in order to engage in conversation. Severa studies have demonstrte that the quality of patient counseling 

is clear!? effected by the envionment in which pharcist counseling is con­ ducted. 

Communication skills/baseline informtion: In some cases patients may be 

generaly awar of potential risks but may not feel comfonable about asking 

specific questions, or may lack the necessar communications skills. Additionally, the absence of baseline inforation frm which questions can be forulated may also seIVe as an impement. There is some evidence that providing 

patients with basic wrttn informtion wil encourage them to be more aggrssive in seeking consultation. Medical Strtegies, Inc. of Boston has developed 

a public access softwar product to provide consumers with curnt information on medcations using patient package insen data develope by the U. 

Pharacopoeial Convention. Based on touch scn technology, PIC enables 

patients to query a data base about prescrption or OTC drgs and obtan both 

print and scren displays. The PIC progr is in use in a number of pharacy 

settngs including independents, HMOs, and teaching hospitas. In our interviews with a number of PIC users, pharcists consistently repone a high 

level of customer satisfaction with the sece; one independent pharst 

crted the PIC system with a significant incre in his customer bas. In all 

cases. pharacists reponed that the informtion printouts stimulate questions 

frm patients and incrased the quality and quantity of verbal counseling 

provided. 

On a positive note, there is some evidence that patient demad for more and better 

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 

some want more control over personal health decisions.' .43 Augmenting this overall 

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 

addition to providing information to callers, the sece 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 

Services To Their Patnts. Nevertheless, The Methods They Use To Overcome 

Barrers Do Not Suggest Simple Or Immediat Solutions. 

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 

patient car. Our analysis indicates that their method ar tyicaly a function of individual 

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 s abilty to apply these skills, but the independent pharacy settng does not, in 

. itself, guarte that a range of clinical servces wil be provided. 

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 

compete for customers with chais, discount pharacies, and MSPs. Populations SCIVed by 

the pharacists ar quite diverse, raging frm workng-class urban patients to mor afuent 

suburban patients. In sum, these pharacists enjoy no external advantage over their 

colleagues. Instead, a combination of skills in clinical pharacy, business management, and 

communications, coupled with an unusually strong professional self-image, appear to be the 

ingredients for a successful clinical pharacy practice. 
r conclusion firi'thec:ase study analysis isthat tlis formula'cannot be duplicated easily 

either through trsaction-based reimbursement inceiltives or regulatory requirements. A vital 

question facing pharcists as .well as those who receive and reimburse pharaceutical 

seIVices is whether the more advanced clinical pharacy care represented by our case-study 

pharcists can become par of mainstram practice. In devising methods to improve clinical 

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: 

Firt, the problems associated with mismedcation present a significant theat to the health of 

older Americans. Recognizing the serious natu of drg-related ilness, PHS has included in 

its draft document Prmoting Healtheventing Disease-Year 200 Objectives for the 

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. 

Second, there is an ongoing cost borne by the Medcar progr for the incidence of 

drg-related ilness among beneficiares. Based on the reent study in Calforna that was 

cited earlier in this report nationwide hospitaiztion costs alone account for billons of 

dollar each year. Additionally, the Medcaid progr absorbs the costs of hospitaizations, 

doctor visits, and institutional care that result from drg-related injures and ilnesses for older 

Americans who are income eligible. The HCFA, in its role as manager of the Medicar and 

Medicaid progrs, has a major stae in ensurg that costs of preventable ilnesses 

avoided 

Third, the Medicar Catastrphic Coverage Act (MCCA) of 1988, which was reently 

repealed, mandated a DUR system and included severa provisions designed to ensure that 

cenan clinical pharcy seIVices be provided to al beneficiares. These provisions were 

based on a reognition by the Congrss that mismedcation problems ar a serious theat to the 

health of older Americans and that clinical pharacy servces can add signficant value to 

overal patient car. Pror to repeal of the MCCA, HCFA was at work designg a DUR 

progr and developing regulations and stadas for parcipating pharacists. The scope 

an outside the Deparent 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. 

. Although a Medicare drg benefit may not be proposed again in the near future, the overal 

issue of drg-related problems among elderly patients is not likely to escape continued 

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, 

demonstrtion and education effort to reuce each of the barers to clinical pharacy car 

described in this repon. We strongly urge that demonstrtion effort include inteIVentions to 

address multiple barers. For example, a project aimed at increasing patient demand could be 

successful in rasing patients' expectations but have no effect on expanding clinical seIVices if 

economic barers ar not addrssed. Additionally, we recommend that all research effons 

measure the effect of clinical pharacy car on both tota cost and clinical outcome. 

There ar a number of vehicles that can be employed by HCFA and PHS to faciltate such 

effons, including the use of Medcaid waivers, Medcaid demonstration projects, and research 

and demonstration grts. Listed below ar examples ofinteIVentions that may be tested: 

Test a capitated system of reimburement to pharacists, measurng the costs and 

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 

information system for patients who meet cen crteria. For example, patients 

who are over 65, tae five or more medcations, have thr or more conditions 

and/or thre or more physicians could be identified as candidates. Clinical 

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 

aleady available to clinical pharacists and document the costs and benefits of 

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 

determning the value of encouraging duplication on a broader scale. 

Furish an experimental group of Medicar beneficiares with blank medication 

chans and instrctions for use. Chans would be completed by physicians, 

pharacists and patients and would include information on the name and purpose 
of both prescrption and OTC drgs, instrctions on administrtion, and 

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. 

Chars would be presented by the patients to both physicians and pharacists 

during offce visits and whenever a prescrption is filled at the pharacy. This is a 

relatively inexpensive way to encourge improved counseling by both pharacists 

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 

expand clinical servces in community pharacy settngs, mid-carr trning 

opponunities wil nee to be expande. 

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 

adults and has considerable expenise in ths ara, should lead an effon to expand scientific 

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. 

As mentioned previously, there is litte consensus within the pharacy profession about 

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 

tak-inventory approach and ar not functional in natu. 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. 
We therefore recommend that APhA and AACP work cooperatively to revise their stadads 

of practice in a more functional context and to create a practical needs assessment model that 

practicing pharacists can use to determine patient nee 

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. 

Underutilization of technicians to perform routine pharcy activities such as packing and 

labeling medication doses and fillng routine orders for stock supplies crates a major 

economic barer to provision of a broad rage of clinical servces in community settgs. 

