DEPARTMENT OF VETERANS AFFAIRS 

WASHINGTON DC 20420 

The Honorable Carolyn N. Lerner 

Special Counsel 

U.S. Office of Special Counsel 

1730 M Street, NW, Suite 300 

Washington, DC 20036 

RE: OSC File No. Dl-14-3389 

Dear Ms. Lerner: 

JAN 0 5 2015 

I am responding to your letter regarding allegations made by a whistleblower at 

the Beckley Department of Veterans Affairs (VA) Medical Center, (hereafter, the 

Medical Center) in Beckley, West Virginia. The whistleblower alleged that pharmacists 

are substituting older psychotropic medications for prescribed ones on the basis of 

economy and were acting as if they were psychiatrists by writing prescriptions in the 

mental health unit. The Secretary has delegated to me the authority to sign the 

enclosed report and take any actions deemed necessary as referenced in 5 United 

States Code § 1213(d)(5). 

The Secretary asked the Under Secretary for Health to refer the whistleblower's 

allegations to the Office of the Medical Inspector, which conducted a site visit to the 

Medical Center on September 9-12, 2014. VA substantiated one of the two allegations 

that pharmacists were substituting prescriptions but did not substantiate that 

pharmacists were exceeding their scope of practice. 

VA made eight recommendations to the Medical Center and one for the Veterans 

Health Administration. Findings from the investigation are contained in the report, which 

I am submitting for your review. 

Thank you for the opportunity to respond. 

Sincerely, 

Enclosure 
DEPARTMENT OF VETERANS AFFAIRS 

Washington, DC 

Report to the 

Office of Special Counsel 

OSC File Number Dl-14-3389 

Department of Veterans Affairs 

Beckley Veterans Affairs Medical Center 

Beckley, West Virginia 

Report Date: November 3, 2014 

TRIM 2014-D-1266 
Executive Summary 

The Secretary requested that the Veterans Health Administration (VHA) investigate 

complaints lodged with the Office of Special Counsel (OSC) by an anonymous 

whistleblower. The Under Secretary of Health (USH) directed the Office of the Medical 

Inspector (OM I) to assemble and lead a team to conduct the inquiry. The whistleblower 

alleged that the Beckley Veterans Affairs (VA) Medical Center (VAMC), Beckley, West 

Virginia (hereafter, the Medical Center) engaged in conduct that may constitute a 

violation of law, rule or regulation, gross mismanagement, an abuse of authority, and a 

specific danger to public health. The whistleblower further that alleged Medical Center 

pharmacists routinely and improperly reject the providers' prescriptions in favor of less 

expensive medications, and clinical pharmacy specialists working in the clinics exceed 

their scope of practice. The VA team conducted a site visit to the Medical Center on 

September 9-12, 2014. 

Specific Allegations of the Whistleblower 

1. Medical Center pharmacists were ordered by management to deny provider 

prescription orders for approved medications based on cost; and 

2. Medical Center pharmacists improperly prescribe medications to patients in 

clinics, and essentially function as psychiatrists. 

Conclusions to Allegation 1 (aripiprazole and ziprasidone) 

• VA substantiated that the Medical Center's Pharmacy and Therapeutics (P&T) 

Committee encouraged providers to switch Veterans from aripiprazole or 

ziprasidone prescribed by other Veterans Health Administration (VHA) providers, 

based on a Pharmacy cost-savings goal for Fiscal Year 2013 related to atypical 

antipsychotics. VA's evidence is derived primarily from interviews with mental 

health (MH) prescribing providers, and perceptions were consistent from one 

provider to the next. On the basis of these interviews, we believe the 

preponderance of evidence leads to our substantiating the allegation. Therefore, 

VA concludes that the P& T Committees' decision was not in compliance with 

VHA's policy on VA National Formulary (VANF) management process, which 

prohibits restrictions of VANF medications at the local level based solely on 

economics and/or without legitimate need for a change in therapy, and thus may 

have constituted a substantial and specific danger to public health and safely. 

Although each Veteran had his or her medications reviewed by their MH provider 

before any adjustment took place, many providers felt that they had no option 

other than to prescribe some other medication in place of the originally prescribed 

aripiprazole or ziprasidone. They followed this guidance, despite their 

disagreement with the change in treatment, citing concerns about the side effects 

of weight gain and sedation. 

II 
• VA substantiated that the MH representative to the P&T Committee voiced concerns 

to the Committee about the blanket restriction on continued therapy with aripiprazole 

or ziprasidone for patients who are stable on such medications, including transferred 

patients who were prescribed these medications at another VA medical center, 

without a clinical determination of the need to change the patient's therapy. VA is 

concerned that the P& T Committee did not follow the procedures in VHA Handbook 

1108.05, Outpatient Pharmacy Services, May 30, 2006, and VHA Handbook 

1108.08, VHA Formulary Management Process, February 26, 2009. 

• Although there is no local policy that requires a physician to serve as Chairperson 

of the Medical Center P& T Committee, or that prohibits the Chief of Pharmacy 

from serving in that capacity, the Medical Center could improve its policy making 

and medication oversight with a physician as chairperson or the Chief of 

Pharmacy as secretary, as is the practice in other VHA medical centers. 

Recommendations to the Medical Center 

1. Immediately stop the practice of automatically removing patients from VANF 

medications (without a legitimate clinical need) initiated by an authorized provider at 

another VA medical facility, when a patient transfers their care to the Medical 

Center. 

