Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

State Pharmacy Boards’ Oversight of 

Patient Counsebng Laws 

JUNE GIBBS BROWN 

Inspector General 

August 1997 

OEI-01-97-00040 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 

protect the integrity of the Department of Health and Human Services programs as well as the 

health and welfare of beneficiaries served by them. This statutory mission is carried out through a 

nationwide program of audits, investigations, evaluations, sanctions, and fraud alerts. The 

Inspector General informs the Secretary of program and management problems and recommends 

legislative, regulatory, and operational approaches to correct them. 

OFFICE OF EVALUATION AND INSPECTIONS 

The OIG’s Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, the 

Congress, and the public. The inspection reports provide findings and recommendations on the 

efficiency, vulnerability, and effectiveness of departmental programs. 

OEI’s Boston Regional Office prepared this report under the direction of Mark R. Yessian, Ph.D., 

Regional Inspector General. Principal OEI staff included: 

Boston Region Headauarters 

Kenneth Price Jennifer Antic0 

Elise Stein 

To obtain a copy of this report, contact the Boston Regional Office by telephone at 

(617) 5651050 or by fax at (617) 565-3751. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

State Pharmacy Boards’ Oversight of 

Patient Counseling Laws 

JUNE GIBBS BROWN 

Inspector General 

August 1997 

OEI-01-97-00040 
EXECUTIVE SUMMARY 

PURPOSE 

To assess State pharmacy boards’ oversight of State patient counseling laws. 

BACKGROUND 

-ICATION AS A NATIONAL PROBLEM 

Adverse drug reactions associated with the misuse of prescription drugs are widespread. 

They reduce the quality of health care received by millions of people. They also add as 

much as $100 billion a year to health care costs. 

Pharmacists can help address this problem--by serving as a last line of defense to identify 

and correct prescription errors and by providing patients with oral and written information 

to improve their understanding and use of prescription drugs. This patient education role 

has been of longstanding interest to The Food and Drug Administration (FDA) and is 

central to a public-private prescription information program recently approved by the 

Secretary of the Department of Health and Human Services (HHS). 

STATE PATIENT COUNSELING LAWS HAVE QUESTIONABLE EFFECTS 

In 1990, Congress required that pharmacists offer to counsel Medicaid beneficiaries who 

present prescriptions and that States establish counseling standards. Nearly all States 

responded by passing patient counseling laws that extend to all patients, not just Medicaid 

beneficiaries. They look to State pharmacy boards to oversee compliance with the laws. 

Recent survey results suggest that the offer to counsel often is not extended. Worse yet, 

investigations conducted by “shoppers” pretending to be patients reveal that pharmacists 

often fail to warn patients about drug interactions that could be harmful or even fatal. 

Our inquiry, based primarily on a survey of State pharmacy boards, focuses on the 

performance of the boards in ensuring compliance with patient counseling laws. 

FINDINGS 

Statephamtacy boards have played an active role in explaining and urging pharmacist 

compliance withStatepatient counseling laws. 

During the past year, 38 of 46 responding boards conducted educational efforts directed to 

pharmacists. 

The boards have carried out three major types of educational activities. They include: (1) 

the distribution of newsletters, (2) the presentation of information at professional 

association meetings, and (3) the provision of information during inspection visits. 

1 
However, the boards’ enforcement of the counseling laws has been minimal. 

They have made little use of “shopping” visits, whereby board representatives pose as 

patients to assess compliance with counseling requirements. In the past year, only 17 of 

46 responding boards made such visits. Generally, they were made only to pharmacies 

against which a complaint had been lodged. 

They have relied on inspection visits as the major means of enforcement. Such visits are 

conducted with widely varying degrees of frequency. At best they offer limited 

opportunities for assessing the extent and adequacy of counseling. 

They have taken few final, formal disciplinary actions involving violations of patient 

counseling laws. Of the 354 actions taken during the past year by 23 reporting boards, 

208 (59 percent) were in just 3 States. 

The boards identified major obstaclesto the successful implementationof patient 

counseling ikws. 

ECONOMICS OFPHARMACY PRACTICE. About three-fourths of the boards 

noted as a major obstacle the limited reimbursement for counseling 

services; about one-half noted the lack of pharmacy owners’ commitment to 

counseling. Workload pressures on pharmacists often too great to allow for 

routine counseling. 

IJMITED PATIENT DEMAND. About 60 percent of the boards underscored 

the lack of patient knowledge about the patient counseling requirements. 

Patients often reluctant to spend the additional time counseling would 

require. 

LACK OF RESOURCESFOR ENFORCEMENT. Cited by close to one-half of 

the boards as a major obstacle. Insufficient staff support, especially for 

labor intensive “shopping” investigations. Complaints about having 

responsibility for enforcing Federal Medicaid counseling requirements 

without additional funding. 

RECOMMENDATIONS 

The HHS Secretary and the FDA are committed to a public-private prescription 

information program that by the year 2000 will result in at least 75 percent of the 

individuals receiving new prescriptions being given useful patient written information. 

The Health Care Financing Administration (HCFA) is committed to Federal-State efforts 

that will result in full adherence to Medicaid patient counseling requirements. 

Pharmacy boards, through their oversight efforts, have a vital role in ensuring that 

progress is made in providing individuals with useful written and oral information. Our 

review indicates that there is much room for progress in State oversight efforts and that 

11 
major obstacles impede the integration of counseling into pharmacy practice. We offer 

two sets of recommendations intended to address this situation--one to FDA, the other to 

HCFA. 

The FDA should collaboratewithStatepharmacy boards to collect survey data on the 

usefulness of writteninformation offered to patients receiving new prescriptions. 

Pharmacy boards, in concert with FDA, could conduct “shopping” efforts to a sample of 

pharmacies to determine the extent and type of information being offered to patients. A 

joint effort of this kind would help FDA carry out its responsibility to measure progress 

being made in offering “useful” written information to patients. At the same time, it 

would facilitate State board oversight of counseling law provisions governing the provision 

of both oral and written information. 

The HCFA shouldfacilitate State efforts to enforce the Medicaid patient counseling 

mandate. 

Working in partnership with the States and the above-noted HHS agencies, HCFA could 

take the following initiatives: 

DEVELOP AND ASSESSSTATE PROGRESS TOWARD A PATIENT COUNSELJNG 

PERFORMANCE OFUECTIVE. This objective could resemble the year 2~ 

objective noted above. The States’ annual drug utilization review reports 

could reflect progress made in meeting it. 

DEVELOP GUIDELINES ON STATE OVERSIGHT OF THE FEDERAL PATIENT 

COUNSELING MANDATE. Such guidelines, incorporating best practices 

currently being carried out by the States, could help State boards in 

developing cost-effective enforcement approaches. 

COMMENTS ON THE DRAFT REPORT 

Within the Department, we solicited and received comments on the draft report from 

FDA, HCFA, the Health Resources and Services Administration (HRSA), and the 

Assistant Secretary for Planning and Evaluation (ASPE). From external organizations, we 

requested and received comments from the National Association of Boards of Pharmacy, 

the Citizens’ Advocacy Center, Public Citizen’s Health Research Group, the American 

Pharmaceutical Association, the National Association of Chain Drug Stores, the National 

Community Pharmacists Association, and the American Society of Health-System 

Pharmacists. We include the complete text of comments in appendix C. Below we 

summarize the major thrust of the comments on our recommendations and, in italics, offer 

our responses. We made a number of minor edits in the report in response to comments. 

.. . 111 
FDA,HCF’A,HRSA, AND ASPE COMMENTS 

The FDA, HCFA, and ASPE concurred with our recommendations. In our drafi report, 

we suggested that one initiativethatHCFA could take infacilitatingState efforts to 

enforce the Medicaidpatient counseling mandatewouldbe to “facilitatethe convening of a 

nationalsymposiumon oral counseling by pharmacists.n In thisfinal report, we have 

eliminatedthatsuggestion because pharmacy associationshave decided to sponsor such a 

symposiumin September 1997. We stillsuggest, however, thatHCFA pay careful 

attentionto the issues raised in the symposiumand that it exert leadership in examining 

and even showcasingconstructivewaysof addressing the major obstacles to patient 

counseling thatwe ident@ed in this report. 

The HRSA did not comment specifically on the recommendations, but it noted that the 

draft report made it appear that it was the responsibility of the State pharmacy boards to 

enforce the Federal Medicaid patient counseling requirement. We modifiedthe 

introductorytext to clan3 thatStatestypicallyhave relied upon the boards as the 

enforcement armfor both Federal and Statecounseling laws. 

EXTERNAL ORGANIZATIONS’ COMMENTS 

These comments serve as an important complement to our report. They add useful 

perspective, especially with respect to the obstacles to patient counseling. The 

associations tend to emphasize the need for Federal initiatives to address these obstacles 

(especially with respect to the economics of pharmacy practice) while more generally 

expressing their concern about any broadening of the Federal role. The consumer-based 

organizations call for stronger Federal action in ensuring that patients are adequately 

informed. We are sensitiveto the scope of the obstacles inhibitingoral counseling by 

pharmacistsand to the primary role of Stategovernmentin enforcing existing counseling 

laws. At the same time, we must reemphasizethatour survey reveals that the enforcement 

of Federal and Stateoral counseling lawshas been minimal. It is vital, we believe, for 

both levels of governmentto give greater attentionto the implementationof these laws and 

to suppon “shopping”and other techniquestowardthat end. 

iv 
TABLE OF CONTENTS 

PAGE 

EXECUTIVESUMMARY 

INTRODUCTION ........................................... 

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...4 

Boards Active in Conducting Educational Outreach . . . . . . . . . . . . . . . . . . . . 4 

Boards’ Enforcement of Counseling Laws is Minimal . . . . . . . . . . . . . . . . . . 5 

Boards Identify Major Obstacles to Patient Counseling Laws . . . . . . . . . . . . . . 6 

RECOMMENDATIONS ......................................g 

CO~~MENTS~N~EDRAFTREPORT ..,...................... 10 

APPENDICES 

A: Survey of State Pharmacy Boards ............................. A-l 

B: The MedGuide Effort .................................... .B-1 

C: Complete Comments on the Draft Report ......................... C-l 

D: Endnotes ............................................ D-l 
INTRODUCTION 

PURPOSE 

To assess State pharmacy boards’ oversight of State patient counseling laws. 

BACKGROUND 

Mismedication as a National Problem 

Mismedication is a major national problem. It contributes to adverse drug reactions that 

severely impact the quality of health care received by millions of persons, particularly the 

elderly.’ It also adds greatly to health care costs. Costs associated with the waste in 

misused drugs and the results of not receiving intended therapy have been estimated to 

account for as much as $100 billion a ~ear.~ 

Patient failure to comply with a prescribed drug regimen is one factor responsible for this 

problem. Studies have shown that noncompliance rates average between 30 and 50 

percent.3 But there are also other important contributing factors, such as the inadequate 

prescribing and dispensing of drugs.4 

Pharmacists as Counselors 

In hospitals and nursing homes, pharmacists, working collaboratively with physicians, 

have long played important clinical roles. In community pharmacies, the barriers to such 

roles have been imposing and the practice of clinical pharmacy has been less 

pronounced.’ But with the advances in computer technology and software, community 

pharmacists have ready access to drug product information that can be helpful to patients. 

In many cases, they also have access to patient profile information that can help guide 

pharmacist counseling of patients. 

Thus, pharmacists are in a key position to help address the mismedication problem noted 

above. In one sense, they can serve as a last line of defense, to identify and correct any 

prescription errors at the point of dispensing. In another, they can act in a proactive 

manner as a part of the patient care team to foster better patient understanding and use of 

prescription drugs. 6 Such a role is in accord with the Food and Drug Administration’s 

longstanding efforts to increase patient information about prescription drugs. It is also in 

accord with the prescription information action plan recently developed by a broadly based 

task force and approved by the Department of Health and Human Services (see appendix 

A). 
State Patient Counseling Laws 

In 1990, Congress underscored the counseling role of pharmacists by including it as one 

of the components of the Drug Utilization Review requirements it incorporated into the 

Medicaid program. It stipulated that pharmacists must offer to counsel each Medicaid 

beneficiary who presents a prescription and that State governments must establish 

standards for the counseling of these individuals.7 

Nearly all States responded by enacting 

patient counseling laws that applied not 

only to Medicaid beneficiaries, but to all 

consumers. The scope of the laws is 

limited. For instance, in most States an 

offer to counsel can be extended in a 

written form handed to the patient by a 

pharmacy technician. Nevertheless, the 

laws have served to heighten the 

professional roles and responsibilities of 

community pharmacists. The States 

typically have given the responsibility of 

enforcing the laws to State Boards of 

Pharmacy, the entities responsible for 

licensing and, where necessary, 

disciplining pharmacists. 

Questionable Effects of the Laws 

STATE PATIENT COUNSELING LAWS 

States 

Delivery 

Offer must be made verbally 17 

Counseling, when performed, must 

be face-to-face by pharmacist 46 

Scope 

Inclusive of all ambulatory patients 42 

Inclusive of refills 17 

Content 

Mandate patient profiles 43 

Mandate minimum set of information 9 

Source: Derived from information compikd by the National 

Associatioo of Boards of F’hannacy, 1996. 

The actual effects of the laws in fostering useful patient counseling remains questionable. 

For instance, a July 1994 survey conducted by the National Association of Boards of 

Pharmacy indicated that patients reported offers to counsel only 38 percent of the time.8 

Another survey conducted at about the same time by the New York City Office of the 

Public Advocate found that only 42 percent of independent community pharmacists and 27 

percent of chain pharmacists extended offers to counsel.9 

One of the most troubling and widely publicized signs that the laws may not be having the 

intended effect was provided in August 1996 in a national news magazine under a cover 

story entitled: “Danger at the Drugstore: Pharmacists are your last defense against risky 

drug interactions. Too many are blowing it.“l’ The story was based on the efforts of 

reporters who posed as consumers seeking to fill combinations of prescriptions which 

would be dangerous or even deadly if taken together. In the 245 pharmacies visited in 7 

cities, more than one-half of the pharmacists failed to warn the reporters/consumers of the 

risks associated with mixing the drugs. A similar study conducted earlier in the District 

of Columbia by researchers at Georgetown University Medical Center found that more 

than 30 percent of the pharmacists filled the prescriptions without any warning.” 

2 
This Inquiry 

This inquiry focuses on the role of State pharmacy boards in overseeing compliance with 

State patient counseling laws. It is based on the premise that effective oversight can help 

foster the intent of the laws. It sets forth the extent and nature of the boards’ educational 

and enforcement efforts, and closes with a review of what board officials regard as major 

obstacles to successful implementation of the laws. 

The information we present comes from three sources. The primary source is a survey 

we conducted of all State pharmacy boards in the country. We administered the survey 

from November 1996 through January 1997. We sent questionnaires to 51 boardsI and 

received responses from 46 of them, representing a response rate of 90 percent. (The 

survey results appear in appendix A). I3 The second source is telephone interviews with 

board officials in 12 to 15 States. Typically, we initiated these interviews to obtain some 

elaboration on information provided on a returned questionnaire. Finally, mainly for 

context, we draw on a review of pertinent reports and literature concerning patient 

counseling by pharmacists and concerning problems associated with misuse of prescription 

drugs. 

We conducted this inspection in accordance with the Quality Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

3 
FINDINGS 

State pharmacy boards have played an active role in explaining and urging 

pharmacist compliance with State patient counseling laws. 

b During the past year, 38 of 46 responding boards (83 percent) have conducted 

educational efforts intended to help pharmacists understand or carry out the laws. 

b Among these 38 boards, 28 have carried out three or more different types of 

educational efforts. Typically, they have involved the preparation and distribution 

of newsletters and other written materials, the presentation of information at 

professional association meetings, and the provision of information during 

pharmacy inspection visits. 

This educational thrust of the boards is most apparent in the newsletters which they 

typically send to all pharmacists in their States. Through these newsletters they explain 

the key elements of the counseling law and remind pharmacists of the importance of 

counseling and how they might overcome some of the barriers associated with it. A 

particularly notable example of such educational outreach was an issue of the California 

board’s newsletter. Drawing on information from the California Pharmacists Association 

and the California Society of Health System Pharmacists, it spelled out how pharmacists 

in seven different settings “have implemented pharmaceutical care by emphasizing patient 

counseling and pain management. ”l4 

Through appearances at professional association meetings, the boards get out the same 

message in a more personal way, with opportunity for give and take. The Texas board 

was particularly active in this regard, having made during the past year 29 presentations 

that reached 4,000 pharmacists. The Virginia board held four public forums that 

addressed how pharmacists’ workloads affect their ability to comply with counseling 

requirements and to prevent dispensing errors. The Arizona board developed and 

provided for continuing education credit at professional meetings a live 2 to 3 hour 

program specifically aimed at preventing dispensing errors through patient counseling.” 

Even more personal and direct are the face-to-face exchanges that pharmacy inspectors 

and pharmacists engage in during the course of board inspections of individual 

pharmacies.16 During these inspections, boards are primarily focused on compliance, but 

at least with respect to the counseling law they also tend to be attentive to the educational 

opportunity afforded by their visit. They reinforce the intent of the counseling law, 

answer questions concerning it, and sometimes leave informational materials. 

In contrast to the above efforts directed to pharmacists, boards have devoted much less 

attention to educating patients about the counseling laws. Of 46 responding boards, only 

11 (24 percent) undertook any such initiatives during the past year.17 However, some 

notable efforts have been made and more are being developed. The New York, Texas 

4 
and California boards have prepared information brochures directed to consumers. The 

Nevada board produced a series of public service announcements. The Louisiana, Ohio, 

and other boards are preparing informational postings on the Internet. And the 

Massachusetts board, at this writing, is preparing a guideline that will require all 

pharmacies to post a sign informing consumers of their right to counseling. 

The boards’ enforcement of the counseling laws has been minimal. 

b They have made little use of “shopping” visits, whereby representatives of 

pharmacy boards pose as patients to assess compliance with counseling 

requirements. During the past year, only 17 of 46 responding boards (37 percent) 

made such visits--generally only to pharmacies against which a complaint had been 

lodged. 

Shopping visits to pharmacies are an excellent enforcement tool to determine if and how 

well pharmacists are counseling patients. The Georgetown Medical School, as we noted 

earlier, used this approach to help draw attention to the fact that pharmacists often do not 

provide a sufficient front line of protection for patients. The pharmacy boards, however, 

make little use of this mechanism. Most do not use it at all; most of the others, do so 

sparingly. In a few cases, legal concerns about entrapment seem to inhibit its use. Much 

more often, the limited resources available to the board serve as the restraint. Shopping is 

a labor-intensive activity that can be quite costly if used on other than a highly selective 

basis. la 

Thus, even among the 17 boards citing some recent experience with shopping, only a few 

have used the technique in a proactive manner, randomly visiting pharmacies in the State. 

And even in those cases, relatively few pharmacies were visited.” Shopping, to the 

limited extent it is practiced by the boards, is used essentially as a tool of investigation of 

pharmacies that are the focus of special concern.2o 

b Boards have relied on inspection visits as the primary means of enforcing patient 

counseling laws. Such visits are conducted with widely varying degrees of 

frequency among the states and even at best offer limited opportunities for 

assessing the extent and adequacy of counseling. 

During these visits, inspectors must examine many different elements associated with the 

practice of pharmacy. 21 They include, among other things, the adequacy of the facility 

itself, of the records and record-keeping procedures, of the prescription drug inventory, of 

the compounding practices, and of interactions with patients. The latter involves some 

tangible elements that can be examined, such as the physical area set aside for counseling 

or the type of written material distributed. But the dynamics of offering to counsel and 

then actually counseling are much less conducive to assessment. Pharmacy inspections are 

usually unannounced, but we are told that once the inspectors appear on site, pharmacy 

staff tend to be well aware of their presence. Accordingly, one board official noted: 

“Some of the best counseling in our State goes on when the inspectors are around.” 

5 
How often the inspectors are around in any particular pharmacy varies greatly from Stateto-State. Among 46 reporting boards, 8 (all among the least populated States) indicated 

that during the past year they had conducted site visits to all of the pharmacies in their 

State. On the other hand, 7 reported conducting no such visits and 8 (most among the 

most heavily populated States) reported visits to less than 50 percent of the pharmacies. 

b They have taken few final, formal disciplinary actions involving violations of 

patient counseling laws. Of the 354 actions taken during the past year by 23 

reporting boards, 208 (59 percent) were in just 3 States. 

