Anti-Malaria Drug Policy Philippines Workshop on Anti-Malarial Drug Policy Implementation Review...

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)


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)


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


• 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


• Coverage:

All government (national and local) and private health facilities nationwide


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


• 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)


•• 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


- 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


- 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

Thank youThank you

Anti-Malaria Drug Policy Philippines Workshop on Anti-Malarial Drug Policy Implementation Review...

Documents

Transcript of Anti-Malaria Drug Policy Philippines Workshop on Anti-Malarial Drug Policy Implementation Review...