Because laws and regulations governing the use of tehnicians rest within the pUIiew of 

individual States, initiatives to mamize use of techncians must be taen at the State 

government level in cooperation with State boards of pharacy. 

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 

a cliical provider and stadazing pharaceutical car functions should diute the fear that 

technicians would replace pharcists, rather than supplement the servces they provide. The 

APhA should enlist assistace and consultation frm the State pharacy associations as well 

as the National Association of Boars of Phary and the individual State boar of 

pharcy in such an effon. 
....

COMMENTS


Within the Deparent of Health and Human SeIVices, the Public Health SeIVice and the 

Health Car Financing Administrtion (HCFA) provided comments. The American 

Pharaceutical Association, the American Society of Hospita Pharacists, the American 

Society of Consultant Pharacists, and the American Association of Colleges of Pharacy 

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 

included in the final draft. With the suppon and leadership these organizations ar commned 

to providing, we look forward to initiatives that wil expand clinical pharacy servces and 

improve patient care, parcularly for groups who ar at high risk of drg-related ilness. In 

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? 

The pharcist has always played a dual role: that of drg dispenser and that of drg advisor. 

It is primaly the latter role that emphasizes the use of cognitive skils. and extensive traiing 

by the pharacist, and that seIVesto characterize the pharacist as a health care professional 

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 

characterized by many, inside and outside the profession, as a drg dispenser and 

businessman. At the same time, however, some of those inside the profession have sought to 

promote the pharacist's clinical role, and in the last tWO decades, this professional role has 

gained ground both inside and outside the ra 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 

their functions from, and placing them above, that of drg dispnsing. Abraam Flexner, the 

encyclopedist of medicine, wrote in 1915 that pharists were not professionals, because 

their function was simply to execute physicians ' orrs. The Fedra Government shorty 

followed suit, denying pharcists the commssions in the Ared Forces that physicias and 

others received. 

Within the pharceutical community itslf, attention shifte toward drgs and away from 

pharcists. After World War II, corporate financing favore research in drg development, 

and similar financing was not available for research in the more servce-oriented field of 

clinical pharacy. A common view was that pharacists seIVed merely as the conduits 

through which the public gained access to an ever larger ary of incrasingly sophisticated 

pharaceutical products. The pharacist s capacity to maage this flow of drgs to patients 

was given shon shr. 

The Clinical Pharmacy Movement 

The counteIVailing forces to this way of thinng originate in phary education. 

Educational institutions sought to enhance pharcy s stading as a profession by enlarging 

their curcula. Beginning in 1932, following a study of pharacy s functions commssioned 

by the American Association of Colleges of Pharacy (AACP), the four-year Bachelor of 

Science degree in pharacy was endorsed by national pharacy associations and became 

standad. In the 1950s and 1960s, many colleges of pharacy instituted five-year progrs, 

expanding currcula to include extensive trning in the medcal aspects of drg therapy and in 

T - 1

, 

more communications-oriented aspects of patient counseling. In the mid- 1960s, many schools 

began extending their progrs to six years, awarding Doctor of Pharacy (Phan) degres, 

with the sixth year often devoted to a clinical clerkship with a practicing pharacist; about 40 

Phan programs now exist. 2 

The clinical pharacy movement accelerated within the subfield of hospita pharacy in the 

late 1960s and 1970s. Hospita pharcists began to work with physicians as par of a 

clinical team that performed diagnosis and treatment collaboratively. Pharacists sometimes 

went on rounds with physicians; they performed retrspective and prospective DUR; and they 

oversaw drg distrbution within hospitas. Hospita pharacists worked under fewer 

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 

the simple dispensing functions that may-including may pharacists-have long seen as 

izations have the pharacist s major tasks. Leaders in phary and pharacy org 

increasingly promoted those clinical functions for which pharacists receive unique traiing, 

as they have sought to ponry pharacy as a profession whose sUIVival is vital to public 

health. 

The view of the pharacist as a drg therapy maager rather than merely a drg dispenser has 

received tentative endorsement from entities outside pharacy. A reent cour deision 

characterized the pharacist s role as one of "risk maagement," analogous to the physician 

role of "risk assessment," thus portayig the pharist as something more than a passive 

conduit for products and for the physician s instrctions. 

In sum, forces both inside and outside of pharcy seem to be moving the profession toward 

an increasing emphasis on the pharacist s clinical functions. But it is unclear at this time 

whether these forces will successfully supplant the view, still widespread, of the pharcist as 

a drg dispenser, with litte to offer in the way of unique servces or analytc skils. 

Endnotes 

Hepler C. The Third Wave in Pharceutical Education: The Clical Movement;" 

American Journal of Pharmceutical Education, 51 :369-85, 1987. 

Giblin P.W., Manasse H.R., "Commitments to the Future of Pharacy: Review and 

Opinion of the Phar.D. Curcular Debate, Drug Intellgence and Clinical Pharmcy, 

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 fruently used in discussions of pharacy, defining them will clarfy the 

discussion in this repon. 

As the term "community pharcy" is used in the literature on pharacy, it refers to walkpharcies in non-institutionalized settngs. It includes chai drgstores and "independents. 

Independent pharacies ar the most trditional setting: here, the chief pharacist also 

functions as a small businessperson. "Apothecares" ar those independent pharacies that sell only drgs. 

Institutional pharacy" includes both hospita and nuring home phary. In hospitas, 

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 

nursing homes, pharcists usually do not oversee the distrbution of drgs, which is left 

nurses and other cargivers. In this settng, they ar usualy "consultat pharacists" who 

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 

puroses. Because we have not researhed this lare field exhaustively, our conclusions 

concerning "community pharacy" are not as applicable to home health car as to other 

community pharacy settngs, namely chains and independent pharcies. Speakg 

generally, this repon focuses on the car of ambulatory patient populations and pharcy 

settngs that seIVe them. 

II - I

APPENDIX II 

CASE STUDY METHODOLOGY 

The purpose of conducting the case study was tWo-fold: 

to obseIVe and document activities that comprise clinical pharacy practice; and 

to identify (in the case of clinical pharacists who practice in traditional 

community settings) the barers they face in providing pharaceutical care to 

their patients and to determine the methods they use to overcome those barers. 