Pharmacy board officials, as we will note below, recognize the substantial constraints that 

limit the potential effectiveness of the patient counseling laws. Some also appear to 

believe that too punitive an approach to enforcement could be counterproductive. 

Whatever the rationales, the data we collected indicate that in most States the boards have 

taken few if any final, formal disciplinary actions against pharmacists for reasons that 

relate at least in part to violations of patient counseling laws. Further, of the actions 

taken, only a small percent have involved anything other than a fine or reprimand. 

A number of boards note that while they invoke few if any formal disciplinary actions that 

concern counseling, they do take informal actions, which serve as warnings to pharmacists 

who they found were not sufficiently attentive to patient counseling. Such warnings, 

board officials note, can be an effective way of reminding the pharmacists and the 

pharmacy managers of the intent of these laws. 

The Boards identified major obstacles to the successful implementation of patient 

counseling laws. 

Economics of Pharmacy Practice. The most significant obstacles, according to the 

boards, is the economic reality of pharmacy practice in environments where payers are 

squeezing operating margins and pharmacies are consolidating, often as part of large 

national chains. Thus, about three-fourths of 44 responding boards cited as a major 

obstacle the limited reimbursement for counseling services and about one-half of 45 

boards - the lack of owners’ commitment to counseling.22 Making a point reiterated by 

many of his colleagues in other States, one board official said: “Staffing in corporate 

pharmacies is simply insufficient to allow routine counseling. ” The workload pressures on 

individual pharmacists are simply too great.23 

Limited Patient Demand. The demand side, boards emphasized, must not be overlooked. 

About 60 percent of 45 responding boards underscored that a major obstacle was a lack of 

patient knowledge about the counseling requirement; about one-half stressed the lack of a 

suitable physical area for counseling as a major impediment. 

In their comments to us, boards surfaced two other, perhaps more basic factors inhibiting 

patient demand. One is that many patients tend to overlook the vital importance of drug 

information and just assume that their physicians and pharmacists will not allow anything 

bad to happen to them. Another related factor is that patients do not want to spend the 

6 
extra time that counseling entails. “The entire counseling process,” said one board 

official, “is new and not within what most patients consider ‘traditional practice.’ Even 

when asked, they will refuse. “~4 Of course, the relatively limited educational outreach 

efforts of boards (and other entities) do little to change this patient perspective. 

Lack of Resources for Enforcement. Finally, boards stressed that insufficient resources 

are a major factor impeding their enforcement of patient counseling efforts. Close to onehalf of 45 responding boards identified it as a major obstacle.25 They stress that they 

have insufficient staff to engage in the long and tedious process of identifying those 

pharmacists and pharmacies that are not complying with the counseling laws and, where 

necessary, accumulating enough evidence to serve as the basis for disciplinary action. 

One particularly irksome concern to some boards is that without any additional funding 

they are expected by the State Medicaid agency to serve as the chief entity responsible for 

enforcing the Federal counseling requirement directed to Medicaid beneficiaries. Boards 

note that while the Medicaid agency gets Federal reimbursement for a share of their costs, 

none of that reimbursement gets passed on to them. 

On the other hand, a few officials noted developments that may contribute to increased 

interest attention to counseling, One is the acceleration of automation efforts that can free 

up more pharmacist time for counseling. Another is the threat imposed by large 

malpractice settlements in cases involving drug dispensing errors.26 

7 
RECOMMENDATIONS 

There is a substantial Federal interest in effective implementation and enforcement of 

patient counseling laws. The HHS Secretary and the FDA are committed to public-private 

efforts that will result by the year 2000 in at least 75 percent of the individuals receiving 

new prescriptions being given useful written information.” The HCFA is committed to 

Federal-State efforts that will result in fulfilling the intent of the Medicaid patient 

counseling requirements established by Congress. 

At the State level, the pharmacy boards serve as the main body responsible for overseeing 

pharmacists’ compliance with the Federal and State patient counseling laws. Our review 

indicates that there is much room for improvement in State oversight efforts and that there 

are major obstacles to the full-fledged integration of patient counseling into pharmacy 

practice. We offer two sets of recommendations intended to help address this situation. 

One is directed to the FDA; the other to HCFA. They follow: 

The FDA should collaboratewithStatepharmacy boards to collect survey d&a on the 

usefulness of writteninformation offered to individualsreceiving new prescriptions. 

The FDA is completing a survey assessing the extent to which patients are being given 

written information when receiving new prescriptions. To assess the “usefulness” of the 

information being offered, it will be conducting another survey. This survey effort offers 

a prime opportunity for the FDA and pharmacy boards to work collaboratively to foster 

mutual interests in patient counseling. 

In particular, we suggest that a number of boards, working in concert with FDA, conduct 

“shopping” efforts to a sample of pharmacies to determine the extent and type of 

counseling being offered to patients. In conducting these visits, the boards could obtain 

information that would help them ensure compliance with their States’ own patient 

counseling laws and at the same time collect and send to FDA the written information that 

pharmacists provided to the “shopper. ” The FDA could then assess the usefulness of this 

information in accord with the criteria established in the prescription information action 

plan approved by the HHS Secretary (see appendix B). 

The prospects for a successful cooperative effort of this kind would appear to be good. 

Pharmacy boards have already been working with FDA in helping to enforce FDA 

regulations. Moreover, many board officials have been commissioned by FDA. This 

entitles them with access to communications and information that would otherwise be 

considered confidential. 

8 
The HCFA should facilitate State effoortsto enforce the Medicaidpatient counseling 

mandate. 

The lead role in carrying out this mandate is with the States. But given the partnership 

nature of the Medicaid program, HCFA, the above-noted HHS agencies, and the State 

governments (including State Medicaid agencies and State pharmacy boards or their 

national federation) should work together cooperatively in fostering their common interest 

in patient counseling. Toward that end, we suggest two initiatives which HCFA could 

undertake: 

Develop and assess Stateprogress towarda patient counseling petionnance objective. 

Ideally, this objective would closely parallel the performance objective which the 

Secretary has already endorsed calling for 75 percent of patients by the year 2ooO to 

receive useful written information and which the FDA is monitoring. (Given the nature of 

the Federal mandate, however, it probably should address oral as well as written 

information.) The HCFA could amend its Drug Utilization Review annual report 

instructions to State Medicaid agencies to require State updates, based on survey data, of 

progress being made in meeting the objective. At present, those instructions are much 

more general. 

Develop guidelines on State oversight of the Federal patient counseling mandate. The 

authorizing statute calls upon the States to develop standards for counseling individuals. 

Federal guidelines governing how States ensure enforcement of the standards could 

facilitate State progress in meeting them. If based on input from and best practices 

currently being carried out by the States, these guidelines could be of considerable value 

to State pharmacy boards as they consider how to carry out their enforcement efforts in 

the most cost-effective manner possible. 

9 
COMMENTS ON THE DRAFT REPORT 

Within the Department, we solicited and received comments on the draft report from 

FDA, HCFA, the Health Resources and Services Administration (HRSA), and the 

Assistant Secretary for Planning and Evaluation (ASPE). From external organizations, we 

requested and received comments from the National Association of Boards of Pharmacy, 

the Citizens’ Advocacy Center, Public Citizen’s Health Research Group, the American 

Pharmaceutical Association, the National Association of Chain Drug Stores, the National 

Community Pharmacists Association, and the American Society of Health-System 

Pharmacists. We include the complete text of comments in appendix B. Below we 

summarize the major thrust of the comments on our recommendations and, in italics, offer 

our responses. We made a number of minor edits in the report in response to the 

comments. 

FDA, HCFA, HRSA, AND ASPE COMMENTS 

The FDA, HCFA, and ASPE concurred with our recommendations. In our dra@report, 

we suggested that one initiativethatHCFA could take infacilitatingState eflorts to 

enforce the Medicaidpatient counseling mandatewouldbe to “facilitatethe convening of a 

nationalsymposiumon oral counseling by pharmacists.n In thisfinal report, we have 

eliminatedthatsuggestion because pharmacy associationshave decided to sponsor such a 

symposiumin September 1997. We stillsuggest, however, thatHCFA pay care@1 

attentionto the issues raised in the symposiumand that it exert leadership in examining 

and even showcasingconstructivewaysof addressing the major obstacles to patient 

counseling that we ident$ed in this report.28 

The HRSA did not comment specifically on the recommendations, but it did note that the 

draft report made it appear that it was the responsibility of State pharmacy boards to 

enforce Federal Medicaid statutes. We modiJed our introductorydiscussionto make it 

clear that Statestypicallyhave chosen to rely on the boards as their enforcement arm. 

Further, in both the draft andj?nal report our discussionconcerning the lack of resources 

for enforcement addresses State board concerns that StateMedicaid agencies look to them 

to enforce the Federal patient counseling law withoutsharing any of the Federal finds 

they receive under the Medicaidprogram. 

EXTERNAL ORGANIZATIONS’ COMMENTS 

These comments serve as an important complement to our report. They add useful 

perspective, especially with respect to the obstacles to patient counseling. The 

associations tend to emphasize the need for Federal initiatives to address these obstacles 

(especially with respect to the economics of pharmacy practice) while more generally 

expressing their concern about any broadening of the Federal role. The consumer-based 

organizations call for stronger Federal action in ensuring that patients are adequately 

10 
informed We are sensitiveto the scope of the obstacles inhibitingoral counseling by 

pharmacistsand to the primary role of Stategovernmentin enforcing existing counseling 

laws. At the same time, we must reemphasizethatour survey reveals thatthe enforcement 

of Federal and Stateoral counseling lawshas been minimal. It is vital, we believe, for 

both levels of governmentto give greater attentionto the implementationof these laws and 

to support “shopping”and other techniques towardthat end. 

11 
APPENDIX A 

SURVEY OF STATE PHARMACY BOARDS 

Response Rate to the Survey 

Number of States Surveyed* 51 

Number of Responses 46 

Response Rate 90% 

*Includes the District of Columbia 

Nonrespondents were: the District of Columbia, 

Kansas, Maine, Michigan and South Carolina. 

Survey Questions and Responses 

In your view, how informeddo pharmaciststend to be of their obligationsunder your 

State’spatient counseling requirement? 

Number Percent of States 

Well Informed 24 53 

Very Well Informed 11 24 

1rry Informed 1 tr 1 z. 

Percentages may not total to 100 due to rounding. 

Withinthe past year, has your Board conducted any educationaleflorts intendedto help 

pharmacistsunderstandand/or carry out the State’spatient counseling requirements? 

Number 

of States Percent 

Yes 38 83 

No 8 17 

Total 46 100 

A-l 
If yes, please check (and briefly explain) any offollowing educationaleaorts that apply. 

Number of States Percent of 

Undertaking Effort States 

Made information available at on site inspections 33 89 

Mailed information to pharmacists 31 84 

Made information available at professional 

association meetings 

IConducted other educational efforts I 9 I 24 

Issued media announcements 

Mailed information to patients 

Made information available on the Internet 

I

Total Number of Efforts Reported 

1 N States Responding = 37 (Multiple responses permitted.) 

6 16 

5 14 

3 8 

117 

I Number of Educational Methods Undertaken by States to Help Pharmacists 

Understand and/or Carry Out Patient Counseling Requirements I 

Number of Methods Number of States Percent of States 

1 2 5 

2 7 19 

3 18 49 

4 or more 10 27 

I

Total 

1 Percentages may not add to 100 due to rounding. I 

A-2 
Does your Statehave any continuingeducationrequirementsspectjkally intendedto help 

pharmacistsconductpatient counseling? 

Number Percent of States 

No 43 94 

Yes 3 7 

ITotal 

Withinthe past year, has your Board conducted any shopping eflorts, whereby individuals 

pose as patientsto assess compliancewithpatient counseling requirements? 

Number Percent of States 

No 29 63 

Yes 17 37 

Withinthe past year, has your Board conductedsite visitsof pharmacies to assess their 

compliance withStatepharmacy laws (includingpatient counseling requirements)? 

Number Percent of States 

Yes 39 85 

No 7 15 

A-3 
If yes, about whatpercent of pharmacies in the Statehas your Board visited? 

Number of Mean Median Minimum Maximum

States 

37 71% 80% 10% 100% 

Has your Board conducted other types of proactive enforcement eflorts to assess 

compliance withpatient counseling requirements? 

Number of Percent States 

No 29 63 

Yes 17 37 

ITotal 

Whatis the most recent year for whichyour Board has compiled statisticsconcerning 

complaintsand disciplinaryactivities? 

1996 

1995 

1994 

Total 

Number Percent of States 

19 54 

15 43 

1 3 

35 100 

Years reported were a combination of CY, FY, and 

YTD. 

Percentages may not add to 100 due to rounding. 

A-4 
For that year, please provide the following: 

A) Number of Complaintsof Any Type Made to the PharmacyBoard: 

Number of Mean Median Minimum Maximum States 

30 269 106 6 1576 

B) Number of ComplaintsInvolvingPossible Violationsof PatientCounseling 

Requirements: 

Number of Mean Median Minimum Maximum States 

20 22 12 0 119 

Whatwouldyou say is the primary source of complaintsinvolvingpossible violationsof 

patient counseling requirements? 

IConsumers I 28 I 76 

ILaw Enforcement I 3 I 

IPharmacists 

IPercentages may not add to 100 due to rounding. 

For the prior year, please completethefollowing: 

A) Number of Complaintsof any Type Made to the PharmacyBoard: 

Number of Mean Median Minimum Maximum States 

28 228 89 0 1236 

A-5 
B) Number of ComplaintsInvolvingPossible Violationsof PatientCounseling 

Requirements: 

Number of MeaIl Median Minimum Maximum States 

21 15 8 0 84 

For the most recent year for whichyour Board compiled statisticsconcerning complaints 

and disciplinaryactivities,please provide thefollowing: 

A) Number offlnal, formal disciplinaryactionstaken againstlicensed pharmaciststhat 

were based at least in part onfailure to adhere to patient counseling requirements. 

Number of Mean Median Minimum Maximum States 

34 7 3 0 80 

B) Please indicatethe number of such actionsthathave resulted in revocations, 

suspensions,fines, reprimands, or other disciplinaryactions. 

Fines 

Reprimands 

Other 

Suspensions 

Revocations 

Total 

Number of States 

Percentages may 

Number Percent of Actions 

176 50 

129 36 

24 7 

16 5 

9 3 

354 100 

responding = 23 

not add to 100 due to rounding. 

A-6 
Please indicatehow much of an obstacle each of thefollowing represents to e$ective 

enforcement of patient counseling requirements: 

Not an Minor 

Categories Ranked by States Obstacle Obstacle 

Complexity of the law 

(4:) 

Higher priority enforcement 

issues for the board (167%) 

Opposition from professional 

community (2&j 

Lack of resources (136%) 

Limited complaints/referrals to 

the board (219%) 

Percentages may not add to 100 due to rounding. 

Very Moderate Significant Significant Totals 

Obstacle Obstacle Obstacle 

(lG%) 

(Iii%) 

(Z%) 

(lCt%) 

(lit%) 

Please indicatehow much of an obstacle each of thefollowing represents to pharmacist 

compliance to patient counSelingrequirements: 

Not an Categories Ranked by States Obstacle 

Lack of commitment from 

pharmacy owners/management (9:) 

Underutilization of supportive 

personnel in pharmacies (136%) 

Limited reimbursement for 

counseling services (2%) 

Inadequate computer software 

(167%) 

Insufficient counseling skills of 

pharmacists (167%) 

Percentages may not add to 100 due to rounding. 

Minor Moderate Significant Very 

Obstacle Obstacle Obstacle Significant Total 

Obstacle 

(A%) (2&j (4& (I:%) 

(2o9%) (&) (209%) (4:) 

(9:) (lZ%) (3&j (46) 

(4:) (2F%) (7;) Vh 

(7;) (00) 

A-7 
Please indicatehow much of an obstacle each of thefollowing represents to patients who 

wish to receive pharmacist counseling: 

Categories Ranked by States 

Lack of patient knowledge 

about the counseling 

requirement 

Lack of pharmacist availability 

Prescription area not 

conducive to communication 

between patients and the 

pharmacist 

Insufficient patient access to 

basic prescription drug 

information 

Very Not an Minor Moderate Significant Significant Total 

Obstacle Obstacle Obstacle Obstacle Obstacle 

10 6 

(4;) (li%) (22 %) (4%) (13 %) (lZ%) 

(21%) (136%) (456) (4%) (4:) (HE%) 

(0:) (136%) (3Z) (4:) (136%) (2%) 

(9:) (32) (4& (167%) (0:) (lCZ%) 

Percentages may not add to 100 due to rounding. 

A-8 
APPENDIX B 

THE MEDGUIDE EFFORT 

For about 30 years. the Food and Drug Administration (FDA) has sought to enable 

consumers to receive more and better information about the prescription drugs they use. 

Its first such effort was a requirement that written information be provided that made clear 

the dangers associated with certain inhalation products. Toward the end of the next 

decade, it proposed a rule that would have required drug manufacturers to include patient 

package inserts for 10 classes of drugs. In 1982, the FDA withdrew the proposed 

regulation in response to concerns about over-regulation. 

Throughout the 1980s and into the 1990s FDA continued to stress the importance of 

consumer education, particularly through the issuance of written materials that were 

distributed with the drugs and made clear the best ways to take a drug and any side effects 

associated with it. It conducted a number of surveys of patients assessing how often they 

were provided such information about their prescription drugs. 

By the mid-1990s, FDA found that the rate at which such information was being provided 

had increased. But it felt that the progress was not nearly fast or thorough enough, given 

the continued high incidence of adverse drug events and patient noncompliance with 

prescribed drug regimens. Further, continued advancement in computer technology, it 

felt, made the provision of consumer information more efficient and economical than it 

would have been a decade or two ago. 

Thus, in August 1995, it once again proposed a rule entitled, “Prescription Drug 

Labeling: Medication Guide Requirements.” Widely cited as the “MedGuide” 

requirements, they called for manufacturers to produce written product inserts for certain 

categories of drugs posing particular dangers, encouraged the preparation and distribution 

of written information for all drugs, and established performance standards for both the 

distribution and quality of written information. 

As the performance standard for distribution, FDA proposed using the pertinent goal 

already established by the Public Health Service in the “Healthy People 2000” set of 

performance goals. The goal set forth is that by the Year 2000 at least 75 percent of the 

people receiving new prescriptions would be given useful written patient information. For 

the Year 2006, the goal is 95 percent. 

As the performance standard for determining what is “useful” information, FDA identified 

7 components which must be satisfactory. They are: scientific accuracy, consistency with 

a standard format, nonpromotional tone and content, specificity, comprehensiveness, 

understandable language, and legibility. 

B-l 
In August 1996, Congress, as part of the FDA appropriations bill, included a provision 

giving private sector groups 120 days to “assess the effectiveness of current private-sector 

approaches used to provide oral and written information to consumers” and to submit to 

the HHS Secretary an alternative to FDA’s Medguide plan. If an alternative plan that was 

acceptable to the Secretary was not produced, then FDA would be authorized to proceed 

in carrying out its MedGuide requirements. 

The Secretary appointed the Keystone Group, a private firm, to appoint and develop a 

steering committee comprised of diverse interests. The 34 member Committee met on 

numerous occasions and produced its action plan in December 1996. In January 1997, the 

Secretary approved the plan, which essentially looks to the private sector to foster 

progress in providing more and better written information about prescription drugs to the 

public. It sets forth the performance target that action plan will result in “the distribution 

of useful information to 75 percent of individuals receiving new prescriptions by the year 

2000 and to 95 percent by the year 2006. In determining the kind of information that 

would be regarded as “useful, ” it supplants FDA’s 7 criteria with 11 distinct components. 

With respect to oral counseling, the plan makes three recommendations. The first is that 

State pharmacy boards “continue their efforts to assess the quality of oral counseling 

provided by pharmacists in all settings in which prescription medicines are provided to 

ambulatory patients” “This assessment,” it adds, “should include the nature and 

effectiveness of the ‘offer to counsel’ made to the patient.” 