2. Immediately stop the practice of automatically removing Medical Center patients 

from VANF medications (specifically, aripirazole or ziprasidone) without a legitimate 

clinical need. 

3. Conduct a clinical care review of the condition and medical records of all patients 

who were discontinued from aripirazole or ziprasidone, following the decision of the 

P& T Committee on April 25, 2013, to restrict use of these medications, to ascertain 

whether any adverse patient outcomes occurred as a result of discontinuance of the 

medication. 

4. Upon completion of above review, if adverse events are identified related to a 

patient's clinical care, appropriate disclosures should be made, consistent with the 

requirements of VHA Handbook 1004.08, Disclosure of Adverse Events to patients. 

5. Where warranted, appropriate action should be taken against Medical Center 

leadership and the P& T Committee for approving actions that were not consistent 

with VHA policy on VANF management and may constitute a substantial and 

specific risk to public health. 

6. Educate Medical Center leadership and the P&T Committee on the policy and 

procedure requirements outlined in VHA Handbook 1108.05 and 1108.08. 

7. Improve local policy making and medication oversight by designating a physician as 

chairperson of the P&T Committee and the Chief of Pharmacy as secretary. 

iii 
Recommendations for VHA 

8. Remind and reinforce other Medical Centers on the policy and procedure 

requirements outlined in VHA Handbooks 1108.05 and 1108.08. 

Conclusion (alprazolam) 

• VA did not substantiate that the Medical Center restricted the prescribing of 

alprazolam for cost containment reasons, and that the restriction requiring 

psychiatric review was motivated by safety concerns and therefore was allowable 

according to VHA Handbook 1108.05. 

• Have VHA Program Office review existing policies governing prescribing 

practices. 

Recommendation for the Medical Center 

None 

Conclusion (quantity of medication) 

• VA did not substantiate that the Medical Center restricted the quantity of 

medication dispensed solely for cost. The restriction limiting the prescription 

quantity was motivated by safety concerns as well as cost concerns and therefore 

allowable under VHA Handbook 1108.05. 

Recommendation to the Medical Center 

None 

Conclusion (performance measure) 

• VA substantiated that management did not communicate the opioid performance 

measure to all Primary Care (PC) physicians within 90 days of the beginning of 

the FY, as required by VHA policy. 

Recommendation to the Medical Center 

9. In accordance with VHA policy, ensure performance measures are communicated to 

physicians in a timely manner. 

Conclusion to Allegation 2 

iv 
• VA did not substantiate that pharmacists improperly prescribe medications to 

patients in clinics, and essentially function as psychiatrists. 

Recommendation to the Medical Center 

None 

Summary Statement 

The VA team has developed this report in consultation with other VA and VHA offices to 

address OSC's concerns that the Medical Center may have violated law, rule or 

regulation, engaged in gross mismanagement, an abuse of authority, or risked public 

health or safety. In particular, the Office of General Counsel (OGC) has provided a 

legal review and the Office of Accountability Review (OAR) has examined the issues 

from a human resources perspective, establishing individual accountability, when 

appropriate, for improper personnel practices. VA found actions that constitute a 

violation of VA and VHA policy and pose a substantial and specific danger to public 

health and safety. 

v 
Table of Contents 

Executive Summary ....................................................................................................... ii 

I. Introduction ............................................................................................................... 1 

II. Facility and VISN Profile .......................................................................................... 1 

Ill. Specific Allegations of the Whistleblower ............................................................... 1 

IV. Conduct of Investigation ......................................................................................... 1 

V. Findings, Conclusions, and Recommendations ...................................................... 3 

VI. Summary Statement ............................................................................................ 1 0 

Attachment A .............................................................................................................. A 1 

Attachment 8 .............................................................................................................. 81 

vi 
I. Introduction 

The Secretary requested that the VHA investigate complaints lodged with OSC by an 

anonymous whistleblower. The USH directed OMI to assemble and lead a team to 

conduct the inquiry. The whistleblower alleged that the Medical Center engaged in 

conduct that may constitute a violation of law, rule or regulation, gross mismanagement, 

an abuse of authority, and a specific danger to public health. The whistleblower fu rther 

alleged that Medical Center pharmacists routinely and improperly reject the providers' 

prescriptions in favor of less expensive medications, and clinical pharmacy specialists 

working in the clinics exceed their scope of practice 

II. Facility Profile 

Part of the Veterans Integrated Service Network (VISN) 6, the Medical Center is a 40-

bed general medical and surgical facility without an inpatient psychiatry service. Its 50-

bed community living center offers skilled nursing care, post-acute rehabilitation and 

restorative care, and palliative and respite care for eligible Veterans. The Medical 

Center also operates a home-based primary care program, providing services to 

Veterans in nine counties (Raleigh, Wyoming, Mercer, Summers, Fayette, Greenbrier, 

Monroe, and Pocahontas in West Virginia and Alleghany in Virginia). 

Ill. Specific Allegations of the Whistleblower 

1. Beckley VAMC pharmacists were ordered by management to deny provider 

prescription orders for approved medications based on cost; and 

2. Beckley VAMC pharmacists improperly prescribe medications to patients in 

clinics, and essentially function as psychiatrists. 

