Anti-Malaria Drug Anti-Malaria Drug Policy Policy Philippines Philippines Workshop on Anti-Malarial Drug Policy Implementation Review Wuxi City, Jiangsu Provincial Institute of Parasitic Diseases, P.R. China September 12 – 22, 2005
Dec 24, 2015
Anti-Malaria Drug Anti-Malaria Drug PolicyPolicy
PhilippinesPhilippines
Workshop on Anti-Malarial Drug Policy Implementation Review
Wuxi City, Jiangsu Provincial Institute of Parasitic Diseases, P.R. China
September 12 – 22, 2005
Category A Provinces• 25 Provinces• more than 1000 cases/year or situation worsened
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 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 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
Category D Provinces• 13 provinces• Malaria-free (no more indigenous cases for at least 3 years
GEOGRAPHICAL DISTRIBUTION OF MALARIA PHILIPPINES ( Based on 10-year Average, 1991 – 2000 )
GEOGRAPHICAL DISTRIBUTION OF MALARIA PHILIPPINES ( Based on 10-year Average, 1991 – 2000 )
Source: Malaria Control Program, 2000 Department of Health
Malaria Drug Policy Malaria Drug Policy (DOH Administrative Order No.129-A) MCP-(DOH Administrative Order No.129-A) MCP-
DOHDOHDate: August 23, 2002Date: August 23, 2002
““Previous” Drug PolicyPrevious” Drug Policy
1st line: Chloroquine1st line: Chloroquine
2nd line: Sulfadoxine-2nd line: Sulfadoxine-Pyrimethamine (SP)Pyrimethamine (SP)
3rd line: Quinine3rd line: Quinine
+ Primaquine+ Primaquine
New Drug PolicyNew Drug Policy
1st line: CQ+SP1st line: CQ+SP2nd line: Artemether + 2nd line: Artemether +
lumefantrine lumefantrine [[Coartem™ Coartem™ ]]
3rd line: Quinine + anti- 3rd line: Quinine + anti- biotic (Tetracycline, biotic (Tetracycline, clinda, doxy, erythro)clinda, doxy, erythro)
+ Primaquine+ Primaquine
New Drug PolicyNew Drug Policy
1st line: CQ+SP1st line: CQ+SP2nd line: Artemether + 2nd line: Artemether +
lumefantrine lumefantrine [[Coartem™ Coartem™ ]]
3rd line: Quinine + anti- 3rd line: Quinine + anti- biotic (Tetracycline, biotic (Tetracycline, clinda, doxy, erythro)clinda, doxy, erythro)
+ Primaquine+ Primaquine
Basis for Changing treatment Basis for Changing treatment policypolicy
0
5
10
15
20
25
Grace Period Alert Period Action Period Change Period
< 5%
6- 15%
16 - 24%
> 25%
DRUG TREATMENT FAILURE RATES in the Philippines, 2000
Treatment Failure Rate CQ >>> 25%
SP > 25%
(MCS, 1996-1997; Preliminary Report ENHR, 2000; ADS-MCP, 1997-2000; WHO-RBM, 2000-2001)
Chloroquine (CQ) and Sulfadoxine-Chloroquine (CQ) and Sulfadoxine-Pyrimethamine (SP) Drug Profile in Selected Pyrimethamine (SP) Drug Profile in Selected Study Sites, Philippines Study Sites, Philippines
Kal-Apayao (2000) CQ > 42% Tx F SP > 9% Tx F
Kal-Apayao (2000) CQ > 42% Tx F SP > 9% Tx F
Davao N-ComVal (2000)
Agusan del Sur (97-01)
CQ > 50% Tx F SP > 43% Tx F
Davao N-ComVal (2000)
Agusan del Sur (97-01)
CQ > 50% Tx F SP > 43% Tx F
Palawan (1994-2000)
CQ 39-76% Tx FSP 12.5-20% TxF
Palawan (1994-2000)
CQ 39-76% Tx FSP 12.5-20% TxF
This high treatment failure rates provide This high treatment failure rates provide a very strong evidence for the DOH to a very strong evidence for the DOH to immediately review & change existing immediately review & change existing anti-malarial drug policy in the country.anti-malarial drug policy in the country.