The second recommendation is that “a National Symposium on Oral Counseling by 

Pharmacists about Prescription Medicines be convened in 1997 by pharmacists’ groups, 

including NABP [the National Association of Boards of Pharmacy]. . . The purpose of 

this conference would be to assess the effectiveness of current oral counseling guidelines 

. . . and to assist State boards of pharmacy and NABP in enforcing existing guidelines 

and developing new guidelines, if necessary, for oral counseling.” 

Finally, the third recommendation is that FDA “should continue to conduct periodic 

consumer surveys to determine whether consumers are receiving oral counseling when 

they obtain their prescription medications. ” It adds that for oral counseling “the 

appropriate mechanism to assess the quality of the information. being provided to 

consumers by pharmacists, as well as the offer to counsel, should be developed by 

individual State boards of pharmacy.. . ” 

B-2 
APPENDIX C 

COMPLETE COMMENTS ON DRAFT REPORT 

In this appendix, we present in full the comments we received on the draft report. 

C-l 
Public Health Service 

Food and Drug AdminIstration 

Memorandum 

From: Deputy Commissioner for Management and Systems 

Subject: FDA Responseto OKi Draft Repott: ‘State Pharmacy Boards’ Oversight of Patient 

Counseling Laws,” OEM-9790040 

To: June Gibbs Brown, Inspector General 

Department of Health and Human Services 

We have revlewed the OIC Draft Report: ‘State Phirmacy Boards’ Oversight of Patient 

Counseling Laws,” and offer the following comments: 

I­

* For over thirty years, FDA has sought to enable consumers to receive more and better 

information about the prescription drugs they use. We have recently conducted the fifth in 

a series of surveys of both oral and written information being given to consumers with their 

prescription medications, Our latest survey indicales that the level of verbal counseling is 

still very low and although written information being given to consumers has increased, 

only 6770 of patients reported receiving wrltten information from their pharmacists. 

We strong/y agree with your proposal to have the Food and Drug Administration 

collaborate with state pharmacy bpards by collecting data about the usefulness of written 

information offered to patients by pharmacists, FDA could then assessthe usefulness of 

this information In accord with the criteria established in the Prescription Information 

Action Plan developed by a divorse steering committee made up of health professionals, 

consumers, patient advocacy groups, drug information vendors and the pharmaceutical 

industry. This Plan was accepted by the Secretary on January 13, 1997. This joint effort 

would help FDA carry out its respon’sibility to measure progress being made in offering 

useful written information to patients. 

. 

FDA is committed to the public-private sector efforts in Healthy People 2000 where the 

objective is that at least 75% of individuals receiving new prescriptions be given useful, 

written information. FDA will continue to facilitate both oral and written information 

giveri to consumers by health professionals. Our Office of External Affairs has ongoing 

efforts to help make consumers and health professionals aware of the importance of this 

information. One of the new initiatives in this area is focused on providing information to 

women and encouraging this population to begin a dialogue with their health care 

professionalsabout medications, 

. 
-- 

Page 2 -June Gibbs Brown, IG 

We agree with the premise of your Draft Report that encouraging health care professionals 

to improve th&r communications with consumers about prescription medicines will 

Improve health outcomes and reduce pieventable, medications-related problems. We also 

encourage activities to Increase consumer undarstanding and awareness of the benefits and 

availability of written prescription medicine information, and the importance of oral 

communication between health care professionals and patients. 
DATE: 

TO: 

FROM: 

SUBJECT: 

AUG-4 l9m 

June GibbsBrowa , 

InspeotorGenetnl 

Office of ImpectorGeneral(OIG)DraftReport:%ate PharmacyBoards’ 

Oversight of PatientCounselingLaws,” (OEI-Ol-97+0040) 

We reviewed the above-referencedreportwhichassessesstate pharmacyboards’ 

oversight of patient counselinglaws. 

Our deeailedcomments on the reportiecotmcndatiotu arc attachedfor your 

consideration. Thmk you for the opportunityto reviewandcommenton this sport. 

Attnchment 

. 

. 

. 
. 

.. Comments_ofthe HealthCareFinan&! t’HCFAl.on 

gffh of boector GeneraltOJO\ DraftRSQ@Z 

“State Ph- Boards’Oversirrhtof PatientCOUllSW ’ Laws’: 

[OEI-01-97-00040~ 

OIG Recowdation 

The Food and Dnq Admhistrati~n(FDA) shouldcollaboratewith state pharmacy boards 

to collect surveydataon the usefulness of writteninfomation of&redto patients 

receiving new prescriptions. 

We defer to FDA for commentson specificinitiatives. 

DIG Recwen datioq . 

HCFA should assist with state effortsto edorcc the Medicaidpatient counseling 

mandate. 

JI;ICFARespons 

We concur. WCbelievethere is an urgencyin addressingthe problemsstates are having 

in their efforts to monitorcomplianceof the OmnibusBudgetReconciliationAcr of 1990 

(OBRA 1990)patientcounselingmat&c. Problemssuch as lack of resources,reliance 

cmsporadic pharmacy board inspectionvisits, and the lack of cmsumer educationon 

their right to be counseled,have hamperedthe effectiveaess of the pharmacyboard&ate 

Medicaid agency &ersight of patientcounseling laws. ’ a 

\ 

&iditional cw em on Q&$xmted Initiatives: 

OIG lpjtiative #l 

Develop and hsesr s@teProg& Towarda PatientCounseiingPerformanceObjective 

. We concur. HCFA is conmimd to assistingstates.in fully adhexingto Medicaidpaticnt 

cpun~elir~gnquirements, and meeting that objectiveby year 2000. By doingso, atleast 

75 percerit of individualsreceivingnew prescriptionswill be giveuuseful patient written 

infinmation. We mustrecognize&is objective is not mentionedin the OERA 1990 law, 

nor is it mentioned in XCFA regulations. Starescan only be encouragedto use the 
9 

II 

. . 

objective as a yardstick to improvethe effectivenessof patient counselingeach year, 

HCFAwill assist states by amendingthe Dmg UtilizationReview(DUR)Annual Report 

insttmions to coUectmore specificinformationregarding the compliance.monitoring

efforts that have beenpetformed and how effectivethese effortshave been Questions 

concen&g tbc progressof each state in tnonito~& compliance,m well as the level of 

compliancein the phermrcies with the counselingrequiremeats,will be includedin 

future repon iastructions. This informationwill be &ared with states tn HCFA’s 

Medicaid DURNewsletter. 

Sincemany Medicaidk&iciaries read poorly and/ormay XIOZunderstandthe need 

enoughto&e time reading driigi&fmatioq it is crucialto have on! counseling 

’stmdards as weI]. Mso, since most repeatMedicaiddrugusers are elderly and/or 

chronically ill or disabled,hop&@ high oral standards8re at-b&abledue to a 

traditionallymore cooperativeclienteleand t&fact that constantmedicationis a viial 

part of thtirdaily routine. CounseIingthese individualsare tht top priority. 

. . . OK I@attve #2 

Develop ouidttincs on Stae Oversightof the FederalPatient CounselingMandate 

J-XFAResnonse 

We concur. HCFAis committedto Federal-statepamship. Therefore,WCwill solicit 

input fhm states on the practicesthey find most effective,and distributethis information 

to all pharmacy boards. 

OS3kliti8tive##a . 

Facilitate the Conveniq of a NationaiSymposiumon Oral Counselingby Pharmacists . 

We ccmm. AlthoughFederal leadershipis necessaryin facilitatingthis meeting, 

Congrosshat not sppropriatedthe rescues necessaryto lead this �ndcawr. 

Nevertheless,HCFAis Attrycommittedto assistingstate uversightof the counseling 

requirements,ad thereby improvingthe quality of care of MedicaidPatients. WC 

believe includingthe activitiesdescribedabovewill assist us in accomplishingthis 

oiijectivc~ 
.. 

. 

, ‘* 

. 

AUG I 5 1997 

TO8 InspectorGeneral,DHHS 

FROM: Acting Deputy A' inistr&tor 

$" 

SUBJECTt Office of Insp 

PharmaoyBoar 

(CIN: OEI-OlIn response to an inform 

report, we are providing 

This report walginformal 

HRSA appreciatesthe oppo 

subject draft report.The 

informationon a subject 

importantfor health aare 

patients about prescripti 

reduce medicationmisadve 

One issue that wae not ad 

a barrier to counselingp

communicationskills of p 

addressedis the age, gen 

that exist in providing 

The OIC may want to consi 

referencesfor inalusfon 

Manasse HR Jr. Medic 

z&adventuring as an 

Pharm, 1989:46:.92 

Manasse HR Jr. Medic 

driig misadventuri 

Pharm, 1989:46:1 

Johnson JA, Bootman 

Mortality, Arch Int 

With regard to the chai 

report are plausiblefr 

odd from the perspectiv 

draft text presumestha 

boards to enforce Feder 

ent Counseling Laws/ 

st f-orcommentson the subject 

commentsas listed below. 

ded to HRSA on July 10, 1997, 

ofessionalato communicate with 

medicationsto improveoutcomes and 

ssed in the report that may serve as 

ents is the need to improvethe 

the following published refiources as 

the draft report8 

on use in an imperfectworld. 1: drug 

sue of public policy. Am J Hosp 

Drug-RelatedMorbidityand 

'Med/vol155, Ott 9, 1995. 1949-1956. 

bility,the premises of the 

1 perspeotivs,but they look 

in a State government, The 

lear duty of State pharmacy 

There is no dire& 
. 

. The national symposium pro osed on page nine would be best 

conv8ne.d by HCFA and FDA, csawing on the perspectives of the 

other agencies mentioned, 

It would also be helpful tcl the reader if an extract of the 

relevant portions of oBRA 3990 (Sea, 4401(g)(z)) were attached. 

. . ‘i 

.. 

Page 2 - InspeatorGeneral,DHHS 

duty to do so. Instead,there is an indirsot ahain of 

responsibilitythat must be effectivelytransmittedfrom HCFA and 

a State Medicaid agency t4 that Gtate'spharmao

draft report should prob

responsibility on the sta 

the phamacy board to per 

pharmacy counseling. The 

relative merits of hazd.1’ 

f* 

cost-effectivein combati 

regulationsshould take 

activities. 

boards' con 

board. The 

alarify this, plaoxng the 

Medioaidagency to deputise and fund 

rm the requisitetasks with respect to 

this report might discuss the 

forcement"versus soft "educatio!P 

e for the subsequentdiscussionsof 

nter-professionalpolicy controversy 

dnotea 6 and 28 explainsthe softer 

by most boards;this report should 

sy in the backgroundexplanations, 

on pages four through seven, the text 

sent occura through,"shopping 

T,.poseas patientsto assess 

ints, particularlyregarding 

nt, should be more fully 

sumes that such lrshopping'Bis 

minor quasi-violationslike failursEndnote 18 might profit&blybe ' 

on, and the existinganecdote 

sumes that HCFA counseling 

igh priority among enforcement 

hould reflect State pharmacy 

of drug storage,abuse of drugs, 

are more dangerousproblems that 

e for saarae enforcement 

. The national symposiumpro osed on page nine would be best 

conv8ne.dby HCFA and FDA, csawingon the perspectivesof the 

other agenciesmentioned, 

It would also be helpful tclthe reader if an extract of the 

relevantportions of oBRA 3990 (Sea,4401(g)(z))were attached. 

I 
a ye 

Introduction,Eaokground, 

in misused drugs and the 

therapy have be 

billion a year." 

figure, so the.$lO 

to be corrected if they a 

Contained in the findings 

are different numbers for 

'1 46). It is unclear as to * 

Page 8, paragraph 1 state 

committedto public-priva 

2000 in at least 75 peroe 

prescriptionsbei 

People 2000 obj 

objective 12.8 "Increase 

of people who receiveuse 

for new presorip 

the Keystone gro 

committee "did 

counseling will 

unclear if the 

oral counselin 

Page 3 - InspectorGenerai,DHHS 

Page i ExecutiveSummary,Baakground,states “They also add as 

muah as $100 million to health care co8ta.e Page 1, 

tates Wosts associatedwith the waste 

its of not receivingintended 

to acaount for as much as $100 

llion appearsto be the correct 

n the ExecutiveSummarymay need 

referringto the same cost figure. 

pages six and seven of the report 

e respondingboards (i.e.,45, 44 and . ich number is oorrect. 

"'TheHHS Secretaryand the FDA are 

effortsthat will result by the year 

of the individualsreceivingnew 

ful written information."Healthy 

1 counselingas well by its 

at least 75 percent of the proportion 

1 informationverbally and in writing 

esaribersand dispensers,~~Although 

me to a consensus,the steering 

e very importantrole that oral . ving the goals of this Plan.11It is 

r only written informationor if 

. is attached. If AppendixE 

the text should so state. 

as that text is somewhatur 

concretenessof an "Action 

the real Action Plan that t 

attached and properly aitei 

be made in Endnote 6 as we1 

On page 0, paragraph5, li ? 7‘ referenceis made to a, ll..,presorfptioninformati I actionplan approvedby the I-MS 

Seoretary (see AppendixA)4I The AppendixA in the draft I have 

ie a collectionof statists:a1tables titled lqSurveyof State 

Pharmacy Boards,,'and no IIf::eSCription InformationAction Plan" 

Yl?heMedguideEffort," is intended, 

kf so, furtherediting is indicated, 

:learand the lVcriterialtand the 

?lan” are not obvious in it. If not, 

>e authorshad.in mind should-be 

The appropriatecorrectionshould 

i. 
. 

Page 4 - h8peatOr Cm&a;, DHHS 

0 

Staffquestionamay be referred to MiahaelKerbstih the Division 

of Grantsand ProcurementNanagementon 443-5256. 

ThomasvG. Morford 

* 

co: Mr. Comigan, W/attachment . Mr. Ge&ifig,k/6ttachn\ent 

Mr. Clark,w/attachment

Dr. Paavola,w/attachment

Dr. Robimon, w/.attaoment 

Dr. Mahoney;w/a'ktakant

Dr. Snyder,w/attiachmnt 

.3 
National Association of Boards of Pharmacy 

700 Busse Highway �  Pad Ridge, IL 60068 

����������������  �  Fax: 347/696-0124 

July 18.1997 

. June Gibbs Brown 

Inspector General 

Office of Inspector General 

Department of Health & Human Services *-

Washington, DC 20201 

RE: Draft I.nspcctioa Report “State Pharmacy Boards’ Oversight of Patient 

Counseling Laws” 

Dear Ms. Brown: 

The National Association of Boards of Pharmady (NABP) represents the state boards of 

pharmacy in all jurisdictions of the United States, Guam, Virgin Islands, Puerto Rico, 

nine provinces of Canada, three states in Australia, and New Zealand. NABP assists its 

member boards in developing, implementing, and enforcing uniform standards for the . 

purpose of protecting the public health. 

The NAJ3Pcompliments the Office of the Ins@xztorGeneral for researching this critical 

patient care area and concurs, in general, with tht findings and subsequent ’ 

recommendations. The state boards of pharmacy and NABP also agree with the Office of 

the Inspector General’s assertion that plikrmacistscan help to reduce adverse drug 

reactions and the misuse of prescription drugs by “providing patients with oral and 

written information.” 

Studies conducted by NABP confirm the finding that too many patients, for many of the 

reasons noted in the report, are not being counseled about their prescription medications. 

We believe that counseling is a necessary responsibility of the pharmacist; a 

responsibility of the individual pharmacist, who must be competent and willing to 

counsel, and employer, who must provide the resources and support, to provide 

counseling to patients. 
June Gibbs Brown 

July 18,1997 

Page 2 

SPECIFICOMMENI$ 

. FINDINGS 

SIote pharmucy boards have played an ktive role in explaining ahd urging pharmackt 

compliance with State patient counseling laws. 

The report accurately notes the efforts of the state boards of pharmacy to educate 

pharmacists, through a number of methods and avenues, about patient counseli laws 

and urge their compliance with these laws. The efforts of the boards in this area were 

exceptional and clearly demonstrated that state boards of pharmacy perform meaningful 

functions beyond licensing and discipline. 

State boards, through NABP, did develop the Patient BiIl of Rights (Attachment A) to 

educate patients about their rights under the new counseling laws. Although we agree 

with the report’s conclusion that these efforts were less than those expended to educate 

pharmacists, the reason for such disparity is clearly resources and not an unwilliigness to 

. doso. 

Xhe boar&’ ertfarcement of the counseling laws has been minimal. 

Although the actual disciplinary actions taken by state boards of pharmacy for failing to 

provide counseling may seem low, the activity of the boards of pharmacy to ensure that 

patients are counseled is significant, As noted in the report, a number of boards of 

phaunacy use in.formaIconferences or written warnings to increase the compliance of 

phaqmacists with state counseling laws/rules. These activities often do not result in a 

formal discipliiary action, such as the revocation or suspension of a pharmacist’s license. 

Data from NABP’s Disciplinary Clearinghouse indicate that the state boards of pharmacy 

are taking action in situations where counseling is not occurring or medication errors 

could have been prevented if counseling was provided and more actions than noted in 

previous years. We agree with the finding of the report that more effort needs to be 

devoted to this area and the use of “shoppers” increased, 
June Gibbs Brown 

July 18,1997 

Page 3 

The report accurately identifies a major obstacle which impedes the ability of state boards 

of pharmacy to be more effective .in enforcing counseling laws - tiding. This factor is, 

in NABP’s opinion, the single most limiting obstacle. We cannot emphasize enough the 

importance of state governments and Federal agencies providing additional resources to 

the state boards of phatmacy to enforce counseling laws properly and thereby, better 

protect the public health and welfare. Without adequate and additional funding, the state 

boards of pharmacy arc restricted to.a reactive regulatory stance and limited to 

responding to complaints or taking actions when violations occur and patients injured or 

inappropriately served. 

RECOMMENDATIONS 

The FDA should cokborate with State pharmacy boa& to collect survey data on the 

usefulness of written information offered to’individualr receiving new prescriptions. 

NABP strongly supports this recommendation. Through the NABP, the state boards of. 

pharmacy have worked collaboratively with the FDA on a number of projects and 

enforcement initiatives. We believe that a cooperative partnership which recognizes the 

separate authority of the state boards of pharmacy and FDA and creates a collective 

regulatory synergy will improve the enforcement of counseling laws and patient care: 
June Gibbs Bro& 

JuIy 18.1997 

Page 4 

The HCFA should/crcifitate Stale effom b enformthe Medicaidpatient comsefing 

mandatk 

Develop and assess State progress toward a patient counseling performance 

objective. . 

Although NABP agrees that a performance objective needs to be established and 

recognizes that HCFA bears responsibility for the Drug Utilization Review 

provisions of the Medicaid program, we would urge that any such 

recommendation recognize the authority of the state boards of pharmacy and the 

report’s recommendation be revised to extol HCFA to develop a pefiormance 

objective in concert with the state boards of pharmacy. NABP would be glad to 

assist in this regard and help to represent the state boards of pharmacy. 

Develop guidelines on State oversight of ihe Federal patient counseling 

mandate. 

NABP does not agree that Federal standards for ensuring enforcement will 

necessarily assist states. If the guidelines are not developed iu conjunction with 

the states and do not include Federal funding, the states will be faced with 

additional requirements and no means to sati@ them. The problems with lack of 

enforcement noted in this report will be further exacerbated. The state boards 

should set the standards and adopt these standards as a national, uniform Policy as 

they have done so with other requirements and patient care standards. This can be 

accomplished through the collective efforts of the states and NABP. The 

standards for enforcement once developed, could then be recognized by HCFA 

and additional funding from HCFA provided to the states to ensure that the 

standards can be implemented. 

�  Facilitate the convening of a nakonai symposium on oral counseling by 

pharmacists. ’ 

NABP stronglysupports this recommendation. 

. 
June Gibbs B&n 

July 18,1997 

Page 5 

Thank you for the opportunity to comment on this report. If we can be of any tkther 

assistance to you, please do not hesitate to call upon me. 

. _. RespectfUy yours, 

NATIONAL ASSOCIATION OF 

T 

Executive Dircctor!Secre&q 

Attachment A: Pharmacy Patient’s Bill of Rights 

-5 
-.. --. -. 

