STATE DISCIPLINE OF PHARMACISTS 

OFFICE OF INSPECTOR GENERAL 

OFFICE OF EVALUATION AND INSPECTIONS 

JULY 1990 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG) is to promote the efficiency, 

effectiveness, and integrity of programs in the United States Department of Health and Human 

Services (HEIS). It does this by developing methods to detect and prevent fraud, waste, and 

abuse. Created by statute in 1976,the Inspector General keeps both the Secretary and the 

Congress fully and currently informed about programs or management problems and 

recommends corrective action. The OIG performs its mission by conducting audits, 

investigations, and inspections with approximately 1,300 staff strategically located around the 

country. 

OFFICE OF EVALUATION AND INSPECTIONS 

This report is produced by the Office of Evaluation and Inspections (OEI), one of the three 

major offices within the OIG. The other two are the Office of Audit Services and the Office of 

Investigations. Inspections are conducted in accordance with professional standards 

developed by OEI. The inspections are typically short-term studies designed to determine 

program effectiveness, efficiency, and vulnerability to fraud or abuse. 

This study, entitled "State Discipline of Pharmacists," was conducted to examine the practices 

of State boards of pharmacy in disciplining pharmacists. 

The report was prepared under the direction of Mark R. Yessian, Ph.D., the Regional Inspector 

General, Boston Region, Office of Evaluation and Inspections. Participating in this project 

were the following people: 

Boston Region Headquarters 

Martha B. Kvaal, Project Leader Alan S. Levine 

Carol I. Barash 

Eleanor M. Ellis 

Barry C. McCoy 

Charles E. Vann 

Elizabeth A. Wirick 
STATE DISCIPLINE OF PHARMACISTS 

Richard P. Kusserow 

INSPECTOR GENERAL 

JULY 1990 

EXECUTIVE SUMMARY 

PURPOSE 

The purpose of this inspection was to assess the disciplinary practices of State boards of 

pharmacy. It examined the strengths and vulnerabilities of the pharmacy boards in attempting 

to ensure that pharmacy is practiced safely, competently, and in accordance with pharmacy 

and drug laws. 

BACKGROUND 

This is the sixth in a series of Office of Inspector General (OIG) reports on State boards of 

licensure and discipline. The other reports have focused on boards of medicine, dentistry, 

podiatry, chiropractic and optometry. In this, as in the other reports, the OIG's interest in the 

boards' performance is based on the important front line of protection they afford to the 

public. The inquiry was based on: (1) telephone discussions with representatives from all the 

State boards of pharmacy, (2) visits to six States for in-depth discussions with board 

representatives, (3) discussions with representatives from State and national professional 

organizations and government agencies, and (4) review of pertinent literature and data. 

FINDINGS 

The enforcement responsibilities of State pharmacy boards have become increasingly complex 

and challenging in recent years because of changes in pharmacy practice and the problem of 

drug diversion. 

Many States have taken important steps to strengthen the enforcement capacity of State 

pharnzacy boards. 

Many States have broadened their regulatory and disciplinary controls through 

changes in their pharmacy and drug laws. 

Many States have strengthened the boards' capacity to address drug diversion. 

The number of the most serious types of disciplinary actions taken by State pharmacy boards 

between 1986 and 1988 increased for the nation as a whole. However, virtually all this 

increase occurred in three States, and the incidence of serious disciplinary actions varied 

considerably among the States. 

For the nation as a whole, the most serious types of disciplinary actions taken by 

State pharmacy boards between 1986 and 1988 increased by slightly more than 20 

percent. These actions include revocations, suspensions, probations, and voluntary 

surrenders of licenses. 
Most of the increase in the most serious disciplinary actions between 1986 and 

1988 is attributable to three States. Many pharmacy boards took relatively few 

such actions during this period. 

Rates of the most serious disciplinary action taken by State pharmacy boards 

during this period varied widely-from 1.49 actions per 1000 licensees in one State 

to 45.61 actions per 1000 licensees in another. 

In most States, as in the nation as a whole, the number of revocations and voluntary 

surrenders did not increase between 1986 and 1988. 

The limited use of peer review by many professional pharmacy associations, 

particularly in comparison with that in some other professions, makes the 

disciplinary performance of pharmacy boards all the more significant. 

Pharmacy boards impose the most serious discipline mainly for drug diversion and self-abuse 

of drugs. They rarely address quality of care issues, despite the increasing emphasis in the 

profession on the clinical aspects of pharmacy practice. 

The ability of many State pharmacy boards to protect the public is hampered by limitations in 

their legal authorities, administrative processes, and resources. 

RECOMMENDATIONS 

Tlze State Governments 

State governments should ensure that State pharmacy boards have adequate 

resources and authority for carrying out their enforcement responsibilities 

effectively. 

State governments should take steps to streamline the administrative process so 

that State pharmacy boards are able to process disciplinary cases more efficiently. 

State governments should take steps which enhance the capacity of pharmacy 

boards to deal with drug diversion and impairment of pharmacists. 

State Pharmacy Boards 

State pharmacy boards should review the outcomes of their disciplinary process 

and evaluate whether they are affording the public the maximum protection 

possible. 
State pharmacy boards should disseminate more broadly information on the 

disciplinary actions they have taken. 

The National Association OfBoards OfPharmacy 

The National Association of Boards of Pharmacy (NABP) should intensify its 

efforts to help State pharmacy boards address the changing nature of pharmacy 

practice, particularly with respect to the clinical roles of pharmacists. 

The NABP should work with State pharmacy boards and national professional 

pharmacy organizations to explore viable approaches to assessing the continued 

competence of licensed pharmacists. 

The American Pharmaceutical Association 

The American Pharmaceutical Association (APhA) should exercise its leadership 

in encouraging more peer review of pharmacists' professional performance by 

national and State professional pharmacy organizations. 

The APhA should work with the NABP and other professional pharmacy 

organizations to develop appropriate methods for assessing the continued 

competence of pharmacists. 

The U.S. Public Health Service 

The Public Health Service (PHs) should increase its support to the NABP in its 

efforts to provide leadership to State pharmacy boards. 

COMMENTS 

Comments on the draft report were received fiom the Health Care Financing Administration 

and the Public Health Service within the Department, and from the Drug Enforcement 

Administration of the Department of Justice. These comments were in general agreement 

with the findings and recommendations of the report. Comments were also received fiom 

several national organizations including the American Association of Colleges of Pharmacy 

(AACP), American Pharmaceutical Association (APhA), American Society of Hospital 

Pharmacists (ASHP), National Association of Boards of Pharmacy (NABP), and the National 

Clearinghouse on Licensure, Enforcement and Regulation (CLEAR). These organizations, 

too, were generally supportive of our recommendations, although the APhA and the NABP 

expressed some resel-vations about our recommendation calling for more peer review of 

pharmacists' professional performance by national and State professional pharmacy 

organizations. A summary of these comments and our response to issues raised appear at the 

end of the report. The detailed comments appear in appendix A. 
TABLE OF CONTENTS 

EXECUTIVE SUMMARY 

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

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

The enforcement responsibilities of State pharmacy boards 

have become increasingly complex and challenging in recent 

years because of changes in pharmacy practice and the 

problem of drug diversion .......................................4 

Many States have taken importartt steps to strengthen the 

enforcement capacity of State pharmacy boards .......................5 

The number of tlte most serious types of disciplinary actions 

taken by State pharmacy boards between 1986 and 1988 

increased for the nation as a whole. However, virtually all 

this increase occurred in tltree States, and the incidence of 

serious disciplinary actions varied considerably among the 

States .....................................................7 

Plzurnzacy boards intpose tlte most serious discipline mainly 

for drug diversion and self-abuse of drugs. They rarely 

address quality of care issues, despite tlte increasing emphasis 

in the profession on the clinical aspects of pharmacy practice ...........I1 

The ability of many State pltarmacy boards to protect the 

public is Itanzpered by lintitatio~ts in their legal authorities, 

administrative processes, artd resources ............................I4 

RECOMMENDATIONS ............................................I8 

State Governments .........................................I8 

State Pharmacy Boards .....................................I9 

National Association of Boards of Pharmacy ...................20 

American Pharmaceutical Association ........................21 

The U.S. Public Health Service ...............................21 
COMMENTS ON THE DRAFT REPORT 

AND OIG RESPONSE TO COMMENTS ............................. .22 

APPENDIX A 

Detailed Comments on the Draft Report ......................A-1 

APPENDIX B 

Table of Incidence and Rate of 

Serious Disciplinary Actions, By State, 1986-1 988 ..............B-1 

APPENDIX C 

Methodological Notes .....................................C-1 

APPENDIX D 

.... Endnotes .............................................r':. D-1 

INTRODUCTION 

The purpose of this inspection was to assess the disciplinary practices of State boards of 

pharmacy. It examined the strengths and vulnerabilities of the pharmacy boards in attempting 

to ensure that pharmacy is practiced safely, competently, and in accordance with pharmacy 

and drug laws. Specific attention was focussed on the disciplinary authorities of pharmacy 

boards, on their processes for enforcement and discipline, and on the extent, type, and reasons 

for their disciplinary actions in recent years. 

This report is the sixth in a series of reports issued since 1986 by the Office of Inspector 

General (OIG) on the various State health professional boards: medicine, dentistry, podiatry, 

chiropractic, and optometry. 

The Federal Government has long recognized the paramount role played by State regulatory 

boards in setting the standards for the licensure and discipline of health care practitioners. In 

so doing, it has relied on the States to provide an important front line of protection for the 

health and safety of the public. In particular, the Department of Health and Human Services 

(HHS) has relied on State boards to provide overall assurance that the health care services 

supported by the Medicare and Medicaid programs are provided by health care professionals 

duly licensed and practicing within the terms of the States' practice acts and other related 

laws. Although the Department can sanction providers who have abused or defrauded these 

programs, it continues to depend upon State boards to discipline providers for transgressions 

unrelated to the Medicare or Medicaid programs. 

As expenditures under the Medicare and Medicaid programs have grown to be larger than 

one-fourth of all expenditures for health care in the United States, the Department's interest in 

the performance of State regulatory boards for the various health professions has increased. In 

this context, a report on the performance of State pharmacy boards, particularly in fulfilling 

their disciplinary responsibilities, is both relevant and timely. For many years, nearly all 

States have reimbursed pharmacists for services provided to Medicaid recipients. It is 

possible, too, that Federal health care benefits will be expanded during the 1990s in which 

case the relevance of the State boards of pharmacy to the Department may become even 

greater. 

The information for this inspection was based on four lines of inquiry: (1) telephone 

discussions with the chief executives of the State pharmacy boards during the spring of 1988 

and the spring of 1989; (2) visits to six States (CA, FL, MA, MI, NY, TX) involving 

discussions with several pharmacy board representatives; (3) review of pertinent literature and 

relevant data bases; and (4)discussions with representatives of various major professional 

associations concerned with disciplinary practices of pharmacy boards. (For more 

methodological background, see appendix C.) 

This report presents our findings on the practices of State pharmacy boards in disciplining 

pharmacists. It begins with a brief profile description of State boards of pharmacy. It then 
turns to a discussion of the disciplinary practices of the boards and concludes with 

recommendations for action addressed primarily to State governments and State boards of 

pharmacy. 

STATE BOARDS OF PHARMACY 

Pharmacy boards, like other health professional boards, are administrative agencies created by 

State governments to protect the health, welfare, and safety of the public through the 

regulation of pharmacy practice.1 State governments have empowered pharmacy boards to 

establish the scope of pharmacy practice, to license pharmacists and pharmacies, and to 

discipline those who violate the legal requirements. In the United States today, approximately 

183,000 pharmacists are in active practice in nearly 68,000pharmacies.2 

From their early days in the late 1800s, pharmacy boards, like the other health professional 

boards, were primarily examining boards which emphasized their licensure activities more 

than their discipline function. They were relatively inconspicuous agencies of State 

government which functioned largely autonomously and were comprised solely of 

pharmacists. 

Since the 1960s, the environment has changed considerably for State professional boards. 

With the consumer movement and heightened concern about the quality of health care 

services, more attention has been focussed on the performance of boards in protecting the 

public. Demands for greater accountability led many States to bring professional boards into 

large central agencies, to add public members to complement the professionals, and to place 

more emphasis on discipline. 

Pharmacy boards have, however, developed into entities which vary significantly from other 

health professional boards. Pharmacy boards do more than define the scope of professional 

practice and license and discipline the professionals. They also regulate pharmacies as the 

facilities in which the profession is practiced, and they regulate the distribution of the drug 

product itself. Thus the purview of pharmacy boards is much broader and in some ways their 

task is more complex than that of other health professional boards. 

Pharmacy boards, too, vary significantly among themselves. Boards differ in the scope of 

their responsibilities. For many boards these responsibilities extend beyond the practice act 

and the licensure and discipline of pharmacists and pharmacies. Seventy-five percent of the 

boards, for example, also license and inspect drug manufacturers and wholesaler^.^ Nearly 

forty percent of the boards are the State scheduling authorities for controlled substances? 

Finally, many pharmacy boards have significant responsibilities in administering their States' 

food and drug laws.5 

Pharmacy boards differ in the way they are organized. About 50 percent of the pharmacy 

boards report that they are attached to a larger government department and are not 

independent. Some boards have sole authority to make rules and regulations; some do not. 

Most boards, but not all, can both license and discipline. A few boards are advisory to other 
entities of State government who make final decisions about rules, licenses, and discipline 

concerning pharmacy. Pharmacy boards have an average of seven members, although they 

range from three to 21 members. Seventy percent of the boards have at least one public 

member. In most States, board members are appointed by the Governor for terms ranging 

from 3 to 6 years. 

Pharmacy boards also vary in the staff and other resources which support them. Although the 

large majority of boards have full-time directors, a few do not employ directors or have only 

part-time directors. The number of staff available to boards ranges from one State having one 

part-time person to another State having 31 staff. These data, however, do not always include 

the inspectors and investigators available to the boards. Finally, annual board budgets among 

the reporting 39 States range from a low of $2,500 in one State to a high of $2,874,104 in 

another ~tate.~ 

This widespread variation among the pharmacy boards makes generalizations about them 

difficult. What boards do and how they do it depend in large part on their responsibilities, 

organization, and resources. Nonetheless, we believe that our inquiry has yielded important 

understandings about the strengths and vulnerabilities of the boards as they discipline 

pharmacists-understandings which are pertinent to most pharmacy boards today. 
FINDINGS 

The enforcement responsibilities of State pharmacy boards have become increasingly complex and challenging in recent years because of changes in pharmacy practice and the problem of drug diversion. 

The practice of pharmacy has been undergoing significant and rapid change since World War 

11. Pharmacy boards, as regulators of pharmacy practice, face a challenging task in keeping 

up with the complex changes in drug therapies, distribution systems and practice settings, and 

pharmacists' professional roles and responsibilities. 

Rapid technological changes have resulted in the exploiive proliferation of new drug products 

and the development of sophisticated drug therapies and delivery systems. Computerization 

has affected not only the routine administrative aspects of pharmacy practice such as labeling 

and record keeping but has enabled various more sophisticated applications such as robotics, 

fax machines for transmitting prescriptions, and automated drug profiles for more complete 

monitoring of patients' drug therapies. 

