|Taming an Atypical Formulary Beast|
|By Scott A. Haas, M.D., Kentucky DOC Medical Director|
A formulary is defined as a listing of drugs intended to include a large enough range of medications and sufficient information about them to enable health practitioners to prescribe treatment that is medically appropriate. The concept was introduced into the medical community in the 1950’s. Initially, the formulary was used to allow pharmacists to dispense a generically equivalent form of a brand name drug. Over time, formularies expanded their utility to serve a number of clinical service providers, including physicians, hospitals and insurance administrators. Although formularies have been met with varying degrees of acceptance or resistance, their place in modern medicine has been set in stone. With the myriad of medication choices facing physicians, a compendium of pharmaceutical information and available equivalent alternatives has become a useful tool. For medical administrators responsible for ever-growing pharmaceutical budgets, formularies are absolutely essential.
The Physician’s Desk Reference contains information on over 4,000 brand name drugs. Add to that the number of over the counter medications that are available without a prescription and it becomes easy to see how overwhelming treating medical and mental health conditions can become. The Food and Drug Administration (FDA) approves a number of new medications, alternative preparations for existing medications and over the counter combinations each year. For the correctional prescriber, keeping up with additions to the available medication arsenal is essential to competent practice but also a daunting task. However, prescribing is only one component of responsible medical care. Cost-effectiveness and fiscal responsibility are also expected, especially in light of today’s burgeoning state budget deficits. It is unreasonable to expect medical providers to know how much each drug or each individual strength of a drug costs. To that end, formularies help to provide a guide for cost-effective prescribing of medications indicated for specific clinical conditions.
In the Kentucky Department of Corrections (KYDOC), the drug formulary evolved in the late 1990’s in response to a continually expanding pharmaceutical budget and an inability to control it. Departmental physicians and nurse practitioners average over 21,000 medication orders each month. In 2005, during the peak of pharmaceutical expenditures, these prescriptions cost over $6 million dollars per year for just over 12,000 inmates. It was determined that although medical providers are certainly expert in treating medical and mental health conditions, they may not always be in the best position to balance efficacy, risk and cost. One major factor contributing to a provider’s inability to equitably manage those three variables is that most prescribers are not keenly aware of the cost of each drug that they prescribe, nor should it be expected of them. Providing a formulary eliminates the need for the providers to understand complex pricing regimens and offers clinical and scientific support for the prescribing of any drug on the formulary.
The development of a model drug formulary involves several disciplines providing input into the creation of a listing of medications that will provide an adequate selection of treatments to effectively address the medical conditions presented by an inmate population in a cost-effective fashion. In the KYDOC, pharmacists, medical physicians, psychiatrists, optometrists and nurses served as members of the Pharmacy & Therapeutics Committee (P&T) charged with creating, monitoring and revising the formulary based on the most up to date pharmaceutical, scientific and FDA information. Consequently, medical providers are expected to prescribe from the available selection of formulary drugs. However, in many cases formulary agents are ineffective, contraindicated or otherwise not tolerated by the patient necessitating the use of a drug that is not available on the formulary. In some instances, the only available drug to treat a rare condition is a non-formulary selection. When providers believe that a formulary alternative is not a viable treatment, non-formulary medication may be requested by the provider. The provider is expected to provide information regarding the diagnosis of the patient, medication history, allergies, co-morbid medical conditions, as well as any justifications that exist which explain why a formulary medication is not a clinically prudent choice. Such requests are reviewed by the Department’s medical director who authorizes the request, denies the request and makes alternative recommendations, or asks for additional clinical information. The medical director maintains regular contact with a number of pharmacists and physicians of various specialties in order to assist the prescriber in selecting the most appropriate and cost-effective treatment option. And although cost is never the deciding factor in clinical decision-making, it must be a consideration when dealing with a fixed medical budget.