Attachment A , 

.- Pharmacy Patiexxt's 

EWLL OF RIGHT’S 

PREAMBLE 

IN ACIWOWLEDGMEii OF an 1ncreasIngly infdrmed and cost-conscious public, and with spe$lc 

Seferencc to the proliferation and complexity of drug therapy. Pharmacists have recognized the need for : 

‘Pharmacy Patient’s Bill of Rights.’ To reinforce their commitment to protect the health and well-being of the1 

xxients. Phzmncists wed a common reference to describe their covenantal relationship with the public. II 

rcugnidon of the public’s tight to freedom of choice and the Pharmacists’ professional fehrlonship with thei 

,atients, tbls document delineates: 1) the patient’s rights and rtiponsibilities with respect to appropriate drug 

herapy. and 2) the patient’s responsibilities and Pharmacist’s riehrs with respect to the quality ofseenrice 

>tovided. Such a charter is setforthwith and shall be known‘as the “Pharmacy Patient’s Bill of Rights.’ 

PATIENT RltGHTS/PH~RMACIST’S RESPOL’bIBILITIES 

hztiunts have tba dgbt to expect tbefr’pbawnacfst to: 

1. Be professionally competent and adhere to accepted standards of pharmacy practice. 

1. Treat them with dignity, consistent with profesbional standards for all patients, regardless of manner oi 

%tyment. race, sex, age. nationality, religion, disability. or other discriminatory factors. 

3. hct in their best interest when maklng phatmaceurical care decisions. 

4. Serve as their rdvoate for appropriate drug thenpy and to make reasonable efforts to recommend 

alternative choices in coordination with the patlenw’ other health care providers. 

3. Wtintain their medical, records, keeping them confidential. using them routinely to maximize their care 

And making them available to the patient for review upon request. 

6. Provide counseling, using the methods appropriate to the patients’ physlcal, psychosocial and intellec­

. tual stm.ls. 

7. Have their prescriptions dispensed and pharmacy services provided at a pharmacy of their choice In 

an atmosphere which allows for confidenclal communication and in an environment which is privat& 

properly lighted, well ventilated and clean. 

8. Monitor drug therapy within their medical regimen forsafety and efficacy and make reasonable effotu 

to detect and prevent drug allergies, adverne reactions, contraindications or inappropriate dosage. ’ 

9. Monitor their compliance and proper drug use and institute remedial interventions when necessary. 

10. Prominently post the Pharmacy Pattent’s Bill qf Rights. 

PATIENT RESPONSIBILITItiS/P~ARMACIST’S RIGHTS 

III orderJ3wpbarntacfsts to meet rhifr responsfbilfttes co pdfenta as setforrb t 

tbfs “Pharmacy Patien;‘s Biff of Rt’ghts,apatients are responsible for= 

1, Provfding the peison;rl demographlcs, rhedical history and payment ,mechanism including thttd patty 

payor lnformatlon necessary for Pharmacists to lndlviduallze care, the method of its provision and its 

reimbursement. 

2. Implementing the drug therapy regimen conscientiously and reporting their clinical response ;o their 

pharmacist, especially untoward reactions and any changes in their health status and medical care, 

3. Cooperating with the pharmacist and authorizingtheir physician or other health care practitioner to 

release the medical infotmationtiecessaryfor the pharmacist to practice responsibly. 

I 

. ‘. . .s 
.citizen .* Advocacy Center

A lhining, Research,and SupportNetworkfor Publtc llllll Memberaof lZeu1t.htkm Regrclatorycrnd Governing Boa&a

June 12, 1997 

Ms. June GibbsBrown 

InspectorGeneral 

Departmentof Healthand HumanServices . 

Wash&ton, DC 20201 

Dear InspectorGeneralBrown: 

Thankyou for askingfor our comment8on your draftreport, “StatePharmacy 

Boards’Oversightof PatientCounselingLaws”, The CitizenAdvocacyCenter (CAC)is 

a 501 (c) (3) trainingand supportcenterfor publicmemberswho8erveon statehealth 

licensingboards, includingboard8 of pharmacy, CACparticipatedas a memberof the 

SteeringCommitteefor the CollaborativeDevelopmentof a Long-RangeActionPlan for 

the Provisionof UsefulPrescriptionMedicineInformationthat submittedits ActionPlan 

to SecretaryShalalain December1996. CACtook a leadrole in promotingthe need for 

more and better oral cowlseling, In a February26, 1997letterto SecretaryShalala,CAC 

stated, “Certainlywithregard to pharmaoy,t&ereis plentyof legi8lationalreadyon the 

books in the form of OBRA1990requirements(underHCFAjurisdictio&nd lawsin 

over 40 state8(understatepharmacyboardjurisdiction)requirmgpharmaciststo offer to 

counselpatients. However,the actualdeliveryof oral counselingneedsto be improved.” 

The new OIGreport reinforceswhatmanybelievedto be the case-that state’ 

patientcounselinglawsare not working. Whilerecognizingthat the state board8face 

major obstacle8to the successfulimplement&ionof patientcounselinglaw8(lackof ’ 

resourcesfor enforcement,economicsof pharmacypractice,andlimitedpatientdemand), 

the report also finds-that“theboards’enforcementof the counselinglawshave been 

minimal”. This findingcannotandniustnot be ignored. In three shortparagraphs,the 

report pinpoint8the problemof poor enforcement,as follows: 

‘They havemadelittleuse of “shopping”visits, wherebyboardrepresentativespose a8 

patientsto assesscompliancewithcounselingrequirements. In the past year, only 17 of 

46 re8pondingboard8madesuchvisits. Generally,they weremadeonly to pharmacies 

againstwhicha complainthad been lodged, 

1424SixteenthStreet,NW0Suite1059Washington, DC20096 

PHONEi(202) 462.1174 FAX (202) 2656664 
f

-* 

They have relied on inspectionvisits as the majormeaneof enforcement.Suchvisit8are 

conductedwith widelyvarying degreesof frequency. At best they offer limited 

Opportuniti&$orassessingthe extentand adequacyof counseiing. 

They have taken fewfinal , formaldisciplinaryactionsinvolvingviolation8of patient 

coweiing hW8. Of the 354 action8takenduringthe paatyear by 23 reportingboards, 

208 (59 pent) were in just 3 stfites.” 

That bring8 u8 to the recommendations.We agreewitheachof the 4 

recommendation8in the report - ono addre8Sed to FDA, the other 3 to HCPA. WC 

believe, however,there is a needfor a fifth recommendation- one addressedto the state 

boardsof pharmacy. Sucha recommendationshouldstatebhmtlythat while them is a 

goodunderstandingof the diff~culticsthe stateboards,facein enforcingpatient 

counselinglaws, that cannotbe used as an excusefor lax enforcement.Unenforcedlaws 

breed a contemptfor governmentthat eats awayat the fabricof our society. Legislatures 

in 46 stateshave determinedin their wisdomthat citizensneedto receivegoodoffersto 

be counseled,andwhenthey acceptsuchoffers-toreceivehigh qualitycounseling. They 

have directedthe boardsof pharmacyto see to it that theselaws are enforced. All the 

sympathyand understandingin the world concerningthe diffculties the boards face 

enforcingthese lawscannotexplainaway the abysmalrecordto date. A strong statement 

to this effect in the final report wouldbe appropriate. CAChas madeoverturesto the 

NationalAssociationof Boardsof Pharmacyto help bring aboutbetter enforcement,and 

we havebeen pleasedwith the positiveresponseof NABP. ButNABPis not the 

enforcementagency, The state boards,individually,mustbe held accountable. A 

statementto that effectby the OIGwouldbe mostwelcome. .I 

Da It4 ’ )A. Swankin, Esq, m esident

2 
Buytn Up � CongressWarch � Critical Mats � Global Trade Watch - Health Rescarch Group � Litigvion &up 

Jogn Uaybmok. President 

Public Citizen’s Health Research Group’s Comments On: 

State Pharmacy Boards’ Oversight of Patient Counseling Laws (OEI-01-97-00040) 

Submitted - June 19.1997 

Public’s Citizen’s Health Research Gmup sincerely appreciates the opportunity it 

has been given to comment on this topic of vital inkrest to the health of prescriptlon drug 

consumers. 

Since 1972, Public Citizen’s Health Research Group has been promoting researchbased, system-wide changes in health care policy as well as advocating for the appropriate 

prescribing and use of prcsoriptian drugs. The Health Research Group teMles before 

Congress and petitions the Food and Drug Administration (FDA) on issues such as 

banning or relabeling of drugs and the misleading advertising of prescription And nonprescription drugs by their manufacturers. Our publications help consumers make 

informed decisions about the health care they receive and the drugs they are prescribed. 

This draft report identifies “mismedication,” a term with no known definition, as a 

major national problem and promotes the irrational notion that failure of consumers to 

always be compliant (obedient) with their physicians’ prescribed drug regimens is a major 

factor contributing to adverse drug reactions. This ambiguous articulation has led to an 

erroneousanalysis and to unprqductivc recommendations that do not address the urgency 

or the seriousnessof the most pressing problem faced daily by millions of .prescription drug 

~WMWWW- ~E~w~LWII~drug Induced injury. 

The focus of this draft report is improving consumer access to useful prescription 

drug information1 by effective implementation and enforcement of existing laws requiring 

pharmacists to counsel consumers about their prescriptions. it is Public Citizen’s view, as 

a member of the steering committee responsible for developing the Acfhn Plan for the 

Pm&ion of U&id Prescription Medicine lnfomationZ (The Action Plan), that because of 

the small proportion of consumers receiving oral counseling about the risk& of their 

prescriptions and the dooumented inconsistent and unreliable performance by pharmacists 

in warning of potentially fatal drug interactions, oral counseling cannot be considered a 

priority for consumers. if remains our view that written information meeting The Action 

Plan guidelines is the only source of accurate, consistent, comprehensive, and objective 

Ralph Npdcr, Fuundcr 

IGOO20rh Sttcct NW � Washingwn, DC 20009-1001 - (202) 58&1000 

-+3- Q Pmcdnnm%lw?sC 
information that-a majority of consumersmay receive in the foreseeable future about the 

risks of their prescriptions and how to protect themselves from potential harm. 

AM 77 years’ of waiting consumers still have no reliable source of objective information 

about the risks of prescriptlon drugs, how to recognize adverse effects and what steps to 

take should an adverse reaction appear. Written drug information Is the essential “safety 

net” that consumem urgently need to protect themselves from the inappropriate prescribing 

and dispensing of prescription drugs. 

Wewill concentrate the remainder of our comments on (I) the preventable problems 

facing prescription drug consumers: (2) pharmacisls as counselorsy(3) the distribution of 

oral and written information in .pharrnacles; and (4) who is the last line of defense in 

protecting consumers from preventable drug induced injury? Our recommendations will 

urge the Health Care Financing Administration (HCFA) to require that Medicaid 

beneficiaries receive useful written prescription drug Information meeting the guidelines of 

The Action Plan. To ensure effective impiemendion there must be strong independent 

oversight and quality assurance by the.FDA. 

PREVtNTABLE DRUG INDUCED INJURY: A NATIONAL PROBLEM 

This reports use of the term mismedication has obscured the true nature of the 

problem faced daily by prescription drug consumers, the preventable causes of drug 

induced injury; the adverse drug reactions resulting from inappropriate prescribing”*‘16e7and 

the improper dispensing&Oof prescriptions. Compounding these risks is the distribution of 

inadequate,‘* sometimes dangerous written drug information” by pharmacists. 

By citing the failure of consumers to be compliant (obedient) to their physicians’ 

prescribed drug regimens as a major coritributing cause of adverse drug reactions, this 

report has blamed the victims and has failed to grasp the dimension of the public health 

problem facing prescription drug consumers. In the absence of useful prescription drug 

information, the present situation faced by consumers, to promote consumer obedience 

is irrational and potentially dangerous.‘* 

The pharmaceutical industry has numerous opportunities to promote the use, over 

use, inappropriate use, and potential benefits of prescription drugs by spending millions 

of dollars advertising to doctors, pharmaclsls, and increasingly in direct to consumer 

advertising. Drug industry backed promotion of consumer c6mpliance without ensuring 

consumer access to useful drug information only serves the interests of corporate sates, 

not the public’s health. Citation 27 in this draft report illustrates precisely why there is an 

urgenf need for accurate, consistent, comprehensive, and objective drug information for 

consumers meeting the guidelines of The Actiorl Plan. The vldeo tape referred to in this 

citation and its accompanying printed materials were distributed to members of The Action 

Plan steering committee by the American Pharmaceutical Association. These materials 

were funded by a major drug company, Pfizer Incorporated, and over promote consumer 

-2-
compliance while minimizing the communication of risk information to consumers by 

pharmacists. Public Citizen finds it disturbing that citation 27 suggests this video tape be 

used as a training vehicle in a national symposium on oral counseling for pharmacists. 

PHARMACISTS AS COUNSELORS 

Public Citizen recognizes the ability and dedication of the many pharmacists who 

dally contrIbute to high quality health care by counseling consumers about the risks of their 

drugs. We also recognjze the key role that pharmacists can play in reducing the incidence 

of preventable drug induced injury by providing cunsumers with Useful drug information. 

However, we doubt the commitment of the owners and managers of pharmacies, 

particularly large, corporate chain pharmacies in providing a workplace environment, 

including adequate staffing, to allow pharmacists to counsel consumers about their 

prescription drugs. In this report, 23 of the 45reporting State Boards of Pharmacy (51%) 

cited the lack of coinmitmcnt from pharmacy owrle&management as a significant or very 

significant obstacle to pharmacist compliance with consumer counseling laws. 

The 34 of 45 reporting State Boards (71%) that felt limited reimbursement for 

counseling services was a significant or very significant obstacle to pharmacist compliance 

with counseling laws batter reflects the level of commitment of pharmacy owners, 

managers, corporations and the trade groups representing their interests. In the 

deliberations that created The Action Plan the commitment of the pharmacy trade groups 

representing the interests of pharmacy owners and corporations was to reimbursement, 

no oversight, and no effective enforcement of the plan, not in contributing to a solution for 

a serious public health problem. If there were a professional F;ommltment by pharmacy 

trade groups, then consumers would have had access to useful written drug information 

17 years ago. 

Public Citizen has little confidence that the community pharmacists dedicatgd to 

providing quality care to prescription drug consumers will be allowed to do so in the current 

market driven environment for health care. 

THE UlSlRlBUTlON OF ORAL AND WRI-I-I-EN INFORMATION IN PHARMACIES 

This report documents the minimal effects of the 1990 Omnibus Budget 

Reconciliation Act (OBRA ‘90) and subsequently enacted state laws to ensure consumer 

access to useful drug information by requiring pharmacists to offer to counsel consumers 

about their prescriptions, Results of FDA conducted national telephone surveys of 

randomly selected prescription drug consumers between q982 and I 99613substantiates 

this finding. 

Pharmacist oral counseling to consumers concerning side effects (adverse effects) 

Increased approximately three fold between 1982 and 1996, from eight percent to 23 

-3-
percent respectively. During this same period oral information about a drug’s precautions 

increased two fold, from 13 percent in 1982 to 26 percent in 1996. However, the 

distribution of written Information in any form, regardless of quality, increased over four fold 

from 16 percent in 1982 to 71 percent in 1996. This figure of 71 percent approaches the 

goal of 75 percent mandated by The Action Plan, Only about one-quarkr otConSUmelS 

are receiving any oral information that could aid in reducing their chances of avoiding 

preventable drug induced injury while almost threequarters of consumers are receiving 

wriierl informatlon, though of doubtful quality. 

At the present rate Public Citizen estimates it will take pharmacists over 40 years 

to provide the same proportion of consumers with oral information about the precautions 

(26%) and side effects (23%) of their drugs as those receiving written information in 1996 

(71%). We view It as highly unlikely that the.extent of oral counseling in pharmacies will 

adequately address the problem of preventable drug induced injury in the foreseeable 

future. TBecause pharmacists can now distribute some form of written information to 71 

permnt ot prescription drug consumer?, and consumers have already absorbed this cost 

through higher prescription prices, responsible public health policy dictates that HCFA must 

make its highest priority improving the poor quality of the information that is now being 

distributed by pharmacists and ensuring that IO0 percent of Medicaid beneficiaries receive 

useful written drug information meeting the guidelines of The Action Plan for the Revision 

of Useful Prescrlpfion Mecfieine lnfomtafion as soon as possible. 

WHO IS THE LAST LINE OF DEFENSE? 

This question was prophetically answered by John Gans, Execufiie Vice Presidient 

of the American Phartiaceutical Association when he was quoated in the troubling U.S. 

News & World Report investigation, “Danger at the Drugstore”8, that patients have little 

choice but to look out for themselves and that ‘You have to manage your own care.” Until 

a rational system of health care is adopted in the U.S., in the current chaos’of competing 

corporations, health care consumers are the last line of defense against preventable drug 

induced InJury. .. 

This draft report cites two widely publicized studies**’ showing the extent that 

pharmacists warn consumers of possibly fatal drug interactions. In the survey of 245 

pharmacies in seven cities, more than one-half of the pharmacists failed to warn of 

potentially serious drug interactions.b A similar survey conducted in Washington DC by 

researchers from the Georgetown University Medical Center found that more than 30 

percent of pharmacists filled prescriptions,for two potentially fat-4 interacting dtIJgs without 

any warning.’ Clearly, the logic of consumer noncompliance with prescribed regimens as 

a cause of adverse drug reactions is fallacious. If the pea@? participating in these two 

studies had been actual prescription drug consumers and had been compliant with the 

4-
directions writ& on their prescription containers the results may have been catastrophic. 

The Georgetown University study9 used prescriptions for terfenadine (Seldane) and 

erythromycin to assess the extent that pharmacists warn consumers of possibley fatal drug 

interactions. Of the 10 pairs of prescript&s filled without comment by chain pharmacies, 

nine were accompanied by written information, Six of these nine suggested checking with 

the doctor if terfenadine and eMtir0mycir-t were prescribed togethst. while three contained 

the general statement, “Report any other drugs you take or diseases you have.” The 

written information distributed by these nine pharmacists lacked the contextual information 

nerzssary to adequately warn consumers of the seriousness of ,taKrngterfenadine with 

erythromycin and thus is dangerous. Distributing written information that does not 

adequately warn of a potentially life threatening risk can only be crxxidered as professional 

dereliction by these pharmacists. 

1 

RECOMMENDATlONS 

The first recommendation of this draft report that State Roar& of Pharmacy 

collaborate with the FDA by collecting written information distributed to prescription drug 

consumers for quality evaluation by the agency is pointless. The FDA is required to 

evaluate If the distribution and quality goals for us&~1 written drug Information mandated 

by The Action Plan are achieved by 2000. 

Given the Department of Health and Human Services (DHHS) and the FDA’s stated 

commitment to ensure that consumers will receive useful prescription drug information we 

can find little purpose for the second recommendation, other than oral counseling must be 

addressed, because of its ill advised inclusion in the legislation’4 establishing the process 

that created The Action Plan, OBRA ‘90 was enacted seven years ago to address the 

issue of oral counseling and has had minimal effect. When enacted, this legisl&tion 

required that all Medicaid recipients receive an offer to counsel, and subsequently most 

states required that all oonsumers also receive an offer to counsel by pharmacists. By 

lowering the performance objective of 100.percent established in OBRA ‘90 to parallel the 

distribution objectives for written information in’The Action Plan, 75 percent by 2000, and 

extending a deadline that is already four years old to 2000 is tacit acknowledgment of the 

failure of OBRA ‘90 to provide consumers with useful drug information. 

Following a recommendation made in The Actlon Plan, this draft report recommends 

the convening of a national symposium on oral counseling by pharmacists to be facilitated 

by HWA. However, HCFA need not follow recommendations that are unlikely to produce 

a productive result. The obstacles to consumer counseling are well understood, but the 

issue for consumers has remained for the past 17 years access to useful written 

prescription drug information. 
Public Citizen recommends the following actions be taken by HCFA: 

1. Require that all Medicaid beneficiaries receive useful written prescription drug 

information meeting the agreed upon guldelines of The Action Plan with each new 

and refill prescription. 

