First Workshop of the National Network of Laboratories...

First Workshop of the National Network of Laboratories

Bogota, Colombia September 1- 3, 2010

Trip Report Victor S. Pribluda, Ph.D.

Manager, Latin American Programs

Promoting the Quality of Medicines Program

Implemented by U.S. Pharmacopeia 12601 Twinbrook Parkway Rockville, MD 20852 USA

Tel: (+1) 301-816-8162 Fax: (+1) 301-816-8374

Email: [email protected]

Cooperative Agreement # GHS-A-00-09-00003-00 Sponsoring USAID Missions: USAID/Peru for Amazon Malaria Initiative Grantee: Promoting the Quality of Medicines (PQM) Program Author(s) Name: Victor S. Pribluda Language: English Date of Publication: October 6, 2010

This report is made possible by the generous support of the American people through the United States Agency for International Development (USAID), under Cooperative Agreement No. GHS-A-00-09-00003-00). The contents are the responsibility of the Promoting the Quality of Medicines Program, implemented by the U. S. Pharmacopeia, and do not necessarily reflect the views of USAID, PMI, or the United States Government.

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About PQM The Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for International

Development (USAID), is the successor of the Drug Quality and Information (DQI) program

implemented by the United States Pharmacopeia (USP). PQM is USAID‟s response to the growing

challenge posed by the proliferation of counterfeit and substandard medicines. By providing technical

leadership to developing countries, PQM helps build local capacity in medicine quality assurance

systems, increase the supply of quality medicines to priority USAID health programs, and ensure the

quality and safety of medicines globally. This document does not necessarily represent the views or

opinions of USAID or the United States Government. It may be reproduced if credit is given to PQM

and USP.

Abstract Victor Pribluda travelled to Bogota, Colombia to attend the Workshop of the National Network of

Laboratories on September 2-3, 2010. Additionally, Dr. Pribluda met with national stakeholders to

discuss updates in work plan activities for the Amazon Malaria Initiative (AMI).

Recommended Citation

Pribluda, V. First Workshop of the National Network of Laboratories. Bogota, Colombia; September 1-

3, 2010. Submitted to the U.S. Agency for International Development by the Promoting the Quality of

Medicines Program. Rockville, Maryland: United States Pharmacopeia.

Key Words

AMI, Database, Colombia, INVIMA, malaria, market surveillance, OMCL, NMCP, PQM, quality

control, quality assurance, Three-level approach, USP, National lab network.

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Table of Contents

Acknowledgements ...................................................................................................... 4

Acronyms ...................................................................................................................... 5

Background ................................................................................................................... 6

Purpose of Trip ............................................................................................................ 6

Source of Funding ........................................................................................................ 6

Overview of Activities and Conclusions ..................................................................... 6

Next Steps ..................................................................................................................... 8

Annex 1: Agenda ......................................................................................................... 9

Annex 2: Meeting Participants (Spanish) ................................................................ 12

Annex 3: Additional Meetings .................................................................................. 14

Annex 4: PQM Presentation ...................................................................................... 17

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ACKNOWLEDGEMENTS

The author would like to thank:

The „Subdirección de Medicamentos y Productos Biológicos‟ from INVIMA for their invitation

to participate in this meeting and workshop, in particular Dra. Martha Cecilia Rodríguez

Ramírez, Sub-directora, and Pablo Rincón, from the physical-chemistry laboratory.

The PQM administrative staff and editors for their assistance with logistical arrangements and

for editing the trip report.

The USAID/Colombia Mission, in particular Ms. Thea Villate.

Mr. Anthony Boni and Dr. Peg Marshal at USAID/Washington for their support and advice.

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ACRONYMS

AMI Amazon Malaria Initiative

COHAN Cooperativa de Hospitales de Antioquia

DQI Drug Quality and Information Program

FONADE Financial Fund for Project Development (for the acronym in Spanish)

INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia‟s MRA)

LAC Latin America and Caribbean

MCH Maternal Child Health

MPS Ministerio de la Protección Social (Colombia‟s Ministry of Health)

MRA Medicine Regulatory Authority

NMCP National Malaria Control Program

OMCL Official Medicines Control Laboratory

PAHO Pan American Health Organization

PQM Promoting the Quality of Medicines program

QA Quality Assurance

QC Quality Control

QMS Quality Management System

USAID United States Agency for International Development

USP United States Pharmacopeia

WHO World Health Organization

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Background Since 2002, the U.S. Agency for International Development (USAID) has supported U.S.

