DOD and VA Health Care: Actions Needed to Help Ensure Appropriate Medication Continuation and Prescribing Practices
Released: 2016-01-05T00:00:00

Letter

Background

DOD and VHA Health Care

DOD and VHA provide health care, including medications for psychiatric, pain, and sleep conditions, to servicemembers and veterans through their respective health care systems. DOD provides health care to active duty servicemembers; Reserve and National Guard members on active duty; and other beneficiaries, such as family members and retired servicemembers, through TRICARE, its health care program. TRICARE beneficiaries can obtain comprehensive health care services—including outpatient and inpatient care, mental health care, and prescriptions for medications—through a direct-care system of MTFs operated by the Departments of the Army, Navy, and Air Force, or through a purchased- care system of civilian health care providers. Prescription medications can be obtained through MTF pharmacies, retail pharmacies, and the TRICARE mail-order pharmacy. DOD is required by law to make all clinically appropriate medications available to servicemembers, and, with the exception of certain classes of medications, such as weight-loss medications, DOD makes all Food and Drug Administration-approved prescription medications available. DOD’s formulary process is administered by DOD’s Pharmacy and Therapeutics Committee, and the formulary includes a list of medications that all MTFs must provide and medications that an MTF may elect to provide on the basis of the types of specialized services that the MTF offers (such as cancer medications). DOD classifies certain medications as “nonformulary” on the basis of its evaluation of their cost and clinical effectiveness, and DOD’s nonformulary classification applies to all MTFs and DOD’s purchased- care system. Nonformulary medications are available to beneficiaries at a higher cost, unless the provider can establish medical necessity.

Veterans who served in active military duty, and were discharged or released under conditions other than dishonorable are generally eligible for VHA health care. In general, veterans must enroll in VHA health care to receive VHA’s medical benefits—a set of services that includes a full range of hospital and outpatient services, mental health care, and prescription medications. VHA provides health care services at various types of facilities, including VAMCs and community-based outpatient clinics. Veterans may obtain prescription and over-the-counter medications through VAMC or community-based outpatient clinic pharmacies, VHA’s mail-order pharmacy, or through certain non-VHA pharmacies. VA’s formulary provides access to medications for eligible beneficiaries. VHA manages VA’s formulary and makes decisions about whether to add medications to the formulary on the basis of clinical and cost effectiveness and, like DOD, provides access to nonformulary medications when providers establish medical necessity. Because VHA only fills prescriptions written by VHA providers or providers VHA has authorized its patients to see, VHA generally has direct control over the medications that are prescribed to its patient populations.

PTSD and Mild TBI

PTSD is a trauma and stressor-related disorder that can occur after a person is exposed to a traumatic or stressful event such as a death or serious injury; its onset may be delayed. As defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, to be diagnosed with PTSD, patients must have experienced four types of symptoms that continue for more than 1 month after the event: persistently re-experiencing the event such as through flashbacks persistently avoiding trauma-related stimuli such as places or situations that are reminders of the event; negative changes in cognitions and mood that began or worsened after the event, such as persistent negative beliefs about oneself or the world; and changes in arousal and reactivity that may include aggressive or self-destructive behavior and insomnia.

The symptoms cause significant distress or impairment—for example, in the patient’s social relationships and work life—and the duration of symptoms varies, according to the Diagnostic and Statistical Manual of Mental Disorders. That is, some patients with PTSD have symptoms for less than 3 months while others may experience symptoms for longer than a year and sometimes for many years. In addition to providing medication therapy, DOD and VHA provide psychotherapy, which has been shown to be effective in the treatment of PTSD in clinical research studies, as well as other types of therapies.

Mild TBI (also known as a concussion) is caused by a blow or jolt to the head that temporarily disrupts the normal function of the brain. The diagnosis is based on several factors including that the patient has an alternation of consciousness that may last from a moment up to 24 hours or has a loss of memory for the events immediately before or after the injury that lasts for a day or less. There are many causes of this condition—such as blasts and car accidents—and, while not all patients with mild TBI have symptoms, those that do typically experience symptoms immediately following the event. Headache is the most common symptom, and other common symptoms include dizziness, fatigue, irritability, and insomnia. A very small proportion of patients with mild TBI have symptoms that persist beyond 6 months, although symptoms may last longer after repeated mild TBIs. In addition to providing medication therapy for certain symptoms, DOD and VHA provide other services for the treatment of mild TBI symptoms which may include physical and occupational therapy and neuropsychological care. Servicemembers that are diagnosed with mild TBI as a result of combat also have a higher risk of experiencing PTSD. Additionally, servicemembers with either PTSD or mild TBI often experience other co- occurring conditions, such as chronic pain, which may be related to their combat-related injuries.

