Transcript Anti-Malaria Drug Policy Philippines

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
Malaria Drug Policy
(DOH Administrative Order No.129-A) MCP-DOH
Date: August 23, 2002
“Previous” Drug Policy
New Drug Policy
1st line: Chloroquine
1st line: CQ+SP
2nd line: SulfadoxinePyrimethamine (SP)
3rd line: Quinine
2nd line: Artemether +
lumefantrine [Coartem™ ]
3rd line: Quinine + antibiotic (Tetracycline,
clinda, doxy, erythro)
+ Primaquine
+ Primaquine
Basis for Changing treatment policy
DRUG TREATMENT FAILURE RATES in the Philippines, 2000
Treatment Failure Rate
CQ >>> 25%
SP > 25%
> 25%
16 - 24%
25
20
6- 15%
15
10
< 5%
5
0
Grace Period
Alert Period
Action Period
Change Period
(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 antimalarial drug policy in the country.
Combination therapy becomes a more viable
alternative in improving efficacy of available
drugs.
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
SP
39
35
36
32
4
17
89% (32/36)
47% (15/35)
Laac, CV
CQ+SP
Coartem
40
40
38
36
7
0
82% (31/38)
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 DOHCenters 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%
> 25%
COARTEM
100% Efficacy
16 - 24%
25
20
6- 15%
15
10
< 5%
5
0
Grace Period
Alert Period
Action Period
Change Period
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:
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