IV. Conduct of the Investigation 

The VA team consisted of Deputy Medical Inspector; 

Clinical Program Manager, both of OMI ; , 

Human Resources Specialist (Employee Relations/Labor Relations), Huntington VA 

Medical Center, and PharmD, Deputy Chief Consultant for Professional 

Pharmacy Practice and Pharmacy Benefit Management Services, VHA. VA reviewed 

relevant Medical Center policies, procedures, reports, memoranda, and other 

documents, a full list of which is in Attachment A. On September 9, 2014, the team held 

an entrance briefing with the Medical Center Director, Associate Director, Chief of Staff 

(COS), Director for Patient Care Services, Chief of Pharmacy Services, and Quality 

Management Coordinator. Apart from the Chief of Pharmacy, the same individuals 

attended the exit briefing on September 12. During the visit, VA toured the inpatient 

and outpatient pharmacy and interviewed the following Medical Center staff: 

1 

(b)(6) (b)(6) (b)(6) (b)(6) (b)(6)
Interviewed in-person 

• Chief of Pharmacy and Chair of the P&T Committee 

• MD, COS 

• Chief, Mental Health Service Line (MHSL) 

• Associate COS, Primary Care Service Line (PCSL) 

• Anticoagulation Clinical Pharmacy Specialist 

• Physician Assistant (PA), Mental Health (MH) 

• CBOC 

• MH 

• Clinical Care Coordinator, PCSL 

• NP, Assistant Chief, MHSL 

• PA, MH 

• , Nurse Practitioner (NP), MH 

• , Associate Chief Pharmacy 

• Clinical Psychologist, MH: CBOC 

• , Psychologist, MH, Home based Primary Care 

• Antimicrobial Steward 

• 

• (Pain Management Clinic to June 1, 2014; presently MH) 

• , Physician, MH 

• , PA, MH 

• , PCSL 

• , NP, PCSL 

• , MD, PCSL 

Interviewed by Phone 

• , MD, MH and P&T Liaison for MH (Located at Richmond, VAMC) 

• , MH 

V. Findings, Conclusions, and Recommendations 

Allegation 1 

Background 

VHA Policy and National Clinical Guidance 

VHA Handbook 1108.08, VHA Formulary Management Process, describes the process 

for making medications available to Veterans through formulary management. The 

VANF lists the medications that must be available for prescription at all VA facilities. 

2 

(b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (b)(6) (

b

)

(

6

)
These medications cannot be withheld from Veterans based on local decisions made by 

a VISN or individual medical center solely for economic or administrative reasons. VHA 

designed the formulary management process to provide pharmaceutical products of the 

highest quality and best value, while ensuring the portability and standardization of this 

benefit to all eligible Veterans. 

Further, the Handbook says the P& T Committee is responsible for performing all 

functions set by The Joint Commission Accreditation Manual for Hospitals and by the 

American Society of Health-System Pharmacists (ASHP) Statement on the P&T 

Committee (paragraph15.a, page 9). The ASHP statement says: 

"The P&T committee is composed of actively participating physicians, other 

prescribers, pharmacists, nurses, administrators, quality-improvement 

managers, and other health care professionals and staff who participate in the 

medication-use process. Customarily, P& T member appointments are based 

on guidance from the medical staff. The P& T committee should serve in an 

evaluative, educational, and advisory capacity to the medical staff and 

organizational administration in all matters that pertain to the use of 

medications (including investigational medications). The P&T committee is a 

policy-recommending body to the medical staff and the administration of the 

organization on matters related to the safe and therapeutic use of 

medications. The P&T committee is responsible to the medical staff as a 

whole, and its recommendations are subject to approval by the organized 

medical staff as well as the administrative approval process. The basic 

policies and procedures that govern the P&T committee's administration of 

the formulary system should be incorporated, as appropriate, in the health 

system's medical staff bylaws, medical staff rules and regulations, and other 

organizational policies." (paragraph 4, page 164). 

The Handbook outlines procedures for the restriction of selected medications listed on 

the VANF: 

"Restrictions to prescribing can be established for VANF items that require 

close monitoring to ensure appropriate use. For example in the case of antiinfectives, facility level restrictions intended to prevent resistance are 

permissible. Restrictions may include evidence-based guidelines or 

prescribing privileges for providers with specific expertise. Restrictions are 

not to be based solely on economics, nor are they to be so limiting as to 

prevent patients with legitimate medical needs from receiving these 

medications and supplies" (paragraph 17.aa, page 15). 

In addition, the Handbook forbids VA medical centers from discontinuing medications 

ordered at another VA medical center solely for administrative reasons: 

3 
"There will be no administrative action taken to discontinue pharmacotherapy 

initiated by an authorized provider VA medical center, when a patient 

transfers care to a second VA medical center ... " (paragraph 17. t, page 14) 

VHA Handbook 1108.05 Outpatient Pharmacy Services, May 30, 2006, outlines 

procedures for VA Medical Centers' P&T Committees to restrict the quantity of selected 

medications dispensed, directing that no prescription can be filled for more than a 90 

day supply and that no prescription may exceed 12 months of therapy, including refills. 

For some prescriptions, a 30-day supply or less may be mandated. The Handbook 

directs that "In all instances, the P&T Committee must consider safety, patient care 

needs, and VISN resources when establishing such guidelines or restrictions," 

(paragraph 5.d, page 3). 

Aripiprazole and Ziprasidone 

VA/DoD Clinical Practice Guidelines (CPG) are comprehensive statements about 

specific diseases; each provides diagnostic criteria and recommendations for 

pharmacologic management of its subject disease. VA and DoD clinicians developed 

these guidelines by systematically reviewing evidence of benefits and harms of 

alternative care options. VA medical centers use CPGs as examples of best prescribing 

practices and as guides in the development of prescribing policies. CPGs provide 

guidance and recommendations to prescribers but are not considered mandatory. The 

CPG for Major Depressive Disorder (MOD) recommends the prescription of 

antidepressants such as venlafaxine SA and antipsychotic drugs such as aripiprazole 

and ziprasidone for patients not previously treated with antipsychotic or antidepressant 

medication or who developed a clinical deterioration of their psychiatric disorder; 

however, the CPG does not address therapeutic adjustments for patients with MOD who 

are already stable on pharmacotherapy. 

