```
                                                                 
VA Health Care: Implementation of Prescribing Guideline for	 
Atypical Antipsychotic Drugs Generally Sound (29-APR-02,	 
GAO-02-579).							 
                                                                 
The Department of Veterans Affairs (VA) provides health care	 
services to veterans who have been diagnosed with		 
psychosis--primarily schizophrenia, a disorder that can 	 
substantially limit their ability to care for themselves, secure 
employment, and maintain relationships. These veterans also have 
a high risk of premature death, including suicide. Effective	 
treatment, especially antipsychotic drug therapy, has reduced the
severity of their illnesses and increased their ability to	 
function in society. VA's guideline for prescribing atypical	 
antipsychotic drugs is sound and consistent with published	 
clinical practice guidelines used by public and private health	 
care systems. VA's prescribing guideline, recommends that	 
physicians use their best clinical judgment, based on clinical	 
circumstances and patients' needs, when choosing among the	 
atypical drugs. Most Veterans Integrated Service Networks and	 
facilities use VA's prescribing guideline; however, five VISNs	 
have additional policies and procedures for prescribing atypical 
antipsychotic drugs. Although these procedures help manage	 
pharmaceutical cost, they also have the potential to result in	 
more weight given to cost than clinical judgment which is not	 
consistent with the prescribing guideline.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-02-579 					        
    ACCNO:   A03182						        
  TITLE:     VA Health Care: Implementation of Prescribing Guideline  
for Atypical Antipsychotic Drugs Generally Sound		 
     DATE:   04/29/2002 
  SUBJECT:   Drugs						 
	     Mental health care services			 
	     Mental illnesses					 
	     Physicians 					 
	     Veterans benefits					 
	     Veterans hospitals 				 
	     VA Veterans Integrated Service Network		 

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GAO-02-579
     
A

Report to the Chairman, Committee on Veterans? Affairs, House of
Representatives

April 2002 VA HEALTH CARE Implementation of Prescribing Guideline for
Atypical Antipsychotic Drugs Generally Sound

GAO- 02- 579

Letter 1 Results in Brief 2 Background 3 VA Prescribing Guideline for
Atypical Antipsychotic Drugs Is Sound 11

Guideline Generally Implemented as Intended, but Some Facility Policies
Conflict with It by Overemphasizing Cost 15 Conclusions 21 Recommendation
for Executive Action 22 Agency Comments and Our Evaluation 22

Appendixes

Appendix I: Scope and Methodology 24

Appendix II: VA Prescribing Guideline for Atypical Antipsychotic Use 27

Appendix III: Process VA Used to Develop Its Prescribing Guideline for
Atypical Antipsychotic Drugs 28

Appendix IV: Results from GAO Survey of VA Psychiatrists 30

Appendix V: Comments from the Department of Veterans Affairs 32

Appendix VI: GAO Contact and Staff Acknowledgments 33 Tables Table 1:
Atypical Antipsychotic Drugs 5

Table 2: Guidelines for Antipsychotic Drug Use When Clinical Judgment Does
Not Indicate a Particular Drug 12 Table 3: Guidelines and Procedures Used by
VISNs for Prescribing Atypical Antipsychotic Drugs 17

Figures Figure 1: Average Daily Cost per Patient for Antipsychotic Drugs,
Fiscal Year 2001 6

Figure 2: Number of VA 30- day Prescriptions for the Five Atypical Drugs in
2001 7 Figure 3: Number of Patients Beginning Treatment on Each

Atypical Antipsychotic Drug in 2001 8 Figure 4: Percentage of Responding
Psychiatrists in Each VISN

Who Reported That They Did Not Feel Free To Prescribe the Atypical
Antipsychotic Drug of Their Choice 18 Figure 5: Timeline of Task Force 28

Abbreviations

CATIE Clinical Antipsychotic Trials of Intervention Effectiveness GAO United
States General Accounting Office NAMI The National Alliance for the Mentally
Ill PORT Patient Outcomes Research Team TMAP Texas Medication Algorithm
Project VA Department of Veterans Affairs VHA Veterans Health Administration
VISN Veterans Integrated Service Network

Lett er

April 29, 2002 The Honorable Christopher H. Smith Chairman Committee on
Veterans? Affairs House of Representatives

Dear Mr. Chairman: The Department of Veterans Affairs (VA) provides health
care services to veterans who have been diagnosed with psychosis- primarily
schizophrenia, a disorder that can substantially limit their ability to care
for themselves, secure employment, and maintain relationships. These

veterans also have a high risk of premature death, including suicide. For
many of them, effective treatment, especially antipsychotic drug therapy,
has reduced the severity of their illnesses and increased their ability to

function in society. In fiscal year 2000, VA spent $1.1 billion to provide
psychiatric care for almost 200,000 veterans with psychosis. Of this amount,
$123 million was spent on antipsychotic drugs. In fiscal year 2001,

the amount for antipsychotic drugs jumped 29 percent to $158 million- or 7
percent of VA?s total drug costs.

Since 1989, new antipsychotic drugs have been approved in the United States.
These new ?atypical? drugs are effective and much less likely to cause
involuntary body and facial movements, tremors, and contractions

associated with the traditional drugs for schizophrenics. However, atypical
antipsychotic drugs are expensive, and the cost differences among them can
vary significantly. All atypical antipsychotic drugs are on VA?s national
formulary, 1 except the newest, which is available through nonformulary
approval processes. To ensure that veterans with mental disorders receive

the most appropriate yet cost- effective drug, VA issued a guideline in July
2001 for prescribing atypical antipsychotic drugs for newly diagnosed
patients or for patients not responding favorably to their current
medication. According to VA officials, the guideline was needed to better
manage the cost associated with atypical antipsychotic drugs and the effect
of the drug companies? marketing of these drugs to physicians. However,

1 Formularies are lists of medications that health care organizations
encourage or require their providers to use when they write prescriptions
for patients. Physicians are generally free to prescribe any drug on VA?s
formulary.

the guideline emphasizes that clinical factors rather than cost ultimately
determine physicians? prescribing decisions.

You asked us to review whether this guideline may result in restricted
access to the more costly atypical antipsychotic drugs and, in turn,
adversely affect the quality of care for veterans. To address these
concerns, you asked us to determine (1) if VA's clinical guideline for
prescribing atypical antipsychotic drugs is consistent with medical
community practices for managing serious mental illnesses and

(2) whether implementation of the guideline is consistent with its intent to
ensure that prescribing decisions are ultimately based on physicians?
clinical judgment. To conduct our work, we interviewed or obtained documents
from VA officials responsible for developing the guideline, representatives
from federal agencies responsible for mental health issues, professional
medical organizations, mental health advocacy groups, private mental health
care providers, private pharmacy benefits management companies, and state
Medicaid or mental health departments in California, Florida, Georgia,
Massachusetts, and Texas. Also, we obtained and reviewed four clinical
guidelines for antipsychotic drug use that are widely accepted by public and
private health systems. Further, we contacted pharmacists in each of

VA?s 22 Veterans Integrated Service Networks (VISN) and visited or contacted
14 facilities in 8 of them to determine whether the guideline was being
used. 2 We also surveyed VA psychiatrists about how the guideline affected
their prescribing practices. In addition, we reviewed VA antipsychotic drug
utilization data for each VISN and its medical facilities. (For more
information on our methodology, see appendix I.) We conducted our work from
September 2001 through April 2002 in accordance with generally accepted
government auditing standards.

