|
AREA OF WORK
ESSENTIAL MEDICINES: ACCESS, QUALITY AND
RATIONAL USE 1
Country Issues and Challenges :
Indonesia's National Drug Policy is out of date, and was written before the
decentralization; therefore the policy no longer matches with the realities of
the country, notably (but not exclusively) in the field of drug supply and management.
Furthermore, the current NDP does not address the division of roles between the Ministry
of Health and the National Agency for Drug and Food Control (earlier, drug and food
control was under the Ministry). Hence, revision of the NDP will be one of the priorities for this biennium.
In addition, a number of developments at the international level will have implications
for access to medicines in Indonesia; these include notably developments with regard to
trade agreements. Yet national capacity to analyze the implications and develop appropriate
strategies to safeguard access to medicines is still limited, therefore, strengthening this
capacity will be another priority for WHO's work in Indonesia.
Expected Contribution :
- Update the National Drug Policy and support its implementation.
- Strengthen national capacity to analyze the implications of global trade agreements.
ESSENTIAL MEDICINES: ACCESS, QUALITY AND RATIONAL USE 2
Country Issues and Challenges :
Indonesia has a well-functioning agency for drug and food control, which is increasingly
used by WHO as a training institution for similar agencies in the region. Yet in order for
the Indonesian agency to be able to properly function as a partner to WHO, and as a training
institution for others, it is imperative that certain lacunas, identified during several
evaluation and assessment missions undertaken by WHO teams in the pervious biennium will be
effectively addressed. These notably relate to harmonization of standards at the global and
regional level, and the regulation of drugs produced by new technologies (such as biotechnology)
and the battle against counterfeit drugs.
Expected Contribution :
- Strengthen performance of drug regulatory authorities.
ESSENTIAL MEDICINES: ACCESS, QUALITY AND RATIONAL USE 3
Country Issues and Challenges :
The use and prescription of drugs in Indonesia is not always very rational, due to
a variety of factors, including lack of awareness and information among prescribers as
well as patients. This is aggravated, on the one hand by abundant advertising, sometimes
questionable marketing techniques, and perverse incentives for prescribers and pharmacists
to favour expensive drugs, and on the other hand, by a lack of awareness and critical
attitude among the patients/general public. Improvements in drug use, by the general public
and in hospitals therefore has the potential to significantly improve the quality of care.
Thus, improving rational use of drugs will be an important area where WHO can and should
support the country.
Certain activities aimed at improving the use of medicines will build on successful trial
projects regarding promoting public education, carried out with WHO's support in the previous biennium.
Expected Contribution :
- Improve awareness and knowledge on rational and appropriate use and prescription of drugs.
BLOOD SAFETY AND CLINICAL TECHNOLOGY
Country Issues and Challenges :
HIV/AIDS and hepatitis are recognized as major public health problems in SEAR countries
and also in Indonesia. The majority of these infections can be prevented through the provision
of safe blood. However, quality in screening for immuno-haematology and transfusion transmissible
infections has been observed to be inadequate resulting in transfusion of blood that is of
questionable quality and safety. To achieve these, a functional quality system needs to be in place.
There is need to impart training on selected areas of quality system, especially documentation,
and increase the number of participants in the national external quality assessment schemes.
Expected Contribution :
- Implementation of quality management systems for blood transfusion services.
- External quality assessment system for blood and blood products strengthened.
IVD: IMMUNIZATION AND VACCINES DEVELOPMENT 1
Country Issues and Challenges :
Indonesia began acceleration of polio eradication efforts in 1995 with the first NID,
an AFP surveillance network and three polio laboratories. Since then it has made steady progress
towards achieving the goal of polio eradication. No wild virus has been isolated in Indonesia since 1995.
Despite these impressive progress, the economic crisis that afflicted South East Asia and
Government Decentralization, had severely affected routine immunization services. In a large
country the size of Indonesia, national level data often mask provinces and districts with poor
performance. These areas are typically more remote, experiencing on-going conflict and/or facing
budgetary constraints for implementation of EPI programs. Further, even with an assumed actual OPV3
coverage of 80% and a vaccine efficacy for 3 OPV doses of 80%, only about 64% (0.8 X 0.8) of infants
in each annual birth cohort were fully protected against polio. AFP surveillance indicators were also
beginning to falter. By May 2001, the annualized non-polio AFP rate had slipped below one, to just
0.82 from 1.26 in 1998. This raised the possibility that wild virus or VDPV could potentially occur
in areas of low OPV coverage and remain undetected.
Based on this information the Technical Consultative Group (TCG) in its meeting in Myanmar
in May 2001 recommended that Indonesia conduct an NID in 2002.
Consequently, with financial and technical support from external sources, the Ministry of Health
and WHO, the Government of Indonesia conducted a successful NID on September 12th and October 9th, 2002.
This success was achieved against many odds--- relatively short lead-time for preparation, newly
launched decentralized system of government, and an uneven flow of funds to several provinces.
With an estimated target of 20.9 million children under five, they achieved a reported coverage
of 103% and 104% for the two rounds. With the deployment of 38 WHO-supported Surveillance Officers
(SO), the non polio AFP rate increased slightly to 1.23 in 2002 but again began to decline in 2003,
(99 as of Nov 2003). A joint national/international AFP surveillance review conducted in June 2003
expressed serious concern at the declining quality of surveillance and made the following key recommendations:
The surveillance structure with the network of SOs needs to be maintained at least for the
next 3-5 years. The central government should ensure that certification standard surveillance.