Medication Management and Continuation during Transitions of Care

As we previously have reported, the length of time that servicemembers take to transition their health care from DOD to VHA or another health care system varies. Some servicemembers may not transition their care to VHA at all and instead seek care from other health care systems and providers. Of those transitioning to VHA, some servicemembers separate from the military and have their first appointment at VHA the following week. Others may take more time to transition to VHA, waiting months or years before scheduling their first appointment.

Effective transitions of care, including for servicemembers transitioning from DOD to VHA, should include education and counseling about medication adherence, medication lists at discharge, and a plan for how to get medications during transitions, according to the National Transitions of Care Coalition—a nonprofit organization that produces tools and resources to assist with such transitions. As we previously have reported, DOD and VHA have established several programs to assist servicemembers, such as those with PTSD or mild TBI, with care transitions, including help with medication management. For example, Army nurse case managers have procedures both to assess if servicemembers receiving care at MTFs have sufficient supplies of medications until their initial VAMC appointment and to share servicemembers’ medication lists with VA liaisons. VA liaisons, who are nurses or social workers stationed at MTFs, in turn, have procedures to ensure that VHA providers receive servicemembers’ medication lists and that transitioning servicemembers have adequate supplies of medications until their initial appointments. Another example is DOD’s inTransition Program. The inTransition Program is a confidential personal coaching program that helps servicemembers with mental health conditions as they move between health care systems or providers. The inTransition Program coaches are social workers who encourage transitioning servicemembers with mental health needs to continue their medications. The continuation of medication therapy, that is, prescribing the same medications when a servicemember separates from DOD and transitions to other health care systems including VHA, is another important element of effective care transitions. Continuing clinically appropriate medications during this transition is especially important for servicemembers and veterans with mental health or pain conditions, such as PTSD, whose symptoms may have been stabilized as a result of medications that DOD providers have prescribed. The treatment of symptoms with medications can enable patients with mental health conditions to return to near-normal functioning and can enhance the effectiveness of psychotherapy.

DOD and VHA Have Developed Medication Treatment Recommendations for PTSD and Mild TBI and VHA Monitors the Prescribing of Certain Medications for PTSD

DOD and VHA Have Collaborated to Develop Clinical Practice Guidelines for Medication Treatment for PTSD and Mild TBI

DOD and VHA have jointly developed clinical practice guidelines related to PTSD and mild TBI, which include recommendations for the treatment of symptoms among servicemembers and veterans with these conditions. Each guideline includes a discussion of, and recommendations on, management of care for servicemembers and veterans with these conditions, such as screening and diagnosis, types of treatment interventions, and assessing treatment responses. The PTSD clinical practice guideline includes evidence-based recommendations to assist DOD and VHA clinicians in their decision making about which medications to prescribe to treat the symptoms of PTSD. The mild TBI clinical practice guideline also includes recommendations related to medications for treating the symptoms of the condition; these recommendations are based on expert opinions, rather than evidence- based research, because of the lack of published studies on mild TBI medication treatments. The guidelines state that the recommendations should not prevent providers from using their own clinical expertise in the care of an individual patient and should never replace sound clinical judgment. In addition to providing guidance for clinical decision making, the guidelines are intended to help improve the quality and continuum of care and the health outcomes for servicemembers and veterans with PTSD and mild TBI.

The PTSD guideline recommends that patients with PTSD be offered certain types of antidepressants and discourages the use of benzodiazepines, a type of sedative. According to the guideline, the use of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors (types of antidepressants) are strongly recommended because there is good evidence that they are effective in reducing the core symptoms of PTSD and are generally well tolerated by servicemembers and veterans with PTSD. In contrast, the guideline states that the use of benzodiazepines should be discouraged because of their lack of effectiveness in treating PTSD and because the risks may outweigh potential benefits. The guideline also states that there is evidence to suggest that benzodiazepines may worsen recovery and, once they are initiated, they can be very difficult to discontinue due to significant withdrawal symptoms.

Additionally, the guideline states that the use of antipsychotics (atypical and conventional) to treat PTSD is not supported because the existing evidence is insufficient to warrant their use. The guideline specifically recommends against the use of one atypical antipsychotic (risperidone) to supplement the use of antidepressants in treating PTSD, based on evidence from a VA study. This study showed that risperidone did not reduce the symptoms of PTSD and its use did not justify the risk for adverse events.

