“Compartiendo Experiencias e Iniciativas regionales”

Presentación del tema: "“Compartiendo Experiencias e Iniciativas regionales”"— Transcripción de la presentación:

1 “Compartiendo Experiencias e Iniciativas regionales”
Reunión del Foro LAC AISR Panama; 20 de Julio, 2011 I would like to share with you some experience from PATH with alternatives to cytological screening in prevention of cervical cancer. Dr. Jose Jeronimo; M.D. Senior Advisor, Women’s Cancers Reproductive Health 1

2 CareHPV ™ : Experiencia de Nicaragua.
I would like to share with you some experience from PATH with alternatives to cytological screening in prevention of cervical cancer. 2

3 ~270,000 muertes anuales; 88% in países en desarrollo

4 Comparación con mortalidad materna
This table celebrates the remarkable achievements the world has made in reducing mortality due to pregnancy-related complications (sometimes called “maternal mortality”). But these same mothers also are vulnerable to cervical cancer 10 or 20 years after their first pregnancy and while they still support their families and communities.

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7 Sensibilidad de la citologia: CIN 2+
HART Tuebingen Hannover Jena French public Two meta-analysis recently published agreed on sensitivity of cytology to be around 50%. But in the past decade or so we have discovered and validated alternatives to Pap. French private Seattle Canada Combined 0% 10% 30% 50% 70% 90% 100% Cuzick J, Clavel C, Petry KU, et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. The International Journal of Cancer.2006;119:1095–1101. Mayrand HM, Duarte-Franco E, Rodrigues I, et al. Human papillomavirus DNA versus papanicolaou screening tests for cervical cancer. The New England Journal of Medicine. 2007;357: 7

8 Prueba de HPV-ADN CIN 2+ HPV sensitivity HART Tuebingen Hannover Jena
Results from the same two meta-analysis show high sensitivity for HPV-DNA testing. French public French private Seattle Canada Combined 0% 10% 30% 50% 70% 90% 100% HPV sensitivity Cuzick J, Clavel C, Petry KU, et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. The International Journal of Cancer.2006;119:1095–1101. Mayrand HM, Duarte-Franco E, Rodrigues I, et al. Human papillomavirus DNA versus papanicolaou screening tests for cervical cancer. The New England Journal of Medicine. 2007;357: 8

9 Proyecto START* Objetivo: Desarrollar una nueva prueba de VPH para sitios con recursos limitados. The HC2 HPV DNA Test The careHPV™ Test careHPV was created using hc2 as the starting point. Although the technology is the same, multiple modifications were made: to have less instruments. to make the run of the test much simpler and suitable for low-resource settings. careHPV can be run in places where HC2 is not possible to run: does not need running water; can be run using a special battery; no air conditioning is needed; is more portable; lab tech does not need to have high level of training. 9 *Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention (START).

10 The careHPV ™ Test (prototype) tested during the START Project; most of the work was done manually.

11 The lab technician followed basic instructions from a small poster that was posted above the equipment on the wall.

12 Proyecto START-UP* Picture of the latest version of the test.
*Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention – Utility and Program Planning (START-UP). 12

13 START-UP proyectos demostrativos
Masaya This slide shows that Nicaragua is the only country in Latin America that has been included in START-UP’s demonstration project study. This also shows that the study site is located in a province, and it is developed through the public system. 13

14 START-UP study: Clinic in Nicaragua
careHPV testing in the Monimbo Health Center in Masaya Province (Nicaragua). 14

15 Diseño del Estudio + Reclutamiento Tamizaje Colposcopia y Biopsia
careHPV™ Test: muestra vaginal auto-tomada careHPV™ Test: muestra cervical tomada por proveedor Pap IVAA Negativas (Control en 5 años) + Colposcopia y Biopsia Referencia Crioterapia o LEEP Control en un año 15