2. Establish a deadline of January 7998 for meeting the distribution requirement. This 

would be one year after commercial information vendors agreed to The Action Plan 

guidelines for useful written drug information. 

3. Guarantee, strong independent oversight and quality assurance by the FDA. This 

would include giving the agency authoFityto remove written information not meeting 

The Action Plan guidelines from distribution and fining pharmacy owners and 

corporations for distributing written information not meeting The Action Plan 

guidelines. -1 

Sincerely, 

Larry D. Sasich, Pharm.D., M.P.H., FASHP 

Research Analyst, 

Public Citiien Health Research Group. 

. 
ENDNOTES . . 

1.Throughout our comments we will define “useful prescription drug information” as 

information that enables the consumer to use the drug properly and appropriately, 

receive the maximum benefit, and avoid harm BSdefined in the Action Plan for the 

Provision of Useful Prescription Medicine Information presented to Donna E. Shalala, 

Secretary of the Department of Health and Human Sertices, December 1996. 

2. Action Plan for the Provision of Useful Prescription Medicine Information, presented 

to Donna E. Shalala, Secretary of the Department of Health and Human Services by 

the Steering Committee for the Collaborative Development of a Long-Range Action 

Plan for the Provision of Useful Prescription ‘Medicine Information, December 1998. 

3. Department of Health and Human Services, Food and Drug Adminisjration. 

Prescription drugs: patient package inserts requirements and draft guideline patient 

package inserts. federal RegisterVol. 45 No. 179, September 12,1980, page 60754. 

4. Avom J, Chen M, Hartley R. Scientific versus commercial sources of influence on the 

prescribing behavior of physicians. American Journal of Mecflcine 1982;73:4-8. 

5. Willoox SM, Himmelslein DU. Woolhandler S. inappropriate drug prescribing for the 

community-dwelling elderly. Journal of the American Medical Association ?994;272: 

292-296. 

6. Carlson AM, Morris LS. Coprescriptlon of terfenadine and erythromycin or 

ketoconazole: an assessment of potential hah. Journal of the American 

Pharmaceutical Association 1996:NS36:263-269 and Thompson D, Oster G. Use of, 

terfenadine and contraindicateddrugs. Journalof fhe Am&can Medical Associafion 

1996;275:1339-1341. . 

7. Moore TJ. Deadly Medicine, New York: Simon & Schuster; 7995. 

8. Headden S, Lenzy T, Kostyu P, Roebuck K,‘Locke L, Burgower Hordern B. et 31. 

Danger at the drugstore. U.S. News & WorjcfRepoti, August 26,1996. 

. 9. CavutO NJ, Woosley RL, Sale M. Pharmacies and prevention of potentially fatal drug 

Interactions. Journal of fhe American Medical Associafion 1996; 275:1086[letter]. 

10. Sasich LD, Wolfe SM. Deficiencies in patient information leaflets concerning 

gastroi@testinal complications of nonsteroidal anti-inflammatory drugs. Journal of 

General Internal Medicine 1997;12(suppl 1):79[abstract], and Department of Health and 

t-luman Servlces, Food and Drug Administration. Prescription Drug Product Labeling; 

Medication Guide Requirements, Proposed rule. Federal Register Vol. 60, No. 164, 

August 24.1995. pages 44193 and 44104. 

-7-
1I. Public Citizen obtajned drug information leaflets from a Washington DC pharmacy 

in late 1996 containing dangerous FDA disapproved-unapproved use information. A 

leaflet for short-acting nifedipine capsules (Adalat, Procardia) contained use information 

for hypertension. The use of short-acting nifedipine capsules to treat hypertensive 

emergencies was disapproved by the FDA in 1985. Current approved labeling for this 

drug warns in bold type that this form of nifedipine should not be used to treat 

hypertension for safety reasons, A leaflet for bromocriptine (Parlodel) contained 

information on the use of this drug to stop breast milk production in new mothers who 

choose not to breast-feed, The use of bromocriptine for this purpose was disapproved 

by the FDA because of heart attacks and strokes in young mothers. 

12. Wynne HA, Long A. Patient awareness of the adverse effects of non-steroidal antiinflammatory drugs (NSAlDs). f3f#s!1 Journal of Clinical Phamtacology 1QQ6:42:25% 

256. 

13. Morris LA, Tabak ER, Gondek K. Counseling patients about prescribed medication: 

1Zyear trends. Medical Care 1997 (in press). 

14. Agriculture, Rural Development, Food and Drug Adminisfration, and Relafed 

Agencies Appropriations Ad, 1997, PL 104-I 80 (August 6, 1996), fitle VI, Section 601, 

Effective Medication Guides. 
-- 

American 2215 Ccnstitution Avenue. NW 

Pharmaceuticat Washmyton, DC 20037-2985 The National Professional 

Association (202) 628-44 10 Fax (202) 783-235 1 Society of Pt7arrnacists 

-

August 6,1997 

The Honorable June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

5250 Wilbur J. Cohen Building 

330 Independence Avenue, S.Wi 

Washington, D.C. 20201 ’ 

Dear Ms. Brown: 

Thank you for the opportunity to comment on the draft report, State Pharmucy Boar& 

Oversighzof Patient CounselingLaws (OEI-Ol-9740040). 

This report is remarkably timely. The past year has seen an unprecedented surge in the 

attention given by the Congress, the Secret of Health and Human Services, the 

pharmacy profession, pharmacy store owners, and consumers themselves to the important 

problem of improving drug information provided to consumers. Your report is likely to 

contribute significantly to greater understanding of the need to solve this problem, and of 

the barriers that must be overcome before consumers can be assured of routinely receiving 

essential diug information from pharmacists. 

Mismedication as a National Problem. The report does a fine job of citing several key 

studies documenting the human and financial cost of suboptimal prescribing, dispensing, 

and patient adherence to their prescribed drug regimen. While it is customary to cite the 

most recent studies to establish the nature and extent of a social problem, this approach 

may inadvertently lead policymakers to believe this problem has been only recently realized 

by health services researchers. Nothing could be further from the truth. 

In fact, the great morbidity and mortality associated with poorly-managed pharmacotherapy 

has been documented in numerous studies for many years. For example, eight years to the 

day prior to the publication in Archives of Inter& Medicine of the paper entitled “DrugRelated Morbidity and Mortality” by Johnson and Bootman, which reported the estimate of 

an expert pharmacist panel, JAMA published a similar estimate by an expert medical 

school panel entitled “Assuring the Quality of Health Care for Older Persons.” The JAMA 

authors placed the “adverse effects of drugs” among the top five greatest priorities for 

quality improvement in care of the elderly - along with four of the greatest sources of 

morbidity and mortality in our society: congestive heart failure, hypertension, pneumonia, 

and breast cancer. 

Citing some of this older research will help to establish the grim reality that public and 

private policy may fairly be criticized as producing much more talk lbarl action toward a 

solution. An annotated bibliography of severa such studies is provided as an attachment. 
Pharmacists as Counselors. One of the bright spots in this otherwise dismal picture of 

persistent preventable morbidity and mortality has been the dramatically improved 

performance of pharmacists in providing drug information to consumers. These 

educational services are a promising part of any effort to reduce the human and fiscal cost 

of mismanaged drug therapy. The pharmacist’s contribution goes far beyond the written 

handouts discussed in the recommendations section of draft report. 

Surveys performed at several intervals over the past fifteen years have shown direct 

pharmacist counseling of consumers has improved from 20 percent in an FDA survey 

conducted in 1982 (Federal Register, Volume 50, No. 164, page 44191) to 51 percent of 

consumers responding to the National E%armacyConsumers’ Survey, conducted by the 

American Pharmaceutical Association (APhA) in 1996. 

The draft report is correct in its contention that these services, when provided, are 

valuable. Some readers of your report may not be aware of the evidentiary basis for this 

assertion, and for this reason we suggest that the report add numerous other citations to 

studies that confirm the effectiveness of the pharmacist as a source of drug therapy patient 

education and management. A brief annotated bibliography of several recent studies is 

attached for your reference and use. Copies of these articles are available upon request. 

Board Enforcement of Counseling Laws. Use of the “shopping” technique is a 

potentially powerful tool for identifying inadequate counseling practices. The advantage of 

this approach is that it can discover directly the experience of the typical consumer who 

receives products and services in a pharmacy., if such “shoppers” are not identifiable as 

such. 

“Shoppers” utilized for this purpose tiust be well-trained in counseling techniques, and 

must be well-supervised, to ensure validity and equity in their findings. A critically 

important aspect of such training should be in assessing the workplace circumstances of 

pharmacist employees, who may simply be unable to counsel given the level of staffing and 

the volume of dispensing they are required to perform by their employer. For these 

reasons, it may be helpful for State pharmacy boards to have a “best practices” model to 

inform their efforts in making wise use of this quality monitoring tool. APhA has been 

collaborating with the National Association of State Boards of Pharmacy (NABP) and 

appropriate physician and consumer organizations to cosponsor a conference to debate and 

develop guidelines, such as a model oral counseling assessment mechanism, and would 

urge the OIG and the Department to provide financial support for this conference. 

Finally, APhA believes it makes sense, given the scant resources of pharmacy boards, to 

reserve such resource-intensive methods as “shopping” for investigating pharmacies and 

pharmacists about which complaints h.avebeen filed relating to the quality of counseling 

services. 

2 
Regulatory pressure on pharmacies and pharmacists to increase patient counseling may 

produce some small incremental reallocation of resources to improve pharmacist 

counseling. But it would be a mistake to expect a “crack down” on pharmacists or store 

owners to produce many benefits for the public because margins in the retail sector of 

pharmacy are extremely thin and getting thinner for reasons beyond the control of the 

pharmacist and many store owners. Already, financial pressures have forced 

approximately a thousand indep&dent retail pharmacies to be sold or closed each year in 

the early 1990s. even without the additional pressure of a call by regulators to reassign 

pharmacists to counseling duties: 

These realities are so broadly accepted as to be reflected not only in comments from store 

owners and pharmacists but, as the draft report indicates, in comments from most 

pharmacy regulators, who understand that the disincentives for counseling are formidable. 

What is needed is a concerted effort by those representing all stakeholders to convince 

payors, consumers, and store owners of the value of counseling services. The draft report 

can play a stronger role in awakening public policymakers to these realities of the 

marketplace. 

Barriers to Patient Counseiing. The OIG report correctly identifies the three major 

barriers impeding full implementation of section 4401(g) of the Omnibus Budget 

Reconciliation Act of 1990 (OBRA ‘90). 

Relative imnortance of the Barriers Identified bv the OIG. In presenting these, we believe 

it makes the most sense to present these in order of the frequency with which they were 

mentioned by the State pharmacy board officials surveyed by the OIG: 

(1) Economics of Pharmacy Practice (cited by about 75 % of respondents); 

(2) Limited Patient Demand (cited by about 60%); and 

(3) Lack of Resources for Enforcement (cited by just SO%,despite the direct incentive 

to emphasize this problem which might be ascribed to State board officials). 

This sequence more accurately reflects State officials’ awareness of the fundamental 

diseconomies dominating today’s marketplace which punish, rather than reward, 

pharmacists for patient counseling activities. State officials understand that it would be 

both inequitable and ineffective to attempt to reverse these powerful economic disincentives 

solely by imposing ever greater financial or other civil penalties. 
patlent Demand. APhA’s 1996 National Pharmacy Consumer Survey assessed the views 

of a random sample of over 980 consumers who reported at least one visit to a pharmacy in 

the preceding six months. The survey validates to some extent the State board officials’ 

perception that there is limited consumer demand for pharmacist counseling services, but 

paints a somewhat more complex picture. Consider the following evidence from the 

survey: 

�  The most important reason given by cousumers for choosing their pharmacy is 

“convenience” (37% of respondents) - specifically, how close the pharmacy is to home 

or work (33%): This is more than twice the percentage identifying either “price” 

(18%) or ‘service” (16%) as the reason for their choice of pharmacy. 

�  Results from this survey revealed that between 76% and 93% of consumers believe that 

their needs for most dispensing-related services are already being met by their 

pharmacist. This high level of satisfaction with-the current level of pharmacists’ 

service indicates consumers believe pharmacists are already providing essential 

counseling services when these are needed, and may feel no need to ask for what is not 

already being provided. 

�  The survey does provide some evidence that about 20% of pharmacy consumers desire 

more contact with their pharmacist to discuss their prescription drug therapy, but 

significant barriers interfere with their obtaining these services: 

b Nearly half of those expressing a desire to have greater access to their pharmacist 

are daunted by the perception that the pharmacist is “too busy” to speak with them. 

Over one-third of consumers have difficulty distinguishing pharmacist(s) from other 

pharmacy personnel. I 

Finally, the services consumers most often report they’d like to receive from the 

pharmacist are the services least likely to be performed at the time of dispensing: 

About 70 percent of consumers want the pharmacist (1) to remind customers by 

mail or telephone that it is time to have a prescription refdled, and (2) call to find 

out how the prescription is working. This suggests the greatest unmet demand for 

pharmacist counseling services are those which are provided to the consumer while 

they are not in the pharmacy. 

�  Relatively few consumers are willing to pay the entire cost of enhanced counseling 

services out of pocket, suggesting that these services will not be used at an optimal 

level by the consumer until the expense is covered by health plans in the same manner 

as other health care services; 

4 
The National Pharmacy Consumers’ Survey does supply evidence that most cousumers are 

open to a more intensive level of service from their pharmacist. Over two-thirds of 

consumers would view “somewhat favorably” or “very favorably” a new, higher level of 

service in which the pharmacist would provide more counseling before and after the filling 

of prescriptions, as well as engage in greater interaction with their physician to facilitate 

any needed adjustments to their drug regimen. Fully 31% of pharmacy consumers 

expressed a willingness to switch pharmacies to gain access to this higher level of service, 

if there was no cost to the consumer. 

Economic_Barriers. The report accurately depicts the dilemma of 

pharmacists and their employers in the current marketplace. There are two major 

economic barriers standing in the way of consumers receiving more and better counseliug 

from their pharmacist. Both are the result of drug pmducf reimbursement reductions that 

are squeezing pharmacist counseling services out of the pharmacy. These barriers deserve 

more explanation in the report, even though it is unlikely that the market will embrace 

higher drug product reimbursement as a solution. -

In the past, pharmacists were able to finance patient counseling activities from the margin 

they received from selling pharmaceuticals. Demands from within the profession and from 

the Federal and State governments for greater pharmacist counseling have coincided with 

the increasing domination of the market by third party payors, who have been increasingly 

successful in demanding drug product discounts from pharmacists. By 1995, a senior Blue 

Cross/Blue Shield Association official was able to report that reduced reimbursement to 

pharmacies accounted for fully 60% of all savings achieved by the Association in managing 

the drug benefits offered through the Federal Employees Health Benefits Program 

(FEHBP). 

Such reimbursement reductions inevitably spur changes in pharmacy practice. In a market 

dominated by slim and declining margins, pharmacies that can dispense more prescriptions 

per hour are economically advantaged over those which cannot. Pharmacies where 

pharmacist employees spend time on non-revenue generating counseling of patients can 

only expect to benefit if patients select that pharmacy on the basis of service - which the 

draft report has correctly identified as an area of soft consumer demand. 

One remedy for this situation would be for private and public sector payors, such as the 

Federal and State governments - through the FEHBP, State employee, Medicare, and 

Medicaid programs - to pay for some or all pharmaceutical care services. Data from the 

Washington State Medicaid Drug Use Review demonstration project show that paying 

pharmacists for counseling activities easily pays for itself out of drug product costs alone 

if payment is tied to documented, clinically necessary changes in drug therapy which have 

been suggested to the physician by the pharmacist. Additional savings from reduced 

morbidity and mortality may reasonably be expected, though that demonstration project 

was not designed to capture evidence of such savings from reduced health care utilization. 
A large controlled study done by the University of-Southern California and Kaiser 

Permanente (publication pending) found that either of two different models of pharmacist 

counseling significantly reduce hospitalizations compared to the control group. The two 

models of pharmacist counseling were the “OBRA ‘90” counseling model and Kaiser 

Permanent&s own counseling program, in which pharmacists are instructed to focus 

wunseling efforts on high risk drug products and related patient populations. 

Patients who received “OBRA ‘90” counseling services from Kaiser pharmacists were 

interviewed for the USC/Kaiser study about the frequency of wunselii they received. 

These patients reported receiving “OBRA ‘90” counseling interventions at over twice the 

rate of patients served in community pharmacies during the course of the study. It appears 

that these Kaiser pharmacists, serving under the same legal obligations as their professional 

colleagues in community pharmacies, provided a substantlally higher level of service. 

Why? The most likely explanation for this is that Kaiser pharmacists enjoyed a significant 

infusion of resources in the form of more technicians and management encouragement and 

support for counseling. Financial incentives support effective counseling by Kaiser and its 

employee pharmacists, inasmuch as staff receive bonuses if their efforts result in reduced 

preventable health care utilization. 

The existence or absence of financial incentives for pharmacy owners and pharmacists has 

a powerful impact on whether certain pharmacy practice innovations produce more 

counseling service, or simply result in reduced professional staffing. For example, the 

draft report suggests that increased use of technicians, as well as automation of the 

dispensing aspect of pharmacy practice, can theoretically free up the pharmacist to provide 

counseling services. This is certainly true, however, if the owner of the pharmacy does not 

realize revenue from the services of the pharmacist, the owner has an incentive to replace 

the pharmacist with automation and/or technicians and pocket the savings, rather than 

continue to pay the pharmacist to provide unpaid drug therapy management to consumers. 

A related barrier deserving mention and follow up study is that some State pharmacy 

boards limit, by regulation, the USCof technicians that might be used to free up the 

pharmacist for counseling services. 

Additional Studies on Economic Barriers. Several studies confirm the impression of the 

State pharmacy board executives surveyed by the OIG that there are significant economic 

barriers to pharmacists spending time with patients. These studies should be cited in the 

report: 

�  Barnes et al, in a 1996 survey of 400 pharmacists published in The Annals of 

Phamcotherupy found that the most significant barriers to implementation of the 

6 
OBRA ‘90 patient counseling requirements were (1) excessive workload; (2) lack of 

financial compensation; (3) patients’ attitudes (e.g., lack of interest in counseiing). 

�  Rupp et al, in a 1992 study published in Medical Cure, documented that there is a 

statistically significant inverse relationship between greater volume of prescriptions 

dispensed and the amount of pharmacist .oversight and counseling of those 

prescriptions. The authors noted in this study: 

“this fmding suggests that pharmacists’ willingness or ability to intervene in 

problematic new prescription orders decreases as the volume of prescriptions they 

dispense per hour increases. ” 

�  According to the May 8, 1995 issue of Forbes magazine, “the growing power of 

[insurance plans] to dictate the price of prescription drugs has slashed retail pharmacy 

gross margins to 25%) from 35% in 1989. That’s $5.5 billion carved right out of 

operating profits. ” Declining per unit profits create a powerful incentive for pharmacy 

owners to increase volume and improve the productivity of their employee pharmacists 

in performing those activities for which the store receives revenue. Thii directly 

affects the time available for counseling. 

�  Results from the 1996 APhA National Pharmacy Consumers’ Survey indicate that 

nearly 60% of those desirjng greater access to their pharmacist reported that these 

health professionals appear “COObusy” to talk with them. 

Additional Recommendations Regarding Federal Govetnment Action. The draft report 

properly notes that there is a substantial Federal interest in improving the quantity and 

quality of pharmacist counseling of consumers. The draft recommendations fall short of 

addressing the key economic incentives discussed in the body of the report, however. 

APhA has several additional recommendations to suggest, described below. 

(a) Federal Costs Associated with Drug-related Morbiditv & Mortality. An important 

Federal interest which is not mentioned is the cost of s&optimal drug therapy which is 

charged to Medicare, Medicaid, FEHBP, CHAMPUS and other insurance or health plan 

arrangements sponsored or financed by the Federal Government. Although the report 

mentions the scientific and clinical literature (in&ding estimates from FDA) which 

estimate substantial costs associated with preventable drug-related morbidity and mortality, 

these costs should be projected to the large patient populations covered under these health 

care programs, even if these estimates are only based on the approximate drug utilization of 

these populations. 

