Anti-Malaria Drug Policy Philippines Workshop on Anti-Malarial Drug Policy Implementation Review Wuxi City, Jiangsu Provincial Institute of Parasitic Diseases, P.R. China September 12 – 22, 2005

GEOGRAPHICAL DISTRIBUTION OF MALARIA PHILIPPINES ( Based on 10-year Average, 1991 – 2000 ) Category A Provinces 25 Provinces more than 1000 cases/year or situation worsened Category B Provinces 22 Provinces 100 to < 1000 cases/year or situation has improved in the last 5 yrs Category C Provinces 18 Provinces less than 100 cases/year Category D Provinces 13 provinces Malaria-free (no more indigenous cases for at least 3 years Source: Malaria Control Program, 2000 Department of Health

Purpose of Phil. Anti-malarial Drug Policy The Primary Purpose . . . to ensure prompt, effective and safe treatment of malarial disease through the selection of optimal regimen for different clinical situations. This is one of the basic technical elements of the WHO Global Malaria Control Strategy.

Anti-malarial Drug Policy The National Anti-malarial Drug Policy is the set of recommendations and regulations concerning anti-malarial drugs and their utilization in a country. It is part of the National Malarial Control Program Policy.

New National Policy on Diagnosis and Chemotherapy for Malaria DOH Administrative Order No. 129 - A S.2002 23 August 2002

Malaria Drug Policy (DOH Administrative Order No Malaria Drug Policy (DOH Administrative Order No.129-A) MCP-DOH Date: August 23, 2002 “Previous” Drug Policy 1st line: Chloroquine 2nd line: Sulfadoxine-Pyrimethamine (SP) 3rd line: Quinine + Primaquine New Drug Policy 1st line: CQ+SP 2nd line: Artemether + lumefantrine [Coartem™ ] 3rd line: Quinine + anti- biotic (Tetracycline, clinda, doxy, erythro) + Primaquine

Basis for Changing treatment policy DRUG TREATMENT FAILURE RATES in the Philippines, 2000 Treatment Failure Rate CQ >>> 25% SP > 25% < 5% 6- 15% 16 - 24% > 25% (MCS, 1996-1997; Preliminary Report ENHR, 2000; ADS-MCP, 1997-2000; WHO-RBM, 2000-2001)

Chloroquine (CQ) and Sulfadoxine-Pyrimethamine (SP) Drug Profile in Selected Study Sites, Philippines Kal-Apayao (2000) CQ > 42% Tx F SP > 9% Tx F Palawan (1994-2000) CQ 39-76% Tx F SP 12.5-20% TxF Davao N-ComVal (2000) Agusan del Sur (97-01) CQ > 50% Tx F SP > 43% Tx F

This high treatment failure rates provide a very strong evidence for the DOH to immediately review & change existing anti-malarial drug policy in the country. Combination therapy becomes a more viable alternative in improving efficacy of available drugs.

Espino et al, 2001. Preliminary report, WHO/RBM-ADS/MCP Combination CQ+SP vs Coartem™ , Agusan del Sur and Compostela Valley, Philippines, 2001 - therapeutic efficacy surveillance done in small population to predict outcome of treatment in known drug resistant areas Study Site Drugs N 28-day Tx F Cure Rate ADS CQ+SP 39 36 4 89% (32/36) SP 35 32 17 47% (15/35) Laac, CV CQ+SP 40 38 7 82% (31/38) Coartem 40 36 0 100% Espino et al, 2001. Preliminary report, WHO/RBM-ADS/MCP

Malaria Drug Policy (A.O.129-A) MCP-DOH 100% efficacy of A-L combination, however restricted to be used as 2nd line drug bec. of: limited findings of its safety for very young children, pregnant women & breastfeeding mothers. Inadequate capability of the current health infrastructure in many endemic areas to provide confirmatory diagnosis. DOH: more time to explore & further study the use of artemisinin-based combinations before it is adopted as 1st line drug

Malaria Drug Policy (A.O.129-A) MCP-DOH Provides policies & guidelines for diagnosis and combination chemotherapy for malaria Objective: Further reduce the development of drug resistance & ultimately towards reducing morbidity & transmission & preventing complications & malaria deaths