Pharmacy practice has also been affected by the concerns of consumers and third-party payers, 

both public and private, over the rapidly increasing costs of health care. Economic factors 

have contributed significantly to the emergence of mail order pharmacies as well as drug 

repackaging companies which are encouraging the dispensing of prescription drugs by 

physicians and other health care professionals. Cost containment efforts by private insurers 

and the Federal Government have resulted in greater emphasis on shorter hospital stays and 

increased reliance on outpatient care. As a result, pharmacy is being practiced more and more 

in settings other than community pharmacies and hospitals. Practice in nursing homes, 

ambulatory care facilities, and patients' homes, for example, may require different regulatory 

approaches by pharmacy boards. 

The role of the pharmacist, too, has been experiencing significant change. No longer is the 

pharmacist primarily the compounder of medicines now that drug products are developed and 

manufactured by pharmaceutical companies. Gradually, an additional role for pharmacists as 

therapeutic advisors has been evolving. 7The nation's pharmacy schools have revised curricula 

and degree programs to incorporate clinical training to address this new role. And the national 

standards for pharmacy practice developed by the American Pharmaceutical Association 

(APhA) and the American Association of Colleges of Pharmacy (AACP) in 1979clearly 

articulated clinical responsibilities for practicing pharmacists.8 The challenge to pharmacy 

boards has been, and continues to be, whether and how best to translate these clinical 

expectations into the States' regulatory requirements governing the practice of pharmacy. 9 

Finally, pharmacy boards have had to cope with the changing regulatory responsibilities 

imposed on them by the Federal Government. Recent Federal initiatives which significantly 

affect the regulatory and enforcement efforts of State pharmacy boards include tighter controls 
over controlled substances, State licensure of wholesale prescription drug distributors, and the 

new national practitioner data bank. 

According to one pharmacy board official, all these changes in pharmacy practice have been 

"progressing faster than the boards of pharmacy's ability to regulate that practice." lo Indeed, 

keeping up with the rapidly changing face of pharmacy was identified recently by pharmacy 

board executives as the major challenge facing pharmacy boards today." 

In addition to the dramatic changes occurring in pharmacy practice, the serious national 

problem of drug diversion has complicated the enforcement responsibilities of State pharmacy 

boards. For several years, the diversion of prescription drugs from legitimate distribution 

channels for illicit use has been most acute at the retail level-practitioners and pharmacies. 

More than 10years ago, the General Accounting Office (GAO) estimated that over 200 

million dosage units of prescription drugs were being diverted each year at the retail level. 

More recently, the Drug Enforcement Administration (DEA) has estimated that 80 to 90 

percent of the prescri tion drugs diverted for non-medical use is occurring at the practitioner 

and pharmacy levels. ?2 

Diversion of controlled substances at the pharmacy level occurs in several ways. It can result 

from direct illegal sales of controlled substances by pharmacists or from outright theft of 

drugs from pharmacies, either by pharmacists for their own use or by others. Diversion can 

also result from prescription forms which are counterfeit or have been stolen or altered in 

some way. And finally, a more subtle form of diversion can occur when pharmacists, either 

knowingly or unknowingly, dispense controlled substances which have not been issued for 

legitimate medical purposes. This practice, often referred to as "non-therapeutic dispensing", 

can involve controlled substances being dispensed to addicts or to the public for other 

unapproved clinical indications or for further distribution.13 

Many States have taken important steps to strengthen the enforcement capacity of State 

pharmacy boards. 

Many States have broadened their regulatory and disciplinary controls through 

changes in their pharmacy and drug laws. 

Pharmacy is often described as the most highly regulated of all health professions. In recent 

years, many State legislatures and pharmacy boards have been moving to address the changes 

occurring in pharmacy by further expanding their regulatory control. Slightly more than 

two-thirds of the States, for example, have separate regulations governing the practice of 

pharmacy in institutional settings or requiring computerized storage of prescription records. 

Nearly one-half have regulations governing nuclear pharmacies where radioactive drugs and 

devices are handled. A growing number of States now re uire pharmacists to keep patient 

profile records and to provide counseling to their patients. Y4 Controversial regulatory issues 

such as the use of pharmacy technicians, mail order pharmacies, and the dispensing of 
prescription drugs by health professionals other than pharmacists are currently under debate in 

many States. 

The National Association of Boards of Pharmacy (NABP) has provided important leadership 

to States in their efforts to stay abreast of the rapid changes in pharmacy practice. In 1977, the 

NABP developed a Model State Pharmacy Act as well as model regulations for institutional 

pharmacy, nuclear pharmacy, and pharmacy computerization to serve as guidelines to State 

boards. Over the last 3 years alone, the NABP has developed guidelines and model laws or 

regulations on issues such as wholesale drug distribution, anabolic steroids, use of sterile 

pharmaceuticals in home health care, mail order pharmacies, patient counseling, and impaired 

pharmacists. 

During the past 3 or 4 years, at least one-fourth of the States have also been strengthening 

their boards' authority to discipline pharmacists.15 At present, every board reported having 

authority to revoke and suspend licenses and most, but not all, have authority to place 

licensees on probation or to deny the renewal of licenses. However, only approximately 

two-thirds of the boards have authority to impose fines for violations, and only about 

one-third of the boards reported having written guidelines for their use in deciding which 

penalties to impose. -* ...,

Disciplinary penalties may be imposed by pharmacy boards only for reasons (or grounds) 

specified in the States' pharmacy practice acts. These grounds vary somewhat from State to 

State. However, the majority of States have adopted those grounds recommended in the 

NABP Model Act. These include unprofessional conduct; incapacity which prevents a 

pharmacist from practicing with reasonable skill, competence and safety to the public; court 

convictions for acts involving gross immorality or moral turpitude; fraud, deceit or 

misrepresentation; and violations of State and Federal pharmacy or drug laws. 1 6' 

Many States have strengthened the boards' capacity to address drug diversion. 

Nine States have now adopted a multiple copy prescription program which enables State 

authorities, including pharmacy boards, to monitor the distribution of Schedule 11 controlled 

substances from the prescriber to the dispenser to the consumer. The experience of several 

States suggests that these programs can result in a 30 to 50 percent reduction in Schedule I1 

prescriptions. They have been effective in combatting problems with forged prescriptions and 

in reducing theft of controlled substances from pharmacies. These programs, too, have 

enhanced the efficiency of State regulators, including pharmacy board inspectors and other 

law enforcement personnel, by facilitating their review of prescription data through 

aggregated reports as opposed to the time-consuming review of individual scripts on site. 17 

Nearly half the States have adopted requirements for separate registration of all practitioners, 

including pharmacists, who handle controlled substances. This registration is different from 

the pharmacist's license to practice and separate from the DEA registration which is issued to 

the pharmacy rather than the pharmacist. Such a registration can be used by the boards to 
restrict or deny the pharmacist's privileges to dispense controlled substances while still 

retaining the basic privilege to practice. The registmion can also be a source of additional 

revenues for investigating drug diversion. 18 

Finally, several States have established Task Forces sf local, State, and sometimes Federal 

agencies concerned with drug diversion to improve coordination and communication among 

them. 

In efforts such as these, many States have recognized the critical and unique role which can be 

played by pharmacy boards in combatting drug diversion by pharmacists and pharmacies. 

Among all the agencies combatting drug diversion, only the pharmacy boards have the legal 

authority to revoke the licenses of pharmacists and pharmacies and thereby to terminate their 

legal rights to practice. 

The number of the most serious types of disciplinary actions taken by State pharmacy 

boards between 1986 and 1988 increased for the n&'on as a whole. However, virtually all 

this increase occurred in three States, and the incidence of serious disciplinary actions 

varied considerably among the States. 

For the nation as a whole, the most serious types of disciplinary actions taken by 

State pharmacy boards between 1986 and 1988 increased by slightly more than 20 

percent. These actions include revocations, suspensions, probations, and voluntary 

surrenders of licenses. 

Because comprehensive disciplinary data was not avdable from any existing sources, we 

asked the board executives in all 50 States plus the District of Columbia to provide us with 

information on the number and type of serious disciplinary actions taken by their boards in 

1986, 1987, and 1988. We received information for dl 3 years from all but four States. 

Nevada and New York were unable to provide data for all 3 years. Oklahoma provided data 

only for revocations, and Kentucky provided no data for 1988. (See appendix B for a 

state-by-state breakdown of serious disciplinary actions reported for the period 1986-1988 and 

appendix C for a more detailed description of our methodology.) 

We found that the number of the most serious disciplinary actions-revocations, suspensions, 

probations, and voluntary surrenders-imposed by pharmacy boards on pharmacists and 

pharmacies increased by slightly more than 20 percent during this 3-year period. These 

actions increased from 799 in 1986 to 969 in 1988.19 Suspensions accounted for nearly 60 

percent of this increase and were approximately 40 percent of all the most serious actions 

imposed during this period (see figure I). 

As noted earlier, pharmacy boards also take other kids of formal disciplinary actions such as 

reprimands and fines. These other kinds of penalties are important disciplinary tools and can 

be used effectively by boards. We did not include these other types of actions in our analysis 
Figure I 

Serious State Disciplinary 

Actions Against Pharmacists 

and Pharmacies, 1986-1988 

Number of Actions 

1200 

1000 

800 

600 

400 

200 

0 

1986 1987 1988 

Probations 266 312 336 

Suspensions 315 355 414 

Vol. Surrenders 36 51 38 

Revocations 182 166 181 

Revocations Val. Surrenders 

Suspensions Probations 

Source: 49 State Boards of Pharmacy 

as reported to the Office of Inspector 

General, HHS, May 1989. 
summarized here. This is not because we considered them unimportant, but because we 

considered the data available to us on these actions too imprecise for reliable analysis. 20 

Most of the increase in the most serious disciplinary actions between 1986 and 

1988 is attributable to three States. Many pharmacy boards took relatively few 

such actions during this period. 

About 97 percent of the overall increase in the most serious disciplinary actions resulted from 

the actions of three States. In fact, one State alone accounts for 57 percent of this increase. 

Our analysis indicates that many pharmacy boards imposed these most serious penalties 

infrequently during the 3-year period between 1986 and 1988. The median rate of discipline 

among the States was approximately eight of these most serious actions per 1000 licensees 

during this time2'. Further, 15 States reported taking 10 or fewer of these most serious actions 

during this entire period. In fact, seven States reported fewer than 5 such actions. All these 

States were those we categorized as small or extra-small except for one medium-sized State. 

Seven States, all small or extra-small, took no serious actions at all for one of these 3 years. 

(See appendix C for a more detailed description of our typology.) 

Rates of the most serious disciplinary action taken by State pharmacy boards 

during this period varied widely-from 1.49 actions per 1000 licensees in one State 

to 45.61 actions per 1000 licensees in another. 

In addition, considerable variation is also apparent when disciplinary actions are correlated 

with location and size. States in the Midwest disciplined at the highest rate of 15.55 actions 

per 1000 licensees-nearly twice as often as those in the West and nearly three times as often 

as those in the Northeast. The large States disciplined most frequently-at a rate of 15.57 

actions per 1000 licensees. This rate was more than one and one-half times the rate of the 

extra-small and the extra-large States, both of which disciplined least frequently and at nearly 

equal rates. 

How are we to account for these wide variations in the performance of the boards? Perhaps 

some boards are more committed to aggressive discipline than others. It could be that those 

boards with fewer actions are dealing with more complicated cases or resolving informally 

types of cases which other boards might bring to hearings. Finally, these variations might 

result to some degree from differences in the administrative process or in the resources 

available to the boards. It is likely that each of these factors to some extent affects the 

disciplinary performance of the boards. 

In most States, as in the nation as a whole, the number of revocations and voluntary 

surrenders did not increase between 1986 and 1988. 
Revocations and voluntary surrenders of licenses are the most serious of all disciplinary 

penalties imposed by the boards. Yet we found that the use of these penalties did not change 

much overall and accounted for only 25 percent of all the serious actions taken during the 

entire period. 

We think it is important to note, too, that the number of revocations summarized here may 

overstate the severity of the boards' disciplinary activity. Although revocations are the 

ultimate penalty available to boards, they are often neither as permanent nor as serious as the 

public may think. Boards can, for instance, reinstate the licenses they once revoked. In fact, 

at least 243 licenses were reinstated in 1987.~~Boards also may impose revocations, only to 

stay them and effect a lesser penalty. The boards reported to us only the most serious penalty 

for those actions involving multiple penalties. Thus our data on the number of revocations 

does not reflect the actions actually effected. 

We recognize also that the disciplinary practices of State pharmacy boards encompass 

significant activity which is not captured through analysis of the most serious disciplinary 

actions they impose. As we shall see, the majority of complaints and problems are handled by 

administrative staff through a variety of informal interventions. Nevertheless, we think 

serious disciplinary actions are an important indicator of the rigor of pharmacy boards in 

fulfilling their responsibilities to the public. 

The limited use of peer review by many professional pharmacy associations, 

particularly in comparison with that in some other professions, makes the 

disciplinary performance of pharmacy boards all the more significant. 

We found that the APhA and most State professional associations of pharmacists have been 

largely inactive in monitoring the performance of their members in recent years. The APhA as 

well as some State professional associations have formalized processes in their bylaws for 

review of their members' conduct. However, fears of antitrust litigation have dampened the 

peer review efforts of most associations with which we had contact. Peer review by 

professional associations has been less limited in other professions such as medicine, dentistry, 

and podiatry. 

To be sure, the performance of pharmacists is monitored to some extent by other government 

agencies. The States' Medicaid Fraud Control Units as well as the DEA and other State 

agencies with responsibilities for controlled substances laws can punish wrongdoing by 

pharmacists. The Office of Inspector General can exclude pharmacists and pharmacies from 

participation in the Medicare and Medicaid programs. Data from our case study States 

showed that these pharmacy boards had, for the most part, imposed serious disciplinary 

penalties against those pharmacists and pharmacies sanctioned by the OIG between 1984 and 

1988.~~ 

Nonetheless, perhaps to a greater extent than other health regulatory boards, pharmacy boards 

are the primary protectors of the public in relation to the practice of their licensees. Other 
mechanisms useful in monitoring the performance of other health professionals, such as 

mandatory reporting laws and hospital peer review committees, are not as prominent in 

monitoring the performance of pharmacists. 

Pharmacy boards impose the most serious discipline mainly for drug diversion and selfabuse of hgs. They rarely address quai* of care issues, &spite the increasing emphasis 

in the profession on the clinical aspects of pharmacy practice. 

Approximately half of all the formal disciplinary actions reported to us by pharmacy board 

executives for the period 1986-1988 were for reasons of diversion and impairment. These 

officials estimated that nearly one-fourth of these actions were the result of diversion by the 

pharmacist for economic gain; nearly three-fourths of them primarily for impairment of the 

pharmacists due to self-abuse of drugs. Analysis of the those disciplinary actions reported to 

the NABPYs Disciplinary Clearinghouse confmed these reports. Slightly more than half the 

violations reported to the Clearinghouse for the years 1986, 1987, and 1988 involved drug 

diversion and self-abuse of drugs. 