Findings 

At the Medical Center, the Chief of Pharmacy, a non-physician, serves as the Chairman 

of the P&T Committee. On April 25, 2013, the Medical Center P&T Committee meeting 

minutes reflect a decision to restrict the continued prescription of aripiprazole and 

ziprasidone to patients already on these medications (see Attachment B). The minutes 

state that these restrictions are based on a Pharmacy cost-savings goal for FY 13 

related to atypical antipsychotics. The minutes do not provide a clinical justification for 

the decision. According to VHA Handbook 1108.08, restrictions are not to be based 

solely on economics, nor are they to be so limiting as to prevent patients with legitimate 

medical needs from receiving these medications and supplies. 

VA interviewed the MH representative to that Committee meeting and learned that she 

had objected to the blanket restriction on continued therapy with aripiprazole and 

ziprasidone for patients who are stable on such medications, including transferred 

patients who were prescribed such medications at another VA medical center, without a 

medical need for a change in the patient's therapy. The minutes of the April25, 2013, 

4 
P&T Committee meeting in which the local guidelines were approved do not reflect these 

objections. However, VA found documentation of the MH representative's objections in an 

earlier set of Committee minutes dating back to December 2012. 

Other MH prescribers told VA that they had little or no input into the locally-developed 

clinical guidelines approved by the P& T Committee. However, we found emails from the 

Chief of Pharmacy to at least one MH provider asking him to provide input on this matter. 

Prescribing providers in the MH Service Line told us that the Pharmacy Service was 

asking MH providers to discontinue aripirazole or ziprasidone prescribed for Veterans 

as psychiatric inpatients at other VA medical centers, usually Hunter Holmes McGuire 

VA Medical Center, Richmond, Virginia or Salem VA Medical Center, Salem, Virginia. 

The COS told VA that the MH providers had been asked to review their patients on 

aripiprazole and to consider other medications that were less expensive. The COS 

also related that some of the providers did choose to use other medications for 

patients. The COS said that when providers felt aripiprazole was the most appropriate 

medication for particular patients, they documented the justification. If the pharmacy 

disapproved the request, the provider could appeal this decision to the COS. The COS 

assured us that only when the provider had asked for an alternative antipsychotic 

medication was it offered to the patients, emphasizing that there were no automatic 

changes from aripiprazole to another atypical antipsychotic. MH providers told us that 

they prescribed the less expensive medications, even though they were concerned 

about the side effects of weight gain and sedation. These providers also indicated that 

they were aware of an appeal process but were under the impression that appealing a 

pharmacy decision to deny a request would not result in the COS overturning that 

decision. Providers told us that they did not submit appeal requests because of what 

they felt was a forgone conclusion. 

Conclusions to Allegation 1 

• VA substantiated that the Medical Center's P&T Committee encouraged providers 

to switch Veterans from aripiprazole or ziprasidone prescribed by other VHA 

providers, based on a Pharmacy cost-savings goal for Fiscal Year 2013 related to 

atypical antipsychotics. VA's evidence is derived primarily from interviews with 

mental health prescribing providers, and perceptions were consistent from one 

provider to the next. On the basis of these interviews, we believe the 

preponderance of evidence leads to our substantiating the allegation. Therefore, 

VA concludes that the P&T Committees' decision was not in compliance with 

VHA's policy on VA National Formulary (VANF) management process, which 

prohibits restrictions of VANF medications at the local level based solely on 

economics and/or without legitimate need for a change in therapy, and thus may 

have constituted a substantial and specific danger to public health and safely. 

Although each Veteran had his or her medications reviewed by their MH provider 

before any adjustment took place, many providers felt that they had no option 

other than to prescribe some other medication in place of the originally prescribed 

aripiprazole or ziprasidone. They followed this guidance, despite their 

5 
disagreement with the change in treatment, citing concerns about the side effects 

of weight gain and sedation. 

• VA substantiated that the MH representative to the P&T Committee voiced concerns 

to the Committee about the blanket restriction on continued therapy with aripiprazole 

or ziprasidone for patients who are stable on such medications, including transferred 

patients who were prescribed these medications at another VA Medical Center, 

without a clinical determination of the need to change the patient's therapy. VA is 

concerned that the P&T Committee did not follow the procedures in the VHA 

Handbook. 

• Although there is no local policy that requires a physician to serve as Chairperson 

of the Medical Center P&T Committee, or that prohibits the Chief of Pharmacy 

from serving in that capacity, the Medical Center could improve its policy making 

and medication oversight with a physician as chairperson or the Chief of 

Pharmacy as secretary, as is the practice in other VHA medical centers. 

Recommendations to the Medical Center 

1. Immediately stop the practice of automatically removing patients from VANF 

medications (without a legitimate clinical need) initiated by an authorized provider at 

another VA medical facility, when a patient transfers their care to the Medical 

Center. 

2. Immediately stop the practice of automatically removing Medical Center patients 

from VANF medications (specifically, aripirazole or ziprasidone) without a legitimate 

clinical need. 