Results in Brief VA?s guideline for prescribing atypical antipsychotic drugs
is sound and consistent with published clinical practice guidelines commonly
used by

public and private health care systems. VA?s prescribing guideline, like
other practice guidelines, recommends that physicians use their best
clinical judgment, based on clinical circumstances and patients? needs, 2 In
January 2002, VA announced the merger of networks 13 and 14 into a single
organization known as network 23. We report on these two networks separately
because at the time of our survey they were operating as individual
networks.

when choosing among the atypical drugs. VA?s prescribing guideline also
includes a cost factor, stating that if no clinical reason exists to
prescribe one atypical antipsychotic drug over another, physicians should
begin treatment with one of the less expensive atypical drugs on VA?s
formulary. Almost all of the public and private sector psychiatric experts
we

interviewed agree that VA?s use of cost as a factor to prioritize atypical
antipsychotic drugs is reasonable, appropriate, and consistent with
providing quality and cost- effective medical care. Most VISNs and
facilities use VA?s prescribing guideline and have implemented it in various
ways, including supplementing its distribution with group discussions.
However, facilities within five VISNs have additional policies and
procedures for prescribing atypical antipsychotic drugs. While these
procedures help manage pharmaceutical cost, they also have the potential to
result in more weight given to cost than clinical judgment which is not
consistent with the prescribing guideline. For example, our survey indicates
that the vast majority of VA psychiatrists-

91 percent- report they are able to prescribe the atypical antipsychotic
drugs that are best for their patients, but 9 percent report not feeling
free to do so. These psychiatrists are concentrated in VISNs where one or
more facilities have additional procedures.

We are recommending that VA monitor implementation of the guideline by VISNs
and facilities to ensure that facilities? policies and procedures conform to
the intent of the guideline by not restricting physicians from prescribing
atypical antipsychotic drugs on VA?s formulary. In commenting on a draft of
this report, VA concurred with our recommendation.

Background Over the past several decades, the introduction of two types of
drugs- traditional and atypical antipsychotic drugs- for treating
schizophrenia,

and in some cases, bipolar disorder, have enabled physicians to better
manage their patients? mental illnesses, resulting in a better quality of
life for many veterans. Because schizophrenia severely impairs thinking,
language, perception, mood, and behavior, schizophrenics often withdraw from
society and retreat into a world of delusions, hallucinations, and
fantasies. With drug treatment, approximately 60 to 70 percent of
schizophrenics experience either complete remission or only mild

symptoms of the disease; the remaining 30 to 40 percent continue to
experience psychotic symptoms. Most patients with schizophrenia are
maintained on antipsychotic drugs throughout their lives since symptoms
return in over 70 percent of stable patients who stop taking their drugs.

Bipolar disorder, also known as manic- depressive illness, is characterized
by extreme and unpredictable mood swings, ranging from high excitement or
euphoria- where the patient is energetic and confident- to despair or deep
depression, where the patient may feel sad, helpless, apathetic, angry, or
suicidal. As with schizophrenia, bipolar disorder can impair a patient?s
ability to function. To control bipolar episodes, physicians often prescribe
mood- stabilizing drugs, but in cases where these drugs are not effective,
physicians may prescribe antipsychotic drugs on a short- term basis. The
introduction of traditional and atypical antipsychotic drugs has also helped
facilitate a shift in treatment settings for adults with severe mental
illness, both in the VA system and in the general medical community, from
expensive inpatient care in hospitals to less costly outpatient care in
community- based treatment facilities.

Traditional antipsychotic drugs were first introduced in the 1950s. While
these drugs are effective in treating psychosis, they can often cause severe
side effects, such as involuntary body and facial movements, tremors, and
contractions. For example, after 5 years of taking traditional drugs,
patients have a 32 percent chance of developing a sometimes irreversible
movement disorder, and after 25 years, they have a 68 percent chance. The
Food and Drug Administration first approved atypical antipsychotic drugs in
1989, and five are currently available for use. (See table 1.) They are
considered as effective as traditional drugs in treating psychosis, but they
are much less likely to cause the severe involuntary movements associated
with the traditional drugs. While atypical drugs also have side effects-

some of which can be serious- most occur with less severity than the side
effects associated with traditional drugs. The side effects vary among the
atypical drugs and include sedation, sexual dysfunction, cardiac problems,
and sudden drops in blood pressure. Additional side effects are weight

gain and elevated cholesterol that could lead to heart disease and diabetes.
3 Various studies and psychiatrists we interviewed have concluded that
because the side effects are reduced, patients are more likely to stay on
their drug therapy and have fewer relapses of psychosis when taking atypical
antipsychotic drugs.

3 Clozapine can also cause a life- threatening blood disorder. The
manufacturer?s prescribing information recommends prescribing it only to
patients who fail therapy on at least two other antipsychotic medications
and states that patients taking it are required to have weekly blood tests
for the first 6 months and every other week thereafter.

Table 1: Atypical Antipsychotic Drugs Drug name (brand name) Year approved

Clozapine (Clozaril) 1989 Risperidone (Risperdal) 1993 Olanzapine (Zyprexa)
1996 Quetiapine (Seroquel) 1997 Ziprasidone (Geodon) 2001 Source: Food and
Drug Administration.

Over the last few years, the number of prescriptions for atypical
antipsychotic drugs has increased dramatically in VA. In fiscal year 1999,
62 percent of all antipsychotic drug prescriptions were for atypical drugs;
by fiscal year 2001, more than 80 percent were for atypical drugs.
Antipsychotic drugs- both traditional and atypical- are VA?s third most
expensive class of drugs. 4 In fiscal year 2001, VA filled more than 1.5
million 30- day antipsychotic prescriptions for more than 176,000 patients
at a cost of $158 million, accounting for 7 percent of its total pharmacy

budget. 5 Overall, atypical antipsychotic drugs are more costly than
traditional antipsychotic drugs. For VA, the average daily cost of atypical
drugs is about 17 times higher than the average daily cost of traditional
drugs. However, the average daily cost among atypical drugs varies. In
fiscal year 2001, clozapine cost about $8 a day per patient, while
quetiapine

cost less than $3 a day. (See fig. 1.) 4 The most expensive class of drugs
in VA is antilipemic (blood cholesterol lowering drugs) and the second most
expensive class is antidepressants. 5 To count prescriptions, VA
standardized them in 30- day units. For example, a prescription that covered
drugs for 90 days would be counted as three 30- day prescriptions.

Figure 1: Average Daily Cost per Patient for Antipsychotic Drugs, Fiscal
Year 2001 9

Price in dollars

8.07

8 7

6.28

6 5

5.01

4

3.15 2.94

3 2 1

0.26

0 Clozapine

Risperidone Olanzapine

Quetiapine Ziprasidone

Traditional drugs

Source: VA Pharmacy Benefits Management.