Drug Diversion 

' For many pharmacy boards, drug diversion cases consume considerable time and effort from 

both administrative staff and board members. Discussions with board officials in our case 

study States confmed that drug diversion cases are among those having top priority for 

investigation and prosecution and for receiving the most severe disciplinary sanctions. 

In identifying and developing drug diversion cases, pharmacy boards typically work with 

officials from local and State law enforcement agencies as well as from the DEA. 

Approximately two-thirds of the boards reportedly utilize the DEA's ARCOS reports to 

identify potential diversion.24 However, less than 20 percent of the boards reported that they 

rely primarily on ARCOS, because its reports are considered too untimely and not always 

readily available to pharmacy inspectors. Most pharmacy boards identify potential diversion 

cases primarily through pharmacy inspections and from information received from other 

government agencies. Several boards reportedly have instituted their own systems for 

tracking the distribution of controlled substances by manufacturers and wholesalers. 

In several States, the pharmacy boards have focussed particular attention on the problem of 

non-therapeutic dispensing by pharmacists. Federal controlled substances legislation allows 

prescribers to write prescriptions only for legitimate medical purposes in the usual course of 

their professional practice. The law defines a corresponding responsibility for pharmacists to 

fill only le itirnate prescriptions and makes them accountable for the prescriptions they 

dispense.29The pharmacy boards in California, Michigan, and Texas, for example, have 

widely publicized the corresponding responsibility of pharmacists and have imposed 

discipline on those who violate these legal requirements. 
Impairment 

In recent years, many pharmacy boards have come to recognize the importance of therapeutic 

interventions when dealing with pharmacists impaired by the abuse of alcohol or other drugs. 

Although the extent of chemical dependence among pharmacists is not known for sure, the 

APhA has suggested that chemical dependency affects a "substantial" number of pharmacists 

and pharmacy students. 26 

' With the leadership of organizations such as the AACP, APhA, and NABP and some State 

pharmacy associations and pharmacy boards, the number of education and treatment programs 

for impaired pharmacists has increased dramatically since the early 1980s. Approximately 80 

percent of the States now have programs to assist impaired pharmacists. These programs are 

usually operated by the State pharmacy associations or by private, non-profit agencies under 

contract to State government agencies. The NABP has encouraged pharmacy boards to 

establish cooperative relationships with rehabilitation programs and to offer rehabilitation as 

either adjuncts or alternatives to formal discipline. 

In five of our six case study States, the pharmacy boards had official connections with 

treatment programs. Three of the boards usually direct impaired pharmacists into gise 

programs, sometimes in conjunction with action against the license but sometimes not. The 

other two pharmacy boards havehad only one option when dealing with impaired 

pharmacists: mandatory revocation of license in one State; surrender of the license during 

treatment in the other. In both States, however, recent or pending legislation will grant the 

boards more latitude in the actions they can take. In all these States, impaired pharmacists 

who enter these programs voluntarily are not reported to the boards unless they are considered 

by program staff to be of danger to the public or drop out of the programs prematurely. 

Considerable variation exists among these boards in the extent to which they monitor the 

progress of pharmacists they have ordered into treatment and the degree to which they rely on 

the programs to determine when treatment has been completed successfully. 

Quality of Care 

With pharmacy boards devoting so much of their time and effort to problems of diversion, 

impairment, and technical violations, one might ask how much attention boards focus on 

pharmacists who may be incompetent. The answer is that boards seem to be doing very little 

either to identify pharmacists who may be incompetent or to ensure that practicing 

pharmacists have maintained at least minimal levels of competence. 

During the 3-year period 1986-1988, the States reported to the NABP fewer than two dozen 

disciplinary actions for reasons they described as incompetence. Moreover, board 

representatives from our case study States reported that although their practice acts included 

incompetence as one grounds for discipline, their boards had rarely, if ever, disciplined 

pharmacists for incompetence. 27 
Why is this the case? The explanations seem to be that competence is difficult to define and 

the profession of pharmacy does not appear to have achieved consensus on standards of 

competence. We found striking contradiction among the board officials with whom we spoke 

about competency issues. These officials variously defined competence as "We have no 

definition" to "Competence is following the rules." Many officials thought that standards for 

judging competence did not exist. Some thought the standards of competence were the 

requirements of the ractice acts. Another official said the standards for competence were his 

"own gut feelings." & 

Without consensus on definitions and standards, it is not surprising that no mechanisms have 

been widely instituted for assessing the continued competence of practicing pharmacists. Like 

other health licensing boards, pharmacy boards do not require periodic reexamination of 

licensees and, with the exception of mandatory continuing education, have not adopted other 

approaches helpful in assuring continued competence, such as peer review, practice audits, or 

self-assessment procedures. Although pharmacy inspectors do scrutinize pharmacists' practice 

sites through routine inspections, this process focuses on the pharmacists' compliance with the 

technical requirements of pharmacy law rather than on the quality of his or her performance. 

As a result, pharmacists who may be incompetent can continue to practice as long as they do 

not come to the attention of the boards and as long as they renew their licenses periodically by 

filing a form and paying a fee. Although continuing education is mandatory for pharmacists 

in most States and can be effective in improving knowledge and skillsF9 the system does not 

require phar~nacists to demonstrate periodically that their skills and knowledge continue to 

meet minimum levels of competence. 

Concerns about the capacity of health licensing boards to assure the continued competence of 

professionals reflect the increasing attention being focussed today on the quality of health care 

services generally. Pharmacy boards have only begun to address quality of care issues. As the 

executive from a large pharmacy board observed during one of our discussions: 

We don't get into quality of care. Our statute doesn't really address the clinical 

role of pharmacists or the practice of pharmacy outside the pharmacy. It's time 

for us to begin to address standards of practice for this. 

Progress has been slow and uneven among the States in defining scope of practice 

requirements for the emerging clinical roles of pharmacists. Similarly, the oversight process 

of most boards does not address the performance of pharmacists in clinical settings. Thus, 

disciplinary actions for inadequate clinical performance have been few. The task is complex 

and, as we have seen, presents a major challenge to the pharmacy boards. 
The ability of many State pharmacy boards to protect the public is hampered by limitations 

in their legal authorities, administrative processes, and resources. 

Insufficient Legal Authorities 

Many pharmacy boards still do not have adequate legal authority to discipline pharmacists and 

pharmacies. The grounds for discipline contained in the pharmacy practice acts are sometimes 

vaguely defined. This is particularly true for the complex grounds such as incompetence or 

unprofessional conduct. Moreover, some boards lack authority to discipline pharmacists 

without full evidentiary hearings, even when they have been convicted in criminal courts or 

disciplined by other State boards or government agencies. 

Many pharmacy boards do not have a full complement of penalties at their disposal. As we 

have seen, all boards can revoke or suspend the licenses of pharmacists and pharmacies. 

However, five boards lack authority to impose probation; eight cannot issue reprimands; and 

11 are not able to impose restrictions on licenses. At least 15 boards cannot impose fines for 

infractions of pharmacy law. Of those boards which can, some are able to impose only small 

fines or can fine only for violations of controlled substances laws. Many board 

representatives with whom we spoke said fines were an effective intermediate penalty for 

disciplining pharmacists and an effective sanction to impose on pharmacies which, because 

they are businesses, can be difficult for boards to close down even temporarily. Finally, many 

boards lack the authority to require mental, ph sical, or knowledge-based examinations of 

pharmacists as part of the disciplinary process. Y0 

Pharmacy boards are also hampered in their ability to act quickly when they identify 

pharmacists (or pharmacies) who pose an immediate danger to the public's welfare. A few 

pharmacy boards have no authority to suspend licenses on an emergency basis. A few others 

have the authority but only for violations of controlled substances laws. Even boards which 

are empowered to take emergency suspensions can have difficulty using this authority. We 

encountered several States in which boards impose these suspensions very rarely. This is not 

because the boards have no need but because these actions are very time-consuming to 

prepare and must meet the very high standards of proof required by the courts or the States' 

Attorneys General. Board representatives from one State we visited said emergency 

suspensions in their State can take as long as 2 years to obtain. 

This inability of boards to act quickly in emergency situations can pose dangers to the health 

and welfare of the public. One pharmacy inspector shared with us his concerns about a 

pharmacist he knows well who is alcoholic. "I don't have the time it would take to spend with 

him to document what I would need. All I can do is try to persuade his wife to make him stop 

practicing." An inspector from another State described his efforts with an elderly pharmacist 

who continues to practice in his own store despite serious memory problems. In this case, the 

inspector feels his only recourse is to convince the pharmacist to retire. In the meantime, he 

has been encouraging other staff from the store to watch him closely and the local pharmacy 

association to provide some relief assistance so he does not practice as frequently. 
Administrative Barriers 

The ability of many pharmacy boards to protect the public is also jeopardized by 

their limited exchange of information with other entities. 

We found that potentially rich sources of information about possible wrongdoing by 

pharmacists remain largely untapped by pharmacy boards. In our case study States, board 

officials reported their States had no comprehensive laws requiring the reporting to them of 

potential or actual wrongdoing by pharmacists. Consequently, they receive few, ifany, 

referrals from hospitals, nursing homes, insurance companies, or the courts. Individual 

pharmacists make few referrals to the boards as do the professional associations of 

pharmacists in these States. As a result, pharmacy boards most often learn about potential 

cases from consumers, other law enforcement agencies including the DEA, and from 

pharmacy inspectors through their inspections of pharmacies or reviews of controlled 

substances records and reports. 

Moreover, many pharmacy boards have not been sharing information with each other on the 

disciplinary actions they have taken. We found that during the period 1986 through 1988, 

more than one-fourth of all boards never reported any of their disciplinary actions to the 

voluntary Disciplinary Clearinghouse maintained by NABP. In fact, two-thirds of the boards 

did not report any actions for at least 1of these 3 years. Similarly, since 1985 only one-fourth 

of the States reported any disciplinary actions to the clearinghouse maintained by National 

Clearinghouse on Licensure, Enforcement, and Regulation (CLEAR). This failure of so many 

pharmacy boards to regularly share important disciplinary information with each other 

increases the vulnerability of the public to wrongdoers who are licensed to practice in more 

than one State or who transfer their licensure to other States to avoid discipline. 

Not only do many pharmacy boards not share information with each other, but a sizeable 

number do not publicize their disciplinary actions even to the professional pharmacy 

community in their States or to the general public. Only slightly more than half the pharmacy 

boards were participating in NABP's newsletter project in 1988. Funded primarily by 

NABP's Bureau of Voluntary Compliance, these State newsletters contain both national news 

and State-specific information, including summaries of disciplinary actions, in an effort to 

enhance pharmacists' voluntary compliance with State and Federal pharmacy laws. 

The ability of pharmacy boards to protect the public by assuring prompt discipline 

for serious offenses is hampered by the time-consuming nature of the disciplinary 

process itself. This process can be very elaborate and often unwieldy for dealing 

with detailed pharmacy law and for adjudicating the serious, often very complex, 

disciplinary cases. 

Pharmacy boards vary considerably in the specifics of their disciplinary processes and in the 

latitude given to administrative staff for resolving complaints and dealing with violations. 

Nevertheless, we found that most boards have tried to maximize resources by prioritizing the 
cases they pursue and by adopting multiple levels of intervention for dealing with different 

kinds of violations. 

The enforcement process is swiftest and simplest for the least serious violations. Minor 

infractions, frequently those discovered during routine pharmacy inspections, are often dealt 

with by the inspectors immediately with written or verbal warnings. More serious violations, 

or repeated or uncorrected minor violations, are typically dealt with through meetings between 

the pharmacist and a supervisory inspector or an informal committee which includes some 

board members. This strategy of prioritization seems to serve the boards well. It permits the 

administrative staff to resolve the majority of complaints and violations through various 

informal mechanisms so that only the most serious cases are considered by the entire board for 

formal discipline. In recent years, these kinds of cases have primarily involved drug 

diversion, impairment of pharmacists due to abuse of alcohol or drugs, and serious fraud. 

The irony, however, is that the most serious cases, including those which presumably pose the 

greatest threat to the public's welfare, are those cases which can take the longest time for 

boards to deal with. These cases are often complex ones requiring time-consuming 

investigation and legal preparation. These cases can also take a very long time to process 

because of the multiple reviews and clearances required as part of the disciplinary process. 

These reviews often involve staff from different State agencies which usually have competing 

priorities. Many pharmacy boards, for example, must share inspectors and investigators with 

other licensing boards or must rely on staff from offices of attorney general for their legal 

assistance. 

Furthermore, long delays can result from the hearing process itself. Representatives from 

several boards complained to us about the long delays which result in their States from the 

frequent continuances granted to defendants. One board has no regularly scheduled meetings 

for considering disciplinary cases. Long delays thus result from the logistical difficulties of 

arranging members' schedules. To make matters worse, if the case is not concluded in I day 

or a last minute continuance is granted, the lengthy process of rescheduling the hearing must 

begin anew. Finally, delays can occur after the hearing process is concluded due to stays 

granted during the appeals process or, in those States with boards which are advisory, from 

further deliberations by other State officials. 

Some States have taken steps to expedite their disciplinary process. Some do not require the 

full judicial process or evidentiary hearings for certain kinds of cases. Others are making 

increased use of stipulated settlements negotiated by staff for subsequent approval by board 

members or are relying on Administrative Law Judges rather than evidentiary hearings of the 

boards for those cases which cannot be stipulated. 

Despite measures such as these, the investigation and adjudication processes can take a long 

time. Several board officials from our case study States told us of cases taking a year, 2 years, 

or even longer before the board had concluded its deliberations. Barriers which hamper more 

timely resolution of the most serious cases exist in many States. Nearly one-third of the board 

executives with whom we spoke singled out administrative bottlenecks in their States' 
administrative processes as major factors hindering their boards' efforts to assure prompt 

discipline. 

Inadequate Resources 

Nearly 60 percent of the pharmacy board executives with whom we spoke thought their ability 

to enforce Rharmacy laws and to discipline effectively has been hampered by insufficient 

resources. The fees boards charge their licensees are one indicator of resources available to 

boards as the budgets for two-thirds of the pharmacy boards reportedly depend on the amount 

of receipts they collect. We examined the renewal fees for both pharmacists and pharmacies 

and found them to be quite low. This was the case even though 20 percent of the States 

increased their renewal fees for pharmacists and 25 percent of the States increased the renewal 

fees for pharmacies between 1987 and 1988. The average annual cost of a pharmacist's 

license was $43.12 in 1988, an increase of less than $4 since 1987. The average annual cost 

of a pharmacy permit was $84.33 in 1988, a decrease of slightly more than $5 since 1987.~~ 

Insufficient resources hinder the ability of pharmacy boards to enforce the laws and discipline 

pharmacists in several important ways. First, the number of staff available to do the job 

promptly and thoroughly may be insufficient. Although representatives from several boards 

mentioned they had had small increases in staff in the last few years, many more indicated a 

need for additional legal expertise and for more pharmacy inspectors. The staff of many 

boards are stretched thin. On the average, pharmacy boards have five inspectors for 

conducting inspections and investigating reports of potential wrongdoing. In many States, 

these inspectors are shared with other boards.33 In consequence, fewer and fewer pharmacy 

boards have been conducting routine inspections of pharmacies once a year, a process 

important for educating pharmacists as well as for identifying violations. Only one of our 

case study States reported being able to conduct routine inspections annually. Another rarely, 

if ever, performs them. 