7 
(b) Economic Incentives to Counsel are Annronriate and Timelv. APhA believes the OIG 

report should recommend that fee for service programs, beginning with those operated or 

funded by the Federal Government, provide financial incentives for these services as well. 

These payments couid be conditioned on documentation that a prescriber has accepted a 

clinically-relevant drug therapy change recommended by a pharmacist. Such a program 

could be put into place today, using existing electronic claims coding standards. The entire 

objective of such a program should be to reduce drug-related morbidity and mortality in 

key populations of interest to the Federal Government, such as older Americans. 

(c) Oral CounselinP Obiectives bf the Secretarv. The draft report discusses the,HHS 

Secretary’s support for increased distribution of written information to pharmaceutical 

consumers. It is important to note that the Secretary has for several years embraced the 

Health People 2000 goals, which were updated in 1995 to call for -

“[Objective 12.81 Increase to at least 75 percent the proportion of people who 

receive useful information verbdy and in writingfor new prescriptions from 

prescribers or dispensers. ” [emphasis supplied] 

APhA believes this report will help encourage pharmacy boards, consumers, pharmacy 

owners and pharmacists to begin an unprecedented cooperative effort to enhance the quality 

and frequency of pharmacist service received by the public. Once again, thank you for 

your consideration of the views of America’s pharmacy profession. 

\L9l(n A. Gans, PharmD 

Executive Vice President 

Enclosures 

JAGldgs 

8 
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American 2215 Constitution Avenue. NW 

Pharmaceutical Washinglon, DC 20037-29% The National Professional 

Association (202) 628-4410 Fax (202) 783-2351 Sociefy of Pharmacists 

OLDER AMERICANS NEED PHARMACEUTICAL CARE SERVICES 

PROBLEM: Preventable drug related problems inflict substantial morbidity and 

mortality, costing Medicare, employers, and health insurers biIIions every year. 

Drug-Elated morbidity and mortality are estimated to cost $77 bihion in the 

US. each year. Archives of Internal Medicine, October 1995. 

Adverse drug events are among the top five greatest and most preventable 

threats to the health of elderly Americans, after Congestive Heart Failure, 

Breast Cancer, Hypertension, & Pneumonia. JAMA, October 1987. 

Twenty-eight percent of hospitalizations of elderly Americans are due to 

noncompliance with drug therapy (1 I %) and adverse drug reactions (17%). 

Archives of Internal Medicine, April 1.990. 

Patient compliance with drug therapy deteriorates as the number of drugs taken 

by the patient increases. Because 25% of the elderly use three or more drugs 

daily, the elderly are particularly at risk. The Gerontologist, March 1994. 

Of elderly patients taking three or more chronic prescription drugs, over onethird are re-hospitalized within six months of discharge from a hospital. Twenty 

percent of readmissions are due to drug problems, principally undertreatment, 

noncompliance, and adverse drug reactions. Medical Care, October 1991. 

32,000 senior citizens each year suffer hip fractures from falls caused by 

adverse drug events. - New England Journal of Medicine, February 1987. 

The inappropriate use of prescription drugs is a potential health problem that is 

particularly acute for the elderly. The U.S. General Accounting Office analyzed 

1992 Medicare data and found that about 5.25 million of noninstitutionalized 

elderly Medicare enrollees used at least one drug identified as generally 

unsuitable for elderly patients given that safer drugs exist. - GAO, July 1995. 

In an average year, 32,800 people die from pneumococcal disease and 20,000 

die from influenza-almost all elderly. Medicare spends as much as $1 billion 

for treatment of influenza-associated diseases each year. Seventy-three percent 

of the elderly have never been immunized for pneurnococcal pneumonia; 49% 

of the elderly have not been vaccinated against infIuenz.a. GAO, June 1995. 

Infhrenza vaccination reduced hospitalization costs an average of $117 for each 

of the 41,418 elderly people immumzed during a three year period. - The New 

England Journal of Medicine, September 1994. 

PROBLEM: Perverse incentives. Until pharmacists are paid for pharmaceutical care, 

their livelihood depends on faster dispensing of prescriptions, making it uneconomical 

for them to spend time with patients & physicians solving drug therapy problems. 
.- 2 

PHARMACEUTICAL CARE IMPROVES PATIENT CARE AND OUTCOMES 

0 Pharmacist teaching and monitoring of drug therapy in a group of AfricanAmerican asthma patients reduced emergency department (ED) visits by over 

70% and hospitalizations by 80%) compared with no significant reduction in ED 

visits and a 50% reduction in hospitalizations in a control group receiving “usual 

care from local physicians. ” [Kelso TM, et al, Am Jml of Med Sciences, June 

lf=l 

0 Asthma patients who are high users of hospital emergency departments 

experienced an 80% decline in ED visits after ongoing pharmacist counseling. 

[Pauley TR, et al, Annals of Pharmacotherapy, Jan 19951 

0 Geriatric consumers, who account for about 30% of drug use in the U.S., were 

able to reduce the number of drugs taken and achieve significantly better 

compliance with their drug regimen after counseling by pharmacists, with no 

increase in costs. [Lipton HI,, and Bird JA, Gerontologist, March 19941. 

0 Ambulatory patients used significantly fewer health services, saving over $640 

a year in health costs per individual, as a result of comprehensive pharmacist 

counseling, [Borgsdorf LR, et al, Am Jrnl of Hosp Pharm, March 19941. 

0 Community pharmacists counseling patients identified and resolved problem 

drug therapy in -2% of new prescription orders, with about 28% of these 

judged capable of causing “patient.ham” if the pharmacist had not intervened. 

[Rupp MT, et al, Medical Care, Ott 19921. 

0 Physicians accepted about 83% of pharmacists’ recommendations for drug 

therapy changes in an ambulatory care clinic. For 80% of recommendations, 

“improvement or resolution of a patient’s disease state” occurred. cost 

reductions were noted. [Lobas NH, et al, Am Jml of Hosp Pharm, July 19921. 

0 Medicare would realize net savings of $280,000, 139 hospitalizations, and 63 

deaths per 100,000 errrollees each year if it paid pharmacists to advise enrollees 

to be vaccinated for influenza, according to an estimate based on an experiment 

in North ~Carolina. [Grabenstein JD, et al, Medical Care June 1992.1 

0 The addition of a clinical pharmacist to a hospital-based geriatric clinic reduced 

the number of medications associated with an adverse drug reaction by 42%, 

and produced direct cost savings of $54/patient, in the first six months. 

(Phillips SL, Carr-Lopez SM. Am Jrnl of Hosp Pharm, May 19901 

0 Hypertensive patients who received pharmacist counseling were more compliant 

with their treatment, and achieved better blood pressure control, than a control 

group. [McKenney JM, et al, Circulation, Nov. 1973; McKenrtey JM, et al, 
.- 3

Contemp Pharm Pratt, Fall 19781_ 

0 Relative to a control group, diabetic patients who received pharmaceutical care 

were more compliant in keeping clinic appointments, made fewer medication 

errors, saw symptoms improve in 5 of 8 variables measured, and had a lower 

incidence of.hospital admissions and “medical contacts”. [Sczupak CA, Conrad 

WF, Am Jml of Hosp Phaxm, Nov 19771. 
National Association of Chain Drug Stores 

Thomas &I. Ryan . . Chairmnn of the Board 

Ronald L. Ziegler 

President & CEO 

f

f 

June 30,1997 

The Honorable June Gibbs Brown 

Inspector General 

United States Department of Health and Human Services 

Room 5250 Cohen Building 

Washington, DC 20201 

RE: OEI-0 l-97-00040 

Dear Ms. Brown: 

On behalf of the National Association of Chain Drug Stores (NACDS), I am pleased to 

include the attached document which provides our perspectives on the drat? report, “State 

Pharmacy Boards’ Oversighis of Patient Counse&g Laws. n We appreciate the 

opportunity to comment on this draft report. 

NACDS membership consists of more than 130 retail chain community pharmacy 

companies. Collectively, chain community pharmacy accounts for the largest component 

of pharmacy practice with over 86,000 pharmacists. Chain community pharmacy is 

comprised of 18,500 traditional chain drug stores, over 6,000 supermarket pharmacies 

and nearly 5,000 mass merchant pharmacies. The NACDS membership base operates 

nearly 30,000 retail community pharmacies with annual sales totaling over $110 billion in 

prescription drugs, over-the-counter (OTC) medications and health and beauty aids 

(HBA). Chain operated community retail pharmacies fill approximately 6(! percent of the 

more than 2.5 billion prescriptions dispensed annuahy in the United States. 

Thank you for the opportunity to comment on this report. Please call on us if we can 

provide any additional information to your office about this or other issues. 

Sincerely, 

Officer 

413 North Lee Street, P.0. Box 1417-D49, Alexandria, Virginia 22313-1480 Phone: 703-549-3001 Edx’ 703-836-4869 
COMMENTS OF THE NATIONAL ASSOCIATION OF CHAIN DRUG STORES 

DRAFT REPORT 

“STATE PHAkpvlACY BOARDS’ OVERSIGHT OF PATIENT COUNSELING LAWS” 

General Overview 

Consumers of prescription medications are entitled to a meaningfui offer to be counseled, 

consistent with state law. Interaction with the pharmacist should help consumers better 

understand how to take their medications. 

NACDS also believes that consumers are entitled to receive comprehensive written information 

about their prescription medications that reinforces and supplements the oral information 

provided to the consumer by health professionals. Such written information can also serve as a 

reference source for the consumer during the course of prescription use. 

The OIG report clearly identifies current issues relating to state board of pharmacy enforcement 

of patient counseling laws. However, NACDS believes that the report describes the situation as 

a “glass half empty” rather than a “glass half full.” While there are clearly strides to be made in 

improving the quality and quantity of oral counseling, FDA’s own data illustrate the progress 

that has been made to.date by pharmacists in providing oral counseling to consumers. 

While the oral counseling provisions were included in Medicaid legislation enacted in 1990,the 

law required that these provisions take effect January 1,1993. Since that time, consistent and 

appreciable strides have been made in improving the quantity and quality of oral counseling. In 

fact, FDA reported that 32 percent of consumers reported that they received oral counseling in 

1992, which increased to 42 percent in 1994and 47 percent in 1996. 

Therefore, substantial progress in complying with oral counseling laws has already been made by 

pharmacy in just three short years, in spite of multiple challenges to the development of this 

practice. As with any significant and substantive change in the practice of a health professional, 

a period of adjustment must be expected by all parties involved, including consumers. 

Moreover, the success of oral counseling depends upon a complex dynamic of multiple factors in 

the health care system working well together. These include boards of pharmacy, pharmacists, 

consumers, pharmacy benefit managers (PBMs),and other thii parties, all of whom have a 

vested interest in its success, and all of whom have to contribute to making it successful. 

The practice, economic and social barriers and challenges that must be addressed to increase 

m&.ningful oral counseling by pharmacistsare described below. 

. 

ce m: Many state boards impose outdated and antiquated practice requirements on 

pharmacies, requirements that shift pharmacists’focus to prescription dispensing rather than 

consumer interaction. That is, many state boards impose unrealistic technician-to-pharmacist 

ratios, and some states require that only pharmacistsperform non-judgmental tasks that could be 

performed by well-trained technical personnel. NACDS is working to revise these antiquated 

and outdated practice acts so that pharmacistscan spend more time with consumers on such 

National Association of Chain Drug Stores 

June 27.1997 

Page 1 
activities as oral counseling. This movement will also be facilitated by the evolution of 

automated pharmacy dispensing systems. 

An additional practice barrier is the fact that pharmacists are often unaware of the intended use 

of the prescription medication, or the patient’s diagnosis. Knowledge of the prescriber’s 

intended use of the drug would facilitate the interaction between the pharmacist and the 

consumer, especially when the drug is being used for an off-label use. 

To facilitate and encourage oral counseling, many chain pharmacies are restructuring their 

prescription departments to provide a private area for the consumerto talk with the pharmacist 

about the medication. 

. B~hallenges: We concur with the draft report’s fmding that a significant obstacle to 

providing oral counseling is the economics of pharmacy practice, where, according to the report, 

“payers are squeezing operating margins.” When OBRA 90 was enacted, no additional 

provisions for payment were provided to states to defray pharmacists’ costs of providing 

counseling to Medicaid recipients, essentiaily resulting in an unfunded mandate on pharmacists 

and the states. 

As the report also indicates, OBRA 90 vested the enforcement of these new laws with the states 

without providing for additional resources. In addition, most states extended the counseling 

requirements to non-Medicaid recipients, meaning that the unfunded mandate was extended in 

most states to all pharmacy consumers, not just Medicaid recipients. 

At this point, almost 70 percent of all prescriptions are paid for by third party plans. These plans 

are paying pharmacies less per prescription, not more, and are squeezingpharmacy margins. In 

almost all cases, third-party plan reimbursement, including Medicaid, does not even compensate 

pharmacies adequately for the cost of filling the prescription, much less for providing 

counseling. 

In 1991, before the pharmacy counseling provisions were implemented, HCFA found that the 

average cost of dispensing a Medicaid prescription was about $5.50. This amount did not 

include the cost of counseling. In its final rule implementing the patient counseling guidelines, 

HCFA itself indicated that the cost of a counseling session was about $2.50-$3.00. 

When the HCFA-estimated additional costs of counseling are addedto the cost of providing the 

prescription, it increases the cost of dispensing to, on average $838.50 per prescription, well 

below the current average per-prescription Medicaid payment to pharmacies. At this point, 

Medicaid’s average dispensing fee per prescription has declined by 14.4%in 1996 inflationadjusted dollars from $4.93 in 1991to $4.22 today. This underscoresthe economic challenge to 

the provision of oral counseling by community retail pharmacies. 

Consumer Cu: Consumers need to better-understandand appreciate the value of the 

pharmacist in helping them manage their medications. Physicians and other health care 

professionals also have to sensitize consumersto the need to obtain as much information about 

their medications as possible, including through oral communications. 

National Associationof Chain Drug Stores 

June 27,1997 

Page 2 
Consumers can also help their own cause by demanding that their health benefit plans cover the 

cost of pharmacists providing oral counseling as a part of the prescription drug benefit. 

Unfortunately, third party prescription benefit plans continue to focus on reducing 

reimbursement for the product cost. 

Instead, health benefit plans and PBMs should adopt reimbursement policies that encourage the 

delivery of pharmacy services which reduce overall drug expenditures through better drug use. 

Community pharmacy is eager to work with consumer and patient advocacy groups to increase 

consumer demand for oral counseling at local pharmacies. 

Response to OIG Suggestions 

NACDS would like to offer brief comments on the suggestions made by the OIG in its draft 

report relative to methods to improve oral counseling. NACDS is participating with almost 

every other national pharmacy organization in cosponsoring a national symposium on pharmacy 

oral counseling. The symposium is scheduled to be held this fall, which will help implement 

part of the “Action Plan for the Provision of Useful Prescription Medicine Information.” 

This plan was developed in lieu of the MedGuide action plan proposed by the FDA. This 

upcoming symposium will assess the current array of pharmacy oral counseling guidelines, 

evaluate the need for any refinement to these guidelines, and seek to develop an action plan to 

address many of the challenges to the further provisions of oral counseling as described above. 

NACDS has serious reservations, however, about other recommendations made in the report that 

would prescribe a broader role for the Federal government, notably HCFA and FDA, in setting 

performance objectives for oral counseling.by pharmacists, as well as-Federaloversight of such 

counseling. NACDS believes that the regulation of the practice of pharmacy is the purview of 

the states. Any additional performance objectives-orstandards that are needed, including any 

necessary oversight mechanisms, should be developed by the state boards of pharmacy in 

conjunction with the profession of pharmacy. 

It is important to recognize that, while an increase in the quality and quantity of oral counseling 

is a goal that is desirable and achievable, any further efforts to establish additional standards or 

oversight must be accompanied by an equally-committed and forceful effort to address some of 

the challenges that currently impede the further development of oral counseling. 

uk/govtlfdaloigrptZ! 

National Association of Chain Drug Stores 

June 27,1997 

Page 3 

. 
June 13, 1997 

June Gibbs Brown 

Inspector General 

De artrnentof Health & Human Scrviccs 

Wilbur J, Cohen Building, Suite 5250 

330 Independence Aye,, SW __ Wasbingtoa, D.C. 20201 

Nations1 RI3: Draft inspection report, “State Pharmacy Boards’ Oversi ht 

COMMUNITY of Patient Counselmg Laws.” Q$&Z-W~~ 

PHARMACISTS 

Association Dear Inspector General, June Gibbs Brbwn: 

We agree with your basic premise that effective oversight can help foster the 

intent of the federal and statt atient counseling laws. We commend your 

office for doing this study anB our rccognitlon that proper use of mcdicino is 

a major ublic policy Issue, d t also agree with your view that hatznacists 

arc In a Eey role towsprc the appropfiatouse of medication, bo% tllrough 

identifying and correcting prescri tlon errors, and tirough effective 

intcruction wlth patients to foster e Cttcrpatient understanding and UN qf mcd)Ane. Incidentally, several studies have documented the cost of 

inappropriate medication well in excess of $100 million a year noted in ybur 

report, (See attached.,Thc?6 Billion DoZlurQueslk) 

The oversfght of the non-Medicaid laws, of course, rests exclusive1 with thp 

state pharmacy boards. Your investigation h,u determined that “tic % 

enforcement of the laws has been minimal”, We belleve it is pattlculqrly 

NCPA important that your investigation o$obstacles to effective pharmacist 

2Of Ihngedeld Road counseling found that the pr@cipIebarrier was “limited reimbursemcpt for 

Aknndrla.Vlqinb counseling service-s.”The Prescription Infomlation Actioh Plan ap roved by 

12314.2885 Secretary Sbalala, at page.33,conclu,desthak.“third-party payers Pmcluding 

phone government agencies) should consider the health care and economic benefits 703.683.8200 * , they will likely receive due to improved oral and written comxnunkation and 

rbx arc strongly encouraged to provide paym$nt lp health care professionals for 

703.683.3619 providing these services.” Your departmenthas a wide range of optibns 

available to help facilitate the removal of this principlebarrier to more effective 

patlenl counseling. 

Another particularly enlightenjng aspect of your investigation is’that 94% of 

the state pharmacy boardsindicated that their stat0had no contlnulng 

education requircqents specifically inlended to help pharmacists conduct 

aticnt counseling; Under thcpmspective drug review provisions of the 1990 

R edicaid amendments,each state’sprogmp Is required LOconduct a&c and 

ongoing educational outreach pro.gra& to educatepractltioncrs, ph,umacists 

I -0, *.a \=. I. f’ 4. a. *I*.. . . . . 

5 
InSpector General Brown 

Page TWO 

June 13, 1997 

and doctors, on comnion drug therapy problems. We recommend that your 

department encourage slate Medicaid progMmsthrough funds made av$labIe 

lo state pharmacist association ‘iddonductthe ieleitant continuing edudatloh ; .B I. 

programs. . .-

Considering your finding that lack of patient knowledge about the counseling 

requirement is aIso a major obstacle; 1t would seem that similar Medicaid 

patient education programs would be appropriate. Of course the development 

of state standards called for in the ‘90 amendments could help achieve these 

and other objectives, 

The planning for the National Symposium on Oral Counseling by pharmacists 

called for in the Secretary Shalala’s Prescription Information Action Plan is 

well underway. In fact, several weeks after the plan approval, we hosted a 

meeting of the CEOs of Qe major national pharmacy organizations where a 

consensus was developed in support of convening the private sector 

sponsored symposium. 

The Center for Drugs and Public Policy has been contracted to assist with the 

symposium, and recently an advisory commitlee met in our offices to help 

assure that consumer, private third-p&ty payor and other intercstcd parties am 

involved both in the development of the program and participation ?t *the 

s m oslum which will be held September 19-21 at the Landsdowne 

EYon erence Center in Leesburg, Virginia. (SC&eliclosed related ma$~@Is), It 

is pLarlicuIarlyexcitiag ‘tosee all of pharmacy supporting this effort. 