16 Instrucciones para Auto-Toma Vaginal

17 Nicaragua: Resultados preliminares
Método de tamizaje Sensibilidad* (95% CI) Especificidad* careHPV Vaginal (Auto-toma) 79.6% (65.7, 89.8) 87.3% (86.0, 88.6) careHPV Cervical 83.7% (70.3, 92.7) 90.4% (89.3, 91.5) IVAA 69.4% (54.6, 81.8) 73.8% (72.1, 75.5) Pap (ASCUS+) 36.7% (23.4, 51.7) 97.3% (96.6, 97.9) This slide helps to emphasize the best performance of careHPV compared to the other tests. The sensitivity of VIA is high, but almost 30% of women have a positive VIA result compared to 17% for careHPV using a self-collected sample. Also important to highlight that for every 100 women that you want to screen in the community using: VIA: all those 100 women would need to come to the health center for a pelvic evaluation; and 30% of them would need additional evaluation and treatment, and with all that effort you are detecting and treating 68.9% of cases of pre-cancer. CareHPV: you can screen all those 100 women with self-collected samples done at their homes. Only 17 women would need to come to the clinic for a pelvic evaluation, and with that more limited effort you would detect and treat more cases (82.2%) of pre-cancer and cancer.

18 Encuesta acerca de auto-toma
Alrededor de 82% de mujeres aceptaron tomarse la muestra vaginal; y de ellas: 85.8% pensaron que es fácil. 45.6% prefirieron la auto-toma a un examen ginecológico 54.2% dijeron que lastimarse ellas mismas era una preocupación. 36.0% dijeron que la principal preocupación era obtener una “buena muestra”.

19 Aprendizaje del estudio demostrativo
Es posible realizar una prueba de HPV de alta calidad en areas de bajos recursos. careHPV™ tiene mayor sensibilidad que el Pap e IVAA. Auto-toma puede incrementar el acceso a los programas de tamizaje o aún ser tomada en casa. Tamizaje en el nivel comunitario: sólo mujeres con resultado positivo serían referidas al centro de salud. Posibilidad de incorporarse en paquetes que se den a nivel comunitario o domicilios.

20 Centro de Excelencia para Entrenamiento en IVAA y Crioterapia
I would like to share with you some experience from PATH with alternatives to cytological screening in prevention of cervical cancer. 20

21 IVAA Normal After washing the cervix with 5% acetic acid for one minute; this cervix looks normal since there is no acetowhite epithelium.

22 IVAA Anormal o Positiva
In this case the cervix shows areas with white changes; this is considered abnormal or positive result.

23 Aceto-white lesion evident after washing the cervix with 5% acetic acid.

24 Unmagnified view

25 Centros de Excelencia para Entrenamiento (CEE) en Latinoamérica.
Collaboration between PATH, Jhpiego, and INEN.

26 Materiales para Entrenamiento Clinico
Clinical materials based on Jhpiego training, refined and adapted for use in Latin America

27 Materiales de Promoción y Consejería
Materials have been validated following field use

28 Materiales para monitoreo y supervisión
Supportive supervision includes a program review, review of clinical skills and visual assessment, and the collaborative development (with health facility) of an action plan (with person responsible and date!) for agreed upon actions in response to any issues identified.

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32 Expansion de los CEEs dentro del pais
PIURA LA LIBERTAD UCAYALI LIMA POVERTY INACCESSIBILITY AYACUCHO

33 Expansion of TECs in the region

34 Valor de tener CEEs Paquete validado para entrenamiento en IVAA y crioterapia. CEEs son un buen recurzo existente en Latinoamerica para paises que deseen empezar a introducir IVAA y crioterapia. Validado y apoyado por diversos paises y agencias con experiencia en IVAA y crioterapia. Highlight planned expansion of TEC training to be provided through out Peru

35 Experiencia Regional con el Sistema de Inyección Uniject™
I would like to share with you some experience from PATH with alternatives to cytological screening in prevention of cervical cancer. 35