- 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 

were helpful to us in identifyig a candidate pool, includig the American Phareutical 

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 

selections from an initial pool of 35 candidates based on telephone intervews durg which 

we solicited information about the natur of the phart s practice, the population seIVed, 

the pharcist s therapeutic specialty, and her/his wingness to parcipate in the case study. 

Our fmal selection was based in pan on geogrphical diversity; urban, ru and suburan 

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 

nominated practice in chain pharacies. 

The pharacists selected for our study are listed below: 

Julee Alexander 

Lifesource, Inc. 

900 Lakspur Lading Cirle, Suite 250 . 

Larkspur, CA 94939 

Nancy Culberson 

Lexington Famly Prctice Pharcy 

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 

Amherst Pharacy 

332 Lumbenon Rd. 

O. Box 56

Lumbenon, NJ 08048 

In each case, we made site visits to obseIe the pharacist s practice over a 2- to 3-dy 

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 prescrption OTe drgs patinfs

concs lab data 

drgs 

Min. 

allergiesl pat drugs course of treatmenV diagnostic data 

chronic conditions hospilaiztion 

From Physician 

Much of our analysis of clinical pharacy is strctu 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 

itself a major function of the clinical pharacist. 

Information from Patnts 

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 may inquir about what 

over-the-counter (OTC) or nonprescrption drgs the patient is presently tag. Still at a 

faily basic level-though not al pharacists collect this inforation-ar the patient 

diseases and other conditions, as well as the patient s weight, height and age, which afect 

dosage levels. At the next level is informtion that a pharcist can collect on a patient s drg 

use history. This' includes the patient's past prescrption drg use, past OTC drg use, and past 
ilnesses. Finally, the pharacist may inquire about the patient s concerns about the drg 

regimen, such as whether previous reactions to other medcations wil reoccur. 

The pharacist most likely gets all this information dictly frm the patient. (OTC drg only from the patient, since these drgs are usually information typically can be obtaned 


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 

main concerns and questions, the pharcist can obtan data frm the patient s physician or 

physicians that can be useful in managig the patient s drg therapy. Most basic here ar the 

patient's vita statistics-though the pharacist may ocasionally read the patient's blood 

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 

hospitaizations. Finally, the physician can shar with the pharacist data from patient 

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 

such as a hospita, a nursing home, ora home health agency, where physicians tyically 

cooperate closely with pharcists. But it is not routinely available to pharacists working in 

a community settng. The practicing community pharacists we spoke with al said that 

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 

dosage drug-drug 

interactons 

drug-dsease

interctons 

Max. 

Min. 

duplications dru-alergy 

interactions 

In the community setting, the most useful tye of review that pharacists conduct is 

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 

in order to discern large-scale prescrbing pattrns. Most community pharacists do not 

oversee such a large pool of prescrptions, nor do they have the son of regulatory perspective 

that would mae retrspective DRR an appropriate tak for them. We have hear of no 

community pharacist who performs retrspective DRR, and it seems to lie outside the 

continuum of community practice. 

The first line of defense the pharacist can employ against drg-related iless is a manual or 

automate review of new prescrptions for potential counter-indications. At the most basic 

level, the review may screen for missing or improper (for a given drg) dosage informtion. 

On a more sophisticate level, the review may include whatever informtion the pharcist 

has collected on the patient's drg history. An automated review uses computer softar that 

can be progrmed to scren for therapeutic duplications in a patient s drg regimen, which 

can occur especialy when multiple prescrbers ar involved in a patient s therapy. Becomig 

more complex still is a screening for a wide rage of drg interactions, including drg-drg, 

drg-allergy, drg-diet and drg-disease interactions. It should be noted that if an automated 

system is used, the number of interactions software packages ar programmed to spot can var 

greatly. 
The pharcist who uses a computerized system wil have to examine those prescriptions the 

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, 

and wil use professional judgment to decide how to proceed: whether to dispense the drg 

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. 

Pharacists use computer programs primarly to save time-to speed the identification of 

potentional drg interactions. If a pharacist has the time, a personal examinarion of all new 

prescrptions is the highest level of professional scrtiny prescrptions could receive at the 

point of sale. But often, pharacists ar simply too busy, and in this case, computer progrs 

are trmendously helpful tools. 

(3) Patient Counseling

Patient Counseling 

new prescriptions 

follow-up 

verbal counseling 

wrttn information


information and 

name of chcking chng

drugs administrtion explanation copiiac: for ADRs 

Min. Max. 

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 

that the patient understads (1) why she is tang the medcation, (2) how she is to tae it, and 

(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, 

in terms of retention of knowledge and incidence of side effects frm drgs. 1 The minimal 

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 

patients received them.2 But as 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 

complete side effect and interaction information; some community pharacists either 

purchase these leafets or receive them frm pharacy organizations. Other soures of wrtten 

information include leafets disnibuted to pharacists by drg manufacturrs and, 

occasionally, leafets on drgs, drg classes, or conditions that pharacists produce 

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 

effective form.3 This suggests that the element of privacy, whether in person or on the 

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 

uncertnties on the patient' par and veriy that the patent understads crtical inormation. 

InfonnaJon Conveyed


The .specific informtion conveyed to patients once agai cover a wide rage, frm minimal 

to maximal. The most basic information the pharacist can give the patient is the prscbe 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. 

Moving to the next level, the pharcist can explain the drg s prope adstrtion 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 

drg works as it should. They can also war the patient about potential side effects and 

adverse interactions. 

Follow-up ActivitieslM onitoring 

All this information can be conveyed at the time of the initial prescrption, which is when 

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 

personalized attention , a pharacist wil check 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 

however, should be viewed as an unusually intense patient counseling pratice. 

