1

PHARMACY BENEFITS MANAGEMENT SERVICES (PBM) WITHIN THE VA 

Helping to achieve safe 

medication use

ISSUE 7 VOLUME 2 JULY/AUGUST 2012

 PHARMACY BENEFITS MANAGEMENT SERVICES WITHIN

THE VA ..................... 1

 MEDICATION SAFETY NEWS 

FROM THE VA NATIONAL

PHARMACY BENEFITS 

MANAGEMENT SERVICES 

[PBM] AND THE FOOD AND

DRUG ADMINISTRATION

[FDA]........................ 2

 IMPROVING DRUG SAFETY

MONITORING IN THE VA: 

COMBINING DATA FROM

THE ADVERSE REACTION

TRACKING SYSTEM [ARTS] 

AND THE VA ADVERSE

DRUG EVENT REPORTING

SYSTEM [VA ADERS] .... 2-3Medication

Pharmacy care within the Department of Veterans Affairs (VA) falls 

under the national guidance of the Pharmacy Benefits Management 

Services (PBM), a team of medical and pharmacy authorities, whose 

primary functions include:

Maintaining the national drug formulary, which ensures that veterans have improved access to the same drug products and supplies 

across the system nationwide while keeping pharmacy costs at a 

low level; and

Promoting, optimizing, and assisting VA practitioners with the safe 

and appropriate use of all medications, enhancing both patient 

outcomes and satisfaction. PBM achieves this second goal by:

Developing recommendations and policies for drug use based 

on current evidence reported in the published medical literature demonstrating clinically relevant outcomes; and

Identifying, tracking, monitoring, and preventing adverse drug 

events, in collaboration with the VA Center for Medication 

Safety (VA MedSAFE), a comprehensive pharmacovigilance 

center. 

Since its establishment in 1995, the PBM oversees the national drug 

plan for the entire VA system, which serves more than 8.34 million 

Veterans enrolled in the VA Health Care System and provides more 

than 139 million prescriptions per year. 

PBM has utilized various contracting techniques to maintain a generous 

and standardized drug benefit nationally while at a low cost, even as 

drug expenditures continue to rise. PBM has helped the VA to keep its 

average acquisition cost for a 1-month supply of medication stable for 

nearly 10 years ($12.79 in October 1998 compared to $13.57 in May 

2007, which is a change of less than 1% per year). However, PBM’s 

management of VA’s national drug plan relies first and foremost on 

comprehensive review of a medication’s evidence in the scientific literature demonstrating safe and effective patient outcomes . In this way, 

the best value drugs may not necessarily equate to the least expensive, 

but because they demonstrate the most efficacy as well as safety, they 

become preferred drugs on the formulary.

PBM collaborates with VA MedSAFE to undertake qualityimprovement and safety initiatives that ultimately assess, monitor, and 

enhance the safe and appropriate use of medications in Veterans within 

the VA Health Care System nationwide. These efforts make use of VA 

integrated databases to help identify and evaluate drug safety issues and 

utilization trends. Because the VA has a closed system, PBM/VA MedSAFE has the ability to track medication use at a national or patientspecific level and encourage the use of evidence-based therapies. For 

example, several years ago, PBM/VA MedSAFE identified all patients 

within the VA system-wide receiving short-acting nifedipine for the 

treatment of hypertension and arranged for a switch in their prescriptions to safer medications due to reports in the medical literature associating its use with an increased risk of myocardial infarction .

For more information on the PBM and formulary management within 

the VA, please visit: http://www.pbm.va.gov/ .

REFERENCES:

1. Sales MM, Cunningham, FE, Glassman PA, Valentino MA, Good, CB. Pharmacy benefits management in the Veterans 

Health Administration: 1995 to 2003. Am J Managed Care. 2005; 11:104-112.

2. Good CB, Valentino MA. Access to affordable medications: The Department of Veterans Affairs pharmacy plan as a national 

model. Am J Public Health. 2007 December; 97(12): 2129–2131. 

EDITOR-IN-CHIEF | Marie Sales, Pharm.D.

