Achieving the Sustainable Development Goals (SDGs) related to the health sector depends on adequate manufacturing, regulation, planning, financing, assessment, acquisition, management, and use of pharmaceuticals. Equitable access to quality medicines has become a priority in Indonesia, considering the inequality in the availability and utilization of healthcare services across geographical regions, urban-rural and socio-economic groups, the high prices of new products, market changes, and the percentage of healthcare expenditure on medicines. Therefore, the Indonesian government has mandated several targets related to the fulfillment of medicines in the current National Medium-Term Development Plan (RPJMN) 2020-2024, namely the percentage of Community Health Centers (Puskesmas) with the availability of essential drugs.

This study is conducted to identify, explore and analysis the issue related pharmaceutical system in Ensuring Drug Provision and Access To Essential Medicine. This research used a mixed-methods approach, combining quantitative and qualitative methods that complement each other during data collection, analysis, or both. Primary data is obtained through in-depth interviews and focus group discussions (FGDs) with relevant stakeholders, while secondary data was collected from documents available at the Ministry of Health and other targeted institution databases, such as the e-catalog database. The quantitative approach captures information about the e-logistics profile for drug supply, while the qualitative approach captures information related to the research objectives. The research will also be supplemented with (a) a literature review, (b) regulatory analysis, and (c) confirmation workshops for consensus.

The selection of drugs included in the National Formulary (Fornas) reflects the rational use of drugs with safety, efficacy, and cost-effectiveness. Pharmacoeconomic and Health Technology Assessment (HTA) approaches are the basis for drug selection decision-making. These requirements fulfill the aspect of cost-effectiveness and safety, efficacy, and clinical effectiveness. The local ingredient requirement (TKDN) in drug procurement encourages using domestically-produced drugs but presents challenges in drug availability.

Accurate and hierarchical planning in the Drug Needs Plan (RKO) can promote effective national drug planning, thus avoiding the potential for national over-supply or under-supply of drugs. In addition to using consumption-based methods, the RKO needs to be combined with morbidity-based methods, and buffer stock calculations should be adjusted considering the lead time for each region. Challenges in RKO development, such as capacity, competence, motivation, workload, and the number of human resources involved, should be comprehensively addressed.

Financing is an aspect that describes how resources use to achieve the goals. From the results of the National Health Accounts for 2021 (Pusjak PDK Kemenkes, 2023), it is known that the amount of Total Pharmaceutical Expenditure (TPE) in Indonesia in 2021 will reach IDR 175.2 trillion or around 25.8% of Indonesia's Total Health Expenditures (THE). This significant expenditure is expected to support the implementation of priority program activities and the implementation of JKN. Compared to the value of e-purchasing drugs through e-catalogs in 2021, IDR 5.68 trillion, or around 3% of the total pharmaceutical spending in the same year. This indicates that e-catalogs are not always complied with as a reference or are of little interest, and many government/private agencies prefer other mechanisms in drug procurement. Suppose it is identified that spending on 40 essential medicines in all health facilities in 2021 is known to be 19.8 T or 11.3% of total pharmaceutical spending (Pusjak et al. of Health, 2023). The highest drug expenditure value was paracetamol (2.9 T), then diclofenac sodium (2.5 T), and amoxicillin (2.2 T). The most significant expenditure of 40 essential medicines was at pharmacies, which amounted to 14.7 T. Although not detailed according to the JKN scheme, the description of drug spending shows a high drug consumption pattern for infectious and non-infectious cases. Monitoring drug financing of this kind provides benefits for the Ministry of Health to observe whether the fulfillment of drug needs has been obtained and what the obstacles are.

Procurement in the E-catalog aims to ensure transparency, effectiveness, and efficiency in planning and procuring drugs, especially JKN drugs. The proportion of e-purchasing less than 30% RKO, specifically for 40 essential drugs, has decreased in the 2020-2022 period, whereas the proportion of e-purchasing 60-100% RKO has increased; this indicates certainty for the pharmaceutical industry in drug production and avoids potential losses. Determining 40 essential medicines as an indicator of the RPJMN encourages the fulfillment of drug availability. The multi-price – multi-provider policy, intended as a relaxation to prevent drug shortages, is very dependent on the capacity of health facilities to negotiate with providers. On the other hand, drug prices vary and can affect drug access.