Combination therapy becomes a more Combination therapy becomes a more viable alternative in improving efficacy viable alternative in improving efficacy of available drugs.of available drugs.
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%
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%
- therapeutic efficacy surveillance done in small population to predict outcome of treatment in known drug resistant areas- therapeutic efficacy surveillance done in small population to predict outcome of treatment in known drug resistant areas
Espino et al, 2001. Preliminary report, WHO/RBM-ADS/MCPEspino et al, 2001. Preliminary report, WHO/RBM-ADS/MCP
Combination CQ+SP vs Combination CQ+SP vs CoartemCoartem™ , Agusan del ™ , Agusan del
Sur and Compostela Valley, Philippines, 2001Sur and Compostela Valley, Philippines, 2001
Malaria Drug Policy Malaria Drug Policy (A.O.129-A) MCP-DOH(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 Malaria Drug Policy (A.O.129-A) MCP-DOH(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 Malaria Drug Policy (A.O.129-A) MCP-DOH(A.O.129-A) MCP-DOH
• Coverage:
All government (national and local) and private health facilities nationwide
Malaria Drug Policy Malaria Drug Policy (A.O.129-A) MCP-DOH(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 Malaria Drug Policy (A.O.129-A) MCP-DOH(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. Components of Phil. Malaria Control Program Malaria Control Program Drug PolicyDrug Policy
• • Anti-malarial drug list according to use & guidelines for drug useAnti-malarial drug list according to use & guidelines for drug use
- Combination treatment for - Combination treatment for P. falciparum P. falciparum malariamalaria
uncomplicated: 1uncomplicated: 1stst line: CQ+SP line: CQ+SP
22ndnd line: Artemether-Lumefantrine line: Artemether-Lumefantrine
33rdrd line: Quinine + T/D line: Quinine + T/D
severe: severe: QN + T/D/ClindaQN + T/D/Clinda
+ Primaquine (single dose)+ Primaquine (single dose)
- Tx for - Tx for P. vivaxP. vivax malaria (CQ + Prima) malaria (CQ + Prima)
- Tx for mixed infection (CQ+SP+Prima)- Tx for mixed infection (CQ+SP+Prima)
- Tx for pregnant women & children <1 y.o. (QN)- Tx for pregnant women & children <1 y.o. (QN)
- chemoprophylaxis (Doxy/mefloquine)- chemoprophylaxis (Doxy/mefloquine)
• • Anti-malarial drug list according to use & guidelines for drug useAnti-malarial drug list according to use & guidelines for drug use
- Combination treatment for - Combination treatment for P. falciparum P. falciparum malariamalaria
uncomplicated: 1uncomplicated: 1stst line: CQ+SP line: CQ+SP
22ndnd line: Artemether-Lumefantrine line: Artemether-Lumefantrine
33rdrd line: Quinine + T/D line: Quinine + T/D
severe: severe: QN + T/D/ClindaQN + T/D/Clinda
+ Primaquine (single dose)+ Primaquine (single dose)
- Tx for - Tx for P. vivaxP. vivax malaria (CQ + Prima) malaria (CQ + Prima)
- Tx for mixed infection (CQ+SP+Prima)- Tx for mixed infection (CQ+SP+Prima)
- Tx for pregnant women & children <1 y.o. (QN)- Tx for pregnant women & children <1 y.o. (QN)
- chemoprophylaxis (Doxy/mefloquine)- chemoprophylaxis (Doxy/mefloquine)
Components of Phil. Components of Phil. Malaria Control Program Malaria Control Program Drug PolicyDrug Policy
•• Diagnosis (laboratory confirmation – Microscopy/RDT)Diagnosis (laboratory confirmation – Microscopy/RDT)
- QA/AS – microscopy pilot-test - QA/AS – microscopy pilot-test
- QA/AS – RDT (future plan)- QA/AS – RDT (future plan)
• • Regulations for treatment & provision of drugsRegulations for treatment & provision of drugs
- all probable & confirmed malaria using 1- all probable & confirmed malaria using 1stst line – administered by line – administered by
trained field health workerstrained field health workers
- Tx of P. falciparum & severe/complicated malaria using A-L & - Tx of P. falciparum & severe/complicated malaria using A-L &
QN+T/D – only dispensed by a physician/PHN upon lab. confirmationQN+T/D – only dispensed by a physician/PHN upon lab. confirmation
