Deciding which drugs get onto the formulary: a value-based approach.

OBJECTIVES: Hospitals, physicians, payers, and patients face economic and ethical decisions about the use of biotechnology drugs, commonly called specialty medications. These often target a small population, have data based on smaller clinical trials, are expensive, and may have questionable advantage. This is a result of how the Food and Drug Administration (FDA) approves medications, which is based only on safety and efficacy. Cancer drugs, once approved by the FDA, regardless of cost or value must be covered by Medicare. Some states have laws requiring additional coverage as well. All of this has created an unintended consequence: It has driven up costs with questionable evidence to support the medication's value, placing patients, payers, and providers in an ethical conflict. In this new era of health care transformation, health care leaders must focus on creating value to support a sustainable health system. Christiana Care Health System's Value Institute has designed a new model to evaluate specialty medications, using value as its main criterion. METHODS: This article describes the process and outcomes using a new value model for evaluating specialty medications for a hospital formulary. It also introduces a new criterion of evaluation entitled "Societal Benefit" that provides a rating on quality- of-life issues. With measurable factors of efficacy, risk, cost, and quality-of-life concerns, our methodology provides a more balanced approach in the evaluation of specialty medications. RESULTS: Specialty medications are the fastest growing segment of drug expense, and it is hard to understand how these medications will be sustainable under health care reforms. Unlike other countries, the United States has no national agency providing cost-effectiveness review; review occurs, if at all, at a local level. Laws governing Medicare and most private insurers' coverage of FDA-approved medication and some clinical quality standards conflict with cost-effectiveness, making this type of review difficult. Finally, because these medications affect the health system as a whole, it is a great example to begin to support health care reform. CONCLUSIONS: Hospitals need to challenge the value of specialty medication. Although our model will continue to evolve, value is now our central consideration when selecting specialty medications to be added to the formulary. We share this experience to encourage other hospitals to design their own approach to this vital issue.

The impact of ethnicity and gender on agreementof severe allergy history between inpatient andoutpatient electronic medical record

Objective: To evaluate the rate of allergy documentation during inpatient admissions and determine if discrepancies exist between ethnicities and English proficiency, genders, and by medication classes. Methods: Patients at an outpatient clinic with severe medication allergies documented in their electronic medical record were identified. Inpatient hospital admissions following the date this allergy was documented were reviewed and the presence or absence of this documentation in the inpatient electronic medical record was noted. An overall rate of successful documentation of allergies was calculated by dividing the number of admissions where the allergy was entered into by the total number of admissions where the opportunity to enter the allergy existed. Each patients ethnicity, gender, and the class of medication to which they were allergic to, was also recorded to determine if difference exist within each demographic. Results: Overall, allergy information was successfully entered in 84.6% of 246 hospital admissions. This rate was significantly lower (37.5%) among patients whose ethnicity groups, on average, have lower rates of English fluency. There was no significant difference between genders. Allergies to cephalosporins were less likely to be entered (44.4%). Conclusion: Patients who are not proficient in speaking English may be at an increased risk of experiencing an adverse drug reaction as their severe allergies are less likely to be documented during a hospital admission (AU)

Objetivo: Evaluar la tasa de documentación de alergias durante el ingreso hospitalario y determinar si existen discrepancias entre razas y dominio del inglés, géneros, y grupos terapéuticos. Métodos: Se identificó a pacientes en una clínica ambulatoria con alergias graves a medicamentos documentadas en su historial electrónico. Se revisaron los ingresos hospitalarios posteriores a la fecha de la documentación de la alergia y se registró la presencia o ausencia de esta documentación en la historia electrónica hospitalaria. La tasa total de documentación satisfactoria se calculó dividiendo el número de ingresos en los que se había registrado la alergia entre el número total de ingresos en los que existía la oportunidad de que existiese la alergia. También se registró la raza, género y grupo terapéutico de los medicamentos a los que era alérgico cada paciente, para determinar si existían diferencias entre demografías. Resultados: En general, la información de alergias se registró correctamente en el 94,6% de los 246 ingresos hospitalarios. Esta tasa fue significativamente menor (37,5%) en pacientes cuyos grupos étnicos, en general, tenían menor dominio del inglés. No hubo diferencias significativas entre géneros. Las alergias a cefalosporinas fueron las menos frecuentes de ser registradas (44,4%). Conclusión: Los pacientes que no tienen dominio del inglés pueden tener un mayor riesgo de experimentar una reacción adversa, ya que sus alergias graves son menos probablemente documentadas durante el ingreso hospitalario (AU)

The impact of ethnicity and gender on agreement of severe allergy history between inpatient and outpatient electronic medical records.

OBJECTIVE: To evaluate the rate of allergy documentation during inpatient admissions and determine if discrepancies exist between ethnicities and English proficiency, genders, and by medication classes. METHODS: Patients at an outpatient clinic with severe medication allergies documented in their electronic medical record were identified. Inpatient hospital admissions following the date this allergy was documented were reviewed and the presence or absence of this documentation in the inpatient electronic medical record was noted. An overall rate of successful documentation of allergies was calculated by dividing the number of admissions where the allergy was entered into by the total number of admissions where the opportunity to enter the allergy existed. Each patients ethnicity, gender, and the class of medication to which they were allergic to, was also recorded to determine if difference exist within each demographic. RESULTS: Overall, allergy information was successfully entered in 84.6% of 246 hospital admissions. This rate was significantly lower (37.5%) among patients whose ethnicity groups, on average, have lower rates of English fluency. There was no significant difference between genders. Allergies to cephalosporins were less likely to be entered (44.4%). CONCLUSION: Patients who are not proficient in speaking English may be at an increased risk of experiencing an adverse drug reaction as their severe allergies are less likely to be documented during a hospital admission.