Post Midyear 2012 - SEFH · Teofilina : TBW . Vancomicina : TBW, ABW . The best size descriptor for drug dosing in obese patients is . not. ... (TDM) is . a viable alternative for

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Post Midyear 2012

Rafael Ferriols Lisart Hospital Clínico Universitario de Valencia

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Evidence Based Approaches to Pharmacokinetic Dilemmas 2012

Therapeutic Dilemmas in PK/PD, Penumonia and Multi-Drug Resistence

Clinical Pearls

•Verdadero TRUE

•Falso FALSE

La farmacocinética tiene un interés relativo en mi área de trabajo, pues no

realizamos monitorización de fármacos.

MDRD should be used for renal drug dosing Evidence Based Approaches to Pharmacokinetic Dilemmas 2012

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MDRD should be used for renal drug dosing Evidence Based Approaches to Pharmacokinetic Dilemmas 2012

The best size descriptor for drug dosing in obese patients is not ideal body weight as determined by the Devine method

●Elevada prevalencia. Alteración LADME (Vd).

● Peso deseable, peso ideal



Medidas directas: Peso corporal total; masa libre de grasa. Índice de masa corporal (BMI): Método preferido por la OMS Superficie corporal (BSA): oncología Peso corporal ajustado (ABW): Peso dosificación Peso magro (LBW)).


OTROS DESCRIPTORES


Demirovic JA et al. AJHP, 2009

Park EJ et al. Ann Pharmacother ,2012

Winter MA et al. Pharmacotherapy, 2012

LBW (Jammahasatian) incorporando a la ecuación CG proporciona estimaciones del CLcr precisos, exactos y aplicables en la práctica clínica en pacientes con obesidad mórbida

La estratificación por BMI mejora la exactitud y precisión en la estimación de CG.

Clcr CG: - ABW: bajo peso - IBW: normal - ABW0,4: sobrepeso, obeso, obesidad mórbida


Fármaco Descriptor

Alprazolam TBW

Bisoprolol % IBW

Dalteparina ABW

Enoxaparina (estudio 1) BSA

Enoxaparina (estudio 2) TBW

Etoposido BSA

Ifosfamida TBW , % IBW

Litio BMI

Fenitoína IBW

Remifentanilo LBW

Teofilina TBW

Vancomicina TBW, ABW


Si el paciente se ajusta al perfil de los pacientes de algún estudio clínico, usar este descriptor.

Si el paciente se ajusta al perfil de los pacientes de algún estudio farmacocinético, usar este descriptor.

Si el paciente se ajusta al perfil de los pacientes de algún estudio con un fármaco similar, usar este descriptor.

Si el paciente difiere substancialmente de los estudios o no hay estudios, evaluar la utilización del LBW o ABW.

Evaluar si la utilización del TBW para la dosificación puede superar los riesgos de la intoxicación

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• Pai MP et al. Antimicrobial dosing considerations in obese adult patients: Insights from the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2007;27:1081-91.

• Lemmens HJ. Perioperative pharmacology in morbid obesity. Curr Opin Anaesthesiol. 2010;23:485-91

• Hunter RJ et al. Dosing chemotherapy in obese patients: actual versus assigned body surface area (BSA). Cancer Treat Rev. 2009;35:69-78. • Griggs JJ et al. Appropriate chemotherapy dosing for obese adult patients with cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2012;30:1553-61

• Nutescu EA et al. LMWH Dosing Recommendations in Obese Patients. Ann Pharmacother. 2009;43:1064-83.

• Erstad BL. Dosing of medications in morbidly obese patients in the intensive care unit setting. Intensive Care Med. 2004;30:18-31.

•Kendrick JG et al. Pharmacokinetics and drug dosing in obese children Journal of Pediatric Pharmacology and Therapeutics. 2010;15:94-109.


• Only ~25% of drugs have size descriptor-based dosing recommendations.

• All size descriptors for drug dosing are “Population Estimates”

• Individualized Dosing Carefully monitoring patient’s clinical

status and symptoms and adjust dosage acccordingly.

Therapeutic drug monitoring (TDM) is a viable alternative for some drugs.

• Simple adjustments based on total body weight or some component of it (e.g., lean body weight) cannot be applied across all patients or drugs, since changes in blood volume, organ size or metabolic capacity, and other factors are not uniformly related to body weight alone.