Malaria Drug Policy (A.O.129-A) MCP-DOH Coverage: All government (national and local) and private health facilities nationwide

Malaria Drug Policy (A.O.129-A) MCP-DOH Implementation: To be implemented in phases Why? - NMCP to manage the increase in cost of diagnosis & treatment - Centers for Health Development (15 Regional Health Offices) to strengthen & expand its capacity for implementation

Malaria Drug Policy (A.O.129-A) MCP-DOH Implementation: Priority 1: - Project sites where capacity building for drug policy implementation has already been carried out/underway - Malaria microscopy centers at the Rural Health Units are already established/upgraded Priority 2: Category A provinces (GFATM-MC) Priority 3: Category B provinces Priority 4: all other endemic provinces

Components of Phil. Malaria Control Program Drug Policy • Anti-malarial drug list according to use & guidelines for drug use - Combination treatment for P. falciparum malaria uncomplicated: 1st line: CQ+SP 2nd line: Artemether-Lumefantrine 3rd line: Quinine + T/D severe: QN + T/D/Clinda + Primaquine (single dose) - Tx for P. vivax malaria (CQ + Prima) - Tx for mixed infection (CQ+SP+Prima) - Tx for pregnant women & children <1 y.o. (QN) - chemoprophylaxis (Doxy/mefloquine)

Components of Phil. Malaria Control Program Drug Policy • Diagnosis (laboratory confirmation – Microscopy/RDT) - QA/AS – microscopy pilot-test - QA/AS – RDT (future plan) • Regulations for treatment & provision of drugs - all probable & confirmed malaria using 1st line – administered by trained field health workers - Tx of P. falciparum & severe/complicated malaria using A-L & QN+T/D – only dispensed by a physician/PHN upon lab. confirmation - supervised Tx (ST) shall be adopted - referral of patients (i.e. indications of severe malaria, pregnant women, children < 5 y.o.) using the existing referral system

Components of Phil. Malaria Control Program Drug Policy - Tx in outbreaks emergency situation: P. falciparum: A-L, + prima (ensure rapid cure w/ lowest risk of Tx failure P. vivax: CQ + prima • Support Systems: - Health Human Resource Dev’t: Re-training of health personnel - Logistics Mgt. System (ensure continuous supply of drugs, lab. supplies, under/over-stocking, drug expiration, etc) a) provision of 1st line drugs & lab. supplies – shared responsibility of DOH-Centers for Health Devt & Local Govt Units b) Sourcing out of funds & provision of 2nd & 3rd line drugs: Central Office, DOH c )Distribution mechanism – to ensure proper allocation & availability of drugs, supplies

Components of Phil. Malaria Control Program Drug Policy - Reporting & Surveillance System • Roles & Responsibilities - Identified roles of the National, Regional, LGU (Provl Health Office, Rural Health Units, Village Health Workers, other volunteers), NGOs • Regulations on QA & monitoring of Tx efficacy - Re-training of all health personnel /institutions - Established sentinel sites to conduct therapeutic efficacy studies

Current Treatment Failure Rate to CQ+SP as first-line drug >15% < 5% 6- 15% 16 - 24% > 25% COARTEM 100% Efficacy DRUG TREATMENT FAILURE RATES, Philippines, 2002

CQ+SP and Coartem™ Efficacy in Selected Study Sites Philippines, 2001-2004 Kalinga & Isabela 2004 CQ+SP 94% ACPR AL 98-100% Palawan, 1995 CQ+SP 87%ACPR 2005 on-going TES Com Val & ADS, 2001 CQ+SP 85% ACPR AL 100% ACPR 2005 on-going TES

Current Situation: Tasks at Hand: First line drug CQ+SP with 85% efficacy in some areas (interim policy until when?) Tasks at Hand: Use drugs wisely to prolong their useful lifespan - Retrain health personnel on new drug policy - Improve diagnosis, improve compliance (ST) - Train hospital-based MDs on case management Monitor drug efficacy at sentinel sites

Monitoring drug efficacy and post-marketing surveillance  Treatment response to recommended drugs being monitored in sentinel sites to detect signs of decreasing drug susceptibility  Supervised treatment and laboratory diagnosis needed to avoid misuse of drugs  Post-marketing surveillance to identify problems related to adverse reactions, stability, quality and drug efficacy

Thank you