(4) PhysicianIharmacist Consultation

Physician/Pharmacist Consultation 

contact between


physician and physician phones coloction of pharacy 

wi medica prctce;
 pharmcist. pharacist Ie seek 

to authrie pharacit's advce pharmact reviews 

medical file of each patient .:ri on drg Ptio 

Max. . Min.


pharmcist phones sharng of exam in-prsn patnt 

physicin to discuss data, la da, ca coferenc; 

therapeutic or pring issues diagnostic data (family practce mod) 
The flow of information between the pharacist and the physician is of key imponace to 

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 

fill a prescrption. In some cases, the pharacist, after reviewing the prescrption, may have 

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. 

some States, such as Washington, individual pharacists can arange with individual 

physicians to change prescrptions, within clear limits on their own, if they think it is 

warted. By and large, however, pharacists must seek the express permssion of the 

physician to mae changes in a prescrbed therapeutic regien. Seeking such changes when 

appropriate is at the hean of the risk management that pharacists ar increasingly expected 

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 

payment to both pharacists and physicians may be capitate and where there ar incentives 

to dispense lower-priced drgs. ) A less expensive generic substitute for the prescrbed drg 

may be available, or a less expensive non-generic substitute, and the pharcist may wish 

dispense one of these in place of an expensive prescrbed drg. If a patient is paying cash for 

the drg the matter is most pressing, but even if a patient has third-pany insurance, overal 

systems costs wil be lowere if a less expensive drg is dispensed, so a pharcist might 

contact a physician to discuss price-relate substitution in any case. Agai, in many States, 

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 

expensive pharaceutical or therapeutic substitutes for more expensive drgs without the 

prescrber s express permssion. 

The issue of these pharaceutical and therapeutic substitutes merits fuer 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 

a dierent form. The new drg is changed slightly from the old drg: it may be changed 

from a pil into a caplet, or the dosage may be doubled; but chemically it is the same as the old

drg. Nonetheless, the manufactuer emphasizes the unique quality of the new drg in its 

det!rling, suggesting as strongly as it can that it is somehow more effective than the old drg. 

As one pharacist has obseIVed, "Effective brand-name product positioning with prescrbers, 

coupled with a relative lack of comparative price information for patients and prescrbers, 
have enabled manufacturers to establish single-source drg prices largely independent of 

therapeutic uniqueness or cost of comparative proucts. It is not unusual to find a ten-fold 

price differential (betWeen a single-source drg and its pharaceutical alternate). 

Therapeutic substitution is initiated when a pharacist contats a physician to request a 

change in the prescription drg, for example, from one diuretic to another that is less costly. 

Although therapeutic interchange is common in 5 .
maaged car settings and hospitas, it is rae

in the COmnunity setting.

Physician-Initiated Contact 

More unusual, and charctering a closer interprofessional relationship than the pharacist 

contacting the physician, is the physician seeking consultation with the pharcist. 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 

for the pharacist on the physician s pan. If the two enjoy a parcularly close professional 

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 

prescrbing for the patienL Such contat is quite unusual in most wal-in pharcy settgs. 

Also unusual is the sharg of a physician s examnation data lab test data and diagnostic 

data on patients with a pharacisL As noted above, pharsts raly possess these data 

when performng DUR, but they indicated they would fmd such information valuable. 

Institutonal Contact 

Unusually close contact between physicians and pharcists is 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 

parcular questions or problems arose. 

Still more intensive would be regular patient car conferences involving pharacisL and 

physicians, in which the tratment and progrss of all patients could be discussed Ths kind 

of patient car conference occurs in teaching hospitas, but almost never in the community 

settng. In one of the pharacies we visited such conferences were held weekly in which all 

staf pharacists and other clinical sta parcipated but not physicians, and the progress of 

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, Patient Education and Counseling, 7: 359-66, 1985. 

McBean, 167 - 172. 

Knowlton C., "The Practice of Community Pharcy: InteIVention Opponunities 

Toward Optimizig Medication Use" (Washington D. : U.S. Depanent of Health 

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 

Pharacists, included in the "ASHP' s Guidelines on the Pharcist s Role in Drg 

Use ' Evaluation. 

Medication Risks Among the Elderly: Cures, Cautions and Consequences Steffen R., 


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


Hepler C.D., Strnd L., "Definition of Pharaceutical Car, " (Depanent of Pharmacy Health Cae Administration, University of Florida, 1989) p. 

Caer B.L., "Repon of the Comminee on Clinical Servces in Community Pharacy 

50:190- 1986. Prctice, American Journal of PharmceUtical Education, 

Kalman S.H., Schlegel J.E, "Stadads of Practice for the Profession of Pharacy, 

American Pharmcy, 
 NS19 (3) : 21-35, 1979.

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 

Pharcist Monitorig, American Journal of Hospital Pharmcy,
 46:729-32, 1989. 

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 Pharmcy Practice, 1:2, 50-56, 1978. on Hypenensive Patients," 


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, Drug Intellgence and ClinicalPharmcy, 
 8:572-75, 1974.

13. Brown D.J. et al., "Evalua,tion of Clinical Pharacist Consultations in a Famly Prac36: 912- 15, 1979. tice Offce, American Journal of Hospital Pharmacy,


v - I 
pp. 

14. Results of a demonstrtion projet funded by the John A. Harord Foundation- of New 

York. The projectis direted by Helene Lipton PhD. of the University of California in 

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 

sta, hospital administrtors and physicians who car for the patients in the study 

group. Prliminar findings have been presented to the Harord Foundation and a 

final repon wil be completed in March 1990. 

15. Hammarlund E. et al., "The Effects of Drg Counseling and Other Educational

Strtegies on Drug Utilization of the Elderly," Medical Care, 23:2, 165- 170, 1985.


16. Kimberlin c., "Communications," chapter in Werteimer A., Smith M. , ed., Pharmacy 

Practice: Social and Behaioral Aspects, 3d ed. (Baltimore: Williams and Wilkins, 

1989) pp. 159-78. 

See Also: 

Knapp D.A. et al., "The Pharcist as Drg Advisor," in Werteimer and Smith, 

l00- 105. 

Werteimer A.I. et al., "More on the Pharacist as Drg Consultat: Th 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, 


Jang R. et al., "An Evaluation of the Value of Drg 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., "Pharacist/atient Counseling Prtices," Contemporary Pharmacy Practice 1:67-71, 1978. 

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 Com18:409- , 1984. munity Pharacists," Drug Intellgence and Clinical Pharmcy, 


Hammel R.W., "Barers to Appropriate Consultation," Wisconsin Pharmcist, 58:4, 

14-15, 1989. 

V - 2

, 

p. 

17. Morrs L.A. et al., Patient Receipt of Prescription Drug Informtion OPE Study 67 

prepard for the U.S. Foo and Drg Administrtion, September 1983. p 21. 

18. Ross S. et al., "The Effect of Mandatory Patient Counseling Regulation on the CounContemporary Pharmcy Practice, 4:2, seling Practices of Pharacy Practitioners," 

64, 1981.