Pharmacopeia (USP) participation—first through the Drug Quality and Information (DQI) program and,

currently, through the Promoting the Quality of Medicines (PQM) program—in the Amazon Malaria

Initiative (AMI). Within the context of AMI, PQM has collaborated with the countries to strengthen

their Quality Assurance Systems. In Colombia, PQM has worked mainly in three areas: (a) Supporting

the National Malaria Control Program (NMCP) to establish Medicine Quality Monitoring (MQM)

activities in sentinel sites through the use of basic tests; (b) Developing a Manual of Procedures for the

Integral Management of the Supply of Malaria Medicines that integrates the three-level approach for

Quality Control (QC) throughout the supply chain; and (c) Strengthening testing capabilities and the

Quality Management System at the Official Medicine Control Laboratory (OMCL) at Instituto Nacional

de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia‟s Medicine Regulatory Authority

(MRA).

Besides the NMCP activities at sentinel sites, all MQM activities in Colombia are performed and

coordinated by INVIMA. In order to improve the interaction between INVIMA and the laboratories of

the National Network of Food Laboratories and to promote the creation of a National Network of

Quality Control Laboratories, the MRA organized a Workshop with the Departmental Public Health

Secretaries and Laboratories. The proposed National Network of Quality Control Laboratories aims to

support the MRA QA/QC activities at the national level and to establish MQM programs at the

departmental level. INVIMA invited PQM to attend and give a presentation at this meeting.

Purpose of Trip This primary objective of the trip was to participate in the meeting organized by INVIMA and introduce

the concept of Basic Tests and the Three-level approach for Quality Control to the representatives from

the Departmental Secretaries of Health.

Source of Funding This trip was supported with funds from USAID/Peru for the Amazon Malaria Initiative.

Overview of Activities and Conclusions The First Workshop of the National Network of Laboratories took place on September 2-3, 2010. See

Annex 1 for a detailed agenda and Annex 2 for a full list of participants. For details on additional

meetings with in-country partners, please see Annex 3.

The primary objectives of the Workshop were to improve the interaction between INVIMA and the

National Network of Food Laboratories and to promote the creation of a National Network of Medicines

Quality Control Laboratories. On September 2 (Day 1 of the meeting), activities and presentations were

related to the National Network of Food Laboratories, and PQM only attended the inauguration event.

PQM participated on September 3 (Day 2 of the meeting) when activities for the establishment of the

National Network of Quality Control Laboratories were discussed.

The presentations provided information on the following topics:

Framework of INVIMA‟s QC activities

Examples of other laboratory networks operating in Latin America

o Network of QC laboratories under the Pan-American Health Organization

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o Network in QC laboratories in Peru

Program to develop a National Network of Medicines QC Laboratories in Colombia

Basic tests and the three-level approach in medicine QC

Representatives of INVIMA and the Departmental Secretaries and Laboratories discussed their needs,

capabilities, and challenges in establishing local MQM programs. Many Departmental Health Offices do

not have the financial resources, personnel, and equipment to set up a lab. The departmental

representatives created a list of proposals and commitments to establish collaborations with INVIMA to

develop the laboratory network.

Highlights from the presentations (see Annex 4 for the PQM presentation) include:

1. Post-marketing surveillance of medicines

INVIMA is solely responsible for implementing MQM activities in the pharmaceutical market

These activities are performed within the “DeMuestra la Calidad de Medicamentos” Program

Quality assessments are made for medicines sampled from:

o Manufacturers and/or establishments holding marketing authorization

o Complaints or Adverse Reactions identified through the pharmacovigilance program

Sampling priority is given to:

o High demand medicines

o Medicines used in the “Plan Obligatorio de Salud” (Social Security Health Program)

Since 2004 there has been an increase in the number of API analyzed and a decrease in the non-

conformities encountered

MQM is coordinated with Departmental Secretaries of Health, which conduct most of the

sampling

INVIMA contracts the services of four university laboratories to support QC (Universidad

Nacional, Universidad del Atlántico, Universidad de Antioquía, and Universidad de Cartagena)

Samples failing QC tests are sent to INVIMA lab for confirmatory testing

INVIMA promotes the implementation of Good Storage Practices and performs routine

assessments at wholesalers and in storage facilities.

2. Establishing a National Network of Laboratories

Objectives of the network are:

o Increase countrywide QC capabilities through harmonized procedures and operations

o Support INVIMA QC programs

o Develop departmental QC proficiency and capabilities to decentralize MQM activities

o Provide inter-laboratory assistance

Participating laboratories have been identified through documentary review and on-site visits

Some laboratories already received training in physical-chemistry and microbiology

methodologies

11 Departmental laboratories that have analytical capabilities have been prioritized to

participate in the network

INVIMA will act as the network coordinator (National Reference Laboratory or “NRL”) and

the network will eventually include all the Public Health Laboratories actively participating

in coordinated MQM activities

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Laboratories lacking capabilities to perform compendia/validated methodologies will

perform Physical and Visual Inspection and Basic Tests (Thin Layer Chromatography or

“TLC” and Disintegration)

3. Utilizing the three-level approach for Quality Control

The PQM presentation focused on the effectiveness of basic tests (TLC and Disintegration) to assess

certain critical quality attributes and the implementation of the three-level approach as a viable and

useful alternative for laboratories lacking full QC capabilities. The main points discussed were:

Advantages of utilizing Global Pharma Health Fund Minilabs® to perform basic tests

o All required lab equipment included

o Provides methodologies and reference standards for numerous medicines included in

WHO Model List of Essential Medicines

Emphasis on the need to coordinate activities with the NRL

Possibility to develop new basic tests depending on country‟s needs

Implementation of the three-level approach to support QC activities throughout the supply

chain, from procurement to use

o Level 1: Visual and Physical Inspection

o Level 2: Basic Tests

o Level 3: Compendial/validated methods

4. Workshop discussions

During the workshop the attending representatives of the Secretaries of Health and

Laboratories prepared a summary of the capabilities, needs, and challenges they face to

implement MQM activities in their corresponding departments

o Representatives were requested to create a list of follow-up commitments to be submitted

to the Sub-department of Medicines and Biological Products of INVIMA (Subdirección

de Medicamentos y Productos Biológicos)

The director of the Sub-department of Medicines and Biological Products requested from the

Departmental Secretaries of Health a detailed list of their needs to support monitoring

activities. Based on those, financial support is requested from the Ministry of Health

(Ministerio de la Protección Social or “MPS”)

Representatives from Departmental Secretaries of Health expressed great interest in

implementing the three-level approach to support MQM activities.

o Some departments lacking qualified personnel, lab equipment, or the capability to

purchase Minilabs® indicated their willingness to start implementing at least Visual and

Physical Inspection (Level 1)

A proposal will be submitted by INVIMA to the MPS requesting support for the

establishment of the National Network of Laboratories.

Next Steps INVIMA and the Departmental Laboratories will follow-up with PQM for additional technical support

on the use of Minilabs® for performing basic tests and the implementation of the three-level approach

for MQM activities.

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Annex 1

AGENDA

1er SEMINARIO-TALLER DE LA RED NACIONAL DE LABORATORIOS SEPTIEMBRE 2 Y 3 DE 2010

“OPERATIVIZACION DE LA RED NACIONAL DE LABORATORIOS DE ALIMENTOS Y CONFORMACION DE LA RED DE LABORATORIOS DE CONTROL DE CALIDAD A MEDICAMENTOS EN EL MARCO DE LA

VIGILANCIA SANITARIA DEL PAÍS”

OBJETIVO GENERAL: Mejorar la interacción entre el INVIMA y los laboratorios de la Red Nacional de Laboratorios de Alimentos y promover por la conformación de la Red Nacional de Laboratorios de Control de Calidad a Medicamentos. OBJETIVOS ESPECIFICOS:

◘ Coordinar con los laboratorios de la Red de Alimentos, las actividades a desarrollar para el fortalecimiento de la capacidad operativa de los laboratorios de la Red.

◘ Establecer canales de comunicación efectivos para asegurar una respuesta oportuna frente a las necesidades de IVC, vigilancia epidemiológica y capacidad de respuesta de los LSP.

◘ Promover la conformación de la Red de Laboratorios de Análisis de Calidad de Medicamentos. ◘ Sensibilizar a los LSP en normatividad, políticas, necesidades nacionales entre otros. ◘ Generar estrategias conjuntas para aplicar en las Secretarías de Salud Departamentales y del

Distrito y en la coordinación de la red en su jurisdicción, entorno a la vigilancia sanitaria para el mejoramiento de acciones en el ámbito de Alimentos y Medicamentos.

Participantes: Secretarios de Salud Departamentales y del Distrito Coordinadores de IVC Coordinadores de Laboratorios de Salud Pública Departamentales y del Distrito. Organiza: Subdirección de Alimentos y Bebidas Alcohólicas Subdirección de Medicamentos y Productos Biológicos. Colaboradores: Organización Panamericana de la Salud - OPS United States Pharmacopeia - USP Ministerio de la Protección Social- MPS Metodologías a desarrollarse en la reunión Charlas magistrales Talleres grupales Plenarias abiertas

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CONTENIDO DÍA 1

SUBDIRECCIÓN DE ALIMENTOS Y BEBIDAS ALCOHÓLICAS

Hora Tema Responsable

7:30-8.00 Inscripción de participantes Equipo logística

8.00-8.45

Instalación del evento / Palabras de bienvenida por los integrantes de la mesa directiva

Dr. Jairo Céspedes Camacho Director INVIMA Dr. Lenis Urquijo, Director General de Salud Pública Dra. Ana Cristina Nogueira- Representante OPS- Colombia Dra. Laura Pasculli- Subdirectora de Alimentos y Bebidas Alcohólicas. Dra. Martha Rodriguez- Subdirectora de Medicamentos y Productos Biológicos. Dra. Patricia Botero Arias Coordinadora General SABA

8:45–9:15

LABORATORIO NACIONAL DE REFERENCIA

Dra. Laura Pasculli Henao Subdirectora Alimentos y Bebidas Alcohólicas

9:15-10:00

Laboratorios de Alimentos como apoyo al Sistema Nacional de Vigilancia Sanitaria

Elizabeth Jiménez Laverde. Coordinadora Grupo de Laboratorios de Alimentos y Bebidas Alcohólicas

10:00-10:15 Receso café 10:15-11:00 Estructura de la Red Colombiana de

Metrología

Dra. Olga Lucía Pesca- Min. Comercio

11.00-11.20 Canales de Comunicación con el LNR-INVIMA Mercedes Vargas Coord. Lab. Microbiología.