36 Oxitocina en Uniject ITT (Indicador de Tiempo y Temperatura)
Reservorio Usar Usar Primero No Usar (Punto de eliminacion) No Usar (Sobrepasa punto de eliminacion) Válvula Parts of Uniject Reservoir size varies with drug or vaccine Valve prevents re-use Uniject is held by the port when giving an injection Needle size varies with drug or vaccine Needle shield keeps injection sterile until point of use. TTI TTI appears on each oxytocin in Uniject pouch. Check the TTI on the Uniject package to see if the inner square is lighter than the outside circle Discard the oxytocin-Uniject if the inner square is the same color or darker than the outside circle Puerto Aguja Tapa

37 Oxitocina en Uniject™: El valor en la prevención de la hemorragia post-parto
Beneficio Valor: escenario de uso en la comunidad Valor adicional: escenario de uso en la institución Facilidad de uso/simplicidad Potencial para extender la cobertura de oxitocina para prevención de la HPP en comunidades que no están siendo actualmente cubiertas Permite la expansión a tipos de proveedores que pueden administrar la dosis de prevención a las mujeres Permite el tratamiento inicia de manera rápida donde el tratamiento no esta disponible de otra manera Alta aceptabilidad contribuye a mayor adherencia al uso de MATEP e incrementa los estándares de calidad Ahorra tiempo en el trabajador de salud Elimina la dificultad en romper las ampollas Auto-descartable Elimina el reuso de agujas Pre-llenada Asegura la administración de dosis exacta Indicador de Tiempo y Temperatura (ITT) Asegura la calidad de oxitocina Single dose Prefilled Nonreusable Easy to use TM Uniject es una marca de BD. 1 Fuente: Piloto de Introducción de Oxitocina en Dispositivo Uniject™ Durante el Manejo Activo de la Tercera Etapa del Parto (MATEP) a Nivel Institucional en Guatemala.

38 Condiciones de almacenamiento de la oxitocina en general
Temperatura Actividad del medicamento 2- 8 °C Oxitocina se mantiene activa por 2 años 25 ° C Oxitocina se mantiene activa por máximo de 9 meses. Perdida de actividad depende de fluctuación de temperatura > 30 ° C Oxitocina se mantiene activa por un máximo de 3 meses. Perdida de actividad se acelera con aumento de temperatura Oxytocin is a heat sensitive medication. Storage requirements of oxytocin vary depending on the stability studies performed by the manufacturer. In general, the recommendation is to store oxytocin in a refrigerator when available to ensure it is effective for its intended shelf-life (usually 2 years). Oxytocin may be stored in a cool place (< 30°C) for a maximum of 3 months if a refrigerator is not available. If a refrigerator or ice box is not available, a Time Temperature Indicator (TTI) will indicate when the product has expired. Fuente: Use of uterotonic drugs for prevention and treatment of post-partum hemorraghe in tropical climates: Guidance for essential drugs and safe motherhood programs

39 Oxitocina en Uniject Estado Regulatorio
Registration information Approved: Honduras Guatemala Bolivia Paraguay Argentina India Application Planned or Pending: Mexico Dominican Repuublic Nicaragua Costa Rica Panama Colombia Ecuador Peru Chile Brazil Uruguay Mali Ghana Indonesia Producer information: BIOL (Argentina) Registered and marketed in Argentina Registered in Guatemala, Honduras and Paraguay, 9 additional Latin America registrations expected Actively working to develop markets in LAC Has started the WHO prequalification process Gland Pharma (India) Registered in India (but not on market) Contract manufacturer, competency in high volume low margin products Kalbe Pharma (Indonesia) Initiating stability studies in 2011 Indonesian registration expected in 2012 Gland Pharma (Actualmente produciendo) Kalbe Pharma (en estudios de estabilidad) Instituto Biológico Argentino (BIOL) (Actualmente produciendo) Aprobado Aplicación planeada o pendiente Fabricantes

