SYSTEM DYNAMICS MODEL FOR ENHANCE THE INDONESIAN FOOD AND DRUG AUTHORITY EFFORT TO ELIMINATE PRESCRIPTION DRUGS SALE IN UNAUTHORIZED FACILITIES: A CASE STUDY IN WEST SUMATRA PROVINCE

• Main Author: Gusrianto, Putra
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/63015
• Institution: Institut Teknologi Bandung

Indonesia has a high rate of violation of prescription drug sales by non-authorized facilities such as drug stores, retail stores, as well as by doctors and other health professionals. However, to ensure the product's safety, efficacy, and quality, the distribution and dispense of drugs must comply to all applicable laws and regulations. Thus, under current regulations, prescription drugs, psychotropics, and narcotics cannot be obtained freely. These drugs can only be obtained with a doctor's prescription and are administered by a pharmacist. Inappropriate prescription drug sales result in drug misuse and irrational use, reducing the quality of drug therapy, increasing morbidity and mortality, wasting resources, reducing drug availability, increasing costs, increasing the risk of side effects, and accelerating the emergence of antimicrobial drug resistance. Every year, Indonesia witnesses’ violations of the illegal sale of prescription drugs, particularly in the province of West Sumatra, which was sampled for this study. In 2015, 39.85% of all facilities inspected by the Provincial Office of Indonesian FDA in Padang had violations. Additionally, it decreased to 16.06 percent in 2016, but increased again the following year which from 2017 to 2020 in a row: 42.28%; 53.85%; 56.04%; and 68.35%. The impact of the COVID-19 pandemic appears to have influenced the increase in these violations, with 2020 having the highest percentage of violations over the last five years. Additionally, criminal investigations into prescription drug violation have increased in West Sumatra over the last five years. Investigators seized a total of Rp. 1,656,774,000, - worth of evidence from Provincial Office of Indonesian FDA in Padang during this time period. The problem of prescription drug sales in unauthorized facilities is extremely complex, as it involves a large number of factors/variables and parties. This presents a challenge for the Indonesian FDA’s efforts to eradicate these violations. Thus, this study applied a system dynamic approach to analyze the variables affecting the sale of prescription drugs at unauthorized facilities and then simulate scenarios based on these variables in order to generate scenarios that can be used as recommendations for reducing administrative violations and criminal offenses associated with the sale of prescription drugs. System dynamics is a way of thinking and a conceptual tool for comprehending the structure and dynamics of a complex prescription drug sales violation system in order to develop structures and strategies that increase the probability of eradicating these violations through model simulations. The study collected data through a literature review, observation, and in-depth interviews with experts. The data was then analyzed using PESTEL and the System Thinking framework through the Rich Picture Diagrams (RPD). Additionally, a system dynamic model is developed by defining the model's boundaries, identifying variables, and designing causal loops and stock and flow diagrams. To accommodate the simulation, scenario configuration and model validation are performed. Finally, the simulation results are analyzed and summarized in order to make recommendations and propose solutions to the problem. The variables that influence the violation of prescription drug sales in unauthorized facilities in West Sumatra Province have been identified through a system dynamic model, namely 31 variables from factors: public perception and knowledge, responsibilities of pharmacists and other health workers, and law enforcement. While the modeling simulation of ten scenarios demonstrates that the pharmacist's responsibility is a significant factor. Each scenario involving these variables has a beneficial effect on lowering the ratio and total number of violations, increasing the ratio of pharmacy compliance, and increasing the index of deterrent effect. Thus, the most effective strategy for eradicating these violations is to increase public perception and knowledge, pharmacists' and other health workers' responsibilities, and law enforcement.