19. Capbell, R.K. et al., "Compliance with Washington State s Professional Practice 

NS29:5, pA7, 1989. Regulations: 1974 vs. 1987," American Pharmacy, 


20. Kimberlin Communications," p. 164. 

21. Knapp D.A., "Barers Faced By Pharacists When Attempting to Maximize Their 

Contrbution to Society, American Journal of Pharmceutical Education, 43, 357­

359, 979 

22. Molzon J.A., "Legal and Prfessional Issues Related to the Use of Pharacy Technicians as Supportve Personnel," ( Anaheim, Caifornia: proceegs from the 

pA. American Society for Pharcy Law Annual Meetig, April 9, 1989)photocopied, 

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 
, 

Bilow J.A. et al., "A Comprehensive Communication Skils Progr in a Four- Year 33. 

Pharacy Currculum, American Journal of PharmaceUtical Education, 48:42-

1984. 

34. Kimberlin Communications. 

35. Morrs L.A. et al., 
 A National Surey of Prescription Drug Informtion Provided to

OPE Study 73, prepard for the U.S. Foo and Drug Admnistrtion, 1986, Patients, 

36. Institute for Health Policy Analysis of the Georgetown University Medical Center, 

workshop on "Communicating the Benefits and Risks of Prscrption Drgs" (Isle 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). 

37. McCalum D.B. et al., "Communicating the Benefits and Risks of Prscrption Drgs," 

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, 

Drug Intellgence and Clinical Pharmcy, 18:525-29, 1984. 

39. Pharmcist Perception Versus Consumer Realities, Schering Repon IV, (New Jersey: 

Schering Laboratories) 1982. 

40. Ibid. 

41. Knapp, "Barers Faced," p. 358. 

Ludy J.A. et al., "The Patient-Pharacist Interaction in Two Ambulatory Settgs-Its 42. 

Drug Intelligence and Clinical Relationship to Patient Satisfaction and Drg Misuse," 

Pharmcy, 11:81-89, 1977. 

Beardsley R.S. et al., "Prvacy As A Factor in Patient Counseling," Journal of the 

NS 17:366-68, 1977.
 American Pharmceutical Association, 


McBean BJ. et al., "An Evaluation of Four Method of Pharacist-Conducted Patient 

115:167- 172, 1982. Education," Canaian Pharmcy Journal, 

43. McCallum, p. 

California P har­
 44. Marks M.R., "A Medication Sleuth at the End of a. Phone Line," 

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 

From A6sistant Secretary for Health 

OIG Dra ft Report6 " The Clinical Role of the Community


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


'To In6pector General, OS 

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 'v atients. We sre a160 working on increasing our 

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


The reports effectively capture the dilem facing comunity 

pharmacists rega=ding the implementation of progressive patient


oriented pharmacy services, i. e., clinical pharmcy services.

The reports should have a positive impact on the pharmcy 

profession by identifying the most significant barriers to the


provision of pharmceutical care for patients, especially older
 persons. 

A recent strategy planning conference on .Pharmcy in the 21st 

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 

consumer groups, and governent and corporate health care

decision makers. A copy of the Executive Sumry (Attachment A) 

is attached.


We regre the the OIG inspectors did not include in their


inspection and caSE studies the Indian Health Service (IHS) 

pharmacy program. IHS has nearly 30 years of experience in


providing clinical pharmcy services with extensive utilization 

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 overall content of the report. The additional coments 

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 

services, particularly for amulatory elderly patients. 
Page 2


PHS Comment


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


includes research, demonstration, and education efforts to reduce


each of the barriers to clinical pharmcy services as described 

by OIG. PHS welcomes the opportunity to develop strategies to


reduce the barriers to clinical pharmcy services for amulatory 

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


model that clearly demonstrates the pharmcy services concept 

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


indicators and treatment priorities for elderly amulatory 

patients. NIA has recently published a Request for Applications


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


research applications on druq utilization reviews, pharmcoepidemiology, and . other areas related to the improvement of 

medication prescribinq and use by older persons. Tw million 

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


Aqing. It is anticipated that approximtely 8-10 hiqh quality 

applications will be funded with startinq dates of


December 1, 1990.


However, this recommendation may be more effectively accomlished 

if conducted in conjunction with an exprt panel from appropriate


PHS agencies and professional orqanizations. Indicators can be
 may be at developed but they will only tell you which patients 

.. .

\.. 

__.

Page 3


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

shortened practical needs assessment process (see coments on


recommendation III. below) that can be used at each encounter


wi th each patient to determne his/her particular need for 

clinical intervention. In addition, the term adverse drg negative or adverse outcome 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


Paqe 6, Paraqraph 2 . The question raised in this


paragraph is the key issue in the report and can be


c1 up as follows: How can the comunity 

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


standards of clinical pharmcy care as applied to 

patient need. There are good reasons for that, and


,;"H:: l."E:c:so;ms may add difficulty to the implementation 

nf T.Ec mrendations II. and III. 

First, patient needs vary with time, i. e., each


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


comprehensive services. Once that patient is 

stabilized, the need for intensive monitoring will


drastically decrease. To continue monitoring those 

patients intensively just because they are on multiple


drug regimens would be an inappropriate use of


pharmacists' professional time. Therefore, approaches 

like the one proposed by Koechler, et al., in the


American Journal .of Hospital Pharmacy (AJ), which 

incorrectly assume a continual high level of need, will


resul t in wasted pharmcy efforts. The authors point 

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


Second, the ability to determne patient needs and the 

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


the ability of the pharmcist to collect and 

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 careful review 


the articles listed and other work on simlar subjects 

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


accomplished through memorization and requrgi tation. 

Clinical pharmacy practitioners have long recognized


that students were not taught clinical problem .solving skills. Dr. Strand has formlized a process that 

forces (teaches) students to utilize clinical problem


solving skills via the collection and integration of


patient and disease databases with drg databases. 

This is one of the end products of Dr. Strand' s work on


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). 

Unfortunately, their criteria-based process did not


address changing needs over time, plus it failed to


identify a large percentage of patients who required
 pharmacy intervention. 

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. 