Good Distribution Practice (GDP) as a guideline for drug distribution in Indonesia should be obeyed by Pharmaceutical Wholesalers. BPOM plays a role in issuing GDP certificates, and the Ministry of Health manages PBF e-Reports for reporting drug distribution to health facilities every three months. Regulatory support and this application should be able to monitor the drug distribution process. However, some obstacles remain, such as damaged drugs, drugs approaching expiration, long delivery times, and limited warehouse capacity.

Irrational drug use and AMR incidence in Indonesia are crucial and need serious attention. A study in 43 hospitals in Indonesia in 2017 showed that the application of clinical pharmacy standards was only around 53.5% and needed to be improved in monitoring drug levels in the blood. In addition, it was also found that a high proportion of hospitals needed to meet the standard ratio of pharmacists to beds to carry out managerial and clinical activities. Several studies evaluating the quality of antibiotic use (8 hospitals) using the Gyssens method found that 70-80% was irrational. But unfortunately, there is no nationally documented data, and there is no budget support and monitoring and evaluation related to PPAB (Guidelines for the use of Antibiotics).

Monitoring and evaluation are activities to monitor and assess the achievement of goals, interpretation and conclude the results achieved, identify obstacles, and provide feedback for future improvements. To monitor the achievement of the RPJMN indicators related to the availability of essential medicines at the Puskesmas, the Directorate General of Pharmaceuticals has built the SELENA application (Electronic System for Pharmaceutical Management and Services), which is integrated with e-money to facilitate the collection of achievement reports on the availability of 40 essential medicines at the Puskesmas. Before 2022, the Directorate General of Pharmaceuticals will manually collect reports on these indicators' achievements. The Puskesmas reports the availability of essential medicines regularly every month. The information reported describes the availability of 40 essential drug items in the form of yes or no for each drug item in each puskesmas. Meanwhile, to monitor pharmaceutical services, the Directorate General of Pharmaceutical Health has developed the SIMONA application (Information System for Monitoring and Development of Pharmaceutical Service Facilities) to collect pharmaceutical service reports from pharmaceutical services, including the presence/absence of SOP (Standard et al.), prescription services, etc. Although various applications from the Central Government are available to support monitoring and evaluation activities, they still need to be more cohesive and a burden. In overcoming these obstacles, the Ministry of Health is currently building and developing the SATU SEHAT Logistics Platform (National Digital Inventory), which will integrate all existing information systems to facilitate reporting, efficiency, and effectiveness of data management.

From the situation analysis, several recommendations are formulated as follows.

1) At the drug selection stage, which only refers to NLEM (National List of Essential Medicines), it is necessary to consider conformity criteria with FORNAS. The use of drugs in hospitals, according to FORNAS is proposed to be the basis for setting indicators for the 2024-2029 RPJMN.

2) At the planning stage, it is necessary to increase resource capacity to ensure the accuracy of RKO preparation by considering morbidity and strengthening resources (HR capacity, IT, and outreach).

3) Capacity strengthening to accelerate pharmacoeconomic and HTA decision processes, supports HTA for preventive promotive programs, and strengthen monitoring of the policy implementation based on HTA results.

4) It is necessary to strengthen the system that guarantees the availability of drugs by implementing TKDN policies and strengthening mechanisms that can encourage the use of TKDN.

5) Need to monitor irrational drug use and include it in the indicators of the 2025-2029 RPJMN.

6) In addition to information on drug availability in the monitoring and evaluation system, this needs to be supplemented with information related to drug adequacy and constraints experienced by the regions to accelerate the government's response in overcoming drug shortages.

7) Integration of the currently built Information System and acceleration of the use of SATU SEHAT and the National Digital Inventory (DIN)