The mild TBI guideline provides general guidance on medications for treating the condition’s symptoms and on those medications that warrant particular caution, including antipsychotics and benzodiazepines. According to the guideline, there is insufficient evidence for recommending the use of one medication over another to treat the symptoms of mild TBI. As a result, the guideline provides general recommendations about medications, such as ibuprofen or naproxen— nonsteroidal anti-inflammatory medications—that may be used to treat common symptoms, such as tension headaches that occur periodically. Because some patients with mild TBI may experience seizures and confusion, the guideline cautions against the use of medications that can increase a patient’s susceptibility to seizures, including antipsychotics, and medications that can cause confusion, such as benzodiazepines. Further, the use of medications to treat the condition itself (brain injury) is not recommended since the Food and Drug Administration had not approved any medications for this purpose as of April 2009, as stated in the guideline.

The PTSD and mild TBI guidelines also include clinical guidance for treating insomnia and pain in servicemembers and veterans with these conditions. The guidelines emphasize that, when possible, initial treatment for insomnia should begin with nonmedication options, and recommend treatments, such as good sleep hygiene practices and cognitive behavioral therapy. Should medications also be needed, the guidelines state that insomnia may be treated with the use of certain sleep medications that are not benzodiazepines, such as zolpidem. For pain, the guidelines recommend individualized treatment plans tailored to the types of pain the patient is experiencing. If medications are included in the treatment plans, the guidelines recommend, for example, that non- steroidal anti-inflammatory medications be used to treat pain resulting from injuries to the bones and muscles. The PTSD guideline further recommends that providers prescribe low doses of opioids or other centrally acting pain medications (which reduce the transmission of pain through the brain), if required, and only in the short term, because they can cause confusion, and then transition their patients to the use of non- steroidal anti-inflammatory medications.

VHA Monitors the Prescribing of Medications to Treat PTSD, but DOD and the Army Do Not; None Monitor Mild TBI Medications Given Lack of Specific Medication Recommendations in Mild TBI Clinical Guideline

VHA monitors the prescribing of medications that are included in the PTSD guideline, but DOD and the Army do not monitor such prescribing among servicemembers. As part of its Psychotropic Drug Safety Initiative, which began in 2013, VHA tracks the prescribing of benzodiazepines, antipsychotics, and other psychiatric medications to treat veterans with PTSD. VHA tracks the prescribing of these medications quarterly at the VAMC, VISN, and national levels. Specifically, VHA tracks the percentage of veterans with PTSD who have been prescribed: (1) a benzodiazepine, (2) an antipsychotic (atypical and conventional) without a separate diagnosis of severe mental illness, and (3) medications from certain classes of psychiatric medications for 60 days or more.

As part of the Psychotropic Drug Safety Initiative, VHA requires each VAMC to develop and implement a plan to improve on any measure for which the individual VAMC was performing significantly below the average of all VAMCs. This requirement encompasses measures focused on reducing prescriptions for benzodiazepines, antipsychotics, and other classes of psychiatric medications to treat veterans with PTSD. If a VAMC does not have any measures that meet the criteria, VHA still requires the VAMC to implement a plan to reduce prescriptions for psychiatric medications based on at least one measure, such as the percentage of veterans with PTSD who have been prescribed a benzodiazepine. In 2015, 22 VAMCs had developed plans to decrease the percentage of veterans with PTSD who are prescribed benzodiazepines and 26 had developed plans to decrease the percentage of veterans with PTSD who are prescribed antipsychotics (without a diagnosis of severe mental illness). Specifically, one VAMC created a clinical reminder in its electronic medical record that is activated when a veteran with PTSD (without a diagnosis of severe mental illness) is prescribed an atypical antipsychotic. To order the prescription, the VHA provider must justify why the medication is needed. This VAMC decreased the percentage of veterans with PTSD who had been prescribed antipsychotics by almost half, from 21.8 percent in 2013 to 11.5 percent in 2015. In addition to continually monitoring these measures, VHA officials told us that they review VAMCs’ improvement plans twice a year and provide VAMCs feedback. As part of the initiative, VHA provides patient-level data to VAMCs—such as information about each patient with PTSD who is prescribed a benzodiazepine along with the name of the provider who prescribed the medication—so that VAMCs can prioritize patients where prescribing practices can be improved. In 2013, VHA also began tracking annually the percentage of veterans with PTSD who are prescribed antidepressants and other medications including prazosin—a medication recommended for PTSD patients who experience nightmares—nationally and by VISN, and the results are shared with VISN pharmacy executives, who are responsible for tracking pharmacy and patient outcome data.