Salaries which are not competitive is a second major consequence of limited resources. 

Several board representatives complained to us about the inability of their States to attract and 

retain experienced legal staff to work with them in the development and prosecution of cases. 

Others mentioned the difficulties of recruiting pharmacists to work as inspectors given the 

higher salaries available to them elsewhere. Even the level of compensation offered to board 

members is low in most States: an average per diem of $49.58 plus expenses last year. 34 

Finally, pharmacy boards faced with insufficient resources sometimes do not have the support 

services critical to their overall performance. Orientation for board members and training for 

staff, essential given the scope and dynamism of boards' regulatory responsibilities, is limited 

in some States. Computerization; vital for keeping current records on licensees and tracking 

disciplinary actions, has lagged for some as well. We witnessed the deliberations of one 

pharmacy board, for example, which had to rely on the defendant for information about 

previous disciplinary actions. 
RECOMMENDATIONS 

Given the situation described in the previous pages, we offer several recommendations with 

respect to the enforcement and disciplinary practices of State pharmacy boards. Our central 

recommendations are directed to State governments and to State boards of pharmacy. We 

address several other important recommendations to the National Association of Boards of 

Pharmacy, the American Pharmaceutical Association, and the U.S. Public Health Service. 

THE STATE GOVERNMENTS 

State governments should ensure that State pharmacy boards have adequate 

resources and authority for carrying out their enforcement responsibilities 

effectively. 

If boards are to protect the public, they need adequate resources. They need a sufficient 

number of well-qualified, adequately paid staff and board members. They need computer 

systems and training for both staff and board members. .. ., 

Resources available to the boards need not be limited by overall constraints on stare budgets. 

States should ensure that the fees for pharmacy licenses and permits generate revenues 

sufficient for the boards' needs and that the revenues generated be available for use by the 

boards. Other mechanisms for generating revenues also exist. We learned of one board which 

has authority to recover from defendants the costs of the time incurred by the board's 

investigators and lawyers. 

Boards need a full range of disciplinary options at their disposal--options which are effective 

and flexible for both pharmacists and pharmacies. States ought to have written disciplinary 

guidelines for imposing penalties. Although each case is unique, guidelines which describe 

ranges of penalties for various offenses are important for assuring fairness and consistency in 

board decisions and useful for practitioners. 

Pharmacy practice acts should state clearly and specifically the grounds for discipline so that 

both regulators and pharmacists understand what is and is not acceptable. Practice acts too 

should empower boards to require physical, mental, or knowledge-based examinations of 

pharmacists when necessary. 

States should ensure that boards have authority to act promptly in order to protect the public's 

welfare. In certain cases, boards should be able to take action against licensees without full 

evidentiary hearings. They should be held to standards of proof which protect the rights of 

pharmacists but are not so burdensome as to jeopardize the rights of the public. It is 

imperative that boards have both the authority and a workable process for suspending 

immediately the licenses of those who threaten the health and safety of the public. This is not 

the case now in most States. 
State governments should take steps to streamline the administrative process so 

that State pharmacy boards are able to process disciplinary cases more efficiently. 

The time-consuming nature of the disciplinary process in many States coupled with the 

inability of most boards to effect emergency actions jeopardizes the protection afforded by 

boards to the public. States should streamline their processes as much as possible and rid 

them of unnecessary reviews and other time-consuming procedures. 

State governments should take steps which enhance the capacity of pharmacy 

boards to deal with drug diversion and impairment of pharmacists. 

By strengthening their overall efforts to address drug diversion and impairment, States can 

enhance the capacity of pharmacy boards, as well as other health professional boards, for 

dealing more effectively with these serious problems. State governments might consider, for 

example, supporting treatment programs for all health professionals including pharmacists 

who come to the attention of their licensing boards. 

States should consider adopting stronger measures for combatting drug diversion such as 

separate registrations for controlled substances and multiple copy prescription programs. 

Such approaches have enhanced the enforcement efforts of pharmacy boards as well as those 

of other agencies. They have been strongly supported by the DEA over the years and more 

recently by The White House Conference for a Drug Free America. 35 

STATE PHARMACY BOARDS 

State pharmacy boards should review the outcomes of their disciplinary process 

and evaluate whether they are affording the public the maximum protection 

possible. 

It is imperative that pharmacy boards carry out their disciplinary responsibilities forcefully. 

The disciplinary data on serious actions suggest that too many boards have not been imposing 

rigorous discipline over the last few years. To be sure, many boards discipline wrongdoers in 

less formal ways, and many boards too have been hindered by constraints of various kinds. 

Nonetheless, that so many boards imposed so few of these most serious actions during the last 

3 years suggests a need for greater intensity in their disciplinary efforts. 

State pharmacy boards should disseminate more broadly information on the 

disciplinary actions they have taken. 

Pharmacy boards should do a better job of sharing with each other information on the serious 

disciplinary actions they take. Failure to report completely and timely on serious actions to 

CLEAR and to the NABP Disciplinary Clearinghouse limits the ability of boards to protect 

the public from pharmacists who escape discipline in one State by moving to another State 

where they are also licensed. It also undermines the effectiveness of NABP's process for 
verifying the credentials of those pharmacists wishing to transfer their licensure from one 

State to another. State boards should take immediate steps to improve their voluntary 

reporting through these existing mechanisms. They should not delay until implementation of 

the new practitioner databank, authorized under Section V of the Medicare and Medicaid 

Patient and Program Protection Act of 1987, when reporting of disciplinary actions becomes 

mandatory. 

NATIONAL ASSOCIATION OF BOARDS OF PHARMACY 

For many years, the National Association of Boards of Pharmacy (NABP) has provided 

important leadership to State pharmacy officials in the areas of licensure, discipline, and 

regulation of pharmacy practice. As pharmacy practice continues to change and the demands 

on boards continue to grow, we urge the NABP to continue to provide this leadership to State 

boards. In so doing, we encourage the NABP to broaden and increase its financial base so it 

can continue these important efforts independent of any financial association with pharmacy 

organizations which may be regulated by its membership. We offer the following specific 

recommendations: 

The NABP should intensify its efforts to help State pharmacy boards address the 

changing nature of pharmacy practice, particularly with respect to the clinical roles 

of pharmacists. 

The NABP should focus particular attention on assisting boards in developing regulatory 

requirements and oversight procedures which address patient care responsibilities of 

pharmacists. In so doing, the NABP should work with other professional pharmacy 

organizations, especially the APhA, the AACP, the American Council on Pharmaceutical 

Education (ACPE), the American Society of Consultant Pharmacists (ASCP), and the 

American Society of Hospital Pharmacists (ASHP). 

The NABP should also help boards identify useful strategies for dealing with drug diversion. 

The NABP should work with State pharmacy boards and national professional 

pharmacy organizations to explore viable approaches to assessing the continued 

competence of licensed pharmacists. 

We agree with the conclusions of the 1975 AACPIAPhA Task Force on Continuing 

that pharmacists should be required to demonstrate continued professional 

competence to State licensing boards as a condition of relicensure. Most boards have adopted 

mandatory continuing education as a mechanism for assuring continued competence. Boards 

now need to explore and experiment with various mechanisms for assessing periodically the 

professional competence of practicing pharmacists. The task is complex and controversial. 

The NABP has a vital role to play in charting the direction for this effort involving State 

boards and the professional pharmacy organizations. 
THE AMERICAN PHARMACEUTICAL ASSOCIATION 

The American Pharmaceutical Association (APhA) should exercise its leadership 

in encouraging more peer review of pharmacists' professional performance by 

national and State professional pharmacy organizations. 

The relative lack of peer review by professional pharmacy organizations is unfortunate. 

Without a process to permit review of professional performance by peers, the profession 

abdicates responsibility for policing itself and undermines the confidence of the public in its 

professionalism. It is important that the professional pharmacy organizations renew these 

efforts and be guided less by the threat of antitrust litigation than by the examples of the few 

State pharmacy associations and the associations of other professions such as medicine, 

dentistry and podiatry which have more active peer review programs. As the most broadly 

based professional organization of pharmacists, the APhA should take the lead in this effort 

which should also include its affiliated State associations as well as other national professional 

organizations such as the ASCP and the ASHP. 

The APhA should work with the NABP and other professional pharmacy 

organizations to develop appropriate methods for assessing the continued 

competence of pharmacists. 

Ten years ago, the APhA and the AACP pioneered the development of the professional 

practice standards for pharmacy37-the fust order of business recommended in 1975by the 

Task Force on Continuing Competence. The second order of business charted by the Task 

Force was the development and implementation of mechanisms for assessing performance 

based on the standards. Little has been accomplished in this arena during the last 10years. 

We urge the APhA to work with other professional and regulatory organizations to experiment 

with approaches such as self-assessment tests, peer review, and practice audits. The task is 

difficult and complex but, as the experience of several medical specialty boards suggests, is 

nonetheless possible. 38 

THE U.S. PUBLIC HEALTH SERVICE 

The Public Health Service (PHs) should increase its support to the NABP in its 

efforts to provide leadership to State pharmacy boards. 

The PHs has provided financial assistance to other professional organizations but has had 

little involvement over the years with the NABP. We encourage the PHs to explore ways to 

support the NABP in its efforts to assist the boards. The PHs, for example, might consider 

working with the NABP in developing and piloting mechanisms for assessing the continued 

competence of pharmacists. The PHs with its broad purview is well positioned to encourage 

broad interdisciplinary efforts toward this end. 
COMMENTS ON THE DRAFT REPORT 

AND OIG RESPONSE TO COMMENTS 

We received comments on the draft report from the Health Care Financing Administration and 

the Public Health Service within the Department of Health and Human Services and from the 

Drug Enforcement Administration in the Department of Justice. Comments were also 

received from the American Association of Colleges of Pharmacy (AACP), American 

Pharmaceutical Association (APhA),American Society of Hospital Pharmacists (ASHP), 

National Association of Boards of Pharmacy (NABP), and the National Clearinghouse on 

Licensure, Enforcement and Regulation (CLEAR). 

The OIG response to the major issues raised in these comments from these government 

agencies and national organizations are contained below. The detailed comments fiom these 

agencies and organizations appear in appendix A. 

Overall, no one disagreed with our recommendations that State governments should ensure 

that State boards of pharmacy have adequate resources and authorities and should streamline 

administrative processes to enhance efficiency. Our recommendations that State pharmacy 

boards review the outcomes of their disciplinary processes and disseminate more broadly the 

outcomes of disciplinary action to assure maximum protection of the public were also 

generally supported. Further, no one disagreed with our recommendation that the APhA, the 

NABP, other professional pharmacy organizations, and the State boards should work together 

to explore and develop viable approaches for assessing the continued competence of licensed 

pharmacists. 

The APhA and the NABP both had concerns about our recommendation calling for more peer 

review of pharmacists' professional performance by national and State professional pharmacy 

organizations. The NABP was concerned that our call for stronger peer review suggested a 

weakening or replacing of the disciplinary responsibilities of the pharmacy boards. The APhA 

was concerned about professional associations having adequate resources to undertake peer 

review efforts and about the possibility of antitrust litigation. 

In our view, peer review of pharmacists' professional performance by the professional 

organizations need not, and indeed should not, duplicate or replace the legal responsibilities of 

the State pharmacy boards for licensure and discipline. We recognize that peer review, too, 

has both cost and legal implications for professional associations. Nonetheless, we think that 

as professional organizations, the pharmacy associations have the responsibility and the 

opportunity to play an important role in identifying and assisting practitioners whose 

performance falls below acceptable standards and in referring to the State boards those whose 

performance has violated legal requirements. 

Health Care Financing Administration 

The HCFA was generally supportive of our recommendations. 
Public Health Service 

We are pleased with PHs' concurrence with our recommendation to provide increased 

support to NABP in its efforts to provide leadership to State pharmacy boards. We 

recognize that PHs has worked collaboratively with NABP over the years and 

encourage PHs to consider some financial assistance for specific undertakings as it has 

provided in the past to other national organizations of the various State health 

professional boards. 

The PHs observes that the estimates of active pharmacists used in the report are 

overstated. We, too, have recognized the discrepancy between the PHs projected 

estimates and the manpower estimates available from the NABP and the State boards. 

The rationale for the estimates we used is explained in appendix C and, we believe, 

remains valid. 

Drug Enforcement Administration 

We are pleased with DEA's positive response to our findings and recommendations. As 

noted in the report, DEA has frequent interactions with State boards of pharmacy 

involving their respective responsibilities for regulating the distribution of controlled 

substances. 

American Association of Colleges of Pharmacy 

We appreciate the positive comments from the AACP on our report and its support, in 

particular, of increased professional peer review. 

American Pharmaceutical Association 

We are pleased that APhA agrees generally with our recommendations to the State 

governments and the State pharmacy boards. 

As noted above, APhA has concerns about our recommendation that it encourage more 

peer review by professional pharmacy associations. We recognize the important 

leadership exercised by the APhA over the years in addressing issues such as pharmacist 

impairment and in developing standards of practice and a Code of Ethics for the 

profession. While the difficulties associated with peer review efforts are significant, as 

the APhA points out, we are pleased that it plans to consider carefully this , 

recommendation. 

We regret that the APhA did not comment specifically on our recommendation that it 

work with the NABP and other professional pharmacy organizations to develop 

appropriate methods for assessing the continued competence of pharmacists. We 

continue to regard this effort as a high priority which warrants the attention and 

leadership of the APhA. 
American Society of Hospital Pharmacists 

We appreciate the response from ASHP, which, while not addressing specifically the 

findings and recommendations of the report, offers more general comments about our 

inquiry as it relates to the practice of pharmacy today. 

The ASHP suggests that the report should have addressed more completely the public 

health hazards of pharmacist incompetence and the role of boards in regulating 

non-pharmacist and mail order dispensing of prescription drugs. We believe an in-depth 

examination of these issues was beyond the purview of this particular inquiry which 

focussed on an assessment of the disciplinary practices of the State boards of pharmacy. 

We strongly disagree with the ASHP comment that regulation of both the dispensing 

and clinical aspects of pharmacy practice by State pharmacy boards would be "highly 

unrealistic and unwise." On the contrary, we believe regulation of the entire spectrum 

of pharmacy practice is essential to the responsibilities and mandates of State boards to 

protect the public by assuring safe, competent practice of pharmacy regardless of 

practice setting. As we noted in the report, a major challenge facing the boards today is 

the need to address the changing nature of pharmacy practice in which incre2ing 

numbers of practitioners are assuming responsibilities for patient care and well as for 

prescription dispensing. 

National Association of Boards of Pharmacy 

We appreciate the overall positive response of the NABP to the findings and 

recommendations of the report. Our comments on particular issues raised by the NABP 

follow. 

