Protecting society from poor quality medicines is a formidable task for national medicine regulatory authorities, especially in a resource-limited setting such as in Indonesia. Although post-market surveillance is a routine activity for medicine regulators, each country has a different method in performing this task. To date, there are no globally recognized methods for estimating the prevalence of substandard and falsified medicines in a country, or for assessing their impact on health or the economy. With support from the UK government’s National Institute for Health
Research, the Faculty of Pharmacy at Universitas Pancasila (UP) will collaborate with Imperial College London and Erasmus School of Health Policy and Management (ESHPM) to pilot a sentinel surveillance system for medicine quality, and to develop methods for estimating the prevalence, health, and economic impact of poor quality medicines.
The concept arose from earlier research into the factors that incentivize the production, trade or consumption of falsified or substandard medicines. Substandard and falsified medicines are not distributed evenly throughout the market. Instead, they cluster around specific risk factors, which differ for substandard and for falsified medicines. Examples of risks for substandard medicines include irrationally low price, or poor product stability combined with a long distribution chain. Examples of risks for falsified medicines include demand for off-label use or availability in the unregulated supply chain.
We plan to conduct sentinel surveillance for substandard and falsified medicines in a number of
areas, and then use the resulting data as the basis for developing national estimates of the risk of substandard and falsified medicines nationwide. (The process is modeled on a similar process used to develop methods for the estimation of populations at risk for HIV, pioneered in Indonesia in 2002 and subsequently adopted as a global gold standard by the World Health Organisation). Sentinel surveillance will be conducted in up to 9 districts within 5 provinces in Indonesia. The sample collection will be conducted in collaboration and with guidance from Balai Besar POM (BBPOM), and/or Badan Pusat Statistik (BPS), and in close coordination with the local Dinas Kesehatan. The process will involve mystery shoppers who will visit selected health care facilities and pharmacies for high-risk medicines purchasing.
The medicines obtained will then transported to Jakarta for a complete compendial test according to Indonesian Pharmacopeia standards (FI) or the United States Pharmacopeia (USP). The complete compendial test comprises of testing for solid preparations, testing for semi-solid and non-sterile liquid preparations, testing for contamination, testing for sterile products, determining levels of active substances, determining the potential for antibiotics (note: if there are antibiotics among the tested products), identification of active substance type, and degradation testing. The identification of assay and type of active substance will be conducted using a spectrophotometric method or other relevant methods. To that end, we seek to involve a laboratory manager to supervise and manage the laboratory testing process throughout this study to support the estimation of the prevalence of substandard and falsified medicines.
Scope of work
The selected candidate is expected to provide the following work:
- Develop detailed laboratory testing work plan, protocol, and budget, along with
epidemiologist and program manager
- Manage laboratory logistics procurement (e.g. reference standard, equipment, etc.)
- Coordinate with external labs (BPOM or other) as necessary
- Management of records and lab documents (ISO Documents), including appropriate management of electronic reporting formats
- Conduct data validation
- Conduct data analysis
- Prepare laboratory testing report
- Support the prevalence of substandard and falsified medicines estimation (coordinate with researcher in epidemiology)
- Attend regular meeting with other researchers within the study (under the estimation of
substandard and falsified prevalence group)
- Master degree, preferably in Analytical Chemistry/ Pharmacy/equivalent experience
- At least 5 years experience in working in the area laboratory
- Familiar with chromatography and spectrophotometry analytical method
- Able to prove certified training in laboratory
- Has good communication, strategic thinking, management, and monitoring skills
- Thorough and very well organized
- Fluent in Indonesian language and has a good command of spoken English
How to Apply