VA Health Care: Implementation of Prescribing Guideline for Atypical Antipsychotic Drugs Generally Sound
Published: 2002-04-29T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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, 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,  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. 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.
subsections: section_title: Background
paragraphs: 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.   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.
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.  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. 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.)
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.)
In 2001, most patients began treatment on risperidone, olanzapine, or  quetiapine. (See fig. 3.)
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.  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.  The Cochrane Collaboration, an  organization that systematically reviews randomized clinical medical trials,  reviewed the evidence comparing two of the atypical drugs, risperidone  and olanzapine.  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.
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.  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, 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  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.
section_title: VA Prescribing Guideline for Atypical Antipsychotic Drugs Is Sound
paragraphs: VA’s guideline for prescribing atypical antipsychotic drugs is consistent  with published clinical practice guidelines commonly used by public and  private health care systems.  Like most other practice guidelines, VA’s  guideline recommends that physicians use their best medical judgment,  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.
subsections: section_title: VA’s Prescribing Guideline Is Consistent with Commonly Used Clinical Guidelines
paragraphs: VA’s prescribing guideline, which supplements its broader psychosis  treatment guidelines, is similar to the four clinical guidelines most widely  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.
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.
section_title: Experts Acknowledge That Using Cost as a Factor Is Reasonable and Appropriate
paragraphs: Because available scientific evidence and expert opinion suggest that all  atypical drugs are appropriate treatment for psychosis, incorporating cost  into VA’s prescribing guideline is reasonable, appropriate, and consistent  with providing cost-effective health care.  The Institute of Medicine has  concluded that when no marginal therapeutic benefit is expected from  more expensive drugs, guideline developers may reasonably recommend  less expensive drugs.
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 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,  state health officials agreed that cost could be a factor in prescribing these  drugs.
section_title: Guideline Generally Implemented as Intended, but Some Facility Policies Conflict with It by Overemphasizing Cost
paragraphs: Most VISNs use VA’s prescribing guideline.  The policies and procedures for  implementing the guideline vary as some facilities have added a  requirement for prescribing atypical antipsychotic drugs.  This additional  requirement calls for pharmacists or senior psychiatrists to review  prescriptions for one of the atypical antipsychotic drugs and to confer with  the prescribing psychiatrist on the appropriateness of the prescription.   The vast majority of psychiatrists who responded to our survey reported  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.
subsections: section_title: Most VISNs Use VA’s Prescribing Guideline
paragraphs: We contacted the formulary leaders at each VISN and had further  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.
section_title: Intent of Prescribing Guideline Generally Followed, but Cost- Containment Procedures Could Conflict with It
paragraphs: Since VA issued the prescribing guideline, it has reiterated its policy that  the guideline not interfere with physicians’ clinical judgment.  Most  psychiatrists we interviewed agree that the intent of VA’s policy is being  followed.  The vast majority of the psychiatrists who responded to our  survey—91 percent—indicated that they have been able to prescribe the  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.)
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.  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 cost- control 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  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.  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.  In response, VA’s  Under Secretary for Health issued a notice on January 16, 2002, reiterating  the conference report’s message.
section_title: Conclusions
paragraphs: 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.
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.
section_title: Recommendation for Executive Action
paragraphs: To ensure that the atypical antipsychotic prescribing guideline is  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.
section_title: Agency Comments and Our Evaluation
paragraphs: VA provided written comments on a draft of this report, which are  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.
section_title: Scope and Methodology
paragraphs: 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   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.
section_title: VA Prescribing Guideline for Atypical Antipsychotic Use
paragraphs: Department of Veterans Affairs Pharmacy Benefits Management, Medical Advisory Panel, and Mental Health Strategic Healthcare Group Guideline for Atypical Antipsychotic Use Selection of therapy for individual patients is ultimately based on physicians'  assessment of clinical circumstances and patient needs.  At the same time, prudent policy requires appropriate husbanding of resources to VA to meet the needs of all our veteran patients.  These guidelines are not intended to interfere with clinical judgment.  Rather, they are intended to assist practitioners in providing cost effective, consistent, high quality care.  The following recommendations are dynamic and will be revised, as new clinical data become available. 1)  Prioritize the use of atypical antipsychotic medication for new antipsychotic medication starts and for patients not      responding to or having problematic side effects on typical antipsychotic medication. 2) Though differences in the clinical effectiveness and pharmacoeconomic profile of the atypicals 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 specific issues, begin therapy with an effective, less expensive agent.
At the present time, this would lead to the preference of quetiapine and risperidone over olanzapine. 3)  Utilize current local approaches of clinical assessment to determine response to medication and whether medication      changes are indicated. Such assessments should include the presence and severity of positive and negative symptoms,      AIMS score, tremor, weight and GAF. 4)  For patients currently on olanzapine, consider a trial of risperidone or quetiapine in the face of relapse or significant/      problematic weight gain  or other side effects.
First episode of psychosis  or *may need to adjust for age, co- morbidities, and other  factors    a.)  Risperidone OR    (trial for up to 10 weeks)
Response?    b.)  Quetiapine OR    (trial for up to 10 weeks)
Response?   c.) Olanzapine (trial for up to10 weeks)    d.) Clozapine (trial for up to 6 months)
Response?
Typical antipsychotic if never tried    (trial for up to 10 weeks)  OR   Clozapine if never tried (trial for 6   months)
Consider a trial of haloperidol or fluphenazine decanoate for patients non-adherent to therapy.
section_title: Process VA Used to Develop Its Prescribing Guideline for Atypical Antipsychotic Drugs
paragraphs: 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.
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.  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 recommendations were consistent with recommendations of other leading  medical organizations.
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.  Most other published  guidelines for atypical antipsychotic drugs were developed using some  combination of evidence from scientific literature and experts’ judgments.
section_title: Results from GAO Survey of VA Psychiatrists
paragraphs: Percentage answering “Yes” “No”
VISN (location) 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) 17 (Dallas) 18 (Phoenix) 19 (Denver) 20 (Portland)
Francisco) 22 (Long Beach)
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?
section_title: Comments from the Department of Veterans Affairs
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Cherie M. Starck, Beverly J.  Brooks-Hall, William R. Simerl, Michael Tropauer, Karen M. Sloan, Deborah  L. Edwards, and Susan Lawes made key contributions to this report.
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