The NABP asks that we include in the report the actual disciplinary data collected from 

the States to support our findings regarding the incidence and rates of serious discipline 

imposed by the boards in recent years. These State-specific data were not included in 

the draft of the report because the focus of our inquiry emphasized a national picture of 

the disciplinary practices of the State boards. In response to this particular request, we 

have included as part of the final report (see appendix B) the State-specific data we 

collected. These data were gathered through telephone discussions with pharmacy 

board officials in all States in order that we might have for our analysis the most 

comprehensive, up-to-date data available. In those few instances where data are 

missing, the State officials were unable to provide us with numbers of serious 

disciplinary actions for their boards. A detailed explanation of our methodology 

appears in appendix C. 

As noted and discussed above, the NABP is concerned with our call for strengthened 

peer review by the professional pharmacy associations. In our view, such an effort 

would not duplicate or replace the responsibilities of the State boards but would be 

complementary to their efforts to protect the public. 
The NABP makes note of our comment in the report about the "corresponding 

responsibility" of pharmacists for the legitimacy of the prescriptions they dispense for 

controlled substances. This responsibility is clearly articulated in Federal law (Title 21, 

Code of Federal Regulations, Section 1306.4), and, as noted in the report, is being 

aggressively enforced by some pharmacy boards, including three of our six case study 

States, as a critical strategy for curtailing drug diversion. 

We are concerned with the thrust of the NABP comments about emergency suspensions 

of licenses. We reiterate the importance to the public of boards having adequate 

authorities and workable processes for suspending, on an emergency basis, the licenses 

of pharmacists who threaten the health and safety of the public. Whatever the reasons, 

the situations described in the report are, in our view, simply not defensible. 

National Clearinghouse on Licensure, Enforcement and Regulation 

The comments from CLEAR were generally positive. However, with respect to our 

analysis of the incidence of serious disciplinary actions imposed by the boards between 

1986 and 1988, CLEAR comments that further explanation for the increases or lack of 

increases in these actions would have been helpful. We agree that such an explanation 

is important. In response, we suggest that the value of our inquiry was to document the 

disparity that exists nationally in the rate of serious discipline imposed by the boards 

based on our collection and analysis of the most recent, most comprehensive 

disciplinary data available at present from State pharmacy boards. Although we suggest 

possible reasons for this disparity in our report, further exploration was beyond the 

purview of this particular inquiry and is, we believe, more properly the responsibility of 

the State governments and their respective boards of pharmacy. 

APPENDIX A 

COMMENTS ON THE DRAFT REPORT 

We received comments on the draft report from the Health Care Financing Administration and 

the Public Health Service within the Department of Health and Human Services and from the 

Drug Enforcement Administration in the Department of Justice. Comments were also 

received from several national organizations including the American Association of Colleges 

of Pharmacy (AACP), American Pharmaceutical Association (APhA), American Society of 

Hospital Pharmacists (ASHP), National Association of Boards of Pharmacy (NABP), and the 

National Clearinghouse on Licensure, Enforcement and Regulation (CLEAR). The actual 

comments received follow in this appendix. 
Memoralidurn 

MAR 12 m 

Date 

Gail R. Wilensky, Fh.D. 

From Mministrator 

OIG Draft Report: "State Discipline of Fhannacists" (CVII-01-89-89020) Subject 

Ihe m r Gemzal 

Office of the Secretary 

We are to y w request for ccmPents on the arbject report. 

"ile no remrpnenjatiom mmade directly to HCTA, we beliwe that 

those made to the other entities are raascnable. We a~preciatethe 

CPPomity to review the mts of this study. 
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Serv~ce 

Memorandum MAR20 1990 

Date ' 

Assistant Secretary for Health From 

Subject Comments on Office of Inspector General (OIG) Draft Report "State 

Discipline of Pharmacists," OAI-01-89-89020, January 1990 

To Inspector General, OS 

As requested, we have reviewed the subject draft report and have 

the following comments on the recommendation addressed to PHS and 

statistical data cited in the report. 

OIG Recommendation 

The Public Health Service (PHs) should increase its support to 

the NABP in its efforts to provide leadership to State pharmacy 

boards. 

PHs Comment 

We concur. PHs is collaborating with the National Association of 

Boards of Pharmacy (NABP) in its efforts to provide leadership to 

State pharmacy boards through informal meetings and by its 

participation on the Pharmacy Manpower Steering Committee which 

NABP co-chairs along with the American Association of Colleges of 

Pharmacy. However, PHs does not provide financial or technical 

assistance to the NABP due to unavailability of funds. 

The Health Resources and Services Administration through its 

Bureau of Health Professions, is pursuing non-financial 

collaborative efforts with other Government components (Health 

Care Financing Administration and National Institutes of Health), 

to identify ways and means to provide technical assistance 

to NABP. . 

Technical Comment 

The draft report on pages 2 and A2 noted the estimated number of 

active pharmacists in the U.S. as being approximately 183,000. 

This number is overstated according to data compiled by the 

Health Resources and Services Administration'e Bureau of Health 

Professions. Based on the 1978 federally funded Pharmacy 

Inventory, which is Supply Model 

Estimate of active U.S. for 1989 was 157,900. 

James Mason, M.D., Dr. P.H. 
Drug Enforcement Administration 

Honorable Richard P. Kusserow 

Inspector General 

Department of Health and Human 

Services 

Washington, D.C. 20201 

Dear Mr. Kusserow: 

This is in response to your draft report "State Discipline of 

Pharmacistsu dated January 1990. I commend your office and those involved 

for this excellent evaluation of the pharmacy disciplinary process. he 

Drug Enforcement Administration's (DEA) concern in this matter pertains to 

controlled substances, while the report is addressing the discipline of 

pharmacists by state pharmacy boards for infractions dealing with all 

phases of pharmacy practice. Specific areas of study in the report agree 

with recommendations that have been made in the past by state officials at 

DEA national conferences. 

The section of the report dealing with Multiple Copy Prescription 

Programs (MCPP) on page 6 is supportive of a program which has been 

endorsed by the DEA. MCPP is an effective deterrent to pharmaceutical 

diversion. Data compiled from states who have instituted the program 

document a 30 to 50 percent reduction in Schedule 11prescriptions. In 

addition, agencies responsible for investigating diversion of controlled 

substances have successfully applied MCPP intelligence information in 

targeting illegal activities. At the present time, nine states have - enacted MCPP with 40 percent of the physicians and pharmacists in the 

United States operating under the program. . The DEA concurs with your recommendation for separate registration for 

controlled substances. This recomndation responds favorably to the 

finding that many boards do not have adequate legal authority to discipline 

pharmacists. The separate registration creates an avenue through which the 

judicial and administrative processes can take appropriate action against 

individuals responsible for the diversion of controlled substances. 
me DEA recognizes that inadequate resources, administrative barriers 

and insufficient legal authorities reduce the ability of pharmacy boards to 

enforce pharmacy laws and to discipline effectively. In response to this 

situation, the United States Code was amended in 1984 to enhance the DEA's 

authority to revoke or suspend DEA controlled substance registrations 

issued to registrants that are inconsistent with the public interest. This 

amendment to the Code has enabled the DEA to work in tandem with the states 

and has filled a void created when states have been unable to effectively 

discipline violative registrants. 

he DEA had enjoyed a close working relationship with the National 

Association of Boards of Pharmacy (NABP) and I was pleased to see the 

recormendation that the NABP continue to provide leadership to the state 

boards. 

I feel the findings and recomnendations in the report are justified, 

and the information and methodology of research was thorough. I thank you 

for providing me with the opportunity to cwment on a subject that is 

important to the DEA. 

Sincerely, A 

J n C. Lawn 8inistrator 
5

4 

. . 

. ' t. 

'k.' 

 

A 

&-.rs~-

AMERICAN ASSOCIATION 

OF COLLEGES OF PHARMACY 

February 27, 1990 

+. hlr. ,Richard P. Kusserow 

Inspector General 

Department of Health and Human Services 

Washington, DC 20201 

Dear Mr. Kusserow: 

Thank you for the opportunity to comment on your draft repon, "State Discipline of 

Pharmacists." You and the Boston Regional Office are to be congratulated on the timeliness 

and accuracy of your obsenrations and recommendations. 

After careful review, we offer several obsemations: 

o The Report refers to quality of health care in several places. We observe that 

it is difficult for regulator). boards, including those in pharmacy, to assess and/or 

ensure quality. For example, Boards mandate requirements to enter practice 

(i.e. education, experience, licensure) and have implemented procedural 

requirements (i.e. continuing education, patient profiles, patient consultation) 

with little objective evidence that these affect the quality of pharmaceutical 

senices. Perhaps research and demonstration projects in the area of outcome 

measures/assessments are needed. 

It also follons that standards, as the Report has aclmowledged, exist within the 

profession. Specifically, the APhA/AACP Standards of Practice, published over 

a decade ago, are currently undergoing review for revision/revalidation. These 

Standards are used by colleges of pharmacy in cumculum development and 

assessment, state boards of pharmacy and as a foundation for the NABP's 

national licensing examination. Additionally, ASHP has a iomprehensive set of 

facility, personnel and process standards for various types of institutional 

practices. The ASHP's standards are excellent examples of the profession's 

attempt to ensure the quality of pharmaceutical services. It is essential that - - efforts in standard development and refinement continue. 

o Clearly pharmacy practice (and health care) is changing at a rapid pace. If we 

assume that such change is basically in the best interest of the public health, 

then pharmacy boards should attempt to stimulate change rather than impede 

it. There is a thin line bcnvccn reality and perception and between boards 

sening in the public interest (as they are charged) and in the interest of the 

1426 Prince Street Alexandria, Virginia 22314 (703) 739-2330 
hlr. hchard P. Kusserow 

February 27, 1990 

Page 2 

profession. However, pharmacists are professionals and need to be held 

responsible for their actions. Pharmacy boards should revise their pharmacy 

practice acts so as to enable pharmacists to expand the scope of their practices 

to the limit as defined by the profession, not testria practice. 

o The Repon's observation about the lack of peer review by the profession is a 

valid and powerful one. In the face of this mid, dl the public has to rely on 

is the state regulatory agencies. The recent articulation of the concept of 

pharmaceutical care (Pbannrrcy in tbe 21st Century, copy enclosed) which 

focuses on the outcomes of drug therapy, suggests that pharmacy needs to be 

responsive to calls for peer review. 

If you have any questions or require additional clarification, please feel free to call on us. 

Sincerely, 

Carl E. Trinca, Ph.D. 

Executive Director 

enclosure 
2215 Const~tutmAvenue. W 

Pharmaceutical wash~ngton.DC 20037 TheNational Prof~'ona1 

Association (202) 6284410 FAX (202) 783-2351 Society of Phsmrtr 

March 6, 1990 

Richard P. Kusserow 

Inspector General 

Department of Health and Human Services 

Washington, DC 20201 

Dear Mr. Kusserow: 

The American Pharmaceutical Association is pleased to respond to the 

draft report of the Office of the Inspector General entitled "State 

Pisci~line of pharmacist^". As the national professional society of 

pharmacists, we are gratified by the substantial analysis that our 

profession has received in recent reports from your office. More 

importantly, we are pleased that the critical role that pharmacists play 

in providing quality health services to patients is finally becoming 

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

recognition of APhA's leadership role for the profession on these issues. 

Our comments include both general reflection on the report, its findings 

and recommendations, as well as specific responses to the recommendations 

addressed directly to APhA. We ask that they be carefully considered in 

the preparation of the final report on this subject. 

WSPONSE TO FINDINGS AND THE OVERALL REPORT 

In general, the draft report's findings appear to have been developed in 

a fair and reasonable manner, and are presented in a balanced fashion. 

We particularly commend the IG staff for making on-site visits to examine 

first hand the workings of several boards of pharmacy. 

The draft report identifies several related issues regarding pharmacy 

boards' capabilities and resources. APhA certainly agrees that boards of 

pharmacy should be provided with the financial, materfal and human 

resources necessary to accomplish their work. While these needs 

obviously vary from state to state, it is clear that no board of 

pharmacy, such as one cited in the report, can be expected to effectively ,, 

accomplish its mission with a budget of $2500 and one part-time staff 

person. We hope that the final report will stimulate states to provide 

boards of pharmacy with the resources they require. 

The draft report identifies two other substantial general factors that 

impact on the capabilities of boards of pharmacy: 

o the greater complexity of the tasks and responsibilities of 

pharmacy boards compared to their counterparts in other 

professional disciplines; and, 
Richard P. Kusserow 

March 6, 1990 

Page -2-

o the dramatic changes in the nature and scope of pharmacy practice 

in recent years, with increased emphasis on patient care and 

educational activities of pharmacists in many different types of 

practice settings. 

The former issue is not easily resolved. Pharmacy is unique in that both 

its practitioners and the settings in which they practice are regulated 

by the same governmental entity. Pharmacists are responsible for the 

proper control and provision of both powerful and potentially dangerous 

medications and important patient and information services. This unique 

mix of services and products places on pharmacists, and theoretically 

requires of the boards which regulate their practice, levels of 

regulatory control that are the most demanding and detailed in the health 

professional regulatory arena. 

As mentioned in the draft report, control efforts to date have been 

focused on structural and procedural components (i.e. equipment and 

plumbing requirements within pharmacies, restrictions on which pharmacy 

personnel may remove or place medication containers on pharmacy shelves, 

controlled substances classification and tracking) rather than on outcome 

measures of the pharmacy services provided. APhA agrees that measuring 

the quality of care outcomes is the desired goal. Nevertheless, as the 

entire health care field is learning, the shift from measuring process to 

measuring outcome in delivery of care is a very complex task which will 

require both additional resources and fundamental re-evaluation of 

regulatory and accreditation activities. 

The ability of pharmacy boards to keep up with the rapid changes in 

pharmacy practice is, in our view, less problematic. Although much 

remains to be done, APhA has been encouraged in recent years by changes 

in a few state pharmacy practice acts which have articulated substantial 

patient care and education functions in addition to traditional 

medication distribution and control activities. Often, these changes 

have been a result of effective collaboration between state pharmacy 

associations, the National Association of Boards of Pharmacy (NABP), and 

the state boards of pharmacy, using the APhA/AACP Standards of Practice 

and components of NABP's Model Practice Act. Some state boards have also 

either expanded or modified their membership to include practitioners 

from the many varied types and settings of pharmacy practice now in 

existence. This trend should be encouraged, in order to assist pharmacy 

boards in their understanding of the full scope of pharmacy practice now 

and for the future. 

The draft report notes the emphasis currently placed on drug diversion 

and pharmacist impairment by boards of pharmacy. These issues, 

reflective of perhaps our society's greatest social problem, must be 

addressed by all of us. APhA does support the role of boards of pharmacy 

in monitoring conpliance by pharmacists with all laws and regulations 

governing drug diversion. It is important to point out, however, that 

arrest records for DU controlled substance violations in the most recent 

years indicate pharmacist involvement in less than one-tenth of one 

percent of cases. 
Richard P. Kusserow 

March 6 , 1990 

Page -3-

The draft report is correct in its identification of impairment and the 

accompaniment of drug diversion for self-use as a problem which the state 

boards of pharmacy, along with the profession as a whole, have the 

responsibility to address. 'In fact, the profession--through APhA's 

singular leadership--and the boards of pharmacy have undertaken an 

aggressive program to do just that. 

