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Background: The tip of iceberg phenomenon in Indonesia, which is related to drug abuse, is already at an alarming stage. The effects of Tramadol drug abuse are not only on the health side but on the socio-economic aspects of society as well as security and order. The POM Agency has issued Head of POM Agency Regulation No.10 Year 2019 regarding Guidelines for the Management of Certain Drugs which are often misused with the aim of protecting the public from misuse and misuse of certain drugs. PBF is a distribution company for certain drugs which is suspected to still be a gap for the distribution of certain drugs such as Tramadol. This study aims to determine the implementation of the policy of managing certain drugs which are often abused in Jakarta specifically the distribution of tramadol drugs by PBF. Subjects and Methods: This study used a qualitative approach by means of interviews and document review, this research was conducted in March to June 2020. The main informants in this study were BPOM officials, BBPOM in Jakarta, Jakarta Provincial Health Office and 6 PBF. The variables studied were the size and objectives of the policy, resources, characteristics of the implementing agency, communication between organizations, disposition of implementers, and the social, economic, political environment. Data were collected by interview and document review. Data were analyzed descriptively. Result: the implementation of policies on the management of certain drugs which are often abused in Jakarta, especially the distribution of Tramadol drugs by PBF has not been optimal. The size and objectives of the implementation policy are optimal. Resources in the form of budgets have not been allocated specifically, facilities are good, HR is not optimal in terms of numbers, Characteristics of implementing agencies in the form of relationships between organizations are not optimal and fragmentation is good, Communication between organizations namely transmission, consistency and clarity is optimal, Implementing disposition in the form of understanding , the direction of acceptance and intensity is good, and social, economic and political environmental factors have supported the implementation of the policy. Conclusion: The performance of the implementation of policies on the management of certain drugs which are often abused in the Jakarta area, in particular the distribution of Tramadol Medicines in the Regulation of the Head of POM RI Number 10 of 2019 based on the theoretical variable Van meter and Van horn approach in general has not been optimally implemented.
The challenges of drug and food control require the BPOM Technical Operation Unit (UPT) to work optimally amid limited resources. The analysis of the relative efficiency of the BPOM Technical Operation Unit in 2019 was carried out with the aim of improving the planning, budgeting, and strategic policies of BPOM to improve performance at each UPT. Calculation of relative efficiency using the DEA (Data Envelopment Analysis) method. This study uses a mixed method with a cross sectional research design. The research sample was 31 UPT BPOM that met the requirements as a DMU (Desicion Making Unit), and 10 informants for the deepening of the process that were missed in the analysis using the DEA method. First, a sensitivity analysis was conducted to determine the input and output variables that could be included in the study. The results of the sensitivity analysis, there are 3 inputs and 4 outputs that can be analyzed by the DEA method. The results of the DEA analysis showed that there were 15 efficient UPTs and 16 inefficient UPTs. The results of the deepening of the process are known that the efficient and inefficient UPT have implemented efficiency strategies well, such as saving on official travel by paying at cost, involving human resources in other fields if there is a high workload in one field, the policy of providing overtime pay is only in the field of sample testing and administration, budget optimization with budget revisions. In relation to cross-sectoral, efficient UPT implements ways to involve higher institutions so that there is awareness from related cross-sectors. In the priority program for safety food in the village and the safety food in the market, UPTs which is not efficient, simplifies the process and makes regular visits. DEA is a method of relative efficiency analysis with the concept of maximizing the ratio of output and input. The existence of a VRS (Variable return to Scale) model that has considered the process that is expected to eliminate the shortcomings contained in the calculations using the DEA method, but because the calculations are carried out mechanically, it is necessary to deepen the process to explore things that are not obtained from the calculations, especially for organizations that are involves considerable external factors
There are 714 Medical Device Distributors (PAK) that have been inspected by the Directorate of Medical Devices and Household Health Supplies (PKRT), the Ministry of Health of the Republic of Indonesia during 2016-2018 with the results of 119 PAK fulfilling the requirements for Good Distribution Medical Device Practice (CDAKB), 442 PAKs did not meet CDAKB requirements, 46 PAKs were recommended to obtain CDAKB certificates and 153 PAKs had their PAK permits revoked. This study aims to determine the performance of the implementation of Regulation of the Minister of Health Number 4 of 2014 in the Implementation of the 2019 CDAKB and the relationship between variables that influence it. This research method is qualitative, carried out from March to July 2020, through in-depth interviews with informants, observation, and document review. The results showed that in 2019 there were 386 PAKs that had monitored and evaluated the implementation of the CDAKB, of which there were 114 PAKs that had met the CDAKB requirements. Several factors that can hinder policy implementation include standards and policy targets that have not been translated into performance indicators, incentives from policy resource variables that have not been properly recorded and socialized, and characteristics of the implementing agency in terms of limited human resources and sub-optimal relations between organizations. . The researcher recommends the need to formulate regulations that contain mandatory CDAKB certification for all PAK and make the implementation of CDAKB an indicator of activities.
Tesis ini membahas gambaran pelaksanaan proses sertifikasi CPKB di Direktorat Inspeksi dan Sertifikasi Obat Tradisional, Kosmetik dan Produk Komplemen. Penelitian ini adalah penelitian kualitatif dengan teknik wawancara mendalam dan penelusuran dokumen. Hasil penelitian menyarankan agar dilakukan penambahan SDM di Seksi Sertifikasi Kosmetik sehingga dapat dibedakan antara SDM yang melayani sertifikasi CPKB dan Surat Keteangan Impor serta dilakukan pengembangan dan evaluasi SDM yang melaksanakan proses sertifikasi CPKB. Selain itu merevisi prosedur kerja sertifikasi CPKB dengan melakukan evaluasi tahapan proses sertifikasi sehingga diketahui waktu yang dibutuhkan dari setiap tahapan.
The thesis discusses the implementation of certification process of GMP Cosmetics in The Directorate Inspection and Certification of Traditional Medicines, Cosmetics and Complement Product. This research is a qualitative research by an interview and document investigation. The result of the research suggests to add human resources in the section of cosmetics certification in order to be able to differenciate between the human resources which is in charge of GMP Cosmetics certification service and import letter as well as development and evaluation of human resources which implements GMP Cosmetics certification process. Besides that, to revise the working procedure of GMP Cosmetics certification by evaluating the certification process so that the time needed in each phase is known.