3. Conduct a clinical care review of the condition and medical records of all patients 

who were discontinued from aripirazole or ziprasidone, following the decision of the 

P&T Committee on April 25, 2013, to restrict use of these medications, to ascertain 

whether any adverse patient outcomes occurred as a result of discontinuance of the 

medication. 

4. Upon completion of above review, if adverse events are identified related to a 

patient's clinical care, appropriate disclosures should be made, consistent with the 

requirements of VHA Handbook 1004.08. 

5. Where warranted, appropriate action should be taken against Medical Center 

leadership and the P&T Committee for approving actions that were not consistent 

with VHA policy on VANF management and may constitute a substantial and 

specific risk to public health. 

6. Educate Medical Center leadership and the P&T Committee on the policy and 

procedure requirements outlined in VHA Handbook 1108.05, and VHA Handbook 

1108.08. 

6 
7. Improve local policy making and medication oversight by designating a physician as 

chairperson of the P& T Committee and the Chief of Pharmacy as secretary. 

Recommendations for VHA 

8. Remind and reinforce other Medical Centers on the policy and procedure 

requirements outlined in VHA Handbook 1108.05 and VHA Handbook 1108.08 for 

the processing of formulary medications. 

Alprazolam 

At the May 2014 P&T Committee meeting, members addressed prescribing restrictions 

for the benzodiazepine, alprazolam. Alprazolam is a controlled substance with a known 

potential for addiction and risk of respiratory depression or death, if combined with 

alcohol or other opioids. Alprazolam is the most commonly misused benzodiazepine 

and contributes to an increasing number of drug-related deaths in West Virginia. ·

2 In 

addition, the USH established a goal of achieving a 10 percent decrease in the 

combined use of opioids and benzodiazepines by September 15, 2014. 3 Based on 

these concerns, the Medical Center P&T Committee determined that new prescriptions 

for alprazolam should be reviewed by a psychiatrist for patient safety before dispensing, 

and the current 422 patients with an active order for alprazolam should be 

grandfathered in and not reviewed. 

Conclusion 

• VA did not substantiate that the Medical Center restricted the prescribing of 

alprazolam for cost containment reasons, and that the restriction requiring 

psychiatric review was motivated by safety concerns and therefore was allowable 

according to VHA Handbook 1108.05. 

Recommendation for the Medical Center 

None 

Prescription Quantities 

The December 13, 2012, minutes of the P&T Committee document their discussion on 

restricting quantities of several medications, including venlafaxine SA,4 ziprasidone, 

lamotrigine, and duloxetine to a 30-day supply (with refills, when the provider thought 

refills were appropriate). VA found medical staff and the members of the Pharmacy 

1 Shah NA, Abate MA, Smith MJ, et al. Characteristics of alprazolam-related deaths compiled by a centralized state 

medical examiner. AM J Addict 2012;21 Supplement 1 :S27-34. 2 Trust for America's Health (TFAH). Prescription drug abuse 2013: Strategies to stop the epidemic. [Issue Report). 

2013;408045 (October). Accessed May 6, 2014. 3 Memorandum from the Under Secretary for Health, "Opioid Safety Initiative Requirements," April2, 2014. 4 SA refers to sustained action. 

7 
Service in agreement that this restriction was based on safety considerations as well as 

Medical Center resource concerns. The providers did not indicate that the resources of 

primary care clinics were strained because of the 30-day supply limitation per 

prescription. Providers did not identify any Veteran who had their medication 

interrupted by this restriction. 

Conclusion 

• VA did not substantiate that the Medical Center restricted the quantity of 

medication dispensed solely for cost. The restriction limiting the prescription 

quantity was motivated by safety concerns as well as cost concerns and therefore 

allowable under VHA Handbook 1108.05. 

Recommendation to the Medical Center 

None 

Opiate prescriptions linked to performance ratings 

VA Handbook 5007, Pay Administration, Part IX, Paragraph 12 (d.) March 24,2013, 

states, "Physicians and dentists must be advised of the specific goals and objectives 

that will be measured in determining their eligibility for performance pay and the 

maximum monetary value associated with those goals and objectives. These goals and 

objectives and the maximum amount of performance pay available in connection with 

achieving the specified goals and objectives [must] be communicated by an appropriate 

management official to the individual physician or dentist within 90 days of the 

beginning of each fiscal year. For newly hired physicians and dentists, goals and 

objectives [must] be communicated within 30 days of their entrance on duty." 

The COS and the Chief, PCSL reported that they did include a measure on opioid 

reduction in the FY 2014 Physician Performance Plan for PC physicians. They added 

this measure to the Plan in January 2014 rather than at the beginning of FY 2014. They 

added this measure based on their assessment of the need for coordinated measures 

to reduce the prescription reductions in a clinically appropriate manner which was 

apparent to many VHA clinical leaders before the beginning of FY 2014. The USH 

issued a memorandum in April 2014 directing VHA to reduce opioid and 

benzodiazepine prescriptions in a clinically appropriate way. The COS and Chief, PCSL 

felt that their decision to add this performance measure to the FY2014 Physician 

Performance Plan for PC physicians was confirmed by the guidance found in the USH's 

memorandum. 

The COS and the Chief, PCSL told VA that they had monitored the physician-level 

prescribing data on such prescriptions throughout the fiscal year and found that the data 

did not take into account the opioid prescriptions written by mid-level providers for which 

8 
the primary care physicians were responsible. 5 In the absence of accurate monthly 

physician prescribing data, they removed this measure from the Plan in August 2014. 

VA reviewed all the relevant Plans, and confirmed that the measure had been removed. 

