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~tsin   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, 1986-19 88  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 
wholesaler^.^ 
boards, for example, also license and inspect drug manufacturers and  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 com- 
plex and challenging in recent years because of changes in pharmacy practice and the prob- 
lem 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 
7
therapeutic advisors has been evolving.  The 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 
Y4 
profile records and to provide counseling to their patients.  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. 16 ' 
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 
18 
revenues for investigating drug diversion. 
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.2 0 
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 25percent 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 243licenses were reinstated in 1987.~B~oards 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 dataon 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 1984and 
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 self- 
abuse of h g s .  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 NABPYsD isciplinary 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 
29
dispense. The 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 
26 
and pharmacy students. 
'  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.2 7  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~naciststo  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 Ysical, or knowledge-based examinations of 
0 
pharmacists as part of the disciplinary process. 
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 enforceR  harmacy 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 
34 
members is low in most States: an average per diem of $49.58 plus expenses last year. 
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 
35 
recently by The White House Conference for a Drug Free America. 
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 
38 
nonetheless possible. 
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  
m  
MAR  12 
Date 
Gail R. Wilensky, Fh.D.  
Mministrator 
From 
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.  W e a~preciatethe 
CPPomity to review the m t s of this study.  DEPARTMENT  OF  HEALTH  & HUMAN  SERVICES   Public Health Serv~ce 
Memorandum
MAR20  1990 
Date   ' 
Assistant  Secretary  for  Health 
From 
Comments  on  Office  of  Inspector  General  (OIG)  Draft  Report  "State 
Subject  
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  t o  PHS  and 
s t a t i s t i c a l  data  cited  in  the  report. 
OIG  Recommendation 
The  Public  Health  Service  (PHs)  should  increase  its support  t o  
the  NABP  i n  i t s  efforts  t o  provide  leadership  t o  State pharmacy 
boards. 
PHs  Comment 
We  concur.  PHs  i s  collaborating  with  the  National  Association  of 
Boards  of  Pharmacy  (NABP)  i n  i t s  e f f o r t s   t o  provide  leadership  t o  
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), 
t o   identify ways  and  means  to  provide  technical.  a ssistance 
to  NABP. 
Technical  Comment 
The  d r a f t   report  on  pages  2  and  A2  noted  the estimated  number  of 
active  pharmacists  i n  the  U.S.  a s  being  approximately  183,000. 
This  number  is overstated  according  t o  data compiled  by  the 
Health  Resources  and  Services  Administration'e  Bureau  of  Health 
Professions.  Based  on  the  1978 federally funded  Pharmacy 
Inventory,  which  i s     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.  h e  
Drug  Enforcement  Administration's  (DEA) concern in this matter pertains t o  
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  t o  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.  m e  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 t o  registrants that are inconsistent with the public interest.  This 
amendment  to the Code has enabled the DEA  t o  work  in tandem with the states 
and has filled a  void created when  states have been unable t o  effectively 
discipline violative registrants. 
h e D EA  had enjoyed a close working relationship with the National 
Association of  Boards of Pharmacy  (NABP)  and I was  pleased  t o  see the 
recormendation that the NABP continue to provide leadership t o  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 
8
J  n  C.  Lawn
inistrator  " 
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)6 284410 FAX (202)7 83-2351  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~lineo f  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 D U c ontrolled 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--oro ther 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  
today there are 46 state-level impaired pharmacist programs, largely as a   f 1
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 refinement.s  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   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.  
1  ~xedutiveV ice 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  20201  
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~ittedb y  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 
t h e  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.&   ,& 
. 