- supervised Tx (ST) shall be adopted- supervised Tx (ST) shall be adopted
- referral of patients (i.e. indications of severe malaria, pregnant - referral of patients (i.e. indications of severe malaria, pregnant
women, children < 5 y.o.) using the existing referral systemwomen, children < 5 y.o.) using the existing referral system
•• Diagnosis (laboratory confirmation – Microscopy/RDT)Diagnosis (laboratory confirmation – Microscopy/RDT)
- QA/AS – microscopy pilot-test - QA/AS – microscopy pilot-test
- QA/AS – RDT (future plan)- QA/AS – RDT (future plan)
• • Regulations for treatment & provision of drugsRegulations for treatment & provision of drugs
- all probable & confirmed malaria using 1- all probable & confirmed malaria using 1stst line – administered by line – administered by
trained field health workerstrained field health workers
- Tx of P. falciparum & severe/complicated malaria using A-L & - Tx of P. falciparum & severe/complicated malaria using A-L &
QN+T/D – only dispensed by a physician/PHN upon lab. confirmationQN+T/D – only dispensed by a physician/PHN upon lab. confirmation
- supervised Tx (ST) shall be adopted- supervised Tx (ST) shall be adopted
- referral of patients (i.e. indications of severe malaria, pregnant - referral of patients (i.e. indications of severe malaria, pregnant
women, children < 5 y.o.) using the existing referral systemwomen, children < 5 y.o.) using the existing referral system
Components of Phil. Components of Phil. Malaria Control Program Malaria Control Program Drug PolicyDrug Policy
- Tx in outbreaks emergency situation: - Tx in outbreaks emergency situation:
P. falciparumP. falciparum: A-L, + prima (ensure rapid cure w/ lowest risk of Tx failure : A-L, + prima (ensure rapid cure w/ lowest risk of Tx failure
P. vivaxP. vivax: CQ + prima: CQ + prima
• • Support Systems:Support Systems:
- Health Human Resource Dev’t: Re-training of health personnel- Health Human Resource Dev’t: Re-training of health personnel
- Logistics Mgt. System (ensure continuous supply of drugs, lab. supplies, - Logistics Mgt. System (ensure continuous supply of drugs, lab. supplies,
under/over-stocking, drug expiration, etc)under/over-stocking, drug expiration, etc)
a) provision of 1a) provision of 1stst line drugs & lab. supplies – shared responsibility of DOH- line drugs & lab. supplies – shared responsibility of DOH-
Centers for Health Devt & Local Govt UnitsCenters for Health Devt & Local Govt Units
b) Sourcing out of funds & provision of 2b) Sourcing out of funds & provision of 2ndnd & 3 & 3rdrd line drugs: Central Office, line drugs: Central Office,
DOHDOH
c )Distribution mechanism – to ensure proper allocation & availability of c )Distribution mechanism – to ensure proper allocation & availability of
drugs, suppliesdrugs, supplies
- Tx in outbreaks emergency situation: - Tx in outbreaks emergency situation:
P. falciparumP. falciparum: A-L, + prima (ensure rapid cure w/ lowest risk of Tx failure : A-L, + prima (ensure rapid cure w/ lowest risk of Tx failure
P. vivaxP. vivax: CQ + prima: CQ + prima
• • Support Systems:Support Systems:
- Health Human Resource Dev’t: Re-training of health personnel- Health Human Resource Dev’t: Re-training of health personnel
- Logistics Mgt. System (ensure continuous supply of drugs, lab. supplies, - Logistics Mgt. System (ensure continuous supply of drugs, lab. supplies,
under/over-stocking, drug expiration, etc)under/over-stocking, drug expiration, etc)
a) provision of 1a) provision of 1stst line drugs & lab. supplies – shared responsibility of DOH- line drugs & lab. supplies – shared responsibility of DOH-
Centers for Health Devt & Local Govt UnitsCenters for Health Devt & Local Govt Units
b) Sourcing out of funds & provision of 2b) Sourcing out of funds & provision of 2ndnd & 3 & 3rdrd line drugs: Central Office, line drugs: Central Office,
DOHDOH
c )Distribution mechanism – to ensure proper allocation & availability of c )Distribution mechanism – to ensure proper allocation & availability of
drugs, suppliesdrugs, supplies