11:20-11:40 Interacción de las actividades de IVC con el LNR y LSP

Myriam Rivera Coord. Lab. Fisicoquímico.

11:40-12:00 Necesidad de implementación de un SGC en los laboratorios de la Red.

Lynda Prieto Coordinadora de Calidad Laboratorios INVIMA

12.00-12:15 Sesión de preguntas SABA

12:15-1:30: Almuerzo 1:30- 3:30 Mesas de trabajo – Fortalecimiento de la

Vigilancia Sanitaria- Levantamiento de necesidades.

Grupo de Laboratorios de Alimentos- Grupo de Vigilancia Epidemiológica SABA

3:30-3:45 Receso café 3:45-5:30 Resultados relatorías- Establecimiento de

Compromisos con las DTS.

Subdirectoras y Coordinadoras Laboratorios

5:30-6:00 Cierre del día

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CONTENIDO DÍA 2

SUBDIRECCION DE MEDICAMENTOS Y PRODUCTOS BIOLOGICOS

Hora Tema Responsable 8:00-8:45 Situación de la Vigilancia de Medicamentos en

Colombia.

Dra. Martha Cecilia Rodríguez Ramírez Subdirectora de Medicamentos y Productos Biológicos

8:45-9:15 Red Panamericana de Laboratorios oficiales de control de calidad de medicamentos en las Américas.

José María Parisi OPS, Oficina Central Washington D.C.

9:15 – 9:45 Experiencia de la red de laboratorios de control de calidad de medicamentos en Perú.

Lic. Ofelia Villalba CNCC Perú

9:45- 10:00 Receso - café

10:00-10:30 Propuesta de conformación de la Red de Control de Calidad a Medicamentos.

Efrén Bohórquez Coordinador Laboratorio de Fisicoquímico de Medicamentos

10:30-10:45 Sesión de preguntas- Plenaria

10:45-11:10 Proceso para la toma y recepción de muestras. Pablo Rincón Laboratorio Fisicoquímico de Medicamentos.

11:10-11:45 Pruebas Básicas para Control de Calidad de Medicamentos y Enfoque de Tres Niveles para el Control de Calidad

Víctor Pribluda- USP

11:45-12:00 Sesión de preguntas- Plenaria

12.00-1:30 Almuerzo 1:30-3:30 Taller- Red de Laboratorios de Análisis de Control

de Calidad a Medicamentos

Grupo de Laboratorios de Medicamentos

3:30-3:45 Receso - café

3:30- 5.15 Consolidación y aprobación de propuestas y Compromisos - Cierre del Evento

Subdirectoras Coordinadoras de Laboratorios-Secretarios de Salud- LSP.

5:15-5:30 Entrega de materiales y certificaciones Equipo logística

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Annex 2

Lista de Participantes

1er SEMINARIO-TALLER DE LA RED NACIONAL DE LABORATORIOS SEPTIEMBRE 2 Y 3 DE 2010

DEPARTAMENTO PARTICIPANTE

CARGO

Amazonas LUZ MILA MURCIA Coordinador LSP

Antioquia

SUSANA PATRICIA RENDÓN IVC Medicamentos

MARIA EUGENIA GÓMEZ Coordinador LSP

IVÁN DE ZEA IVC Medicamentos

Arauca ALIX ROBINSON Coordinadora LSP

Atlántico

MARLEN GUERRA Coordinador LSP

AILEN MOLINA Coordinadora LSP Ambiente

LUIS POSSO BENITEZ Delegado Secretaria de Salud

Bogotá D.C.