In addition, VHA has begun a program, known as Academic Detailing, to make resources available to providers to assist them in incorporating evidence-based recommendations in the treatment of veterans with mental health conditions, including PTSD. In 2014, VHA developed a guide for clinicians on treating PTSD patients that summarizes key recommendations for medication treatment included in the PTSD guideline and provides other information, such as guidance on how to discontinue benzodiazepines by tapering their dosage over time. As part of the program, pharmacists meet one-on-one with providers that have a high proportion of patients who had been prescribed certain medications (e.g., benzodiazepines, opioids) for whom there are significant safety concerns, including risk for abuse, to identify and address any treatment gaps, according to a VHA official. Each VISN is responsible for implementing an Academic Detailing program and was required to have a program in place by September 30, 2015. VHA officials told us that as of October 2015, 6 of the 21 VISNs had fully implemented such a program.

In contrast to VHA, neither DOD nor the Army monitors the prescribing of medications to treat servicemembers with PTSD in accordance with the guideline recommendations, on an ongoing basis. DOD officials told us that DOD relies on each military service to review the medication prescribing practices of its providers and helps facilitate medication reviews by generating reports for all MTFs that include a list of patients who are prescribed multiple psychiatric and pain medications. DOD officials also told us that they track the prescriptions of certain medications included in the PTSD guideline, such as antipsychotics, by individual military service but do not track prescriptions according to PTSD diagnosis on an ongoing basis. We found that the Army also does not monitor the prescribing of medications that are included in the guideline recommendations on an ongoing basis. Instead, Army officials told us they have emphasized the importance of the PTSD recommendations in their recently issued policies and provider training. Specifically, the Army issued a PTSD policy in 2012, reissued it in 2014, and provided related training on the medication recommendations in the guideline. The policy and training stated that prescribing benzodiazepines to patients with PTSD should be avoided and that prescribing atypical antipsychotics to patients with PTSD warrants caution, given concerns with potential adverse health effects.

The Army issued a policy in 2012 that required MTFs to review their prescribing practices for atypical antipsychotics, but the policy did not apply to benzodiazepines, and it expired in 2014. Army officials stated that they issued the policy on atypical antipsychotics given concerns that these medications could be prescribed without sufficient clinical rationale by providers in the treatment of PTSD but said that they do not plan to re- issue it. Providers and pharmacists we interviewed from one Army MTF told us that they are continuing to conduct these reviews because they identified a higher-than-expected prescribing rate and believe improvements can be made with additional efforts, such as further education of providers. In contrast, providers and pharmacists we interviewed from another Army MTF said that they were no longer conducting the reviews because the policy expired. Army officials told us that they are focusing their monitoring efforts on the extent to which the clinical outcomes among servicemembers with PTSD improve over time. These officials added that they do not have the same level of concern about atypical antipsychotic prescribing for patients with PTSD as they did 5 years ago because they believe recent efforts to raise awareness about prescribing antipsychotics for PTSD have been effective. After we asked Army officials about the effects of the policy, they responded by conducting an analysis, which showed that the proportion of servicemembers with PTSD (without a separate diagnosis of severe mental illness) prescribed atypical and other antipsychotics decreased by almost half, from 19 percent in fiscal year 2010 to 10 percent in fiscal year 2014. Army officials stated that they could repeat their analysis, if needed, but did not identify any specific plans to do so. They added that they could similarly track the percentage of servicemembers with PTSD prescribed a benzodiazepine using the same data source.

Although a decrease in the proportion of servicemembers prescribed atypical antipsychotics is important, the Army’s lack of ongoing monitoring of the prescribing of these medications may increase the risk that the PTSD guideline recommendations are not effectively followed. Federal internal control standards require federal agencies to have control activities in place to establish and review performance measures over time and then implement ongoing monitoring to assess the quality of performance and ensure that the findings of reviews are promptly resolved. Without ongoing monitoring of Army providers’ prescribing of antipsychotics and benzodiazepines to servicemembers with PTSD, the Army may be unable to identify and address prescribing practices that are inconsistent with the guideline and do not have a clinical justification.

Neither VHA nor DOD and the Army monitor the prescribing of medications to treat mild TBI because the mild TBI guideline does not include specific medication recommendations. According to a VHA official, VHA does not conduct such monitoring because mild TBI is associated with a wide range of symptoms, and, thus, treatment regimens need to be individualized based on each patient’s symptoms. In addition, this official added that, in contrast to the PTSD guideline, the mild TBI guideline does not recommend the use of a particular medication over another and there are no strict contraindications for certain medications. DOD officials told us that the individual military services have processes in place to review the prescribing practices of its providers. Army officials stated that the Army has procedures in place that may include the review of medication prescribing decisions, including for mild TBI, such as peer reviews that are part of the Army’s privileging process. Army officials explained that each department within an Army MTF is responsible for developing standards for their specialty and monitoring, for example, whether providers follow related evidence-based medical practices, which may include prescribing medications. Army officials also stated that they are currently focusing their TBI monitoring efforts on tracking the clinical outcomes of TBI patients and have begun to pilot this effort in the TBI clinics at seven Army MTFs.