VA Pharmacy Benefits Management Services [PBM] & Center for Medication Safety [VA MedSAFE]

1st Avenue—1 Block North of Cermak Road | Building 37; Room 139 | Hines, Illinois | 60141

www.pbm.va.gov

safety in seconds

A M ONT H L Y P U B LI C AT IO N FRO M V A M E D S AF E: 

V A ’S CO M P R EH E N SI V E P H A R M ACO V IG IL A NC E C E NT E R
2

NEWS YOU CAN USE

FROM THE FOOD AND DRUG ADMINISTRATION (FDA)

NEUROLOGY

Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)

07/23/2012

FDA’s review of seizure risk associated with dalfampridine (Ampyra) therapy in multiple sclerosis patients showed seizures occurring at 

the recommended dose in the product label and within the first week of starting therapy. Seizures, a known and documented adverse 

event with dalfampridine (Ampyra), can increase with higher levels of the drug since elimination occurs via the kidneys. FDA recommends assessing renal function before starting dalfampridine (Ampyra). Dalfampridine (Ampyra) is contraindicated in patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min) or with a history of seizures. For patients with mild renal impairment (creatinine clearance < 51-80 mL/min), consider risk versus benefits before initiating treatment with dalfampridine (Ampyra).

ONCOLOGY

New information regarding QT prolongation with ondansetron (Zofran)

06/29/2012

Preliminary information from a recent study indicates dose-dependent QT-prolongation with ondansetron (Zofran), and specifically with 

the 32mg single intravenous dose. Patients at risk for this adverse event include those with congenital long QT syndrome, congestive 

heart failure, bradyarrhythmias, uncorrected electrolyte abnormalities, and use of concomitant medications that prolong the QT interval. 

The manufacturer (GlaxoSmithKline) will update product labeling to state that no single intravenous dose should exceed 16 mg due to 

risk of QT prolongation. A lower intravenous dose of 0.15mg/kg every 4 hours for 3 doses may be used in adults with chemotherapyinduced nausea and vomiting. Oral dosing recommendations as well as lower intravenous dosing recommendations remain the same. 

FDA will reveal final study results when available. 

INFECTIOUS DISEASES

Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment

06/26/2012

According to reports found in the FDA’s Adverse Event Reporting System (AERS) database as well as in the medical literature, nonconvulsive status epilepticus has occurred with the use of cefipime. Cases involved patients greater than 50 years of age, having renal dysfunction, inappropriate dosing adjustments, underlying concurrent illness, or history of seizures on beta-lactam or cephalosporin antibiotics. Seizures resolved upon discontinuation of cefipime and/or after hemodialysis. FDA recommends adjusting cefipime doses in patients 

with a creatinine clearance equal to or below 60 mL/min. If seizures occur during treatment with cefipime, FDA recommends discontinuing cefipime or adjusting the dose for those with renal impairment. 

Getting the most from 

our safety surveillance

IMPROVING DRUG SAFETY MONITORING IN THE VA: 

COMBINING DATA FROM THE ADVERSE REACTION

TRACKING SYSTEM (ARTS) AND THE VA ADVERSE 

DRUG EVENT REPORTING SYSTEM (VA ADERS)

The VA uses two separate spontaneous adverse drug event (ADE) 

reporting systems to manage provider- and patient-reported 

ADEs:

the Allergy/Adverse Reaction Tracking System (ARTS), 

which resides within the VA electronic medical record and houses 

all allergies as well as adverse drug reactions (ADR) entered into 

the Computerized Patient Record System (CPRS) by providers 

for use in direct patient care; and

the VA Adverse Drug Event Reporting System (VA ADERS), a web-based spontaneous ADE reporting system that allows for system-wide tracking/monitoring of ADEs on an aggregate or individual level, and from which MedWatch reports can 

be generated from provider entries for electronic submission to 

the FDA.

ARTS serves as a safety tool, with utility occurring at the point of 

care when providers enter patient-reported allergies or adverse 

events associated with medications into the Allergy/Adverse Reactions section of the patient chart in CPRS during a clinic visit. 

ARTS stores patient- and drug-specific data regarding unwanted 

medication effects in a centralized database. During each prescription order entry in CPRS, the information is cross-checked 

for any previously associated and documented adverse reaction/

event. This helps to prevent repeat exposure of patients to the 

same potentially harmful drug or class of drugs.

VA ADERS is the VA’s nationwide web-based ADE reporting 

system available at all VA Facilities, also used for safety purposes. Users with access to read notes in CPRS can submit ADE 

reports to the VA ADERS database. VA ADERS standardizes 

ADE reporting within the VA, and enables completion of MedWatch forms from the application with electronic submission directly to the FDA. Additionally, VA ADERS provides ADE 

trending reports and a platform for medical centers to share process improvements.

(Continued on page 3) 

TABLE 1. 