HELBERT VERA Coordinador LSP

MARIA CRISTINA PRIETO

IGNACIA ESPINOZA

Bolívar MARLY JERES ARIAS

Boyacá

MABEL MEDINA ALFONSO Coordinadora LSP

LUIS ANTONIO MUÑOZ

CLEMENCIA SIERRA MAYORGA Medicamentos

SARA BACARES NIÑO Medicamentos

CLAUDIA NOPE RODRIGUEZ

Caldas

Caquetá LUIS ANCISAR CADENA CARVAJAL Supervisor droguerías

MARIA CARMEN PINZÓN Coordinador LSP

Cauca VICTORIA ELJACH Coordinador LSP

Cesar INGRID PINO Prof. Microbióloga

MARIA TERESA ARIAS Coordinador LSP

Choco

NARCO ANTONIO MARTINEZ Director Salud Pública

JOSE RENTERIA PALACIO Riesgo Ambiental

MARTHA RENTERIA BEJARANO Lab. Micro alimentos

Córdoba RUBY HERNÁNDEZ Coordinador LSP

MARIA DEL ROSARIO DOMINGUEZ Coordinador IVC

Cundinamarca

GLORIA FUERTES

FLOR ALBA MARTINEZ

ANA LIDA MORENO

DENIS NORBERTO HERANANDEZ

Guainia YOSMAR CRISTINA SANCHEZ Coordinador LSP

Guaviare DIANA CEDEÑO Profesional LSP alimentos

Huila LUIS ALBERTO MORA Alimentos

MARIA CONSUELO ANGARITA Coordinador Salud pública

Guajira ETHEL MENDOZA Coordinador LSP

JOSUÉ FONSECA

Magdalena MARCO DONADO BARROS Coordinador LSP

Meta

Nariño

MARTHA CECILIA PAZ Ingeniera de alimentos

NORA ESPINOZA DELGADO Delegado Secretaria de Salud

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LILIANA PATIÑO Coordinador LSP

Norte de Santander JOSE URIBE NAVARRO Coordinador salud ambiental

GLADIS MORA LEAL Coordinador LSP

Putumayo

YESNED ROJAS Profesional LSP

SANDRA RODRIGUEZ

MAYER PEÑA Delegado Secretaria

Quindío GLORIA PATRICIA LONDOÑO ZULUAGA Coordinador LSP

LILIANA VALDES MEJIA Director seccional de salud

Risaralda JAIRO OROZCO HINCAPIE Director operativo SP

GLORIA PATRICIA URREGO Microbiología de alimentos

San Andrés KITEL WILSON POWEL Coordinador LSP

Santander LEONOR CHACON DE MENDIETA Coordinador LSP

Sucre NAYIB CARRILLO Coordinador LSP

ROCIO PEREZ Coordinador IVC

Tolima ISRAEL PEREZ RAMÍREZ Coordinador zoonosis

AXEL LOMBARDO RAMÍREZ Coordinador LSP

BERMANIS BECERRA IMITOLA Ingeniera de alimentos

HERMES SALAMANCA

Valle del Cauca MARIA BEATRIZ OLAYA Coordinador LSP

Vaupes DIANA MARIA GOMEZ Coordinador seguridad sanitaria

ALEXANDER CONTRERAS Coordinador LSP

Vichada ZAMIR ENRIQUE ZAMORA LSP y delegada

ENTIDAD PARTICIPANTE

CARGO

USP VICTOR PRIBLUDA

OPS JOSE MARIA PARISSI

Lab. Medicamentos

Perú

OFELIA VILLALBA

Ministerio

SANDRA LILIANA FUENTES

DANIEL RUBIO

JANETH SOLANO

Instituto Nacional de Salud

MARTHA CECILIA RUIZ

ANGELA CORONADO

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Annex 3

Bogota Visit: Additional Meetings

Meetings with INVIMA and the Ministry of Health (Ministerio de la Protección Social - MPS)

Objectives:

1. Update authorities on the preliminary results of a study assessing the availability of malaria

medicines in the private and informal sector in the Departments of Antioquia, Chocó, and Córdoba.

The study is being performed in collaboration with the Cooperativa de Hospitales de Antioquia

(COHAN)

2. Discuss development of PQM Medicine Quality Database (MQDB)

These topics were discussed at two separate meetings:

September 1, at INVIMA headquarters

Participants:

Dr. Jairo Céspedes: General Director

Dra. Clara Isabel Rodriguez Serrano: Sub-director of Registration

Dra. Martha Cecilia Rodríguez Ramírez: Sub-director of Medicines and Biological Products

Dr. Rodolfo Burgos: Counselor to the General Director

Dr. Victor Pribluda: PQM

September 3, at the MPS

Participants:

Dr. Lennis Urquijo: Director of Public Health at the MPS

Dr. Julio Padilla: Coordinator of the National Malaria at the MPS

Ms. Janeth Solano: Pharmacist at the MPS

Dr. Victor Pribluda: PQM

Meeting Proceedings and Conclusions 1. PQM presented a summary of the study performed in Antioquia, Chocó, and Córdoba, highlighting

the following findings:

High prevalence of malaria medicines in the private and informal sector in the three

departments

Numerous private and informal sector facilities were identified in the vicinity of local Public

Health facilities (less than 1000 meters)

Several different APIs identified

Some of the medicines are not within the national therapeutic guidelines

Medicines identified with no approved registration and expired registration

Many facilities have deficient storage conditions (lacking proper control of temperature and

humidity and direct exposure to sunlight)

Prices are significantly higher than those paid by the MPS during procurement

Health authorities at INVIMA and the MPS were extremely interested and worried by the results,

and requested a copy of the final report of the study. They expressed that since malaria medicines

are provided to the population free of charge, the prevalence of medicines that escape regulatory

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control represents a serious risk to the population and calls for immediate corrective actions to

address these findings.

