Off-Label Drugs Use Regulation and Their Application in Clinical Practice
Dra. Yulia Trisna, Apt., M. Pharm.*
(dr. Cipto Mangunkusumo National Central General Hospital)
Off-label drug use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. For now, pharmaceutical and medical science have developed rather fast. There are so many drugs that have one/more indications, but, some indication of those drugs aren’t listed in BPOM/FDA. Off-label drug use can sometimes evoke negative connotations and may diminish public expectations, so as a one of medical staff, we should know more about the information, implementation, and safeness of the Off-label drugs use in hospital practice.
Update PERKA Badan POM about Drug Registration in Indonesia
Dra. Nurma Hidayati. Apt., M.Epid.*
(Board Deputy of Teurapetics & NAPZA Producs Control, The National Agency of Drug & Food Control, Republic of Indonesia)
The progress of drug’s research and development is intensively being considered as the rapid technological growth. The pharmaceutical industry is a capital-intensive and knowledge-based industry that relies on innovation ability. In a quick technological change and evolving innovation, newly invented drugs will be found which has properties more effective than ever before. Discovering new drugs requires permission from the related agents in the country to be marketed. In Indonesia, the agency of Drugs and Food called BPOM (Badan Pengawas Obat dan Makanan). Along with that issue, the procedure to get the legal license of drugs especially in Indonesia which is not known clearly by the pharmacists became one of the obstacles in the drugs’ development. Therefore, the purposes of these workshops are to explain the procedures of drugs’ registration, to know about the marketing authorization of drugs and to know the basic document to registration drugs in Indonesia.
Feasibility Study of Pharmaceutical Business Development Pathway in Indonesia
Drs. Sie Djohan, Apt.
(Business Development and Management System Director of Kalbe Farma Tbk)*
As time goes by, rapid economic growth sometimes has no impact on profitability. The most important aspect in getting the success of the business is to pull out the entire effort to get maximum profit in the result. One of the rapidly growing marketplace in Indonesia is in the medical field, especially medicine and medical devices. Considering a business opportunity in pharmacy is one of the responsibilities of a business developer.Therefore, the objective of these workshops is to explore pharmacists role in pharmacy business development in Indonesia, to deepen the knowledge of pharmacists role in Industry especially in developing pharmacy business and to be critical of pharmaceutical marketing and business issues.