VA’s Formulary Included More than Half of the Psychiatric, Pain, and Sleep Medications on DOD’s Formulary; Officials Agree That Differences Do Not Affect Medication Continuation

Our review found that VA’s formulary included more than half of the psychiatric, pain, and sleep medications on DOD’s formulary. These medications are prescribed to treat symptoms that are common among servicemembers and veterans with PTSD or mild TBI. DOD and VHA officials we spoke with agreed that the formulary differences did not affect the continuation of medications for servicemembers transitioning from DOD to VHA. (See app. I for a complete list of the psychiatric, pain, and sleep medications on the DOD and VA formularies, as well as information on DOD prescriptions for these medications.) We also found that the vast majority of these medications that were actually prescribed by DOD in fiscal year 2014 were on both formularies. (See table 1.) Additionally, we found the most agreement between the formularies for psychiatric medications, with the medications on VA’s formulary representing 98 percent of the prescriptions that had been filled by DOD in fiscal year 2014.

VHA officials told us that clinical considerations and cost are factors in determining whether to include a medication on the formulary.

Specifically, they said they first consider which medications are the safest and most effective for treating each condition, and then they select the most cost-effective options. As a result of this process, the VA formulary includes fewer medications than DOD’s. For example, VHA officials told us that VA’s formulary did not include the pain medication piroxicam because the formulary already included safer alternatives. VHA officials also said the VA formulary only included two sleep medications because of concerns about the appropriateness of some sleep medications for the treatment of insomnia. Further, VHA officials and providers noted that sleep problems are often a symptom of other conditions, including those related to mental health, and, therefore, treating the underlying condition may also treat the insomnia. Rather than including more of these medications on the VA formulary, VHA has developed evidence-based clinical recommendations for treating insomnia, which includes off-label use of other types of medications, such as antidepressants; over-the- counter medications, such as antihistamines; and nonmedication treatments.

DOD and VHA officials told us they do not believe that the differences between the formularies affected the extent to which VHA providers continued medications prescribed by DOD providers, when clinically appropriate. In support of this position, officials noted the results of VHA’s 2015 study on this issue. Specifically, VHA conducted this study to assess the extent to which differences in the DOD and VA formularies affected medication continuation and found that VHA providers infrequently changed or discontinued medications for nonclinical reasons, including formulary differences. As part of the 2015 study, VHA pharmacists reviewed DOD and VHA data on a sample of 729 servicemembers who transitioned from DOD to VHA in 2013 with a psychiatric, pain, or sleep medication to determine whether their medications were changed by VHA providers upon transition. For the 167 servicemembers whose medications were changed or discontinued, VHA pharmacists reviewed the individual medical records to determine the reasons why. VHA determined that 24 servicemembers (3 percent of the 729 servicemembers reviewed) had psychiatric, pain, or sleep medications that were changed or discontinued for nonclinical reasons, which could include formulary differences, upon transitioning to VHA.

Consistent with the findings of the 2015 VHA study, providers, pharmacists, and case managers we interviewed at three VAMCs and two Army MTFs, as well as military and veterans’ stakeholder groups, were generally unaware of specific instances of medications being changed or discontinued for nonclinical reasons, including formulary differences. Although VHA providers and pharmacists said that this type of change could occur, they most commonly said that medications are changed for clinical reasons, such as side effects, the medication not working, interactions with other medications, and general disagreement with the prior treatment approach. Additionally, several VHA providers we interviewed said most of the psychiatric, pain, and sleep medications they would want to prescribe are already on the VA formulary, and we found that the majority of the medications providers said were not on the formulary have recently been added. For example, duloxetine, an antidepressant added to VA’s formulary in 2015, was a commonly mentioned nonformulary medication during our interviews with providers.

Given the differences in the formularies, some stakeholders have suggested that DOD and VA establish a single formulary. The advantages and disadvantages of doing so would depend, in part, on the resulting formulary—that is, whether VA adopts all of the medications on DOD’s formulary or, instead, VA and DOD agree to a new list of medications. When we discussed the concept of a single formulary with officials, VHA officials expressed concern that adopting DOD’s formulary could diminish elements of their formulary process that they believe are important from a clinical and cost perspective. Specifically, VHA officials told us that adopting DOD’s formulary would result in including medications that VHA has determined to be less safe than other alternatives. For example, the DOD formulary includes a recently Food and Drug Administration-approved extended release opioid medication associated with a greater risk of overdose, if used incorrectly, due to the larger amount of the active ingredient present in the medication, compared to some other pain medications (such as immediate release opioids). VHA officials told us they decided not to include this medication on the formulary, given its ongoing efforts to improve the safety of opioid prescribing. In addition, the Congressional Budget Office estimated that VA’s costs would increase if it were to adopt the psychiatric, pain, and sleep medications on the DOD formulary. VHA officials explained that they are able to control pharmacy costs by requiring providers to prescribe the most cost-effective medications, unless there is a clinical reason to prescribe something else. Clinical reasons could include medication continuation or concerns about particular side effects for certain patients.