PQM informed the health authorities about the second phase of this study which will include

sampling and QC of medicines in these sectors.

The final report of the study will be sent to the meeting participants and also to the Viceministro de

Salud y Bienestar, Dra. Beatriz Londoño Soto.

2. Development of PQM Medicine Quality Database (MQDB)

PQM provided a summary of the database that has been developed and the possibility of including

MQM results obtained in Colombia. A practical demonstration of MQDB with the actual database

was not possible due to the inability of connecting an outside computer to the institutions‟ internet

access network. INVIMA and MPS representatives requested more information on the MQDB.

Authorization to include Colombia‟s data in the database should be requested from the

Viceministro de Salud y Bienestar, Dra. Betariz Londoño Soto.

Next Steps

PQM will share the final study report on the availability of malaria medicines in the private and

informal sector with authorities at INVIMA and the MPS

PQM will update INVIMA and the MPS on the development of the second stage of the study to

assess the quality of medicines sampled at the private and informal sector

PQM will provide additional information to INVIMA and the MPS on the MQDB and

requirements to include country‟s data before the public launching of the MQDB.

B) Meeting with USAID/Colombia

Objective: Update USAID representative on PQM activities in Colombia

Date: September 2, 2010

Participants: Lic. Thea Villate Bocconello, Development Assistance Specialist/IDP

(USAID/Colombia), Dr. Victor Pribluda (PQM)

Meeting Proceedings and Conclusions Since the USAID representative was not familiar with PQM, Victor Pribluda provided a brief summary

of the program and its objectives. A more extensive presentation followed describing the various

programs in which PQM participates in Latin America and the Caribbean (LAC), particularly AMI

through which PQM collaborates with various in-country partners in Colombia. The assistance to the

INVIMA lab and other activities performed in the past in Colombia were discussed, with particular

emphasis on the results of sentinel site MQM activities and the ongoing study in the private and

informal sector.

Finally, PQM briefed USAID on the purpose of the current visit and future activities with the INVIMA

lab programmed for this year.

USAID/Colombia thanked PQM for the update and asked to receive additional information on past

activities as well as updates regarding current and future activities.

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Next Steps

PQM will send information on past and current activities in Colombia.

PQM will send a copy of the final report from the study on the availability of malaria

medicines in the private and informal sector.

PQM will provide frequent updates to USAID/Colombia on activities and results generated

through PQM collaborations with in-country partners.

C) Meeting with a representative of the Financial Fund for Project Development (FONADE)

Objective: Provide technical information on GPHF Minilabs®

Date: September 2, 2010

Participants: Andrés Oyola (FONADE), Dr. Victor Pribluda (PQM)

FONADE is a state development agency that collaborates with all Colombian ministries in executing

projects. The purchase of a number of Minilabs® to support the National Network of Quality Control

Laboratories will be done through Global Fund financing, and FONADE is an in-country partner for

the Global Fund.

PQM summarized its experience with Minilabs® in MQM activities and provided technical

information on their capabilities as well as the purchasing and delivery processes.

FONADE thanked PQM for the information, and PQM volunteered to provide additional assistance if

required.


Pruebas Básicas y Enfoque de Tres Niveles para Control de Calidad

Víctor S. Pribluda, Ph.D. Programa de Promoción de la Calidad de Medicamentos

Farmacopea de los Estados Unidos de América

1er Seminario-Taller de la Red Nacional de Laboratorios

Bogotá, Colombia 2–3 Septiembre 2010

msm

Text Box

ANNEX 4


Resumen de la Presentación

Calidad de Medicamentos y uso de GPHF Minilab®

Pruebas Básicas

Enfoque de Tres Niveles para Control de Calidad


Farmacopeas reconocidas internacionalmente

BP, EP, IP, JP y USP

Farmacopeas oficiales nacionales

Metodología del fabricante

La calidad de los medicamentos se evalúa

en base a estándares establecidos por:

Calidad de Medicamentos


Atributos Críticos de Calidad:

Etiquetado y Envase

Identidad

Ensayo/Valoración

Desintegración

Impurezas

Disolución

Uniformidad

Esterilidad



Sub-estándard

Producto de marca o genérico que no cumple con los estándares oficiales correspondientes a identidad, pureza, contenido, envase y/o etiquetado, entre otros atributos

Falsificado (counterfeit)

Medicamento que de un modo deliberado provee información incorrecta de identidad, contenido y/u origen



Minilab® de GPHF

Una herramienta complementaria para el control de calidad


Inspección Visual y Física

Pruebas Básicas

Desintegración:

• Proceso físico necesario para la disolución

Cromatografía de Capa Delgada (CCD, TLC)

• Identificación del Ingrediente FarmacéuticoActivo (IFA)

• Presencia de Impurezas

• Evaluación Semi-cuantitativa del Contenido(rango de 20%)

Metodología del Minilab®


Holograma original de artesunato de Guilin Pharmaceutical Co.