HCFA is encouraged to designate a representative for the Advisory 

Committee and to suggest appropriate individuals to the Center on Drugs and 

Public Policy to participate aethe symposium. It is important, however, to 

note that while support for the symposium by HCFA is important, it is a ’ 

private sector pharmacy Icd initiative 

Incidentally, the purposes of the symposium include an assessment of 

guidelines as noted in your rep&t (see B-2), but are per Secretary Shalakb’s 

Prescription Information Action Plan more comprehensive: 

�  the effectiveness of current oral counseling guidelines relating to 

prescription medicines �  identication of “best practices” for oral counseliig �  sug estions for refincmcnt to current guidelines, if needed, with rcfcrral to 

State t oards of pharmacy. �  strategies to reduce the economic, pradice, and social barriers’relating to 

provldlng useful oral information about prescription medicines. 
. . 

Inspector Genera1Brown 

June 13, 1997 

Page Three 

Regarding the FDA, WCcertainly support their involvement in an assessment 

of the “usefulness” of written information Provided to patients and would 

encourage a similar assessment of ‘*&en mformation provided by the boar& 

of pharmacy to pharmacists. .-

Again, thank you for the 9 ortunity for community pharmacy to comment 

on this report, and its signupicant findings. We stand ready to assist your 

department in taking meaningful steps to address the findings. 

CXdj 

Enclosures 
z 

El $ AMERICAN SOCIETYOF HEALTH-SYSTEMPHARMACISTS ,. , -.,.

. Pharmacists41healthsystems helpingp t uqf medications _--

July lo,1997 

Ms. June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

5250 Cohen Building 

330 Independence Avenue, S.W. 

Washington, DC 20201 

RE: Draft Repoti, “State Pharmacy Boards’ Oversight of Patient Counseling Laws.” 

Dear Ms. Brown: 

The American Society of Health-System Pharmacists (ASkP) appreciatesthe opportunity to comment on 

this draft report. ASHYis the 30,000-membernational professional organization that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care 

organizations, and other components of health care systems. 

As a long-time proponent of patient counseling, ASHP has a particular interest in the subject matter of 

the draft report. Because of its strong commitment to patient counseling, ASHP has taken an active role 

in supporting this aspect of patient care as part of iti mission to help pharmacists provide pharmaceutical 

care that results in positive patient-care outcomes. In the 197Os,ASHP established “Guidelines on 

Pharmacist-ConductedPatient Counseling.” These guidelines have been revised and expanded over the 

years, and a copy of the most recent (1996) revision is enclosed. The guidelines indicate AMP’S 

commitment to the principle that pharmacists should educate and counsel all patients to the fullest extent 

possible, going beyond the minimum requirements of laws and regulations. Anything less is inconsistent 

with pharmacists’responsibilities and talents. . 

‘Ibe importance of informing consumers about the vital patient care role of pharmacists and expanding 

efforts to preventmedieation emors and other drug-related problems are also prominent portions of our 

1997-1998Leadership Agenda (also enclosed). ASHP has provided input to state boards of pharmacy 

when those boards develop patient-counseling rules. ASHP was represented on the steering cO~i&% 

that developedthe ActionPlanfor the Provision,of UsefirlPrescriptionMedicine Informationthat was 

approved by Secretary Shalala in January of this year. And ASHP is one of the eight organizations 

planning and providing funding for the National Symposium on Oral Counseling that was called for by 

the Action Plan. I 

We shardd the executive summary of the report with our Board of Directors and leaders of our Afftliated 

State Societies. The comments below are partly a result of the responsesreceived from these members. 

BACKGROUND SECTION (Pages l-3 of the Draft Report) 

Page 1 of the report states that pharmacists can help patients “as a last line of defense, to identify and 

correct prescription errors” and “in a proactive manner to foster better patient understanding and use of 

prescription drugs;” ASHP encourages the Inspector General to stress pharmacists’proactive and prospective abilities for intervention as a vital and productive member of the patient care team. 

?272’WlSCONSIN AVENUE I BETHESDA,MD 20814 m 301-657-3000 m FAX: 301-652-8278 m www.ashp.org 
Ms. June Gibbs Brown 

July 10, 1997 .. Page 2 

FINDINGS SECTION (Pages 4-7 of the Draft Report) 

While ASHP is in general agreement with the findings of the inspector General contained in the draft 

report, we would like to bring the following concerns to your attention: 

Although the data used to prepare the draft report came primarily from a survey of state boards of pharmacy conducted as recently as November 1996to January 1997,we would argue that the information 

from your survey is not completely accurate and up-to-date. For example, a coalition of pharmacy 

groups in Illinois has been working with that state’sBoard of Pharmacy to establish rules and regulations enhancing pharmaceutical care and patient counseling. In May of this year, the Illinois Board of 

Pharmacy accepted the coalition’s recommendations for revising that state’srules for patient counseling. 

Although the state board’sadoption of these recommendations is only the first step in the process of 

establishing better patient counseling rules in Illinois, and implementation of those rules cannot occur 

without the appropriate infrastructure and funding, it is an example of how state pharmacy organizations 

are dealing with the problem. 

Pharmacy organizations in other states have had similar successes. Through the work of pharmacy ’ 

groups in Texas within the last three months, that state has expanded its counseling requirements to 

include a once-a-year consultation on refills and maintenance medications, but this has not been enforced 

yet due to its recency. Texas pharmacy groups are currently holding meetings to discuss the affect pharmacists’working conditions have on their ability to offer counseling. . 

ASHP applauds these efforts by state pharmacist organizations and state boards of pharmacy to improve 

the dissemination of medication information to patients. We suggest that the Inspector General conduct 

follow-up surveys to determine what recent and on-going efforts have been initiated to solve the problems noted in the draft report. 

Pharmacy Boards’ Enforcement of Counseling Laws 

ASHP agrees with the finding, noted on page 5 of the draft report, that board of pharmacy enforcement 

of counseling laws has been minimal.. This is due, partly, to differences in how pharmacy boards deal 

with complaints and implement enforcement of state laws and regulations, a factor that the draft report 

does not seem to address. In addition to dierences in how pharmacy boards implement enforcement of 

pharmacist counseling, there are differences, as noted on page 6 of the draft report, in how punitive 

boards are. Some are-funded solely by the fmes they issue, and these may be more inclined to carry out 

enforcement procedures. 

ASHP believes strongly that implementation and enforcement of pharmacy practice laws and regulations 

should be left up to the individual states, and we recommend that a study or studies be conducted to 

determine what factors, related to state board of pharmacy operations and funding, have a positive 

influence on effective enforcement of counseling laws. 
Ms. June Gibbs Brown 

July 10, 1997 

Page 3 

State Boards’ Identification of Obstacles to Implementing Patient Counseiing Laws 

Lack of Resourcesfor Enforcement 

ASHP agrees that state boards of pharmacy lack sufficient staff and funding to investigate and enforce 

federal and state counseling requirements. While some state boards are funded by the fines they impose, 

others are not reimbursed for any costs related to the enforcement of counseling requirements, and even 

have limited funding to disseminate educational information about counseling. 

Economicsof PharmacyPractice 

On page 6, the drafI report lists “Economics of Pharmacy Pqctice” as one of the obstacles state pharmacy boards identified as impediments to patient counseling. This includes “limited reimbursement for 

counseling services” and “lack of owners’commitment to counseling.” ASHP and its members agree 

with both of these observations. 

In today’smarketplace, pharmacists are expected to increase the number of prescriptions they till and 

patients they serve while simultaneously cutting costs and, in many cases, staff This leads to patients 

equating the quality of pharmaceutical care and services with the quick delivery of prescriptions, which 

further lowers the priority of counseling as a service that can and should be provided by pharmacists. If 

the numbers cited in the draft report are correct - that as much as $100 billion a year is added to healthcare costs due to patients misusing drugs and not receiving intended therapy’ - some consideration must 

be given to increasing insurance carriers’and other payers’ (e.g., government) motivation to pay more at 

the pharmacy counseling level to encourage compliance with medication therapy and thereby reduce the 

overall cost of providing health care. 

ASHP has received some interesting comments regarding what the draft report calls “lack of owners’ 

commitment to wunseling.” In Endnote 28 (page C-4), the draft report states that “owners and managers 

of pharmacies,particularly large, corporate chainphatmacies, express considerable concern that without 

reimbursement for cognitive services offered by pharmacists, oral counseling could have undesirable 

financial effects on their operations.” ASHP members who provided us with comments on the Executive 

Summary of the draft report, while agreeing that areimbursement mechanism should be established for 

cognitive services, noted that a major impediment to proper pharmacist involvement in patient medication education is the attitude of non-pharmacist owners of pharmacies, particularly chain store owners, 

who have little interest in promoting counseling activities that may decrease the volume of prescriptions 

dispensed. 

Some ASHP members contend that the reason some state pharmacy boards do not enforce counseling 

laws is because these boards have members who represent certain corporate interests that resist efforts at 

stronger enforcement. They believe that this situation will not change until boards are restructured to 

‘Some minor corrections need to be made to the draft report Page 1 of the report correctly cites the 

estimatedcosts as S 100 billion a year. Page i of the Executive Summary incorrectly states the cost as %100 million a 

year. The date of the source for this estimate - an article in the Journal of the American Medical Association - is 

cited incorrectly in Endnote 2 (page C- 1 of the report) as June 2 1, 1996; the article actually appeared in JAM4 on 

June 21, 1995. 
Ms. June Gibbs Brown 

July 10, 1997 

Page 4 : 

provide more input from practitioner pharmacists and consumers. One member noted that “economic 

reality places an unfair burden on a pharmacist who may choose to question company policy.... Proper 

counseling will not become universal or even widespread until the laws are changed to place sanctions 

on pharmacy owuers who do not require their employed pharmacists to counsel patients.” ‘Ihe wnsensus 

is that ways should be found to fine and discipline corporate owners as well as individual pharmacists for 

not complying with patient counseling laws. 

LimitedPatientDemand 

On page 7, the draft report lists “Limited Patient Demand” as another obstacle identified as an impediment to patient counseling. ASHP believes that this is more of a perception than a reality. Demand 

should not be a barrier to counseling. Federal regulations and state laws require that pharmacists offer to 

counsel patients, not that the patients should ask Pharmacists are often told by patients that they prefer 

to go to particular pharmacies because of theprinted material the pharmacists provide there. Personal 

discussions with pharmacists could have an even greater impact on patient satisfaction. 

-z* 

Counseling must be a part of the prescription process and not a separate task performed by the pharmacist. While offering counseling as an “extra”service requiring additional time might be discouraging 

to some, our experience indicates that patients will spend the time needed for counseling if it is built into 

the process and is routinely performed. Clearly, patients require oral and written reinforcements to 

assure safe use and compliance with the prescribed drug regimen. 

RECOMMENDATIONS SECTION (Pages 8-9 of the Draft Report) 

Recommendations Directed to the Food and Drug Administration 

On page 8, the draft report recommendsthat the FDA collaborate with state boards ofpharmacy to 

collect survey data - particularly through “shopping”visits - “to determine the extent and type of wunseling being offered to patients.” While ASHP agrees that “shopping”visits may be helpful indicators of 

the amount of counseling that is provided (or if it is even offered), this is only one approach to factfmding, and it is a labor-intensive and costly approach. Other survey methods should be considered, 

such as customer satisfaction surveys, which might be a better indicator of whether the patient has 

received any counseling at all, and whether the patient is pleased with the information provided by the 

pharmacist. Surveys could also be used to examine whether the pharmacy environment is appropriate for 

the interaction between pharmacists and patients, and they could identify and offer suggestionsto correct 

structural deficiencies and proceduresthat can improve the delivery of healthcare information. 

Recommendations Directed to the Health Care Financing Administration 

On page 8, the draft report recommends that the HCFA should “facilitate State efforts to enforce the 

Medicaid patient counseling mandate.” Unfortunately, it is likely that this “facilitation” .willbe largely 

ineffective unless pharmacists and state boards receive some type of economic incentive to comply with 

the federal mandate. One solution would be for HCFAto ensure that reimbursement for pharmacy 

services be adequate enough to cover counseling. The Inspector General’sfinal report needs to 
Ms. June Gibbs Brown 

July 10, 1997 

Page 5 .* 

address the important issue of how to fund the initiatives it recommends. ASHP suggests,as an initial 

phase, that HHS and HCFA measure the true costs of providing complete medication distribution and 

education, and then assist in developing a plan to make the appropriate resources available. 

On page 9, the draft report recommends that HCFA should play a “stimulative role” in convening the 

national symposium on oral counseling by pharmacists recommended by the Action Planfor the 

Provisionof UsefulPrescriptionMedicine Informationthat was approved by Secretary Shalala. As 

noted above, ASHP and seven other organizations - the Academy of Managed Care Pharmacy, the 

American Pharmaceutical Association, the American Society of Consultant Pharmacists, the National 

Community Pharmacists Association, the National Association of Boards of Pharmacy, the National 

Association of Chain Drug Stores, and the Pharmaceutical Care Management Association - are sponsoring this symposium under the auspices of the Center on Drugs and Public Policy, University of 

Maryland School of Pharmacy. Most of the constructive work of the symposium, which is scheduled to 

be held on September 19-21,1997, will be conducted through small group workshops that will address 

three major issues: consumers, pharmacy practice, and compensation. The goal of the symposium is to 

develop a wmmon set of specific strategic plans for action that can be implemented by pharmacists to 

provide effective oral counseling to consumers. The sponsoring organizations plan to invite HCFA 

representatives to participate in the symposium on various levels. 

ASHP looks forward to working with the Department of Health and Human Services, the Food and Drug 

Administration, the Heaith Care Financing Administration, and private-sector pharmacy organizations to 

address the concerns raised in the Inspector General’sdraft report Our Affiliated State Chapters are 

prepared to work with their boards of pharmacy on this issue. Please call us if you have any questions 

about our comments, and we can discuss a further role that national and state professional pharmacy 

organizations may play in ensuring compliance with this important practice issue. 

Sincerely, 

_ 

. 

. 

.. 

Executive Vice President 

q:\gcs\counsei.bm:sc 

Enclosures 

CC: Board of Directors 
G-103 

ASHPGuidelinesonPhktiaGtXtitiductedPtitiknt 

EducationandCounseling 

Am J Health-Syst F’twm. 1997: 34~4314 

Providing pharmaceutical axe entails accepting responsibUity for patients’ pharmacothenpeudc outcomes. Pharmacists can contribute to positive outcomes by educating and counAlng patients to prepare 

and motivate them to follow their pharmacotherapeutic regimens and monitoring plans. Ihe purpose of this 

document is to help pharmadsts provide effective ptlent educationand courwling. 

In work@ with individual patienti, patient groups, 

families, and caregivers, pharmacists should approach 

cducadon and counseling as interrelated activities. 

ASHPbelt- phannadsts should educate and counsei 

ail patients to the extant pordble, going beyond the 

minImum rquhments of laws and regulations: simply 

offering to counsel k Inconsistent with phaxmadsts’ 

rqonsiitles. In pharmaceutical care, pharmadsts 

should encourage patients to seek education and counseling and should eliminate barriers to provUng it 

Rnmudss should also seek opportunities to pan&ipate in h&h-system patlaWctucatlon programs and to 

supporttheeduMonaleffor&ofotherhealthareteam 

member% phumrdm should crollabom with otha 

health axe team men&as, as rppmprlate, to detemUne 

whatspdecinfotmatkmandcumMngarerqulzedin 

cadl p8lialt arc sltuatIon. A cootd&uted effott 8morl& 

he&h are team membQI will enhance patients’ adhaence to pharmacotherapeutlc f@nens, monitoring of 

drug effects, and feedback to the health system. 

MHP b&eves these patient eduutionnd counxllng guidelines are appliable in all practice sett@s­

&@dfng acute lnpatimt care, ambulatory are, home 

arc, and long-tam -whetha the sctUngs are 

associated with Integrated health systems or managtd 

care oganlzafions or are frestandlng. Ike guidelines 

may need to be adapted; for example, for use in telephonecounseiingor fcucounsellngfamifymcmbersor 

are@vas instead of prtlcm.Patient cduattonand

cuunsd@usually~atthetlmepresa@lonsare 

dispens&utmayal4okprovided&sr#purtesavke.lhetechniquesandtheamttntshouldkad@sted 

tomeathespedfIcneedsd&hepatkntandtocompty 

withthepoUdamdfxoc&msof’the~sctting. 

Inh4thsystems.othetkaithazeteamwmkrs 

shareInthere3ponsihiUtytoOte8ndcuunsclpatlam 83spedfled In the p8tknU are plans. 

Thehumanandeconomicco nsqueMsofinappcoprlate mzdkatioa use bavv been the subject of profes­

*tiplwc=Jooogrmionrl -foralorc 

thantwodeade%‘-‘Lackofsuffid~thwmkdgeabout 

thdrhealthpmbIemsmdmediatbasbonecauseof 

pucnu nonadheraKe to uldt lJhmmmhmpeutic 

regimens and monttodng pb nithout �dquate 

hmwIedge~p8tlalt8 amot be eecuve pt.nas ln 

managingthdrowncaze.Tl2epharmacyprofessionhas 

acceptedfcsponsibUltyforpmvidingpatknt&ucat&n 

5 
ASHP Reports Patient education and counseling 

and counseling in the context of pharmaceutical care to 

improve patient adherence and reduce medication-related problems.69 

Concerns about improper medication use contributed 

to the provision in the Omnibus Budget Reconciliation 

Act of 1990 (OBRA‘90)that mandated an offer to counsel 

Medicaid outpatients about prescription medications. 

Subsequently, states enacted legislation that generally 

extends the-offer-tcKounse1 requirement to’outpatients 

not cover& by Medicaid. Future couit cases may establish that pharmacists, in part because of changing laws, 

have a public duty to warn patients of adverse effects and 

potential interactions of medications. The result could be 

increased liability for pharmacists who fail to educate 

and counsel their patients or who do so incorrectly or 

incomplete1y.*0 

Pharmacists’ knowledge and skills 

In addition to a current knowledge of pharmacotherapy, pharmacists need to have the knowledge and skills 

to provide effective and accurate patient education and 

counseling. They should know about their patients’ ctdtures, especially health and illness beliefs, attitudes, and 

practices. They should be aware of patients’ feelings 

toward the health system and views of their own roles 

and responsibilities for decision-making and for managing their care.” 

Effective, open-ended questioning and active listening are essential skiils for obtaining information from 

and sharing information with patients. Pharmacists have 

to adapt messages to fit patients’ language skills and 

primary languages, through the use of teaching aids, 

interpreters, or cultural guides If necessary. Pharmacists 

also need to observe and interpret the nonverbal messages (e.g., eye contact, facial expressions, body movements, 

vocal characteristics) patients give during education and 

counseling sessions.L2 

Assessing a patient’s cognitive abilities, learning style, 

and sensory and ph$%%l status enables the pharmacist 

to adapt information and educational methods to meet 

the patient’s needs. A patient may learn best by hearing 

spoken instructions; by seeing a diagram, picture, or 

model; or by directly handling medications and administration devices. A patient may lack the visual acuity to 

read Iabels on presaiption~~~ntainers, markings on syringes, or written handout material. A patient may be 

unable to hear oral instructions or may lack sufficient 

motor skills to open a child-resistant container. 

Lnaddition to assessing whether patients knowhow to 

use their medications, pharmacists should attempt to 

understand patients’ attitudes and potential behaviors 

concerning medication use. The pharmacist needs to 

determine whether a patient is willing to use a medication and whether he or she intends to do 50.‘~.~’ 

Environment 

Education and counseling should take place in an 

environment conducive to patient involvement, 

learning, and acceptance-one that supports pharmacists’ efforts to establish caring relationships with patients. Individual patients, groups, families, or caregivers should perceive the counseling environment as 

comfortable, confidential, and safe. 

Education and counseling are most effective when 

conducted in a room or space that ensures privacy and 

opportunity to engage in confidential communication. If such an isolated space is not available, a common area can be restructured to maximize visual and 

auditory privacy from other patients or staff. Patients, 

including those who are disabled, should have easy 

access and seating. Space and seating should be adequate for family members or caregiven. The design 

and placement of desks and counters should minimize 

barriers to communication. Distractions and tnterrup 

tions should be few, so that patients and pharmacists 

can have each other’s undivided attention. 