In 2001, 30- day prescriptions were written for all five atypical
antipsychotic drugs, with olanzapine and risperidone prescribed most often
to veterans. (See fig. 2.)

Figure 2: Number of VA 30- day Prescriptions for the Five Atypical Drugs in
2001 600,000

Number of Prescriptions

523,456

500,000

478,842

400,000 300,000 200,000

198,723

100,000

74,656 10,192

0 Clozapine

Risperidone Olanzapine

Quetiapine Ziprasidone

Source: VA Pharmacy Benefits Management.

In 2001, most patients began treatment on risperidone, olanzapine, or
quetiapine. (See fig. 3.)

Figure 3: Number of Patients Beginning Treatment on Each Atypical
Antipsychotic Drug in 2001 30000

Number of Patients 25000

23,892 21,075

20000 15000

12,087

10000 5000

74 365

0 Clozapine

Risperidone Olanzapine

Quetiapine Ziprasidone

Note: Patients were considered to have begun treatment on an atypical
antipsychotic drug if they had not received a prescription for that drug
since October 1998.

Source: VA Pharmacy Benefits Management.

Choosing which atypical antipsychotic drug to prescribe for patients can be
difficult. Experts have concluded that the scientific evidence is not
sufficient to favor any one of the atypical drugs. 6 Each has been proven
effective in clinical trials, but effectiveness appears to depend on the
particular patient. A panel of academic researchers reviewed available
scientific evidence in 1999 and concluded that the three most widely used

atypicals- risperidone, quetiapine, and olanzapine- are comparable in
efficacy, safety, and patient tolerability. 7 The Cochrane Collaboration, an
organization that systematically reviews randomized clinical medical trials,
reviewed the evidence comparing two of the atypical drugs, risperidone and
olanzapine. 8 It concluded that little evidence exists to suggest choosing
one drug over the other. Three internal VA panels in the last 3 years agreed
that none of the three most widely used atypical drugs could be judged
better than the others.

Studies conducted by drug manufacturers have been inconclusive in comparing
atypical drugs. The studies often were too short in duration to draw
conclusions about the drugs? long- term effects. In addition, many studies
excluded substance abusers and those who were violent and uncooperative- a
significant problem in determining effectiveness because many schizophrenics
meet these criteria.

The National Institute of Mental Health has recently funded a $42 million
study that will compare the five atypical antipsychotic drugs available
today to each other and to a traditional antipsychotic drug. This study, the

Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), will
examine 1, 800 schizophrenic patients, including patients with substance
abuse and other medical problems. Four VA facilities are among the 53
medical facilities participating in CATIE. One of the objectives of the
CATIE study is to identify specific patient profiles for each drug in order
to guide physicians in selecting the best atypical drug for their patients.
The study?s results are expected to be available by 2006.

6 Evidence suggests that clozapine is more effective- particularly for
schizophrenics who do not respond to traditional drugs. However, clozapine
is associated with a risk of life- threatening blood disorder. Ziprasidone
was not included in most reviews of scientific evidence because the FDA had
not yet approved it when they were completed. 7 Miller et al. 1999. The
Texas Medication Algorithm Project (TMAP) Schizophrenia Algorithms. Journal
of Clinical Psychiatry. Vol. 60, no. 10, pp. 649- 657. 8 Gilbody et al.
2002. Risperidone versus other atypical antipsychotic medication for
schizophrenia (Cochrane Review). The Cochrane Library, issue 1.

VA physicians are generally free to prescribe any drug on the formulary.
VISNs and facilities can place restrictions on some drugs that require close
monitoring to ensure appropriate use, but these restrictions cannot be based
solely on cost. Usually psychiatrists are the practitioners that prescribe
atypical drugs for psychotic patients, although some facilities allow other
types of physicians to write refill prescriptions or to prescribe

these drugs for nonpsychotic patients with dementia or diseases such as
Parkinson?s and Alzheimer?s. VA policy requires that all drugs on the
formulary be available at each VA pharmacy. VA further requires its 22 VISNs
to establish approval processes for prescribers to obtain drugs not listed
on their formularies. In addition, to provide flexibility in meeting local
patient needs, VA allows VISNs to add drugs to network formularies to
supplement the national formulary. 9 Pharmacy and Therapeutics

committees in each VISN, consisting of physicians, pharmacists, and other
health care professionals are usually responsible for selecting these
additional drugs.

According to VA?s Pharmacy Benefits Management Strategic Health Care Group?s
Medical Advisory Panel officials, 10 VA chose not to limit the number of
atypical drugs available on the formulary because such limits potentially
restrict physicians? ability to prescribe the most appropriate drug for
their patients. Four of the five atypical antipsychotic drugs- olanzapine,
risperidone, quetiapine, and clozapine- are listed on VA?s national
formulary. The fifth, ziprasidone, which the Food and Drug Administration
approved in 2001, is not listed on the national formulary, but is available
through local nonformulary approval processes. VA generally does not place
drugs on the formulary until they have been on the

market at least 1 year. To educate physicians about the increasing
importance and cost of atypical antipsychotics and to provide uniform
information in the face of increasing pharmaceutical industry marketing to
VA psychiatrists, VA issued the

guideline for prescribing atypical antipsychotics to supplement VA?s overall
treatment guidelines for managing patients with psychosis. In addition to
discussing appropriate drug therapy, the overall treatment guidelines
include sections on the evaluation, diagnosis, and social rehabilitation of
9 U. S. General Accounting Office, VA Drug Formulary: Better Oversight Is
Required, but Veterans Are Getting Needed Drugs, GAO- 01- 183 (Washington,
D. C.: Jan. 29, 2001), p. 3. 10 The panel consists of 11 VA and 1 Department
of Defense practicing physicians, from multiple specialties, including
psychiatry.

patients with psychoses. The overall treatment guidelines currently
recommend that psychiatrists treating patients with psychosis either
prescribe moderate doses of traditional antipsychotic drugs or prescribe

atypical antipsychotic drugs. VA is currently revising the guidelines for
managing patients with psychosis, including recommending atypical drugs
before traditional drugs for these patients. While the National Alliance for
the Mentally Ill (NAMI) and the National Mental Health Association stated
that physicians could consider cost when prescribing antipsychotic drugs,
each has voiced concerns that some local VA officials might use the
guideline more stringently to cut costs- either by restricting physician
access to more expensive atypical drugs for new patients or by switching
stable patients to the less expensive atypical drugs. Officials from the
American Psychiatric Association and the

National Association of VA Physicians and Dentists have expressed similar
concerns.