Recommendation III. Needs Based Conce t


Paqe 20


Rather than focus on developing a set of needs based


standards, priority should be placed on developing a
 . practical standardized review process for pharmcists 

to use for each patient encounter, i. e., a shortened


practical version of Dr. Strand' s process. Needs based 

sta..darcs for every patient may be impossible due to 

the constantly changing nature of individual patient


needs and the variability among individual pharmcists in their ability to assess patient needs. This process 

would be directly comparable to the medical approach of


patient needs assessment (see diagram below). One 

approach which uses a shortened practical pharmcy 

needs assessment process, simlar to the medical model, 

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 history and Practical shortened Not developed


version physical based on


chief eomplaint (problem


Maybe some combination


Applied at every of lES approach


patient encounter (process) and AJP

approach (indications) 

Outcomes 

Succeuful Identified Large % Sma II % PS% S: 

successful requiring more succenful. Dx as requiring 

comuhensi ve
 intervention comprehensive and treated workup needs assessment

,

;:., 

Page 6


A practical snortened version of the comprehensive approach


resu tS 1n l 
 ) successful needs assessment and intervention

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


those requiring comprehe sive evaluation. Physicians do not 

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 esentat+on', findinqs, " and 

The breakdown of clinical pharmcy services into four groups 

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


prospective drug utilization review (DUR), pharmacist 

agement of chronic patients, and some patient


consul tation activities. 

dJ1V, " 'tour Compo ts of C:+inica:+ Pharm 

rt:, C::ra'O on o ent Informtion, " Paqe 

IVWhile 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 

collecting a database is to dete:mne what type and 

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',. 

Uti 1" ;r, r. eview DUR 

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.


In prospective CUR processes the pharmcist compares 

therapy against the criteria such as those listed in


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


DUR is done at all is determned by: 

the extent of the database available to the


pharmcist 

thp. knowledge of the pharmacist in both drug and 

disease informtion 


the ability of the pharmcist to collect and 

integrate drug, disease, and patient data to
 identify and solve drg related problems1 

the pharmacist' s efficiency in performng item c, and once the pharmcist has optiml data, 

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 t C 5elinq, Paqes IV-4 and IVPaqe IV-4, Paraqraph 3 . The first statement on patient 

counseling about pharmcists giving informtion is 


incorrect. The ultimte outcome of . patient counseling 

is to verify the patient' . understanding of how to 

appropriately take the medication prescribed. That 

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


potentially even more important factor in determning the efficacy of patient counseling. Learning has been 

shown to be increased when the person receiving the


information becomes actively involved in the process.


By the time patients reach the pharmcy they have 

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
 knowledge). Using open ended questions, the pharmcist 

verifies that the patient understands critical


information. If incomplete understanding is detected,


the pharmacist merely fills in the gaps. The 

consultation concludes with the patient verbalizing or


the patient demonstrating his/her understanding of key
 elements. This is a patient needs based approach to 

patient consultation. Attachment C presents a sumary 

outlining the interactive, patient needs based approach


to patient consultation taught to IRS pharmcists. 

?aae S , araqr ph 4 Since the purose of

counseling 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


:. w,c;cpe:c ed things might happen (adverse


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


consultation, and belongs under DUR or under pharmcist 

managed care. It describes the patient need assessment


process that occurs when patients on chronic


medications come in for refills. Therefore, the


statement that they (the scientific informtion 

pharmacists) raise their counseling to a higher level


should be eliminated. 

Graph " Physician Consultation, . Paqe rvA 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 

The statement that APhA/AACP prescribe a maximl level 

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


practice and the APhA/AACP standards. Probably the 

preeminent organization in the field of standard


setting and compliance monitoring is the Joint


Commission on Accreditation of Health Care
 Organizations (JCACO). JCACO, through its 

experience, has looked at health care delivery


functions and has developed a prescribed process to set
 Tnp st ndards. In each functional area, the range of 

services stretches from none to optiml. Once the 

range is established, they select their standard


somewhere between none and optiml and define this as a


minimal standard. 

Heal th Care Fuction 

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 

to the none side of the graphic depiction. There are 

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


representatives from all areas of pharmcy 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.


In addition, a shortened version of Dr. Strand' s need


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


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
 intervention. 

The" APhA/AAC? involve other professional organizations 

and redo their standards of practice based on


functional rather than task inventory . 

Broaden the definition of prospective DUR to include


all adverse outcomes.


Appendix II, page 11-1, .Pharmcy Settings. It is 

unclear where managed care practice and mail service


fall in the definition. Certain managed care settings 

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 

committment to improving pharaceutical care, parcularly for patient populations that suffer 

most from drg-related ilness. 

We agre that the Indian Health SeIVice provides an excellent practice model for 

pharaceutical care. Our reason for not including it in our case studies was that ilS more 

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 

course of conducting our study, we inteIViewed a number of expert in the field who 

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 

professional carers to trsferrg ilS stada to other practice settgs. We acknowledge 

the ilS's reputation for innovation and excellence in clinical pharacy car and regrt that 

the scope of the study did not permit a more extensive examnation of maaged car and 

institutional settings.


Our responses to PHS' s technical comments ar as follows: 

Standrd setting and needs assessment process: We agre with PHS and have 

made revisions in our discussion of Recommendation Il. 

Description of components of clinical pharmcy: We appreciate the thorough 

crtique PHS has provide We have made a number of the suggeste changes 

in both grphic presentations and text. We have not ma al suggested changes for severa reasons: Firt, the descrption of components as presente in 

the repon is meant to descrbe the spectrm of servces that currntly exists, 

should exist in a nees-based and not, as PHS suggests in its comments, what 


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 pharmacists and other expert descrbed their work as well as the obseations we 

made in those practice settngs we visite Consequently, it seIVes only as an 

analytical and descrptive tol in ths repon, rather than as a stadad. Third, 

because the individual components of the clinical pharacy as we descrbed 

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 example, the PHS makes a goo case for including what we have called "followup counseling" under the DRR component, rather than the Patient Counseling 
component. We submit that because the tasks involved in "follow-up" counseling 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 counseling role. 

Again, we thank PHS for its support and for its incisive comments, which we believe have 

improved the quality of the repon. 
11"1 .. ,-C' 

.te 

Gail R. Wilensky, Ph.D(Y

"ro"" AdmitrtQr ""t -

SIJJect . OIG Draft Report: '"e Clcal Role of the Community Phacit, 

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 

We have reviewed the subjeCt repons. One of the repons address the 

barrers to the proviion of clica servces to ambulatory patients in community 

phannacy settings. The ot.her repon presents ca studies of community 

pharmacists who have sua-.eeded in providing a broad raee of these clica 

servces. 