Suspect drugs 

ranked by 

number of 

reports after 

crossreferencing 

ARTS with VA 

ADERS.
3

Getting the most from our 

safety surveillance

IMPROVING DRUG SAFETY MONITORING IN THE VA: COMBINING DATA 

FROM THE ADVERSE REACTION TRACKING SYSTEM (ARTS) AND THE 

VA ADVERSE DRUG EVENT REPORTING SYSTEM (VA ADERS)

Relating data from the ARTS and VA 

ADERS programs strengthens VA’s capability for capturing adverse event information when compared to using each system 

alone, since underreporting remains an 

issue with spontaneous reporting. Also, at 

this time, there is no automatic link between ARTS and VA ADERS to allow for 

entries in one system to automatically 

populate the other. To bridge the gap 

between systems and to increase the overall reporting to VA ADERS, the ARTS 

information is screened on a monthly basis by VA ADERS staff. Information 

from ARTS is then cross-referenced with 

VA ADERS datasets to identify ADE 

entries captured in ARTS (but not entered 

into VA ADERS) for inclusion into the 

VA ADERS database. This allows for 

detection of a greater number of true observed reactions. 

Merging data from the two sources allows 

for more ADE information to be collected, 

compounding the potential to identify, 

monitor, and report adverse reactions associated with medications within the VA. 

VA ADERS creates one draft report per 

ADE imported from ARTS data that contains the basic components for the event: 

patient identifiers, reactant (drug), event 

(symptom or reaction) and the date of the 

event. This results in multiple draft reports loaded into the VA ADERS application for most facilities on a monthly basis 

so that reporters on-site can access for 

evaluation and completion. Regardless of 

severity or complexity of the event, additional information is required for submitting a final report to the VA ADERS database. Completion of these reports by site 

reporters and submission into the VA ADERS system helps to establish a more 

comprehensive database of observed 

ADEs in VA to use in tracking and trending, as well as reviewing for events of 

interest within and among facilities. VA 

ADERS applies two criteria to identify 

events of interest from the monthly ARTS 

files in the creation of its draft reports:

Criteria 1: ARTS entries marked as 

“Observed” with no corresponding 

VA ADERS entry.

Rationale: These “Observed” events 

appear as documented in the patient 

chart, but not in VA ADERS. The 

inclusion of all known observed drug 

reactions in VA patients within VA 

ADERS helps strengthen its potential 

for use by providers in monitoring 

ADEs at the facility level as well as 

reducing risk of harm at the patient 

level. 

Criteria 2: ARTS entries marked as 

“Historical” with no corresponding 

VA ADERS entry, but with prescription records reflecting that VA dispensed the reactant drug within the 6 

months prior to the “Historical”

ARTS entry.

Rationale: A patient who has a 

“Historical” entry for an ADR and 

who has also received the suspect 

drug associated with the ADR from 

the VA within the last 6 months may, 

in fact, have experienced that ADR 

due to use of the VA provided medication. In this case, it would represent an “Observed” ADR entered 

incorrectly as “Historical”. 

Since July 2009 to present, ARTS entries 

of all VA facilities are screened using 

Criteria 1, from which subsequent draft 

VA ADERS reports are created for each 

event meeting criteria. In addition to Criteria 1, individual facilities or entire 

VISNs may request to use Criteria 2 for 

“Historical” entries with a VA prescription within the last 6 months in their facility or network. At this time, 15 facilities 

and 1 network have requested Criteria 2 

be applied at their facility to identify potential reactions to report.

Integration of data from the two programs 

has enabled improved system-wide identification of most commonly reported medications associated with an allergy/adverse 

reaction within the VA. The most common agents reported with adverse events 

(regardless of severity) as a result of linking ARTS and VA ADERS data appear in 

Table 1 (see page 2).

Contributed by:

Von Moore, Pharm.D. 

PROVIDER

RECOMMENDATIONS

Providers should continue to 

report any adverse events associated with medication use 

by entering the information 

into CPRS' Allergies/Adverse 

Reactions field and via local 

reporting mechanisms. 

Facilities should continue to 

report adverse events into VA 

ADERS and from VA ADERS to 

the FDA (as appropriate). 

As previously mentioned, the 

two systems (ARTS and VA 

ADERS) are not automatically 

linked, but their contents complement each other by providing a more robust collection of 

adverse event/reaction information available for VA facilities to review as they work to 

meet their patient and facility 

safety goals. Therefore, reporting to the ARTS file by entering the Allergy/Adverse Reaction information in the patient chart remains first and 

foremost, since this process 

directly impacts patient care 

activities. The subsequent link 

and population of the VA ADERS database with ARTS information equips the VA with 

more detailed ADE data to help 

enhance system-wide awareness of ADEs occurring in the 

VA as well as future medication 

risk reduction efforts. 

For more information about the 

ARTS and VA ADERS programs, please click on the following link: VA Adverse Drug 

Event Reporting System (VA 

ADERS): Monitoring Adverse 

Drug Reactions Across A Nationwide Health Care System 

Using Information Technology .

(Continued from page 2)