PROGRAMME

1. Teaching
2. Research
3. Services

1.TEACHING ACTIVITIES

1.1. Medical Undergraduate Programme (S1)

Medical Undergraduate Problem-based Clinical Pharmacology Teaching
Department of Clinical Pharmacology has developed innovative approaches for undergraduate teaching on rational therapeutics for medical students. Modules have been field-tested. From the students’ comments so far, clinical pharmacology is the most enjoyable class.

A survey to measure the implementation of problem-based pharmacotherapy teaching in undergraduate medical curricula has been started. The survey aims at examining the implementation of Guide to Good Prescribing, an internationally accepted teaching model on pharmacotherapy, developed by WHO. Data collection and analysis and repor thas been completed.

Other activity in medical undergraduate programme was student participated in the 19th Asian Medical Student Conference, Kuala Lumpur, 1998. She was presenting the experiences of problem-based pharmacotherapy teaching implemented in Gadjah Mada University by the Department of Clinical Pharmacology, from the student perspectives. The Center took care some portions of her travel & accommodation expenses.

The Department also provided assistance for other medical schools to improve the quality of pharmacology/clinical pharmacology teaching for medical undergraduates. In July 10, 2003, a team from Brawijaya University, Malang visited the Department. The aims of the visit were to develop the plan of action to improve the clinical pharmacology teaching for medical undergraduates. In 16-17 July 1998, a team from Department of Pharmacology, Sriwijaya University (Palembang) visited the Department. The aims of the visit were to develop the plan of action to improve the clinical pharmacology teaching, and to develop research and activities in promoting rational drug use in the region.

1.2 Graduate Programme (S2)

The Department has currently run a master degree programme in medicines management and policy since 1996. The course is attended by health managers from public and private institutions in Indonesia.

Medicine is important component in health care, and most of the health budget has been spent on medicines. Improper medicines policy and management in a health care unit would consequently bring about some significant medical and economic. Expertise in this area is, therefore, a determinant for the success of medical care not only for the executive officers who are in charge of drug provisions but also for the health managers in determining strategies.

Higher education programmes for health care professionals, like in public health management, hospital management, health promotion, etc., are offered in many universities in Indonesia. Unfortunately, higher education programmes for drug managers in health services are still insufficient. For this purpose, this Programme offers an opportunity to achieve a Master Degree in medicines policy and management.

The Master Degree Programme in Medicines Policy and Management is an S2-level education that prepares professionals to be able to manage medicines policy at macro-level (national) and micro-level (in district health offices, public and private hospitals, or institutions), strategic management and health programmes related to medicine use. Nowadays, this expertise is highly needed in the decentralization of health care and pharmaceutical management


1.3 Course and Training

National Training Courses on:
· Drug Evaluation for New Drug Application
. Drug evaluation for New Biological Products
. Drug Evaluation for New Antidiabetics
· Drug Evaluation for New Anticancers
· Drug Evaluation for New Antihypertensives
· Clinical Research
· Pharmacokinetics and Bioavalability Studies
· Applied Statistics for Clinical Research
· Drug Management in Hospital
· Behavioral Intervention to Improve Rational Use of Drug
· Medicines and Therapeutics Information
· Public education in rational drug use
· Etc.

International Training Courses on:
· Drug Policy Issues in Developing Countries (2001)
· Promoting Rational Drug Use (1989, 1990, 1993, 2000)
· Drugs and Therapeutics Committee (2001)
· International Workshop on Proposal Development (1998)
· Southeast Asian Drug Metabolism Workshop (1996)

In service training, short term training and consultancies

The Department routinely provides short-term training course for staff of Directorate General of Drug and Food Control, Ministry of Health, researchers or staff from other institutions on clinical pharmacology and drug evaluation.
The course durations vary from 2 weeks to 5 months, depend on the topics chosen and the individual needs. Such short-term trainings have been tailored for graduate and post graduate students, researchers from other institutions, staff of Ministry of Health, WHO fellowships, fellowships from Save the Children Fund, medical and pharmacy students from famous universities in USA, Netherlands, etc.

A member of the Department was assigned by the Ministry of Health of Indonesia to develop a practical guide for pharmacists and assistant pharmacists, in providing information on medication. The activities include the development of booklet, followed by the field test of the booklet.

In collaboration with the Ministry of Health, the Department has also been involved in in-service training on rational drug use, targeted to doctors as well as paramedics. The Department have been assigned by the Ministry of Health to develop modules and practical guides to conduct public education in promoting rational drug use, to be used by health center personnel. Overuse of injection is used as a model of incorrect practice. This project was funded by the Health Project IV of the Ministry of Health (MOH), and was completed in 1998. Dissemination of the module to other provinces has been conducted in 1998.

2. RESEARCH

Clinical Research
Department of Clinical Pharmacology has been conducting phase I to III clinical research for modern drugs and traditional herbs for various indications such as post-operative pain, high-risk hypertension, antiinflammatory in rheumatoid conditions, diabetics, asthma, anxiety, etc. Department of Clinical Pharmacology applies international standard methodology and ethics, i.e., Good Clinical Research Practices (GCP) Guidelines for all researches.

Department of Clinical Pharmacology welcomes collaborations with individual researcher, research institutions, public and private health care institutions, drug regulatory authorities, and pharmaceutical industries to conduct clinical research, clinical research management, monitoring, data management, and data analysis.

