Evaluasi Keagenan Bahan Aktif pada Supply Chain Perusahaan Farmasi X

Christofer Kevin Dion Tanadi, Dr. apt. T.N. Saifullah Sulaiman, S.Si., M.Si.; apt. Ulfi Astuti Adibah, S.Farm.

2023 | Skripsi | FARMASI

Munculnya kasus meninggalnya anak setelah mengonsumsi sirup parasetamol menunjukkan bahwa terdapat cemaran etilen glikol (EG) dan dietilen glikol (DEG) yang melebihi ambang batas normal sehingga mendorong Badan POM RI mewajibkan seluruh industri farmasi untuk melaksanakan kualifikasi ulang supplier bahan aktif terkait ketersediaan dokumen keagenan bahan aktif serta ketertelusuran jalur supply chain-nya yang menyebabkan terhambatnya jalur supply chain bahan aktif di industri farmasi. Penelitian ini diselenggarakan dengan tujuan untuk melihat besarnya dampak yang muncul dari kebijakan Badan POM RI terhadap supply chain bahan aktif di Perusahaan Farmasi X, serta dapat memberikan informasi mengenai kategori kontribusi supplier bahan aktif terhadap munculnya hambatan pada supply chain bahan aktif tersebut.
Penelitian ini berupa penelitian yang bersifat deskriptif kuantitatif dengan menggunakan checklist yang telah dikembangkan melalui database Masterlist Bahan Aktif Perusahaan Farmasi X per Februari 2023. Data dianalisis statistik deskriptif dengan bantuan tabel distribusi frekuensi yang didasarkan oleh jumlah bahan aktif yang tidak disertai dokumen keagenan serta data kemudian dianalisis kembali berdasarkan negara asalnya.
Hasil penelitian menunjukkan bahwa terjadinya hambatan administratif pada supply chain bahan aktif di Perusahaan Farmasi X yang mana sebanyak 61 dari 63 (98.8%) supplier dan 527 dari 684 (77.1%) bahan aktif terhambat dalam pemenuhan dokumen keagenan bahan aktif. Ditemukan 7 kategori kontribusi supplier dengan mayoritas supplier yang tidak memenuhi persyaratan terdapat pada kelas interval bahan aktif 1-11 (80.9%). Supplier bahan aktif yang tidak memenuhi persyaratan tersebut berasal dari 27 negara yang tersebar pada 4 benua.

The emergence of cases of child deaths after consuming paracetamol syrup showed that there were ethylene glycol (EG) and diethylene glycol (DEG) contaminants that exceeded the normal threshold, which prompted the Indonesian Food and Drug Administration to require the entire pharmaceutical industry to re-qualify active ingredient suppliers regarding the availability of active ingredient agency documents and traceability of the supply chain, which caused obstruction of the active ingredient supply chain in the pharmaceutical industry. This study was conducted to see the magnitude of the impact that arises from the policy of the Indonesian Food and Drug Administration on the active ingredient supply chain at Pharmaceutical Company X, and can provide information on the category of contribution of active ingredient suppliers to the emergence of obstacles in the active ingredient supply chain.
This is a quantitative descriptive research using a checklist that has been developed from the Active Ingredient Masterlist database of Pharmaceutical Company X as of February 2023. The data were analyzed by descriptive statistics methods with the help of a frequency distribution table based on the number of active ingredients that were not accompanied by agency documents and the data was re-analyzed based on the country of origin.
The results showed that administrative impediments occurred in the active ingredient supply chain at Pharmaceutical Company X, where 61 out of 63 (98.8%) and 527 out of 684 (77.1%) active ingredients suppliers were hindered in fulfilling active ingredient agency documents. There were 7 categories of supplier contribution with the majority of suppliers that did not meet the requirements were in the interval class of active ingredients 1-11 (80.9%). Suppliers of active ingredients that did not meet the requirements came from 27 countries that spread across 4 continents.

Kata Kunci : dokumen keagenan farmasi, bahan aktif, supplier, supply chain