VA Prescribing VA?s guideline for prescribing atypical antipsychotic drugs
is consistent

Guideline for Atypical with published clinical practice guidelines commonly
used by public and

private health care systems. Like most other practice guidelines, VA?s
Antipsychotic Drugs Is guideline recommends that physicians use their best
medical judgment, Sound

based on clinical circumstances and patients? needs, when choosing among the
atypical drugs. VA?s prescribing guideline also recommends that physicians
use cost as a factor in deciding which atypical antipsychotic to prescribe
when no clinical reason exists to choose one drug over another-

a practice most of the public and private sector psychiatric experts we
interviewed agreed is reasonable, appropriate, and consistent with providing
quality cost- effective medical care.

VA?s Prescribing Guideline Is VA?s prescribing guideline, which supplements
its broader psychosis Consistent with Commonly treatment guidelines, is
similar to the four clinical guidelines most widely

Used Clinical Guidelines accepted by public and private health systems- the
Texas Medication

Algorithm Project (TMAP); The Expert Consensus Guideline Series: Treatment
of Schizophrenia; The Schizophrenia Patient Outcomes Research Team (PORT);
and the American Psychiatric Association Practice Guideline for the
Treatment of Patients with Schizophrenia. (See table 2.) Like VA?s
guideline, each suggests that therapy be based on physicians? assessment of
patient needs and is not intended to interfere with clinical judgment.

Table 2: Guidelines for Antipsychotic Drug Use When Clinical Judgment Does
Not Indicate a Particular Drug Guideline Patient( s) First line of drug
treatment Effective date

VA Guideline for Atypical * New psychosis patients Prescribe risperidone or
quetiapine-- the two less 2001 Antipsychotic Use  Patients having problems
expensive atypical antipsychotics-- if no patientspecific with traditional
drugs

issue suggests another drug. Next, prescribe olanzapine. Texas Medication
Algorithm  New schizophrenia patients

Prescribe olanzapine, quetiapine, and risperidone, in 1999 Project 
Patients who have failed

any order. treatment with traditional drugs The Expert Consensus

 Schizophrenia patients Prescribe olanzapine, quetiapine, and risperidone,
in 1999 Guideline Series: Treatment of

any order. Schizophrenia The Schizophrenia Patient  Schizophrenia patients
Prescribe antipsychotic medications other than

1998 Outcomes Research Team clozapine. American Psychiatric  Schizophrenia
patients Prescribe traditional antipsychotic medications or

1997 Association Practice Guideline

risperidone; other atypical antipsychotics may also be for the Treatment of
Patients appropriate. with Schizophrenia Source: GAO review of private and
public sector clinical guidelines.

VA?s prescribing guideline aims to assist physicians in selecting from its
national formulary the most cost- effective atypical antipsychotic drugs for
their patients without interfering with their clinical judgment. VA?s
prescribing guideline for atypical antipsychotic drugs is reprinted in
appendix II. For information on how the guideline was developed, see
appendix III. Specifically, VA?s guideline states that

 the guideline is to be used only for new patients or for patients not
responding favorably to traditional medications,

 therapy is ultimately based on physicians? assessment of patient needs and
the guidelines are not intended to interfere with clinical judgment, and

 because no consensus exists in scientific literature to support that one
atypical antipsychotic drug is superior to another, physicians should begin
treatment with one of the less expensive atypical antipsychotic drugs on
VA?s national formulary if there are no patient specific reasons to
prescribe one drug over another.

For cases where no clinical reason exists to prescribe one atypical drug
over another, VA?s guideline includes an algorithm showing the suggested
treatment order for prescribing the four atypical antipsychotic drugs on
VA?s formulary. The guideline?s algorithm recommends that physicians first
prescribe risperidone or quetiapine, in either order, to patients with a
first episode of psychosis or patients with chronic psychosis who have
relapsed. The algorithm lists olanzapine as the next drug that physicians
should try, and clozapine as the last drug. The guideline?s treatment order
reflects VA?s

prices of the drugs- risperidone and quetiapine are significantly less
expensive than olanzapine. Clozapine is not only the most expensive drug,
but it is seldom used because of its risk of causing a life- threatening
blood disorder. Because ziprasidone has only recently received Food and Drug
Administration approval, it is not included on VA?s national formulary, and
it is not included in the algorithm. However, the guideline states that it
may be considered for patients with intolerance or a poor response to the
other atypical drugs.

In the preface to its algorithm VA?s prescribing guideline discusses the
importance of cost- effective high quality care. According to officials
responsible for developing the TMAP and PORT guidelines, their guidelines
did not include cost because they were meant to be broad and apply to a wide
variety of organizations. Nevertheless, some health care systems that use
these guidelines also consider cost. For example, the Texas Department of
Mental Health and Mental Retardation has a supplemental policy that
recommends using the less expensive atypical antipsychotics before other
atypicals when appropriate. It asks its physicians to choose

the least expensive of the three drugs recommended by TMAP for new patients
when their clinical judgment does not indicate the use of one atypical drug
over another. The Massachusetts Medicaid behavioral health program has a
similar approach. It follows the PORT guidelines, and in 1999 issued a
memorandum with additional guidance and a cost- effectiveness study to its
psychiatrists pointing out that risperidone was less expensive and just as
effective as olanzapine for new patients. The

memorandum and study were issued to highlight the importance of using cost
as a factor in deciding which drug to prescribe.

Experts Acknowledge That Because available scientific evidence and expert
opinion suggest that all Using Cost as a Factor Is atypical drugs are
appropriate treatment for psychosis, incorporating cost Reasonable and
Appropriate into VA?s prescribing guideline is reasonable, appropriate, and
consistent with providing cost- effective health care. The Institute of
Medicine 11 has concluded that when no marginal therapeutic benefit is
expected from more expensive drugs, guideline developers may reasonably
recommend less expensive drugs. 12

Almost all of the psychiatric experts we interviewed- including those in
charge of TMAP and PORT- said that asking physicians to consider drug cost
as a factor when prescribing atypical antipsychotic drugs is reasonable,
appropriate, and consistent with providing cost- effective quality medical
care to patients. Psychiatrists from the National Institute of Mental
Health, which funds antipsychotic drug research, also agreed that it was
appropriate for psychiatrists to consider less expensive atypical drugs. The
co- chairman of VA?s Committee on Care of Severely Chronically

Mentally Ill Veterans 13 stated that the VA guideline represents quality
medical care because no scientific evidence exists to recommend one drug
over another and because physicians make the final prescribing decisions

based on their medical judgment. State mental health officials from
California, Georgia, and Florida- states that do not use cost to rank
medications- recognize the importance of considering costs when choosing
among them. For example, the medical director of Georgia?s Division of
Mental Health, Mental Retardation and

Substance Abuse stated that in the face of recent state budget cuts of 2.5
to 5 percent, the state may consider adopting guidelines similar to VA?s
that include cost as a factor. While neither Florida nor California
officials suggest that physicians should use atypical drugs in any
particular order, 11 The Institute of Medicine is an associated organization
of the National Academy of Sciences. Its mission is to advance and
disseminate scientific knowledge to improve human health.

12 Committee on Clinical Practice Guidelines, Division of Health Care
Services, Institute of Medicine, Guidelines for Clinical Practice: From
Development to Use (Washington, D. C.: National Academy Press, 1992), pp.
