1. 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

2. 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

3. 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.

4. 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.

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

6. 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

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

8. 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
( )
CQ % Tx F
SP % TxF
Davao N-ComVal (2000)
Agusan del Sur (97-01)
CQ > 50% Tx F
SP > 43% Tx F

9. 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.

10. 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 day Tx F Cure Rate
ADS CQ+SP % (32/36)
SP % (15/35)
Laac, CV CQ+SP % (31/38)
Coartem %
Espino et al, Preliminary report, WHO/RBM-ADS/MCP

11. 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

12. 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

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

14. 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

15. 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

16. 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)

17. 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

18. 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

19. 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

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

21. CQ+SP and Coartem™ Efficacy in Selected Study Sites Philippines, 2001-2004
Kalinga & Isabela 2004
CQ+SP % ACPR
AL %
Palawan, 1995
CQ+SP %ACPR
on-going TES
Com Val & ADS, 2001
CQ+SP % ACPR
AL % ACPR
on-going TES

22. 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

23. 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

24. Thank you