o s p   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 ~isciplineo f 
~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 r e s ~ o n s f ~ i l i t i e s ~ r n ~ ~ ~  
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.  A t  
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.  A t  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. ~ e i c u l p r l vin 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 M e  
t h e  and effort that State pharmacy boards  devote 
to combating this noourge and notes that thia 
concentrated effort i s  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 OIG1sview 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 w i t h  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.~F urthenuore, 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~nposslbleu nless 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 i c b t 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,twsf inding 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 
IConti n m  
The delay imposed  on the disciplinary systarn  by the 
insufficient resource8 noted in the OIG  r a p e  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 w i l l  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  :  National Clearinghouse  
4 
on Licensure, Enforcement and Regulation  
IIron Works Pike, P.O.Box 11910, Lexington, Kentucky 40578-9989, (606) 231-1892 
1 
Eugene L. Ketchum, Executive Director 
PRESIDENT 
Bruce Douglas  March 30,1990 
Division Director 
CO Dept. of Regulatory Agencies 
PRESIDENT- ELECT 
Martha B. Kvaal 
Elizabeth Stewart 
Deputy Regional Inspector General 
Assistant Chief Counsel 
A2 Office of Attorney General  for Evaluation and Inspections 
IMMEDIATE  U.S.Dept. of Health and Human Services 
PAST PRESIDENT  JFK Federal Building  Room 1407 
Ksrr Schmitt  Boston, Massachusetts  02203 
Director of Testing 
MI Depr. of Licensing & 
Regulation 
Dear Ms. Kvaal: 
STEERING COMMITTEE 
Irv Dcshayes 
Chairman  It has been our pleame to review the January, 1990 draft copy of State 
NF. Board of Examiners in  Discipline of  Pharmacists.  This is a very thorough document that captures and presents in 
Audiolog). 6.Speech Patholog!.  an informative manner current disciplinary practices among pharmacy boards.  There is littlc 
Claudia FOUIZ  doubt that there will bc gcneral agrccmcnt with the finding that an obvious nccd exists in 
Chief Dcpty Director  many stares for more statutory authority bcfore appropriate disciplinary actions can be takcn 
2A Dept. of Consumer Affairs 
against pharmacists. 
James  ..I Gufley 
Deputy Director for Enforcement 
VA Dept. of Commerce  With respcct to Lhc  information we arc given that 97% of Lhc rcccnt incrcasc in 
William Marcus  "most scrious disciplinary actions" has occurrcd in just three states and hat furlhcr, 15 states 
Deputy Attorney General  took 10 or fewer of these "most scrious actions" for the period 1986-88, it would have bccn 
CA Dept, of Justice  hclpful to understand what accounted for thc incrcasc or lack of  increasc in such actions. 
William G. Miller  Whilc thc corrclation madc with location and size is interesting, it does not ncccssarily 
Joint Secretary  explain what is going on in thesc statcs. 
GA State Examlninp Boards 
Donald C.Murra?. Jr. 
We fcel it is particularly important that thc report points out the nccd for Lhc 
Director 
DC Depl. of Consumer 6:  ficld of pharmacy to address ihc issucs of standards for quality of care and the nccd to sharc 
Rcgulacory Affairs  information on disciplinary actions lakcn.  With regard to the lauer, we apprcciatc that you 
Paul Quinlnn  mention CLEAR as a repository for statc board disciplinary actions and agrce that reporting 
Director  to boh CLEAR'S National Disciplinary Information System (NDIS)and the National 
NE Real Estate Commission 
Association of  Boards of Pharmacy (NABP) Disciplinary Clearinghouse is an extrcmcly 
Mar!  Romclfanger  important stcp toward resolving this problem.  Wc also agrec that i1 is not in a health 
Deputy Execu:i\,c D~recco: 
KY Board of Nursing  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, 
Barbara Showers 
Director of Examina!ions  valuable disciplinary information is lost that could stop practitioners from crossing stutc lincs 
WJ Dept. of  Regulac~on&  lo rcsume practicc wiLl10ut challcngc sinlply bccause appropriatc inforniation was not sharcd. 
Licensing 
Also, as a practical administrative maucr, it will be far simpler for boards that arc in  lllc 
Caroline Stellmnnn  practice of sharing disciplinary information lo comply with the requircmcn~so f thc NPDB. 
Member 
MD Board ol Examiners of 
Nurses  Thank you for thc opportunity lo comnlcnl on this report. 
Ron Weavcr 
Administrator 
Professional Licensing Scrviccs 
Sincerely, 
\'A  Dept. of Health 
John 6. Welsh. Jr. 
Senior Counsel 
WA House of Representatives  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 L a w 19 88-19 89, 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-01-89-891 60, draft report, January 1990. 
8.   Sa rnuel 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.  
18 .   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.