That program involves the establishment of Pharmacist Recovery Programs 

in 46 states over the past eight years. Established in cooperation with 

state boards of pharmacy, such programs are designed to identify, 

evaluate, treat, and rehabilitate impaired pharmacists and to 

successfully return them to practice. We therefore take substantial 

pride in the draft report's mentioning that state boards' activities 

include reinstatement of licenses. This fs at least as much a reflection 

of successful pharmacist recovery programs as it is a reflection of any 

"...overstate[ment] [of] the severity of boards' disciplinary activity." 

Because of the proven success of Pharmacist Recovery Programs, boards of 

pharmacy now have less need to revert to disciplinary actions to assure 

the public is protected from pharmacists suffering from impairment. 

Consequently, the volume of disciplinary actions taken by an individual 

board of pharmacy should not necessarily be used as a measure of its 

effectiveness in dealing with pharmacist impairment and resultant drug 

diversion. In Virginia, for example, it has been reported that when the 

state's Pharmacist Recovery Program was founded, "more than 40 

pharmacists in the state had lost their licenses that year because of 

drug or alcohol abuse. With the program underway, such disciplinary 

action is a rarity." 

The movement to establish Pharmacist Recovery Programs got its largest 

boost in 1982, when the APhA House of Delegates adopted the following 

policy: 

1. APhA believes that pharmacists should not practice while subject 

to physical or mental impairment due to the influence of 

drugs--including alcohol--or other causes that might adversely 

affect their abilities to function properly istheir professional 

capacities. 

2. APhA supports establishment of detection processes as well as 

counseling, treatment, prevention, and rehabilitation programs 

for pharmacists and pharmacy students who are subject to physical 

or mental impairment due to the influence of drugs--including 

alcohol--or other causes, when such impairment has potential for 

adversely affecting their abilities to function properly in their 

professional capacities. 
Richard P. Kusserow 

March 6, 1990 

Page -4-

APhA's strategy from the beginning has been to help establish impairment 

assistance programs in the states and in the schools. Soon after the 

1982 policy on pharmacy impairment was adopted, APhA began a relationship 

with the University of UtahSchool on Alcoholism and Other Drug 

Dependencies. The internationally recognized school, which this year 

will be holding its 39th session, conducts a one-week, intensive summer 

course on a broad range of areas related to chemical dependency. In 

1983, APhA agreed to become the sponsor of the Pharmacists Section, one 

of 18 sections of the school and to use that opportunity to help 

implement the new policy. The session would be used to help foster the 

development of impaired pharmacist assistance programs at the state level. 

Although APhA's involvement goes back to 1982, state level activity had 

begun even earlier, with the first state impaired pharmacist program 

established in 1979. In the same year that APhA became involved, two 

other state programs were established. A recent APhA survey shows that 

f 1

today there are 46 state-level impaired pharmacist programs, largely as a 

result of APhA's sponsorship of the University of Utah scho??. 

All programs have a close working relationship with the state boards of 

pharmacy, and APhA has worked closely with the National Association of 

Boards of Pharmacy to nurture that relationship. The programs serve the 

needs of the boards and the public well--they provide a mechanism whereby 

pharmacists who are afflicted with the illness of chemical dependence are 

identified (or self-identified), voluntarily removed from practice, 

treated, and rehabilitated. Further, the programs assure that impaired 

pharmacists entering into the programs do not return to practice until 

successfully treated and rehabilitated. 

RESPONSE TO RECOHMENDATIONS 

The draft report's recommendations are addressed to state governments, 

state boards of pharmacy, NABP, APhA and the U.S. Public Health Service. 

Consistent with the comments made above, APhA supports: 

o the recommendations made to state governments ta provide resources, 

streamline procedures and enhance the capacity of state boards to 

effectively carry out their responsibilities. 

o the recommendation that state governments consider supporting 

impairment programs for pharmacists. A major deficiency in many 

Pharmacist Recovery Programs is a lack of adequate funding, so such 

state financial support would be welcome. One state, Texas, 

already accomplishes this by allocating a portion of each 

pharmacist licensure and relicensure fee to the state pharmacy 

association to help offset the cost of its Pharmacist Recovery 

Program. In another state, California, the state legislature has 

enacted legislation establishing and funding a program to assist 

impaired health professionals. 
Richard P. Kusserow 

March 6, 1990 

Page -5-

o the recommendations to state pharmacy boards to review the outcomes 

of their processes and procedures as they relate to the protection 

of the public, and to make infonnation on disciplinary actions 

available as appropriate. 

o the recommendation to NABP to assist atate boards of pharmacy in 

addressing the changing nature of pharmacy practice. APhA believes 

that NABF has made progress in this area in recent years, and will 

continue to work cooperatively with NABP, as it has done, to 

facilitate that process. 

The recommendation calling on the U.S. Public Health Service to increase 

its support to NABP requires further study and information. It is 

unclear to APhA at this stage What benefits would accrue in a strictly 

bilateral relationship between NABP and USPHS. However, inclusion of 

USPHS in a broadly participatory process on the subject of state 

discipline of pharmacists could prove to be valuable. 

Finally, but =st critically for APhA, are those recommendations made 

directly to us. The draft report calls on APhA to: 

o exercise its leadership in encouraging more peer review of 

pharmacists' professional performance by national and State 

professional pharmacy organizations. 

o work with the NABP and other professional pharmacy organizations to 

develop appropriate methods for assessing the continued competence 

of pharmacists. 

The draft report describes a "...relative lack of peer review by 

professional pharmacy organizations [that] is unfortunate." The report 

further suggests that organizations be less concerned with threats of 

antitrust litigation than in renewing efforts in this area. APhA's 

historical commitment to professional practice is clearly evidenced by: 

o the development in 1852, and subsequent refinements of, the 

profession's only Code of Ethics; . 

o the identification and articulation of the profession's Standards 

of Practice, in conjunction with the American Association of 

Colleges of Pharmacy (AACP); 

o the establishment within the APhA Bylaws of a Judicial Board 

(although currently not operational because of concerns about the 

antitrust posture of the Federal Trade Commission and the 

Department of Justice); 

o the establishment of, and continued sole financial support for, the 

Board of Pharmaceutical Specialities, the profession's recognized 

system for approving and certifying specialties and specialists 

within the pharmacy profession; and 
Richard P. Kusserow 

March 6, 1990 

Page -6-

o the previously discussed efforts in establishing a nationwide 

program to address pharmacist impairment. 

The level and extent of APhA"s efforts in these and other 'peer review" 

activities must continue to be based on the legal, professional and 

resource constraints of both the organization and the health care system 

generally. APhA is currently engaged in a project with MCP and NABP to 

revalidate and, as appropriate, further evolve the profession's Standards 

of Practice. When originally conducted in 1978,this project was 

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

practice standards, define the necessary competencies to practice at the 

level of the standards, and develop programs to assure pharmacists 

obtained and maintained those competencies. Our commitment to this 

activity continues, subject of course to overall staff and budgetary 

resources. 

Similarly, any commitment to an even more comprehensive "peer review" 

system to assure the quality and competence of pharmacists will require 

tremendous financial and staff resources to assure both complete and fair 

investigatory and due process procedures for pharmacists being 

evaluated. Perhaps most critically, the concept of a national standard 

for pharmacist performance presupposes a national level of uniformity of 

resources to deliver pharmacy care, and a national consensus on the part 

of patients as to what they desire or demand from their pharmacists. 

Clearly these conditions do not yet exist, and must be developed if any 

program of peer review is to be successful. We would welcome the 

opportunity to obtain federal or other grant support to further develop 

these concepts. APhA will take under advisement and carefully consider 

this recommendation of the draft report. 

It has also been our personal organizational experience that the concerns 

about antitrust litigation are in fact substantial and valid. Even when 

adequate resources are available to assure a sound peer review process, 

professional organizations are quite vulnerable to lawsuits by both 

individual and government agencies, such as the Federal Trade Commission 

and Department of Justice. APhA believes that OIG ispware of the FTC's 

recent heightened interest in this area, particularly regarding health 

care associations. We would therefore welcome the input of the OIG in 

communicating its views on this subject to the other federal regulatory 

agencies whose views on this subject appear to be substantially different 

from those of the Inspector General. 

Organizationally, APhA remains committed to assisting and encouraging 

pharmacists in advancing the professionalism, comprehensiveness, and 

quality of pharmacy care that they provide. We will continue to work in 
1 

Richard P. Kusserow 

March 6, 1990 

Page -7-

conjunction with colleagues in pharmacy practice, education, research and 

regulation to achieve these goals. We appreciate the chance to respond 

to what we believe is an excellent draft report on this subject and stand 

ready to work with the Department on behalf of the profession and the 

patients we serve. 

~xedutive Vice President 
4630 Montgomery Avenue 

Bethesda. MD 20814 

March 16, 1990 

Richard P. ltusserow 

Office of the Inspector General 

Department of Health *and hms.n Services 

Washington D. C 2020 1 

Dear Mr. Ku8serow: 

Tbank you for asking the American Bociety of Boepital Phaxmaciuts (AS=) to 

camment on the draft report of 'State Discipline of Phaxmacists.' 

The State boards of pharmacy are to ensure that pharnacy is practiced mafely, 

competently, and in accordance with pharmacy and drug laws. The citations and 

disciplinary actions by the boards of pharmacy are key to insuring the safety 

of the public. The draft report does not mention any public health hazards 

related to pharmacist in-petence. Wedication errors ccn~itted by all health 

care practitioners contribute to problcms in the health care syste~. The 

report may be viewed as incanplete without discussion of the public health 

hazard that an incapetent pharmacist poses to society. 

There are sane other areas of pharmacy practice in which state boards' of 

regulatory authority is not yet fully developed. mil order prescriptions and 

non-pharmacist dispensing are two such areas. The report should include sane 

analysis of the role of boards of pharmacy in regulating these areas. 

We would also like to add our thoughts about the profession as we have seen it 

evolve. The pharmacy practice area is in a state of transition. At one end 

of the spectrum, we have practitioners who spend most of their professional 

the in the mechanics of prescription dispensing. At the other extrame are 

. pharmacists who spend most of their time in direct patient care (clinical). 

The largest preponderance of practitioners have a mix of both dispensing and 

clinical activities. State boards are focused on regulating the activities of 

the dispensing group because that concept of practice is all .that is &died 

in state pharmacy law and regulations. It vould be highly unrealirtic and 

unwise to expect state boards to regulate the entire 8pectrum of pharmacy 

practice. This practice may inhibit the further developnent of the profession 

along clinical lines by tending to lock in the current state of practice, even 

if the focus might be on what is currently progressive. 

Pharmacy practice has moved toward the prunotion of canpetericy with the 

speciality practice areas and certifying specialists in a variety of practice 

settings. This recognition fosters the self-assessment and self-developnent 

of practitioners. The ASHP is working to meet the needs of these 

practitioners by the developnent of the many self-study instructional 
materials, ACCRUE: Executive Uanagement Seminar Series, and is caumitted to 

the developent of a clinical staff developtent program. The ASHP's 

Practitioner Recognition Program is designed to foster excellence in practice 

and provide recognition to those practitioners willing to make the voluntary 

carmnitment to self-developnent. The educational focus of ASBP has ken 

structured to meet the needs of the practitioners in the v&ried practice 

settings and encourages than to advance themselves. 

Perhaps it should be considered to organize a conference to -lore the most 

appropriate way to regulate pharmacy practice looking mpecifically at the 

outcaues of practice rather than the methods of practice. Currently, the 

possibility of euch a conference fcr king pursued by the Joint mimeion of 

Pharmacy Practitioners (JBP). 

We hope that the staff cauments and reccllnmendations will be useful in the 

preparation of the final report. Call on ur, again ahould your office need 

additional input. &,& 

osp . Oddis, Sc.D. 

wcut?ve Vice President 

cc: hard of Directors 
National Association of Boards of pharmacyU 

O'Hare Corporate Center 7300Higgins Road Suite 103 

Park Ridge, /L 6006B 312/698-6227 

March 8, 1990 

Mr. Richard Russerow 

Inspector General 

Department Of Health & Human Services 

Office of the Inspector General 

Washington, DC 20201 

Dear Inspector General Ku~serow: 

Thank you for providing the National Association of 

Boards of Pharmacy (NABP) with this opportunity to ~0nUnent 

on the draft report of the nState ~iscipline of 

~harmacisls,~NABP is the national association that 

represents the state boards of pharmacy in all 50 states, 

the District of Columbia, Puerto Rico, the Virgin Islands, 

some provinces of Canada, and the Phanaacy Board of 

Victoria, Australia. 

We commend the staff of the Boston Regional Inspector 

General for Evaluation and Inspections office for their 

careful and detailed analysis of the State pharmacy boards. 

The report objectively identifies critical issues with a 

clear understanding of the intricate and delicate nature of 

pharmacy regulation. The report recognizes the problems 

imposed on the State pharmacy boards by understaffing and 

inadequate resources and emphasizes the need fo* the State 

pharmacy boards to be empowered with the broadest form of 

penalties, including the right to reprimand and Fine, in 

order to be fully effective. 

NABP appreciates the complimentary remarks made in 

regard to our efforts to provide the State pharmacy boards 

with assistance in meting their responsibility to protect

the public health and welfare. We look forward to working 

with the Office of the Inspector General, the Public Health 

Service, and other government agencies to accomplish the 

recommendations outlined in the report. 
SPECIFIC COMMENTS: 

XNTRO WCTION : 

Page 1 Federal Acknowledaement of the Role of State 

Boards of Phamacv. 

NABP concurs that 8tate pharmacy boards sew* as 

the afrontline of protection for the health and 

safety of the pub1ic.W It ie essential that both 

federal and state government. increase their 

support and cooperative afforts with State phazmacy 

boards in order to keep this *frontline of 

protectionm operable and affective. 

FINDINGS : 

Page 4 The enforcement res~onsf~ilities~rn~~

Boards have become breas-lex and 

ac 

diversion, 

The OZG report accurately recognizes that the 

practice of pharmacy ha8 changed dramatically in 

recent years. As noted in the report, the 

challenge now facing State pharmaoy boards is how 

to effectively regulate this changing practice. At 

the minimum, NABP agrees with the OIG report that 

State pharmacy boards must translate clinical 

pharmacy services into State regulatory 

requirements for governing the practice of 

pharmacy. However desirable such a translation may 

be, it can occur only if State pharmacy boards are 

empowered by legislative changes to broaden the 

definition of the practice of pharmacy to 

encompass more than the mere dispensing of a drug 

product, 

Page 8 o 'nc se in tun-ious 

W n ctio s between 1986 and 1988 is 

~ttributableto three states. 