A single formulary could also be achieved by DOD and VA collaboratively selecting which medications to include. This approach could result in cost savings for DOD if the new formulary excluded higher cost medications. Although VHA officials told us they would be supportive of this approach, DOD officials said they are not because they view it as a reduction of the benefit that they currently provide, and believe it is important to have a more comprehensive formulary to better accommodate prescriptions written by civilian health care providers. In addition, DOD officials told us that current law requires them to include all clinically appropriate Food and Drug Administration-approved medications. DOD officials told us that including more medications on the formulary is beneficial because individual patients respond differently to different medications.

VHA Has Two Key Efforts to Help Ensure Continuation of Medications, but Lack of Clarity of One Effort May Limit Its Effectiveness

VHA’s Nonformulary Request Process Helps Ensure Continuation of Medications and Most Requests Are Adjudicated within 96 Hours and Approved

VHA’s nonformulary request process is one key effort that helps newly transitioned veterans, including those with PTSD or mild TBI, avoid medication discontinuations that could occur as the result of differences in the DOD and VA formularies, according to providers we interviewed and VHA documents we reviewed. Data provided by VHA show that the most commonly DOD-prescribed psychiatric, pain, and sleep medications not on the VA formulary are prescribed by VHA providers through this process. According to VHA policy, providers may request a medication not on the VA formulary by submitting a nonformulary request, which is reviewed by a pharmacist. The pharmacist, in turn, either approves or denies the request based on whether the provider has demonstrated that there is a clinical necessity for the medication. To be approved, requests for nonformulary medications must meet one of several clinical criteria. For example, a request will be approved if the provider has documented that the veteran has had an allergic reaction to a formulary medication. The pharmacist who reviews the request must approve or deny it within 96 hours, and a provider may appeal a request that a pharmacist initially denied.

VHA monitors the rates in which VAMCs approve nonformulary requests and the extent to which they adjudicate the requests within the required timeframe of 96 hours. VAMCs report data quarterly to VHA on the number of nonformulary requests that their pharmacists approved and denied, the number of denied requests that providers subsequently appealed, and the number of appealed requests that were overturned. VHA does not collect data on the reasons why pharmacists deny nonformulary requests. VHA officials told us they do not collect such data because the only reason for a denial is that the provider did not establish clinical justification for the medication.

VAMCs also report to VHA the number of nonformulary requests that pharmacists adjudicated outside of VHA’s required 96-hour timeline. For nonformulary requests that take longer than 96 hours to adjudicate, VAMCs are required to report the reasons for the delayed adjudication. For example, some of the reasons that VAMCs have reported include that a request was referred to a specialist (e.g., a physician or another pharmacist) for additional review and that the required documentation to determine the appropriateness of the request (e.g., lab value) was unavailable at the time of the request. VHA officials combine data from VAMCs within each of the VISNs to report nonformulary request data quarterly to VISN pharmacists. VHA officials told us they examine the data, among other things, to identify outliers across VISNs related to the number of nonformulary requests that take longer than 96 hours to adjudicate, and they discuss these results during quarterly meetings with VISN pharmacists who are responsible for overseeing the request process with their respective VAMCs. For example, in 2013, VHA officials identified a VISN with a relatively high number of nonformulary requests with delayed adjudication and discussed this outlier at a meeting with VISN pharmacists. This discussion led the VISN to implement several changes that ultimately resulted in a lower number of requests with delayed adjudication. Specifically, the VISN created an automated nonformulary request form that tracks how long each request takes from submission to adjudication. This change allows a provider that submits a nonformulary request, as well as the pharmacists that review the request, to be aware of requests that approach the required 96-hour timeframe for adjudication.

VHA’s nonformulary request data show that pharmacists approved the majority of the nonformulary requests that providers submitted from fiscal years 2012 through 2014. Specifically, they approved 81 percent of the 2.1 million total nonformulary requests, or about 1.7 million, during this time period. (See table 2.) Of the 19 percent of requests that were denied (about 399,000), providers appealed 1 percent of these (about 4,600), and most were overturned (61 percent). Providers we interviewed from all three VAMCs told us that pharmacists approved the majority of nonformulary requests they submitted.