Artesunato 50 mg 002-03 PVH lote 000902 de “Guilin Pharmaceutical Co.”



Falsificación “Perfecta” de Lamivudine (Hong Kong 2000)


Falsificado Verdadero


Desintegración


Artesunato

No contiene IFA

Cromatografía de Capa Delgada

Fácil de Interpretar y Reproducible



Sulfato de Quinina

No contiene IFA



Impureza (Artesunato)

Contenido Bajo(Artemeter)




Portátil

Capacidad de Identificar Medicamentos Sub-estándar y Falsificados

Fácil de:

Usar

Interpretar

Capacidad de Analizar:

55 Medicamentos de la Lista Modelo deMedicamentos Esenciales de la OMS

Varias Muestras Simultáneamente

Resultados Reproducibles

Bajo Costo de Análisis y Mantenimiento

Características del Minilab®


Antimicrobials (16) Antimalarials (13) Anti-TB medicines (8)

Amoxicillin

Ampicillin

Cefalexin

Cefixime

Cefuroxime

Chloramphenicol

Ciprofloxacin

Cloxacillin

Erythromycin

Levofloxacin

Metronidazole

Moxifloxacin

Phenoxymethylpenicillin

Sulfamethoxazole

Tetracycline

Trimethoprim

Amodiaquine

Artemether

Artesunate

Atovaquone

Chloroquine

Halofantrine

Lumefantrine

Mefloquine

Primaquine

Proguanil

Pyrimethamine

Quinine

Sulfadoxine

Ciprofloxacin

Ethambutol

Isoniazid

Levofloxacin

Moxifloxacin

Prothionamide

Pyrazinamide

RifampicinNon

Antinfectives (7)

Acetylsalicylic acid AminophyllineFurosemideGlibenclamideParacetamolPrednisoloneSalbutamol

Antifungals (1) Anthelminthics (3)

Griseofulvin Albendazole

Mebendazole

Praziquantel

Estándares del Minilab®

Antiretrovirals (7)

Didanosine

Indinavir

Lamivudine

Nevirapine

Oseltamivir

Stavudine

Zidovudine



Etiquetado y Envase

Identidad

Ensayo/Valoración

Desintegración

Impurezas

Disolución

Uniformidad

Esterilidad

Pruebas Básicas y Atributos Críticos de Calidad

PB


Porcentaje de no-conformidades en 325 muestras de un total de 771 medicamentos sub-estandard provenientes de una base de datos de la OMS recopilada entre 1982-

1999. Incluye antibioticos, antimalaricos y antituberculosos de múltiples paises

Más del 76% de medicamentos

no-conformes podrían haber sido identificados por

una prueba básica de CCD

No Contiene IFA

60%

IngredienteCorrecto

7%

17%

ContenidoIncorrecto

Ingrediente Incorrecto

16%

¿Cuán Efectivas son las Pruebas Básicas?


MiniLab: Análisis no-compendial

Laboratorio portátil y descentralizado

Equipo de bajo costo

Recursos humanos no especializados

Procesamiento corto de resultados

Análisis simples

Costo bajo de análisis

Análisis compendial

Laboratorio centralizado

Equipo costoso

Recursos humanos especializados

Procesamiento largo de resultados

Análisis complejos

Costo alto de análisis

LOCM:

Minilab® vs. LOCM

Pruebas de Verificación y

Confirmatorias


Lecciones Aprendidas en el uso de Minilab®

¿Quién administra el uso de los Minilab®?

Programas Nacionales

ARM

Entidades a Cargo de Adquisición

LOCM

Coordinación para implementación de medidas correctivas

Coordinación con LOCM es crítica

Capacitación continua de personal

Pruebas de verificación/confirmatorias



Etiquetado y Envase

Identidad

Ensayo/Valoración

Desintegración

Impurezas

Disolución

Uniformidad

Esterilidad

Tres Niveles de Control de Calidad para Evaluar Atributos Críticos

N1: IVF

N2: PB

N3: PC


NivelTipo de

AnálisisTipo de Pruebas Objetivo

Personalresponsable de

efectuar el análisis

1Inspección

Visual y Física

Visual:-Propiedades delinserto y embalajeFísica:- Aspecto, condicionesy características físicas del medicamento

Identificar- Medicamentos vencidos- Información insuficiente,

errónea y/o fraudulenta- Envase dañado - Daños y/o alteraciones

del medicamento

Personal en cada etapa de la cadena de suministro, desde la adquisición hasta el uso, a nivel local y/ocentral.