This would require intensified supervision and technical support to the SOs.
Measles and NT surveillance can be integrated with AFP surveillance.
Improve the skills of provincial and district surveillance staff in case investigation
and follow-up action and in the use of surveillance data for decision-making.
Assuming this improvement can be sustained, the Government may not have to undertake any
additional Supplementary Immunization Activities for polio during the next two years.
Expected Contribution :
- Achieve and maintain Indonesia as Polio Free.
IVD: IMMUNIZATION AND VACCINES DEVELOPMENT 2
Country Issues and Challenges :
Measles vaccine was introduced into EPI program in 1984. WHO SEARO estimates that there are
about 38,000 measles deaths per year in Indonesia. Indonesia has established the goal of "Universal
Childhood Immunization" (UCI); measles vaccine coverage of 80% is used as the indicator for this goal.
Since 1992, the reported measles vaccine coverage has been in the range of 85-90%, although the most
recent 2002-03 Demographic Health Survey estimates the coverage to be only 71.6% with significant
urban-rural variation (urban - 78% and rural 66%). Moreover, the proportion of villages achieving >
80% coverage has been steadily declining in recent years.
Efforts have been made to target "high-risk" villages for supplemental measles vaccination
activities. A "high-risk" village is defined as one that did not reach the UCI (<80% measles coverage)
for 3 straight years. These activities are called "crash vaccination". All children 6-59 months are
targeted for measles vaccination. In 2002, 25% of all villages were targeted for "crash" vaccination
during polio NIDs. Reported coverage in these villages was 78%, compared to near 100% for polio.
A comprehensive and long-term vaccination strategy is needed to interrupt and maintain interruption
of measles virus circulation. This strategy must include vaccination activities to markedly reduce
nd maintain low levels of measles susceptibility in both preschool-aged and school-aged children.
However, routine measles immunization remains the foundation of any sustainable measles mortality
reduction as well as for strategies of measles elimination.
To move towards measles elimination, given present levels of vaccination coverage and the current
measles epidemiology, it will be necessary to provide a second opportunity for measles immunization
to all children 9-59 months of age years of age, not only those living in high risk villages.
Quality measles surveillance is a critical component of the measles elimination strategy. GOI
plans to implement an integrated AFP, measles and NT surveillance beginning 2004 and 4 measles
laboratories are being established.
Expected Contribution :
- Adequate support provided to implement strategies a) to achieve sustainable reduction
in Measles mortality, b) to interrupt transmission in areas where measles elimination goals
have been set and c) to achieve elimination of Maternal and Neonatal Tetanus.
IVD: IMMUNIZATION AND VACCINES DEVELOPMENT 3
Country Issues and Challenges :
To ensure the quality of vaccines, Indonesia has in place a system of licensing the product
and product facilities, surveillance for the vaccine performance in field conditions and compliance
with GMP (Good Manufacturing Practices) and evaluation of clinical trial data in licensing decisions.
A competent and functioning independent National Regulatory Authority (NRA) is in place.
The quality of vaccines delivered to the children also depends on the quality of cold chain
and its management in term of storage and transport from the manufacturer up to the vaccination
session. A 2001-2002 study by PATH and MOH showed that 75% of Indonesia's vaccine might be exposed
to freezing temperature during distribution. This could affect the potency of freeze sensitive
vaccines such as HB, TT, DPT and DT. Many of the cold chain technicians currently on the job have
been working for several years and perhaps they need refresher training with updated operation
procedures/guides. Thus, the priority activities during the next two years are to have a cold chain
management assessment, revised operating procedures/manuals and refresher training of the cold chain staff.
Expected Contribution :
- Assuring Quality of Vaccines.
IVD: IMMUNIZATION AND VACCINES DEVELOPMENT 4
Country Issues and Challenges :
Indonesia has a written safe injection policy and use only AD syringes for immunization and
it promotes the use of AD syringes and disposable syringes for curative care as well. It uses
Uniject for HepB birth dose and AD syringes for the other doses using GAVI funds. However, it
has not yet adopted a national policy on the safe disposal of sharps and needles.
WHO will support initiatives to develop a national policy for the safe disposal of sharps
and needles and help implement that policy through advocacy and technical guidelines.
GOI is also implementing a system of monitoring and prompt investigation of Adverse Event
Following Immunization (AEFI).
Expected Contribution :
- Assuring Immunization Safety.
IVD: IMMUNIZATION AND VACCINES DEVELOPMENT 5
Country Issues and Challenges :
Indonesia reported 78% of districts reported 80% coverage in 2000, a drop from 90%
of districts reporting 80% coverage in 1999.
With the decentralization of funds and authority, there is a lack of clarity on the roles and
responsibilities of decision-making have largely shifted to the districts. This has had an adverse
effect on EPI and other health services due to lack of clear guidelines and lack of technical/managerial
skills among the district staff. Thus, there is an urgent need for strengthening of the managerial
and technical capacity of EPI managers at district and provincial levels. GAVI has awarded a grant
of up to $40 million for introduction of Heb B vaccination in the routine EPI and for strengthening
immunization services ($12 million).
Therefore, the objective of WHO support will be to provide adequate technical guidance on the
effective use of GAVI funds to strengthen routine EPI. The plan includes to components.
A WHO-supported full time national consultant to provide technical assistance
on the effective use of the GAVI funds.
Development of a model at district/health centre levels on the collection, analysis
and use of immunization data for decision-making and program improvement.
Expected Contribution :
- Strengthening reporting system.
|