Further, the vast majority of nonformulary requests that providers submitted from fiscal years 2012 through 2014 were adjudicated within 96 hours. Of the approximately 2.1 million nonformulary requests that providers submitted to pharmacists during this time, 98 percent were adjudicated within 96 hours. Providers we interviewed from the three VAMCs in our review told us that pharmacists adjudicated the majority of their nonformulary requests within the required timeframe, and several providers said they frequently received decisions on their requests within 1 or 2 hours of submitting them and sometimes sooner if they spoke directly with a pharmacist about the request. The VHA data also showed that the vast majority of requests that providers appealed were adjudicated within the required timeline of 96 hours (91 percent) from fiscal years 2012 through 2014. Of the nonformulary requests that took longer than 96 hours to adjudicate, three pain medications and one psychiatric medication were among the most frequently requested medications by providers. However, the extent to which requests for these four medications were ultimately approved or denied is unknown because VHA officials do not separately track the results of nonformulary requests for specific medications, including those taking longer than 96 hours to adjudicate.

VHA Issued a Policy to Help Ensure Continuation of Certain Medications for Transitioning Servicemembers, but It Lacks Clarity

VHA issued a policy in January 2015 that instructs providers not to discontinue mental health medications initiated by DOD providers due to differences in the DOD and VA formularies; another key effort to help ensure medication continuation. VHA officials said that the reason for issuing this policy was to provide added assurance that patients with mental health conditions—who are among the most vulnerable—would not have their mental health medications changed or discontinued for nonclinical reasons upon transitioning from DOD to VHA. However, the policy lacks clarity regarding which types of medications should be considered mental health medications and, therefore, are not to be discontinued. Specifically, the policy is unclear on whether providers should continue (when clinically appropriate) all of the medications prescribed by DOD providers for patients with mental health conditions or only the psychiatric medications (such as antidepressants) that were prescribed specifically to treat their mental health condition.

As pain and sleep medications treat symptoms that are commonly experienced by patients with mental health conditions, such as PTSD, VHA providers and pharmacists we interviewed had varying interpretations of whether these medications would be considered mental health medications under the new policy. For example, VHA providers had different interpretations about whether they should continue eszopiclone, a medication for the treatment of insomnia which is on DOD’s formulary, but not VA’s. Some VHA providers said they would have to switch medications for patients who transition from DOD on this medication to one on the VA formulary, unless there is a clinical reason not to do so. Other VHA providers said that the policy could cover other types of medications prescribed to patients with mental health conditions, such as sleep medications. In addition, in our review of VHA’s 2015 study of transitioning servicemembers, we found that among the 24 servicemembers whose medications were changed or discontinued for nonclinical reasons, more than half of them (13 of 24) had a pain or sleep medication changed.

VHA officials acknowledged that the definition of a mental health medication could be subjective and that they intended the policy to be broad and to apply to any medication that is prescribed to treat a mental health condition. Therefore, they stated that pain and sleep medications should be considered mental health medications under the policy. However, they also noted that some pain and sleep medications are not intended for long term use, so providers may choose to discontinue prescribing them for clinical reasons.

Given that VHA’s policy lacks clarity regarding which types of medications should be considered mental health medications, VHA providers may be inappropriately changing or discontinuing mental health medications due to formulary differences. Such changes could lead to adverse health effects, such as exacerbation of symptoms or new side effects. This lack of clarity in VHA’s policy is inconsistent with federal internal control standards, which state that agencies should establish control activities, such as developing clear policies, in order to accomplish the agency’s objectives.

VHA officials told us that they are planning to conduct another study of transitioning servicemembers to determine if the new policy is having the intended effect. Specifically, VHA officials told us that they plan to review the prescriptions of about 5,000 servicemembers who transitioned from DOD to determine whether their medications were continued at VHA when clinically appropriate. VHA officials told us that they have been working with DOD officials to obtain the data needed to conduct this study.

Conclusions

Servicemembers and veterans diagnosed with PTSD or mild TBI may experience significant difficulties and impairments in their social relationships and work life. VHA and DOD have jointly developed a clinical practice guideline for PTSD patients that includes evidence-based recommendations to aid clinicians in their decision making about which medications to prescribe to treat the symptoms of PTSD. However, the Army does not have a mechanism in place to monitor on an ongoing basis whether MTFs are prescribing medications that are consistent with these recommendations.