Pharmacokinetic drug-drug interactions are mostly of theorical rather than practical importance to patient safety

Más del 75% de las alertas, generalmente, no son consideradas por farmacéuticos y médicos porque son consideradas clínicamente irrelevantes

Existe un elevado grado de concordancia en las distintas fuentes de información sobre la significación de las interacciones farmacológicas

• Verdadero TRUE

• Falso FALSE

• Verdadero TRUE

• Falso FALSE

Pharmacokinetic drug-drug interactions are mostly of theorical rather than practical importance to patient safety

• Most interaction alerts are clearly of theoretical (or unimportant) clinical consequence • We are responsible for making drug therapy safe for our patients – it is imperative that we recognize the potential for severe problems and prevent harm • We must work to change the system so it works better – reduce alert fatigue and make the “really” important interactions hard to override when they are, in fact, appropriate

Carbapenems causing seizures? A valproate interaction incognito

Antiepileptic drugs (AEDs) and generic substitution

What is the Status of Generic AEDs?

• The FDA says they are equivalent

• There is little objective evidence that generic forms of AEDs are inferior to the brand name drugs when AEDs are initiated

• There is some evidence that the incidence/frequency of seizures may

increases the month following a change in the AED source

If you are going to change the AED source … • Make sure every one is in agreement (pharmacist, patient, provider) • Make the change when the patient is clinically stable and no anticipated changes in daily activities/life style • No changes in other medications • Keep the same dosage form • Avoid multiple manufacturers

Antimicrobial Pharmacokinetics/pharmacodynamics in critically ill patients


Varying severity of illness. Inclusion of non-critically ill patients Unknown MICs. MICs are the drivers of pharmacodynamic goals Differing total daily doses. Higher total daily dose in intermittent group %T > MIC unknown. Serum concentrations not performed


Importancia de la dosis de carga 1. Alcanzar el “objetivo” inicial es

importante para la curación clínica 2. Vd elevado =Dosis elevada 3. Cl elevado = Frecuencia elevada 4. Al menos, 24h. Balance del riesgo de nefrotoxicidad con dosificación agresiva 1. La NF suele ser reversible 2. Depende de la dosis y duración

Filosofía PK/PD Vancomicina

Atención ambulatoria

Transición

Urgencias

Chronic Obstructive Pulmonary disease (COPD) Guideline update


ROFLUMILAST • “Roflumilast may be useful to reduce exacerbations in patients with FEV1 < 50% predicted, chronic bronchitis, and frequent exacerbations” • Recommended as 2nd and alternative choice in Stage C and Stage D patients (both high risk for exacerbation) combined with a long-acting bronchodilator • There are no comparison or add-on studies of roflumilast and inhaled corticosteroids.

Salmeterol vs. tiotropio como broncodilatador de primera línea ACP 2011 Guideline: • “Clinicians should prescribe monotherapy using either long-acting anticholinergics or long-acting inhaled β-agonists for symptomatic patients with COPD and FEV1< 60% predicted.” • “Clinicians should base choice of specific monotherapy on patient preference, cost, and adverse effect profile.” Gold Guidelines 2011: • “tiotropium was superior to salmeterol in reducing exacerbations, although the difference was small.” • No preference noted comparing long-acting anticholinergics or long-acting inhaled β-agonists


ACP 2011 Guideline: • Does not address the use of antibiotics for the treatment of stable COPD Gold Guidelines 2011: “ A recent trial of daily azithromycin showed efficacy on exacerbation end-points; however, treatment is not recommended because of an unfavorable balance between benefits and side effects.” • “Thus, the use of antibiotics, other than for treating infectious exacerbations of COPD and other bacterial infections, is currently not indicated.”

Azitromicina para prevenir las exacerbaciones COPD

Dyslipidemia Guideline Update: NCEP ATP IV* *National Cholesterol Education Panel (NCEP) Adult Treatment Panel IV

• What evidence supports LDL-C goals for secondary prevention? • What evidence supports LDL-C goals for primary prevention? • What is the impact of the major cholesterol drugs on efficacy and safety?

Hypertension Guideline Update


¿Que diurético recomendaría, en general, a los pacientes con hipertensión que necesitan iniciar tratamiento con diuréticos para controlar su tensión?

• Furosemida A

• Hidroclorotizida B

• Clortalidona C


Paciente diabético


Focus on Clinical Outcomes Initiate medications according to national guidelines; keep the regimen simple: once/twice-a-day dosing; communicate with patients about taking medications as directed; encourage self-monitoring of BP; use technologies to monitor progress/maintenance of goal BP’s Empower Informed Activated Patients Assess patient knowledge, skills, behaviors, confidence and barriers to adherence; encourage problem-solving and behavior change interventions; urge the use of pill boxes for daily use; help patients develop a system for refilling prescriptions

