“PHARMACEUTICAL PRACTICE

ASSURE SAFET AND EFFICACY OF

MEDICINE”

Disusun oleh:
SENTOT PURWANDI
Source: PhRMA adaptation based on Dimasi JA. Cost of developing a new drug. Tufts Center for the
Study of Drug Development (CSDD). R&D Cost Study Briefing; November 18, 2014.
Source:Tufts Center for the Study of Drug Development (CSDD). Cost of developing a new drug. Briefing. Boston,
Mass.: CSDD. Pubished November 2014. Accessed March 2015.
Rp 8,7 triliun Rp 15,1 triliun Rp 12,6 triliun
 BPOM

BPOM stands for Badan Pengawas Obat & Makanan,an

Indonesian Agency for Drug and Food Control. It works similarly
to the US Food and Drug Administration. It has three important
roles: legislation, standardization, and regulation of food and
drug products.
 Impurities
Impurities defined as a foreign particle that affects the purity of a substance.
Usually, impurities occurring in many pharmaceutical or medicinal preparations
may be of the following types.

• Foreign particle that bring about adverse or toxic reactions when present in
excess beyond their limits. Example: lead, heavy metals, arsenic etc.
• Impurities which may not cause toxic effects but bring about
deterioration of the activity of chemical. Example: hard soap containing
excess of water.
• Impurities that cause incompatibility of active ingredient with other
substance or which reduce the properties of active ingredient.
 Impurities

Drug substances Specifications

• Appearance
• Chemical and stereo chemical identity
• Crystalline form
• Physical properties
• pH, colour and clarity of solution
• Assay
• Impurities (Inorganic, Organic)
Ranitidine Case
September 13, 2019
Statement From:
Director - Center for Drug Evaluation and Research
Janet Woodcock M.D.
The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some
products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-
nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a
substance that could cause cancer) based on results from laboratory tests
When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA
is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that
information when it is available
The agency is working with international regulators and industry partners to determine the source of
this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any
possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing
investigation. The agency will provide more information as it becomes available
Consumers and health care professionals should report any adverse reactions with ranitidine to the
FDA’s MedWatch program to help the agency better understand the scope of the problem.
September, 26 2019]
The U.S. Food and Drug Administration is alerting health care professionals and patients to a
voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens,
Walmart, and Rite-Aid and manufactured by Apotex Corp. These medicines may contain low levels of a
nitrosamine impurity called N-nitrosodimethylamine (NDMA
This recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines. The
agency also recently alerted patients and health care professionals of Sandoz Inc.’s voluntary recall of
prescription ranitidine hydrochloride capsules due to an NDMA impurity on Sept. 23.
FDA’s actions
FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on
patients who have been taking ranitidine. Additionally, FDA recently posted a testing method, which can be
used by regulators and industry to detect nitrosamine impurities in ranitidine. FDA has asked ranitidine
manufacturers to conduct laboratory testing to examine levels of NDMA in ranitidine and to send samples
of ranitidine to the agency to be tested by our scientists.
FDA will take appropriate measures based on the results of this ongoing investigation. Some manufacturers
have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other
international regulators conduct their investigations of the NDMA impurity.
FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes
available.
[Oct, 23, 2019]
The U.S. Food and Drug Administration is releasing a second liquid chromatography-mass
spectrometry (LC- MS) method for manufacturers and regulators to detect and quantify NDMA in
ranitidine. The agency is using this method to test potential NDMA-containing ranitidine samples.
The second LC-MS method for NDMA in ranitidine uses a more widely available technology than the
first posted method. The agency is sharing the second method to provide alternatives to firms wishing
to test their drug products for NDMA.
FDA is also alerting health care professionals and patients to two voluntary recalls of ranitidine:
Dr. Reddy’s Laboratories Ltd is voluntary recalling all prescription and over-the-counter (OTC)
ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by
retailers such as Walgreens, Walmart, CVS, Target, and Kroger.
Sanofi is voluntarily recalling OTC ranitidine due to possible NDMA contamination.
VIVA – Badan Pengawas Obat dan Makanan (BPOM) baru-baru in meminta industri farmasi untuk menarik obat
ranitidin. Keputusan ini diambil lantaran produk tersebut terdeteksi mengandung cemaran N-Nitrosodimethylamine
(NDMA) yang melebihi batas ambang atau 96 nanogram.
Selain itu BPOM juga meminta industri farmasi untuk menghentikan produksi ranitidin. Hasil temuan US Food and
Drug Administration (US FDA) dan European Medicine Agency (EMA) menyatakan bahwa cemaran NDMA sendiri
bersifat karsinogenik dan memicu timbulnya kanker.
Meski demikian, Kepala BPOM, Penny K Lukito sendiri mengimbau masyarakat untuk tidak meresponnya dengan panik.
Ini karena pihak BPOM sendiri, lanjut Penny, telah melakukan langkah-langkah untuk mengatasi ketersediaan
pengobatan untuk penyakit tukak lambung dan tukak usus ada alternatif lainnya.
"Terkait risiko harus bijaksana untuk merespons dan mengartikannya, karena ada aspek konsentrasi dan lamanya
pemarana sehingga tidak perlu panik. Efek risiko jika kalau dikonsumsi dalam waktu lama," ungkap Penny saat
konferensi pers di Kantor BPOM, di Percetakan Negara, Jakarta Pusat, Jumat, 11 Oktober 2019.
Penny menjelaskan, dalam standar studi global yang dilakukan oleh US FDA obat ini baru memicu kanker bila dilakukan
selama 70 hari pemakaian. Jika tidak digunakan dalam jangka waktu tersebut, risiko karsinogenik sendiri cenderung
rendah.
TERIMA KASIH
!!!