145- 146. 13 This committee was established in 1996 by statute to assess
VA?s ability to effectively treat severely mentally ill veterans. Annually,
the committee issues a report containing data on the care provided to
seriously mentally ill veterans.

state health officials agreed that cost could be a factor in prescribing
these drugs. Guideline Generally

Most VISNs use VA?s prescribing guideline. The policies and procedures for
Implemented as implementing the guideline vary as some facilities have added
a

requirement for prescribing atypical antipsychotic drugs. This additional
Intended, but Some

requirement calls for pharmacists or senior psychiatrists to review Facility
Policies

prescriptions for one of the atypical antipsychotic drugs and to confer with
Conflict with It by

the prescribing psychiatrist on the appropriateness of the prescription. The
vast majority of psychiatrists who responded to our survey reported
Overemphasizing Cost they are free to prescribe the atypical antipsychotic
drugs consistent with their best clinical judgment. However, we identified
some facility policies and procedures that conflict with the intent of VA?s
prescribing guideline,

which asks physicians to consider cost only if there is no clear clinical
choice for one drug over another. Most VISNs Use VA?s

We contacted the formulary leaders at each VISN and had further Prescribing
Guideline

discussions with psychiatrists and pharmacists in selected VISNs to
determine if the prescribing guideline was being used. Eighteen of the
formulary leaders reported that their VISNs use VA?s prescribing guideline.
Two other formulary leaders reported that their VISNs were using different
guidelines- one VISN modified the guideline to include ziprasidone in the
algorithm and the other VISN developed a guideline that does not suggest a

treatment order or use cost as a determining factor under any circumstances.
The remaining two formulary leaders stated that their VISNs do not use
guidelines for prescribing atypical antipsychotic drugs.

In implementing VA?s prescribing guideline, some VISNs simply distributed
the guideline to facilities for use, and some facilities combined guideline
distribution with group discussions on the costs of atypical antipsychotic
drugs. Officials from one VISN distributed the guideline to its facilities
along with pocket- sized cards for each psychiatrist showing the prices and

doses for every antipsychotic drug. Despite the fact that most VISNs use the
guideline, not all psychiatrists told us they were aware of it.
Specifically, in our survey we asked psychiatrists if they had seen or been
briefed on the prescribing guideline. Of those responding, 66 percent
reported that they had, 11 percent reported that they were unsure, and 23
percent reported that they had not.

In addition, formulary leaders, psychiatrists, and pharmacists in five VISNs
told us that several facilities require physicians to follow additional
policies and procedures for prescribing atypical antipsychotic drugs. (See
table 3.) Some of them also told us that the need to manage cost is the
primary reason for implementing additional prescribing procedures for
atypical antipsychotic drugs at their facilities.

Table 3: Guidelines and Procedures Used by VISNs for Prescribing Atypical
Antipsychotic Drugs Use other or Use VA?s Use VISN additional prescribing
specific

procedures at one VISN (location) guideline

guidelines or more facilities

1 (Boston) !

2 (Albany) !

3 (Bronx) ! !

4 (Pittsburgh) 5 (Baltimore) !

6 (Durham) !

7 (Atlanta) !

8 (Bay Pines) ! !

9 (Nashville) !

10 (Cincinnati) !

11 (Ann Arbor) !

12 (Chicago) !

13 (Minneapolis) !

14 (Omaha) !

15 (Kansas City) !

16 (Jackson) ! a

17 (Dallas) !

18 (Phoenix) ! b !

19 (Denver) !

20 (Portland) !

21 (San Francisco) !

22 (Long Beach) ! !

a VISN guidelines do not distinguish among the atypical antipsychotic drugs,
except for clozapine. b VISN modified VA?s prescribing guideline to include
ziprasidone in the algorithm.

Source: GAO Interviews with VA Officials.

Intent of Prescribing Since VA issued the prescribing guideline, it has
reiterated its policy that

Guideline Generally the guideline not interfere with physicians? clinical
judgment. Most Followed, but CostContainment

psychiatrists we interviewed agree that the intent of VA?s policy is being
Procedures followed. The vast majority of the psychiatrists who responded to
our survey- 91 percent- indicated that they have been able to prescribe the
Could Conflict with It

atypical antipsychotic drugs that are best for their patients. Nevertheless,
a number of psychiatrists- 9 percent of those who responded to our survey-
reported they did not feel free to prescribe the antipsychotic drug of their
choice. These psychiatrists are generally concentrated in a few VISNs. For
example, in VISN 22, 33 percent of responding psychiatrists reported that
they did not feel free to prescribe the atypical antipsychotic drug that
they believed was best for some of

their patients, and in VISN 18, the rate was 22 percent. Three other VISNs
had rates of more than 10 percent. Conversely, four VISNs had no
psychiatrists who felt they could not exercise their clinical judgment in

prescribing these drugs. (See fig. 4.) (See appendix IV for additional
survey information for each VISN.)

Figure 4: Percentage of Responding Psychiatrists in Each VISN Who Reported
That They Did Not Feel Free To Prescribe the Atypical Antipsychotic Drug of
Their Choice

14 Number of VISNs

13

12 10

8 6 4

4 3

2

1 1

0 0 1 to 10 11 to 20 21 to 30 above 30 Percentage of responding
psychiatrists in each VISN

Source: GAO survey of VA psychiatrists.

Our survey showed that several VISNs with one or more facilities that have
additional prescribing requirements for atypical antipsychotic drugs also
had relatively high percentages of psychiatrists who reported they were not

always free to prescribe the most appropriate atypical drug. For example,
VISN 22- which had the highest percentage of physicians who reported they
were not free to prescribe the drug of their choice- has four facilities
that require pharmacists to review prescriptions for olanzapine.

Psychiatrists? concerns may be related to cost control procedures at some
facilities that have limited access to atypical antipsychotic drugs-
practices which conflict with the prescribing guideline. For example, the
Miami VA Medical Center no longer requires physicians to first select among
the traditional antipsychotic drugs before prescribing any atypical drugs,
but it does require that psychiatrists prescribe risperidone and

quetiapine before prescribing olanzapine. The chief pharmacist at the center
told us that this policy was implemented to control cost. This policy
conflicts with the prescribing guideline, because cost has greater weight
than physicians? clinical judgment. Furthermore, VA psychiatrists at other
facilities reported that their managers exerted pressure to prescribe the

lower cost atypical drugs. One psychiatrist stated that facility
administrators pushed for prescribing less expensive atypical drugs, even
though the psychiatrist?s evaluation of some patients indicated that these
drugs would be less effective than the more costly atypical drug olanzapine.
In addition, 31 of the 876 psychiatrists that we included in our survey
analysis reported that they believed prescribing high- cost atypical
antipsychotic drugs could affect their performance ratings.

About 22 percent of the psychiatrists who responded to our survey reported
that they are required to follow additional VISN or facility procedures for
prescribing olanzapine. While these procedures help the

facility manage pharmaceutical use, they have the potential to overemphasize
cost- containment if they put pressure on physicians to prescribe the less
expensive drugs. Examples where this could happen are discussed below.