The report recommend that HCFA develop a sttegy, indivdua and with 

the Public Health Servce, to reduce barrers to providing clca pharcy 

servces, pacularly for ambulatory elderly patients. We do not concu with 

recommendation. HCFA aleady ba a strateI) to improve clca pharmcy 

servces though its manged care intiative. Thoug the maged cae intitie, 

many $tgte Medicaid prOaram have or are teti& drg uttion revew systems 

and capitation programs that encourage the kid of cordinated care ca1:d for in 

the OIG report Unfortnately, :t.: repon did not address these effort by HCFA 

and the: States. 

Medicare coerage of drgs for outptients is cmme1y lited in scpe 

and, for the most par do DOt pay for drgs that ambulatory beneficiares could 

obtain from communty phaci. Thus th remmendations caot apply to 

the non-Medd popWaQon of Medica beneficies. 

Moreor, becaus of the lited scope of the Medica outpatient drug 

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 servces.
..

For Medcad, however. coeraee of presption dres is optional for the 

States. The lcve.l of outpatient drug coerage vaessiiIcantl acros the States. 

Although $;.; ; lrOci ccct broad Federa requirments. they 

responsible for admiterig 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 

leaders in providing clica pharcy servccs to the elderly in community

pharcy settgs. It is unortunate that the 010 report doc not r these 

importnt effort in ths area. 

HCF A is al engaged In reseach and demonstrtion project studyg 

method to reduce the inappropriate us of c1p by the elderly. The Uniersity 

. of Wisconsin has developed a set of quaty ca indicators that us Medcad drg 

and hospitaJ clai to monitor quality of cae in Medicad nuring homes. The 

University of Miesota 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 

area. As we develop our strateiY, we wi consider OIO' 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 

sufficiently crtical to wart a more strcture and comprehensive depanmenta response 

that combines the best effons of HCFA and PHS. 
American 2215 ConS\lutlO ""ue, f# Pharmaceutical Wa-hlngton, DC 20037 Th Nilil Prfesl Association (202) 628-410 FAX (202) 783- 2351 of Phfr 

March 6 , 1990


Richard P. Kusserow


Inspector Gc ral 

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 

society of pharmacists , we are gratified by the substantial analysis that 

our profession has received in recent reports from your office. More importantly. e are pleased that the critical role that pharmacists play


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

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


offers to pa tients . 

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


in March of last year , we did note the particular need that elderly 

patients have for effective review and magement of their 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 

to improve the quality of patients ' drug therapy. It is far aore thn 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.


We also suggested in that: let:ter that 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


being provided was a critical element of the report, and AP applauds OIG for that: effort. 

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 

that direct , face-to- face contact betWeen pharmcist and patient and a 

close . collegial r lationship with the physician (or other prescriber) are essential tc 
 ize the quality of the pharmacy services provided.


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 

o There are no clear standards that define the optim 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


American As oci,,"ion oi Cclleges of Pharmcy (AACP) in a process of 

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


o Clinical services are not widely provided tu comity 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


for pharmacists ' cognitive services. 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


-PageRESPONSE TO RECOMMNDATIONS 

The draft report' s recommendations are made to the U. S. Pulic Health 

Service (USPHS), the Health Care Financing Administration (HCFA), the National Institute on Aging 
 NIA), APhA, AACP, state governents and


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.


o the recommendation that the NIA ... take a leadership role in 

developing risk indicators and treatment priorities for elderly,


ambulet ry patients. 

APhA generally supports 
 his recommendation, with the understanding


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 

Practice. en originally conducted in 1978, this project was envisioned


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


standards , define the necessary competencies to practice at the level of 

the standards , and develop programs to assure pharmcists obtained and 

maintained those competencies. APhA remains committed to this activity, subject of course to staff and budgetary resources. We would ertainly 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 ­

o the recommendation that state governents.. . 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. 

Following Ln aciopcion of current policies on pharmcy technician by the 

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 

practice is warranted , and will seek opportuities to work with other 

national associations and state pharmacy associations on this issue.


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


important draft report on the clinical role of the commity pharmacist. 

APhA eagerly seeks the opportunity to work with you whenever possible and


appropriate to adva ce patient-oriented 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 

creative solutions and we believe that with APhA' s leadership, clinical pharacy seIVices can 

be expanded to improve patient car significantly. 

On a more technical note, we have made changes in terminology suggested by APhA and have 

added language to emphasize the pharacist s role in analyzing and evaluating patient data. 
r-IJlI"'I L!:U1 l.rl.:II

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 '" t;
 P is pleased to provide comments on the draft eIG 

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 impr oper 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


case study methodology permitted the identification of ALL typs of 

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 ang€able use of the terms and concepts of drug utilization 

rev iew (DUR) and pros ect ve moni tor ing throughout the report creates

confusion. As the definition on page 1 states: "DUR is a formal ' program 

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,


and economics) and. professional experience, not on explicit criteria. 

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 clinical services are provided depends on the follow ing 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


outlined in the enclosed report entitled. Directions for clinical


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


Indian Heal th Service and is attached 
 s an appendix.


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. 
A. ollect ion of Pat ient Information 

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


publication entitled. 
 Criteria for DruQ Use Evaluation . How much,


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 medication prescribed. This outcome requires that the patient


u.. 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-


C= = Additionally, the . 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/diseasestate/drug database.


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


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. 

Additionally, in this section, in Figure 4, entitled .Physician 

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 

in the nature of each patient' s needs. Indicators eould be developed, 

but they will only identify the patients whO MAY be at high risk (not


those who are at high risk). What is actually needed is a hort, 

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 hCI' en none and optimal, and this is defined as a minimal 

standa:d. A?: ;/!I.!K.. tandards, which are operational standards, are

minimal. Given its age, the document can be revised to a relatively 

small deg:ee and still represent appropriate minimal standards for


clinical pharmacy in community settings in the 1990' s. Primarily, what 

needs to be done with these standards is to revise them so that they are


functionally-based instead of task-inventory based.


ASHP has alsc develo ed numerous standards and guidelines on clinical 

pract ice for its members. The pertinent standards have been enclosed in 

the appendi this letter. 