40 Oxitocina en Uniject Experiencias Presentes y Pasadas
India: - Estudio de calidad en planeación - Estudio con OiU planeado Guatemala: Piloto de introducción en instituciones completado en Dic País considerando introducción a gran escala Honduras: Piloto de introducción en instituciones en proceso Piloto de introducción en comunidades planeado Nicaragua: - Piloto de introducción en instituciones en planeación. Mali: Piloto de introducción y evaluación en 2007 País considerando uso nacional Vietnam: - OiU administrada por matronas en 2005 - Gynuity tiene estudios planeados Ghana: - Muestreo de calidad completo - Estudio de seguridad y viabilidad en comunidades en proceso. - Estudio de almacenamiento planeado Indonesia: - Uso por matronas en - Muestreo de la calidad de oxitocina, estudio de habilidad de pago y estudios de estabilidad en proceso Angola: - Estudios de aceptabilidad y viabilidad en Argentina: - Piloto de introducción en 2009 - Preparación para precalificación de la OMS en proceso

41 Actividades en Desarrollo en Latino- America
Guatemala: Piloto de introducción en instituciones completado en Dic País ha incluido oxitocina in jeringa pre-llenada como parte de las guías nacionales para la atención de partos. País en proceso de toma de decisiones con respecto a introducción nacional. Nota: USP esta desarrollando un estudio de calidad de uterotonicos, incluyendo oxitocina. Resultados estarán disponibles en Agosto de 2011. Honduras: Piloto de introducción a nivel institucional en desarrollo Piloto de introducción para uso de oxitocina en Uniject por parteras tradicionales iniciara en Julio de 2011.

42 DMPA IM vs. depo-subQ en Uniject
Depo-subQ provera 104 DMPA IM 150 150 mg MPA Se aplica cada 3 meses Vial de vidrio con autobloqueo jeringa 1” aguja Inyección intramuscular Sitio: el tejido muscular profundo 99% eficacia de los anticonceptivos Depo-Provera marca: fabricado por Pfizer Equivalentes genéricos 104 mg MPA Se aplica cada 3 meses Precargada en el Uniject sistema de inyección 3/8” aguja Inyección subcutánea Sitio: la grasa subcutánea 99% eficacia de los anticonceptivos Pfizer producto: patente hasta el año 2020 Ningún otro fabricante Now we will introduce depo-subQ provera 104, which is a new formulation of the popular DMPA IM 150, also known by the Pfizer brand Depo-Provera. Depo subQ 104 will be available in Uniject. This slide shows the new product and compares it with the current standard 3-month progestin-only injectable contraceptive. DMPA 150 mg IM, or Depo-Provera, is packaged in a glass vial and delivered via intramuscular injection using a needle and syringe. One injection gives three months of safe and effective contraceptive protection. DMPA, or Depo-Provera, was developed by Upjohn in the early 1960s and approved for contraceptive use in the 1990s. In addition to Pfizer’s Depo-Provera brand, DMPA IM is also made by generic manufacturers in locations including South Africa, India, Thailand and Indonesia. The new formulation –depo-subQ provera 104—is also a Pfizer product. It is formulated with a lower dose of the active ingredient for delivery via subcutaneous injection using a smaller, shorter needle than the standard IM injection. The approved delivery sites are the subcutaneous fat of the abdomen or anterior thigh, and studies are in process now to assure that depo-subQ 104 is equally effective delivered in the fat of the back of the upper arm. Pfizer formulated depo-subQ provera 104 to be delivered in a prefilled format via subcutaneous injection. Pfizer is the only manufacturer producing depo-subQ provera 104 in Uniject. Depo-subQ in Uniject’s price has not yet been established. It is registered with the European regulatory authorities, and will be registerered in other countries starting in the middle of 2012. Standard actual Nueva opcion

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