 In VA?s Greater Los Angeles Healthcare System, Los Angeles, California,
part of VISN 22, all psychiatrists provide written justifications for
olanzapine prescriptions, which are reviewed by pharmacists or senior

psychiatrists. For routine requests- such as those for VA patients who are
already stable on olanzapine or patients who did not respond favorably to
other atypical antipsychotic drugs- the pharmacist fills the prescription.
For nonroutine requests- such as those for new patients who have not
previously taken atypical antipsychotic drugs- the pharmacist forwards the
request and written justification to a senior psychiatrist who reviews them
and may discuss recommended

treatment options with the prescribing physician. 14 In the 4 months after
the prescribing guideline was implemented, 11 percent of all olanzapine
requests were denied as part of its cost containment procedures. However,
according to a member of the facility?s Pharmacy and Therapeutics Committee,
the facility may eliminate these costcontrol

measures entirely as a result of a January 2002 notice from the Under
Secretary for Health that discusses VA policy when treating patients with
psychosis.

 The VA San Diego Healthcare System, San Diego, California, part of VISN
22, also regulates olanzapine use, but it does not require prescribing
physicians to provide written justification. Instead, pharmacists trained in
the use of drugs to treat mental illness are

required to review all prescriptions for olanzapine and discuss treatment
options with prescribing physicians, recommending the lower cost risperidone
or quetiapine first for patients who have not tried them. For cases where
the psychiatrist does not agree with the pharmacist?s

recommendation, the case is forwarded to the chief psychiatrist or the
facility?s pharmacy and therapeutics committee for final approval or denial.

 The Carl T. Hayden VA Medical Center, Phoenix, Arizona, part of VISN 18,
requires clinical pharmacists to review prescriptions for olanzapine for
patients who have not tried less expensive atypical drugs and to discuss
with the prescribing physician the clinical reason for choosing one drug
over another. The pharmacist may recommend risperidone and quetiapine;
however, if the psychiatrist disagrees with the recommendation, the
prescription is referred to the chief psychiatrist

14 The Greater Los Angeles Healthcare System implemented this policy for
nonroutine requests when it implemented VA?s prescribing guideline.

for review. If the matter is still not resolved, another psychiatrist will
review the case. If the original prescribing psychiatrist still disagrees
with the recommendation, the matter is referred to and decided by the
facility?s chief of medicine. In addition, psychiatrists have been asked to
examine their cases of veterans who are currently on olanzapine to

determine if these veterans could be switched to a less expensive atypical
drug. If this practice results in switching, using cost to justify changing
the drugs of patients would not be consistent with the intent of VA?s
prescribing guideline. In July 2001, the Secretary of Veterans Affairs
testified before the Senate Committee on Veterans? Affairs that physicians
are free to prescribe any

medication on the VA formulary, consistent with VA policy that formulary
drugs cannot be restricted based solely on cost. 15 At the same time, the
Deputy Under Secretary for Health asked VISN directors to ensure that none
of their facilities? policies or procedures restrict physician access to the
atypical drugs. Further, the Assistant Deputy Under Secretary for Health
stated that the clinical judgment of each veteran?s individual psychiatrist
should determine which atypical antipsychotic drug to prescribe. Also, the
conference report on VA?s fiscal year 2002 appropriations directed the
Secretary of Veterans Affairs to communicate

to physicians existing VA policy that physicians are to use their best
clinical judgment when choosing atypical antipsychotic drugs. 16 In
response, VA?s Under Secretary for Health issued a notice on January 16,
2002, reiterating the conference report?s message.

Conclusions Atypical antipsychotic drugs are essential to providing quality
mental health care; however, they vary significantly in cost. To educate
physicians on the effectiveness of atypical antipsychotic drugs and their
costs, VA implemented a prescribing guideline, based on scientific evidence
and

expert consensus. This guideline is consistent with widely accepted
guidelines in other public and private health care systems. If properly
implemented, it would result in both quality and cost- effective mental
health care, and providing it to VA physicians is appropriate.

15 Veterans Health Administration Directive 2001- 044, sec. 3f, July 24,
2001. 16 H. R. Rep. No. 107- 272, at 56 (2001).

In managing pharmacy costs, one of the major challenges facing managers at
VA facilities is the high cost of atypical antipsychotic drugs.
Consultations between prescribing physicians, senior psychiatrists, and
pharmacists on the appropriate use of atypical drugs- including asking
physicians to explain their drug choices and to consider using an
alternative less expensive atypical drug- could be effective ways to help
manage the cost of drugs as well as to educate physicians on the clinical
aspects of each drug. Such consultations provide vital information for

consideration by physicians when choosing the most appropriate drugs for
their patients with psychosis, and nationally the vast majority of
psychiatrists report that their clinical judgment, not cost factors,
determines which atypical drugs they prescribe. However, procedures at a few
facilities have limited or could restrict access to certain atypical
antipsychotic drugs on VA?s national formulary because of cost
considerations. Such procedures are contrary to VA?s prescribing guideline

for atypical antipsychotic drugs. Recommendation for

To ensure that the atypical antipsychotic prescribing guideline is Executive
Action

implemented consistent with VA intent, we recommend that the Secretary of
Veterans Affairs direct the Under Secretary for Health to monitor
implementation of the guideline by VISNs and facilities. In doing so, the
Secretary should ensure that facility policies and procedures conform to the
intent of the guideline and allow physicians to prescribe the most
appropriate atypical antipsychotic drugs for their patients.

Agency Comments and VA provided written comments on a draft of this report,
which are

Our Evaluation reprinted in appendix V. VA concurred with our recommendation
that the

prescribing guideline be implemented consistently throughout the VA health
care system. VA also stated that the Veterans Health Administration (VHA)
will continue to coordinate with VISN clinical managers to ensure the intent
of the guideline is understood by all involved and appropriately implemented
systemwide. VA also stated that VHA would continue to routinely monitor
prescribing patterns of atypical antipsychotic drugs through its national
drug utilization database in order to identify and

address any outliers in drug usage that might become apparent. However, we
found that while VHA was periodically reviewing atypical antipsychotic drug
utilization mainly at the national and VISN levels, it had no formal plan

to systematically review the data to monitor compliance with the guideline
at the facility level. Thus, we caution VA from relying too heavily on

national and VISN data. Doing so might not detect individual facility
policies that could restrict access to the more costly atypical
antipsychotic drugs. We are sending copies of this report to the Secretary
of Veterans Affairs; appropriate congressional committees; and other
interested parties. We will also make copies available to others upon
request. If you have any

questions on matters discussed in this report, please contact me at (202)
512- 7101. Another contact and key contributors are listed in appendix VI.