Implement a Team Approach Implement a collaborative model based on a team approach; apply office practice policies/procedures to improve BP control; support self-management and problem prevention Advocate for Health Policy Reform Elevate medication adherence as a critical healthcare issue; develop policies to support prevention and chronic illness; management including self-management; structure/finance healthcare that stimulates behavioral aspects of care in communities; seek regulatory changes to improve use of home BP monitors

Midazolam intranasal pediátrico. 0,2-0,5 mg/kg. Dmáx: 10 mg/dose. [ ]: 5 mg/ml. T0: 4-6’; Tmáx:10-14´

Propofol for alcohol withdrawal syndrome. Refractarios a BDZ

Physostigmine; It`s back. Toxicidad anticolinérgica. 0,5-2mg IV c/15-30´ CI: Alteraciones cardiacas, bradicardia, obstrucción GI/urinaria

GABA NMDA

Use of intranasal medications in the emergency department. Midazolam, fentanilo, naloxona

Where the pain is skin deep. Topical analgesia in the ED. Lidocaina/Prilocaina 2,5%. Efecto prolongado, mucosas, neonatos. Inicio lento, oclusivo. Lidocaina 4% Inicio rápido, no oclusiva. Sin experiencia >2ª. Gel L(idocaina).E(epinefrina). T(etracaina). Heridas abiertas, reducir el sangrado y la absorción sistémica

Emergency Medicine pearls

Hot Topics in emergency Medicine

● Utilización tras las medidas convencionales (calcio, glucagon, hiperinsulinemia-euglicemia).

● Dosificación: 1.5 ml/kg IV , durante 1 min, luego 0.5 ml/kg/min durante 10 min tras la recuperación de la circulación. Repetir si es necesario.

● Dosis media: 3.7 ml/kg. No sobrepsar los 10 ml/kg.

● Evidencias: Escasas.

● Riesgos: pancreatitis, hiperlipemia, interferencias analíticas,

Thrombolysis in PE

Thrombolytic therapy (SK, UK,rtPA) •Rapid clot lysis improvement in pulmonary perfusion & cardiovascular function • Eliminates venous thrombi • Reducing risk of recurrent PE • May prevent chronic vascular obstruction and persistent pulmonary HTN

The use of thrombolytic therapy is still controversial. • Perform risk stratification on all patients. • If indicated, DO NOT DELAY thrombolysis. • Beware of possible complications. • Evidence has failed to prove diferences

Give me fat, or Give me death! Use of lipid emulsion therapy in calcium-

channel blocker and other toxicities

Update in Emergency Department Practice: Service Optimization & Collaborative Practice

Estrategias para optimizar el tipo y nivel de servicios en urgencias Desarrollar acuerdos de colaboración para implementar en urgencias

Identificar los servicios que se podrían ofrecer Ordenes tratamiento, errores de medicación, preguntar al personal, identificar la actividad de otros SF, … Optimizar los servicios No se puede hacer todo, plan de viabilidad con la mayor demanda, centrarse en el medicamento. Identificar servicios esenciales (medicación y poblaciones de alto riesgo) y de formación.

Desafíos Aceptar nuestro “papel inicial” Cobertura Responsabilidades fuera de urgencias Recursos limitados Necesidades Fuentes de información Espacio de trabajo adecuado Entrenamiento adecuado Vías de comunicación


Collaborative Drug Therapy Management (CDTM)


Collaborative Drug Therapy Management (CDTM)


Identificar barreras

Desafios

Estrategias para la integración

• Ganar apoyo • Documentar la reducción de EM y mejora en la

seguridad del paciente. Analizar la intervenciones y errores identificados.

• Farmacéutico con experiencia o formación adecuada

Falta de apoyo

Financiación

Personal

• ¿Qué vas a hacer por urgencias? Discutir antes de empezar las expectativas: Necesidades URG-SF, priorización, tiempos de implementación, seguimiento

• Tiempo: horas, días, dedicación • Enfermedad, vacaciones, trabajo,… • Ordenadores, información , comunicación, …

Papel del farmacéutico

Cobertura

Apoyo inadecuado staff

Recursos

• Definir los servicios que se van a ofrecer • Documentar la actividad y recoger datos • La reducción de costes y la mejora en el tratamiento y

seguridad son claves para personal adicional. • Reducción de carga de trabajo en otros equipos sanitarios

Estrategias

•Empezar poco a poco

•Ser flexible con las necesidades ED

•Discutir las necesidades con los

elementos clave

•Priorizar (seguridad)

Developing Ambulatory Care Clinical Services: Financial Incentives and Service Value


Begin with a thorough understanding of the organization’s current services: can you meet the needs of your patients?





Improving Patient Outcomes: Highlights from the ASHP-APhA Medication Management in Care Transitions Project


How Can Hospitals Reduce Readmissions?