VA also found that the Chief, PCSL had implemented a performance measure aimed at 

reducing opioid prescriptions. This measure was in line with the clinical goal of reducing 

opioid prescriptions when clinically appropriate and in line with the Opioid Safety 

Initiative Requirements set forth by the USH in a Memorandum of April 2, 2014. The 

measure was removed from all of the Physician Performance Plans before the end of 

the fiscal year. 

Conclusion 

• VA substantiated that management did not communicate the opioid performance 

measure to all PC physicians within 90 days of the beginning of the FY, as 

required by VHA policy. 

Recommendation to the Medical Center 

9. In accordance with VHA policy, ensure performance measures are communicated to 

physicians in a timely manner. 

Allegation 2 

Findings 

Clinical pharmacy specialists (CPS) are registered pharmacists who have had an 

additional year of training beyond education and training clinical pharmacists receive. 

This additional training familiarizes the pharmacist with patients who are usually treated 

for a chronic medical condition that requires close medication monitoring. CPSs are 

especially suited to initiate, adjust and terminate medications for patients requiring 

chronic anticoagulation, anti-hypertensive therapy, or cholesterol reduction treatment. 

VHA Directive 2008-043, August 7, 2008, Scope of Practice for Pharmacists with Direct 

Patient Care, provides that VA CPSs are assigned to work in clinical settings and to 

function as providers of medication management services, including initiating, adjusting 

or canceling medications. In addition, CPSs order monitoring tests, order consultations, 

and conduct comprehensive reviews of a patient's health and drug history. The CPS' 

clinical roles and limitations are outlined in a written scope of practice and must include 

the individual's prescriptive authority. VHA Directive 2009-14, March 12, 2009, 

Establishing Medication Prescribing Authority for Clinical Pharmacy Specialists, states 

that CPSs may prescribe controlled substances only if the state of licensure or 

5 Mid-level providers including advanced practice nurses (APN) and physician assistants (PA) may only prescribe 

opioid medications in VHA medical facilities if their state of licensure permits them to do so. If APN or PA does not 

have opioid prescription privileges, the physician assigned as the mid-level provider's collaborating or supervising 

physician signs and is responsible for the prescription. 

9 
registration permits. Each such scope of practice also identifies the supervising 

physician and must be approved by the COS. 

The VA Center for Medication Safety, the VHA Pharmacy Benefits Management 

Services, the VA Medical Advisory Panel and the VISN Pharmacy Executives jointly 

published the guidance, "Pharmaceutical Use Outside of Approved Indications: 

Guidance on 'Off-Label' Prescribing," in August 2013. This provides general principles 

and recommendations when considering pharmaceutical use outside of approved 

dosing, chronology, disease or disease state, or populations. Under this policy 

guidance, "off label" prescribing at VHA medical facilities is permissible. 

The Medical Center had assigned a single CPS to work closely with a pain 

management physician in the Pain Management Clinic. In this capacity, the CPS 

initiated, adjusted, and terminated medications. 

On April 8, 2014, the CPS wrote an initial prescription for lamotrigine for a Veteran with 

chronic back pain, consistent with the practice of the pain management physician.

6 

Lamotrigine is a medication that is FDA indicated for the treatment of epilepsy but is 

used "off label" for the treatment of chronic pain unresponsive to medications approved 

for pain management. Lamotrigine is not a controlled substance. On May 7, 2014, the 

CPS increased the lamotrigine dose consistent with the recommendation to start that 

medication with a low dose and increase the dose slowly. 

VA reviewed the scope of practice for all Medical Center CPSs and found them to be 

compliant with VHA Directive 2008-043. Our review of the scope of practice for the 

CPS in the Pain Management Clinic indicated that she was authorized to initiate and 

adjust lamotrigine. As required by the Directive, the COS authorized her scope of 

practice, and her supervising provider reviewed performance quarterly. We also 

learned from Pharmacy Services management that the pain management physician 

often used this medication as an analgesic. The CPS holds pharmacy licenses in North 

Carolina and South Carolina, neither of which permits CPSs to prescribe scheduled 

medications. Her scope of practice at the Medical Center does not include prescribing 

scheduled medication, so the Medical Center does not permit her to prescribe these 

medications. 

We reviewed the Veteran's medical record and found the care and medications 

prescribed to be appropriate. 

Conclusion for Allegation 2 

• VA did not substantiate that pharmacists improperly prescribe medications to 

patients in clinics, and essentially function as psychiatrists. 

6 In May 2014, the CPS was assigned to the pain management clinic. However, she was re-assigned to the Mental 

Health Service Line in June 2014. 

10 
Recommendation to the Medical Center 

None 

VI. Summary Statement 

The VA team has developed this report in consultation with other VA and VHA offices to 

address OSC's concerns that the Medical Center may have violated law, rule or 

regulation, engaged in gross mismanagement, an abuse of authority, or risked public 

health or safety. In particular, OGC has provided a legal review and OAR has 

examined the issues from an human resources perspective, establishing individual 

accountability, when appropriate, for improper personnel practices. VA found actions 

that constitute a violation of VA and VHA policy and pose a substantial and specific 

danger to public health and safety. 

11 
Attachment A 

Documents Reviewed by VA 

Department of Veterans Affairs, VA Handbook 1108.08, VHA Formulary Management 

Process, February 26, 2009. 

Department of Veterans Affairs, VHA Handbook 1108.05 Outpatient Pharmacy 

Services, May 30, 2006. 

CPG for Management of Major Depressive Disorder (MOD) and Management of Bipolar 

Disorder in Adults. 