Sincerely yours, Cynthia A. Bascetta Director, Health Care- Veterans? Health
and Benefits Issues

Appendi Appendi xes x I

Scope and Methodology To determine how the Department of Veterans Affairs
(VA) developed its prescribing guideline, and what it expected to accomplish
with it, we interviewed and obtained relevant documentation from the
officials who developed the guideline, including officials from VA?s
Pharmacy Benefits Management Strategic Healthcare Group, its Medical
Advisory Panel, the Mental Health Strategic Healthcare Group, and the Office
of Quality and Performance. We also spoke with VA?s Assistant Deputy Under
Secretary for Health, obtained records of internal VA communication
concerning the guideline, and reviewed testimony from senior VA officials.

To determine the clinical guidelines for atypical antipsychotic drugs that
are commonly used and accepted by the general medical community, and to
compare VA?s prescribing guideline on atypical antipsychotic drugs to these
guidelines, we interviewed officials and obtained documentation from several
organizations, including the  Institute of Medicine,

 Department of Health and Human Services? National Institute of Mental
Health, Substance Abuse and Mental Health Services Administration, and
Centers for Medicare and Medicaid Services, and  National Association of
State Mental Health Program Directors.

We compared VA?s guideline with the four most commonly used guidelines- The
Texas Medication Algorithm Project; The Expert Consensus Guideline Series:
Treatment of Schizophrenia; The Schizophrenia Patient Outcomes Research
Team; and the American Psychiatric Association Practice Guideline for the
Treatment of Patients with Schizophrenia- and interviewed officials from the
Texas Medication

Algorithm Project and the Schizophrenia Patient Outcomes Research Team. We
also interviewed experts on the use of atypical antipsychotic drugs.

To determine commonly used policies for prescribing atypical antipsychotic
drugs, we interviewed officials from private mental health care delivery
systems, pharmacy benefits management companies, and the Department of
Defense. For geographical dispersion, we selected and obtained information
from five states? Medicaid or mental health departments in California,
Florida, Georgia, Massachusetts, and Texas. To determine the nature and
extent of the guideline?s implementation in VA?s

Veterans Integrated Service Networks (VISN), we interviewed each VISN

formulary leader. Formulary leaders are the liaisons between VISN management
and VA officials responsible for managing the national formulary. We visited
or contacted the following 14 VA facilities chosen in part because of their
procedures for prescribing atypical antipsychotic drugs:

VISN 1 - Edith Nourse Rogers Memorial Veterans Hospital, Bedford,
Massachusetts; and Providence VA Medical Center, Providence, Rhode Island.

VISN 2 - Canandaigua VA Medical Center, Canandaigua, New York; Samuel S.
Stratton VA Medical Center, Albany, New York; and VA Healthcare Network
Upstate New York at Syracuse, Syracuse, New

York. VISN 7 - Atlanta VA Medical Center, Decatur, Georgia. VISN 8 - James
A. Haley Veterans Hospital, Tampa, Florida; and Miami VA Medical Center,
Miami, Florida.

VISN 11 - VA Ann Arbor Healthcare System, Ann Arbor, Michigan; and John D.
Dingell VA Medical Center, Detroit, Michigan.

VISN 18 - Carl T. Hayden VA Medical Center, Phoenix, Arizona. VISN 20 - VA
Puget Sound Health Care System, Seattle, Washington. VISN 22 - VA Greater
Los Angles Healthcare System, Los Angeles, California; and VA San Diego
Healthcare System, San Diego, California.

To determine local policies and practices on atypical antipsychotic drug
usage at the 14 facilities that we visited or contacted, including how the
guideline was implemented, we interviewed pharmacy leadership, mental health
leadership, or individual psychiatrists and we collected relevant

documents. To assess the effect of these guidelines and other atypical
antipsychotic drug policies and procedures on psychiatrists throughout the
VA system, we surveyed VA psychiatrists. Using electronic mail, we
distributed an internet- based survey to VA?s entire November 2001 reported
population of 1,723 psychiatrists. Of these psychiatrists, 903 or
approximately 52 percent

responded. Response rates by VISN ranged from 33 percent to nearly 72
percent. However, for analysis purposes, we included only the 876
psychiatrists who prescribed an atypical antipsychotic drug in the 12 months
prior to the mailing of our survey in November 2001.

We took steps to determine if psychiatrists who reported they lacked freedom
to prescribe the more costly atypical antipsychotic drugs were more likely
to respond to our survey than were psychiatrists who reported they had such
freedom. For each VISN, we compared the response rate from its psychiatrists
with their responses to the survey question ?When, in your clinical
judgment, a more costly atypical antipsychotic drug is warranted, do you
feel free to prescribe the more costly drug?? We found

no indication that psychiatrists? answers to the question were related to
their VISN?s response rate. In addition, we conducted telephone interviews
on a random sample of 29 nonrespondents. We asked them the same question- if
they felt free to prescribe the more costly atypical antipsychotic drugs.
Their responses to this question were similar to those

from psychiatrists who responded to the survey. Based on these results, we
have no reason to believe that psychiatrists who felt restricted in their
prescribing practices were over- represented in our survey results and
therefore, our results are generalizable to the entire population. To help
identify problems with guideline implementation, we interviewed officials or
reviewed documents from two large mental health advocacy groups-- the
National Alliance for the Mentally Ill and the National Mental Health
Association. We also interviewed officials from the National Association of
VA Physicians and Dentists and VA?s Committee on the Care of Severely
Chronically Mentally Ill Veterans. In addition, we reviewed

correspondence from the American Psychiatric Association regarding VA?s
prescribing guideline.

VA Prescribing Guideline for Atypical

Appendi x II

Antipsychotic Use Department of Veterans Affairs Pharmacy Benefits
Management, Medical Advisory Panel, and Mental Health Strategic Healthcare
Group Guideline for Atypi al Antipsy hoti Use

Selection of therapy for individual p tients is ultimately based on
physicians' ssessment of clinical circumstances and p tient needs. At the
same time, prudent policy requires ppropriate husbanding of resources to VA
to meet the needs of ll our veteran p tients. These guidelines re not
intended to interfere with clinical judgment. Rather, they re intended to
ssist practitioners in providing cost effective, consistent, high quality c
re. The following recommendations re dynamic nd will be revised, s new
clinical data become vailable.