• Better, safer care during inpatient stay • Attend to medication needs at discharge • Improve communication with patients before and after discharge • Improve communication with other providers • Review practice patterns


Objective: to enhance the patient discharge process through multi‐disciplinary communication and direct pharmacist involvement in an effort to reduce adverse medication events, and hospital readmissions • Validate medication RECONCILIATION • Deliver patient centered EDUCATION • Resolve medication ACCESS issues during transition • Coordinate a comprehensive COUNSELING approach • Equates to a HEALTHY compliant patient at home


Reconciliation Compare home, hospital and discharge medication lists

Education In person pharmacist medication education Review indications, dosing, and possible side effects Pictorial‐based personalized medication card Medication organizer “pill box”, medication education leaflets

Access Verified prescription insurance coverage Assisted with insurance formulary restrictions before the patient left the hospital Social workers assisted with uninsured patients and patient assistance program enrollments

Counseling Questionnaire Two follow‐up phone calls Reinforce compliance of medication regimen, identify adverse events, answer questions regarding patient’s medications,...




Goals of the project were three-fold: 1. Improve patient safety by demonstrating that pharmacists can reduce medication errors upon hospital discharge (A. Reconciliation; B. Education) 2. Improve patient access to outpatient prescriptions by eliminating common barriers that delay the filling of discharge prescriptions 3. Financially justify additional pharmacists for hospital-wide implementation of project PRIMED by generating revenue for the onsite outpatient pharmacies


Fase Piloto •1 mes, 1 F, 2 unidades •Alta •Recogida de datos

1 Ampliación • 2 F • Alta (reconciliación, educación, L-V,…) •Ingresado (reconciliación, TDM, visita, educación,…) • Recogida de datos •3 meses: 825 pts; 52%

2 Implantación •6 F, 3 T •Alta •Recogida de datos

3


Quality Metrics Defined Medication reconciliation “Interventions” • Differences between prior to admission, inpatient meds, and discharge med list • Unexplained by progress notes or course of stay • Unexplained missing meds based on patient problem list (i.e., systolic HF, not on ACEI) • Missing or unnecessary medications • Extended courses of therapy (antibiotics)

Clinical impact: Multidisciplinary review of interventions • MD, PA, Pharmacist • Classified via NCC MERP Index Financial metrics defined Time associated with each stage of service Financial impact of cost avoidance: • Relied on previous literature to look at cost avoidance associated with interventions based on severity



Potential Error Severity


Satisfacción del paciente

Innovative Practice: Sustainable Approaches for reducing 30-Day Hospital Readmissions.

Pharmacist Involvement in Improving Transitions of care, Readmissions Rates, and Quality Indicators

PACT Model (Pharmacist Affecting Care Transitions)

Inpatient Program Referral to outpatient Medication Therapy Management (MTM) Collaboration

Acuerdos con organizaciones farmacéuticas externas (COF, Farmacias AP,OF,..) para la realización de sesiones MTM con pacientes.


Pharmacy´s Role in Reducing Readmissions: A review of Established Programs & Outcomes

Regla 1: ¡Conocer el entorno del hospital/organización! Regla 2: Centrarse en los servicios que tienen un valor y resultados de impacto. Regla 3: Sostenibilidad

Inpatient Care Transition Outpatient

Cuestiones clave

¿Pacientes objetivo?, ¿Cómo identificarlos?

¿Cuáles son las necesidades y que intervención se ofrecerá?

¿Quién y cuándo?

¿Cómo será el proceso de comunicación con el paciente?, ¿y con el resto del equipo?


Pharmacy´s Role in Reducing Readmissions: A review of Established Programs & Outcomes

• Riesgo de reingreso basado en factores de riesgo • Estratificar la “intensidad” de la atención Evaluación del riesgo

• EA, omisiones, discrepancias, duplicidad,… • Adherencia: simplificación, educación • Medicación de alto riesgo, nuevas terapias, ttos complejos

Atención relacionada con la medicación

• Preveer las necesidades • Plan ambulatorio. Instrucciones al alta.

Educación al paciente • Instrucciones para el autocuidado, manejo de la

enfermedad • Herramientas para la autoeducación

Planificación sanitaria

• Planificar visitas antes del alta hospitalaria. • Definir procesos para la comunicación de inf. relevante.

Comunicación y coordinación

Rafael Ferriols Lisart

Hospital Clínico Universitario de Valencia [email protected]

Documents

Post Midyear 2012 - SEFH · Teofilina : TBW . Vancomicina : TBW, ABW . The best size descriptor for drug dosing in obese patients is . not. ... (TDM) is . a viable alternative for