The‘hnvironment should be equipped with appropriate learning aids, e.g., graphics, anatomical models, 

medication administration devices, memory aids, 

written material, and audiovisual resources. 

Pharmacist and patient roles 

Pharmacists and patients bring to education and 

counseling sessions their own perceptions of their 

roles and responsibilities. For the experience to be 

effective, the pharmacist and patient need to come to 

a common understanding about their respective roles 

and responsibilities. It may be necessary to clarify for 

patients that pharmacists have an appropriate and 

important role in providing education and counseling. 

Patients should be encouraged to be active participants. 

The pharmacist’s role is to verify that patients have 

sufficient understanding, knowledge, and skill to follow their pharmacotherapeutic regimens and monitoring plans. Pharmacists should also seek ways to 

motivate patients to learn about their treatment and to 

be active partners in their care. Patients’ role is to 

adhere to their pharmacotherapeutic regimens, monitor for drug effects, and report their experiences to 

pharmacists or other members of their health care 

teams.*zls Optimally, the patient’s role should include 

seeking information and presenting concerns that 

may make adherence difficult. 

Depending on the health system’s policies and procedures, its use of protocols or clinical care plans, and 

its credentialing of providers, pharmacists may also 

have disease management roles and responsibilities 

for specified categories of patients. This expands pharmacists’ relationships with patients and the content of 

education and counseling sessions. 

Process steps 

Steps in the patient education and counseling proc432 Am I Health-Syst Pharm Vol 54 Feb 15 1997 
Patient education and counseling ASHP Retorts 

ess will vary according to the health system’s policies 

and procedures, environment, and practice setting. 

Generally, the following steps are,appropriate for patients receiving new medications or returning for refillsi2’21: 

1. 

2. 

-z 

+-3. 

. 

4. 

Establish caring relationships with patients as appropriate to the practice setting and stage in the 

patient’s health care management. introduce yourself as a pharmacist, explain the. purpose and ex-. 

petted length of the sessions, and obtain the patient’s agreement to participate. Determine the patient’s primary spoken language. 

Assess the patient’s knowledge about his or her 

health problems and medications, physical and 

mental capability to use the medications appropriately, and attitude toward the health problems and 

medications. Ask open-ended questions about each 

medication’s purpose and what the patient expects, 

and ask the patient to describe or show how he or 

she wilt use the medication. 

Patients returning for refill medications should be 

asked to describe or show how they have been using 

their medications. They should also be asked to 

describe any problems, concerns, or uncertainties 

they are experiencing with their medications. 

Provide information orally and use visual aids or 

demonstrations to fill patients’ gaps in knowledge 

and understanding. Open the medication containers to show patients the colors, sizes, shapes, and 

markings on oral solids. For oral liquids and injectables. show patients the dosage marks on measuring 

devices. Demonstrate the assembly and use of administration devices such as nasal and oral inhalers. 

As a supplement to face-to-face oral communication, provide written handouts to help the patient 

recall the information. 

If a patient is experiencing problems with his or her 

medications, gather appropriate data and assess the 

problems. Then adjust the pharmacotherapeutic 

regimens according to protocols or notify the prescribers. 

Verify patients’ knowledge and understanding of 

medication use. Ask patients to describe or show 

how they will use their medications and identify 

their effects. Observe patients’ medication-use. capability and accuracy and attitudes toward following their pharmacotherapeutic regimens and monitoring plans. 

Content 

The content of an educatioiand counseling session 

may include the information listed below,as appropriate for each patient’s pharmacotherapeutic regimen 

and monitoring plan .6.9.mThe decision to discuss specific pharmacotherapeutic information with an individual patient must be based on the pharmacist’s 

professional judgment. 

1. The medication’s trade name, generic name, common synonym, or other descriptive name(s) and, 

when appropriate, its therapeutic class and efficacy. 

2. The medication’s use and expected benefits and 

action. This may include whether the medication is 

intended to cure a disease, eliminate or reduce 

symptoms, arrest or slow the disease process, or 

prevent the disease or a symptom. 

3. me medication’s expected onset of action and what 

to do if the action does not occur. 

4. me medication’s route, dosage form, dosage, and 

administration schedule (including duration of therapy). 5. Directions for preparing and using or administering 

the medication. This may tnclude adaptation to fit 

patienti’ lifestyles or work enviionments. -

6. Adion to be taken in case of a missed dose. 

7. Precautions to be observed during the medication’s 

use or administration and the medication’s potential risks in relation to benefits. For injectable medications and administration devices, concern about 

latex allergy may be discussed. 

8. Potential common and severe adverse effects that 

may occur, actions to prevent or minimize their 

occurrence, and actions to take if they occur, including notifying the prescriber, pharmacist, or 

other h-ealth care provider. 

9. Techniques for self-monitoring of the phannacotherapy. 

10. Potential drugdrug (including nonprescription), 

drug-food, and drugdisease interactions or contraindications. 

Il. The medication’s relationships to radiologic and 

laboratory procedures (e.g., timing of doses and 

potential interferences with interpretation of resuks). 

12. Prescription refill authorizations and the process 

for obtaining refills. 

13. Instructions for 24-hour access to a pharmacist. 

14. Proper storage of the medication. 

IS. Proper disposal of contaminated or discontinued 

medications and used administration devices. 

16. Any other information unique to an individual 

patient or medication. 

These points are applicable to both prescription and 

nonprescription medications. Pharmacists should 

counsel patients in the proper selection of nonprescription medications. 

Additional content may be appropriate when pharmacists have authorized responsibilities in collaborative disease management for specified categories of 

patients. Depending on the patient’s disease management or clinical care plan, the following may be covered: 

1. The disease state: whether it is acute or chronic and 

its prevention, transmission, progression, and recurrence. 

2. Expected effects of the disease on the patient’s 

normal dally living. 

3. Recognition and monitoring of disease complications. 

Documentation 

Pharmacists should document education and counseling in patients’ permanent medical records as consistent with the patients’ care plans, the health system’s policies and procedures, and applicable state and 

Vol 54 Feb 15 1997 Am J Health-Syst Pharm 433 
‘= -* 

ASHP Rep0rt.s Patient education and counseling 

federal laws. When pharmacists do not have access to 

patients’ medical records, education and counseling 

may be documented .in the pharmacy’s patient profiles, on the medication orderor prescription form, or 

on a specially designed counseling record. 

The pharmacist should record (1) that counseling 

was offered and was accepted and provided or refused 

and (2) the pharmacist’s perceived level of the patient’s understanding? As:appropriate, the. .content 

should be documented (for example; counseling about 

fooddrug interactidns). All documentation should be 

safeguarded to respect patient confidentiality and privacy and to comply with applicable state and federal 

laws.lO 

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Phum. 1972; 29:121-7. 

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Council on Patient Information and Education: 1987. 

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misadventuring as an issue of public policy, part 1.Am 1Hosp 

Pharm. 1989; 4632944. 

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misadventutig as an issue of public policy, part 2. elm 1Hasp 

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5. JohnsonjA, Bootman JL Drug-related morbidity and mortality: a cost-f-illness model. Arch Intan Med. 1995; 155:1949-

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Herrier RN, Boyce RW. Communicating risk to patients. Am 

Phutm. 1995: NUSfJun):12-4. 

APM special report: medication administration problem 

solving in ambulatory care. Washington, DC: American Pharmaceutical Association: 1994. 
ASHP Leadership Agenda, 1997-98 

Rationale and Implementation 

Increase awareness among the public in general and among health-system decision-makers 

specifically about the vital patient care role of pharmacists. 

Rationale.A new mission for pharmacists-helping people make the best use of medications-has been declared, but 

pharmacists need public understanding and support in order to achieve widespread acceptance and recognition for this 

role. Decision-makers in heaitlt systems do not fully apprekie the value of pharmacists in patient care and in the 

continuiq of care. There is a risk in today’s cost-cutting c&ronment that some health-system executives may 

compromise the quality of patient care by simply cunailing their employment of pharmacists without seeking ways for 

pharmacists to help improve patient outcomes while lowering costs. 

Implementation. ASHP has expanded its efforts to increase the general public’s awareness of the value of healthsystem pharmacists. An aggressive. proactive public relations program is being developed with the assistance of a 

communications fmn and with the involvement of affiliated state societies. In 1996-97. ASHP launched a 

communicationscampaign to increase the awareness of health-system decision-makers about the vital patient care role 

of pharmacists. One thrust of the campaign. which will continue in 1997-98, is communicating directly with hcalths)stem esecutives and another is developing tools that individual ASHY members can use to help them demonstrate the 

\rluc of pharmacists in their practice settings. 

Foster expanded efforts b? health systems to prevent medication errors 

and other drug-related problems. 

Rationale.The safety of medication use is a growing public concern as reflected by the news media and by the 

scientific and professional literature. In the health-system environment, responsibility for the safety of the medicationuse process is shared by many persons in addition to pharmacists. including physicians. nurses. administrators, various 

technical personnel. and patients. Health systems are not consistently applying proven methods for reducing 

medication errors.-By virtue of their education and training, pharmacists are in a position to lead efforts within health 

systems to assess and improve the safety of medication use. Highly visible activity by health-system pharmacists on 

this issue will enhance public awareness of the patient care role of pharmacists. 

Implementation.ASHP will build ou its previous work and launch new initiatives lo foster safe medication use in 

health systems. in doing so, it will collaborate with the ASHP Research and Education Foundation and other health 

professions and organizations. 
Accelerate efforts to help health-system pharmacists 

setie patients across the continuum of care. 

Rationale. The ongoing formation of integrated health care delivery systems will require ASHP members to be well 

equipped to serve the needs of patients in all components of integrated systems and to foster continuity of care across 

those components. The demand for health-system pharmacists in certain areas such as ambulatory care may grow 

faster than in acute care, presenting new opportunities for pharmacists to improve patient outcomes. Health systems 

will be giving more atteat+n to disease prevention and health promotion, activities that are relatively underdeveloped . _. in pharmacy education and practice. 

Implementation. ASHP will identify and begin development of initiatives to ensure that pharmacists are well 

equipped for their evolving roles in all components of health systems. including ambulatory care, chronic care, longterm care, disease prevention, and health promotion. These initiatives will cover pharmacy management and leadership 

as well as clinical practice. 

Build strategic partnerships that will advance the health-system pharmacist’s 

role in the medication-use process. 

. 

Rationale. The providers of health care setvices will continue to consolidate tbrougb the development of integrated 

delivery systems that cover all components of health care. In this environment. ASHY must actively seek new types of 

collaborative relationships that will create opportunities for advancing the health-system pharmacist’s role in = * coordinating the medication-use process as well as expanding AMP’s capacity to serve members. 

Implementation. AU-P has identified existing and desirable partnerships (organizational. interdisciplinary. business) 

that offer strategic possibilities and has determined which offer the best potential for strategic alliances. ASHP is 

systematically pursuing the establishment of strong working relationships with several key groups. The top priorities 

are medical organizations. managed care provider organizations. and standard-setting and performance-measurement 

organizations in health care. 

ASHP Mission Statement 

Themission of ASHP is to represent-its members and to provide leadership that 

will enable pharmacists in organized health-care settings to 

(1) extend pharmaceutical care focused on achieving positive patient 

outcomes through drug therapy; 

(2) provide services that foster the efficacy, safety, and cost-effectiveness of 

drug use; 

(3) contribute to programs and services that emphasize the health needs of 

the public and the prevention of disease; and 

(4) promote pharmacyas an essential component of the health-care team. 

--Approved by the ASHP House of Delegates. June 3.1992 

4 
APPENDIX D 

ENDNOTES 

1. For studies addressing the quality of care impacts associated with mismedications, see 

A.J. Wood and J.A. Oates, “Adverse Reactions to Drugs,” in R. Petersdorf et al., 

Harrison’s Principles of InternalMedicine, 12th ed. (New York: McGraw Hill, 1991), 

373-9; Stephen H. Long, “Prescription Drugs and the Elderly: Issues and Options, n 

HealthA@irs 158 (Spring II, 1994), 157-74;U.S. General Accounting Office, 

PrescriptionDrugs and the Elderly: Many StillReceive PotentiallyHarm@ Drugs Despite 

Recent Improvements,GAO/HEHS-95-152, July 1995; Jeffrey A. Johnson et al., “DrugRelated Morbidity and Mortality: A Cost-of-Illness Model,” Archives of Internal 

Medicine, 155 (October 9, 1995), 1949-56; Adverse Drug Reactionsin the Elderly: 

Hearing before the Special Committeeon Aging, United States Senate, 104th Cong., 2nd 

Sess., March 28, 1996; and Robert McCarthy, “Patient Compliance: Strategies to 

Overcome a Costly Problem,” Medical UtilizationManagement24 (July 11, 1996) 14, 5-

8. 

2. This assessment was made by Paul Rogers, chair of the National Conference on 

Prescription Medicine Information and Education. See “FDA Pushes for Prescription 

Drug Information, ” Journal of the American Medical Association(273) 23, June 21, 1995, 

1815-16. The FDA Commissioner has estimated that failure to get consumers adequate 

information about prescription drugs costs about $20 billion a year in direct costs 

associated with patients who have not adhered to a prescribed drug regimen and about $80 

billion in indirect costs such as those associated with days lost from work. See Philip J. 

Hilts, “F.D.A. Seeks Clear Information Inserts with Prescription Drugs,” New York 

Times, August 24, 1995, A21. 

3. On the basis of a review of 50 studies, the FDA concluded that noncompliance rates 

averaged from 30 to 50 percent. See “Prescription Drug Product Labeling: Medication 

Guide Requirements; Proposed Rule,” Department of Health and Human Services, Food 

and Drug Administration, Federal Register, 21 CFR Part 201, wt al., August 24, 1995, 

44186. 

4. See, for instance, Timothy S. Lesar, et al., “Factors Related to Errors in Medication 

Prescribing,” Journal of the American Medical Association,(277) 4, January 22129, 1997, 

312-17. 

5. See Office of Inspector General, “The Clinical Role of the Community Pharmacist,” 

OEI-01-89-89160, November 1990. 

6. The American Pharmaceutical Association and other pharmacy professional 

organizations are encouraging the development of “pharmaceutical care” - whereby 

pharmacists play an important role in counseling patients. Professional medical 

associations support pharmacist roles in helping ensure that patients understand and adhere 

D-l 
to drug therapy prescribed by physicians. However, they tend to be wary of more activist 

roles by community pharmacists. This was most apparent in the minority report of the 

American Medical Association, the American Academy of Family Physicians, and the 

American College of Obstetricians and Gynecologists to the private-sector action plan 

recently approved by the Secretary of Health and Human Services (see appendix B). In 

their comments, they express concern that pharmacy organizations have sought to use the 

action plan “as a mechanism to legitimize the role of the pharmacist as a primary 

counselor of patients about prescription drugs.” “It is,” they add, “the unwavering view 

of the physician organizations that this is inappropriate as it distorts the reality of actual 

practice. ” 

7. The Omnibus Budget Reconciliation Act of 1990 (P.L. 101-508). 

8. The National Association of Boards of Pharmacy, Consumer Patient Counseling 

Survey, 1996. 

9. New York City Office of the Public Advocate, Prescription for Danger: Drugstore 

Counseling Routinely Ignored, 1996. 

10. U.S. News and World Report (121) 8, August 26, 1996, 46-53. At about the same 

time, a television news show ran a major segment on the same topic. 

11. Nicholas John Cavuto, et al., Letter to the Editor, “Pharmacies and Prevention of 

Potentially Fatal Drug Interactions,” Journ.al of the American Medical Association (275) 

14, April 10, 1996, 1086-7. 

12. We sent the survey to the 50 State pharmacy boards and the pharmacy board of the 

District of Columbia. 

13. Three boards did not respond to our survey: Maine, Kansas, and District of 

Columbia. Two, Michigan and South Carolina, suggested that we contact the State 

Medicaid agency to discuss enforcement of the Medicaid counseling law. In those two 

cases, we did conduct discussions with Medicaid agency representatives, but we regarded 

those two States as nonrespondents for our survey of pharmacy boards. 

14. California State Board of Pharmacy, Department of Consumer Affairs, Fall 1995. 

15. Although this and other such outreach efforts by boards would provide pharmacists 

with opportunities to obtain continuing education credits, only 3 of 46 reporting boards 

indicated that their State had a continuing education requirement for pharmacists that was 

specifically intended to help them conduct patient counseling. 

16. During the past year, 39 of 46 reporting boards (85 percent) conducted on-site visits 

of pharmacies. In these States, the median percentage of pharmacies visited was 80 

percent. 

D-2 
17. Our reference here and throughout the report is to boards responding to a particular 

question. Thus, while 46 boards responded to some or all of our survey, the number 

responding to any particular question varies slightly. 

18. One board official commented as follows: It is virtually impossible to make a “paper 

case. ” Each disciplinary action requires more than one undercover shopping visit and is 

very labor intensive. This is a problem for an agency that is short on personnel.” 

19. One board noted that several shopping efforts have been undertaken in the past year 

and that in almost all cases pharmacists are complying with the OBRA 1990 legislation. 

Two other boards were less positive in describing their results. One noted an overall 

compliance rate of 70 percent. One simply noted that the results of shopping visits to 

three dozen pharmacies “were not satisfactory.” He noted that they found that 

pharmacists tend to skip counseling on patients they didn’t know. 

20. Even though the investigation may involve “shopping,” the complaint/concern leading 

to it does not necessarily involve a possible counseling violation. 

21. Pharmacy boards also enforce patient counseling laws through their response to 

complaints. In our survey, we asked how often such complaints were related to patient 

counseling. We present the responses in appendix A. However, upon follow-up 

discussions with a number of board officials we determined that boards had widely 

varying interpretations of “counseling-related;” thus any generalizations on this matter 

would be suspect. It may be pertinent to note though that among 37 reporting boards, 28 

(76 percent) estimated that consumers were the primary source of complaints involving 

possible violations of patient counseling requirements. 

22. The economic barriers to counseling were also emphasized in a prior Office of 

Inspector General study. See OEI-89-89160, “The Clinical Role of the Community 

Pharmacist,” November 1990. 

23. A few officials, however, suggested that the “attitudes” of pharmacists also 

contributed to a lack of counseling. 

24. This perception has been documented in many prior studies over many years. For 

instance, a 1982 Schering Laboratory study found that among 15 possible reasons offered 

for choosing a pharmacy, consumers they surveyed ranked the following as the first 

reason: “Pharmacist fills prescriptions promptly. ” See Schering laboratories, “Pharmacist 

Perceptions vs. Consumer Realities: Updating the View from Both Sides of the Counter,” 

The Schering Report IV, Kenilworth, New Jersey, 1982. 

25. Here, and throughout the text, we use the term “major” to describe responses 

identified by respondents as “significant” or “very significant.” 

D-3 
26. For instance, an October 1996 verdict a South Carolina case resulted in a $16 million 

settlement against a chain pharmacy for an improperly filled prescription leading to severe 

brain damage for a child. (Court of Common Pleas, York County, South Carolina. 

Docket Numbers: 9%CP-46-405 and 95-CP-46-406.) 

27. The national health promotion and disease prevention objectives issued by the 

Department of Health and Human Services in its report entitled, “Healthy People 2oO0,” 

calls for a commitment to written and oral counseling. Objective 12.8, added in 1995, 

states: “Increase to at least 75 percent the proportion of people who receive useful 

information verbally and in writing for new prescriptions from prescribers and 

dispensers. ” 

28. Physician groups, as we have noted, express considerable concern that oral 

counseling initiatives could lead to undesirable intrusions into the practice of medicine. 

Similarly, owners and managers of pharmacies, particularly large, corporate chain 

pharmacies, express considerable concern that without reimbursement for cognitive 

services offered by pharmacists, oral counseling could have undesirable financial effects 

on their operations. The HCFA and pharmacy associations could help address these 

concerns by showcasing ways in which pharmacists and physicians are working together in 

some community settings. Similarly, they could help draw attention to initiatives such as 

the one in Wisconsin where the Medicaid program is reimbursing pharmacists for 

“pharmaceutical care” at varied levels, depending on the extent of care being provided to 

patients. 

D-4