Consensus Goals: 1) Prioritize the use of atypical antipsy hotic medication
for new antipsy hotic medication starts and for patients not

responding to or having problemati side effe ts on typi al antipsy hoti medi
ation. 2) Though differen es in the lini al effe tiveness and pharma
oeconomi profile of the atypi als have been suggested by

some studies, there is no consensus in the literature to support one being
globally superior to another; therefore, once the physician determines there
are no patient specifi issues, begin therapy with an effective, less
expensive agent. At the present time, this would lead to the preferen e of
quetiapine and risperidone over olanzapine. 3) Utilize urrent local
approaches of clini al assessment to determine response to medi ation and
whether medication

hanges are indi ated. Such assessments should include the presence and
severity of positive and negative symptoms, AIMS s ore, tremor, weight and
GAF. 4) For patients currently on olanzapine, onsider a trial of risperidone
or quetiapine in the face of relapse or significant/

problemati weight gain or other side effects. Suggested dosage range for
treating

psy hosis* First episode of psychosis or

risperidone 2 - 6 mg chroni psy hosis in relapse

quetiapine 250 - 800mg olanzapine 5 - 20mg

lozapine 200 - 600mg * may need to adjust for age, o First line:

morbidities, and other fa tors a. ) Risperidone OR b. ) Quetiapine ( trial
for up to 10 weeks)

Response? Yes

Maintain on medi ation

No Switch to: b. ) Quetiapine OR a. ) Risperidone ( trial for up to 10
weeks)

Response? 1 Yes

Maintain on medi ation

No Switch to: 2

. ) Olanzapine ( trial for up to10 weeks) d. ) Clozapine ( trial for up to 6
months) 3

Response? 1 Yes

Maintain on medi ation

No Switch to: Typi al antipsy hoti if never tried ( trial for up to 10
weeks) OR

Clozapine if never tried ( trial for 6 months)

1 Consider a trial of haloperidol or fluphenazine decanoate for patients
non- adherent to therapy. 2 Ziprasidone may be considered in patients with
significant intolerance or poor response while taking another atypi al
antipsy hoti . The pla e of ziprasidone in the guideline will be ome better
defined as more safety and effi a y data be ome available. See ziprasidone
non formulary criteria for use at www. vapbm. org

3 Patient eligible for lozapine trial - suboptimal response or adverse
events to 2 or more antipsychoti s

Source: VA.

Process VA Used to Develop Its Prescribing

Appendi x II I Guideline for Atypical Antipsychotic Drugs In February 2001,
VA?s Pharmacy Benefits Management Strategic Healthcare Group?s Medical
Advisory Panel formed a task force of two VA psychiatrists and two VA
pharmacists to develop a guideline for prescribing atypical antipsychotic
drugs. According to the panel, such a guideline would help physicians
prescribe them appropriately and cost effectively. The task members were
selected based on their mental health clinical

expertise and diverse skills. See figure 5 for the timeline and process of
the task force.

Figure 5: Timeline of Task Force February 2001

VA task force formed. Began scientific literature review of atypical drugs'
effectiveness and safety.

April/ May 2001

Completed literature review, reviewed guidelines from some VISNs, and
drafted guidelines.

May 2001

Requested comments from VA pharmacy?s Medical Advisory Panel and VA's Chief
Consultant for Mental Health.

June 2001

Modified guidelines based on comments.

July 2001

Guidelines approved, posted to VA website, and sent to VISNs.

The task force reviewed scientific literature on the effectiveness,
including side effects, of the atypical antipsychotic drugs and examined
existing VISN guidance on prescribing these drugs. 17 Based on these
reviews, the task force drafted the guideline for prescribing atypical
drugs. The draft guideline was then reviewed and modified by the Medical
Advisory Panel and VA mental health officials. VISN pharmacy leaders and the
Medical

Advisory Panel approved the guideline. In July 2001, VA Pharmacy Benefits
Management posted the guideline to its web site and sent it to the VISNs. In
the past, VA Pharmacy Benefits Management has used the same process to
develop several similar guidelines for prescribing other classes of drugs.

The Institute of Medicine, in a recent report on VA?s national formulary,
commended VA for these previous pharmacy- specific guidelines, stating that
they were based on current scientific and clinical research data and its 17
The task force reviewed literature on olanzapine, risperidone, quetiapine,
and ziprasidone. Clozapine was excluded from the review because of its life-
threatening side effects.

recommendations were consistent with recommendations of other leading
medical organizations. 18

VA?s commissioning of a task force of health care professionals to review
medical literature and develop a guideline based on that literature is an
accepted practice. For example, the Department of Defense and the

American Psychiatric Association developed clinical practice guidelines this
way. Supplementing the literature with input from medical experts, as VA
did, is also consistent with accepted medical practice. An Institute of
Medicine report on developing clinical guidelines strongly urges that
processes for developing and revising guidelines be firmly based on
scientific evidence and expert clinical judgment. 19 Most other published
guidelines for atypical antipsychotic drugs were developed using some
combination of evidence from scientific literature and experts? judgments.

18 VA Pharmacy Formulary Analysis Committee, Division of Health Care
Services, Institute of Medicine, Description and Analysis of the VA National
Formulary (Washington, D. C.: National Academy Press, 2000), pp. 194- 195.
19 Institute of Medicine, Guidelines for Clinical Practice: From Development
to Use, p. 18.

Appendi x I V

Results from GAO Survey of VA Psychiatrists Percentage answering Percentage
answering ?Yes?

?No?

Question Question #2

Question #2 Question #2

VISN (location) #1 olanzapine quetiapine risperidone Question #3

1 (Boston) 51 5 5 2 0 2 (Albany) 73 71 9 4 9 3 (Bronx) 72 54 2 2 10 4
(Pittsburgh) 73 8 8 4 4 5 (Baltimore) 68 14 0 0 5 6 (Durham) 69 7 7 3 4 7
(Atlanta) 76 15 10 6 4 8 (Bay Pines) 74 12 5 5 13 9 (Nashville) 66 23 12 9
18 10 (Cincinnati) 76 12 6 6 6 11 (Ann Arbor) 79 31 13 7 8 12 (Chicago) 78 8
0 0 0 13 (Minneapolis) 61 0 0 0 0 14 (Omaha) 47 6 0 0 0 15 (Kansas City) 58
15 16 3 13 16 (Jackson) 72 15 7 7 8 17 (Dallas) 70 20 17 17 3 18 (Phoenix)
49 41 50 36 22 19 (Denver) 68 0 3 0 4 20 (Portland) 64 9 17 8 10 21 (San 44
10 8 7 7

Francisco) 22 (Long Beach) 65 76 9 4 33 VA total 66 22 10 6 9

Questions 1. Prior to receiving GAO?s email notifying you of this survey,
had you

been briefed on or provided a copy of these guidelines? 2. When prescribing
_________, do psychiatrists at your facility have to

follow procedures not required for most other drugs, such as obtaining
approval, providing justification, or some other procedure?

3. When, in your clinical judgment, a more costly atypical antipsychotic
drug is warranted, do you feel free to prescribe the more costly drug?

Comments from the Department of Veterans

Appendi x V Affairs

Appendi x VI

GAO Contact and Staff Acknowledgments GAO Contact Michael T. Blair Jr.,
(404) 679- 1944 Staff

In addition to the contact named above, Cherie M. Starck, Beverly J.
Acknowledgments Brooks- Hall, William R. Simerl, Michael Tropauer, Karen M.
Sloan, Deborah L. Edwards, and Susan Lawes made key contributions to this
report.

(290119)

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Page i GAO- 02- 579 VA Atypical Antipsychotic Drugs

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Appendix I

Appendix I Scope and Methodology

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Appendix I Scope and Methodology

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Appendix II

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Appendix III

Appendix III Process VA Used to Develop Its Prescribing Guideline for
Atypical Antipsychotic Drugs

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Appendix IV

Appendix IV Results from GAO Survey of VA Psychiatrists

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Appendix V

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Appendix VI

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