Ensuring that medication regimens are continued when clinically appropriate is critical for servicemembers transitioning their health care from DOD to VHA, including those with PTSD and mild TBI. We did not find evidence that the differences in the DOD and VA formularies for these medications result in the inappropriate discontinuation of medications. Although VA’s formulary includes just over half of the medications on the DOD formulary, those on both formularies represent the most commonly DOD-prescribed psychiatric, pain, and sleep medications. However, we found that VHA’s new policy to ensure the continuation of mental health medications lacks clarity on the types of medications considered mental health medications, and, as a result, VHA providers may be inappropriately changing or discontinuing mental health medications due to formulary differences, potentially increasing the risk of adverse health effects for transitioning servicemembers.

Recommendations for Executive Action

We recommend that the Secretary of Defense direct the Secretary of the Army to implement processes to review and monitor Army MTF prescribing practices for medications discouraged under the PTSD guideline and address identified deviations.

We recommend that the Secretary of Veterans Affairs direct the Under Secretary for Health to clarify which types of medications are covered by VHA’s January 2015 policy on medication continuation.

Agency Comments

DOD provided written comments on a draft of this report, which we have reprinted in appendix II. In its comments, DOD agreed with our conclusions and generally concurred with our recommendation. DOD stated that any policy that it may issue related to the monitoring of prescribing practices would be directed toward all of the military services. DOD also provided technical comments, which we have incorporated in the report as appropriate.

VA also provided written comments on a draft of this report, which we have reprinted in appendix III. In its comments, VA agreed with our conclusions and concurred with our recommendation. VA stated that it will issue written guidance to its providers clarifying which types of medications are covered by its 2015 policy on medication continuation, with an estimated completion date of March 2016. VA also provided technical comments, which we have incorporated in the report as appropriate.

We are sending copies of this report to the appropriate congressional committees, the Secretary of Defense, the Secretary of Veterans Affairs, and other interested parties. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov.

If you or your staff have any questions about this report, please contact me at (202) 512-7114 or draperd@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix IV.

Appendix I: Formulary Comparison

We found that the Department of Veterans Affairs (VA) formulary included 57 percent of the psychiatric, pain, and sleep medications on the Department of Defense (DOD) formulary, as of August 2015, and these medications represented the most frequently prescribed psychiatric, pain, and sleep medications on the DOD formulary in fiscal year 2014. (See table 3.)

For a sample of psychiatric, pain, and sleep medications included on both the DOD and VA formularies and that were frequently prescribed by DOD providers in fiscal year 2014, we also compared the specific formulations that were available on each formulary. We conducted this supplemental analysis because DOD and Veterans Health Administration (VHA) officials told us that prescribing different formulations of the same medication may have clinical significance for certain medications or certain patients. Specifically, we reviewed differences in the medication formulations according to their available dosage form (e.g., liquid or tablet), modified release formulation (e.g., extended or immediate release), salt form (e.g., hydrochloride or sulfate), strength, and also their route of administration (e.g., oral or nasal). We selected the five psychiatric and five pain medications most frequently prescribed and filled by DOD for active duty servicemembers in fiscal year 2014 that were on both DOD and VA formularies. For sleep, the VA formulary only included two medications, so we reviewed the formulations for both.

We found that the VA formulary included all of the formulations that were on the DOD formulary for 7 of these 12 medications. The formulation differences for the remaining 5 psychiatric, pain, and sleep medications resulted from differences in dosage form and modified release formulation. That is, 2 of the 5 medications were available on the DOD formulary but not the VA formulary in the liquid form, and the remaining 3 medications were available on the DOD formulary but not on the VA formulary in the extended release form. For example, the DOD and VA formularies both include immediate release formulations of the sleep medication zolpidem, but the DOD formulary also includes the extended release version. We obtained the perspectives of DOD and VHA officials regarding the clinical significance of the formulation differences that we observed, and they agreed that these differences were not generally clinically significant and would only have implications for specific patients, such as certain patients who cannot swallow pills and who would benefit from the liquid forms. In addition, DOD and VHA officials both said that the primary difference between immediate release and extended release medications would be the frequency with which the patient needs to take the medication, but there could be differences in their effectiveness for certain patients. VHA officials noted that the formulations of medications that are not included on the VA formulary are often those for which there is a limited need in their patient population, but, in situations where these specific formulations are clinically indicated, they would utilize the nonformulary request process to prescribe that medication. DOD officials agreed that some of the formulations not available on VA’s formulary are often not clinically indicated.

Appendix II: Comments from the Department of Defense

Appendix III: Comments from the Department of Veterans Affairs

Appendix IV: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact named above, Janina Austin, Assistant Director; Jennie F. Apter; Pamela Dooley; Joshua D. Ferencik; Jacquelyn Hamilton; Toni Harrison; Katie McConnell; and Daniel Ries made key contributions to this report.