On pages A-2 and A-3 of Appendix I, the report

notes that the analysis of disciplinary actions may 

not be wcompletely accurate or all-inclusive.n 

Recognizing the limits of the study and the 

incomplete data, it would be useful to alarify the 

above statement with the actual data. At the 

minimum, it is necessary to identify the three 

states responsible for skewing the overall 

increase in disciplinary actions. 
Page 8 (CoUnuecU, 

It is important to recognize that, although the 

number of serious disciplinary actions imposed by a 

board is a good external evaluator, it fa one of 

many indicators. It has been our experience that 

State pharmacy board8 are much more aative in 

protecting the public health than i8 indicated by

the disciplinary data information aontained in the 

OIG report. As mentioned in the raport, educational programs as well as LnFormal and fonaal 

interventions by administrative rtaff also have a 

dramatic effect on the protrction of the public 

health. Unfortunately, outcome o~easuresexamining 

the overall effect of the total spectrum of State 

pharmacy board actions have not been defined ar 

analyzed, 

State pharmacy boards are taking a more active tole 

in addressing the quality of care and clinical 

aspects of pharmacy practice. While the progress 

to date has been slow and, at times, erratic, it 

can proceed at a faster pace with the ausistance of 

the Office of the Inspector General and other 

government agencies, 

- The limited use of veer review bv-v nrafessional 

mmacv associations. ~eiculprlvin com~arison 

with mt in some other nrofespions, makes the 

disci~linarvoerfo-ce of pbarmacv board^ all 

the more sianif 

we agree that tk:%ciplinary performance of State 

pharmacy boards is significant, because no other 

process for review exists. However, we strongly 

advise against the development of any peer review 

system by professional oxganizations for use by 

the State pharmacy boards, 5 

A review process conducted by organizations like 

the American Pharmaceutical Association.(APhA), 

Internal to its members and goals, fs needed and 

long overdue. The development of such a system

could enhance the regulatory efforts of the State 

pharmacy boards by increasing voluntary compliance 

with the law, The HABP Foundation's Bureau of 

Voluntary ~ompliance(BVC) is charged with exactly this purpose. Over the past ten years, the BVC has 

developed educational programs, video tape presentations, and seminars to promote voluntary 

compliance among the nation's pharmacists. 

Representatives from the Food and Drug 

Administration, Drug Enforcement Agency, and 
Pages 10-11 

IContinusd) 

Consumer Product Safety commieeion 

participate in the BVC aeetingr and 

programs and hold ex-officio member 

status. HABP would certainly welaome the 

office of the Inspector General's 

participation in the meetings and 

deliberations of this important conimittee. 

Peer review systems designed with this purpose in 

mind would better serve the public health. 

Establishing peer review syatups, .imply becaune 

they presently do not exist, may be detrimental. 

It would seem more pnrdent to follow the 

recommendations of the OIG report and concentrate 

our resources towards increasing the activity of 

State pharmacy boards in quality of care issues and 

in the clinical aspects of pharmacy practice. A 

peer review system organized through APhA could 

then be used to baseline the standards of care of 

the community of practicing pharmacists. 

Any violation of the State pharmacy practice act, 

which would be expanded to meet the changes in 

practice and include clinical functions, should be 

reported to, and acted upon, by the State pharmacy 

board where constitutional authority and due 

process are already in place. Such authority 

should not be placed with peer review syotems that 

are organized through the auspices of a 

professional interest association. 

Many of the problems other health professions are 

currently facing in regard to their disciplinary 

activity are the result of relying solely upon 

peer review systems outside the legal authority of 

their State licensing boards. The National 

Disciplinary Data Bank was enacted to correct the 

failed efforts of some professions to discipline 

incompetent or dangerous practitioners, The peer 

review systems that other professions rely upon 

are often rendered ineffective by threatened legal 

action, 

The current structure of the State pharmacy boards 

and the authority empowered to them by their State 

phamacy practice acts is working well. Although 

many of these pharmacy practice acts may need to be 

updated in order to meet the challenges of the 

future, they should not be replaced or 

circumvented. 
Pages 11-12 

Prua Diversion 

Protecting the American public from the untoward 

and dangerous effects of drug diversion is a 

crucial item on the regulatory agenda of State 

pharmacy boards. If our natlonlsdrug delivery 

system is to remain aafe, we bust prevent and halt 

drug diversion. The OIG report achow18dgem Me 

the and effort that State pharmacy boards devote 

to combating this noourge and notes that thia 

concentrated effort is diverting attention from 

other regulatory areas, such as continued 

competence. State pharmacy boards need additional 

federal funding and rupport in order to continue 

their present efforts in the fight against drug

diversion and to expand their responsibilities to 

meet the future challenges of pharmacy practice, 

The Prescription Drug Marketing Act of 1987 

provides a framework for State pharmacy boards to 

curtail drug diversion activities through State 

licensure of wholesalers and drug distributors. We 

urge federal agencies to support the offorts of 

the State pharmacy boards to implement this Act and 

to develop additional legislation to stop drug 

diversion. 

One particular comment in the report that merits 

attention, nThe law defines a corresponding 

responsibility for pharmacists to fill only 

legitimate prescriptions and makes them accountable 

for the prescriptions they di~pense.~While this 

may be the OIG1s view of the law, the courts do not 

follow this concept from either a disciplinary 

standpoint or from a civil liability standpoint. 

On several occasions, NABP has emphasized the fact 

that the courts narrowly construe the phamacistts 

professional role, limiting the duty of the 

pharmacist to appropriately filling lmgitimate 

prescriptions, State boardo of pharmacy are moving 

towards defining that corresponding responsibility 

cited in the OIG report, i.e., defining quality of 

care and competence standards. Let US hope that 

the courts will cooperate with this changing 

concept. 

Page 13 

Qualitv of Care 

According to the OIG report, case study States 

reported, Vhat although their practice acts 

included incompetence as grounds for discipline, 

their boards had rarely, if evex, disciplined 
Page 13 

(ContinuedL 

pharmacists for in~ompetence.~ Furthenuore, the 

report contends that "no mechanisms have been 

widely instituted for asseasing the continued 

competence of practicing pharmacimt~.~ 

State pharmacy boards have difficulty enforcing 

competency issues for a number of reasons, The 

report indicates that a primary reason is the fact 

that no consensus exiots regarding definitions or 

standards. Efforts by the State pharmacy boards 

to move ahead in this area are vigorously opposed 

by special interest groups, State pharmacy boards 

are often defeated by the intensive lobbying 

efforts of these special interest groups. 

The State pharmacy boards would most likely accept 

this responsibility if the accompanying standards 

and definitions are also enacted. Unfortunately, 

in the face of such strong opposition from the 

special interest groups, passage of such 

requirements seems i~nposslble unless the OIG report 

is taken to heart by state governments and 

legislatures. 

The NABP M u mentioned in the OIG report 

does define the practice of pharmacy and addresses 

standards of practice which can be implemented by 

appropriate regulation. 

Pages 14-15 

Insyff icbt V A u t h 

We agree with the OIG report that the grounds for 

discipline contained in the pharmacy practice acts 

are sometimes vaguely defined. Grounds for 

discipline are broadly defined in order to provide 

the board with the widest latitude in which to 

implement the grounds through appropriate rules and 

regulations, NAEP recommends the continuation of 

such generalities in order to provide the 

appropriate latitude for enforcement, 

We are concerned with the repor,tws finding that 

emergency suspensions ncan take as long as two 

years to obtain," Normally, statutes that permit 
Pages 

' 

14-15 - 

the suspension of a license on an emergency basis 

can be quickly implemented. It is the finalization 

of such an emergency rumpansion that can take a 

long period of tine. However, once under emergency

suspension, a liaense our only be restored through 

the courts. 

NABP believes that the State phsro~acyboards are 

empowered with more authority than mom0 roaliee. 

The problem lies with the inability of some State 

pharmacy boards to exerci8e this authority 

effectively because they are undarmtaffed, lack the 

resources, or are reluctant to be proactive. 

Pages 15-16 

ive Barriers 

The GIG report's discussion of administrative 

barriers supports NABP's concept of an effective 

disciplinary clearinghouse. In fact, NABP *st 

aggressively pursue State pharmacy boards to gain 

their cooperation to voluntarily subnit 

disciplinary action information to the Association 

for distribution among the other State pharmacy 

board members. 

Since the completion of the OIG report, the NABP 

Disciplinary Clearinghouse has been fully 

computerized. Almost all State pharmacy boards 

now participate in the NABP Clearinghouse, 

Additionally, the FDA and NABP have agreed to 

ahare disciplinary information concerning 

wholesalers and manufacturers in order to increase 

the reporting of such information to the State 

pharmacy boards and to allow for the more effective 

resolution of enforcement problems through federal 

and state cooperation. . The report also recognizes the problems that exist 

in ".,,the time consuming nature of the 

disciplinary process it~elf.~Hany times, hovever, 

State pharmacy boards cannot control this process. 

It is a function of how often a State pharmacy 

board meets, which is often directly related to the 

resources available to the board. Additionally, 

the system is slowed by delays permitted by boards 

and hearing officers and other legal maneuvering 

of attorneys, 
Pages 15-16 

IContinm 

The delay imposed on the disciplinary systarn by the 

insufficient resource8 noted in the OIG rape is a 

serious matter. Some states have dmalt with this 

problem by centralizing licursing boards under one 

umbrella agency. The information we have 

collected rrms to indiaate that aontralizstion 

often diluteo alroady mcarce rerourcas and 

decreases regulatory offoctiv.nemm. 

NABP supports the recomondationo of tha report that call 

for increaeed support and funding for State pharmacy 

boards. We will continue our efforts to 8erve a 

leadership role for tha State pharmacy boards as they begin 

to address the changing natura of pharaaoy practice. We 

caution against the creation of paer rovirw groups unless 

their purpose is well defined and activities tightly 

controlled. 

In closing, we want to again indicate that NABP is most 

eager to work with the Office of the Inspector Gonaral, the 

Public Wealth Sarvice, and other government agencies to 

ensure that the public health and welfare is protected. 

Sincerely, 

NATIONAL ASSOCIATION 

OF BOARDS OF PHARMACY 

C. A. Catieone w 

Executive Director 

cc NABP Executive Committee 

State Boards of Pharmacy 
1 

National Clearinghouse : 

I

4 on Licensure, Enforcement and Regulation 

Iron Works Pike, P.O.Box 11910, Lexington, Kentucky 40578-9989, (606) 231-1892 

PRESIDENT 

Bruce Douglas 

Division Director 

CO Dept. of Regulatory Agencies 

PRESIDENT -ELECT 

Elizabeth Stewart 

Assistant Chief Counsel 

A2 Office of Attorney General 

IMMEDIATE 

PAST PRESIDENT 

Ksrr Schmitt 

Director of Testing 

MI Depr. of Licensing & 

Regulation 

STEERING COMMITTEE 

Irv Dcshayes 

Chairman 

NF. Board of Examiners in 

Audiolog). 6.Speech Patholog!. 

Claudia FOUIZ 

Chief Dcpty Director 

2A Dept. of Consumer Affairs 

James I. Gufley 

Deputy Director for Enforcement 

VA Dept. of Commerce 

William Marcus 

Deputy Attorney General 

CA Dept, of Justice 

William G. Miller 

Joint Secretary 

GA State Examlninp Boards 

Donald C.Murra?. Jr. 

Director 

DC Depl. of Consumer 6: 

Rcgulacory Affairs 

Paul Quinlnn 

Director 

NE Real Estate Commission 

Mar! Romclfanger 

Deputy Execu:i\,c D~recco: 

KY Board of Nursing 

Barbara Showers 

Director of Examina!ions 

WJ Dept. of Regulac~on& 

Licensing 

Caroline Stellmnnn 

Member 

MD Board ol Examiners of 

Nurses 

Ron Weavcr 

Administrator 

Professional Licensing Scrviccs 

\'A Dept. of Health 

John 6. Welsh. Jr. 

Senior Counsel 

WA House of Representatives 

Eugene L. Ketchum, Executive Director 

March 30,1990 

Martha B. Kvaal 

Deputy Regional Inspector General 

for Evaluation and Inspections 

U.S.Dept. of Health and Human Services 

JFK Federal Building Room 1407 

Boston, Massachusetts 02203 

Dear Ms. Kvaal: 

It has been our pleame to review the January, 1990 draft copy of State 

Discipline of Pharmacists. This is a very thorough document that captures and presents in 

an informative manner current disciplinary practices among pharmacy boards. There is littlc 

doubt that there will bc gcneral agrccmcnt with the finding that an obvious nccd exists in 

many stares for more statutory authority bcfore appropriate disciplinary actions can be takcn 

against pharmacists. 

With respcct to Lhc information we arc given that 97% of Lhc rcccnt incrcasc in 

"most scrious disciplinary actions" has occurrcd in just three states and hat furlhcr, 15 states 

took 10 or fewer of these "most scrious actions" for the period 1986-88, it would have bccn 

hclpful to understand what accounted for thc incrcasc or lack of increasc in such actions. 

Whilc thc corrclation madc with location and size is interesting, it does not ncccssarily 

explain what is going on in thesc statcs. 

We fcel it is particularly important that thc report points out the nccd for Lhc 

ficld of pharmacy to address ihc issucs of standards for quality of care and the nccd to sharc 

information on disciplinary actions lakcn. With regard to the lauer, we apprcciatc that you mention CLEAR as a repository for statc board disciplinary actions and agrce that reporting 

to boh CLEAR'S National Disciplinary Information System (NDIS)and the National 

Association of Boards of Pharmacy (NABP) Disciplinary Clearinghouse is an extrcmcly 

important stcp toward resolving this problem. Wc also agrec that i1 is not in a health 

profession's best intcrcst to wail for operation of the NationaLPractitioncr Data Bank (NPDBj 

to bcgin the practice of reporting information to a central repository. Through delay, 

valuable disciplinary information is lost that could stop practitioners from crossing stutc lincs 

lo rcsume practicc wiLl10ut challcngc sinlply bccause appropriatc inforniation was not sharcd. 

Also, as a practical administrative maucr, it will be far simpler for boards that arc in lllc 

practice of sharing disciplinary information lo comply with the requircmcn~s of thc NPDB. 

Thank you for thc opportunity lo comnlcnl on this report. 

Sincerely, 

Pam Brincgar 

Projcct Director. NDIS 

. . .. . .... ... . . .. 

Affiliate Organization of The Councll of State Governments 
- - 

APPENDIX B 

INCIDENCE AND RATE OF SERIOUS DISCIPLINARY ACTIONS 

IMPOSED BY STATE BOARDS ON PHARMACISTS AND PHA RMACIES 

BY STATE 1986- 1988' 
(1) As reported by State pharmacy board officials to the Office of Inspector General, HHS, May-June 1989. 

Actions included in these figures are revocations, suspensions, probations, and voluntary sunenders for 

both pharmacists and pharmacies. New York and Nevada provided no data; Oklahoma provided figures 

only for revocations; and Kentucky provided data for 1986 and 1987 only. 