Pharmacokinetics and Bioavailability Studies
Bioavailability study is a step in establishing the quality of pharmaceutical product, prior to or after marketing approval. This study aims to ascertain if a pharmaceutical product is appropriately absorbed after administration. Besides its importance in establishing the quality of conventional dosage forms of pharmaceutical products, such study is also crucial in providing the evidence of good absorption of modified formulation such as controlled-release preparations and fixed-dose combinations.

Department of Clinical Pharmacology provides services in bioavailability studies of new formulations as well as comparative bioavailability studies. An international standard methodology for phase I clinical trial, i.e., Good Clinical Research Practices Guidelines are applied to all bioavailability studies. Such study shall be completed within 3-7 months, depending on the study design and the pharmacokinetic properties of the study drug. Since 1987, Department of Clinical Pharmacology has accomplished more than 160 studies.


Pharmaceutical Management Studies
Series of activities have been developed, aimed at increasing the awareness of health managers at national, provincial, as well as district levels towards to the issues of decentralization in pharmaceutical sector. Seminar on Decentralization: Preparation of the District Health Managers was conducted in 5 May 1999, attended by provincial and district health managers, and chief pharmacists of district health offices in the region.

A study was conducted, aimed at evaluating the drug management and drug use pattern during the transition of decentralization. This project was supported by WHO-Indonesia, 1999.

Rational Use of Medicine Studies
The Department also conduct studies on improving the use of medicines, including the pharmacoeconomic aspects of medicine use. It is important to recognize that these studies were not aimed only at discovering the problems, but also aimed at improving the rational and efficient use of pharmaceuticals, and economical aspect of drug use.

Various activities on action researches have been undertaken to develop innovative problem-based educational interventions to promote rational use of drug.

A research project was funded by WHO-Indonesia, aimed at replicating the well-proven self-monitoring strategy in other healthcare setting, i.e., in other districts and in hospitals. The output of this project included indicator-based (integrated Monitoring-Training-Planning) modules, guidelines for implementation at hospital and district levels, and results of the process evaluation. Activities was started in January 1999 and completed in June 1999.

Similar activities involving 2 teaching hospitals have also been done. The objective of this program was to develop guidelines and field-test strategies to improve efficient drug utilization at hospital level, facilitated by Pharmacy and Therapeutic Committees (PTCs). Activities included preparation (team building), baseline surveys, workshop followed by activities facilitated by PTCs, and evaluation workshop.

Medicines Policy Studies
As requested by the Ministry of Health of Indonesia, a survey was conducted to evaluate the implementation of Indonesian National Drug Policy, the first evaluation since its enacting in 1983. The national survey was conducted in 1997-1998 by the Department, and was funded by WHO-DAP. The results of the evaluation was presented in a National Seminar attended by policy makers and stakeholders in July, 1998, and was taken into account in the revision of the NDP, which is currently underway. Following the survey, it was considered that serial small-surveys were needed, to monitor the availability and affordability of key drugs during monetary crisis in Indonesia. The following serial surveys were conducted in July 1998, October 1998, and February 1999, March 1999, and March 2002

Educational Studies
A survey was conducted to measure the implementation of problem-based pharmacotherapy teaching in undergraduate medical curricula in Indonesia. The survey aims at examining the implementation of Guide to Good Prescribing, an internationally accepted teaching model on pharmacotherapy, developed by WHO.

A national survey was done, to identify to what extents the principles of rational use of drugs are taught to pharmacy students. Questionnaires were sent to education managers as well as to students’ organizations in public and private schools of pharmacy in Indonesia. The results indicated that principles of rational use of drugs are taught very less at schools of pharmacy. Moreover, students practically are not exposed to national health program such as malaria, tuberculosis, diarrhea, vitamin A, etc. There are constraints to redesign the curricula, since pharmacy curricula were basically designed with majoring in technology (manufacturing, chemical analysis, quality control, etc.), not in health or public health. Some rooms for incorporation of principles of rational drug use and public health, however, have been identified.

A survey was also being done, to examine the practice of pharmacotherapy teaching in paramedical curricula. In public health facilities, paramedics usually provide treatment of illnesses and prescribe medication, while pharmacotherapy is not, if it is not very little, being taught during their formal training.


3. SERVICES

Decicion Making
. WHO Expert Committee on Essential Medicine
. WHO Expert Committee on Medicines Inducing Dependency
. National Committee for New Drug Application
. Revision of National Essential Drug List
. Revision of Askes Formulary List
. Developing National Guide on GCP for Modern Medicine
. Revision of Indonesian Pharmacopeia


Public Education
. Develop innovative strategies in improving skills in selecting appropiate medicine at grass-root level
. Information & Consultation Services on Drug and Therapeutics


Providing Expertise, Technical Assistance and Consultancy
. International consultancy on the implementation of GCP guide in clinical research
. International consultancy on setting up bioavailability testing centres
. International consultancy on developing drug registration system
. International consultancy on programmes to improve the quality use of medicines
. International consultancy on medicine policy and management
. Taskforce member to UN Secretariat for analytical work on millenium project development goals in access to essential medicines
. WHO Advisory Panel for drug management and policy
. Pre-marketing evaluation on efficay and safety of new drug registration
. Developing strategies to improve prescribing practices and the function of DTC in hospitals
. Developing strategies to improve prescribing practices in health care services at district level
. Scientific support to ISFI in developing her professional competency standard


International scientific event organizer and scientific meeting on drugs and therapeutics