Veterans Health Administration , Directive 2008-043, Scope of Practice for Pharmacists 

and Direct Patient Care, August 7, 2008. 

Veterans Health Administration, Handbook 1100.19, Credentialing and Privileging, 

October 15, 2012. 

Veterans Health Administration, Directive 2009-014, Establishing Medication 

Prescribing Authority for Clinical Pharmacy Specialists, March 2, 2009. 

Veterans Integrated Service Network, Pharmacy Executive Recommendations for 

Antipsychotic Section in Schizophrenia and Schizoaffective Disorders, June 2012. 

VA Center for Medication Safety, VHA Pharmacy Benefits Management Services VA 

Medical Advisory Panel and VISN Pharmacy Executives, Pharmaceutical Use Outside 

of Approved Indications Guidance on "Off-label" Prescribing, August 2013 

Under Secretary for Health memorandum: "Opioid Safety Initiative Requirements, " 

April 02, 2014. 

Acting Deputy Under Secretary for Health for Operations and Management ( 1 ON) 

Memorandum, January 24, 2014. 

Veterans Administration, Handbook 5007 titled Pay Administration, Part IX, Paragraph 

12(d.), 

Medical Center, Pharmacy & Therapeutics committee meeting minutes, FY2013 and 

FY2014. 

Medical Center, Mental Health Special Drug Request (SDR) Consults FY2013 and FY2014. 

Medical Center, Pharmacy Staff meeting minutes FY2013 and FY2014. 

Medical Center, By-Laws, Rules and Regulations of the Medical Staff. 

A1 
Medical Center, Pharmacist's Scope of Practice. 

Medical Center, Pharmacist's Performance Appraisals 

A2 
Attachment 8: 

See Minutes of April 25, 2014 C&P Committee Meeting 

(separate document) 

B1 
Attachment B 

PHARMACY AND THERAPEUTICS COMMITTEE 

Thursday, April25. 2013-2 p.m. 

AGENDA 

APPROVAL OF MINUTES: The February and March 2013 minutes were approved 

as written. 

QUALITY ASSURANCE: Results from Monitoring and Evaluation 

1. Adverse Drug Reactions {ADRs) (Dec Jan) 

(Follow..ups) Documents attached 

2. Medication Errors - Pharmacy (!.errors reported) Document attached 

3. Medication Errors -Consolidated Man Outpatient Pharmacy (CMOP) 16 

See text box 

4. Medication Errors -Nursing 1•t Qtr Document attached 

5. CLC DUE (Dec. Jan, Feb, Mar) Document attached f;.~YBd or Lost In 

6. Narcotic Inspection (Jan, Feb), also follow-up Apr 2012 Report- 5-Miumg from order 

Documents attached 2·Wrong Quantity 

7. High Alert Medications (Monthly Ward Inspections} No issues ~:g:~:. poor quality 

8. Ethics (Recurring Item} No issues 2-Miscettaneous reasons 

9. Allergy Ingredient Report (Feb, Mar) No issues 

10. Anticoagulation Referrals from 4th atr, FY 12 from December MeetingNothing referred 

OLD BUSINESS: 

1 . Ch ie f o fS ta ff Recommen d at I ons R ega rd lng P hannacy I n a ttl tiv es 

Month Monthly Assigned Monthly Savings Of. Target Achieved 

Goal Achieved 

Oct $80824 $81,256 101% 

Nov $72.387 $108 541 150% 

Dec $72 246 $117,509 163% 

Jan $72,246 $119,461 165% 

Feb $72,246 $110.488 153% 

Mar $72,246 $139,046 184% 

2. Aripiprazole - Mental Health Provider Plan to meet Pharmacy Cost 

Saving Goal for FY13 related to Atypical Antlpsychotfcs-plan attached 

3. VA Medical Center Non-Formulary Management Process-MCM written 

and being routed for concurrence and signature 

4. Switch High Dose Hydrocodone/APAP 500mg to 325mg-Complete 

5. Lantus/Levemlr.....Complete 

6. MUE on Zolpidem-Complete 

7. MUE on ModaftnJI-Complete 
Ptge2 

A.g.oda, P&T Commm_., April25, 2013 

8. MUE em Mometasone N ... I...Complete 

9. Lanaopruole 30mg Don-Complete 

8. Pota .. lum Chlorldt (KCL} 8 mEq DoH-Complete 

9. Uae of Gt Coekta!l-fbr Outpdenta-Complete 

10. ComblventRnpfmat-comp!otb, one change approved out of 

committee 

11. TDAP for Emptoyeea-complote 

12. Sugar Free Metamucli...Complete 

NEW BUSINESS: 

1. "VaiU. of the Month" March-Advocacy and Aprll..ftteptet 

2. MCM on Standing Order ProtoCol• fot U1e Community LIVIng 

Center (CLC)-document attached 

3. ez.tlmlbe- Co~ savlng&-document attached 

.4. National Contract Announcement- Fish Oil-document attached 

5. Request fot Renal Dfalyals Medications to have dnt.Nnt ttnt.frame 

Limits-document attached 

8. Rosuvntatin to Atotva~tatin Conversion-document •ttached 
DEPARTM!NT OF ftr!RAN& AFFAIRS M.eDtCAL CENTER 

. BECKLEY, WEST VIRGINIA 

PHARMACY ANO THERAPEUTICS (P& T) COMMITTEE 

April 25, 2013 

PRESENT: 

EXCUSED: 