Components of Phil. Components of Phil. Malaria Control Program Malaria Control Program Drug PolicyDrug Policy
- Reporting & Surveillance System - Reporting & Surveillance System
• • Roles & ResponsibilitiesRoles & Responsibilities
- Identified roles of the National, Regional, LGU (Provl - Identified roles of the National, Regional, LGU (Provl
Health Office, Rural Health Units, Village Health Workers, Health Office, Rural Health Units, Village Health Workers,
other volunteers), NGOsother volunteers), NGOs
• • Regulations on QA & monitoring of Tx efficacyRegulations on QA & monitoring of Tx efficacy
- Re-training of all health personnel /institutions- Re-training of all health personnel /institutions
- Established sentinel sites to conduct therapeutic - Established sentinel sites to conduct therapeutic
efficacy studiesefficacy studies
- Reporting & Surveillance System - Reporting & Surveillance System
• • Roles & ResponsibilitiesRoles & Responsibilities
- Identified roles of the National, Regional, LGU (Provl - Identified roles of the National, Regional, LGU (Provl
Health Office, Rural Health Units, Village Health Workers, Health Office, Rural Health Units, Village Health Workers,
other volunteers), NGOsother volunteers), NGOs
• • Regulations on QA & monitoring of Tx efficacyRegulations on QA & monitoring of Tx efficacy
- Re-training of all health personnel /institutions- Re-training of all health personnel /institutions
- Established sentinel sites to conduct therapeutic - Established sentinel sites to conduct therapeutic
efficacy studiesefficacy studies
0
5
10
15
20
25
Grace Period Alert Period Action Period Change Period
< 5%
6- 15%
16 - 24%
> 25%
DRUG TREATMENT FAILURE RATES, Philippines, 2002
Current Treatment Failure Rate to CQ+SP as first-line drug
>15%
COARTEM100% Efficacy
CQ+SP and Coartem™ CQ+SP and Coartem™ Efficacy in Selected Study Sites Efficacy in Selected Study Sites Philippines, 2001-2004Philippines, 2001-2004
Com Val & ADS, 2001
CQ+SP 85% ACPR AL 100% ACPR 2005 on-going TES
Com Val & ADS, 2001
CQ+SP 85% ACPR AL 100% ACPR 2005 on-going TES
Kalinga & Isabela 2004
CQ+SP 94% ACPR
AL 98-100%
Kalinga & Isabela 2004
CQ+SP 94% ACPR
AL 98-100%
Palawan, 1995
CQ+SP 87%ACPR
2005 on-going TES
Palawan, 1995
CQ+SP 87%ACPR
2005 on-going TES
Current Situation:Current Situation:
First line drug CQ+SP with 85% First line drug CQ+SP with 85% efficacy in some areas (interim efficacy in some areas (interim policy until when?)policy until when?)
First line drug CQ+SP with 85% First line drug CQ+SP with 85% efficacy in some areas (interim efficacy in some areas (interim policy until when?)policy until when?)
Tasks at Hand: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
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 Monitoring drug efficacy and and post-marketing post-marketing surveillancesurveillance
Treatment response to recommended drugsTreatment response to recommended drugs being monitored in sentinel sites tobeing monitored in sentinel sites to detect signs of decreasing drug detect signs of decreasing drug
susceptibilitysusceptibility
Supervised treatment and laboratory Supervised treatment and laboratory diagnosis needed to avoid misuse of drugs diagnosis needed to avoid misuse of drugs
Post-marketing surveillance to identify Post-marketing surveillance to identify problems related to adverse reactions, problems related to adverse reactions, stability, quality and drug efficacystability, quality and drug efficacy
Treatment response to recommended drugsTreatment response to recommended drugs being monitored in sentinel sites tobeing monitored in sentinel sites to detect signs of decreasing drug detect signs of decreasing drug
susceptibilitysusceptibility
Supervised treatment and laboratory Supervised treatment and laboratory diagnosis needed to avoid misuse of drugs diagnosis needed to avoid misuse of drugs
Post-marketing surveillance to identify Post-marketing surveillance to identify problems related to adverse reactions, problems related to adverse reactions, stability, quality and drug efficacystability, quality and drug efficacy