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

based on cur rent pract ice and funct ional, rather than task-inventory, 

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

1. Include other ambulatory settings, sueh as the Indian Health 

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 opportunity to review the OIG draft report entitled. 
 The Cl inical RQle c! Communi tv Pharmacist . The growth of pat ient-or iented. clinical ' pharmacy services is crucial to the efficient, safe. cost-effective 

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. 

/I (!J

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 

(73) 928.n 

Mzrcn 28, '99 

Rj:hard F. Kw E"Ow 

In' ;-E'N Ge:1e a1 . 

: Cone . B. il':::'g 

332 lJdet'enden:e Avenue, S\\ 

\\a.,hinb'! on . IX 20201 

rAa.." K-.,"c..:w. 

\";. a.. "' \ or, tle two dra rert, ClcaJ Role of tle 

:::"f Ie' C"c::nmer,


Commun. y Pnarmc:l:' and '"e Qica Role of the Comunty Phcit: 

Ca!o S:ue,e; We a?OIc:g;z. fC.. the delay ir respondig to your reest for 

l:!'mer' ' E. eve:, we tool: the tie to sed copies of thes report to ou 

leade :, sc: Iha: we cou. ircorpnle the views of pnctcig consultat 

:=~Lc:LC. ii\tc our COInents 

",'h:. re\iewe: thes report is thI thes are Tne consu.le:.: vie.,. of th 

e'l:ei7k :. ...e:: 
 C::ne in ter of underslandig the subjf! and aCC"tel)' asseinb'

aspe' of provjci:1g chnica phacy sees ir D.' :r Lo,e p:';.:. . f and nei=ati\'e 

C:::""f:' v-' " aJ" pi C'la: plea to se tht your c: studiE! ti'" co:-""7, 

cae ;jE-': cc:r.;.:. : pharci;.'. ",.ho provide services to long ter residents. 

TncrL i'.. c;- t..z:, ",ith the "grying of A%erica," th importnt area of r, 

pr.a.'". a:y pra::l.e ..-i beome even more regne: for the vauable and 

ne.essar: servi:e: tht are provie: to elderl)' reents ir varow home 

e;" :-, c:-, 

V. e a a1;: plea.E"': thz: your repon citec constant seces provided to nuring 

mp; 0; a &uccesfu non-prouct relalec reimbursent lIC\me , a.' 81, 

ir"en:;ve systen-, for clca1 pharmcy &eT\ices. We must point out, however,

,r. reir:, !-!lr!oE' enl a"angemp are made privately beee 10ng term tha 

fadlj . adminitntor an constat phadsts in c: wh the care consulUlI admistrator re.ognes the positive impact.cm patient cae 

phzrm::ts can mae. However. tht payment to constat phacits Is not 

recognied by governt thd par payozs. spcay Medcaid an Medcar, 

where the only payment incentive rema prouct rete. Your rert identies 

the problems irherent in a &ystem wher the payment intive Is prouct=baec. 
. . $(j

MI. Ri . E:. J(usseTow 

Mach 2., 199 

Page Two 

Your draf report alo ma good inti steps towa iden\:b the long ten 

heath care savings tht ca accre to the overa health cae system :when drg 

therapy is properly maged. We fuy conc with tht menl To fuer confi tht conclusion, we have enose a reprit oC an arcle by Dr. 

Kidder of HCFA tht re\'iews several publihed report indicatig tht clcal 

pharmcy ser.'ices in the nuring home envinment can produce signnt 

savings to lhe overa heaL". cae costs oC elderly America. 

We believe that vour office ha made a goo start towad workig on these issues

of great IDpon.,1J" 10 pr.acy ard the public we seIVe. To fuer th work, we 

invite your office to meet with us to dis 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 where a pilot stud)' coud be intiated ard managed. We believe tht

such a sr.Jc\ could produce conclusive e\;dence tht the reimburseent 

incenu \'1: for cin.ca1 pharmcy must be chnged to a servce provided outcome 

oriented system and tht in doing so, patient cae woul improve and the overall 

costs IL' tj" ':c. J ,,;.;, ed heath care system would deceae. 

We look forward :v m tig v,;th your sta in the near futu. 

"tJ 

R Tim Webster


Exective Diector

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 

OF COLLEGES OF PHACY 

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, The Clinical Role of tbe 

COlnmunity Pharmactt and The Clinical Role of the Community Pha1't: Case Studies.

Q\' erall, the report are 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. 

I am pleased to offer these comments, diraed speca at The Clinical Role of rbe Community Pbarmctsr 
 v.1th the hope that these remarks wi asist you and your collcag'":s :.S you prepare the fin:!! 
 eport. My comments are died 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 

Cost effectiveness of ambulatory clca 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 a strctured, ongmng, oranizatioll''''1 authoried, qualiry-assurance process degn to en that drugs are 1/.''/ 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, ar applicable to the ambul....." .., 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 Its Appedix contan desptions of the activities 

performed by phanacists in ambulatory segs. They are prested in a spectrum of schematic diagrms to' i1ustrat minimum and maxum degee of clca 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. 

The keynote paper presented at the Conference (Hepler and Strd) is enclosed for your information. It elaborates on the theme of pba7"eulcai 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. It is clear that drug-drug. drug-disease and drug-aler 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 

care. A5 your repon points out, there are numerous barer 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 

In conclusion, the Inspector General's Repn outles In succct det 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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Reference 

1- SI MI fa cI ph CI - t8. Am J
 HOI I'lwI98 39:. Sr Mi c: Cc I'... e &l c:e mr. QII Re B8l 19 &(1l) 10. 3. eo CP, ML Pr di ;N fa a JC -.. 

I..t pM-=

11-" to AmCi Socy II 1986

far holl CI: loi T:u"' ofHo 1987a 5. SlMH Mod Ca a fOl JRI. l.e ctibioti 

Am J 80s Ph= 1.78; 35:&11. 

6. 51011 MH cp.. c.Coliaa. AmJ Bos Pf4n 1;78; 3S:76-. 

4r -. bJ 11 AS !I ef Di 19. 1m. . I "" do AS c- .. i'..oe 

A5 r-:..I"- - tI Pb::

1I AS Ba It II DN-t.. RI CI i'.c

rL Di II Ap3Q l5L 

Cop !!a. Sa oIli
 lD AlIi-. 

lt m.IbAm J B=;"- 19S :5;3