(2) Number of active pharmacists plus number of licensed pharmacies as reported to the National 

Association of Boards of Pharmacy by States in 1987. For those States not reporting to the NABP, the 

OIG obtained data by telephone from the state pharmacy boards. 
APPENDIX C 

METHODOLOGICAL NOTES 

The information for this inspection is based on four lines of inquiry: 

Review of pertinent literature and relevant data bases, including studies, books, 

articles from professional newsletters and journals, publications and papers fiom 

various private and public organizations, and statistical data aggregated by private 

and public organizations. 

Telephone discussions with representatives of the State pharmacy boards during 

the spring of 1988 and the spring of 1989. In 1988 we talked with representatives 

from 42 States and the District of Columbia about the major challenges facing their 

boards, the major reasons for disciplinary actions, primary sources of information 

about potential cases, and recent significant changes in authorities. In 1989 we 

talked with representatives from all 50 States and the District of Columbia to 

obtain quantitative data on disciplinary actions and discussed drug diversion, 

foreign-trained pharmacists, exemplary board practices and barriers to 

effectiveness. In most cases we talked with the chief executives of the boards, but 

in a few instances we spoke with other staff suggested to us by the executives. 

Visits of 2 to 3 days each to six States (CA, FL,MA, MI, NY, TX) for discussions 

with pharmacy board representatives which typically included the board president, 

the public member of the board, the chief executive, an inspector, and an attorney. 

We deliberately chose States which were among the largest in terms of numbers of 

pharmacists and pharmacies, of Medicare beneficiaries and Medicaid recipients, 

and of Medicaid payments for prescription drugs in 1987. These States represented 

all sections of the country as well as diversity in their organizational structure. 

Finally, we had shorter personal discussions with staff from nine smaller States 

during the annual meeting of the NABP in Charleston, South Carolina in May 1989. 

Discussions with representatives of organizations and agencies concerned with 

issues related to State pharmacy boards. These included staff from the FDA, PHS, 

and HCFA within the Department of Health and Human Services, the Drug 

Enforcement Administration, American Association of Colleges of Pharmacy, The 

American Council on Pharmaceutical Education, American Pharmaceutical 

Association, National Association of Boards of Pharmacy, National Association of 

State Controlled Substances Authorities, National Clearinghouse on Licensure, 

Enforcement and Regulation, the United States Pharmacopeial Convention, Inc., 

and staff from several State pharmacy associations. 
Numbers of Pharmacists and Pharmacies 

There is considerable uncertainty about the number of pharmacists in the United States today. 

The Public Health Service in its Sixth Report to the President & Congress on the Status of 

Health Personnel in the United States includes pharmacy manpower estimates projected from 

figures obtained in the 1970s. These projections are considered unreliable by many in the 

pharmacy profession. Yet the currently available State-specific data on licensed pharmacists 

double count those pharmacists licensed in more than one State and do not distinguish those in 

active practice from those who are not currently practicing. 

After discussions with representatives fiom the PHs and the NABP, we decided to use data on 

the active pharmacists and licensed pharmacies provided by the States to the NABP in 1987. 

These estimates are published by NABP in its 1988-1989 Survey of Pharmacy Law. We 

telephoned the board executives from those few States not included in the NABP report to 

obtain estimates from them on the number of active pharmacists or pharmacies in their States. 

The figure we used for the total number of active pharmacists nationwide is 183,946. The 

figure we used for the number of licensed pharmacies is 67,947. Our quantitative analysis of 

disciplinary actions and our size groupings of the States are based on these estirnatz. 

Analysis of Disciplinary Actions 

During May and June 1989 we talked with pharmacy board officials in every State and the 

District of Columbia for data on the disciplinary actions taken by the boards against both 

pharmacists and pharmacies in 1986, 1987, and 1988. We asked for the number of 

revocations, suspensions, probations, voluntary surrenders, or other formal actions they 

specified. 

Forty-seven boards were able to provide us with data for all 3 years, although they could not 

always provide a separate count for actions against pharmacists and against pharmacies. Two 

States-Nevada and New York--could not provide the data for any of the 3 years. Oklahoma 

provided figures only for revocations, and Kentucky could not provide data on 1988 actions. 

We cannot confm that the data on disciplinary actions is completely accurate or all-inclusive. 

We did try to resolve any questions or inconsistencies with follow-up telephone calls to the 

board officials who, typically, were very responsive. 

We found that some States kept records on disciplinary actions by fiscal year rather than 

calendar year. For these States, we included in our analysis their 3 most recent and complete 

years of data. We also analyzed the data for a 3-year period in order to eliminate year-to-year 

fluctuations and to draw more reliable conclusions. In so doing, we combined disciplinary 

actions reported for both pharmacists and pharmacies because many States could not separate 

the two and because oftentimes boards take action against both the pharmacist and the 

pharmacy in a given case. Finally, we computed a rate of discipline for the 3-year period for 
each State. We divided the numbers of actions taken against both pharmacists and pharmacies 

by the combined number of active pharmacists and licensed pharmacies in each State. 

Groupings of States by Region and Size 

We analyzed the data on disciplinary actions provided to us by the board executives according 

to groupings we identified based on size and region of the country. In both these groupings, 

we omitted Nevada and New York because their data was not available. 

With respect to region, we used the U.S. Bureau of the Census categorizations to identify four 

regions of the country. They are as follows: 

1 Northeast: CT,MA, ME, NH, NJ, PA, RI, and VT. 

2 South: AL, AR, DC, DE, FL,GA, KY, LA, MD, MS, NC, OK, SC, 

TN,TX, VA, and WV. 

3 Midwest: IA, IL, IN, KS, MI, MN, MO, NE,ND, OH, SD, and WI. 

4 West: AK, AZ, CA, CO, HI, ID, MT, NM, OR, UT, WA, and WY. 

With respect to size, we used variance analysis to identify five clusters of States based on the 

number of active pharmacists and licensed pharmacies. They are as follows: 

1 Extra-Small: AK, DC, DE, HI, ID, ME, MT, ND, NH, RI, SD, VT, and WY. 

2 Small: AR, CO, IA, KS, MS, NE,NM, OR, UT, and WV. 

3 Medium: AL, AZ, CT,KY, LA, MD, MN, MO, NC, OK, SC, TN, VA, 

WA, and WI. 

4 Large: GA, IL, IN, MA, MI, NJ, and OH. 

5 Extra-Large: CA, FL, PA, and TX. 
APPENDIX D 

ENDNOTES 

1. For a more extensive discussion of State licensing boards, see: 

Doug Roederer and Benjamin Shimberg, Occupational Licensing: Centralizing State 

Licensure Functions, Council of State Governments, Lexington, Kentucky, 1980. 

Benjamin Shimberg, Occupational Licensing: A Public Perspective, Educational 

Testing Service, 1980. 

2. The American Association of Colleges of Pharmacy and the National Association of 

Boards of Pharmacy are co-managers of the Pharmacy Manpower Project. This project, 

supported by 13 major pharmacy organizations, is a recent effort to gather more 

comprehensive data on pharmacists than is currently available. (See appendix C for 

additional detail about the sources of our manpower estimates.) 

3. These responsibilities are being further expanded by the Prescription Drug Marketing 

Act of 1987 which requires the States to license wholesale prescription drug distributors 

according to Federal guidelines. 

4. Scheduling Aurhorities Directory 1988, National Association of State Controlled 

Substances Authorities, The Council of State Governments, Lexington, Kentucky. 

5. U.S.Department of Human Services, Public Health Service, Food and Drug 

Administration, State Law Data, 1989. 

6. Survey of Pharmacy Law1 988-1 989, National Association of Boards of Pharmacy, 

Park Ridge, Illinois. 

Resources and Responsibilities Survey of all pharmacy board executives by NABP in 

early 1989. 

7. Charles D. Hepler, "The Third Wave in Pharmaceutical Education: The Clinical 

Movement," American Journal of Pharmaceutical Education, Volume 5 1, Number 4, 

Winter 1987. 

U.S. Department of Health and Human Services, Office of Inspector General, Office of 

Analysis and Inspections, Clinical Pharmacy for Ambulatory Patients, Inspection 

Number OAI-01-89-89 160, draft report, January 1990. 

8. S arnuel H. Kalman and John F. Schlegel, "Standards of Practice for the Profession of 

Pharmacy," American Pharmacy, Volume NS19, Number 3, March 1979. 
For elaboration on changes in pharmacy, see: 

"The Continuing Competence of Pharmacists, Final Report of the AACPIAPhA Task 

Force on Continuing Competence in Pharmacy," Journal of the American 

Pharmaceutical Association, Volume NS 15, Number 8, August 1975. 

"Pharmacy in the 21st Century", Executive Summaries of Strategic Planning 

Conferences, March 25-28, 1984 and October 11-14, 1989, American Association of 

Colleges of Pharmacy. 

Nicholas G. Popovich, Ph.D., "Emerging Practice Activities: Specialist and Technician 

Roles in Pharmacy", NABP Newsletter, Volume 18, Number 3, March 1989. 

U.S. Department of Health and Human Services, Public Health Service, Sixth Report to 

the President & Congress on the Status of Health Personnel in the United States, June 

1988, pp. 8-1 to 8-17. 

"State boards up close: How pharmacists rate them", Drug Topics, May 19, 1986, p. 32. 

Telephone discussions with State pharmacy board executives, Office of Analysis and 

Inspections, OIG, spring 1988. 

U.S. General Accounting Office, Retail Diversion of Legal Drugs-A Major Problem 

With No Easy Solution, GGD-78-22, March 1978. 

U.S. General Accounting Office, Comprehensive Approach Needed to Help Control 

Prescriptiorz Drug Abuse, GGD-83-2, October 1982. 

U.S. Department of Justice, Drug Enforcement Administration, Multiple Copy 

Prescription Programs Resource Guide, July 1987. 

For a more detailed discussion of non-therapeutic dispensing, see Carol E. Fisher, 

Harvey Dunham, Fred S. Brinkley, Jr., "Controlling Non-Therapeutic Dispensing in the 

State of Texas," Texas State Board of Pharmacy,April 1989. 

Survey of Pharmacy Law1988-1989, op. cit. 

U.S. Department of Health and Human Services, Office of Inspector General, Clinical 

Pharmacy for Ambulatory Patients, op. cit. 

Telephone discussions with State pharmacy board executives, Office of Analysis and 

Inspections, OIG, Spring 1988. 

Data on types of penalties and grounds for discipline derive from the 1989 NABP 

survey of State pharmacy board executives. 
17. U.S. Department of Justice, Drug Enforcement Administration, Multiple Copy 

Prescription Program Resource Guide, op. cit Information also based on personal 

interview with staff from the OEce of Diversion Control, Drug Enforcement 

Administration, U.S .Department of Justice. 

1 8. U.S. Department of Justice, Drug Enforcement Administration, "Committee Report on 

CSA Laws Presented at the 2nd National Conference on the Control and Diversion of 

Controlled Substances," Tuscson, Arizona, 1986. 

19. These data include actions for both pharmacists and pharmacies. Although pharmacy 

boards frequently discipline both as part of the same case, pharmacists are disciplined 

much more frequently than pharmacies overall. We include actions against both 

because many boards were unable to provide us with separate data for each. 

20. Widespread variation existed in the types of these other formal penalties and in the 

extent to which the same penalty was considered formal or informal by different boards. 

Further, the boards reported often imposing these other penalties in combination with 

the most serious penalties and were often unable to give us unduplicated counts. 

21. We aggregated the data reported on revocations, suspensions, probations, and voluntary 

surrenders for both pharmacists and pharmacies for the entire 3-year period. We 

computedrates of disciplinary actions per 1000 active pharmacists and pharmacies in 

each State as reported to the NABP (see appendices B and C). 

22. Survey of Pharmacy Law--1988-1989, op. cit., p.50. 

We provided each of our case study States with a listing of those pharmacists and 

pharmacies sanctioned by OIG since 1984 whose exclusion was still in effect as of 

October 31,1988. There were 114 providers among the six States. Our analysis of the 

States' responses showed that the States had also disciplined three-fourths of these 

providers and that, in nearly two-thirds of these cases, State action preceded the OIG 

exclusion notice. The States reported having taken no action against 18 percent of these 

providers. Approximately 7 percent of these providers had State action pending against 

them at the time of our inquiry. 

24. Telephone discussions with State pharmacy board executives, Office of Analysis and 

Inspections, OIG, spring 1989. The ARCOS (Automation of Reports and Consolidated 

Orders System) is a computerized tracking system instituted by the DEA to monitor the 

distribution of selected controlled substances by drug manufacturers and distributors 

based on quarterly or monthly reports filed by these companies with the DEA. 

25. U.S. Department of Justice, Drug Enforcement Administration, "Pharmacist's Manual," 

April 1986. 
26. Helping the Impaired Pharmacist, A Handbook for Planning and Implementing State 

Programs, American Pharmaceutical Association, Washington, D.C., 1985, p. 1. 

For further background information on therapeutic approaches to pharmacists' 

impairment, see also Ronald L. Williams, "Helping our Impaired ColleagueMe're on 

a Roll!" American Pharmaceutical Association, Washington, D.C.,September 1988. 

27. In our discussions, we defined incompetence as a deficiency in minimal skills or 

knowledge which adversely affect professional judgment. 

28. The AACP, APhA and NABP are presently reviewing the 1979 Standards of Practice. 

The boards must deal with how best to translate these professional standards into 

regulatory requirements. 

29. Daniel A. Nona, W. Robert Kenny and David K. Johnson, "The Effectiveness of 

Continuing Education as Reflected in the Literature of the Health Professions," 

American Journal of Pharmaceutical Education, Volume 52, Summer 1988.. 

30. Data on types of penalties and grounds for discipline derive from the 1989 NABP 

survey of State pharmacy board executives. 

3 1. We attempted to examine the funding levels of pharmacy boards over the last several 

years but were unable to locate any comprehensive data. The NABP surveys all the 

boards biannually for updated information on their resources and responsibilities. 

Although 50 boards responded to the 1989 survey, only 39 provided information on the 

level of their current budgets. The information available from the last biannual survey 

was aggregated in a form not useful for comparisons with this year's data. 

32. This analysis of fees is based on data included in Survey of Pharmacy Law, op. cit., for 

the years 1988-1989 and 1987-1988. 

33. Resources and Responsibilities Survey of all pharmacy board executives by NABP in 

early 1989. Responses varied from two States having 16 inspectors to one State 

reporting no inspector because the board executive conducts the inspections. The 

average number of inspectors among the States responding was 4.7; nearly half the 

States had no more than three inspectors. In only slightly more than half the States 

were the inspectors employed directly by the board rather than by another State agency. 

34. Survey of Pharmacy Law 1988-1989, op.cit., p. 5. 

35. White House Conference for a Drug Free America, Final Report, June 1988. 

36. "The Continuing Competence of Pharmacists, Final Report of the AACPJAPhA Task 

Force on Continuing Competence," op. cit. 
37. Samuel H. Kalrnan and John F. Schlegel, "Standards of Practice for the Profession of 

Pharmacy," op. cit. 

38. Benjamin Shimberg, "What is Competence? How Can It Be Assessed?'Power and 

Conflict in Continuing Professional Education, edited by Milton R. Stein, Wadsworth, 

Inc., 1983.