In fiscal year 2008, the Kentucky Department of Corrections spent over $46 million in providing medical care to its inmate population. Of that amount, $5.7 million was spent on pharmaceuticals. Like Kentucky, many states are struggling with the management of pharmaceutical expenditures and rising health care costs. The first step in pharmacy cost containment is identifying the drug class, or classes that are driving budgetary expansion. In Kentucky, the class of drugs responsible for the largest area of spending growth was atypical antipsychotic medications. In 2006 the P&T Committee found that non-formulary psychotropic medications accounted for just over 2% of all prescriptions. Atypical antipsychotic medication represented only 5% of all psychiatric prescriptions but was responsible for over 60% of the total dollars spent on psychiatric medication. It was apparent to the committee that decreasing that 5% would have a significant and positive impact on expenditures. In response, an aggressive management plan was put into place with the intention of limiting the potentially devastating fiscal impact that this class of drugs was creating. With scientific evidence from the CATIE-1, CATIE-2 and CUTLASS studies of atypical antipsychotic efficacy and tolerability compared to traditional antipsychotics, it became possible to provide informed recommendations on formulary alternatives for the treatment of many psychiatric conditions; alternatives that also had the support of the scientific community.
In just a few short years the percentage of atypical antipsychotics dropped to less than 3% of all psychiatric prescriptions. Today, non-formulary psychiatric medications represent only 0.38% of all prescriptions and atypical antipsychotics represent less than 36% of psychiatric dollars spent in the KYDOC. The end result is that the Department now realizes comparative savings of nearly $500,000 dollars per year due to the aggressive management and responsible, scientifically-based prescribing of this single class of drugs.
Although the above example reveals the success of a single initiative, there have been a number of such action plans undertaken by the P&T Committee over the past several years. Similar management plans have been put into place for conditions such as hypercholesterolemia, hyperthyroidism, asthma and infectious diseases. All P&T recommendations carefully assess a medication’s FDA indication, scientific review, clinical efficacy, side-effect and risk profile, as well as cost. Once the committee agrees on a plan of action, the results of that initiative are reviewed at each subsequent meeting in order to evaluate the positive and negative impacts on the inmate population, prescribers and pharmacy budget. Based primarily on those factors, a plan is continued, revised or terminated.
Over the past several years, the Kentucky Department of Corrections has watched its pharmaceutical expenditures contract while many other states have struggled with increasing pharmacy budgets. Kentucky’s model and success are but one example of what many states and agencies have also demonstrated. As the wholesale cost of pharmaceutical products has risen by an average rate of 6.9% per year over the past four years, the KYDOC has enjoyed an 8.1% decrease in pharmacy expenditures during the same period. Of even greater significance is the fact that this decrease in pharmaceutical spending has occurred during a time frame in which Kentucky’s inmate population has increased to over 13,000 inmates.
A theory espoused by some professionals is that aggressive formulary management creates a negative impact on overall inmate health. At least one indicator of such a negative impact is secondary care costs. It could be hypothesized that decreasing the available pharmaceutical options would result in an increase in hospitalization and off-site visits to specialty care providers due to illnesses not being adequately addressed by the readily available formulary medications. However, Kentucky has experienced a static secondary care budget for the past three fiscal years, indicating that formulary adherence does not necessarily equate to decreased efficacy.
Through the collaborative efforts of the Medical Division’s physicians, psychiatrists and nurse practitioners, the Department has realized $1.2 million in cost avoidance that it would not have had available without judicious formulary management. Their understanding, patience and tolerance of the recommendations from the P&T Committee have been the primary determinants of success for the Department’s medical budget.
In summary, formularies have become a cornerstone of modern medicine whether they are welcomed or not. Although they are considered by many to limit the options of medical providers, their primary mission in the Kentucky Department of Corrections is to provide consolidated, scientific and fiscal information with which clinicians can balance the best medical interest of their patients with the fiscal interests of the taxpayers of the Commonwealth. A well-reasoned formulary management approach can provide valuable feedback to medical providers, scientifically based quality of care to patients and cost-effectiveness of prescribing without negatively impacting patient outcomes. During these difficult economic times, the Kentucky Department of Corrections has demonstrated one method to deliver all three of those attributes with great success.
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