2Pruebas Básicas

- Desintegración- Cromatografía de Capa Delgada

Evaluar cuatro atributos críticos de calidad- Identidad- Contenido- Impurezas - Desintegración

- Personal entrenado en Pruebas Básicas- Personal del LOCM

3Pruebas

Compendialeso Validadas

De acuerdo a las especificaciones del registro

Evaluar todos los atributos críticos de calidad

Personal del LOCM

Enfoque de Tres Niveles para Control

de Calidad


Evaluación Pre-Licencia de

Comercialización

Registro

Evaluación Post-Licencia de Comercialización

Adquisición

N1, N2, N3

Licitaciones Donaciones

Otros procesos de adquisición

Cadena de Distribución

TransporteAlmacenamiento

Centros de Dispensación

Uso

N1

Enfoque de Tres Niveles

en el Marco de Aseguramiento de Calidad

N1, N2, N3N1, N3


A - Medicamentos con historia previa de buena calidad producidos por fabricantes confiables

Licitaciones Donaciones

Otros procesos de adquisición

Muestras No-conformes y Subconjunto de Muestras

Conformes

N1

N3N2

Muestreo

N3

A

B


Adquisición

B - 1: Falta de información de historia previa de calidad del medicamento. 2: Medicamentos

considerados de riesgo debido a historia previa del fabricante o a atributos del producto.



Cadena de Distribución

AlmacenamientoProlongado y Centros

de Dispensación

Muestras No-conformes y

Subconjunto de Muestras ConformesMuestreo

N1 y N2 N2 y/o N3

Muestreo

MuestrasDañadas / No-

ConformesTransporte y Alamcenamiento

CortoN1 N2 y/o N3


Etapa con Requerimiento de

Monitoreo de Calidad

Adquisición Responsable Adquisición

MiniLab & LOCM

Registro

Almacenamiento Central

Transporte

Nivel de Monitoreo

Nivel 1 & 3

Nivel 1 & 2 ó 3

Nivel 1 & 2

Nivel 1

Ente Responsible

Instrumento

ARM

LOCM

Responsable Almacenamiento

MiniLab

Responsable Transporte

Programa Nacional/ARM

MiniLab & LOCMAlmacenamiento Periférico

Dispensación Nivel 1 & 2 ó 3


¿Dónde, Quién y Cómo?


2 Fases con Pocos Resultados No-conformes: Pre-distribución, N = 100 Muestras

10%

Pasan

N = 8

100%

Fallan

N = 10

100%

Dudosas

N = 10

Tipo de Análisis: MiniLab® - Inspección V/F (N1) & Pruebas Básicas (N2)

Sitio de Análisis: Depósito Central / Laboratorio Nacional

Muestras Analizadas: 100% (N = 100)

Resultados: 80 pasan, 10 fallan, y 10 dudosas

Communicar

Resultados

Identificar

Acciones

Correctivas

Implementar

Acciones

Correctivas

Tipo de Análisis: Pruebas Confirmatorias – Inspección V/F (N1)

& Análisis Compendial (N3)

Sitio de Análisis: Laboratorio Nacional


Resultados: 18 pasan y 10 fallan


3 Fases con Muchos Resultados No-conformes Mercado Periférico, N = 100 Muestras

10%

Pasan

N = 4

100%

Fallan

N = 50

100%

Dudosas

N = 10

Tipo de Análisis: MiniLab® - Inspección V/F (N1) & Pruebas Básicas (N2)

Sitio de Análisis: Sitio Centinela



Communicar

Resultados

Identificar

Acciones

Correctivas

Implementar

Acciones

Correctivas

Tipo de Análisis: Pruebas Confirmatorias – Inspección V/F (N1) & Análisis Compendial (N3)



Resultados: 3 pasan y 7 fallan

Tipo de Análisis: Pruebas de Verificación – Inspección V/F (N1) & Pruebas Básicas (N2)




10%

Pasan

N = 1

100%

Fallan

N = 5

100%

Dudosas

N = 4


El enfoque de tres niveles permite

De un modo eficiente

Rápido

En ámbitos diversos

Identificar problemas de calidad

Para una gama amplia de medicamentos

En diferentes etapas de la cadena de suministro

En actividades de vigilancia del mercado

Expandiendo el alcance de las actividades de monitoreo de calidad y reduciendo la carga impuesta al LOCM

Enfoque de Tres Niveles para Control de Calidad Conclusiones


Fabricación

Venta al por mayor

Farmacia

Falsificación


¿Preguntas?


Muchas Gracias

This presentation is made possible by the generous support of the American people through the United States Agency for International Development (USAID), under Cooperative Agreement number GHS-A-00-09-00003-00. The contents are the responsibility of the U. S. Pharmacopoeia Promoting the Quality of Medicines Program and do not necessarily reflect the views of the United States Government.

Víctor S. Pribluda

Gestor de Programas en America Latina

Programa de Promoción de Calidad de Medicamentos

Email: [email protected]

Phone: 1+ 301-816-8258

First Workshop of the National Network of Laboratories...

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