Room 3C-115b 

05/05 

03/05 

05/05 

04/05 

05/05 

04/05 

03/05 

01105 

03/05 

03/05 

04/05 

(}3/05 

05/05 

Chief, Pharmacy/Chairperson 

Chief of Staff 

Chief, Dental Service 

Surgeon, Acute Care Service Line (ACSL) 

Associate Chief, Pharmacy 

Clinical Pharmacy Speclalist 

Chief, Primary Care Service Line (PCSL) 

Clinical Pharmacy Specialist 

Clinical Pharmacy Specialist 

Quality Management (QM) Coordinator 

Clinical Pharmacy Specialist 

Clinical Care Coordinator (CCC), Crittcal Care 

Team 

Secretary, Pharmacy/Recorder 

03/05 Medical Director, PCSL 

01/05 Medical Director, Geriatrics and Extended 

Care Service line (G&ECSL) 

03/05 Physician's Assistant, Mental Health Service Lit 

(MHSL) 

00/05 lnfectfon Control Coordinator 

01105 Bar Code Medication Administration 

(BCMA) Coordinator 

03/05 Physician, PCSL 

CALL TO ORDER: The meeting was called to order by the chairperson at 2 p.m., 

fn Room 3C-115b. There were 12 voting members in attendance at this meetfng which 

represents a quorum (at least 51percent of committee members). 

APPROVAL OF MINUTES: The minutes of the February and March 2013 meetings 

were approved as written, with a correction to the February minutes to include the need 

for follow-up on the patient who reported an ADR with tamsulosin. The need for followup on this ADR was not included in the follow-up actions from the ADR discussion In the 

February 2013 meeting. 

CONFIDENTIAL QM DOCUMENT 

Jll l !.S.l'. 57fU 

Du Not Rtl<11tw 0 1thmlt Atttl1vrit1Jtinn (b)(6)

(b)(6)
' 

Page 19 

P&T Committee, April25, 2013 

Rl'l()Ommendatiori/Actlon: None 

Folfow-up: June 2013 

2. TOPIC: Atlplprazole-Spedt:llQrug Requeat (SOR) ·. 

orscustion: the A.S$66Itlte Chief, Pb!!r-yworked with the MH providers to develop a 

more ~~mve pfaltreg~ifl.g ~ use·of afS'Pteal antipaychotlcs as she h~ agreed to 

do In the'February 2013 m&etlng . 

. the Assoclat~~. Pllarmacy'm.t¢Wfth MH prescribers. Thf.\y agreed upon the 

afgorttttms listed below. They hav& dveral new prescribers ('.Oming on board that will 

halp them follow up quicker after they make changes. We are being lenient in 

approving those on atyplcals for psychosis/schizophrenia/history of 51/Homicidal 

Ideation (HI), etc. Ariplprazole and zlprasidone are both being targeted (turned off from 

filling at the Consolidated Man Outpatient Pharmacy [CMOP], no 90 day supplies are 

being Issued, addressing them· as they request their refills). SORs are required to 

continue or to initiate these two antipsychotlcs. The Associate Chief, Pharmacy Is 

personally addressing the SDRs. 

ANTiPSYCHOTIC ALGORITHMS BASED ON INDICATION 

PQcho!fJ 

Shown In alphabetical Order and does not imply preference 

Halopatldol, Loxapine, Perphenatlne, Quetrapine, or Risperldone 

Six weeks!& minimum for an adequakt trial 

! 

Alternate antipsychotic listed above 

Six weeks Is minimum for an adequate IJ1sl 

vrs 

Con&lder tong-acting injectable J.lrial .. _ 3 to 6 months Is mfnfmum for 

an adequate trial 

+ Aripipm:ole, inc. or Ziprasidone 

,,01iJH!i'fl4t: QM lRJCl/MBNT 

J!J :,:,,s;c sms < ' i11Jttll'il.,.~ 
, 

Page37 

P&T Committee, April 25, 2013 

The committee members reviewed the document proposing the oonversfon from 

rosuvastatln to atorvastat!n and the recommended changes to the SOR for rosuvastatin, 

The committee members were In agreement to make the conversron and to make the 

changes to the SOR for rosuvastatln. 

Conclusion: The committee members were in agreement to make the conversion from 

rosuvastatln to atorvastalin and to make the changes to the SOR for rosuvastatin. 

Recommendation/action: F>atients wlH be converted from rosuvastatln to atorvastatin as 

refills are requested on rosuvastatln according to the conversion table below: 

These conversions wfll be accomplished by the pharmacy staff. Patients will be sent an 

informational letter by the pharmacy when the conversion is made. 

Follow-up: June 2013 

Around the room: 

No topics. for discussion. 

There being.no further items for discussion, the meeting adjourned at 3:15 p.m. 

Chairperson 

Date: 5-20-2013 

~ON-CONCUR: 

C()Nfi'.f1JEN1'!Al Q!lf DOCUA:IENT 

.f8 ES.C 'f7fl.'i 

JJtJN(lf ft ··' '.\(! fVifiltHtfAl-' 1 •F•/'t!1timt 

(b)(6) (b)(6)
Pa{ie 38 

P&T Committee, April 25, 2013 

~~fbtSAPPR~: 

Director 1 Date: .sso/U 

Comments: 

REVIEWED: 

Associate Director for Patient 

Care Executive 

Date: IJ 

COi\''FllJEN71AI: Q1lf l>Ot::U1JfEN1' 

,?P ~ ,.. { 7fJS 

!Jf! Not f{,..t · -utAmlmritnti1m 

(b)(6)

(b)(6) (b)(6)